Good Stuff Happens in 1:1 Meetings: Why you need them and how to do them well
Facilities & Construction Track - New Standards for Infection Control & Patient Safety
2. How to Receive Continuing Education (CE) Credits?
1. Attend the educational session and review all course materials.
2. Utilizing the forms on the table or at the registration desk, indicate
which sessions you attended.
3. Turn the form in at the Registration Desk.
3. Accessing the Live Chat
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using the “login” button.
2. Once you’re logged in, scroll down to the agenda and click on the
“view session” button under the session you’re attending.
3. There is a chat box on the right-hand side of the screen where you
can send your questions and chat with other attendees about what
you’re experiencing at your organization.
4. Please note, you can use the in-session chat throughout the session—
no need to wait until the end. You can also view the speakers’ full bios
on this page.
5. Facilities & Construction Track:
New Standards for Infection Control
and Patient Safety
Katherine Anderson, MPH, CIC, HEM, Infection Preventionist, ECRI
James Davis, MSN, RN, CCRN-K, HEM, CIC, FAPIC, Infection Prevention
Manager, ECRI
6. Learning Objectives
1. Identify strategies to improve workplace safety for healthcare
employees.
2. Outline the implementation of new industry safety guidelines.
3. Explain recently released public safety guidelines and its effect on
operations.
4. Evaluate changes in the legislative pipeline and changes on the
horizon
8. Challenges
• Supply (including PPE and cleaning supplies)
can be unreliable
• Lack of safety measures for patients and staff
that can lead to MDROs in the facility
environment
• Facility design that lacks ergonomics within
the central sterile supply areas
• For example, poor lighting in central sterile
supply areas can cause eye strain and
increased fatigue, sinks that are not an
appropriate height can cause back pain
Case Study: Employee Ergonomics and
Safety in the Central Supply Department
Appendix N. Part 1—Transport, Leak Testing, Cleaning: Transcript/Facilitator Notes -
Implementation Guide. Content last reviewed May 2017. Agency for Healthcare Research and
Quality, Rockville, MD.
https://www.ahrq.gov/hai/tools/ambulatory-
surgery/sections/implementation/implementation-guide/app-n-fac-notes.html
9. Solution
• Create an ergonomically friendly central sterile supply can
increase employee satisfaction and reduce injuries
• Examples include decontamination workflow that drives
instruments toward their destination, sterilizers with auto
loading features to minimize pushing and pulling, and adequate
lighting to relieve eye strain
Impact
• Decrease in employee injuries (e.g., sharp injuries during
reprocessing)
• Increase in patient safety with correctly reprocessed
duodenoscopes
• Increase in overall employee satisfaction
Case Study: Employee Ergonomics and
Safety in the Central Supply Department
10. Safety Risk Assessment (SRA)
• A Safety Risk Assessment is the foundation for creating a safe
workplace for employees.
• The purpose of an SRA is to “help foster a proactive approach to
patient and [employee] safety by mitigating risks from the physical
environment that could directly or indirectly contribute to harm.”
• It is a FGI requirement for new construction and renovation projects.
• Must include an interdisciplinary team.
11. Safety Risk Assessment (SRA)
Components
Assessment Facility Area Project Scope
Infection Control Risk
(ICRA)
All 1. New construction
2. All renovations
Patient handling and
movement (PHAMA)
Areas where patient handling,
transport, transfer, and
movement occur
1. New construction
2. Major renovation and renovations changing functional
use of space
3. Minor and minimal renovations where patient
handling occurs
Fall Prevention Any area to which a patient or
family member has access
1. New construction
2. Major renovation and renovations changing functional
use of space
3. Minor and minimal renovations where patient
handling occurs
12. Safety Risk Assessment (SRA)
Components
Assessment Facility Area Project Scope
Medication Safety Medication safety
zones
1. New construction
2. All renovations
Behavioral and Mental
Health Risk
Any area where
behavioral health
patient care is
provided
1. New construction
2. Major renovation and renovations changing functional use of
space
3. Minor and minimal renovations where patient handling occurs
Patient Immobility Inpatient locations 1. New construction
2. Major renovation and renovations changing functional use of
space
3. Minor and minimal renovations where patient handling occurs
13. Safety Risk Assessment (SRA)
Components
Assessment Facility Area Project Scope
Security Risk All 1. New construction
2. All renovations
Disaster, Emergency,
and Vulnerability
All 1. New construction
2. Major renovation and renovations changing functional use of
space
14. Facility Guidelines Institute (FGI)
2022 Updates
Major highlights:
1. Although anterooms are not required for airborne infection
isolation rooms (AIIR) in the emergency department (ED), an ICRA
must be completed to determine whether an anteroom is
necessary.
