Infection Control & Safety

Comprising ten chapters, ASGE’s Policy and Procedure Reference Guide for Ambulatory Surgical Centers (ASCs) is intended to provide an organized list of ASGE guidelines that may be considered appropriate for adoption in an endoscopy facility.

Presented in chart form, the Reference Guide highlights ASGE guidelines that meet standards and conditions in the Centers for Medicare and Medicaid Services (CMS) Condition for Coverage.

For a quick summary of recommendations when reviewing any of the ASGE Guidelines we recommend going to the “Recommendations” section located at the bottom of each ASGE Guideline.

To read the overview or additional chapters, please click here.

Introduction

The topic of infection control is in a state of considerable flux. ASGE is your partner in making sure that you are up to date on infection control issues, so consult ASGE references frequently to stay abreast of current and evolving issues in infection control.

Historically, safety in the gastrointestinal (GI) endoscopy unit has focused on infection control, particularly around the reprocessing of endoscopes. Two highly publicized outbreaks in which the transmission of infectious agents was related to GI endoscopy have highlighted the need to address potential gaps along the endoscopy care continuum that could impact patient safety.1

The Centers for Medicare and Medicaid Services (CMS) standards require that an ASC must have a formal infection control program. The infection control program must be based on a nationally recognized infection control guideline, directed by a designated health care professional with training in infection control, be ongoing, include actions to prevent, and identify and manage infections and communicable diseases. It must include a mechanism to immediately implement corrective actions and preventive measures that improve the control of infection within the ASC. The infection control and prevention program must include documentation that the ASC has considered, selected and implemented nationally recognized infection control guidelines.2

CMS Conditions for Coverage and Standards Related to Infection Control & Safety
  1. §416.44(a) Standard: Physical Environment

    The ASC must provide a functional and sanitary environment for the provision of surgical services.

    1. Each operating room must be designed and equipped so that the types of surgery conducted can be performed in a manner that protects the lives and assures the physical safety of all individuals in the area.
    2. The ASC must have a separate recovery room and waiting area.

  2. §416.50(f) Standard: Privacy and Safety

    The patient has the right to (2) Receive care in a safe setting.

  3. §416.51 Condition for Coverage – Infection Control

    The ASC must maintain an infection control program that seeks to minimize infections and communicable diseases.

  4. §416.51(b) Standard: Infection Control Program

    The ASC must maintain an ongoing program designed to prevent, control, and investigate infections and communicable diseases. In addition, the infection control and prevention program must include documentation that the ASC has considered, selected, and implemented nationally recognized infection control guidelines.

    The program is – (1) Under the direction of a designated and qualified professional who has training in infection control.

    The program is – (2) An integral part of the ASC’s quality assessment and performance improvement program.

    The program is – (3) Responsible for providing a plan of action for preventing, identifying, and managing infections and communicable diseases and for immediately implementing corrective and preventive measures that result in improvement.

  5. §416.51(a) Standard: Sanitary Environment

    The ASC must provide a functional and sanitary environment for the provision of surgical services. by adhering to professionally acceptable standards of practice.

For more in-depth information regarding interpretative guidance andsurveyor procedures, access the CMS State Operations Manual, Guidance for Surveyors: Ambulatory Surgical Centers (Appendix L).1

ASGE Guidelines and Recommendations Related to §416.44, §416.50(f), §416.50(f)(2), §416.51 and §416.51(a)

ASGE has published several guidelines detailing ways to minimize the risk of transmission of infection within the endoscopy unit, including the following:

In addition to meticulous endoscope reprocessing, a specific infection prevention plan must be implemented to prevent the transmission of pathogens in the unit and to provide guidance should a breach occur.

Active Infection Prevention Surveillance programs and ongoing educational and competency evaluation of staff regarding activities within the pre-procedure, intra-procedure, and post-procedure phases are necessary to ensure overall safety of patients and healthcare workers. Infection prevention plans for a specific unit must be directed by a qualified person. Although state regulations may vary, the Centers for Medicare and Medicaid Services (CMS) allows the unit to designate the specific training and competency of the individual.

The infection prevention plan must be documented in writing and should include a set of policies and procedures appropriate for and targeted to the specific procedures performed in addition to likely sources of nosocomial infection in the unit. The plan should include a process for the ongoing assessment of compliance with the program and methods for correction.1

ASGE Guidelines and Recommendations Related to §416.44(a), §416.50(f), §416.50(f)(2), §416.51 and §416.51(a)

Issue

ASGE Guideline

ASGE Applicable Recommendations

Infection control specific for the nonsterile endoscopy environment.

Guidelines for safety in the gastrointestinal unit.


GASTROINTEST ENDOSC 2014; 79(3): 366-682
  • 1-2 (Hand Hygiene)
  • 1-2 (PPE)
  • 1-15 (Safe medication administration practices)
  • 1-3 (Safe handling of potentially contaminated equipment or surfaces in the patient environment)
  • 1-4 (Terminal Cleansing)

Endoscope Reprocessing, Disinfection, Sterilization and Storage.

  • Issues with reprocessing duodenoscopes
  • Newer issues (i.e., scope hang time, water bottle replacement, culturing endoscopes between procedures, endoscope durability).

Multisociety guideline on reprocessing flexible gastrointestinal endoscopes and accessories.

GASTROINTEST ENDOSC 2021; 93(1): 11-303
  • 1-20

Reprocessing Failure and Breach of Disinfection Protocol.

ASGE Guideline for Infection Control During GI Endoscopy

GASTROINTEST ENDOSC 2018; 87(5): 1167-76
  • 1-5

Tips for Applying Recommendations from ASGE Guidelines

1. A statement should be made citing the ASGE references as recommendations from a nationally recognized specialty society that were used in the development of this reference.

2. If other nationally recognized society guidelines are also being used to develop policies and procedures, it is important to review those policies and reconcile differences so that contradictory policies are not developed.

3. The Association of Operating Room Nurses (AORN) has specific policies requiring surgical attire, staffing, and restricted areas that endoscopy facilities may not wish to adopt. In the interpretive guidelines, AORN’s standards are mentioned  as an example of nationally recognized standards. CMS surveyors, therefore, may hold facilities to those standards unless they have specifically adopted others.

4.  Documentation of the adoption of ASGE guidelines should be referenced in the meeting minutes of the organization’s governing body. The reference should include the guideline, the portion of the guideline to be adopted, and an education plan for staff and providers as needed.

Endnotes
  1. CMS State Operations Manual, Guidance for Surveyors: Ambulatory Surgical Centers (Appendix L). Centers for Medicare and Medicaid Services. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_l_ambulatory.pdf

     

  2. Guidelines for Safety in the Gastrointestinal Unit. GASTROINTEST ENDOSC 2014; 79(3): 366-68.

     

  3. Multisociety Guideline on Reprocessing Flexible Gastrointestinal Endoscopes and Accessories. GASTROINTEST ENDOSC 2021; 93(1): 11-30.

     

  4. ASGE Guideline for Infection Control During GI Endoscopy. GASTROINTEST ENDOSC 2018; 87(5): 1167-76