Kent State University/CAED

60114148

Designing for Highly

Infectious Contagions CAEDAIACES001

Chris Woolverton PhD, Patrick Casey AIA,

Greg Lavriha PE, and Gerald McDonnell PhD

2/23/15

Credit(s) earned on completion of this course will be reported to AIA CES for AIA members. Certificates of Completion for both AIA members and non-AIA members are available upon request.

This course is registered with AIA

CES for continuing professional

education. As such, it does not

include content that may be

deemed or construed to be an

approval or endorsement by the

AIA of any material of construction or any method or manner of handling, using, distributing, or dealing in any material or product. _______________________________________

Questions related to specific materials, methods, and services will be addressed at the conclusion of this presentation.

Course Description

Concern over infectious disease is capturing the public’s attention and

necessitates better systems to manage infectious contagions in health

care facilities at biosafety levels 2 through 4—including laboratories and

care settings.

Today's focus is on the role the design of facilities play in the

management of infectious contagions in health care settings.

This course is explores how design impacts infection control with a focus

on strategies, systems and equipment than can be implemented in any hospital to handle both a growing concern with and increasing

prevalence of infectious contagions.

Learning Objectives

1. Participants will be able to classify and differentiate various elements in health care

design based on standards for Biosafety Levels, including the practices, procedures,

containment equipment, and building system requirements that determine each level of

classifications.

2. Learners will recognize the major differences in air ventilation systems as compared

between the three main Biosafety Levels in research and laboratory spaces; new

standards, pending standards, and new technologies will be discussed.

3. Attendees will be able to specify the characteristics that guide architectural and

engineering considerations when designing for biosafety in health care settings, including

the ability to recognize minimum standards and identify enhancements that exceed

minimum standards to increase safety.

4. Participants will identify at least three design-related conditions that permit cross-

contamination and then recognize strategies, equipment, or system designs that serve to

mitigate cross-contamination and protect humans from microbial pathogens.

Biosafety as a Design Element

Christopher J. Woolverton, Ph.D.

Professor of Environmental Health Sciences

Director, Center for Public Health Preparedness

Healthcare-associated Infections

www.cdc.gov, December 2014 http://www.cdc.gov/HAI/state-based/index.html

UCLA Warns Nearly 160 Patients About Dangerous 'Superbug' Exposure http://www.nbcnews.com/

2 deaths possibly linked to 'superbug' at UCLA hospital after 7 infected, 179 exposed www.foxnews.com/

UCLA hospital cites medical scopes in superbug CRE outbreak http://www.cnn.com/

UCLA Outbreak Highlights Challenge Of Curbing Infections www.npr.org/

Nearly 200 UCLA Patients Possibly Exposed to Bacteria That Can Kill 40 Percent of Those Infected ktla.com/

Feb 18-20, 2015

21st Century Human

Pathogens (and drug resistance passed on to many)

Pathogens Recognized in last 25 Years

Pathogens Re-emerging (conquered no more)

BACTERIA Bartonella henselae Ehrlichia spp. Helicobacter pyloria Borrelia burgdorferi

BACTERIA Clostridium difficile Streptococcus pyogenes Staphylococcus aureus

FUNGUS Encephalitozoon spp. Crytococcus gattii

FUNGUS

PROTIST Babesia spp. Acenthamoebia spp. Naegleria spp.

PROTIST

VIRUS Avian influenza (H7N9) Bourbon virus Chikungunya virus Hendra virus Hepatitis C virus Hepatitis E virus Human Immunodeficiency Virus Human herpesvirus 6 Human herpesvirus 8 MERS-CoV Parvovirus B19

VIRUS Dengue virus Ebola virus Enterovirus A71 Enterovirus D68 Measles virus Mumps virus Polio virus

2001 Hamilton, NJ Post Office

Select Agents are Everywhere You Look

10

Characteristics of Tier 1 Select Agents

Agent % Lethality

(if untreated)

Incubation

Period (days)

Infectious Dose

(# organisms)

Vaccine/

Treatment

Bacteria

Anthrax >90 1-6 1-103 Yes/Yes

Plague 90 2-3 100-15,000 No/Yes

Tularemia 35 3-6 10-50 No/Yes

Brucellosis 5 5-60 10-100 No/Yes

Virus

Smallpox 30 7-17 10-100 Yes/No

Ebola 50-90 4-21 1-10 No/No

VEE 1 2-6 10-100 No/No

Toxin

Botulinum

Toxin

>90 1-5 1 ng/kg No/Yes

BioSafety Lowers Risk

• Identify agent hazards & perform initial assessment of risk

• Standard Operating Procedures (SOPs)

