Texas Digestive Specialists

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 review of the laboratory's test menu, review of the laboratory's records, and staff interview, the laboratory failed to have documentation of performing twice annual accuracy assessments for 23 of 23 tests in 2023 and 2024. The findings included: 1. A review of the laboratory's test menu identified the laboratory performed testing utilizing the following 22 stains: H&E CD 3 CD 20 CK OSCAR KI-67 MLH- 1 PMS2 MSH-6 CMV P53 Chromogranin Synaptophysin H-pylori Gastrin MSH2 SMA Trichrome Iron AFB PAS Aician Blue PAS Fungus PAS D 2. The laboratory also performed grossing the samples. 3. A review of the laboratory's records determined the facility failed to have documentation of performing twice annual accuracy assessments for each of the identified tests in 2023 and 2024. 4. The pathology manager confirmed the findings in an interview conducted on 09/24/2025 at 1000 in the laboratory. D5785

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative at the entrance and exit conferences. The facility representative was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --