Strategies for Airborne Infection

Control Under Challenging

Environments and Patient
Conditions
ENGINEERING CONTROLS
Wayne R. Thomann, Dr.P.H
Duke University Medical Center

2008 APIC Conference

June 17, 2008
Denver Colorado
 ON-GOING AND EVOLVING
CHALLENGES
 Protective Inpatient Environments
 New Expectations for Inpatient Units
 Organ transplants and oncology patients
 Processing Centers for Cellular Therapies
 Protective Outpatient Environments
 Treatment Centers
 Outpatient surgery
 Community Containment
ASSESSMENT OF BIOAEROSOL
REDUCTION METHODS IN STEM
CELL TRANSPLANT UNITS AT A
UNIVERSITY HOSPITAL

T. S. Alderman, MS, W.R. Thomann,

Dr.P.H., D.L. Hunt, Dr.P.H.
Duke University Medical Center
INTRODUCTION
 Fungal Spores Present a Risk of
Opportunistic Infections
 Both exogenous and endogenous sources
 Control is Essential to the Safety of
Immunocompromised Patients
 Aspergillus sp. represent greatest
“exogenous” risk
ENGINEERING CONTROLS FOR A
PROTECTIVE ENVIRONMENT
 Long Recognized Infection Control Tool
 New JCAHO Expectation
 Manage airborne infection risks
 CDC Environmental Infection Control
Guidelines
PATIENT UNITS INVESTIGATED
 “Standard” Intensive Care Unit
 Adult Stem Cell Transplant Unit
 Pediatric Stem Cell Transplant Unit
 All have Different Engineering Controls
 Viable Spore Sampling Methodologies
 Thermo Andersen cascade impaction
sampler
 Mattson-Garvin slit-to-agar sampler
 ENGINEERING CONTROL MEASURES
FOR STUDY UNITS
Control Measures ICU ATU PTU
Air handling unit (95% efficient filtration) + + +

Air changes per hour in patient rooms (designed) 6 12 12

Point-of-use supply HEPA-filtration in patient rooms - - +

Point-of-use supply HEPA-filtration throughout unit - - +

Recirculation HEPA-filtration in each patient room - + +

Recirculation HEPA units in unit hall - - +

Pressure gradient established throughout unit - + +

Continuous electronic monitoring of HVAC system - - +

Airflow monitor at doorway of each patient room - -* +

Enter unit through airlock - + +#

+ indicates that the control measure is available

* static pressure indicator installed within the patient room
# indicates an interlocked airlock
RESULTS - FUNGAL SPORES
 Nine Fungal Genera Isolated
 No Aspergillus sp. Isolated from Patient
Rooms in the Stem Cell Transplant
Units
 Significantly Lower Spore Counts in
Patient Rooms
 Use of All Engineering Controls Resulted
in Significantly Lower Spore Counts
 COMPARISONS OF MEAN SPORE
CONCENTRATIONS FOR PATIENT
ROOM SAMPLE LOCATIONS
Satterthwaite
Mean (cfu/m3) SD p-value
t-value (df)
ICU

Bedside vs. 6.41 5.29 3.86 (55.4) 0.0003

Outside Rm. 14.42 12.88
ATU

Bedside vs. 2.61 3.57 2.50 (115) 0.014

Rm. Entry 4.34 4.15
Bedside vs. 2.61 3.57 4.86 (71.5) <0.0001
Outside Rm. 9.67 10.84
Rm. Entry vs. 4.34 4.15
Outside Rm. 9.67 10.84 -3.58 (77.7) 0.0006

PTU

Bedside vs. 1.31 2.47 0.7(177) 0.49

Rm. Entry 1.59 2.86
Bedside vs. 1.31 2.47 2.88 (76.7) 0.005
Outside Rm. 2.94 3.59
Rm. Entry vs. 1.59 2.86
Outside Rm. 2.94 3.59 -2.31 (85.9) 0.02
MEAN CONCENTRATIONS OF APERGILLUS
SP. AND TOTAL VIABLE SPORES
Positive for Percent Aspergillus Total Viable
N SD
Aspergillus Positive Conc. (cfu/m3) Spore Conc.
(cfu/m3)

ICU 44 15 34.0 0.8 1.15 14.42

Unit Hall ATU 61 7 11.0 0.3 0.92 9.67

PTU 47 2 4.3 0.1 0.49 2.94

ATU 59 0 0.0 0.0 0.00 4.34

Rm. Entry
PTU 84 0 0.0 0.0 0.00 1.59

ICU 51 7 13.7 0.3 0.83 6.41

Bedside ATU 68 0 0.0 0.0 0.00 2.61

PTU 84 0 0.0 0.0 0.00 1.31

ATU 18 1 5.6 0.2 0.82 16.5

Airlock
PTU 31 1 3.2 0.1 0.43 19.5

Stairwell * 30 17 57.0 2.8 3.2 60.8

 VIABLE SPORE CONCENTRATIONS
AT UNIT ENTRANCES

Unit Entrance Data

25
22.8

20
17.9
16.7 ICU
Mean (cfu/m3)

15
12.3
ATU
10.7 PTU
9.5 9.6
10

5
2.4

Main Hosp. Hall Airlock Just Inside Unit

PRESSURE CHANGE READINGS TAKEN
AT VARIOUS UNIT DOORWAYS
Pressure Differential
(CDC Recommendation: > 2.5 Pa.)