– Donning/doffing, disinfection, hand hygiene, specific equipment use, use of sharps, maintenance

• Respiratory Protection Program

– May be required even with engineering controls

• Medical Surveillance

– Blood banking, baselines, vaccine, occupational medicine release

• Emergency Response Plans (ERPs) & Equipment

Engineering Controls

Work Practices

CDC/NIH Guidance

Work Practices Special practices & precautions Safety Equipment Primary Barrier (Personal Protective Equipment) Engineering Controls Secondary Barrier (Building & room design, ventilation, sewer, water, etc. Administrative Controls Compliance with regs, safety training, proficiency testing, etc.

Biosafety Regulations, Standards, and Guidance

ALL WORKPLACE HAZARDS OSHA General Duty Clause

and other standards (Regulatory)

INFECTIOUS AGENTS NIH/CDC BMBL

(Guidance)

SOME INFECTIOUS AGENTS Transport, Import, Export

(Regulatory)

GOOD LAB PRACTICE CLSI M29-A3 (Guidance)

BLOODBORNE PATHOGENS

OSHA Standard (Regulatory)

MEDICAL LAB SAFETY

ISO 15189/15190 (Standard)

RECOMBINANT DNA

NIH (Guidance)

Control entry and spread of communicable diseases Public Health Service Act (42 U.S. Code § 264; Section 361)

Infection Control Compliance assisted with

Joint Commission Oversight

The Joint Commission is a nonprofit organization that accredits U.S. health care agencies and programs as a condition of licensure and the receipt of Medicaid reimbursement.

The Joint Commission was formerly the Joint

Commission on Accreditation of Healthcare Organizations (JCAHO) and previous to that the Joint

Commission on Accreditation of Hospitals (JCAH).

BSL Agents

1 Not known to consistently cause disease in healthy adults

2 Associated with human disease, hazard = percutaneous injury, ingestion, mucous membrane exposure

3 Indigenous or exotic agents with potential for aerosol transmission; disease may have serious or lethal consequences

4 Dangerous/exotic agents which pose high risk of life-threatening disease, aerosol-transmitted lab infections; or related agents with unknown risk of transmission

Biosafety Levels for Infectious Agents

www.cdc.gov

BSL Practice

1 Standard Microbiological Practices

2 BSL-1 practice plus: Limited access, Biohazard warning signs, "Sharps" precautions,

Biosafety manual defining any needed waste decontamination or medical surveillance policies

3 BSL-2 practice plus: Controlled access, Decontamination of all waste,

Decontamination of lab clothing before laundering, Baseline serum antibody analysis

4 BSL-3 practices plus: Clothing change before entering, Shower on exit, All material

decontaminated on exit from facility

Recommended Biosafety Level Practices

www.cdc.gov

Biosafety Level 1 (BSL-1)

BSL-1 BSL-2

BSL-3 BSL-4

Healthcare Design to Control Disease Spread

Source: https://www.osha.gov/SLTC/etools/hospital/hazards/tb/tb.html

OSHA Respiratory Standard: 29 CFR1910.134

• All patient and lab space to include:

– Nonporous floor, walls, table tops, chairs, and stools.

– Negative airflow directed to “dirtiest” area

– Sink for hand washing; Eyewash station.

– Controlled access, double-door entry; take-away windows.

• PPE and disinfection supplies nearby.

• Secure space for waste storage.

• Proper pest control practices.

• Separate storage area for personal belongings.

High Containment Space Recommendations

Risk Assessment leads to Clear Guidance

Questions ?

The University of Texas Medical Branch

Designing for Contagion Transmission Reduction

Patrick M. Casey, AIA

Office of Facilities Planning and Construction

February 23, 2015 23

Discussion Outline

1. Introduction

Personal Story

UT System – Who we are?

