Summary:
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 a review of the chemical log sheet and an interview with the MOHS Laboratory Manager (MLM), the laboratory utilized an expired bluing agent for the staining procedure. The surveyor noted the expired reagent was used for 25 out of 31 days, on 12 QC slides and 137 patients. The findings include: 1. A review of the chemical log sheet revealed an expired Scotts Tap (ST) water was used as a component for the Hematoxylin and Eosin (H&E) staining protocol. The ST water package indicated an expiration date of 4-28-2023, but the laboratory continued to use it from 5-01-2023 through 5-25-2023. 2. MLM confirmed the above findings during the exit conference on 11-19-2024 at 2:20 PM. 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 --