Digestive Health Clinic Llc

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on a review of the Centers for Medicare and Medicaid Services (CMS) 209 personnel form, competency assessment records and an interview with the laboratory supervisor on 7/18/2024, the laboratory failed to assess testing personnel competency and training in 2023 and 2024. The findings include: 1. A review of the CMS 209 form identified four testing personnel. 2. A review of competency assessment records identified the laboratory failed to have documentation of annual competency for two testing personnel in 2023. 3. A review of competency assessment and training records identified the laboratory failed to have documentation of training for one new testing personnel in 2024. 4. An interview with the laboratory supervisor on 7/18/2024 at 1: 18 pm confirmed the above findings. 5. The laboratory reports performing 36,000 tests annually. 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 D5475 CONTROL PROCEDURES CFR(s): 493.1256(e)(3)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (3) Check fluorescent and immunohistochemical stains for positive and negative reactivity each time of use. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of laboratory quality control (QC) documents and an interview with the laboratory director (LD) on 7/25/2022, the laboratory failed to have documentation of daily Hematoxylin and Eosin (H&E) QC for November 2021. The findings include: 1. A review of H&E daily QC logs identified that the laboratory failed to have daily QC documentation of H&E stains for the month of November 2021. 2. An interview with the LD on 7/25/2022 at 1:40 pm confirmed that the laboratory failed to have documentation of H&E stain QC for November 2021. 3. The laboratory performed H&E stains 20 days in November 2021 on 704 patient cases. 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 D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on record review and an interview with the laboratory director on 11/18/20, the laboratory failed to establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. The findings include: 1. The laboratory has no written policies or procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements such as temperatures out of range for testing instruments. See D5781 2. An interview with the laboratory director on 11/18/2020 at 3:50 pm, confirmed that the laboratory had failed to establish and follow a quality assessment policy and procedure to monitor, assess, and, when indicated, correct problems identified in the laboratory. D5781