Western Wisconsin Urology

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 procedures and interview with the medical laboratory technician (MLT) the laboratory did not follow the laboratory procedure and did not review one of one non-consensus scored result returned by the PT provider in 2022 to verify the accuracy of the score. Findings include: 1. Review of PT records from 2022 showed the second event from the Wisconsin State Laboratory of Hygiene (WSLH) included a non-consensus result for sample SU-4. The laboratory reported bacteria, the expected result was calcium carbonate crystals. The records show no indication of review by the laboratory. 2. Review of the laboratory's procedure, "WSLH Proficiency Testing" showed the procedure required review of non-consensus results. The procedure provides the following instructions when an unreported or non-consensus result is received from the PT provider, "the performing laboratory personnel will research the results, and discuss with all laboratory personnel their findings. Results report and documented research results/methods are then signed by MLT and filed into the WSLH Proficiency Testing binder". 3. Interview with the MLT testing personnel on January 29, 2024, at 12:40 PM confirmed the non-consensus score was not identified or evaluated to verify the accuracy of the score. 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 D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on surveyor review of patient test reports, laboratory procedures, and interview with the laboratory lead tech, the reference intervals (normal values) for urine microscopic's were not available. Findings include: 1. Review of patient test reports in the electronic medical record and on the paper "Urinalysis Report" for urine microscopic results show that the laboratory does not list the reference intervals (normal values) on the patient test reports. 2. Review of the "Urine Reporting Formats" laboratory procedure does not state what the normal values are for urine microscopic result reporting. 3. Interview with the laboratory lead tech, staff A, on March 7, 2018 at 2:00 PM confirmed that no reference intervals were available for the reported urine microscopy test results. 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 --