Summary:
Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 01/15/2026. 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. D5415 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(c) (c) Reagents, solutions, culture media, control materials, calibration materials, and other supplies, as appropriate, must be labeled to indicate the following: (c)(1) Identity and when significant, titer, strength or concentration. (c)(2) Storage requirements. (c)(3) Preparation and expiration dates. (c)(4) Other pertinent information required for proper use. This STANDARD is not met as evidenced by: Based on surveyor's observations and staff interview, the laboratory failed to document expiration date on four of four secondary reagent containers observed in the laboratory. Findings included: 1. Surveyor's observations on 01/15/2025 at 1010 hours in the laboratory revealed four secondary reagent containers observed had labels with missing reagent's expiration date. These were: a. One medium snap-on-lid plastic tub labeled "10% (percent) NBF (neutral buffered formalin)" - preparation date: 12/22 /2025 - did not have documentation of expiration date. b. One medium snap-on-lid plastic tub Labeled "XS-3" (xylene substitute) - preparation date: 01/06/2026 - did not have documentation of expiration date. c. One medium snap-on-lid plastic tub labeled "100% Alcohol" - preparation date: 01/08/2026 - did not have documentation of the type of alcohol or expiration date. d. One medium container of blue liquid labeled "Prowave" (proprietary alcohol blend used for tissue processing) - preparation date: 01 /08/2026 - did not have documentation of expiration date. 2. In an interview on 01/15 /2026 at 1010 hours in the laboratory, the facility's Histology Technician 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 --