Summary:
Summary Statement of Deficiencies 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 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 the lack of documented training available for review on the day of survey 8/9 /18 for the Beckman Coulter AcT Diff 2 Hematology Analyzer, the laboratory testing personnel responsible for performing Complete Blood Counts (CBC's) and listed on the Centers of Medicare and Medicaid Services 209 form as testing personnel #1-7 had no documented training before performing and resulting CBC's on the hematology analyzer. The AcT Diff 2 was installed on January 9, 2017. 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 --