Mubende Regional Referral Hospital Laboratory

Risk Management SOP MRRHL/SOP M/017

Title: Risk Management SOP SOP NO: MRRHL/SOP M/017

Version: 3
Written by: Nayiga Juliet Signature Date

18/04/2020

Reviewed by: Kentaro Juliet 20/05/2020

Approved by: Kentaro Juliet 01/06/2020

Retired by:

Effective date: 01/06/2020

Review History

Version number Effective Date Retirement date Author

1 15/12/2016 01/10/2018 Nayiga Juliet

2 01/10/2018 01/06/2020 Nayiga Juliet

3 01/06/2020 Nayiga Juliet

Record of review

Version Date of Review Description of amendments Remark Next review

no review made by date

2 May Kentaro Adjusted the SOP to fit the document Version changed -
2020 Juliet control format. from 2 to 3

3 May

2021

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Distribution List

Copy Number Location

Original Copy Master file

Copy 1 Main laboratory

1. Title: Procedure for Risk Management

2. Abbreviations, definitions and terms

2.1 Abbreviations

N.A. Not applicable LM Laboratory Manager

QM Quality Manual SO Safety Officer
QO Quality Officer RCA Root Cause Analysis
SOP Standard Operating Procedure
MRRHL Mubende Regional Referral Hospital Laboratory
2.2 Definitions and Terms

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Risk is the chance that something will happen that will have an impact on the
achievement of Mubende regional referral Hospital Laboratory’ objectives. It can also
be defined as the effect of uncertainty. Any such uncertainty can have positive or
negative effects. It is measured in terms of likelihood (frequency or probability of
the risk occurring) and consequence (impact or magnitude of the effect of the risk
occurring).
Risk Assessment is the process used to evaluate the risk and to determine
whether precautions are adequate or more should be done. The risk is compared against
predetermined acceptable levels of risk.
Risk: Is the effect of uncertainty. Any such uncertainty can have positive or negative effects.

Likelihood: Is the frequency or possibility of occurrence.

Risk Identification: Identifying Potential Sources of Error

Risk evaluation: Is the process of determining, subjectively, whether the risk is high or
low and whether it is acceptable or not.
Risk Mitigation/Control: Controlling Errors in such way that residual risk is
manageable. Actions or control measures that are put in place to reduce or eliminate the
risk.
Risk Monitoring: Monitoring the effectiveness of the implemented Preventive actions
Risk management: Includes a system to identify, report, prioritize, investigate and trend
patterns of events with the potential for causing adverse patient outcomes for example physical
injuries, effects on patients’ results and adverse effects on property or other assets of the
laboratory or hospital at large.

Risk Matrix: Is the measure of severity of the impact of a potential error (severity or
consequence) multiplied by the probability of how likely that the error will occur (likelihood).
Also known as probability and impact matrix used to raise awareness and increase visibility of
risks

Risk Assessment Register:

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List of all identified potential risks, their probability, consequence and associated mitigation
measures

Near miss: Any process variation that did not affect an outcome but for which a recurrence
carries a significant chance of a serious adverse event.

Laboratory error: Failure of a planned action to be completed as an intended or use of a wrong

plan to achieve an aim occurring at any part of the laboratory cycle.

Failure mode and effects analysis (FMEA): Prospective risk analysis process of high risk
processes to identify needed improvements that will reduce the chances of an unintended adverse
event.
Risk Tolerance: The threshold level of risk exposure which, when exceeded, will trigger
an escalation to bring the situation to the attention of a Laboratory manager.
Hazard vulnerability analysis (HVA): Process for identifying natural and manmade hazards
and the direct and indirect effect these hazards may have on the hospital and community.

Facility management and safety risks: All risks including but not limited to damage to the
hospital property by fire, vandalism, theft, patient escapes, patient falls, damage to patients
property, major equipment failure.

Sentinel event: An unanticipated occurrence involving death or major permanent loss of

function.

3. Responsibilities, tasks and accountabilities

Task Responsible Accountable

Identify all potential risks during work processes All laboratory staff QO

Review all laboratory data and information to identify potential QO and SO LM

risks that are likely to affect patient results (Risk assessment).

Review work processes and procedures to identify risks that can QO and SO LM
affect patients’ safety as well as the quality of results (Risk

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assessment).

Reporting of risks within the laboratory. All staff LM

Evaluation and ranking of risks QO and SO LM

Conducting RCA and putting up preventive actions QO, SO and other LM

laboratory staff

Monitoring and review of the effectiveness of preventive actions QO and SO LM

Reporting results of risk management to top management. QO LM

4.0 Safety and Environment

N/A

5.0 Purpose of the procedure

The purpose of this SOP is:

To guide MRRHL staff on how to evaluate the impact of work processes and potential failures
on examination results as they affect patients’ safety, and modify processes to reduce or
eliminate the identified risks and document decisions and actions taken.

