Bellin Hfmc-East De Pere

Summary Statement of Deficiencies D2004 ENROLLMENT CFR(s): 493.801(a)(3) For each specialty, subspecialty and analyte or test, participate in one approved proficiency testing program or programs, for one year before designating a different program and must notify CMS before any change in designation; This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records, federal Certification and Survey Provider Enhanced Reports (CASPER), and interview with the technical consultant, the laboratory did not participate in an approved proficiency testing program for one year before designating a different program for hematology in 2022. Findings include: 1. Review of PT records for 2022 showed the laboratory participated in the College of American Pathologists (CAP) PT program for hematology in event one. Further review showed the laboratory participated in the Wisconsin State Laboratory of Hygiene PT program for hematology in event two and three. 2. Review of CASPER 155D report showed the laboratory received PT results from CAP for the first event in 2022. Further review showed laboratory PT results from WSLH for events two and three in 2022. 3. Interview with the technical consultant on June 28, 2023, at 9:00 AM confirmed the laboratory did not participate in an approved proficiency testing program for one year before designating a different program for hematology in 2022. 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 D5447 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(i)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each quantitative procedure, include two control materials of different concentrations; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory records and interview with the technical consultant, staff A, the laboratory did not test two levels of quality control (QC) materials of different concentrations each day of patient testing for direct bilirubin for twenty-two of twenty-two days in April 2021. Findings include: 1. Review of the "Missing DBIL QC results for liqucheck QC1 & 2" investigation report revealed Liquicheck Pediatric QC was tested for direct bilirubin in April 2021. Further review revealed a second level of QC was not tested for direct bilirubin in April 2021. 2. Interview with staff A on November 8, 2021 at 12:25 PM confirmed the laboratory did not test two levels of QC materials of different concentrations each day of patient testing for direct bilirubin for twenty-two of twenty-two days in April 2021. This is a repeat deficiency from September 7, 2017. 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 --