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 the surveyors' review of the laboratory's policies & procedures, twelve (12) randomly selected patients' test records, and interviews with the laboratory's histopathology practice manager (PM) and office lead (OL); the laboratory failed to establish and follow written policies and procedures to assess quality of its preanalytical, analytic, and postanalytic systems. The findings included: 1. The laboratory did not have a complete quality assurance plan with policies and procedures that included patients' test results management (self-audits) to assess the preanalytical, analytic, and postanalytic systems and