Summary:
Summary Statement of Deficiencies D0000 The Skin Professionals West 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 May 1, 2025. The following standard-level deficiencies were cited: 493.1252: Test systems, equipment, instruments, reagents, materials, and supplies . D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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, document review, and interview with laboratory personnel, the laboratory failed to ensure four of five bottles of Histopathology dyeing materials in use did not exceed expiration in 2024 and 2025. Findings are as follows: 1. The laboratory performed Mohs Micrographic surgery with microscopic examination under the subspecialty of Histopathology as confirmed by the Mohs technician (MT) during a tour of the laboratory at 1:05 p.m. on 05/01/2025. 2. The laboratory was required to label and document when dyeing and staining materials are opened and expire as indicated in the Hematoxylin & Eosin Stain Procedure found in the Mohs Lab Procedure Manual. 3. The following dyeing materials were observed as expired during the tour of the laboratory: Avantik Tissue Marking Dye Color Expiration Blue 8/31/24 Black 9/30/24 Green 9/30/24 Yellow 9/30/24 4. Monthly Quality Assurance Checklists completed in August 2024 through May 2025 indicated the staining and dyeing materials in use did not exceed expiration dates. 5. In an interview at 1:11 p.m. on 05/01/2025, the MT confirmed the above findings. 6. The laboratory performed 175 Mohs microscopic exams between August 31, 2024 and May 1, 2025 as confirmed by the MT in an email received at 8:22 a.m. on 05/06/2025. . Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --