Summary:
Summary Statement of Deficiencies D5891 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(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 postanalytic systems specified in 493.1291. This STANDARD is not met as evidenced by: Based on review of patient test results records, the laboratory's policies and procedures manual, and interviews with the administrator and medical assistant (MA), it was determined that the laboratory failed to follow the established written policies and procedures for quality assessment as part of an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the preanalytic, analytic, and postanalytic systems. The findings include: 1. Based on the survey on October 30, 2024, no documentation was available to support the monthly checking of records as specified in the laboratory's policies and procedures. 2. For one (1) out of five (5) randomly chosen patient test results reviewed for Mohs, the date of service in the log sheet did not match other records. No