Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on September 3, 2021. Pediatrics in Brevard clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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, the laboratory failed to verify the educational qualifications (degrees) for 1 of 6 Testing Personnel, (B). Findings: Cross Reference D6065. Based on record review and interview, the laboratory failed to verify the educational qualifications (degrees) for 1 of 6 Testing Personnel, (B). 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 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 -- 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 interview, the laboratory failed to verify the educational qualifications (degrees) for 1 of 6 Testing Personnel, (B). Findings: Review of the CMS 209 Laboratory Personnel Report, signed by the Laboratory Director on 08/31 /2021, showed there were six employees listed as moderate complexity testing personnel, (A to F). Review of the laboratory records showed there was no documentation of the educational degree for Testing Personnel B available for review. According to the Clinical Laboratory Improvement Amendments (CLIA) Application for Certification signed and dated by the Laboratory Director on 08/31/2021, the laboratory had an estimated annual test volume of 950. On 09/03/2021 at 9:20 AM, Technical Consultant B stated she did not have the educational degree for Testing Personnel B. -- 2 of 2 --