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 review and interview with the Laboratory Manager, the laboratory failed to ensure the testing tersonnel met the qualification requirements at 493.1423. Findings include: 1. The laboratory failed to ensure testing personnel was qualified. 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 high school diploma or equivalent; and This STANDARD is not met as evidenced by: 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 -- . Based on record review and interview with the Laboratory Manager, the laboratory failed to ensure personnel performing creatinine testing using the Abbott iStat were qualified for 1 (Testing Personnel #1) of 16 testing personnel listed on the CMS-209 form. Findings include: 1. A record review of the laboratory's testing personnel records revealed a foreign degree for Testing Personnel #1. 2. A request by the surveyor for the foreign equivalency evaluation for Testing Personnel #1's foreign degree was made on 2/11/21 at 9:19 am and the documents were not made available. 3. An interview on 2/11/21 at 10:50 am with the Laboratory Manager confirmed the foreign equivalency evaluation was not available for Testing Personnel #1. 4. The laboratory was given an additional 7 days to supply the necessary education documents. The documents were not received. -- 2 of 2 --