INFECTION PREVENTION AND

CONTROL ESSENTIALS FOR

AMBULATORY
CARE
A RESOURCE
WORKBOOK
Table of Contents

Acknowledgements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

MODULE 1: Infection Preventionist’s Role in Ambulatory Care . . . . . . . . 4

MODULE 2: Infection Prevention & Control Plan/Risk Assessments . . . 11

MODULE 3: Infection Prevention & Control Basics . . . . . . . . . . . . . . . . . . . 78

MODULE 4: Epidemiology & Infectious Diseases . . . . . . . . . . . . . . . . . . . 117

MODULE 5: Occupational-Employee Health . . . . . . . . . . . . . . . . . . . . . . . . 118

MODULE 6: Construction & Water Management . . . . . . . . . . . . . . . . . . . . 127

MODULE 7: Environmental Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

MODULE 8: Cleaning/Disinfection/Sterilization . . . . . . . . . . . . . . . . . . . . . 156

2
Acknowledgements
Development of this Workbook required input and expertise from a team of subject matter
experts who selected and organized the materials from a range of facilities and other resources.
The Association for Professionals in Infection Control and Epidemiology acknowledges the
valuable contributions from the following individuals:

Contributors

Judie Bringhurst, RN, MSN, CIC

Infection Preventionist and Instrument Reprocessing Specialist
University of North Carolina Hospitals
Chapel Hill, NC

Pamela S. Falk, MPH, CIC, FAPIC, FSHEA

Epidemiologist
Northside Hospital
Sandy Springs, GA

Carolyn Kiefer, BSN, RN, CIC

Infection Preventionist
Carilion Medical Center
Roanoke, VA

Carol McLay, DrPH, MPH, RN, CIC, FAPIC

CEO
Infection Control International
Lexington, KY

Sara Townsend, MS, HQS, CIC, FAPIC

Infection Prevention Manager
Children’s Hospital of Philadelphia
Philadelphia, PA

Project Management

Elizabeth M.R. Hartke

Director, Practice Resources
Association for Professionals in Infection Control and Epidemiology

Elizabeth Garman
Vice President, Communications and Practice Resources
Association for Professionals in Infection Control and Epidemiology

Groff Creative
Cover Design, Text Design and Layout
Silver Spring, MD

3
Module 1

Infection Preventionist’s Role in

Ambulatory Care

Contents
1.1 Emerging Models of Ambulatory Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Constance Cutler, RN, MS, CIC, FSHEA, FAPIC; Jill Lindmair-Snell, MSN, RN, CIC, FAPIC,
and Brian Dennen, MBA, AIA, NCARB
Prevention Strategist, Winter 2018, p.56-60
https://apic.org/publication_types/prevention-strategist/

1.2 Infection Control Compliance Rounding Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

Forms & Checklists for Infection Prevention, Volume 1

Resources
Infection Preventionist Competency Model
Association for Professionals in Infection Control and Epidemiology (APIC)
https://apic.org/professional-practice/infection-preventionist-ip-competency-model/

One and Only Campaign

Centers for Disease Control and Prevention (CDC)
https://www.cdc.gov/injectionsafety/1anonly.html

Bloodborne Pathogen and Needlestick Prevention

Occupational Safety and Health Administration (OSHA)
https://www.osha.gov/SLTC/bloodbornepathogens/gen_guidance.html

Healthcare-Associated Infections in Outpatient Settings

CDC
https://www.cdc.gov/hai/settings/outpatient/outpatient-settings.html

4
1.1
FEATURE

Emerging models of
ambulatory care
BY CONSTANCE CUTLER, RN, MS, CIC, FSHEA, FAPIC, Healthcare data show increasing shifts
JILL LINDMAIR-SNELL, MSN, RN, CIC, FAPIC, AND from inpatient to outpatient care.1 Figure 1
BRIAN DENNEN, MBA, AIA, NCARB
illustrates this trend, which is predicted to

I
continue into at least the next 10 years. As
t used to be that an infection preventionist (IP) was responsible healthcare facilities compete on value not
for only one location, usually a hospital, but now they have more volume, there are six market forces driving
than one outpatient venue because of acquisitions and mergers. this change (Figure 2):1
1. Compression
Those days are coming to an end as healthcare evolves in new ways 2. Care management
with many outpatient facilities now under the IP’s umbrella. If your 3. Contraction
facility is similar to the authors’, you may have an outpatient pain 4. Consolidation
clinic, cancer care center, immediate/urgent care facility(ies), owned 5. Consumerism
6. Connectivity
physician offices, offsite endoscopy procedure site, and an ambula- There is also a change in all specialties for
tory surgery center, as well as others. All provide new opportunities which patients will be treated as outpatients,
and challenges, which this article will address to give you an idea ranging from a slight increase (5.6 per-
how to start and what resources are able to assist you. cent) in colorectal patients to a substantial
MARK WINFREY/SHUTTERSTOCK.COM

56 | WINTER 2018 | Prevention

5
increase (44.4 percent) in hematology oncol-
ogy patients.1 Studies show that revenue
derived from outpatients is rising dramati-
cally, as compared to inpatient revenue.2
Outpatient ophthalmology and colorec-
tal surgeons’ offices have also been impli-
cated in disease transmission, as shown in
these headlines (Figure 3) that show some
occurrences, including a shocking one
where anal catheters were reused in 2018.
Now that the stage is set for our shift-
ing focus as IPs, we can prepare to take
on these new arenas. To start, do your
research on historic outbreaks when care
Figure 1. Increasing shift to outpatient care. Adapted from Truven Market Expert. 2017-2027 Total US Market.1
was mostly provided to inpatients.

PATIENT-TO-PATIENT
TRANSMISSION
As recently as the 1970s, outpatient
hemodialysis centers saw clusters of cases
of both hepatitis B and C occurring at their
free-standing centers. These were addressed
by recommendations from the Centers for
Disease Control and Prevention (CDC) and
other agencies to do blood testing and use
separate cleaning protocols and machines
on known positive patients. Thankfully, in
recent years the numbers of these blood- Figure 2. Six types of market forces. Adapted from Truven Market Expert. 2017-2027 Total US Market.1
borne pathogens in dialysis patients have
decreased with improved oversight by both
dialysis personnel and IPs. Dialysis cen-
ter issues haven’t completely disappeared,
though. An article reviewing hepatitis B
virus (HBV) in dialysis centers summarized
several outbreaks that occurred from 1992
through 2014. There were 16 outbreaks
that involved 118 patients on maintenance
dialysis; 10 fatal cases occurred; multiple
deficiencies in standard or hemodialysis-
specific procedures was the most common
route of patient-to-patient transmission
Figure 3. Infection prevention headlines. Adapted from Truven Market Expert. 2017-2027 Total US Market.1
of HBV.3
A survey of clinicians found that
12 percent of physicians and 3 percent of
nurses indicated syringe reuse occurs in
their workplace.4 This, along with other
WHAT CAN AN IP DO?
surprising and depressing results, led the • Review what kind of issues have occurred in the past and with what frequency.
CDC to develop the “One Needle, One • Make the business case that it is “potentially” scary out there but that regular
Syringe, One Time” Campaign. visits from a qualified IP can mitigate the real risks.
• Go out and see for yourself what’s actually happening, focusing first on the
AMBULATORY SURGICAL riskiest areas:
CENTERS - Those performing sterilization of instruments.
An assessment performed by the Centers - Those doing high-level disinfection.
for Medicare & Medicaid Services (CMS) - The others “just” providing routine patient care such as using syringes.
of ambulatory surgical centers (ASCs)

w w w.apic.org | 57
6
FEATURE

Figure 4. Summary of ASC pilot survey findings. Adapted from Truven Market Expert. 2017-2027 Total US Market.1

showed that practices in those increas- surveyor in evaluating healthcare practices make sure the ASC is prepared for a regula-
ingly prevalent areas also pose infection during an onsite visit.10 The surveyor will tory visit any time. In addition to the work-
prevention risks, leading to a specialization observe at least one surgical procedure and sheet, the IP should establish and maintain
in ASCs for IPs.5 The actual pilot survey follow a patient from registration through an environmental rounding program. A
is summarized in Figure 4. discharge.10 The ICSW will be used to multi-disciplinary team can examine the
ASCs pose unique challenges and an obtain details about the facility includ- center for potential patient safety and
IP may take on responsibility for them, ing the types of procedures performed, infection prevention concerns. The team
specializing in them. The concept of hav- number of procedural rooms, types of should observe medication administra-
ing surgery and going home on the same contracted or employed services, hand tion in all areas: aseptic technique, surgi-
day started in 1970, when two physicians hygiene, medication practices, cleaning cal procedures, cleaning of patient care
opened the first freestanding ASC in and reprocessing of reusable medical items, reprocessing of medical equipment
Phoenix.6 Surgery in an ASC offers patients devices, environmental cleaning, point of including transporting, decontaminating,
a cost-effective and convenient alternative care testing, and the infection prevention and sterilizing of surgical instruments.
to surgery in a hospital setting. As of 2017, program.10 The surveyor will interview or Observing these practices can assist the
there were approximately 5,500 Medicare- perform observations to acquire enough IP in creating a prioritized risk assessment
certified ASCs in the United States.7 The information to complete the worksheet; to develop a successful IPC program plan.
shift continues from inpatient to outpa- however, if a breach in IPC practices is
tient as CMS adds to the 3,500 procedures noted, the breach will be documented.10 MICROHOSPITAL
approved for payment in an ASC.6 Surgeries Infection prevention has become more Microhospitals, sometimes known as
that were typically scheduled in hospital important as the number of complex sur- neighborhood hospitals, are an emerging
operating rooms are being performed in gical procedures that are performed in model of care delivery. Components of
ASCs. In January 2018, CMS no longer ambulatory settings increases. If the IP a microhospital typically include 8-12
required total knee replacement surgery to has not previously worked in a periopera- emergency department rooms, a similar
be performed only in an inpatient setting.8 tive setting, they may not feel comfortable count of inpatient beds, and limited diag-
Since CMS reimburses for surgical pro- with the environment. It is vital for the IP nostics; they often incorporate procedural
cedures, there is an expectation that ASCs to inquire and learn about all processes and medical office space as well (Figure 5).
follow CMS’s Conditions for Coverage within the ASC. Additionally, to be effec- The characteristics of some health systems
(CfC). In 2009, CMS enhanced the CfC tive, the IP must develop relationships with that have built microhospitals can be seen
by adding specific requirements for an IPC anesthesia providers, surgeons, surgical in Figure 6. These facilities are typically
program in an ASC.9 The ASC infection techs, nursing, sterile processing, environ- located in suburban and exurban areas and
control surveyor worksheet (ICSW) is an mental services, facilities, nursing, and are predominantly in states without certif-
18-page document that assists the CMS leadership. The IP can use the ICWS to icate-of-need regulations. Many facilities

58 | WINTER 2018 | Prevention

7
share resources, including IPs, with their
parent organization.

HOSPITAL AT HOME
Another concept which is taking hold
is called “hospital at home.” My 90-year-
old mother may benefit from this in the
near future because she travels to and
from physician visits, and an inpatient stay
could become unnecessary if this becomes
more prevalent. I know she would prefer
to receive care this way. These “hospital at
home” programs provide hospital-level care Figure 5. Components of aa microhospital. Adapted from Truven Market Expert. 2017-2027 Total US Market.1
and monitoring and lead to quick recovery
at a lower cost. To take part in this concept,
a patient would be “admitted” from the
emergency department and transported
home by ambulance, then met there by a ST. VINCENT
nurse with equipment who would provide (Indianapolis)
daily physical rounding.11

METHODOLOGY ST. LUKE’S

HEALTH SYSTEM
The decisions of healthcare networks to (Kansas City)
move care outside the four walls of the hos-
pital are strategic to increase market share BAYLOR SCOTT
or locations in far-flung areas. The strate- & WHITE HEALTH
gies shown in Figure 7 display the method- (Dallas)
ical approach health systems follow.
An article published in the American
Journal of Infection Control describes a Figure 6. Health systems with microhospitals. Adapted from Truven Market Expert. 2017-2027 Total US Market.1

Figure 7. Methodical approach to health systems. Adapted from Truven Market Expert. 2017-2027 Total US Market.1

w w w.apic.org | 59
8
FEATURE

I do have, because patients do not always centers, physician practices, and other health-
understand the definition of surgical site care clients on engagements ranging from broad
infections or other HAIs, is if the agency strategic visioning to focused operational initia-
includes the following question in its sur- tives. He has a Master of Business Administration
vey of outpatient and ambulatory surgery from Northwestern University’s Kellogg School of
centers: “At any time after leaving the facil- Management and a Bachelor of Architecture from
ity, did you have any signs of infection?” Iowa State University; he is a licensed architect in
READ MORE ABOUT There’s no need to reinvent the wheel, Illinois and a member of the National Council of
just educate yourself by attending courses Architectural Registration Boards.
AMBULATORY CARE IN THE especially designed with a focus on ambu-
AMERICAN JOURNAL OF latory surgery centers or other outpatient
References
1. Truven Market Expert. 2017-2027 Total US Market.
INFECTION CONTROL venues. The basic principles haven’t Accessed September 2018.
2. American Hospital Association. Trendwatch Chartbook
Health care worker hand contamination at changed though. If it’s necessary to do 2016: Trends Affecting Hospitals and Health Systems.
critical moments in outpatient care set- for safe inpatient care, it’s necessary to do https://www.aha.org/system/files/research/reports/
tw/chartbook/2016/2016chartbook.pdf. Published
tings. Bingham J, Abell G, Kienast L, et al. Am for safe outpatient care. 2016. Accessed September 2018.
J Infect Control, Vol. 44, Issue 11, p1198–1202. In conclusion, movement of care is hap- 3. Fabrizi F, Dixit V, Messa P, Martin P. Transmission of hepati-
pening and will continue to occur in health tis B virus in dialysis units: a systematic review of reports on
outbreaks. Int J Artif Organs, 2015;38(1):1-7. doi:10.5301/
Safe Injection Practices: Opportunities for systems and hospitals from inpatient to ijao.5000376.
Improvement in Ambulatory Care. Kuznets outpatient venues. My hope is that the IP 4. Kossover-Smith RA, Coutts K, Hatfield KM. One needle,
one syringe, only one time? A survey of physician and nurse
N, Lerner B, Davidson J. Am J Infect Control, will embrace this change and understand knowledge, attitudes, and practices around injection safety.
Vol. 46, Issue 6, S4–S5. and be able to use the information and Am J Infect Control, doi.org/10.1016/j.ajic.2017.04.292.
Published June 2017. Accessed June 2018.
A pragmatic approach to infection preven- resources provided in this article to survive 5. Schaefer MK, Jhung M, Dahl M, et al. Infection control
tion and control guidelines in an ambula- and thrive in this new world of outpatient assessment of ambulatory surgical centers. JAMA, 2010;
303(22):2273-9. doi: 10.1001/jama.2010.744.
tory care setting. Ng J, Le-Abuyen S, Mosley and ambulatory healthcare.
6. Ambulatory Surgery Center Association. Ambulatory
J, et al. Am J Infect Control, Vol. 42, Issue 6, Surgery Centers: A Positive Trend in HealthCare. Published
Jill Lindmair-Snell, MSN, CIC, FAPIC, is a October 2011.
p671–673. 7. Rechtoris, M. 51 Things to Know About the ASC Industry.
system infection prevention manager for Advocate Becker’s ASC Review. https://www.beckersasc.com/
Aurora Health where she is responsible for acute asc-turnarounds-ideas-to-improve-performance/50-
things-to-know-about-the-asc-industry-2017.html.
systematic approach to determine how a care and ambulatory surgery centers. Jill has more Published February 2017. Accessed September 2018.
healthcare system has changed, or would than 25 years of healthcare experience, with the 8. 2018 Final ASC Medicare Payment Rule Released.
need to change, the staffing models for last 11 years in infection prevention and control. Ambulatory Surgery Center Association website. https://
www.ascassociation.org/aboutus/latestnews/news-
IPs and support staff required to build and She has a Master of Science in Nursing from the archive/newsarchive2017/latestnews112017/2017
sustain effective IPC programs.12 University of Phoenix. 11finalrule2018. Published November 2017. Accessed
September 2018.
The challenges may seem insurmount- 9. Temple, M. Chapter 64: Ambulatory Surgery Centers. In:
able, especially to a novice IP, but doing Constance Cutler, RN, MS, CIC, FSHEA, Grota P, ed. APIC Text Online. APIC 2018.
10. Ambulatory Surgery Center Infection Control
your homework and making the business FAPIC, spent 37 years as a hospital/healthcare Surveyor Worksheet. Center for Medicare &
case for increased resources are good first system-based infection preventionist, and is now Medicaid Services website. https://www.cms.gov/
Medicare/Provider-Enrollment-and-Certification/
steps. Physically going to see these outpa- a consultant for Chicago Infection Control, Inc. SurveyCertificationGenInfo/Downloads/Survey-and-
tient/ambulatory facilities is the key, and She has worked in both large and small hospi- Cert-Letter-15-43.pdf. 2015.
prioritization based on a risk assessment of tals, many with extensive networks of outpatient/ 11. Healthcare solutions: Hospital at home. Johns Hopkins
University website. https://www.johnshopkinssolutions.
infection transmission will assist in break- ambulatory sites. Connie is a former treasurer com/solution/hospital-at-home/. Accessed October
ing this down into manageable steps. and board member on the Certification Board 2018.
12. Bartles R, Dickson A, Oluwatomiwa B. A systemic approach
It’s possible to survive and thrive because of Infection Control and Epidemiology, and past to quantifying infection prevention staffing and coverage
of growing needs for IPC expertise in the president of the Chicago Metropolitan Chapter of needs. Am J Infect Control, 2018;46(5):487-91.
current and future healthcare environ- APIC. She has a Bachelor of Science in Nursing 13. CDC Outpatient Settings Policy Options for Improving
Infection Prevention. The Joint Commission website.
ment. So, what resources does the IP have from Creighton University, a bachelor’s in biol- https://www.jointcommission.org/cdc_outpa-
when facing shifting focus from inpatient ogy from Villanova University, and a master’s in tient_settings_policy_options_for_improving_infec-
tion_prevention.aspx. Accessed September 2018.
to outpatient? Fortunately, there are many, biology from Drexel University. Additional resources
with more coming out from a variety of The Environment of Care and Healthcare-Associated Infections.
(published by ASHE)
sources all the time. Brian Dennen, MBA, is a director with Ankura’s
Guidelines for Design and Construction (published by Facility
These areas are all surveyed by accred- Healthcare Capital Asset Strategy team. He has Guidelines Institute).
iting agencies, and even accrediting bod- served in senior positions in healthcare admin- OSHA Bloodborne Pathogens and Needlestick Prevention
Standard
ies such as The Joint Commission have istration and in project management of major
CDC’s Guidelines Library: https://www.cdc.gov/infection-
developed, and are developing, publica- capital initiatives. Brian works with national control/guidelines/index.html
tions to assist the IP.13 A potential concern and regional health systems, academic medical CDC’s Injection Safety: https://www.cdc.gov/injectionsafety/

60 | WINTER 2018 | Prevention

9
1.2
6-3. Infection Control Compliance
Rounding Checklist
Compliance Rounding Check List: Infection Control

Date:

Location:

Individual(s) performing Compliance Rounds:

Other individuals present:

YES NO N/A Action Plan Owner

Patient rooms appear clean and sanitary; free from clutter and visible debris.

Alcohol based hand rubs (ABHR) near point of use, in working order, not
located over electrical outlets/switches and not expired. Soap dispenser and
towels available near sinks.

Disposable gloves and other PPE located conventient to areas of use.

Dated supplies within expiration dates.

Sharps containers less than 3/4 full and located near point of use.

Clean equipment is stored in clean area, dirty equipment in designated soiled

holding areas (i.e. soiled utility rooms).

Soiled linen is located in contained hampers/bags and not overfilled.

Area free from visible dust including fire sprinkler heads and vent grills.

Patient contact surfaces are disinfected between patients.

Overhead lights free from visible insects, dust and debris.

Floors coverings appear to be well maintained in halls and public areas.

Floor finish appears to be well maintained in patient rooms, visibly clean.

Patient equipment cleaned and disinfected between each patient use.

Ice machine exterior comonents visibly clean upon inspection.

Refrigerators clean, maintained per policy.

Eye wash stations visibly clean, maintained per policy.

EVS closets clean, orderly. Floor sink cleaned on regular basis.

Reference
Debbie Hurst, RN, BSN, CHESP, CIC

10
Module 2

Infection Prevention & Control Plan/

Risk Assessments

Contents
2.1 Ambulatory Care Suite of Quick Observation Infection Prevention Tools . . . . . . . . . . . . . . 13
Centers for Disease Control and Prevention (CDC)
https://www.cdc.gov/infectioncontrol/pdf/QUOTS/Ambulatory-Care-Suite-P.pdf

2.2 Tuberculosis (TB) Risk Assessment Worksheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

CDC, Division of Tuberculosis Elimination

2.3 Risk Assessment for Infection Surveillance, Prevention and Control Programs
in Ambulatory Healthcare Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

2.4 IPC Assessment Tool for Outpatient Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

CDC/HHS

2.5 A pragmatic approach to IPC guidelines in an ambulatory care setting . . . . . . . . . . . . . . . 72

Jessica Ng, MSc, CIC; Sheila Le-Abuyen, MPH, CPHI(C); Jane Mosley, MScN, RN;
Michael Gardam, MD, MSc, CM, FRCPC, CIC
American Journal of Infection Control, June 2014 Vol 42, Issue 6, p. 671-673
https://www.ajicjournal.org/article/S0196-6553(14)00127-8/fulltext

2.6 Infection Prevention in a System of Ambulatory Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75

Sandy Smith
Prevention Strategist, Fall 2019, p. 49-50
https://rise.apic.org/web/apic/publications/issue.aspx?issueId=prevention_strategist_-_
fall_2019&issueTitle=Prevention%20Strategist%E2%80%94Fall%202019

Resources
Outpatient Settings Policy Options for Improving Infection Prevention
CDC
https://www.cdc.gov/hai/pdfs/prevent/Outpatient-Settings-Policy-Options.pdf

Infection Prevention Observation Tools Library

Association for Professionals in Infection Control and Epidemiology (APIC)
http://ipcobservationtools.site.apic.org/observation-tools-library

Tuberculosis Control in Healthcare Settings

CDC
https://www.cdc.gov/tb/topic/infectioncontrol/TBhealthCareSettings.htm

11
Tuberculosis Centers of Excellence
CDC
https://www.cdc.gov/tb/education/tb_coe/default.htm

State Tuberculosis Resources

CDC
https://www.cdc.gov/tb/links/tboffices.htm

National Tuberculosis Controllers Association

http://www.tbcontrollers.org

Find TB Resources
https://findtbresources.cdc.gov

Tuberculosis Screening, Testing, and Treatment of U.S. Health Care Personnel:

Recommendations from the National Tuberculosis Controllers Association and CDC, 2019
Lynn E. Sosa, MD; Gibril J. Njie, MPH; Mark N. Lobato, MD; et al.
Morbidity and Mortality Weekly Report
May 17, 2019; 68(19); 439-443
https://www.cdc.gov/mmwr/volumes/68/wr/mm6819a3.htm?s_cid=mm6819a3_w

12
 Standard Precautions: Observation of Hand Hygiene
AMB-1
Provision of Supplies
2.1
Instructions: Observe patient care areas or areas outside of patient rooms. For each category, record the observation. In the column on the right,
sum (across) the total number of “Yes” and the total number of observations (“Yes” + “No”). Sum all categories (down) for overall performance.

Room Room Room Room Room Summary of Observations

Standard Precautions: Observation Categories
1 2 3 4 5
Yes Total Observed

Are functioning sinks readily  Yes  Yes  Yes  Yes  Yes

1 accessible in the patient care area?  No  No  No  No  No

Are all handwashing supplies, such  Yes  Yes  Yes  Yes  Yes
2 as soap and paper towels, available?  No  No  No  No  No

 Yes  Yes  Yes  Yes  Yes

13
3 Is the sink area clean and dry?
 No  No  No  No  No

Are any clean patient care supplies

 Yes  Yes  Yes  Yes  Yes
4 on the counter within a splash-zone
 No  No  No  No  No
of the sink?
Are signs promoting hand hygiene  Yes  Yes  Yes  Yes  Yes
5 displayed in the area?  No  No  No  No  No

Are alcohol dispensers readily  Yes  Yes  Yes  Yes  Yes

6 accessible?  No  No  No  No  No

Are alcohol dispensers filled and  Yes  Yes  Yes  Yes  Yes
7 working properly?  No  No  No  No  No

Total YES and TOTAL OBSERVED

 Standard Precautions: Observation of Hand Hygiene AMB-1
Provision of Supplies

Date:______________

Observer Role:  Nurse  Tech  Other__________ Initials:______

Location/Unit:____________

14
Notes and comments:
 Standard Precautions: Observation of AMB-2
Personal Protective Equipment Provision
Instructions: Observe patient care areas or areas outside of patient rooms. For each category, record the observation. In the column on the right,
sum (across) the total number of “Yes” and the total number of observations (“Yes” + “No”). Sum all categories (down) for overall performance.

Room Room Room Room Room Summary of Observations

Standard Precautions: Observation Categories
1 2 3 4 5
Yes Total Observed

Are gloves readily available

 Yes  Yes  Yes  Yes  Yes
1 outside each patient room or
 No  No  No  No  No
any point of care?
Are cover gowns readily
 Yes  Yes  Yes  Yes  Yes
2 available near each patient
 No  No  No  No  No
room or point of care?

15
Is eye protection (face shields or
goggles) readily available near  Yes  Yes  Yes  Yes  Yes
3 each patient room or point of  No  No  No  No  No
care?
Are face masks readily available
 Yes  Yes  Yes  Yes  Yes
4 near each patient room or point
 No  No  No  No  No
of care?
Are alcohol dispensers readily  Yes  Yes  Yes  Yes  Yes
5 accessible and functioning?  No  No  No  No  No

Total YES and TOTAL OBSERVED

 Standard Precautions: Observation of AMB-2
Personal Protective Equipment Provision

Date:______________

Observer Role:  Nurse  Tech  Other__________ Initials:______

Location/Unit:____________

16
Notes and comments:
 Isolation: Observation of Area Exterior to Contact Isolation Rooms AMB-3
Instructions: Observe areas outside of isolation rooms. Observe each practice and record the observation. In the column on the right, sum (across) the total number
of “Yes” and the total number of observations (“Yes” + “No”). Sum all categories (down) for overall performance. Disregard not applicable categories. For example,
cover gowns should be outside contact precautions rooms, but may not be required outside a room with airborne isolation precautions only.

Summary of Observations
Room Room Room
Isolation room: Observation Categories
1 2 3 Total
Yes
“Yes”& “No”

 Yes  Yes  Yes

1 Is an isolation sign at the patient’s door?
 No  No  No

 Yes  Yes  Yes

Are gloves available outside of each patient room
2  No  No  No
or treatment area?  N/A  N/A  N/A

17
Are cover gowns available near each patient room  Yes  Yes  Yes
3 or treatment area?  No  No  No

Is other PPE for standard precautions (e.g., eye  Yes  Yes  Yes
4 protection, face masks) available near each patient  No  No  No
room or treatment area?  N/A  N/A  N/A

 Yes  Yes  Yes

Are surgical face masks or face shields or N95
5  No  No  No
respirators available near patient room?  N/A  N/A  N/A

Is dedicated patient equipment, such as stethoscopes  Yes  Yes  Yes

6 or blood pressure cuffs, available?  No  No  No

TOTAL (Do not include N/A in totals)

 Isolation: Observation of Area Exterior to Isolation Rooms AMB-3

Date:______________

Observer Role:  Nurse  Tech  Other__________ Initials:______

Location/Unit:____________

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Notes and comments:
 Isolation: Observation of Area Exterior to Airborne
AMB-4
Infection Isolation Rooms
Instructions: If there are any patients requiring Airborne Infection Isolation on unit, observe area outside of each isolation room. Observe each practice and
record the observation. In the column on the right, sum (across) the total number of “Yes” and the total number of observations (“Yes” + “No”). Sum all
categories (down) for overall performance.

Room Room Room Summary of Observations

Isolation room: Observation Categories
1 2 3
Yes Total Observed

Is an Airborne Infection Isolation sign at the  Yes  Yes  Yes

1 patient’s door?  No  No  No

 Yes  Yes  Yes

2 Is the door to the room closed?
 No  No  No

Does a manometer or other measurement

19
 Yes  Yes  Yes
3 mechanism indicate negative pressure in the
 No  No  No
room?
Are appropriate respirators, (N-95) in multiple sizes
 Yes  Yes  Yes
4 and/or charged, powered air purifying respirators
 No  No  No
(PAPR), available?
Are respirators stored outside the room or in an  Yes  Yes  Yes
5 anteroom?  No  No  No

Total YES and TOTAL OBSERVED

 Isolation: Observation of Area Exterior to
AMB-4
Airborne Infection Isolation Rooms

Date:______________

Observer Role:  Nurse  Tech  Other__________ Initials:______

Location/Unit:____________

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Notes and comments:
 Standard Precautions: Observation of Needlestick Prevention AMB-5
and Care of Laundry
Instructions: Observe patient care areas or areas outside of patient rooms. For each category, record the observation. In the column on the right,
sum (across) the total number of “Yes” and the total number of observations (“Yes” + “No”). Sum all categories (down) for overall performance.

Room/ Room/ Room/ Room/ Room/ Summary of

Standard Precautions: Observation Categories Area Area Area Area Area Observations
1 2 3 4 5 Yes Total Observed

 Yes  Yes  Yes  Yes  Yes

1 Are sharps containers available?
 No  No  No  No  No

Are sharps containers properly  Yes  Yes  Yes  Yes  Yes

2 secured and not full?  No  No  No  No  No

Are sharps containers positioned  Yes  Yes  Yes  Yes  Yes

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3 at 52” to 56” above floor?  No  No  No  No  No

Are hampers for soiled laundry  Yes  Yes  Yes  Yes  Yes
4 labeled or color-coded?  No  No  No  No  No

Are clean linen supplies spatially

separated from soiled areas or  Yes  Yes  Yes  Yes  Yes
5 waste and covered or contained  No  No  No  No  No
within a cabinet?

Total YES and TOTAL OBSERVED

 Standard Precautions: Observation of Needlestick Prevention AMB-5
and Care of Laundry

Date:______________

Observer Role:  Nurse  Tech  Other__________ Initials:______

Location/Unit:____________

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Notes and comments:
 Injection Safety: Observation of Centralized Medication Area AMB-6

Instructions: Observe medication preparation area. For each category, record the observation. Observe each practice below and answer Yes, No, or N/A.
Sum all Yes and No responses. Divide by sum of “Yes”+”No”. Disregard not applicable categories.

Medication preparation room: Observation Categories

If multi-dose injectable medications are present, is the medication container

1  Yes  No  N/A
maintained in a dedicated medication preparation space?
Is the medication preparation area free of opened single dose vials or opened
2  Yes  No
single use containers?
If open multi-dose vials are present, are they dated and within the Beyond Use
3  Yes  No  N/A
Date (BUD) and the manufacturer’s expiration period?

23
Medications are prepared in a clean area free from contamination or contact with
4  Yes  No
blood, body fluids, or contaminated equipment.
Are splash guards installed at sinks that are located close to medication prep
5  Yes  No
areas?
6 Are sinks readily accessible to healthcare providers?  Yes  No

7 Are hand washing supplies, such as soap, and paper towels, available?  Yes  No

8 Are alcohol dispensers readily available, filled, and functioning properly?  Yes  No

TOTAL (Total YES and No Only)

 Injection Safety: Observation of Centralized Medication Area AMB-6

Date:______________

Observer Role:  Nurse  Tech  Other__________ Initials:______

Location/Unit:____________

24
Notes and comments:
 Cough Courtesy: Waiting Room AMB-7

Instructions: Observe the ambulatory care point of care testing area. For each category, record the observation. Sum all Yes and No responses.
Divide by sum of “Yes” + ”No”.

Summary of
Ambulatory Waiting Room: Observation Categories
Observations

As patients first register for care, is there visible signage instructing them to alert the staff
1  Yes  No
of a respiratory infection?
Are face masks and tissues readily available for patients and visitors with respiratory or
2  Yes  No
flu-like symptoms?

3 Are hand hygiene supplies readily available to visitors in the waiting room?  Yes  No

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4 Are trash receptacles readily available to visitors in the waiting room?  Yes  No

TOTAL
 Cough Courtesy: Waiting Room AMB-7

Date:______________

Observer Role:  Nurse  Tech  Other__________ Initials:______

Location/Unit:____________

26
Notes and comments:
 Environment of Care: Vaccine Storage Areas AMB-8

Instructions: Observe vaccine storage area. For each category, record the observation. Sum all Yes and No responses.
Divide by sum of “Yes” + ”No”.

Summary of
Vaccine Storage Area: Observation Categories
Observations

Are vaccine storage refrigerator and freezer temperatures within the appropriate ranges
1  Yes  No
(Refrigerator: 2° C to 8° C; 36° F to 46° Freezer: -50° C to -15° C; -58° F to +5° F)?

2 Are vaccine storage refrigerator and freezer temperatures recorded twice daily?  Yes  No

Are safeguards, such as self-closing hinges and door alarms, in place to ensure that the
3  Yes  No

27
refrigerator/freezer doors remain closed.

4 Are refrigerator/freezer door gaskets clean?  Yes  No

Are vaccines stored in the center of the refrigerator and freezer spaces, in the original packaging,
5  Yes  No
and inside designated storage trays?

6 Are drinks and food absent from the refrigerator/freezer?  Yes  No

TOTAL
 Environment of Care: Vaccine Storage Areas AMB-8

Date:______________

Observer Role:  Nurse  Tech  Other__________ Initials:______

Location/Unit:____________

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Notes and comments:
 Injection Safety: Point of Care Testing AMB-9

Instructions: Observe the ambulatory care point of care testing area. For each category, record the observation. Sum all Yes and No responses.
Divide by sum of “Yes” + ”No”.

Patient Care Area: Observation Categories Summary of Observations

1 Are sharps containers properly secured and not full?  Yes  No

2 Are sharps containers available at the point of use?  Yes  No

Are cleaning and disinfection supplies for examination tables and test surfaces readily
3  Yes  No
available?

29
4 Is a new single-use auto-disabling lancing device used for each patient?  Yes  No  N/A

Are all point of care testing devices being disinfected after each use with an EPA-
5  Yes  No
registered product that is consistent with manufacturer instructions for use?

6 Is the required personal protective equipment for disinfectant use readily available?  Yes  No

TOTAL
 Injection Safety: Point of Care Testing AMB-9

Date:______________

Observer Role:  Nurse  Tech  Other__________ Initials:______

Location/Unit:____________

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Notes and comments:
2.2
09/27/2006 Centers for Disease Control and Prevention
Division of Tuberculosis Elimination

Appendix B. Tuberculosis (TB) risk assessment worksheet

This model worksheet should be considered for use in performing TB risk assessments for health-
care facilities and nontraditional facility-based settings. Facilities with more than one type of setting
will need to apply this table to each setting.

Scoring √ or Y = Yes X or N = No NA = Not Applicable

1. Incidence of TB
What is the incidence of TB in your community (county or region served by Community rate_______
the health-care setting), and how does it compare with the state and national State rate ____________
average? What is the incidence of TB in your facility and specific settings National rate _________
and how do those rates compare? (Incidence is the number of TB cases in Facility rate __________
your community the previous year. A rate of TB cases per 100,000 persons Department 1 rate _______
should be obtained for comparison.)* This information can be obtained from Department 2 rate _______
the state or local health department. Department 3 rate _______
Are patients with suspected or confirmed TB disease encountered in your Yes No
setting (inpatient and outpatient)?
If yes, how many patients with suspected and confirmed TB disease are Year No. patients
treated in your health-care setting in 1 year (inpatient and outpatient)? Suspected Confirmed
Review laboratory data, infection-control records, and databases containing 1 year ago _____ _____
discharge diagnoses. 2 years ago _____ _____
5 years ago _____ _____
If no, does your health-care setting have a plan for the triage of patients with Yes No
suspected or confirmed TB disease?
Currently, does your health-care setting have a cluster of persons with Yes No
confirmed TB disease that might be a result of ongoing transmission of
Mycobacterium tuberculosis within your setting (inpatient and outpatient)?

2. Risk Classification
Inpatient settings
How many inpatient beds are in your inpatient setting?
How many patients with TB disease are encountered in the inpatient setting in 1 Previous year ______
year? Review laboratory data, infection-control records, and databases 5 years ago ______
containing discharge diagnoses.
Depending on the number of beds and TB patients encountered in 1 year, what ο Low risk
is the risk classification for your inpatient setting? (See Appendix C.) ο Medium risk
ο Potential ongoing
transmission
Does your health-care setting have a plan for the triage of patients with Yes No
suspected or confirmed TB disease?
Outpatient settings
How many TB patients are evaluated at your outpatient setting in 1 year? Previous year ______
Review laboratory data, infection-control records, and databases containing 5 years ago ______
discharge diagnoses.
Is your health-care setting a TB clinic? Yes No
(If yes, a classification of at least medium risk is recommended.)
Does evidence exist that a high incidence of TB disease has been observed in Yes No
the community that the health-care setting serves?
Does evidence exist of person-to-person transmission of M. tuberculosis in the Yes No
health-care setting? (Use information from case reports. Determine if any
tuberculin skin test [TST] or blood assay for M. tuberculosis [BAMT]
conversions have occurred among health-care workers [HCWs]).
Does evidence exist that ongoing or unresolved health-care–associated Yes No

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transmission has occurred in the health-care setting (based on case reports)?

Is there a high incidence of immunocompromised patients or HCWs in the Yes No
health-care setting?
Have patients with drug-resistant TB disease been encountered in your health- Yes No
care setting within the previous 5 years? Year ________
When was the first time a risk classification was done for your health-care
setting? __________________
Considering the items above, would your health-care setting need a higher risk Yes No
classification?
Depending on the number of TB patients evaluated in 1 year, what is the risk ο Low risk
classification for your outpatient setting? (See Appendix C) ο Medium risk
ο Potential ongoing
transmission
Does your health-care setting have a plan for the triage of patients with Yes No
suspected or confirmed TB disease?
Nontraditional facility-based settings
How many TB patients are encountered at your setting in 1 year? Previous year ______
5 years ago ______
Does evidence exist that a high incidence of TB disease has been observed in Yes No
the community that the setting serves?
Does evidence exist of person-to-person transmission of M. tuberculosis in the Yes No
setting?
Have any recent TST or BAMT conversions occurred among staff or clients? Yes No

Is there a high incidence of immunocompromised patients or HCWs in the Yes No

setting?
Have patients with drug-resistant TB disease been encountered in your health- Yes No
care setting within the previous 5 years? Year ________
When was the first time a risk classification was done for your setting?
Considering the items above, would your setting require a higher risk Yes No
classification?
Does your setting have a plan for the triage of patients with suspected or Yes No
confirmed TB disease?
Depending on the number of patients with TB disease who are encountered in a ο Low risk
nontraditional setting in 1 year, what is the risk classification for your setting? ο Medium risk
(See Appendix C) ο Potential ongoing
transmission

3. Screening of HCWs for M. tuberculosis Infection

Does the health-care setting have a TB screening program Yes No
for HCWs?
If yes, which HCWs are included in the TB screening ο Janitorial staff
program? (Check all that apply.) ο Maintenance or engineering staff
ο Physicians ο Transportation staff
ο Mid-level practitioners (nurse practitioners [NP] and ο Dietary staff
physician’s assistants [PA]) ο Receptionists
ο Nurses ο Trainees and students
ο Administrators ο Volunteers
ο Laboratory workers ο Others_________________
ο Respiratory therapists

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ο Physical therapists
ο Contract staff
ο Construction or renovation workers
ο Service workers
Is baseline skin testing performed with two-step TST for HCWs? Yes No

Is baseline testing performed with QFT or other BAMT for HCWs? Yes No

How frequently are HCWs tested for M. tuberculosis infection?

Are the M. tuberculosis infection test records maintained for HCWs? Yes No

Where are the M. tuberculosis infection test records for

HCWs maintained? Who maintains the records?

If the setting has a serial TB screening program for HCWs to test for M. tuberculosis infection, what are the
conversion rates for the previous years? †
1 year ago _________________ 4 years ago _________________
2 years ago _________________ 5 years ago _________________
3 years ago _________________
Has the test conversion rate for M. tuberculosis infection been ο Increasing
increasing or decreasing, or has it remained the same over the ο Decreasing
previous 5 years? (check one) ο No change

Do any areas of the health-care setting (e.g., waiting rooms or Yes No

clinics) or any group of HCWs (e.g., lab workers, emergency If yes, list _________________________
department staff, respiratory therapists, and HCWs who _________________________________
attend bronchoscopies) have a test conversion rate for M. _________________________________
tuberculosis infection that exceeds the health-care setting’s
annual average?
For HCWs who have positive test results for M. tuberculosis Yes No Not applicable
infection and who leave employment at the health setting, are
efforts made to communicate test results and recommend
follow-up of latent TB infection (LTBI) treatment with the
local health department or their primary physician?

4. TB Infection-Control Program
Does the health-care setting have a written TB infection-control plan? Yes No
Who is responsible for the infection-control program?
When was the TB infection-control plan first written?
When was the TB infection-control plan last reviewed or updated?
Does the written infection-control plan need to be updated based on the timing of Yes No
the previous update (i.e., >1 year, changing TB epidemiology of the community or
setting, the occurrence of a TB outbreak, change in state or local TB policy, or
other factors related to a change in risk for transmission of M. tuberculosis)?
Does the health-care setting have an infection-control committee (or another Yes No
committee with infection control responsibilities)?
If yes, which groups are represented on the infection-control
committee? (Check all that apply.) ο Laboratory personnel
ο Physicians ο Health and safety staff
ο Nurses ο Administrator
ο Epidemiologists ο Risk assessment
ο Engineers ο Quality control (QC)
ο Pharmacists ο Others (specify)_________
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If no, what committee is responsible for infection control in

the setting?

5. Implementation of TB Infection-Control Plan Based on Review by Infection-Control Committee

Has a person been designated to be responsible for Yes No
implementing an infection-control plan in your health-care
setting? If yes, list the name: _________________________
Based on a review of the medical records, what is the average number of days for the following:
• Presentation of patient until collection of specimen _____
• Specimen collection until receipt by laboratory _____
• Receipt of specimen by laboratory until smear results are provided to health-care provider _____
• Diagnosis until initiation of standard antituberculosis treatment _____
• Receipt of specimen by laboratory until culture results are provided to health-care provider _____
• Receipt of specimen by laboratory until drug-susceptibility results are provided to
health-care provider _____
• Receipt of drug-susceptibility results until adjustment of antituberculosis treatment,
if indicated _____
• Admission of patient to hospital until placement in airborne infection isolation (AII) _____
Through what means (e.g., review of TST or BAMT
conversion rates, patient medical records, and time analysis)
are lapses in infection control recognized?
What mechanisms are in place to correct lapses in infection
control?
Based on measurement in routine QC exercises, is the Yes No
infection-control plan being properly implemented?
Is ongoing training and education regarding TB infection- Yes No
control practices provided for HCWs?

6. Laboratory Processing of TB-Related Specimens, Tests, and Results Based on Laboratory Review
Which of the following tests are either conducted in-house at your health- In-house Sent out
care setting’s laboratory or sent out to a reference laboratory?
Acid-fast bacilli (AFB) smears
Culture using liquid media (e.g., Bactec and MB-BacT)
Culture using solid media
Drug-susceptibility testing
Nucleic acid amplification (NAA) testing
What is the usual transport time for specimens to reach the laboratory for the following tests?
AFB smears ___________
Culture using liquid media (e.g., Bactec, MB-BacT) ___________
Culture using solid media ___________
Drug-susceptibility testing ___________
Other (specify) ___________
NAA testing ___________
Does the laboratory at your health-care setting or the reference laboratory Yes No
used by your health-care setting report AFB smear results for all patients ______________________
within 24 hours of receipt of specimen? What is the procedure for ______________________
weekends?

7. Environmental Controls
Which environmental controls are in place in your health-care setting? (Check all that apply and describe)

Environmental control Description

ο AII rooms _____________________

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ο Local exhaust ventilation (enclosing devices and exterior devices) _____________________

ο General ventilation (e.g., single-pass system, recirculation system.) _____________________
ο Air-cleaning methods (e.g., high-efficiency particulate air [HEPA] filtration and ultraviolet germicidal
irradiation [UVGI]) ___________________________________________________________
What are the actual air changes per hour (ACH) and design for various rooms in the setting?

Room ACH Design

_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________
_____________________________________________________________________________________

Which of the following local exterior or enclosing devices such as exhaust ventilation devices are used in
your health-care setting? (Check all that apply)
ο Laboratory hoods
ο Booths for sputum induction
ο Tents or hoods for enclosing patient or procedure
What general ventilation systems are used in your health-care setting? (Check all that apply)
ο Single-pass system
ο Variable air volume (VAV)
ο Constant air volume (CAV)
ο Recirculation system
ο Other____________________
What air-cleaning methods are used in your health-care setting? (Check all that apply)
HEPA filtration
ο Fixed room-air recirculation systems
ο Portable room-air recirculation systems
UVGI
ο Duct irradiation
ο Upper-air irradiation
ο Portable room-air cleaners
How many AII rooms are in the health-care setting?
What ventilation methods are used for AII rooms? (Check all that apply)
Primary (general ventilation):
ο Single-pass heating, ventilating, and air conditioning (HVAC)
ο Recirculating HVAC systems

Secondary (methods to increase equivalent ACH):

ο Fixed room recirculating units
ο HEPA filtration
ο UVGI
ο Other (specify) _________________

Does your health-care setting employ, have access to, or collaborate with an Yes No
environmental engineer (e.g., professional engineer) or other professional with
appropriate expertise (e.g., certified industrial hygienist) for consultation on design
specifications, installation, maintenance, and evaluation of environmental controls?
Are environmental controls regularly checked and maintained with results recorded in Yes No
maintenance logs?
Are AII rooms checked daily for negative pressure when in use? Yes No
Is the directional airflow in AII rooms checked daily when in use with smoke tubes or Yes No
visual checks?

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Are these results readily available? Yes No

What procedures are in place if the AII room ______________________________________
pressure is not negative?
Do AII rooms meet the recommended pressure differential of 0.01-inch water column Yes No
negative to surrounding structures?

8. Respiratory-Protection Program
Does your health-care setting have a written respiratory-protection program? Yes No
Which HCWs are included in the respiratory ο Janitorial staff
protection program? (Check all that apply) ο Maintenance or engineering staff
ο Physicians ο Transportation staff
ο Mid-level practitioners (NPs and PAs) ο Dietary staff
ο Nurses ο Students
ο Administrators ο Others (specify)_________________
ο Laboratory personnel _______________________________
ο Contract staff _______________________________
ο Construction or renovation staff _______________________________
ο Service personnel _______________________________

Are respirators used in this setting for HCWs working with TB patients? If yes, include manufacturer,
model, and specific application (e.g., ABC model 1234 for bronchoscopy and DEF model 5678 for routine
contact with infectious TB patients).
Manufacturer Model Specific application
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________
______________________________________________________________________________________

Is annual respiratory-protection training for HCWs performed by a person with advanced Yes No
training in respiratory protection?
Does your health-care setting provide initial fit testing for HCWs? Yes No
If yes, when is it conducted? ____________________________
Does your health-care setting provide periodic fit testing for HCWs? Yes No
If yes, when and how frequently is it conducted? ____________________________
What method of fit testing is used? Describe.
______________________________________________________________________________________
______________________________________________________________________________________

Is qualitative fit testing used? Yes No

Is quantitative fit testing used? Yes No

9. Reassessment of TB risk
How frequently is the TB risk assessment conducted or updated in the health-care
setting?
When was the last TB risk assessment conducted?
What problems were identified during the previous TB risk assessment?
1) ______________________________________________________________________________
____________________________________________________________________________
2) _____________________________________________________________________________
_____________________________________________________________________________
3) _____________________________________________________________________________
_____________________________________________________________________________

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4) _____________________________________________________________________________
_____________________________________________________________________________
5) _____________________________________________________________________________
_____________________________________________________________________________
What actions were taken to address the problems identified during the previous TB risk assessment?
1) ______________________________________________________________________________
____________________________________________________________________________
2) _____________________________________________________________________________
_____________________________________________________________________________
3) _____________________________________________________________________________
_____________________________________________________________________________
4) _____________________________________________________________________________
_____________________________________________________________________________
5) _____________________________________________________________________________
_____________________________________________________________________________

Did the risk classification need to be revised as a result of the last TB risk assessment? Yes No
* If the population served by the health-care facility is not representative of the community in which the
facility is located, an alternate comparison population might be appropriate.
†
Test conversion rate is calculated by dividing the number of conversions among HCWs by the number of
HCWs who were tested and had prior negative results during a certain period (see Supplement,
Surveillance and Detection of M. tuberculosis infections in Health-Care Settings).

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2.3
Risk Assessment for Infection Surveillance, Prevention and Control Programs
in Ambulatory Healthcare Settings

Explanation of Risk Assessment Tool and the Template for a

Risk Assessment Report
This Risk Assessment tool, beginning on page 43, can be used to conduct a facility risk assess-
ment for acquiring and transmitting infections in a variety of ambulatory healthcare settings.
The results of the risk assessment can then be reported using the accompanying template for a
Risk Assessment Report (beginning on page 40). The findings of the risk assessment should
be used to provide information about where an organization should focus its infection
surveillance, prevention and control activities.

A facility risk assessment is conducted by identifying and reviewing potential risk factors for
infection related to the care, treatment, and services provided and to the environment of care
in a specific healthcare setting. The identified risks of greatest importance and urgency are
then selected and prioritized. Based on these identified risks, facility personnel should
develop the organization’s Infection Surveillance, Prevention and Control (ISPC) Plan (i.e.,
an action plan).

The ISPC Plan should include a goal for reducing the risk of infection associated with each of
these identified risks, a measurable objective for each goal, and evidence based strategies for
meeting each of these objectives. The Plan should also identify the personnel responsible for
implementing the strategies and include mechanisms for evaluating the effectiveness of meet-
ing the ISPC Plan’s objectives.

Assessment Process
1. Convene a team to conduct the risk assessment.

2. Identify potential risk factors in each of the following categories:

• Community and populations served
• Potential for specific infection
• Treatment and care practices
• Instrument and medical device cleaning, disinfection and handling
• Environment of care
• Emergency management
• Others identified by the organization

3. Assess and score each potential risk factor based on the following:
a. Potential impact of the event/condition on patients and personnel, determined by
evaluating the potential for patient illness, injury, infection, death, need for admission
to an inpatient facility; the potential for personnel illness, injury, infection, shortage;
potential to impact the organization’s ability to function/remain open; and degree of
clinical and financial impact.

38
 b. Probability of the event/condition occurring determined by evaluating the risk of the
potential threat actually occurring. Information regarding historical data, infection
surveillance data, the scope of services provided by the facility, and the environment of
the surrounding area (topography, interstate roads, chemical plants, railroad, ports, etc.)
are considered when determining this score.
c. Organization’s preparedness to deal with the event/condition determined by consider-
ing policies and procedures already in place, staff experience and response to actual
situations, and available services and equipment.

4. After risk scores are assigned in the three assessment groups, total the numbers in each
group to provide a numerical risk level for each event/ condition.

5. Rank the events/conditions from the highest to lowest score in the table provided. Select
the risks with the highest scores for priority focus for developing the annual ISPC Plan.
NOTE: Some events/conditions with a lower score may be selected because they are an
accreditation or regulatory requirement.

The risk assessment and ISPC Plan should be reviewed and approved by the organization’s
quality assurance and performance improvement committee (or other designated committee).
The risk assessment and ISPC Plan should be reviewed annually (and sooner if circumstances
change).

39
 Cover Page for Risk Assessment Report

Risk Assessment Report for Infection Surveillance, Prevention and Control

(ISPC) Program

Year: 20__

Organization Name: ________________________________

Date of Report: __________________

Overview
A facility risk assessment for acquiring and transmitting infections should be conducted annu-
ally in each healthcare facility. [Note: An annual risk assessment is required for organizations
accredited by The Joint Commission and other accreditation organizations.] The risk assess-
ment provides a foundation for the Infection Surveillance, Prevention and Control Program
because it is used is used to provide information about where an organization should focus its
infection surveillance, prevention and control activities.

This facility risk assessment was conducted by identifying and reviewing potential risk factors
for infection related to the care, treatment, and services provided and to the environment of
care in a specific healthcare setting. The identified risks of greatest importance and urgency
were selected and prioritized and are noted below. Based on these identified risks, facility
personnel will develop the organization’s Infection Surveillance, Prevention and Control (ISPC)
Plan (i.e., an action plan, with goals and measurable objectives.)

The ISPC Plan includes a goal for reducing the risk of infection associated with each of the
prioritized risks, a measurable objective for each goal, and evidence based strategies for
meeting each of these objectives. The Plan also (1) identifies the personnel responsible for
developing the Plan and implementing the ISPC Program strategies and (2) includes mecha-
nisms for evaluating the effectiveness of the meeting the ISPC Program’s objectives.

Assessment Tool
An organizational Infection Risk Assessment tool (below) was reviewed and adapted for use by
(Organization name) by the following personnel:

______________________________________________________________________________

The Risk Assessment tool was used to identify potential infection risk factors in each of the
following categories:
• Community and populations served
• Potential for specific infection

40
• Treatment and care practices
• Instrument and medical device cleaning, disinfection and handling
• Environment of care
• Emergency management
• Others identified by the organization

Process
The following personnel conducted the risk assessment:

______________________________________________________________________________

The group identified, assessed and scored each potential risk factor based on the following:
1. Potential impact of the event/condition on patients and personnel, determined by evaluat-
ing the potential for patient illness, injury, infection, death, need for admission to an inpatient
facility; the potential for personnel illness, injury, infection, shortage; potential to impact the
organization’s ability to function/remain open; and degree of clinical and financial impact.
2. Probability of the event/condition occurring, determined by evaluating the risk of the
potential threat actually occurring. Information regarding historical data, infection surveil-
lance data, the scope of services provided by the facility, the environment of the surround-
ing area (topography, interstate roads, chemical plants, railroad, ports, etc.), and health
department data, are considered when determining this score.
3. Organization’s preparedness to deal with the event/condition, determined by considering
policies and procedures already in place, staff experience and response to actual situations,
and available services and equipment.

Ranking of Scores
After risk scores are assigned in the three assessment groups, the numbers in each group were
totaled to provide a numerical risk level for each event/condition. The numerical risk level can
range from 0 (lowest vulnerability) to 9 (highest vulnerability). The risk factors (i.e., events/
conditions) were then ranked from highest to lowest risk level in the table below. The risks with
the highest scores will be used for priority focus for developing the annual ISPC Plan. NOTE:
Some events/conditions with a lower score may be selected because they are an accreditation
or regulatory requirement, or can be quickly and easily implemented.

41
Distribution of Risk Assessment
The Risk assessment was shared with others, such as the ____________________, to solicit
comments. The original group evaluated and incorporated the comments, as needed, and
finalized this risk assessment. The risk assessment will be taken to the (governing body)
______________ and the ______________Committee for final approvals before the Infection
Surveillance, Prevention and Control Plan is developed. After final approval of the risk assess-
ment findings, the ISPC Plan will be developed by __________with periodic reports back to the
____________Committee until the Plan has been fully implemented.

Results
A numerical risk level of 9 is identified as the highest perceived potential risk.

Event or Condition Score

42
 Risk Assessment for the Infection Surveillance, Prevention and Control (ISPC) Program
Year: 20___
Organization Name: ________________________________
Date of Report: __________________

What is potential impact What is probability of What is organization’s

Numerical
Event or Condition of event/condition on event/condition preparedness to deal with
risk level
patients and staff? occurring? this event/condition?
High Med Low None High Med Low None None Poor Fair Good
Total
(3) (2) (1) (0) (3) (2) (1) (0) (3) (2) (1) (0)

COMMUNITY & POPULATIONS SERVED:

43
EMERGING INFECTIOUS DISEASE

POTENTIAL FOR SPECIFIC INFECTION:

Page 6 of 12
 What is potential impact What is probability of What is organization’s
Numerical
Event or Condition of event/condition on event/condition preparedness to deal with
risk level
patients and staff? occurring? this event/condition?
High Med Low None High Med Low None None Poor Fair Good
Total
(3) (2) (1) (0) (3) (2) (1) (0) (3) (2) (1) (0)

CARE PRACTICES:

44
Page 7 of 12
 What is potential impact What is probability of What is organization’s
Numerical
Event or Condition of event/condition on event/condition preparedness to deal with
risk level
patients and staff? occurring? this event/condition?
High Med Low None High Med Low None None Poor Fair Good
Total
(3) (2) (1) (0) (3) (2) (1) (0) (3) (2) (1) (0)

INSTRUMENT & MEDICAL DEVICE CLEANING, DISINFECTION & HANDLING

45
Page 8 of 12
 What is potential impact What is probability of What is organization’s
Numerical
Event or Condition of event/condition on event/condition preparedness to deal with
risk level
patients and staff? occurring? this event/condition?
High Med Low None High Med Low None None Poor Fair Good
Total
(3) (2) (1) (0) (3) (2) (1) (0) (3) (2) (1) (0)

ENVIRONMENT OF CARE:

46
Page 9 of 12
 What is potential impact What is probability of What is organization’s
Numerical
Event or Condition of event/condition on event/condition preparedness to deal with
risk level
patients and staff? occurring? this event/condition?
High Med Low None High Med Low None None Poor Fair Good
Total
(3) (2) (1) (0) (3) (2) (1) (0) (3) (2) (1) (0)

EMERGENCY MANAGEMENT:

OTHER:

47
1. Potential impact of the event/condition on patients and personnel: determined by evaluating the potential for patient illness, injury, infection, death, need for admission to
an inpatient facility; the potential for personnel illness, injury, infection, shortage; potential to impact the organization’s ability to function/remain open; and degree of clinical
and financial impact.
2. Probability of the event/condition occurring: determined by evaluating the risk of the potential threat actually occurring. Information regarding historical data, infection
surveillance data, the scope of services provided by the facility, and the environment of the surrounding area (topography, interstate roads, chemical plants, railroad, ports,
etc.) are considered when determining this score.
3. Organization’s preparedness to deal with the event/condition: determined by considering policies and procedures already in place, staff experience and response to actual
situations, and available services and equipment.

