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 laboratory director, the laboratory failed to have a policy or procedure to assess the competency for four out of four technical consultants for the position of technical consultant. Findings Include: 1. The laboratory performed approximately 14,951 moderately complex hematology and chemistry tests a year. 2. A review of the laboratory procedures revealed the laboratory failed to have a policy or procedure to assess the competency of the position of technical consultant for four out of four technical consultants. 3. An interview on 04/06/2022, at 1:40 PM, with the laboratory director, confirmed the laboratory failed to have a policy or procedure to assess the competency for the position of technical consultant. 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 materials used in testing. (5) Calibration and calibration verification procedures. (6) 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 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)