Resource Guide on Resumption of Endoscopic Facility Operations

As the federal government, State governments, and local authorities lay the groundwork for reopening of ambulatory surgical centers, DHPA thought it would be helpful to share an analytical framework through which endoscopic facilities can assess the appropriate timing and safeguards for resuming operations. This memorandum presents such a framework and collects various guidelines and other resource materials that could prove useful as you work through this process.

DHPA recognizes that there is no one-size-fits-all approach to resuming operations at endoscopic facilities. The resumption of operations will be a function of many variables, including but not limited to (i) the rate of new COVID-19 cases in particular communities, (ii) access to COVID testing for patients, (iii) adequacy of personal protective equipment and other safeguards for patients and facility staff, and (iv) rules put in place by State and local authorities that impact the ability of endoscopic facilities to resume operations in particular communities.

DHPA prepared this resource guide as a complement to a set of recommendations and best practices for resumption of elective endoscopy being issued jointly by DHPA and the American Gastroenterological Association.

*** Updated May 11, 2020 ***

Timing for Reopening of Elective Procedures

1. There should be a sustained reduction in the rate of new COVID-19 cases in the relevant geographic area for at least 14 days, and the facility shall have appropriate personal protective equipment (PPE). Joint Statement: Roadmap for Resuming Elective Surgery after COVID-19 Pandemic.
   1. The Trump Administration’s guidelines for “Opening Up America Again” state in phase one that elective surgeries “can resume, as clinically appropriate,” on an outpatient basis at facilities that adhere to CMS guidelines.”
   2. In response to the Administration’s statement with respect to Phase One, CMS provided a set of recommendations for re-opening facilities to provide non-emergent non-COVID-19 health care. Those recommendations are tied to a set of Gating Criteria issued by the Trump Administration, including a downward trajectory of documented cases within a 14-day period.
   3. Notwithstanding the Trump Administration and CMS guidelines, Governors are being given broad leeway to chart a course for their own States.

Factors that determine start date for elective procedures

1. Community COVID trends – segregate into low, medium, high prevalence areas using a variety of sources. Some are listed below:
   1. The Institute for Health Metrics and Evaluation (IHME) – this site is coming under criticism for using data input method rather than epidemiological method to calculate projections, but still contains useful information regarding trends and local health facility capacity.
   2. Johns Hopkins COVID website.
   3. Stat – allows drill down by state and county.
   4. State Departments of Health.
2. Local, state and federal authorities’ relevant guidelines or executive orders.
3. Availability of existing resources (PPE, hospital beds, ICU beds).
4. Risk of the procedure (e.g., EGD more likely to aerosolize than colonoscopy).
5. Safety of environment for staff (adequate PPE, enhanced endoscopy facility cleaning procedures, restrictive patient throughput, restrictive visitor policy).
6. Risk of the patient having COVID based on symptoms, exposure history and local disease prevalence.

Prioritizing of Cases

1. Scheduling of endoscopies should continue to be prioritized by level of urgency, contingent on individual patient considerations and physician professional judgment.

Patient COVID pre-screening and COVID testing

1. Use of pre-screening questionnaire.
2. If pre-procedure COVID-19 testing cannot be performed, clinicians should consider having patients keep a daily temperature log for 10 days prior to the procedure, or for procedures scheduled on shorter notice, as many days as are available.
3. A symptom questionnaire and temperature check should be administered to all patients on the day of procedure.
4. Reliability of COVID-19 testing is variable, and many are not FDA approved but may be authorized under Emergency Use Authorization (EUA). Types of tests:
   1. Serology – tests for antibodies – tells who has been infected and may possibly be immune.
   2. Polymerase Chain Reaction (PCR) testing – tests for antigen – tells who is infected (80-85% specific).
5. Practical considerations:
   1. Testing is ordered through the medical practice or endoscopic facility but may be performed at local reference lab, private lab, medical practice or local hospital.
   2. Many unknowns (test turnaround time, sensitivity, possible immunity, etc.) will not have clarity in sufficient time to be of value in an endoscopic facility re-opening strategy—hence the need for pre-screening questionnaire, PPE and other listed precautions
   3. Responsibility for testing costs is as follows:
      1. Medicare and Medicaid currently pay for COVID testing when ordered through a Medicare or Medicaid provider
      2. Most commercial plans are covering COVID testing with no out of pocket costs to members per the AHIP website summary page. This includes Cigna, Humana, United and the Blues.
6. Prevalence of infection locally may help determine need for universal testing
7. Mask recommendations are based upon availability of pre-procedure PCR-based COVID-19 testing:
   1. If no test is done, all procedure room personnel should use N95 masks or equivalent
   2. If test is positive, either postpone procedure or move to inpatient setting
   3. If test is negative, standard surgical mask are acceptable for use by all endoscopy personnel
   4. If no testing available and there is no availability of N95 mask or equivalent, consider delaying resumption of endoscopic procedures until resources are available

Staff screening

1. Current practice at endoscopic facilities includes, but is not limited to, use of COVID exposure questionnaire and daily temperature checks for all staff

Social distancing protocols within the endoscopic facility for patients and staff

1. Establish minimum spacing between patients in waiting room, pre-op. post-op
2. Person accompanying patient not permitted in facility
3. Stagger cases temporally
4. Consider alternating rooms to allow aerosolized particles to clear
5. Where available and feasible, consider providing standard surgical masks to all patients upon facility entry
6. Consider having endoscopy unit staff work at their own individual stations to avoid possible cross contamination
7. Establish organize workflow patterns and establish clear job descriptions/roles to avoid cross contamination

Scope reprocessing

1. Standard endoscope reprocessing based upon GI society joint statement guidelines

Room turn around and endoscopic facility cleaning

1. Continued disinfecting of all high touch and horizontal surfaces in procedure rooms per GI society joint statement guidelines
2. Consider alternating patient bathrooms and cleaning between each use

Personal Protective Equipment (PPE)

1. PPE usage guidelines (Joint GI Society Statement: Use of Personal Protective Equipment in GI Endoscopy (April 1, 2020))
2. PPE availability appears to correlate inversely with geographic infection prevalence. IHME is a good site for such local capacity data
3. Facemasks are the most controversial item in the PPE category
   1. N95 masks – require fit test by certified fitter – OSHA recently relaxed enforcement of guidelines for respiratory protection in light of the N95 shortage due to COVID-19, although guidance continues to be updated. Joint GI Society April 1, 2020 Statement on PPE recommended fitting by occupational health specialist.
   2. The FDA reissued the Emergency Use Authorization (EUA) [May 7, 2020] for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators and removed from the list of Appendix A: Authorized Respirators those respirators that failed to demonstrate a minimum particulate filtration efficiency of 95 percent in testing conducted at NIOSH.
   3. FFP2, P2, DS, Korea 1st Class are other filtering face piece respirators which are thought to have similar performance characteristics to N95 masks (per 3M technical bulletin) and do not require fitting
   4. Standard surgical face masks are not thought to confer the same level of protection as filtering face piece respirators, but study data on comparative efficacy are plagued by methodological limitations

Anesthesia for endoscopy

1. There is no change to current practice regarding endotracheal intubation for EGD
2. Routine endotracheal intubation of patients undergoing elective upper endoscopy is not recommended per ASGE guidelines.
3. Consider supplemental oxygen delivery by mask in order to minimize aerosolization.