Developed by: K. Arias, M. Patrick, K. Delahanty and S. Odachowski

Page 10 of 12
 GOALS AND OBJECTIVES

OBJECTIVE
RISK EVENT/ CONDITION GOAL (measurable, includes
timeframe for completion)

48
Page 11 of 12
 RISK EVENT/ OBJECTIVE
GOAL (measurable, includes STRATEGIES IMPLEMENTATION
CONDITION timeframe for completion)
Respon-
Method for Evaluating
sible
Person(s) Effectiveness

49
Page 12 of 12
2.4 Infection Prevention and Control Assessment Tool for Outpatient Settings

This tool is intended to assist in the assessment of infection control programs and practices in outpatient settings. In
order to complete the assessment, direct observation of infection control practices will be necessary. To facilitate the
assessment, health departments are encouraged to share this tool with facilities in advance of their visit.

Please note, Not Applicable should only be checked if the element or domain is not applicable to the types of services
provided by the facility (e.g., the facility never performs point-of-care testing, controlled substances are never kept at
the facility). If a particular service is provided by the facility but is unable to be observed during the visit (e.g., no
injections were prepared or administered during the visit) that section should still be completed by interviewing relevant
personnel about their practices.

Overview

Section 1: Facility Demographics

Section 2: Infection Control Program and Infrastructure

Section 3: Direct Observation of Facility Practices

Section 4: Infection Control Guidelines and Other Resources

Infection Control Domains for Gap Assessment

I. Infection Control Program and Infrastructure

II. Infection Control Training and Competency

III. Healthcare Personnel Safety

IV. Surveillance and Disease Reporting

V.a/b. Hand Hygiene

VI.a/b. Personal Protective Equipment (PPE)

VII.a/b. Injection Safety (if applicable)

VIII.a/b. Respiratory Hygiene/Cough Etiquette

IX.a/b. Point-of-Care Testing (if applicable)

X.a/b. Environmental Cleaning

XI.a/b. Device Reprocessing

XII. Sterilization of Reusable Devices (if applicable)

XIII. High-level Disinfection of Reusable Devices (if applicable)

VERSION 2.3 – SEPTEMBER 2016 1

50
DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Disease Control and Prevention
Section 1: Facility Demographics
Facility Name (for health
department use only)
NHSN Facility Organization ID
(for health department use
only)
State-assigned Unique ID
Date of Assessment
Type of Assessment ☐ On-site ☐ Other (specify):
Rationale for Assessment ☐ Outbreak
(Select all that apply) ☐ Input from accrediting organization or state survey agency
☐ Other (specify):
Is the facility licensed by the
☐ Yes ☐ No
state?
Is the facility certified by the
☐ Yes ☐ No
Centers for Medicare &
Medicaid Services (CMS)?
Is the facility accredited? ☐ Yes ☐ No

If yes, list the accreditation organization:

☐ Accreditation Association for Ambulatory Health Care (AAAHC)
☐ American Association for Accreditation of Ambulatory Surgery
Facilities (AAAASF)
☐ American Osteopathic Association (AOA)
☐ The Joint Commission (TJC)
☐ Other (specify):
Is the facility affiliated with a ☐ Yes (specify – for health department use only):
hospital? ☐ No
Which procedures are ☐ Chemotherapy ☐ Endoscopy ☐ Ear/Nose/Throat
performed by the facility? ☐ Imaging (MRI/CT) ☐ Immunizations ☐ OB/Gyn
☐ Ophthalmologic ☐ Orthopedic ☐ Pain remediation
Select all that apply.
☐ Plastic/reconstructive ☐ Podiatry ☐ Other (specify):
What is the primary ☐ Chemotherapy ☐ Endoscopy ☐ Ear/Nose/Throat
procedure-type performed by ☐ Imaging (MRI/CT) ☐ Immunizations ☐ OB/Gyn
the facility?
☐ Ophthalmologic ☐ Orthopedic ☐ Pain remediation
Select only one. ☐ Plastic/reconstructive ☐ Podiatry ☐ Other (specify):
How many physicians work at
the facility?
What is the average number
of patients seen per week?

VERSION 2.3 – SEPTEMBER 2016 2

DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control
51 and Prevention
 Section 2: Infection Control Program and Infrastructure

I. Infection Control Program and Infrastructure

Elements to be assessed Assessment Notes/Areas for Improvement

A. Written infection prevention policies and procedures are  Yes  No
available, current, and based on evidence-based guidelines
(e.g., CDC/HICPAC), regulations, or standards.

Note: Policies and procedures should be appropriate for the services

provided by the facility and should extend beyond OSHA
bloodborne pathogens training
B. Infection prevention policies and procedures are re-assessed at  Yes  No
least annually or according to state or federal requirements,
and updated if appropriate.
C. At least one individual trained in infection prevention is  Yes  No
employed by or regularly available (e.g., by contract) to
manage the facility’s infection control program.

Note: Examples of training may include: Successful completion of

initial and/or recertification exams developed by the
Certification Board for Infection Control & Epidemiology;
participation in infection control courses organized by the state
or recognized professional societies (e.g., APIC, SHEA).
D. Facility has system for early detection and management of  Yes  No
potentially infectious persons at initial points of patient
encounter.

Note: System may include taking a travel and occupational history,

as appropriate, and elements described under respiratory
hygiene/cough etiquette.

II. Infection Control Training and Competency

Elements to be assessed Assessment Notes/Areas for Improvement

A. Facility has a competency-based training program that provides  Yes  No
job-specific training on infection prevention policies and
procedures to healthcare personnel.

Note: This includes those employed by outside agencies and

available by contract or on a volunteer basis to the facility.

See sections below for more specific assessment of training

related to: hand hygiene, personal protective equipment (PPE),
injection safety, environmental cleaning, point-of-care testing,
and device reprocessing

VERSION 2.3 – SEPTEMBER 2016 52 3

III. Healthcare Personnel Safety

Elements to be assessed Assessment Notes/Areas for Improvement

A. Facility has an exposure control plan that is tailored to the  Yes  No
specific requirements of the facility (e.g., addresses potential
hazards posed by specific services provided by the facility).
Note: A model template, which includes a guide for creating an
exposure control plan that meets the requirements of the OSHA
Bloodborne Pathogens Standard is available
at: https://www.osha.gov/Publications/osha3186.pdf
B. HCP for whom contact with blood or other potentially infectious  Yes  No
material is anticipated are trained on the OSHA bloodborne
pathogens standard upon hire and at least annually.
C. Following an exposure event, post-exposure evaluation and  Yes  No
follow-up, including prophylaxis as appropriate, are available at
no cost to employee and are supervised by a licensed healthcare
professional.
Note: An exposure incident refers to a specific eye, mouth, other
mucous membrane, non-intact skin, or parenteral contact with
blood or other potentially infectious materials that results from
the performance of an individual’s duties.
D. Facility tracks HCP exposure events and evaluates event data  Yes  No
and develops/implements corrective action plans to reduce
incidence of such events.
E. Facility follows recommendations of the Advisory Committee on  Yes  No
Immunization Practices (ACIP) for immunization of HCP,
including offering Hepatitis B and influenza vaccination.
Note: Immunization of Health-Care Personnel: Recommendations of
the ACIP available at:
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6007a1.htm
F. All HCP receive baseline tuberculosis (TB) screening prior to  Yes  No
placement; HCP receive repeat testing, if appropriate, based on
the facility-level risk assessment.
Note: For more information, facilities should refer to the Guidelines
for Preventing the Transmission of Mycobacterium
tuberculosis in Health-Care Settings, 2005 available at:
http://www.cdc.gov/mmwr/preview/mmwrhtml/
rr5417a1.htm ?s_cid=rr5417a1_e
G. If respirators are used, the facility has a respiratory protection  Yes  No
program that details required worksite-specific procedures and
elements for required respirator use, including provision of  Not Applicable
medical clearance, training, and fit testing as appropriate.
H. Facility has well-defined policies concerning contact of  Yes  No
personnel with patients when personnel have potentially
transmissible conditions.
These policies include:
i. Work-exclusion policies that encourage reporting of
illnesses and do not penalize with loss of wages,  Yes  No
benefits, or job status.
ii. Education of personnel on prompt reporting of illness
to supervisor.  Yes  No
53
VERSION 2.3 – SEPTEMBER 2016 4
IV. Surveillance and Disease Reporting

Elements to be assessed Assessment Notes/Areas for Improvement

A. An updated list of diseases reportable to the public health  Yes  No
authority is readily available to all personnel.
B. Facility can demonstrate knowledge of and compliance with  Yes  No
mandatory reporting requirements for notifiable diseases,
healthcare associated infections (as appropriate), and for
potential outbreaks.
C. Patients who have undergone procedures at the facility are  Yes  No
educated regarding signs and symptoms of infection that may be
associated with the procedure and instructed to notify the
facility if such signs or symptoms occur.

V.a. Hand Hygiene

Elements to be assessed Assessment Notes/Areas for Improvement

A. All HCP are educated regarding appropriate indications for hand
hygiene:
i. Upon hire, prior to provision of care
 Yes  No
ii. Annually  Yes  No
B. HCP are required to demonstrate competency with hand  Yes  No
hygiene following each training
C. Facility routinely audits (monitors and documents) adherence to  Yes  No
hand hygiene.
D. Facility provides feedback from audits to personnel regarding  Yes  No
their hand hygiene performance.
E. Hand hygiene policies promote preferential use of alcohol-based  Yes  No
hand rub (ABHR) over soap and water in most clinical situations.

Note: Soap and water should be used when hands are visibly
soiled (e.g., blood, body fluids) and is also preferred after caring
for a patient with known or suspected C. difficile or norovirus
during an outbreak.

54
VERSION 2.3 – SEPTEMBER 2016 5
VI.a. Personal Protective Equipment (PPE)

Elements to be assessed Assessment Notes/Areas for Improvement

A. HCP who use PPE receive training on proper selection and use of
PPE:  Yes  No
i. Upon hire, prior to provision of care
ii. Annually  Yes  No
iii. When new equipment or protocols are introduced  Yes  No
B. HCP are required to demonstrate competency with selection  Yes  No
and use of PPE following each training.
C. Facility routinely audits (monitors and documents) adherence to  Yes  No
proper PPE selection and use.
D. Facility provides feedback from audits to personnel regarding  Yes  No
their performance with selection and use of PPE.

VII.a. Injection Safety (This element does not include assessment of pharmacy/compounding practices)

If injectable medications are never prepared or administered at the facility check  Not Applicable here and skip to Section
VIII.a. Respiratory Hygiene/Cough Etiquette.
Elements to be assessed Assessment Notes/Areas for Improvement
A. HCP who prepare and/or administer parenteral medications
receive training on safe injection practices:
i. Upon hire, prior to being allowed to prepare and/or  Yes  No
administer parenteral medications
ii. Annually  Yes  No
iii. When new equipment or protocols are introduced  Yes  No
B. HCP are required to demonstrate competency with safe  Yes  No
injection practices following each training.

C. Facility routinely audits (monitors and documents) adherence to  Yes  No

safe injection practices.

D. Facility provides feedback from audits to personnel regarding  Yes  No

their adherence to safe injection practices.

E. Facility has policies and procedures to track HCP access to  Yes  No

controlled substances to prevent narcotics theft/diversion.
 Not Applicable
Note: Policies and procedures should address: how data are (Facility does not
reviewed, how facility would respond to unusual access patterns, prepare or
how facility would assess risk to patients if tampering (alteration administer controlled
or substitution) is suspected or identified, and who the facility substances)
would contact if diversion is suspected or identified.

VERSION 2.3 – SEPTEMBER 2016 6

DEPARTMENT OF HEALTH 55 & HUMAN SERVICES

Centers for Disease Control and Prevention
VIII.a. Respiratory Hygiene/Cough Etiquette

Elements to be assessed Assessment Notes/Areas for Improvement

A. Facility has policies and procedures to contain respiratory  Yes  No
secretions in persons who have signs and symptoms of a
respiratory infection, beginning at point of entry to the facility
and continuing through the duration of the visit.

Policies include:
i. Offering facemasks to coughing patients and other  Yes  No
symptomatic persons upon entry to the facility, at a
minimum, during periods of increased respiratory
infection activity in the community.
ii. Providing space in waiting rooms and encouraging
persons with symptoms of respiratory infections to sit as  Yes  No
far away from others as possible.

Note: If available, facilities may wish to place patients with

symptoms of a respiratory infection in a separate area while
waiting for care.
B. Facility educates HCP on the importance of infection prevention  Yes  No
measures to contain respiratory secretions to prevent the
spread of respiratory pathogens.

IX.a. Point-of-Care Testing (e.g., blood glucose meters, INR monitor)

If point-of-care testing is never performed at the facility check  Not Applicable here and skip to Section X.a. Environmental
Cleaning
Elements to be assessed Assessment Notes/Areas for Improvement
A. HCP who perform point-of-care testing receive training on
recommended practices:
i. Upon hire, prior to being allowed to perform point-of-  Yes  No
care testing
ii. Annually  Yes  No

iii. When new equipment or protocols are introduced  Yes  No

B. HCP are required to demonstrate competency with  Yes  No
recommended practices for point-of-care testing following each
training.
C. Facility routinely audits (monitors and documents) adherence to  Yes  No
recommended practices during point-of-care testing.
D. Facility provides feedback from audits to personnel regarding  Yes  No
their adherence to recommended practices.

VERSION 2.3 – SEPTEMBER 2016 7

DEPARTMENT OF HEALTH 56 & HUMAN SERVICES

Centers for Disease Control and Prevention
X.a. Environmental Cleaning

Elements to be assessed Assessment Notes/Areas for Improvement

A. Facility has written policies and procedures for routine cleaning  Yes  No
and disinfection of environmental surfaces, including
identification of responsible personnel.
B. Personnel who clean and disinfect patient care areas (e.g.,
environmental services, technicians, nurses) receive training on
cleaning procedures
i. Upon hire, prior to being allowed to perform
environmental cleaning
 Yes  No

ii. Annually  Yes  No

iii. When new equipment or protocols are introduced  Yes  No
Note: If environmental cleaning is performed by contract personnel,
facility should verify this is provided by contracting company.
C. HCP are required to demonstrate competency with  Yes  No
environmental cleaning procedures following each training.
D. Facility routinely audits (monitors and documents) adherence to  Yes  No
cleaning and disinfection procedures, including using products in
accordance with manufacturer’s instructions (e.g., dilution,
storage, shelf-life, contact time).
E. Facility provides feedback from audits to personnel regarding  Yes  No
their adherence to cleaning and disinfection procedures.
F. Facility has a policy/procedure for decontamination of spills of  Yes  No
blood or other body fluids.

VERSION 2.3 – SEPTEMBER 2016 8

DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control and Prevention
57
X.a. Environmental Cleaning, continued

Operating Room

For the purposes of this checklist, an operating room is defined as a patient care area that met the Facilities Guidelines Institute’s (FGI)
or American Institute of Architects’ (AIA) criteria for an operating room when it was constructed or renovated. This is the same
definition that is used in the National Healthcare Safety Network’s Procedure-associated Module for the SSI Event
(http://www.cdc.gov/nhsn/pdfs/pscmanual/9pscssicurrent.pdf)

If the facility does not have an operating room check  Not Applicable here and skip to section XI.a. Device Reprocessing
Elements to be assessed Assessment Notes/Areas for Improvement
G. Operating rooms are terminally cleaned after last procedure of  Yes  No
the day.

H. Facility routinely audits (monitors and documents) adherence to

recommended infection control practices for surgical infection
prevention including:

i. Adherence to preoperative surgical scrub and hand  Yes  No

hygiene

ii. Appropriate use of surgical attire and drapes  Yes  No

iii. Adherence to aseptic technique and sterile field  Yes  No
iv. Proper ventilation requirements in surgical suites  Yes  No
v. Minimization of traffic in the operating room  Yes  No
vi. Adherence to cleaning and disinfection of environmental  Yes  No
surfaces

I. Facility provides feedback from audits to personnel regarding  Yes  No

their adherence to surgical infection prevention practices.

VERSION 2.3 – SEPTEMBER 2016 9

DEPARTMENT OF HEALTH & HUMAN SERVICES

Centers for Disease Control and Prevention
58
XI.a. Device Reprocessing

The following basic information allows for a general assessment of policies and procedures related to reprocessing of reusable medical
devices. Outpatient facilities that are performing on-site sterilization or high-level disinfection of reusable medical devices should
refer to the more detailed checklists in separate sections of this document devoted to those issues.

Categories of Medical Devices:

• Critical items (e.g., surgical instruments) are objects that enter sterile tissue or the vascular system and must be sterile prior
to use (see Sterilization Section).

• Semi-critical items (e.g., endoscopes for upper endoscopy and colonoscopy, vaginal probes) are objects that contact mucous
membranes or non-intact skin and require, at a minimum, high-level disinfection prior to reuse (see High-level Disinfection
Section).

• Non-critical items (e.g., blood pressure cuffs) are objects that may come in contact with intact skin but not mucous
membranes and should undergo cleaning and low- or intermediate-level disinfection depending on the nature and degree of
contamination.

Single-use devices (SUDs) are labeled by the manufacturer for a single use and do not have reprocessing instructions. They may not
be reprocessed for reuse except by entities which have complied with FDA regulatory requirements and have received FDA clearance
to reprocess specific SUDs.

Note: Cleaning must always be performed prior to sterilization and disinfection

Elements to be assessed Assessment Notes/Areas for Improvement

A. Facility has policies and procedures to ensure that reusable  Yes  No
medical devices are cleaned and reprocessed appropriately prior
to use on another patient.

Note: This includes clear delineation of responsibility among HCP for

cleaning and disinfection of equipment including, non-critical
equipment, mobile devices, and other electronics (e.g., point-of-
care devices) that might not be reprocessed in a centralized
reprocessing area.
B. The individual(s) in charge of infection prevention at the facility  Yes  No
is consulted whenever new devices or products will be
purchased or introduced to ensure implementation of
appropriate reprocessing policies and procedures.
C. HCP responsible for reprocessing reusable medical devices
receive hands-on training on proper selection and use of PPE
and recommended steps for reprocessing assigned devices:

i. Upon hire, prior to being allowed to reprocess devices  Yes  No

ii. Annually  Yes  No
iii. When new devices are introduced or  Yes  No
policies/procedures change.

Note: If device reprocessing is performed by contract personnel,

facility should verify this is provided by contracting company.
D. HCP are required to demonstrate competency with reprocessing  Yes  No
procedures (i.e., correct technique is observed by trainer)
following each training.

59
VERSION 2.3 – SEPTEMBER 2016 10
XI.a. Device Reprocessing, continued

Elements to be assessed Assessment Notes/Areas for Improvement

E. Facility routinely audits (monitors and documents) adherence to  Yes  No
reprocessing procedures.

F. Facility provides feedback from audits to personnel regarding  Yes  No

their adherence to reprocessing procedures.

G. Facility has protocols to ensure that HCP can readily identify  Yes  No
devices that have been properly reprocessed and are ready for
patient use (e.g., tagging system, storage in designated area).

H. Facility has policies and procedures outlining facility response  Yes  No

(i.e., risk assessment and recall of device) in the event of a
reprocessing error or failure.

I. Routine maintenance for reprocessing equipment (e.g.,  Yes  No

automated endoscope reprocessors, steam autoclave) is  Not Applicable
performed by qualified personnel in accordance with (Reprocessing
manufacturer instructions; confirm maintenance records are equipment is not
available. used at the facility)

60
VERSION 2.3 – SEPTEMBER 2016 11
 Section 3: Direct Observation of Facility Practices
Certain infection control lapses (e.g., reuse of syringes on more than one patient or to access a medication container
that is used for subsequent patients; reuse of lancets) have resulted in bloodborne pathogen transmission and should be
halted immediately. Identification of such lapses warrants appropriate notification and testing of potentially affected
patients.

If an element is unable to be observed during an assessment (e.g., no patients received point-of-care testing during the
visit), assess the element by interviewing appropriate personnel about facility practices. Notation should also be made
in the notes section that the element was not able to be directly observed.

V.b. Hand hygiene

Elements to be assessed Assessment Notes/Areas for Improvement

A. Supplies necessary for adherence to hand hygiene (e.g., soap,  Yes  No
water, paper towels, alcohol-based hand rub) are readily
accessible to HCP in patient care areas.
Hand hygiene is performed correctly:

B. Before contact with the patient  Yes  No

C. Before performing an aseptic task (e.g., insertion of IV or  Yes  No
preparing an injection, administering eye drops)
 Not Applicable
D. After contact with the patient  Yes  No
E. After contact with objects in the immediate vicinity of the  Yes  No
patient
F. After contact with blood, body fluids or contaminated surfaces  Yes  No
G. After removing gloves  Yes  No
H. When moving from a contaminated-body site to a clean-body  Yes  No
site during patient care
 Not Applicable

VI.b. Personal Protective Equipment (PPE)

Elements to be assessed Assessment Notes/Areas for Improvement

A. Sufficient and appropriate PPE is available and readily accessible  Yes  No
to HCP.
PPE is used correctly:

B. PPE, other than respirator, is removed and discarded prior to  Yes  No

leaving the patient’s room or care area. If a respirator is used, it
is removed and discarded (or reprocessed if reusable) after
leaving the patient room or care area and closing the door.

C. Hand hygiene is performed immediately after removal of PPE.  Yes  No

VERSION 2.3 – SEPTEMBER 2016 61 12

VI.b. Personal Protective Equipment (PPE), continued

Elements to be assessed Assessment Notes/Areas for Improvement

D. Gloves
i. HCP wear gloves for potential contact with blood, body  Yes  No
fluids, mucous membranes, non-intact skin, or
contaminated equipment.
ii. HCP do not wear the same pair of gloves for the care of  Yes  No
more than one patient.
iii. HCP do not wash gloves for the purpose of reuse.  Yes  No
E. Gowns
i. HCP wear gowns to protect skin and clothing during  Yes  No
procedures or activities where contact with blood or  Not Applicable
body fluids is anticipated.
ii. HCP do not wear the same gown for the care of more  Yes  No
than one patient.
 Not Applicable
F. Facial protection
i. HCP wear mouth, nose, and eye protection during  Yes  No
procedures that are likely to generate splashes or  Not Applicable
sprays of blood or other body fluids.

VII.b. Injection safety (This element does not include assessment of pharmacy/compounding practices)

If injectable medications are never prepared or administered at the facility check  Not Applicable here and skip to Section
VIII.b. Respiratory Hygiene/Cough Etiquette
Elements to be assessed Assessment Notes/Areas for Improvement
A. Injections are prepared using aseptic technique in a clean area
free from contamination or contact with blood, body fluids or  Yes  No
contaminated equipment.
B. Needles and syringes are used for only one patient (this includes
manufactured prefilled syringes and cartridge devices such as  Yes  No
insulin pens).
C. The rubber septum on a medication vial is disinfected with
alcohol prior to piercing.  Yes  No
D. Medication containers are entered with a new needle and a new
syringe, even when obtaining additional doses for the same  Yes  No
patient.
E. Single dose (single-use) medication vials, ampules, and bags or
bottles of intravenous solution are used for only one patient.  Yes  No
F. Medication administration tubing and connectors are used for  Yes  No
only one patient.
 Not Applicable
(Facility does not use
tubing or connectors)
G. Multi-dose vials are dated by HCP when they are first opened  Yes  No
and discarded within 28 days unless the manufacturer specifies
a different (shorter or longer) date for that opened vial.  Not Applicable
(Facility does not use
Note: This is different from the expiration date printed on the vial. multi-dose vials or
discards them after
single patient use)
62
VERSION 2.3 – SEPTEMBER 2016 13
VII.b. Injection safety (This element does not include assessment of pharmacy/compounding practices), continued

Elements to be assessed Assessment Notes/Areas for Improvement

H. Multi-dose vials to be used for more than one patient are kept in  Yes  No
a centralized medication area and do not enter the immediate
patient treatment area (e.g., operating room, patient  Not Applicable
room/cubicle). (Facility does not use
multi-dose vials or
Note: If multi-dose vials enter the immediate patient treatment area discards them after
they should be dedicated for single-patient use and discarded single patient use)
immediately after use.
I. All sharps are disposed of in a puncture-resistant sharps  Yes  No
container.

J. Filled sharps containers are disposed of in accordance with state  Yes  No

regulated medical waste rules.

K. All controlled substances (e.g., Schedule II, III, IV, V drugs) are  Yes  No
kept locked within a secure area.
 Not Applicable
(Controlled
substances are not
kept at the facility)
L. HCP wear a facemask (e.g., surgical mask) when placing a  Yes  No
catheter or injecting material into the epidural or subdural space
(e.g., during myelogram, epidural or spinal anesthesia).  Not Applicable
(Facility does not
perform spinal
injection procedures)

VIII.b. Respiratory Hygiene/Cough Etiquette

Elements to be assessed Assessment Notes/Areas for Improvement

A. Facility:

i. Posts signs at entrances with instructions to patients  Yes  No

with symptoms of respiratory infection to:
a. Inform HCP of symptoms of a respiratory
infection when they first register for care, and
b. Practice Respiratory Hygiene/Cough Etiquette
(cover their mouths/noses when coughing or
sneezing, use and dispose of tissues, and
perform hand hygiene after hands have been
covered with respiratory secretions).
ii. Provides tissues and no-touch receptacles for
disposal of tissues.  Yes  No
iii. Provides resources for performing hand hygiene in
or near waiting areas.  Yes  No

VERSION 2.3 – SEPTEMBER 2016 14

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DEPARTMENT OF HEALTH & HUMAN SERVICES

IX.b. Point-of-Care Testing (e.g., blood glucose meters, INR monitor)

If point-of-care testing is never performed at the facility check  Not Applicable here and skip to Section X.b. Environmental
Cleaning

Elements to be assessed Assessment Notes/Areas for Improvement

A. New single-use, auto-disabling lancing device is used for each  Yes  No
patient.
 Not Applicable
Note: Lancet holder devices are not suitable for multi-patient use.
B. If used for more than one patient, the point-of-care blood  Yes  No
testing meter is cleaned and disinfected after every use
according to manufacturer’s instructions.  Not Applicable

Note: If the manufacturer does not provide instructions for cleaning

and disinfection, then the testing meter should not be used for
>1 patient.

X.b. Environmental Cleaning

Elements to be assessed Assessment Notes/Areas for Improvement

A. Supplies necessary for appropriate cleaning and disinfection  Yes  No
procedures (e.g., EPA-registered disinfectants) are available.

Note: If environmental services are performed by contract

personnel, facility should verify that appropriate EPA-registered
products are provided by contracting company
B. High-touch surfaces in rooms where surgical or other invasive  Yes  No
procedures (e.g., endoscopy, spinal injections) are performed
are cleaned and then disinfected with an EPA-registered  Not Applicable
disinfectant after each procedure.
C. Cleaners and disinfectants are used in accordance with  Yes  No
manufacturer’s instructions (e.g., dilution, storage, shelf-life,
contact time).
D. HCP engaged in environmental cleaning wear appropriate PPE to  Yes  No
prevent exposure to infectious agents or chemicals (PPE can
include gloves, gowns, masks, and eye protection).

Note: The exact type of correct PPE depends on infectious or

chemical agent and anticipated type of exposure.

VERSION 2.3 – SEPTEMBER 2016 15

64

DEPARTMENT OF HEALTH & HUMAN SERVICES

XI.b. Device Reprocessing

Elements to be assessed Assessment Notes/Areas for Improvement

A. Policies, procedures, and manufacturer reprocessing instructions  Yes  No
for reusable medical devices used in the facility are available in
the reprocessing area(s).
B. Reusable medical devices are cleaned, reprocessed (disinfection  Yes  No
or sterilization) and maintained according to the manufacturer
instructions.

Note: If the manufacturer does not provide such instructions, the

device may not be suitable for multi-patient use.
C. Single-use devices are discarded after use and not used for more  Yes  No
than one patient unless they have been appropriately
reprocessed as described in the note below.

Note: If the facility elects to reuse single-use devices, these devices

must be reprocessed prior to reuse by a third-party reprocessor
that it is registered with the FDA as a third-party reprocessor and
cleared by the FDA to reprocess the specific device in question.
The facility should have documentation from the third party
reprocessor confirming this is the case.
D. Reprocessing area:
i. Adequate space is allotted for reprocessing activities.  Yes  No
ii. A workflow pattern is followed such that devices clearly  Yes  No
flow from high contamination areas to clean/sterile
areas (i.e., there is clear separation between soiled and
clean workspaces).
E. Adequate time for reprocessing is allowed to ensure adherence  Yes  No
to all steps recommended by the device manufacturer, including
drying and proper storage.

Note: Facilities should have an adequate supply of instruments for

the volume of procedures performed and should schedule
procedures to allow sufficient time for all reprocessing steps.
F. HCP engaged in device reprocessing wear appropriate PPE to  Yes  No
prevent exposure to infectious agents or chemicals (PPE can
include gloves, gowns, masks, and eye protection).

Note: The exact type of correct PPE depends on infectious or

chemical agent and anticipated type of exposure.
G. Medical devices are stored in a manner to protect from damage  Yes  No
and contamination.

VERSION 2.3 – SEPTEMBER 2016 16

65

DEPARTMENT OF HEALTH & HUMAN SERVICES

XII. Sterilization of Reusable Devices

If all device sterilization is performed off-site, complete elements M-O and check Not Applicable for the remaining elements in this
section.

If sterilization of reusable devices is never performed (either at the facility or off-site) check  Not Applicable here and skip to
Section XIII.
Elements to be assessed Assessment Notes/Areas for Improvement
A. Devices are thoroughly cleaned according to manufacturer
instructions and visually inspected for residual soil prior to  Yes  No
sterilization.  Not Applicable
Note: Cleaning may be manual (i.e., using friction) and/or
mechanical (e.g., with ultrasonic cleaners, washer-disinfector,
washer-sterilizers).

Ensure appropriately sized cleaning brushes are selected for

cleaning device channels and lumens.
B. Cleaning is performed as soon as practical after use (e.g., at the
point of use) to prevent soiled materials from becoming dried  Yes  No
onto devices.  Not Applicable
C. Enzymatic cleaner or detergent is used for cleaning and
discarded according to manufacturer’s instructions (typically  Yes  No
after each use)  Not Applicable
D. Cleaning brushes are disposable or, if reusable, cleaned and
high-level disinfected or sterilized (per manufacturer’s  Yes  No
instructions) after use.  Not Applicable
E. After cleaning, instruments are appropriately
wrapped/packaged for sterilization (e.g., package system  Yes  No
selected is compatible with the sterilization process being  Not Applicable
performed, items are placed correctly into the basket, shelf or
cart of the sterilizer so as not to impede the penetration of the
sterilant, hinged instruments are open, instruments are
disassembled if indicated by the manufacturer).
F. A chemical indicator (process indicator) is placed correctly in the  Yes  No
instrument packs in every load.
 Not Applicable
G. A biological indicator, intended specifically for the type and cycle
parameters of the sterilizer, is used at least weekly for each  Yes  No
sterilizer and with every load containing implantable items.  Not Applicable
H. For dynamic air removal-type sterilizers (e.g., prevacuum steam
sterilizer), an air removal test (Bowie-Dick test) is performed in  Yes  No
an empty dynamic-air removal sterilizer each day the sterilizer is  Not Applicable
used to verify efficacy of air removal.
I. Sterile packs are labeled with a load number that indicates the
sterilizer used, the cycle or load number, the date of  Yes  No
sterilization, and, if applicable, the expiration date.  Not Applicable
J. Sterilization logs are current and include results from each load.  Yes  No
 Not Applicable
K. Immediate-use steam sterilization, if performed, is only done in  Yes  No
circumstances in which routine sterilization procedures cannot
be performed.  Not Applicable

66
VERSION 2.3 – SEPTEMBER 2016 17
XII. Sterilization of Reusable Devices, continued

Elements to be assessed Assessment Notes/Areas for Improvement

L. Instruments that undergo immediate-use steam sterilization are  Yes  No
used immediately and not stored.
 Not Applicable
M. After sterilization, medical devices are stored so that sterility is  Yes  No
not compromised.
 Not Applicable
N. Sterile packages are inspected for integrity and compromised  Yes  No
packages are reprocessed prior to use.
 Not Applicable
O. The facility has a process to perform initial cleaning of devices (to  Yes  No
prevent soiled materials from becoming dried onto devices) prior
to transport to the off-site reprocessing facility.  Not Applicable

VERSION 2.3 – SEPTEMBER 2016 18

67

DEPARTMENT OF HEALTH & HUMAN SERVICES

XIII. High-Level Disinfection of Reusable Devices
If all high-level disinfection is performed off-site, complete elements L-N below and check Not Applicable for the remaining elements
in this section.

If high-level disinfection of reusable devices is never performed (either at the facility or off-site) check here:  Not Applicable
Elements to be assessed Assessment Notes/Areas for Improvement
A. Flexible endoscopes are inspected for damage and leak tested as  Yes  No
part of each reprocessing cycle. Any device that fails the leak
test is removed from clinical use and repaired.  Not Applicable
B. Devices are thoroughly cleaned according to manufacturer  Yes  No
instructions and visually inspected for residual soil prior to high-
level disinfection.  Not Applicable

Note: Cleaning may be manual (i.e., using friction) and/or

mechanical (e.g., with ultrasonic cleaners, washer-disinfector,
washer-sterilizers).

Ensure appropriately sized cleaning brushes are selected for

cleaning device channels and lumens.
C. Cleaning is performed as soon as practical after use (e.g., at the  Yes  No
point of use) to prevent soiled materials from becoming dried
onto instruments.  Not Applicable
D. Enzymatic cleaner or detergent is used and discarded according  Yes  No
to manufacturer instructions (typically after each use).
 Not Applicable
E. Cleaning brushes are disposable or, if reusable, cleaned and  Yes  No
high-level disinfected or sterilized (per manufacturer
instructions) after use.  Not Applicable
F. For chemicals used in high-level disinfection, manufacturer
instructions are followed for:
i. Preparation
 Yes  No
 Not Applicable
ii. Testing for appropriate concentration  Yes  No
 Not Applicable
iii. Replacement (i.e., upon expiration or loss of efficacy)  Yes  No
 Not Applicable

VERSION 2.3 – SEPTEMBER 2016 19

68

DEPARTMENT OF HEALTH & HUMAN SERVICES

XIII. High-Level Disinfection of Reusable Devices, continued

Elements to be assessed Assessment Notes/Areas for Improvement

G. If automated reprocessing equipment (e.g., automated  Yes  No
endoscope reprocessor) is used, proper connectors are used to
assure that channels and lumens are appropriately disinfected.  Not Applicable
H. Devices are disinfected for the appropriate length of time as  Yes  No
specified by manufacturer instructions.
 Not Applicable
I. Devices are disinfected at the appropriate temperature as  Yes  No
specified by manufacturer instructions.
 Not Applicable
J. After high-level disinfection, devices are appropriately rinsed as  Yes  No
specified by the manufacturer.
 Not Applicable
K. Devices are dried thoroughly prior to reuse.  Yes  No
Note: For lumened instruments (e.g., endoscopes) this includes  Not Applicable
flushing all channels with alcohol and forcing air through
channels.
L. After high-level disinfection, devices are stored in a manner to  Yes  No
protect from damage or contamination.
 Not Applicable
Note: Endoscopes should be hung in a vertical position.
M. Facility maintains a log for each endoscopy procedure which  Yes  No
includes: patient’s name and medical record number (if
available), procedure, date, endoscopist, system used to  Not Applicable
reprocess the endoscope (if more than one system could be
used in the reprocessing area), and serial number or other
identifier of the endoscope used.
N. The facility has a process to perform initial cleaning of devices  Yes  No
(to prevent soiled materials from becoming dried onto devices)
prior to transport to the off-site reprocessing facility.  Not Applicable

VERSION 2.3 – SEPTEMBER 2016 20

69

DEPARTMENT OF HEALTH & HUMAN SERVICES

Section 4: Infection Control Guidelines and Other Resources

• General Infection Prevention

☐ CDC/HICPAC Guidelines and recommendations: http://www.cdc.gov/HAI/prevent/prevent_pubs.html

• Healthcare Personnel Safety

☐ Guideline for Infection Control in Healthcare Personnel: http://www.cdc.gov/hicpac/pdf/InfectControl98.pdf

☐ Immunization of HealthCare Personnel: http://www.cdc.gov/vaccines/spec-grps/hcw.htm

☐ Occupational Safety & Health Administration (OSHA) Bloodborne Pathogens and Needlestick Prevention
Standard: http://www.osha.gov/SLTC/bloodbornepathogens/index.html

☐ OSHA Respiratory Protection Standard:

https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=12716&p_table=STANDARDS

☐ OSHA Respirator Fit Testing: https://www.osha.gov/video/respiratory_protection/fittesting_transcript.html

• Hand Hygiene

☐ Guideline for Hand Hygiene in Healthcare Settings: http://www.cdc.gov/mmwr/PDF/rr/rr5116.pdf

☐ Hand Hygiene in Healthcare Settings: http://www.cdc.gov/handhygiene/

Examples of tools that can be used to conduct a formal audit of hand hygiene practices:

☐ http://www.jointcommission.org/assets/1/18/hh_monograph.pdf
☐ http://compepi.cs.uiowa.edu/index.php/Research/IScrub

• Personal Protective Equipment

☐ 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare
Settings: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf

☐ Guidance for the Selection and Use of Personal Protective Equipment in Healthcare
Settings: http://www.cdc.gov/HAI/prevent/ppe.html

• Injection Safety

☐ 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare
Settings: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf

☐ CDC Injection Safety Web Materials: http://www.cdc.gov/injectionsafety/

☐ CDC training video and related Safe Injection Practices Campaign materials:
http://www.oneandonlycampaign.org/

VERSION 2.3 – SEPTEMBER 2016 70 21

 • Respiratory Hygiene/Cough Etiquette

☐ 2007 Guidelines for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare
Settings: http://www.cdc.gov/hicpac/pdf/isolation/Isolation2007.pdf

☐ Recommendations for preventing the spread of influenza:

http://www.cdc.gov/flu/professionals/infectioncontrol/

• Environmental Cleaning

☐ Guidelines for Environmental Infection Control in Healthcare Facilities:

http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_HCF_03.pdf

☐ Options for Evaluating Environmental Infection Control:

http://www.cdc.gov/HAI/toolkits/Evaluating-Environmental-Cleaning.html

• Equipment Reprocessing

☐ Guideline for Disinfection and Sterilization in Healthcare Facilities:

http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf

☐ FDA regulations on reprocessing of single-use devices:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071434

• Point-of-Care Testing

☐ Infection Prevention during Blood Glucose Monitoring and Insulin Administration:

http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html

☐ Frequently Asked Questions (FAQs) regarding Assisted Blood Glucose Monitoring and Insulin Administration:
http://www.cdc.gov/injectionsafety/providers/blood-glucose-monitoring_faqs.html

• Resources to assist with evaluation and response to breaches in infection control

☐ Patel PR, Srinivasan A, Perz JF. Developing a broader approach to management of infection control breaches
in health care settings. Am J Infect Control. 2008 Dec; 36(10); 685-90
http://www.ajicjournal.org/article/S0196-6553(08)00683-4/abstract

☐ Steps for Evaluating an Infection Control Breach:

http://www.cdc.gov/hai/outbreaks/steps_for_eval_IC_breach.html

☐ Patient Notification Toolkit: http://www.cdc.gov/injectionsafety/pntoolkit/index.html

• Antibiotic Stewardship

☐ Get Smart Programs & Observances: http://www.cdc.gov/getsmart/

VERSION 2.3 – SEPTEMBER 2016 71 22

2.5 American Journal of Infection Control 42 (2014) 671-3

Contents lists available at ScienceDirect

American Journal of Infection Control American Journal of

Infection Control

journal homepage: www.ajicjournal.org

Practice forum

A pragmatic approach to infection prevention and control guidelines

in an ambulatory care setting
Jessica Ng MSc, CIC a, *, Sheila Le-Abuyen MPH, CPHI(C) a, Jane Mosley MScN, RN a,
Michael Gardam MD, MSc, CM, FRCPC, CIC a, b
a
Department of Infection Prevention and Control, Women’s College Hospital, Toronto, Ontario, Canada
b
Department of Infection Prevention and Control, University Health Network, Toronto, Ontario, Canada

Key Words: The vast majority of infection prevention and control (IPAC) experience and practice guidance relates to
Outpatient the inpatient setting. We have taken a pragmatic approach to applying IPAC guidance in our ambulatory
Infection Prevention and Control Program setting, and here we identify and describe the 4 key areas where we modified our IPAC program and
Transition
adapted current guidelines to fit with our setting.
Practice change
Copyright  2014 by the Association for Professionals in Infection Control and Epidemiology, Inc.
Published by Elsevier Inc. All rights reserved.

Women’s College Hospital (WCH) is an academic health care SCREENING AND SURVEILLANCE
facility in Ontario, Canada, with a primary focus on the health of
women. WCH transitioned from an acute care hospital to an In contrast to inpatient settings, the antibiotic resistant organ-
ambulatory care hospital during 2006. The transition of infection ism (ARO) status of patients is largely unknown in standalone
prevention and control (IPAC) practices from an acute care ambulatory care settings. Laboratory turnaround times are critical
approach to an approach appropriate to ambulatory care has been for preventing ARO transmission amongst inpatients.6 When WCH
gradual but determined. was an inpatient facility, this was achieved by patient ARO
The vast majority of IPAC experience and practice guidance re- screening upon admission and immediate telephone calls to IPAC
lates to inpatient settings. The Centers for Disease Control and when a positive laboratory result was received. As we transitioned
Prevention,1 Public Health Agency of Canada,2 World Health Or- into an ambulatory care setting, ARO screening became moot
ganization,3 College of Physicians and Surgeons of Ontario,4 and because patients would visit and leave the hospital within a day,
Provincial Infectious Diseases Advisory Committee5 all publish IPAC long before results were available. Therefore, we worked with the
guidance documents but provide little concrete direction for laboratory to stop immediate ARO reporting by telephone. In a few
ambulatory care settings. As a result, until recently, we loosely of our clinical areas, we also eliminated ARO screening for the
adapted inpatient practices to fit our ambulatory setting. purpose of implementing IPAC measures and encouraged screening
In light of this, we conducted an extensive review of our IPAC only for clinical decision-making purposes such as choosing the
program in 2011, evaluating where gaps existed and identifying appropriate perioperative antimicrobial prophylaxis.
where practice changes were needed to fit our new reality. We also Because it is difficult to attribute a patient infection to a health
consciously moved to a less rigid, more pragmatic approach to care encounter in an ambulatory care setting, we do not formally
applying IPAC guidelines in our setting. In this report, we identify track and publicly report infection rates. Instead, we have focused
and describe the 4 key areas where we modified our program and our efforts on public health reporting of communicable diseases
adapted current guidelines, specifically screening and surveillance, and process surveillance of IPAC practices within our hospital, such
isolation practices and personal protective equipment (PPE) use, as promoting good respiratory etiquette, improving compliance
environmental cleaning, and hand hygiene (Table 1). with antibiotic prophylaxis guidelines, and ensuring the use of a
surgical safety checklist.

* Address correspondence to Jessica Ng, MSc, CIC, Department of Infection

ISOLATION PRACTICES AND PPE USE
Prevention and Control, Women’s College Hospital, 76 Grenville St, Toronto,
Ontario, Canada M5S 1B2.
E-mail address: [email protected] (J. Ng). Despite understanding that Routine Practices (RP)7 (ie, Centers
Conflicts of interest: None to report. for Disease Control and Prevention standard precautions) should

0196-6553/$36.00 - Copyright  2014 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.ajic.2014.02.011

72
672 J. Ng et al. / American Journal of Infection Control 42 (2014) 671-3

Table 1
Key areas differing in approach to infection prevention and control (IPAC) in an ambulatory care setting

Area Inpatient care Ambulatory care

Screening Patients are screened upon admission to implement AP Patients are not screened for IPAC purposes
Surveillance Larger focus on outcome surveillance; infection rates for AROs Difficult to attribute causation and track infection rates. Main focus is
such as MRSA and Clostridium difficile are tracked on process surveillance such as antibiotic prophylaxis and use of a
surgical safety checklist
Isolation precautions AP are implemented, which include specific strategies for Emphasis on use of RP for all patients, including patients with a
and PPE use patient placement, use of PPE, and environmental cleaning known ARO
Environmental Daily and terminal cleaning for patient rooms. Terminal cleaning Focus on cleaning patient equipment between use and a thorough
cleaning required for patients identified with an ARO end-of-day room cleaning for all patients, including patients with
a known ARO
Hand hygiene Patient environment is well defined in the moments for hand Patient environment is less defined in the moments for hand hygiene
hygiene. A direct observer can monitor hand hygiene at ease Direct observer for monitoring hand hygiene raises numerous issues
Alternative methods such as engaging patients as observers have
been effective

AP, Additional Precautions; ARO, antibiotic resistant organism; MRSA, methicillin-resistant Staphylococcus aureus; PPE, personal protective equipment; RP, Routine Practices.

be applied to all patients at all times, staff members often relied on HAND HYGIENE
the patient flagging system to guide practice. Before becoming an
ambulatory care hospital, WCH screened inpatients for AROs and Until recently, there have been few resources addressing specific
patients who were positive for an ARO were identified with an hand hygiene practice guidelines for an outpatient setting. Since
electronic flag. When a patient was flagged for an ARO, there would 2008, the WCH approach to hand hygiene practices has been based
be heightened attention to perform hand hygiene, use PPE (often in on the program developed by the Ontario Ministry of Health and
excess), and ensure appropriate environmental cleaning. Because of Long-Term Care.9 This program was created primarily to help
this, adherence to RP for patients not flagged with an ARO was often inpatient facilities improve health care worker hand hygiene
lax. compliance. Therefore, we found that applying the moments for
To provide clarity and address the inconsistent use of RP and hand hygiene in an ambulatory care setting required adaptations.
Additional Precautions (AP),7 we revised our policy to emphasize We had to redefine the patient environment and focus on the
the systematic application of RP for all patients, including patients concept of performing hand hygiene at the point-of-care in a clinic
known to be carrying an ARO. For staff, this meant that ARO status room. Although the Hand Hygiene Human Factors Toolkit issued by
does not automatically necessitate AP; instead, it would depend on the Canadian Patient Safety Institute10 recommends installing
the risk of exposure to uncontained secretions. Finally, to further alcohol-based hand rub dispensers by the door inside and outside a
prevent the selective use of RP, we are in the process of deactivating patient room, we chose to focus resources on ensuring that, at a
the ARO flagging option in our patient record system. minimum, alcohol-based hand rubs are provided at the point-of-
care; that is, on a health care provider’s desk or within reach of
ENVIRONMENTAL CLEANING exam bed areas. As a result of this work, hand hygiene compliance
before contact with patients or patient environments increased
The cleaning practices for patients and hospital environments from 80%-93% during the period 2010-2013.
are not as well defined in an ambulatory care setting. Generally, In accordance with best practices for monitoring hand hy-
because outpatient visits create less environmental contamination, giene,3,11,12 WCH began monitoring hand hygiene practices by
less intensive cleaning is needed compared with an inpatient direct observation. However, adapting this approach to our clinical
setting. At WCH, there have often been misconceptions regarding areas proved difficult because most patient visits involve 1 patient
what needs to be cleaned and how frequently; RP for environ- and 1 health care provider in a private examination room. To
mental cleaning were often only focused on ARO-positive patients. observe practices meant that an auditor would have to be present
To facilitate cleaning, ARO-positive patients would be scheduled as in the same room as the patient and health care provider. Not only
the final visit of the day and then a so-called terminal clean would was this highly uncomfortable for all involved, but it also raised
be performed. These practices posed a risk because RP for envi- concerns related to patient privacy and workflow disruption.
ronmental cleaning were not being applied to all patients. Moreover, the Hawthorne effect would have significantly biased
In 2012, we discontinued these practices and engaged the the results for health care providers’ hand hygiene compliance.
frontline staff, clinical managers, and clinical directors to allocate Compounding the challenges was the fact that the direct observer
adequate resources to ensure that routine practice environmental method was labor-intensive because few hand hygiene indications
cleaning could be applied to all patients. We also emphasized that were observed during a typical patient visit lasting 15-30 minutes.
special cleaning by environmental services was no longer required To address these challenges, we instituted an alternative
for ARO-positive patients if there was no visible soiling of the method for hand hygiene monitoring that was inspired by an
environment. We explained that with diligent use of RP, ARO- approach described by Bittle and LaMarche.13 This method engages
positive patients could be scheduled at any time. An audit con- patients to observe their health care providers’ compliance to hand
ducted April 2013-December 2013 confirmed that 97% of frontline hygiene. We invited patients to complete a survey card after their
staff (N ¼ 67) were following this policy and cleaned patient visit with their health care provider. During the pilot program,
equipment between uses. Lastly, best practices for environmental patients returned 75.1% of the survey cards distributed, and overall
cleaning in an inpatient setting include specific guidelines on daily hand hygiene compliance was 96.8%. The accuracy/interrater reli-
and terminal cleaning of patient rooms.8 With no patients requiring ability of patient observations were determined to be in concor-
discharge or transfer from our hospital, we shifted from the con- dance with an independent observer 87% of the time, suggesting
cepts of daily and terminal cleaning to applying RP of environ- that patients were generally able to correctly evaluate health care
mental cleaning between patient visits and thorough cleaning at provider hand hygiene practices. Based on these results, we
the end of each day. concluded that engaging patients as observers is an effective

73
 J. Ng et al. / American Journal of Infection Control 42 (2014) 671-3 673

method for monitoring health care provider hand hygiene practices in Ontario 2012. Available from: http://www.publichealthontario.ca/en/
eRepository/BP_IPAC_Ontario_HCSettings_2012.pdf. Accessed September 1, 2013.
in an ambulatory care setting.14
6. Ontario Agency for Health Protection and Promotion, Provincial Infectious
Diseases Advisory Committee. Annex A e screening, testing and surveillance
CONCLUSIONS for antibiotic-resistant organisms (AROs). Annexed to: Routine Practices and
Additional Precautions in all health care settings 2013. Available from: http://
www.publichealthontario.ca/en/eRepository/PIDAC-IPC_Annex_A_Screening_
The dearth of practical IPAC guidelines appropriate for an Testing_Surveillance_AROs_2013.pdf. Accessed September 1, 2013.
ambulatory care setting motivated us to assume a more prag- 7. Ontario Agency for Health Protection and Promotion, Provincial Infectious Dis-
matic approach to applying IPAC best practice guidelines to our eases Advisory Committee. Routine Practices and Additional Precautions in All
Health Care Settings. 3rd edition. Toronto, ON: Queen’s Printer for Ontario;
hospital. The decision to take this approach has allowed us to
November 2012. Available from: http://www.publichealthontario.ca/en/
translate and define current best practice guidelines for use in eRepository/RPAP_All_HealthCare_Settings_Eng2012.pdf. Accessed April 15, 2014.
ambulatory care settings. We have identified IPAC practices that 8. Ontario Agency for Health Protection and Promotion, Provincial Infectious
may be applicable for an inpatient setting but do not easily Diseases Advisory Committee. Environmental Cleaning for Prevention and
Control of Infections 2012. Available from: http://www.publichealthontario.ca/
transfer to an outpatient setting. Our hope is that this work will en/eRepository/Best_Practices_Environmental_Cleaning_2012.pdf. Accessed
lead to further development of IPAC best practice guidelines for September 1, 2013
ambulatory care settings. 9. Ontario Agency for Health Protection and Promotion. Just Clean Your
Hands program. 2013. Available from: http://www.publichealthontario.ca/
en/BrowseByTopic/InfectiousDiseases/JustCleanYourHands/Pages/Just-Clean-
References Your-Hands.aspx#.Uionu-FsGHV. Accessed September 1, 2013.
10. Canadian Patient Safety Institute. Human Factors Toolkit. 2012. Available from:
1. Centers for Disease Control and Prevention. Guide for IPAC for outpatient http://www.handhygiene.ca/English/Tools/Pages/Human-Factors-Toolkit.aspx.
settings: minimum expectations for safe care 2011. Available from: http:// Accessed September 1, 2013.
www.cdc.gov/HAI/pdfs/guidelines/standatds-of-ambulatory-care-7-2011.pdf. 11. Ontario Agency for Health Protection and Promotion, Provincial Infectious
Accessed September 1, 2013. Diseases Advisory Committee. Hand Hygiene 2010. Available: http://www.
2. Canadian Committee on Antibiotic Resistance (CCAR). Infection prevention publichealthontario.ca/en/eRepository/2010-12%20BP%20Hand%20Hygiene.pdf.
and control best practices for long term care, home and community care Accessed September 1, 2013.
including health care offices and ambulatory clinics 2007. Available from: http:// 12. Boyce JM, Pittet D, Healthcare Infection Control Practices Advisory Committee,
www.phac-aspc.gc.ca/amr-ram/ipcbp-pepci/pdf/amr-ram-eng.pdf. Accessed HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Guideline for hand hygiene
September 1, 2013. in health-care settings: recommendations of the Healthcare Infection Control
3. World Health Organization. Hand hygiene in outpatient care, home-based care Practices Advisory Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene
and long-term care facilities 2012. Available from: http://www.who.int/gpsc/ Task Force. MMWR Recomm Rep 2002;51:1-45.
5may/EN_GPSC1_PSP_HH_Outpatient_care/en/. Accessed September 1, 2013. 13. Bittle MJ, LaMarche S. Engaging the patient as observer to promote hand
4. The College of Physicians and Surgeons of Ontario. Infection control in the hygiene compliance in ambulatory care. Jt Comm J Qual Patient Saf 2009;35:
physician’s office 2004. Available from: http://www.cpso.on.ca/uploadedFiles/ 519-25.
policies/guidelines/office/Infection_Controlv2.pdf. Accessed September 1, 2013. 14. Le-Abuyen S, Ng J, Kim S, De La Franier A, Khan B, Gardam M, et al. Patient-as-
5. Ontario Agency for Health Protection and Promotion, Provincial Infectious observer approach: an alternative method for hand hygiene auditing in an
Diseases Advisory Committee. Infection prevention and control programs ambulatory care setting. Am J Infect Control 2014;42:439-42.

74
2.6 FEATURE

Infection prevention in a
system of ambulatory settings
Children’s Hospital of Philadelphia
shows how it’s done
BY SANDY SMITH

W
ith an extensive network that stretches close to a 200-mile radius and includes a 540-plus-
bed main hospital, a research center, four surgery centers, 31 physician practices, 11 specialty
care centers, and emergency care, the Children’s Hospital of Philadelphia (CHOP) wants to
ensure that it offers quality care in the places where patients are seen most frequently: facilities in the
ambulatory setting. In a session titled “Making a Case for an Ambulatory IPC Program,” at the APIC
2019 Annual Conference, Lori Handy, MD, MSCE, associate medical director, infection prevention,
and Sara Townsend, MS-HQS, CIC, FAPIC, infection prevention supervisor for the Philadelphia-based
hospital, discussed how CHOP has successfully restructured its infection prevention and control (IPC)
program to cover its vast system.

The ambulatory care setting is “where most of our patients manager, had developed a business case for this restructure,
are seen, so it was a cornerstone when we were thinking about recognizing the growth of the institution.
what our restructured program would look like,” Handy said.
“We were already providing infection prevention services in GETTING THE IPC HOUSE IN ORDER
ambulatory settings, but we wanted to do it in a more formalized Before implementing any system-wide changes, the IPC
way,” she noted. To support this vision of infection prevention department itself had to change. Prior to the launch of
in ambulatory care, Sarah Smathers, the department’s senior CHOP’s dedicated ambulatory program, the department
ALL PHOTOS COURTESY OF CHILDREN’S HOSPITAL OF PHILADELPHIA.

Members of the Children’s Hospital of Philadelphia ambulatory infection prevention control

team, from left to right: Regina Wagoner, infection preventionist; Sara Townsend, infection
prevention supervisor; Lori Handy, associate medical director, infection prevention and control;
Grayson Privette, infection preventionist II; and Kimberly Wilson, hand hygiene manager. Sara Townsend (left) and Lauren Satchell, infection prevention associate II.

48 | FALL 2019 | Prevention

75
had one part-time infection preventionist (IP) devoted to generally positive, answers revealed a need for better monitor-
the ambulatory setting, with ambulatory sites assigned to ing of respiratory etiquette and more education about infection
IPs within the department. With limited ability to regularly prevention, Townsend said.
visit sites, CHOP “relied on those offices to call to ask for In another early initiative, the IPC team worked with ambula-
help,” Handy said. “Sometimes, we’d get a lot of informa- tory partners on a risk assessment, determining the likelihood
tion from these calls and sometimes we didn’t know what of events, identifying the risks to the organization if those
we didn’t know.” events occurred, and evaluating current systems for readiness.
Knowing this was not an ideal way to deliver reliable infec- These data were then used to help the team set priorities. “The
tion prevention practice, the IPC leadership began to think problem with collecting that much data at the beginning is you
through a holistic approach for the system. “We wanted to feel you have to do everything,” Handy said.
look at our program in a different way, to see if we could Using the CHOP system’s own framework for improve-
find a way to improve role clarity within the department,” ment, the team began by developing a charter to clearly
said Townsend. identify the work that lay ahead. “We wanted to iron out
With this in mind, CHOP reorganized the IPC department. how we could move this project forward,” Handy said. She
Handy and Townsend formed a strong physician-administra- noted that this process “feels a little tedious sometimes,
tive leader dyad, which had shown to be successful in other but is really important. For example, we had to write down
areas of the network and was known to be supported by the the goal that we wanted a program-based approach to the
literature, to oversee CHOP’s IPC ambulatory and procedure ambulatory network.”
services program. Additionally, measures had to be clarified. Handy noted
Additional staffing changes were also made during the key questions: “How are we going to know that what
department reorganization. Today, the department has an we’re doing is better than what we did before? Would we
entire team focused on ambulatory care and procedure ser- look at the number of people educated? Or the number of
vices that includes two full-time IPs; the ambulatory team is exposure events?”
also supported by the department’s data and logistics team. The team set specific goals for what would be accomplished
The latter includes two IP associates who manage data and in the first year, identifying primary drivers for these goals—
surveillance, a clinical practice analyst, and the hand hygiene responsive learning and proactive prevention—as well as sec-
program manager. This ambulatory team works throughout ondary drivers. It also included a “parking lot” for ideas that
the CHOP enterprise. were worth exploring in the future.
Putting an idea on hold is “hard to do, but it’s really impor-
SETTING FIRST PRIORITIES tant,” Handy explained. “It allows you to focus on the first
A first step for the newly constituted ambulatory IPC team couple of priorities.” At the same time, Handy advised choos-
was assessing IP practices and knowledge across CHOP’s vast ing one’s words carefully in these situations. “Try to say to
network. A survey was sent out to partners, asking both quan- your stakeholders, ‘That’s important work, and I can get back
titative and qualitative questions. “We really wanted to better to you in October.’ We found decent response when we were
understand where we were at, so we could understand where able to phrase things like that, compared to ‘I can’t get to that
we should be going,” Townsend said. While the responses were right now.’”