2. The size of interior decontamination rooms increased from 80 to
100 sq. ft.
3. EDs are required to have video surveillance at public entrances and
a duress alarm where entrances are locked.
4. Incorporate wayfinding into building design.
15. Designing Facilities that Respond
and Adapt to Emergency Conditions
Source: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
16. Evaluating entry points:
• Entry points for patient and employee-use must be clearly defined
• Dedicated entrance to screen patients with suspected fever-causing viruses like influenza
and COVID-19
• Consider rerouting patients who are suspected of being infectious to a separate area (e.g.,
triage room or decontamination)
Evaluating waiting rooms:
• Ensure adequate ventilation
• For non-emergent visits, patients can wait in the cars
• Consider establishing multiple waiting rooms: 1 for infectious patients and 1 for patients
with physical injuries/noninfectious disease
• Design the ED with flexible patient care areas that can sustain a heavy influx of patients
• Ensure visibility is maintained
Designing Facilities that Respond
and Adapt to Emergency Conditions
17. During planning for central storage facilities, consideration for storage
of emergency preparedness supplies, linens, etc. should be included.
• May be located off-site provided a transportation plan is in place
• Consider disaster risk factors for each location, structure, and supply
path
• Also consider emergency power sources for storage facilities, location
of floodplains, and structural integrity of the warehouse, bridges,
overpasses, and anything else along the supply path.
Designing Facilities that Respond
and Adapt to Emergency Conditions
18. For emergency preparedness planning and design, facilities should
consider:
• which areas of the facility are likely to be converted to patient care
in the event of a disaster
• The areas are not intended for everyday patient care
• Space for an incident command center with a minimum clear floor
area of 200 sq. ft.
Designing Facilities that Respond
and Adapt to Emergency Conditions
19. For new construction, the
following areas shall be located at
al elevation above the 100-year
floodplain and storm surge:
1. Pharmacy
2. Laboratory
3. Blood bank/storage
4. Sterile processing facilities
For renovations, critical function
areas (#1-4) shall be relocated
above the floodplain or storm surge
elevation unless infeasible (e.g.,
space does not permit).
• The healthcare facility must create a
mitigation plan in this situation.
Designing Facilities that Respond
and Adapt to Emergency Conditions
20. For AIIR design, facilities should
incorporate a means for
communication, such as:
• Nurse call system
• Phones
• Windows
• Other electronic means
Designing Facilities that Respond
and Adapt to Emergency Conditions
Image source:
https://www.flickr.com/photos/bancimatgesinfermer/49099067278/in/photostream/
21. Pathogen X
“[Pathogen] X represents the knowledge
that a serious international epidemic
could be caused by a pathogen currently
unknown to cause human disease.”
– The World Health Organization (WHO)
23. The next pandemic will likely be substantially
different from COVID-19, whether it is natural or
synthetic
Pathogen X could be far worse than
anything we have seen before
Natural and potentially biological threats will
occur at an increasing frequency
We are not prepared for Pathogen X, whatever it
may be
Future Implications of Pathogen X
24. Will We Learn From SARS-CoV-2?
“By creating health infrastructure and new pipelines for access to
essential … materials, the U.S. can [be] prepared if and when they are
dealing with any novel disease outbreak.”
- Karan and Luby, StatNews, 2021
26. 1. Personal protective equipment (PPE)
• Goal: have effective, comfortable, and affordable Personal
Protective Equipment (PPE).
2. Stockpiles and supply chains
• Goal: restore and expand the ability of the United States
to produce the vital supplies to stop the next pandemic in
its tracks.
3. Biosafety, biosecurity, and prevention of
catastrophic biological events
4. Regulatory improvement
Building
Core
Capabilities
Pillar 4: Building Core Capabilities
28. Airborne Infection Control
Per ASHRAE’s Position Document on Infectious Aerosols, there are 3
ways to mitigate transmission of an airborne pathogen using a
mechanical system:
1) Trap it (filtration)
2) Kill it (disinfection)
3) Flush it (ventilation)
29. Airborne Infection Control
Relative humidity is an important consideration in any HVAC system
because “our natural respiratory defenses are quickly impaired at 20%
relative humidity, resulting in increased susceptibility to respiratory
infections such as COVID-19.” - Stephanie Taylor, MD, March, CIC
Relative humidity >60% can also have negative effects (e.g., mildew
growth).
