Risk Assessment in Medical Laboratories

Total Laboratory process

- The clinical laboratory is increasingly integrated with patient care, assisting diagnosis, monitoring therapies and predicting clinical outcomes.

- There are many procedures and processes that are performed in a laboratory

What is Risk?

Combination of the probability of occurrence of harm and the severity of that harm

hazard– potential source of harm
harm–physical injury or damage to the health of people
severity– measure of the possible consequences of a hazard

Why Risk Management is important for Medical Laboratories?

• We analyze many samples from which we derive information

• The information impacts upon decision making and health of others.

• Poor information can lead to poor outcomes.

• Our samples have some variables that we can control, and others that are difficult to control, and others that we can not either foresee or control.

The Medical Laboratory has a wide Risk footprint

resiko med lab has a wide risko footprint

The Risk Management Framework

• Plan for Risk

• Identify Risk

• Examine for Risk Impact

• Develop Risk Mitigation Strategies

• Monitor and Control Risk outcome

Risk Definitions

• Risk analysis – systematic use of available information to identify hazards and to estimate the risk

• Information from the manufacturer

• Information from patient satisfaction surveys Risk Definitions

• Information from technical records (QC, Calibration, Maintenance)

• Information from process mapping and brainstorming

• Preanalytic, analytic, post analytic (ISO language: pre-examination, examination, post examination)

• Information from other laboratory records

• Information from gap analysis using accreditation or ISO standards

• Organizational information ( agreements between organizations)

• Risk assessment – overall process comprising a risk analysis and a risk evaluation

• Risk estimation – process used to assign values to the probability of occurrence of harm and the severity of that harm

• Risk evaluation – process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk:

- Failure mode and effects analysis (FMEA)

Risk management – systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk

Application of risk mitigation measures

- Frequency and character of quality control testing

- Training

- Accreditation to a recognized standard (ISO 15189:2012)

Contributors to Pre analytical Laboratory Risk

• Information regarding pre-analytical steps or processes that could affect the quality of the result may be lacking.

- Can a sample be collected in a gel separation clot tube

- What affects do gels have on the analytical component if not properly centrifuged?

• “Ideal” conditions (type of sample, differences between collection tubes, anticoagulants, centrifugation RPMs and time) for the sample are often not described by the manufacturer.

• Adequate patient preparation/instruction may not be given.

• Transport of medical samples from collection sites to the analytical laboratory, especially when the analytical laboratory is some distance from the site of collection.

Measures to Minimize PreAnalytical Laboratory Risk

• Urge professional societies to educate laboratories about key information that should be provided by or asked of manufacturers.

• Require the patient condition/diagnosis be shared with the laboratory when tests are requested so that results can be evaluated in the medical context.

• Require documentation that patient has been given and UNDERSTANDS instructions to prepare for the test.

• Ensure that laboratory manuals/procedures are CURRENT.

• Countries need to adopt appropriate transport standards

Contributors to Analytical Laboratory Risk

• The analytical process is an integral part of the overall quality system. Its contribution is significant, but the laboratory should maintain focus on the overall system.

• There is often no appreciation for an individual’s contribution to the quality of the test result. • There is often NO PLAN for analytical quality.

• Laboratories that don´t follow maintenance and calibration instructions from manufacturers are risking their patients.

• Laboratories that do not validate the methods they use are risking their patients.

• There is limited understanding of QC theory and application.

• High staff turnover creates training challenges, and these must be addressed.

• Technical communications between laboratory staff at change of shift are often unclear or not given.

Measures to Minimize Analytical Laboratory Risk

• Each person performing testing should be made aware they can cause error with each action they may take.

• The culture of the laboratory needs to change from hiding errors and problems.

• Laboratories need to encourage staff to communicate problems to Management without fear of retribution.

Laboratories should PLAN for quality. They should know the total error for each test (bias and imprecision) and what is acceptable/not acceptable.

Frequency of QC should be planned, particularly for:-High volume laboratories-Immediacy of treatment

• All patient samples should be treated with equal vigilance

• Some situations may require more vigilance however • Critical lab specialties ( blood banking, infectious disease, molecular)

Contributors to PostAnalytical Laboratory Risk

• Validation of the test result may be performed by someone other than the person who performed the test. Sometimes, staff do not communicate key information regarding the result.

• Lack of information technology (LIS, QC Software) in the laboratory. Lack of these technologies often increases transcription errors and decrease efficiencies and delay of treatment while waiting for printed reports.

• The laboratory should have documented procedures for result validation and ensure these procedures are followed.

• Management should provide resources to implement information technologies that will improve both efficiency and quality in the laboratory.

• There needs to be regular retrospective review of QC data to identify weaknesses in the control of the analytical process.

• Laboratories should determine the reference range for their laboratory based on the instrumentation/methods they use and the community they serve (gender and age).

• When two or more instruments/methods are used to produce results for the same test, the laboratory must demonstrate the comparability of results and reference range for those instruments/methods.

• Laboratories need to have a formal mechanism to communicate results, both critical values and others, to the physician.