Summary:
Summary Statement of Deficiencies D0000 The Katy Digestive Center laboratory was found to be in compliance with the Conditions of the CLIA regulations found at 42 CFR 493.1 through 493.1780, CLIA requirements for laboratories as a result of an initial survey on May 5, 2026 and certification is recommended. Standard level deficiencies were cited. D5805 TEST REPORT CFR(s): 493.1291(c) (c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: I. Based on a random review of the laboratory's grossing logs, patient's test reports, and staff interview, the laboratory failed to document the correct date that the patient's tissue was grossed for eleven of eleven patient's test reports reviewed on October 30, 2025. Findings include: 1. A random review of the laboratory's grossing logs from October 2025 revealed the laboratory grossed the following 11 patient's tissue specimens on October 30, 2025: Patient ID: MA25-108 Patient ID: MA25-109 Patient ID: MA25-110 Patient ID: MA25-111 Patient ID: MA25-112 Patient ID: MA25-113 Patient ID: MA25-114 Patient ID: MA25-115 Patient ID: MA25-116 Patient ID: MA25-117 Patient ID: MA25-118 2. A review of the patient's test reports revealed the laboratory failed to document the correct date that the patient's tissue was grossed for the 11 patients: Patient ID: MA25-108 Test report indicated grossing was performed on 11/5/25 Patient ID: MA25-109 Test report indicated grossing was performed on 11 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 -- /5/25 Patient ID: MA25-110 Test report indicated grossing was performed on 11/5/25 Patient ID: MA25-111 Test report indicated grossing was performed on 11/5/25 Patient ID: MA25-112 Test report indicated grossing was performed on 11/5/25 Patient ID: MA25-113 Test report indicated grossing was performed on 11/5/25 Patient ID: MA25-114 Test report indicated grossing was performed on 11/5/25 Patient ID: MA25-115 Test report indicated grossing was performed on 11/5/25 Patient ID: MA25-116 Test report indicated grossing was performed on 11/7/25 Patient ID: MA25-117 Test report indicated grossing was performed on 11/7/25 Patient ID: MA25-118 Test report indicated grossing was performed on 11/7/25 3. In an interview on 5/5/25 at 11:05 a.m. in the laboratory, after review of the records, the office manager confirmed the above findings. II. Based on a random review of patient's test reports from November 2025 to April 2026 and staff interview, the laboratory failed to document the correct suite number of the testing facility on five of five patient's test reports reviewed. Findings include: 1. A random review of patient's test reports from November 2025 to April 2026 the laboratory failed to document the correct suite number of the testing facility on the following 5 patient's test reports: Patient ID: MA25-49 Reported: 11/3/25 Patient ID: MA25-112 Reported: 11/10/25 Patient ID: MA26-221 Reported: 4/15/26 Patient ID: MA26-222 Reported: 4/15/26 Patient ID: MA26-223 Reported: 4/15/26 2. In an interview on 5/5/26 at 10:00 a.m. in the laboratory, after review of the records, the office manager confirmed the above findings. -- 2 of 2 --