GNL - Facilities Best Practice

2. Lessons Learned

Infectious Disease / Biohazard Isolation Unit

Facilities Requirements

Other Alternative Solutions

Changes in CDC Protocol

Personal Story

Kent State – 1980 to 1989

University of Texas – 2015

About: The University of Texas System

About: The University of Texas

• Established 1876

• Academic – 220,000 + Students

• Healthcare – 1.3 million hospital days of

treatment

• Research – $2.5 billion in research funding

Galveston National Lab - completed 2008

Galveston National Lab – BS L4

BSL-4 Change Room

BSL-4 Body Shower

BSL-4 Suit Change Room

BSL-4 Chemical Shower (Air Lock)

BSL-4 BSL-4 Lab

BSL-4 Chemical Shower

Complexity Box-in-Box

Complexity Penetrations

Complexity Bio-Seal Doors

Complexity Air Filtering

Complexity Effluent Treatment

Complexity Bio-Safety Cabinet

Current Research

UTMB – Ebola Involvement

Dr. Tom Ksiazek – Headed up contact tracing for the Centers for Disease Control and Prevention (CDC) in Sierra Leone for six weeks August-September 2014; providing ongoing counsel to CDC

and other organizations.

Dr. James Le Duc – Member of World Health Organization (WHO) Emergency Committee on Ebola, member of the Global Outbreak and Alert Response Network (GOARN) Steering

Committee, speaker at National Academy of Sciences conference on U.S. Ebola research strategy, and numerous additional advisory roles.

Ksiazek and Le Duc – Texas Task Force on Infectious Disease Preparedness and Response.

UTMB – Ebola Research Underway

Anti-filovirus small interfering RNAs (siRNA) – a novel class of drug

developed in collaboration with Tekmira Pharmaceuticals that has

shown great promise in laboratory animals against the latest strain of

Ebola-Zaire from the current outbreak.

• Recently began clinical trials in humans

Recombinant Vesicular Stomatitis Virus (rVSV) – a vaccine candidate

that has proven effective at protecting laboratory animals challenged

with Ebola and has shown promising results even after animals have

shown signs of infection. Developed with Profectus BioSciences.

• Entering Phase 1 clinical trials soon

Studies of fully human anti-filovirus monoclonal antibodies (ZMappTM)

– conducted in collaboration with Dr. James Crowe, Jr., Vanderbilt

University, and corporate partner Mapp Biopharmaceutical.

UTMB 2014 - Biocontainment Care Unit

Commissioned by Governor’s Office and CDC – Translate the science of

biocontainment into optimal patient care and isolation practices and

provide rooms capable of CCU/ICU level care.

BioContainment Critical Care Unit (BCCCU)

= Critical Care Unit

+ Biocontainment Patient Care Unit

46

“...biocontainment patient care unit” or BPCU is a “facility designed and operated to maximize patient care with appropriate infection control practices and procedures. These units are secure, physically separated from other patient care areas, and have special air-handling systems and advanced personal protection measures for staff.” Phillips et al., Ft Detrick MD, 2006

BCCCU at UTMB: Learn from Others

47

Who:

Providence St. Patrick’s Hospital, Missoula, MT University of Nebraska Medical Center, Omaha, NE

Emory University, Atlanta, GA

What:

Site and Location Access and Adjacencies Configuration BioContainment Size and number of beds Isolation Technology Anterooms Family Spaces Technology (UV, laminar flow) Air Changes Laboratory Autoclave Dialysis, Minor Procedures Support Spaces Alternative Uses Challenges

BCCCU: Four Bed Unit

48

Four 300 S.F. ICU Room

• 120 S.F. Anteroom

• Separate Toilet Room

Equipment enables variable use

• NICU

• Bariatric

• Family Occupancy

400 S.F. Laboratory with Anteroom

Autoclave Room

Complete Support Spaces

IT for monitoring and telemedicine

BCCCU: Eight Bed Unit

49

Eight 300 S.F. ICU Room

• 120 S.F. Anteroom

• Separate Toilet Room

Other capabilities as for the four room

suites

More robust staff support space in

anticipation of larger patient population

TDCJ (Texas Department of Criminal

Justice) capable

BCCCU: Conceptual Cost Estimate

50

BCCCU: Conceptual Schedule

51

BCCCU: Next Steps

52

First 30-45 Days

• Submit Funding Request and Approval

• Receive Funding Approval

• Appoint Architect/Engineer

• Confirm Project Team Organization

• Begin Schematic Design

• Visit to Peer Institutions

• Begin Procurement of Construction Manager

BCCCU: Alternative Solutions

53

Safe Ebola Isolation

www.odulair.com+1 307 459 1350 info@odulair.com

The patent pending Odulair Ebola Isolation Unit is a self-contained, rapidly deployed facility that provides

unprecedented protection for your medical team and environs. Odulair ... Healthcare where you need it!

