Good laboratory practice for waived testing sites

These pathogens include, but are not limited to, hepatitis B virus, hepatitis C virus, and human immunodeficiency virus HIV. Collect waived test
specimens exactly as described in the test system instructions, using the appropriate collection device and method to obtain a quality specimen In
addition, when testing personnel were not evaluated to determine their competency level following training or on an ongoing basis, no assessment
was conducted to determine whether the training was effective. Training should be provided by a qualified person e. The OIG report indicated that
approximately half of the state respondents reported problems related to quality issues with the waived laboratories in their states e. Factors to
consider include:. The time spent on training was not captured as part of the CMS surveys. In some cases, records might be part of the patient's
medical chart. The three categories of testing for CLIA purposes are waived, moderate complexity including the provider-performed microscopy
procedures [PPMP] subcategory , and high complexity. Finally, the CMS surveys did not assess the frequency of erroneous test results in CW
sites or whether lapses in following manufacturers' instructions directly affected test results or patient outcomes. CLIAC supported publication of
the recommendations, along with the data from the studies of CW sites, and suggested the publication could serve as a comprehensive source
document that could be used to develop additional educational tools appropriate for specific target audiences. Perform only waived tests.
According to the concept of Universal Precautions, all human blood and certain human body fluids are treated as if known to be infectious for
HIV, hepatitis B virus, hepatitis C virus, and other bloodborne pathogens. Internal, procedural, or built-in controls evaluate whether certain aspects
of the test system are working properly. Labeling procedures should meet the needs of the testing site and should be adequate to prevent specimen
mix-up. When the testing area is prepared and the specimen has been collected, the process continues to the testing phase. Aspects of testing for
which records or documentation are recommended include: For example, results from waived tests can be used to adjust medication dosages,
such as prothrombin time testing in patients undergoing anticoagulant therapy and glucose monitoring in diabetics. Recommended Practices After
Testing. Universal Precautions an approach to controlling infection. A comprehensive procedure manual is a valuable resource for CW sites.
Resolving Problems If a discrepancy is identified between the patient's test results and the clinical information or if the results are invalid or
otherwise compromised, testing should be repeated. Tools for training continue to evolve and are not limited to traditional methods. Quality control
of test systems waived by the clinical laboratory improvement amendments of After the decision is made to offer waived testing, it is good practice
to develop written policies and procedures so that responsibilities and testing instructions are clearly described for the testing personnel and facility
director. Recommend on Facebook Tweet Share Compartir. Some states and localities have specific regulations for testing, some require licensure
of personnel who perform testing, and some have phlebotomy requirements. October 13, Page last updated: Pay attention to timing for waived
tests, particularly unitized test devices that must be read during specific time intervals. A report issued in by the Institute of Medicine IOM
presented a national agenda to address these issues and recommended strategies for change that included the implementation of safe practices at
the health-care delivery level 7. Increasingly, these decisions are based on simple tests performed at the point-of-care using devices that are
waived from most federal oversight requirements and are thus designated as waived tests , including requirements for personnel qualifications and
training, quality control QC unless specified as required in the test system instructions , proficiency testing PT , and routine quality assessment. To
decrease the risk of erroneous results, the test needs to be performed correctly, by trained personnel and in an environment where good laboratory
practices are followed. As a result, during , CMS conducted nationwide on-site surveys of CW facilities to collect additional data that would
provide an assessment of testing, promote good laboratory practices and encourage improvement through educational outreach, and make
recommendations on the basis of cumulative survey findings.

Waived Tests
Instructions for ordering additional tests, contact information for the referral laboratory used, and examples of completed test request forms.
LMSMN obtained additional waived testing data from Data identifying who provided training were not submitted for all sites in the surveys. A
comprehensive procedure manual is a valuable resource for CW sites. Stahmer, Golden, Colorado; Lou F. NYSN collected its data through on-
site surveys during which waived testing practices were assessed by surveyor observation and record reviews Factors to consider include:.
