Summary:
Summary Statement of Deficiencies D0000 A Recertification Survey was conducted on July 31, 2025 at approximately 9:00AM. The laboratory was surveyed according to 42 CFR Part 493 Clinical Laboratory Improvement Amendments (CLIA) requirements. Deficiencies were identified as follows: D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (b)(7) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on interview and laboratory document and policy review, the laboratory failed to have signed proficiency testing (PT) attestation forms for 9 out of 9 PT events reviewed. Findings included: A laboratory policy titled, "2.4.2 Proficiency Test Policy (External Assessment Test)," including a "Procedure Review / Signature" page signed by Laboratory Director (LD) #1 on 07/10/2024, revealed, "10. PT Records 10.1 GI [gastrointestinal] Lab maintains records of each PT event, including a copy of the PT program report forms, work records, evaluation reports, and any