• Infection Control Ventilation Compliance
✓ ASHRAE 170
Michael Rerucha <MICHAEL.RERUCHA@luhs.org>
Bill.Middleton@CEPROINC.COM
773.580.4401
Trinity/Loyola
•
Loyola University Medical Center is a quaternary care facility with 547 licensed beds, a Level I
Trauma Center, nationally recognized Burn Center, renowned Transplant Center and a special
20-bed unit for patients undergoing stem cell transplant. The center provides top hospital care
in all medical specialties including ortho, nephrology, cardiology, cancer, ophthalmology and
surgery
Our Vision
•
As a mission-driven innovative health organization, we will become the national leader in
improving the health of our communities and each person we serve. We will be your most
trusted health partner for life.
Loyola Campus
ASHRAE 170 AGENDA
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Introductions – Loyola…CEPro
The Bible for Healthcare Ventilation standards driven by Infection Control
AHJ Survey preparedness and/or Infection Prevention – which is more of a priority
USP 797 (Sterile Compounding)/800 (Hazardous Drug)/ and NOW 825 (Radiopharmaceutical
Compounding) Mandates, Compliance Planning and Checklist application
– How much pressure is the right amount between critical spaces adjacent to one another?
– What is the pressure pass/fail threshold? Positive or Negative…. for all rooms?
– Facilities role in compliance failures found during the every 6 month certification process
– Cleanroom HVAC/Controls design, Test & Balance, certification, and commissioning
– To be VAV or not to be…. that is the question
– Control strategies to reduce nuisance alarms
– Cascading air pressure design and monitor sensing port location importance
– Iso classifications driving cleanroom design Air Changes per Hour
• ACH standards, clarification, filtration, and ways to achieve/exceed minimums
Inventory, Risk Assessment and Testing for Infection Control Ventilation Compliance Testing
– Systems and Space Asset Inventory
– Inspection/Testing Data gathered/pass-fail criteria agreement/Frequency
– Plan for Correction/CMMS integration
• Building Automation and Controls Calibration
– Documentation/Collaborative Archiving Site
Overall BAS & Central Systems HVAC knowledge serving critical spaces - Systems and Space Points
of Failure
Laboratory Fume Hoods/Bio-Safety Cabinets/Laminar Flow Bench Certification during Function
Space Compliance Testing
Healthcare – Unique
Compliance
Value Proposition Experts
Educators
CEPro, Inc.
Space &
Equipment
Certification
Critical Environments Professionals
Test & Balance
HVAC expertise
BCxP certified
Healthcare
Pharma/Bio-Science
Unique Value Proposition
Energy Engineers
Automation
Calibration
Tech’s
Specialty Design
Build GC
Plan for
Correction
Healthcare Success Stories
CEPro knows: Standards & Compliance
The Guidelines documents began as General Standards published in the Federal Register on February 14, 1947, as part of the
implementing regulations for the Hill-Burton program. The FGI Guidelines for Design and Construction of Hospitals and
Outpatient Facilities recommends minimum program, space, risk assessment, infection prevention, architectural detail, and
surface and furnishing needs for clinical and support areas of hospitals, rehabilitation facilities, and ambulatory care
facilities. The document also addresses minimum engineering design criteria for plumbing, electrical, and heating, ventilation, and
air-conditioning (HVAC) systems, the latter by incorporating ANSI/ASHRAE/ASHE Standard 170: Ventilation of Health Care Facilities.
The Joint Commission, many federal agencies, and authorities in 42 states use the Guidelines either as a code or a
reference standard when reviewing, approving, and financing plans; surveying, licensing, certifying, or accrediting
facilities; or developing their own codes.
Hill-Burton Act was signed into law by President Harry S. Truman. The bill, known formally as the Hospital Survey
and Construction Act, was a Truman initiative that provided construction grants and loans to build hospitals
Mike and Aaron from TLC Engineering, members of the 170 committee
Accreditation & Certification documentation
…….accreditation and certification is recognized nationwide as a symbol of
quality that reflects an organization’s commitment to meeting certain
performance standards
…..improve health care for the public, in collaboration with other
stakeholders, by evaluating health care organizations and inspiring them to
excel in providing safe and effective care of the highest quality and value.
