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 surveyor observation and interview with laboratory director (LD) 5/7/26, the laboratory failed to ensure 1 bottle of expired Potassium Hydroxide (KOH) reagent was not available for use in patient testing. Findings: During facility tour at approximately 10:00 a.m., surveyor observed 1 bottle of "EDM3" KOH reagent, Lot # 010126, with an expiration date on 01/23/26, beside the microscope in the room in which KOH Wet Prep testing is performed. Interview with LD at approximately 10:00 a.m. confirmed the KOH reagent had an expiration date of 01/23/26. The reagent was immediately disposed of. 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 --