Avamar Gastroenterology Inc

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 record review, direct observation and an interview with Testing Personnel (TP) #1, TP#2 and the Inform Diagnostics sales representative (SR), the laboratory failed to label the secondary container of a Sodium Hypochlorite cleaning solution with the strength or concentration, storage requirement, preparation and expiration dates and lot number (pertinent information required for proper use) which was utilized for cleaning procedures in the tissue grossing hood of high complexity tissue biopsy testing procedures in the subspecialty of Histopathology. This deficient practice had the potential to affect 31,976 out of 31,976 patient tissue biopsy specimens from the last CLIA inspection on 04/23/2024 through 07/07/2026. Findings Include: 1. Review of the laboratory's "Accessioning and Grossing Procedure" and "Grossing" policies and procedures, approved via signature and date by the Laboratory Director on 08/22/2025 and provided for inspection review did not find any instructions of the laboratory's labeling policies and procedures for secondary containers of prepared solutions. 2. Direct observation of the Histopathology tissue grossing hood on 07/07/2026 at 2:20 PM found a secondary bottle of Sodium Hypochlorite cleaning solution labeled only with "Sodium Hypochlorite" without any indication of the strength or concentration, storage requirement, preparation and expiration dates and lot number (pertinent information required for proper use). 3. On 07/07/2026 at 2:20 PM the Inspector requested the laboratory's policy and procedure for labeling secondary containers of prepared solutions from TP#1, TP#2 and the SR. 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 -- TP#1, TP#2 and the SR confirmed the laboratory did not establish a policy and procedure for labeling secondary containers of prepared solutions and the laboratory did not label secondary container of the Sodium Hypochlorite cleaning solution as required by CLIA regulation. TP#1, TP#2 and the SR were unable to provide the requested documentation on the date of the inspection. 4. Review of laboratory documentation revealed the laboratory completed 31,976 patient tissue biopsy specimens from the last CLIA inspection on 04/23/2024 through 07/07/2026. 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: * This is a repeat deficiency * Based on direct observation and an interview with Testing Personnel (TP) #1, TP#2 and the Inform Diagnostics sales representative (SR), the laboratory failed to ensure solutions were not utilized for Histopathology cleaning procedures when they had expired. This deficient practice had the potential to affect 24,597 out of 24,597 patient tissue biopsy specimens between 10/31/2024 through 07/07/2026. Findings Include: 1. On 07/07/2026 at 2:20 PM, direct observation of the laboratory found two bottles of ParaGard tissue embedder cleaner, lot number 132108, with an expiration date of 10/31/2024 in use. Further observation found three additional unopened bottles of the same lot and expiration in the cupboard. 2. On 07/07/2026 at 2:20 PM TP#1, TP#2 and the SR confirmed the two opened bottles of ParaGard tissue embedder cleaner had been used past the expiration date. 3. Review of laboratory documentation revealed the laboratory completed 24,597 patient tissue biopsy specimens between 10/31/2024 through 07/07/2026. -- 2 of 2 --

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(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 record review and an interview with the sole Testing Personnel (TP), the laboratory failed to ensure the Quick Dip #2 and Quick Dip #3 stains, utilized for high complexity tissue biopsy testing procedures performed in the subspecialty of Histopathology, were not used when they had exceeded their expiration dates. This deficient practice had the potential to affect 662 out of 662 tissue biopsy testing procedures performed between 12/09/2022 through 03/20/2023, Findings Include: 1. Review of the laboratory's "Histology Procedure Manual", approved by the Laboratory Director via signature and date on 08/20/2021 and provided on the date of the inspection, found a policy and procedure titled "Reagents" which revealed the following statement: "6. All expired reagents should be discarded..." 2. Review of the laboratory's 2022, 2023 and 2024 "Reagent Log In Form: revealed the Quick Dip #2 and Quick Dip #3 stains were used beyond their expiration dates as listed below: Quick Dip #2 Lot Opened Expiration Last Used Number Date Date Date 2033853 01 /28/22 12/08/22 02/01/23 Quick Dip #3 Lot Opened Expiration Last Used Number Date Date Date 2102917 03/15/22 02/04/23 03/20/23 3. The sole TP stated they were unaware of what may have happened at the time of the documentation and confirmed the Quick Dip #2 and #3 stains were utilized for patient tissue biopsy testing procedures when they had exceeded their expiration dates. The interview occurred on 04/23/2024 at 9:50 AM. 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 D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on record review and interviews with testing personnel (TP) #1 and the Sales Representative for the professional component (SR), the laboratory failed to blindly verify the accuracy of the tissue biopsy grossing procedures performed, that are not listed in Subpart I, at least twice annually. Findings Include: 1. Review of the laboratory's tissue biopsy policies and procedures, provided on the date of the inspection, did not find any instructions to blindly verify the tissue biopsy grossing procedures performed, at least twice annually. 2. The Surveyor requested the laboratory's 2016, 2017 and 2018 blind tissue biopsy grossing test accuracy verification (TAV) documentation from TP#1 and SR. TP#1 and SR stated the laboratory had a misunderstanding between proficiency testing and quality assurance and confirmed the laboratory did not conduct any blind TAV activities for the tissue biopsy grossing procedures performed in 2016, 2017 and 2018 to date, as required, and were unable to provide the requested documentation on the date of the inspection. The interviews occurred on 03/20/2018 at 2:28 PM. 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 --