Summary:
Summary Statement of Deficiencies D0000 A recertification survey was performed on , July 24, 2024. The facility was found to be NOT in compliance with all applicable CLIA requirements for specialties /subspecialties for 42 CFR. 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 proficiency test (PT) records and interview with the laboratory technical supervisor (TS) , the laboratory testing personnel (TP) and lab director (LD) failed to attest that PT samples were tested in the same manner as patient specimens. Findings: 1. Review of PT records of 2023 - 2024 revealed the lack of signed attestation statements for the College of American Pathologist (CAP) Liquid Chromatography/Mass Spectophotometry (LC/MS) testing. 2. Review of PT records of 2023 - 2024 revealed the lack of a TP signed attestation statement for the American Proficiency Institute (API) 2023 Event 1 urine drug screen testing performed on the Pictus 500 analyzer. The LD signed. 3. Interview with the TS (CMS 209) on 7/24/24 at 2:12 PM in the FACP office confirmed the aforementioned findings. 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 --