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 observation and interview with the histotechnician and pathology manager 8 /22/24, the laboratory failed to discard KOH (potassium hydroxide) which exceeded its expiration date. Findings: During a tour of the facility at approximately 12:20 p.m., the surveyor observed 1 bottle of HealthLink Potassium Hydroxide 10% (lot #9301, expiration date 10/28/21) in a tray beside the microscope located in the hall, available for use. During interview at approximately 12:35 p.m., the histotechnician and pathology manager stated that since the KOH is not used by laboratory staff, they did not know it was expired. 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 --