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 review of the list of tests performed, direct observation, interview with the technical consultant, and review of patient logs the laboratory failed to ensure testing personnel did not use expired reagent from 3/21/2025 - 9/3/2025. The findings include: 1. Review of the list of tests performed submitted by the laboratory revealed wet mounts/potassium hydroxide (KOH) preps are performed by the laboratory. 2. Direct observation on 9/3/2025 at 9:30 AM, revealed the KOH solution bottle in the laboratory expired on 3/20/2025. 3. Technical consultant confirmed on 9/5/2025 at 9: 30 AM the expired outdate of 3/20/2025, for the KOH in use. 4. Review of patient logs revealed the laboratory performed 186 wet mount/KOH tests from 3/21/2025 - 9/3 /2025. 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 --