BCCCU: Alternatives Solutions

54

BCCCU: Alternatives Solutions

55

BCCCU: Alternatives Solutions

56

BCCCU: Alternatives Solutions

57

BCCCU: Alternatives Solutions

58

BCCCU: Alternative Solutions

Student Designs

59

BCCCU: Other Alternatives

60

61

Patrick M. Casey, AIA

The University of Texas System Administration

Office of Facilities Planning and Construction

pmcaseyaia@gmail.com

TEL: 216.978.7070

Questions?

Designing For Highly Infectious Contagions Ventilation Considerations

Greg Lavriha, PE Associate, Mechanical Karpinski Engineering

Not easy

Complex buildings

24/7 Buildings

Infrastructure Limits

Patient Flow

Facility Standards

Lots of cooks

Form a team

success

Patient Care Areas

Standards

Guidance on level 4

Airborne infectious isolation (AII)

• The isolation of patients infected with organisms spread by airborne droplet nuclei less than 5 micron in diameter.

Envelope integrity

Exhaust discharge height

Exhaust discharge - location

Monitoring

• Permanent, local device • Visually indicates pressure condition

Emergency power

Energy recovery

Ante-room

Retrofit

Minimum requirements

Filtration

Fan redundancy

Filter redundancy

Redundant filters

Redundant filters & fans

Tracking airflow

Electronic monitor

Midpoint

Research Areas

BSL 2

BSL 3

BSL 4

Thank You

Recent challenges in cleaning, disinfection and sterilization

in healthcare facilities

Dr. Gerald McDonnell

HealthCare Challenges

• Cost management

• Blame culture – Legal implications

• Safety considerations

• Environmental considerations

• National and international standards/guidelines – Quality standard

– Auditing

• Increasing infection and patient complication concerns

1. The Microbial Challenges

Biosafety

Healthcare Associated Infections (HAI)*

Infections as a result of treatment in a hospital or a healthcare service unit, but secondary to the patient's

original condition Generally appear 48 hours or more after hospital admission

or within 30 days after discharge

*Also known as nosocomial infections

‘While healthcare executive may recognize the serious threat to patient health that

healthcare associated infections present, they often aren’t aware of the significant financial

drain associated with these infections

Hollenbeak, APIC, HFMA

• USA population: ~300M – In hospital (2%): 6M

• Estimated HA-infections 600,000 (10%) per year – Worldwide can range from 5-19%

• Increased length of stay ~7-9 days • Estimated deaths: 60,000 (10%) per year • Estimated cost to healthcare: $2B USD per year

– 10% reduction alone saves $200M BRL

• An additional 10-60% infections present after discharge – Additional treatment – Rehospitalization

Typical Costs

Results extrapolated based on International analysis

Microorganisms-HAIs

• Typical pathogens include – Staphylococcus aureus (21.8%);

• Including methicil lin-resistant S. aureus (MRSA)

– Enterobacteriaceae (20.2%);

– Pseudomonas spp (17.2%);

– Enterococci (10.0%);

– Escherichia coli (9 1%);

– Candida spp (8.8%);

– Coagulase-negative staphylococci (7.0%); and

– Acinetobacter spp (5.1%)

• Increasing concerns include – Carbapenem- resistant Klebsiella

pneumoniae and other Enterobacteriaceae • Resistant to almost all available antimicrobial agents

• High rates of morbidity and mortality

– Atypical mycobacteria (e.g., Mycobacterium abscessus)

• Long term development of infection

• Associated with aldehyde resistance

– Viruses • Norovirus and other non-enveloped viruses

• Ebola and other enveloped viruses

– Clostridium difficile

Prevention Culture

Immunization Containment Decontamination

Sterilization

Disinfection

Ascaris, Cryptosporidium, GiardiaVegetative Helminths and Protozoa

Staphylococcus, Streptococcus, EnterococcusGram positive bacteria

Pseudomonas, Providencia, EscherichiaGram negative bacteria

More

Resistant

Aspergillus, Trichophyton, Candida,

Chlamydomonas

Vegetative Fungi and Algae

CryptosporidiumProtozoal Oocysts

HIV, Hepatitis B virus, Herpes Simplex virusEnveloped virusesLess

Resistant

Adenoviruses, RotavirusesLarge, non-enveloped viruses

Aspergillus, PenicilliumFungal Spores

Giardia, AcanthamoebaProtozoal Cysts

Poliovirus, Parvoviruses, Papilloma virusesSmall, Non-Enveloped Viruses

Mycobacterium tuberculosis, M. terrae, M.

