Quality Assurance in the Laboratory

This is a primer for Quality Assurance; how to define it, the type of documentation to maintain, what to include in a QA Plan and how to implement it in your laboratory. PURPOSE The purpose of a quality assurance program is to improve the reliability, efficiency, and quality of the laboratory service. GOALS The goals of a quality assurance program are to: • IMPROVE the overall quality and efficiency of the laboratory service. • EVALUATE the effectiveness of the laboratory's policies and procedures. • IDENTIFY problems and make corrections • ASSURE accurate, reliable, and prompt performance of tests and reporting of test results. DEFINITIONS The process of Quality Assurance consists of four stages: 1) Planned review of all policies and procedures for their effectiveness. 2) Identification of any problems through this review process. 3) Corrective action taken to prevent future problems. 4) Follow-up review of the effectiveness of corrective actions. There are three major phases of laboratory testing that a QA program should evaluate: 1) Pre-Analytical — Specimen collection/storage/pro-cessing, personnel training, etc. 2) Analytical — Quality control, preventive maintenance , calibrations, etc. 3) Post-Analytical — Result reporting, turnaround times, etc. The examples listed above are some of the major elements that would be addressed in QA reviews in a laboratory. Refer to the COLA Criteria for Quality Laboratory Performance, question numbers 284-299 for the remaining elements that should be a part of a complete QA Program. A further breakdown of these elements are listed at the end of this LabGuide. There are two situations that prompt a QA review: 1) Routine, scheduled review of an element. 2) In response to an identified problem or complaint needing immediate attention. The final essential piece of a QA Program is documentation. All QA activities must be documented completely. This should include: 1) Date of the review or date the problem or complaint was identified. 2) Initials of person performing review. 3) Scope of the review. 4) Results of review and any corrective action taken. 5) Date and description of follow-up review of the effectiveness of corrective action. The first step in the QA process is to develop a written QA Program addressing all elements in the phases of testing listed above. The second step is to schedule the implementation of the plan. Pick an element to evaluate. Decide how the evaluation will be conducted and over what period of time. Determine what is …