Uthealth East Texas Hope Cancer Center

Summary Statement of Deficiencies D0000 An onsite survey conducted 10/09/2023 found the laboratory in compliance with 42 CFR Part 493, Requirements for Laboratories. 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 a review of laboratory policy, laboratory maintenance documents, and confirmed in interview, the laboratory failed to ensure the retention of daily, weekly, monthly, and quarterly maintenance for the Architect c4000 chemistry analyzer for 6 of 18 months reviewed from May 2022 to September 2023. The findings included: 1. Review of the laboratory policy titled "Quality Assessment Program" section "Record Retention" stated the following: "All routine laboratory records are kept for at least 2 years." 2. Review of maintenance activities for the Architect c4000 chemistry analyzer had the following maintenance items to be performed daily, weekly, monthly: Daily: Procedure: 6024 Check 1 mL Syringes Procedure: 6028 Check DI Water Purity Procedure: 6070 Daily Maintenance Weekly: Procedure: 6019 Check ICT Components Procedure: 6021 Clean Mixers Procedure: 6023 Clean Sample /Reagent Probes Procedure: 6056 Clean Cuvettes with Detergent Procedure: 6308 Check HC Wase Pump Tubing Monthly: Procedure: 6016 Check Dispense components Procedure: 6018 Clean Cuvette Washer Nozzles Procedure: 6026 Check Syringes and Valves Procedure: 6300 Clean ICT Drain Tip 3. Review of the laboratory "Maintenance History Report" for the Architect c4000 from May 2022 to September 2023 had the following months with missing documentation of one or more of the above procedures: May 2022: No daily documentation was retained for procedure 6028 "Check DI Water Purity" and procedure 6070 "Daily Maintenance". 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 -- No weekly maintenance documentation was retained. No monthly maintenance documentation was retained. June 2022: No daily documentation was retained for procedure 6028 "Check DI Water Purity" and procedure: 6070 "Daily Maintenance". No weekly maintenance documentation was retained. No monthly maintenance documentation was retained. July 2022: No daily documentation was retained for procedure 6028 "Check DI Water Purity" and procedure: 6070 "Daily Maintenance". No weekly maintenance documentation was retained. No monthly maintenance documentation was retained. August 2022: No daily documentation was retained for procedure 6028 "Check DI Water Purity" and procedure: 6070 "Daily Maintenance". No weekly maintenance documentation was retained. No monthly maintenance documentation was retained. September 2022: No daily documentation was retained for procedure 6024 "Check 1 mL Syringes" and procedure: 6070 "Daily Maintenance". No weekly maintenance documentation was retained. No monthly maintenance documentation was retained. October 2022: No daily documentation was retained for procedure 6028 "Check DI Water Purity" and procedure: 6070 "Daily Maintenance". No weekly maintenance documentation was retained. No monthly maintenance documentation was retained. The surveyor queried about the missing maintenance reports and the technical consultant (TC) 2 stated the Architect c4000 chemistry analyzer had been performed but the reports had not been printed to include a complete record of the maintenance for the months above. 4. In an interview on 10/9 /2023 at 14:30 hours, in the office, the TC2 confirmed that the laboratory failed to ensure the retention of maintenance documentation for the Architect c4000 chemistry analyzer. 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 surveyor observation, laboratory policy, and confirmed in an interview the laboratory failed to follow its policy for the documentation of the date opened for use for three of three stains observed on October 9, 2023. The findings included: 1. A review of the laboratory policy titled "Labeling of Reagents" had the following instructions: "Requirements for reagents obtained from vendors: Date received. Date opened. Expiration date if different than printed on reagent." 