Summary:
Summary Statement of Deficiencies D0000 An announced CLIA initial survey was conducted at the Adma Biocenter on 05/08 /2024 by South Carolina Department of Environmental Control (SCDHEC). The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D6063- 42 C.F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel. D6065-42 C.F.R. 493.1423 Standard; Testing personnel qualifications 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 the review of CMS 209 Laboratory Personnel Report (CLIA) form, absence of educational documentation and staff interview, the laboratory failed to document qualifications requirements for 5 out of 14 testing personnel (TP) performing moderately complex 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 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 -- 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: Based on record review and staff interviews, the laboratory failed to ensure 5 or of 14 testing personnel had documentation of their high school diploma as listed under 42 CFR Section 493.1423 to qualify as moderately complex testing personnel. Findings included: 1. The laboratory listed 14 testing personnel on the CMS-209 personnel form on the day of survey. 2. No (high school diplomas) education records were present for review on the day of the survey for 5 of 14 testing personnel (TP5, TP7, TP9, TP10, TP12). 3. In an interview on 05/08/2024 at 2:35 pm in the conference room, the director of quality assurance, internal affairs confirmed the findings above. -- 2 of 2 --