Summary:
Summary Statement of Deficiencies D6029 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(11) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(11) 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 personnel records, the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, and lack of documentation of training, the laboratory director failed to ensure Testing Personnel #3, #4, and #5, listed on the CMS 209 personnel form, received appropriate training for performing complete blood count (CBC) testing with the Sysmex pocH-100i hematology analyzer, prior to testing patient specimens. Findings include: Review of personnel records for the testing personnel listed on the CMS 209 personnel form revealed no documentation of training on the Sysmex pocH-100i hematology analyzer for Testing Personnel #3 (date of hire 9-18-17), #4 (date of hire 8-22-16), and #5 (date of hire 8-14-17), prior to testing patient specimens on the Sysmex pocH-100i hematology analyzer. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate 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 personnel records since the last survey on 8-8-16, the CMS 209 personnel form, and lack of documentation of semiannual evaluations by the technical consultant, the technical consultant failed to evaluate and document the performance of Testing Personnel #3, #4, and #5, responsible for moderate complexity testing, at least semiannually during the first year these individuals tested patient specimens. Findings include: Review of personnel records since the last survey on 8-8-16 and the CMS 209 personnel form revealed semiannual evaluations performed for Testing Personnel #3 on 4-17-18, for Testing Personnel #4 on 1-11-17, and for Testing Personnel #5 on 3-20-18 were performed by an individual other than the technical consultant. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. This STANDARD is not met as evidenced by: Based on review of personnel records since the last survey on 8-8-16, the CMS 209 personnel form, and lack of documentation of annual evaluations by the technical consultant, the technical consultant failed to evaluate and document the performance of Testing Personnel #1, #2, and #4, responsible for moderate complexity testing, at least annually. Findings include: Review of personnel records since the last survey on 8-8-16 and the CMS 209 personnel form revealed annual evaluations performed for Testing Personnel #1 on 3-26-17 and 2-26-18, for Testing Personnel #2 on 3-16-17 and 2-26-18, and for Testing Personnel #4 on 3-6-17 and 2-26-18 were performed by an individual other than the technical consultant. -- 2 of 2 --