Building Life Science Facilities and the Commissioning Process:

Process Improvements for Regulatory Compliance and Facility Readiness

Debra C Sharpe, MPH CCHO RBP

Director of Laboratory Services & Compliance, WorkingBuildings, LLC

2011 WorkingBuildings

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Core Services
More than 600 projects contracted 120 Million square feet Cx $11.2 billion construction costs Commissioning/Retro-Commissioning Sustainable Consulting Laboratory Operations and Compliance Management Quality Management & Project Collaboration Software Services Cost & Risk Mitigation Programs Security Analysis-Risk Threat Analysis Standard Operating Procedure Development Laboratory Facilities Management & Move Planners

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WorkingBuildings has twelve regional offices. During the last 60 months WorkingBuildings provided services for more than $11.2 billion of construction projects and $3 billion sustainable projects.
Our firm is comprised of:
Registered Architects Engineers (Mechanical and Electrical) Energy Managers Laboratory Specialists LEED Accredited Professionals Facility Managers Scientists Programmers Quality Assurance Quality Control (QAQC) Risk Managers

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Experience
Debra Sharpe, MPH, CCHO, RBP Director Laboratory Services and Compliance Provides client based products and services including, laboratory design, commissioning, retro-commissioning, regulatory compliance services, including biosafety and biosecurity program management and Select Agent registration, ongoing facilities maintenance, standard operating protocol review, gap analysis, risk threat analysis, facility management and operations for laboratories. Prior to this position worked for Southern Research (SR) for 8 years as the Director of Compliance and Security in addition to being President of BioSafety Solutions LLC (BSL), a whollyowned laboratory compliance consulting company. The work at SR focused primarily on drug discovery, drug development, and engineering research. Co-Director for Safety and Environmental Health at Auburn University for seven years. Environmental Scientist and Safety Supervisor in the electric utility industry(PEPCO) for 10 years managing environmental health and safety programs

DrPH University Alabama Birmingham Master of Public Health Tulane Bachelor of Science, Biology, St Marys College of Maryland

Commissioning for Operations

Commissioning
The process of ensuring that systems are designed, installed, functionally tested, and capable of being operated and maintained to perform in conformity with the design intent
- ASHRAE Guideline 1 - 1996

Commissioning for Operations

Commissioning Process A quality-based method that

is adopted by an Owner to achieve successful construction projects.
- ASHRAE Guideline 0 - 2005

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Benefits to Owners
Better documentation of the Owners needs Fewer unidentified deficiencies at takeover Systems operate at maximum energy efficiency Better trained operators Saves Money!

The economic benefits of commissioning lie in avoiding the added costs associated with non-commissioned facilities.

Benefits to Designers
Clearer understanding of Owners needs reduces redesign work Independent design reviews reduce RFIs Feedback on actual systems operability lessons learned to take to the next project.

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Benefits to Contractors
Better design documents Early identification of issues reduces re-work Clear documentation of system functionality at turnover Reduced warranty call-backs

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When to Use Commissioning

Technically complicated facilities like laboratories, or health care facilities Typical Project Size $3,000,000+ Engaged early by the owner is best Pre-design (preferably) Assist in programming OPR Workshop Specific tasks defined for each phase

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When to Use Commissioning

Typical Project Scope Mechanical (chillers, boilers, VAVs) Controls (BAS, power monitoring) Electrical (switchboards, transformers, generators) Life Safety (Fire Alarm, emergency lighting) Security (card readers, door alarms, CCTV) Building Envelope

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Commissioning Firm Qualifications

History of the firm Evidence that commissioning is a principal enterprise of the firm Experience with the type of facility being built Commissioning expertise and capability Local experience over the last five (5) years on projects of similar size and scope

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Commissioning Firm Qualifications Prior commissioning reference contacts Resumes of key (commissioning) management personnel and their positions Professional liability insurance

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Commissioning Authority Qualifications

Minimum 5 years commissioning experience Certification by a nationally recognized authority Building Commissioning Association (BCA) University of Wisconsin (Department of Engineering Professional Development) AABC Commissioning Group (ACG)

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Cost of Commissioning
0.5% - 1.5% of the total construction 2% - 3% of mechanical construction 1% - 2% of electrical construction Meta-Study - $1.00 per square feet

