Summary:
Summary Statement of Deficiencies D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, personnel records on the day of survey, and an interview with the technical supervisor, the laboratory director failed to ensure 2 of 7 testing personnel received the appropriate training for high complexity testing prior to testing patient specimens. Findings include: 1. Review of personnel records on 1/25/2024 revealed no documentation of training verified by the laboratory director for 2 of 7 testing personnel. No documentation of initial training for testing personnel #6 (date of hire 7- 11-22) and testing personnel #7 (date of hire 8-5-22) listed on the CMS 209 personnel form prior to performing high complexity testing on patient specimens. 2. The technical supervisor confirmed during an interview on 1-25-24 at 10:30 a.m. that no initial training was performed on testing personnel #6 and #7. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. 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 Centers for Medicare and Medicaid (CMS) 209 laboratory personnel form, personnel records since the last survey, and an interview with the technical supervisor, the technical supervisor failed to evaluate and document the performance for 2 of 7 testing personnel semiannually during the first year these individuals performed high complexity testing. Findings include: 1. Review of the CMS 209 Laboratory personnel form and personnel records since the last survey on 5- 4-22, revealed no semiannual evaluations by the technical supervisor for 2 of 7 testing personnel. No documentation of semiannual evaluation of testing personnel #6, (date of hire 7-11-22), and testing personnel #7, (date of hire 8-5-22), for high complexity testing. 2. During an interview at 10:30 a.m. on 1-25-24, the technical supervisor confirmed the semiannual evaluations were not performed. -- 2 of 2 --