Avian Influenza Technical Series

1
Avian Influenza Technical Series

• Animal and Human Health Laboratories
• Session 4
• Laboratory Accreditation Certification,
• Agencies and Resources
• Presented by
• Craig M. Free, P.E.
• Diversified Laboratory Sciences, Inc.
• In cooperation with
• The United States Department of State,
  Biosecurity Engagement Program
• Sandia National Laboratories, International
  Biological Threat Reduction Program

2
Laboratory Accreditation Certification

• Session 4 Outline
• Definitions
• Timeline for Laboratory Operational Assurance
• Commissioning vs. Certification
• Commissioning Process
• Commissioning Procedures (Construction Phase)
• Commissioning for High Containment Laboratories
• Estimated Cost of Commissioning
• Current and Proposed Laboratory Standards Related
  to Facilities
• Financial and Technical Resources
• On-line Resources
• Commissioning Resources
• Summary

3
Laboratory Accreditation Certification

• Definitions
• Commissioning A quality-oriented process for
  achieving, verifying, and documenting that the
  performance of facilities, systems, and
  assemblies meets defined objectives and
  criteria. ASHRAE Guideline 0
• Certification To attest as being true or as
  represented or as meeting a standard. Websters
  On-line dictionary
• Laboratory Planning/Programming Up to 20
  overall completion
• Laboratory Design Development (DD) 20 50
  overall completion
• Laboratory Construction Documents (CDs) 50
  100 overall completion

4
Laboratory Accreditation Certification

• Timeline of Laboratory Operational Assurance
• When does laboratory operational assurance begin?
• A the beginning of the design process.
• When should the services of the commissioning
  team be engaged?
• Preferably at the beginning of the DD phase, but
  no later than the beginning of the CD phase.
• When does the laboratory operational assurance
  phase end?
• Never

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Laboratory Accreditation Certification

• Commissioning vs. Certification
• Commissioning
• Commissioning validates the operational
  performance of a facility in accordance with the
  CDs. Typically conducted by 3rd party and hired
  directly by the building owner.
• Commissioning provides a means by which the
  facility personnel and research staff can receive
  facility related training.
• Commissioning provides a means by which research
  institutions can measure operational efficacy of
  the laboratory.
• Commissioning provides documentation for baseline
  operation of systems.

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Laboratory Accreditation Certification

• Commissioning vs. Certification (continued)
• Certification
• Certification ensures that a facility, process,
  or piece of equipment is functioning in
  accordance with published standards published and
  administered by a regulatory entity.
• Related example Biological Safety Cabinet
  certification - ANSI/NSF 49.
• There are currently no laboratory certification
  standards and, thus, no accrediting or
  certification entity.
• High containment design and operation is driven
  by the biosafety Risk Assessment (RA). Since the
  RA is developed specifically for each lab,
  developing criteria for certification becomes
  problematic.
• Certifying a lab without published certification
  standards can introduce significant liability
  issues.

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Laboratory Accreditation Certification

• Commissioning Process
• Laboratory Planning
• Establish Commissioning Team
• Review Owner Requirements
• Identify Commissioning Scope and Budget
• Develop Commissioning Plan
• Laboratory Design (DD and CD Phases)
• Conduct Design Peer Review
• Develop Commissioning Specifications
• Laboratory Construction
• Schedule Commissioning Activities and Meetings
• Review Construction Submittals
• Finalize Test Procedures Based Upon Actual
  Equipment Purchased
• Execute Commissioning Test Procedures
• Conduct Owner Training
• Document baseline operational conditions and
  nuances of each system

8
Laboratory Accreditation Certification

• Commissioning Procedures (Construction Phase)
• Pre-functional testing
• Visually verifying that the building support
  equipment has been installed in accordance with
  the CDs and with the manufacturer's
  recommendations.
• Identified potential maintenance issues
• Flow (TAB) verification
• Verify that the contractors testing, adjusting,
  and balancing (TAB) report is accurate.
• Functional testing
• Conducts physical performance tests of each major
  piece of equipment to ensure they are operating
  as designed.
• Integrated systems testing
• Conducts physical performance tests to verify
  that the major systems interact as designed.
• Planted failure testing
• Create failures with equipment or systems to see
  how the users react to the problem.

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Laboratory Accreditation Certification

• Commissioning for High Containment Laboratories
• (Critical systems that are often designed or
  tested incorrectly)
• Failure sequences (BSL-3 BSL-4)
• Loss of power, switchover to from grid to
  emergency power
• Restoration of power, switchover from emergency
  to grid power
• Temporary loss of power (lt 2 seconds)
• Loss of equipment due to failure
• Loss of equipment due to planned maintenance
• Laboratory envelope integrity (BSL-3 BSL-4)
• Conducting smoke tests to locate major breaches
  in containment envelope
• Breathing air systems (BSL-4)
• Compressed air systems for door seals (BSL-4)
• Efficacy testing of liquid effluent
  decontamination systems (BSL-3 BSL-4)

10
Laboratory Accreditation Certification

• Estimated Cost of Commissioning
• The cost of commissioning varies greatly from
  project to project. The following are some of the
  reasons for this cost variance
• Level (scope) of commissioning
• Starting point of commissioning
• Complexity of project
• Size of project
• General cost associated for a typical
  commissioning project
• 1 - 3 per square foot
• ½ to 3 of total construction cost
• General cost associated for a high containment
  (BSL- 3 4) laboratory
• 10 - 30 per square foot of high containment
  space
• 2 to 5 of total construction

11
Laboratory Accreditation Certification

• Current and Proposed Laboratory Standards
• Related to Facilities
• ANSI/NSF 49 Standard for BSC operation
• Certification available
• Biotechnology performance criteria for
  microbiological safety cabinets. BS EN
  124692000. European Committee for
  Standardization
• Certification available
• Association for Assessment and Accreditation of
  Laboratory Animal Care, International (AAALAC)
• Accreditation available
• Laboratory Biorisk Management Standard (CEN
  Working Agreement 157932008)
• Certification not yet available

12
Laboratory Accreditation Certification

• Financial and Technical Resources
• U.S. Department of State,
• Biosecurity Engagement
• Program (BEP)
• http//www.bepstate.net/

13
Laboratory Accreditation Certification

• On-line Resources
• WHO Laboratory Biosafety Manual
• http//www.who.int/csr/resources/publications/bios
  afety/WHO_CDS_CSR_LYO_2004_11/en/
• Association for Assessment and Accreditation of
  Laboratory Animal Care, International (AAALAC)
• http//www.aaalac.org/resources/theguide.cfm
• Health Canada Laboratory Biosafety Guidelines
• http//www.phac-aspc.gc.ca/publicat/lbg-ldmbl-04/i
  ndex.html
• CDC/NIH Biosafety in Microbiological and
  Biomedical Laboratories
• http//www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.h
  tm
• International Veterinary Biosafety Workgroup
• http//tecrisk.com/projekte/projekt1/Handbook_0703
  23.pdf
• International Biosafety Working Group
• http//internationalbiosafety.org/english/index.as
  pb

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Laboratory Accreditation Certification

• SUMMARY
• Biosafety begins with the laboratory users, not
  the secondary barrier, .i.e. the facility
• Operational assurance of the facility begins with
  design and never ends
• Training for all personnel is key
• Regularly scheduled maintenance is crucial
• Annual commissioning is recommended

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Laboratory Accreditation Certification

• Questions/Comments?