Summary:
Summary Statement of Deficiencies D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on review of proficiency testing records for 2021, 2022, and to date July 19, 2023 and interview with the the technical consultant (TC), the laboratory failed to maintain a copy of records for proficiency testing (PT), including the signed attestation statement and a copy of the PT program report forms used by the laboratory to record PT results (raw data) for a minimum of two years for nine of nine events. Findings: 1. Review of PT records showed the laboratory failed to provide a signed attestation form for the following PT testing events: -2021 Chemistry Core - first event, second event, and third event -2022 Chemistry Core - first event, second event, and third event -2023 Chemistry Core - first event, second event, and third event 2. Review of PT records showed the laboratory failed to provide a copy of the PT program report forms used by the laboratory to record PT results (raw data) for the following PT testing events: -2021 Chemistry Core - first event, second event, and third event -2022 Chemistry Core - first event, second event, and third event -2023 Chemistry Core - first event, second event, and third event 3. Interview with TC on July 19, 2023 at 9:00 AM confirmed the laboratory failed to maintain a copy of all 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 -- records for proficiency testing, including the attestation statement and a copy of the PT program report forms used by the laboratory to record PT results for a minimum of two years. -- 2 of 2 --