Baptist Memorial Medical Group, Inc-Humfp

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of a final patient test report, laboratory policy, personnel competency assessment records, and staff interview, the laboratory failed to ensure the testing personnel (TP) policy included requirements for reassessment of competency when test methodology changes as required in Subpart M, resulting in two of five testing personnel that did not have reassessment of competency prior to patient testing, when the laboratory changed complete blood count (CBC) methodology in 2022. The findings include: 1. Observation of the laboratory on 08/10/2023 at 9:55 am revealed a Sysmex XN 330 (serial 15142) (new instrument since last survey) in use for CBC patient testing. 2. Review of patient test records revealed the first patient (155700913) from the Sysmex XN 330 (serial 15142) reported on 08/02/2022. 3. Review of the laboratory policy titled "Competency" revealed no requirement for reassessment of competency when test methods change. 4. Review of the laboratory personnel competency records revealed no competency assessment performed for TP one or five for the Sysmex XN 330 prior to patient testing on 08/02/2022.. 5. Interview with the technical consultant on 08/10/2023 at 12: 30 pm confirmed the laboratory policy did not include the requirement for reassessment of competency when test methodology changes. She further confirmed the lack of competency assessments for TP one and five prior to patient testing on the Sysmex XN330 that began on 08/02/2022. 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 the Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS-209), review of testing personnel records and interview with the technical consultant, the laboratory director failed to ensure documentation of the highest level of education for testing personnel number one in 2019 and 2020. The findings include: 1) Review of the Form CMS-209 revealed the name of testing personnel number one (new since the last survey date). 2) Review of personnel records for testing personnel number one revealed no documentation of the highest level of education. The date of hire was July 29, 2019. 3) Interview with the technical consultant on March 2, 2020 at 1:00 p.m. confirmed the laboratory director failed to ensure documentation of the highest level of education for testing personnel number one in 2019 and 2020. 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 --