6.0 Scope

This procedure applies to all processes and procedures in sample generation and
handling in and outside the laboratory.

7.0 Procedure

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Procedure for risk management takes into consideration the following activities;

a) Risk evaluation/Ranking the Risk

b) Risk acceptance
c) Risk mitigation or control
d) Monitor and Review the risk

Figure 1: Risk assessment plan

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IDENTIFY THE SYSTEMS (PROCESS MAPPING,

REVIEW OF LABORATORY DATA AND
RISK INFORMATION)
IDENTIFY HAZARDS AND POSSIBLE HARMS
ANAL (RISKS)
YSIS

RISK ESTIMATE RISK LEVEL (LIKELIHOOD/SEVERITY)

EVAL
UATI
ON

COMPARE RISK WITH ACCEPTANCE CRITERIA

RISK
ACCEPTANCE ACCEPT OR REJECT THE RISK

YES NO

7.1 Risk analysis

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Risk analysis involves identifying systems or procedure where errors or harm can occur and
identifying the harm itself.

Mubende Regional Referral Hospital Laboratory identifies risks in the following ways;

 The laboratory QO and SO review all work processes and procedures (pre examination,
examination and post examination) to recognize and describe risks that might affect the
work outputs. This is done through process mapping.
 Quality officer reviews laboratory data and information to identify risks or potential non
conformity. These include data about incidents, complaints, near misses, internal audits,
safety inspections, Quality indicators, patients information on Hospital Management
Information System (HMIS) registers, Proactive risk assessment, customer satisfaction
surveys, review of corrective actions taken, infection control risk assessment, failure to
abide by the financial policies and the systematic reviews of processes .
 Analysis of data is done to identify risks within its environment.
 And a risk assessment register is prepared.

7.2 Risk evaluation and acceptance

Risk evaluation involves assessing the probability/likelihood of happening of the risk

and its severity.
 Estimate the likelihood and severity of the risk using the matrix and document
the risk level.
 Determine the risk magnitude, which is the combination/computation of
likelihood and consequence for example low, medium, high and extreme.
 These risk rankings are also added to the Risk Assessment Register.
 Compare the risk magnitude against predetermined acceptable levels of risk (risk
tolerance) and take mitigation measures (preventive actions).
 The laboratory only tolerates risks that score from 1-6, that is to say low and
moderate risks. Any risks with a score of 8 and above (high risk and extreme
risk) requires that the QO, SO and other team members do RCA and determine

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potential causes then put in place preventive measures to remove the potential
causes of the risks.

Figure 2. Matrix table showing how risks are rated at MRRHL
Likelihood of Consequence/ severity
occurrence
1 2 3 4 5

Insignificant/ Minor Moderate Major Catastrophic

negligible

5 Almost 5 10 15 20 25

Certain

4 Likely 4 8 12 16 20

3 Possible 3 6 9 12 15

2 Unlikely 2 4 6 8 10

1 Rare 1 2 3 4 5

Note: The responses base on the scores determined by the risk assessment team.

Figure 3: Table showing description of Severity Rating in MRRHL

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LEVEL SEVERITY DESCRIPTION

1 Insignificant Negligible injury/harm to patient care or staff or processes

Barely noticeable reduction in quality or scope of projects/objectives
Unsatisfactory patient experience not related to patient care
Incorrect medication dispensed but not taken

2 Minor Minimal harm to patient or staff (fist aid treatment needed) or has an
effect on the process but will not affect the Process outcome.
For example, incorrect medication or dosage administered with no side
effects

3 Moderate Serious /important;

Will affect the process outcome, patient or staff in a negative way. For
example incorrect laboratory results leading to incorrect dosage or
medication administered with potential adverse effects, physical attack
causing moderate injury and communication gap resulting in a poor
outcome.

4 Major Major injuries or long term disability for example, delayed treatment for
severe malaria due to delayed laboratory results leading to cerebral
malaria ant the outcome is cerebral palsy which is a permanent
disability, niddle prick injury causing a staff or patient to acquire HIV or
Hepatitis B that have no cure.
Damage to laboratory equipment or premises

5 Catastrophic Unexpected death or severe damage to property and loss of life. For
example, death of patient due to wrong blood group, building being
struck by lightning, patient or staff committing suicide in the hospital
premises.

