Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 25, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiency was 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 review of the American Proficiency Institute (API) documents and staff interview the laboratory failed to complete the Attestation Statements for 2018 event 1, and 2018 event 2 before submitting the results. Findings: 1. Review of the API documentation for Event 1 of 2018 Chemistry Misc. Neither the Laboratory Director (LD) or the Testing Personnel (TP) signed the attestation statement. For Event 2 2018 Chemistry Misc. the TP did not sign the attestation statement. 2. Staff interview with the LD on February 25, 2019, at approximately 2pm in the office, the LD confirmed that events 1 and 2 of 2018 for the Chemistry Misc testing were not signed properly by the LD and the TP as stated above. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --