Summary:
Summary Statement of Deficiencies D0000 The following deficiencies were cited during a validation survey completed on 01/09 /2020 for the federal requirements of 42 CFR Part 493 for Laboratories. 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 the review of 2018-2019 proficiency test records, laboratory policy, and interview with the General Supervisor, the laboratory failed to ensure attestation statements were physically signed by the Laboratory Director and testing personnel. Findings are: A. Review of 2018-2019 proficiency test records revealed the laboratory director failed to physically sign attestations statements for 5 of 5 test events in 2018 and 4 of 4 in 2019. 1. CAP (College of American Pathologists) Proficiency testing program UT (Urine Toxicology) -A 2019, kit date 04/03/19 Undated electronic signature for both the Laboratory Director and Testing Person #1. UT-B 2019, kit date 08/21/19 Undated electronic signature for both the Laboratory Director and General Supervisor (as the testing person) UT-C 2019, kit date 11/14/19 Undated electronic signature for both the Laboratory Director and General Supervisor (as the testing person) DMPM (Drug Monitoring for Pain Management) - A, kit dated 03/07/18 Undated electronic signature for both the Laboratory Director and General Supervisor (as the testing person) DMPM, kit dated 09/12/18 Undated electronic signature for the Laboratory Director. The testing person did not sign. 2. API (American Proficiency Institute) Proficiency Program Chemistry - Miscellaneous (Urine Drug Screens) 2018- 1 Electronic signature for the Laboratory Director on 05/09/18. 2018-2 Electronic signature for the Laboratory Director on 10/25/18. 2019-1 Electronic signature for the Laboratory Director on 05/03/19. 2019-2 Electronic signature for 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 2 -- Director on 10/17/19. B. Review of the laboratory's Proficiency Testing Policy, reviewed by the Laboratory Director on 08/25/17, 08/07/18, and 08/16/18 indicated; "The Lab Director will review and sign all attestations, results, and