The test results generated by clinical laboratories aid in both diagnosis of patients' medical conditions and their continuous treatment monitoring. Since laboratory test results form an integral part of medical decisions, it becomes an absolute necessity that results generated by the lab are highly reliable and accurate. In recent years the field of laboratory medicine has shown tremendous technological advancements and automation in all of its major processes, which include pre-examination (pre-analytical), examination (analytical), and post-examination (post-analytical) processes. Despite the automation of processes, some risks are persistent, and those, if not controlled adequately, could result in a wrong diagnosis, wrong treatment, and ultimately morbidity and mortality. So identification and mitigation of potential risks associated with laboratory processes shall always be given prime importance. Risk management in laboratories, like any industry, follows similar strategies that include creating a process map that gives a better understanding of process flow among staff. Followed by which potential sources of errors are identified and assessed for their impact based on severity, the likelihood of occurrence, and detectability, implementing controls and checks to prevent and detect error before it harms the patient. This technical report is to emphasize that patients can be harmed not only by the issuance of erratic results but also due to failure of certain processes like delayed result generation or delayed critical results communication, etc.
Whole textbooks could be written on that subject. To add to Maria's answer, a good QA program at a lab should include:
Assessments of random lab results
Assessments observing tasks being performed
MBWA (Management by wandering around)
Good corrective action tracking and completions, and PACA
Performance analysis using trending of metric results
Management involvement, Good managment practices
Development, training and qualificaiont of personnel
Incident investigations with causal analysis and corrective and mitigating actions
Human Performance Improvement, including keepting a transparent non-punitive environment for problem reporting
Don't blame the lab worker - the person closest to the problem
Calibration program - M&TE
Maintenance of equipment, including reliability
Arielle, I hope my answer will help you.
It depends on the type of laboratory in question. For Physics, you should use a Risk Management type, as in general they should be solid, at most flame. If it is a Chemical laboratory, with subst. gases, grease, etc... you will have to use a Butterfly type Assessment.
Search on Google for the different types of Assessment and you should find what suits you best.
Here are the names of some of the existing techniques: FMEA; HAZOP; Preliminary risk analysis; Fault Tree Analysis;
Event Tree Analysis; Check list; WhatIf; The 5 Whys.
But NEVER forget about use the signalization and Warnings.
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