Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of personnel training and competency assessment records, Standard Operating Procedures (SOPs), as well as interview with the Practice Manager (PM), the laboratory failed to establish and approve procedures to assess initial training of Testing Personnel (TP) and annual competencies for the Clinical Consultants (CCs) and the Technical Consultant (TC). FINDINGS: 1. There was no documentation of initial training for the new TP hired October 28, 2024. It was noted that the six-month competency assessment was performed and documented, June 8, 2025. 2. There was no documentation of annual CC and TC competency assessment performance. 3. The current, approved SOPs did not include instructions for performing such activity. 4. The PM confirmed the findings on August 5, 2025, at approximately 10:15 A.M. 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, and other materials used in testing. (b)(5) Calibration and calibration verification 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 -- 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)