Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, the General Laboratory Procedure Manual, and the Blood Bank Procedure Manual, the procedure manuals were not approved, signed, and dated by the current laboratory director, since this individual assumed the laboratory director responsibilities on 8-26-16. 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 CMS 209 personnel form, and lack of documentation of training, the laboratory director failed to ensure Blood Gas Testing Personnel #5 and #6, listed on the CMS 209 personnel form, received appropriate 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 -- training for performing arterial blood gas testing with the Instrumentation Laboratories GEM Premier 3500 analyzer, prior to testing patient specimens. Findings include: Review of personnel records for blood gas testing personnel, listed on the CMS 209 personnel form, revealed no documentation of training on the GEM Premier 3500 analyzer for Testing Personnel #5 (date of hire 1-5-17) and Testing Personnel #6 (date of hire 1-19-17), prior to testing patient arterial blood gas specimens on the GEM Premier 3500 analyzer. 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 8-25-16, 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 Blood Gas Testing Personnel #5 and #6, responsible for arterial blood gas testing, at least annually. Findings include: Review of personnel records for Blood Gas Testing Personnel #5 and #6, listed on the CMS 209 personnel form, revealed no annual evaluation performed by the technical consultant for Testing Personnel #5 (date of hire 1-5-17), and Testing Personnel #6 (date of hire 1-19-17), responsible for arterial blood gas testing on the GEM Premier 3500 analyzer. -- 2 of 2 --