QUALITY MANAGEMENT

A quality management (QM) program is essential to ensure the safety of patient samples and maintenance of quality laboratory operations. The QM program should include a quality assurance (QA) program, which is set up to evaluate the laboratory's analytical performance by comparing test performance. The College of American pathologists (CAP) has specific guidelines on developing and implementing QM programs and their component plans. Individual assay controls must be in place to ensure assay performance. The laboratory must have written standard operating procedures (SOPs) for laboratory processes to ensure the quality, and integrity of the test data. If specific water types are required per manufacturer for certain testing procedures, the laboratory must ensure that records of water quality testing are complete and indicate that the required standards for water quality are consistently met. Reports generated by a laboratory information system (LIS) must be concise, readable, and in a standardized format.