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 the surveyor's review of the laboratory's testing reagent expiration dates, and an interview with laboratory personnel (LP) on 11/4/2020 between 2:00 p.m. and 3:30 p..m, it was determined several reagents used for tissue staining were expired. Findings include: 1. On 11/4/2020, an inspection was conducted between 2:00 p.m and 3:30 p.m. 2. During a review of the reagent expiration dates , it was noted at approximately 2:30 p.m. that the expiration dates on several containers of the reagents used in the tissue staining process were expired. The LP recognized that these reagents were indeed expired. These reagents were currently in use. 3. The vendor, reagent and expiration dates are indicated below Vendor Reagent Expiration Date Advantik Eosin 8/1/2020 Advantik Eosin 6/22/2017 A/M Gill's Hem. 1/17/2020 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 --