Summary:
Summary Statement of Deficiencies D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (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 the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with the Technical Supervisor (TS); the laboratory failed to attest to the routine integration of PT samples for 2 of 18 PT events reviewed from Event 1 of 2025 through Event 1 of 2026. Findings include: 1. Review of laboratory policy and procedure manuals identified the procedure, "193561.27 CIMPAR Lab CMS" which stated, under section titled established PT program guidelines "All documentation of the PT participation is retained this include: .... Copies of the attestation form signed by the testing personnel and the laboratory director." 2. Review of 18 API PT attestation records, from Event 1 of 2025 through Event 1 of 2026, revealed no LD (or designee) or testing personnel (TP) signatures on 2 of 18 attestation records. a. 2026 Chemistry - core - 1st event b. 2025 Chemistry - core - 3rd event 3. An interview with the TS at 01:34 PM, on 07/02/2026, confirmed the LD (or Designee) and TP failed to attest to the routine integration of PT samples for the events listed above. D5200 GENERAL LABORATORY SYSTEMS CFR(s): 493.1230 Each laboratory that performs nonwaived testing must meet the applicable general laboratory systems requirements in 493.1231 through 493.1236, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing. The laboratory must monitor and evaluate the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- overall quality of the general laboratory systems and correct identified problems specified in 493.1239 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of the laboratory's policy and procedure manual, American Proficiency Institute (API) proficiency testing (PT) records, and interview with laboratory Technical Supervisor (TS); the laboratory failed to ensure 1 of 18 API PT events were evaluated for the years of 2025 and 2026 (See 5211), the laboratory failed to verify the accuracy of proficiency testing (PT) performance for triiodothyronine (T3) for four of four PT events reviewed in 2025 through 2026 (See D5215), and the laboratory failed to ensure