Minniti Center For

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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to verify the accuracy of PT results obtained from the Wisconsin State Laboratory of Hygiene (WSLH) for the third Hematology event in 2024 from 11/14/24 to 3/4/25. The finding includes: 1. The laboratory received a score of 100% for the analytes Hemoglobin and Hematocrit %. for samples AT-11,12,13,14 and 15 for the Third Hematology event in 2024 2. The results stated "not scored- insufficient peer group." 3. The WSLH PT report states "Federal regulations require an automatic score of 100% for not scored or non- consensus samples, but this may not be indicative of instrument/method performance. Participants flagged as such must perform and document an internal self-evaluation to satisfy regulatory/accreditation requirements. 4. There was no documented evidence the laboratory performed and documented an internal self evaluation for the not scored samples by WSLH. 5. The TP #1 as listed on the CMS-209 form confirmed on 3/4/25 at 11:20 am, the accuracy of the PT results were not verified. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. 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 surveyor review of the Proficiency Testing (PT) records and interview with the Testing Personnel (TP), the laboratory failed to document the evaluation of all unsatisfactory PT scores and

Summary Statement of Deficiencies D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. This STANDARD is not met as evidenced by: Based on surveyor review of Calibration (C) records, Manufactures Instructions (MI) and interview with the Testing Personnel (TP), the laboratory failed to follow MI for "Calibration Procedure" for Hematology Tests performed on the Beckman coulter Hematology analyzer on 8-25-21. The findings include: 1. A review of C records revealed that the laboratory failed to correctly perform and document "Calibration". a) on 08/25/21 Calibration failed for White blood Cell Count (WBC). b) The MI states "If FAILED appears, the % diff value and/or CV% exceeds the high acceptable limit. You cannot save FAILED calibration results. Call your local Coulter Service Representative for assistance." 2. There was no documented evidence that the laboratory followed the aforementioned procedure. 3. The TP confirmed on 6/2723 at 1:00 pm that the laboratory failed to follow the MI. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies 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 review of the Procedure Manual (PM), Patient work records and interview with the Testing Personnel (TP), the laboratory failed to follow their PM policy for "Act Diff #2 Flags and Codes" for Hematology tests ran on the Beckman Coulter AcT diff 2 from November 2019 to the date of survey. The finding includes: 1) The PM stated "X flag indicates that one of the multiple Alert criteria was not met. 1. Thoroughly mix and rerun the sample. 2. If the flag does not repeat report result. 3. If flag repeats, clean the aperture as instructed in zapping the aperture. 4. If after cleaning, problem persists contact your Beckman Coulter Representative". a) Patient number 8314 run on 11/05/19 with "X" flagged results was not rerun. b) Patient number 3535 run on 11/14/19 with "X" flagged results was not rerun. 2) The TP #1 on CMS form 209 confirmed on 4/20/21 at 11:05 am the above mentioned procedure was not followed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

Summary Statement of Deficiencies D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on surveyor review of Performance Specifications (PS) records and interview with the Testing Personnel (TP), the laboratory failed to verify accuracy for Hematology tests performed on the Beckman Coulter Act 2 analyzer before reporting patient test results from December 2017 to the date of survey. The TP confirmed on 6 /20/18 at 10:00 am that accuracy was not done. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --