Premier Dermatology

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on review of laboratory policy, patient test records, and confirmed in interview, the laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least 2 unique patient identifiers for 34 of 34 slides in 2022 (December), 35 of 35 slides in 2023 (December) and 29 of 29 slides in 2024 (June). Findings included: 1. Review of the laboratory policy titled "SLIDE LABELING" revealed: " 2. Slides are to be labeled with mohs log accession number, patient last name, number of stages will be marked with Roman numeral; stage I, II, Ill, etc. Quadrant or number of tissue /chucks [sic] per stage will be marked numeral; # "1 ", "2", "3", etc. and, number of slides per case will be marked, level 'A', for first cuts, level 'B' for second and so on." The laboratory policy did NOT include labeling instructions to reliably identify patients using at least two unique patient identifiers to distinguish between specimens. 2. A random review of patient slides from 2022 (December), 2023 (December) and 2024 (June) revealed: 12/13/2022: 19 slides labeled with a patient last name, Mohs accession number, number of stages, quadrant number and slide number; 15 slides were labeled with patient last name and first initial, Mohs accession number, number of stages, quadrant number and slide number The Mohs accession numbers were as Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- follows: 22M-077, 22M-078, 22M-079, 22M-080, 22M-081, 22M-082, 22M-083 12 /05/2023: 35 slides were labeled with patient last name and first initial, Mohs accession number, number of stages, quadrant number and slide number The Mohs accession numbers were as follows: 23M-052, 23M-053, 23M-054, 23M-055, 23M- 056, 23M-057, 23M-058 06/11/2024: 29 slides were labeled with patient last name and first initial, Mohs accession number, number of stages, quadrant number and slide number The Mohs accession numbers were as follows: 24M-022, 24M-023, 24M-024, 24M-025, 24M-026, 24M-027 The laboratory failed to ensure patient histopathology (Mohs) slides were labeled with at least two unique patient identifiers. 3. During an interview on 06/17/2024 at 2:52 pm, the Receptionist after a review of the records, confirmed the above findings. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: I. Based on review of laboratory policies, environmental records, and confirmed in staff interview, the laboratory failed to monitor the room temperature and humidity requirements for 20 of 20 days in 2022 (August through December), 53 of 53 days in 2023 (January through December) and 27 of 27 days in 2024 (January through June). Findings included: 1. Review of laboratory policy titled: "LABORATORY DAILY MAINTENANCE" stated: "7. Temperature charts and logs are checked daily or whenever in use [sic]" 2. Review of the laboratory "ROOM TEMP/HUMIDITY" records for 2022, 2023 and 2024 revealed: "1. 68 degrees F to 80 degrees F for temp & lwss [sic] than 60% for humidity [sic] 2. The room temperature will be checked at the beginning of each workday. Any

Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy and procedures, observation, and interview, the laboratory failed to ensure the microscope maintenance was performed annually for one of one year reviewed. Findings follow. Review of the laboratory's Policy and Procedure approved on 1/27/15 for the Microscope stated, "have regular service contracts performed." Observation of the sticker on the microscope showed service was performed on 10/08/18 and next service was due on 10/2019. Interview with the Laboratory Director at 11:35 in the laboratory stated he would send the 2019 service record. As of 9/30/2020 no documentation has been received. 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, testing logs, and interview, the laboratory failed to ensure reagents were not used past their expiration date for 6 of 9 bottles. Findings follow. At 9:15, 5 unopen bottles, and 1 open bottle of Tissue-Plus O.C.T. Compound were 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 -- found in the cabinet with an expiration date of 5/2020. Review of the Mohls testing records showed 45 patients were processed from 6/01/2020 - 9/24/2020. There were no logs for the H&E (Hematoxylin and Eosin) cases, so they were not counted. Interview with the Histotech at 9:15 verified the bottles were expired. She stated she was not aware the expiration dates were on the bottom of the bottle. -- 2 of 2 --