Total Gastroenterology Pa

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Total Gastroenterology PA on 11/14/24 to 11/21/24. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: 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. This STANDARD is not met as evidenced by: Based on observation, lack of documentation, and interview the laboratory failed to define, monitor, and document conditions for proper storage of reagents for Immunohistochemical CD3 testing from 5/30/2024 to 11/1/2024. Findings included: During a tour of the Immunohistochemical CD3 (IHC) testing area on 11/14/2024 at 11:20 am, the reagent refrigerator was observed to have one opened bottle and one unopened bottle of BioSB Immuno DNA reagent labeled to be stored at 20-25 degrees Celsius, one opened BioSB PolyDetector Perioxidase reagent, one opened and one unopened bottle of BioSB PolyDetector Plus reagent, and one opened bottle of AEC BioSB Buffer/Chelator reagent labeled to be stored at 2-8 degrees Celsius. On top of the IHC reagent refrigerator two bottles of Tris Buffered Saline labeled to be stored at 18-25 degrees Celsius were observed. No temperature monitoring device was observed in the IHC refrigerator or in the room, and no documentation of monitoring of the IHC reagents were available for review. The Pathology Manager confirmed on 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 -- 11/14/24 at 1:11 pm, the laboratory had not defined or monitored the storage of reagents used for IHC CD3 testing since the installation of the IHC CD3 testing instrument on 5/30/2024. Photographic evidence was obtained. D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (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 analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on observation, interview, and record review the laboratory failed to follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems from 7/2024 to 11 /2024. Findings included: Review of the Quality Assurance (QA) procedure, approved by the Laboratory Director on 7/10/23, revealed the process was to monitor the pre- analytic, analytic, and post analytic phases monthly. Review of the Job Description for the Laboratory Director revealed responsibilities included ensuring that the physical and environmental conditions of the lab are appropriate for the testing performed. Review of the QA Event Calendar for 2024 revealed no documentation from 7/2024 to 11/2024 to show any QA monthly tasks had been performed following the laboratory's written procedure. There was no evidence the laboratory's QA procedure had identified the the failure to define, monitor and document conditions for proper storage of reagents for Immunohistochemical CD3 testing for 5/30/2024 to 11/1/2024 as cited at D5413. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Total Gastroenterology PA on 09/26/22 - 09/30/2022. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiency: 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 record review and staff interview, the laboratory failed to perform semi - annual competency assessments on one (#C) out of three Testing Personnel (#A, #B, and #C) for the year 2021 and 2022. The findings included: A review of the CMS 209, Laboratory Personnel Report, signed and dated 09/23/22 by the Laboratory Director revealed Staff #C worked as Testing Personnel (TP). A review of TP #C's personnel record revealed a hire date of April 2021. TP #C had no evidence of any competency assessments. A review of the facility procedure titled "Education: Training and Evaluation of Competency" sent by the laboratory on 09/30/22 revealed, "Lab staff will be evaluated for competency before reporting lab results (after training), 6 months after initial training, and thereafter yearly. Competency will be pertinent to his /her working area." On 09/26/22 at 10:30 a.m., the Office Manager stated she did not know the laboratory was to complete semi - annual competency assessments the first year of employment for TP #C. 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 D0000 An announced CLIA recertification survey was conducted at Total Gastroenterology PA on 07/10/2020. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 record review and interview with the Office Manager, the laboratory failed to follow the laboratory's procedure for competency assessment to perform competency assessment semi - annually for the histopathology technical component that was started in January 2019 for three (#C, #D, and #E) out of three Testing Personnel (#C, #D, and #E). Findings included: Review of the CMS 209 Laboratory Personnel Report revealed Personnel #C, #D, and #E held the position of Testing Person. Review of the laboratory's procedure "General Competency Program" dated 7 /25/18 revealed "Competency must be reassessed for all tasks/workbench(s) being performed by the employee six months after the first initial task competency, at one year from the initial task competency, and annually thereafter. Record review of competency assessments revealed that the 2019 1st 6 month competency assessments had not been performed for Testing Personnel #C, #D, and #E. Interview on 07/10 /2020 at 11:45 AM with the Office Manager confirmed that the first 6 month competency assessment had not been performed for Testing Person #C, #D, and #E for 2019. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- 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 record review and interview with the Office Manager, the laboratory failed to verify the accuracy histopathology testing for one (2019) of two years reviewed (2019-2020) for 3 out 3 Testing Personnel (#C, #D, and #E). Findings included: Peer review records for histopathology for Testing Personnel #C, #D, and #E were requested but could not be provided by the laboratory for 2019. Interview on 07/10/20 at 01:00 PM with the Office Manager confirmed that the laboratory did not have the 2019 peer reviews for the histopathology testing. 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. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to prepare a negative control slide for the Immunohistochemical (IHC) stain for Helicobacter pyloric from January 2019 to date of survey. Findings included: Review of the log titled, "Staining Quality Control Review Summary" showed the laboratory failed to document a negative control slide for Helicobacter pyloric stain from January 2019 to date of survey. Phone interview on 7/10/20 at 12:30 PM with Testing Personnel D confirmed that the negative control slide had not been prepared. -- 2 of 2 --

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 record review and interview with the Office Manager, the laboratory failed to have competency evaluations on one (#A) of two testing personnel for 2 out of 2 (2017-2018) years reviewed. Findings Included: Review of competency evaluations found that Testing Person #A did not have competency evaluations for each title ( Clinical Consultant, Technical Supervisor, General Supervisor, and Testing Personnel) completed for 2017 and 2018 . The Laboratory Director was Testing Person #B. Testing Person #B was responsible for completing the competency evaluations since they served in the position of Technical Supervisor. On 06/28/18 at 11:15 AM, the Office Manager confirmed that the competency evaluations were not completed in 2017 and 2018 for Testing Person #A. 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 record review and interview with the Office Manager, the Laboratory Director failed to sign the policies as reviewed after becoming the Laboratory Director on 08/08/16. Findings Included: Review of personnel records revealed that the 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 -- laboratory had a change in Laboratory Director that was effective 08/08/16. Review of the Histology Policy & Procedure Manual revealed it was marked as reviewed on 3/16 /16, 3/10/17, and 3/9/18 but contained no signatures by the Laboratory Director. Interview on 06/29/2018 at 10:30 AM with the Office Manager confirmed that the new Laboratory Director had not signed the manuals. -- 2 of 2 --