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 personnel records 8/25/26 and deficiency cited at D6065, the laboratory failed to verify that 2 of 5 TP (testing personnel #4 and #5) met the minimum education requirements for performing moderate complexity testing. 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 (b)(2) Have earned a doctoral, master's, or bachelor's degree in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution; or (b)(3) Meet the requirements in 493.1405(b)(3)(i)(B), (b)(4)(i)(B), (b)(4)(i)(C) or (b)(5)(i)(B); or (b)(4) Have earned an associate degree in a chemical, biological, clinical or medical laboratory science, or medical laboratory technology or nursing from an accredited institution; or (b)(5) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least a duration of 50 weeks and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(6)(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 the laboratory's policies and procedures, review of personnel records, and interview with the TC(technical consultant #2) on 8/25/26, the laboratory failed to verify that 2 of 5 TP(testing personnel #4 and #5) met the minimum education requirements for performing moderate complexity testing. Findings: Review of the laboratory's Personnel Competency Assessment policy states, "...Before any non-waived testing begins, the team member must present a copy of their high school diploma or transcript with graduation dates, General Educational Development (GED), Associates in Science Degree, or Bachelor's Degree, to be stored in the personnel file in the lab or in the online competency software..." Review of personnel records revealed there was no education documentation on file for TP#4. The office manager provided a copy of a bachelor's degree for TP#5, but the degree was not in a chemical, biological, clinical or medical laboratory science, or medical technology, or nursing from an accredited institution. There was no other education documentation on file for TP#5. During interview at approximately 1 p.m., TC#2 confirmed there were no acceptable diplomas or transcripts on file for the TP. He stated he had their clinical medical assistant(CMA) documentation but no other education on file. -- 2 of 2 --