Uab Cancer Center At Russell Medical

Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on the reviews of the XP-300 maintenance logs and the Hematology Quality Control (QC)records, the laboratory failed to: a) Document the manufacturer's required quarterly maintenance (refer to D5429). b) Establish a mechanism to monitor for shifts and trends (refer to D5441). c) Provide QC printouts with the lot numbers and expiration dates (refer to D5447). 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 a review of the Hematology Sysmex XP-300 maintenance records, a review of the Sysmex XP-300 Instructions For Use, and an interview with the Technical Consultant (TC), the laboratory failed to document quarterly maintenance for the Hematology analyzer. This was noted for ___ possible months out of _____ months reviewed in 2023 through 2025. The findings include: 1. A review of the Hematology 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 -- maintenance records revealed quarterly (every 3 months) maintenance on the Sysmex XP-300 Maintenance Log was documented for the following dates: January 17, 2025 and May 5, 2025. No documentation of quarterly maintenance from November 2023 - December 2024 and August 2025. 2. A review of the Sysmex XP-300 Instructions For Use revealed in section 12 page 12-12 under Clean SRV "...if either the counter value exceeds 4,500, or if 3 months have passed since the last maintenance, a message will appear prompting the operator to perform periodic maintenance (SRV cleaning)..." 3. The TC confirmed the above findings during the exit conference on 10-01-2025 at 1: 37 PM. 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 a review of the Hematology Sysmex XP-300 Quality Control (QC) records and an interview with the Technical Consultant (TC), the laboratory failed to establish a procedure that monitors the shifts and trends of test performance over time. This was noted from the date of the last survey, 07-27-2023, to the date of the current survey, 10-01-2025. The findings include: 1. A review of the Sysmex XP-300 QC records revealed only the daily QC data from the instrument were retained from 2023- 2025. No evidence of Levey Jennings charts or peer group data was available for review at the time of the survey. 2. During an interview with the TC at approximately 1:30 PM, the TC stated that the laboratory just recently participated in submitting their QC data for peer group comparison. D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) (d)(3)(i) Each quantitative procedure, include two control materials of different concentrations; This STANDARD is not met as evidenced by: Based on reviews of the Hematology Quality Control (QC) records and an interview with the Technical Consultant (TC), the laboratory failed to retain documentation of the three levels of QC with the Lot Number and Expiration Date each day of patient testing. The surveyor noted there was no QC documentation for 8 of the 31 days in October 2023, 2 of the 31 days in May 2024 and 6 of the 31 days in August 2024. The findings include: 1. A review of the Hematology Quality Control (QC) records revealed the laboratory failed to retain the QC printouts with the Lot Numbers and Expiration dates prior to patient testing for the following days: A) October 2023: 10/2, 10/3, 10/9, 10/12, 10/13, 10/14, 10/27, 10/31 B) May 2024: 5/28, 5/31 B) August -- 2 of 3 -- 2024,: 8/20, 8/22, 8/23, 8/28, 8/29, 8/30. 2. During an interview on 10-01-2025 at 1:37 PM, the TC confirmed the above findings. -- 3 of 3 --

