Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey was conducted on 3/12/2026. Standard level deficiencies were cited. D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of Form CMS-209, personnel records, proficiency testing, and the laboratory's procedure manual, the laboratory failed to ensure 3 of 3 hematology proficiency testing (PT) events in 2025 were analyzed by personnel who routinely perform testing on the Sysmex XN-330. Findings included: 1. Review of the Form CMS-209 laboratory Personnel Report (CLIA) included a total of 7 testing persons (TP) for Sysmex XN-330. According to personnel records, TP-1, TP-2, and TP-3 had been active testing persons for more than 2 years. 2. Review of American Proficiency Institute (API) hematology PT events 1, 2, and 3 in 2025 revealed TP-1 analyzed all three events. 3. Review of the laboratory's procedure "LAB-004" stated, "Proficiency testing is to be rotated and performed by ALL testing personnel on ALL testing systems, where applicable." The laboratory did not follow their own procedure for rotating and performing PT by personnel who routinely perform hematology testing on the Sysmex XN-330. 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, 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 -- 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)