Bellin Hfmc Kewaunee

Summary Statement of Deficiencies D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing (PT) records and Bellin HFMC Algoma and Bellin HFMC Kewaunee Advia 560 sample reports, and interview with the testing personnel, Staff A, the laboratory did not verify the accuracy for thirty-five of thirty-five "Not scored- insufficient peer group" "Hematocrit %" proficiency testing results and did not verify the accuracy of comparison studies performed in 2019 and 2020. Findings include: 1. Review of WSLH PT records showed the laboratory did not verify the accuracy for thirty-five of thirty-five "Not scored-insufficient peer group" "Hematocrit %" proficiency testing results in 2019 and 2020. 2. Review of the Bellin HFMC Algoma and Bellin HFMC Kewaunee sample reports showed the laboratories performed comparison studies at both locations in order to verify the accuracy of the hematocrit analyte. Further review showed no documentation to verify the accuracy of the comparison studies. 3. Interview with the testing personnel, Staff A, on March 1, 2021 at 11:55 AM confirmed the laboratory did not evaluate the accuracy for thirty-five of thirty-five "Not scored-insufficient peer group" "Hematocrit %" PT results and did not verify the accuracy of comparison studies performed in 2019 and 2020. 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 --