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 procedures, laboratory records, and interviews, it was determined that the laboratory failed to establish written policies and procedures to assess the competency of four of four Technical Supervisors who performed cytology microscopic evaluations during 2017 and to the date of the survey in 2018. Findings include: 1. The Survey Team requested and the laboratory failed to provide a procedure to detail how competency assessment would be performed and documented for four of four Technical Supervisors. 2. The Survey Team requested and the laboratory failed to provide records of competency assessment for four of four Technical Supervisors who performed cytology microscopic evaluations during 2017 and to the date of the survey in 2018. 3. During an interview on 12/3/2018 at 2:25 PM, Cytotechnologist A stated there were no competency assessment records for the Technical Supervisors. 4. During an interview on 12/4/2018 at 1:45 PM, the Laboratory Directory/Technical Supervisor A confirmed these findings. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 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 -- 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)