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 laboratory observation, patient test records, and staff interviews, the laboratory failed to ensure that it did not use four of four lots of tissue marking dyes beyond their expiration in micrographically oriented histographic surgery (Mohs) histopathology patient testing. The findings include: 1. Observation of the Mohs laboratory on 07/02/2024 at 8:10 a.m. revealed the following opened Avantik tissue marking dyes: - Green (lot: 121757) with an expiration date of 5/31/2023 - Yellow (lot: 118666) with an expiration date of 3/31/2023 - Black (lot: 122217) with an expiration date of 5/31/2023 - Blue (lot: 121983) with an expiration date of 5/31/2023 2. A review of random review of patient records revealed the laboratory performed Mohs testing on 06/28/2023 (Case M23-029), 11/28/2023 (Case M23-169), 02/21 /2024 (Case M24-057), and 06/18/2024 (Case M24-196). 3. An interview with the histotechnician on 07/02/2024 at 11:30 a.m. confirmed that the laboratory used the observed tissue marking dyes for patient testing (including the four cases reviewed) after expiration. 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 --