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 KOH (potassium hydroxide) reagent and interview with personnel, only expired KOH reagent was available for use in testing patient samples in exam room 3. Findings include: 1. Observation of KOH reagents available in exam room 3 on January 10, 2018 at 2:15 PM revealed three bottles of expired KOH reagent. The first bottle, lot K11715, showed an expiration date of July 31, 2014. The second bottle, 20 % KOH with DMSO (Dimethyl sulfoxide), lot K11AH3 expired October 31, 2014. The third bottle, 10 % KOH, lot K119M5 expired September 30, 2014. 2. Interview with staff A on January 10, 2018 at 2:15 PM confirmed all KOH reagent available in exam room 3 expired in 2014 and that no unexpired reagent was available in this room for patient testing. 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 --