Summary:
Summary Statement of Deficiencies D0000 The laboratory was found to be in compliance with 42 CFR Part 493, Requirements for Laboratories as a result of a validation survey completed on November 19, 2025. D2121 HEMATOLOGY CFR(s): 493.851(a) (a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of laboratory proficiency testing records, and confirmed in interview, the laboratory failed to achieve a passing score (80% or higher) for red blood cell count (RBC) and hematocrit, for one of two hematology proficiency testing events reviewed in 2025. The findings included: 1. Review of the Wisconsin State Laboratory of Hygiene (WSLH) proficiency testing records for 2025 event one and event two included the following hematology failures: 2025 Hematology Event 2 Analyte/Test - Score RBC - 0% Hematocrit - 0% 2. In an interview on 11/19/2025 at 11:35 hours, in the office, testing personnel (TP) 1 confirmed the laboratory did not achieve a passing score for RBC and hematocrit testing for the specialty of hematology. D2128 HEMATOLOGY CFR(s): 493.851(e) (e)(1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be 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 -- maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of laboratory proficiency testing records, proficiency testing