2. In a tour of the laboratory on 10/9/2023 at 11:15 hours surveyor observed the following three stains opened and in use without documentation of when the stain was opened for use: Stat Lab Hema-Diff #1 Fixative, Lot 165212, received 2/10/2023, expired 8/31/2024 Stat Lab Hema-Diff #2 Xanthene, Lot 15172, received 7/5/2022, expired 12/31/2023 Stat Lab Hema-Diff #3 Thiazine, Lot 149829, received 7/5/2022, expired 11/30/2023 3. In an interview on 10/9/2023 at 11:15 hours, in the laboratory, the technical consultant (TC) 2 confirmed that the stain was in use for patient testing and that personnel had failed to document when it had been opened for use. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory -- 2 of 3 -- must perform and document 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 a review of maintenance records, the Centers for Medicare and Medicaid (CMS) form 116, and confirmed in interview, the laboratory failed to document weekly maintenance for the Sysmex XS-1000i hematology analyzer for 30 of 61 weeks reviewed from July 2022 to August 2023. The findings included: 1. Review of the laboratory maintenance form titled "Sysmex XS-1000i Maintenance Log" (LSS- 10-6115_April 2017_XS-1000i) had the following maintenance tasks to be performed: Daily: Perform Shutdown Verify Background Verify Pressure/Vacuum Perform Quality Control Weekly: Power Down IPU Monthly Maintenance: Perform Monthly Rinse (1,200 cycles) 30,000 Cycle Maintenance: Replace Air Pump Replace Piercer 2. Review of laboratory maintenance records from July 2022 to August 2023 had the following seven months where weekly maintenance was not documented: February 2023 March 2023 April 2023 May 2023 June 2023 July 2023 August 2023 3. A review of the laboratory provided CMS 116, section VII "Non-Waived Testing" listed the estimated annual test volume for hematology at 47,742. 4. In an interview on 10/9/2023 at 14:15 hours, in the office, the technical consultant (TC) 2 confirmed that powering down the IPU was part of the weekly maintenance and that the laboratory had failed to document it for the above months. Key: IPU - Information Processing Unit -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. . 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 the review of competency records from 2020 to 2021 and confirmed in interview found the laboratory failed to document competency assessment for 1 of 2 technical consultant (TC). The findings were: 1. Review of laboratory competency records from 2020 to 2021 revealed there was no competency assessments for TC#2. 2. An interview with TC#2 on 3/16/2022 at 10:00 am in the office confirmed that there was no competency assessment documented for TC#2. Key: TC= Technical consultant D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in 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 -- electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on the review of manufacturer's instructions for use, the laboratory's temperature log from 2021, and confirmed in an interview found the laboratory failed to follow the manufacturer's instructions of relative humidity for eight of 50 days reviewed for 1 of 1 instrument: Sysmex XS-1000i hematology instrument. The findings were: 1. Review of the manufacturer's instruction for use, XS-1000i/XS-800i instruction for use (Code#: 461-2629-2; Printed in Japan; Date of last revision: June 2013) on page 11-1 11.3 XS-1000i/XS-800i performance /specifications revealed the relative humidity is 30% to 85%. 2. Review of the laboratory's temperature log revealed the acceptable ranges for humidity was 20% to 85%. 3. Further review of the laboratory's temperature log from 2021 revealed eight of 50 days reviewed were out of acceptable range for Sysmex XS-1000i (SN#: 75408). 1/11/21 27% 1/12/21 27% 1 /13/21 28% 1/15/21 25% 1/28/21 29% 1/29/21 29% 3/08/21 26% 4/02/21 27% 3. Random review of the patient results for the above dates revealed the following patient testing on Sysmex XS-1000i (SN#: 75408). 