Grayson Privette and Regina Wagoner review hand hygiene data for
Members of the Children’s Hospital of Philadelphia ambulatory infection prevention control team. Children’s Hospital of Philadelphia primary care sites.

w w w.apic.org | 49
76
 “We wanted to look at our program in will be observing hand hygiene collection practices and revamping
the training process to improve compliance and data integrity.
a different way, to see if we could find Working in the individual offices and settings was not as
easy as it might seem. There were siloes, even within a single
a way to improve role clarity within small office. Townsend recalled how she thought she had a
the department.” great relationship with the nurses at a particular site. The nurses
were good at letting her know when test results for reportable
communicable diseases had come back positive. However, “at
the same site, someone told Lori they didn’t know what our
Once potential goals were identified, the team ranked them website, @CHOP, was.” This comment led the IPC team to start
in terms of effort needed to execute the task and levels of asking questions such as, “Do administrators, physicians, and
impact. Emphasis was placed on those goals with the highest nurses who work at the same office have meetings together?”
impact and lowest barriers to implementation. Additionally, the According to Townsend, the incident “made us aware of the
ambulatory IPC team agreed that if a facility asked a question fact that, just because you talk often to one type of professional,
about an idea that didn’t make the list of goals, the team would they may not share that information with their colleagues.”
be available to consult.
MOVING FORWARD
MAKING CONNECTIONS Even with those challenges, CHOP’s IPC team soon learned
The team has faced multiple hurdles, to be sure, including the that personnel who worked in ambulatory settings “want our
sheer number of sites and the distances between them. To help team’s input in their daily work and also want our team to
make in-person connections, the team identified a number of understand their work,” Townsend said. “We recognize this is
ambulatory forums where leaders of certain areas—like nurse a complicated process, and it’s going to take time and evolve.”
managers or medical directors—would meet. The ambulatory And there is work that remains to be done. “There still is confu-
IPC team began attending those meetings, which allowed them sion over which communicable diseases must be reported to the
to “start identifying groups of people we could meet face to IPC team. Our infection prevention website needs some work
face,” Handy said. to make it simpler so that staff in clinics and other ambulatory
Even with these outreach efforts, the team cannot possibly settings can find what they need when they need it,” Handy said.
meet everyone. In the beginning, the team struggled to get the More generally, “We need to work on how to connect people
attention of staff outside the main facility, who were suddenly in the network to our team,” Townsend stressed. “That’s hard
receiving emails from people they didn’t know. Recognizing with so many sites and so few people. To do this well, you need
that important messages are better received when the recipient to be able to adapt and adopt.” Handy further explained the
connected with the person sending it, “we needed to leverage our team’s long-term objective: “We hope to provide the opportunity
regional medical directors for impact,” Handy said. “At times, for reliable practices and the ability to develop transparent data
for key messaging, I would send an email out to the regional because with data we can drive improvement. What we hope to
medical director, who would then send it out to their staff.” do is reach all the practice partners, to put the picture together
The team quickly learned there were institutional differences regarding what IPC is, and how we can ultimately help them.”
that needed to be overcome. For example, most of their initial
resources provided a five-digit phone number, but some locations Sandy Smith is a medical writer for Prevention Strategist.
outside the main campus did not have access to that quick-dial sys-
tem—and didn’t know how to complete the rest of the sequence.
In another instance, the IPC team considered various
high-tech ideas, such as alerts in the electronic health record
system, to help remind nurses to call an IP if they noticed any
cases of reportable diseases. But after talking with the ambula-
tory teams, “we learned that we didn’t need to be fancy; what
they actually wanted was a sign for the back of their door, READ MORE ABOUT INFECTION PREVENTION IN
reminding them to call us,” Handy said. AMBULATORY CARE SETTINGS IN THE
AMERICAN JOURNAL OF INFECTION CONTROL
IMPROVING DATA SUBMISSION Ambulatory infection prevention risk assessment: Not all ambulatory
The network already had a hand hygiene program developed in sites are created equal. Havill NL, Nucci D, Sullivan L, Dembry L-M. Am
both the inpatient and ambulatory settings, but data submission J Infect Control, Vol. 42, Issue 6, S87-S88.
was inconsistent in the ambulatory setting. “The variation of data Infection surveillance systems in primary health care: A literature
led to variable compliance results,” Townsend said. “Also, there review. Manning ML, Pogorzelska-Maziarz M. Am J Infect Control, Vol. 44,
was a lack of understanding about the different hand hygiene Issue 4, 482-484.
moments in the ambulatory setting.” A future focus for the team

50 | FALL 2019 | Prevention

77
Module 3

Infection Control & Prevention Basics

Contents
3.1 Hand Sanitizer Factsheet . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
Centers for Disease Control and Prevention (CDC)
https://www.cdc.gov/handwashing/pdf/hand-sanitizer-factsheet.pdf

3.2 Core Practices for Infection Prevention in all Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82

CDC/Healthcare Infection Control Practices Advisory Committee (HICPAC)
https://www.cdc.gov/hicpac/pdf/core-practices.pdf

3.3 Clean Hands Count . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Association for Professionals in Infection Control and Epidemiology (APIC)
Forms & Checklists for Infection Prevention, Volume 1

3.4 Personal Protective Equipment Efficiency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98

APIC
Forms & Checklists for Infection Prevention, Volume 1

3.5 Personal Protective Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

APIC
Forms & Checklists for Infection Prevention, Volume 1

3.6 Cover Your Cough . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

CDC Posters in English and Spanish

3.7 Handwashing, at Home, at Play, and Out and About . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105

CDC Posters in English and Spanish

3.8 Five Moments for Hand Hygiene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107

World Health Organization (WHO)

3.9 Healthcare worker hand contamination at critical moments in outpatient

care settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108
James Bingham, MS; Ginnie Abell, BA, RN, CIC; LeAnne Kienast, BS, et al.
American Journal of Infection Control
Nov. 2016, Vol 44, Issue 11, p. 1198-1202

3.10 Safe Injection Guidelines Pocket Card . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 113

CDC

3.11 Safe Injection Practices Checklist . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114

CDC

3.12 Patient Injection Safety Handout . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

CDC

78
Resources
Standard Precautions for All Patient Care
CDC
https://www.cdc.gov/infectioncontrol/basics/standard-precautions.html

Chart for Recommendations for Application of Standard Precautions for the Care of All
Patients in All Healthcare Settings
CDC
https://www.cdc.gov/infectioncontrol/guidelines/isolation/appendix/standard-precautions.html

One and Only Campaign

CDC
https://www.cdc.gov/injectionsafety/1anonly.html

Five Moments for Hand Hygiene

WHO
https://www.who.int/gpsc/5may/background/5moments/en/

79
3.1 Handwashing and Hand Sanitizer Use
at Home, at Play, and Out and About
Germs are everywhere! They can get onto hands and items we touch during
daily activities and make you sick. Cleaning hands at key times with soap and
water or hand sanitizer is one of the most important steps you can take to avoid
getting sick and spreading germs to those around you.

There are important differences between washing hands with soap and water
and cleaning them with hand sanitizer. For example, alcohol-based hand
sanitizers don’t kill ALL types of germs, such as a stomach bug called norovirus,
some parasites, and Clostridium difficile, which causes severe diarrhea. Hand
sanitizers also may not remove harmful chemicals, such as pesticides and
heavy metals like lead. Handwashing reduces the amounts of all types of germs,
pesticides, and metals on hands. Knowing when to clean your hands and which
method to use will give you the best chance of preventing sickness.

When should I use?

Soap and Water Alcohol-Based Hand Sanitizer

• Before, during, and after preparing food • Before and after visiting a friend or a loved
• Before eating food one in a hospital or nursing home, unless
the person is sick with Clostridium difficile
• Before and after caring for someone (if so, use soap and water to wash hands).
who is sick
• Before and after treating a cut or wound • If soap and water are not available, use an
alcohol-based hand sanitizer that contains
• After using the bathroom, changing
at least 60% alcohol, and wash with soap
diapers, or cleaning up a child who
and water as soon as you can.
has used the bathroom
• After blowing your nose, coughing,
* Do NOT use hand sanitizer if your hands are visibly
or sneezing
dirty or greasy: for example, after gardening,
• After touching an animal, animal food or playing outdoors, or after fishing or camping
treats, animal cages, or animal waste (unless a handwashing station is not available).
• After touching garbage Wash your hands with soap and water instead.

• If your hands are visibly dirty or greasy

U.S. Department of Health and Human Services

Centers for Disease Control and Prevention
80
CS270631
 How should I use?

Soap and Water Alcohol-Based Hand Sanitizer

• Wet your hands with clean running water Use an alcohol-based hand sanitizer that
(warm or cold) and apply soap. contains at least 60% alcohol. Supervise
• Lather your hands by rubbing them young children when they use hand sanitizer
together with the soap. to prevent swallowing alcohol, especially in
schools and childcare facilities.
• Scrub all surfaces of your hands, including
the palms, backs, fingers, between • Apply. Put enough product on hands to
your fingers, and under your nails. Keep cover all surfaces.
scrubbing for 20 seconds. Need a timer? • Rub hands together, until hands feel dry.
Hum the “Happy Birthday” song twice. This should take around 20 seconds.
• Rinse your hands under clean,
running water. Note: Do not rinse or wipe off the hand
sanitizer before it’s dry; it may not work
• Dry your hands using a clean towel or as well against germs.
air dry them.

For more information, visit the CDC handwashing website, www.cdc.gov/handwashing.

81
3.2
Core Infection Prevention and Control Practices for
Safe Healthcare Delivery in All Settings –
Recommendations of the Healthcare Infection
Control Practices Advisory Committee

Preface
The Healthcare Infection Control Practices Advisory Committee (HICPAC) is a federal advisory
committee chartered in 1991 to provide advice and guidance to the Centers for Disease Control and
Prevention (CDC) and the Secretary of the Department of Health and Human Services (HHS) regarding
the practice of infection control and strategies for surveillance, prevention, and control of healthcare-
associated infections, antimicrobial resistance and related events in United States healthcare settings.
CDC has been developing recommendations for healthcare infection control to prevent infections in
patients and healthcare personnel since the 1970’s. These recommendations continue to evolve over
time as evidence bases are built and serve as a foundation for healthcare safety across settings, a
basis for quality improvement efforts, and part of the process that identifies important research gaps.
Guideline development methods have since moved beyond expert opinion alone and incorporated
systematic approaches to evidence analysis. A number of core practices are recommended by CDC
and considered standards of care and/or accepted practices (e.g., aseptic technique, hand hygiene
before patient contact) to prevent infection in healthcare settings. These widely agreed upon
practices are elements of care that are not expected to change based on additional research, either
because of an overwhelming preponderance of evidence (e.g., hand hygiene requirements), or in
some cases due to ethical concerns (e.g., randomizing patients to procedures performed by trained
versus untrained personnel). Therefore, these accepted practices are categorized as strong
recommendations, even when high-quality randomized controlled trials are not available to support
them. In an effort to streamline and systematize the process for updating existing guidelines without
recreating the analytic process for each of these accepted/core practices, in March 2013, CDC
charged HICPAC to review existing CDC guidelines and identify all recommendations that warrant
inclusion as core practices. A HICPAC workgroup was formed that was led by HICPAC members and
contained representatives from the following stakeholder organizations: America’s Essential
Hospitals, the Association for Professionals in Infection Control and Epidemiology (APIC), the Council
of State and Territorial Epidemiologists (CSTE), the Public Health Agency of Canada (PHAC), the
Society for Healthcare Epidemiology of America (SHEA), and the Society of Hospital Medicine (SHM).
The Workgroup provided updates and obtained HICPAC input at the June 2013, November 2013, April
2014, and July 2014 public meetings. HICPAC voted to finalize the recommendations at the July 2014

82

Last updated: March 15, 2017 Page 1 of 15

Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings
Recommendations of the HICPAC

meeting. Additional information about HICPAC is available at the HICPAC website

(www.cdc.gov/hicpac).

Introduction
Adherence to infection prevention and control practices is essential to providing safe and high-
quality patient care across all settings where healthcare is delivered. Substantial attention has been
focused in recent years on improving infection prevention practices within acute care hospitals to
optimize patient safety; many of these practices also need to be applied across multiple aspects of
patient care. In addition, changes in healthcare during the past decade, driven at least in part by
efforts to contain costs, have resulted in an increasing proportion and range of healthcare services
being delivered outside of the acute care setting.1,2 These ambulatory and community-based
healthcare encounters also can lead to infectious complications that can be prevented using those
same infection prevention and control practices.
This document concisely describes a core set of infection prevention and control practices that
are required in all healthcare settings, regardless of the type of healthcare provided. The practices
were selected from among existing CDC recommendations and are the subset that HICPAC and its
Core Practices Working Group determined were fundamental standards of care that are not expected
to change based on emerging evidence or to be regularly altered by changes in technology or
practices, and are applicable across the continuum of healthcare settings. This document also is
intended to improve consistency of language, reduce redundancy across guidelines, and provide a
convenient reference wherein these recommendations are maintained. A review of existing CDC
guidelines demonstrated many examples of similar recommendations in multiple guidelines with
variability in language. The recommendations outlined in this document are intended to serve as a
standard reference and reduce the need to repeatedly evaluate practices that are considered basic
and accepted as standards of medical care. Readers are urged to consult the full text of CDC
guidelines (see references) for additional background and rationale related to the core practice
recommendations captured here.

Scope
The core practices in this document should be implemented in all settings where healthcare is
delivered. These venues include both inpatient settings (e.g., acute, long-term care, rehabilitation,
behavioral health) and outpatient settings (e.g., physician and nurse practitioner offices, clinics,
urgent care, ambulatory surgical centers, imaging centers, dialysis centers, physical therapy and
rehabilitation centers, alternative medicine clinics). In addition, these practices apply to healthcare
delivered in settings other than traditional healthcare facilities, such as homes, pharmacies, and
health fairs.
Healthcare personnel (HCP) referred to in this document include all persons, paid and unpaid, in
the healthcare setting having direct patient contact and/or potential for exposure to patients and/or
to infectious materials (e.g., body substances, used medical supplies and equipment, soiled
environmental surfaces). This also includes persons not directly involved in patient care (e.g., clerical

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staff, environmental services, volunteers) who could be exposed to infectious material in a healthcare
setting.

Methods
CDC healthcare infection control guidelines3-19 were reviewed, and recommendations included in
more than one guideline were grouped into core infection prevention practice domains (e.g.,
education and training of HCP on infection prevention, injection and medication safety). Additional
CDC materials aimed at providing general infection prevention guidance outside of the acute care
setting20-22 were also reviewed. HICPAC formed a workgroup led by HICPAC members and including
representatives of professional organizations (see Contributors for full list). The workgroup reviewed
and discussed all of the practices, further refined the selection and description of the core practices,
and presented drafts to HICPAC at public meetings in June 2013, November 2013, April 2014, and July
2014 to inform HICPAC’s final recommendations. The recommendations (see Table) were approved
by the full Committee in July 2014.

Conclusions
Adherence to basic infection prevention and control practices are essential, not only in acute care
hospitals but also in settings with limited infection prevention infrastructure. The frequency of
infectious outbreaks stemming from errors in infection control across settings (e.g., reuse of syringes
between patients leading to transmission of viral hepatitis23-25) underscores the critical importance of
adherence to these core infection prevention practices wherever healthcare is provided.
Recommendations highlighted in this document represent minimum expectations, and healthcare
personnel and facilities will need to supplement them according to their settings, procedures
performed, and patient populations.
Readers should consult the full texts of CDC healthcare infection control guidelines for
background, rationale, and related infection prevention recommendations for more comprehensive
information. We encourage professional associations and societies and the research community to
develop tools to facilitate implementation and maintenance of these core infection prevention
practices across the continuum of healthcare.

Text References
1. Hsiao CJ, Cherry DK, Beatty PC, Rechsteiner EA. National Ambulatory Medical Care Survey: 2007
Summary. National health statistics reports; no 27. Hyattsville, MD: National Center for Health
Statistics. 2010.
2. Medicare Payment Advisory Committee. A data book: Health care spending and the Medicare
program, June 2016 [PDF - 4.1 MB] (http://www.medpac.gov/docs/default-source/data-
book/june-2016-data-book-health-care-spending-and-the-medicare-program.pdf?sfvrsn=0).
3. Bolyard EA. Tablan OC, Williams WW, Pearson ML, Shapiro CN, Deitchmann SD. Guideline for
Infection Control in Healthcare Personnel, 1998 (https://stacks.cdc.gov/view/cdc/7250). Hospital
Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1998 Jun;
19(6):407-63.

84
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4. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site
Infection, 1999 (https://stacks.cdc.gov/view/cdc/7160). Hospital Infection Control Practices
Advisory Committee. Infect Control Hosp Epidemiol 1999 Apr 20(4):250-78.
5. Boyce JM, Pittet D, Healthcare Infection Control Practices Advisory Committee, Society for
Healthcare Epidemiology of America, Association for Professionals in Infection Control, Infectious
Diseases Society of America, and the Hand Hygiene Task Force. Guideline for Hand Hygiene in
Health-Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory
Committee and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force
(https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm). Infect Control Hosp Epidemiol.
2002 Dec 23(12 Suppl):S3-40.
6. Sehulster L, Chin RY, Healthcare Infection Control Practices Advisory Committee. Guidelines for
Environmental Infection Control in Health-Care Facilities. Recommendations of CDC and the
Healthcare Infection Control Practices Advisory Committee [PDF - 2.31 MB]
(https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines.pdf). MMWR
Recomm Rep 2003 Jun 6:52(RR-10):1-42.
7. Jensen PA, Lambert LA, Iademarco MF, Ridzon R. Guidelines for Preventing the Transmission of
Mycobacterium tuberculosis in Health-Care Settings, 2005 [PDF - 4.2 MB]
(https://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf). MMWR Recomm Rep. 2005 Dec 30:54(RR-
17):1-141.
8. Siegel JD, Rhinehart E, Jackson M, Chiarello L, Healthcare Infection Control Practices Advisory
Committee. Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006 [PDF -
553 KB] (https://www.cdc.gov/infectioncontrol/pdf/guidelines/mdro-guidelines.pdf). Am J Infect
Control, 2007 Dec 35 (10 Suppl 2):S165-93.
9. Siegel JD, Rhinehart E, Jackson M, Chiarello L, Healthcare Infection Control Practices Advisory
Committee. 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious
Agents in Healthcare Settings [PDF - 1.42 MB]
(https://wwwdev.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines.pdf). Am J Infect
Control. 2007 Dec 35(10 Suppl 2)S65-164.
10. Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA, Healthcare Infection Control Practices
Advisory Committee, Guideline for Prevention of Catheter-Associated Urinary Tract Infection
2009 [PDF - 650 KB] (https://www.cdc.gov/infectioncontrol/pdf/guidelines/cauti-guidelines.pdf).
Infect Control Hosp Epidemiol, 2010 Apr 31(4):319-26.
11. Centers for Disease Control and Prevention. Guidance for Control of Infections with Carbapenem-
Resistant or Carbapenemase-Producing Enterobacteriaceae in Acute Care Facilities [PDF - 381 KB]
(https://www.cdc.gov/hai/pdfs/cre/cre-guidance-508.pdf). MMWR 2009 Mar 20:58 (10):256-60.
12. Division of Viral Disease, National Center for Immunization and Respiratory Diseases, Centers for
Disease Control and Prevention. Updated Norovirus Outbreak Management and Disease
Prevention Guidelines (https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6003a1.htm). MMWR
2011 Mar 4:60(RR-3):1-18.
13. O’Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H,
Mermel LA, Pearson ML, Raad I, Randolph AG, Rupp ME, Saint S, Healthcare Infection Control
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Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-Related

Infections [PDF - 678 KB] (https://www.cdc.gov/infectioncontrol/pdf/guidelines/bsi-
guidelines.pdf). Am J Infect Control. 2011 May 39(4 Suppl 1):S1-34.
14. Rutala WA, Weber DJ, Healthcare Infection Control Practices Advisory Committee. Guideline for
Disinfection and Sterilization in Healthcare Facilities, 2008 [PDF - 1.26 MB]
(https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf). Am J Infect
Control. 2013;41(5 Suppl):S67-71.
15. Tablan OC, Anderson LJ, Besser R, Bridges C, Haijeh R, Healthcare Infection Control Practices
Advisory Committee. Guidelines for Preventing Healthcare-associated Pneumonia, 2003
Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee
https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5303a1.htm. MMWR Recomm Rep 204 Mar
26:53(RR-3):1-26.
16. World Health Organization. WHO Guidelines on Hand Hygiene in Health Care: First Global Patient
Safety Challenge Clean Care Is Safer Care [PDF - 4.26 MB]
(http://whqlibdoc.who.int/publications/2009/9789241597906_eng.pdf). Geneva. World Health
Organization, 2009.
17. Centers for Disease Control and Prevention. Immunization of Healthcare Personnel:
Recommendations of the Advisory Committee on Immunization Practices (ACIP) [PDF - 705 KB]
(https://www.cdc.gov/mmwr/pdf/rr/rr6007.pdf). MMWR Recomm Rep. 2011 Nov 25:60(RR-7):1-45.
18. U.S. Public Health Service Working Group on Occupational Postexposure Prophylaxis, Kuhar DT,
Henderson DK, et. al., https://stacks.cdc.gov/view/cdc/20711. September, 2013.
19. US Department of Labor. Occupational Safety & Health Standards. 29 CFR 1910.1030, Bloodborne
Pathogens
(https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10051&p_table=STANDARDS).
March 6, 1992.
20. Centers for Disease Control and Prevention. Recommendations for Preventing Transmission of
Infections Among Chronic Hemodialysis Patients
(https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm). MMWR. April 27,
2001/50(RR05); 1-43.
21. Centers for Disease Control and Prevention. Guide to Infection Prevention in Outpatient Settings:
Minimum Expectations for Safe Care [PDF - 632 KB]
(https://www.cdc.gov/hai/pdfs/guidelines/ambulatory-care-04-2011.pdf). April, 2011.
22. Centers for Disease Control and Prevention. Basic Infection Control and Prevention Plan for
Outpatient Oncology Settings [PDF - 1.67 MB] (https://www.cdc.gov/hai/pdfs/guidelines/basic-
infection-control-prevention-plan-2011.pdf). December, 2011.
23. Thompson ND, Perz JF, Moorman AC, Holmberg SD. Nonhospital health care-associated Hepatitis
B and C virus transmission: United States, 1998-2008. Ann Intern Med. 2009;150:33-39.
24. Greeley RD, Semple S, Thompson ND, et al. Hepatitis B outbreak associated with a hematology-
oncology office practice in New Jersey, 2009. Am J Infect Control. 2011;39:663-670.
25. Thompson ND, Perz JF, Moorman AC, et al. Nonhospital health care–associated hepatitis B and C
virus transmission: United States, 1998–2008. Ann Intern Med 2009;150:33-39.
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Core Practices Table

Core Practice Category Core Practices Comments
1. Leadership Support 1. Ensure that the governing body of the healthcare facility or organization To be successful, infection prevention programs require
References and resources: is accountable for the success of infection prevention activities. visible and tangible support from all levels of the healthcare
1-12 2. Allocate sufficient human and material resources to infection facility’s leadership.
prevention to ensure consistent and prompt action to remove or
mitigate infection risks and stop transmission of infections. Ensure that
staffing and resources do not prevent nurses, environmental staff, et.
al., from consistently adhering to infection prevention and control
practices.
3. Assign one or more qualified individuals with training in infection
prevention and control to manage the facility’s infection prevention
program.
4. Empower and support the authority of those managing the infection
prevention program to ensure effectiveness of the program.
2. Education and Training 1. Provide job-specific, infection prevention education and training to all Training should be adapted to reflect the diversity of the
of Healthcare Personnel on healthcare personnel for all tasks. workforce and the type of facility, and tailored to meet the
Infection Prevention 2. Develop processes to ensure that all healthcare personnel understand needs of each category of healthcare personnel being
References and resources: and are competent to adhere to infection prevention requirements as trained.

87
1-4, 6-8, 10-13 they perform their roles and responsibilities.
3. Provide written infection prevention policies and procedures that are
available, current, and based on evidence-based guidelines (e.g., CDC/
HICPAC, etc.)
4. Require training before individuals are allowed to perform their duties
and at least annually as a refresher.
5. Provide additional training in response to recognized lapses in
adherence and to address newly recognized infection transmission
threats (e.g., introduction of new equipment or procedures).
3. Patient, Family and 1. Provide appropriate infection prevention education to patients, family Include information about how infections are spread, how
Caregiver Education members, visitors, and others included in the caregiving network. they can be prevented, and what signs or symptoms should
References and resources: prompt reevaluation and notification of the patient’s
2-5, 7-8, 10-11 healthcare provider. Instructional materials and delivery
should address varied levels of education, language
comprehension, and cultural diversity.

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Core Practice Category Core Practices Comments

4. Performance Monitoring 1. Monitor adherence to infection prevention practices and infection Performance measures should be tailored to the care
and Feedback control requirements. activities and the population served.
References and resources: 2. Provide prompt, regular feedback on adherence and related outcomes
1-14 to healthcare personnel and facility leadership.
3. Train performance monitoring personnel and use standardized tools
and definitions.
4. Monitor the incidence of infections that may be related to care
provided at the facility and act on the data and use information
collected through surveillance to detect transmission of infectious
agents in the facility.
5. Standard Precautions Use Standard Precautions to care for all patients in all settings. Standard Precautions are the basic practices that apply to all
Standard Precautions include: patient care, regardless of the patient’s suspected or
5a. Hand hygiene confirmed infectious state, and apply to all settings where
5b. Environmental cleaning and disinfection care is delivered. These practices protect healthcare
5c. Injection and medication safety personnel and prevent healthcare personnel or the
5d. Risk assessment with use of appropriate personal protective environment from transmitting infections to other patients.
equipment (e.g., gloves, gowns, face masks) based on activities being
performed
5e. Minimizing Potential Exposures (e.g. respiratory hygiene and cough

88
etiquette)
5f. Reprocessing of reusable medical equipment between each patient
and when soiled
5a. Hand Hygiene 1. Require healthcare personnel to perform hand hygiene in accordance Unless hands are visibly soiled, an alcohol-based hand rub is
References and with Centers for Disease Control and Prevention (CDC) preferred over soap and water in most clinical situations due
resources: 3, 7, 11 recommendations. to evidence of better compliance compared to soap and
2. Use an alcohol-based hand rub or wash with soap and water for the water. Hand rubs are generally less irritating to hands and
following clinical indications: are effective in the absence of a sink.
a. Immediately before touching a patient
Refer to “CDC Guideline for Hand Hygiene in Health-Care
b. Before performing an aseptic task (e.g., placing an indwelling device)
Settings” or “Guideline for Isolation Precautions: Preventing
or
Transmission of Infectious Agents in Healthcare Settings,
handling invasive medical devices
2007” for additional details.
c. Before moving from work on a soiled body site to a clean body site
on the same patient
d. After touching a patient or the patient’s immediate environment
e. After contact with blood, body fluids or contaminated surfaces
f. Immediately after glove removal
3. Ensure that healthcare personnel perform hand hygiene with soap and
water when hands are visibly soiled.
4. Ensure that supplies necessary for adherence to hand hygiene are
readily accessible in all areas where patient care is being delivered.

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Core Practice Category Core Practices Comments

5b. Environmental 1. Require routine and targeted cleaning of environmental surfaces as When information from manufacturers is limited regarding
Cleaning and indicated by the level of patient contact and degree of soiling. selection and use of agents for specific microorganisms,
Disinfection a. Clean and disinfect surfaces in close proximity to the patient and environmental surfaces or equipment, facility policies
References and frequently touched surfaces in the patient care environment on a regarding cleaning and disinfecting should be guided by the
resources: 4, 7, 10, 11, more frequent schedule compared to other surfaces. best available evidence and careful consideration of the risks
13, 21 b. Promptly clean and decontaminate spills of blood or other and benefits of the available options.
potentially infectious materials.
Refer to “CDC Guidelines for Environmental Infection Control
2. Select EPA-registered disinfectants that have microbiocidal activity
in Health-Care Facilities” and “CDC Guideline for Disinfection
against the pathogens most likely to contaminate the patient-care
and Sterilization in Healthcare Facilities” for details.
environment.
3. Follow manufacturers’ instructions for proper use of cleaning and
disinfecting products (e.g., dilution, contact time, material
compatibility, storage, shelf-life, safe use and disposal).
5c. Injection and 1. Use aseptic technique when preparing and administering medications Refer to “Guideline for Isolation Precautions: Preventing
Medication Safety 2. Disinfect the access diaphragms of medication vials before inserting a Transmission of Infectious Agents in Healthcare Settings,
References and device into the vial 2007” for details.
resources: 11, 17-20 3. Use needles and syringes for one patient only (this includes
manufactured prefilled syringes and cartridge devices such as insulin
pens).

89
4. Enter medication containers with a new needle and a new syringe, even
when obtaining additional doses for the same patient.
5. Ensure single-dose or single-use vials, ampules, and bags or bottles of
parenteral solution are used for one patient only.
6. Use fluid infusion or administration sets (e.g., intravenous tubing) for
one patient only
7. Dedicate multidose vials to a single patient whenever possible. If
multidose vials are used for more than one patient, restrict the
medication vials to a centralized medication area and do not bring them
into the immediate patient treatment area (e.g., operating room,
patient room/cubicle)
8. Wear a facemask when placing a catheter or injecting material into the
epidural or subdural space (e.g., during myelogram, epidural or spinal
anesthesia)

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Core Practice Category Core Practices Comments

5d. Risk Assessment 1. Ensure proper selection and use of personal protective equipment (PPE) PPE, e.g., gloves, gowns, face masks, respirators,
with Appropriate based on the nature of the patient interaction and potential for goggles and face shields, can be effective barriers to
Use of Personal exposure to blood, body fluids and/or infectious material: transmission of infections but are secondary to the
Protective a. Wear gloves when it can be reasonably anticipated that contact with more effective measures such as administrative and
Equipment blood or other potentially infectious materials, mucous membranes, engineering controls.
References and non-intact skin, potentially contaminated skin or contaminated
Refer to “Guideline for Isolation Precautions: Preventing
resources: 7, 11, 20 equipment could occur.
Transmission of Infectious Agents in Healthcare Settings,
b. Wear a gown that is appropriate to the task to protect skin and
2007” as well as Occupational Safety and Health
prevent soiling of clothing during procedures and activities that
Administration (OSHA) requirements for details.
could cause contact with blood, body fluids, secretions, or
excretions.
c. Use protective eyewear and a mask, or a face shield, to protect the
mucous membranes of the eyes, nose and mouth during procedures
and activities that could generate splashes or sprays of blood, body
fluids, secretions and excretions. Select masks, goggles, face shields,
and combinations of each according to the need anticipated by the
task performed.
d. Remove and discard PPE, other than respirators, upon completing a
task before leaving the patient’s room or care area. If a respirator is

90
used, it should be removed and discarded (or reprocessed if
reusable) after leaving the patient room or care area and closing the
door.
e. Do not use the same gown or pair of gloves for care of more than
one patient. Remove and discard disposable gloves upon completion
of a task or when soiled during the process of care.
f. Do not wash gloves for the purpose of reuse.
2. Ensure that healthcare personnel have immediate access to and are
trained and able to select, put on, remove, and dispose of PPE in a
manner that protects themselves, the patient, and others
5e. Minimizing 1. Use respiratory hygiene and cough etiquette to reduce the transmission Refer to “Guideline for Isolation Precautions:
Potential Exposures of respiratory infections within the facility. Preventing Transmission of Infectious Agents in
References and 2. Prompt patients and visitors with symptoms of respiratory infection to Healthcare Settings, 2007” for details.
resources: 1, 7, 11, 16 contain their respiratory secretions and perform hand hygiene after
contact with respiratory secretions by providing tissues, masks, hand
hygiene supplies and instructional signage or handouts at points of
entry and throughout the facility
3. When space permits, separate patients with respiratory symptoms from
others as soon as possible (e.g., during triage or upon entry into the
facility).

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Core Practice Category Core Practices Comments

5f. Reprocessing of 1. Clean and reprocess (disinfect or sterilize) reusable medical equipment Manufacturer’s instructions for reprocessing reusable
Reusable Medical (e.g., blood glucose meters and other point-of-care devices, blood medical equipment should be readily available and used to
Equipment pressure cuffs, oximeter probes, surgical instruments, endoscopes) establish clear operating procedures and training content for
References and prior to use on another patient and when soiled. the facility. Instructions should be posted at the site where
resources: 2-4, 7-8, a. Consult and adhere to manufacturers’ instructions for reprocessing. equipment reprocessing is performed. Reprocessing
11-13 2. Maintain separation between clean and soiled equipment to prevent personnel should have training in the reprocessing steps and
cross contamination. the correct use of PPE necessary for the task. Competencies
of those personnel should be documented initially upon
assignment of their duties, whenever new equipment is
introduced, and periodically (e.g., annually). Additional
details about reprocessing essentials for facilities can be
found in HICPAC’s recommendations Essential Elements of a
Reprocessing Program for Flexible Endoscopes
(https://www.cdc.gov/hicpac/recommendations/flexible-
endoscope-reprocessing.html).
Refer to “CDC Guideline for Disinfection and
Sterilization in Healthcare Facilities” for details.
6. Transmission-Based 1. Implement additional precautions (i.e., Contact, Droplet, and/or Implementation of Transmission-Based Precautions may
Precautions Airborne Precautions) for patients with documented or suspected differ depending on the patient care settings (e.g.,

91
References and resources: diagnoses where contact with the patient, their body fluids, or their inpatient, outpatient, long-term care), the facility design
7, 11 environment presents a substantial transmission risk despite adherence characteristics, and the type of patient interaction, and
to Standard Precautions should be adapted to the specific healthcare setting.
2. Adapt transmission-based precautions to the specific healthcare setting,
Refer to “Guideline for Isolation Precautions: Preventing
the facility design characteristics, and the type of patient interaction.
Transmission of Infectious Agents in Healthcare Settings,
3. Implement transmission-based precautions based on the patient’s
2007” for details.
clinical presentation and likely infection diagnoses (e.g., syndromes
suggestive of transmissible infections such as diarrhea, meningitis, fever
and rash, respiratory infection) as soon as possible after the patient
enters the healthcare facility (including reception or triage areas in
emergency departments, ambulatory clinics or physicians’ offices) then
adjust or discontinue precautions when more clinical information
becomes available (e.g., confirmatory laboratory results).
4. To the extent possible, place patients who may need transmission-
based precautions into a single-patient room while awaiting clinical
assessment.
5. Notify accepting facilities and the transporting agency about suspected
infections and the need for transmission-based precautions when
patients are transferred.

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Core Practice Category Core Practices Comments

7. Temporary invasive 1. During each healthcare encounter, assess the medical necessity of any Early and prompt removal of invasive devices should be part
Medical Devices for Clinical invasive medical device (e.g., vascular catheter, indwelling urinary of the plan of care and included in regular assessment.
Management catheter, feeding tubes, ventilator, surgical drain) in order to identify Healthcare personnel should be knowledgeable regarding
References and resources: the earliest opportunity for safe removal. risks of the device and infection prevention interventions
8, 1 2. Ensure that healthcare personnel adhere to recommended insertion associated with the individual device, and should advocate
and maintenance practices for the patient by working toward removal of the device as
soon as possible.
Refer to “CDC Guidelines for Environmental Infection
Control in Health-Care Facilities” and “CDC Guideline for
Disinfection and Sterilization in Healthcare Facilities” for
details.
8. Occupational Health 1. Ensure that healthcare personnel either receive immunizations or have It is the professional responsibility of all healthcare
References and resources: documented evidence of immunity against vaccine-preventable organizations and individual personnel to ensure adherence
1, 7, 16, 20 diseases as recommended by the CDC, CDC’s Advisory Committee on to federal, state and local requirements concerning
Immunization Practices (ACIP) and required by federal, state or local immunizations; work policies that support safety of
authorities. healthcare personnel; timely reporting of illness by
2. Implement processes and sick leave policies to encourage healthcare employees to employers when that illness may represent a
personnel to stay home when they develop signs or symptoms of acute risk to patients and other healthcare personnel; and
infectious illness (e.g. fever, cough, diarrhea, vomiting, or draining skin notification to public health authorities when the illness has

92
lesions) to prevent spreading their infections to patients and other public health implications or is required to be reported.
healthcare personnel.
Refer to OSHA’s website for specific details on healthcare
3. Implement a system for healthcare personnel to report signs,
standards: Occupational Safety and Health Administration -
symptoms, and diagnosed illnesses that may represent a risk to their
Infectious Diseases
patients and coworkers to their supervisor or healthcare facility staff
(https://www.osha.gov/SLTC/healthcarefacilities/infectious_
who are responsible for occupational health
diseases.html).
4. Adhere to federal and state standards and directives applicable to
protecting healthcare workers against transmission of infectious agents
including OSHA’s Bloodborne Pathogens Standard, Personal Protective
Equipment Standard, Respiratory Protection standard and TB
compliance directive.

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Table References
1. Bolyard EA. Tablan OC, Williams WW, Pearson ML, Shapiro CN, Deitchmann SD. Guideline for
Infection Control in Healthcare Personnel, 1998. Hospital Infection control Practices Advisory
committee. Infect Control Hosp Epidemiol. 1998 Jun; 19(6):407-63. (Available at
https://stacks.cdc.gov/view/cdc/7250.)
2. Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for Prevention of Surgical Site
Infection, 1999. Hospital Infection Control Practices Advisory committee. Infect control Hosp
Epidemiol 1999 Apr 20(4):250-78. (Available at https://stacks.cdc.gov/view/cdc/7160.)
3. Boyce JM, Pittet D, Healthcare Infection control Practices Advisory Committee, Society for
Healthcare Epidemiology of America, Association for Professionals in Infection control, Infectious
Diseases Society of America, Hand Hygiene Task Force. Guideline for Hand Hygiene in Health-Care
Settings: recommendation of the Healthcare Infection Control Practices Advisory committee and
the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force. Infect control Hosp Epidemiol. 2002 Dec
23(12 Suppl):S3-40. (Available at https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5116a1.htm.)
4. Sehulster L, Chin RY, Healthcare Infection Control Practices Advisory Committee. Guidelines for
Environmental Infection Control in Health-Care Facilities. Recommendations of CDC and the
Healthcare Infection Control Practices Advisory Committee. MMWR Recomm Rep 2003 Jun
6:52(RR-10):1-42. (Available at
https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines.pdf [PDF - 2.31
MB].)
5. Jensen PA, Lambert LA, Iademarco MF, Ridzon R. Guidelines for Preventing the Transmission of
Mycobacterium tuberculosis in Health-Care Settings, 2005. MMWR Recomm Rep. 2005 Dec
30:54(RR-17):1-141. (Available at https://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf [PDF - 4.15
MB].)
6. Siegel JD, Rhinehart E, Jackson M, Chiarello L, Healthcare Infection Control Practices Advisory
Committee. Management of Multidrug-Resistant Organisms in Healthcare Settings, 2006. Am J
Infect control, 2007 Dec 35 (10 Suppl 2):S165-93. (Available at
https://www.cdc.gov/infectioncontrol/pdf/guidelines/mdro-guidelines.pdf [PDF - 553 KB].)
7. Siegel JD, Rhinehart E, Jackson M, Chiarello L, Healthcare Infection Control Practices Advisory
Committee. 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious
Agents in Healthcare Settings. Am J Infect Control. 2007 Dec 35(10 Suppl 2)S65-164. (Available at
https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-guidelines.pdf [PDF - 1.42 MB].)
8. Gould CV, Umscheid CA, Agarwal RK, Kuntz G, Pegues DA, Healthcare Infection Control Practices
Advisory committee, Guideline for Prevention of Catheter-Associated Urinary Tract Infection
2009. Infect control Hosp Epidemiol, 2010 Apr 31(4):319-26. (Available at
https://www.cdc.gov/infectioncontrol/pdf/guidelines/cauti-guidelines.pdf [PDF - 650 KB].)
9. Centers for Disease Control and Prevention. Guidance for Control of Infections with Carbapenem-
Resistant or Carbapenemase-Producing Enterobacteriaceae in Acute Care Facilities. MMWR 2009
Mar 20:58 (10):256-60. (Available at https://www.cdc.gov/hai/pdfs/cre/cre-guidance-508.pdf
[PDF - 381 KB].)

93
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Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings
Recommendations of the HICPAC

10. Division of Viral Disease, National Center for Immunization and Respiratory Diseases, Centers for
Disease Control and Prevention. Updated Norovirus Outbreak Management and Disease
Prevention Guidelines. MMWR 2011 Mar 4:60(RR-3):1-18. (Available at
https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6003a1.htm.)
11. O’Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H,
Mermel LA, Pearson ML, Raad I, Randolph AG, Rupp ME, Saint S, Healthcare Infection Control
Practices Advisory Committee. Guidelines for the Prevention of Intravascular Catheter-Related
Infections. Am J Infect Control. 2011 May 39(4 Suppl 1):S1-34. (Available at
https://www.cdc.gov/infectioncontrol/pdf/guidelines/bsi-guidelines.pdf [PDF - 678 KB].)
12. Centers for Disease Control and Prevention. Guide to Infection Prevention for Outpatient Settings:
Minimum Expectations for Safe Care. November, 2015. (Available at
https://www.cdc.gov/infectioncontrol/pdf/outpatient/guide.pdf [PDF - 1.43 MB].)
13. Rutala WA, Weber DJ, Healthcare Infection Control Practices Advisory Committee. Guideline for
Disinfection and Sterilization in Healthcare Facilities, 2008. Am J Infect Control.2013;41(5
Suppl):S67-71. (Available at https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-
guidelines.pdf [PDF - 1.26 MB].)
14. Tablan OC, Anderson LJ, Besser R, Bridges C, Haijeh R, Healthcare Infection Control Practices
Advisory Committee. Guidelines for Preventing Healthcare-associated Pneumonia, 2003
Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee.
MMWR Recomm Rep 204 Mar 26:53(RR-3):1-26. (Available at
https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5303a1.htm.)
15. Centers for Disease Control and Prevention. Immunization of Healthcare Personnel:
Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR
Recomm Rep. 2011 Nov 25:60(RR-7):1-45. (Available at
https://www.cdc.gov/mmwr/pdf/rr/rr6007.pdf [PDF - 705 KB].)
16. Centers for Disease Control and Prevention. Injection safety materials. (Available at
https://www.cdc.gov/injectionsafety/.)
17. Centers for Disease Control and Prevention. The One & Only Campaign injection safety training
materials. (Available at https://www.cdc.gov/injectionsafety/1anonly.html.)
18. U.S. Public Health Service Working Group on Occupational Postexposure Prophylaxis, Kuhar DT,
Henderson DK, et. al., Updated U.S. Public Health Service Guidelines for the Management of
Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis. September,
2013. (Available at https://stacks.cdc.gov/view/cdc/20711.)
19. US Department of Labor. Occupational Safety & Health Administration. 29 CFR 1910.1030 Bloodborne
Pathogens. March 6, 1992. (Available at
https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_id=10051&p_table=STANDARDS.)
20. Centers for Disease Control and Prevention. Recommendations for Preventing Transmission of
Infections Among Chronic Hemodialysis Patients. MMWR. April 27, 2001 / 50(RR05);1-43.
(Available at https://www.cdc.gov/mmwr/preview/mmwrhtml/rr5005a1.htm.)

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Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings
Recommendations of the HICPAC

Suggested Citation
Healthcare Infection Control Practices Advisory Committee. Core Infection Prevention and Control
Practices for Safe Healthcare Delivery in All Settings–Recommendations of the Healthcare Infection
Control Practices Advisory Committee (HICPAC) 2017.

Contributors
HICPAC Workgroup Members
Ruth M. Carrico, PhD, RN, CIC, HICPAC Member (Workgroup Chair); Gina Pugliese, RN, MS, HICPAC
Member (Workgroup Co-Chair); Deborah S. Yokoe, MD, MPH, HICPAC Member (Workgroup Co-
Chair); Loretta L. Fauerbach, MS, CIC; Susan Courage, Public Health Agency of Canada; Kathleen Dunn,
BScN, MN, RN, Public Health Agency of Canada; Neil O. Fishman, MD, HICPAC; Silvia Munoz-Price,
MD, PhD, America’s Essential Hospitals; Michael Anne Preas, RN CIC, Association of Professionals of
Infection Control and Epidemiology, Inc. (APIC); Mark E. Rupp, MD, Society for Healthcare
Epidemiology of America (SHEA); Sanjay Saint, MD, MPH, Society of Hospital Medicine (SHM); and
Rachel Stricof, MPH, Council of State and Territorial Epidemiologists (CSTE).

HICPAC Members
Neil O. Fishman, MD, University of Pennsylvania Health System; Hilary M. Babcock, MD, MPH,
Washington University School of Medicine; Ruth M. Carrico, PhD, RN, CIC, University of Louisville School
of Medicine; Sheri Chernetsky Tejedor, MD, Emory University School of Medicine; Daniel J. Diekema, MD,
University of Iowa Carver College of Medicine; Mary K. Hayden, MD, Rush University Medical Center;
Susan Huang, MD, MPH; University of California Irvine School of Medicine; W. Charles Huskins, MD, MSc,
Mayo Clinic College of Medicine; Lynn Janssen, MS, CIC, CPHQ, California Department of Public Health;
Gina Pugliese, RN, MS, Premier Healthcare Alliance; Selwyn O. Rogers Jr., MD, MPH, FACS, The University
of Texas Medical Branch; Tom Talbot, MD, MPH, Vanderbilt University Medical Center; Michael L. Tapper,
MD, Lenox Hill Hospital; and Deborah S. Yokoe, MD, MPH, Brigham & Women’s Hospital.

HICPAC Ex Officio Members

William B. Baine, MD, Agency for Healthcare Research and Quality (AHRQ); David Henderson, MD,
National Institutes of Health (NIH); Elizabeth Claverie-Williams, MS, U.S. Food and Drug
Administration (FDA); Daniel Schwartz, MD, MBA, Center for Medicare and Medicaid Services (CMS);
and Gary A. Roselle, MD, Department of Veterans Affairs (VA); Rebecca Wilson, MPH, CHES, Health
Resources and Services Administration (HRSA).

HICPAC Liaison Representatives

Kathleen Dunn, BScN, MN, RN, Public Health Agency of Canada; Janet Franck, RN, MBA, CIC, DNV
Healthcare, Inc.; Diana Gaviria, MD, MPH, National Association of County and City Health Officials
(NACCHO); Michael D. Howell, MD, MPH, Society of Critical Care Medicine (SCCM); Marion Kainer,
MD, MPH, Council of State and Territorial Epidemiologists (CSTE); Emily Lutterloh, MD, MPH,
Association of State and Territorial Health Officials (ASTHO); Michael Anne Preas, RN CIC, Association
of Professionals of Infection Control and Epidemiology, Inc. (APIC); Mark E. Rupp, MD, Society for
Healthcare Epidemiology of America (SHEA); Sanjay Saint, MD, MPH, Society of Hospital Medicine
95
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Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings
Recommendations of the HICPAC

(SHM); Robert G. Sawyer, MD, FACS, FIDSA, FCCM, Surgical Infection Society (SIS); Margaret
VanAmringe, MHS, The Joint Commission; and Amber Wood, MSN, RN, CNOR, CIC, CPN, Association
of periOperative Registered Nurses (AORN).

Acknowledgments
Melissa Schaefer, MD; Joseph Perz, DrPH; Michael Bell, MD; Erin Stone, MA; and Jeffrey Hageman,
MHS, the Division of Healthcare Quality Promotion (DHQP), the Centers for Disease Control and
Prevention.

96
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3.3
PATIENTS AND VISITORS

KNOW THE TRUTH TO PROTECT

YOURSELF FROM SERIOUS INFECTIONS

TRUTH TRUTH
On average, healthcare providers Alcohol-based hand sanitizer does not
clean their hands less than half of create antibiotic-resistant superbugs.
the times they should.
THE NITTY GRITTY:
THE NITTY GRITTY: Alcohol-based hand
This can put you at risk for a serious infection. It’s OK sanitizers kill germs quickly
to ask your care team questions like, “Before you start and in a different way than
the exam, would you mind cleaning your hands again?” antibiotics. Using alcohol-
Another way to bring it up is to thank them for cleaning based hand sanitizers to
their hands if you are uncomfortable asking. clean your hands does not
cause antibiotic resistance.

TRUTH ALCOHOL-BASED HAND SANITIZER

Alcohol-based hand sanitizer kills is a product that contains at least 60% alcohol to kill
most of the bad germs that make you germs on the hands.
sick.
THE NITTY GRITTY:
Your hands have good
germs on them that your
TRUTH
body needs to stay healthy. Your hands can spread germs.
Your hands can also have
bad germs on them that THE NITTY GRITTY :
make you sick. Alcohol- Make sure you and your visitors are cleaning your hands
based hand sanitizers kill at these important times:
the good and bad germs,
but the good germs quickly
come back on your hands.

TRUTH
Alcohol-based hand sanitizer does not
kill C. difficile .

THE NITTY GRITTY:

If you have a C. difficile infection, make sure your
healthcare providers wear gloves to examine you. You
and your loved ones should wash your hands with soap
and water to prevent the spread of C. difficile.

WHAT IS C. DIFFICILE?
C. difficile or “C. diff” is a common healthcare-
associated infection that causes severe diarrhea.

www.cdc.gov/HandHygiene

This material was developed by CDC. The Clean Hands Count Campaign is made possible by a partnership between the CDC Foundation and GOJO.

Reference
97
CDC
 3.4 Forms & Checklists
Forms &for
Checklists
Infectionfor
Prevention,
Infection Prevention,
Volume 1 Volume
67 1 67

Forms & Checklists for Infection Prevention, Volume 1 67

2-5. Personal
2-5. Personal ProtectiveProtective EquipmentEquipment
Competency
Competency
Protective Equipment
ency Personal Protective
Personal Protective
EquipmentEquipment
(PPE) Competency
(PPE) Competency
Validation Validation
Donning andDonning
Doffingand Doffing
Standard Precautions
Standard Precautions
and Transmission
and Transmission
Based Precautions
Based Precautions

tective Equipment (PPE) Competency Validation

Orientation Orientation
Donning and Doffing
Type of validation:
Type ofReturn
validation:
demonstration
Return demonstration Annual Annual
Precautions and Transmission Based Precautions
Other Other

Orientation
Employee Name:
Employee Name: Job Title: Job Title:
nstration Annual
Other
Competent Competent
Donning PPE Donning PPE
YES YES
NO NO
Job Title:
1. Perform 1.Hand
Perform
Hygiene
Hand Hygiene
2. Don Gown:2. Don Gown: Competent
Donning PPEcovering
Fully Fully
torso
covering
from neck
torsoto
from
knees,
neckarms
to knees,
to endarms
of wrists
to end of wrists
YES NO
3. Tie/fasten
3. inTie/fasten
back of neck
in back
andof
waist
neck and waist
4. Don Mask/Respirator:
4. Don Mask/Respirator:
ck to knees, arms toSecure
Secure ties/elastic
end of bands
ties/elastic
wrists at middle
bandsofathead
middle
& neck
of head & neck
5. Fit flexible
nd waist 5. band
Fit flexible
to nose
band
bridge
to nose bridge
6. Fit snug 6.
to Fit
facesnug
and to
below
face chin
and below
(Fit-check
chin respirator
(Fit-checkifrespirator
applicable)
if applicable)
middle7. ofDon Goggles
head Don
&7.neck orGoggles
Face Shield:
or Face Shield:
Place over face
Placeand
over
eyes;
faceadjust
and eyes;
to fitadjust to fit
dge
8. Don Gloves:
8. Don Gloves:
chin (Fit-check respirator if applicable)
Extend to cover
Extendwrist
to cover
of gownwrist of gown
d:
Doffing PPE Doffing PPE
just to fit
9. Remove 9. Gloves:
Remove Gloves:
Grasp outside
Grasp
of glove
outsidewith
of opposite
glove withgloved
opposite
hand; gloved
peel off
hand; peel off
wn
10. Hold removed
10. Holdglove
removed
in gloved
glove
hand
in gloved hand
Doffing PPE
11. Slide fingers
11. Slide
of ungloved
fingers ofhand
ungloved
underhand
remaining
underglove
remaining
at wrist
glove at wrist
12. Peel
opposite glove
gloved 12. off
Peel
hand; over
glove
peel firstoff
off glove
over first glove
13. Discard gloves
ed hand 13. Discard
in waste
gloves
container
in waste container
14. Remove
nd under Goggles
14.
remaining Remove
glove orwrist
at Goggles
Face Shield:
or Face Shield:
Handle by headHandle
band
by or
head
earband
pieces
or ear pieces
e
15. Discard in
15.designated
Discard in designated
receptacle ifreceptacle
re-processed
if re-processed
or in waste or
container
in waste container
tainer
16. Remove 16.Gown:
Remove Gown:
hield:
Unfasten ties/fastener
Unfasten ties/fastener
r pieces
tacle if re-processed or in waste container
98
68 Forms & Checklists for Infection Prevention, Volume 1

17. Pull away from neck and shoulders, touching inside of gown only
18. Turn gown inside out
19. Fold or roll into bundle and discard
20. Remove Mask/Respirator (respirator removed after exit room/closed
door):Grasp bottom, then top ties or elastics and remove
21. Discard in waste container
22. Perform Hand Hygiene
Competent
Standard Precautions & Transmission Based Precautions
YES NO

21. Staff correctly identifies the appropriate PPE for the following scenarios:
a. Standard Precautions (PPE to be worn based on anticipated level of
exposure)*
b. Contact / Contact Enteric Precautions (gown & gloves)
c. Droplet Precautions (surgical mask)
d. Airborne Precautions (fit-tested respirator if applicable)

*NOTE: Examples include: mask for coughing/vomiting patient, goggles/face shield for irrigating draining wound,
gown for dressing change if scrubs may touch patient, etc.

Comments or follow up actions:

Employee Signature
Validator Signature / Date

References
CDC at http://www.cdc.gov/HAI/pdfs/ppe/ppeposter148.pdf NC SPICE; 9-2016

99
3.5
SEQUENCE FOR PUTTING ON
PERSONAL PROTECTIVE EQUIPMENT (PPE)
The type of PPE used will vary based on the level of precautions required, such as standard and contact, droplet or
airborne infection isolation precautions. The procedure for putting on and removing PPE should be tailored to the specific
type of PPE.

1. GOWN
• Fully cover torso from neck to knees, arms
to end of wrists, and wrap around the back
• Fasten in back of neck and waist

2. MASK OR RESPIRATOR
• Secure ties or elastic bands at middle
of head and neck
• Fit flexible band to nose bridge
• Fit snug to face and below chin
• Fit-check respirator

3. GOGGLES OR FACE SHIELD

• Place over face and eyes and adjust to fit

4. GLOVES
• Extend to cover wrist of isolation gown

USE SAFE WORK PRACTICES TO PROTECT YOURSELF

AND LIMIT THE SPREAD OF CONTAMINATION
• Keep hands away from face
• Limit surfaces touched
• Change gloves when torn or heavily contaminated
• Perform hand hygiene

100
HOW TO SAFELY REMOVE PERSONAL PROTECTIVE EQUIPMENT (PPE)
EXAMPLE 1
There are a variety of ways to safely remove PPE without contaminating your clothing, skin, or mucous membranes with
potentially infectious materials. Here is one example. Remove all PPE before exiting the patient room except a respirator, if
worn. Remove the respirator after leaving the patient room and closing the door. Remove PPE in the following sequence:
1. GLOVES
• Outside of gloves are contaminated!
• If your hands get contaminated during glove removal, immediately
wash your hands or use an alcohol-based hand sanitizer
• Using a gloved hand, grasp the palm area of the other gloved hand
and peel off first glove
• Hold removed glove in gloved hand
• Slide fingers of ungloved hand under remaining glove at wrist and
peel off second glove over first glove
• Discard gloves in a waste container

2. GOGGLES OR FACE SHIELD

• Outside of goggles or face shield are contaminated!
• If your hands get contaminated during goggle or face shield removal,
immediately wash your hands or use an alcohol-based hand sanitizer
• Remove goggles or face shield from the back by lifting head band or
ear pieces
• If the item is reusable, place in designated receptacle for
reprocessing. Otherwise, discard in a waste container

3. GOWN
• Gown front and sleeves are contaminated!
• If your hands get contaminated during gown removal, immediately
wash your hands or use an alcohol-based hand sanitizer
• Unfasten gown ties, taking care that sleeves don’t contact your body
when reaching for ties
• Pull gown away from neck and shoulders, touching inside of gown only
• Turn gown inside out
• Fold or roll into a bundle and discard in a waste container

4. MASK OR RESPIRATOR
• Front of mask/respirator is contaminated — DO NOT TOUCH!
• If your hands get contaminated during mask/respirator removal,
immediately wash your hands or use an alcohol-based hand sanitizer
• Grasp bottom ties or elastics of the mask/respirator, then the ones at
the top, and remove without touching the front
• Discard in a waste container

5. WASH HANDS OR USE AN

ALCOHOL-BASED HAND SANITIZER OR
IMMEDIATELY AFTER REMOVING
ALL PPE

PERFORM HAND HYGIENE BETWEEN STEPS IF HANDS

BECOME CONTAMINATED AND IMMEDIATELY AFTER
REMOVING ALL PPE
101
 HOW TO SAFELY REMOVE PERSONAL PROTECTIVE EQUIPMENT (PPE)
EXAMPLE 2
Here is another way to safely remove PPE without contaminating your clothing, skin, or mucous membranes with potentially
infectious materials. Remove all PPE before exiting the patient room except a respirator, if worn. Remove the respirator after
leaving the patient room and closing the door. Remove PPE in the following sequence:

A B C
1. GOWN AND GLOVES
• Gown front and sleeves and the outside of gloves are
contaminated!
• If your hands get contaminated during gown or glove removal,
immediately wash your hands or use an alcohol-based hand
sanitizer
• Grasp the gown in the front and pull away from your body so
that the ties break, touching outside of gown only with gloved
hands
• While removing the gown, fold or roll the gown inside-out into
a bundle D E
• As you are removing the gown, peel off your gloves at the
same time, only touching the inside of the gloves and gown
with your bare hands. Place the gown and gloves into a waste
container

2. GOGGLES OR FACE SHIELD

• Outside of goggles or face shield are contaminated!
• If your hands get contaminated during goggle or face shield removal,
immediately wash your hands or use an alcohol-based hand sanitizer
• Remove goggles or face shield from the back by lifting head band and
without touching the front of the goggles or face shield
• If the item is reusable, place in designated receptacle for
reprocessing. Otherwise, discard in a waste container

3. MASK OR RESPIRATOR
• Front of mask/respirator is contaminated — DO NOT TOUCH!
• If your hands get contaminated during mask/respirator removal,
immediately wash your hands or use an alcohol-based hand sanitizer
• Grasp bottom ties or elastics of the mask/respirator, then the ones at
the top, and remove without touching the front
• Discard in a waste container

4. WASH HANDS OR USE AN

ALCOHOL-BASED HAND SANITIZER
OR
IMMEDIATELY AFTER REMOVING
ALL PPE

PERFORM HAND HYGIENE BETWEEN STEPS IF HANDS

BECOME CONTAMINATED AND IMMEDIATELY AFTER
REMOVING ALL PPE

Reference
CDC
102
!
` el contagio de germenes
Deten ` que te enferman a ti y a otros!

