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 reagent records review, lack of documentation, and interview with staff, the laboratory failed to record the lot number and expiration date for Eosin Y stain reagent in use between 03/11/2016 and 09/04/2018. Findings include: 1. The reagent records log failed to include the date, lot number and expiration date of the reagent in use after the expiration date of 03/11/2018 until new reagent lot number was recorded on 09/04/2018 . 2. In an interview with staff on 10/10/2018 at approximately 1:45 P. M. staff stated the laboratory failed to record the reagent that replaced the expired Eosin Y stain prior to the expiration date of 03/11/2018. 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 --