Nashville Gastroenterology & Hepatology

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 Department of Health and Human Services Centers for Medicare and Medicaid Services Laboratory Personnel Report (CLIA) (Form CMS- 209), the laboratory's procedure, laboratory personnel records, and staff interview, the laboratory failed to follow the procedure for competency assessment for testing person one that performed grossing procedures of patient tissue samples when the laboratory failed to perform the 2024 competency assessment and failed to include all six required procedures for the 2025 competency assessment. The findings include: 1. A review of Form CMS-209 revealed two testing personnel (testing person one performed grossing procedures, and testing person two performed tissue examination) who performed patient testing for histopathology. 2. A review of the laboratory procedure titled "Lab Personnel Competency Assessment Policies" revealed the following: "All personnels shall have an annual competency assessment done by the medical director based on their responsibilities in the lab". The personnel competency assessments included: 1. Direct observation of routine patient test performance; 2. Monitoring the quality of routine performance; 3. Review of all worksheets, quality controls, and preventative maintenance; 4. Direct observation of instrument maintenance and function checks; 5. Assessment of test performance through random peer review; 6. Assessment of problem-solving skills. 3. A review of the laboratory personnel records for testing person one, who performed grossing of patient specimens for histopathology testing, revealed the following: Documentation of the 2024 competency assessment was not available on the date of the survey (06/26 /2025). The competency assessment performed on 06/23/2025 did not include 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 -- documentation of (1) direct observation of routine patient test performance, (2) monitoring quality of routine performance, (3) direct observation of instrument maintenance and function checks, or (4) assessment of test performance through random peer review. Problem-solving indicated "NA." 6. An interview with the laboratory director on 06/26/2025 at 12:30 p.m. confirmed the survey findings. Word Key: CLIA- Clinical Laboratory Improvement Amendments NA- Not Applicable D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e)(2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. This STANDARD is not met as evidenced by: Based on a review of the laboratory's stain quality control log, stain protocol, and staff interviews, the laboratory failed to define the predicted characteristics of the Alcian Blue and Periodic Acid Schiff (AB/PAS), Hematoxylin and Eosin (H&E), or Giemsa stains used for histopathology patient testing in 2024 through the survey date (06/26 /2025). The findings include: 1. A review of the laboratory's log titled "Stain Quality Control Log" for March 2024, August 2024, January 2025, May 2025, and June 2025 revealed no documentation of the predicted stain characteristics of the AB/PAS, H&E, or Giemsa stain quality. 2. A review of the laboratory stain protocol procedure revealed no definition of predictable stain characteristics of the AB/PAS, H&E, or Giemsa stain quality. 3. An interview with the laboratory director on 06/26/2025 at 12: 30 p.m. confirmed the survey findings. -- 2 of 2 --

Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of patient test reports, review of laboratory procedures, and staff interview, the laboratory failed to ensure procedures for histopathology tissue processing and testing were approved by the laboratory director prior to patient reporting which began on 6/24/23. The findings include: 1. Review of patient test reports revealed patient reporting for histopathology began on 6/24/23 (patient: 23-1- 1) with a total of 573 patient tests reported at the time of the survey (9/20/23). 2. Review of the "Nashville Gastroenterology & Hepatology Standard Operating Procedures" manual revealed the current laboratory director failed to sign and date the manual indicating approval of the procedures at the time of survey (9/20/23). 3. Interview with the laboratory director on 9/20/23 at 12:15 pm confirmed the laboratory began histopathology patient testing prior to the laboratory director's documentation of procedure manual approval. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. 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 -- This STANDARD is not met as evidenced by: Based on observation of the laboratory, review of the manufacturer's operating manuals, lack of records, review of patient test reports, and staff interview, the laboratory failed to document ambient temperature and humidity in the laboratory were histopathology tissue processing and testing was performed from 6/24/23 to the date of the survey (9/20/23). The findings include: 1. Observation of the laboratory on 9/20/23 at 8:15 a.m. revealed the following equipment in use for processing tissues for histopathology testing: -Sakura Tissue-Tek VIP tissue processor -Leica HistoCore Arcadia H paraffin embedding station -MICROM Rotary Microtome HM 355 S - Leica Autostainer XL automated slide stainer 2. Review of the manufacturer's operating manuals revealed the following operating limits: -Sakura Tissue-Tek VIP: Temperature range of 10 to 40 degrees Celsius with maximum relative humidity of 85%. -Leica HistoCore Arcadia H: Temperature range of 20 to 30 degrees Celsius with relative humidity range of 20 - 60%. -MICROM Rotary Microtome HM 355 S: Temperature range of 5 to 40 degrees Celsius with maximum relative humidity of 60%. -Leica Autostainer XL: Temperature range of 15 to 35 degrees Celsius with relative humidity range of 20 - 80%. 3. Review of the laboratory's records revealed no documented monitoring of ambient temperature and humidity. 4. Review of final patient test reports revealed patient test reporting began on 6/24/23 (23-1-1) with a total of 573 patient tests reported at the time of survey (9/20/23). 5. Interview with the laboratory director on 9/20/23 at 12:15 pm confirmed the laboratory did not document ambient temperature and humidity in the area the histopathology tissue processing and testing equipment was used for patient testing from 6/24/23 to the date of the survey (9 /20/23). -- 2 of 2 --