`al
Cubrete
toser Cúbrete la boca y la nariz
~
con un panuelo cuando
tosas o estornudes
o

cúbrete con la parte

superior del brazo cuando
tosas o estornudes, no
con las manos.
~
Tira el panuelo usado
a la basura.

Lavate
`
las
manos ` de toser o estornudar.
despues

Lávate las manos con

agua tibia y jabón

utiliza un limpiador
de manos a base
de alcohol.

Minnesota
Minnesota Department of Health
717 SE Delaware Street Antibiotic
Minneapolis, MN 55414 Resistance
612-676-5414 or 1-877-676-5414 Collaborative
www.health.state.mn.us
Handwashing
at Home, at Play, and Out and About
Germs are everywhere! They can get onto your hands and items you touch
throughout the day. Washing hands at key times with soap and water
is one of the most important steps you can take to get rid of germs and
avoid spreading germs to those around you.

How can washing your hands keep you healthy?

Germs can get into the body through our eyes, nose, and mouth and make
us sick. Handwashing with soap removes germs from hands and helps
prevent sickness. Studies have shown that handwashing can prevent 1 in
3 diarrhea-related sicknesses and 1 in 5 respiratory infections, such as a
cold or the flu.

Handwashing helps prevent infections

for these reasons:
People often touch their eyes, nose, and mouth
without realizing it, introducing germs into
their bodies.

Germs from unwashed hands may get into foods and drinks when
people prepare or consume them. Germs can grow in some types
of foods or drinks and make people sick.

Germs from unwashed hands can be transferred to other objects,

such as door knobs, tables, or toys, and then transferred to
another person’s hands.

What is the right way to wash your hands?

1. Wet your hands with clean running water (warm or cold) and
apply soap.
2. Lather your hands by rubbing them together with the soap.
3. Scrub all surfaces of your hands, including the palms, backs, fingers,
between your fingers, and under your nails. Keep scrubbing for at least
20 seconds. Need a timer? Hum the “Happy Birthday” song twice.
4. Rinse your hands under clean, running water.
5. Dry your hands using a clean towel or air dry them.
CS 280522A
Lavado de manos
en casa, en donde jugamos y cuando salimos
¡Los microbios están en todas partes! Pueden llegar a sus manos y a los
objetos que toca a lo largo de todo el día. Lavarse las manos con agua y
jabón en momentos clave es una de las medidas más importantes que
puede tomar para librarse de los microbios y evitar transmitirlos a quienes
lo rodean.

¿Cómo es que lavarse las manos lo mantiene sano?

Los microbios pueden entrar al cuerpo a través de los ojos, la nariz y la
boca, y enfermarnos. Lavarse las manos con jabón elimina los microbios
que estén en ellas y ayuda a prevenir las enfermedades. Los estudios
han mostrado que lavarse las manos puede prevenir 1 de cada 3
enfermedades diarreicas y 1 de cada 5 infecciones respiratorias, como el
resfriado o la influenza (gripe).

Lavarse las manos ayuda a prevenir

infecciones por estas razones:

Con frecuencia, las personas se tocan los ojos,

la nariz y la boca sin darse cuenta, y de ese
modo introducen microbios en el cuerpo.
Los microbios de las manos que no se lavaron pueden llegar a los
alimentos y a las bebidas cuando las personas los preparan o los
consumen. Los microbios pueden multiplicarse en algunos tipos
de alimentos o bebidas y causarles enfermedades a las personas.
Los microbios de las manos sin lavar pueden transferirse a otros
objetos, como las manijas de las puertas, las mesas o los juguetes
y, luego, transferirse a las manos de otra persona.

¿Cuál es la forma correcta de lavarse las manos?

1. Mójese las manos con agua corriente limpia (tibia o fría) y enjabónelas.
2. Frótese las manos con jabón, formando espuma.
3. Frote todas las superficies, incluidos los dedos, entre los dedos, debajo
de las uñas, las palmas y el dorso de las manos. Siga frotándose las
manos por al menos 20 segundos. ¿Necesita un reloj? Tararee dos
veces la canción “Cumpleaños feliz”.
4. Enjuáguese las manos con agua corriente limpia.
5. Séquese las manos con una toalla limpia o al aire.
CS 280522A MLS-283078
3.8

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3.9 American Journal of Infection Control 44 (2016) 1198-202

Contents lists available at ScienceDirect

American Journal of Infection Control American Journal of

Infection Control

j o u r n a l h o m e p a g e : w w w. a j i c j o u r n a l . o r g

Major Article

Health care worker hand contamination at critical moments in

outpatient care settings
James Bingham MS a,*, Ginnie Abell BA, RN, CIC b, LeAnne Kienast BS a,
Lorie Lerner MSN, MDiv, RN, CNS c, Brittney Matuschek BS a,
Wanda Mullins MPH, BSN, RN, CIC d, Albert Parker PhD e, Nancy Reynolds BSN, RN, CIC b,
Diane Salisbury MSN, RN, CIC f, Joan Seidel MA, BSN, RN, CIC g,
Elizabeth Young BSN, RN, CIC h, Jane Kirk MSN, RN, CIC a
a
GOJO Industries, Inc, Akron, OH
b
Summa Health System, Akron, OH
c LJL Consulting, Akron, OH
d Cleveland Clinic Akron General, Akron, OH
e
Center for Biofilm Engineering, Department of Mathematical Sciences, Montana State University, Bozeman, MT
f
Salisbury IP Consulting, LLC, Akron, OH
g University Hospitals Portage Medical Center, Ravenna, OH
h
Infection Prevention Consultant, Vermilion, OH

Key Words: Background: The delivery of health care in outpatient settings has steadily increased over the past 40
Hand hygiene years. The risk of infection in these settings is considered to be low. However, the increasing severity of
Ambulatory care illness and complexity of care in outpatient settings creates a need to reexamine the transmission of patho-
WHO 5 Moments
gens in this setting.
Glove
Materials and Methods: Seventeen health care workers from 4 wound care facilities were sampled during
Wound care
Standard precautions 46 patient care encounters to determine the presence of health care-associated pathogens (ie, methicillin-
resistant Staphylococcus aureus, vancomycin-resistant Enterococcus, multidrug-resistant Acinetobacter species,
and Clostridium difficile) on their hands at key moments of care.
Results: Health care workers acquired at least 1 pathogen on their hands during 28.3% of all patient care
encounters. Hands sampled before a clean or aseptic procedure and hands sampled after body fluid ex-
posure risk were each contaminated in 17.4% of instances. Hand contamination occurred in 19.6% of instances
where health care workers wore gloves during care compared with 14.6% when health care workers were
ungloved.
Conclusions: Contamination of health care workers’ hands presents a significant risk of pathogen trans-
mission in outpatient settings. Gloving education, hand hygiene solutions at the point of care, and hand
hygiene surveillance are important solutions for reducing transmission of pathogenic organisms.
© 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier
Inc. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/
licenses/by-nc-nd/4.0/).

BACKGROUND of physician offices, hospital emergency departments, hospital and

nonhospital-based clinics, surgical centers, and many other specialized
The delivery of health care has transitioned from centralized, acute service centers.1,2 During the 10-year period from 1997-2007, out-
care hospitals to community-based outpatient (ambulatory) care patient care visits increased by 25% to an estimated 1.2 billion visits
settings over the past several decades. Outpatient care settings consist with a rate of 4 visits per year per person.3 The rise in utilization of
outpatient care centers has been attributed to advancement in medical
technology, insurance reimbursement, convenience of care, and efforts
to control health care costs.
* Address correspondence to James Bingham, MS, GOJO Industries, Inc, PO Box 991,
Akron, OH 44309.
Infection prevention infrastructure and resources in outpatient
E-mail address: [email protected] (J. Bingham). settings are often not equivalent to those of acute care hospitals.4,5
Conflicts of Interest: None to report. The lack of infection prevention resources combined with the

0196-6553/© 2016 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. This is an open access article under the CC BY-NC-
ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
http://dx.doi.org/10.1016/j.ajic.2016.04.208
108
 J. Bingham et al. / American Journal of Infection Control 44 (2016) 1198-202 1199

increasing severity of illness, increasingly complicated proce- to the moment immediately after wound treatment (Fig 1). WHO
dures, and time pressure make infection prevention programs and moments 2 and 3 relate to the moments in the Canadian guide-
practices critical to protect patients and health care workers (HCWs) lines 4 moments and are similar to the indications for hand hygiene
from health care-associated infections (HAIs) in outpatient set- recommended in the CDC guidelines. Only paired samples taken
tings. In 2014, the Centers for Disease Control and Prevention (CDC) before moment 2 and after moment 3 from the same patient were
updated the guide to infection prevention in outpatient settings to included in the results. Participants were allowed to be sampled
highlight the need for dedicated infection prevention staff, train- while giving care to a maximum of 3 patients (ie, 6 total samples)
ing, HAI surveillance, and the use of standard precautions.1 In per day to limit workflow disruption. Samples were only taken from
addition, the World Health Organization (WHO) adapted their rec- HCWs who were providing care during the entire patient encoun-
ommendations on hand hygiene best practices for outpatient ter of a single patient (ie, rooming to exam conclusion). When
settings.2 multiple patient encounters were sampled from the same HCW
Hand hygiene is among the most important measures to prevent during the same clinic day, the encounters sampled were always
the transmission and acquisition of HAIs.6 The WHO has defined 5 taken sequentially and never occurred simultaneously. Observa-
key moments for hand hygiene in outpatient care settings and CDC tion of hand hygiene upon room entry and self-reported glove use
has suggested 6 key situations when hand hygiene should be were recorded during patient care. Three of the facilities followed
performed.6,7 Despite the hand hygiene recommendations, the sci- CDC hand hygiene guidelines, whereas 1 facility followed the WHO
entific evidence of microbial transmission during critical moments guidelines.
of care in outpatient care settings is limited.2 In this study, the
primary research objective was to quantify the presence of health Hand sampling
care-associated pathogens on the hands of HCWs at 2 of the key
moments for hand hygiene in an outpatient care setting and to de- A hand sampling method described in the American Society for
termine the influence of glove use. In addition, the study sought to Testing and Materials Standard Test Method E1115-10 was used to
clarify the distribution of hand contamination among HCWs in out- recover bacteria from HCWs’ hands. Briefly, a sterile, powder-free
patient care facilities. surgical glove was placed on the dominant hand of the partici-
pant, and 50 mL sterile sampling solution (0.075 mol/L phosphate
MATERIALS AND METHODS buffer, pH 7.9, containing 0.1% polysorbate 80, 0.1% sodium thio-
sulfate, and 0.3% lecithin) was added to the glove. The glove was
Study design secured at the wrist with a tourniquet, and the gloved hand was
uniformly massaged for 1 minute by the research staff. While the
The institutional review board at each facility approved the study. glove remained on the hand, 20 mL sampling solution was asepti-
HCWs at 4 wound care facilities in northeastern Ohio were invited cally removed from the glove and placed in a sterile sample cup.
to participate on each day of sampling and those who chose to par- After sampling, the participants washed hands to remove any re-
ticipate signed an informed consent. Sampling took place on 2 sidual sampling solution.
separate days at each facility. Participants were asked to perform
routine patient care activities, including hand hygiene, with no de- Bacteria recovery and identification
viation from their routine practices, except requiring hand hygiene
before entering the examination room. Research staff monitored and The sampled solution was centrifuged at 10,000 g for 10 minutes,
recorded the application of hand hygiene before entering the ex- and 15 mL supernatant was discarded. The pellet was resus-
amination room. For this study, a patient care encounter was defined pended in the remaining 5 mL supernatant, and the concentrated
as the entire care process for 1 patient, including patient rooming, sample was plated on various growth media. The limit of detec-
initial patient contact, wound care, and patient discharge. During tion for the identification of each pathogen was 250 CFU per hand.
the patient care encounter hand samples were taken before per- The identification of methicillin-resistant Staphylococcus aureus
forming a clean or aseptic procedure (WHO moment 2) and after (MRSA), vancomycin-resistant Enterococcus (VRE), multidrug resis-
gloves were removed following body fluid exposure risk (WHO tant Acinetobacter sp, and Clostridium difficile are described
moment 3). In this study moment 2 corresponded to the moment previously.8 Gram stains were performed on all isolates and coagu-
immediately before wound treatment and moment 3 corresponded lase tests were used to further confirm MRSA-positive samples.

Fig 1. Patient encounter and hand sampling schematic.

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1200 J. Bingham et al. / American Journal of Infection Control 44 (2016) 1198-202

Table 1 Table 2
Breakdown of health care worker hand contamination during patient care encounters Incidence of hand contamination based on glove use

Moment 2 events: Moment 3 events: Positive samples (n = 16)

Before clean or Following body Patient care
Time of care Gloved Ungloved
aseptic procedure fluid exposure risk encounters
Pathogen (n = 46) (n = 46) (n = 46) Moment 2: Before clean or aseptic procedure 40.0 (2/5) 14.6 (6/41)
Moment 3: Following body fluid exposure risk 17.4 (8/46) NA (0/0)
Methicillin-resistant 4.4 (2) 10.9 (5) 13.0 (6)
Combined 19.6 (10/51) 14.6 (6/41)
Staphylococcus aureus
Vancomycin-resistant 2.2 (1) 0.0 (0) 2.2 (1) NOTE. Values are presented as % (positive samples/total samples).
Enterococcus NA, not available.
Acinetobacter 0.0 (0) 2.2 (1) 2.2 (1)
Clostridium difficile 10.9 (5) 4.4 (2) 15.2 (7)
Any pathogen 17.4 (8) 17.4 (8) 28.3 (13) setting (eg, patients, environment, or staff) and not colonized with
NOTE. Values are presented as % (n). any of the targeted organisms. MRSA and C difficile were detected
during 13.0% and 15.2% of patient care encounters, respectively,
whereas VRE and Acinetobacter were each only detected in 2.2% of
Growth of any single organism was recorded as a positive for hand encounters. There was no access to patient medical records; there-
contamination. fore, correlation between the organisms identified from HCW hands
and any known patient colonization or infection could not be made.
Statistical analysis Intrafacility hand contamination rates at moment 2 and moment
3 were similar and rates among facilities were also comparable.
The odds of hand contamination was assessed by a mixed effects
logistic regression model with random effects for date crossed with Influence of glove use on hand contamination
facility, and HCW nested in facility. The random effects accounted
for the repeated measures taken from each HCW, date, and facili- Glove use during the patient encounter was self-reported by par-
ty. At moment 2, gloved and ungloved users were analyzed ticipants; however, the duration of glove use during care was not
separately. At moment 3, there were no ungloved users. Thus, the tracked. Hence, regardless of duration, wearing gloves at the moment
effect of glove use is based solely on moment 2 data. Individual value of care was recorded as either positive or negative for glove use.
plots, residual plots, and Hosmer and Lemeshow goodness-of-fit tests Overall, hand contamination occurred in 19.6% of instances where
were used to assess the fit of the logistic regression model to the HCWs wore gloves during care compared with 14.6% when HCWs
data. All analyses were performed using lme4 in R (R Foundation did not wear gloves (Table 2).
for Statistical Computing, Vienna, Austria).9 All statements of sta- During patient care that occurred at moment 2, HCWs wore
tistical significance are based on Wald tests at a significance level gloves in 10.9% of occurrences (5 out of 46) (Table 2). Appropriate-
of 5%. ness of glove use at this stage of patient care was not assessed and
hand hygiene immediately before donning gloves was not re-
RESULTS corded. Hand contamination rates were 14.6% (6 out of 41) for
ungloved hands and 40.0% (2 out of 5) for gloved hands. The con-
Prevalence of hand contamination tamination rate for ungloved hands was statistically significantly
>0% (P < .0005) but the rate of contamination for gloved hands was
Seventeen HCWs from 4 facilities were sampled during 46 patient not (P = .657). Lack of significance in the latter case may be due to
care encounters to determine the presence of health care-associated the low sample size (n = 5) of glove users at moment 2. The odds
pathogens on their hands during critical moments of care. Hand of contamination was 3.9 times larger for gloved HCWs compared
hygiene with an alcohol-based handrub was performed by the HCW with ungloved HCWs, but this increase was not statistically signif-
when entering the patient room to eliminate transient organisms icant (P = .181).
present from contact with previous patients, environmental sur- Gloves were worn during all wound care treatments (ie, the care
faces, or other sources. No confirmation of the effectiveness of hand given at moment 3) (Table 2). Hands sampled immediately after glove
hygiene during this step was performed considering the broad- removal after wound treatment were found to be contaminated in
spectrum antimicrobial activity of alcohol-based handrubs and the 17.4% (8 out of 46) of occurrences, which was statistically signifi-
relatively high detection limit (250 CFU per hand). Hands were cantly >0% (P < .0005). A comparison of the odds of contamination
sampled before beginning wound treatment (ie, before clean/ between glove users could not be ascertained because there were
aseptic procedure [WHO moment 2]) and after wound treatment no ungloved HCWs during wound care treatment.
(ie, after body fluid exposure risk [WHO moment 3]). After the hand
sampling procedure at moment 2, handwashing to remove the sam- Influence of HCWs
pling solution also removed any remaining transient organisms. This
prevented any cross-contamination into the sampling at moment Seventeen HCWs from 4 facilities were sampled during the study,
3. which represented 85.0% of the eligible staff. On average, each patient
HCWs acquired a health care-associated pathogen on their hands encounter took 60 minutes for established patients or 90-120
during 28.3% (13 out of 46) of patient care encounters (Table 1). minutes for new patients, and each HCW provided care to 6-10 pa-
When broken down by moments during care, 17.4% (8 out of 46) tients per clinic day. Paired samples were taken during 9, 15, 10,
of hands sampled at moment 2 and 17.4% (8 out of 46) of hands and 12 patient encounters at facility A, B, C, and D, respectively. On
sampled at moment 3 were positive for at least 1 pathogen. There average, each HCW was sampled during 1.8, 2.1, 2.5, and 1.1 patient
were 3 patient care encounters (6.5%) where the HCW’s hands were encounters at facility A, B, C, and D, respectively, on each sam-
positive at both moment 2 and moment 3. However, only 1 of those pling day. When combined for all facilities, samples were taken
cases involved the same organism. No HCWs were sequentially pos- during 1.7 patients encounters per HCW per clinic day, on average.
itive between patients for the same organism. This suggests HCWs This rate of sampling represented 17.0% of the high to 28.3% of the
in the study were contaminated by sources within the outpatient low daily patient load for each HCW.

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Table 3 at risk of colonization or infection with pathogenic organisms. De-

Analysis of hand contamination by health care workers contaminating hands after glove removal is a CDC recommendation
Percent of contaminated health care workers (IB), and WHO guidelines clearly state that wearing gloves does not
Hand Moment 2: Moment 3:
replace the need for hand hygiene.6,7 Whether the contamination
contamination Before clean or Following body Patient care is related to the quality of the gloves or HCW practices in donning
events aseptic procedure fluid exposure risk encounters and doffing of gloves, knowledge and practices of infection pre-
1 47.1 (8) 35.3 (6) 64.2 (11) vention procedures (including donning and doffing of gloves) should
2 0.0 (0) 16.7 (2) 16.7 (2) be part of staff onboarding and also regularly reviewed. The recent
NOTE. Values are presented as % (n). Ebola virus disease outbreak in West Africa demonstrated the po-
tential for self-contamination when doffing gloves and other
protective equipment, and led to the practice of trained observers
Eleven (64.2%) of 17 HCWs in the study were contaminated with of HCWs when donning and doffing of protective equipment.27
a pathogen at least once during the combined 46 patient encoun- Because of the contamination of HCW hands at moment 2 and
ters, whereas 2 (16.7%) of 12 HCWs who gave care to at least 2 moment 3 and the time pressure placed on HCWs, hand hygiene
patients were contaminated during 2 of those patient encounters solutions need to be placed in convenient locations. Inconvenient
(Table 3). Eight HCWs (47.1%) were contaminated at least once at placement of dispensers or sinks is cited as a reason for poor hand
moment 2, whereas 6 HCWs (35.3%) were contaminated at least once hygiene compliance by CDC and WHO.2,6 Wound care clinics present
at moment 3. The data indicate that the majority of HCWs’ hands a special challenge to place hand hygiene in convenient locations;
become contaminated during patient care and contamination is not therefore, manufacturers of hand hygiene products should consid-
associated with a subset of HCWs. er options for nontraditional health care settings so that HCWs do
not have to leave the patient zone to perform hand hygiene. As the
DISCUSSION delivery of health care shifts toward outpatient care settings, in-
fection preventionists and HCWs in these settings should be
As health care transitions from hospital settings to outpatient consulted to advise a convenient location for hand hygiene dis-
settings the need for scientific evidence to support outpatient in- pensing products to accommodate their unique workflow patterns.
fection prevention practices increases. Although much has been One method to address the workflow and special hand hygiene re-
published about hand hygiene and hand contamination in hospi- quirements for outpatient settings is workflow mapping. Son et al28
tals very little research has been conducted in outpatient care created workflow maps detailing the steps required to complete the
settings.2,6 This study may be the first to investigate the presence 5 most common tasks, including indicating when hand hygiene was
of pathogens on HCWs’ hands at WHO moments 2 and 3 for hand necessary. This process could be applied to the routine tasks of ad-
hygiene in an outpatient setting. These moments for hand hygiene mitting patients to their room, helping patients onto the exam table,
typically occur behind privacy curtains or closed doors and even removal of wound dressing, application of new dressing, and helping
in hospital settings are less likely to be observed and recorded. In the patient exit the room.
wound care settings, moments 2 and 3 occur during almost every This study sought to understand the distribution of hand con-
patient encounter, providing an opportunity for transmission and/ tamination among HCWs in outpatient care facilities. The majority
or acquisition of health care-associated pathogens by patients and of HCWs’ hands (64.2%) became contaminated during patient care,
HCWs. demonstrating that contamination is not concentrated within a
In this study, HCWs’ hands were contaminated during 28.3% of subset of HCWs. The distribution of sampling was not controlled
patient care encounters and when broken down by moments of care, in the study. The majority of HCWs were sampled during 1-2 patient
17.4% of the time before a clean or aseptic procedure (ie, before encounters; however, several HCWs were sampled during 5-6 patient
wound treatment) and 17.4% of the time after body fluid exposure encounters. Increasing the sampling of those HCWs who were only
risk (ie, after wound treatment). These contamination rates are sampled during 1 or 2 patient encounters may result in an in-
similar to those reported during different moments of care in other creased percentage of HCWs with contaminated hands during patient
outpatient settings, further supporting the importance of hand care. Hand hygiene surveillance programs should be implemented
hygiene in these settings.10-14 Hand contamination occurred as fre- to monitor compliance with hand hygiene guidelines due to the
quently after casual patient contact as it did after wound care, widespread hand contamination. In the outpatient setting, moni-
emphasizing that even brief contact can result in hand contami- toring of hand hygiene compliance should include more than just
nation. Studies, including 2 outpatient studies,12,13,15-18 found hand room entry and room exit, but also within the patient zone. Ob-
contamination with organisms such as VRE, S aureus, and C difficile serving hand hygiene behavior at WHO hand hygiene moments 2
following casual or low-risk contact. Contamination rates in this and 3 is necessary for patient safety in a wound care setting.
study support the current WHO and CDC recommendations for hand
hygiene before a clean or aseptic procedure and after body fluid ex-
posure risk as ways to prevent the transmission of pathogens. LIMITATIONS
Glove use is explicitly linked with infection prevention and hand
hygiene practices.6,7,19 Wearing gloves when there is a potential for The results reported in this study may not be representative of
contact with blood, body fluids, mucous membranes, nonintact skin, all outpatient settings. Wound care facilities were chosen for this
or contaminated equipment is a basic tenet of standard precautions.20 study because the care administered in this setting was likely to
Furthermore, glove use is the strongest recommended infection include both a clean or aseptic procedure and body fluid exposure
control procedure to prevent the contamination of HCWs’ hands.21-24 risk. This setting may bias the results toward higher levels of hand
In this study, gloves were not worn during 89.1% of contact before contamination due to the type of care administered and the pres-
wound care. During wound care, when there was potential for ex- ence of pathogens in wounds. Wound care center patients may also
posure to blood, body fluids, and nonintact skin, gloves were be at higher risk for multidrug resistant organisms due to previ-
universally worn. Studies have shown the rate of hand hygiene is ous or current antimicrobial therapy, invasive procedures, and
lower when gloves are worn.25,26 This study suggests that substi- hospitalization. The sources of hand contamination could not be de-
tuting glove use for hand hygiene can place both HCWs and patients termined because environment contamination was not quantified

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1202 J. Bingham et al. / American Journal of Infection Control 44 (2016) 1198-202

or characterized, baseline colonization of HCWs was not identified, 12. Grabsch EA, Burrell LJ, Padiglione A, O’Keeffe JM, Ballard S, Grayson ML. Risk of
environmental and healthcare worker contamination with vancomycin-resistant
and patient records were not accessed to determine infection status.
enterococci during outpatient procedures and hemodialysis. Infect Control Hosp
Epidemiol 2006;27:287-93.
13. Lam RF, Hui M, Leung DY, Chow VC, Lam BN, Leung GM, et al. Extent and
CONCLUSIONS predictors of microbial hand contamination in a tertiary care ophthalmic
outpatient practice. Invest Ophthalmol Vis Sci 2005;46:3578-83.
14. Zuckerman JB, Zuaro DE, Prato BS, Ruoff KL, Sawicki RW, Quinton HB, et al.
Outpatient care settings, especially wound care centers, present Bacterial contamination of cystic fibrosis clinics. J Cyst Fibros 2009;8:186-92.
unique infection prevention challenges. The hand contamination re- 15. Bhalla A, Pultz NJ, Gries DM, Ray AJ, Eckstein EC, Aron DC, et al. Acquisition of
nosocomial pathogens on hands after contact with environmental surfaces near
ported at moment 2 and moment 3 provides a strong case for hospitalized patients. Infect Control Hosp Epidemiol 2004;25:164-7.
attention to hand hygiene and infection prevention practices in these 16. Pittet D, Dharan S, Touveneau S, Sauvan V, Perneger TV. Bacterial contamination
settings to protect both patients and HCWs. The results of this study of the hands of hospital staff during routine patient care. Arch Intern Med
1999;159:821-6.
emphasize the need for attention to glove donning and doffing prac- 17. Casewell M, Phillips I. Hands as route of transmission for Klebsiella species. Br
tices because glove use did not prevent contamination of the hands. Med J 1977;2:1315-7.
The study also highlights the need for hand hygiene surveillance 18. Pessoa-Silva CL, Dharan S, Hugonnet S, Touveneau S, Posfay-Barbe K, Pfister R,
et al. Dynamics of bacterial hand contamination during routine neonatal care.
and hand hygiene solutions at the point of care so HCWs can clean
Infect Control Hosp Epidemiol 2004;25:192-7.
their hands without leaving the patient zone. 19. Ellingson K, Haas JP, Aiello AE, Kusek L, Maragakis LL, Olmsted RN, et al. Strategies
to prevent healthcare-associated infections through hand hygiene. Infect Control
Hosp Epidemiol 2014;35:937-60.
20. Siegel JD, Rhinehart E, Jackson M, Chiarello L. 2007 Guideline for isolation
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safe care. Atlanta, GA: Centers for Disease Control and Prevention; 2014. practice guidelines for Clostridium difficile infection in adults: 2010 update by
2. World Health Organization. Hand hygiene in outpatient care, home-based care the society for healthcare epidemiology of America (SHEA) and the Infectious
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 3.10
Injection Safety Guidelines From CDC
■ Follow proper infection control practices and maintain
aseptic technique during the preparation and
administration of injected medications (e.g., perform
hand hygiene).

■ Never administer medications from the same syringe to

more than one patient, even if the needle is changed.

■ Never enter a vial with a used syringe or needle.

■ Do not use medications packaged as single-dose or

113
single-use for more than one patient.

■ Do not use bags of intravenous solution as a common

Injection Safety source of supply for more than one patient.

■ Limit the use of multi-dose vials and dedicate them to

Guidelines a single patient whenever possible.
from the
■ Always use facemasks when injecting material or inserting
Centers for Disease a catheter into the epidural or subdural space.
Control and Prevention
Adapted from: Guideline for isolation precautions: preventing transmission
of infectious agents in health care settings 2007. Atlanta, GA: US Department
of Health and Human Services, CDC; 2007. Available at: http://www.cdc.gov/
hicpac/pdf/isolation/isolation2007.pdf
306089-L
3.11INJECTION SAFETY CHECKLIST
The following Injection Safety checklist items are a subset of items that can be found in the CDC Infection Prevention Checklist for
Outpatient Settings: Minimum Expectations for Safe Care.
The checklist, which is appropriate for both inpatient and outpatient settings, should be used to systematically assess adherence
of healthcare providers to safe injection practices. Assessment of adherence should be conducted by direct observation of
healthcare personnel during the performance of their duties.

Practice If answer is No, document plan

Injection Safety
Performed? for remediation
Proper hand hygiene, using alcohol-based hand rub or
soap and water, is performed prior to preparing and Yes No
administering medications.
Injections are prepared using aseptic technique in a clean
area free from contamination or contact with blood, body Yes No
fluids, or contaminated equipment.
Needles and syringes are used for only one patient (this
includes manufactured prefilled syringes and cartridge Yes No
devices such as insulin pens).
The rubber septum on a medication vial is disinfected
with alcohol prior to piercing. Yes No
Medication vials are entered with a new needle and a
new syringe, even when obtaining additional doses for Yes No
the same patient.
Single-dose or single-use medication vials, ampules, and
bags or bottles of intravenous solution are used for only Yes No
one patient.

Medication administration tubing and connectors are

used for only one patient. Yes No
Multi-dose vials are dated by healthcare when they are
first opened and discarded within 28 days unless the
manufacturer specifies a different (shorter or longer) date Yes No
for that opened vial.
Note: This is different from the expiration date printed on the vial.

Multi-dose vials are dedicated to individual patients

whenever possible. Yes No
Multi-dose vials to be used for more than one patient are
kept in a centralized medication area and do not enter
the immediate patient treatment area (e.g., operating
room, patient room/cubicle). Yes No
Note: If multi-dose vials enter the immediate patient treatment
area, they should be dedicated for single-patient use and
discarded immediately after use.

The One & Only Campaign is a public health effort to eliminate unsafe
medical injections. To learn more about safe injection practices, please
visit www.cdc.gov/injectionsafety/1anonly.html.

306089-G

114
3.12
Glossary
healthcare providers – doctors, nurses and other trained
healthcare professionals

hepatitis B – a liver disease caused by the hepatitis B virus (HBV)

hepatitis C – a liver disease caused by the hepatitis C virus (HCV)

HIV – the virus that can lead to acquired immune deficiency

syndrome, or AIDS

injection – forcing a fluid into the body by means of a syringe

IV – intravenous, or “within a vein”

needle – a sharp pointed object used for injection or removal of

fluid from the body

syringe – an instrument used to inject fluids into the body or

draw them from it

transmission – spread, as of an infection from one patient to

another

vial – a small container or bottle that holds medicine

Safe Injection Practices Coalition

The Safe Injection Practices Coalition (SIPC) is a partnership of
healthcare-related organizations led by the Centers for Disease
Control and Prevention that was formed to promote safe
injection practices in all U.S. healthcare settings. The SIPC has
developed the One & Only Campaign – a public health education
and awareness campaign – aimed at both healthcare providers
and patients to advance and promote safe injection practices.

Become an active partner

in your health care.

115
 Did you know?
Most healthcare providers follow safe injection
practices. Though not common, unsafe practices
sometimes occur. Healthcare providers can spread
diseases like hepatitis B, hepatitis C, or HIV if they
reuse injection equipment like needles or syringes
on more than one patient or to access vials that Vial
are shared between patients.

Needle Syringe

Here is what you should know Who should be aware of safe injection
practices?
about safe injection practices:
Anyone who receives an injection or IV therapy
What are safe injection practices? should be aware of these practices. Anyone who
Safe injection practices are a set of practices that gives an injection or IV therapy (like a healthcare
healthcare providers should follow when they provider) should understand and follow safe
give injections. For example, healthcare providers injection practices.
should not use the same syringe on more than What can patients do to find information
one patient, even if the needle is changed. A good about safe injection practices?
rule to remember is One Needle, One Syringe, only Patients can take the following steps to learn more
One Time. about safe injection practices:

Why are safe injection practices so • Talk with your healthcare provider about safe
important? injection practices.
These practices will prevent the spread of diseases • Go to www.cdc.gov/
like hepatitis B, hepatitis C, or HIV. injectionsafety/1anonly.html for more
information.

For more information, please visit: www.cdc.gov/injectionsafety/1anonly.html.

306089-K

116
Module 4

Epidemiology & Infectious Diseases

Resources
Principles of Epidemiology
Centers for Disease Control and Prevention (CDC)
https://www.cdc.gov/csels/dsepd/ss1978/lesson1/section10.html

Chart of Clinical Syndromes or Conditions Warranting Empiric Transmission-Based

Precautions in Addition to Standard Precautions
CDC
https://www.cdc.gov/infectioncontrol/guidelines/isolation/appendix/
transmission-precautions.html

Measles outbreak toolkit

CDC
https://www.cdc.gov/measles/toolkit/state-health-departments.html

Measles
CDC
https://www.cdc.gov/measles/hcp/index.html

Chicken Pox
CDC
https://www.cdc.gov/chickenpox/hcp/index.html

Shingles
CDC
https://www.cdc.gov/shingles/hcp/index.html

Respiratory Synctial Virus Infection

CDC
https://www.cdc.gov/rsv/clinical/index.html

Meningitis
CDC
https://www.cdc.gov/meningitis/clinical-resources.html

Multidrug Resistant Organisms Management

CDC
https://www.cdc.gov/infectioncontrol/guidelines/mdro/index.html

Red Book 2018

American Academy of Pediatrics
https://redbook.solutions.aap.org/Book.aspx?bookid=2205

117
Module 5

Occupational/Employee Health

Contents
5.1 Recommended vaccines for healthcare workers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 120
Immunization Action Coalition
https://www.immunize.org/catg.d/p2017.pdf

5.2 Checklist for Bloodborne Pathogens Content Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

Forms & Checklists for Infection Control, Volume 2

5.3 Sharps Injury Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Forms & Checklists for Infection Control, Volume 2

5.4 Employee Training Record . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

Forms & Checklists for Infection Control, Volume 2

5.5 Injection Safety Competency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Forms & Checklists for Infection Control, Volume 1

Resources
Healthcare Worker Guidelines
Centers for Disease Control and Prevention (CDC)/Healthcare Infection Control Practices
Advisory Committee (HICPAC)
https://www.cdc.gov/hicpac/pdf/infectcontrol98.pdf

Vaccine guidelines for healthcare providers/professionals

CDC
https://www.cdc.gov/vaccines/hcp/index.html

Standards for Adult immunization Practice

CDC
https://www.cdc.gov/vaccines/hcp/adults/for-practice/standards/index.html

Bloodborne Pathogens Quick Reference Guide

Occupational Safety and Health Administration (OSHA)
https://www.osha.gov/SLTC/bloodbornepathogens/bloodborne_quickref.html

Immunization Action Coalition

https://www.immunize.org/

Influenza
Society for Healthcare Epidemiology of America (SHEA)
https://www.shea-online.org/index.php/practice-resources/priority-topics/influenza

118
Measles
CDC
https://www.cdc.gov/infectioncontrol/guidelines/measles/index.html

Red Book 2018

American Academy of Pediatrics
https://redbook.solutions.aap.org/Book.aspx?bookid=2205

Control of Communicable Diseases Manual

American Public Health Association
https://www.apha.org/ccdm

119
5.1 Healthcare
Healthcare
vaccines
vaccines and
and
Personnel
Personnel Vaccination
Vaccination
recommendations
recommendations in brief
Recommend
Recommendations
in brief
Hepatitis B – If previously unvaccinated, give a 2-dose (Heplisav-B) or 3-dose (Engerix-B
measles and mumps vaccines measles
the first birthday and separated
given on and
thebyfirst
mumps vaccin
or after
28 days
more, and at least 1 dose of live rubella
or
birthday and sepa
Hepatitis B – If previously unvaccinated, give a 2-dose (Heplisav-B)
or Recombivax HB) series. Give intramuscularly (IM). For HCP who perform tasks
or 3-dose (Engerix-B
vaccine). HCP with 2 more,doses
documented and ofat least 1 dose o
or may
Recombivax HB) series. MMR are not recommended vaccine). HCP with 2 docu
to be serologically
that involve exposure to bloodGive intramuscularly
or body (IM).serologic
fluids, obtain anti-HBs For HCP who perform
testing tasks
MMR
tested for immunity; but if they are not
are tested andrecommende
that may involve exposure to blood or body fluids, obtain anti-HBs serologic
1–2 months after dose #2 (for Heplisav-B) or dose #3 (for Engerix-B or Recombivax testingor equivocal
results are negative for measles,
tested for immunity; but if
HB).
1–2 months after dose #2 (for Heplisav-B) or dose #3 (for Engerix-B or Recombivax
mumps, and/or rubella, these HCP should be
considered to have presumptive results are negative
evidence of or equi
Influenza
HB).– Give 1 dose of influenza vaccine annually. Inactivated injectable vaccine is immunity to measles, mumps, mumps, and/or rubella, th
and/or rubella
given IM, except when using the intradermal influenza vaccine. Live attenuated considered
and are not in need of additional MMR doses. to have presum
Influenza – Give(LAIV)
influenza vaccine 1 dose of influenza
is given vaccine annually. Inactivated injectable
intranasally. vaccine is immunity
• Although birth before 1957 generally to measles, mum
is con-
MMRgiven IM, except
– For healthcare when(HCP)
personnel usingborn
theinintradermal influenza
1957 or later without vaccine.
serologic evidenceLive attenuated
sidered acceptable evidenceand of measles,
are not in need of add
ofinfluenza
immunity orvaccine (LAIV) is
prior vaccination, given
give intranasally.
2 doses of MMR, 4 weeks apart. For HCP mumps, and rubella immunity, 2 doses of MMR
born prior to 1957, see below. Give subcutaneously (Subcut). vaccine should be • Although
considered for unvacci-birth before 1957
MMR – For healthcare personnel (HCP) born in 1957 or
Varicella (chickenpox) – For HCP who have no serologic proof of immunity, prior
later without nated HCP born before 1957sidered
serologic evidence who do not
laboratory evidence of disease or immunity to
have
acceptable evidenc
of immunity or prior vaccination, give 2 doses of MMR, 4 weeks apart. For
measles HCP
and/or mumps. Onemumps,
dose of and
MMR rubella immun
vaccination, or diagnosis or verification of a history of varicella or herpes zoster
born prior
(shingles) by a to 1957, see
healthcare below.
provider, give Give
2 dosessubcutaneously
of varicella vaccine,(Subcut).
4 weeks apart. vaccine should be consideredvaccine should
for HCP with no be conside
Give Subcut.
laboratory evidence of disease nated HCP born before 19
or immunity
Varicella (chickenpox) – For HCP who have no serologic proof of immunity,
Tetanus, diphtheria, pertussis – Give 1 dose of Tdap as soon as feasible to all HCP
to rubella. For these same HCP
prior who do not
laboratory
have evidence of immunity, 2 doses of MMR
evidence of dise
vaccination, or diagnosis or verification of a history of varicella or herpes
vaccinezoster
are recommended measles
during an and/or mumps. O
outbreak
who have not received Tdap previously and to pregnant HCP with each pregnancy
(shingles) byTd a healthcare of weeks
measles or mumps and 1vaccine
dose during should
an be consider
(see below). Give boosters everyprovider, give 2 doses
10 years thereafter. Give IM.of varicella vaccine, 4 apart.
outbreak of rubella. laboratory evidence of dise
Give Subcut.
Meningococcal – Give both MenACWY and MenB to microbiologists who are routine- to rubella. For these same
Varicella
ly exposed to isolates of Neisseria meningitidis. Every 5 years boost with MenACWY if
Tetanus, diphtheria, pertussis – Give 1 dose of Tdap as soon as feasible
risk continues. Give MenACWY and MenB IM.
to all HCP
It is recommended have
that all HCP evidence
be immune to of immunity
varicella.
who have not received Tdap previously and to pregnant HCP with each Evidence of immunityvaccine
pregnancy are recommended
in HCP includes
documentation of 2 doses of varicella vaccine
of measles or mumps and
Hepatitis A, typhoid, and polio vaccines are not routinely recommended for HCP who may have on-the-job exposure to fecal material.
(see below). Give Td boosters every 10 years thereafter. Give IM. given at least 28 days apart, laboratory
outbreak evidence
of rubella.
Hepatitis B to be HBsAg positive should be counseled and of immunity, laboratory confirmation of disease,
Meningococcal
Unvaccinated healthcare personnel – Give (HCP)bothand/ MenACWYmedicallyand MenB to microbiologists who
evaluated. are routine-
or diagnosis or verification of a history of vari-
Varicella
or thoselywho
exposed to isolates
cannot document previous Neisseria
of vac- Formeningitidis. Every 5ofyears
HCP with documentation boost with
a complete cella MenACWY
or herpes zosterif(shingles) by a healthcare
cination should receive either a 2-dose series of 2-dose (Heplisav-B) or 3-dose (Engerix-B or Re- provider. It is recommended that all H
risk continues. Give MenACWYcombivax
Heplisav-B at 0 and 1 month or a 3-dose series
and MenB IM.
HB) vaccine series but no documen- Tetanus/Diphtheria/Pertussis varicella. Evidence of immun
(Td/Tdap)
of either Engerix-B or Recombivax HB at 0, 1, tation of anti-HBs of at least 10 mIU/mL (e.g.,
Hepatitis
and A, typhoid,
6 months. HCP andwhopolio vaccines
perform tasks arethat
not routinely recommended for HCP who may have on-the-job exposure All HCPs to fecal
who material.
have not or aredocumentation
unsure if they haveof 2 doses o
those vaccinated in childhood): HCP who are at
may involve exposure to blood or body fluids risk for occupational blood or body fluid expo- previously received a dose given
of Tdap at least
should 28 days apart,
receive a dose of Tdap as soon as feasible, with-
Hepatitis
should be testedB for hepatitis B surface anti- to beanti-HBs
sure might undergo HBsAgtestingpositive
upon should
hire or be counseled and of immunity,
out regard to the interval since the previous dose
laboratory confi
body (anti-HBs) 1–2 months after dose #2 of matriculation. medically
See references 2 and 3 for details.
Unvaccinated
Heplisav-B or dosehealthcare
#3 of Engerix-B personnel
or Recom-(HCP) and/
evaluated. of Td. Pregnant HCP shouldor bediagnosis
revaccinatedor verification o
or those
bivax HB towho
documentcannot document previousInfluenza
immunity. vac- For HCP with documentationduring each pregnancy. All HCPs
of a complete cella should
or herpes then zoster (shing
receive Td boosters every 10provider. years thereafter.
•cination
If anti-HBsshould receive
is at least either
10 mIU/mL a 2-dose series of 2-dose (Heplisav-B) or 3-dose (Engerix-B or Re-
(positive), All HCP, including physicians, nurses, paramedics,
Heplisav-B
the vaccinee is atimmune.
0 and 1No month
further or a 3-doseemergency
serologic series medical combivaxtechnicians, employees
HB) vaccine series but Meningococcal
no documen- Tetanus/Diphtheria/Per
testing or vaccination is recommended. of nursing homes and chronic care facilities,
of either Engerix-B or Recombivax HB atstudents 0, 1, in these tation of anti-HBs
professions, of at least 10
and volunteers, mIU/mL
Vaccination with(e.g.,
MenACWY and MenB is
• If anti-HBs
and is less HCP
6 months. than 10whomIU/mLperform(negative),
tasks that
should receivethoseannualvaccinated influ- recommended
in childhood):
vaccination against HCP who for at All
aremicrobiologists
routinely exposed to isolatespreviously
HCPs who whoare have not or are
of N. meningitidis.
the vaccinee is not protected from hepatitis B
may received a dose o
virusinvolve exposure and to blood or body fluids
enza. Live attenuated influenza vaccine (LAIV)
risk for occupational blood or body fluid expo-
(HBV) infection, should receive may be given only to non-pregnant healthy HCP The two vaccines may be given concomitantly
receive a dose of Tdap as so
should
another be tested
2-dose for hepatitis
or 3-dose series of HepB B surface anti- sure might undergo
age 49 years and younger. Inactivated injectableanti-HBs testing
but at upon
different hire or
anatomic sites, if feasible.
body (anti-HBs)
vaccine on the routine 1–2schedule,
months after dose
followed by #2 of vaccine matriculation. Seeoverreferences 2references
and 3 for details. out regard to the interval sinc
influenza (IIV) is preferred LAIV
anti-HBs testing 1–2 months later.
Heplisav-B or dose #3 of Engerix-B or Recom- A vaccinee for HCP who are in close contact with severely of Td. Pregnant HCP should
1 CDC. Immunization of Health-Care Personnel: Recom-
whose anti-HBs remains less than 10 mIU/
bivax HB2 to document immunity. immunosuppressed Influenzapatients (e.g., stem cell mendations of the Advisory during
Committee each pregnancy. All H
on Immunization
mL after complete series is considered a transplant recipients) when they require protec-
All HCP, including physicians, nurses, paramedics, receive Td boosters every 10
Practices (ACIP). MMWR, 2 011; 60(RR-7).
• If anti-HBs is at least 10 mIU/mL (positive),
“non-responder.” tive isolation. 2 CDC. Prevention of Hepatitis B Virus Infection in the Unit-
Forthe
non-responders:
vaccinee isHCP who are non-responders
immune. No further serologic emergency medical technicians,ed employees Meningococcal
States. Recommendations of the Advisory Committee
should be considered susceptible to HBV and Measles, Mumps, Rubella (MMR) on Immunization Practices. MMWR, 2018; 67(RR1):1–30.
testing or vaccination is recommended. of nursing homes and chronic3 care facilities,
should be counseled regarding precautions to HCP who workstudents
in medicalin facilities
theseshould be
professions,
IAC.
and
Pre-exposure
volunteers,
with a Documented
Management Vaccination
for Healthcare Personnel
Hepatitis B Vaccine Series Who Have
with MenACWY
• If anti-HBs
prevent HBV infection
is lessand the need
than to obtain (negative),
10 mIU/mL immune to measles, mumps, and rubella.
should receive annual vaccination Not Had Post-vaccination Serologic Testing. Accessed at for microbiol
against influ- recommended
HBIG prophylaxis for any known or probable • HCP born
the vaccinee
exposureis to not protected
B surfacefromantigenhepatitis B inenza.
1957 or later can be considered
Live attenuated
www.immunize.org/catg.d/p2108.pdf. routinely exposed to isolates
parenteral hepatitis immune to measles, mumps, or rubellainfluenza
only vaccine (LAIV)
The two vaccines visit CDC’s may be giv
virus (HBV) infection, and
(HBsAg)-positive blood or blood with unknown should receive may be given only
if they have documentation of (a) laboratoryto non-pregnant
For additional specific ACIP recommendations,
healthy HCP
website at www.cdc.gov/vaccines/hcp/acip-recs/index.
another
HBsAg 2-dose
status. It is alsoorpossible
3-dosethat series
non- of HepBconfirmation of disease or immunity or
age 49 years and younger. Inactivated injectable
html or visit IAC’s
but at different
website at www.immunize.org/acip.
anatomic sit
responders
vaccineare onpeople who are schedule,
the routine HBsAg positive. followed (b)byappropriate vaccination against measles,
HBsAg testing is recommended. HCP found influenza vaccine
mumps, and rubella (i.e., 2 doses of live
(IIV) is preferred over LAIV references
anti-HBs testing 1–2 months later. A vaccinee for HCP who are in close contact Technical content reviewed by the Centers for Disease Control and Prevention
with severely 1 CDC. Immunization of Health-Ca
whose anti-HBs remains less
Immunization Action Coalition Saint Paul, Minnesota than 10 mIU/ • - -
651 647 9009 www.immunize.org
immunosuppressed •
patients (e.g.,www.vaccineinformation.org
•
stem cell mendations of the Advisory Comm
mL after 2 complete series is considered a transplant recipients) when www.immunize.org/catg.d/p2 017.pdf •Practices
they require protec- Item #P2 017 (3/18)MMWR, 2 011; 6
(ACIP).
“non-responder.” tive isolation. 2 CDC. Prevention of Hepatitis B Vi
For non-responders: HCP who are non-responders ed States. Recommendations of th
should be considered susceptible to HBV and Measles, Mumps, Rubella (MMR) on Immunization Practices. MMW
should be counseled regarding precautions to 3 IAC. Pre-exposure Management fo
HCP who work in medical facilities should be
with a Documented Hepatitis B V
prevent HBV infection and the need to obtain immune to measles, mumps, and rubella. Not Had Post-vaccination Serolog
HBIG prophylaxis for any known or probable • HCP born in 1957 or later can be considered www.immunize.org/catg.d/p2108
parenteral exposure to hepatitis B surface antigen immune to measles, mumps, or rubella only For additional specific ACIP recom
(HBsAg)-positive blood or blood with unknown if they have documentation of (a) laboratory website at www.cdc.gov/vaccines/
HBsAg status. It is also possible that non- confirmation of disease or immunity or html or visit IAC’s website at www
responders are people who are HBsAg positive. (b) appropriate vaccination against measles,
HBsAg testing is recommended. HCP found mumps, and rubella (i.e., 2 doses of live Technical content reviewed by the Centers for Di

