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 a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, educational documents, and an interview with the laboratory director (LD) on 3/11/2026, the laboratory failed to ensure two (2) testing personnel qualified with the minimum educational requirements. See 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 (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 a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, educational documents, and an interview with laboratory director, the laboratory failed to ensure two (2) of five (5) testing persons met the educational requirements for testing personnel performing moderate complexity testing. Findings include: 1. A review of the laboratory's CMS 209 form identified five (5) testing personnel performing moderate complexity testing. 2. Personnel file review on 3/10 /2026 for TP #1, who performs moderate complexity testing, showed documentation of a foreign bachelor's degree in Medical Laboratory Science. 3. Personnel file review on 3/10/2026 for TP #5, who performs moderate complexity testing, showed documentation of a foreign high school diploma. 4. The personnel files for TP#1 and TP#5 did not contain documentation verifying the degrees were evaluated and determined to be equivalent to degrees from an accredited United States educational institution. 5. During an on-site interview on 3/11/2026 at 11:00 AM, the Laboratory Director confirmed that no credential evaluation or equivalency documentation was available for these two TPs. 6. The laboratory reports performing approximately 3,275 moderate complexity tests annually. -- 2 of 2 --