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 inspection of the open container of 10% potassium hydroxide (KOH) used by the Physician Assistant (PA) for fungal wet mounts in this lab and discussion with the Quality Compliance manager, the laboratory failed to ensure that only in date reagents are used on patient specimens. Findings include: 1. During the survey 01/25 /2021, the surveyor requested to visually examine the KOH bottle. When it was produced, it was noted to be expired as of 02/18/2020. 2. The Quality Compliance manager confirmed the finding during interview on 01/25/2021 at approximately 1230. 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 --