Immunization Action Coalition Saint Paul, Minnesota • 651- 647- 9009 • www.immunize.org • www.vaccineinformati
120 www.immunize.org/catg.d/p2 017.pd
 nnel
nel Vaccination
Vaccination
Healthcare Recommendations
Recommendations
Personnel Vaccination Recommendations
in brief measles and mumps vaccines given on or after
measles
briefvaccines and recommendations andbirthday
the first mumps andvaccines given on
separated or after
by 28 days or measles and mumps vaccines given on or after
in
the first
more, brief
birthday
and at and
leastseparated
1 dose ofby
live28rubella
days or
ve a 2-dose (Heplisav-B) or 3-dose (Engerix-B the first birthday and separated by 28 days or
a 2-dose (Heplisav-B) more, and at least 1with
dose of live rubelladoses of
uscularly Hepatitis
(IM). For BHCP –orIf3-dose
who (Engerix-B
perform
previously tasks
unvaccinated, vaccine).
give
vaccine). a 2-dose HCP 2 documented
(Heplisav-B) or 3-dose (Engerix-B more, and at least 1 dose of live rubella
larly (IM). For HCP who perform tasks MMRHCP are notwith 2 documented
recommended doses
to be of
serologically vaccine). HCP with 2 documented doses of
body fluids,or obtain anti-HBs
Recombivax HB)serologic testing
series. Give intramuscularly
MMR are not
tested (IM). For
forrecommended HCP
immunity; buttoif be who
they are testedtasks
perform
serologically and
y-B)
fluids, obtain MMR are not recommended to be serologically
or dose #3 anti-HBs
that (for
mayEngerix-Bserologic
involve testing
or Recombivax
exposure to blood tested
or body for fluids,
immunity; obtain
but anti-HBs
if they are
results are negative or equivocal for measles,serologic
tested and testing tested for immunity; but if they are tested and
or dose #31–2 (formonths
Engerix-B or Recombivax
after results
dose #2 (for Heplisav-B) are
ornegative
dose #3orrubella,
equivocal
(for Engerix-B forHCP
measles,
or Recombivax
mumps, and/or these should be results are negative or equivocal for measles,
HB). mumps, and/orto
considered rubella, these HCP should
have presumptive evidence be of mumps, and/or rubella, these HCP should be
ne annually. Inactivated injectable vaccine is considered immunity to have
to presumptive
measles, mumps, evidence
and/or of
rubella
nnually.
ermal Inactivated
Influenza
influenza injectable
vaccine.
– Give Live
1 dose vaccine
attenuated is
of influenza vaccine
considered to have presumptive evidence of
al influenza vaccine. Live attenuated andannually.
immunity tonot
are inInactivated
measles,
needmumps, injectable
and/orMMR
of additional vaccine
doses. is
rubella immunity to measles, mumps, and/or rubella
asally. given IM, except when using the intradermal and are notinfluenza
in need ofvaccine.
additionalLive MMR
• Although birth before 1957 generally is con-
attenuated
doses. and are not in need of additional MMR doses.
lly. influenza vaccine (LAIV) is given intranasally.
• Although
rn in 1957 or later without serologic evidence sidered birth before 1957
acceptable generally
evidence is con-
of measles, • Although birth before 1957 generally is con-
n 1957 or later without serologic evidence sidered
mumps,acceptable
and evidence
rubella of measles,
immunity, 2 doses of MMR
2 dosesMMR of MMR, 4 weeks
– For apart.
healthcare For HCP(HCP)mumps,
personnel born inand 1957 or later
rubella without
immunity, serologic
2 doses of MMR evidence sidered acceptable evidence of measles,
ses of MMR,
cutaneously 4 weeks
of (Subcut). apart. For HCP
immunity or prior vaccination, give 2vaccine
doses should
of MMR,be considered
4 weeks for
apart. unvacci-
For HCP mumps, and rubella immunity, 2 doses of MMR
vaccine
nated should
HCP be considered
born before 1957 for who
unvacci-
do not have
aneously (Subcut).
born prior vaccine should be considered for unvacci-
ave no serologic prooftoof1957, see below.
immunity, priorGive nated
subcutaneously
HCP born
laboratory (Subcut).
before
evidence 1957 who do
of disease ornot have to
immunity nated HCP born before 1957 who do not have
no serologic proof of immunity, prior laboratory
measles evidence
and/or of diseaseOne
mumps. or immunity
dose of to
MMR
Varicella
n of a history (chickenpox)
of varicella or herpes–zoster
For HCP who have no
measles
serologic
and/or mumps.
proof of immunity,
One dose ofHCP
MMR
prior laboratory evidence of disease or immunity to
a history of varicella
e 2 doses ofvaccination, or herpes
varicella vaccine, zoster
4 weeks
or diagnosis orapart.
verification vaccine
of a should
history be
of considered
varicella or for
herpes with
zosterno measles and/or mumps. One dose of MMR
doses of varicella vaccine, 4 weeks apart. vaccine should evidence
laboratory be considered for HCP
of disease with no
or immunity vaccine should be considered for HCP with no
(shingles) by a healthcare provider, give 2 doses of varicella vaccine, 4 weeks apart.
laboratory evidence
to rubella. of disease
For these same or immunity
HCP who do not laboratory evidence of disease or immunity
1 dose of Tdap GiveasSubcut.
soon as feasible to all HCP to rubella. For these
have evidence ofsame HCP who
immunity, do not
2 doses of MMR to rubella. For these same HCP who do not
ose of Tdap as soon as feasible to all HCP havevaccine
evidence areofrecommended
immunity, 2 doses
duringofanMMR
outbreak
and toTetanus,
pregnant HCPdiphtheria,
with eachpertussis
pregnancy– Give 1 dose
vaccine of Tdap as soon
are recommended as feasible
during to all HCP
an outbreak
have evidence of immunity, 2 doses of MMR
dyears
to pregnant HCP with each pregnancy of measles or mumps and 1 dose during an vaccine are recommended during an outbreak
thereafter.
who Give
have IM.
not received Tdap previously and
of measles to pregnant
or mumps
outbreak of rubella.
HCP
and 1 with
dose each
during pregnancy
an
rs thereafter. Give IM. Give Td boosters everyoutbreak of measles or mumps and 1 dose during an
nd MenB to(see below).
microbiologists who are routine- 10 yearsofthereafter.
Varicella
rubella. Give IM. outbreak of rubella.
MenB to microbiologists
ngitidis.Meningococcal
Every 5 years boost who are
with both
– Give routine-
MenACWY MenACWY ifVaricella
and MenB to microbiologists who are routine-
dis. Every Varicella
enB IM. 5 lyyears boosttowith
exposed MenACWY
isolates if meningitidis.
of Neisseria It is recommended that all HCP be immune to
It is varicella.
recommended Everythat
5 years boost with MenACWY if
IM. Evidence ofall HCP
immunitybe in
immune to
HCP includes It is recommended that all HCP be immune to
risk continues. Give MenACWY and MenB
ended for HCP who may have on-the-job exposure to fecal material.varicella.
IM.
Evidence ofofimmunity
documentation in HCP
2 doses of includes
varicella vaccine varicella. Evidence of immunity in HCP includes
for HCP who may have on-the-job exposure to fecal material. documentation
given at of28
2 doses of varicella vaccine
Hepatitis A, typhoid, and polio vaccines are not routinely recommended forleast
HCP who dayshave
may apart, laboratory
on-the-job evidence
exposure to fecal material. documentation of 2 doses of varicella vaccine
to be HBsAg positive should be counseled and given ofat least 28 days
immunity, apart,confirmation
laboratory laboratory evidence of disease, given at least 28 days apart, laboratory evidence
bemedically
HBsAg positive of immunity, laboratory confirmation of disease,
Hepatitis B should be counseled and
evaluated. or diagnosis
or diagnosis
to be HBsAg or verification
positive should
or verification
of a history
of a history
of vari- and
be counseled of immunity, laboratory confirmation of disease,
edically evaluated.
For HCP with documentation of a complete cellamedically
or herpes zoster (shingles)
evaluated. by of vari-
a healthcare or diagnosis or verification of a history of vari-
Unvaccinated healthcare personnel (HCP) cella
and/ or herpes
or HCP
2-dose with documentation
(Heplisav-B) of a (Engerix-B
or 3-dose complete or Re- provider. zoster (shingles) by a healthcare cella or herpes zoster (shingles) by a healthcare
or those who cannot document previous vac-
provider. For HCP with documentation of a complete
dose (Heplisav-B)
combivax
cination HB) shouldor 3-dose
vaccine receive (Engerix-B
series but no
either or Re- series ofTetanus/Diphtheria/Pertussis
documen-
a 2-dose 2-dose (Heplisav-B) or 3-dose (Engerix-B (Td/Tdap) or Re- provider.
ombivax
tation HB)
Heplisav-B vaccine
of anti-HBs at 0ofseries 1but
at least
and month nomIU/mL
10 documen-
or a 3-dose Tetanus/Diphtheria/Pertussis
(e.g.,series combivax HB) vaccine series (Td/Tdap)
butifno documen-
tion ofofanti-HBs of at All HCPs who have not or are unsure they have Tetanus/Diphtheria/Pertussis (Td/Tdap)
those vaccinated
either Engerix-B in least or10Recombivax
childhood): mIU/mL HCP (e.g.,
whoHBareat 0,atAll
1, HCPstation who have of anti-HBs
not or of unsure
are atofleast if10they
mIU/mL
have (e.g.,
hose vaccinated in childhood): HCP who are at previously received a dose Tdap should
risk for
andoccupational
6 months. HCP bloodwho orperform
body fluid expo-
tasks thatpreviously
receivethose vaccinated
received
a dose doseinof
ofa Tdap aschildhood):
Tdap
soon should HCP who
as feasible, are at All HCPs who have not or are unsure if they have
with-
sk sure
for occupational
might
may undergo
involve blood
exposure or body
anti-HBs to testingfluidor
blood expo-
uponbody hire orreceive
fluids risk forof previously received a dose of Tdap should
urematriculation.
might undergo anti-HBs or anti- out aregard dose tooccupational
Tdap as soon
the interval blood or previous
as feasible,
since the bodywith-fluid expo-
dose
should be See
tested for testing
references hepatitis upon
2 and hiredetails.
B3surface
for out regard sure might
to the intervalundergo anti-HBs testing upon hire or receive a dose of Tdap as soon as feasible, with-
atriculation. See references of Td. Pregnant HCP since
should thebeprevious
revaccinated dose
body (anti-HBs) 1–2 2months
and 3 for afterdetails.
dose #2 of of Td. Pregnant
matriculation. See references 2should
and 3 then for details. out regard to the interval since the previous dose
Influenza during eachHCP should
pregnancy. be HCPs
All revaccinated of Td. Pregnant HCP should be revaccinated
nfluenza Heplisav-B or dose #3 of Engerix-B or Recom- during each pregnancy.
All HCP, receive Td
Influenza boosters All everyHCPs should
10 years then
thereafter. during each pregnancy. All HCPs should then
bivaxincluding physicians,immunity.
HB to document nurses, paramedics,receive Td boosters every 10 years thereafter.
l HCP, including
emergency physicians,
medical nurses, paramedics,
technicians, employees Meningococcal
All HCP, including physicians, nurses, paramedics, receive Td boosters every 10 years thereafter.
mergency • Ifmedical
anti-HBstechnicians,
is at least 10 mIU/mL (positive),
employees
of nursing homes and chronic care facilities, Meningococcalemergency
nursing
students
the
homes vaccinee
in these
is immune.
andprofessions,
chronic careand No further serologicVaccination
facilities,
volunteers, Vaccination withmedical
MenACWY technicians,
and MenB employees
is Meningococcal
testing or vaccination is recommended. of nursing
recommended with homes
MenACWY
for and and chronic
microbiologists MenB care
is
who facilities,
are
udents
should in receive
these professions,
annual vaccination and volunteers,
against influ-recommended students Vaccination with MenACWY and MenB is
hould • Live
receive annualisvaccination
If anti-HBs less than 10againstmIU/mL (negative),routinely
influ- forinmicrobiologists
exposed these professions,
to isolates ofwho and
are volunteers,
N. meningitidis. recommended for microbiologists who are
enza. attenuated influenza vaccine (LAIV) routinelytwo should
exposed receive annual
to isolates vaccination against influ-
nza. Livebethe
may attenuated onlyinfluenza
vaccinee
given is non-pregnant
to vaccine healthy
not protected (LAIV)
from HCPTheBThe
hepatitis vaccines may beof N. meningitidis.
given concomitantly routinely exposed to isolates of N. meningitidis.
twoat
but enza.
vaccines Livemay
different attenuated
be given
anatomic influenza
concomitantly
sites, vaccine (LAIV)
if feasible.
ayage
be given
49virus
yearsonly
(HBV)
andto non-pregnant
infection,
younger. andhealthy
Inactivatedshould HCP
receive
injectable may be given only to non-pregnant healthy HCP The two vaccines may be given concomitantly
ge influenza
49 years and
another younger.
vaccine2-dose(IIV)or Inactivated
is3-dose
preferred injectable
series over HepB but at
ofLAIV different anatomic sites, if feasible.
age 49 years and younger. Inactivated injectable but at different anatomic sites, if feasible.
references
fluenza
for HCP vaccine
vaccine
who are (IIV)
on in theisclose
preferred
routine
contact over
schedule,
with LAIV followedreferences
severely by 1 CDC. influenza vaccine (IIV) is preferred over LAIV
Immunization of Health-Care Personnel: Recom- references
r HCP who are in testing
anti-HBs
immunosuppressed closepatients
contact
1–2 months with
(e.g.,severely
later. cell
stem A vaccinee
1 CDC.mendations
Immunization
for HCPofwho of Health-Care
the Advisory Personnel:
are in Committee
close onRecom-
contact Immunization
with severely 1 CDC. Immunization of Health-Care Personnel: Recom-
mmunosuppressed
whose
transplant patients
anti-HBs
recipients) when (e.g.,
remains theystem
less
requirecell protec-
than 10 mIU/mendations Practices of (ACIP).
the Advisory
immunosuppressed MMWR, Committee on Immunization
2011; 60(RR-7).
patients (e.g., stem cell mendations of the Advisory Committee on Immunization
ansplant recipients)
mL when they
after 2 complete require
series protec-
is considered Practices
a 2 CDC. (ACIP). MMWR, 2011; 60(RR-7).
tive isolation. Prevention recipients)
transplant of Hepatitis B whenVirus Infection
they in the Unit-
require protec- Practices (ACIP). MMWR, 2011; 60(RR-7).
ve isolation.“non-responder.” 2 CDC.ed Prevention of Hepatitis B Virus
States. Recommendations
tive isolation.
Infection
of the Advisory in the Unit-
Committee 2 CDC. Prevention of Hepatitis B Virus Infection in the Unit-
Measles,
ForMumps,
Mumps, Rubella
non-responders: HCP
(MMR)
who are non-responders
ed States. Recommendations
on Immunization of the
Practices. Advisory
MMWR, Committee
2018; 67(RR1):1–30. ed States. Recommendations of the Advisory Committee
Measles, Rubella (MMR) on 3Immunization
IAC.Measles, Practices.
Pre-exposure Mumps, MMWR, 2018;
Management Rubella 67(RR1):1–30.
for Healthcare (MMR) Personnel on Immunization Practices. MMWR, 2 018; 67(RR1):1–30.
HCPshould
who work in medical susceptible
be considered facilities should to HBVbe and 3 IAC. Pre-exposure Management for BHealthcare Personnel
CPimmune
whoshould
work with a Documented Hepatitis Vaccine Series Who Have
to in
bemedical
measles,
counseled facilities
mumps, should
and
regarding rubella.be
precautions to
with aNot HCP
Documented whoHepatitis
work inBmedical
Had Post-vaccination facilities
Vaccine Series
Serologic Testing.Who should
Have
Accessed at be
3 IAC. Pre-exposure Management for Healthcare Personnel
mmunepreventto measles, HBV mumps,
infection and rubella. with a Documented Hepatitis B Vaccine Series Who Have
• HCP born in 1957 or laterand canthe need to obtainNot Had
be considered immune to measles,
Post-vaccination Serologicmumps,
www.immunize.org/catg.d/p2108.pdf. and rubella.
Testing. Accessed at
Not Had Post-vaccination Serologic Testing. Accessed at
HCPimmune
born
HBIG in prophylaxis
1957 or later can
for any be considered
known
to measles, mumps, or rubella only or probable www.immunize.org/catg.d/p2108.pdf.
• HCP born inACIP
1957 or later can bevisit considered www.immunize.org/catg.d/p2108.pdf.
For additional specific recommendations, CDC’s
immuneif they tohave
measles,
parenteral exposuremumps,
documentation orofrubella
to hepatitis only antigen
(a)Blaboratory
surface For additional atspecific
websiteimmune ACIP recommendations,
to measles, mumps,visit
www.cdc.gov/vaccines/hcp/acip-recs/index. orCDC’s
rubella only
if they have documentation of For additional specific ACIP recommendations, visit CDC’s
(HBsAg)-positive
confirmation of disease blood or (a)
or laboratory
blood
immunity with
or unknown website
html ator
www.cdc.gov/vaccines/hcp/acip-recs/index.
ifvisit
they have
IAC’s documentation
website of (a) laboratory
at www.immunize.org/acip. website at www.cdc.gov/vaccines/hcp/acip-recs/index.
confirmation
(b)HBsAg of
appropriate disease
status. It isoralso
vaccinationimmunity
possible
against or that non- html or visit confirmation
measles, IAC’s website atof www.immunize.org/acip.
disease or immunity or html or visit IAC’s website at www.immunize.org/acip.
(b) appropriate
responders
mumps, andvaccination
are people
rubella against
(i.e., who
2 doses measles,
are HBsAg
of live positive. (b) appropriate vaccination against measles,
Technical content reviewed by the Centers for Disease Control and Prevention
mumps, and rubella
HBsAg testing(i.e., 2 doses of liveHCP Technical
is recommended. found content reviewed mumps, and rubella
by the Centers for Disease (i.e., 2 and
Control doses of live
Prevention
int Paul, Minnesota • 651- 647- 9009 • www.immunize.org • www.vaccineinformation.org Technical content reviewed by the Centers for Disease Control and Prevention
aul, Minnesota • 651 - 647 - 9009 • www.immunize.org • www.vaccineinformation.org
Immunization Action Coalitionwww.immunize.org/catg.d/p2 651- 647
Saint Paul, Minnesota •017.pdf - 9009
• Item www.immunize.org
#P2• 017 (3/18) • www.vaccineinformation.org
www.immunize.org/catg.d/p2 017.pdf • Item #P2 017 (3/18)
www.immunize.org/catg.d/p2 017.pdf • Item #P2 017 (3/18)

121
 5.2 3-5. Checklist for
FormsBloodborne

Training Content
& Checklists
Forms & Checklists
for Infection Pathogens
forPrevention,
Infection Prevention,
Volume 2 Volume
113 2 113

Forms & Checklists for Infection Prevention, Volume 2 113

3-5. 3-5.
Checklist
Checklist
for Bloodborne
for Bloodborne
Date:
Pathogens
Pathogens Reviewer:

Training
Training
Content
Content
Note “Yes” or “No” as
to if required content is
Subject matter to include:

t for Bloodborne Pathogens

included in training

Epidemiology, symptoms, and transmission of bloodborne pathogen diseases

Content Date: Date: Reviewer: A copy and explanation of the OSHA bloodborne pathogen standard
Reviewer:

An explanation of our ECP and how to obtain a copy

Note “Yes” or Note “Yes” orSubject
“No” as “No” asmatter
Subject
to include:
matter to include:
An explanation of methods to recognize tasks and other activities that may involve exposure to blood
to if required content
to if required
is content is
and OPIM, including what constitutes an exposure incident
included in training
included in training
An explanation of the use and limitations of engineering controls, work practices, and PPE
Epidemiology,Epidemiology,
symptoms, andsymptoms,
transmission
and of
transmission
bloodborneofpathogen
bloodborne
diseases
pathogen diseases
An explanation of the types, uses, location, removal, handling, decontamination, and disposal of PPE
er to include: A copy and explanation
A copy andofexplanation
the OSHA bloodborne
of the OSHApathogen
bloodborne
standard
pathogen standard
An explanation of the basis for PPE selection
An explanation
Anofexplanation
our ECP andof how
our ECP
to obtain
and how
a copy
to obtain a copy

y, symptoms, and transmission of bloodborne Information

pathogen on the hepatitis B vaccine, including information on its efficacy, safety, method of
diseases
An explanationAnofexplanation
methods toofrecognize
methodstasks
to recognize
and other tasks
activities
and other
that activities
may involvethatexposure
may involve
to blood
exposure to blood
administration, the benefits of being vaccinated, and that the vaccine will be offered free of charge
and OPIM, including
and OPIM,what including
constituteswhatanconstitutes
exposure incident
an exposure incident
xplanation of the OSHA bloodborne pathogen standard
Information on the appropriate actions to take and persons to contact in an emergency involving
An explanationAnofexplanation
the use andoflimitations
the use and of engineering
limitations ofcontrols,
engineering
workcontrols,
practices,work
andpractices,
PPE and PPE
blood or OPIM
on of our ECP and how to obtain a copy
An explanationAn
Anofexplanation
the types, uses,
explanation of
ofthe location,
the types, uses,
removal,
procedure location,
to handling,
follow ifremoval,
decontamination,
handling,
an exposure decontamination,
incident and disposal
occurs, of
and
including PPE
disposal
the methodof PPE
of
reporting
on of methods to recognize tasks and other activities the involve
that may incidentexposure
and the medical
to bloodfollow-up that will be made available
cluding what constitutes an exposure Anincident
explanation
Anofexplanation
the basis forofPPE
the basis
selection
for PPE selection
Information on the post-exposure evaluation and follow-up that the employer is required to provide
on of the use and limitations of engineering for the
controls, employee following an exposure incident
Information on thework
Information practices,
hepatitis
onBthe and PPE
vaccine,
hepatitis
including
B vaccine,
information
includingon information
its efficacy,onsafety,
its efficacy,
method safety,
of method of
administration,
administration,
the benefits ofthe
being
benefits
vaccinated,
An explanation of the signs and of being and
labelsvaccinated,
that thecolor
and/or vaccine
andcoding
thatwill
thebevaccine
offered
required will
by free
beof
the offered
chargefree
standard and of charge
used at
on of the types, uses, location, removal, handling, decontamination, and disposal of PPE
this facility
Information onInformation
the appropriate
on theactions
appropriate
to take actions
and persons
to taketo and
contact
personsin an
to emergency
contact in an involving
emergency involving
on of the basis for PPE selection blood or OPIMblood or OPIM for interactive questions and answers with the person conducting the training session.
An opportunity
An explanation Anofexplanation
the procedureof the
to follow
procedure
if anto
exposure
follow ifincident
an exposure
occurs,
incident
including
occurs,
the method
includingofthe method of
n the hepatitis B vaccine, includingreporting
Comments: information theon its efficacy,
reporting
incident and safety,
thethe
incident method
medical theof
andfollow-up
medical
thatfollow-up
will be made
that available
will be made available
n, the benefits of being vaccinated, and that the vaccine will be offered free of charge
Information on Information
the post-exposure
on the post-exposure
evaluation andevaluation
follow-upandthatfollow-up
the employer
that the
is required
employerto is
provide
required to provide
n the appropriate actions to take and
for persons tofor
the employee contact
the in anan
following
employee emergency
followinginvolving
exposure incident
an exposure incident
M
An explanation Anofexplanation
the signs andof the
labels
signs
and/or
and labels
color coding
and/or required
color coding
by therequired
standardby and
the standard
used at and used at
on of the procedure to follow if an exposure incident
this facility thisoccurs,
facility including the method of
incident and the medical follow-up that will be made available
An opportunity Anforopportunity
interactiveforquestions
interactive
andquestions
answers with
and answers
the personwith
conducting
the person the
conducting
training session.
the training session.
n the post-exposure evaluation and follow-up that the employer is required to provide
yee following an exposure incident
Comments: Comments:
on of the signs and labels and/or color coding required by the standard and used at

ty for interactive questions and answers with the person conducting the training session.

Reference
Debbie Hurst, RN, BSN, CIC

ReferenceReference
Debbie Hurst,
Debbie
RN, Hurst,
BSN, CIC
RN, BSN, CIC 122
 5.3 3-7. Sharps Injury
FormsLog
& Checklists
Forms & Checklists
for Infection
forPrevention,
Infection Prevention,
Volume 2 Volume
1152 115

Forms & Checklists for Infection Prevention, Volume 2 115

3-7. Sharps
3-7.
Year:
Sharps
Injury
Injury
Log Log
Incident Date Incident ID # Device Type Device Brand Incident Brief Description

njury Log
Location of Incident

Year: Year:

Incident Date
Incident
Incident
Date ID #Incident
Device
ID # TypeDeviceDevice
Type Brand
Device Brand
Incident Incident
Brief Description
Brief Description
Location Location of Incident of Incident

Device Type Device Brand Incident Brief Description

Location of Incident

29 CFR 1910.1030, OSHA’s Bloodborne Pathogens Standard, in paragraph (h)(5), requires an employer to establish and maintain a Sharps Injury Log for
recording all percutaneous injuries in a facility occurring from contaminated sharps. The purpose of the Log is to aid in the evaluation of devices being used in
healthcare and other facilities and to identify problem devices or procedures requiring additional attention or review. This log must be kept in addition to the
injury and illness log required by 29 CFR 1904.The Sharps Injury Log should include all sharps injuries occurring in a calendar year. The log must be retained
for five years following the end of the year to which it relates. The Log must be kept in a manner that preserves the confidentiality of the affected employee.

29 CFR 1910.1030, 29 CFR OSHA’s

1910.1030,
Bloodborne
OSHA’sPathogens
Bloodborne
Standard,
Pathogens
in paragraph
Standard, (h)(5),
in paragraph
requires (h)(5),
an employer
requires
to establish
an employer
and to
maintain
establishaand
Sharps
maintain
Injury aLog
Sharps
for Injury Log for
recording all percutaneous
recording all injuries
percutaneous
in a facility
injuries
occurring
in a facility
from contaminated
occurring fromsharps.
contaminated
The purpose
sharps.
of the
TheLog
purpose
is to aid
of the
in Log
the evaluation
is to aid inofthedevices
evaluation
being of
used
devices
in being used in
healthcare and other
healthcare
facilities
andand
other
to facilities
identify problem
and to identify
devices problem
or procedures
devicesrequiring
or procedures
additional
requiring
attention
additional
or review.
attention
This log
or review.
must beThis
keptlogin must
addition
be kept
to the
in addition to the
injury and illnessinjury
log required
and illness
by 29
log CFR
required
1904.The
by 29 CFR
Sharps 1904.The
Injury Log
Sharps
shouldInjury
include
Logall
should
sharpsinclude
injuries
alloccurring
sharps injuries
in a calendar
occurringyear.
in aThe
calendar
log must
year.
be The
retained
log must be retained
for five years following
for five the
years
end
following
of the year
the to
end
which
of theit year
relates.
to which
The Log
it relates.
must beThekeptLog
in must
a manner
be keptthat
in preserves
a mannerthethatconfidentiality
preserves theofconfidentiality
the affected employee.
of the affected employee.
ns Standard, in paragraph (h)(5), requires an employer to establish and maintain a Sharps Injury Log for
urring from contaminated sharps. The purpose of the Log is to aid in the evaluation of devices being used in
Reference
lem devices or procedures requiring additional attention or review. This log must be kept in addition to the
The Sharps Injury Log should include all
George sharpsRN,
Allen, injuries occurring
PhD, in a calendar
FAPIC, CIC,year.CNORThe log must be retained
h it relates. The Log must be kept in a manner that preserves the confidentiality of the affected employee.

Reference
Reference
George Allen,
George
RN, Allen,
PhD, FAPIC,
RN, PhD,
CIC,
FAPIC,
CNOR CIC, CNOR 123
6
5.4
116
Forms
Forms & Checklists for Infection Prevention, Volume 2
116 & Checklists
Forms & Checklists
for Infection
forPrevention,
Infection Prevention,
Volume 2 Volume 2

116 Forms & Checklists for Infection Prevention, Volume 2

3-8. Employee Training Record
3-8. 3-8.
Employee
Employee
Training
Training
Record
Record

3-8. Employee Training Record

Name of employee:
Name of employee:
Name of employee:
Employee number:
EmployeeEmployee
number: number:
Department:
Department:Department:
Name of employee:
Job title:
Job title: Job title: number:
Employee
Date
Training Subject Comments
Department: Date
Trained Date Retrained
Training Subject
Training Subject Comments Comments
Trained Trained Retrained Retrained
Job title:

Date
Training Subject Comments
Trained Retrained

I have received and understood the safety and health training listed above and acknowledge that it has
Ibeen
I have received given
haveand to me.
received
understood
and understood
the safety the
andsafety
healthand
training
health
listed
training
above
listed
andabove
acknowledge
and acknowledge
that it has that it has
been givenbeen
to me.
given to me.
Employee’s Signature Date Supervisor’s Signature Date
Employee’s Signature
Employee’s Signature Date Date Supervisor’sSupervisor’s
Signature Signature Date Date

I have received and understood the safety and health training listed above and acknowledge that it has
been given to me.

Employee’s Signature Date Supervisor’s Signature Date

Reference
Reference
Reference
OSHA, https://www.osha.gov/SLTC/etools/safetyhealth/employeetrainingrec.pdf
OSHA, https://www.osha.gov/SLTC/etools/safetyhealth/employeetrainingrec.pdf
OSHA, https://www.osha.gov/SLTC/etools/safetyhealth/employeetrainingrec.pdf
124

Reference
5.5
Forms & Checklists for Infection Prevention, Volume 1 69
Forms & Checklists for Infection Prevention, Volume 1 69

2-6. Injection Safety Competency

2-6. Injection Safety Competency
Injection Safety Competency Validation
Injection Safety Competency Validation
Point of Care Testing
Point of Care Testing
Orientation
Type of validation: Return demonstration Orientation Annual
Type of validation: Return demonstration Annual Other
Other
Employee Name: Job Title:
Employee Name: Job Title:
Competent
Medication Preparation N/A
Competent
YES NO
Medication Preparation N/A
1. Perform hand hygiene prior to preparing or administering YES NO

medications
1. Perform hand hygiene prior to preparing or administering
medications
2. Injections are prepared using aseptic technique in a clear area
free
2. Injections are from contamination
prepared using asepticortechnique
contact with blood,area
in a clear body fluids, or
contaminatedor
free from contamination equipment
contact with blood, body fluids, or
contaminated equipment
3. Needles and syringes are used for only one patient (this
3. Needles andincludes
syringesmanufactured prefilled
are used for only one syringes and cartridge
patient (this
devices)
includes manufactured prefilled syringes and cartridge
devices) 4. Rubber septum on medication vial is disinfected with alcohol
prioron
4. Rubber septum to medication
piercing vial is disinfected with alcohol
prior to piercing
5. Medication vials are entered with a new needle and new
5. Medication syringe,
vials areeven when
entered obtaining
with additional
a new needle and doses
new for same
patient
syringe, even when obtaining additional doses for same
patient 6. Single-dose or single-use medication vials, ampules, and
6. Single-dosebags/bottles
or single-useof intravenous
medication solution
vials, are used
ampules, and for only one
patient
bags/bottles of intravenous solution are used for only one
patient 7. Medication administration tubing and connectors are used for
7. Medication only one patient
administration tubing and connectors are used for
only one8.patient
Multi-dose vials are dated when first opened and discarded
within
8. Multi-dose vials 28dated
are days when
unlessfirst
manufacturer
opened and specifies a different
discarded
(shorter
within 28 days ormanufacturer
unless longer) date for that opened
specifies vial
a different
(shorter 9.
or longer)
Multi-dosedate for are
vials thatdedicated
opened vial to individual patients whenever
possible (e.g., insulin vials, lidocaine,
9. Multi-dose vials are dedicated to individual patients etc.)whenever
possible 10.
(e.g., insulin vials,
Multi-dose vialslidocaine,
to be usedetc.)
for more than one patient are
kept to
10. Multi-dose vials in be
a centralized medication
used for more than onearea and do
patient arenot enter the
immediate
kept in a centralized patient treatment
medication area andarea (e.g.,
do not operating
enter the room,
patient treatment
immediate patient room/cubicle)
area (e.g., operating room,
patient room/cubicle)
11. Insulin pens dedicated to only one patient
11. Insulin pens dedicated to
12. Medication only one patient
is administered within 1 hour of preparation
12. Medication is administered within 1 hour of preparation

125
70 Forms & Checklists for Infection Prevention, Volume 1

Competent
Point of Care Testing (e.g., glucometer, PT/INR) N/A
YES NO

13. Perform hand hygiene

14. Don gloves
15. Single-use, auto-disabling fingerstick device used for one
patient only & discarded into sharps container
16. Individual patient dedicated glucometer (preferred) is
stored to avoid cross-contamination and inadvertent use on
additional patients (ideally, in the patient room)—best practice
is to clean/disinfect prior to storage per manufacturer’s
instructions
17. Shared glucometers/equipment must be cleaned and
disinfected after every use per manufacturer’s instructions
(if the manufacturer does not specify how the device should
be cleaned and disinfected, then it should not be shared)
18. Gloves removed
19. Hand hygiene performed

Comments or follow up actions:

Employee Signature
Validator Signature / Date

References
CDC at http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html
One and Only Campaign at http://www.oneandonlycampaign.org/ NC SPICE; 9-2016

126
Module 6

Construction and Water Management

Contents
6.1 Infection Control Risk Assessment (ICRA) Matrix of Precautions for
Construction & Renovation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
https://apic.org/Resource_/TinyMceFileManager/Education/ASC_Intensive/Resources_
Page/ICRA_Risk_Assessment_for_Construction_and_Renovation.pdf

6.2 What Clinicians need to know about Legionnaires disease . . . . . . . . . . . . . . . . . . . . . . . . 134

Centers for Disease Control (CDC)
https://www.cdc.gov/legionella/downloads/fs-legionella-clinicians.pdf

6.3 Healthcare Facility Water Management Program Checklist . . . . . . . . . . . . . . . . . . . . . . . . 135

CDC
https://www.cdc.gov/HAI/pdfs/Water-Management-Checklist-P.pdf

Resources
Environmental Infection Control guidelines
CDC
https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html#anchor_
1556902049

Infection Prevention Manual for Construction & Renovation

Association for Professionals in Infection Control and Epidemiology (APIC)
https://rise.apic.org/WEB/ItemDetail?iProductCode=SLS9808&Category=BOOKS

Guidelines for Design and Construction of Outpatient Facilities

Facility Guidelines Institute
https://www.fgiguidelines.org/guidelines/2018-fgi-guidelines/

ANSI/ASHRAE Standard 188:2018, Legionellosis: Risk Management for Building Water Systems
American Society of Heating, Refrigerating, and Air Conditioning Engineers
https://www.ashrae.org/technical-resources/bookstore/ansi-ashrae-standard-188-2018-legio-
nellosis-risk-management-for-building-water-systems

ANSI/ASHRAE Standard 188-2018 for Legionnaires’ Disease Risk Management

American National Standards Institute (ANSI) blog
https://blog.ansi.org/2018/09/ansi-ashrae-standard-188-2018-legionnaires/#gref

Legionella
CDC
https://www.cdc.gov/legionella/clinicians.html

127
6.1 Infection Control Risk Assessment
Matrix of Precautions for Construction & Renovation
Step One: Infection Control Risk Assessment
Matrix
Using the following of Precautions
table, identify the Typefor Construction
of Construction & Renovation
Project Activity (Type A-D)

Step One:Inspection and Non-Invasive Activities.

Includes, table,
Using the following but is not limited
identify theto:Type of Construction Project Activity (Type A-D)
ƒ removal of ceiling tiles for visual inspection only, e.g., limited to 1 tile per 50
Inspection
square feet and Non-Invasive Activities.
TYPE A
ƒ Includes,
paintingbut(butis not sanding)
limited to:
removal of ceiling
ƒ ƒ wallcovering, tilestrim
electrical for visual inspection
work, minor only, e.g.,
plumbing, and limited to which
activities 1 tile per 50
do not
square feet
generate dust or require cutting of walls or access to ceilings other than for
TYPE A
ƒ visual inspection.
painting (but not sanding)
ƒ wallcovering,
Small electrical activities
scale, short duration trim work,which
minorcreate
plumbing, and activities
minimal dust which do not
generate dust or require
Includes, but is not limited to: cutting of walls or access to ceilings other than for
visual inspection.
TYPE B ƒ installation of telephone and computer cabling
ƒ Small scale,
access shortspaces
to chase duration activities which create minimal dust
ƒ Includes,
cutting but is notorlimited
of walls ceilingto:
where dust migration can be controlled.
TYPE B ƒ installation of telephone and computer cabling
Work that generates a moderate to high level of dust or requires demolition or
ƒ access
removal to chase
of any fixedspaces
building components or assemblies
ƒ cutting of walls or
Includes, but is not limited ceiling
to: where dust migration can be controlled.
ƒ Work thatofgenerates
sanding walls for apainting
moderate to high
or wall level of dust or requires demolition or
covering
TYPE C ƒ removal of floorcoverings, ceiling tiles andor
removal of any fixed building components assemblies
casework
ƒ Includes,
new wallbutconstruction
is not limited to:
sanding
ƒ ƒ minor ductofwork
wallsorfor paintingwork
electrical or wall covering
above ceilings
removal
TYPE C ƒ ƒ major of floorcoverings,
cabling activities ceiling tiles and casework
new
ƒ ƒ any wall construction
activity which cannot be completed within a single workshift.
ƒ minor duct work or electrical work above ceilings
Major demolition and construction projects
ƒ major cabling activities
Includes, but is not limited to:
ƒ any activity which cannot be completed within a single workshift.
TYPE D ƒ activities which require consecutive work shifts
ƒ Major demolition
requires and construction
heavy demolition or removal projects
of a complete cabling system
Includes, but is
ƒ new construction. not limited to:
TYPE D ƒ activities which require consecutive work shifts
ƒ requires heavy demolition or removal of a complete cabling system
Step 1: _________________________________________________________
ƒ new construction.

Step 1: _________________________________________________________

Steps 1-3 Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX; C Fine CA
Steps 4-14 Adapted with permission Fairview University Medical Center Minneapolis MN Forms modified /updated;
provided courtesy of Judene Bartley, ECSI Inc. Beverly Hills MI 2002. [email protected] Updated, 2009.

Steps 1-3 Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX; C Fine CA
Steps 4-14 Adapted with permission Fairview University128Medical Center Minneapolis MN Forms modified /updated;
provided courtesy of Judene Bartley, ECSI Inc. Beverly Hills MI 2002. [email protected] Updated, 2009.
 Infection Control Risk Assessment
Matrix of Precautions for Construction & Renovation
Step Two:
Using the following table, identify the Patient Risk Groups that will be affected.
Step
If moreOne:
than one risk group will be affected, select the higher risk group:
Using the following table, identify the Type of Construction Project Activity (Type A-D)
Low Risk Medium Risk High Risk Highest Risk
ƒ Office Inspection and Non-Invasive
ƒ Cardiology ƒ Activities.
CCU ƒ Any area caring for
areas Includes, but is not limited to:
ƒ Echocardiography ƒ Emergency Room immunocompromised
ƒ removal of
ƒ Endoscopy ceiling tiles for visual inspection
ƒ Labor & Delivery only, e.g., patients
limited to 1 tile per 50
square feet Medicine ƒ Laboratories
ƒ Nuclear ƒ Burn Unit
TYPE A
ƒ painting
ƒ Physical(butTherapy
not sanding) (specimen) ƒ Cardiac Cath Lab
ƒ wallcovering,
ƒ Radiology/MRI electrical trim
ƒ work,
Medicalminor plumbing, and
Units Central Sterile
ƒ activities whichSupply
do not
generate dust or require cutting
ƒ Respiratory of wallsNursery
ƒ Newborn or access to ceilings other than
ƒ Intensive Care for
Units
visual inspection.
Therapy ƒ Outpatient Surgery ƒ Negative pressure
Pediatrics
Small scale, short duration ƒactivities which create minimal isolation
dust rooms
Includes, but is not limited to:ƒ Pharmacy ƒ Oncology
Post Anesthesia ƒ Operating rooms
TYPE B ƒ installation of telephone and ƒ computer cablingCare
Unit including C-section
ƒ access to chase spaces rooms
ƒ Surgical Units
ƒ cutting of walls or ceiling where dust migration can be controlled.
Step 2__________________________________________________________
Work that generates a moderate to high level of dust or requires demolition or
removal of any fixed building components or assemblies
Step Three: Match the
Includes, but is not limited to:
Patient Risk Group (Low,
ƒ sanding of walls Medium, High,orHighest)
for painting with the planned …
wall covering
Construction Project Type (A, B, C, D) on the following matrix, to find the …
TYPE ƒ removal of
C of Precautions
Class (I, floorcoverings,
II, III or IV) orceiling
level oftiles and casework
infection control activities required.
new wall construction
Class I-IV or Color-Coded Precautions are delineated on the following page.
ƒ
ƒ minor duct work or electrical work above ceilings
IC Matrix ƒ- Class
majorof Precautions:
cabling activities Construction Project by Patient Risk
ƒ any activity which cannot be completed within a single workshift.
Construction Project Type
Major demolition and construction projects
Patient Risk Group TYPE A TYPE B TYPE C TYPE D
Includes, but is not limited to:
LOW Risk Group I II II III/ IV
TYPE D ƒ activities which require consecutive work shifts
MEDIUM Risk Group heavy demolition
ƒ requires I II of a complete cabling
or removal III system IV
HIGH Risk Group
ƒ new construction.I II III/ IV IV
HIGHEST Risk Group II III/ IV III/ IV IV
Note: Infection Control approval will be required when the Construction Activity and Risk Level indicate
Step
that Cl1:
ass _________________________________________________________
III or Class IV control procedures are necessary.

Step 3 ______________________________________________________

Steps 1-3 Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX; C Fine CA
Steps 4-14 Adapted with permission Fairview University Medical Center Minneapolis MN Forms modified /updated;
provided courtesy of Judene Bartley, ECSI Inc. Beverly Hills MI 2002. [email protected] Updated, 2009.
Steps 1-3 Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX; C Fine CA
Steps 4-14 Adapted with permission Fairview University Medical Center Minneapolis MN Forms modified /updated;
provided courtesy of Judene Bartley, ECSI Inc. Beverly Hills MI 2002. [email protected] Updated, 2009.
129
 Infection Control Risk Assessment
Matrix of Precautions
Description for Construction
of Required Infection & Renovation
Control Precautions by Class
During Construction Project Upon Completion of Project
Step1. One:
Execute work by methods to minimize raising dust 1. Clean work area upon completion of task.
Using the
fromfollowing table, identify the Type of Construction Project Activity (Type A-D)
CLASS I

construction operations.
2. Immediately replace a ceiling tile displaced for
visual inspection
Inspection and Non-Invasive Activities.
1.
Provide active means
Includes, but to
is prevent airborne
not limited to:dust from 1. Wipe work surfaces with cleaner/disinfectant.
dispersing into atmosphere. 2. Contain construction waste before transport in
2. Waterƒmistremoval of ceiling
work surfaces tiles
to control forwhile
dust visual inspection only,
tightly e.g.,containers.
covered limited to 1 tile per 50
cutting. square feet 3. Wet mop and/or vacuum with HEPA filtered
CLASS II

TYPE A
3. Seal unused doors with duct tape.
ƒ painting (but not sanding) vacuum before leaving work area.
4. Block off and seal air vents. 4. Upon completion, restore HVAC system
ƒ wallcovering,
5. Place dust mat at entrance and electrical trimarea
exit of work work, minorwhere
plumbing, and
work was activities which do not
performed.
6. Remove orgenerate dust or require cutting of walls or access to ceilings other than for
isolate HVAC system in areas where
work is being performed
visual inspection.
.
1.
Remove or Isolate HVAC system in area where 1. Do not remove barriers from work area until
work isSmall scale,to short
being done preventduration
contaminationactivities
of whichcompleted
create minimal dust by the owner’s
project is inspected
Includes, but is not limited to:
duct system. Safety Department and Infection Prevention &
2. Complete all critical barriers i.e. sheetrock, Control Department and thoroughly cleaned by
TYPE B installation
ƒ plastic,
plywood, to seal of
areatelephone
from non workand area
computer cabling
the owner’s Environmental Services
ƒ access
or implement to cube
control chase spaces
method (cart with Department.
CLASS III

plastic covering and sealed connection to work site 2. Remove barrier materials carefully to
ƒ cutting
with HEPA vacuumof forwalls or ceiling
vacuuming prior towhere
exit) dust migration
minimizecan be controlled.
spreading of dirt and debris
beforeWork
construction begins. associated with construction.
that generates a moderate to high level of dust or requires demolition or
3. Maintain negative air pressure within work site 3. Vacuum work area with HEPA filtered
removal of any fixed building componentsvacuums.
utilizing HEPA equipped air filtration units.
or assemblies
4. Contain Includes, butwaste
construction is notbefore
limited to: in
transport 4. Wet mop area with cleaner/disinfectant.
tightly covered containers. 5. Upon completion, restore HVAC system
ƒ sanding of walls for painting or wall covering
5. Cover transport receptacles or carts. Tape covering where work was performed.
TYPE C unlessƒsolidremoval
lid. of floorcoverings, ceiling tiles and casework
1. IsolateƒHVAC newsystem
wall construction
in area where work is being 1. Do not remove barriers from work area until
done to prevent contamination of duct system. completed project is inspected by the owner’s
ƒ minor duct work or electrical work aboveSafety
2. Complete all critical barriers i.e. sheetrock,
ceilings
Department and Infection Prevention &
plywood, major tocabling
ƒ plastic, seal areaactivities
from non work area Control Department and thoroughly cleaned by
or implement control cube method (cart with the owner’s Environmental Services Dept.
ƒ any activity which cannot be completed within a single workshift.
plastic covering and sealed connection to work site 2. Remove barrier material carefully to minimize
Major
with HEPA demolition
vacuum and construction
for vacuuming prior to exit) projectsspreading of dirt and debris associated with
before construction begins. construction.
Includes,
negativebut is not limited to: site
CLASS IV

3. Maintain air pressure within work

3. Contain construction waste before transport in
TYPE D utilizing activities
ƒ HEPA which
equipped requireunits.
air filtration consecutive worktightly
shiftscovered containers.
4. Seal holes, pipes, conduits, and punctures.
5. Construct requires and
ƒ anteroom heavy demolition
require all personnelor to
removal4.of Cover
a complete cabling
transport system
receptacles or carts. Tape
ƒ new
pass through thisconstruction.
room so they can be vacuumed covering unless solid lid.
using a HEPA vacuum cleaner before leaving work 5. Vacuum work area with HEPA filtered
site or they can wear cloth or paper coveralls that vacuums.
are removed each time they leave work site. 6. Wet mop area with cleaner/disinfectant.
Step6. 1:All_________________________________________________________
personnel entering work site are required to
7. Upon completion, restore HVAC system
wear shoe covers. Shoe covers must be changed
where work was performed.
each time the worker exits the work area.

Steps 1-3 Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX; C Fine CA
Steps 4-14 Adapted with permission Fairview University Medical Center Minneapolis MN Forms modified /updated;
Steps 1-3courtesy
provided Adaptedof with permission
Judene Bartley, V Kennedy,
ECSI B Barnard,
Inc. Beverly St Luke
Hills MI 2002.Episcopal Hospital, Houston
[email protected] TX; C Fine
Updated, CA
2009.
Steps 4-14 Adapted with permission Fairview University Medical Center Minneapolis MN Forms modified /updated;
provided courtesy of Judene Bartley, ECSI Inc. Beverly Hills MI 2002. [email protected] Updated, 2009.

130
Step 4. Identify the areas surrounding the project area, assessing potential impact

Unit Below Unit Above Lateral Lateral Behind Front

Risk Group Risk Group Risk Group Risk Group Risk Group Risk Group

Step 5. Identify specific site of activity e.g., patient rooms, medication room, etc.
__________________________________________________________________

Step 6. Identify issues related to: ventilation, plumbing, electrical in terms of the occurrence
of probable outages.
__________________________________________________________________

Step 7. Identify containment measures, using prior assessment. What types of barriers?
(E.g., solids wall barriers); Will HEPA filtration be required?
_________________________________________________________________
(Note: Renovation/construction area shall be isolated from the occupied areas during construction and shall be
negative with respect to surrounding areas)

Step 8. Consider potential risk of water damage. Is there a risk due to compromising
structural integrity? (e.g., wall, ceiling, roof)
Step 9. Work hours: Can or will the work be done during non-patient care hours?

Step 10. Do plans allow for adequate number of isolation/negative airflow rooms?

Step 11. Do the plans allow for the required number & type of handwashing sinks?

Step 12. Does the infection prevention & control staff agree with the minimum number of sinks for
this project? (Verify against FGI Design and Construction Guidelines for types and area)

Step 13. Does the infection prevention & control staff agree with the plans relative to clean
and soiled utility rooms?

Step 14. Plan to discuss the following containment issues with the project team.
E.g., traffic flow, housekeeping, debris removal (how and when),
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________

Appendix: Identify and communicate the responsibility for project monitoring that includes infection
prevention & control concerns and risks. The ICRA may be modified throughout the project.
Revisions must be communicated to the Project Manager.

Steps 1-3 Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX; C Fine CA
Steps 4-14 Adapted with permission Fairview University Medical Center Minneapolis MN Forms modified /updated;
provided courtesy of Judene Bartley, ECSI Inc. Beverly Hills MI 2002. [email protected] Updated, 2009.

131
 Infection Control Construction Permit
Permit No:
Location of Construction: Project Start Date:
Project Coordinator: Estimated Duration:
Contractor Performing Work Permit Expiration Date:
Supervisor: Telephone:
YES NO CONSTRUCTION ACTIVITY YES NO INFECTION CONTROL RISK GROUP
TYPE A: Inspection, non-invasive activity GROUP 1: Low Risk
TYPE B: Small scale, short duration, GROUP 2: Medium Risk
moderate to high levels
TYPE C: Activity generates moderate to high levels of GROUP 3: Medium/High Risk
dust, requires greater 1 work shift for completion
TYPE D: Major duration and construction activities GROUP 4: Highest Risk
Requiring consecutive work shifts
CLASS I 1. Execute work by methods to minimize raising dust from 3. Minor Demolition for Remodeling
construction operations.
2. Immediately replace any ceiling tile displaced for visual
inspection.
CLASS II 1. Provides active means to prevent air-borne dust from 6. Contain construction waste before transport in tightly
dispersing into atmosphere covered containers.
2. Water mist work surfaces to control dust while cutting. 7. Wet mop and/or vacuum with HEPA filtered vacuum
3. Seal unused doors with duct tape. before leaving work area.
4. Block off and seal air vents. 8. Place dust mat at entrance and exit of work area.
5. Wipe surfaces with cleaner/disinfectant. 9. Isolate HVAC system in areas where work is being
performed; restore when work completed.
1. Obtain infection control permit before construction begins. 6. Vacuum work with HEPA filtered vacuums.
CLASS III 2. Isolate HVAC system in area where work is being done to 7. Wet mop with cleaner/disinfectant
prevent contamination of the duct system. 8. Remove barrier materials carefully to minimize
3. Complete all critical barriers or implement control cube spreading of dirt and debris associated with
method before construction begins. construction.
9. Contain construction waste before transport in
Date 4. Maintain negative air pressure within work site utilizing tightly covered containers.
HEPA equipped air filtration units. 10. Cover transport receptacles or carts. Tape covering.
Initial 5. Do not remove barriers from work area until complete 11. Upon completion, restore HVAC system where work
project is checked by Infection Prevention & Control and was performed.
thoroughly cleaned by Environmental Services.
1. Obtain infection control permit before construction begins. 8. Do not remove barriers from work area until completed
CLASS IV 2. Isolate HVAC system in area where work is being done to project is checked by Infection Prevention & Control
prevent contamination of duct system. and thoroughly cleaned by Environmental. Services.
3. Complete all critical barriers or implement control cube 9. Vacuum work area with HEPA filtered vacuums.
method before construction begins. 10. Wet mop with disinfectant.
Date 4. Maintain negative air pressure within work site utilizing 11. Remove barrier materials carefully to minimize
HEPA equipped air filtration units. spreading of dirt and debris associated with
Initial 5. Seal holes, pipes, conduits, and punctures appropriately. construction.
6. Construct anteroom and require all personnel to pass 12. Contain construction waste before transport in tightly
through this room so they can be vacuumed using a HEPA covered containers.
vacuum cleaner before leaving work site or they can wear 13. Cover transport receptacles or carts. Tape covering.
cloth or paper coveralls that are removed each time they 14. Upon completion, restore HVAC system where work
leave the work site. was performed.
7. All personnel entering work site are required to wear shoe
covers.

Additional Requirements:

___________ ___________ Exceptions/Additions to this permit

Date Initials Date Initials are noted by attached memoranda
Permit Request By: Permit Authorized By:
Date: Date:

Adapted with permission V Kennedy, B Barnard, St Luke Episcopal Hospital, Houston TX. Form modified 5
/updated & provided courtesy of Judene Bartley, ECSI Inc Beverly Hills MI 2002. [email protected]
Updated, 2009

132
6.2
What Clinicians Need to Know about
LEGIONNAIRES’ DISEASE
Legionnaires’ disease is a sometimes fatal form of pneumonia that is on the rise in the United States.
Unfortunately, this disease is also underrecognized and underdiagnosed. Clinicians are in a unique
position to make sure cases are detected, allowing rapid investigation by public health officials and
prevention of additional cases.

Diagnosis and Testing Order both a culture

Clinical features of Legionnaires’ disease include cough, fever, and radiographic of a lower respiratory
pneumonia. Signs and symptoms for Legionnaires’ disease are similar to pneumonia specimen and a urinary
caused by other pathogens; the only way to tell if a pneumonia patient has
Legionnaires’ disease is by getting a specific diagnostic test. Indications that warrant
antigen test when testing
testing include: patients for Legionella.
• Patients who have failed outpatient antibiotic therapy for community-acquired
pneumonia
• Patients with severe pneumonia, in particular those requiring intensive care
Legionnaires’ Disease Is On the Rise
• Immunocompromised patients with pneumonia*

Incidence (cases/100,000 population)

2.0 2000–2015*
1.8
1.6
• Patients with a travel history (patients who have traveled away from their home 1.4

within 10 days before the onset of illness) 1.2

1.0

• All patients with pneumonia in the setting of a Legionnaires’ disease outbreak

0.8
0.6
0.4
• Patients at risk for Legionnaires’ disease with healthcare-associated pneumonia 0.2

(pneumonia with onset ≥48 hours after admission) 0

2000

2002
2003

2005
2006
2001

2009
2004

2007
2008

2010
2011
2012
2013
2014
2015
* Clinicians may also consider testing for Legionnaires’ disease in patients with other risk *National Notifiable Diseases Surveillance System
Year

factors for this infection (see page 2).

Testing for healthcare-associated Legionnaires’ disease is especially important if

In the United States, reported
any of the following are identified in your facility:
cases of Legionnaires’ disease
• Other patients with healthcare-associated Legionnaires’ disease diagnosed have grown by nearly four and
in the past 12 months
a half times since 2000. More
• Positive environmental tests for Legionella in the past 2 months than 6,000 cases of Legionnaires’
• Current changes in water quality that may lead to Legionella growth (such as low disease were reported in 2015,
chlorine levels) but this number is likely an
Infection control staff may have more information about these situations in underestimate as the illness is
your facility. thought to be underdiagnosed.
The preferred diagnostic tests for Legionnaires’ disease are culture of lower More illness occurs in the
respiratory secretions (e.g., sputum, bronchoalveolar lavage) on selective
summer and early fall, but
media and the Legionella urinary antigen test. Serological assays can be
nonspecific and are not recommended in most situations. Best practice is to obtain Legionnaires’ disease can
both sputum culture and a urinary antigen test concurrently. Sputum should ideally happen any time of year.
be obtained prior to antibiotic administration, but antibiotic treatment should not
be delayed to facilitate this process. The urinary antigen test can detect Legionella
infections in some cases for days to weeks after treatment. The urinary antigen
test detects Legionella pneumophila serogroup 1, the most common cause of
Legionnaires’ disease; isolation of Legionella by culture is important for detection
of other species and serogroups and for public health investigation. Molecular
techniques can be used to compare clinical isolates to environmental isolates and
confirm the outbreak source.
133
Treatment Timely reporting of
If your patient has Legionnaires’ disease, see the most recent guidelines for Legionnaires’ disease
treatment of community-acquired pneumonia (http://bit.ly/CommunityPneumonia) cases is important for
and hospital-acquired pneumonia (http://bit.ly/HospitalPneumonia). Macrolides
and respiratory fluoroquinolones are currently the preferred agents for treating
controlling clusters
Legionnaires’ disease. and outbreaks.

Reporting
Make sure your infection control department or lab are promptly reporting cases Commons Sources
of Legionnaires’ disease to your local health department. Timely identification of Infection
and reporting of cases is important, as this allows public health officials to quickly
identify and stop potential clusters and outbreaks by linking new cases to Outbreaks of Legionnaires’
previously reported ones. disease are most often associated
with large or complex water
systems, like those found in
Etiology hospitals, long-term care facilities,
Legionnaires’ disease is a severe form of pneumonia that often requires hotels, and cruise ships.
hospitalization and is fatal in about 10% of cases overall, and in 25% of healthcare-
associated cases. Legionnaires’ disease is caused by Legionella bacteria. There are at The most likely sources of
least 60 different species of Legionella, and most are considered capable of causing infection include:
disease. However, most disease is caused by L. pneumophila, particularly serogroup 1.

Water used for showering

Transmission (potable water)
While Legionella is found in natural, freshwater environments, it can become a health
concern in human-made water systems (e.g., plumbing system of large buildings,
cooling towers, certain medical devices, decorative fountains, hot tubs) where
conditions allow it to multiply and come in contact with vulnerable persons. People
contract Legionella by inhaling aerosolized water droplets containing the bacteria, Cooling towers (parts of large
or, less commonly, by aspiration of contaminated drinking water. Legionella is usually air conditioning systems)
not transmitted from person to person; however, a single episode of person-to-
person transmission has been reported. Fortunately, most people exposed to the
bacteria do not become ill.

Risk Factors Decorative fountains

Risk factors for developing Legionnaires’ disease include:

• Age ≥50 years
• Smoking (current or historical) Hot tubs

• Chronic lung disease, such as emphysema or COPD

• Immune system disorders due to disease or medication
• Systemic malignancy
• Underlying illness, such as diabetes, renal failure, or hepatic failure

Prevention
The key to preventing Legionnaires’ disease is maintenance of the water systems
in which Legionella may grow. If Legionella is found in a healthcare facility’s water
system, the facility should work to eliminate the bacteria. CDC encourages all
building owners, and especially those in healthcare facilities, to develop
comprehensive water management programs to reduce the risk of Legionella
growth and spread. Learn more about how to develop a water management
program at www.cdc.gov/legionella/WMPtoolkit.

cdc.gov/legionella | CS278126-A 05/15/2017

134
 6.3 Healthcare Facility Water
Healthcare
Management
Healthcare Facility Water Program Checklist Manageme
Available from: www.cdc.gov/hai/prevent/water-management.html
Management Program Checklist Available from: www

Available from: www.cdc.gov/hai/prevent/water-management.html

This checklist is intended to assist in the development
This checklist is intended to assist in the development of an all-hazards approach to in awater
healthcare management
facility, and may be used to:
• Evaluate a comprehensive water managemen
in a healthcare facility, and may be used to:
• Identify individuals to participate in the water
ntended to assist in the
• development of an all-hazards
Evaluate a comprehensive approach
water management to water management
program. • Assist in conducting assessments, including ha
acility, and may be used
• to:
Identify individuals to participate in the water management program. and infection control risk assessments.
a comprehensive water management
• Assist program.
in conducting assessments, including hazard analyses, environmental risk assessments,
• Inform water monitoring practices guided by t

individuals to participateandin the water management

infection program.
control risk assessments. Depending on complexity of the building plumbing sys
several water management plans. These plans should
conducting assessments, including
• Inform hazard
water analyses,
monitoring environmental
practices guided by riskthe
assessments,
management program. points are identified as well as monitoring methods an
ction control risk assessments.
Depending on complexity of the building plumbing systems, a comprehensive program may include
water monitoring practices guided by the management program. Establish a Water Management Program Team
several water management plans. These plans should include areas within the system where control
For all facility types, establish clear lines of communica
omplexity of the building plumbing systems, a comprehensive program
points are identified as well as monitoring methods and procedures. may include the water utility/drinking water provider, as well as th
anagement plans. These plans should include areas within the system where control ☐ Define membership (at a minimum, the following
fied as well as monitoring methods and procedures. should be represented; may include others depe
Establish a Water Management Program Team on facility size, type
• facility administration/ownership or C-Suite
For all facility types, establish clear lines of communication to facilitate dialogue with representatives • from
facilities management
er Management Program
the waterTeamutility/drinking water provider, as well as the local health department, on an • asfacilities
needed basis.
engineer
pes, establish clear lines of communication to facilitate dialogue with representatives from
☐ Define membership (at a minimum, the following ‘roles’ For nursing homes, the group may consist
• infection prevention
/drinking water provider, as well as the local health department, on an as neededofbasis. ☐ Develop a charter that defines roles and respons
should be represented; may include others depending three or more individuals representing
of members, chair, meeting schedule, etc.
mbership (at a minimum, the following
on facility ‘roles’
size, type For nursing homes, the group may management,
consist nursing (someone filling the
☐ Have you identified team members who should:
epresented; may include of three or more individuals role
representing of infection control), and the facilities
• others
facilitydepending
administration/ownership or C-Suite ☐ Y ☐ N Be familiar with the facility water syst
ize, type management, nursing (someone engineer;
filling the ad hoc members with subject
• facilities managementrole of infection control), and the facilities ☐ Y ☐ N Identify control locations and control
matter expertise (to provide advice) may
administration/ownership
• or C-Suite
facilities engineer ☐ Y ☐ N Identify and take corrective actions
engineer; ad hoc members with subject be water consultants.
es management ☐ Y ☐ N Monitor and document program perfo
• infection prevention matter expertise (to provide advice) may
es engineer Larger facilities ☐ Y ☐ N may
representation Communicate to the C-suite, staff, hea
☐ Develop a charter that defines be water
rolesconsultants.
and responsibilities include a designee from the C-suite, riskwater supplier (if needed)
drinking
on prevention
of members, chair, meetingLarger schedule, etc.representation may management, infection☐prevention,
facilities Y ☐ N Oversee the program
harter that defines roles and responsibilities ☐Y ☐
☐ Have you identified team members include a designee from the C-suite, facilities
risk engineers, central services,
N Access necessary resources to implem
who should:
s, chair, meeting schedule, etc. management, infection prevention, laboratory, and ad ☐ hoc Develop
members from Management Policies and Pro
the Water
☐ Y ☐ N Be familiar withfacilities the facility water central
engineers, system(s)services, clinical departments or water consultants.
dentified team members who should: Describe your building water systems
☐ Y ☐ N Identify control laboratory,
locations andand control
ad hoc members
limits from ☐ Text description of the building water systems, ca
Be familiar with the facility water system(s) clinical departments or water consultants.
☐ Y ☐ N Identify and take corrective actions ☐ Develop flow diagrams that describes these syste
dentify control locations and control limits
☐ Y ☐ N Monitor and document program performance
dentify and take corrective actions
☐ Y ☐ N Communicate to the C-suite, staff, health department, and representatives of the
Monitor and document program drinking performance
water supplier (if needed) Updated: 12/11/2018

☐ Y ☐ staff,
Communicate to the C-suite, health the
N Oversee department,
program and representatives of the
drinking water supplier (if needed)
☐ Y ☐ N Access necessary resources to implement changes
Oversee the program
☐ Develop the Water Management Policies and Procedures, Plans, and Protocols
Access necessary resources to implement changes
e Water Management Policies
Describe yourand Procedures,
building Plans, and Protocols
water systems
☐ Text description of the building water systems, campus water systems, etc.
uilding water systems
☐ Develop flow diagrams that describes these systems
ption of the building water systems, campus water systems, etc.
w diagrams that describes these systems
135

Updated: 12/11/2018 Page 1 of 4

Healthcare Facility Water Management Program Checklist

Identify external hazards (i.e., compromised supply) and describe plans for mitigating or managing
these events:
☐ Trace or no disinfectant residual upon entry into the building
☐ Water main breaks
☐ Low pressure events
☐ Flushing hydrants
☐ Boil Water Advisory
☐ Nearby construction
☐ Other (specify):

Identify areas where biofilms may be present and areas where opportunistic pathogens of premise
plumbing may grow and spread
☐ Identify storage tanks and describe (water turnover See From Plumbing to Patients: Water
rates, residence times, etc.) Management Programs for Healthcare
☐ Identify areas of stagnation (dead legs, vacant Facilities
units/rooms, etc.) (https://www.cdc.gov/hai/prevent/water-
management.html)
☐ Identify areas with hand-held showers, faucets with
aerators/flow restrictors,
☐ Identify areas with no residual disinfectant
☐ Identify areas where temperatures can support microbial growth
☐ Identify locations of commodes and hoppers
☐ Y ☐ N Do all commodes and hoppers have covers that can be closed when flushing?
☐ Y ☐ N If no cover present, are they located in a separate room with a door that can closed?
☐ Identify sinks and sink locations
☐ Y ☐ N Do sinks in patient care areas have aerators and flow restrictors?
☐ Y ☐ N Identify electronic sinks/faucets and temperature setting for mixing valve
☐ Y ☐ N Do all sinks in patient care areas have drains that are offset from faucet flow stream?
☐ Y ☐ N Are there barriers (splash guards) between sinks and adjacent medication preparation
areas and patient supplies?
☐ Y ☐ N If splash guards are present, is medication prep and clean supply storage > 3 feet from
sinks?

