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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 reviews of the Beckman Coulter AcT diff 2 calibration and quality control records, the on-line Operator's Guide, and an interview with the Laboratory Supervisor, the surveyor determined the laboratory failed to follow the manufacturer's instructions to verify calibrations by running quality controls (QC) for one of two calibrations performed in 2019. The findings include: 1. A review of calibration records for the Beckman Coulter AcT diff revealed the instrument was calibrated on 5 /12/2019 at 2:16 PM. However, there was no documentation QC was run after the calibration. (Three levels of QC were only run in the morning 8:04 to 8:08 AM.) 2. A review of the Coulter AcT diff 2 Operator's Guide (available on-line), under the CALIBRATION section on page 5-16 revealed, "...16. Verify calibration by running 4C PLUS Cell Control. ...". 3. During an interview and review of the records on 9/7 /2021 at 4:09 PM, the General Supervisor confirmed the laboratory failed to perform QC after the 5/12/2019 calibration, and further confirmed QC should be performed 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 -- after calibrations. The surveyor then asked if any patient CBC's (Complete Blood Counts) were performed after 2:16 PM on 5/12/2019; the Supervisor stated two patient CBC's were run at 3:57 PM and at 5:25 PM. . D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D6033 TECHNICAL CONSULTANT-MODERATE COMPEXITY CFR(s): 493.1409 The laboratory must have a technical consultant who meets the qualification requirements of 493.1411 of this subpart and provides technical oversight in accordance with 493.1413 of this subpart. This CONDITION is not met as evidenced by: Based on a review of the CMS-209 form, a lack of documentation, and an interview with the laboratory manager, the surveyor determined the laboratory failed to hire a qualified technical consultant. The findings include: 1. A review of the CMS-209 revealed, the laboratory did not list a qualified technical consultant. 2. During an interview on 8/21/2018 at 9:55 AM, When asked about the previous TC listed on the 2016 CMS-209, the manager stated he had resigned. The surveyor then asked when the previous TC resigned and the manager stated sometime in early 2017 after he had assisted the laboratory with