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 • Commissioning Team • 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.” Webster’s On-line dictionary • Laboratory Planning/Programming: Up to 20% overall completion • Laboratory Design Development (DD): 20 – 50% overall completion • Laboratory Construction Documents (CD’s): 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

5. Laboratory Accreditation & Certification Commissioning vs. Certification Commissioning • Commissioning validates the operational performance of a facility in accordance with the CD’s. 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.

6. 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.

7. 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 CD’s and with the manufacturer's recommendations. • Identified potential maintenance issues • Flow (TAB) verification • Verify that the contractor’s 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.

9. 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 (< 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 Commissioning Team The following represents the typical composition of a commissioning team: Mechanical Engineer HVAC Controls specialist Electrical Engineer Architect Life Safety Specialist Operations & Maintenance Specialist

11. 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

12. 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 12469:2000. 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 15793:2008) • Certification not yet available

13. Laboratory Accreditation & Certification Financial and Technical Resources • U.S. Department of State, Biosecurity Engagement Program (BEP) • http://www.bepstate.net/

14. Laboratory Accreditation & Certification On-line Resources • WHO Laboratory Biosafety Manual • http://www.who.int/csr/resources/publications/biosafety/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/index.html • CDC/NIH Biosafety in Microbiological and Biomedical Laboratories • http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm • International Veterinary Biosafety Workgroup • http://tecrisk.com/projekte/projekt1/Handbook_070323.pdf • International Biosafety Working Group • http://internationalbiosafety.org/english/index.aspb

15. 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

16. Laboratory Accreditation & Certification Questions/Comments?