Incyte Pathology - Gritman Medical Center Branch

Summary Statement of Deficiencies 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 a direct observation, review of the reagent log form and an interview with the laboratory consultant on 5/19/2026, the laboratory failed to properly label secondary reagent containers for Hematoxylin and Eosin (H&E) staining with lot number and expiration date. The findings include: 1. A direct observation of secondary reagent containers used for H&E staining of frozen sections identified a label with reagent name and expiration date. 2. A review of the laboratory's reagent log form listed reagent names and corresponding lot numbers and expiration dates. The expiration dates on the log did not correspond with the expiration dates on the reagent containers identifying that the laboratory failed to properly label the secondary containers with the lot numbers and expiration dates. The primary containers were not located onsite. 3. In interview with the laboratory consultant on 5 /19/2026 at 1:00 pm it was stated that the secondary containers were filled off-site by another company and transported to the laboratory and that was the only documentation available for the staining reagents. 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 --

Summary Statement of Deficiencies D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on a record review and an interview with the laboratory compliance officer on 4 /26/2022, the laboratory failed to perform maintenance on the Leica CM1850 cryostat as defined by the manufacturer and with at least the minimum specified frequency. The findings include: 1. The Leica CM1850 cryostat manual states that the instrument must have the plastic coupling oiled and the specimen cylinder lubricated weekly. 2. A record review of the cryostat maintenance and turnaround log identified that the laboratory failed to document the weekly maintenance required by the manufacturer for the Leica cryostat CM1850. 3. An interview with the laboratory compliance officer on 4/26/2022 at 5:04 pm confirmed that the laboratory failed to document performance of weekly maintenance on the Leica cryostat CM1850. 4. The laboratory reports performing 3 frozen section procedures annually. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This STANDARD is not met as evidenced by: Based on a review of laboratory records and an interview with the laboratory compliance officer on 4/26/2022, the laboratory failed to document daily Hematoxylin and Eosin (H&E) stain quality. The findings include: 1. A review of the cryostat maintenance and turnaround log identified that the laboratory failed to document H&E stain quality each day of testing. 2. An interview with the laboratory compliance officer on 4/26/2022 at 5:22 pm confirmed that the laboratory failed to document H&E stain quality daily. 3. The laboratory reports performing 3 frozen section procedures annually. -- 2 of 2 --