Summary:
Summary Statement of Deficiencies 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: Based on a record review and an interview with the laboratory's Technical Consultant (TC) #1, the laboratory failed to ensure that all testing personnel (TP) met the educational requirements for moderate complexity testing personnel under CLIA regulations. The laboratory employs 97 testing personnel and performs approximately 12670 moderate complexity tests per year. Findings include: 1. A review of the laboratory's personnel records revealed that TP#63, hired in June 2023, had a Bachelor's of Science in Nursing that had been earned outside the U.S. without any documentation that the credits earned had been evaluated for U.S. equivalency by a national credentialing service before allowing the staff member to perform non- waived testing on patient specimens. 2. An interview with the TC#1 at 2:45 P.M., on 01/26/24, confirmed the lack of documentation of U.S. educational equivalency. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --