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 and review of personnel records on the day of survey, the laboratory director failed to ensure that prior to testing patient specimens Testing Personnel #2 - 16 received the appropriate training for high complexity testing and demonstrated that they could perform all testing operations reliably to provide and report accurate results. Findings include: Review of personnel records since testing began on 1/28 /2022 revealed no documentation of training verified by the Laboratory Director for Testing Personnel #2 - #16 listed on the CMS 209 personnel form prior to performing high complexity testing on patient specimens. The lab has tested 2,588 patient samples since testing began. 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. 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 review of the CMS 209 Laboratory personnel form and personnel records from 1/28/2022 when testing began through 9/28/2022, the technical supervisor failed to evaluate and document the performance of Laboratory Testing Personnel #2 - 16 semiannually during the first year these individuals performed high complexity testing. Findings include: Review of the CMS 209 Laboratory personnel form and personnel records revealed no semiannual evaluations by the technical supervisor documenting the performance of Laboratory Testing Personnel #2 - 16 since 7/28 /2022 when all interpretive testing personnel working remotely would have been due for semiannual evaluations. -- 2 of 2 --