30. Airborne Infection Control
The following airborne infection control categories represent the major
strategies for reducing airborne infectious particles:
1. HEPA Filtration
2. Negative pressure and/or AIIRs or units
3. Humidification to 40-60% relative humidity levels
4. Air dilution via natural or mechanical ventilation
5. Air purification (UVGI or bipolar ionization)
32. The Need for Room MAI Will
Continue
• As of 2015, based on an extrapolation from a survey conducted by the National
Ebola Training and Education Center, CLADE X estimated that:
• There was a national capacity of 400 high-consequence infectious disease
airborne isolation beds.
• These numbers were published in 2018 as a result the gaps identified
related to the Ebola epidemic.
• While these numbers were deemed appropriate under ideal conditions for
the exercise, CALDE X notes that "this is the best-case scenario, and that
actual [national] capacity is likely a fraction of this number."
34. Suggested Minimum Requirements
for AIIR
1. Negative pressure generation within the room of at least 0.01 in. W.c. to the
outside hall/environment
2. Room air exhausted to the outdoors (no mixing / be aware of outside intake
in relation to exhaust)
3. Positive airflow into the room from the outside hall/environment
4. Minimum 150 cfm airflow into the room
5. Minimum 12 air changes per hour (ACH) inside the room
6. Appropriate intake and exhaust duct locations in relation to the patient
• Exhaust low near the head (highest infectious load)
• Supply high near the feet (preferably at the ceiling)
35. Consultation Observations: MAI
Rooms
Our experience via consultation in acute and long-term care settings has shown
us that:
• MAI rooms rarely meet minimal AII requirements
• Expedient patient isolation has been used as a solution for inadequate
resources, funding gaps, and pandemic planning miscalculations
• Healthcare providers and others have been put at risk due to a lack of
pandemic response infrastructure nationally
36. Airborne Infection Isolation Rooms
Airborne infection isolation rooms (AIIRs) have specific engineering features
intended to isolate and more quickly remove infectious aerosols (CDC 2019):
• All healthcare facilities should undertake an Infection Control Risk
Assessment (ICRA) to identify the need for AIIRs
• Acute care facilities are required to have at least one AIIR
• Ambulatory/surgical and long-term care facilities have no mandated AIIR
requirements
Many acute care facilities, long-term care facilities, and nursing homes lack the
resources to build and maintain AIIRs in the needed quantities during an
airborne disease pandemic
37. Makeshift Patient Airborne Isolation
Methods
Makeshift airborne isolation (MAI) methods were developed to support safer
care of patients/residents with airborne diseases in various care settings
Two general MAI methods:
• Transport and procedure MAI ─ Certain patient/resident transport within
healthcare facilities and specified airway management or aerosol-
generating procedures when AIIR capacity is exceeded or nonexistent
• Room MAI ─ Installations within patient/resident rooms during an airborne
disease outbreak or pandemic
38. Patient Room MAI Methods
Most room MAI require partial assembly or are DIY methods; one room MAI
does not require assembly
Three primary room MAI methods:
• Expedient patient isolation
• Local negative pressure zone
• Ventilated headboard
https://www.cdc.gov/niosh/surveyreports/pdfs/301-05f.pdf
39. Expedient Patient Isolation
Expedient patient isolation rooms could be
used for single- or two-patient/resident rooms
in healthcare facilities
Expedient patient isolation is created using a
non-ducted portable HEPA filtration unit, flame
retardant plastic curtain, tape, utility chain,
and a PVC frame
The suction side of the HEPA filtration unit
creates an inner containment zone for
patients/residents
https://www.cdc.gov/niosh/surveyreports/pdfs/301-05f.pdf
40. Expedient Patient Isolation
• FDA authorized/approved uses ─ None
• Reusable components ─ 3
• Single-use components ─ Flame retardant
plastic curtain and tape
• Assembly instructions ─ up to 11 steps
• Reprocessing instructions are not provided.
