Summary:
Summary Statement of Deficiencies D0000 An onsite validation survey was conducted on May 21, 2026. The laboratory was found to be in compliance with condition level deficiencies. The following standard- level deficiencies were cited. 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 the laboratory's policy, procedures, lack of a supervisory competency assessment procedure, and an interview with the technical consultant (TC), the laboratory failed to have a policy or procedure in place to assess the competency of 1 of 1 TC. Findings: 1. Review of laboratory policies and procedure on May 21, 2026, revealed that competency assessment procedures were for testing personnel performing blood gas testing on the Radiometer ABL 90 Flex. 2. The laboratory failed to provide a policy or procedure for the assessment of competency for the TC. 3. By interview on May 21, 2026, at 9:00 am, the TC confirmed that a supervisory competency assessment was performed for delegated responsibilities, but there was no policy or procedure in place for the assessment of the TC. 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 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 -- 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)