Summary:
Summary Statement of Deficiencies D0000 At the time of the announced onsite recertification survey, Advanced Dermatology and Cosmetic Surgery, was found to not be in compliance with the CLIA laboratory requirements of 42 CFR 493. 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 reagent log and interview, the laboratory failed to ensure the Eosin Y stain used for Mohs testing was not expired prior to patient testing for 11 days in 2022. The findings include: The review of the laboratory form titled "Daily Quality Control Slide" showed patient testing was performed on 4/6/22, 4/13/22, 4/20 /22, 4/27/22, and 5/4/22 using Eosin Y stain with lot number 96733 and an expiration date of 3/31/22. The review of the laboratory Mohs log showed approximately 78 patients were tested over the 5 days the expired Eosin Y was used. Further review of the form titled "Daily Quality Control Slide" showed patient testing was performed on 10/5/22, 10/12/22, 10/19/22, 10/26/22, 11/2/22, and 11/9/22 using Eosin Y stain with lot number 1050777 and expiration date of 9/2022. The review of the laboratory Mohs log showed approximately 107 patients were tested over the 6 days the expired Eosin Y was used. During the interview with the Area Clinical Manager on 7/13/23 at 9: 05am, it was confirmed the documentation showed expired Eosin Y stain was used. 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 --