Risk management in a clinical pathology laboratory: Application of brainstorming and probability analysis for risk reduction.

Abstract

Risk management includes identifying various risks, assessing the probability of occurrence, and evaluating the severity of their consequences. As clinical laboratories are integrally involved in patient care, risks in the laboratories could present grave consequences in some instances. This study aimed to utilize simple techniques for risk management in a clinical laboratory. All potential risks in the pathology laboratory of a tertiary-level hospital were identified and classified into natural calamity, environmental, manpower-related, pre-analytical, analytical, post-analytical, and laboratory hazard-related risks through a brainstorming session. The probability of occurrence of each risk was estimated from departmental and hospital records. The possible impact of risk (score 1-10) was categorized into catastrophic, critical, serious, minor negligible, and insignificant. The unweighted risk score was calculated by multiplying the probability of occurrence and impact score. Inadequate sample-to-anticoagulant ratio had the highest probability of occurrence (22.85%), followed by quantity insufficient for analysis (7.30%) and laboratory information system (LIS) breakdown (6.58%). The highest unweighted risk score in our study was inadequate sample-to-anticoagulant ratio (score 91.40), followed by improperly labeled samples (score 35.61), manpower competency issues (score 32.88), sample insufficient for analysis (score 29.20), and LIS breakdown (score 26.30). We found that among all the categories, risks involving the pre-analytical phase had the highest risk scores. The other important risks included manpower competency issues requiring continued on-the-job training of staff as a risk reduction strategy. Brainstorming and probability analysis could be easily used for risk management in a clinical laboratory.