Clarus Dermatology-Stellis Health Buffalo Clinic

Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: . Based on observation and interview with laboratory personnel, the laboratory failed to dispose excess Histopathology tissue in accordance with applicable Federal, State, and local requirements from 02/15/20 through 01/27/22. Findings are as follows: 1. The laboratory performed Histopathology testing for Mohs micrographic surgery as confirmed by the Mohs Technician (MT) during a tour of the laboratory at 1:10 p.m. on 01/27/22. 2. Instruction to dispose excess tissue as biohazardous waste according to Federal, State, and local laws was not found in the Stellis Mohs Lab Manual. 3. A biohazard container for excess tissue disposal was not observed in the laboratory during the tour. 4. The laboratory performed an estimated 350 Mohs cases annually as indicated on the CLIA application Form CMS-116 completed on date of survey, 01/27 /22. 5. In an interview at 1:20 p.m. on 01/27/22, the MT 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 --

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 the correct address of the performing laboratory was indicated on the patient test report and Mohs map. Findings are as follows: 1. The laboratory performed Histopathology (Mohs dermograhic surgery) testing as confirmed by the Histotechnician (HT) during a tour of the laboratory on 9/6/18 at 8:05 a.m. 2. Patient test report and corresponding Mohs map (Male, DOB: 9/9/81, Date performed: 5/1/18, Case #: BM18-006) reviewed on date of survey did not indicate the correct address of the performing laboratory. Address of laboratory shown on both documents was "2603 39th Avenue NE, Suite D202, St. Anthony, MN" instead of the correct address as "1700 MN State Highway 25 North, Buffalo, MN" 3. In an interview on 9/6/18 at 10:30 a.m., the HT 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 --