avian influenza technical series

Avian Influenza Technical SeriesAvian Influenza Technical Series

Animal and Human Health LaboratoriesAnimal and Human Health Laboratories

Session #4Session #4Laboratory Accreditation & Certification,Laboratory Accreditation & Certification,

Agencies and ResourcesAgencies and Resources

Presented by:Presented by:

Craig M. Free, P.E.Craig M. Free, P.E.Diversified Laboratory Sciences, Inc.Diversified Laboratory Sciences, Inc.

In cooperation with:In cooperation with:

The United States Department of State, Biosecurity Engagement ProgramThe United States Department of State, Biosecurity Engagement ProgramSandia National Laboratories, International Biological Threat Reduction ProgramSandia National Laboratories, International Biological Threat Reduction Program

Laboratory Accreditation & CertificationLaboratory Accreditation & Certification

Session #4 OutlineSession #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


Definitions:Definitions:• CommissioningCommissioning: “A quality-oriented process for achieving, : “A quality-oriented process for achieving,

verifying, and documenting that the performance of facilities, verifying, and documenting that the performance of facilities, systems, and assemblies meets defined objectives and systems, and assemblies meets defined objectives and criteria.” ASHRAE Guideline 0criteria.” ASHRAE Guideline 0

• CertificationCertification: “To attest as being true or as represented or as : “To attest as being true or as represented or as meeting a standard.” Webster’s On-line dictionarymeeting a standard.” Webster’s On-line dictionary

• Laboratory Planning/ProgrammingLaboratory Planning/Programming: Up to 20% overall : Up to 20% overall completioncompletion

• Laboratory Design Development (DD)Laboratory Design Development (DD): 20 – 50% overall : 20 – 50% overall completioncompletion

• Laboratory Construction Documents (CD’s)Laboratory Construction Documents (CD’s): 50 – 100% : 50 – 100% overall completionoverall completion


Timeline of Laboratory Operational AssuranceTimeline 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 Preferably at the beginning of the DD phase, but no later than the

beginning of the CD phase.beginning of the CD phase.

• When does the laboratory operational assurance phase end?When does the laboratory operational assurance phase end?• NeverNever


Commissioning vs. CertificationCommissioning vs. Certification

CommissioningCommissioning

• Commissioning validates the operational performance of a facility Commissioning validates the operational performance of a facility in accordance with the CD’s. Typically conducted by 3in accordance with the CD’s. Typically conducted by 3rdrd party and party and hired directly by the building owner.hired directly by the building owner.

• Commissioning provides a means by which the facility personnel Commissioning provides a means by which the facility personnel and research staff can receive facility related training.and research staff can receive facility related training.

• Commissioning provides a means by which research institutions Commissioning provides a means by which research institutions can measure operational efficacy of the laboratory.can measure operational efficacy of the laboratory.

• Commissioning provides documentation for baseline operation of Commissioning provides documentation for baseline operation of systems.systems.


Commissioning vs. Certification (Commissioning vs. Certification (continuedcontinued))

CertificationCertification

• Certification ensures that a facility, process, or piece of equipment Certification ensures that a facility, process, or piece of equipment is functioning in accordance with published standards published is functioning in accordance with published standards published and administered by a regulatory entity.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, There are currently no laboratory certification standards and, thus, no accrediting or certification entity.no accrediting or certification entity.

• High containment design and operation is driven by the biosafety High containment design and operation is driven by the biosafety Risk Assessment (RA). Since the RA is developed specifically for Risk Assessment (RA). Since the RA is developed specifically for each lab, developing criteria for certification becomes problematic.each lab, developing criteria for certification becomes problematic.

• Certifying a lab without published certification standards can Certifying a lab without published certification standards can introduce significant liability issues.introduce significant liability issues.


Commissioning ProcessCommissioning 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


Commissioning Procedures (Construction Phase)Commissioning Procedures (Construction Phase)

• Pre-functional testingPre-functional testing• Visually verifying that the building support equipment has been installed in Visually verifying that the building support equipment has been installed in

accordance with the CD’s and with the manufacturer's recommendations.accordance with the CD’s and with the manufacturer's recommendations.• Identified potential maintenance issuesIdentified potential maintenance issues

• Flow (TAB) verificationFlow (TAB) verification• Verify that the contractor’s testing, adjusting, and balancing (TAB) report is Verify that the contractor’s testing, adjusting, and balancing (TAB) report is

accurate.accurate.

• Functional testingFunctional testing• Conducts physical performance tests of each major piece of equipment to ensure Conducts physical performance tests of each major piece of equipment to ensure

they are operating as designed.they are operating as designed.

• Integrated systems testingIntegrated systems testing• Conducts physical performance tests to verify that the major systems interact as Conducts physical performance tests to verify that the major systems interact as

designed.designed.

• Planted failure testingPlanted failure testing• Create failures with equipment or systems to see how the users react to the Create failures with equipment or systems to see how the users react to the

problem.problem.


Commissioning for High Containment LaboratoriesCommissioning for High Containment Laboratories(Critical systems that are often designed or tested incorrectly)(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 Conducting smoke tests to locate major breaches in containment

envelopeenvelope

• 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+ & Efficacy testing of liquid effluent decontamination systems (BSL-3+ & BSL-4)BSL-4)


Commissioning TeamCommissioning Team

The following represents the typical composition of a The following represents the typical composition of a commissioning team:commissioning team:

• Mechanical EngineerMechanical Engineer• HVAC Controls specialistHVAC Controls specialist• Electrical EngineerElectrical Engineer• ArchitectArchitect• Life Safety SpecialistLife Safety Specialist• Operations & Maintenance SpecialistOperations & Maintenance Specialist


Estimated Cost of CommissioningEstimated Cost of Commissioning

• The cost of commissioning varies greatly from project to project. The The cost of commissioning varies greatly from project to project. The following are some of the reasons for this cost variance: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


Current and Proposed Laboratory Standards Current and Proposed Laboratory Standards

Related to FacilitiesRelated 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. Biotechnology – performance criteria for microbiological safety cabinets. BS EN 12469:2000. European Committee for StandardizationBS EN 12469:2000. European Committee for Standardization• Certification availableCertification available

• Association for Assessment and Accreditation of Laboratory Animal Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC)Care, International (AAALAC)• Accreditation availableAccreditation available

• Laboratory Biorisk Management Standard (CEN Working Agreement Laboratory Biorisk Management Standard (CEN Working Agreement 15793:2008)15793:2008)• Certification not yet availableCertification not yet available


Financial and Technical ResourcesFinancial and Technical Resources

• U.S. Department of State,U.S. Department of State,

Biosecurity Engagement Biosecurity Engagement

Program (BEP)Program (BEP)• http://www.bepstate.net/http://www.bepstate.net/


On-line ResourcesOn-line Resources

• WHO Laboratory Biosafety ManualWHO Laboratory Biosafety Manual• http://www.who.int/csr/resources/publications/biosafety/http://www.who.int/csr/resources/publications/biosafety/

WHO_CDS_CSR_LYO_2004_11/en/WHO_CDS_CSR_LYO_2004_11/en/

• Association for Assessment and Accreditation of Laboratory Association for Assessment and Accreditation of Laboratory Animal Care, International (AAALAC)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


SUMMARYSUMMARY

• Biosafety begins with the laboratory users, not the secondary Biosafety begins with the laboratory users, not the secondary barrier, .i.e. the facilitybarrier, .i.e. the facility

• Operational assurance of the facility begins with design and Operational assurance of the facility begins with design and never endsnever 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


Questions/Comments?Questions/Comments?