Conduct an Infection Control Risk Assessment (ICRA Adapt for potential water exposures both direct
and indirect)
☐ Identify patients at increased risk (e.g., burn patients, patients with immune suppression, patients
with lung disease/injury, patients with indwelling devices (e.g., central venous catheters, peritoneal
dialysis catheters, etc.), patients with open wounds, patients undergoing endoscopy, etc.)
☐ Risk stratify procedures and processes
☐ Identify potential exposures to water

136
Updated: 12/11/2018 Page 2 of 4
Healthcare Facility Water Management Program Checklist

Identify control point locations and determine how control measures will be applied using both the
environmental assessment and ICRA
Decide how to monitor control measures (some examples)
☐ Water temperature
See: Guidelines for Environmental Infection Control in Healthcare Facilities
(https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html)
☐ Residual disinfectant
☐ Heterotrophic plate count (HPC)
☐ Total Organic Carbon
☐ Review trend data and report out of control results
☐ Determine frequency for monitoring
☐ Other (specify):

Set control limits for control measures that will be monitored (water temperature, residual
disinfectant, HPC, and/or total organic carbon).
Corrective Actions (some examples)
☐ Eliminate dead legs, unused branches
☐ Remove or repurpose high risk features (e.g., water features, decorative fountains)
☐ Flush taps/fixtures in vacant rooms
☐ Decontamination (shock treatment or remediation using supplemental treatment for short period
of time)
☐ Change fixtures/hand held showers
☐ Point of use filtration; supplemental building disinfection systems
Routine and intermittent supplemental disinfection (requires registration with State drinking water
program); once one starts to treat water facility is now a small drinking water utility subject to
drinking water regulations
☐ Raise hot water temperature if in tepid zone (16°C - 38°C)
☐ Other (specify):

Outbreak and Contingency Response Plans

☐ Ability to detect, investigate, and respond to See also
a sentinel infection or cluster that is HAI Outbreak Investigation Toolkit
potentially linked to a water source (https://www.cdc.gov/hai/outbreaks/
☐ Collect epidemiologically linked samples outbreaktoolkit.html)
☐ Notify Health Department Tap Water Quality and Infrastructure Discussion
☐ Arrange for molecular typing or relatedness Guide for Investigation of Potential Water-
testing Associated Infections in Healthcare Facilities [PDF
- 5 pages] (https://www.cdc.gov/hai/pdfs/Water-
☐ Reassess water control measures and apply Quality-Discussion-Guide-P.pdf)
corrective actions

Updated: 12/11/2018 137 Page 3 of 4

Healthcare Facility Water Management Program Checklist

Verification: has the plan been implemented as designed and are you following it?

Validation: Determine what conditions, outcomes inform you that your program is effective
☐ Perform clinical surveillance for infections due to opportunistic pathogens of premise plumbing
See: From Plumbing to Patients: Water Management Programs for Healthcare Facilities
(https://www.cdc.gov/hai/prevent/water-management.html)
☐ Identify clusters and conduct an epidemiologic investigation
☐ Routine environmental sampling for Legionella (optional consideration)
Base decisions on building environmental assessment, water quality data, and context of whether
disease is present or absent: Legionella Routine Environmental Sampling
(https://www.cdc.gov/legionella/wmp/monitor-water.html#env-sampling).

Documentation
☐ Team Roster: Names, titles, contact info, team responsibility, member roles
☐ Building Description: Location, building age, use, occupants, visitors, bed occupancy rate, additions
or renovations, etc.
☐ Water system description: both text and process diagrams, location of attached equipment
☐ Control Measures: identify control measures, locations in the system where critical limits can be
monitored and where controls can be monitored and applied
☐ Confirmatory procedures: verification steps, and validation to show effectiveness of the water
management plan as designed
☐ Sampling and testing: document collection and transport methods, chain of custody, and
laboratory identified performing assays if environmental testing is conducted, results

Communication Plan
☐ Notification to building staff/occupants that a plan is in place and provide team’s contact info; issue
regular updates as plan is implemented or modified
☐ Reports to team, infection control, hospital administration, other affected parties if control limits
are exceeded, and corrective actions to be applied
☐ Consider quarterly and annual reports: reports to management and occupants, consider part of
facility quality review; since activity is part of Continuous Quality Improvement (CQI).
☐ Notification protocols with public health points of contact for when a sentinel infection or cluster is
detected.

Updated: 12/11/2018 138 Page 4 of 4

Module 7

Environmental Cleaning

Contents
7.1 Environmental Checklist for Monitoring Terminal Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . 140
CDC

7.2 Options for Evaluating Environmental Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 141

CDC

Resources
Guidelines for Environmental Infection Control in Health-Care Facilities
CDC
https://www.cdc.gov/infectioncontrol/guidelines/environmental/index.html

Pesticide Product and Label System

Environmental Protection Agency
https://iaspub.epa.gov/apex/pesticides/f?p=PPLS:1

Disinfection and Sterilization

CDC
https://www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html

Chemical Disinfectants
CDC
https://www.cdc.gov/infectioncontrol/guidelines/disinfection/disinfection-methods/
chemical.html

Bed Bugs
CDC
https://www.cdc.gov/parasites/bedbugs/faqs.html

139
7.1 CDC Environmental Checklist for Monitoring Terminal Cleaning1

CDC Environmental Checklist for Monitoring Terminal Cleaning1

Date:
Unit:
Room
Date: Number:
Initials
Unit: of ES staff (optional):
2

Room Number:
Evaluate
Initials oftheES following priority
staff (optional): 2 sites for each patient room:

High-touch Room Surfaces 3

Cleaned Not Cleaned Not Present in Room
Bed rails /the
Evaluate controls
following priority sites for each patient room:
Tray table Room Surfaces3
High-touch Cleaned Not Cleaned Not Present in Room
IV pole (grab area)
Bed rails / controls
Call
Traybox
table/ button
Telephone
IV pole (grab area)
Bedside
Call box table handle
/ button
Chair
Telephone
Room
Bedside sink
table handle
Room
Chair light switch
Room inner
sink door knob
Bathroom
Room lightinner door knob / plate
switch
Bathroom light
Room inner door knobswitch
Bathroom handrails
inner doorby toilet
knob / plate
Bathroom sink light switch
Toilet
Bathroomseat handrails by toilet
Toilet
Bathroomflushsink
handle
Toilet bedpan
seat cleaner
Toilet flush handle
Evaluate
Toilet bedpanthe following
cleaner additional sites if these equipment are present in the room:
High-touch Room Surfaces3 Cleaned Not Cleaned Not Present in Room
IV pump control
Evaluate the following additional sites if these equipment are present in the room:
Multi-module
High-touch Room monitor controls
Surfaces 3
Cleaned Not Cleaned Not Present in Room
Multi-module
IV pump control monitor touch screen
Multi-module monitor cables controls
Ventilator control panel
Multi-module monitor touch screen
Multi-module monitor cables
Mark the monitoring
Ventilator control panelmethod used:
Direct observation Fluorescent gel
MarkSwab cultures
the monitoring method used:ATP system Agar slide cultures
Direct observation Fluorescent gel
Swab cultures ATP system Agar slide cultures

____________________________
1
Selection of detergents and disinfectants should be according to institutional policies and procedures
____________________________
2
Hospitals may choose to include identifiers of individual environmental services staff for feedback
purposes.
3Selection of detergents and disinfectants should be according to institutional policies and procedures
1
2Sites most frequently contaminated and touched by patients and/or healthcare workers
Hospitals may choose to include identifiers of individual environmental services staff for feedback
purposes.
3
Sites most frequently contaminated and touched by patients and/or healthcare workers
140
7.2

Options for Evaluating Environmental Cleaning

Prepared by:
Alice Guh, MD, MPH1
Philip Carling, MD2
Environmental Evaluation Workgroup3

December 2010

1
Division of Healthcare Quality Promotion, National Center for Emerging and Zoonotic
Infectious Diseases, CDC, Atlanta, Georgia
2
Carney Hospital and Boston University School of Medicine, Boston, MA; Dr. Philip Carling has
been compensated as a consultant of Ecolab and Steris. He owns a patent for the fluorescent
targeting evaluation system described in this document (DAZO Fluorescent Marking Gel).
3
Brian Koll, Beth Israel Medical Center, New York, NY; Marion Kainer and Ellen Borchers,
Tennessee Department of Health, Nashville, TN; and Brandi Jordan, Illinois Department of
Public Health, Chicago, IL

141
Introduction:
In view of the evidence that transmission of many healthcare acquired pathogens (HAPs)
is related to contamination of near-patient surfaces and equipment, all hospitals are
encouraged to develop programs to optimize the thoroughness of high touch surface
cleaning as part of terminal room cleaning at the time of discharge or transfer of patients.
Since dedicated resources to implement objective monitoring programs may need to be
developed, hospitals can initially implement a basic or Level I program, the elements of
which are outlined below. Some hospitals should consider implementing the advanced or
Level II program from the start, particularly those with increased rates of infection caused
by healthcare acquired pathogens (e.g., high Clostridium difficile infection rate). All
hospitals that have successfully achieved a Level I program should advance to Level II.

At present, the objective monitoring of the cleaning process of certain high touch surfaces
(e.g., the curtain that separates patient beds) beyond those outlined in the attached
checklist is not well defined. Additionally, there is no standard method for measuring
actual cleanliness of surfaces or the achievement of certain cleaning parameters (e.g.,
adequate contact time of disinfectant) or for defining the level of microbial contamination
that correlates with good or poor environmental hygienic practices. As our understanding
of these issues evolve and a standardization of assessment in these respective areas can be
developed and practically implemented, hospitals that have obtained a high compliance
rate with surface cleaning as outlined in the Level II program are encouraged to advance
their efforts in optimizing environmental hygienic practices.

Level I Program

Elements of the program:

1. The program will be an infection preventionist/hospital epidemiologist

infection prevention & control (IPC) based program internally coordinated and
maintained through environmental services (ES) management level
participation. The goal should be seen as a joint (IPC/ES), team effort during
planning implementation and ongoing follow-up phases.

2. Each program will be hospital-specific and based on a joint (IC/ES) definition

of institutional expectations consistent with the CDC standards1,2 and the
attached check list. The responsibilities of ES staff and other hospital
personnel for cleaning high touch surfaces (e.g., equipment in ICU rooms) will
be clearly defined.

3. Structured education of the ES staff to define programmatic and institutional

expectations will be carried out and the proportion of ES staff who participate

142
 will be monitored (see Elements of the Educational Intervention – Appendix
A).

4. Development of measures for monitoring along with methods and identified

staff for carrying out monitoring will be undertaken by the IPC/ES team.
Monitoring measures may include competency evaluation of ES staff by ES
management, IPC staff or, preferably, both. Teams are also encouraged to
utilize patient satisfaction survey results in developing measures. Regular
ongoing structured monitoring of the program will be performed and
documented.

5 Interventions to optimize the thoroughness of terminal room cleaning and

disinfection will be a standing agenda item for the Infection Control
Committee (ICC) or Quality Committee as appropriate for the facility.

6. Consideration of the feasibility of moving to the Level II program will be

discussed by the ICC and documented in the committee minutes.

Reporting:

Results should be reported to the ICC and facility leadership.

Level II Program

Elements of the Program

1. The program will be an infection preventionist/hospital epidemiologist infection

prevention & control (IPC) based program internally coordinated and maintained
through environmental services (ES) management level participation. The goal
should be seen as a joint (IPC/ES), team effort during planning implementation
and ongoing follow-up phases.

2. Each program will be hospital-specific and based on a joint (IC/ES) definition of

institutional expectations consistent with the CDC standards1,2 and the attached
check list. The responsibilities of ES staff and other hospital personnel for
cleaning high touch surfaces (e.g., equipment in ICU rooms) will be clearly
defined.

3. Either covertly or in conjunction with ES staff, an objective assessment of the

terminal room thoroughness of surface disinfection cleaning will be done using
one or more of the methods discussed below (see Objective Methods for

143
 Evaluating Environmental Hygiene - Appendix B) to document the pre-
intervention thoroughness of disinfection cleaning (generally referred to as the
“TDC Score” calculated as # of objects cleaned / total # of objects evaluated X
100). Such results will be maintained by the institution and used internally to
optimize programmatic and educational interventions.

4. Structured education of the ES staff to define programmatic and institutional

expectations will be carried out and the proportion of ES staff who participate will
be monitored. It would be expected that the results of the pre-intervention
objective evaluation of disinfection cleaning be incorporated into the ES
educational activity in a non-punitive manner (see Elements of the Educational
Intervention – Appendix A).

5. Scheduled ongoing monitoring of the TDC cleaning using one or more of the
objective monitoring approaches discussed in Appendix B will be performed at
least three times a year. The monitoring will use a projected sample size based on
the previous level of TDC in order to detect a 10-20% change in performance (see
Sample Size Determination – Appendix C). The results will be recorded in an
excel spreadsheet to calculate aggregate TDC scores (see Appendix D).

6. The results of the objective monitoring program and the objectively developed
TDC scores will be used in ongoing educational activity and feedback to the ES
staff following each cycle of evaluation. It is recommended that such results be
shared more widely within and beyond the institution as useful and appropriate.

7. Results of the objective monitoring program and interventions to optimize the

thoroughness of terminal room cleaning and disinfection will be a standing agenda
item for the Infection Control Committee (ICC).

Reporting:

Results should be reported to the ICC and facility leadership and could be reported to
the state health department through the state prevention collaborative coordinator by
various mechanisms (e.g., NHSN template), depending on infrastructure.

________________
1
Guidelines for Environmental Infection Control in Healthcare Facilities, 2003
(http://www.cdc.gov/hicpac/pdf/guidelines/eic_in_HCF_03.pdf)
2
Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
(http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf)

144
 Appendices to the Conceptual Program Model for Environmental
Evaluation
APPENDIX A

Elements of the Educational Intervention

Environmental Services Line Personnel – A presentation should be developed for all

line staff involved in terminal room cleaning and should:
A. Provide an overview of the importance of HAIs in a manner commensurate with their
educational level using as many pictorial illustrations as is feasible.
B. Explain their role in improving patient safety through optimized hygienic practice.
C. Review specific terminal room cleaning practice expectations.
D. Discuss the manner in which their practice will be evaluated. For Level II programs,
a participatory demonstration of the monitoring method is very useful.
E. Provide them with information from the baseline evaluation emphasizing or possibly
exclusively showing them results for those objects which have been most thoroughly
cleaned (Level II).
F. Stress the non-punitive nature of the program.
G. Inform them that their good performance will be broadly recognized (i.e., beyond
their department) and highlighted within their department for others to emulate.
(Level II)
H. Repeatedly reinforce the importance of their work, and how it directly relates to the
hospital’s goals and mission and how it is appreciated by patients and plays a major
role in a patient’s satisfaction with the hospital.

Many hospitals have provided a small (possibly ES staff-language specific) pictorial

booklet to the environmental services personnel at the conclusion of the presentation
which is often developed to be language skill appropriate.

ES managers – As senior managers will be actively involved in the design and

implementation of either Level I or Level II programs, educational interventions for them
will need to be customized. While many of these individuals have an excellent
understanding of the basic policies and procedures involved in terminal room cleaning,
most will benefit from focused educational interventions related to our evolving
understanding of the role of the environment in healthcare-associated pathogen (HAP)
transmission. Evaluation of mid-level managers also needs to be customized. Most
importantly, the impact of the program on mid-level ES managers needs to be monitored
since additional formal and informal education is frequently needed for those individuals
who are somewhat unsure of the importance of developing programmatic approaches to
optimize terminal room cleaning.

145
Other groups – Given the overall importance of optimizing the thoroughness of hygienic
practice in healthcare settings, hospital specific educational interventions graphically
illustrating the impact of the program should be considered for both Level I and Level II
programs. Such communications should be developed for a range of audiences within the
hospital including the senior hospital administration, the medical staff, nursing personnel
on the units, executive nursing and medical staff committees and the hospital’s board of
managers or directors.

APPENDIX B

Objective Methods for Evaluating Environmental Hygiene

In considering implementation of a Level II program, the advantages and limitations of

various monitoring approaches must be considered carefully. The factors which
distinguish each approach to Level II monitoring are discussed below and summarized in
Fig.1. With any method or methods used it is important that neither the system itself
(fluorescent marker) nor its use (precleaning cultures or ATP measurements) induce a
Hawthorne type effect.

Direct Practice Observation – Covert monitoring of disinfection cleaning can provide

an objective assessment of individual ES staff performance and compliance with
cleaning protocols. This approach has been used to objectively evaluate and improve
ICU environmental hygiene in one hospital.1 While conceptually feasible, logistical
issues related to maintaining such a program outside a research setting may limit
adaptation of this form of Level II monitoring. Furthermore, the complexity of
monitoring cleaning practice in individual patient rooms without the evaluator being
recognized as such might represent a difficult confounding issue.

Swab Cultures – While several outbreak intervention studies have associated decreased
environmental contamination by target organisms as a result of modified cleaning
practice leading to decreased acquisition of targeted pathogens, none of the reports
specifically note if serial environmental culture results were actually used to provide
practice feedback to the ES staff. Although swab cultures are easy to use, the cost of
processing, including isolate identification, the delay in analyzing results, the need to
determine pre-cleaning levels of contamination for each object evaluated in order to
accurately assess cleaning practice, and the limited feasibility of monitoring multiple
surfaces in multiple patient rooms as part of an ongoing Level II monitoring program
represent issues which could limit the broad application of this system.

Agar Slide Cultures – Agar coated glass slides with finger holds were developed to
simplify quantitative cultures of liquids. The slides have been adopted for use in
environmental surface monitoring in healthcare settings.2 These studies have used agar

146
coated slide systems to evaluate cleaning practice by quantifying aerobic colony counts
(ACCs) per cm.2,3 While studies have measured aggregate ACCs before and after
cleaning, no studies to date have evaluated the actual thoroughness of cleaning of the
same objects to determine if objects with relatively high ACCs were either poorly
cleaned or actually overlooked by the ES staff. Although some difficulties have been
encountered in utilizing the agar slide cultures on other than large, flat surfaces, they
potentially provide an easy method for quantifying viable microbial surface
contamination. There is a need, similar to that noted above for swab cultures, to
determine pre-cleaning levels of contamination for each object evaluated in order to
accurately assess cleaning practice.

Fluorescent Markers – Fluorescent gel, powder, and lotion have all been developed for
the purpose of marking high touch objects prior to room cleaning. While the powder and
lotion have been used as part of educational interventions, their overt visibility (lotions
and powder), ease with which they can be disturbed (powder), and difficulty with easy
removal (lotion if allowed to air dry) may limit their use in a monitoring system and
there is little or no published experience in their use for this purpose. In contrast, the
fluorescent gel dries transparent on surfaces, resists abrasion, and there are several
studies demonstrating the accuracy of the system in objectively evaluating cleaning
practice and quantifying the impact of educational interventions on such cleaning.4,5
Because these fluorescent markers are all designed to indicate physical removal of an
applied substance, surfaces that are effectively disinfected but less effectively cleaned
may be more likely flagged as failing to meet a quality standard using one of these
markers than one of the culture techniques.

ATP Bioluminesence – The measurement of organic ATP on surfaces using a luciferase

assay and luminometer has been used to evaluate cleanliness of food preparation
surfaces for more than thirty years. A specialized swab is used to sample a standardized
surface area which is then analyzed using a portable handheld luminometer. The total
amount of ATP, both microbial and non-microbial, is quantified and expressed as
relative light units. Although readout scales vary more than 10 fold and sensitivity varies
between commercially available systems, very low readings are typically associated with
low aerobic colony counts (ACCs).6 Very high readings may represent either a viable
bioburden, organic debris including dead bacteria or a combination of both. An
independent study in 2007 by the U.K. National Health Service evaluating the potential
role of the ATP tool in assessing cleaning practice concluded that the tool could
potentially be used effectively for ES education.7 Although it is likely that part of the
lack of correlation between ATP readings and ACCs noted in the preceding studies
relates to the fact that ATP systems measure organic debris as well as viable bacterial
counts, several studies have noted additional environmental factors which may increase
or decrease ATP readings. Because a large proportion of surface contamination with
ATP is non-microbial in origin, surfaces that are effectively disinfected but less
effectively cleaned may be more likely flagged as failing to meet a quality standard

147
using the ATP tool than one of the culture techniques. Additionally, high concentrations
of bleach may potentially quench the ATP bioluminescence reaction and result in a
signal reduction, but further research is needed to better understand the impact of bleach-
based disinfectants on the use of the ATP system. If a bleach-based disinfectant is used,
it is important that the surface is dry before using the ATP tool. Similar to the culture
methods described above, it is unclear whether “threshold values” for a clean hospital
surface can be established using existing methods, suggesting use of the ATP tool is
likely to require pre-cleaning levels of contamination for each object evaluated in order
to accurately assess cleaning practice. Despite these limitations, the ATP system has
been used to broadly document significant improvement in daily cleaning as well as
provide quantitative measurement to indicate the level of cleanliness of high touch
surfaces.8,9

Final Points

No matter which of the Level II monitoring approaches is chosen by the hospital, it is

important that the monitoring be performed by hospital epidemiologists, infection
preventionists or their designees who are not part of the actual ES cleaning program.
Such an approach assures the validity of the information collected and provides an
opportunity for the Infection Control and Prevention Department to independently
champion the value of well performed disinfection cleaning.

A more detailed and fully referenced discussion of the above noted approaches to Level
II monitoring of terminal room cleaning, may be found in the article Evaluating
Hygienic Cleaning in Healthcare Settings: What You Don’t Know Can Harm Your
Patients by P.C. Carling and J.M. Bartley in the June, 2010 supplement to the American
Journal of Infection Control
http://www.ajicjournal.org/issues/contents?issue_key=S0196-6553(10)X0005-0
.

APPENDIX C

Sample Size Determination

Logistical issues must also be considered as part of planning for the implementation of
an enhanced program. Before a decision has been made to use one of the Level II
methods to objectively monitor cleaning practice, it is important to determine the
number of surfaces to be evaluated for establishing baseline level of thoroughness of
cleaning and the number of data points which must be monitored on a regular basis to
accurately assess improvement or deterioration in practice. While it would be ideal to be
able to identify small fluctuations in practice accurately (e.g., 10% relative change), such
an approach would be highly labor intensive. Instead, a meaningful change in cleaning
practice (e.g., 20% relative change) can be detected without having to evaluate a
substantial number of surfaces. Previous experience suggests that conducting a baseline

148
 evaluation of all available surfaces (listed in the checklist) in a 10-15% sample of
representative patient rooms is reasonable in a hospital with ≥150 beds. When hospitals
have achieved a thoroughness of cleaning rate of >80%, the number of surfaces to be
monitored can be decreased to those available in a 5% sample of rooms per evaluation
cycle unless there is a deterioration in practice. In hospitals with less than 150 beds, all
available surfaces (listed in the checklist) in a minimum of 15 rooms may be monitored
for baseline and ongoing evaluation.

APPENDIX D

Calculation of Aggregate Thoroughness of Disinfection Cleaning (TDC) Score

The results of the evaluation of each object listed on the check list can be recorded in the
attached excel spreadsheet template. The percentage of individual surfaces cleaned
across multiple patient rooms will be automatically calculated by the excel spreadsheet.
Because it has been found that cleaning practice within an institution is more likely to
vary between types of objects than by patient units, the high touch surfaces listed in the
check list have been grouped into 5 categories for calculating aggregate TDC scores:
High Touch I, High Touch II, High Touch III, Bathroom Surfaces, and Equipment
Surfaces. The aggregate TDC scores for each category of objects can be reported to the
HAI prevention collaborative coordinator by various mechanisms (e.g., NHSN),
depending on infrastructure.

References:
1. Hayden MK, Bonten MJ, Blom DW, Lyle EA. Reduction in acquisition of vancomycin-
resistant enterococcus after enforcement of routine environmental cleaning measures.
Clin Infect Disease 2006;42:11,1552-60.
2. Dancer SJ, White LF, Lamb J, Girvan EK, Robertson C. Measuring the effect of
enhanced cleaning in a UK hospital: a prospective cross-over study. BMC Med
2009;June8:7-28.

3. Griffith CJ, Cooper RA, Gilmore J, Davies C, Lewis M. An evaluation of hospital

cleaning regimes and standards. J Hosp Infect 2000;45:19-28.

4. Carling PC, Parry MM, Rupp ME, Po JL, Dick BL, Von Beheren S. for the Healthcare
Environmental Hygiene Study Group. Improving cleaning of the environment
surrounding patients in 36 acute care hospitals. Inf Control Hosp Epidem 2008;
29:11,1035-1041.

5. Goodman ER, Platt R, Bass R, Onderdonk AB, Yokoe DS, Huang SS. Impact of an
environmental cleaning intervention on the presence of methicillin-resistant

149
 Staphylococcus aureus and vancomycin-resistant enterococci on surfaces in intensive
care unit rooms. Infect Control Hosp Epi Demiol 2008; 29:593-599.

6. Aycicek H, Oguz U, Karci K. Comparison of results of ATP bioluminescence and

traditional hygiene swabbing methods for the determination of surface cleanliness at a
hospital kitchen. Int J Hyg Environ Health 2006;209:203-6.
7. Willis C, Morley J,Westbury J, Greenwood M, Pallett A. Evaluation of ATP
bioluminescence swabbing as a monitoring and training tool for effective hospital
cleaning. Br J of Infect Control 2007 8:17-21.

8. Boyce JM, Havill NL, Dumigan DG, Golebiewski M, Balogun O, Rizvani R. Monitoring
the effectiveness of hospital cleaning practices by use of an adenosine triphosphate
bioluminescence assay. Infect Control Hosp Epidemiol 2009;30,7:678-84.

9. Boyce JM, Havill NL, Lipka A, Havill H, Rizvani R. Variations in hospital daily cleaning
practices. Infect Control Hosp Epidemiol 2010;31,1:99-101.

150
Figure 1

Evaluating Patient Zone Environmental Hygiene

Useful for Directly Published Use in

Ease of Identifies
Method Individual Evaluates Programmatic
Use Pathogens
Teaching Cleaning Improvement

Direct Practice Low No Yes Yes 1 Hospital

Observation

Swab cultures High Yes Not Studied Potentially 1 Hospital

Agar slide cultures Good Limited Not Studied Potentially 1 Hospital

Fluorescent gel High No Yes Yes 49 Hospitals

ATP system High No Yes Potentially 2 Hospitals

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 INSTRUCTIONS FOR EVALUATING THE CLEANING OF
OBJECTS IN THE PATIENT ZONE
The group of objects on the checklist was chosen on the basis of information regarding
the contamination of these surfaces with healthcare-associated pathogens (HAPs) as well
as a consideration of the likelihood they would be touched during routine care by
healthcare personnel without changing gloves or performing hand hygiene prior to using
these items.

The following descriptions and suggestions should be used to standardize, to the degree
feasible, the manner in which the thoroughness of cleaning can be most consistently
evaluated. If the evaluation system utilizes a fluorescent gel targeting system, the targets
should generally be placed very near but not in/on the area of the object touched in
routine use (as noted in the outline below) in order to avoid disturbing the target during
actual use of the object. If one of the direct evaluation systems (one of the two culture
methods or the ATP method as described in the Appendix) is being used, the primary
hand touch area of each object should be evaluated as noted in the outline below, taking
particular care to evaluate exactly the same area of the object before and after cleaning.

All available objects noted below should be marked in each room.

Patient Area

Bed rails – If the bed rail incorporates bed controls, evaluate the control area (on the
patient side) slightly away from the control buttons. If the rails do not contain the new
style control areas, the rails are best evaluated on the smooth inner surface in an area
easily accessible to cleaning.

Tray table - The top of the tray table should be evaluated in one corner.

Call boxes – Evaluation is done on the back mid portion of the call box in an area easily
accessible to cleaning. If tiny call buttons are used, mark the separate TV control box
instead if feasible.

Telephones – Evaluation is best done on the back side of the hand-held portion of the
telephone near the top of the phone, away from the end that is attached to the phone wire.

Bedside tables – The drawer pull is evaluated.

Patient chair – Evaluation is done in the center of the seat of the chair close to the rear
of the cushion. If the cushion is covered in textured fabric, evaluate the arm of the chair.

152
IV pole – For hanging IV poles, the shaft of the pole just above the textured grab area
should be evaluated. For standing IV poles, the chest-high portion where hand contact is
most common should be evaluated.

Toilet Area

Sinks – If using a targeting system, the best place to mark the sink rim is towards the rear
in order to avoid water splash interference with evaluation of the target. If direct
evaluation is used, the faucet handle should be evaluated.

Bathroom and patient room light switches – When using a targeting method, a target is
placed on the plate portion of the light switch. When using a direct evaluation system,
the switch or plate should be evaluated because of its relatively large surface area.

Door knobs and door levers – The inside door knob or lever is marked for each
bathroom door and each patient room door. If using a targeting system on a round door
knob, the mark is best placed as close to the middle of the face of the door knob as
possible. If the knob has a locking mechanism, place the target on the circular door plate
that surrounds the handle. Lever-type handles are marked on any easily cleanable surface
somewhat away from the end of the lever where direct hand contact would be most
frequent. Similarly, when using a fluorescent system, door push plates are marked in the
middle of the smooth part of the plate. When using direct evaluation systems, the most
frequently contacted portion of the door knob, lever or push plate should be evaluated.

Toilet area hand holds (bathroom handrails) – Evaluate the most accessible surface of
the hand hold just off the edge of the textured surface at the curve where the hand hold
goes towards the wall. If there are two hand holds, mark the one most likely to be
touched by a patient using the toilet.

Toilet seats – When using a targeting method, the target is placed on the back of the
toilet seat just below the outside edge of the seat in an area readily accessible to cleaning
activities. When using a direct evaluation method, the surface of the toilet seat should be
evaluated, being sure to evaluate the same area before and after cleaning.

Toilet handles – When using a targeting method, the target is placed on top of the handle
approximately two thirds away from the end of the handle.

Bed pan cleaning equipment – Two types of bed pan cleaning equipment designed as
part of toilet units are in general use in hospitals.

153
 Hinged pipe type cleaner - The most commonly used bed pan cleaner consists of a
pipe with a small shower head type device that is lowered over the toilet bowl by
the user. When the arm is lowered, the toilet flush water is sprayed in a stream
through the cleaner head. This device is best targeted by marking the spray head
(the most common area which would be touched by users).

Spray hoses – Some toilets have a spray hose with a lever-type trigger on the
handle which is depressed to activate the spray head. Evaluate the handle itself.

Where Applicable

IV Pump control panel – Evaluate an area that is just adjacent to the portion of the panel
that is most frequently touched by healthcare providers.

Monitor control panel – When using a targeting method, the control panel should be
evaluated in an area immediately adjacent to a part of the panel which is directly
contacted by caregivers’ hands. When using a direct method, the control area itself is
evaluated.

Monitor touch screen – The touch screen should be evaluated in the lower right hand
corner in an area easily accessible to cleaning.

Monitor cables – Evaluate the junction box area.

Ventilator control panel – Evaluate an area immediately adjacent to a part of the panel
which is most frequently touched by healthcare provider.

154
155
Module 8

Cleaning, Disinfection, Sterilization

Contents
8.1 Essential Elements of a Reprocessing Program for Flexible Endoscopes—
Recommendations of the Healthcare Infection Control Practices
Advisory Committee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159
Centers for Disease Control and Prevention (CDC)/Healthcare Infection Control Practices
Advisory Committee (HICPAC)
https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html

8.2 HICPAC Sample Policy Template: Reprocessing Flexible Endoscopes . . . . . . . . . . . . . . . . 171

CDC/HICPAC
https://www.cdc.gov/hicpac/pdf/FlexEndoReprocessing-Policy.docx

8.3 HICPAC Sample Competency Verification Tool:

Reprocessing Flexible Endoscopes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 176
CDC/HICPAC
https://www.cdc.gov/hicpac/pdf/FlexEndoReprocessing-Competency.docx

8.4 HICPAC Sample Audit Tool: Reprocessing Flexible Endoscopes . . . . . . . . . . . . . . . . . . . . 194

CDC/HICPAC
https://www.cdc.gov/hicpac/pdf/FlexEndoReprocessing-AuditTool.docx

8.5 Autoclave Biological Indicator (BI) Test Results Log . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

8.6 Reported Gastrointestinal Endoscope Reprocessing Lapses:

The Tip of the Iceberg . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 198
Alexandra M. Dirlam Langlay, PhD; Cori L. Ofstead, MSPH; Natalie J. Mueller, MPH; et al.
American Journal of Infection Control
December 2013, Vol 41, Issue 12, p. 1188-1194
https://www.ajicjournal.org/article/S0196-6553(13)00974-7/fulltext

8.7 Special problems associated with reprocessing instruments in outpatient

care facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Judie Bringhurst MSN, RN, CIC
American Journal of Infection Control
June 2019, Vol 47, Supplement, p. A58-A61
https://www.ajicjournal.org/article/S0196-6553(19)30155-5/fulltext

156
Resources
Association for the Advancement of Medical Instrumentation
www.aami.org

The Joint Commission

www.jointcommission.org

Accreditation Association for Ambulatory Health Care

www.aaahc.org

Centers for Medicare & Medicaid Services

www.cms.gov

Disinfection and Sterilization Guidelines

CDC
https://www.cdc.gov/infectioncontrol/guidelines/disinfection/index.html

Sterilization
Association of periOperative Registered Nurses (AORN) guidelines
https://aornguidelines.org/tool/filter?categoryid=42865

High Level Disinfection

AORN guidelines
https://aornguidelines.org/tool/filter?categoryid=42845

High Level Disinfection

Food & Drug Administration (FDA)
https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices-informa-
tion-manufacturers/fda-cleared-sterilants-and-high-level-disinfectants-general-claims-process-
ing-reusable-medical-and

Instrument Cleaning
AORN guidelines
https://aornguidelines.org/tool/filter?categoryid=42841

Flexible Endoscope
Association of periOperative Registered Nurses (AORN) guidelines
https://aornguidelines.org/tool/filter?categoryid=42855

The FDA Continues to Remind Facilities of the Importance of Following Duodenoscope

Reprocessing Instructions
FDA Safety Communication
https://www.fda.gov/medical-devices/safety-communications/fda-continues-remind-facili-
ties-importance-following-duodenoscope-reprocessing-instructions-fda

Standards of Infection Prevention in Reprocessing Flexible Gastrointestinal Endoscopes

https://www.sgna.org/Portals/0/SGNA%20Standards%20of%20infection%20prevention%20
in%20reprocessing_FINAL.pdf?ver=2018-11-16-084835-387

157
Spaulding Classification System
https://cdn.hpnonline.com/inside/2014-06/1406-PnP.html

Multisociety Guideline on Reprocessing Flexible GI Endoscopes: 2016 update

Prepared by: Reprocessing Guideline Task Force, Bret T. Petersen, MD, FASGE (Chair);
Jonathan Cohen, MD, FASGE; Ralph David Hambrick III, RN; Navtej Buttar, MD; David A. Green-
wald, MD, FASGE; Jonathan M. Buscaglia, MD, FASGE; James Collins, RN; Glenn Eisen, MD, MPH,
FASGE
Gastrointestinal Endoscopy
February 2017, Vol 85, Issue 2, p. 282-294.e1
https://www.giejournal.org/article/S0016-5107(16)30647-2/fulltext

ANSI/AAMI ST58:2013 (R2018)

Chemical and High-Level Disinfection in Health Care Facilities
https://webstore.ansi.org/Standards/AAMI/ANSIAAMIST582013R2018

ANSI/AAMI ST79:2017
Comprehensive guide to steam sterilization and sterility assurance in health care facilities
https://my.aami.org/store/detail.aspx?id=ST79

ANSI/AAMI ST91:2015
Comprehensive guide to flexible and semi-rigid endoscope processing in health care facilities
https://www.aami.org/productspublications/ProductDetail.aspx?ItemNumber=2477

158
8.1
Essential Elements of a Reprocessing Program for
Flexible Endoscopes – Recommendations of the
Healthcare Infection Control Practices Advisory
Committee

Preface
The Healthcare Infection Control Practices Advisory Committee (HICPAC) is a federal advisory committee
chartered to provide advice and guidance to the Centers for Disease Control and Prevention (CDC) and the
Secretary of the Department of Health and Human Services (HHS) regarding the practice of infection control
and strategies for surveillance, prevention, and control of healthcare-associated infections, antimicrobial
resistance and related events in United States healthcare settings. At the July 2015 HICPAC Meeting, CDC
asked HICPAC for guidance on ways to improve facility-level training and ensuring competency for
reprocessing endoscopes. To develop recommendations for HICPAC to consider, a HICPAC workgroup was
formed that contained the following key stakeholder organizations: Accreditation Association for Ambulatory
Health Care (AAAHC), Association for the Advancement of Medical Instrumentation (AAMI), American
Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE), Association of
periOperative Registered Nurses (AORN), Association for Professionals in Infection Control and Epidemiology
(APIC), Centers for Medicare & Medicaid (CMS), Council of State and Territorial Epidemiologists (CSTE), DNVGL
Healthcare, Food and Drug Administration (FDA), International Association of Healthcare Central Service
Material Management (IAHCSMM), Public Health Agency of Canada (PHAC), Society of Gastroenterology
Nurses and Associates (SGNA), Society for Healthcare Epidemiology of America (SHEA), and The Joint
Commission (TJC). The Workgroup provided updates and obtained HICPAC input at the November 2015, March
2016, and July 2016 HICPAC Meetings. HICPAC voted to finalize the recommendations at the July 2016
meeting. Additional information about HICPAC is available on the HICPAC Website
(https://www.cdc.gov/hicpac/).

Introduction
Healthcare facilities should have a reliable, high-quality system for endoscope reprocessing which minimizes
infection risks. To achieve this goal, all reprocessing programs must have an infrastructure that supports
training and competencies, quality measurement, and management. The following guidance is provided to
assist healthcare facilities, including clinical and administrative staff, to achieve a reliable, high-quality
reprocessing program. A toolkit of sample documents accompanies this guidance to help facilities create and
maintain the infrastructure to support their flexible endoscope reprocessing program (available from:
https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html).

Last update: January 25, 2017 Page 1 of 12

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Essential Elements of a Reprocessing Program for Flexible Endoscopes
Recommendations of the HICPAC

Recommendations
Essential Steps for Flexible Endoscope Reprocessing
To ensure flexible endoscopes are safe for patient use, all staff involved in reprocessing this equipment must
understand and consistently follow a number of steps which have been distilled down to seven essential steps.
Ensuring adherence to these steps requires a complete and effective reprocessing program. These
recommendations apply to all settings where endoscopic procedures are performed and where endoscopes
are reprocessed.

1. Pre-cleaning
a. Pre-clean flexible endoscopes and reusable accessories by following the device manufacturer’s
instructions for use (IFU). Perform pre-cleaning immediately following completion of the
endoscope procedure to help prevent the formation of biofilm.
2. Leak Testing
a. For endoscopes that require leak testing, perform the leak test using manufacturer’s IFU after
each use and prior to manual cleaning. Leak testing detects damage to the external surfaces
and internal channels of the endoscope that can lead to inadequate disinfection and further
damage of the endoscope.
3. Manual Cleaning
a. Perform meticulous manual cleaning including brushing and flushing channels and ports
consistent with the manufacturer’s IFU before performing high-level disinfection (HLD) or
sterilization. Perform manual cleaning within the timeframe specified in the manufacturer’s
IFU. Manual cleaning is the most critical step in the disinfection process since residual organic
material can reduce the effectiveness of HLD and sterilization.
4. Visual Inspection
a. After manual cleaning, visually inspect the endoscope and its accessories. Visual inspection
provides additional assurance that the endoscope and its accessories are clean and free of
defects. Complex devices such as flexible endoscopes may require the use of lighted
magnification or additional methods to assist with the inspection process.
5. Disinfection or Sterilization
a. Following cleaning and visual inspection perform HLD or sterilization in accordance with the
manufacturer’s IFU. Carefully review and adhere to the endoscope manufacturer’s
reprocessing instructions and to the IFU for chemicals or sterilants and any equipment (e.g.,
automated endoscope reprocessors) used for reprocessing to help ensure that effective
disinfection occurs.
6. Storage
a. After reprocessing is complete, store endoscopes and accessories in a manner that prevents
recontamination, protects the equipment from damage, and promotes drying. Store processed
flexible endoscopes in a cabinet that is either:
1. of sufficient height, width, and depth to allow flexible endoscopes to hang vertically
without coiling and without touching the bottom of the cabinet OR

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Essential Elements of a Reprocessing Program for Flexible Endoscopes
Recommendations of the HICPAC
2. designed and intended by the manufacturer for horizontal storage of flexible endoscopes
7. Documentation
a. Maintain documentation of adherence to these essential steps each time an endoscope is
reprocessed. Documentation is essential for quality assurance purposes and for patient tracing
in the event a look back is necessary.

Essential Elements of a Reprocessing Program for Flexible Endoscopes

Administrative
1. Leadership of the healthcare organization or practice setting where flexible endoscopes are used
and/or reprocessed is accountable for:
a. Allocating sufficient human and material resources to ensure that the selection, use, and
reprocessing of endoscopes and related accessories are managed in a manner that minimizes
infection risk and supports patient and healthcare worker safety.
b. Supporting and empowering the authority of those responsible for managing infection prevention
practices to ensure effectiveness of the program.
c. Ensuring that the essential elements of an endoscope reprocessing program are followed and that
endoscopes are reprocessed according to manufacturers’ IFU.
2. Policies
a. In all practice settings where endoscopy is performed, policies related to the reprocessing of
endoscopes should be developed by a multidisciplinary team that includes physicians, nurses,
endoscope reprocessing personnel, infection preventionists, and other personnel who are involved
in the use and reprocessing of endoscopes. For facilities with limited personnel where formation of
a multidisciplinary team is not possible, consider seeking external expertise to obtain
multidisciplinary input.
b. Policies should address the selection, use, transport, reprocessing, and storage of endoscopes and
accessory devices to ensure compliance with endoscope and reprocessing equipment
manufacturers’ IFUs. In addition, policies should clearly include requirements for documentation
of adherence to essential reprocessing steps, parameters regarding the physical setting where
endoscope reprocessing occurs, staff education, training, and assessment of competency, ongoing
quality assurance procedures, and protocols for responding to equipment and HLD/sterilization
failures or breaches (see sections below).
c. Policies should include the management of “loaner” endoscopes (i.e., endoscopes that are not
owned by the healthcare facility but are provided for temporary use by manufacturers, equipment
suppliers or other healthcare facilities) to ensure adherence to the same reprocessing standards
described above required for facility-owned equipment. This includes:
1. Assessing the condition (i.e., visual inspection, leak testing) of loaner endoscopes prior to use.
2. Cleaning and high level disinfection or sterilization of loaner endoscopes supplied by the
manufacturer or another healthcare facility prior to use.
d. Policies must be in compliance with all federal and local regulatory (e.g., FDA, CMS, OSHA, state
health departments) and relevant accrediting organization (e.g. AAAASF, AAAHC, DNVGL
Healthcare, TJC) standards and requirements. Policies should also take into consideration the

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Essential Elements of a Reprocessing Program for Flexible Endoscopes
Recommendations of the HICPAC
standards and recommendations from professional organizations (e.g., AAMI, AGA, AORN, ASGE,
SGNA).
3. Management should ensure that:
a. Policies related to the reprocessing of endoscopes are in place and are reviewed on a regular basis
as required by the facility governing body and any applicable regulatory organization. In addition,
policies should be updated regularly when new equipment/products are purchased and when new
information is published.
b. Single-use devices should not be reprocessed. If a facility chooses to reprocess a single use device,
FDA regulations for reprocessing of single use devices must be followed.
c. Occupational health needs are addressed that include but are not be limited to the provision of
hepatitis B vaccine, prevention of exposure to infectious agents (e.g., bloodborne pathogens,
enteric pathogens) and availability of post-exposure prophylaxis when indicated, convenient
access to and appropriate use of personal protective equipment (PPE), and monitoring for
exposure to chemicals used for reprocessing when applicable. The CDC provides multiple
resources related to occupational health.1,2
d. Patient scheduling and staffing levels are adequate to allow for enough time to consistently
perform adequate reprocessing of endoscopes and to avoid delays between completion of an
endoscopic procedure and initiation of reprocessing of the endoscope used for that procedure.
Management should be knowledgeable about the manufacturer’s IFUs related to delayed
reprocessing to ensure that appropriate steps are taken if a reprocessing delay occurs.
e. Staff has access to personnel with infection prevention knowledge and training to support the
development and implementation of infection prevention policies and procedures.
f. All personnel involved in the reprocessing of endoscopes, including the supervisors and managers
of reprocessing personnel, receive ongoing education, training and assessment of competency as
outlined in the Education, Training and Competencies section.
1. If personnel are responsible for reprocessing more than one type of endoscope, verify
reprocessing competency for each type of endoscope, including the appropriate use of all
equipment required for reprocessing.
2. Endoscope reprocessing certification is encouraged but does not negate the need for ongoing
assessments of competency.
g. At minimum, water used for reprocessing of endoscopes meets the specifications that are
recommended by the device and reprocessing equipment manufacturers.3,4 Professional society
guidelines that recommend more stringent water specifications should be considered.5
h. All the essential elements of an effective endoscope reprocessing program are met and
maintained.

Documentation
1. Documentation requirements vary depending upon the methods and the products that are used for
HLD or sterilization.
2. For all methods of reprocessing using HLD or sterilization, document endoscope and patient
identifiers. Tracking is essential in the event of a disinfection failure and for responding to device or
product recalls.

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3. Ensure that there is a process in place to record the procedure end time and the start time for manual
cleaning. Recording these times enables reprocessing personnel to ascertain how long the endoscope
has been awaiting reprocessing, to prioritize reprocessing of specific endoscopes, and to determine
whether routine reprocessing within the manufacturer’s recommended time to cleaning is achievable,
and if not, to implement the manufacturer’s procedures for delayed processing.
4. Maintain documentation of the effectiveness of the products used for cleaning and disinfection (e.g.,
document the results of testing for effective concentrations of the chemical disinfectant, expiration
dates for test strips and chemical disinfectants).
5. Maintain records of preventive maintenance and repair of endoscopes and reprocessing equipment
(e.g., leak testers, automated endoscope reprocessors [AERs], sterilizers).
6. Documentation should include the investigation of critical or potential critical events such as HLD or
sterilization process failures or equipment failures.
7. Retain documentation as designated by the facility record retention policy. This includes
documentation for AERs and retired endoscopes.

Inventory
1. Conduct an endoscope inventory to identify all endoscopes and method of reprocessing in use by the
facility. Information reviewed for each endoscope should include but is not limited to the:
a. Endoscope manufacturer and model
b. Location of use
c. Number of procedures performed
d. Location of the endoscope manufacturer’s IFUs
e. Location for reprocessing
f. Equipment used for HLD and/or sterilization
g. Status of the endoscope (i.e., retired, out for repair, in use)
2. Ensure that each endoscope has a unique identifier to facilitate tracking. Tracking should include the
ability to determine when specific endoscopes were used for specific patients, loaned to other units or
facilities, reprocessed, or repaired. Tracking is also essential for responding to device or product
recalls.

Physical Setting
1. The reprocessing area should be in a space that is separate from the patient procedural area.
2. Review the physical setting to ensure a “one way” work flow that separates contaminated work spaces
from clean work spaces.
3. If a separate room is used for manual cleaning of endoscopes, ensure a directional airflow that
maintains negative pressure within that room relative to adjoining spaces.
4. Ensure that heating, ventilation, and air conditioning parameters are appropriate for the chemicals and
equipment in use.
5. Staff should have access to a handwashing sink that is separate from the reprocessing sink(s).
6. Install eyewash stations, either plumbed or self-contained, within the endoscopy reprocessing room
where chemicals that are hazardous to the eyes are used. Eyewash stations should not be installed in a
location that requires flushing of the eyes in the decontamination sink.

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7. Ensure that manufacturer’s IFUs for reprocessing of the endoscopes and for use of the AERs and
associated chemicals are readily available.
8. Provide designated space to enable access to files electronically (e.g., computer) or hard copy (e.g., in
binders for IFUs and Safety Data Sheets for chemicals used to reprocess flexible endoscopes.

Education, Training, and Competencies

1. Education and training should include the rationale for each of the seven essential steps of
reprocessing outlined in this document. Training and competency assessments should be based upon
the endoscope manufacturer’s IFUs as well as the reprocessing equipment and chemicals used. If more
than one type/model of endoscope is used, staff should be able to demonstrate they are competent to
reprocess each specific type of endoscope.
a. Model-specific competency assessment check lists may be required.
b. Post visual educational aids and standard operating procedures to reinforce best reprocessing
practices.
2. Education and training should also address decontamination, cleaning and sterilization of reusable
accessories that breach the mucosal barrier (e.g., biopsy forceps).
3. Ensure that trainers and managers are competent to reprocess endoscopes and are able to adequately
train and verify the competency of their staff.
4. Perform staff competencies:
a. Initially upon hire and periodically as required by facility policy. An educational update
followed by direct observation of staff performing endoscope reprocessing is recommended.
b. Whenever a new model of endoscope, reprocessing equipment (e.g., AER, leak tester), or
chemical is purchased.
c. Whenever there are updates to the manufacturer’s IFUs.
d. That include essential steps of reprocessing from pre-clean to storage and documentation.
e. That include a review of procedures to be followed in the case of equipment failure (e.g., use
of manual reprocessing methods as per manufacturer’s IFU or use of an alternative automated
reprocessor that is validated for the endoscope).
f. That include how and when to perform supplemental testing or other assessments of
endoscope cleaning (e.g., tests that measure residual organic material or adenosine
triphosphate) when those tests are used by the facility.
5. Certification in reprocessing of endoscopes does not mitigate the need for orientation, ongoing
education training/education and competency assessments.

Risk Assessment and Quality Assurance

1. A risk assessment or comprehensive gap analysis should be conducted to ensure that:
a. All essential steps of reprocessing and essential elements of an endoscope reprocessing
program are met and maintained.
b. Flexible endoscopes are precleaned at the point of use and transported safely to the
reprocessing area.
c. Staff competencies are verified
d. Sufficient numbers of reprocessing personnel are available when routine and/or emergency
endoscopic procedures are performed

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Recommendations of the HICPAC
e. Manufacturer’s IFUs are readily available and followed
f. Necessary reprocessing equipment and supplies are available
g. Physical space is adequate for reprocessing
h. Heating, ventilation and air conditioning parameters are monitored and controlled
i. Storage of endoscopes is appropriate
j. Documentation providing complete traceability is maintained.
2. When conducting the risk assessment or gap analysis, if an AER is used, assess for documentation that
AER has been validated for reprocessing the endoscope and endoscope components. Obtain the
model-specific reprocessing protocols for both the endoscope and AER and verify compatibility.
3. Perform periodic audits of facility reprocessing protocols and the completeness of documentation to
monitor compliance. Gap analyses and risk assessments should be conducted periodically and
whenever new endoscopes are purchased, manufacturer’s IFUs change, and when changes occur in
guidance from professional and regulatory organizations.

Disinfection/Sterilization Breach or Failure

1. Breaches in adherence to essential disinfection and sterilization steps can be a result of malfunctioning
of equipment and/or human error. Each breach is a result of unique circumstances and should be
evaluated to determine the risk of disease transmission. A multi-disciplinary team that includes
infection prevention, risk management, and endoscopy personnel should review each event carefully
to determine the necessary corrective steps and the need for patient notification.
2. There are several resources available to assist in a breach evaluation. The multi-disciplinary team
should use one or more of these documents to guide their investigation.5-7
3. When a breach involves a suspicion of patient exposure to an improperly reprocessed endoscope, the
decision to notify patients of their potential exposure should be made in consultation with an infection
preventionist and state and local health departments.
4. If a healthcare provider suspects persistent bacterial contamination of an endoscope following
reprocessing, either because of an increase in infections after endoscopic procedures or because of
the results of microbiological culturing of endoscopes, the healthcare provider should file a voluntary
report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.8

Unresolved Issues
1. Supplemental measures for duodenoscope reprocessing following HLD
• Some healthcare facilities have chosen to use a supplemental method(s) following high level
disinfection for reprocessing of duodenoscopes. Because there is currently insufficient evidence to
adequately assess the balance between potential benefits and unintended consequences
associated with these supplemental methods, these methods have not been included as essential
elements of a reprocessing program9. Examples of supplemental measures as of July 2016 include
but are not limited to:
o Repeat high level disinfection
o Microbiological culturing and quarantine until negative culture
o Liquid chemical sterilant processing system
o Ethylene oxide sterilization

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Recommendations of the HICPAC
o FDA-cleared low-temperature sterilization
2. Endoscope Storage Interval
• The available data on the maximum interval of endoscope storage before reprocessing is required
prior to use is inconclusive. The length of time may depend on multiple factors as identified on
organizational risk assessment that may include endoscope usage/turnover of endoscopes used
and manufacturer’s instructions-for-use.
3. Endoscope Storage Space
• The storage cabinet features that are optimal for prevention of contamination have not been
determined (e.g., cabinet ventilation parameters, capacity to store accessories).
4. Replacement of Endoscopes
• While endoscopes should be serviced no less frequently than indicated in the FDA-cleared
manufacturer’s IFUs, the optimal time interval for replacement of the endoscope and its
associated parts is unknown.

References
1. Centers for Disease Control and Prevention. Healthcare Infection Control Practices Advisory Committee.
Bolyard EA, Tablan OC, Williams W, et. al., Guideline for infection control in health care personnel, 1998.
Available at: https://stacks.cdc.gov/view/cdc/7250. Accessed August 3, 2015.
2. Healthcare Infection Control Practices Advisory Committee. Core Infection Prevention and Control
Practices for Safe Healthcare Delivery in All Settings – The Recommendations of the Healthcare Infection
Control Practices Advisory Committee (HICPAC). 2017. Accessed August 3, 2016 prior to publication.
Available at: https://www.cdc.gov/hicpac/pdf/core-practices.pdf.
3. Association for the Advancement of Medical Instrumentation. Technical Information Report 34: Water for
the Reprocessing of Medical Devices. 2014.
4. Association for the Advancement of Medical Instrumentation. ST91 Flexible and semi-rigid endoscope
processing in health care facilities 2015.
5. Van Wicklin SA, Spry C, Conner R. Guideline For Processing Flexible Endoscopes. In: Connor, R,. ed. AORN
Guidelines for Perioperative Practice: AORN; 2016.
6. American Society for Gastrointestinal Endoscopy Standards of Practice Committee, Banerjee S, Nelson DB,
et al. ASGE Standards of Practice Committee Statement: Reprocessing failure. Gastrointest Endosc.
2007;66(5):869-871.
7. Weber DJ, Rutala WA. Assessing the risk of disease transmission to patients when there is a failure to follow
recommended disinfection and sterilization guidelines. Am J Infect Control. 2013;41(5 Suppl):S67-71.
8. US Food and Drug Administration. Infections Associated with Reprocessed Flexible Bronchoscopes: FDA
Safety Communication; Issued September 17, 2015. 2015. Available at:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm462949.htm. Accessed June 14, 2016,
2016.
9. Rutala WA, Weber DJ. ERCP scopes: what can we do to prevent infections? Infect Control Hosp Epidemiol.
2015;36(6):643-648.

