Summary:
Summary Statement of Deficiencies 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: Based on review of the laboratory's policies and procedures, review of personnel records, and interview with TP (testing personnel) 9/13/19, the technical supervisor (laboratory director) failed to perform and document a semiannual competency evaluation for 1 of 5 testing personnel (TP #1) during the first year of testing patient specimens. The laboratory's "Competency Assessment Policy" states "... Procedure ... 1. The competency assessment is required at six months and one year after hiring. Upon a satisfactory score for each task performed, it is given yearly thereafter on each employees anniversary. 2. For new employs an assessment is given after the initial hire date, six months, then annually. ..." Review of personnel records revealed TP #1 was trained in June 2017 and had competency evaluations documented in September 2017 (3 month probationary) and September 2019 (annual), but none in 2018. There was no documentation available to indicate that TP #1's competency was evaluated twice during his first year of testing patient specimens. During interview at approximately 10:10 a.m., TP #1 stated that he was unsure whether he had a competency evaluation in 2018. 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 --