Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 05/27/2026. The laboratory was found in substantial compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. 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's observations, review of laboratory's test records and staff interview, the laboratory failed to ensure reagents were not used beyond their expiration date for two of two bottles of expired Epredia Neg-50 reagent, used as Mohs surgery frozen section media in histopathology slides' preparation. Findings included: 1. Surveyor's observations on 05/27/2026 at 0902 hours in the laboratory revealed the following two bottles of expired in use Epredia Neg-50 reagent sitting on top of the Cryostat: Lot number: 131374N Expiration date: 2025-12-04 Lot number: 131888N Expiration date: 2025-12-25 2. Review of laboratory's test records from 12 /25/2025 through 05/27/2026 revealed histopathology slides for the following thirteen patient cases were prepared with the expired Neg-50 reagents: SA26-001 SA26-002 SA26-003 SA26-004 SA26-005 SA26-006 SA26-007 SA26-008 SA26-009 SA26-010 SA26-011 SA26-012 SA26-013 3. In an interview on 05/27/2026 at 0905 hours in the laboratory, the facility's Practice Manager (as indicated on submitted Entrance/Exit Conference document) confirmed the 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 --