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 on 10-22- 2019, the laboratory director failed to ensure Testing Personnel #7, #8, #9 and #11 listed on the CMS 209 personnel form received appropriate training for performing complete blood count (CBC) testing with the Medonic M-Series 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 Medonic M-Series hematology analyzer for Testing Personnel #7, #8, #9 and #11 prior to testing patient specimens. D6067 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(4)(ii) Each individual performing moderate complexity testing must have training to ensure that the individual has-- (A) the skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (B) the 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 -- skills required for implementing all standard laboratory procedures; (C) the skills required for performing each test method and for proper instrument use; (D) the skills required for performing preventive maintenance, troubleshooting and calibration procedures related to each test performed; (E) a working knowledge of reagent stability and storage; (F) the skills required to implement the quality control policies and procedures of the laboratory; (G) an awareness of the factors that influence test results; and (H) the skills required to assess and verify the validity of patient test results through the evaluation of quality control sample values prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on interview with the laboratory director and the lack of documented training available for review on the day of survey (10/22/2019) for the Medonic M-Series hematology analyzer, the laboratory testing personnel responsible for performing complete blood counts (CBC) and listed on the Centers of Medicare and Medicaid Services (CMS) 209 personnel form as testing personnel #7, #8, #9, and #11 had no documented training before performing and resulting CBCs on the hematology analyzer. -- 2 of 2 --