Summary:
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 proficiency testing (PT) reports and interview with a technical consultant (Staff A) the laboratory did not review one of one non-consensus result returned by the PT provider for a urinalysis image identification in the second event in 2022 of the 'Misc QA POC' (Miscellaneous Quality Assessment Point of Care) challenge to verify the accuracy of the non-consensus score. Findings include: 1. Review of PT records showed the second event of the 'Misc QA POC' event in 2022 from the Wisconsin State Laboratory of Hygiene (WSLH) PT Program included a non-consensus result for the second urinalysis sediment image. The laboratory reported bacteria, the expected result was calcium carbonate crystals. The records showed no indication of review of the non-consensus result by the laboratory. 2. Interview with Staff A on June 19, 2024, at 11:35 AM confirmed the laboratory did not identify or evaluate the non-consensus score to verify the accuracy of the urine sediment result. 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 --