https://www.cdc.gov/niosh/surveyreports/pdfs/301-05f.pdf
41. Local Negative Pressure Zone
Portable negative pressure air machines could be used for any patient/resident
room configuration in healthcare facilities
• Do not require additional materials to create a near-patient/resident
region of negative pressure and do not have any FDA authorized/approved
uses
Negative pressure air machines should be used according to your facility's
policy and the manufacturer's IFU
Verify device function before use in a patient/resident room:
• Use a handheld aerosol counter to verify that the integrated HEPA filter is
functioning
• Use a handheld smoke generator or smoke tube to verify an inward
airflow (i.e., smoke testing); Repeat smoke testing and document the
results
Target at least 12 air changes per hour in the patient/resident room
42. Advantages and Disadvantages of
Room MAI Methods
Advantages
• May help to confine airborne pathogens near the
patient/resident and protect front-line healthcare
workers
• Multi-patient/resident room MAI options
• Patients/residents can be conscious
• Patients/residents do not need a supplemental
oxygen source during use
Disadvantages
• Not authorized or approved by FDA
• Requires multidisciplinary committee review
before use
• Biomedical Engineering/Facilities staff assistance
to construct/assemble and monitor use
• Effectiveness may vary and is user-dependent
(e.g., positioning, settings, verifying function)
• Requires user training and workflow modifications
• Unknown costs for initial purchase and use (e.g.,
replacements costs for single-use items, cleaning
and disinfection expenses)
43. Other Disadvantages of Room MAI
Methods
Expedient patient isolation:
•HVAC return vents within the inner containment zone must be
sealed or otherwise isolated from the zone
•Patients/residents may not like being surrounded by plastic
Ventilated headboard:
•Significant effort to assemble (approx. 37 steps)
•May not be possible to perform aerosol-generating procedures
while a person's head is within the ventilated headboard
44. Lessons Learned from SARS-CoV-2:
Room MAI
The CDC reports as of May 7, 2021:
Increased risk of SARS-CoV-2 infection at greater distances than 6 feet is
possible under these circumstances:
• "Enclosed spaces with inadequate ventilation or air
handling within which the concentration of exhaled respiratory fluids,
especially very fine droplets and aerosol particles, can build-up in the air
space."
• "Increased exhalation of respiratory fluids if the infectious person is
engaged in physical exertion [increased work of breathing] or raises their
voice (e.g., exercising, shouting, singing)."
• "Prolonged exposure to these conditions, typically more than 15
minutes."
45. Prerequisites for Safe Implementation
of Room MAI Methods
Determine if and how to use a DIY room MAI method in your facility via review
by an appropriate multidisciplinary committee (e.g., risk management, patient
safety, quality improvement, infection prevention)
Ensure that your facility's ventilation/HVAC inspection and preventive
maintenance program complies with OSHA Technical Manual Section III, Chapter
3, meeting ANSI/ASHRAE/ASHE Standard 170-2021: Ventilation of Health-Care
Facilities.
Inventory the following items that may be present in your facility:
i. Portable HEPA filtration units
ii. Portable negative pressure air machines
iii. Replacement filters (e.g., pre-filters, HEPA filters)
47. Responsibilities and Considerations
1. Rounding (safety officer?)
2. HEPA function checks
3. HVAC seals
4. Filter maintenance
5. Ducting inspections – proximity to
outside intakes
6. Pressure differential logging
7. Temperature controls
• More heat – less space –
workers in PPE
8. Pressure and other effects on
adjacent areas or rooms
(monitoring)
9. Noise
10.Life safety
11.Documentation
50. The Ideal Solution – Better Design
for Pathogen X
Open Building Approach – Three Systems:
• The primary system includes the main, permanent, independent core
(columns, beams, and utilities)
• The secondary system is made up of panels, creating a modular unit or “room”
(floor, wall, and ceiling)
• The tertiary system is built-in furniture and equipment, which are customizable
modules that fit within the panels
• These three systems work together to make up a complete and integrated
system of parts that form one modular building unit.
52. Key Takeaways
• Facility design has a critical impact on infection control, patient safety,
and occupational health.
• FGI will release guideline updates in Spring 2022.
• Our reliance on PPE to address engineering control gaps is not
appropriate or sustainable.
• MAI rooms and other arrangements are only a stop gap measure.
• We need to plan and prepare for the next pandemic now.
Katherine
As we continue to navigate the COVID-19 pandemic, we’ve learned that healthcare facilities must retain staffing. Employees must feel valued, appreciated, and need a safe workplace. Facility design can play an extremely important role in an employee’s safe environment. A facility should implement the best ergonomic environment possible that does not negatively affect the wellbeing of the employee to help with staff retention.
Duodenoscopes are orally inserted endoscopes that are used to inspect the duodenum and access the common bile duct or pancreatic duct during endoscopic retrograde cholangiopancreatography (ERCP) procedures. Duodenoscopes have a complex design; the devices have long, narrow channels and a distal elevator recess that incorporates a user-controlled forceps elevator. Most FDA-cleared duodenoscope models are reusable and require reprocessing (i.e., cleaning and high-level disinfection [HLD] or sterilization) after use according to the duodenoscope instructions for use (IFU). Reprocessing duodenoscopes is highly complex and requires over 100 steps. Duodenoscopes are typically reprocessed in the central sterile supply department. The central sterile supply department (or also called the sterile processing department (SPD)) is an area of a healthcare facility that performs decontamination, cleaning, high-level disinfection, and sterilization of reusable medical devices
The consequences of ineffective duodenoscope reprocessing can be severe. There are many reports of contaminated, reprocessed duodenoscopes that have caused patient infections with multidrug-resistant organisms such as carbapenem-resistant Enterobacterales.
