Summary:
Summary Statement of Deficiencies D2004 ENROLLMENT CFR(s): 493.801(a)(3) (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; and This STANDARD is not met as evidenced by: Based of review of the laboratory records and interview with the laboratory director (LD); the laboratory failed to participate in one approved proficiency testing (PT) program for one year before designating a different program in the specialties of microbiology and diagnostic immunology. Findings include: 1. Review of laboratory records revealed the laboratory was enrolled in Wisconsin State Laboratory of Hygiene (WSLH) for only two of three events in the year of 2024 before switching to American Proficiency Institute (API) in the year of 2025. Event: PT Program: 2023, Event 2 API 2023, Event 3 API 2024, Event 1 API 2024, Event 2 WSLH 2024, Event 3 WSLH 2025, Event 1 API 2. Interview with the LD on 04/21/2025, at 12:29 pm, confirmed the laboratory failed to participate in one approved PT program for one year before designating a different program in the specialties of microbiology and diagnostic immunology. 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 --