Unitypoint Clinic

Summary Statement of Deficiencies D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on review of proficiency testing (PT) records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at 1:45 pm on 04/23 /2024, the laboratory failed to perform a self evaluation when it received a score of zero for two out of seven testing events from 01/01/2022- 04/23/2024. The findings include: 1. For 2023 testing event 2, the laboratory received a score of zero for failure to submit PT results before the submission deadline for the following survey: FH9- B 2023 Hematology Auto Differentials. The survey included all analytes in a complete blood count (CBC) and automated white blood cell differential. 2. For 2023 testing event 3, the laboratory received a score of zero for failure to submit PT results before the submission deadline for the following survey: PCARM- C 2023 Point-of-Care Cardiac Markers. The survey included the analyte, D-dimer. 3. At the time of the survey, the laboratory did not have records indicating it had performed a self- evaluation for the failed PT scores. D6054 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least annually, after the first year. 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 -- This STANDARD is not met as evidenced by: Based on review of personnel records and confirmed by laboratory personnel identifier #2 (refer to the Laboratory Personnel Report) at 12:49 pm on 04/23/2024, the technical consultant failed to assess and document the competency of individuals performing moderate complexity testing (complete blood count and D-dimer) at least annually for 2 out of 23 testing personnel (personnel identifiers #7 and #18) in 2023. -- 2 of 2 --

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 the laboratory's AcT Diff 2 Calibration policy, Beckman Coulter AcT Diff 2 calibration records and confirmed by laboratory personnel identifiers #2 and #3 (refer to the Laboratory Personnel Report) at approximately 12:00 pm on 03/05 /2020, the laboratory failed to perform calibration procedures every six months on the Beckman Coulter AcT Diff 2 hematology analyzer for two out of two time periods from 09/14/2018- 01/03/2020. The findings include: 1. The laboratory's AcT Diff 2 Calibration policy stated the following: "Calibration must take place under the following circumstances: every 6 months in compliance with CLIA regulations." 2. Calibration records showed the laboratory calibrated the hematology instrument on 09 /14/2018, 05/29/2019, and 01/03/2020. 3. At the time of the survey, personnel identifiers #2 and #3 confirmed that the two time periods between calibrations exceeded the six month time frame written in the laboratory's policy. D5781