Meeting CMS Requirements for Coverage of Infection Control at
Ambulatory Endoscopy Centers
Laura Strohmeyer RN, CGRN, CASC
Clinical Director, GI, AmSurg
Objectives
 Review CMS Conditions for Coverage (CfC) on Infection Control as they pertain to
Endoscopy Ambulatory Centers
 Examine common CMS deficiencies occurring at Endoscopy Ambulatory Centers
 Identify strategies to meet Infection Control CfC’s at Endoscopy Ambulatory Centers
Endoscopy in the News
 January 2008- Hepatitis C outbreak in Nevada caused by reusing syringes, vials
 May 2009- Five patients have tested positive for HIV and 33 have tested positive for
hepatitis since February, when the VA started notifying more than 11,000 people
treated at three VA medical centers to get follow-up blood checks because they could
have been exposed to infectious body fluids. The hospitals are in Miami, Murfreesboro,
Tenn., and Augusta, Ga. Other
 Go to www.MyEndoSite.com for more Endoscopy in the News, Guidelines, and other
reprocessing information
Nevada ASC Problems
CMS Conditions for Coverage on Infection Control

416.51 (Q-240): The ASC must maintain an infection control program that seeks to
minimize infections and communicable diseases.

416.51a (Q-241): The ASC must provide a functional and sanitary environment for the
provision of surgical services by adhering to professionally acceptable standards of
practice.

416.51b (Q-242): 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.

416.51b1 (Q-243): The program is under the direction of a designated and qualified
professional who has training in infection control.

416.51b2 (Q-244): The program is an integral part of the ASC’s quality assessment and
performance improvement program.
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
416.51b3 (Q-245): The program is an responsible for providing a plan of action for
preventing, identifying and managing infections and communicable diseases for
immediately implementing corrective and preventative measures that result in
improvement.
Common CMS deficiencies
Infection Control Program
 Don’t have a written plan
 Policy, goals
 Board meeting minutes
 QAPI minutes
 Focus studies
 Infection Control Professional
o Don’t have one person identified
o No training or not enough
o No ongoing training
o No job description
o No documentation
 Infection Control Guidelines
o None identified
o Not approved by Board
o Not followed
 Administration of Drugs
o Syringes prepared ahead of time
o Medications drawn up > 1 hour
o Syringes not labeled
o IV bags prepared ahead > 1 hour
 Sanitary Environment
o Don’t know kill time for surface disinfectants
o Not observing dry time
o Clean vs. dirty
o Hand Hygiene, PPE, Procedure room doors open during procedures
 Scope Reprocessing Deficiencies
o Not following manufacturer’s instructions
o No designated clean vs. dirty
o Re-use of single use devices (bite blocks, polyp traps, dilation syringes)
o No competencies, or not done in last 12 months
o Scopes not contained during transport/ improper PPE
o No designated clean and dirty areas
o Reuse of single-use disposable brushes/sponges
o Reusing enzymatic solution/rinse water; mixed incorrectly
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o Not cleaning work surfaces between scopes
o Incorrect scope storage- no scope cabinet, storing with valves or video cap
o Unfamiliar with manufacturer instructions
 Enzymatic cleaner- dilution, soak time
 High-level disinfectant- time, temp , dates
 MEC test strips- checked with each use, dip time, read time, QC
 Scope washers- settings: cycle time, temp, PM’s
 Flushing pumps (Procedure and scope room)- tubings changed,
decontamination, flow verification
 Water bottles- HLD or sterilized, sterile water only
 Scopes- follow most recent instructions
Strategies to Meet CMS Infection Control CfC’s at Ambulatory Endoscopy Centers
Infection Control Program
 Program Setup
o Infection Control Program
o Nationally Recognized Guidelines
 Training
o Infection Control Professional
o Staff training, credentialed staff
 Surveillance
o Audit staff competency and compliance
o Track patient/employee infections\
Guidelines
Review CMS guidelines (interpretive guidelines)
 Search CMS Ambulatory Surgery Center Guidelines
o CMS- Part 416- Appendix L- Guidance for Surveyors Ambulatory Surgery Centers
https://www.cms.gov/GuidanceforLawsAndRegulations/02_ASCs.asp
 Appendix L of the State Operations Manual
o Infection Control Surveyor Worksheet
 CDC- Guide for Infection Prevention in the Ambulatory Setting: Minimum Expectations
for Safe Care
Program Setup
 Evaluate current Endoscopy Infection Control Issues
o Scope Reprocessing
o Spaulding criteria
 High level disinfection
 Sterilization
o Safe Injection Practices
o Rapid turnover
 Identify Infection Control Professional
o Job description
o Board Approval
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 Surveillance of patient and employee infections
 Annual goals and evaluation of plan
Nationally Recognized Guidelines: Choose guidelines that pertain to your center.
 Society of Gastroenterology Nurses and Associates (SGNA) www.sgna.org
o SGNA Standards of Infection Control in Reprocessing of Flexible Gastrointestinal
Endoscopes 2009
o SGNA Position Statement on Reprocessing of Water Bottles Used During
Endoscopy 2009
o SGNA Guideline for Use of High Level Disinfectants & Sterilants for Reprocessing
Flexible Gastrointestinal Endoscopes 2007
 American Society for GI Endoscopy
o Infection Control during GI Endoscopy
o Multisociety guideline on reprocessing flexible gastrointestinal endoscopes: 2011
o ASGE- Reprocessing failure
 APIC: Position Paper: Safe Injection Practices
 CDC: Hand Hygiene, Personal Protective Equipment, Environmental cleaning
Training
 Infection Control Professional
o APIC Membership
o SGNA Membership
o Conferences
 APIC: Infection Prevention for ASC’s: Meeting CMS Conditions for
Coverage
o Webinars
o AORN: ASC Infection Prevention Course (online)
o Certification (state specific)
o Ongoing: Stay informed of updates
 Staff
o Review of infection control policies
o Review of guidelines
o Bulletin Boards
o Posters
o Staff meetings
 Physicians, anesthesia, contracted staff
 Documentation
Surveillance- Patients
 Track suspected and reported infections, ask on post-op calls, may take months to
identify
o Phlebitis
o Diarrhea
o Fever
 Infection Control Breech
Scope reprocessing
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Sterilization
 Infection Control Outbreaks
Surveillance- Personnel
 Track reported infections
o GI infections
o Flu
o MRSA
 Prevention
o Hepatitis B Immunizations
o TB skin tests
o Flu vaccine
Compliance
 Competencies
o Scope Reprocessing
o Sterilization
 Audits
o Scope Reprocessing
o Sterilization
o Hand Hygiene
o Safe Injection Practices
Reporting
 Staff Meetings
 Quality Assurance Performance Improvement
o Infection Control Report
o Infection Control Plan and evaluation
o Infection Control focus studies
o Policies and Procedures
o Infection Control outbreak, concerns
 Governing Board
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