States Department of Health
Accreditation & Certification documentation
…….accreditation and certification is recognized nationwide as a symbol of
quality that reflects an organization’s commitment to meeting certain
performance standards
…..improve health care for the public, in collaboration with other
stakeholders, by evaluating health care organizations and inspiring them to
excel in providing safe and effective care of the highest quality and value.
States Department of Health
Top 10 Deficiency’s Found
The Impact of Hospital Acquired Infections (HAI’s)…
The Center for Disease and Prevention (CDC)
estimates that 1.7 million people contract a
hospital acquired infection annually, and
nearly 99,000 of them die (Klevens et al.,
2007).
Hospital-Acquired Infections
kill 99,000
Americans
each year
That’s the equivalent of a
jumbo jet full of passengers
crashing every other day
High Return on Investment by Implementing
Environmental Infection Control Compliance
15
The Impact of Hospital Acquired Infections (HAI’s)…
Hospital-Acquired Infections
kill 99,000
Americans
each year
Education
Procedural
Immuno-suppression,
patient conditions
Infection Control
Prolonged and
inappropriate use of
invasive devices and
antibiotics
Cause’s of HAI’s
Population
Geographic
Environmental
Guidelines, standards and
policy
Equipment
Human Resources
Air impurities can travel great distances
Droplet/contact precautions Airborne precautions
Smaller, Evaporated Droplets, solid
particulate/Infectious Droplet Nuclei
Small Infectious Droplets
Large Infectious Droplets
CDC – Airborne
Contact Exposure
Droplet transmission
Terminology:
Micron – metric unit of measure for length equal to 0.001 mm, or about 0.00004 inch. Its symbol is μm and is used to
measure the thickness or diameter of microscopic objects, see slides
Aerosol/Aerosolized/Airborne – liquid or solid particles suspended in air; they can be visible > 10-40μm or invisible <10
μm, divided into Large Droplets (drop close causing local contamination) or Small Droplets (buoyant forces overcome
gravity, drops further away) or Droplet Nuclei (evaporated droplets, leaving solid particulate or Infectious Droplet Nuclei
that free floats for long distances & periods of time). Respiratory Infection primary source
Aerosol Generation – not just procedural, but patient created see next slide
“Virus Transmission in Indoor Air” – Steven Welty CAFS, CIE, LEED AP
“Aerosols, Droplets and Airborne Spread” – Justin Morgenstern, First10EM
Filter Fractional Efficiency
HEPA Filters
Filter Frame and Seal,
Install properly
HEPA Filter Certification
• Overall System Design &
Risk Assessment
• Airflow velocity
• Airborne Particle Count
• Volumetric Filter Leak Test
• Scanning
• Documentation
• NAFA Certification
• Energy efficiency
The photometer is a particle
counter that is used to calculate
the efficiency of a ventilation
installation with HEPA filters.
Air transports the pathogens that contaminate
people and surfaces
What goes up must come down
Hospital air samples, on average, on average 5 times more contaminated than surfaces
Evidence shows reducing pathogens from the air can reduce surface contamination by 66%
Pressure relationships….& ACH’s
Visualization of Integrated
Critical Asset Data
Pressure relationships….& ACH’s
Visualization of Integrated
Critical Asset Data
Pressure relationships….
Visualization of Integrated
Critical Asset Data
Installation considerations…..
Visualization of Integrated
Critical Asset Data
ASHRAE 170 AGENDA
•
•
•
•
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Introduction
The Bible for Healthcare Ventilation standards driven by Infection Control
AHJ Survey preparedness and/or Infection Prevention – which is more of a priority
USP 797 (Sterile Compounding)/800 (Hazardous Drug)/ and NOW 825 (Radiopharmaceutical
Compounding) Mandates, Compliance Planning and Checklist application
– How much pressure is the right amount between critical spaces adjacent to one another?
– What is the pressure pass/fail threshold? Positive or Negative…. for all rooms?
– Facilities role in compliance failures found during the every 6 month certification process
– Cleanroom HVAC/Controls design, Test & Balance, certification, and commissioning
– To be VAV or not to be…. that is the question
– Control strategies to reduce nuisance alarms
– Cascading air pressure design and monitor sensing port location importance
– Iso classifications driving cleanroom design Air Changes per Hour
• ACH standards, clarification, filtration, and ways to achieve/exceed minimums
Overall central systems HVAC knowledge serving critical spaces - Systems and Space Points of
Failure
Laboratory Fume Hoods/Bio-Safety Cabinets/Laminar Flow Bench Certification during Function
Space Compliance Testing
Inventory, Risk Assessment and Testing for Infection Control Ventilation Compliance
– Systems and Space Asset Inventory
– Inspection/Testing Data gathered/pass-fail criteria agreement/Frequency
– Plan for Correction/CMMS integration
• Building Automation and Controls Calibration
– Documentation/Collaborative Archiving Site
USP 797/800 Cleanroom
Solutions - Environmental
Quality and Control
Goal of Chapter <797>
Goal of Chapter <800>
• USP 800’s intent is “to protect personnel and the
environment when handling HDs. This includes but
is not limited to receipt, storage, mixing, preparing,
compounding, dispensing, administering, disposing,
and otherwise altering, counting, crushing, or
pouring HDs, and includes both sterile and
nonsterile products and preparations.”
• According to the Centers for Disease Control (CDC),
about eight million healthcare workers are possibly
exposed to hazardous drugs (HDs) each year
• USP 800 will apply to all personnel who compound
HDs and all places where they are prepared,
including pharmacies, hospitals and other
healthcare institutions, physicians’ practice facilities,
patient clinics, veterinarians’ offices and other
locations/facilities where HDs are stored,
transported and administered
USP <797>/<800> CERTIFICATION OF COMPLIANCE
PHARMACY COMPOUNDING AREA CERTIFICATION
Every 6 months
• Airflow Testing
• Room Segregation/Design
• Room Pressurization
• HEPA Challenging/Leak Testing
• Non-Viable & Viable Particle Counting
• Temperature and Humidity sensing calibration
EQUIPMENT CERTIFICATION (PECs, CAI/CACIs)
Every 6 months
• Airflow Velocity Testing
• HEPA Challenging/Leak Testing
• Dynamic Airflow Smoke Pattern Test with Video
• Non-Viable Particle Counting
• Viable Air & Surface Testing – MONTHLY SURFACE
MEDIA FILL TESTING
Every 6 Months
• Training, In-House Process support or Turnkey Offering, Fingertip Testing,
Remediation Plan Development
REMEDIATION***
CALIBRATION
DOCUMENTATION/TRENDING
DEEP CLEANING BEST PRACTICE
Secondary Engineering Controls
Non-HD Compounding
HD Compounding
Segregated Compounding Area (SCA)
Containment Segregated Compounding Area
A designated, unclassified space, area, or
room with a defined perimeter that
contains a PEC and is suitable for preparation
of Category 1 CSPs only
A designated, unclassified room with a
defined perimeter that contains a C-PEC and
is suitable for preparation of Category 1 HD
CSPs only
No pressurization or air change requirements
Negative pressure and >12ACH
Buffer Room (Cleanroom)
Buffer Room (Cleanroom)
An ISO Class 7 or cleaner room with fixed
walls and doors where PEC(s) that generate
and maintain an ISO Class 5 environment are
physically located. The buffer room may only
be accessed through the ante-room.
An ISO Class 7 or cleaner room with fixed
walls and doors where PEC(s) that generate
and maintain an ISO Class 5 environment are
physically located. The buffer room may only
be accessed through the ante-room.
Positive Pressure >30 ACH
Negative Pressure >30 ACH
Primary Engineering Controls
A device or zone that provides an ISO Class 5 air quality environment for sterile compounding.
Types of PEC’s
Non-HD Compounding
• Laminar Flow Clean Bench (LFCB) / Laminar Airflow Workstation (LAFW)
• Compounding Aseptic Isolator (CAI)
• Also called a RABS (Restricted Access Barrier System)
• Biological Safety Cabinet (BSC)
HD Compounding
• Compounding Aseptic Containment Isolator (CACI)
• Also called a RABS (Restricted Access Barrier System)
• Biological Safety Cabinet (BSC)
These are NOT HOODS!!
Dynamic/Interactive Document
Starts with a question…
What is the BUD of the
CSP’s being prepared?
Single Patient / Immediate Use?
Compounding of CSPs for direct and
immediate administration to a patient
is not subject to the requirements for
Category 1 or Category 2 CSPs…
USP <797>/<800> CERTIFICATION OF COMPLIANCE
PHARMACY COMPOUNDING AREA CERTIFICATION
Every 6 months
• Airflow Testing
• Room Segregation/Design
• Room Pressurization
• HEPA Challenging/Leak Testing
• Non-Viable & Viable Particle Counting
• Temperature and Humidity sensing calibration
EQUIPMENT CERTIFICATION (PECs, CAI/CACIs)
Every 6 months
• Airflow Velocity Testing
• HEPA Challenging/Leak Testing
• Dynamic Airflow Smoke Pattern Test with Video
• Non-Viable Particle Counting
• Viable Air & Surface Testing – MONTHLY SURFACE
MEDIA FILL TESTING
Every 6 Months
• Training, In-House Process support or Turnkey Offering, Fingertip Testing,
Remediation Plan Development
REMEDIATION
CALIBRATION
DOCUMENTATION/TRENDING
DEEP CLEANING BEST PRACTICE
Collaborative, Integrated & Turnkey
Specialty General Contracting success process….
=
GUARANTEED COMPLIANCE
Plan
- Owners Project Requirements OPR Development
- Identify Planning Team
members
- Roles & Time commitment
- Communication Platform
- Tentative Schedule
- Conceptual Cost Model For
Budgeting
- Site Assessment & Gap
analysis
- Compliance Cx requirements
Compliance
Consulting
Design Development
& Review
- Contract Agreement
- Basis of Design
- OPR
- Schematic Design
- Centralization
- State approval/ Local permitting
- Budget/Capital Approval
- Major Design evaluation
- Construction Documentation
completed
- Competitive Bid job walk,
scope/Compliance Cx process
review
- RFI review/respond
- Bid analysis
- Team members final selection
Design
Construction
- Contract Agreement
- Pre-Construction meeting
- OPR goals & BOD review
- Schedule review
- Compliance Cx plan
- Pre-Functional Checklist
- Submittal review and approval
- General Construction
- Compliance Cx plan
- Integrated Functional
Testing
- HEPA Filters integrity test
- Final T&B/Set Pressurization
- Final Compliance Cx Inspection
- Deep Clean (Sterilization)
- Viable Air & Surface Testing
- Room Certification
Build
COST EFFICIENT, NO CHANGE ORDERS, SPEED TO
MARKET, HIGH QUALITY, GUARANTEED COMPLIANCE
Occupancy
- O&M delivery/review
- Compliance Cx report
delivery
- Workflow Training
- Six-month Certification
Turnover
Operations
Collaborative, Integrated & Turnkey
Specialty General Contracting success process….
=
GUARANTEED COMPLIANCE
Design Development
Specialty
General
Construction
Occupancy
Plan
& Review Contracting
Design Build vs. Design Bid Build:
• 11% less cost (on budget, no change orders)
• 33% faster
• Owners reduced risk (cost issues, speed,
design intent collaborative and complete)
• Higher quality (end user needs met, less down
time, increased revenue generation, lower
difficulty in start-up/operations, fewer call
backs)
Compliance
Design
Build
Turnover
•
Increased
warranty
coverage
with
less
Consulting
Operations
mediated interpretation of design
- Owners Project Requirements OPR Development
- Identify Planning Team
members
- Roles & Time commitment
- Communication Platform
- Tentative Schedule
- Conceptual Cost Model For
Budgeting
- Site Assessment & Gap
analysis
- Compliance Cx requirements
- Contract Agreement
- Basis of Design
- OPR
- Schematic Design
- Centralization
- State approval/ Local permitting
- Budget/Capital Approval
- Major Design evaluation
- Construction Documentation
completed
- Competitive Bid job walk,
scope/Compliance Cx process
review
- RFI review/respond
- Bid analysis
- Team members final selection
- Contract Agreement
- Pre-Construction meeting
- OPR goals & BOD review
- Schedule review
- Compliance Cx plan
- Pre-Functional Checklist
- Submittal review and approval
- General Construction
- Compliance Cx plan
- Integrated Functional
Testing
- HEPA Filters integrity test
- Final T&B/Set Pressurization
- Final Compliance Cx Inspection
- Deep Clean (Sterilization)
- Viable Air & Surface Testing
- Room Certification
COST EFFICIENT, NO CHANGE ORDERS, SPEED TO
MARKET, HIGH QUALITY, GUARANTEED COMPLIANCE
- O&M delivery/review
- Compliance Cx report
delivery
- Workflow Training
- Six-month Certification
USP <797>/<800> CERTIFICATION OF COMPLIANCE
PHARMACY COMPOUNDING AREA CERTIFICATION
Every 6 months
• Airflow Testing
• Room Segregation/Design
• Room Pressurization
• HEPA Challenging/Leak Testing
• Non-Viable & Viable Particle Counting
• Temperature and Humidity sensing calibration
EQUIPMENT CERTIFICATION (PECs, CAI/CACIs)
Every 6 months
• Airflow Velocity Testing
• HEPA Challenging/Leak Testing
• Dynamic Airflow Smoke Pattern Test with Video
• Non-Viable Particle Counting
• Viable Air & Surface Testing – MONTHLY SURFACE
MEDIA FILL TESTING
Every 6 Months
• Training, In-House Process support or Turnkey Offering, Fingertip Testing,
Remediation Plan Development
REMEDIATION***
CALIBRATION
DOCUMENTATION/TRENDING
DEEP CLEANING BEST PRACTICE
$1.6m per hospital
ASHRAE 170 AGENDA
•
•
•
•
•
•
•
Introductions – Loyola…CEPro
The Bible for Healthcare Ventilation standards driven by Infection Control
AHJ Survey preparedness and/or Infection Prevention – which is more of a priority
USP 797 (Sterile Compounding)/800 (Hazardous Drug)/ and NOW 825 (Radiopharmaceutical
Compounding) Mandates, Compliance Planning and Checklist application
– How much pressure is the right amount between critical spaces adjacent to one another?
– What is the pressure pass/fail threshold? Positive or Negative…. for all rooms?
– Facilities role in compliance failures found during the every 6 month certification process
– Cleanroom HVAC/Controls design, Test & Balance, certification, and commissioning
– To be VAV or not to be…. that is the question
– Control strategies to reduce nuisance alarms
– Cascading air pressure design and monitor sensing port location importance
– Iso classifications driving cleanroom design Air Changes per Hour
• ACH standards, clarification, filtration, and ways to achieve/exceed minimums
Inventory, Risk Assessment and Testing for Infection Control Ventilation Compliance Testing
– Systems and Space Asset Inventory
– Inspection/Testing Data gathered/pass-fail criteria agreement/Frequency
– Plan for Correction/CMMS integration
• Building Automation and Controls Calibration
– Documentation/Collaborative Archiving Site
Overall BAS & Central Systems HVAC knowledge serving critical spaces - Systems and Space Points
of Failure
Laboratory Fume Hoods/Bio-Safety Cabinets/Laminar Flow Bench Certification during Function
Space Compliance Testing
Developing a Comprehensive
“Infection Control Ventilation Compliance ”
Strategy
Serving Healthcare systems for over
30 years
Your Logo
Developing a Comprehensive
“Infection Control Ventilation Compliance”
Strategy
•
Educate and Collaborate with Senior Leadership – Identify system sponsor
•
IP/C Risk Assessment & Inventory
✓ Identification of Critical Function Space & Systems
✓ Environment of Care Virtual Tour
•
Compliance Testing
✓ Testing Scope & Baseline Agreement - FGI ASHRAE 170…the Bible
✓ Quality Management Toolset
•
Correction of Deficiencies
✓ Expedite, Develop & Implement Plan for Corrections
- Codes, Standards, Guidelines Referenced to justify spend
- CMMS interface
✓ UV Technology Implementation
✓ Design/Budget/Build/Recertify as passed
✓ New Construction Implementation – Capital Projects T&B integration/Commissioning. MEP spec
•
Closing the Loops
✓ Documentation - Hard Copy and/or On-Line/Cloud hosted
✓ Training provided on tool use
✓ Pre-Survey Preparedness for Accreditation
✓ Repeat/Promote as Service Offering
•
•
Low Investment,
High Return – Cost Efficiencies, take off Operations hands, collaborate with Clinical side
• Total Systems Startup, Diagnostics and Analysis
• Air/Hydronics/Sound
• Central/Localized/Controls/BAS
Calibration/Commissioning
• Infection Control Ventilation Compliance testing Integration
to construction T&B
• Duct Leakage Testing & Sealing
• Professional Documentation/Reports
Web-based
• SOP development
• Energy Assessments and M&V
• Laboratory Environment & Controls expertise
• NIST – Calibrated Instrumentation annually
The Solution
Asset Inventory
▪ Environment of
Care Virtual Tour
▪ Room and Systems
Inventory
▪ Risk Assessment
The Solution
Asset Inventory
▪ Environment of
Care Virtual Tour
▪ Room and Systems
Inventory
▪ Risk Assessment
Visualization of Integrated
Critical Asset Data
Visualization of Integrated
Critical Asset Data
Visualization of Integrated
Critical Asset Data
Visualization of Integrated
Critical Asset Data
ACH = 21
O.R.4 (T2181)
The Solution – IC Data Action Plan
Deficiencies/Plan of Corrections
Integrate into your CMMS work order system
The Solution
Components of an Effective Solution
▪ Inventory Identification for critical
spaces and systems
▪ Established baseline data for each
room and system, with information on
specific asset requirements driving
pass/fail criteria
▪ Standardization of inspection &
testing process
▪ Plan for Improvement automated
processes
▪ Quick access to inspection & testing
historical data and drawings
▪ Analytical reports for trending and
benchmarking
Cloud based and
hardcopy binder
organized following
FGI categorization
for easy access to
information
ASHRAE 170 AGENDA
•
•
•
•
•
•
•
Introductions – Loyola…CEPro
The Bible for Healthcare Ventilation standards driven by Infection Control
AHJ Survey preparedness and/or Infection Prevention – which is more of a priority
USP 797 (Sterile Compounding)/800 (Hazardous Drug)/ and NOW 825 (Radiopharmaceutical
Compounding) Mandates, Compliance Planning and Checklist application
– How much pressure is the right amount between critical spaces adjacent to one another?
– What is the pressure pass/fail threshold? Positive or Negative…. for all rooms?
– Facilities role in compliance failures found during the every 6 month certification process
– Cleanroom HVAC/Controls design, Test & Balance, certification, and commissioning
– To be VAV or not to be…. that is the question
– Control strategies to reduce nuisance alarms
– Cascading air pressure design and monitor sensing port location importance
– Iso classifications driving cleanroom design Air Changes per Hour
• ACH standards, clarification, filtration, and ways to achieve/exceed minimums
Inventory, Risk Assessment and Testing for Infection Control Ventilation Compliance Testing
– Systems and Space Asset Inventory
– Inspection/Testing Data gathered/pass-fail criteria agreement/Frequency
– Plan for Correction/CMMS integration
• Building Automation and Controls Calibration
– Documentation/Collaborative Archiving Site
Overall BAS & Central Systems HVAC knowledge serving critical spaces - Systems and Space Points
of Failure
Laboratory Fume Hoods/Bio-Safety Cabinets/Laminar Flow Bench Certification during Function
Space Compliance Testing
Building Automation data collection…..CALIBRATION
during testing & data gathering! Don’t rely on BAS alone
Identify Ventilation Systems Critical Failure points:
•
•
•
•
•
•
•
•
Filtration
Duct leaks/cleanliness
Balancing dampers
Duct lining
Flow/Diffusers
Controls/BAS
Doors/Ceilings
Processes
Identify Ventilation Systems Critical Failure points:
• Filtration
• Duct cleanliness
• Balancing dampers
• Duct lining
• Flow/Diffusers
Literally a HUNDRED• failure
points
Controls/BAS
• Doors/Ceilings
that could lead to• increased
Processes
Environmental infection!...without
knowing
ASHRAE 170 AGENDA
•
•
•
•
•
•
•
Introductions – Loyola…CEPro
The Bible for Healthcare Ventilation standards driven by Infection Control
AHJ Survey preparedness and/or Infection Prevention – which is more of a priority
USP 797 (Sterile Compounding)/800 (Hazardous Drug)/ and NOW 825 (Radiopharmaceutical
Compounding) Mandates, Compliance Planning and Checklist application
– How much pressure is the right amount between critical spaces adjacent to one another?
– What is the pressure pass/fail threshold? Positive or Negative…. for all rooms?
– Facilities role in compliance failures found during the every 6 month certification process
– Cleanroom HVAC/Controls design, Test & Balance, certification, and commissioning
– To be VAV or not to be…. that is the question
– Control strategies to reduce nuisance alarms
– Cascading air pressure design and monitor sensing port location importance
– Iso classifications driving cleanroom design Air Changes per Hour
• ACH standards, clarification, filtration, and ways to achieve/exceed minimums
Inventory, Risk Assessment and Testing for Infection Control Ventilation Compliance Testing
– Systems and Space Asset Inventory
– Inspection/Testing Data gathered/pass-fail criteria agreement/Frequency
– Plan for Correction/CMMS integration
• Building Automation and Controls Calibration
– Documentation/Collaborative Archiving Site
Overall BAS & Central Systems HVAC knowledge serving critical spaces - Systems and Space Points
of Failure
Laboratory Fume Hoods/Bio-Safety Cabinets/Laminar Flow Bench Certification during Function
Space Compliance Testing
“CEPro does a great job for us
here at Loyola ensuring
Laboratory safety for all of our
workers while providing a
compliant environment for our
clinical analysis.” - Roman Golash
Occupation: Microbiologist, Director of Pathology - Loyola, Col. U.S. Army
Education: B.S. Northern Illinois University M.S. Thomas Jefferson University
M.B.A. Lake Forest Graduate School of Management. U.S. Army- Command and
General Staff College
Civic involvement: American Legion Post 690. Military Officers Association of
America. American Society for Microbiology. Illinois Society for Microbiology.
Reserve Officers Association. Association of the United States Army. Palatine CERT
giving lectures on terrorism. ACT for American. South Central Association of Clinical
Microbiologists.
LABORATORY CERTIFICATION – Annually
•
•
•
•
•
Airflow Testing
Room Segregation/Design
Room Pressurization
Non-Viable Particle Counting
Lighting, Noise, Temperature, Humidity
EQUIPMENT CERTIFICATION
(Fume Hood’s, Biological Safety Cabinet’s, Ventilated Enclosure’s,
Laminar Flow Clean Bench’s, Grossing Stations, Snorkels)
•
•
•
•
•
Airflow Velocity Testing
HEPA Leak Test
Airflow Smoke Pattern Test and Video
Non-Viable Particle Counting
Viable (Bacterial and Fungal) Testing
REMEDIATION
CALIBRATION
DOCUMENTATION
110 Testing
Hoods, Benches and Cabinets
…..are not all the same
And effect the space differently.
T&B/Certify both spaces & equipment at same
time! Repair/Remediate just in time
Thank you
Michael Rerucha <MICHAEL.RERUCHA@luhs.org>
Bill.Middleton@CEPROINC.COM
773.580.4401