Figure 4: Table showing description of Likelihood Rating

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LEVEL LIKELIHOOD DESCRIPTION

1 Rare Not expected and has never occurred

2 Unlikely Not likely to occur under normal

circumstances but can occur

3 Possible Possible/known to occur

4 Likely Common occurrence

5 Almost Certain Repeating experience

Figure 5: Table showing how risks are graded and evaluated at MRRHL with the required
actions

Score Grade Actions to be taken Risk

Acceptance
1-3 Low risk No action is taken for these risks Acceptable

4-6 Moderate risk Minimal action is required from the team or section or Tolerable
department concerned. Action executed within 6-8 months.

Interim risk control measures, such as administrative

controls or PPE, may be implemented while longer term
measures are being established.

8-12 High risk Action is taken within 3-6 months with documented RCA Not acceptable
Require reporting to laboratory management.
Preventive action forms are filled.

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15-25 Extreme risk Work shall not start unless interim risk control measures Not acceptable
have been taken to minimize the risk.
Immediate actions to remove or reduce the risk with
documented RCA
Reported to hospital top management.
Preventive action forms are filled

7.3 Risk mitigation and control

In risk migration MRRHL estimates the cost of mitigation VS no mitigation and where no
mitigation is more costly than mitigation, RCA is done and preventive actions identified to
remove or reduce the risk.

For risks where mitigation is not required continuous monitoring and evaluation is done.

7.4 Ongoing evaluation or monitoring for effectiveness

Laboratory QO and SO monitor for effectiveness of preventive actions taken and as well as
monitor for new harm.

7.5 Frequency of conducting risk evaluation.

Mubende Regional Referral Laboratory identifies risks every day as they happen. However,
systematic evaluation of work processes to identify potential pitfalls within the operation system
(risk assessments) is conducted once a year but each day during work, if a potential risk is
identified, it’s assessed and modification within the work processes can be made to prevent
occurrence of the harm.

7.6 Risk assessment report

The laboratory QO and SO prepares the risk evaluation report which includes the following;

 Process or method used to identify the different risks for example through process
mapping of examination procedures (pre examination, examination and post

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examination), review of laboratory data and information, evaluation reports and many
others.
 The risks identified for example loss of sample, failed internal quality control, loss of
results and many others.
 The risk grading and the required actions
 Evidence of RCA for high and extreme risks
 Preventive actions taken
 And evidence of review for effectiveness of actions taken.
 Date of report and personnel reporting and reviewer.

Note: results of risk assessment are shared in the laboratory meetings with staff including the
actions to be taken to reduce or eliminate the risk.

Risks identified from review of records do not require an assessment report rather they are
evaluated and if found to have the potential to cause harm, they are logged onto the
corrective/preventive action form.

 Root cause analysis is done in a team

 Risk assessment results are shared in management review meeting or where preventive
actions to be taken require resources that can be provided by hospital management,
communication is made.
8.0 Related documents

SOP on preventive action MRRHL/SOP M/014

9.0 References

ISO 15189:2012.

10.0 Attachments
Appendix 1-Risk assessment guiding tool
Appendix 2-process mapping tool
Appendix 3-Risk assessments register

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Appendix 1: Risk assessment guiding tool

Pre-analytical phase
1. Is the work flow and new procedures well observed?
2. Are samples stored well before testing?
3. Has the client understood the instructions?
4. Has the patient consented to the procedure?
5. Is the laboratory accessible to all clients?
6. Has the patient understood the specimen to be brought?
7. Are the forms correctly and fully filled?
8. Is there readily available specimen collection containers?
9. Are the specimen containers properly labeled with unique identifiers?
10. Is the rider trained on sample transportation?
11. Is the personnel trained on sample packaging?
12. Is the time the sample is taken and delivered to the laboratory documented?
13. Are dispatch forms correctly and fully labeled?
14. Are personnel trained on sample reception?
15. On arrival are samples registered and given unique laboratory identifiers?
16. Are details on the dispatch verified and matched together with those on the
sample?

Analytical phase
1. Are samples fully tracked to the different work stations?
2. Are the personnel competent on sample analysis?
3. Are the equipment well serviced and calibrated?
4. Are Quality controls run daily together with samples to be analyzed?
5. Are reagents and chemicals stored according to the manufacturers’
instructions?
6. Are the personnel competent in result interpretation?
Post-Analytical phase
1. Are results checked and documented on the patients’ forms?

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2. Are laboratory records reviewed periodically?

3.Are environmental records monitored and reviewed?
4. Is the equipment serviced and calibrated?
5. Are equipment maintenance records kept?
6. Are quality controls run daily?
7. Is the personnel competent is using equipment?
8. Are results released and dispatched to the end user?
9. Are results dispatched timely manner and are they useful to the patient?