Commissioning for Operations

Program Phase
Owners Program of Requirements Documentation of the Design Intent Preliminary Commissioning Plan

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Integrate The Process

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Pre-Design Phase

Pre- Design

Design

Construction

Occupancy

Commissioning for Operations

Process Flows & SOPs

EVIDENCE / ACCESSIONING Existing LAB STORAGE
(1) Freezer (1) Dry (4) Permanent Storage Freezers PRE PCR / EXTRACTION Bone Sand Hood Chem Hood (2) Freezers UV Box LN2 for Freezer Mill PCR / AMPLIFICATION POST PCR / ANALYSIS

COURIER / MAIL

NON COC / SECURITY

Research
STORAGE / EQUIPMENT (1)-20C, (1) 4C (Lockable)
Corbet Liquid Handling (2)BSC A1 DI H2O (Type1) (2)BT Centrifuge EXTRACTION (Currently share with Automation) PCR / AMPLIFICATION POST PCR / ANALYSIS SEQUENCING RX ANALYSIS

BATCH DATA FOR REVIEW @ DESKS

Can be single space for up to 6 people & 8 kneespaces

RESEARCH LAB Same requirements as other groups for PCR process

Commissioning for Operations

Emergency eyewash and shower are readily available; location is determined by risk assessment.
-BMBL 5th

Operational Discussions

Safety Shower/Eye Wash Station. A combination emergency plumbing fixture with drench-type shower and two eye/face wash heads. Installed in every chemical, battery, and radiological use area and as otherwise required.

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8

Parallel Axis Squeeze Chute Designed to work hard so you dont have to. Highly regarded for its effortless operation, efficient design and superior craftsmanship, the Hi-Hog Parallel Axis Squeeze Chute sets the standard for all others to follow.

Equipment Cutsheets
Grease zerts on all hinge collars. Both sides can be opened from the working side for sorting or animal access. Each side is equipped with four side access panels which swing down and out of the way for clear, unobstructed access. All closed-in panels are sheeted with 14 ga. sheet metal and caulked to minimize noise. With two lower access panels on each side of the squeeze you have greater control over animal access. Lower access panels swing up and lock securely out of your way. Optional Sternum Bar. (not shown)

Features
Optional head tie bar. Effortless parallel squeeze action draws sides inward and forward while keeping your livestock centered and balanced. The fully reversible controls are smooth and fast, even with an animal in the squeeze. Double ratchet design provides continuous width adjustments from 32 down to 12 .

All latches and controls can be easily operated with mitts on.

Neck injection access door.

Superior quality 3/8 double braided nylon ropes travel on nylon wheels for years of smooth, trouble free operation. Side pockets offer a safe and secure location to slide a back-up bar. Rear tailgate locks both up and down. The responsive rope control frees the handler to effectively work their animals flight zone. No foot catches. All gaps are minimized and side exit panels are sheeted to a height of 32 . 100% extra heavy duty steel construction. Load bars (scales) attach easily to heavy duty squeeze platform. Checkerplate floor with traction ribs.

Commissioning for Operations

Design Phase Narrative

Mission, Goals & Meeting Minutes Service/Research Definition Regulatory Compliance Standard Operating Procedures (SOPs) Equipment Cut Sheets & Coordination Waste Handling Materials Receiving Inventory Control Security Staffing & Scheduling Service Contracts Community Outreach Initiatives Existing Utilities & Providers Internal Design Standards

Commissioning for Operations

Review Documentation

Commissioning for Operations

Basis of Design Document the course of Changes during

a project Documentation of decisionmaking process and change justification is imperative Becomes benchmark by which all design decisions are made and success is measured.