The case study in this slide is just for 1 job in the central sterile area. The case study highlights why facility design is so important for the safety of both patients and employees. Now that we’ve discussed the importance of design, let’s explore some facility guidance updates.
[source: https://www.ecri.org/components/HDJournal/Pages/Duodenoscope-Reprocessing-Workflow-Survey.aspx?tab=2, https://www.evolvedsterileprocessing.com/post/ergonomics-in-cssd]
Katherine
As we continue to navigate the COVID-19 pandemic, we’ve learned that healthcare facilities must retain staffing. Employees must feel valued, appreciated, and need a safe workplace. Facility design can play an extremely important role in an employee’s safe environment. A facility should implement the best ergonomic environment possible that does not negatively affect the wellbeing of the employee to help with staff retention.
Duodenoscopes are orally inserted endoscopes that are used to inspect the duodenum and access the common bile duct or pancreatic duct during endoscopic retrograde cholangiopancreatography (ERCP) procedures. Duodenoscopes have a complex design; the devices have long, narrow channels and a distal elevator recess that incorporates a user-controlled forceps elevator. Most FDA-cleared duodenoscope models are reusable and require reprocessing (i.e., cleaning and high-level disinfection [HLD] or sterilization) after use according to the duodenoscope instructions for use (IFU). Reprocessing duodenoscopes is highly complex and requires over 100 steps. The consequences of ineffective duodenoscope reprocessing can be severe. There are many reports of contaminated, reprocessed duodenoscopes that have caused patient infections with multidrug-resistant organisms such as carbapenem-resistant Enterobacterales.
The case study in this slide is just for 1 job in the central sterile area. The case study highlights why facility design is so important for the safety of both patients and employees. Now that we’ve discussed the importance of design, let’s explore some facility guidance updates.
[source: https://www.ecri.org/components/HDJournal/Pages/Duodenoscope-Reprocessing-Workflow-Survey.aspx?tab=2, https://www.evolvedsterileprocessing.com/post/ergonomics-in-cssd]
Katherine
Patient and staff safety in a hospital or other health care facility can be protected by a properly designed built environment. The safety risk assessment is a multidisciplinary, documented assessment process used to proactively ID hazards and risks and mitigate underlying conditions of the built environment that may contribute to adverse safety events. Assessing safety risks and incorporating preventive measures into the design of health care facilities can minimize such safety problems as health care-associated infections, patient falls, medication errors, and security risks.
E.g., an ICRA is a safety risk assessment and is involved in all renovations.
Quote pulled from FGI guidelines white paper, pg. 5.
These changes come from the FGI’s Guidance for Designing Health and Residential Care Facilities that Respond and Adapt to Emergency Conditions, a 716-page document published in March 2021. The white paper includes the proposed changes for 2022.
FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine
The SRA targets 6 areas of safety (seen in the table), as required by the FGI. The SRA process includes evaluation of the population at risk and the nature and scope of the project; it also proposes built environment solutions to mitigate identified risks and hazards. There are many experts that must help assist with the various assessments listed. This includes but is not limited to facility management staff, risk manager, IPs, architects, security/safety specialists, quality improvement specialists, etc.
Source = https://www.ahrq.gov/patient-safety/settings/hospital/resource/safety-assess.html
FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine
FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine
Risks, such as IP and security, should be considered even for small projects. The safety assessment (initiated by governing body) should identify the basic aspects of risks associated with the project early in the planning please. These identified risk areas and related solutions will evolve over the course of project design, construction, and commissioning. After completing the SRA process, the governing body shall provide the SRA report. SVAs are important as we can see because they are involved with all construction and renovation projects.
FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine
SVAs will be important to keep in mind as the FGI’s Guidelines for Design and Construction documents 2022 updates are published this spring. It is updated every 4 years. [source: https://fgiguidelines.org/revision-process/2022-revision-cycle/]
These changes come from the FGI’s Guidance for Designing Health and Residential Care Facilities that Respond and Adapt to Emergency Conditions, a 716-page document published in March 2021. The white paper includes the proposed changes for 2022. It is expected to be published spring 2022. This slide highlights the major changes that are to come.