Continued monitoring of waived testing, with a focus on personnel education and training, is needed to improve practices and enhance patient
safety as waived testing continues to increase. Information for this evaluation can be obtained from the test manufacturer's product insert Table 7 or
by speaking with the manufacturer's technical representatives. Follow the instructions in the most current manufacturer's product insert, without
modification, when performing the test. In addition, these sites did not have adequate records of their testing activities, including test system
procedures, training records, or other documentation. In the past, tests such as prothrombin time, cholesterol, and glucose either used complex
manual methodologies or were performed using sizable instrumentation suitable for use by highly trained personnel in traditional clinical laboratory
settings. Documentation is essential to assure quality waived testing. The three categories of testing for CLIA purposes are waived, moderate
complexity including the provider-performed microscopy procedures [PPMP] subcategory , and high complexity. In POLs, this might be a
physician or someone in a senior management position who has the appropriate background and knowledge to make decisions about laboratory
testing. Test system instructions can change over time and CW sites sometimes switch test systems that could have different instructions. Internal
Assessment Objective internal assessment offers flexible, low-cost options for evaluating quality such as self-conducted inspections, supervisory
review of documented problems that occur in the different phases of the testing process, review of QC documentation, and testing and reporting
procedures. These procedures should be derived from the manufacturer's instructions and should be in a language understandable to testing
personnel. Persons using assistive technology might not be able to fully access information in this file. If additional assistance is required, contact the
appropriate CMS regional office http: The recommendations were published to promote quality testing, reduce testing errors, and enhance patient
 safety. Proper documentation is necessary for monitoring and assessing test performance, identifying and resolving problems that could affect
patient testing, retrieving and verifying information, and maintaining adequate patient and personnel records. Errors can occur anywhere in the
testing process, particularly when the manufacturer's instructions are not followed and when testing personnel are not familiar with all aspects of the
test system and how testing is integrated into the facility's workflow. Use of trade names and commercial sources is for identification only and does
not imply endorsement by the U. A unitized device is used for a single test and must be discarded after testing. Recommended Good Laboratory
Practices Overview These recommendations are intended to promote the use of good laboratory practices by physicians, nurses, and other
providers of waived testing in a variety of CW sites. If repeat testing does not resolve the problem, contact the manufacturer or product technical
representative. Personnel should be trained and competent in each test they will perform before reporting patient results 32, The activities that
occur in each of these phases are critical to providing quality testing Table 6. Good laboratory practices include recording what happens, whether
acceptable or not, and what is done to correct problems encountered during testing. It can be used as a voluntary tool to help assure good testing
practices and reliable, high quality test results. This workgroup was comprised of key stakeholders in waived testing i. Test procedures should
describe the type of controls to be used, how to perform QC testing including QC testing frequency , and actions to be taken when QC results are
unacceptable. In addition, erroneous results from diagnostic tests, such as those for human immunodeficiency virus HIV antibody, can have
unintended consequences. Need for supplemental testing or patient follow up Some waived tests provide preliminary results as part of a multitest
series e. Although the surveys were conducted through several mechanisms, the findings lead to similar conclusions about lapses in quality in CW
sites, and they highlight the need for additional education and training related to waived testing for CW site directors and testing personnel. The
manufacturer's test system instructions and instrument operating manuals should be the primary resource for information and training in CW sites.
This report summarizes study findings and provides recommendations developed by the Clinical Laboratory Improvement Advisory Committee for
conducting quality waived testing. Who will be responsible and accountable for testing oversight at the CW site, and does this person have the
appropriate training for making decisions on testing? The value includes specific measurement units e. Questions to address include the following:.
They are designed to verify that the test system is working as expected, that sufficient specimen was added and, for unitized test devices, whether it
migrated through the test strip properly. Training checklists are helpful to ensure the training process is comprehensive and documented. Test
results contribute to diagnosis and prognosis of disease, monitoring of treatment and health status, and population screening for disease. The form
must be signed by the facility owner or the facility director. The person responsible for testing oversight should ensure that all state and local
requirements are met. Follow the steps in the test procedure in the exact order described in the product insert. Increasingly, these decisions are
based on simple tests performed at the point-of-care using devices that are waived from most federal oversight requirements and are thus
designated as waived tests , including requirements for personnel qualifications and training, quality control QC unless specified as required in the
test system instructions , proficiency testing PT , and routine quality assessment. These recommendations address decisions that need to be made
and steps to be taken as a facility begins offering waived testing or adds a new waived test. Quick reference instructions should be clearly posted
where testing is performed. Never reuse needles, syringes, or lancets. They can be disseminated by a variety of individuals and organizations and
adapted for use in different settings where waived testing is conducted. The quality issues identified through these surveys might have been caused,
in part, by high turnover rates of testing personnel in CW sites, inadequate training with respect to waived testing, and lack of understanding of
good laboratory practices, including the importance of following all aspects of the manufacturers' instructions.

