Summary:
Summary Statement of Deficiencies D0000 . The HHS Neuromuscular Pathology - Dr. Adam Loavenbruck laboratory was found to be out of compliance with the regulations of the Clinical Laboratory Improvement Amendments of 1988 (42 C.F.R. part 493) upon completion of the initial survey performed on January 12, 2026. The following standard-level deficiencies were cited: 493.1236 Evaluation of proficiency testing performance 493.1445 Laboratory director responsibilities . D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to verify the accuracy of the single Histopathology test performed in the laboratory at least twice annually in 2025. Findings are as follows: 1. The laboratory performed microscopic slide review under the specialty of Histopathology as confirmed by the Laboratory Director (LD) during a tour of the laboratory at 2:40 p. m. on 1/12/26. 2. 2025 twice annual case accuracy evaluations were not found in quality assurance documents provided by the laboratory via email on 1/16/26. The laboratory was unable to produce this documentation upon request. 3. A policy for twice annual case accuracy evaluations was not found in the Hennepin Healthcare Laboratories Quality System procedure provided by the laboratory. The laboratory was unable to provide this policy upon request. 4. In an email received on 1/22/26, the laboratory coordinator confirmed twice annual case accuracy evaluations were not performed in 2024 and the laboratory did not have a policy in place to evaluate accuracy of the Histopathology tests at the time of survey. 5. The laboratory performed 57 Histopathology cases in 2025 as indicated on the Dr. Loavenbruck 2025 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 -- Workload spreadsheet provided by the laboratory. In an email on 1/22/26, the laboratory coordinator confirmed the above findings. . -- 2 of 2 --