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 review of laboratory personnel records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 8: 45 am on 02/18/22, the laboratory failed to meet the testing personnel requirements by providing documentation to qualify the testing personnel who perform moderate complexity as specified in standard 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 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 -- This STANDARD is not met as evidenced by: Based on review of laboratory personnel records and confirmed by laboratory personnel identifier #1 (refer to the Laboratory Personnel Report) at approximately 8: 45 am on 02/18/22, the laboratory failed to have documentation to qualify six out of 21 testing personnel (identifiers #2 - #7) who perform moderate complexity testing. The findings include: 1. Testing personnel identifiers #2 - #7 all began performing moderate complexity testing since the last survey performed on 1/21/2020. 2. At the time of the survey, the laboratory did not have diplomas and/or transcripts to qualify testing personnel identifiers #2 - #7 to perform moderate complexity testing. -- 2 of 2 --