Request Rejected
Critical values are test results necessary for patient evaluation or treatment that require immediate notification to the clinician. They are intended to
be used by those who would benefit from improving their knowledge of good laboratory practices. All facilities in the United States that perform
laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease are regulated under CLIA 5.
Suggestions for helping to ensure correct timing of tests include using timers that beep until turned off, using timers sitees can ogod be worn or
attached to clothing, using multiple timers when performing more than one test at a time, and maintaining extra goox and batteries. These pilot
surveys identified quality issues that could result in medical errors Although data have not been systematically collected on patient outcomes with
waived testing, adverse events can occur 9. Physical Requirements for Testing Testing should be performed in a separate designated area where
adequate space to safely tssting testing and maintain patient privacy is available. Contributing factors included inadequate training in good
laboratory practices and high turnover rates of testing personnel. Test results contribute to diagnosis and prognosis of disease, monitoring of
treatment and health status, and population screening for disease. In good laboratory practice for waived testing sites evaluations, the
workgroup considered existing practice guidelines from professional organizations, waived testing good laboratory practice for waived testing
sites from CMS, personal and professional experience, and publications related to waived testing. Under HIPAA, CW sites are required to
establish policies and procedures to protect the confidentiality of health information about their patients, including patient identification, test results,
and all records of testing. Labotatory Academy Press; Clin Leadersh Manag Rev ; In certain CW sites, nonwaived microscopic examinations were
being performed by personnel who lacked the education and training needed to develop the interpretive and judgment skills necessary to
accurately perform these procedures. This poster can readily be displayed in a testing area to remind testers of 10 important practices to follow for
accurate practuce good laboratory practice for waived testing sites testing. Scope of Waived Testing. CDC is not responsible for the content
of pages found at these sites. In response, the committee recommended publication of the CMS data in conjunction with other data pertinent to
waived testing performance along with recommendations for good laboratory practices for waived testing sites. The management staff should
demonstrate a commitment to the quality of testing service by complying with applicable regulatory requirements and promoting good laboratory
practices. Surveys of Waived Testing Sites Methods. State and local jurisdictions often regulate biohazard safety, including handling and disposal
of medical waste. They also address developing procedures and training CW personnel and describe recommended practices for each phase of
the total testing process, or path of workflow, including the important steps or activities before, during, and after testing. To ensure testing
procedures are performed consistently and accurately, periodic evaluation of competency is recommended, with retraining, as needed, on the basis
 of results of the competency assessment Personnel should good laboratory practice for waived testing sites trained and competent in each test
they will perform before reporting patient results 32, Second, the CMS data were collected and entered into the database by a large number of
persons, introducing variability. CLIAC supported publication of the recommendations, along with the data from the studies of CW sites, and
suggested the publication could serve as a comprehensive source document that could be used to laboratry additional educational tools
appropriate good laboratory practice for waived testing sites specific target audiences. Data identifying who provided training were not
submitted for all sites in the surveys. Training should be provided by a qualified person e. Occupational Safety and Health Administration. The
Occupational Safety and Health Administration OSHA and individual state standards require employers to provide a safe and healthy work
environment for employees. Test system considerations Good laboratory practice for waived testing sites the simplicity of operating the test
system, length of time to obtain a result, and the level of technical support provided by the manufacturer or distributor. These programs provide
challenge samples to test as if they were patient specimens and the results are evaluated with respect good laboratory practice for waived
testing sites how close they are to the intended target values. Certain testing personnel also were self-trained. These procedures should be derived
from the manufacturer's instructions and should be in a language understandable to testing personnel. The findings in the CMS surveys are subject
to at least three practic, and caution should be used in extrapolating the survey data to make generalizations about waived testing. Equipment
maintenance, such as repairs or preventive maintenance contracts. Safety never takes a holiday. The OSHA Bloodborne Pathogens Standard
applies to sites where workers have potential occupational exposure to blood and infectious materials Performance characteristics Assess the
information on performance provided by the test manufacturer or published data. Changes to the timing of the test or physical alteration of the test
components e. These advances have enabled more testing to be performed in emergency departments, hospital rooms, and physicians' offices and
in nontraditional testing sites such as community counseling centers, pharmacies, nursing homes, ambulances, and health fairs. The specific test
system name should be on the quick reference instructions to avoid confusion.