Baptist Memorial Medical Center

Summary Statement of Deficiencies D5787 TEST RECORDS CFR(s): 493.1283(a) (a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on laboratory observation, a review of patient Complete Blood Count with White Blood Cell differential (CBC w/Diff) reports, and staff interview, the identity of the person who performed three of four CBC w/Diff patient tests in 2024 and 2025 could not be identified. The findings include: 1. Laboratory observation on 04/10/25 at 9:00 a.m. revealed the Sysmex XN 330 instrument used for CBC w/Diff patient testing. 2. A review of four CBC w/Diff reports revealed that the testing person could not be identified for three of four reports reviewed (patient one - performed on 04/01 /24, two-performed on 11/08/24, and three-performed on 02/17/25). The three reports were for patients of commercial accounts. 3. The technical consultant confirmed the survey findings during an interview on 04/10/25 at 12:45 p.m. 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 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 laboratory policy, personnel records, and staff interview, the laboratory failed to follow its' policy for training and competency assessment when the sole testing person (one of one) did not have documentation of training and competency when the laboratory began using a new complete blood count (CBC) instrument in 2022. The findings include: 1. Observation of the laboratory on 01/29/2024 at 9:25 am revealed the Sysmex XN 330 instrument (Serial #15123) used for CBC patient testing (new since 06/01/2022 survey). 2. Review of the laboratory's personnel policy titled "Competency" revealed testing personnel training and competency records would be retained in personnel files for vendor or procedure changes before patient testing. 3. Review of the laboratory's personnel records for testing person one revealed no evidence of training or competency assessment performed prior to CBC patient testing for the Sysmex XN 330 in 2022. 4. Review of patient test records revealed the first patient (#155497965) was reported on 07/25/2022. 5. During an interview on 01/29/2024 at 11:00 am the technical consultant confirmed the laboratory failed to follow its' own personnel policy when the laboratory began patient testing for CBC on the Sysmex XN 330 instrument on 07/25/2022 with no documented training or competency assessment for the sole testing person. 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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory participation in two consecutive proficiency testing (PT) events for the white blood cell (WBC) differential analyte in 2022 event two and 2022 event three, resulting in the first unsuccessful PT occurrence for the WBC differential analyte. (Refer to D2130) D2130 HEMATOLOGY CFR(s): 493.851(f) 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 -- Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of the Centers for Medicare and Medicaid Casper Report 155 (CMS 155) and the laboratory's 2022 American Proficiency Institute (API) proficiency testing (PT) evaluation reports, the laboratory failed to maintain satisfactory performance for two consecutive testing events for the white blood cell (WBC) differential analyte. The findings include: 1. Review of the CMS 155 report revealed the following unsatisfactory WBC differential PT scores: 2022 event two: 0% 2022 event three: 56% 2. Review of the laboratory's PT evaluation report revealed the following: 2022 event two: Score of 0% for the WBC differential for "Failure to Participate" 2022 event three: Score of 56% for the WBC differential analyte, and the first unsuccessful PT occurrence for the WBC differential analyte. -- 2 of 2 --

Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of complete blood count (CBC) quality control (QC) package insert and interview with the technical consultant, the laboratory failed to label CBC QC vials with open date and corrected expiration date in 2022. The findings include: 1. Observation of the laboratory on 06/01/2022 at 9AM revealed quality control vials for performing complete blood count QC labeled as "05- 30-22." There was no indication if this was an open date or expiration date. 2. Review of the CBC QC package insert revealed that controls are good for a maximum of 20 times within 35 days after opening. 3. Interview with the technical consultant on 06/01 /2022 at 2PM confirmed the laboratory failed to label CBC quality control with open date and corrected expiration date in 2022. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value 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 -- of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory's complete blood count (CBC) quality control (QC) and patient test records, and interview with the technical consultant, the laboratory failed to verify correct control limits were used for two of fifteen lots reviewed. A total of five patients reported during the period the incorrect limits were in use (12/02 /2020 to 03/1/2021 and 07/15/2021 to 10/18/2021). The findings include: 1. Review of the laboratory's CBC QC records and patient CBC testing records revealed the following: Lot 079000-in use from 12/02/2020 to 03/01/2021 with incorrect ranges for hematocrit (Package insert = 31.1-37.1% range in use = 32.1-36.1). Patient test record review revealed three patients were reported during the period the incorrect ranges for hematocrit were in use (patient medical record numbers 1C10650437, 1C11546341, 1C1026127). Lot 068200-in use from 07/15/2021 to 10/18/2021 with incorrect ranges for hematocrit (Package insert = 14.8 - 20.2%, range in use = 15.9- 21.3%) and hemoglobin (Package insert = 5.4-6.8 gm/dL, range in use=5.8-7.2 gm /dL). Patient test record review revealed two patients were reported during the period the incorrect QC ranges for hematocrit and hemoglobin were in use (patient medical record numbers: 1C10137261, 1C10213000). 2. Interview with the technical consultant on 06/01/2022 at 2PM confirmed the laboratory failed to verify the control limits in use for hematocrit and hemoglobin analytes for two of fifteen lots review with a total of five patients reported during the periods the incorrect ranges were in use. 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), testing personnel records and interview with the technical consultant, the laboratory director failed to ensure three of four new testing personnel had documentation of highest level of education prior to performing patient testing. The findings include: 1. Review of the Form CMS 209 revealed four new testing personnel since the last survey. The form indicated they were all performing moderately complex patient testing. 2. Review of testing personnel records revealed no evidence of highest level of education for testing personnel numbers four, five, and seven. 3. Interview with the technical consultant on 06/01 -- 2 of 3 -- /2022 at 2PM confirmed the lab director failed to ensure three of four new testing personnel had appropriate education prior to performing patient testing. All three perform patient testing for complete blood count. D6030 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(12) 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)(12) Ensure that policies and procedures are established for monitoring individuals who conduct preanalytical, analytical, and postanalytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills; This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) records and interview with the technical consultant, the laboratory director failed to perform annual, initial, and six month competency assessments for testing personnel number two and four in 2020, 2021, and 2022 (four of sixteen competencies reviewed). The findings include: 1. Review of competency assessment records revealed the following: TP #2--No annual competency for 2020 or 2021 performed by the lab director/technical consultant. TP #4--No initial or 6 month competency performed by the lab director/technical consultant in 2021 and 2022. 2. Interview with the current technical consultant confirmed testing personnel competencies for TP #2 and TP #4 were not performed by the lab director/technical consultant for TP numbers two and four in 2020, 2021 and 2022. -- 3 of 3 --

Summary Statement of Deficiencies D6007 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(1) 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)(1) Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the preanalytic, analytic, and postanalytic phases of testing; This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the verification of performance specification records, the complete blood count patient testing records and interview with the office manager, the laboratory director failed to review and approve the complete blood count instrument verification records prior to patient testing in 2018. The findings include: 1) Observation of the laboratory on December 6, 2018 at 9:15 a. m. revealed the Beckman Coulter AcTdiff2 serial number BE18258 complete blood count instrument in use for patient testing. 2) Review of the verification of performance specification records revealed the instrument installation dated July 10, 2018 with no laboratory director signed approval. The records were incomplete with unreadable half pages of graphs. 3) Review of the complete blood count patient testing records revealed patient testing began on July 20, 2018 with the Beckman Coulter AcTdiff2 serial number BE18258. 4) Interview on December 6, 2018 at 10:30 a.m. with the office manager confirmed the new Beckman Coulter AcTdiff2 serial number BE18258 complete blood count instrument was installed July 10, 2018, and patient testing began July 20, 2018. 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 --