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 an interview with the General Supervisor (GS), the laboratory failed to follow their written policy and procedure to assess competency of the GS, as specified in the personnel requirements in subpart M. All patients tested at this laboratory have the potential to be affected. Findings include: 1. Review of the laboratory's "Competency Assessment" policy and procedure failed to find a written policy and procedure to assess competency of the GS based on the federal regulatory responsibilities of that position. 2. Review of the laboratory's Competency Assessment documentation found the lab failed to assess the GS for competency based on the federal regulatory responsibilities of that position. 3. An interview with the GS, on 2/25/19 at 1:26 pm, confirmed that the lab failed to to assess the GS for competency based on the federal regulatory responsibilities of that position. 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. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other 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 -- 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)