Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on 10/24/2024. The facility was found to be out of compliance with the following condition: 493.1421 Laboratories performing moderate complexity testing; testing personnel 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 Center for Medicaid and Medicare Services (CMS)-209 form, personnel records, and confirmed in staff interview; the laboratory failed to have documentation of education to qualify 1 of 9 testing personnel (TP). 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 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 Center for Medicare and Medicaid Services (CMS) 209 form, personnel records, and confirmed in staff interview; the laboratory failed to provide documentation to ensure minimum education requirements for performing moderate complexity testing for 1 of 9 testing personnel (TP). Findings include: 1. Review of the CMS 209 form listed a total of 9 TPs qualified to perform moderate complexity testing. 2. Review of personnel records revealed no educational documentation to qualify TP#5 for moderate complexity testing. 3.During an interview on 10/24/2024 at 1:00 p.m. in the laboratory, the laboratory director was asked to provide educational documentation for TP#5. No documentation was provided. This confirmed the findings. -- 2 of 2 --