Summary:
Summary Statement of Deficiencies D0000 Recertification survey was conducted on March 12, 2024. Sebastian - Iconic Dermatology clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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 review of the quality control documents and interview, the laboratory failed to use Eosin Stain that was not expired from 10/5/2023 to 12/21/2023. Findings: The laboratory used Eosin in their Hematoxylin and Eosin (H&E) stain to stain slides of patients who had Mohs surgical procedures. Review of the Laboratory Reagent Log for October 2023, November 2023 and December 2023 listed Eosin Lot #L245-04 expiration date 10/04/2023. Review of the Laboratory Reagent Log for January 2024 listed Eosin lot #4350651 expiration date 05/22/2025 was opened on 01/04/2024. Review of the Mohs Accession Log showed Mohs surgical procedures were performed on the following dates: 10/12/2023 - 3 surgical procedures 10/19/2023 - 14 surgical procedures 10/26/2023 - 11 surgical procedures 10/26/2023 - 12 surgical procedures 11/02/2023 - 9 surgical procedures 11/16/2023 - 11 surgical procedures 11 /30/2023 - 9 surgical procedures 11/30/2023 - 11 surgical procedures 12/07/2023 - 9 surgical procedures 12/14/2023 - 12 surgical procedures 12/21/2023 - 10 surgical procedures On 03/12/2024 at 2:08 PM, the Office Administrator acknowledged the reagent logs listed the expired Eosin. 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 --