Center For Digestive Disease

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 08/28/2025. The laboratory was found in compliance with applicable CLIA regulations (42 CFR Part 493, Requirements for Laboratories) for the specialties/subspecialties for which it was surveyed. STANDARD LEVEL DEFICIENCIES were cited. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) (b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on review of laboratory's proficiency testing (PT) records and staff interview, the laboratory failed to ensure attestation signatures of laboratory director/designee and/or testing personnel were documented for three of five PT events reviewed from 2023, 2024 and 2025. Findings included: 1. Review of laboratory's American Proficiency Institute (API) PT records revealed the following API instructions to laboratories: "SIGNATURES REQUIRED - For all PT results, an attestation statement must be signed by testing personnel and the laboratory director and retained for a minimum of 2 years." 2. Further review of laboratory's 2023-2025 PT records revealed the following three of five reviewed API PT events did not have documentation of required attestation signatures: Event: 2023 Microbiology - 3rd Event Tested: November 2023 Missing signature(s): Testing Personnel Event: 2024 Microbiology - 2nd Event Tested: July 2024 Missing signature(s): Testing Personnel Event: 2025 Microbiology - 1st Event Tested: January 2025 Missing signature(s): Laboratory Director/designee and Testing Personnel 3. In an interview on 08/28/2025 at 1010 hours in the open office space, the Testing Person number two (as indicated on submitted Form CMS 209) confirmed the findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 review of laboratory's temperature/humidity records, policies/procedures and staff interview, the laboratory failed to define and monitor room temperature /humidity to ensure histopathology slides' preservation for one of one room where histopathology slides were stored in 2024 and 2025. Findings included: 1. Review of laboratory's temperature/humidity records revealed there was only one room temperature/humidity monitored in 2024 and 2025, the molecular testing room. There were no temperature/humidity records for the room where histopathology slides were stored. 2. Review of laboratory's policies/procedures revealed the policies/procedures did not define requirements for histopathology slides' storage conditions to ensure slides' preservation. 3. In an interview on 08/28/2025 at 1110 hours in the open office space, the facility's Practice Manager (as indicated on submitted Survey Entrance/Exit Conference document), when asked, stated that histopathology slides were stored in a separate room, but the temperature/humidity was not monitored there. This confirmed the findings. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) (b) The laboratory must verify the accuracy of the following: (b)(1) Any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS-approved proficiency testing program. This STANDARD is not met as evidenced by: This is a repeat deficiency from the survey conducted on 10/02/2023. Based on review of laboratory's proficiency testing (PT) records and staff interview, the laboratory failed to document self-evaluation for one of fifteen "Not Graded" PT results from 2024 and 2025. Findings included: 1. Review of laboratory's PT records revealed the laboratory used American Proficiency Institute (API) as their PT provider. 2. Review of the API instructions to laboratories revealed: "Laboratories are responsible for documenting and performing

Summary Statement of Deficiencies D0000 An announced survey of the laboratory was conducted on 10/02/2023. The laboratory was found out of compliance with the CLIA regulations (42 CFR Part 493, Requirements for Laboratories). The CONDITIONS NOT MET were: D6063 - 42 C. F.R. 493.1421 Condition: Laboratories performing moderate complexity testing; testing personnel. . D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on review of laboratory's Proficiency Testing (PT) documents for the Biofire FilmArray Gastrointestinal (GI) Panel for 2022 and 2023 and staff interview, the laboratory failed to retain all documentation for one of five events reviewed, 2022 Microbiology - 2nd (second) Event. Findings included: 1. Review of laboratory's PT documents for 2022 and 2023 revealed the laboratory used the American Proficiency Institute (API) to perform PT for its Biofire FilmArray GI Panel. 2. Further review of the PT documents for 2022 and 2023 revealed the following documents for 2022 Microbiology - 2nd Event (tested June 2022) were not retained: - Attestation document - Test data entry printouts - API Performance Summary - API Comparative Evaluation - API Participant Data Summary - Documentation of evaluation of laboratory's performance 3. In an interview on 10/02/2023 at 1005 hours in the laboratory, the facility's Testing Person number one (as indicated on submitted form CMS 209), after review of the data, confirmed the findings. Key: CMS - Centers for Medicare and Medicaid D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of laboratory's Proficiency Testing (PT) documents for the Biofire FilmArray Gastrointestinal Panel (GI) for 2022 and 2023, review of American Proficiency Institute's (API) instructions for evaluation of results and staff interview, the laboratory failed to follow API instructions for documentation of evaluation of "Unacceptable" results for one of five accuracy verification events reviewed. Findings included: 1. Review of laboratory's PT documents for 2022 and 2023 revealed the laboratory used the API to perform PT for its Biofire FilmArray GI Panel. 2. Review of the API instructions for evaluation of results revealed: "Laboratories are responsible for documenting and performing

