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 the laboratory records and interview with the laboratory representative SB; the laboratory failed to follow their written policy to assess the competency of the clinical consultant, technical consultant and technical supervisor. Findings Include: 1. Review of the laboratory's policy and procedure manual identified the policy, "Competency Assessment Policy", which stated: "Documented competency is required for individual clinical consultants, technical consultants, technical supervisors, general supervisors, and/or testing personnel (if applicable) who perform testing on patient specimens are required to comply with the procedures in their competency assessment in addition to a competency assessment based on their federal regulatory responsibilities. Results of each competency test will be entered in a log and kept in the laboratory management manual, as par of its records". 2. Review of competency records found no competency assessments for the individual listed as the clinical consultant, technical consultant and technical supervisor on the CMS-209 (Laboratory Personnel Report). 3. On survey date 10-20-2021, at 2:30 pm, the laboratory representative SB confirmed the laboratory failed to follow the competency assessment policy and document competency assessments for the clinical consultant, technical consultant and technical supervisor. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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 -- 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)