Summary:
Summary Statement of Deficiencies D0000 An announced recertification survey was conducted on 9/7/21 at Gastroenterology Specialist Inc., a clinical laboratory in Palm Beach Gardens, Florida. Gastroenterology Specialist Inc. is not in compliance with Code of Federal Regulations (CFR) 42, Part 493, Laboratory Requirements. The following is a description of the standard level deficiencies: D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on histopathology twice annual verification of accuracy record review and interview with the histotechnologist , the Laboratory Director failed to ensure that