Observation of Laboratories and Processes

6116.2 - Observation of Laboratories and Processes (Rev. 230; Issued: 07-11-25; Effective: 07-11-25; Implementation: 07-11-25) Observe the laboratory’s physical layout. These observations should include specimen collection and processing, “prep” and clean-up areas, testing and reporting areas, and storage areas. Whenever possible, observe specimen processing and test performance, noting information which would precipitate revisiting an area, interviewing personnel, or requesting records for review. Observe and verify that reagents, kits, and equipment correlate with test menu, clients served, and results reported. Also observe whether staffing and space appear adequate for test volume. Schedule the survey date/time to observe personnel performing specimen processing, testing, and reporting of results in each specialty/subspecialty of service. If it is not possible to observe testing, ask for a verbal walk-through of the procedure. Do not distract staff when observing operations and personnel activities. Focus observations on: • Specimen integrity; • Quality control performance; • Skills and knowledge of personnel regarding: a. Performance of testing; b. Evaluation of test results; c. Identification and resolution of problems; and • Interactions of personnel regarding: a. Availability of supervisor to staff; b. Communication among personnel at all levels within the laboratory and with clients; and c. Interaction of laboratory director in laboratory’s operations. At all times respect patient privacy and do not interfere with patient care and confidentiality.