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 D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the proficiency testing company, American Proficiency Institute (API), it was determined the laboratory had not successfully participated in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- under CLIA. The laboratory did not successfully participate in the specialties of: a) Bacteriology for the analyte Molecular Bacti- GI b) Virology for the analyte Molecular Virology- GI. Refer to D2028 and D2064. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed the laboratory failed to attain an overall testing score of at least 80% in the specialty of Bacteriology. Findings include: 1. 2020 Microbiology- 3rd Event unacceptable score of 0% 2. 2021 Microbiology- 1st Event unacceptable score of 0% D2021 BACTERIOLOGY CFR(s): 493.823(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed that the laboratory failed to participate in the API- Microbiology 3rd event 2020 and API- Microbiology 1st event 2021, resulting in unsatisfactory performance for the specialty Bacteriology. Findings include: 1. API- Microbiology 3rd event 2020 the laboratory failed to participate, resulting in a score of 0% 2. API- Microbiology 1st event 2021 the laboratory failed to participate, resulting in a score of 0%. D2028 BACTERIOLOGY CFR(s): 493.823(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center -- 2 of 4 -- for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed the laboratory failed to achieve satisfactory performance of at least 80% for the same analyte in 2 out of 3 consecutive testing events in the specialty Bacteriology for the analyte Molecular Bacti- GI. Findings include: Molecular Bacti- GI: 1. 2020 Microbiology- 3rd Event unacceptable score of 0% 2. 2021 Microbiology- 1st Event unacceptable score of 0% D2056 VIROLOGY CFR(s): 493.831(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed the laboratory failed to attain an overall testing score of at least 80% for the specialty of Virology. Findings include: 1. 2020 Microbiology- 3rd Event unacceptable score of 0% 2. 2021 Microbiology- 1st Event unacceptable score of 0% D2057 VIROLOGY CFR(s): 493.831(b) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed that the laboratory failed to participate in the API- Microbiology 3rd event 2020 and API- Microbiology 1st event 2021, resulting in unsatisfactory performance for the specialty Virology. Findings include: 1. API- Microbiology 3rd event 2020 the laboratory failed to participate, resulting in a score of 0% 2. API- Microbiology 1st event 2021 the laboratory failed to participate, resulting in a score of 0% D2064 VIROLOGY CFR(s): 493.831(e) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. -- 3 of 4 -- This STANDARD is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed the laboratory failed to achieve satisfactory performance of at least 80% for the same analyte in 2 out of 3 consecutive testing events in the specialty Virology for the analyte Molecular Virology- GI. Findings include: Molecular Virology- GI: 1. 2020 Microbiology- 3rd Event unacceptable score of 0%- failure to participate. 2. 2021 Microbiology- 1st Event unacceptable score of 0%- failure to participate. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a desk review of proficiency testing records obtained from the CMS (Center for Medicare Services) national database and verified with the laboratory's American Proficiency Institute (API) proficiency test results, it was revealed that the laboratory director failed to provide overall management and direction of the laboratory services. Refer to D6018. D6018 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iii) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iii) Ensure that all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

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 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