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 the CMS 209 form, personnel records, and interview with the technical consultant (TC) #1, the laboratory failed to have educational credentials required to qualify one of seven testing personnel (TP) to perform moderate complexity testing prior to reporting patient results (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 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: 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 -- Based on the review of the CMS 209 form, lack of educational credentials, and interview with TC #1, the laboratory failed to have the educational credentials to qualify one of seven TP to perform moderate complexity laboratory testing prior to reporting patient results. Findings: 1. The CMS 209 form provided at survey listed seven moderate complexity TP. 2. No documentation of educational credentials for TP #3 was available for review at the time of survey. 3. TP #3 worked from 7/1/23 to 1 /26/24. 4. Four patient reports for 12 results were released by TP #3. 5. Interview with TC #1 on 4/2/24 at 2:30 p.m. confirmed the laboratory failed to have the educational credentials to qualify one of seven TP to perform moderate complexity laboratory testing prior to reporting patient results. -- 2 of 2 --