Southwest Gastroenterology Associates

Summary Statement of Deficiencies D0000 An onsite recertification survey conducted on August 12, 2026, at Southwest Gastroenterology Associates found the laboratory to be not in compliance with the CLIA regulations found at 42 CFR, Part 493 Laboratory Requirements, with standard deficiencies cited. D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on direct observation, lack of documentation, and interview with the Laboratory Director (LD), the laboratory failed to ensure proper storage conditions were maintained for tissue blocks and slides in 2025 and January through July 2026. The laboratory reports 22,000 histopathology tests annually. Findings include: 1. During a laboratory tour on 08/12/2026 at 9:30 AM, no temperature or humidity monitoring equipment were observed in the tissue block and slide storage room. 2. A request was made for documentation demonstrating proper temperature and humidity was maintained in the tissue block and slide storage room in 2025 and January through July 2026, none was provided. 3. A request was made for a policy that specified proper block and slide storage conditions, none was provided. 3. During an interview with the LD on 08/12/2026 at 10:15 AM, the LD indicated temperature and humidity are not monitored in the tissue block and slide storage room. This confirmed the above findings. 4. The laboratory reports 22,000 histopathology tests annually. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (b) The laboratory must define criteria for those conditions that are essential for 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 -- proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on direct observation, review of the Ventana Anti-Pan Keratin (AE1/AE3 /PCK26) Primary Antibody Manufacturer's Instructions (APK MI), review of the Cell Marque CDX-2 (EPR2764Y) Rabbit Monoclonal Antibody Manufacturer's Instructions (CDX-2 MI), review of the Tissue-Tek VIP6 AI Operator's Manual (VIP6 MI), review of the laboratory's Temperature and Humidity log, and interview with Testing Personnel 2 (TP2), the laboratory failed to document proper temperature storage conditions for the Ventana Anti-Pan Keratin (AE1/AE3/PCK26) Primary Antibody (APK) and the Cell Marque CDX-2 (EPR2764Y) Rabbit Monoclonal Antibody (CDX-2) assays and failed to document proper temperature and humidity storage conditions for the Tissue-Tek VIP6 AI tissue processor for 176 days between January 2025 and July 2026. The laboratory reports 22,000 histopathology tests annually. Findings include: 1. During a laboratory tour on 08/12/2026 at 9:30 AM, immunohistochemical stains, including APK and CDX-2, were observed in the laboratory's refrigerator. A Tissue-Tek VIP6 AI tissue processor was also observed in the laboratory. 2. Review of the APK MI and CDX-2 MI revealed both stains required a storage temperature of 2-8Celcius (C). 3. Review of the VIP6 MI revealed the Tissue-Tek VIP6 AI required a storage temperature of 10-40C and humidity of 30- 85%. 4. Review of the laboratory's Temperature and Humidity log revealed there was no temperature recorded for the refrigerator and no temperature or humidity recorded for the laboratory for 112 days in 2025 and 64 days between January and July 2026. 5. During an interview with the TP2 on 08/12/2026 at 10:15 AM, TP2 indicated temperature and humidity are not recorded by staff on the weekends. This confirmed the above findings. 6. The laboratory reports 22,000 histopathology tests annually. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based upon the initial onsite survey conducted on 01/27/2023, the laboratory was found to be in substantial compliance with the CLIA regulations found at 42 CFR for the specialties/subspecialties in which it was surveyed with standard level deficiencies cited. D3013 FACILITIES CFR(s): 493.1101(e) Records and, as applicable, slides, blocks, and tissues must be maintained and stored under conditions that ensure proper preservation. This STANDARD is not met as evidenced by: Based on direct observation, record review, and confirmed by staff interview, the laboratory failed to monitor and document room conditions that ensure preservation of patient slides for 24 of 24 months (02/2021 - 01/2023). Findings included: 1. During a tour of the laboratory on 01/27/2023 at 11:30 am, the surveyor observed patient slides stored within the laboratory. Dates ranged from 02/2021 - 01/2023. 2. Review of the annual test volume submitted by the laboratory stated: a. Slide interpretation 2021 = 6355 b. Slide interpretation 2022 = 8553 3. During an interview on 01/27/2023 at 11: 40 am in the laboratory, the surveyor requested environmental monitoring logs for the laboratory room. The Laboratory Director stated that the environmental conditions are not monitored and documented within the laboratory. This confirmed the above findings. 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 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 -- for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on review of the laboratory policy, laboratory record review, and confirmed by staff interview, the laboratory failed to define the acceptable Hematoxylin and Eosin (H&E) quality control (QC) stain characteristics for 6 of 6 months (03/2021-05/2021 and 03/2022-05/2022). Findings included: 1. Review of the laboratory policy titled "4. C Histology Staining Quality Control", approved by the Laboratory Director on 02/12 /2021, stated the following: "1. H&E Slide Review, a. The pathologist will assess the quality of the slides daily and initial the stain QC log for each day of staining." 2. Review of the laboratory form titled "Daily Staining QC Log", dated 03/2021-05/2021 and 03/2022-05/2022 listed criteria as: Y = Yes, adequate staining N = No, repeat /adjust The laboratory failed to define acceptable criteria for H&E stain characteristics. 3. During an interview on 01/27/2023 at 10:15 am in the conference room, after review of the above results, the laboratory director confirmed the above findings. -- 2 of 2 --