Summary:
Summary Statement of Deficiencies D0000 A Recertification survey was performed at Laboratory Corporation of America Holdings, CLIA ID 19D2238389, on October 21, 2025. The laboratory was found in compliance with 42 CFR 493 Requirements for Laboratories; however, standard level deficiencies were cited. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, proficiency testing records, and interview with personnel, the laboratory failed to document their evaluation of ungraded proficiency testing results for two (2) of five (5) events reviewed. Findings: 1. Review of the laboratory's "External Proficiency Testing Procedure" revealed the "The Laboratory Director or designee (documented) must review and sign the PT survey evaluation including: graded evaluation, ungraded evaluations including those ungraded due to lack of consensus, regulated and non-regulated challenges, and educational challenges." 2. Review of the laboratory's 2024 and 2025 American Proficiency Institute(API) proficiency testing records revealed the laboratory did not document their evaluation, to include acceptability, of "not graded" results for the following two (2) events: a) 2024 Chemistry Core 1st Event: Total Bilirubin, Samples: CH-02, CH-03, CH-05 b) 2025 Chemistry Core 2nd Event: Total Bilirubin, Samples: CH-07, CH-09, CH-10 3. In interview on October 21, 2025 at 1:30 pm, the Laboratory Director confirmed the acceptability of the ungraded proficiency testing results were not documented for the two (2) identified events. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 5 -- (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)