Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on January 19, 2018. 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 proficiency test (PT) records and interview with the facility supervisor, the laboratory director (LD) failed to attest that PT samples were tested in the same manner as patient specimens. Findings include: 1. Review of American Proficiency Institute (API) PT records revealed the LD failed to sign the 2016 1st & 3rd test event attestation statements. 2. Interview with the facility supervisor on 1/19 /18 in the drug screen collection/record room at approximately 330 PM, confirmed the LD did not sign the attestation forms. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Based on review of testing personnel (TP) competency records and staff interview , the technical consultant (TC) (also the lab director/LD) failed to perform annual competency on testing personnel. Findings include: 1. Review of the TP competency records revealed the competencies were performed by the facility supervisor or the medical laboratory technician (MLT), neither qualified as TC. 2. An interview with the quality improvement coordinator on 1/19/18 at 2:20 PM in the drug screen record /collection room, confirmed the TC (LD) did not perform the competencies. -- 2 of 2 --