Ah Wfb Hematology And Oncology - Elkin

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 review of 2022 hematology records and interview with the TS (technical supervisor) 1/26/23, the laboratory failed to ensure calibration was performed and documented at least once every 6 months for the Coulter DxH 520 hematology analyzer. Review of 2022 DxH 520 hematology records revealed the laboratory performed calibration procedures 10/25/22, but the calibration was not completed. Review of the post-calibration instrument printout revealed it showed the calibration date as the date of the previous calibration performed at installation, 1/24/22. During interview at approximately 12:20 p.m., the TS stated they did not realize the calibration was incomplete. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least 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 -- semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures, review of personnel records, and interview with the TS (technical supervisor) 1/26/23, the TS failed to perform and document competency evaluations semiannually during the first year of testing for 1 of 7 testing personnel (TP #4). Review of the laboratory's "Quality Assurance Policies" revealed on pages 1-2 "Personnel ... Personnel are evaluated semi- annually in the first year of employment and annually thereafter. ..." Review of personnel records revealed TP #4 was hired in March 2021. Training for TP #4 was documented in April 2021, and a 6 month competency evaluation was documented in December 2021. TP #4's next competency was documented in January 2023, approximately 13 months later. During interview at approximately 9:30 a.m., the TS confirmed that TP #4 did not have two competency evaluations during the first year of testing patient specimens. She stated the annual competency evaluation due in June 2022 must have been overlooked. -- 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 review of 2018, 2019, and 2020 laboratory records and interview with the GS (general supervisor) and TP (testing personnel) 2/26/20, the laboratory failed to retain all analytic systems records for at least two years. Findings: 1. 2018 room and refrigerator temperature and room humidity records were not available for review at the time of the survey. 2. 2018 Coulter AcT diff 2 daily maintenance (startup /shutdown) records were not available for review at the time of the survey. 3. Records of a Coulter AcT diff 2 calibration performed 6/22/18 were not available for review at the time of the survey. 4. The assay sheet for 4C-ES Cell Control lot number 068600 /078600/088600 with expiration date 1/27/20 was not available for review at the time of the survey. During interview at approximately 12:50 p.m., the GS and TP #3 stated that the 2018 records must have been accidentally discarded when old records were purged. D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: 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 -- Based on review of 2018, 2019, and 2020 hematology quality control records and interview with TP (testing personnel) 2/26/20, the laboratory failed to discard hematology quality control material that exceeded its expiration date. 72 patients were tested on 2 days using the expired control material. Review of 2018, 2019, and 2020 Coulter AcT diff 2 quality control records revealed the laboratory failed to discard Coulter 4C-ES quality control material (lot number 068000/078000/088000) that expired 11/4/19. The expired control material was used for patient testing on 11/5/19 and 11/6/19. 33 patients were tested 11/5/19 and 39 patients were tested 11/6/19. During interview at approximately 11:55 a.m., TP #3 confirmed that expired controls were used for patient testing. She stated the testing personnel who ran controls those days didn't recognize the icon on the analyzer which indicated the control material was expired. -- 2 of 2 --