The word “Risk” is derivative from the Latin word “riscare” (to dare).Risk Management becomes a reality when human realized that they could “dare the Gods” and aspire to their own goals.

Risk Management is a systematic application of management policies,procedures and practices to the tasks of analyzing,evaluating,controlling and monitoring risk.

Why Risk Management is important for Medical Laboratories

Clinical Laboratories conduct a number of activities, which is a complex process. It includes:

  • Analysis of patients samples from whichinformationsare derived.
  • The information impacts upon decision making and health of the patients.
  • Poor information to clinicians will lead to poor outcome.
  • Errors can occur at any point in the laboratory.
  • Steps are to be taken by the laboratory to ensure that reliable and accurate results are produced.

Hence, the laboratory must examine its processes for hazards where errors could occur and take action to detect and prevent those errors. This can be done by mapping the laboratory processesinto three major phases namely, pre-analytical, analytical and post analytical.

Each phase is then monitored for potentialerrors.As per the International guideline ISO 15189:2012 Clause no.4.14.6Risk Management states thatthelaboratory shallevaluate the impact of work processes and potential failures on the safety of the examination results and shallmodify processes to reduce or eliminate the identified risks and document decisions and actions taken”.

CLSI document EP18-A2 describes Risk management techniques to identify and control error sources in a laboratory. This document is directed toward the laboratory staff and outlines how to develop and maintain a quality control plan (QCP) for medical laboratory testing. This includes assessing performance of equipments, regular quality control assessment and troubleshooting if errors occur.


Risk management tools require the team effort and require some thoughtful time.

It should not be leftas a single person task hence a small team needs to be created to monitor the risks.

The team is required to conduct,monitor and document the risk analysis involved.

The action plans for improvement has to be drawn based on risk assessments.

Risk assessment is based upon.

1.Risk Identification.

2.Severity of the harm/risk.

3.Frequency ofoccurrence.

4.Corrective action& Preventive action in case of a failure.


The procedure for risk assessment and management is classified under the following heads :

A. As the entire operation of the laboratory is divided into three major phases namely, pre-analytical, analytical and post analytical phases to assess the individual phases.
B. Each phase is then examined for potential errors.
C. Each potential error is enumerated and assessed for two categories namely :
a)Frequency b)Severity.
Each of these categories is further sub-divided into three categories which is:
SEVERITY: a) Major, b) Moderate & c) Minor
FREQUENCY: a) Frequent, b) Occasional & c) Remote
The assessment is represented using a matrix.
D. Assess the criticality of risk identified. Criticality of risks is calculated using the formula
Criticality = (Severity X Occurrence)/ 2
E. An appropriate control procedure is introduced which will minimize the risk and make it fall within acceptable limit (risk acceptability matrix).
F. Monitor the identified risks on a yearly basis to evaluate the occurrence of the risks in-spite of the control procedure being implemented. If it is found that the risk is occurring beyond the acceptable limit then the control procedure is revised.

COMPONENTS to be considered in all three phases:
1. Samples:
2. Reagents and consumables
3. Analyzers.
4. Operator
5. Laboratory Environment
6. Quality control materials & data.


After evaluating possible failure modes in the testing process and estimating their criticality or risk, the laboratory then selects appropriate control measures to detect or prevent the error from reaching the patient and maintain risk at a clinically acceptable level.

Quality Controlprocesses and reports reflect best practice of risk control. The laboratory must ensure that the verification procedures used are adequate to determine the accuracy,precision, and other pertinent performance characteristics of the method and laboratory personnel are performing the test methods as required for accurate and reliable results.

Quality control assessment is a common way to monitor the stability of an analytical system The laboratory establishes ranges and control rules that define how much change in assay performance is allowed before QC results are considered out of control. Westgard rules are one such example that employs limits calculated from the mean value and standard deviation of control samples measured when the system is stable and describe when to accept or reject QC results.

The Quality control strategy using QC samples should include the following for each measuring system:
1) The frequency of Quality control sample test events.
2) The type and number of Quality control samples tested per test event.
3) The statistical Quality control(Wesgard Rules) limits used to evaluate the results.
4) The frequency of the periodic review for detecting shifts and trends.
5) The actions taken when the results exceed acceptable limits.

External Quality assessment of proficiency testing (PT) is another control process the laboratory can use to ensure test system performance.

It is ensured that all necessary remedial actions are taken and documented whenever significant deviations from the laboratories  established performance characteristics are identified, and that patients test results are reported only whenthe system isfunctioning properly.


Risk management is a practice, which can minimize the chance of errors in a clinical laboratory and ensure reliability of test results. All the risks and control processes are summarized in a Quality Control Plan (QCP). QCP should be continuously monitored and also revised as further errors are identified, to ensure that patient results are reliable and residual risks are maintained to a clinically acceptable level.

By : Dr Moushumi Saikia

Consultant Biochemist/Quality Manager,

Department of Laboratory Medicine,

Apollo Hospitals Guwahati.

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