Summary:
Summary Statement of Deficiencies D0000 The validation survey was performed on 08/20/2025. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the technical consultant at the conclusion of the survey. 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 a review of records, written policies and procedures, and interview with the technical consultant, the laboratory failed to establish a written policy to assess the competency of the technical consultant, based on the position responsibilities as listed in Subpart M, for one of one person. Findings include: (1) On 08/20/2025, a review of the laboratory policy and procedure manual identified no evidence of a policy for assessing the competency of the technical consultant based on the position responsibilities, including the frequency of the assessments; (2) A review of the Form CMS-209 (Laboratory Personnel Report) and personnel records for competency assessments performed during the review period of August 2023 through the current date identified, although competencies, based on the position responsibilities, had been performed for one of one person listed as the technical consultant on 06/10/2025, the assessment policy was not available for review; (3) The findings were reviewed with the technical consultant who stated on 08/20/2025 at 12:10 pm, a written policy was not available, although competencies had been performed for the position as stated above. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) 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 -- (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 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)