Summary Statement of Deficiencies D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a review of the Sysmex XP-300 Hematology analyzer calibration records and an interview with the Technical Consultant, the laboratory failed to ensure the calibration verification was performed every six months, as per manufacturer's requirements. This was noted on one of two 2021 calibrations reviewed. The findings include: 1. A review of the Sysmex XP-300 calibration records revealed a calibration was performed on 2/18/2021 by a Sysmex service technician. The Sysmex Service Maintenance Certificate documented the 2/18/2021 calibration verification expired on 8/17/2021, however the next calibration verification was not performed until 11/4 /2021. 2. During an interview on 1/27/2022 at 1:40 PM, the surveyor reviewed the Sysmex calibration records with the Technical Consultant, and asked why the second calibration verification in 2021 was performed approximately three months late. The Technical Consultant stated usually the Sysmex service technician performed the calibration when it was due, and she did not know why it was late. The surveyor then 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 -- asked if anyone in the laboratory monitored when the calibration verification was due to ensure it was performed on time; the Technical Consultant confirmed the laboratory had not. . D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on a review of the Sysmex XP-300 calibration certificates, Quality Assurance (QA) records and an interview with the Technical Consultant, the laboratory failed to note the calibration verification had expired in the September and October 2021 QA reviews. The findings include: 1. A review of the Sysmex XP-300 calibration records revealed a calibration was performed on 2/18/2021 by a Sysmex service technician. The Sysmex Service Maintenance Certificate documented the 2/18/2021 calibration verification expired on 8/17/2021, however the next calibration verification was not performed until 11/4/2021. (Refer to D5437.) 2. A review of QA records revealed the laboratory checked the boxes next to "Calibration", "Present and up to date", and "Acceptable" for the calibration. This occurred in September and October 2021 (after the 8/17/2021 expiration). 3. During an interview on 1/27/2022 at 2:15 PM, the surveyor reviewed and confirmed the above noted findings with the Technical Consultant. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --

Summary Statement of Deficiencies D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on a review of the 2017 - 2019 CAP (College of American Pathologists) proficiency testing (PT) records, personnel records, and an interview with Testing Personnel #1, the surveyor determined the laboratory failed to ensure proficiency testing samples were rotated between all personnel who performed moderate complexity Hematology testing on patients. This was noted on seven of seven surveys reviewed. The findings include: 1. A review of CAP attestation statements revealed Testing Personnel (TP) #1 had performed all the testing on the seven surveys performed from 2/6/2017 through 5/10/2019 (the most current survey). None of the PT testing had been performed by TP #2 or #3. 2. A review of the personnel files revealed TP #3 was full time, and had been qualified to perform moderate complexity Hematology testing since the previous survey (on 3/7/2017). TP #2 was trained in the laboratory on 1/21/2019. 3. During an interview on 6/20/2019 at 11:58 AM, TP #1 confirmed she had performed all the Hematology proficiency testing because she was the primary testing personnel. The surveyor then asked about the work schedules for TP #2 and #3; TP #1 stated both were full-time employees in the clinic, however they only performed CBC (Complete Blood Count) testing on patients when TP #1 was off. The surveyor explained the laboratory must schedule all testing personnel included on the CMS-Form 209 (Laboratory Personnel Report) to periodically participate in the performance of proficiency testing. Thus the above noted findings were confirmed. . D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT 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 -- 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 electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on observations and interviews during the entrance tour, a lack humidity records, and a review of the Sysmex XP-300 Instructions for Use Manual, the surveyor determined the laboratory failed to monitor humidity in the room where Hematology testing was performed since the previous survey on 3/7/2017. The findings include: 1. During the initial laboratory tour on 6/20/2019, the surveyor reviewed the current environmental logs for the room in which CBC's (Complete Blood Counts) are performed on the Sysmex XP-300 Hematology analyzer. The surveyor noticed there was no log documenting room humidity; at 9:25 AM Testing Personnel #1 confirmed she did not monitor or document humidity. 2. A review of the Sysmex XP-300 Instructions for Use Manual on page 2-2 included the following, "Installation ... Use the instrument in places where relative humidity ranges between 30% and 85%." 3. A review of the environmental monitoring records revealed the laboratory only recorded the daily room temperatures for the testing area. There was no documentation of the daily room humidity for 2017, 2018, or 2019. 4. During an interview on 6/20/2019 at 9:50 AM, Technical Consultant #1 confirmed the laboratory has not monitored and recorded the daily room humidity, and stated the Testing Personnel thought she had a choice to monitor either temperature or humidity. TP #1 had not realized she needed to document both parameters. SURVEYOR ID# 32558 Licensure and Certification Surveyor -- 2 of 2 --