Summary:
Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) (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 laboratory tour, a review of the policy and procedures, and an interview with Histotech #1, the laboratory used expired chemical for Dermatology biopsy specimens. The surveyor noted the laboratory utilized expired Eosin stain since November 2023. The findings include: 1. A tour of the laboratory revealed the Eosin Y Aqueous chemical lot #113403 expired 11/2023. 2. A review of the policy and procedures 1.4 Chemical Handling and Storage, "Chemical storage areas shall be annually inspected for outdated chemical stock... and disposed of properly." 3. During an interview on 2-4-2025, at 9:54 AM, Histotech #1 confirmed the above findings. 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 --