Methodist Hospitals, Inc, The

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) (a)(1) Maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on observation, record review and interview, the laboratory failed to perform and document preventative maintenance on one of one analyzer for ABX Pentra 60 C+ used for testing in the specialty of hematology for five of five analyte(s) (WBC, RBC, HGB, HCT, PLT) and eight of eight patients (PT-1 to PT-8) tested from 1/04/24 through 10/30/24. Findings included: 1. During a tour of the laboratory on 5-14-2025 at 10:15am, the analyzer, ABX Pentra 60 C+ (SN# 901PCP15208) was observed in use. The following analyte(s) in the subspecialty for hematology are listed below: White Blood Cells (WBC) Red Blood Cells, (RBC), Hemoglobin (HGB), Hematocrit (HCT), Platelet (PLT). 2. Review of the "Pentra 60 C+ User Manual" revision 24/09 /2003, section "2. Maintenance" under 2.1 Hydraulic cycle maintenance chart table states the "Frequency of maintenance cycles depends on the laboratory sample output ...according to the chart table beside:" The chart required once per month autoconcentrated cleaning for less than 100 samples ran or twice per month if greater than 100 samples ran on analyzer. 3. Review of the policy "Methodist Hospitals SL Oncology Hematology Infusion Center", under Autoclean procedures stated the laboratory will "perform auto clean twice a week (preferably Tuesdays and Fridays) and follow manufacturer's instructions." 4. In an interview on 5-14-2025 at 3:38 pm, SP-01 (Technical Consultant) and SP-2 (Practice Manager) acknowledged they do not document maintenance of analyzer or follow cleaning procedures outlined in the laboratory policy and instrument user manual. 5. Review of patients PT-1 to PT-8 indicated patient samples were run on analyzer, ABX Pentra 60 C+ without maintenance being documented as performed. Patient (PT) Collection date PT-1 1.04.24 PT-2 2.07.24 PT-3 3.14.24 PT-4 4.17.24 PT-5 5.23.24 PT-6 6.27.24 PT-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 2 -- 7.03.24 PT-8 10.30.24 6. The annual test volume for subspecialty in Hematology is 68,000. D5441 CONTROL PROCEDURES CFR(s): 493.1256(a)(b)(c)(g) (a) For each test system, the laboratory is responsible for having control procedures that monitor the accuracy and precision of the complete analytic process. (b) The laboratory must establish the number, type, and frequency of testing control materials using, if applicable, the performance specifications verified or established by the laboratory as specified in 493.1253(b)(3). (c) The control procedures must-- (c)(1) Detect immediate errors that occur due to test system failure, adverse environmental conditions, and operator performance. (c)(2) Monitor over time the accuracy and precision of test performance that may be influenced by changes in test system performance and environmental conditions, and variance in operator performance. This STANDARD is not met as evidenced by: Based on observation, record review and interviews, the laboratory failed to monitor over time the accuracy and precision of the quality control (QC) test performance for one of one Hematology analyzer (Pentra 60 C+ serial number 901PCP15208) used to perform testing on five of five analyte(s) (WBC, RBC, HGB, HCT, PLT) on four (PT- 4, PT-5, PT-6. and PT-8) of eight patients reviewed with testing from 1/04/24 through 10/30/24. Findings included: 1. During a tour of the laboratory on 5-14-2025 at 10: 15am, the analyzer, ABX Pentra 60 C+ (SN# 901PCP15208) was observed in use. The following analyte(s) in the subspecialty for hematology are listed below: WBC, RBC, HGB, HCT, PLT. 2. Upon request for printed Quality Control (QC) reports on 5-14-2025 at 12:52 pm, SP-02 (Practice Manager) provided an excel spreadsheet of QC results saved from an external hard drive. Review of the QC report included control data and error flags that were not marked that they had been reviewed or monitored for accuracy, precision, trends or shifts. 3. Review of brochure for Hematology analyzer, ABX Pentra 60 C+ indicated Levy-Jennings graphs may be used to monitor and manage Quality Control (QC). 4. Upon request for QC evaluation documentation (e.g. review, trends and shifts), on 5-14-2025 at 12:52 pm, SP-01 (Technical Consultant) acknowledged that QC was not monitored or evaluated at the end of the lot to determine bias, trends, or shifts. 5. Review of patient PT-1 to PT-8 indicated patient samples were run on analyzer, ABX Pentra 60 C+ without QC evaluation being performed or documented. Patient (PT) Collection date PT-1 1.04.24 PT-2 2.07.24 PT-3 3.14.24 PT-4 4.17.24 PT-5 5.23.24 PT-6 6.27.24 PT-7 7.03.24 PT- 8 10.30.24 6. The annual test volume for subspecialty in Hematology is 68,000. -- 2 of 2 --

Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on record review, observation, and interview, the laboratory failed to retain quality control records for one of one hematology analyzers (Horiba Medical PENTRA 60/C+) for at least two years and eight of eight patients reviewed. Findings include: 1. Review of eight medical records indicated that patient #1 through patient # 8 had testing performed with the hematology analyzer. There were no printouts of quality control on the reviewed dates of patient testing. Patient # 1 on 9/21/20 Patient # 2 on 10/21/20 Patient # 3 on 11/17/20 Patient # 4 on 12/20/20 Patient # 5 on 1/20/21 Patient # 6 on 2/23/21 Patient # 7 on 3/17/21 Patient # 8 on 4/1/21 2. On 11/22/2021 at 12:14 PM, observation of the hematology analyzer for quality control records indicated quality control records were present on the hematology analyzer for the current lot number, but SP2 could not review historical quality control on the analyzer. 3. Review of policy and procedure for quality control that was reviewed and dated by the laboratory director on 4/19/17 read when to run controls, which included: "After calibration. After daily start up is complete. After a reagent lot number change. After a service call or component replacement. If there is an unusual trend or shift in patient results. After 8 hours of patient testing." 4. On 11/22/2021 at 3:15 PM, SP1 confirmed that the Horiba Medical PENTRA 60/C+ deletes previous documentation of quality control, and printouts of daily quality control are not available. 5. The annual test volume for hematology testing is approximately 69,500. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) 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 -- 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 record review, observation, and interview, the laboratory director failed to sign and date the manufacturer's instructions that were being used as the procedures for one of one hematology analyzers (Horiba Medical PENTRA 60/C+) before initial patient testing on 3/11/2020. Findings include: 1. On 11/22/21 at 12:39 pm, upon request for policies and procedures for the Horiba Medical PENTRA 60/C+ hematology analyzer, SP1 indicated the policies for the step-by-step instructions, maintenance, QC, and calibration were located within the hematology analyzer interface. 2. On 11/22/21 at 2:21 pm, review of the manuals found on the Horiba Medical PENTRA 60/C+ indicated the step-by-step procedures were on the instrument, but there was no place for the laboratory director to sign and date their approval. 3. On 11/22/21 at 10:39 am, SP1 indicated that the first day of patient testing with the Horiba Medical PENTRA 60/C+ was on 3/11/2020. On 11/22/2021 at 2:33 pm, SP1 confirmed that there was no additional signoff sheet in the instrument manual to indicate that the laboratory director had reviewed and dated their approval for the current manufacturer's instructions revision. 4. The annual test volume for hematology testing is approximately 69,500. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to document review and approval by the laboratory director on the performance specifications for one of one hematology analyzers (Horiba Medical PENTRA 60/C+) before initial testing on 3/11 /2020. Findings include: 1. Review of the instrument performance analysis for the Horiba Medical PENTRA 60/C+ completed on 3/11/2020 indicated that there was no signature or date from the laboratory director indicating their review and approval. 2. Review of eight medical records indicated that patient #1 through patient # 8 had testing performed on the hematology analyzer. Patient # 1 on 9/21/20 Patient # 2 on 10 /21/20 Patient # 3 on 11/17/20 Patient # 4 on 12/30/20 Patient # 5 on 1/20/21 Patient # 6 on 2/23/21 Patient # 7 on 3/17/21 Patient # 8 on 4/1/21 3. On 11/22/21 at 10:39 am, SP1 indicated that the first day of patient testing with the Horiba Medical PENTRA 60 /C+ was on 3/11/2020. Upon request on 11/22/21 at 2:21 pm, SP1 confirmed there was no additional documentation to show that the laboratory director signed off on the performance specifications. 4: The annual test volume for hematology testing is approximately 69,500. -- 2 of 2 --

Summary Statement of Deficiencies D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on document review and interview, the laboratory failed to follow its written policies and procedures for review and evaluation of proficiency scores less than 100% for 2 of 6 events reviewed (Event 1 2018 and Event 1 2017), for 2 of 6 analytes (Leukocyte Count and White Blood Cell Differential) in hematology. 1. Review of the policy "Laboratory Quality Assurance Action Plan" signed by the Laboratory Director on January 21, 2018, required the laboratory to perform proficiency testing through the American Proficiency Institute (API), but did not address investigation of unsatisfactory proficiency test scores, or results less than 100% and greater than 80%. 2. Review of the policy "Laboratory Quality Assurance Meetings" signed by the Laboratory Director on January 15, 2018, indicated "Proficiency testing performance" would be reviewed. 3. Review of the policy "Proficiency Testing" last signed by the Laboratory Director on April 2, 2015, indicated "any result below 100% would be investigated". 4. Review of the "American Proficiency Institute Performance Summary 2018 Hematology/Coagulation" report for 2018, Event 1, indicated the score for "Leukocyte Count" was 80%. 5. The "Quarterly Lab Quality Assurance Minutes" dated 06/21/18 and signed by the Laboratory Director and SP #6 (Practice Manager), documented a comment for the proficiency testing (Event 1 2018) as "Reviewed". There was no indication the score of less than 100% was investigated as required in the "Proficiency Testing" policy. 6. In interview on 03/14/19 at 12:20 PM, SP #6 and SP #5 confirmed there was no other documentation of an investigation for the 80% score for "Leukocyte Count". 7. Review of the "American Proficiency 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 -- Institute Performance Summary 2017 Hematology/Coagulation" report for 2017, Event 1, indicated the score for "White Blood Cell Differential" was 93%. 8. The "Quarterly Lab Quality Assurance Minutes" dated 07/13/17 and signed by the Laboratory Director and SP #6 (Practice Manager), documented a comment for the proficiency testing (Event 1 2017) as "Reviewed". There was no indication the score of less than 100% was investigated as required in the "Proficiency Testing" policy. 9. In interview on 03/14/19 at 12:33 PM, SP #6 confirmed there was no other documentation of an investigation for the 93% score for "White Blood Cell Differential". -- 2 of 2 --