Centracare Willmar Main Clinic Dermatology

Summary Statement of Deficiencies D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: . Based on document review and an interview with laboratory personnel, the laboratory failed to document all proficiency testing evaluation activities on one of ten events performed in 2021 and 2022. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery under the specialty Histopathology as confirmed by the Histotechnician (HT) during a tour of the laboratory at 10:10 a.m. on February 27, 2023. 2. To verify the accuracy of of the procedure, the laboratory twice per year had the Mohs slides of each Mohs surgeon peer reviewed in a blind review. 3. The MOHS Surgery procedure, found in the Mohs Laboratory Compliance Manual, established this biannual slide review in section 9.4. The procedure directed the laboratory surgeons to meet and discuss the results of the review if there was a conflict. 4. A Mohs Slide Review done on 10/4/21, Mohs # M21-493, found that both reviewing surgeons disagreed with the surgeon who had interpreted the patient slides. Review of the records did not find documentation of the discussion between the surgeons regarding the conflict/disagreement. 5. The laboratory was unable to provide the documentation upon request. 6. In an interview at 11:10 a.m. on February 27, 2023, the HT confirmed the above findings. . D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a 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 -- maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on observation, document review, and an interview with laboratory personnel, the laboratory failed to document Histopathology biannual equipment maintenance activities on the cryostat during 2021 and 2022. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery under the specialty Histopathology as confirmed by the Histotechnician (HT) during a tour of the laboratory at 10:10 a.m. on February 27, 2023. 2. A Leica CM1520 Cryostat was observed as present and available for use during the tour of the laboratory. 3. The Cryostat Procedure, found in the Mohs Laboratory Compliance Manual, established the following maintenance requirements: - that the Cryostat were to be defrosted and air dried every 6 months - that the air filter was to be replaced every 6 months 4. Review of the monthly Cryostat Maintenance Logs did not provide evidence that either of the 6 month maintenance protocols had been performed in 2021 or 2022. 5. The laboratory was unable to provide the documentation upon request. 6. In an interview at 11:10 a.m. on February 27, 2023, the HT confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: . Based on document review and interview with laboratory personnel, the laboratory failed to ensure all test result reports included the address of the laboratory location. Findings are as follows: 1. The laboratory performed Histopathology testing as confirmed by the Technical Consultant (TC) during a tour of the laboratory at 1:00 p. m. on 08/12/21. The effective date of the CLIA Certificate of Registration was 02/17 /21. 2. The address of the laboratory location was not included on test result reports reviewed on date of survey. See below Case number Date of testing M21-115A 03/03 /21 M21-330 06/24/21 3. The estimated Histopathology annual test volume was 650 as indicated on the Form CMS-116 obtained during the survey. 4. In an interview at 2: 40 p.m. on 08/12/21, the TC confirmed the above finding. 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 --