Although an anteroom is not required for airborne infection isolation (AII) rooms in the 2022 edition, health care organizations will be required to conduct an infection control risk assessment (ICRA) to determine whether an anteroom is necessary. The ICRA process will help an organization identify the need for and quantity and placement of anterooms. An associated appendix section offers design guidance on infection prevention considerations for storage, space for donning and doffing personal protective equipment (PPE), and PPE disposal.
The emergency facility requirements in the Hospital document were revised to better distinguish between indoor rooms and outdoor structures for human decontamination. In both the Outpatient and Hospital documents, the size of interior decontamination rooms increased from 80 to 100 square feet; outdoor structures do not have a minimum size.
This change was proposed due to an effort in Massachusetts to pass “Laura’s Law.” Signed in January 2021, the law is named after Laura Levis, a 34-year-old woman who suffered an asthma attack and died outside an ED because she couldn’t find an unlocked entrance.
[source: https://www.hfmmagazine.com/articles/4276-fgi-guidelines-updates-for-2022]
FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine
While including FGI 2022 updates, the FGI’s Guidance for Designing Health and Residential Care Facilities that Respond and Adapt to Emergency Conditions also has current recommendations.
This is an example of human factors.
Wayfinding:
How clarity of access will be provided for the entire campus or facility using a wayfinding system.
Hospital entry points should be clearly identified from all major exterior circulation modes (e.g., roads, bus stops, parking).
Clearly visible and understandable signage, icons, universal symbols, visual landmarks, and/or cues for orientation should be provided.
Boundaries between public and private areas should be well-marked and clearly distinguished.
For emergency preparedness,
Image pulled from page 96 of the FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine
The current recommend strategy for preventing the spread of respiratory illness is respiratory hygiene (e.g., cough etiquette). This includes having signage that alerts patients to report if they have a fever or cough in addition to having tissues, masks, and hand sanitizer available for patients to use.
Heavy influx of patients can occur d/t pandemic, natural disaster, mass shooting, or another event.
[omit]
These guidelines come from the FGI’s Guidance for Designing Health and Residential Care Facilities that Respond and Adapt to Emergency Conditions, a 716-page document published in March 2021. The white paper includes the proposed changes for 2022.
FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine
[omit]
These guidelines come from the FGI’s Guidance for Designing Health and Residential Care Facilities that Respond and Adapt to Emergency Conditions, a 716-page document published in March 2021. The white paper includes the proposed changes for 2022.
FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine
[omit]
These guidelines come from the FGI’s Guidance for Designing Health and Residential Care Facilities that Respond and Adapt to Emergency Conditions, a 716-page document published in March 2021. The white paper includes the proposed changes for 2022.
FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine
[omit]
These guidelines come from the FGI’s Guidance for Designing Health and Residential Care Facilities that Respond and Adapt to Emergency Conditions, a 716-page document published in March 2021. The white paper includes the proposed changes for 2022.
FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine
AIIR Design - Means for communication: the AIIR shall provide for verbal and visual communication between patient and staff without the staff member having to be in the room with the patient. This is to reduce the number of times staff must enter a patient room, reducing exposure to airborne disease, as well as don/doff PPE. This can be achieved with nurse call system, phones, a window, or other electronic means.
[omit]
These guidelines come from the FGI’s Guidance for Designing Health and Residential Care Facilities that Respond and Adapt to Emergency Conditions, a 716-page document published in March 2021. The white paper includes the proposed changes for 2022.
FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine
What exactly is Pathogen X? According to the WHO, Pathogen X represents the knowledge that a serious international epidemic could be caused by a pathogen that is currently unknown and subsequently cause human disease.
Source: https://www.who.int/activities/prioritizing-diseases-for-research-and-development-in-emergency-contexts
Katherine
This table comes from the White House’s American Pandemic Preparedness Plan, which was released in early September 2021. It shows the name of the outbreak, the virus type, year the outbreak began, and the total number of global and US Deaths from the corresponding outbreak. The significance of this is that all the viruses on this list were once a “Pathogen X.” Since the year 2000 alone, there have been 7 serious viral outbreaks that were previously unknown or understudied.
Source: https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf
Katherine
There are multiple future implications of pathogen X. The next pandemic will likely be much different from COVID-19, no matter if is from a natural or synthetic cause. A natural cause would be mean that the cause came from nature, like a zoonotic virus. A synthetic cause would be a disease that was purposely created to be used as a bioweapon with the intent to cause human harm. Whether the threat is naturally, accidental, or a bioweapon as stated, the likelihood of another threat is increasing. This increase in frequency is due to increased zoonotic transmission from animals, which has been driven by population growth, climate change, habitat loss, and human behavior.
