Summary:
Summary Statement of Deficiencies D0000 An on-site validation survey was conducted on 08/26/2026, with the following standard-level deficiencies cited: D3029 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(2) Test procedures. Retain a copy of each test procedure for at least 2 years after a procedure has been discontinued. Each test procedure must include the dates of initial use and discontinuance. This STANDARD is not met as evidenced by: Based on DCA Vantage Hemoglobin A1C Individualized Quality Control Plan (IQCP) procedure review and staff interview, the laboratory failed to retain the Risk Assessment (RA) portion of the IQPC. Findings: 1. Review of the DCA Vantage Hemoglobin A1C IQCP procedure revealed the procedure lacked a Risk Assessment. 2. On 08/26/2026 at 12:30 PM, during an interview, the Technical Supervisor confirmed the laboratory could not locate the Risk Assessment portion of the DCA Vantage Hemoglobin A1C IQCP. 3. The laboratory reported performing 307 Hemoglobin A1C tests annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (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, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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)