Summary:
Summary Statement of Deficiencies D0000 Based on an announced validation inspection, the lab was found to be out of compliance on the following CONDITION LEVEL DEFICIENCY: D6063 - 42 C.F. R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference and by phone call on 02/09/2023. 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 review of personnel records, pre-survey paperwork, and interview, the laboratory failed to provide educational credentials for one of five testing personnel performing moderate complexity testing (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 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 -- Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: Based on review of personnel records, pre-survey paperwork, and interview, the laboratory failed to provide educational credentials for one of five testing personnel required to perform the moderately complex Prothrombin Time & International Normalized Ratio (PT/INR) using the Abbott iSTAT analyzer. Findings follow. 1. Review of educational credentials for testing personnel #1, as listed on the CMS form 209, showed her education was completed in Canada. 2. Review of the pre-survey paperwork titled Laboratory Personnel form showed testing personnel #1 was hired on 08/30/2021. 3. Surveyor requested a US equivalency evaluation on February 8, 2023, at 1005. Interview with the technical consultant on February 8, 2023, at 1010 hours in the conference room confirmed that the laboratory did not have a US equivalency evaluation for testing personnel #1. -- 2 of 2 --