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 Laboratory Director, Clinical Consultant, and the Testing Personnel, the laboratory failed to follow its established policy to assess competency of personnel serving as clinical consultant and technical consultant for 2 (February 2021 to February 2023) of 2 years reviewed. Findings include: 1. A review of the laboratory's "Personnel Competency Policy/Procedure" revealed a section stating, "All testing personnel, Director, Technical Supervisor and General Supervisor must be reviewed for their ability to perform their jobs correctly. Laboratory compliance requires personnel to be reviewed to ensure all personnel have the appropriate training, education and experience for the type of testing being performed. Documentation of the personnel's education must be on file for all Laboratory Personnel. Laboratory compliance requires training/competency to be completed initially, 6 months after the original start date and annually there after." 2. The surveyor requested the competency assessments performed for personnel serving as clinical consultant and technical consultant on 2/22/23 at 8:49 am and the documentation was not made available. 3. An interview on 2/22/23 at 8:49 am with the Laboratory Director, Clinical Consultant, and the Testing Personnel confirmed the laboratory had not performed competency assessments for personnel serving as clinical consultant and technical consultant. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)