Design, Commissioning and Testing of Operating...
Transcript of Design, Commissioning and Testing of Operating...
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Design, Commissioning and Testing of Operating Theatres & Isolating Rooms in Norway
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Design, Commissioning and Testing of Operating Theatre & Isolating
Rooms in Norway
Kari Solem Aune
Senior advisor, Healthcare engineering
Norwegian Hospital Construction Agency
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AGENDA
1. Background- St.Olavs Hospital- Cancer scandal
2. Operating theatres3. Knowledge centre
- Isolating care unit4. Test program
- IQ/OQ- PQ
5. Lessons learned
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ST. OLAVS HOSPITAL
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ST. OLAVS HOSPITAL
1999
2014
Foto: St. Olavs Hospital
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ST. OLAVS HOSPITAL
WARDS
WARDS
WARDS
BRIDGE
BRIDGE
BRIDGE
BRIDGESURGERY
UNIVERSITY TECHNICAL
ENTRANCE GARDEN
CULVERT CULVERTTECHNICAL AREA
ROOF GARDEN
OUTPATIENTS
TECHNICAL
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OPERATING THEATRES
WARDS
WARDS
WARDS
BRIDGE
BRIDGE
BRIDGE
BRIDGESURGERY
UNIVERSITY TECHNICAL
ENTRANCE GARDEN
CULVERT CULVERTTECHNICAL AREA
ROOF GARDEN
OUTPATIENTS
TECHNICAL
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OPERATING THEATRES
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OPERATING THEATRES
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OPERATING THEATRES
Design- Ceiling supply units - 10 CFU / 100 CFU- Downflow ~ 0,28 m/s- Air tight rooms- Overpressure (5 – 10 Pa)- 2 AHUs to serve all theatres
Testing- Room tightness- HEPA-filter test- Recovery test- Air velocity- Functionality
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Requirements
Description
HTM 03-01 DIN 1946-4
(2008)
ASHRAE 2006
Handbook
Japan
HEAS-02-1998
Norway CEN Ventilation
in Hospitals
1. Air Flow
Requirements
8 templates
Min. 0.65m3/s
(22 ACH)
Class 1b
Min. 2400m3/h
(22 ACH)
Class A
Min. 15 ACH
2400m3/h
20 ACH
20 ACH
2. Pressure
Requirements
25 Pa Positive Positive & 15%
surplus air
+ve
P 1.25 mm
H2O
Positive
(5-10 Pa)
3. Filtration HEPA H13 HEPA H13/H14 HEPA H13 HEPA H13 HEPA H14
4. Location of
supply
Ceiling Ceiling Ceiling Ceiling Ceiling
5.
Return/Exhaust
location
Low level Min. 1200m3/hr
to be
returned/exhaust
air low level
At least 2
locations near
the floor
Low Level
(clean room
standard)
2/3 low level
1/3 at the ceiling
6. Set back Not stated Enough to
maintain P
25% of design
flow
----- 1/3 of design
flow
7. Min. outdoor
air
-Building
Regulation Part
F
-CIBSE’s guide
Min 1200 m3/h Min. 5 air
changes/hr
5-10 ACH 20 ACH
8. Site
acceptance test -Smoke test
-BCP test in
operation with
clothing
(<180 CFU/m3)
Leakages test
on HEPA filter
Measurements
of particles
? - Scan test
(particles)
- Velocity
uniformity
HEPA-filter test
(ISO 14644-3)
Recovery test
GENERAL OPERATING THEATRES
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Requirements
Description
HTM 03-01 DIN 1946-4
(2008)
ASHRAE 2006
Handbook
Japan
HEAS-02-1998
Norway CEN
Ventilation
in Hospitals
1. Air Flow
Requirements
Ceiling size
2800x2800mm
0.38m/s velocity
Class 1a
Min. 9200m3/h
3200x3200 mm
Class B & C
Min. 20 ACH
Class 100
Design Velocity:
0.35m/s velocity
Air velocity
0,25 – 0,28
m/s
2. Pressure
Requirements
25 Pa Positive Positive & 15%
surplus air
+ve
P 1.25 mm H2O
Positive
(5-10 Pa)
3. Filtration HEPA H13 HEPA H14 HEPA H13 HEPA H13 HEPA H14
4. Location of
supply
Ceiling Ceiling Ceiling Ceiling Ceiling
5. Return/Exhaust
location
Ceiling
return/exhaust
next to supply
