Summary:
Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of policies and procedures, lack of documentation, and an interview with testing personnel three (TP3) the laboratory failed to fully establish procedures and follow quality assessment activities described in the procedure since December 2023. The findings include: 1. A review of the procedure "Patient Result Review" listed quality assessment activities to review calculations, linearity, clerical error, unusual results, critical values and provider notification, and performance of reflex testing. 2. A request was made for quality assessment policies or procedures describing how quality assessment activities are performed but documentation could not be provided. 3. Documentation for performing review of quality assessment activities could not be provided. 4. An on-site interview with TP3 on 10/29/25 at 2:00 PM confirmed there was no documentation. 5. The laboratory reports performing 78096 tests annually. D5781