Commissioning for Operations

Design Phase
Revise Design Intent Revise Commissioning Plan Revise Basis of Design Commissioning Specifications - Equipment List - Checklist Formats - Test Forms

Commissioning for Operations

Design Phase
Protocols/PPE challenge Security paradigm challenge O&M challenge First responder coordination Inventory and tools analysis Contract services providers Equipment coordination

Commissioning for Operations

Design Phase Challenges

Commissioning for Operations

Design Reviews

Commissioning for Operations

Construction Phase
Owner

O&M protocols/PPE Community outreach First responder coordination Contract services providers Facilities inspections Move management Maintaining existing facility

Commissioning for Operations

Commissioning for Operations

Commissioning
Verification checklists Functional performance testing Systems integration testing O&M personnel training O&M documentation

Commissioning for Operations

Final Acceptance
As-built documentation Complete commissioning report Complete systems (O&M) manual Training documents Specified materials inventory Off-season testing TBD

Commissioning for Operations

Transitional Operations Maintenance &

documentation RFPs for service contracts Move coordination Instrument/equipment validation User walk-through tours Regulatory compliance documents Training

Regulatory Compliance

Commissioning for Operations

Owner Compliance Discussions

What will be used? In vivo/In vitro Volumes & concentrations of biological Agents Volumes & types of chemicals Work or process flow Is this an organization with Institutional Control?

Commissioning for Operations

Owner Compliance Discussions

Review existing state regulations & identify if they go beyond federal regulations (i.e., waste disposal) Review copies of existing policies and procedures Review existing operational documents Identifying appropriate PPE and agent handling protocols based on risk assessment

Commissioning for Operations

Designer Compliance Discussions

Complexity of the Design Can the institution maintain the intended design concept Cost of operation the facility Ways to reduce cost of overhead and maintenance

Commissioning for Operations

Compliance Coordination

Biosecurity Plan Incident Response Plan Biosafety Manual Community Outreach Initiatives Protocols PPE Security Maintenance Safety

Commissioning for Operations

Compliance Coordination

Providing Supportive Facility Cx Documentation to the Regulatory Authorities (i.e., CDC SA Registration) Assisting with the Development of Regulatory Documents Policies and Procedures Developing and Providing Training to Laboratory and Maintenance Staff Meeting with the Regulatory

Owners Perspective

Commissioning for Operations

New Jersey Public Health, Environmental and Agricultural Laboratory

Commissioning for Operations

Consolidated Lab Services

Clinical Public Health Environmental Health Animal Health Plant Health Laboratory Response Network

New Jersey Public Health, Environmental and Agricultural Laboratory

Commissioning for Operations

NJPHEAL

New Jersey Public Health, Environmental and Agricultural Laboratory

Commissioning for Operations

Newborn Screening Services

New Jersey Public Health, Environmental and Agricultural Laboratory

Commissioning for Operations

NJPHEAL Vision
Mission Based Objective 15 Years Response to Deteriorating Lab Anthrax Incidents after 9/11 Increased Funding Opportunities Available Property Secure New Jersey Public Health, Environmental and Agricultural Location Laboratory

Commissioning for Operations

Contractual Structure
Contractor Department of Health and Senior Services Department of Environmental Protection Department of Agriculture

Construction Manager

New Jersey Building Authority (NJBA)

Consultants

Design Team

Transitional Operations Team

New Jersey Public Health, Environmental and Agricultural Laboratory

Site Location & Security

New Jersey State Police Headquarters Campus

Commissioning for Operations

Unique Design Challenges

Space Types Facility Wide Protocols 24/7 Operations Regulatory Requirements Community Relations Katrina, China & Inflation Move Managment Six Years and Counting
New Jersey Public Health, Environmental and Agricultural Laboratory

Commissioning for Operations

Murphys Law
DI Water Leak X 6 Condensation Flood (AHU Down) Controls Sequence Flood Sanitary Blockage Flood No BSL-3 Exhaust Fan Redundancy Static Dissipating Tile New Jersey Public Health, Environmental and Agricultural Shrinkage Laboratory

Commissioning for Operations

Lessons Learned
Centralized Leadership for Decision Making Value Engineering Good or Bad? Documentation is Crucial On-Site Monitoring/Inspections Develop O&M Requirements Early Owner Advocate Prior to

Commissioning for Operations

Transitional Operations
Laboratory Commissioning Design Review for Compliance Protocol Development/Revisions Final Stage Operations Oversight Building O&M Staff Regulatory Compliance Enforcement/ Pre-Inspections Move Coordination Facility Wide/Multi-Science Protocols

Commissioning for Operations

Conclusions
Complex & Time Intensive Process Expertise is Essential Involve Cx agent early in the process Communication/Documentation Consolidated Leadership with Involved Stakeholders Shared Responsibilities Informed Decision Making is Key