Mercyone Grand Avenue Family Medicine

Summary Statement of Deficiencies D6055 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 whenever test methodology or instrumentation changes. The individual's performance must be reevaluated to include the use of the new test methodology or instrumentation prior to reporting patient test results. This STANDARD is not met as evidenced by: Based on review of personnel records, hematology instrument performance specification records, and confirmed by personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 11:00 am on 05/10/2023, the technical consultant failed to document training for the Sysmex XP-300 hematology analyzer prior to reporting patient test results for one out of one testing personnel (personnel identifier #3). The findings include: 1. The laboratory began using the Sysmex XP- 300 hematology instrument to perform patient testing in July 2021. 2. At the time of the survey, the laboratory did not have training records for testing personnel identifier #3. 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 --

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 and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at approximately 10:30 am on 06/29/2021, the laboratory director failed to ensure that prior to testing patient specimens, all testing personnel performing moderate complexity testing received the appropriate training for one out of three new testing personnel (personnel identifier #7) hired since the last survey on 05/28/2019. The findings include: 1. Personnel identifier #7 began performing complete blood count testing in June 2019. 2. At the time of the survey, the laboratory did not have training records available for laboratory personnel identifier #7. 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 --