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 laboratory policies and procedures, lack of competency assessment records and interviews the laboratory failed to establish and follow written policies and procedures to assess the competency of the Technical Supervisors. The laboratory failed to assess the competency of 12 of 12 Technical Supervisors in 2023 and 2024 and January 1, 2025 to the date of the survey in 2025. Findings include: 1. The Survey Team requested and the laboratory failed to provide written policies and procedures to describe the process for assessing the competency of the Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide documentation of competency assessments for 12 of 12 Technical Supervisors in 2023, 2024 and January 1, 2025 to the date of the survey in 2025. Technical Supervisors include: -Technical Supervisor A -Technical Supervisor B -Technical Supervisor C -Technical Supervisor D -Technical Supervisor E -Technical Supervisor F -Technical Supervisor G -Technical Supervisor H -Technical Supervisor I - Technical Supervisor J -Technical Supervisor K -Technical Supervisor L 3. During interviews on February 11, 2025 at 9:30 AM and February 12, 2025 at 11:15 AM, these findings were confirmed with the Survey Contact/Quality Specialist. 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 8 -- 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)