Pathogen X could be far worse than any other pandemic in which we have experienced. We are currently seeing this with COVID-19, which now has had more deaths in the US than the 1918 Spanish-flu pandemic in the US.
Thus, with these future implications in mind, combined with the significance of Pathogen X, we are not prepared at this moment in time.
Sources: [https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf, https://www.statnews.com/2021/08/19/natural-pandemic-terrible-synthetic-one-even-worse/]
Katherine
Everyone working to combat this pandemic recognizes that it takes a national effort to mitigate spread. “The single most important step the U.S. government can take to reduce the magnitude of the next pandemic is to provide the essential support and material resources to countries with ongoing Covid-19 epidemic surges, especially regarding vaccine access (including raw materials and technology transfers), and toward building and strengthening primary health care systems. By creating health infrastructure and new pipelines for access to essential biological materials, the U.S. can help other countries stay prepared if and when they are dealing with any novel disease outbreak.”
Source: https://www.statnews.com/2021/08/19/natural-pandemic-terrible-synthetic-one-even-worse/
Katherine
The White House released the “American Pandemic Preparedness: Transforming our Capabilities” in early September 2021. The document “describes the critical work needed to transform US capabilities to respond rapidly and effectively to any future pandemic of high consequence biological threat,” so Pathogen X. There are 5 pillars to explain the work that must be done to prepare. We will focus on Pilar #4.
Transforming our Medical Defenses
Ensuring Situational Awareness
Strengthen Public Health Systems
Building Core Capabilities
Managing the Mission
While the plan is focused on pandemic preparedness, the capabilities generated will also be extremely valuable for dealing with infectious disease in general — including improvements in vaccines, therapeutics, diagnostics, disease surveillance, public health, and regulation. Moreover, like previous ambitious scientific endeavors, the advances produced by this work will lead to broader benefits to human health.
Source: https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf
Katherine
Pillar 4: Building Core Capabilities. There are 4 core capabilities. The first one being PPE
Personal Protective Equipment
Goal: Have effective, comfortable, and affordable Personal Protective Equipment (PPE).
PPE Innovation. Develop solutions that increase the effectiveness, comfort, reusability, affordability, and manufacturability, including warm or surge capability, of PPE, to provide protection against pathogens with a range of properties.
Pathogen protection within the built environment: Develop and deploy new technologies to improve indoor air quality, surface materials, and related aspects of transportation, buildings, and other infrastructure to suppress pathogen transmission among people. Invest in retrofitting high-risk infrastructure and incentivize private sector adoption of built environment pathogen suppression technologies for public protection
2. Stockpiles and Supply Chains Goal: Restore and expand the ability of the United States to produce the vital supplies to stop the next pandemic in its tracks. (9.1) Refill stockpiles. Refill stockpiles that have been depleted by the current pandemic, to avoid near-term shortages while building longer-term onshore and near-shore manufacturing capacity for essential medical supplies. 15 (9.2) Build resilient supply chains. Ensure a stable and secure supply chain for key active ingredients for making vaccines, therapeutics, and diagnostics and for personal protective equipment.
3. Biosafety, Biosecurity, and Prevention of Catastrophic Biological Events
Goal: Prevent laboratory accidents and deter bioweapons development.
Accelerate biosafety and biosecurity innovation. Expand capabilities to identify and minimize safety and security risks in the design and development in biotechnology and share these tools globally.
Ensure safe and secure R&D. Ensure R&D involving potentially dangerous biological agents is conducted safely and securely, by fostering a global research environment that adopts and enforces high standards.
Deter and detect bioweapons development. Strengthen global norms against the development of pathogens as weapons, including by promoting international norms, transparency, and responsible scientific conduct. Strengthen oversight by developing better approaches to detect violations.
4. Regulatory Improvement
Goal: Improve regulatory capacity to support the development of safe and effective vaccines, therapeutics, and diagnostics.
Regulatory approval for platforms. Improve regulatory systems, which typically focus on individual products, to be able to efficiently approve programmable platform technologies for vaccines, therapeutics, and diagnostics, in order to streamline the review of individual products that use these platforms.
Clinical trial networks. Promote the development and operation of efficient, large-scale clinical trials networks in inter-pandemic times, with the ability to rapidly pivot to pandemic response. Design master protocols, ensure nationwide geographic coverage, train study coordinators to stand up sites quickly, include rural and community hospitals, and develop guidance for data collection and sharing.
Regulatory capacity. Increase regulatory capacity and expand regulatory approaches at the FDA, in order to keep up with expanding needs in the years ahead.
