M Health Fairview Dermatology Bloomington

Summary Statement of Deficiencies D0000 . The M Health Fairview Dermatology Bloomington 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 recertification survey performed on February 27, 2025. The following standard-level deficiencies were cited: 493.1236 Evaluation of proficiency testing performance . 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 2023 and 2024. Findings are as follows: 1. The laboratory performed Mohs micrographic surgery with microscopic examination under the specialty of Histopathology as confirmed by the Laboratory Director during a tour of the laboratory at 1:05 p.m. on February 27, 2025. 2. The laboratory was required to send three Mohs cases and one biopsy case to a peer for biannual comparison in April and November as established in the Proficiency Testing policy found in the Proficiency Peer Review section of the Lab Manual. 3. Documentation of biannual comparisons for 2023 and 2024 was not found during review of laboratory records. The laboratory was unable to provide the missing documentation. 4. The laboratory performed 780 Mohs microscopic examinations annually as indicated on the Form CMS-2567 provided by the laboratory on the date of survey. 5. In an interview at 4:10 p.m. on February 27, 2025, the Patient Care Supervisor confirmed the above findings. . 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: . Based on observation and interview with laboratory personnel, the laboratory failed to ensure one of two bottles of Nuclear Fast Red stain used for Histopathology tissue processing was not used after the expiration date had been exceeded in 2022. Findings are as follows: 1. The laboratory performed Mohs micrographic surgery under the subspecialty of Histopathology as confirmed by the Clinic Manager during a tour of the laboratory at 9:10 a.m. on 12/01/22. 2. The laboratory performed the Mart Immunohistochemical staining protocol for melanomas as confirmed by tissue processing staff during an interview at 9:15 a.m. on 12/01/22. 3. One of two Nuclear Fast Red stain bottles observed in the flammable materials cabinet during the tour was expired. See below. Stain Lot number Expiration Date Nuclear Fast Red 125636 2022- 7-31 4. The expired stain was available for use by the laboratory August through November 2022. 5. In an interview at 9:15 a.m. on 12/01/22, tissue processing staff 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 D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: . Based on observation, record review, interview, and email communications with laboratory personnel, the laboratory failed to establish and follow a procedure for function checks of general laboratory equipment. Findings are as follows: 1. A tour of the laboratory on 12/28/20, at 8:05 a.m., revealed the presence of a Panasonic Refrigerator (Serial Number = 130100097), with an integrated digital temperature display. 2. In an interview on 12/28/20, at 8:15 a.m., the histotechnician (HT) stated that the refrigerator was used to store MART-1 immunohistochemical stains. 3. The Equipment Checks and Maintenance Policy procedure, located in the Lab Manual, did not include instructions for assuring the accuracy of the refrigerator temperature display on a periodic basis. 4. Function check records for the refrigerator temperature display from 2018, 2019, and 2020 could not be located in the laboratory's files. The laboratory was unable to provide the missing procedure or records upon request. 5. In an interview on 12/28/20, at 8:45 a.m., the HT stated that the refrigerator had been previously equipped with a NIST* traceable thermometer unit, which could not be located on the day of the survey. 6. In an email on 12/30/20, the HT confirmed that calibration records for the refrigerator digital temperature display could not be located. In an email on 1/4/21, the HT stated that it could not be determined when, or by whom, the NIST traceable thermometer unit had been removed from the refrigerator. * NIST = National Institute of Standards and Technology . 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 --