Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on July 11, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and an interview with the Clinic's Laboratory director, the laboratory failed to enroll in Peer review program to verify accuracy of its Provider Performed Microscopy(PPM) testing on joint fluids. Findings include: 1.) A review of laboratory documents revealed that there was no evidence of peer review at least twice annually for the years of 2016 to 2018 for synovial (joint) fluids. 2.) An interview with the Clinic's laboratory director at approximately 12:20 pm, on July 11, 2018 in the break room confirmed the abscence of a Peer review program. 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 document review and an interview with the laboratory director, the lab failed to document