chelonae

Mycobacteria

Ascaris, EnterobiusHelminth Eggs

Bacillus, Geobacillus, ClostridiumBacterial Spores

Scrapie, Creutzfeld-Jakob disease, Chronic

wasting disease

Prions

ExamplesMicroorganism

Ascaris, Cryptosporidium, GiardiaVegetative Helminths and Protozoa

Staphylococcus, Streptococcus, EnterococcusGram positive bacteria

Pseudomonas, Providencia, EscherichiaGram negative bacteria

More

Resistant

Aspergillus, Trichophyton, Candida,

Chlamydomonas

Vegetative Fungi and Algae

CryptosporidiumProtozoal Oocysts

HIV, Hepatitis B virus, Herpes Simplex virusEnveloped virusesLess

Resistant

Adenoviruses, RotavirusesLarge, non-enveloped viruses

Aspergillus, PenicilliumFungal Spores

Giardia, AcanthamoebaProtozoal Cysts

Poliovirus, Parvoviruses, Papilloma virusesSmall, Non-Enveloped Viruses

Mycobacterium tuberculosis, M. terrae, M.

chelonae

Mycobacteria

Ascaris, EnterobiusHelminth Eggs

Bacillus, Geobacillus, ClostridiumBacterial Spores

Scrapie, Creutzfeld-Jakob disease, Chronic

wasting disease

Prions

ExamplesMicroorganism

McDonnell, 2007

Antibiotic Resistance?

XTB

MRSA

CRE

Greater Concerns

Adeno-Associated Virus,

1lp3, DependovirusMice Minute Virus (MVM),

Strain I, 1mvm, Parvovirus

Canine Parvovirus,

1p5y, Parvovirus

Porcine Parvovirus,

1k3v, Parvovirus

B19 Parvovirus Capsid,

1s58, Parvovirus

Adeno-Associated Virus,

1lp3, DependovirusMice Minute Virus (MVM),

Strain I, 1mvm, Parvovirus

Canine Parvovirus,

1p5y, Parvovirus

Porcine Parvovirus,

1k3v, Parvovirus

B19 Parvovirus Capsid,

1s58, Parvovirus

Patient Contact

Examples Device Classification

Minimum Inactivation

Level

Intact skin Non-Critical Cleaning and/or Low/Intermediat

e Level Disinfection

Mucous membranes or non-intact skin

Semi-Critical Cleaning and High Level

Disinfection or Sterilization

Sterile areas of the body, including blood contact

Critical Cleaning and Sterilization

2. Handling of Reusable Items

Increased Oversight

Standard Examples

• ANSI/AAMI ST79: Steam sterilization and sterility assurance in health care facilities 2010 A1, A2 2011, A3 2012, A1, A2 2013

• ANSI/AAMI ST58: 2013: Chemical sterilization and high-level disinfection in healthcare facilities

– ANSI/AAMI ST41: 2008: Ethylene oxide sterilization in health care facilities: Safety and Effectiveness

• In preparation – AAMI

• AAMI ST xx: Quality systems

• AAMI ST 91: Flexible endoscopes

• AAMI ST xx: Preparation/handling of non-critical devices

Guideline Examples

• Technical Information Reports

AAMI TIR34: 2007: Water for the reprocessing of medical devices

• Other relevant documents

AORN: Perioperative standards and recommended practices, 2014

SGNA: Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes, 2013.

CDC/ HICPAC: Guideline for disinfection and sterilization in healthcare facilities. 2008

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0 1 2

Resert XL

S40

STERISDG

What could we be missing?

• Only published reports • Source of infection, often

unknown • Latent infections

– Some infections can take years to develop

• Toxicity-related events – Irritation and immune response

• e.g., toxic anterior segment syndrome (TASS) and colitis

– Device rejection

3. Environmental Contamination

3. Handling of Wastes

Questions