South Hills Gastroenterology

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) (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: (b)(1) Water quality. (b)(2) Temperature. (b)(3) Humidity. (b)(4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to monitor and document room temperature and humidity to ensure operating conditions were met for 1 of 1 Olympus BX43 microscope used to perform histopathology microscopic slide examinations from 03/07/2024 to 03/10/2026. Findings include: 1. The manufacturers operating environment specifications stated: "Olympus BX43 microscope: 5-40 degrees Celsius (ambient temperature); maximum 80 % relative humidity." 2. On the day of the survey, 03/10/2026 at 01:15 pm, the laboratory failed to provide documentation for the monitoring of room temperature and humidity to ensure operating conditions were met for the following instruments used to perform histopathology microscopic examinations from 03/07/24 to 03/10 /2026: - 1 of 1 Olympus BX43 microscope 3. The laboratory performed 1,666 histopathology microscopic slide examinations in 2025 (CMS 116, estimated annual volume, dated 02/22/2026). 4. The LD confirmed the above findings on 03/10/2026 at 01:40 pm. 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 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 lack of documentation and interview with the Laboratory Director (LD), the laboratory failed to follow a competency assessment procedure established to assess the competency of 1 of 1 Clinical Consultant (CC) for their supervisory responsibilities in 2022 and 2023. Findings Include: 1. The laboratory's Competency Policy states, "Staff who hold CLIA Supervisor positions: (General Supervisor, Technical Consultant, Technical Supervisor, or Clinical Consultant), will be assessed annually, for their supervisory competence in addition to laboratory testing competence, if performing lab testing." 2. On the day of the survey, 3/7/24 at 1:41 pm, the laboratory could not provide competency assessment documents for 1 of 1 CC (CMS 209 personnel #2) for their supervisory responsibilities in 2022 and 2023. 3. The LD confirmed the findings above on 03/07/2024 at 1:54 pm 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 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 procedure manual, peer review records and interview with the Practice Manager, the laboratory failed to ensure that 2 of 2 Testing Personnel (TP) performed the verification of accuracy of Histopathology slides examined from 01/01/2020 through the date of survey. Findings Include: 1. On the day of survey, 07/12/2022 at 01:15 pm, the laboratory could not provide documentation of twice annual verification of accuracy for Histopathology slides examined from 01/01/2020 through the 07/12/2022 for the following TP: -1 of 2 TP (Laboratory Director from 2014 to 2021) completed peer review once in 2020 and 2021. -1 of 2 TP (CMS 209 personnel #2) completed peer review once in 2021 and 2022. No doucmentation was provided for 2020. 2. 8,868 Histopathology slides were examined from 01/01/2021 through 12/31/2021. 5. The Practice Manager confirmed the findings above on 07/12/2022 around 02:00 pm. D5601 HISTOPATHOLOGY CFR(s): 493.1273(a)(f) (a) As specified in 493.1256(e)(3), fluorescent and immunohistochemical stains must be checked for positive and negative reactivity each time of use. For all other differential or special stains, a control slide of known reactivity must be stained with each patient slide or group of patient slides. Reactions of the control slide with each special stain must be documented. (f) The laboratory must document all control procedures performed, as specified in this section. 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 lack of staining quality control (QC) records and interview with the Practice Manager, the laboratory failed to document all QC procedures performed when Histopathology slides were examined from 11/19/2019 through 07/12/2022. Findings include: 1. On the day of survey 07/12/2022 at 01:25 pm, the laboratory could not provide Quality Control records for stained slides read using Hematoxilyn and Eosin (HE) and Special Stains between 11/19/2019 through the date of survey. 2. 8,868 Histopathology slides were examined from 01/01/2021 through 12/31/2021. 3. The Practice Manager confirmed the findings above on 07/12/2022 around 02:00 pm. -- 2 of 2 --