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 review of the list of tests performed, direct observation, and interview with technical consultant, the laboratory failed to ensure testing personnel did not use expired reagents. 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 2/9/2021, at 10:50AM, revealed the KOH solution bottle in the laboratory expired on 7/31/2020. 3. The testing personnel confirmed on 2/9/2021 at 10:50AM the expired outdate of the KOH. 4. Based on interview with the technical consultant the laboratory had tested and reported 88 patients in from August 1, 2020 through February 9, 2021. 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 --