Summary:
Summary Statement of Deficiencies D0000 A recertification survey was conducted on July 19, 2022. UCF Health clinical laboratory was not in compliance with 42 CFR 493, requirements for clinical laboratories. 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, record review, and interview, the laboratory failed to ensure the Hematoxylin Vintage stain used in their Hematoxylin and Eosin Staining (H&E) was not expired prior to patient testing from 07/05/22 to 07/19/2022. Findings: Observations made during a tour of the laboratory on 07/19/2022 at 10:10 AM showed the opened bottle of Hematoxylin Vintage stain lot number 111225 expired on 06/30/2022. Review of the Reagent Receipt Log showed lot number 111225 of the Hematoxylin Vintage stain was opened on 01/20/2021. The laboratory used the Hematoxylin Vintage stain for H&E stained slides for their Mohs surgical procedures. Review of the "Mohs Micrographic Surgery Log" showed patient slides were stained after the Hematoxylin Vintage stain had expired on the following dates: 07/05/2022 - 4 patients 07/06/2022 - 4 patients 07/07/2022 - 2 patients 07/08/2022 - 2 patients 07/11 /2022 - 6 patients 07/12/2022 - 4 patients 07/13/2022 - 3 patients 07/14/2022 - 2 patients 07/15/2022 - 2 patients 07/18/2022 - 4 patients 07/19/2022 - 1 patient On 07 /19/2022 at 10:15 AM, the General Supervisor acknowledged the Hematoxylin 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 --