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.
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.
This course is registered with AIA
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 crosscontamination 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
Healthcareassociated Infections
http://www.cdc.gov/HAI/state-based/index.html
www.cdc.gov, December 2014
Feb 18-20, 2015
UCLA Warns Nearly 160 Patients About Dangerous 'Superbug' Exposure http://www.nbcnews.com/
Nearly 200 UCLA Patients Possibly Exposed to Bacteria That Can Kill 40 Percent of Those Infected ktla.com/
UCLA hospital cites medical scopes in superbug CRE outbreak http://www.cnn.com/
UCLA Outbreak Highlights Challenge Of Curbing Infections www.npr.org/
2 deaths possibly linked to 'superbug' at UCLA hospital after 7 infected, 179 exposed www.foxnews.com/
Pathogens Recognized in last 25 Years
Pathogens Re-emerging (conquered no more)
BACTERIA
BACTERIA
Bartonella henselae Ehrlichia spp. Helicobacter pyloria Borrelia burgdorferi
Clostridium difficile Streptococcus pyogenes Staphylococcus aureus
FUNGUS
FUNGUS
Encephalitozoon spp. Crytococcus gattii
PROTIST
PROTIST
Babesia spp. Acenthamoebia spp. Naegleria spp.
VIRUS
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
Dengue virus Ebola virus Enterovirus A71 Enterovirus D68 Measles virus Mumps virus Polio virus
21st Century Human Pathogens (and drug resistance passed on to many)
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
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
30
7-17
10-100
Yes/No
Ebola
50-90
4-21
1-10
No/No
VEE
1
2-6
10-100
No/No
>90
1-5
1 ng/kg
No/Yes
Bacteria
Virus Smallpox
Toxin Botulinum Toxin
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
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.
Engineering Controls
Work Practices
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 ยง 264; Section 361)
Infection Control Compliance assisted with Joint Commission Oversight The Joint Commission was formerly the Joint The Joint Commission is a nonprofit Commission that on Accreditation ofhealth Healthcare organization accredits U.S. care Organizations (JCAHO) and to that the Joint agencies and programs as aprevious condition of licensure Commission on Accreditation of Hospitals (JCAH).
and the receipt of Medicaid reimbursement.
Biosafety Levels for Infectious Agents 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, aerosoltransmitted lab infections; or related agents with unknown risk of transmission
www.cdc.gov
Recommended Biosafety Level Practices 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
www.cdc.gov
Biosafety Level 1 (BSL-1) BSL-1
BSL-3
BSL-2
BSL-4
Healthcare Design to Control Disease Spread
OSHA Respiratory Standard: 29 CFR1910.134
Source: https://www.osha.gov/SLTC/etools/hospital/hazards/tb/tb.html
High Containment Space Recommendations • 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.
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
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
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 “...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
46
BCCCU at UTMB: Learn from Others Who:
Providence St. Patrick’s Hospital, Missoula, MT University of Nebraska Medical Center, Omaha, NE Emory University, Atlanta, GA What:
Site and Location Configuration Size and number of beds Anterooms Technology (UV, laminar flow) Laboratory Dialysis, Minor Procedures Alternative Uses
Access and Adjacencies BioContainment Isolation Technology Family Spaces Air Changes Autoclave Support Spaces Challenges 47
BCCCU: Four Bed Unit 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
48
BCCCU: Eight Bed Unit 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
49
BCCCU: Conceptual Cost Estimate
50
BCCCU: Conceptual Schedule
51
BCCCU: Next Steps 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 52
BCCCU: Alternative Solutions
Safe Ebola Isolation 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!
+1 307 459 1350
info@odulair.com
www.odulair.com
53
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
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Questions? Patrick M. Casey, AIA The University of Texas System Administration Office of Facilities Planning and Construction pmcaseyaia@gmail.com TEL: 216.978.7070
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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
Typical Costs • 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
Results extrapolated based on International analysi
Microorganisms-HAIs •
Typical pathogens include –
Staphylococcus aureus (21.8%); •
– – – – – – –
•
Increasing concerns include –
Including methicillin-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%)
Carbapenem- resistant Klebsiella pneumoniae and other Enterobacteriaceae • •
–
–
Atypical mycobacteria (e.g., Mycobacterium abscessus) •
Long term development of infection
•
Associated with aldehyde resistance
Viruses • •
–
Resistant to almost all available antimicrobial agents High rates of morbidity and mortality
Norovirus and other non-enveloped viruses Ebola and other enveloped viruses
Clostridium difficile
Prevention Culture Immunization
Containment
Decontamination
Sterilization Disinfection
Microorganism More Resistant
Prions Bacterial Spores Protozoal Oocysts
Examples Scrapie, Creutzfeld-Jakob disease, Chronic wasting disease Bacillus, Geobacillus, Clostridium Cryptosporidium
Helminth Eggs
Ascaris, Enterobius
Mycobacteria
Mycobacterium tuberculosis, M. terrae, M. chelonae
Small, Non-Enveloped Viruses
Poliovirus, Parvoviruses, Papilloma viruses
Protozoal Cysts
Giardia, Acanthamoeba
Fungal Spores
Aspergillus, Penicillium
Gram negative bacteria Vegetative Fungi and Algae
Pseudomonas, Providencia, Escherichia Aspergillus, Trichophyton, Candida, Chlamydomonas
Vegetative Helminths and Protozoa Ascaris, Cryptosporidium, Giardia Large, non-enveloped viruses Gram positive bacteria Less Resistant
Enveloped viruses
Adenoviruses, Rotaviruses Staphylococcus, Streptococcus, Enterococcus HIV, Hepatitis B virus, Herpes Simplex virus
McDonnell, 2007
Antibiotic Resistance? XTB
MRSA
CRE
Greater Concerns
Adeno-Associated Virus, 1lp3, Dependovirus
Mice Minute Virus (MVM), Strain I, 1mvm, Parvovirus
Porcine Parvovirus, 1k3v, Parvovirus
B19 Parvovirus Capsid, 1s58, Parvovirus
Canine Parvovirus, 1p5y, Parvovirus
2. Handling of Reusable Items 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
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
7 6
Resert XL 5 S40
4 3
STERISDG 2
1 0
0
1
2
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