Additional Resources
Last update: June 28, 2017 Page 8 of 12
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Essential Elements of a Reprocessing Program for Flexible Endoscopes
Recommendations of the HICPAC
• American National Standards Institute Inc., and the Association for the Advancement of Medical
Instrumentation. ST91:2015 Flexible and semi-rigid endoscope processing in health care facilities. Arlington,
VA: AAMI, 2015. [Available from: http://my.aami.org/store/detail.aspx?id=ST91-PDF. Accessed 28
September 2016.]
• American Society for Gastrointestinal Endoscopy (ASGE), Quality Assurance in Endoscopy Committee,
Petersen BT, Chennat J, et. al. Multisociety guideline on reprocessing flexible gastrointestinal endoscopes:
2011. Gastrointest Endosc. 2011 Jun;73(6):1075-84 (under revision).
• American Society for Gastrointestinal Endoscopy Standards of Practice Committee, Banerjee S, Nelson DB,
et al. ASGE Standards of Practice Committee Statement: Reprocessing failure. Gastrointest Endosc.
2007;66(5):869-871.
• Canadian Standards Association. CSA Z314.8-14 Decontamination of reusable medical devices. Chapter 11.
Flexible endoscopes. [Available from: http://shop.csa.ca/search?q=Decontamination&categories=shop.
Accessed 28 September 2016.]
• Sehulster LM, Chinn RYW, Arduino MJ, Carpenter J, Donlan R, Ashford D, Besser R, Fields B, McNeil MM,
Whitney C, Wong S, Juranek D, Cleveland J. Guidelines for environmental infection control in health-care
facilities. Recommendations from CDC and the Healthcare Infection Control Practices Advisory Committee
(HICPAC). Chicago IL; American Society for Healthcare Engineering/American Hospital Association; 2004.
[Available from: https://www.cdc.gov/infectioncontrol/pdf/guidelines/environmental-guidelines.pdf [PDF -
2.32 MB]. Accessed 28 September 2016.]
• Siegel JD, Rhinehart E, Jackson M, Chiarello L, and the Healthcare Infection Control Practices Advisory
Committee, 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in
Healthcare Settings [Available from: https://www.cdc.gov/infectioncontrol/pdf/guidelines/isolation-
guidelines.pdf [PDF - 1.4 MB]. Accessed 28 September 2016.]
• Rutala WA, Weber DJ, and the Healthcare Infection Control Practices Advisory Committee (HICPAC).
Guideline for Disinfection and Sterilization in Healthcare Facilities, Recommendations from CDC and the
Healthcare Infection Control Practices Advisory Committee; 2008 [Available from:
https://www.cdc.gov/infectioncontrol/pdf/guidelines/disinfection-guidelines.pdf [PDF - 1.3 MB]. Accessed
28 September 2016.]
• Rutala WA, and Weber DJ. SHEA Guideline for Disinfection and Sterilization of Prion-Contaminated Medical
Instruments (2010). Infection Control and Hospital Epidemiology. Vol. 31, No. 2 (February 2010), pp. 107-
117. [Available from: http://www.jstor.org/stable/10.1086/650197. Accessed 28 September 2016.]
• Public Health Agency of Canada. Infection Prevention and Control Guideline for Flexible Gastrointestinal
Endoscopy and Flexible Bronchoscopy. 2011. [Available from: http://www.phac-aspc.gc.ca/nois-
sinp/guide/endo/intro-eng.php. Accessed 28 September 2016.]
• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Guideline for Use of High Level
Disinfectants & Sterilants for Reprocessing Flexible Gastrointestinal Endoscopes (2013). Published 1998.
Revised 2003, 2006, 2007, 2010, and 2013. [Available from:
http://www.sgna.org/Portals/0/Issues/PDF/Infection-Prevention/6_HLDGuideline_2013.pdf [PDF - 243 KB].
Accessed 28 September 2016.]
• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Infection Prevention Champion Program.
[Available from: https://www.sgna.org/Issues/Infection-Prevention/Become-A-Champion. Accessed 28
September 2016.]
• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Infection Prevention Toolkit. [Available

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Recommendations of the HICPAC
from: https://www.sgna.org/Issues/Infection-Prevention/Infection-Prevention-Toolkit. Accessed 28
September 2016.]
• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Position Statement: Reuse of Single-Use
Critical Medical Devices (2015). Published February 1998. Revised May 2002, October 2005, August 2008,
March 2012, and May 2013 [Available from: http://www.sgna.org/Portals/0/Issues/PDF/Infection-
Prevention/8_SUDPositionStatement_2013.pdf [PDF - 118 KB]. Accessed 28 September 2016.]
• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Position Statement: Statement on
Reprocessing of Endoscopic Accessories and Valves (2014). Published May 2002. Revised 2005, May 2009,
September 2011, and September 2014 [Available from:
https://www.sgna.org/Portals/0/Education/PDF/Position-
Statements/Reprocessingvalvesdocument_FINAL.pdf [PDF - 123 KB]. Accessed 28 September 2016.]
• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Position Statement: Statement on Water
and Irrigation Bottles Used During Endoscopy (2014). Published May 2002. Revised October 2005, August
2008, May 2009, September 2011, and September 2014. [Available from:
https://www.sgna.org/Portals/0/Education/PDF/Position-Statements/WaterandIrrigationBottles_final.pdf
[PDF - 126 KB]. Accessed 28 September 2016.]
• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Standards of Infection Prevention in
Reprocessing of Flexible Gastrointestinal Endoscopes (2016). Published 1996. Revised 2000, 2005, 2007,
2008, 2011, 2012, 2015, and 2016. [Available from:
https://www.sgna.org/Portals/0/Standards%20for%20reprocessing%20endoscopes_FINAL.pdf [PDF – 309
KB]. Accessed 28 September 2016.]
• Society of Gastroenterology Nurses and Associates, Inc. (SGNA). Standard of Infection Prevention in the
Gastroenterology Setting (2015). Published 2015. [Available from:
https://www.sgna.org/Portals/0/Standard%20of%20Infection%20Prevention_FINAL.pdf [PDF – 235 KB].
Accessed 28 September 2016.]
• The Joint Commission. High-Level Disinfection and Sterilization BoosterPak™. [Available from:
https://www.jointcommission.org/standards_booster_paks/. Accessed 28 September 2016.]
• Van Wicklin SA, Spry C, Conner R. Guideline for Processing Flexible Endoscopes. In: Connor, R. ed. AORN
Guidelines for Perioperative Practice: AORN; 2016. [Available from: http://www.aornstandards.org/.
Accessed 28 September 2016.]

Suggested Citation
Healthcare Infection Control Practices Advisory Committee. Essential Elements of a Reprocessing Program for
Flexible Endoscopes – The Recommendations of the Healthcare Infection Control Practices Advisory
Committee (HICPAC). 2016. Available at: https://www.cdc.gov/hicpac/pdf/flexible-endoscope-
reprocessing.pdf [PDF - 237 KB].

Contributors
HICPAC Workgroup Members
Vickie Brown, RN, MPH; HICPAC Member (Workgroup Co-Chair); Lisa L. Maragakis, MD, MPH; HIPCAC Member
(Workgroup Co-Chair); Elizabeth Claverie-Williams, MS; US Food and Drug Administration (FDA); Barbara

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Recommendations of the HICPAC
Connell, CAE, CMP, American Society for Gastrointestinal Endoscopy (ASGE); Mary Ann Drosnock, MS, CIC,
CFER, RM (NRCM), Association for the Advancement of Medical Instrumentation (AAMI); Glenn Eisen, MD,
MPH, FASGE, American Society for Gastrointestinal Endoscopy (ASGE); Eden Essex, American Society for
Gastrointestinal Endoscopy (ASGE); Karen Hoffmann, RN, BSN, MS, CIC, FSHEA, FAPIC, Centers for Medicare &
Medicaid Services (CMS); Michael L. Kochman, MD, AGAF, FASGE, American Gastroenterological Association
(AGA); Naomi Kuznets, PhD; Accreditation Association for Ambulatory Health Care (AAAHC); Natalie Lind,
International Association of Healthcare Central Service Materiel Management (IAHCSMM); Betty McGinty,
MSHSA, CGRN, BSHA, RN, Society of Gastroenterology Nurses and Associates (SGNA); Laurie O'Neil, RN BN;
Public Health Agency of Canada; Michael Anne Preas RN, BSN, CIC; Association for Professionals in Infection
Control and Epidemiology (APIC); Sharon Roberson, RN, Centers for Medicare & Medicaid Services (CMS);
Zachary Rubin, MD, Society for Healthcare Epidemiology of America (SHEA); Linda L. Spaulding RN, BC, CIC;
DNVGL Healthcare; Rachel Stricof, MPH, Council of State and Territorial Epidemiologists (CSTE); Michael
Tapper, MD, HICPAC Member; Sharon A. Van Wicklin, MSN, RN, CNOR, CRNFA(E), CPSN-R, PLNC, Association of
periOperative Registered Nurses (AORN); Lisa Waldowski MS, APRN, CIC, The Joint Commission; Deborah
Yokoe, MD, MPH, HICPAC Co-Chair

HICPAC Members
Daniel J. Diekema, MD, University of Iowa Carver College of Medicine (Co-Chair); Deborah S. Yokoe,
MD, MPH, Brigham & Women's Hospital (Co-Chair); Hilary M. Babcock, MD, MPH, Washington
University School of Medicine; Vickie M. Brown, RN, MPH, WakeMed Health & Hospitals; Sheri
Chernetsky Tejedor, MD, Emory University School of Medicine; Susan Huang, MD, MPH; University of
California Irvine School of Medicine; Loretta L. Fauerbach, MS, CIC, Fauerbach & Associates, LLC;
Michael D. Howell, MD MPH, University of Chicago Medicine; W. Charles Huskins, MD, MSc, Mayo
Clinic College of Medicine; Lynn Janssen MS, CIC, CPHQ, California Department of Public Health; Lisa L.
Maragakis, MD, MPH, Johns Hopkins University School of Medicine; Jan Patterson, MD, MS, University
of Texas Health Science Center San Antonio; Gina Pugliese, RN. MS, Premier healthcare alliance;
Selwyn O. Rogers Jr., MD, MPH, FACS, The University of Texas Medical Branch; Tom Talbot, MD, MPH,
Vanderbilt University Medical Center; Michael L. Tapper, MD, Lenox Hill Hospital

HICPAC Ex-officios
William B. Baine, MD, Agency for Healthcare Research and Quality (AHRQ); David Henderson, MD,
National Institutes of Health (NIH); Melissa Miller, MD, Agency for Healthcare Research and Quality
(AHRQ); Paul D. Moore, PhD, Health Resources and Services Administration (HRSA); Elizabeth Claverie-
Williams, MS, U.S. Food and Drug Administration (FDA); Gary Roselle, MD, Veterans Administration
(VA); Daniel Schwartz, MD, MBA Center for Medicare & Medicaid Services; Jacqueline Taylor, Health
Resources and Service Administration (HRSA); Judy Trawick, Health Resources and Service
Administration (HRSA)

HICPAC Liaison Representatives

David Banach, MD, MPH, Society for Healthcare Epidemiology of America (SHEA); Vineet Chopra,
MBBS, Society of Hospital Medicine; Craig M. Coopersmith, MD, Society of Critical Care Medicine;
Elaine Dekker, RN, BSN, CIC, America’s Essential Hospitals; Akin Demehin, American Hospital

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Recommendations of the HICPAC
Association (AHA); Kathleen Dunn, BScN, MN, RN, Public Health Agency of Canada; Sandra Fitzler, RN,
American Health Care Association (AHCA); Nancy Foster, American Hospital Association (AHA); Diana
Gaviria, MD, MPH, National Association of County and City Health Officials (NACCHO); Jennifer
Gutowski, MPH, BSN, RN, CIC, National Association of County and City Health Officials (NACCHO);
Valerie Haley, PhD, Association of State and Territorial Health Officials (ASTHO)Holly Harmon, RN,
MBA, American Health Care Association (AHCA); Patrick Horine, MHA, DNVGL Healthcare Inc.; Michael
D. Howell, MD, MPH, Society of Critical Care Medicine (SCCM); Marion Kainer, MD, MPH, Council of
State and Territorial Epidemiologists (CSTE); Emily Lutterloh, MD, MPH, Association of State and
Territorial Health Officials (ASTHO); Sarah Matthews, MD, National Association of County and City
Health Officials (NACCHO); Michael McElroy, MPH, CIC, America’s Essential Hospitals; Lisa McGiffert,
Consumers Union; Jennifer Meddings, MD, Society of Hospital Medicine (SHM); Toju Ogunremi, Public
Health Agency of Canada; Laurie O’Neil, RN, BN, Public Health Agency of Canada; Michael Anne Preas,
RN CIC, Association of Professionals of Infection Control and Epidemiology, Inc. (APIC); Mark E. Rupp,
MD, Society for Healthcare Epidemiology of America (SHEA); Mark Russi, MD, MPH, American College
of Occupational and Environmental Medicine; Sanjay Saint, MD, MPH, Society of Hospital Medicine
(SHM); Robert G. Sawyer, MD, FACS, FIDSA, FCCM, Surgical Infection Society (SIS); Kathryn Spates, the
Joint Commission; Linda Spaulding RN, CIC, DNVGL Healthcare; Donna Tiberi, RN, MHA Healthcare
Facilities Accreditation Program (HFAP); Margaret VanAmringe, MHS, the Joint Commission; Stephen
Weber, MD, Infectious Disease Society of America (IDSA); Elizabeth Wick, MD, American College of
Surgeons (ACS); Amber Wood, MSN, RN, CNOR, CIC, FAPIC, Association of periOperative Registered
Nurses (AORN)

Acknowledgements
Erin Stone, MA, Lynne Sehulster, PhD, Joseph Perz, DrPH, MA , and Jeffrey Hageman, MHS; the Division of
Healthcare Quality Promotion (DHQP), the Centers for Disease Control and Prevention

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8.2
HICPAC Sample Policy Template: Reprocessing Flexible Endoscopes
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monitor compliance, and the
monitor completeness
compliance, of documentation.
and the completeness of documentation.
• Flexible endoscopes designed to be leak tested will be leak tested after each use, after any event that may
• Flexible endoscopes
have damaged •andFlexible
accessories
the endoscope, and will beuse
endoscopes
before precleaned
and ofaccessories
a newly atpurchased,
thewill
point ofrepaired,
use.
be precleaned at loaned
or the point of use.
endoscope.
•• Flexible endoscopes • designed
Flexible to be leak
endoscopes tested will
designed be leak
to be tested
leak after
tested each
will
After leak testing and before high-level disinfection (HLD) or sterilization, flexible endoscopes will beuse,
leak after any
tested event
after that
each mayafter any event
be use,
have damaged
manually cleaned. the endoscope,
have and
damaged before
the use of a
endoscope, newly andpurchased,
before userepaired,
of a newlyor loaned
purchased,endoscope.
repaired, or loaned endosco
•• After leak
Flexible testing and
endoscopes, before
After high-level
leak and
• accessories, testing disinfection
and before
associated (HLD) or sterilization,
high-level
equipment willdisinfection
be visually flexible
(HLD) endoscopes willflexible
or sterilization,
inspected be
for cleanliness, endoscopes wil
manually cleaned. manually cleaned.
integrity, and function before disinfection or sterilization.
•• Flexible
Chemicalsendoscopes, • accessories,
and solutions Flexible and associated
used forendoscopes,
cleaning equipment
andaccessories,
reprocessing and will be endoscopes
visually
associated
flexible inspected
equipment forbe
and will cleanliness,
visually inspected for cleanlin
endoscope
integrity, and function before disinfection
integrity, and or
function sterilization.
before disinfection or sterilization.
accessories will be handled in accordance with local, state, and federal regulations and the manufacturer’s
• Chemicals
IFU. and solutions used for cleaning
• Chemicals and reprocessing
and solutions used for cleaning flexibleand
endoscopes
reprocessing andflexible
endoscope
endoscopes and endoscope
accessories will be handled in accordance
accessories will be with local,
handled instate, and
accordance federal
with
• Flexible endoscopes and accessories will be stored in a manner that minimizes contamination and regulations
local, state, and the manufacturer’s
federal regulations
protectsand the manu
IFU. IFU.
the device or item from damage.
•• Flexible
Records endoscopes •andFlexible
of flexible endoscope accessories will be
endoscopes
processing andstored
and in a manner
accessories
procedures that willthat minimizes
be stored
enable in a contamination
traceabilitymanner
in thethat and
of a protects
minimizes
event contamination an
the device or item from damage.
the device or item
processing failure will be completed and maintained. from damage.
• Recordso Recordsof flexible
will beendoscope
Records
•maintained processing
[insertand
of flexible
for procedures
endoscope
facility-specific that
timeenable
processing traceability that
and procedures
period]. in theenable
eventtraceability
of a in the event of
processing failure will beprocessing
completedfailureand maintained.
will be completed and maintained.
o Records will be maintained o Records for [insert
will befacility-specific
maintained fortime period].
[insert facility-specific time period].

Adapted with permission from “Guidelines and Tools for the Sterile Processing Team. AORN, Inc., 2170 South Parker Road,
Suite 400, Denver, CO 80231. All rights reserved.” Page 1 of 5
Adapted with permission from
Adapted
“Guidelines
with permission
and Toolsfrom
for the
“Guidelines
Sterile Processing
and ToolsTeam.
for theAORN,
SterileInc.,
Processing
2170 South
Team.
Parker
AORN,Road,
Inc., 2170 South P
171
Suite 400, Denver, CO 80231.
Suite
All400,
rights
Denver,
reserved.”
CO 80231. All rights reserved.” Page 1 of 5
HICPAC Sample Policy Template: Reprocessing Flexible Endoscopes
[Insert facility name or a header]
Procedure Interventions
Precleaning
• Preclean flexible endoscopes and accessories at the point of use as soon as possible after the endoscope is
removed from the patient (or the procedure is completed) and before organic material has dried on the
surface or in the channels of the endoscope.
• Perform precleaning in accordance with the endoscope manufacturer’s IFU and by
o preparing a fresh solution of the cleaning product with properties recommended by the manufacturer;
o washing the exterior surfaces of the endoscope with a soft, lint-free cloth or sponge saturated with the
cleaning solution;
o suctioning the cleaning solution through the suction and biopsy channels;
o placing the distal end of the endoscope in the cleaning solution and suctioning the solution through
the endoscope;
o flushing the air, water, and other channels of the endoscope alternately with the cleaning solution and
air, finishing with air;
o visually inspecting the endoscope for damage; and
o discarding the cleaning solution and cleaning cloth or sponge after use.
Transporting
• Transport contaminated flexible endoscopes and accessories to the endoscopy processing room as soon as
possible after use.
• Keep the endoscope wet or damp, but not submerged in liquid, during transport.
• Transport contaminated endoscopes and accessories to the decontamination area in a closed container or
closed transport cart.
o Use a container that is leak proof, puncture resistant, and large enough to contain all contents.
o Use a container that is of sufficient size to accommodate the endoscope when the endoscope is coiled
in large loops.
• Label the transport cart or container with a biohazard legend.
o Securely affix the biohazard label to the cart or container.
• Transport the accessories with the endoscope but contain them separately from the endoscope.
• Begin processing flexible endoscopes and accessories as soon as possible after transport to the endoscopy
processing room or within the manufacturer’s recommended time to processing.
o When it is not possible to initiate the cleaning process within the endoscope manufacturer’s
recommended time to cleaning, follow the manufacturer’s IFU for delayed processing.
o Do not leave flexible endoscopes soaking in enzymatic cleaning solutions beyond the endoscope
manufacturer’s designated contact time unless this is recommended in the manufacturer’s IFU for
delayed processing.
Leak Testing
• Perform leak testing before manual cleaning and before the endoscope is placed into cleaning solutions.
• Perform leak testing in accordance with the endoscope and leak-testing equipment manufacturers’ IFU
and by
o removing all port covers and function valves;
o placing the endoscope in a loose configuration;
o pressurizing the endoscope to the recommended pressure;
o manipulating all moving parts, including the elevator, and angulating the bending section of the distal
end;
o actuating video switches; and
o maintaining pressure and inspection for a minimum of 30 seconds.

Adapted with permission from “Guidelines and Tools for the Sterile Processing Team. AORN, Inc., 2170 South Parker Road,
Suite 400, Denver, CO 80231. All rights reserved.” 172 Page 2 of 5
HICPAC Sample Policy Template: Reprocessing Flexible Endoscopes
[Insert facility name or a header]
• When an endoscope fails a leak test, remove it from service and send for repair or replacement per facility
policy and procedure.
Manual Cleaning
• Perform manual cleaning in accordance with the endoscope manufacturer’s IFU.
• Perform manual cleaning using the type of water and cleaning solution recommended by the endoscope
manufacturer.
• Perform manual cleaning using a freshly prepared cleaning solution.
• Follow the cleaning solution manufacturer’s IFU for
o water quality, hardness, and pH;
o concentration and dilution;
o water temperature;
o contact time;
o conditions of storage; and
o use life and shelf life.
• Completely submerge the endoscope in the cleaning solution during the cleaning process.
o Detach removable parts (e.g., valves, buttons, caps) from the endoscope and submerge them if
recommended by the endoscope manufacturer’s IFU.
• Clean all exterior surfaces of the endoscope with a soft, lint-free cloth or sponge saturated with the
cleaning solution.
• Clean all accessible channels and the distal end of the endoscope with a cleaning brush of the length,
width, and material recommended by the endoscope manufacturer.
• Manually actuate the endoscope valves while cleaning.
• Clean and brush the elevator mechanism (if present) and the recesses surrounding it with a cleaning brush
of the length, width, and material recommended by the endoscope manufacturer.
o Raise and lower the elevator channel throughout the manual cleaning process.
• Use a clean brush for each endoscope cleaning.
o Visually inspect brushes and other items used to clean endoscope channels before use and do not use
if the integrity of the brush or other cleaning item is in question.
• Brush the accessible channels of the endoscope multiple times until no debris appears on the brush.
o Remove debris from the brush before the brush is retracted back through the channel and after each
pass by swirling the brush in the cleaning solution and rinsing it.
• Flush the channels of the endoscope with cleaning solution.
• Flush and rinse the exterior surfaces and internal channels of the endoscope with tap water until all
cleaning solution and residual debris is removed.
• Dry the exterior surfaces of the endoscope with a soft, lint-free cloth or sponge and purge all channels with
air.
• Clean, brush, rinse, dry, and high-level disinfect or sterilize all reusable parts (e.g., valves, buttons, port
covers, tubing, water bottles), accessories (e.g., forceps) and cleaning implements (e.g., brushes, channel
cleaning adapters).
o High-level disinfect or sterilize water and irrigation bottles at least daily.
o Do not allow any residual water or moisture to remain in the water bottle assembly.
o Use sterile water to fill water and irrigation bottles.
• Discard single-use parts, accessories, and cleaning implements after each use and do not reprocess.
Inspecting
• Visually inspect and evaluate endoscopes, accessories, and equipment for
o cleanliness,
o missing parts,

Adapted with permission from “Guidelines and Tools for the Sterile Processing Team. AORN, Inc., 2170 South Parker Road,
Suite 400, Denver, CO 80231. All rights reserved.” 173 Page 3 of 5
HICPAC Sample Policy Template: Reprocessing Flexible Endoscopes
[Insert facility name or a header]
o clarity of lenses,
o integrity of seals and gaskets,
o moisture,
o physical and chemical damage, and
o function.
• Use lighted magnification to inspect endoscopes and accessories for cleanliness and damage, as needed.
• Remove defective endoscopes, accessories, and equipment from service and send for repair or
replacement per facility policy and procedure.

High-Level Disinfection or Sterilization

• Manually clean the endoscope and accessories before mechanical or manual HLD or sterilization.
Mechanical methods
• Check the expiration date of the high-level disinfectant or liquid chemical sterilant before each use.
• Use a test strip or other US Food and Drug Administration (FDA)-cleared testing device specific to the
disinfectant or liquid chemical sterilant and minimum effective concentration of the active ingredient for
monitoring solution potency before each use.
• Perform mechanical processing in accordance with the endoscope manufacturer’s IFU and the mechanical
processor’s IFU.
o Verify compatibility between the endoscope and the mechanical processor before processing.
o Position the endoscope and accessories within the mechanical processor in a manner that ensures
contact of the processing solutions with all surfaces of the endoscope.
o Ensure all connectors between the endoscope and the mechanical processor are connected correctly.
o Monitor the mechanical processing cycle to verify it is completed as programmed.
§ If a mechanical processing cycle is interrupted, repeat the entire cycle.
• Perform mechanical processing using the cleaning, disinfectant, and sterilant solutions and chemicals
recommended by the endoscope manufacturer and the mechanical processor manufacturer.
o Know the location of the safety data sheet for each chemical used.
o Know the location of the chemical spill kit.
Manual methods
• Check the expiration date of the high-level disinfectant before each use.
• Use a test strip or other US Food and Drug Administration (FDA)-cleared testing device specific to the
disinfectant and minimum effective concentration of the active ingredient for monitoring solution potency
before each use.
• Completely immerse the endoscope in the high-level disinfectant solution for the designated time
according to the device and high-level disinfectant manufacturer’s IFU.
• Flush and fill lumens and ports with the high-level disinfectant solution then completely immerse the items
in the disinfectant solution for the designated time.
• Following disinfection, thoroughly rinse the endoscope and all of its channels and ports with water that
meets the manufacturer’s specification or as recommended by professional organizations.
o Rinse all removable parts and endoscope accessories.
May be required for both mechanical and manual methods
• Flush endoscope lumens with 70% to 90% ethyl or isopropyl alcohol according to the endoscope
manufacturer’s IFU.
• Dry the exterior surfaces of the endoscope with a soft, lint-free cloth or sponge.
o Purge the endoscope channels with air.
o Dry all removable parts and endoscope accessories.
Adapted with permission from “Guidelines and Tools for the Sterile Processing Team. AORN, Inc., 2170 South Parker Road,
Suite 400, Denver, CO 80231. All rights reserved.” Page 4 of 5
174
HICPAC Sample Policy Template: Reprocessing Flexible Endoscopes
[Insert facility name or a header]
Sterilization
• Package and sterilize endoscopes and endoscope accessories in accordance with the manufacturers’ IFU.

Storing
• Store flexible endoscopes in accordance with the endoscope and storage cabinet manufacturers’ IFU.
o Do not store flexible endoscopes in their original shipment cases.
o Store flexible endoscopes with all valves open and removable parts detached, but stored with the
endoscope.
• Wear clean, low-protein, powder-free, natural rubber latex gloves or latex-free gloves when handling
processed flexible endoscopes and when transporting them to and from the storage cabinet.
• Identify processed endoscopes with the facility-specific visual cue.
• Visually inspect endoscopes and storage cabinets for cleanliness before placing endoscopes into or
removing them from the cabinet.
• Store sterile items in a sterile storage area per facility policy and procedure.

Records
• Records related to flexible endoscope processing will include the
o date and time,
o identity of endoscope and endoscope accessories,
o method and verification of cleaning and results of cleaning verification testing,
o number or identifier of the mechanical processor or sterilizer and results of process efficacy testing,
o identity of the persons performing the processing,
o lot numbers of processing solutions,
o disposition of defective items or equipment, and
o maintenance of water systems, endoscopes and endoscope accessories, and processing equipment.
• Records related to flexible endoscopy procedures will include the
o date and time,
o identity of the patient,
o procedure,
o identity of the licensed independent practitioner performing the procedure, and
o identity of the endoscope and endoscope accessories used during the procedure.
• Records related to annual training and competency audit will include the
o date and time of training and competency verification
o name of personnel taking training/ competency verification
o results of competency verification
o results of audit tool
• Records related to facility audits should include the
o date and time
o facility name
o completeness of inventory and repair log
o gap analysis
§ actions taken
o risk assessment
§ actions taken

Available from: https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html

Adapted with permission from “Guidelines and Tools for the Sterile Processing Team. AORN, Inc., 2170 South Parker Road,
Suite 400, Denver, CO 80231. All rights reserved.” 175 Page 5 of 5
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes

HICPAC
HICPAC Sample Competency
Sample Competency Tool: Reprocessing
VerificationVerification Tool:Flexible Endoscopes
Reprocessing Flexible Endoscopes
Purpose: Facilities can use this sample Competency Verification Tool as a template to develop their own tool to assess the competency of
HICPAC
personnel Sample
tasked withCompetency Verification
processing all types Tool:
of reusable Reprocessing
flexible endoscopes and Flexible Endoscopes
accessories. This sample tool is designed to be used in
Purpose: Facilities
conjunction with the use this
canAudit Tool.sample Competency
Facilities Verification
are encouraged to useTool as a template
the tools together to
to develop their own tool
verify competency andto assess
audit the competency
current practice as well
of as
personnel tasked with processing all types of reusable flexible endoscopes and accessories. This sample tool is designed to be used
to ensure that their practices are consistent with “Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations in
8.3
conjunction with the
of the Healthcare Audit Tool.
Infection ControlFacilities
Practices encouraged
areAdvisory to use the tools together to verify competency and audit current practice as well as
Committee.”
to ensure that their practices are consistent with “Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations
of the Healthcare Infection Control Practices Advisory Committee.”
Name: Date:

Name: Date:
DEM = Demonstration S = Skills Laboratory CS =
Controlled Simulation KAT = Knowledge Assessment
DO = Direct Observation SBT = Scenario-based RWM =
Review of Written or Visual Materials/Policy Test
DA
DEM == Documentation
Demonstration S = Training
Skills Laboratory P&P
CS Procedure
==
Controlled Review (Specify P&P #s
Simulation V
KAT == Verbalization
Knowledge Assessment
DO = Direct
Audit Observation SBT = Scenario-based RWM = _______________)
Review of Written or Visual Materials/Policy O = Other:
Test
DA = Documentation Training P&P = Procedure Review (Specify P&P #s V = Verbalization
Competency Statements/Performance Criteria Verification Method Not Met
Audit _______________) O = Other:
[See legend above] [Explain why]
Competency Statements/Performance Criteria
Precleaning Verification
☐DEM ☐S Method
☐RWM Not Met
1. Precleans flexible endoscopes and accessories at the point of [See☐Vlegend above] [Explain why]
use as soon as possible after the endoscope has been
Precleaning ☐DEM
☐DO ☐S
☐SBT ☐RWM
☐P&P

176
1. removed
Precleansfromflexible patient (or the
theendoscopes andprocedure completed)
accessoriesis at the point of ☐V
☐Other
and before organic material has dried on the surface
use as soon as possible after the endoscope has beenor in ☐DO ☐SBT ☐P&P
☐DA ☐CS ☐KAT
the channels
removed fromofthe endoscope.
thepatient (or the procedure is completed)
☐Other
and before organic material
2. Performs precleaning in accordance on the surface
has driedwith endoscopeor in ☐DEM ☐S ☐RWM
☐DA ☐CS ☐KAT
manufacturer’s the endoscope.
the channels of instructions for use (IFU) and by ☐V
2. a. preparing
Performs a fresh solution
precleaning of the cleaning
in accordance with the product
endoscopewith ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
properties recommended
manufacturer’s instructions forbyuse manufacturer;
the(IFU) and by ☐V
☐Other
a. preparing a fresh solution of the cleaning product with
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
properties recommended by the manufacturer;
b. washing the exterior surfaces of the endoscope with a ☐DEM ☐Other
☐S ☐RWM
soft, lint-free cloth or sponge saturated with the cleaning ☐DA ☐CS
☐V ☐KAT
b. washing
solution;the exterior surfaces of the endoscope with a ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
soft, lint-free cloth or sponge saturated with the cleaning ☐V
☐Other
solution;
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
☐Other
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 1 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 1 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
[See legend above] [Explain why]
Competency
c. suctioning Statements/Performance
the cleaning Criteria
solution through the suction and ☐DEMVerification
☐S Method
☐RWM Not Met
biopsy channels; legend above]
[See☐V [Explain why]
c. suctioning the cleaning solution through the suction and ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
biopsy channels; ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
d. placing the distal end of the endoscope in the cleaning ☐DEM ☐S ☐Other ☐RWM
solution and suctioning the solution through the ☐DA ☐CS
☐V ☐KAT
d. endoscope;
placing the distal end of the endoscope in the cleaning ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
solution and suctioning the solution through the ☐V
☐Other
endoscope;
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
e. flushing the air, water, and other channels of the ☐DEM ☐S ☐Other ☐RWM
endoscope alternately with the cleaning solution and air, ☐DA ☐CS
☐V ☐KAT
e. finishing
flushing the
withair,
air;water, and other channels of the ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
endoscope alternately with the cleaning solution and air, ☐V
☐Other
finishing with air;
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
f. visually inspecting the endoscope for damage; ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT

177
f. visually inspecting the endoscope for damage; ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
g. discarding the cleaning solution and cleaning cloth or ☐DEM ☐S ☐Other ☐RWM
sponge after use. ☐DA ☐CS
☐V ☐KAT
g. discarding the cleaning solution and cleaning cloth or ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
sponge after use. ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
Transporting ☐DEM ☐S ☐Other ☐RWM
3. Transports the flexible endoscope and accessories to the ☐DA ☐CS
☐V ☐KAT
endoscopy
Transporting processing room as soon as possible after use. ☐DO
☐DEM ☐SBT ☐S ☐RWM
☐P&P
3. Transports the flexible endoscope and accessories to the ☐V
☐Other
endoscopy processing room as soon as possible after use. ☐DO ☐SBT ☐P&P
☐DA ☐CS ☐KAT
☐Other
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 2 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 2 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
[See legend above] [Explain why]
4. Keeps the endoscope wet or damp, but not submerged in ☐DEM ☐S ☐RWM
liquid, during transport. ☐V
☐DO ☐SBT ☐P&P
☐Other
☐DA ☐CS ☐KAT
5. Transports contaminated endoscopes and accessories to the ☐DEM ☐S ☐RWM
decontamination area in a closed container or closed ☐V
transport cart.
☐DO ☐SBT ☐P&P
a. Uses a container that is leak proof, puncture resistant,
☐Other
and large enough to contain all contents.
☐DA ☐CS ☐KAT
b. Uses a container that is of sufficient size to accommodate ☐DEM ☐S ☐RWM
the endoscope when the endoscope is coiled in large ☐V
loops.
☐DO ☐SBT ☐P&P
☐Other
☐DA ☐CS ☐KAT

178
6. Labels the transport cart or container with a biohazard ☐DEM ☐S ☐RWM
legend. ☐V
a. Securely affixes the biohazard label to the cart or
☐DO ☐SBT ☐P&P
container.
☐Other
☐DA ☐CS ☐KAT
7. Transports the accessories with the endoscope but contains ☐DEM ☐S ☐RWM
them separately from the endoscope. ☐V
☐DO ☐SBT ☐P&P
☐Other
☐DA ☐CS ☐KAT
8. Begins to process flexible endoscopes and accessories as ☐DEM ☐S ☐RWM
soon as possible after transport to the endoscopy processing ☐V
room or within the manufacturer’s recommended time to
☐DO ☐SBT ☐P&P
processing.
☐Other
a. When it is not possible to initiate the cleaning process
☐DA ☐CS ☐KAT
within the endoscope manufacturer’s recommended
time to cleaning, follows the manufacturer’s IFU for
delayed processing.
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 3 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
[See legend above] [Explain why]
Competency
b. Does not leaveStatements/Performance
flexible endoscopes soakingCriteria
in enzymatic ☐DEMVerification
☐S Method
☐RWM Not Met
cleaning solutions beyond the endoscope legend above]
[See☐V [Explain why]
b. manufacturer’s designated
Does not leave flexible contact time
endoscopes unless
soaking this is
in enzymatic ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
recommended in the
cleaning solutions manufacturer’s
beyond IFU for delayed
the endoscope ☐V
☐Other
processing.
manufacturer’s designated contact time unless this is
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
recommended in the manufacturer’s IFU for delayed
Leak Testing ☐DEM ☐S ☐Other ☐RWM
processing.
9. Performs leak testing before manual cleaning and before the ☐DA ☐CS
☐V ☐KAT
Leakendoscope
Testing is placed into cleaning solutions. ☐DEM
☐DO ☐S
☐SBT ☐RWM
☐P&P
9. Performs leak testing before manual cleaning and before the ☐V
☐Other
endoscope is placed into cleaning solutions. ☐DO ☐SBT ☐P&P
☐DA ☐CS ☐KAT
10. Performs leak testing in accordance with the endoscope and ☐DEM ☐S ☐Other ☐RWM
leak-testing equipment manufacturers’ IFU and by ☐DA ☐CS
☐V ☐KAT
a. removing
10. Performs leak testing covers
all portin and function
accordance valves;
with the endoscope and ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
leak-testing equipment manufacturers’ IFU and by ☐V
☐Other
a. removing all port covers and function valves;
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
b. placing the endoscope in a loose configuration; ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT

179
b. placing the endoscope in a loose configuration; ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
c. pressurizing the endoscope to the recommended ☐DEM ☐S ☐Other ☐RWM
pressure; ☐DA ☐CS
☐V ☐KAT
c. pressurizing the endoscope to the recommended ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
pressure; ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
d. manipulating all moving parts, including the elevator, ☐DEM ☐S ☐Other ☐RWM
and angulating the bending section of the distal end; ☐DA ☐CS
☐V ☐KAT
d. manipulating all moving parts, including the elevator, ☐S ☐RWM
☐DO
☐DEM ☐SBT ☐P&P
and angulating the bending section of the distal end; ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
☐Other
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 4 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 4 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
[See legend above] [Explain why]
Competency
e. actuating videoStatements/Performance
switches; Criteria ☐DEMVerification
☐S Method
☐RWM Not Met
legend above]
[See☐V [Explain why]
e. actuating video switches; ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
f. maintaining pressure and inspection for a minimum of ☐DEM ☐S ☐Other ☐RWM
30 seconds. ☐DA ☐CS
☐V ☐KAT
f. maintaining pressure and inspection for a minimum of ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
30 seconds. ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
11. When an endoscope fails a leak test, removes it from service ☐DEM ☐S ☐Other ☐RWM
and sends for repair or replacement per facility policy and ☐DA ☐CS
☐V ☐KAT
11. procedure.
When an endoscope fails a leak test, removes it from service ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
and sends for repair or replacement per facility policy and ☐V
☐Other
procedure.
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
Manual Cleaning ☐DEM ☐S ☐Other ☐RWM
12. Performs manual cleaning in accordance with the endoscope ☐DA ☐CS
☐V ☐KAT

180
manufacturer’s
Manual Cleaning IFU. ☐DEM
☐DO ☐S
☐SBT ☐RWM
☐P&P
12. Performs manual cleaning in accordance with the endoscope ☐V
☐Other
manufacturer’s IFU. ☐DO ☐SBT ☐P&P
☐DA ☐CS ☐KAT
13. Performs manual cleaning using the type of water and ☐DEM ☐S ☐Other ☐RWM
cleaning solution recommended by the endoscope ☐DA ☐CS
☐V ☐KAT
13. manufacturer.
Performs manual cleaning using the type of water and ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
cleaning solution recommended by the endoscope ☐V
☐Other
manufacturer.
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
14. Performs manual cleaning using a freshly prepared cleaning ☐DEM ☐S ☐Other ☐RWM
solution. ☐DA ☐CS
☐V ☐KAT
14. Performs manual cleaning using a freshly prepared cleaning ☐S ☐RWM
☐DO
☐DEM ☐SBT ☐P&P
solution. ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
☐Other
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 5 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 5 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
[See legend above] [Explain why]
Competency
15. Follows Statements/Performance
the cleaning solution manufacturer’s Criteria
IFU for ☐DEMVerification
☐S Method
☐RWM Not Met
a. water quality, hardness, and pH; legend above]
[See☐V [Explain why]
15. Follows the cleaning solution manufacturer’s IFU for ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
a. water quality, hardness, and pH; ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
b. concentration and dilution; ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT
b. concentration and dilution; ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
c. water temperature; ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT
c. water temperature; ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
d. contact time; ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT

181
d. contact time; ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
e. conditions of storage; ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT
e. conditions of storage; ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
f. use life and shelf life. ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT
f. use life and shelf life. ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
☐Other
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 6 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 6 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
[See legend above] [Explain why]
Competency
16. Completely Statements/Performance
submerges Criteria
the endoscope in the cleaning ☐DEMVerification
☐S Method
☐RWM Not Met
solution during the cleaning process. [See☐Vlegend above] [Explain why]
a. Detaches
16. Completely removable
submerges theparts (e.g., valves,
endoscope in thebuttons,
cleaningcaps) ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
solution the endoscope
fromduring the cleaning submerges them if
andprocess. ☐V
☐Other
a. recommended
Detaches removable endoscope
by theparts manufacturer’s
(e.g., valves, IFU.
buttons, caps)
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
from the endoscope and submerges them if
17. Cleans all exterior surfaces of the endoscope with a soft, ☐DEM ☐S ☐Other ☐RWM
recommended by the endoscope manufacturer’s IFU.lint-
free cloth or sponge saturated with the cleaning solution. ☐DA ☐CS
☐V ☐KAT
17. Cleans all exterior surfaces of the endoscope with a soft, lint- ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
free cloth or sponge saturated with the cleaning solution. ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
18. Cleans all accessible channels and the distal end of the ☐DEM ☐S
☐Other ☐RWM
endoscope with a cleaning brush of the length, width, and ☐DA ☐CS
☐V ☐KAT
18. material
Cleans allrecommended
accessible channels endoscope
by theand the distalmanufacturer.
end of the ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
endoscope with a cleaning brush of the length, width, and ☐V
☐Other
material recommended by the endoscope manufacturer.
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
19. Manually actuates the endoscope valves while cleaning. ☐DEM ☐Other
☐S ☐RWM
☐DA ☐CS
☐V ☐KAT

182
19. Manually actuates the endoscope valves while cleaning. ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
20. Cleans and brushes the elevator mechanism (if present) and ☐DEM ☐Other
☐S ☐RWM
the recesses surrounding it with a cleaning brush of the ☐DA ☐CS
☐V ☐KAT
20. length, width,
Cleans and and material
brushes recommended
the elevator mechanismby(ifthe endoscope
present) and ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
manufacturer.
the recesses surrounding it with a cleaning brush of the ☐V
☐Other
a. Raises
length, width, lowers
andand the elevator
material mechanism
recommended throughout
by the endoscope
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
the manual cleaning process.
manufacturer.
☐Other
a. Raises
21. Uses a cleanand lowers
brush the elevator
for each mechanism
endoscope cleaning.throughout ☐DEM ☐S ☐RWM
☐DA ☐CS ☐KAT
a. the manual
Visually cleaning
inspects process.
brushes and other items used to clean ☐V
21. Usesendoscope
a clean brushchannels before
for each endoscope does not use them
use andcleaning. ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
a. if the integrity
Visually inspects the brush
of brushes andorother cleaning
otheritems item
used is in
to clean ☐V
☐Other
question.
endoscope channels before use and does not use them
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
if the integrity of the brush or other cleaning item is in
☐Other
question.
☐DA ☐CS ☐KAT
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 7 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 7 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
[See legend above] [Explain why]
22. Brushes the accessible channels of the endoscope multiple ☐DEM ☐S ☐RWM
times until no debris appears on the brush. ☐V
a. Removes debris from the brush before the brush is
☐DO ☐SBT ☐P&P
retracted back through the channel and after each pass
☐Other
by swirling the brush in the cleaning solution and rinsing
it. ☐DA ☐CS ☐KAT
23. Flushes the channels of the endoscope with cleaning ☐DEM ☐S ☐RWM
solution. ☐V
☐DO ☐SBT ☐P&P
☐Other
☐DA ☐CS ☐KAT
24. Flushes and rinses the exterior surfaces of the endoscope ☐DEM ☐S ☐RWM
with tap water until all cleaning solution and residual debris ☐V
is removed.
☐DO ☐SBT ☐P&P
☐Other
☐DA ☐CS ☐KAT

183
25. Dries the exterior surfaces of the endoscope with a soft, lint- ☐DEM ☐S ☐RWM
free cloth or sponge and purges all channels with air. ☐V
☐DO ☐SBT ☐P&P
☐Other
☐DA ☐CS ☐KAT
26. Cleans, brushes, rinses, dries, and high-level disinfects or ☐DEM ☐S ☐RWM
sterilizes all reusable parts (e.g., valves, buttons, port covers, ☐V
tubing, water bottles), accessories (e.g., forceps) and
☐DO ☐SBT ☐P&P
cleaning implements (e.g., brushes, channel cleaning
☐Other
adapters).
☐DA ☐CS ☐KAT
a. High-level disinfects or sterilizes water and irrigation
bottles at least daily.
b. Does not allow any residual water or moisture to remain ☐DEM ☐S ☐RWM
in the water bottle assembly. ☐V
☐DO ☐SBT ☐P&P
☐Other
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 8 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
[See legend above] [Explain why]
Competency
c. Uses Statements/Performance
sterile water Criteria
to fill water and irrigation bottles. ☐DEMVerification
☐S Method
☐RWM Not Met
legend above]
[See☐V [Explain why]
c. Uses sterile water to fill water and irrigation bottles. ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
27. Discards single-use parts, accessories, and cleaning ☐DEM ☐S ☐Other ☐RWM
implements after each use and does not reprocess them. ☐DA ☐CS
☐V ☐KAT
27. Discards single-use parts, accessories, and cleaning ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
implements after each use and does not reprocess them. ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
Inspecting ☐DEM ☐S ☐Other ☐RWM
28. Visually inspects and evaluates endoscopes, accessories, and ☐DA ☐CS
☐V ☐KAT
equipment for
Inspecting ☐DEM
☐DO ☐S
☐SBT ☐RWM
☐P&P
a. cleanliness,
28. Visually inspects and evaluates endoscopes, accessories, and ☐V
☐Other
equipment for ☐DO ☐SBT ☐P&P
☐DA ☐CS ☐KAT
a. cleanliness,
b. missing parts, ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT

184
b. missing parts, ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
c. clarity of lenses, ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT
c. clarity of lenses, ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
d. integrity of seals and gaskets, ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT
d. integrity of seals and gaskets, ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
☐Other
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 9 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 9 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
[See legend above] [Explain why]
Competency Statements/Performance Criteria
e. moisture, ☐DEMVerification
☐S Method
☐RWM Not Met
legend above]
[See☐V [Explain why]
e. moisture, ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
f. physical or chemical damage, ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT
f. physical or chemical damage, ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
g. function. ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT
g. function. ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
29. Uses lighted magnification to inspect endoscopes and ☐DEM ☐S ☐Other ☐RWM
accessories for cleanliness and damage, as needed. ☐DA ☐CS
☐V ☐KAT

185
29. Uses lighted magnification to inspect endoscopes and ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
accessories for cleanliness and damage, as needed. ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
30. Removes defective endoscopes, accessories, and equipment ☐DEM ☐S ☐Other ☐RWM
from service and sends for repair or replacement per facility ☐DA ☐CS
☐V ☐KAT
Removes
30. policy anddefective endoscopes, accessories, and equipment
procedure. ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
from service and sends for repair or replacement per facility ☐V
☐Other
policy and procedure.
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
High-Level Disinfection or Sterilization ☐DEM ☐S ☐Other ☐RWM
31. Conducts mechanical or manual high-level disinfection or ☐DA ☐CS
☐V ☐KAT
sterilization
High-Level following mechanical
Disinfection cleaning as detailed in
or Sterilization ☐DEM
☐DO ☐S
☐SBT ☐RWM
☐P&P
Conducts
31. items mechanical
12-27 above . or manual high-level disinfection or ☐V
☐Other
sterilization following mechanical cleaning as detailed in ☐DO ☐SBT ☐P&P
☐DA ☐CS ☐KAT
items 12-27 above .
☐Other
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 10 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 10 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
[See legend above] [Explain why]
MechanicalCompetency
methodsStatements/Performance Criteria ☐DEMVerification
☐S Method
☐RWM Not Met
32. Checks the expiration date of the high-level disinfectant or [See☐Vlegend above] [Explain why]
liquid chemical
Mechanical sterilant before each use.
methods ☐DEM
☐DO ☐S
☐SBT ☐RWM
☐P&P
32. Checks the expiration date of the high-level disinfectant or ☐V
☐Other
liquid chemical sterilant before each use. ☐DO ☐SBT ☐P&P
☐DA ☐CS ☐KAT
33. Uses a test strip or other FDA-cleared testing device specific ☐DEM ☐S ☐Other ☐RWM
to the disinfectant or liquid chemical sterilant and minimum ☐DA ☐CS
☐V ☐KAT
Uses a test
33. effective concentration
strip or otherofFDA-cleared testing device
the active ingredient for specific ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
to the disinfectant
monitoring liquid chemical
solutionorpotency sterilant
before each use. and minimum ☐V
☐Other
effective concentration of the active ingredient for
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
monitoring solution potency before each use.
34. Performs mechanical processing in accordance with the ☐DEM ☐S ☐Other ☐RWM
endoscope manufacturer’s IFU and the mechanical processor ☐DA ☐CS
☐V ☐KAT
Performs mechanical
34. manufacturer’s IFU. processing in accordance with the ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
endoscope
a. Verifiesmanufacturer’s IFU and the mechanical
compatibility between endoscope and processor
the ☐V
☐Other
manufacturer’s
mechanicalIFU.processor before processing.
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
a. Verifies compatibility between the endoscope and the
b. Positions the endoscope and accessories within the ☐DEM ☐S ☐Other ☐RWM
mechanical processor before processing.
mechanical processor in a manner that ensures contact ☐DA ☐CS
☐V ☐KAT

186
Positions
b. of the endoscope
the processing and
solutions accessories
with all surfaceswithin the
of the ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
mechanical processor in a manner that ensures contact
endoscope. ☐V
☐Other
of the processing solutions with all surfaces of the
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
endoscope.
c. Ensures all connectors between the endoscope and the ☐DEM ☐S ☐Other ☐RWM
mechanical processor are connected correctly. ☐DA ☐CS
☐V ☐KAT
c. Ensures all connectors between the endoscope and the ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
mechanical processor are connected correctly. ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
d. Monitors the mechanical processing cycle to verify it is ☐DEM ☐S ☐Other ☐RWM
completed as programmed. ☐DA ☐CS
☐V ☐KAT
d. •Monitors
Repeatsthethemechanical processing
entire mechanical cyclecycle
if interrupted is
to verify itor ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
completed as programmed.
not completed as programmed. ☐V
☐Other
• Repeats the entire mechanical cycle if interrupted or
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
not completed as programmed.
☐Other
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 11 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 11 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
Competency Statements/Performance Criteria Verification
[See legendMethod
above] Not Met
[Explain why]
35. Performs mechanical processing using the cleaning, [See legend above] [Explain why]
☐DEM ☐S ☐RWM
Performs mechanical
35. disinfectant, processing
and sterilant using
solutions andthe cleaning,
chemicals ☐DEM ☐S ☐V ☐RWM
disinfectant,
recommended and
bysterilant solutions
the endoscope and chemicals
manufacturer and the ☐V
recommended by the endoscope manufacturer and the ☐DO ☐SBT ☐P&P
mechanical processor manufacturer. ☐DO ☐SBT ☐P&P
mechanical processor manufacturer. ☐Other
☐DA ☐Other
☐CS ☐KAT
36. Handles chemicals and solutions used for cleaning and ☐DA ☐CS ☐KAT
☐DEM ☐S ☐RWM
Handles chemicals
36. processing flexible and
endoscopes used
solutionsand for cleaning
endoscope and
accessories in ☐DEM ☐S ☐RWM
☐V
processing
accordanceflexible endoscopes
with local, state, andand endoscope
federal accessories
regulations and the in ☐V
accordance local, state, and federal regulations and the ☐DO ☐SBT ☐P&P
manufacturer’swithIFU.
☐DO ☐SBT
manufacturer’s ☐Other ☐P&P
a. Verbalizes IFU.
the location of the safety data sheets for ☐Other
a. chemicals the location
Verbalizes used for cleaning safety
of theand data sheets
processing for
flexible ☐DA ☐CS ☐KAT
chemicals used for cleaning and processing flexible ☐DA ☐CS ☐KAT
endoscopes.
endoscopes.
b. Verbalizes the location of the chemical spill kit. ☐DEM ☐S ☐RWM
b. Verbalizes the location of the chemical spill kit. ☐DEM ☐S ☐RWM
☐V
☐DO ☐V
☐SBT ☐P&P
☐DO ☐SBT
☐Other ☐P&P
☐DA ☐Other
☐CS ☐KAT

187
☐DA ☐CS ☐KAT
Manual methods ☐DEM ☐S ☐RWM
Manual
37. Checksmethods
the expiration date of the high-level disinfectant ☐DEM ☐S ☐V ☐RWM
37. before the expiration
Checks each use. date of the high-level disinfectant ☐V
☐DO ☐SBT ☐P&P
before each use. ☐DO ☐SBT
☐Other ☐P&P
☐DA ☐Other
☐CS ☐KAT
38. Uses a test strip or other FDA-cleared testing device specific ☐DA ☐CS ☐KAT
☐DEM ☐S ☐RWM
Uses
38. to thea disinfectant other
test strip or and FDA-cleared
minimum testing
effective device specific
concentration of ☐DEM ☐S ☐RWM
☐V
to
thethe disinfectant
active ingredientand
forminimum
monitoringeffective concentration
solution potency before of ☐V
the active ingredient for monitoring solution potency before ☐DO ☐SBT ☐P&P
each use. ☐DO ☐SBT ☐P&P
each use. ☐Other
☐DA ☐CS
☐Other ☐KAT
39. Completely immerses the endoscope in the high-level ☐DA ☐CS ☐KAT
☐DEM ☐S ☐RWM
Completely immerses
39. disinfectant solution for endoscope
thethe designated the high-level
in time according to the ☐DEM ☐V ☐S ☐RWM
disinfectant solution for
device and high-level the designated
disinfectant time according
manufacturer’s IFU. to the ☐V
device and high-level disinfectant manufacturer’s IFU. ☐DO ☐SBT ☐P&P
☐DO ☐SBT
☐Other ☐P&P
☐DA ☐CS
☐Other ☐KAT
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All
Adapted reserved.”
rights with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231. Page 12 of 18
All rights reserved.” Page 12 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
[See legend above] [Explain why]
Competency
40. Flushes Statements/Performance
and fills lumens Criteria
and ports with the high-level ☐DEMVerification
☐S Method
☐RWM Not Met
disinfectant, then completely immerses the items in the [See☐Vlegend above] [Explain why]
40. disinfectant solution
Flushes and fills lumens the designated
for and time.
ports with the high-level ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
disinfectant, then completely immerses the items in the ☐V
☐Other
disinfectant solution for the designated time.
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
41. Thoroughly rinses the endoscope and all of its channels and ☐DEM ☐S ☐Other ☐RWM
ports with water that meets the manufacturer’s ☐DA ☐CS
☐V ☐KAT
41. specifications
Thoroughly rinses recommended
or asthe endoscope and by professional
all of its channels and ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
organizations
ports with waterafter disinfection.
that meets the manufacturer’s ☐V
☐Other
specifications removable
a. Rinses all or as recommended
parts andbyendoscope
professionalaccessories.
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
organizations after disinfection.
required
Maya.beRinses for both mechanical
all removable and manual
parts and endoscope accessories. ☐DEM ☐S ☐Other ☐RWM
methods ☐DA ☐CS
☐V ☐KAT
May be required
42. Flushes endoscope both mechanical
for lumens with 70% toand
90%manual
ethyl or ☐DEM
☐DO ☐S
☐SBT ☐RWM
☐P&P
isopropyl alcohol according to the endoscope manufacturer’s
methods ☐V
☐Other
42. IFU.
Flushes endoscope lumens with 70% to 90% ethyl or ☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
isopropyl alcohol according to the endoscope manufacturer’s
43. Dries the exterior surfaces of the endoscope with a soft, lint- ☐DEM ☐S ☐Other ☐RWM
IFU.
free cloth or sponge. ☐DA ☐CS
☐V ☐KAT

188
a. Purges
43. Dries the endoscope
the exterior surfaces ofchannels
the endoscope
with air.with a soft, lint- ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
free cloth or sponge. ☐V
☐Other
a. Purges the endoscope channels with air.
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
b. Dries all removable parts and endoscope accessories. ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT
b. Dries all removable parts and endoscope accessories. ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
Sterilization ☐DEM ☐S ☐Other ☐RWM
44. Packages and sterilizes endoscopes and endoscope ☐DA ☐CS
☐V ☐KAT
accessories
Sterilization in accordance with the manufacturers’ IFU. ☐DO ☐S
☐DEM ☐SBT ☐RWM
☐P&P
44. Packages and sterilizes endoscopes and endoscope ☐V
☐Other
accessories in accordance with the manufacturers’ IFU. ☐DO ☐SBT ☐P&P
☐DA ☐CS ☐KAT
☐Other
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 13 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 13 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
[See legend above] [Explain why]
Storing Competency Statements/Performance Criteria ☐DEMVerification
☐S Method
☐RWM Not Met
45. Stores flexible endoscopes in accordance with the endoscope [See☐Vlegend above] [Explain why]
and storage cabinet manufacturers’ IFU.
Storing ☐DEM
☐DO ☐S
☐SBT ☐RWM
☐P&P
45. Stores
a. Does
flexible
not store
endoscopes
flexiblein
endoscopes
accordanceinwith
theirthe
original
endoscope ☐V
☐Other
and storage
shipment cabinet
cases.manufacturers’ IFU. ☐DO ☐SBT ☐P&P
☐DA ☐CS ☐KAT
a. Does not store flexible endoscopes in their original
b. Stores flexible endoscopes with all valves open and ☐DEM ☐S ☐Other ☐RWM
shipment cases.
removable parts detached, but stored with the ☐DA ☐CS
☐V ☐KAT
Stores flexible endoscopes with all valves open and
b. endoscope. ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
removable parts detached, but stored with the ☐V
☐Other
endoscope.
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
46. Wears clean, low-protein, powder-free, natural rubber latex ☐DEM ☐S ☐Other ☐RWM
gloves or latex-free gloves when handling processed ☐DA ☐CS
☐V ☐KAT
46. Wears
endoscopes low-protein,
clean,and powder-free,
when transporting themnatural
to andrubber latex
from the ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
storage latex-free gloves when handling processed
gloves orcabinet. ☐V
☐Other
endoscopes and when transporting them to and from the
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
storage cabinet.
47. Verbalizes facility-specific visual cue for identifying processed ☐DEM ☐S ☐Other ☐RWM
endoscopes. ☐DA ☐CS
☐V ☐KAT

189
47. Verbalizes facility-specific visual cue for identifying processed ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
endoscopes. ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
48. Visually inspects endoscopes and storage cabinets for ☐DEM ☐S ☐Other ☐RWM
cleanliness before placing endoscopes into or removing them ☐DA ☐CS
☐V ☐KAT
Visually
48. from theinspects
cabinet.endoscopes and storage cabinets for ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
cleanliness before placing endoscopes into or removing them ☐V
☐Other
from the cabinet.
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
49. Stores sterile items in a sterile storage area per facility policy ☐DEM ☐S ☐Other ☐RWM
and procedure. ☐DA ☐CS
☐V ☐KAT
49. Stores sterile items in a sterile storage area per facility policy ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
and procedure. ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
☐Other
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 14 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 14 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
[See legend above] [Explain why]
RecordingCompetency Statements/Performance Criteria ☐DEMVerification
☐S Method
☐RWM Not Met
50. Records the following processing information: [See
☐Vlegend above] [Explain why]
Recording
a. date and time, ☐DEM
☐DO ☐S
☐SBT ☐RWM
☐P&P
50. Records the following processing information: ☐V
☐Other
a. date and time, ☐DO ☐SBT ☐P&P
☐DA ☐CS ☐KAT
b. identity of endoscope and endoscope accessories, ☐DEM ☐Other
☐S ☐RWM
☐DA ☐CS ☐KAT
☐V
b. identity of endoscope and endoscope accessories, ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
c. method and verification of cleaning and results of ☐Other
☐DEM ☐S ☐RWM
cleaning verification testing, ☐DA ☐CS ☐KAT
☐V
c. method and verification of cleaning and results of ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
cleaning verification testing, ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
d. number or identifier of the mechanical processor or ☐Other
☐DEM ☐S ☐RWM
sterilizer and results of process efficacy testing, ☐DA ☐CS ☐KAT
☐V

190
d. number or identifier of the mechanical processor or ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
sterilizer and results of process efficacy testing, ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
e. identity of the persons performing the processing, ☐Other
☐DEM ☐S ☐RWM
☐DA ☐CS ☐KAT
☐V
e. identity of the persons performing the processing, ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
f. lot numbers of the processing solutions, ☐Other
☐DEM ☐S ☐RWM
☐DA ☐CS ☐KAT
☐V
f. lot numbers of the processing solutions, ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
☐Other
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 15 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 15 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
[See legend above] [Explain why]
Competency
g. disposition Statements/Performance
of defective Criteria
items or equipment, ☐DEMVerification
☐S Method
☐RWM Not Met
legend above]
[See☐V [Explain why]
g. disposition of defective items or equipment, ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
h. maintenance of water systems, endoscopes and ☐DEM ☐S ☐Other ☐RWM
endoscope accessories, and processing equipment. ☐DA ☐CS
☐V ☐KAT
h. maintenance of water systems, endoscopes and ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
endoscope accessories, and processing equipment. ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
51. Records the following procedural information: ☐DEM ☐S ☐Other ☐RWM
a. date and time, ☐DA ☐CS
☐V ☐KAT
51. Records the following procedural information: ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
a. date and time, ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
b. identity of the patient, ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT

191
b. identity of the patient, ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
c. procedure, ☐DEM ☐S ☐Other ☐RWM
☐DA ☐CS
☐V ☐KAT
c. procedure, ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
d. identity of the licensed independent practitioner ☐DEM ☐S ☐Other ☐RWM
performing the procedure, ☐DA ☐CS
☐V ☐KAT
d. identity of the licensed independent practitioner ☐S ☐RWM
☐DO
☐DEM ☐SBT ☐P&P
performing the procedure, ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
☐Other
☐DA ☐CS ☐KAT

Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 16 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 16 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
Competency Statements/Performance Criteria Verification Method Not Met
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
[See legend above] [Explain why]
Competency
e. identity of theStatements/Performance
endoscope and endoscopeCriteria
accessories ☐DEMVerification
☐S Method
☐RWM Not Met
used during the procedure. legend above]
[See☐V [Explain why]
e. identity of the endoscope and endoscope accessories ☐DEM ☐S ☐RWM
☐DO ☐SBT ☐P&P
used during the procedure. ☐V
☐Other
☐DO
☐DA ☐SBT
☐CS ☐P&P
☐KAT
☐Other
☐DA ☐CS ☐KAT

192
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 17 of 18
Adapted with permission from “Perioperative Competency Verification Tools and Job Descriptions. Copyright © 2016 AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved.” Page 17 of 18
 HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes
HICPAC Sample Competency Verification Tool: Reprocessing Flexible Endoscopes

This section to be completed by manager:

This section to be completed by manager:

The
The employee
employee named
named below
below has
has completed
completed facility-required
facility-required competency
competency verification
verification activities
activities related
related to
to reprocessing
reprocessing flexible
flexible endoscopes.
endoscopes.

