Summary:
Summary Statement of Deficiencies D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: Based on record reviews and an interview with the Quality and Regulatory Compliance Director, the laboratory failed to ensure the individuals who performed moderate complexity testing met the qualification requirements of 493.1423 to perform the functions specified in 493.1425 for the testing procedures performed. This deficient practice affected one out of 14 Testing Personnel (TP). Findings Include: 1. The laboratory failed to ensure TP #12 met the education requirements, as specified in subpart M for moderate complexity testing procedures performed. (Refer to D6065) D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a 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 -- high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on document reviews and an interview with the Quality and Regulatory Compliance Director, the Laboratory Director failed to ensure Testing Personnel (TP) #12 had the appropriate education equivalency documentation to perform all test operations reliably to provide and report accurate results. This deficient practice affected one out of 14 TP. Findings Include: 1. Review of the laboratory's Form CMS 209, approved, signed and dated on 07/06/2021 by the Laboratory Director found 14 TP. 2. Review of education documents found that TP #12 had a foreign degree. 3. The inspector requested foreign equivalency documentation for TP #12. 4. An interview with the Quality and Regulatory Compliance Director, on 12/14/2022 at 9:07 AM, confirmed the laboratory failed to ensure TP #12 had the appropriate education equivalency documentation to perform all test operations reliably to provide and report accurate results and was unable to provide the requested documentation for the inspection. -- 2 of 2 --