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's policies and procedures, review of personnel records, and interview with the laboratory manager 4/3/19, the laboratory failed to establish and follow policies and procedures for monitoring the competency of the TC (technical consultant). Review of the laboratory's policies and procedures revealed the laboratory had a policy for conducting testing personnel competency evaluations, but did not have a policy for evaluating the competency of the TC. Review of personnel records revealed the TC was evaluated in May 2017 and May 2018 by the laboratory director. The evaluation included routine testing personnel duties, and included the following statement: "The Technical Consultant follows CLIA Regulations in the performance of assigned duties." The duties were not listed on the evaluation form. During interview at approximately 2:15 p.m., the laboratory manager confirmed that the laboratory did not have a policy for evaluating the competency of the TC. 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 performance of the procedure, including test calculations and interpretation of results. 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 -- (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)