Katherine
All airborne diseases are highlighted within a red box.
This table comes from the White House’s American Pandemic Preparedness Plan, which was released in early September 2021. It shows the name of the outbreak, the virus type, year the outbreak began, and the total number of global and US Deaths from the corresponding outbreak. The significance of this is that all the viruses on this list were once a “Pathogen X.” Since the year 2000 alone, there have been 7 serious viral outbreaks that were previously unknown or understudied.
Source: https://www.whitehouse.gov/wp-content/uploads/2021/09/American-Pandemic-Preparedness-Transforming-Our-Capabilities-Final-For-Web.pdf
Katherine
Thinking about the previous slide, we need to think about employee and patient safety. We saw that most of the serial viral outbreaks over the past 100 years are airborne diseases. We need to implement engineering controls that effectively combat airborne disease.
From a design POV, these approaches typically overlap, and the right strategy depends on whether an HVAC system is in an existing building or planned for new construction.
[omit information below]
These guidelines come from the FGI’s Guidance for Designing Health and Residential Care Facilities that Respond and Adapt to Emergency Conditions, a 716-page document published in March 2021. The white paper includes the proposed changes for 2022.
FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine
Studies have shown that pathogens have a difficult time surviving at higher relative humidity levels. This is especially important to facilities that have cold climates during winter. Providing HVAC equipment capable of maintaining a tighter range of humidity (40-60%) can mitigate pathogens w/o causing other effects.
[omit information below]
These guidelines come from the FGI’s Guidance for Designing Health and Residential Care Facilities that Respond and Adapt to Emergency Conditions, a 716-page document published in March 2021. The white paper includes the proposed changes for 2022.
FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine
UVGI = ultraviolent germicidal irradiation light
[omit information below]
These guidelines come from the FGI’s Guidance for Designing Health and Residential Care Facilities that Respond and Adapt to Emergency Conditions, a 716-page document published in March 2021. The white paper includes the proposed changes for 2022.
FGI White Paper: https://fgiguidelines.org/wp-content/uploads/2021/04/FGI_Guidance_for_Facilities_that_Respond_and_Adapt_to_Emergency_Conditions.pdf
Katherine turns over presentation to Jim
Katherine – Now that we’ve explored the current and future guidelines, Jim will discuss some potential facility modifications.
Jim
[source: Shearer, M. P. Johns Hopkins Center for Health Security. CLADE X Tabletop Exercise. National High-Level Patient Capacity. May 2, 2018. Accessed 5/23/2021 Available online: https://www.centerforhealthsecurity.org/our-work/events/2018_clade_x_exercise/pdfs/Clade-X-BCU-and-ETC-facts.pdf]
Jim
PPE is not the solution
Jim
Jim
Jim
Guidelines for Environmental Infection Control in Health-Care Facilities
Airborne Infection Isolation (AII) refers to the isolation of patients infected with organisms spread via airborne droplet nuclei <5 μm in diameter.
This isolation area receives numerous air changes per hour (ACH) (≥12 ACH for new construction as of 2001; ≥6 ACH for construction before 2001) and is under negative pressure, such that the direction of the airflow is from the outside adjacent space (e.g., corridor) into the room. The air in an AII room is preferably exhausted to the outside, but may be recirculated provided that the return air is filtered through a high efficiency particulate air (HEPA) filter. The use of personal respiratory protection is also indicated for persons entering these rooms.
Jim
MAI technologies that are commonly used to implement MAI methods such as expedient patient/resident isolation, ventilated headboards, and patient/resident isolation transport systems. We will focus on room MAI.
Jim
Focus on expedient patient isolation and local negative pressure zones.
Jim
Jim
Reusable components are the portable HEPA units, utility chains and PVC frame
Jim
Calculated using the air flow rate and room volume
Jim
Calculated using the air flow rate and room volume
Jim
Calculated using the air flow rate and room volume
Jim
[source: CDC. Scientific Brief: SARS-CoV-2 Transmission. Content source: National Center for Immunization and Respiratory Diseases. Last updated May 7, 2021. Accessed May 20, 2021. Available online: https://www.cdc.gov/coronavirus/2019-ncov/science/science-briefs/sars-cov-2-transmission.html?CDC_AA_refVal=https%3A%2F%2Fwww.cdc.gov%2Fcoronavirus%2F2019-ncov%2Fscience%2Fscience-briefs%2Fscientific-brief-sars-cov-2.html]
Jim
Jim
Jim
Jim
Lessons from ICRA.
Jim
Incorporating ICRA methodology
Multiple triage/treatment areas
