Summary:
Summary Statement of Deficiencies D0000 A Recertification Survey was initiated on 09/22/2023 and concluded on 09/22/2023. The facility was found not to be in compliance with the laboratory requirements of 42 CFR Part 493 with deficiencies 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 document review and interview, the laboratory failed to ensure a laboratory director and testing personnel signed a proficiency testing attestation statement for 1 of 3 proficiency test events reviewed. Findings included: A review of a "2023 Chemistry Miscellaneous 1st Event Attestation Statement" indicated, "An attestation statement must be signed by testing personnel and the laboratory director and retained for a minimum of 2 years." The review revealed that the statement was not signed by the laboratory director or the person(s) who performed the test. During an interview on 09/22/2023 at 11:40 AM, Testing Personnel (TP) #2 stated that they usually did not complete the attestation forms for proficiency testing. The attestation statement forms for 2022, events 1 and 2, were not available for review. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. 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 -- This STANDARD is not met as evidenced by: Based on observation, interviews, and document review, the laboratory failed to ensure that an initial competency assessment was documented for 1 (Testing Personnel [TP] #1) of 2 testing personnel reviewed. Findings included: During the laboratory tour on 09/22/2023 at 10:00 AM, TP #1 was observed loading samples on a urine drug screen analyzer. During an interview at 10:00 AM, TP #1 provided an overview of specimen collection, preparation, and testing on the analyzer. A review of TP #1's personnel file revealed TP #1 started working in the laboratory on 10/07 /2022. In response to a request for evidence showing TP #1 received initial training on using the analyzer, the facility provided TP #1's completion certificates from the manufacturer's online modules. During an interview on 09/22/2023 at 11:05 AM, TP #2 stated they observed TP #1 perform laboratory testing and tasks after completion of each online module, but the performance was not documented. -- 2 of 2 --