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 record review and interview with the Technical Consultant (TC1), the laboratory failed to follow the written procedure to assess the competency of all laboratory personnel. Findings include: 1. Review of the laboratory's competency documentation for 2023-2024 on 12/18/2024 revealed no review of TC1 or TC2 for his /her CLIA federal regulatory responsibilities. 2. Record review of the laboratory's Competency of Laboratory Personnel policy on 12/18/2024 revealed the following the policy did not contain information for evaluating the laboratory's Technical Consultants. 3. Staff interview with the TC1 on 12/18/2024 at 11:00am confirmed the above findings. 4. The laboratory performs 7,809 tests annually in the specialty of Microbiology, 11,000 tests annually in Diagnostic Immunology, 1,149,096 tests annually in Chemistry, and 328,290 tests annually in Hematology. 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 2 -- 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)