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 surveyor observation of Potassium Hydroxide (KOH) and Swartz Lamkins reagents and interview with the Office Manager (OM), the laboratory failed to discard expired reagents from April 2012 to the date of survey. The findings include: 1. KOH Lot KO9464 expired April 2012 2. Swartz Lamkins stain Lot K159T3 expired September 2017 3. The OM confirmed on 10/3/24 at 10:30 am that the laboratory failed to discard expired reagents. 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 --