B Jeffrey Wallis Md Pa D/B/A

Summary Statement of Deficiencies D0000 An unannounced complaint survey, #2022011610, was conducted on 08/24/2022 at B. Jeffery Wallis MD PA DBA Advanced Gastroenterology. The laboratory was not in compliance with 42 CFR 493, Requirements for Laboratories. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on record review and interview with the Office Manager the laboratory failed to monitor Formaldehyde and Xylene exposure limits for 2 out of 2 years (2020-2022) reviewed. Findings Included: Review of the "Safety Manual and Records" signed by the Laboratory Director on 11/02/2021 revealed Formaldehyde and Xylene exposure monitoring was to be conducted on an annual basis. Documentation review revealed no evidence to demonstrate the exposure monitoring had been performed for 2020 through the date of survey (8/24/22). On 08/24/2022 at 5:00 PM, the Office Manager confirmed there was no documentation of exposure monitoring. D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on observation, record review, and interview with the Office Manager 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 failed to store liquid chemical waste in a flammable cabinet and failed to store Eosin in a flammable cabinet. Findings Included: A tour of the laboratory on 08 /24/2022 at 4:00 PM revealed 1 container of 5 gallons of liquid chemical waste that contained xylene and 3 containers of 1 gallon (each) of liquid chemical waste that contained 100% reagent alcohol and Eosin. Continued observations also revealed a 1 gallon container of Eosin stored on a shelf above the manual stainer. Review of the laboratory's "Chemical Hygiene Plan" last signed by the Laboratory Director on 11/02 /2021 revealed "Waste disposal will be conducted in accordance with EPA [Environmental Protection Agency] standards. Xylene will be stored in the flammable cabinet until removed by a licensed facility." Review of the SDS (safety data sheet) for Eosin revealed "Store tightly closed in an approved flammable liquid storage area." Review of the SDS for 100% Reagent alcohol revealed "Store in an approved Flammable Liquids storage area." On 08/24/2022 at 4:00 PM, the Office Manager confirmed the Eosin and the chemical waste were not stored in a flammable cabinet. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at B Jeffrey Wallis MD PA dba Advanced Gastroenterology on 12/09/21. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview with the Lab Manager, the laboratory failed to specify where the technical (grossing and slide preparation) and professional (slide interpretation) components for histopathology testing was performed on 3 out of 3 (#1, #2, #3)patient histopathology reports reviewed. Findings Included: Review of final histopathology reports dated 10/13/21 for Patient #1, #2, and #3 revealed two street addresses were listed on each report; however, the reports did not specify which address performed the technical component and which performed the professional component for histopathology testing. On 12/09/21 at 4:15 PM, the Lab Director confirmed that the histopathology reports did not specify where the technical and professional components for histopathology testing was performed. He also stated he did not know that the report needed to specify where the technical and professional components for histopathology was performed. 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 B Jeffrey Wallis MD PA dba Advanced Gastroenterology on 10/09/2019. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level deficiencies: D5781

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 Lab Manager, the laboratory failed to perform competency evaluations on 2 ( Staff # D and E) out of 4 Personnel (#A, B, D, and E) for 2 of 2 years (2016-2017) reviewed. Findings Included: Review of Personnel Competency evaluations found no competencies for Staff #D for being the Testing person and for Staff #E for being a Clinical Consultant. During an interview on 01/05/18 at 11:12 AM the Lab Manager confirmed that competency evaluations where not performed on Staff #D and #E. 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 record review and interview with the Lab Manager, the laboratory failed to verify the accuracy of testing by performing peer reviews twice a year for 2 out of 2 years (2016-2017) reviewed. Findings Included: Review of peer reviews revealed that they were performed 11/17 and 12/16. During an interview on 01/05/18 at 11:27 AM the Lab Manager confirmed that the peer reviews were only conducted once a year. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- 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 record review and interview with the Lab Manager, the laboratory failed to document the humidity for 3 (09/16, 02/17, and 11/17) out of 4 (03/16, 09/16, 02/17, and 11/17) months reviewed. Findings Included: Review of humidity logs for the laboratory found that no humidity had been documented in 09/16, 02/17, and 11/17. During an interview on 01/05/18 at 11:45 AM the Lab Manager confirmed that after 03/16 the humidity was not being documented on the log. D5800 POSTANALYTIC SYSTEMS CFR(s): 493.1290 Each laboratory that performs nonwaived testing must meet the applicable postanalytic systems requirements in 493.1291 unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7) that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the postanalytic systems and correct identified problems as specified in 493. 1299 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on record review and interview with the Lab Manager, the laboratory failed to include the location of where the testing was performed on 4 out of 4 patient reports (#1-4) reviewed. See D5805 which is a repeat deficiency from the 11/12/15 recertification survey. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on record review and interview with the Lab Manager, the laboratory failed to include the location of where the testing was performed on 4 out of 4 patient reports -- 2 of 3 -- (#1-4) reviewed. This is a repeat deficiency from the 11/12/15 recertification survey. Findings Included: Review of patient final reports pulled from 04/06/16 (#1), 09/21 /16 (#2), 02/21/17 (#3), and 10/31/17 (#4) revealed that all of the reports did not have the address of the location of where the testing was performed. During an interview on 01/05/18 at 12:30 PM the Lab Manager confirmed that the address of the location of where the testing was performed was not on the final reports. Review of the