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 direct observation of the Potassium Hydroxide (KOH) and Chlorazol Black E reagents and interview with the facility personnel, the laboratory used the Potassium Hydroxide, 10% and Chlorazol Black E reagents past the expiration dates. Findings include: 1. The laboratory performs KOH preparations on patient slides under the subspecialties of Mycology and Parasitology with a reported annual test volume of 220. 2. Direct inspection of the Potassium Hydroxide, 10% reagent (lot #2545-03) in use at the time of the survey conducted on 11/19/24 indicated an expiration date of 8 /31/23. 3. Direct inspection of the Chlorazol Black E reagent (lot# 1120) in use at the time of the survey conducted on 11/19/24 indicated an expiration date of 4/30/23. 4. The total number of patients tested using the expired reagents could not be determined at the time of the survey. 5. The facility personnel interviewed on 11/19/24 at 9:10 AM confirmed the expired reagents indicated above were 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 --