5
Pascals

PTU
4 ATU
CDC
3

0
Rooms Emerg Emerg Airlock Airlock Stairwell
Exit Exit Door Door
(east) (west) (inner) (outer)
MEAN SPORE CONCENTRATIONS IN
OCCUPIED VERSUS UNOCCUPIED
ROOMS
Occupied vs Non-Occupied Rooms

8.0

7.0

6.0
Mean (cfu/m3)

5.0
Occ
4.0
Non-Occ
3.0

2.0

1.0

0.0
ICU ATU PTU
 EVOLVING INPATIENT
EXPECTATIONS
 At Risk Patients Everywhere/Anywhere
 Our ICU Studies Documented the Risks
 A good, but not great, environment
 Demand to Enhance the “Local”
Environment
 Don’t strive for perfection
 Prioritize the improvements
 IMPROVING THE LOCAL
INPATIENT ENVIRONMENT
 Room Pressurization
 Central system or local adjunct
 Central system has limitations
 Directional Air Flow
 From breathing zone to door
 Re-Filtration or Air Cleaning
 Address both endogenous and exogenous
sources of contamination
ENGINEERING CONTROLS FOR
REDUCING BIOBURDEN
 Airlock with Interlocking Doors
 Prevent simultaneous openings
 HEPA Re-filtration Units to Manage
“Endogenous” Sources of Fungal Spores
 Directional Airflow from Patient Breathing
Zone to Room Entry
 Directional Airflow at >2.5 Pascals
 Isolate Nursing Units from Stairwell
Contaminants
 ADDITIONAL APPLICATIONS OF
BIOAEROSOL CONTAINMENT
CONTROL PRACTICES
 Human Tissue Processing Areas
 Tissue Culture Facilities
 Production Pharmacies
 HUMAN MATERIAL “PROCESSING”
LABORATORY
 FDA Regulations – 21 CFR parts 210,
211, 600, and 610
 Non-prescriptive so address the “intent”
 Assure patient safety (asepsis)
 Protect the “critical area” where sterile product
may be exposed to:
 Environmental contaminants
 Personnel/process “shedding”
 IMPACT OF “CONTAINMENT”
ENGINEERING IN A GMP/GLP
LABORATORY
Fungal Spore Concentrations and Particle Counts in the "Critical Area" of Lab #1

40000 120
Baseline - Neg pressure
- Thorough cleaning
35000
- Removal of cardboard
100
- Restricted access
30000
Pos pressure, No HEPA, pressure
diff = 1.25 Pa 80
25000
particles/ft3

cfu/m3
20000 Supply HEPA, airflow monitor at door, sticky mat, vinyl 60
ceiling tiles, lights replaced, July '04

15000
HEPA housing sealed, ceiling tiles "seated", 40
pressure diff = 7.5 Pa, Oct 04
10000

20
5000

0 0
Apr-04 May-04 Jun-04 Aug-04 Jan-05 Mar-05 Apr-05 May-05 Jun-05

particles spores
 IMPACT OF “CONTAINMENT”
ENGINEERING IN A GMP/GLP
LABORATORY
Fungal Spore Concentrations and Particle Counts Inside Lab Near Door of Lab #1
- Neg pressure
40000 - Thorough cleaning 80
Baseline - Removal of cardboard
- Restricted access
35000 70

30000
Pos pressure, No HEPA, pressure 60
diff = 1.25 Pa

25000 50
particles/ft3

cfu/m3
20000 40

Supply HEPA, airflow monitor at door, sticky

15000 mat, vinyl ceiling tiles, lights replaced, July 30
'04

10000 20
HEPA housing sealed, ceiling tiles "seated",
pressure diff = 7.5 Pa, Oct 04
5000 10

0 0
Apr-04 May-04 Jun-04 Aug-04 Jan-05 Mar-05 Apr-05 May-05 Jun-05

particles spores
CONDITIONS IN THE ADJACENT
“UNPROTECTED” ENVIRONMENT
Fungal Spore Concentrations and Paticle Counts Outside Lab #1 Near Door

40000 80

35000 70

30000 60

25000 50
particles/ft3

cfu/m3
20000 40

15000 30

10000 20

5000 10

0 0
Apr-04 May-04 Jun-04 Aug-04 Jan-05 Mar-05 Apr-05 May-05 Jun-05

particles spores
COFIGURATION OF “CRITICAL”
AREA
“VALIDATION” MONITORING IN THE
CRITICAL AREA
 PROTECTIVE OUTPATIENT
ENVIRONMENTS
 Sicker patients and more complicated
procedures
 Oncology treatment facilities and
outpatient ORs
 Different standard of care?
 May be “Business” Occupancy
 Different HVAC systems and controls
 PROVIDING A PROTECTIVE
OUTPATIENT ENVIRONMENT
 Pressurization, Directional Air Flow, and
Re-Filtration Remain Critical
 Local Application of these Technologies
 COMMUNITY CONTAINMENT
 New Initiative within ASHRAE
 Pressurize for Shelter-In-Place
 Exhaust for “Isolation”
 Re-Filtration is a Key Component in the
Effort
 CONCLUSIONS
 We Can Engineer a Protective Inpatient
Environment
 We Must Adapt Our Knowledge to Our New
Challenges
 Accept the constraints and limitation
 Be creative in addressing these new
obligations
 Set the new standards of care
 CONCLUSIONS
 Use Filtration Units to Pressurize the
Space
 Sterile air “piped” into the containment
zone
 Connect to supply air duct or direct discharge
 Re-Filtration within the Space