Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on April 16, 2019. 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: D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on proficiency test (PT) document review and staff interview, the laboratory director (LD) failed to attest to the routine integration of the PT samples into the patient workload as required. Findings include: 1. American Proficiency Institute (API) PT document review revealed the LD failed to sign the attestation statement for the first and third hematology PT event of 2018. 2. An interview with the LD in a conference room on 4/16/19 at approximately 6:30 p.m. confirmed the LD did not sign the aforementioned attestation statements. 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 proficiency test (PT) document review and staff interview, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- failed to verify PT activities as required. Findings include: 1. AAFP (American Proficiency Institute) PT document review revealed the laboratory failed to perform