Baptist Memorial Medical Group, Inc

Summary Statement of Deficiencies D2014 TESTING OF PROFICIENCY TESTING SAMPLES (b)(6) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory's proficiency testing records and staff interview, the laboratory failed to retain the proficiency testing (PT) attestation statements for one of four PT events reviewed from 2024 and 2025. The findings include: 1. A review laboratory's American Proficiency Institute PT records revealed the laboratory did not retain the PT attestation statements for 2024 Event Two (one of four events reviewed). 2. The technical consultant confirmed the survey findings during an interview on 008/12/25 at 4:30 p.m. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(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. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)

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 observation of the laboratory, review of patient test records, procedure manual for the Sysmex XN-330 complete blood count (CBC) instrument, and interview with the technical consultant, the laboratory failed to ensure the procedure used for the Sysmex XN-330 CBC instrument was approved by the laboratory director prior to patient testing that began on 06/30/2022. The findings include: 1. Observation of the laboratory on 02/21/2023 at 8:40 a.m. revealed the Sysmex XN-330 CBC instrument (serial number 15081) in use for patient testing. 2. Review of patient test records revealed the first CBC reported from the Sysmex XN-330 instrument was on 06/30/2022 (Patient # 12183696). 3. Review of the procedure manual for the Sysmex XN 330 revealed no approval of the procedure by the laboratory director. Procedure in use titled as "CBC performed on Sysmex XN-330/350" with an effective date of 06/27 /2022 and revision date of 07/13/2022. 4. Interview with the laboratory technical consultant on 02/21/2023 at 12:25 confirmed the laboratory director had not approved the procedure for the Sysmex XN-330 CBC with patient testing that began on 06/30 /22 until the date of the survey on 02/21/23. 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 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 -- reporting patient test results. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of patient records and lack of documentation, and interview with the technical consultant, the technical consultant failed to assess competency for two of two testing personnel for the use of the new Sysmex XN-330 Complete Blood Count (CBC) instrument prior to patient testing which began on 06/30/22. 1. Observation of the laboratory on 02/21/2023 at 8:40 a.m. revealed the Sysmex XN-330 CBC instrument (serial number 15081) in use for patient testing. This instrument was new since the last survey date. 2. There was no documentation of competency assessment for two of two testing personnel prior to patient testing which began on 06/30/22 (patient 12183696). 3. Interview with the technical consultant on 02/21/23 at 12:25 pm confirmed the technical consultant did not perform competency assessment for two of two testing personnel for the use of the new Sysmex XN-330 CBC instrument prior to patient testing which began on 06/30 /22. -- 2 of 2 --

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the complete blood count (CBC) data log, the patient test management procedure, and interview with testing personnel number one, the laboratory failed to follow the procedure for patient test management in-house laboratory request and reporting, in 2019. The findings include: 1) Review of the February 2019 CBC instrument data log revealed on February 16, 2019, a CBC was performed in-house on patient number one. 2) Review of the laboratory patient test management procedure revealed, "Requisition: 1. The orders for the laboratory testing will be by verbal or written order from the physician or from the patient's Lab Test Requisition, Encounter Form or the super bill. Verbal orders are followed by written orders from the physician within 30 days. ... Reporting of Results. 1) All tests results performed in-house will be placed in the LIS (if appropriate) and will be scanned into the electronic medical records (if appropriate). If paper charts are used the tests results will be placed on the chart for permanent records." 3) Interview on October 9, 2019 at 11:35 a.m. with testing personnel number one confirmed the following: On February 16, 2019, patient number one's provider gave a verbal order to the laboratory requesting a CBC on patient number one. The verbal CBC request was not followed with a written CBC request via a lab test requisition, encounter form or super bill for patient number one. The verbal order was not followed with a written order from the provider. On February 16, 2019, a CBC was performed on patient number one. 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 -- CBC instrument printout was given/reported to the requesting provider. Patient number one CBC results were not placed in the LIS or the electronic medical record. There are no paper charts. -- 2 of 2 --