Performed by:
1._____________________ Date: _________________________
2.______________________ Date: _________________________
3._______________________ Date: ___________________________

Comments:__________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________________________________________________
____________________________

Reviewed by: _____________________________ Date:

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Appendix II: process mapping tool

Who's
Step What Happens? responsible? Procedures needed? Pitfalls
Clinician determines  Unauthorized person ordering
1. Order placed need Clinician Ordering protocols inappropriate order.
2. Patient presents to Laboratory staff Patient/  Lack of timely service.
laboratory interacts with patient. Laboratory staff. Customer Service  Interaction not client-friendly.
3. Requisition
PRE-ANALYTICAL PHASE

completed and  Incomplete patient data

reviewed by Requisition reviewed for Clinician, Clerk, or Criteria for specimen  Incomplete clinical history.
laboratory staff proper information. Laboratory. acceptability.  Clerical errors.
Specimen  Not checking or following
Note specific test requirements for specimen requirements.
4. Specimen type requested and determine (venous) blood  Inadequate communication to
determined for what type of sample collection SOP for patients regarding specimen self-
collection. needed Laboratory staff each analyte. collection.
5. Specimen Collected. Blood drawn from Blood-Clinician/ Phlebotomy key
patient; sputum, urine, Lab staff. competencies.  Blood-Wrong tube, incorrect
stool, or other specimen Non-blood Phlebotomy training amount of blood.
collected. specimens- checklist.  Injury

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 Non-blood specimens-incorrect
Clinician or specimen or incorrect collection
patient. procedure; improper labelling.
Appropriate information  Clerical errors
6. Specimen logged. recorded in specimen log. Laboratory staff Specimen management  Inadequate information.
Specimen accepted or  Unsatisfactory specimen.
rejected based on Specimen management  Specimens with hazardous
7. Specimen accepted meeting acceptance Criteria for specimen handling conditions.
or rejected. criteria. Laboratory staff acceptability/rejection.  Inadequately labelled specimen.
Requests reviewed for:
 Testing priority-  Processing not performed in
STAT versus routine. Guidelines for STAT timely fashion as ordered.
 If multiple tests to be testing.  Missing some tests on
done, sequential Guidelines for multiple requisition with multiple tests
workstations versus tests from one sample. requested.
aliquoting. Specific SOPs for each  Centrifuge not performed in
 Centrifugation analyte. timely manner.
8. Specimen assigned required. SOP for referred  Referred specimens not
according to test  Send out versus in- specimens transported in a timely manner
request/s house testing Laboratory staff or transported inappropriately.

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Appendix II: Process mapping tool

Who's
Step What Happens? Procedures needed? Pitfalls
responsible?
9. Routine quality Prior to testing,
checks completed. determine if proper SOP for each analyte, QC not done or out of control,
routine QC, reagent Guidelines for quality Inadequate troubleshooting or follow up
ANALYTICAL PHASE

validation, equipment checks of all of QC.

maintenance and logs/Charts for each Improper calibration.
calibration completed. Laboratory staff analyser or test. Inadequate equipment maintenance.
10. Specimen Run analysis on Specific SOP for Not following SOP
analyzed. specimen Laboratory staff each analyte. Taking shortcuts.
11. Test results Review test results for Release of test results without validation
analyzed. accuracy, legibility and Laboratory staff, Specific SOP for or interpretation
validity, crosschecking Supervisor each analyte. Inadequate cross-checking
12. Test results Transfer test results into Test Reporting SOP Clerical errors,
POST-ANALYYTICAL

recorded. logbook, Record results Specimen Analyte printout results listed in different
accurately. Laboratory, Clerk. Management. order than logbook reporting columns.
PHASE

13. Test results Notify Clinician of Laboratory staff, Specimen Results not communicated in timely
communicated/report results via written report Nurse Management fashion.
ed. Verbal reporting if Client satisfaction Results lost.
necessary. guidelines. Critical values not reported.

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Critical Values reporting. Confidentiality breached.

Assure that referral Failure to track referral specimens or
specimens are properly failure to follow-up on overdue
tracked. specimens.
14. Documents and File& store results in a
records maintained, retrieval fashion Unable to retrieve information when
filed and stored. Transfer files to long tern SOP for document & needed.
storage record management Lack of adherence to document retention
Dispose of files at an (including document schedule
appropriate time Laboratory staff and record retention) Water or moisture damage.

Quality Manager................................................................................. Laboratory Manager.......................................................

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Appendix III: Risk Assessment Register

Activities Associated Risk score Grading Is risk Possible root Actions to be Effectiveness Remarks
risks acceptable cause taken of actions
taken

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Attestation Record

I hereby acknowledge that I have read and understood this document.

No Name Initials Signature Date

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