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, the laboratory failed to establish and follow written policies and procedures to assess the competency of its consultant personnel. The laboratory lacked any written policy or procedure requiring a competency assessment for 1 of 1 technical consultant (TC). . The findings include: 1. A review of the laboratory's personnel manual on 05-27-26, revealed that the laboratory failed to establish any written competency assessment policies or procedures for consultant- level personnel. 2. A review of the personnel records on 05-27-206 confirmed that no competency assessment had been performed or documented for the technical consultant since the laboratory began testing. 3. During an interview on 05-27-206, at 4:25 PM, the technical consultant confirmed that the laboratory did not have a written policy requiring a competency assessment for their position, and verified that no evaluation of their regulatory responsibilities had been conducted or documented. . 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 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 -- results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, 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)