ceiling shown on
drawings
Min. 1200m3/hr
low level
At least 2
locations near
the floor
Low Level
(clean room
standard)
2/3 low level
1/3 at the
ceiling
6. Set back Not stated Enough to
maintain P
25% of design
flow
----- 1/3 of design
flow
7. Min. outdoor
air
-Building
Regulation Part F
-CIBSE’s guide
Min 1200 m3/h Min. 5 air
changes/hr
5-10 ACH 20 ACH
8. Site
acceptance test
-Leakage test on
HEPA filter
-Velocity
-BCP test
(<10CFU/m3)
-Leakage test on
HEPA filter
-Flow
visualization
-degree of
protection
-turbulence
? -class 100 scan test
-velocity uniformity
test
HEPA-filter
test (ISO
14644-3)
Recovery test
Air velocity
ULTRA CLEAN/HIGH STERILITY OPERATING THEATRES
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OPERATING THEATRES
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PREVIOUS CANCER SCANDAL
The university’s former laboratories without proper safety ventilation
These working conditions led to several cancer diseases and even some deaths
The headmaster had to apologize in public
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PREVIOUS CANCER SCANDAL
RISK ANALYSIS
CONTAINMENT
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KNOWLEDGE CENTRE
ISOLATING CARE UNIT
WARDS
WARDS
BRIDGE
BRIDGE
BRIDGE
BRIDGESTUDENT AREAS
UNIVERSITY LABS TECHNICAL
ENTRANCE GARDEN
CULVERT CULVERTTECHNICAL AREA
ROOF GARDEN
TECHNICAL AREA
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BSL3 ISOLATING ROOMS
Isolation Care Rooms
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BSL3 ISOLATING ROOMS
SLUICE
ISOLATING ROOM
WC/SHOWER
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BSL3 ISOLATING ROOMS
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TECHNICAL AREAS
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TEST PROGRAM
Validation "light“- DQ, IQ, OQ, PQ
Risk analysis - containment- Personnel - Surroundings
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TEST PROGRAM
IQ - Installation qualification• room tightness• duct tightness• surfaces
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TEST PROGRAM
OQ - Operational qualification• air flow rates• HEPA-filter • electrical/water/gas supply• door interlock• communication system• light• sound pressure
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TEST PROGRAM
PQ - Performance qualification• fire safety/fire alarm• electrical supply• technical failures• containment test• recovery test/internal airflow
pattern• external airflow pattern (CFD)• temperature stability
Pressure cascade- 5 unique
tests- 3 successful
tests
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SWITCHING THE SYSTEM OFF AND ON
0 Pa
-15 Pa
-30 Pa
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ENTERING THROUGH THE DOORS
Corridor door
Room door
Emergency state
0 Pa
-15 Pa
-30 Pa
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FAILURE – AIR SUPPLY FAN
0 Pa
-15 Pa
-30 Pa
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FAILURE – EXHAUST FAN A
0 Pa
-15 Pa
-30 Pa
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FAILURE – EXHAUST FAN B
0 Pa
-15 Pa
-30 Pa
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FAILURE – BOTH EXHAUST FANS
0 Pa
-15 Pa
-30 Pa
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SWITCHING: ISOLATING – NORMAL MODE
0 Pa
-15 Pa
-30 Pa
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LESSONS LEARNED
Enough space for technical systemsSeparate AHUs for each - Operating Theatre- Isolating Care UnitTechnical infrastructure – acceptedValidation "light" – no good idea….
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THANK YOU FOR YOUR ATTENTION
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