1/11/21 Patient ID: 2054471 1/11 /21 Patient ID: 1028075 1/11/21 Patient ID: 1024618 1/11/21 Patient ID: 2054055 1 /11/21 Patient ID: 2042564 1/12/21 Patient ID: 2054302 1/12/21 Patient ID: 2052762 1/12/21 Patient ID: 2029754 1/12/21 Patient ID: 2041953 1/12/21 Patient ID: 2052066 1/13/21 Patient ID: 2034574 1/13/21 Patient ID: 2053658 1/13/21 Patient ID: 2045725 1/13/21 Patient ID: 2053552 1/13/21 Patient ID: 2030312 1/15/21 Patient ID: 2054500 1/15/21 Patient ID: 2053039 1/15/21 Patient ID: 2029529 1/15 /21 Patient ID: 2046289 1/15/21 Patient ID: 2051684 1/28/21 Patient ID: 2051912 1 /28/21 Patient ID: 2032799 1/28/21 Patient ID: 2025145 1/28/21 Patient ID: 2044426 1/28/21 Patient ID: 2054633 1/29/21 Patient ID: 2054000 1/29/21 Patient ID: 2037785 1/29/21 Patient ID: 2036760 1/29/21 Patient ID: 2053491 1/29/21 Patient ID: 2046289 3/08/21 Sample ID: 000501008 3/08/21 Sample ID: 000501009 3/08/21 Sample ID: 000501010 3/08/21 Sample ID: 000501013 4/02/21 Sample ID: 000504289 4/02/21 Sample ID: 000504288 4/02/21 Sample ID: 000504293 4/02/21 Sample ID: 000504313 4/02/21 Sample ID: 000504332 4. An interview with the technical consultant #2 on 3/16/22 at 1:00 pm in the office confirmed the above findings. D5461 CONTROL PROCEDURES CFR(s): 493.1256(d)(6)(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-- Perform control material testing as specified in this paragraph before resuming patient testing when a complete change of reagents is introduced; major preventive maintenance is performed; or any critical part that may influence test performance is replaced. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of manufacturer's instructions for use, the laboratory reagent replacement log from 4/15/21 to 3/15/22, and confirmed in an interview found the laboratory failed to document a quality control run after a change in a reagent on one of one Sysmex XS1000i hematology instrument for eight of 30 days reviewed. The findings were: 1. Review of the manufacturer's instruction for use, XS-1000i/XS-800i instruction for use (Code#: 461-2629-2; Printed in Japan; Date of last revision: June -- 2 of 3 -- 2013) in Chapter 4 revealed the XS-1000i uses the following four reagents. Cellpack Stromatolyser-4DL Stromatolyser-4DS Sulfolyser 2. Random review of the reagent replacement log from 4/15/21 to 3/15/22 revealed eight of 30 days reviewed with no documentation of the quality control run after the following reagent change on the Sysmex XS-1000i (SN#75408) hematology analyzer. 05/05/21 at 9:54 am Cellpack Lot#Y1019 Exp 8/22/22 05/21/21 at 8:52 am Sulfolyser Lot#Y1001 Exp 12/31/21 07 /22/21 at 2:02 pm Cellpack Lot#Y1005 Exp 7/12/22 08/26/21 at 9:56 am Stromatolyser-4DS Lot#Y1006 Exp 2/25/22 10/05/21 at 12:47 pm Sulfolyser Lot#Y1005 Exp 5/23/22 11/10/21 at 1:39 pm Cellpack Lot#Y1075 Exp 1/18/23 12/08 /21 at 8:55 am Stromatolyser-4DS Lot#Y1012 Exp 4/18/22 03/10/22 at 10:11 am Cellpack Lot#Y1128 Exp 6/21/23 3. Random review of the patient test records for the above date revealed the laboratory performed the following patient testing after the reagent change above with no documentation of the quality control run. 05/05/21 at 10:14 am Sample ID: 000508165 05/05/21 at 10:50 am Sample ID: 000508177 05/05 /21 at 11:53 am Sample ID: 000508198 05/05/21 at 1:33 pm Sample ID: 000508219 05/05/21 at 2:17 pm Sample ID: 000508237 05/21/21 at 9:43 am Sample ID: 000510174 05/21/21 at 11:02 am Sample ID: 000510207 05/21/21 at 2:58 pm Sample ID: 000510257 05/21/21 at 3:20 pm Sample ID: 000510157 07/22/21 at 2:07 pm Sample ID: 000517515 07/22/21 at 2:15 pm Sample ID: 000517519 07/22/21 at 2:22 pm Sample ID: 000517524 07/22/21 at 2:43 pm Sample ID: 000517533 07/22/21 at 2: 49 pm Sample ID: 000517511 07/22/21 at 3:03 pm Sample ID: 000517536 08/26/21 at 10:16 am Sample ID: 000521277 08/26/21 at 10:19 am Sample ID: 000521272 08 /26/21 at 10:47 am Sample ID: 000521293 08/26/21 at 10:50 am Sample ID: 000521295 08/26/21 at 1:30 pm Sample ID: 000521329 08/26/21 at 2:55 pm Sample ID: 000521357 10/05/21 at 2:06 pm Sample ID: 2023574996 10/05/21 at 2:13 pm Sample ID: 2023575227 10/05/21 at 2:42 pm Sample ID: 2023575949 11/10/21 at 2: 11 pm Sample ID: 2024492146 11/10/21 at 2:20 pm Sample ID: 2024492350 11/10 /21 at 2:27 pm Sample ID: 2024492550 11/10/21 at 3:00 pm Sample ID: 2024493273 11/10/21 at 3:11 pm Sample ID: 2024493402 12/08/21 at 8:57 am Sample ID: 2025204758 12/08/21 at 9:47 am Sample ID: 2025206757 12/08/21 at 1:10 pm Sample ID: 2025213258 12/08/21 at 1:26 pm Sample ID: 2025213499 12/08/21 at 3: 05 pm Sample ID: 2025217781 12/08/21 at 3:41 pm Sample ID: 2025217253 3/10/22 at 10:23 am Sample ID: 2027599465 3/10/22 at 10:44 am Sample ID: 2027599143 3 /10/22 at 11:34 am Sample ID: 2027600818 3/10/22 at 1:28 pm Sample ID: 2027605173 3/10/22 at 2:23 pm Sample ID: 2027606486 4. An interview with the TC#2 on 3/16/22 at 10:25 am in the office confirmed the above findings. Key: TC=Technical consultant -- 3 of 3 --