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 laboratory observation, review of laboratory logs, and staff interviews, the laboratory failed to ensure that it did not use tissue marking inks (three of three) used for patient tissue processing removed during Micrographic Oriented Histographic Surgery (MOHS) procedures, past the expiration date from 03/31/2026 to the survey date on 05/11/2026. The findings include: 1. Observation of the laboratory on 05/11 /2026 at 11:35 a.m. revealed three tissue marking ink bottles (Green lot #24065, Blue lot # 24078, and Red lot #24067) used for grossing procedures of patient tissue removed during MOHS procedures, with manufacturer's expiration dates of 03/31 /2026. 2. A review of the laboratory's "Quality Control Log- Daily Worksheet" revealed that the laboratory performed patient testing after the manufacturer's expiration date on 04/13/2026, 04/27/2026, and 05/11/2026. 3. An interview with the laboratory processing personnel at 11:40 a.m. and the laboratory director at 1:00 p.m. on 05/11/2026 confirmed the survey findings. 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 --