Yes
Yes No
No (Incompletely
(Incompletely verified,
verified, see
see Action
Action Plan)
Plan)

Action Plan:
Action Plan:

Employee Name: Employee Signature: Date:

Employee Name:
Evaluator Name: Evaluator Signature:
Employee Signature: Date:
Date:

Manager
EvaluatorName:
Name: Manager
EvaluatorSignature:
Signature: Date:
Date:

Manager Name: Manager Signature: Date:

193
Available from: https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html

Available from: https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html

Adapted with permission from Perioperative Competency Verification Tools and Job Descriptions. AORN, Inc., 2170 South Parker Road, Suite 400, Denver, CO 80231.
All rights reserved. Page 18 of 18

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All rights reserved. Page 18 of 18
8.4
HICPAC Sample Audit Tool: Reprocessing Flexible Endoscopes
HICPAC Sample Audit Tool: Reprocessing Flexible Endoscopes
HICPAC Sample Audit Tool: Reprocessing Flexible Endoscopes
HICPAC Sample Audit Tool: Reprocessing Flexible Endoscopes
HICPAC Sample Audit Tool: Reprocessing Flexible Endoscopes
HICPAC Sample Audit Tool: Reprocessing Flexible Endoscopes
Purpose: Facilities can use this sample Audit Tool document as a template to develop their own audit tool
Purpose: Facilities can use this sample Audit Tool document as a template to develop their own audit tool
specific toFacilities
Purpose: their endoscopes andsample
can use this evidence-based
Audit Toolreprocessing
document aspractices.
a template This
to sample
developtool is own
their designed
auditto be
tool
specific to their endoscopes and evidence-based reprocessing practices. This sample tool is designed to be
used in conjunction
specific with theand
to their endoscopes Competency Verification
evidence-based Tool. Facilities
reprocessing are This
practices. encouraged to use
sample tool these tools
is designed to be
used in conjunction with the Competency Verification Tool. Facilities are encouraged to use these tools
together
used to verify competency
in conjunction and audit current
with the Competency practice
Verification as Facilities
Tool. well as toare
ensure that their
encouraged to practices
use theseare
tools
together to verify competency and audit current practice as well as to ensure that their practices are
consistenttowith
together “Essential
verify Elements
competency of a Reprocessing
and audit Program
current practice as wellfor
asFlexible Endoscopes
to ensure that their –practices
Recommendations
are of
consistent with “Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of
the Healthcare
consistent with Infection
“EssentialControl Practices
Elements Advisory Committee.”
of a Reprocessing Program for Flexible Endoscopes – Recommendations of
the Healthcare Infection Control Practices Advisory Committee.”
the Healthcare Infection Control Practices Advisory Committee.”
Auditor: Date:
Auditor: Date:
Auditor: Date:
Audit Item Yes No Comments/Action
Audit Item Yes No Comments/Action
Precleaning
Audit Item Yes No Comments/Action
Precleaning
Precleans the flexible endoscope at the point of use.
Precleaning
Precleans the flexible endoscope at the point of use.
Discards
Precleansthe thecleaning
flexible solution
endoscope andatcloth after use.
the point of use.
Discards the cleaning solution and cloth after use.
Transporting
Discards the cleaning solution and cloth after use.
Transporting
Transports
Transporting the contaminated endoscope and accessories to the
Transports the contaminated endoscope and accessories to the
endoscopy
Transports the processing room asendoscope
contaminated soon as possible after use.to the
and accessories
endoscopy processing room as soon as possible after use.
Ensures theprocessing
endoscopy container or room cartasis soon
labeled with a biohazard
as possible after use.legend.
Ensures the container or cart is labeled with a biohazard legend.
Leak Testing
Ensures the container or cart is labeled with a biohazard legend.
Leak Testing
Performs
Leak Testingleak testing before manual cleaning if indicated.
Performs leak testing before manual cleaning if indicated.
Manual Cleaning
Performs leak testing before manual cleaning if indicated.
Manual Cleaning
Uses a freshly
Manual Cleaning prepared cleaning solution and does not add
Uses a freshly prepared cleaning solution and does not add
additional products
Uses a freshly prepared to the water solution
cleaning unless recommended
and does not by addthe
additional
manufacturer. products to the water unless recommended by the
additional
manufacturer. products to the water unless recommended by the
Completely
manufacturer. submerges the endoscope and accessories.
Completely submerges the endoscope and accessories.
Cleans exterior
Completely surfacesthe
submerges of the endoscope
endoscope andwith a soft, lint-free
accessories.
Cleans
cloth orexterior
sponge. surfaces of the endoscope with a soft, lint-free
Cleans
cloth orexterior
sponge.surfaces of the endoscope with a soft, lint-free
Cleans
cloth orallsponge.
accessible channels and the end of the endoscope with a
Cleans all accessible
cleaningallbrush of thechannels and the
length, width, andend of the endoscope
material recommended withby
a
Cleans accessible channels and the end of the
cleaning brush of the length, width, and material recommended by endoscope with a
the endoscope manufacturer.
cleaning brush of the length, width, and material recommended by
the endoscope manufacturer.
Usesendoscope
the a clean brush for each endoscope cleaning.
manufacturer.
Uses a clean brush for each endoscope cleaning.
If
Uses a clean brush foraneach
the endoscope has elevator, raisescleaning.
endoscope and lowers the elevator
If the endoscope has an elevator, raises and lowers the elevator
throughout the manual cleaning process.
If the endoscope has an elevator, raises and lowers the elevator
throughout the manual cleaning process.
Brushes the the
throughout accessible
manualchannels
cleaning until no debris appears on the
process.
Brushes the accessible channels until no debris appears on the
brush.
Brushes the accessible channels until no debris appears on the
brush.
Removes debris before retracting the brush back through the
brush.
Removes debris before retracting the brush back through the
endoscope.
Removes debris before retracting the brush back through the
endoscope.
Flushes the channels of the endoscope with the cleaning solution.
endoscope.
Flushes the channels of the endoscope with the cleaning solution.
Manually
Flushes the actuates
channels theofvalves during thewith
the endoscope cleaning process.solution.
the cleaning
Manually actuates the valves during the cleaning process.
Flushes and
Manually rinses exterior
actuates the valves surfaces
duringand the internal
cleaningchannels
process. with
Flushes and rinses exterior surfaces and internal channels with
water until all cleaning solution and residual
Flushes and rinses exterior surfaces and internal channels debris is removed.
with
water until all cleaning solution and residual debris is removed.
Dries
water until all cleaning solution and residual debris is removed.and
exterior surfaces and removable parts of the endoscope
Dries exterior surfaces and removable parts of the endoscope and
purgesexterior
Dries all channels withand
surfaces air.removable parts of the endoscope and
purges all channels with air.
Reprocesses
purges all channels with air. accessories, and cleaning implements
reusable parts,
Reprocesses reusable parts, accessories, and cleaning implements
according to reusable
Reprocesses the manufacturer’s instructions
parts, accessories, and for use (IFU).
cleaning implements
according to the manufacturer’s instructions for use (IFU).
Disposes of single-use parts, accessories, and
according to the manufacturer’s instructions for use (IFU). cleaning implements.
Disposes of single-use parts, accessories, and cleaning implements.
Disposes of single-use parts, accessories, and cleaning implements.
Adapted with permission from Guideline Essentials. Copyright © 2016, AORN, Inc, 2170 S. Parker Road, Suite 400, Denver, CO 80231.
Adapted
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HICPAC Sample Audit Tool: Reprocessing Flexible Endoscopes

Audit Item Yes No Comments/Action

Inspection
Inspects and evaluates endoscopes and accessories for
• cleanliness
• missing parts
• clarity of lenses
• integrity of seals and gaskets
• physical or chemical damage
• moisture
• function
Uses additional illumination and magnification for inspection, as
needed.
High-level Disinfection or Sterilization
Manually cleans the endoscope and accessories before mechanical
or manual high-level disinfection or sterilization.
Mechanical methods
Checks the expiration date of the high-level disinfectant or liquid
chemical sterilant before each use.
Uses a test strip or other FDA-cleared testing device specific to the
disinfectant or liquid chemical sterilant and minimum effective
concentration of the active ingredient for monitoring solution
potency before each use.
Positions endoscopes and accessories within the mechanical
processor to ensure contact of the processing solutions with all
surfaces of the endoscope.
Connects the endoscope to the mechanical processor correctly.
Verifies mechanical processing cycles are completed as
programmed.
Manual methods
Checks the expiration date of the high-level disinfectant before
each use.
Uses a test strip or other FDA-cleared testing device specific to the
disinfectant and minimum effective concentration of the active
ingredient for monitoring solution potency before each use.
Flushes and fills lumens and ports with the high-level disinfectant.
Completely immerses the endoscope in the high-level disinfectant
solution for the designated time according to the device and high-
level disinfectant solution manufacturer’s IFU.
Rinses the endoscope with water that meets the manufacturer’s
specification or as recommended by professional organizations
after disinfection.
May be required for both mechanical and manual methods
Flushes lumens using 70% to 90% ethyl or isopropyl alcohol
according to the endoscope manufacturer’s IFU.
Dries exterior surfaces and removable parts of the endoscope and
purges all channels with air.

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195
HICPAC Sample Audit Tool: Reprocessing Flexible Endoscopes

Audit Item Yes No Comments/Action

Sterilization
Packages and sterilizes endoscopic accessories that enter sterile
tissue or the vascular system per the health care facility’s policy
and procedure.
Storage
Wears clean gloves when transporting the endoscope to and from
the storage cabinet.
Based on the cabinet design, stores flexible endoscopes
horizontally or hangs them vertically so they do not coil or touch
the floor of the cabinet.
Stores the flexible endoscope with all valves open and removable
parts detached.
Stores sterile items in a sterile storage area.
Records
Processing records include
• date and time
• identity of endoscope and endoscope accessories
• method and verification of cleaning and results of cleaning
verification testing
• number or identifier of the mechanical processor or sterilizer
and results of process efficacy testing
• identity of the persons performing the processing
• lot numbers of the processing solutions
• disposition of defective items or equipment
• maintenance of water systems, endoscopes and endoscope
accessories, and processing equipment
Procedural records include
• date and time
• identity of the patient
• procedure
• identity of the licensed independent practitioner performing
the procedure
• identity of the endoscope and endoscope accessories used

Available from: https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html

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 AUTOCLAVE BIOLOGICAL INDICATOR (BI) TEST RESULTS LOG
Autoclave Location: Building / Room______________ Autoclave Model & Make____________________ ID #____________________
8.5
Biological Indicator Product Used:______________________ Contact Person___________________________

POSITIVE STERILITY
DATE TECH B.I. B.I. LOAD CYCLE TYPE RUN CONTROL TEST CORRECTIVE ACTION /
(Initials) LOT # EXPIRE # TESTED TIME COLOR COLOR COMMENTS
DATE (min) CHANGE? CHANGE?
(+/-) (+ / - )
PRE
LIQ SOL
VAC 24 hr 48 hr

197
THIS DOCUMENTATION MUST BE KEPT FOR 3 YEARS FROM DATE OF USE
Virginia Tech EHSS Form (04-08)
Autoclave BI Test Results Log
8.6 American Journal of Infection Control 41 (2013) 1188-94

Contents lists available at ScienceDirect

American Journal of Infection Control American Journal of

Infection Control

journal homepage: www.ajicjournal.org

Major article

Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg

Alexandra M. Dirlam Langlay PhD a, Cori L. Ofstead MSPH a, *, Natalie J. Mueller MPH a,
Pritish K. Tosh MD b, Todd H. Baron MD c, Harry P. Wetzler MD, MSPH a
a
Ofstead & Associates, Inc, Saint Paul, MN
b
Division of Infectious Diseases, Mayo Clinic, Rochester, MN
c
Division of Gastroenterology & Hepatology, Mayo Clinic, Rochester, MN

Key Words: Background: Most cases of microbial transmission to patients via contaminated endoscopes have
Instrument cleaning resulted from nonadherence to reprocessing guidelines. We evaluated the occurrence, features, and
Guideline adherence implications of reprocessing lapses to gauge the nature and breadth of the problem in the context of
High-level disinfection
widely available and accepted practice guidelines.
Epidemiology
Methods: We examined peer-reviewed and non-peer-reviewed literature to identify lapses reported in
Colonoscopy
Multidrug-resistant organisms North America during 2005 to 2012 resulting in patient exposure to potentially contaminated gastro-
Infection intestinal endoscopes.
Results: Lapses occurred in various types of facilities and involved errors in all major steps of reproc-
essing. Each lapse continued for several months or years until the problem was discovered except for one
that was described as a single incident. There were significant implications for patients, including
notification and testing, microbial transmission, and increased morbidity and mortality. Only 1 reproc-
essing lapse was found in a peer-reviewed journal article, and other incidents were reported in
governmental reports, legal documents, conference abstracts, and media reports.
Conclusion: Reprocessing lapses are an ongoing and widespread problem despite the existence of
guidelines. Lack of publication in peer-reviewed literature contributes to the perception that lapses are
rare and inconsequential. Reporting requirements and epidemiologic investigations are needed to
develop better evidence-based policies and practices.
Copyright  2013 by the Association for Professionals in Infection Control and Epidemiology, Inc.
Published by Elsevier Inc. All rights reserved.

Gastrointestinal (GI) endoscopes are used in bodily cavities that Guideline nonadherence led to the use of improperly reproc-
are heavily colonized with microorganisms.1 Proper endoscope essed endoscopes at Veterans Affairs (VA) medical facilities in
reprocessing, including thorough cleaning and high-level disin- Tennessee, Florida, and Georgia between 2003 and 2009, requiring
fection (HLD), is necessary between patients to minimize the risk notification of over 10,000 patients.5,6 Other reprocessing lapses
of cross contamination.1 Reprocessing guidelines for fiberoptic (“lapses”) have come to light following investigations into facilities’
endoscopes were first published in 1978.2 Since then, governmental practices.5-8 In 2008, the United States Centers for Medicare and
and professional organizations have updated them and developed Medicaid Services (CMS) conducted unannounced inspections of
new guidelines for reprocessing specific types of endoscopes.1,3,4 infection control practices at 68 ambulatory surgical centers, over
half of which performed endoscopies.7 Among these facilities, 39
had deficiencies in infection control serious enough to warrant
* Address correspondence to Cori L. Ofstead, MSPH, Ofstead & Associates, Inc, 400 citation, and 19 failed to properly reprocess instruments. In 2010,
Selby Avenue, Suite V, Blair Arcade West, Saint Paul, MN 55102.
an observational, multisite study revealed that only 48% of 183 GI
E-mail address: [email protected] (C.L. Ofstead).
Ofstead & Associates, Inc. has received funding from Johnson & Johnson and 3M endoscopes were properly reprocessed, even though managers at
Company for infection prevention studies. Research reported here was supported all sites asserted institutional adherence to guidelines and reproc-
with internal resources from Ofstead and Mayo Clinic. Outside corporations did not essing personnel were aware of being observed.8 Nonadherence
have access to data and were not involved in manuscript preparation. was particularly high (99%) when manual methods were used to
Conflicts of interest: C.L.O. has received honoraria from Johnson & Johnson
and 3M Company for speaking engagements related to instrument reprocessing.
clean endoscopes.8
A.M.D.L., C.L.O., N.J.M., and H.P.W. are employed by Ofstead & Associates, Inc. The A study conducted at Beth Israel Deaconess Medical Center and
remaining authors disclose no conflicts. Harvard Medical School found that GI endoscopy-associated

0196-6553/$36.00 - Copyright  2013 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.
http://dx.doi.org/10.1016/j.ajic.2013.04.022
198
 A.M. Dirlam Langlay et al. / American Journal of Infection Control 41 (2013) 1188-94 1189

complications resulting in an emergency department visit or hos- (Table 2). Individual government documents and certain media
pitalization occurred after approximately 1% of 18,015 outpatient reports described lapses at multiple health care facilities, including
procedures, including screening colonoscopies.9 Complications 4 reports published by state agencies (Table 2).17-20
included fever and other potential signs of infection. Other res- Following the well-publicized lapses at 3 VA medical facilities,
earchers have reported numerous cases of postendoscopy infection unannounced inspections of 36 VA medical facilities with 38
associated with endoscope contamination, including transmission reprocessing units for colonoscopes were conducted by the VAOIG
of multidrug-resistant organisms (MDROs).2,10-12 Although the risk in 2009.5 Among these units, 52.6% were found to have inadequate
of infection following endoscopy is stated to be extremely remote standard operating procedures or documentation of demonstrated
by nearly all major guidelines including the 2008 Centers for staff competence for reprocessing (Table 2). Since then, the VAOIG
Disease Control and Prevention/Healthcare Infection Control Prac- has continued to monitor facilities and publish reviews that indicate
tices Advisory Committee (CDC/HICPAC) Guideline for Disinfection whether processes are in place to ensure effective reprocessing.
and Sterilization in Healthcare Facilities and the 2011 Multisociety These recent reviews described additional lapses in the reprocessing
Guideline on Reprocessing Flexible GI Endoscopes,1,4 existing risk of reusable medical equipment, including GI endoscopes.
estimates were recently found to be outdated, inaccurate, based on Lapses were also readily identifiable in the FDA’s Manufacturer
flawed methods, and too low.13 and User Facility Device Experience (MAUDE) database, which
Since the introduction of reprocessing guidelines, there have consists of adverse event reports involving medical devices. These
been increases in the volume of endoscopic procedures, the are voluntary reports or other reports submitted by device manu-
complexity of endoscope design, and the economic pressures on facturers, distributors, and health care facilities, typically following
institutions. Given the current challenges, we evaluated the device malfunction or incidents resulting in serious patient injury
occurrence, features, and implications of recently reported lapses. or death. Recent MAUDE reports described postendoscopy com-
plications, including infections or chemical colitis, attributed to
METHODS reprocessing errors or defective equipment that was undetected
prior to patient use. When the FDA reviewed MAUDE reports on
Searches for scientific, peer-reviewed journal articles describing endoscopes filed between January 1, 2007, and May 11, 2010, the
lapses were conducted via PubMed. Internet searches were per- agency found 80 reports of lapses and 28 reports of infection
formed to identify lapses published in media reports, including possibly because of inadequate reprocessing (Table 2).21 Supple-
newspapers, magazines, press releases, or other articles. Govern- mental data and references documenting lapses described in
ment Web sites and reports were also reviewed, including sources MAUDE and VAOIG reports are available from the authors on
from state departments of health, the Department of Veterans request.
Affairs Office of Inspector General (VAOIG), CDC’s Epidemic Intel-
ligence Service, and the Food and Drug Administration (FDA). Duration and nature of errors
Whenever possible, multiple sources were obtained to compile
information about a lapse because individual documents often Reports described errors in each of the major reprocessing steps,
contained incomplete information. whereas general noncompliance with guidelines and manufacturer
We sought to identify lapses reported between January 2005 protocols was also cited. Steps were skipped or done improperly for
and June 2012 in North America. Reports that met these search entire endoscopes as well as for certain channels (Tables 1 and 2).
parameters and described a lapse resulting in patient exposure Only 1 lapse was described as a single incident,22 whereas multiple
to a potentially contaminated GI endoscope were included. Lap- lapses continued for several years, exposing numerous patients to
ses were defined as any incident involving 1 or more reprocessing potentially contaminated endoscopes.23-27 In some cases, the lapse
errors resulting in the exposure of 1 or more patients. Errors duration was unknown, either because it was not disclosed or
included nonadherence to cleaning and disinfection guidelines, because investigators were unable to determine when the prob-
improper use of reprocessing equipment, or inadequate standard lems started.28,29
operating procedures or staff competence records for reproces- Many lapses were identified as a result of surveillance or
sing. Endoscopes under consideration included colonoscopes, inspections. The single lapse reported in a peer-reviewed journal
gastroscopes, duodenoscopes (eg, endoscopic retrograde chol- was discovered during surveillance for deviations from reprocess-
angiopancreatography endoscopes), and endoscopes not other- ing protocols.16 Government reports also described improper
wise specified. reprocessing practices identified through inspections or mandatory
adverse event reports.17,18 Generally, states having multiple lapses,
RESULTS such as Pennsylvania, New Jersey, and California, had mandatory
patient safety reporting requirements, whereas other states may
Geographic and facility spread not gather data or publicly report lapses.
Improper cleaning occurred on multiple occasions, and
Reported lapses occurred with various GI endoscopes and employees detected visually apparent residual matter on endo-
procedures at health care facilities throughout the United States scopes during several of these lapses.18,30-34 At 3 hospitals, residue
and Canada (Tables 1 and 2). Public and private facilities, including on duodenoscopes was associated with bacterial infections.31,34 At
hospitals, medical centers from large health systems, outpatient one of the hospitals, guidelines were violated over a period of 20
endoscopy centers, and outpatient surgical centers were involved months when contaminated duodenoscopes were allowed to dry
(Tables 1 and 2). In some cases, multiple facilities within the same before cleaning.30,35 MAUDE reports described multiple lapses
health system were implicated.5,14,15 involving detection of debris or residue in various endoscope
channels or components. Other lapses described in MAUDE reports
Sources of reports involved broken cleaning brushes that were left in endoscopes and
found during subsequent procedures, occasionally after being
Among the lapses identified, only 1 was published in a peer- expelled into patients.
reviewed journal,16 whereas all others were described in media Errors in disinfection often involved lack of HLD for entire endo-
reports and related sources (Table 1) or government reports scopes or certain channels.16,18,19,23,36-39 For example, endoscopes at

199
 1190

Table 1
Lapses published in media reports and related sources: North America, January 2005-June 2012

Estimated patients
Estimated
duration Tested
Type of health care facility Location Pub. Year Type of endoscope Errors of lapse Exposed Notified Tested positive Microorganisms found
Private hospital32,33 North Carolina 2012 GI endoscope NOS No cleaning or sterilization 5 months 10 Yes Yes (viral) ND ND
for 1 channel
Outpatient endoscopy Ontario 2011; 2012 GI endoscope NOS Multiple reprocessing 9 years 6,800 Yes Yes (viral) 408 Hepatitis B;
clinic26,71-73 and chemical issues hepatitis C
Academic medical center36,74 Louisiana 2011 GI endoscope NOS No HLD 8 months 222 Yes Yes (viral) ND ND
Private medical center38,75,76 Oregon 2011 Colonoscope No HLD ND 18 Yes Yes (viral) ND ND
Academic medical center77-79 Louisiana 2011 GI endoscope NOS Inadequate HLD temperature 8 weeks 360 Yes Yes (viral) ND ND
Public hospital30,31,35,80 British Columbia 2010; 2011 Duodenoscope Improper reprocessing; Endoscopes 20 months 536 Yes Yes (viral) 11 Pseudomonas;
allowed to dry before cleaning hepatitis C*; HIV*
Public hospital and academic Minnesota 2010 GI endoscope NOS Improper HLD of 1 channel 3 years 2,600 Yes No ND ND
medical center23,81
Private medical center, California 2010 Colonoscope Improper HLD; Expired disinfectant 16 months 3,400 Yes Yes (viral) ND ND
hospital, and outpatient
surgery center14,82,83
Private hospital24 Pennsylvania 2010 GI endoscope NOS Improper HLD of 1 channel 5 years 75 Yes Yes ND ND
Public hospital27,39,84 British Columbia 2010 Colonoscope; No HLD for 1 channel 28 months 9,000 Yes No ND ND
Gastroscope
Two county hospitals and Florida 2009; 2010 Duodenoscope Improper cleaning of elevator 8 months 191 Yes Yes 13 Klebsiella pneumoniae

200
a regional cancer treatment channel (carbapenemase-producing);
center34,54,56 Escherichia coli
(carbapenemase-producing);
Pseudomonas aeruginosa;
Proteus mirabilis; Serratia
Outpatient surgery Georgia 2009; 2010 Colonoscope Inadequate HLD time 17 months 1,300 Yes Yes ND ND
center41,85,86
Public hospital44,46 Newfoundland 2009 GI endoscope NOS Inadequate disinfectant amount; 17 months 2,900 ND ND ND ND
and Labrador AER malfunction
42,87
Outpatient surgery center Nevada 2008; 2009 GI endoscope NOS Inadequate HLD time 2 years ND Yes Yes ND ND
GI facility NOS22 U.S. NOS 2008 Colonoscope Improper storage of contaminated, Single incident 1 ND ND ND ND
damaged endoscope
Staphylococcus aureus
A.M. Dirlam Langlay et al. / American Journal of Infection Control 41 (2013) 1188-94

Public hospital25,50,52,88,89 Alberta 2007; 2008 Endoscope NOS Improper cleaning and HLD; 4 years 2,872 (300 due to Yes Yes (viral) ND
No disassembly endo-scopes) (methicillin-resistant)
Two private hospitals15,90,91 California 2006 Gastroscope Improper reprocessing >1 year 305 Yes Yes ND ND
Private hospital92 West Virginia 2006 Endoscope NOS Improper HLD 19 months “100s” Yes ND ND ND
Private hospital37,93 Pennsylvania 2005 Colonoscope No HLD of auxiliary channels 4 months 200 Yes Yes (viral) ND ND
Private hospital94 Virginia 2005 GI endoscope NOS Inadequate HLD time 10 days 144 Yes Yes (viral) ND ND
Private hospital28,95 California 2005 GI endoscope NOS Multiple equipment and ND 2,116 Yes Yes (viral) ND ND
operator issues

AER, automated endoscope reprocessor; GI, gastrointestinal; HLD, high-level disinfection; ND, not disclosed; NOS, not otherwise specified.
*Indicates previously identified cases that tested positive.
 A.M. Dirlam Langlay et al. / American Journal of Infection Control 41 (2013) 1188-94 1191

a large medical center received no HLD during an 8-month

procedures or documentation of staff

incompletely reprocessed endoscope
period.36,40 At another large center, HLD was not performed

Improper sterilization and reassembly

Reprocessing a single-use device;

Improper reprocessing; Unchanged

documentation; Knowingly used

on an endoscope channel for nearly 3 years because of

Used improper AER connector;

misinformation from the manufacturer.23 MAUDE reports dis-

competence for reprocessing

Inadequate standard operating
water and cleaning solution
Improper cleaning, HLD, and
Improper cleaning and HLD;
cussed incorrect connectors used to attach endoscopes to

Inadequate staff training

automated endoscope reprocessors (AERs) or flushing aids,
Inadequate reprocessing
Errors

resulting in no HLD of certain channels. Other failures involved

inadequate HLD time or temperature41-43 and errors in disin-
fectant concentration or water quality during reprocess-
ing.14,44,45 At 1 hospital, only 25% of the required amount of
disinfectant was used over a period of 17 months.46 Expired
disinfectant was used for over 1 year at each of 4 other
facilities.14,47 In addition, 1 MAUDE report described a lapse

AER, automated endoscope reprocessor; GI, gastrointestinal; NA, not applicable; ND, not disclosed; NOS, not otherwise specified; VAOIG, Veterans Affairs Office of Inspector General.
where water was used in place of disinfectant, and problems
Gastroscope; Upper GI endoscope;

with endoscope flushing or rinsing were found when residual

chemicals caused chemical colitis.
Gastroscope; Endoscope NOS;
Colonoscope; Endoscope NOS
Colonoscope; Duodenoscope;
Type of endoscope

Improper endoscope storage was also reported.22 One lapse

involved patient exposure to a damaged, contaminated colono-
Non-GI endoscopes

Non-GI endoscopes

scope that was hung unlabeled in a cabinet with clean endo-

GI endoscope NOS

scopes.22 Other errors involved equipment problems, including

Endoscope NOS

AER malfunction or incorrect programming.46,48 In some cases,

Colonoscope

inadequate staff training was recognized as an underlying prob-

lem.5,49 VAOIG investigations revealed insufficient documentation
NOTE. Supplemental data and references documenting lapses described in MAUDE and VAOIG reports are available from the authors on request.

of staff competency at several VA medical centers.5 One state

agency reported receiving 3 notifications when staff knowingly
Pub. Year

used incompletely reprocessed endoscopes on patients.18

Certain individual lapses involved multiple reprocessing
2011
2012

2010
2011

2009

2007

errors.26,30,31,50 At 1 private endoscopy clinic, reprocessing errors

involved expired chemicals, inadequate cleaning and HLD, and
CA Department of Health Services

cross contamination of clean and dirty endoscopes.26,51 At a large

NJ Health Care Quality Institute

general hospital, failure to preclean duodenoscopes contributed to

PA Patient Safety Authority
Reporting agency
MN Department of Health

problems cleaning them.31,35 Multiple cleaning and HLD errors also

occurred at another general hospital.25,50,52

Effects on patient safety

The impact of lapses on patient safety was a focus of media

VAOIG

reports, but not the peer-reviewed journal article or government

FDA

reports, with the exception of MAUDE reports. Lapses discussed in

the media typically involved exposure and notification of hundreds
Multiple US states

of patients, and several lapses involved more than 1,000 patients

Locations

Pennsylvania

(Table 1). Patient notification often recommended testing for

New Jersey
Lapses published in government reports: North America, January 2005-June 2012

Minnesota

California

infection transmission; however, testing was typically done only

US NOS

for viruses such as HIV, hepatitis B, and hepatitis C rather than for
enteric pathogens. In 1 lapse at a single provider’s clinic, 6,800
patients were exposed to potentially contaminated GI endoscopes
7 lapses; 5 facilities
No. with lapses

and offered only viral testing.26 In 2 other lapses, thousands of

20 units

patients treated at large medical facilities were notified about the

Health care facilities

80*

62*
3

lapse but not tested.23,53 In each instance, national health author-

ities had asserted the risk of disease transmission was too low to
warrant testing.23,53
Microorganisms were reported to have been transmitted by
36 facilities;
38 units

contaminated endoscopes.31,34 Various types of microorganisms

inspected
Total No.

107*
NA

NA

NA

and occasionally multiple species were detected, including viruses

91

and bacteria (Table 1). Pseudomonas spp was most common, and
other bacterial pathogens included Serratia spp, Proteus mirabilis,
1 outpatient surgery center;

and Clostridium difficile (Table 1). One MAUDE report described 9

Type of health care facility

Outpatient surgery centers

and surgical practices17

patients who acquired C difficile after undergoing procedures with

Veterans Affairs medical
1 outpatient clinic;

an endoscope that was found to have retained debris. Multidrug-

resistant bacteria, including methicillin-resistant Staphylococcus
5 hospitals20,96

*Indicates reports.

aureus (MRSA) and Klebsiella pneumoniae carbapanemase (KPC)-

facilities5

Hospitals19

producing Klebsiella pneumoniae and Escherichia coli, were detected

following 2 lapses.25,34 One of these lapses involving a contami-
Table 2

ND21

ND18

nated duodenoscope resulted in 13 cases of multidrug-resistant K

pneumoniae among 191 endoscopy patients, indicating a 7% attack

201
1192 A.M. Dirlam Langlay et al. / American Journal of Infection Control 41 (2013) 1188-94

rate.34,54 Two other lapses were associated with patients who causing extraintestinal infection. Endoscopies with contaminated
tested positive for viruses. In 1 instance, 408 of 4,353 exposed devices may place patients at high risk for acquiring MDROs
patients who underwent laboratory testing for bloodborne patho- because bowel preparation alters colonic microflora,69,70 thereby
gens tested positive for hepatitis B or C, including previously reducing patient resistance to colonization with MDROs.
undiagnosed cases and 20 cases of active infection.26,55 Viral At present, there is no central repository for reports on lapses
transmission was attributed to patient lifestyles, yet reports did not and no requirement that local or federal officials maintain records
provide substantiating data to rule out transmission from con- or make them available to clinicians, researchers, or policy makers.
taminated endoscopes.26 In the other instance, 10 patients tested Exposed patients are not routinely recalled for testing because the
positive for hepatitis C and HIV after exposure to a contaminated health risks are assumed to be very low.23,27 This leads to a vicious
duodenoscope; however, these cases had been previously diag- cycle whereby institutions do not notify or test patients when
nosed.55 Nonetheless, these reports revealed that numerous a lapse is discovered because decision makers rely on erroneous
patients were exposed to improperly reprocessed endoscopes that risk estimates that have been propagated in the guidelines.
had been previously used on patients with viral infections. Mandatory reporting of lapses to a national registry would support
Several lapses were associated with serious patient injury. epidemiologic review and investigation and the consideration of
On multiple occasions, reprocessing chemicals remaining in endo- new policies based on sound data.
scopes caused colitis in exposed patients. MAUDE reports described Adherence to reprocessing guidelines needs to be improved.8 In
a variety of patient complications after exposure to contaminated a multisite study that revealed poor adherence, staff reported that
endoscopes, including abdominal pain, inflammation, and bacter- they did not like to do various reprocessing tasks, felt pressure to
emia. In other instances, patients who tested positive for microor- work quickly, and attributed health problems to working with
ganisms after a lapse required treatment and hospitalization.31,56 At endoscopes.8 The link between reprocessing errors and factors that
1 hospital, an ill patient who had undergone endoscopy with may influence health care worker behavior suggests that training
a contaminated duodenoscope was hospitalized with a Pseudo- and competency testing need to be supplemented with account-
monas infection.31 The patient died soon after acquiring the infec- ability measures and active surveillance of reprocessing effective-
tion as a result of the preexisting illness.31 Following another lapse, ness so that contaminated endoscopes can be identified before they
patients who underwent endoscopies and acquired multidrug- are used on patients.
resistant K pneumoniae were found to have longer hospital stays
and 5 times higher mortality than other patients.34,54,56 Limitations

DISCUSSION Because of the lack of a central repository or peer-reviewed

journal articles describing lapses, ad hoc searches of media,
By looking beyond peer-reviewed literature for evidence, we government reports, and other online sources were used to identify
identified numerous recent reprocessing lapses in North America, them. Even when multiple reports on individual lapses were
including several that were associated with patient infection, injury, available, the information was frequently incomplete and difficult
or death.21,31,34,56 Recent lapses have also been reported in other to interpret. Thus, the results of this review may not be generaliz-
countries,10,11,57-61 indicating that improper reprocessing is wide- able. Furthermore, the information provided in media and
spread and continues to occur despite the existence of reprocessing government reports was neither scrutinized by peer reviewers nor
guidelines. Other researchers have acknowledged that most lapses edited for technical accuracy or clarity of communication. Data
never get publicly reported.2,6 Reluctance by institutions to report were sometimes reported using potentially inaccurate terms (eg,
lapses may contribute to the lack of peer-reviewed articles sterilization rather than HLD).
describing them. In addition, some journals do not publish case
reports.62,63 Lack of reporting in peer-reviewed journals contributes Conclusion
to the perception that lapses are rare and inconsequential.
Current endoscopy-associated infection (EAI) risk estimates are Improper endoscope reprocessing is an ongoing and pervasive
erroneously based on the number of infections reported in peer- problem that has the potential to cause significant patient harm.
reviewed articles.13 As a result, numerous experts and organiza- Reprocessing guidelines should be revised to reflect the true risk of
tions have asserted the risk of EAI is virtually nonexistent.1,3,4,12 Based transmitting infections, including enteric pathogens and MDROs,
on existing estimates, fewer than a dozen EAIs would be expected to when lapses occur. These revisions will require additional research
occur each year in the United States. However, multiple cases of EAI because the magnitude of risk associated with particular types of
resulting from individual lapses have exceeded these estimates, lapses is unknown. As such, there is a need for a central repository
indicating current estimates are inaccurate and far too low.13 of data pertaining to lapses and associated outcomes. Infection
Researchers have identified retained debris in lumened instru- preventionists should recognize risks associated with improper
ments, including endoscopes, as a result of inadequate reprocessing reprocessing and continuously evaluate reprocessing effectiveness
and complex device design.64,65 A recent study found that protein to ensure that endoscopes are clean and disinfected prior to use on
residue and water remained on endoscope channels even after every patient.
thorough cleaning.66 Studies by Alfa et al found that 14% of patient-
ready GI endoscopes had bacterial or fungal growth67 and that up Acknowledgment
to 19% of manually cleaned channels tested positive for protein,
hemoglobin, or carbohydrates.68 Detailed outbreak investigations The authors thank Jeremy Ward and Lisa Mattson for the
have implicated endoscopes as likely sources of microbial trans- research, editorial, and logistical assistance provided.
mission.10,11,31,34,64 Matching strains of MDROs were collected from
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for-trial-over-alleged-failure-to-disinfect-colonoscope.html. Accessed April 96. Lynfield R, Harper J. Inadequate endoscope reprocessing. St Paul [MN]: Min-
29, 2011. nesota Department of Health; 2012.

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8.7 American Journal of Infection Control 47 (2019) A58−A61

Contents lists available at ScienceDirect

American Journal of Infection Control

journal homepage: www.ajicjournal.org

State of the Science Review

Special problems associated with reprocessing instruments in outpatient

care facilities: Physical spaces, education, infection preventionists,
industry, reflections
Judie Bringhurst MSN, RN, CIC *
Department of Hospital Epidemiology, UNC Hospitals, Chapel Hill, NC

Key Words: The infection preventionists’ (IPs’) presence and intervention in outpatient facilities continues to lag behind
High-level disinfection the inpatient hospital IPs’ presence. Additionally, in an outpatient world that is heavy on instrument reproc-
HLD essing, IPs must be prepared to assess instrument reprocessing practices, including high-level disinfection
Sterilization and sterilization to keep our patients and staffs safe. This paper presents 3 problems associated with instru-
Ambulatory care
ment reprocessing practices in health care facilities, with a special emphasis on outpatient facilities: physical
Clinics
space problems, training and education problems, and lack of IPs’ presence. We offer solutions and mitigation
Counter-top sterilizers
strategies for these 3 problems. We also give some reflections on the current state of IP presence and respon-
sibilities, and industry responsibilities, and we call for robust partnerships between IPs and the instrument
reprocessing industry.
© 2019 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All
rights reserved.

In the United States, more patients obtain health care in specialty In 2013, Kovaleva et al4 reported on transmission of infections via
clinics, ambulatory surgery centers, and physicians’ offices than in endoscopy and found that, of the 98 outbreaks assessed, 1,113
hospitals. In 2008, there were 1.2 billion ambulatory care visits in the patients were contaminated and 249 patients were infected. Kovaleva
United States, including physicians’ offices, outpatient hospitals, and et al noted that if deficiencies related to cleaning, disinfection, auto-
emergency departments. Nearly 61% of those visits were to primary mated endoscope reprocessors (AERs), contaminated water, and dry-
care physician offices.1 ing were eliminated, approximately 85% of outbreaks would be
Although many outbreaks of infection associated with instrument eliminated. Importantly, neither the works by Weber and Rutala nor
reprocessing in outpatient care facilities go unreported, multiple out- by Kovaleva distinguished between outbreaks associated with inpa-
breaks have been reported. In 2003, Srinivasan et al2 reported an out- tient and outpatient facilities. Additionally, underreporting of trans-
break of Pseudomonas aeruginosa associated with bronchoscopes in an mission of infection associated with endoscopy is ongoing.11
outpatient setting, apparently caused by loose biopsy ports on the bron- This article looks at the following 3 problems associated with
choscopes. Thirty-nine patients were infected, 67% of whom were instrument reprocessing practices in outpatient care facilities: (1)
infected with P aeruginosa. In 2012, a commentary by Weber and Rutala3 physical space problems, (2) training and education problems related
on bronchoscopies, for the 12-year period between 2000 and 2012, found specifically to high-level disinfection (HLD) practices, and (3) lack of
25 outbreaks and pseudo-outbreaks in the literature. The outbreaks infection prevention presence. This article offers solutions or mitiga-
described in their commentary resulted in 82 infections and 4 deaths. tion strategies to these 3 problems. In addition, it will present some
Notably, single use, disposable bronchoscopes are now available. reflections on the current state of infection preventionists’ (IPs’)
presence in outpatient facilities and collaborations between the
* Address correspondence to Judie Bringhurst, MSN, RN, CIC, Department of Hospital
instrument reprocessing industry and IPs.
Epidemiology, UNC Hospitals, 101 Manning Dr., Campus Box 7600, Chapel Hill, NC
27514.
E-mail address: [email protected] (J. Bringhurst). PROBLEM 1: PHYSICAL SPACE PROBLEMS
This work was presented as a 2019 Supplement at the Association for Professionals
in Infection Control and Epidemiology 45th Annual Conference, Minneapolis, MN, June
13-15, 2018.
Ideally, instrument reprocessing should not be performed in
Conflicts of interest: Ms. Bringhurst has received consultant fees from Cogentix patient care areas. Instrument reprocessing contaminates the area in
and honorarium from Medivator. which is it performed. This environmental contamination may lead to

https://doi.org/10.1016/j.ajic.2019.03.006
0196-6553/© 2019 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

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 J. Bringhurst / American Journal of Infection Control 47 (2019) A58−A61 A59

patient and/or staff infections. A space designated specifically for it is recommended to clear the room/area of all items, discard unnec-
instrument reprocessing should be utilized to control quality and essary items, terminally clean the room, and then resupply the room.
ensure safety. The reprocessing area should be divided into distinct This activity has been found to provide space that was previously
work areas whenever feasible as follows: receiving, cleaning, and exhausted by storage of unused supplies. When renovations are not
decontamination; preparation; HLD/sterilization; and storage. Stor- planned, a dirty-to-clean flow and clear separation between clean
age of reprocessed instruments should be in a manner that prevents and dirty activities and clean and dirty items is imperative. Thus, sig-
recontamination. Many endoscopy centers employ ventilated scope nificant improvements to instrument reprocessing areas may be
storage cabinets, whereas other types of health care facilities such as accomplished without renovation. Decluttering, installing upper
physician practices and specialty clinics store their reprocessed shelves to use vertical space, and removing equipment and items that
instruments in a clean storage room. An overriding goal of instrument can be moved to other spaces or rooms greatly increases the usable
reprocessing areas is to establish a dirty-to-clean flow in the area for space and safety of these areas.
the instrument stream, which, ideally, terminates in storage of these When renovations are planned, infection prevention actively
reprocessed items in clean utility rooms and ventilated cabinets spe- engages key personnel in requiring these spaces be expanded and ele-
cifically designed for endoscope storage, not the instrument reproc- vated to national standards and guidelines. When renovations to out-
essing area or room. patient facilities are planned, and in the absence of state design
Double sinks with 1 goose neck faucet serving both sinks are guidelines for physician practices and specialty clinics, the instrument
sometimes found in instrument reprocessing areas. This is not an reprocessing room should be designed to comply with (at least) Facility
issue within itself; however, staff may believe that 1 of these sinks is Guidelines Institute (FGI) Guidelines for the Design and Construction of
“clean” and 1 is “dirty” when both of the bowls in a double bowl sink Health Care Facilities5 and OSHA Bloodborne Pathogen regulations,8
should be either 1 or the other. Ideally, if the installation of separate including but not limited to air changes per hour, pressure differentials,
clean and dirty sinks is not feasible, the sinks should be used as either and the presence of an eyewash where appropriate. The Joint Commis-
both dirty or both clean. If it is unavoidable that both clean and dirty sion (Environment of Care chapter, 02.06.05, element of performance
activities occur in this double sink, the sink should be thoroughly 1) indicates that health care systems planning new or renovated facili-
cleaned with a bleach-based, Environmental Protection Agency-regis- ties should use state rules and regulations for design guidance and/or
tered hospital-grade surface disinfectant after dirty activities and reputable standards and guidelines such as the Guidelines for Design
before being used for clean activities. However, it is noted that this is and Construction of Health Care Facilities, 2018 edition, administered
a less-than-ideal situation and that there may be associated cross- by the FGI. When these rules, regulations, and guidelines do not meet
transmission risks in using the same sink for clean and dirty activities specific design needs, health care facilities should use other reputable
since faucets and drains (areas that are typically unreachable) are standards and guidelines that provide equivalent design criteria. A
contaminated.13 Additionally, the use of the same sink for clean and complicating factor is that outpatient clinic design codes may vary
dirty activities likely may lead to biofilm formation in the discharge from state to state or be absent altogether. IPs are encouraged to check
plumbing that may not allow decontamination even with periodic their respective state regulations regarding outpatient clinic construc-
bleach flushes. Also, a microbial aerosol associated with use of 1 sink tion design codes. For example, North Carolina exempts from state
for clean and dirty activities may contaminate the faucet and/or fau- health care design oversight and regulation, outpatient facilities that
cet aerators. All avenues for the installation of additional sinks should are classified as business occupancy and are more than 30 feet from
be explored. Certainly, if more than 1 dirty or clean sink is required, any hospital facility. Therefore, in North Carolina these outpatient facil-
as is often the case in endoscopy instrument reprocessing rooms, ities should be designed to meet the standards set forth in the FGI6 and
then double or even triple sinks may be installed with the under- the regulations in OSHA Bloodborne pathogens standards as well as
standing that these multiple sink units are designated as either all other standards and guidelines.
clean or all dirty. In addition to the design recommendations for outpatient facilities
Infrequently, instrument reprocessing may occur in very small in the FGI, utility sinks (ie, clean and dirty instrument washing and
spaces (eg, closets) with no sink at all. In these rare cases, and when rinsing sinks) in instrument reprocessing areas should be specified to
space cannot be carved out or dollars found for installation of a sink, be stainless steel, at least 24 inches from side-to-side (inside bowl
one should consider either single use, disposable instruments or width) and sometimes larger according to the clinic’s specific needs,
allowing minimal instrument reprocessing that can include a vapor and at least 8 inches deep or deeper. Importantly, at least 2 utility
management/soaking station device in facilities that reprocess sinks should be installed to accommodate instrument washing and
smooth, nonlumened, nonchanneled items such as some endocavi- rinsing, 1 designated as dirty (washing) and 1 as clean (for rinsing
tary probes. Additionally, using a high-level disinfectant chemical after HLD). Some gastrointestinal scope reprocessing rooms have 3 or
that requires only 1 final rinse (and can thus be rinsed in the rinsing 4 dirty sinks to accommodate high volumes of lumened flexible endo-
tube of the soaking station device) is helpful in these sinkless instru- scopes and decrease delays between use on a patient and soaking.
ment reprocessing areas. This rinse water must be changed with each These sinks designated as dirty and clean should be installed at a sig-
disinfection run and cannot be reused. One may also consider use of nificant distance from each other to avoid cross-contamination. Fur-
an endocavitary ultrasound probe high-level disinfecting system that thermore, a separate handwash sink is required in these rooms to
uses a vaporized hydrogen peroxide as the high-level disinfectant. meet OSHA regulations and to keep staff safe. Manual control of
This type of system requires no rinsing of ultrasound devices such as water sources (vs motion detection) to these sinks is necessary and is
vaginal ultrasound probes. It is stressed that this “sinkless” room is achieved by installing goose neck faucets or spring-loaded pull-down
another less-than-ideal situation and there may be associated cross- faucets with wrist blade controls or single lever controls. It is usually
transmission risks, staff safety risks, and inconsistencies with and not helpful to install splashguards in instrument reprocessing rooms
even violations of Occupational Safety and Health Administration since there should be no clean or sterile patient supplies stored on
(OSHA) regulations in these rare rooms with no sinks. The importance the counters in these areas, and splashguards interfere with the ergo-
of ready access to a handwash sink in case of exposure to blood and nomics of moving items from sinks to counters and vice versa. When
body fluids is underscored. hazardous chemicals are being used, an American National Standards
Inadequate space is 1 of the most frequent problems encountered Institute-approved eyewash should also be installed either on a clean
in outpatient care instrument reprocessing areas. Clutter should be sink or as a separate wall-mounted version to meet staff safety regu-
eliminated. When cluttered instrument reprocessing areas are found, lations consistent with OSHA. Correspondingly, new construction and

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renovations of outpatient facilities such as physicians’ practices, Perhaps the most significant benefit of the workshop is the familiarity
ambulatory surgery centers, and specialty clinics should be consistent students establish with infection prevention. This may ease anxiety
with state design codes, FGI guidelines, and OSHA regulations. associated with reporting of challenges in their facilities to their IP. In
2018, a 1-hour refresher HLD class was established for those who
PROBLEM 2: EDUCATION, TRAINING, VALIDATION, AND have attended the 3-hour workshop and made mandatory every
STANDARDIZATION: FOUR REASONS OUTPATIENT AREAS 365 days. There are infection prevention benefits in requiring the
NEED IPS’ PRESENCE workshop for clinic HCP who may need remediation in HLD practices.
Class materials, revised at least yearly to reflect current issues, are
Because of the large margin of safety inherent in steam steriliza- used for up-to-date education of staff.
tion processes−there is a 1:100 quadrillion chance of the steam-ster-
ilized item not being sterile−whereas there is no margin of safety Validation
associated with HLD of gastrointestinal endoscopes, this article will
focus mainly on HLD challenges and complications in this section.12 Validation studies and their associated documents are a necessary
Per the Spaulding classification scheme, HLD, minimally, is required element of any instrument reprocessing activity. Are the HLD chemi-
for semicritical devices (ie, those that contact mucous membranes or cals in use validated effective by the instrument manufacturer? Are
non-intact skin).7 HLD is a time-consuming, complex process that the automated endoscope reprocessors (AERs) in use validated by the
requires training, education, and competency. Outpatient facilities instrument manufacturer and vice versa? Do our instruments have
that reprocess semicritical devices generally will reprocess them via lumens that are validated to be effectively high-level disinfected with
HLD unless sterilization is an option. specific connectors or hook-ups? The length and diameter of lumens
must be assessed before any HLD or sterilization process is assumed
Education and training to be effective and validated. Most HLD chemical manufacturers and
AER manufacturers have online, easy-to-use validation matrices.
Recently, Olympus published a 111-page reprocessing manual IFUs, Centers for Disease Control and Prevention, facility policies, and
(manufacturer’s instructions for use [IFU]) for their Q180V duodeno- professional organizations’ guidelines should always be consulted for
scope (Olympus America Inc, Center Valley, PA). It is unlikely that cleaning instructions with any instrument, automated instrument
scope room staff have the resources to adhere to 111 pages of clean- reprocessors such as AERs, and HLD chemicals. Adherence to nation-
ing instructions for endoscopes. This gap exposes 1 of the major prob- ally accepted standards, guidelines, and manufacturer’s IFUs must be
lems with HLD, which is that the complexity of many lumened meticulous. These standards, guidelines and IFUs are generally spe-
flexible endoscopes, in particular, has outstripped our ability to meet cific to the product with which they are associated. Most medical
complex and time-consuming HLD instructions. In an effort to medi- devices, instruments, and instrument reprocessors must be evaluated
ate the effects of this gap, a 3-hour HLD workshop curriculum at the by the Food and Drug Administration (FDA) and should have com-
University of North Carolina Hospitals was designed and is delivered plete IFUs9; however, not all instruments found in outpatient care are
by infection prevention. Results from onsite infection prevention subject to FDA evaluation nor are all IFUs written in a manner that is
instrument reprocessing surveys were used to guide the curriculum. decipherable to clinic staffs. The IP’s input pertaining to appropriate
Infection prevention partnered with colleagues in the environmental cleaning, disinfection, and sterilization should include interpretation
health and safety department to produce an occupational health com- of manufacturer’s IFUs where necessary. Improper use and disinfec-
ponent in the workshop applicable to personal protective equipment tion of equipment and instruments may harm the equipment and
(PPE) usage when performing HLD, a process that exposes staff to expose staff and patients to cross-contamination. Furthermore, the
blood and body fluids as well as hazardous chemicals. All personnel IP’s assistance to weave together various IFUs for HLD chemicals and
with HLD responsibilities are required to attend as clinic schedules the instruments and equipment (eg, AERs) for which those chemicals
permit. The workshop is not a “train-the-trainer” class nor is it an are validated is invaluable to clinical staff. For example, some HLD
online module. The workshop is conducted by an IP, personally, face- chemicals are contraindicated for use in certain patients (eg, ortho-
to-face. The lecture portion of the workshop includes, among other phthalaldehyde in bladder cancer patients), certain reprocessing
relevant issues, a review of outbreaks associated with inadequate environments, temperatures and equipment, whereas some HLD
HLD, the rationale for HLD, negative outcomes resulting from re-use chemicals can be heated during the HLD process and some cannot,
of single use items, medical-legal implications, an overview of the per FDA approvals. Manufacturer’s IFUs for the chemicals should be
Spaulding classification scheme, as well as explanations of the neces- reviewed and the FDA list of cleared sterilants and high-level disin-
sity for leak-testing flexible scopes. Students are urged to assume fectants checked for validation of choices of HLD chemicals.10
accountability as health care personnel (HCP) in the instrument
reprocessing environment−what to report to their supervisors and/ Standardization
or hospital infection prevention−and they are educated on the medi-
cal-legal ramifications of errors in the reprocessing environment. The There is no standardization across manufacturers of instrument
workshop portion includes instruction and return demonstration of reprocessing devices and consumables. The infection prevention pro-
donning and doffing appropriate PPE for HLD and the proper tech- fession urges our industry partners to learn more about the chal-
nique for testing minimum effective concentrations of HLD chemicals lenges faced on the front lines of our HLD areas and begin to address
with test strips. Students are given a laminated, enlarged algorithm these challenges in a useful and, as far as possible, simple way. There
of the steps in HLD, a laminated poster describing the appropriate is a plethora of products, each with their own specific, individual
PPE for HLD processes, their own safety glasses, and a large packet of instructions, including enzymatic detergents and other detergent
information, including relevant peer-reviewed literature to place in cleaners with differing water-to-detergent ratios, HLD chemicals
their workspaces. More than 600 HCP have attended the workshop with different soak times and usage days, and HLD chemical test
over the past 6 years. HCP effectiveness (ie, less likelihood of making strips with different wait times and color changes. HCP should be
mistakes during HLD activities) has been variable based on subse- clearly instructed by the IP that, although these variances exist, it is
quent visits to HLD areas. Student comments and evaluations have only critical for personnel to read and follow all instructions that
been positive. Students comment positively on the information they apply to their HLD, detergents, test strips, instruments, and devices.
receive on outbreaks and the workshop portion of the session. Another method to mitigate some of this potential confusion is to

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decrease as much as possible the variety of HLDs and their attendant An IP’s reflections:
consumables available to clinics.
1. It was a mistake for me to assume that people who HLD everyday
PROBLEM 3: LACK OF IPS’ PRESENCE know the right way to do it.
2. Your instrument reprocessing sites, outpatient and inpatient, need
If not already educated, IPs should become educated on the HLD your attention and help−they may not know that yet.
process and proficient in assessing these practices. Multiple resources 3. We CANNOT always make it perfect or even consistent with regu-
specific to HLD practices, processes, and environments exist for the lations and guidelines but we CAN ALWAYS make it better and
inquiring IP’s mind.14-17 In tandem with these resources is all product safer for our patients and our staffs.
information and IFUs that are relevant to HLD processes. Also neces- 4. Start with your first visit−challenges will be uncovered, opportu-
sary for the IP’s education are the regulatory notices that emanate nities for improvement will become clear. Address the challenges
from the Centers for Disease Control and Prevention and the FDA.18 and opportunities that present a risk to patients and staff first.
IPs can develop the skills to assess whether an endoscope is reproc- 5. Once we, IPs, are fully engaged, the myriad elements and complex-
essed correctly, whether all reprocessed instruments and devices are ities of HLD within our facilities will lead us where they need us
being stored appropriately, whether it is clear that an item is clean or to go.
dirty, and how to assist clinics in mediating some less-than-ideal
physical plant situations to make these situations safer.

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