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 direct observation of Histopathology stain reagents and interview with the facility personnel, the laboratory used the stain reagent, Scott Tap Water Substitute, past the expiration date of 4/18/2025. Findings include 1. The laboratory processes dermatopathology tissues and performs the microscopic interpretation of slides in the subspecialty of Histopathology with a reported annual test volume of 150. 2. During the survey conducted on 2/26/26, direct inspection of the Scott Tap Water Substitute, lot # 2409905, indicated an expiration date of 4/18/25. 3. The laboratory used the expired reagent to process patients' slides throughout the timeframe of 4/19/25 through 2/26/26. 90 patients were tested during this timeframe. 4. The facility personnel interviewed on 2/26/26 at 9:40 AM confirmed the expired reagent indicated above was used for patient testing past the manufacturer's expiration date and was in use at the time of the survey. 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 --