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 record review and staff interview, 1 of 5 new Hematology testing personnel records reviewed failed to include documention of educational qualifications. Refer to tag 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: Based on record review and staff interview, 1 of 5 new Hematology testing personnel 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 -- records reviewed failed to include educational qualifications. Findings include: 1) Review on 9/20/2022 of testing personnel records revealed 1 (TP1) of 5 records reviewed failed to include documentation of testing personnel's education. Further review of TP1's record revealed training for Complete Blood Count (CBC) testing was completed in July 2021. 2) Interview on 9/20/2022 10:40 a.m. with the Technical Consultant and Practice Manager confirmed the above finding. The Practice Manager revealed TP1 left the laboratory in September 2021. The Technical Consultant revealed the laboratory was using a different data management system at the time TP1 was with the laboratory and the laboratory could not locate TP1's education from that system. -- 2 of 2 --