Summary:
Summary Statement of Deficiencies D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (1) Identity and when significant, titer, strength or concentration. (2) Storage requirements. (3) Preparation and expiration dates. (4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on review of equipment preventative maintenance (PM) records; current, approved standard operating procedures; Avantik Q512 cryostat and Linistat automated stainer manufacturer's instructions; as well as interview with the Physician Assistant (PA), Avantik Q512 cryostat and Linistat automated stainer patient specimen processing equipment were overdue for PM. Findings: 1. There was no documentation of Avantik Q512 cryostat PM performance since March 2023. 2. There was no documentation of Linistat automated stainer SN# LS5865A2003 PM performance since June 2021. 3. This is contrary to instructions indicated in the current, approved standard operating procedures as well as Avantik Q512 cryostat and Linistat automated stainer manufacturer's instructions. 4. The PA confirmed the findings on June 13, 2024, at approximately 1:30 P.M. 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 --