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 DefinitionsDefinitions Timeline for Laboratory Operational AssuranceTimeline for Laboratory Operational Assurance Commissioning vs. CertificationCommissioning vs. Certification Commissioning ProcessCommissioning Process Commissioning Procedures (Construction Phase)Commissioning Procedures (Construction Phase) Commissioning for High Containment LaboratoriesCommissioning for High Containment Laboratories Commissioning TeamCommissioning Team Estimated Cost of CommissioningEstimated Cost of Commissioning Current and Proposed Laboratory Standards Related to FacilitiesCurrent and Proposed Laboratory Standards Related to Facilities Financial and Technical ResourcesFinancial and Technical Resources On-line ResourcesOn-line Resources Commissioning ResourcesCommissioning Resources SummarySummary

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 0Commissioning: 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 dictionaryCertification: To attest as being true or as represented or as meeting a standard. Websters On-line dictionary Laboratory Planning/Programming: Up to 20% overall completionLaboratory Planning/Programming: Up to 20% overall completion Laboratory Design Development (DD): 20 – 50% overall completionLaboratory Design Development (DD): 20 – 50% overall completion Laboratory Construction Documents (CDs): 50 – 100% overall completionLaboratory Construction Documents (CDs): 50 – 100% overall completion

4. Laboratory Accreditation & Certification Timeline of Laboratory Operational Assurance When does laboratory operational assurance begin?When does laboratory operational assurance begin? A the beginning of the design process.A the beginning of the design process. When should the services of the commissioning team be engaged?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.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?When does the laboratory operational assurance phase end? NeverNever

5. Laboratory Accreditation & Certification Commissioning vs. Certification Commissioning Commissioning validates the operational performance of a facility in accordance with the CDs. Typically conducted by 3 rd party and hired directly by the building owner.Commissioning validates the operational performance of a facility in accordance with the CDs. Typically conducted by 3 rd 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 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 a means by which research institutions can measure operational efficacy of the laboratory. Commissioning provides documentation for baseline operation of systems.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.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.Related example: Biological Safety Cabinet certification - ANSI/NSF 49. There are currently no laboratory certification standards and, thus, no accrediting or certification entity.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.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.Certifying a lab without published certification standards can introduce significant liability issues.

7. Laboratory Accreditation & Certification Commissioning Process Laboratory PlanningLaboratory Planning Establish Commissioning TeamEstablish Commissioning Team Review Owner RequirementsReview Owner Requirements Identify Commissioning Scope and BudgetIdentify Commissioning Scope and Budget Develop Commissioning PlanDevelop Commissioning Plan Laboratory Design (DD and CD Phases)Laboratory Design (DD and CD Phases) Conduct Design Peer ReviewConduct Design Peer Review Develop Commissioning SpecificationsDevelop Commissioning Specifications Laboratory ConstructionLaboratory Construction Schedule Commissioning Activities and MeetingsSchedule Commissioning Activities and Meetings Review Construction SubmittalsReview Construction Submittals Finalize Test Procedures Based Upon Actual Equipment PurchasedFinalize Test Procedures Based Upon Actual Equipment Purchased Execute Commissioning Test ProceduresExecute Commissioning Test Procedures Conduct Owner TrainingConduct Owner Training Document baseline operational conditions and nuances of each systemDocument baseline operational conditions and nuances of each system

8. Laboratory Accreditation & Certification Commissioning Procedures (Construction Phase) Pre-functional testingPre-functional testing Visually verifying that the building support equipment has been installed in accordance with the CDs and with the manufacturer's recommendations.Visually verifying that the building support equipment has been installed in accordance with the CDs and with the manufacturer's recommendations. Identified potential maintenance issuesIdentified potential maintenance issues Flow (TAB) verificationFlow (TAB) verification Verify that the contractors testing, adjusting, and balancing (TAB) report is accurate.Verify that the contractors testing, adjusting, and balancing (TAB) report is accurate. Functional testingFunctional testing Conducts physical performance tests of each major piece of equipment to ensure they are operating as designed.Conducts physical performance tests of each major piece of equipment to ensure they are operating as designed. Integrated systems testingIntegrated systems testing Conducts physical performance tests to verify that the major systems interact as designed.Conducts physical performance tests to verify that the major systems interact as designed. Planted failure testingPlanted failure testing Create failures with equipment or systems to see how the users react to the problem.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)Failure sequences (BSL-3 & BSL-4) Loss of power, switchover to from grid to emergency powerLoss of power, switchover to from grid to emergency power Restoration of power, switchover from emergency to grid powerRestoration of power, switchover from emergency to grid power Temporary loss of power (< 2 seconds)Temporary loss of power (< 2 seconds) Loss of equipment due to failureLoss of equipment due to failure Loss of equipment due to planned maintenanceLoss of equipment due to planned maintenance Laboratory envelope integrity (BSL-3 & BSL-4)Laboratory envelope integrity (BSL-3 & BSL-4) Conducting smoke tests to locate major breaches in containment envelopeConducting smoke tests to locate major breaches in containment envelope Breathing air systems (BSL-4)Breathing air systems (BSL-4) Compressed air systems for door seals (BSL-4)Compressed air systems for door seals (BSL-4) Efficacy testing of liquid effluent decontamination systems (BSL-3+ & 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 EngineerMechanical Engineer HVAC Controls specialistHVAC Controls specialist Electrical EngineerElectrical Engineer ArchitectArchitect Life Safety SpecialistLife Safety Specialist Operations & Maintenance SpecialistOperations & 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:The cost of commissioning varies greatly from project to project. The following are some of the reasons for this cost variance: Level (scope) of commissioningLevel (scope) of commissioning Starting point of commissioningStarting point of commissioning Complexity of projectComplexity of project Size of projectSize of project General cost associated for a typical commissioning project:General cost associated for a typical commissioning project: $1 - $3 per square foot$1 - $3 per square foot ½% to 3% of total construction cost½% to 3% of total construction cost General cost associated for a high containment (BSL- 3 & 4) laboratory:General cost associated for a high containment (BSL- 3 & 4) laboratory: $10 - $30 per square foot of high containment space$10 - $30 per square foot of high containment space 2% to 5% of total construction2% to 5% of total construction

12. Laboratory Accreditation & Certification Current and Proposed Laboratory Standards Related to Facilities ANSI/NSF 49 – Standard for BSC operationANSI/NSF 49 – Standard for BSC operation Certification availableCertification available Biotechnology – performance criteria for microbiological safety cabinets. BS EN 12469:2000. European Committee for StandardizationBiotechnology – performance criteria for microbiological safety cabinets. BS EN 12469:2000. European Committee for Standardization Certification availableCertification available Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC)Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC) Accreditation availableAccreditation available Laboratory Biorisk Management Standard (CEN Working Agreement 15793:2008)Laboratory Biorisk Management Standard (CEN Working Agreement 15793:2008) Certification not yet availableCertification not yet available

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

14. Laboratory Accreditation & Certification On-line Resources WHO Laboratory Biosafety ManualWHO Laboratory Biosafety Manual http://www.who.int/csr/resources/publications/biosafety/WHO_CDS_CSR_LYO_ 2004_11/en/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)Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC) http://www.aaalac.org/resources/theguide.cfmhttp://www.aaalac.org/resources/theguide.cfm Health Canada Laboratory Biosafety GuidelinesHealth Canada Laboratory Biosafety Guidelines http://www.phac-aspc.gc.ca/publicat/lbg-ldmbl-04/index.htmlhttp://www.phac-aspc.gc.ca/publicat/lbg-ldmbl-04/index.html CDC/NIH Biosafety in Microbiological and Biomedical LaboratoriesCDC/NIH Biosafety in Microbiological and Biomedical Laboratories http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htmhttp://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm International Veterinary Biosafety WorkgroupInternational Veterinary Biosafety Workgroup http://tecrisk.com/projekte/projekt1/Handbook_070323.pdfhttp://tecrisk.com/projekte/projekt1/Handbook_070323.pdf International Biosafety Working GroupInternational Biosafety Working Group http://internationalbiosafety.org/english/index.aspbhttp://internationalbiosafety.org/english/index.aspb

15. Laboratory Accreditation & Certification SUMMARY Biosafety begins with the laboratory users, not the secondary barrier,.i.e. the facilityBiosafety begins with the laboratory users, not the secondary barrier,.i.e. the facility Operational assurance of the facility begins with design and never endsOperational assurance of the facility begins with design and never ends Training for all personnel is keyTraining for all personnel is key Regularly scheduled maintenance is crucialRegularly scheduled maintenance is crucial Annual commissioning is recommendedAnnual commissioning is recommended

16. Laboratory Accreditation & Certification Questions/Comments?