Summary:
Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (b)(7) Identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of annual competency evaluation documentation from 2023 and 2024 for one out of seven testing personnel (TP-3) and interview with the General Supervisor (GS-1), the technical supervisor failed to perform the evaluation of competency for testing performed in the speciality of Clinical Cytogenetics. Findings include: 1. The annual competency evaluation documention reviewed during the survey for TP-3 from 2023 and 2024 revealed that the technical supervisor failed to evaluate the competency for high-complexity testing performed in the specialty of Clinical Cytogenetics. 2. The GS-1 interviewed on 1/15/25 at 8:45 AM confirmed the technical supervisor failed to evaluate the 2023 and 2024 annual competency evaluations for the testing personnel indicated above. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. 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 lack of documentation of an annual competency evaluation from 2023 and interview with the General Supervisor (GS-1), the technical supervisor failed to evaluate and document the performance for one out of seven individuals responsible for high complexity testing at least annually after the first year the individual tested patient specimens. Findings include: 1. No evidence of an annual competency evaluation was presented for review from 2023 for one out of seven testing personnel (TP-6) who performs cytogenetic testing on patient specimens. 2.. The GS-1 interviewed on 1/15/25 at 8:45 AM confirmed the technical supervisor failed to evaluate and document an annual competency evaluation for the testing personnel indicated above. -- 2 of 2 --