Biosafety Program Management

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Biosafety ProgramManagement

• EMD Lecture 3

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Biosafety Program

• Institutional oversight acceptance
• President, CEO, CFO
• Institutional Biosafety Committee (IBC)
• peer review, adopt/establish policies
• Biosafety Office
• inform, administer program, assist
• Faculty, staff, students visitors
• merge biosafety into work

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Related Compliance Entities

• IRB
• IACUC
• ICC
• Grants Contracts
• Police, Security
• Other

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Regulations/Responsibilities

• 1970 OSH Act
• 5(a)(1) General Duty Clause
• Related OSHA Standards
• PPE, BBP, EtO, Labels, HAZWOPER, etc.
• NIH Guidelines (rDNA)
• Applicability, scope
• Transport
• DOT, IATA, USDA, CDC/PHS, DoC, other

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Regulations/Responsibilities

• Agencies
• FDA, EPA, NIH OHRP, State, City
• Guidelines
• CDC/NIH BMBL, CDC TB, APIC, WHO, NSF 49, etc.
• Training
• BBP, TB, Shipping, Biosafety, Lab Safety, PPE,
  Infection Control, special hazards

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Information to Employees

• Hazard awareness
• Risk (toxicity/disease), signs/symptoms
• Exposure limits/infectious dose
• Employers responsibilities
• Protective measures (controls)
• Medical surveillance/monitoring
• Emergency response procedures

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Biosafety Program Management

• I GO WHERE
• IM TOWED TO!

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Biosafety Program Management

• IBC as DMV
• speed limits, rules/regulations
• registrations/renewals, fines
• Program is tow truck and pace car
• safely deliver to desired location
• BSO as State Police
• inform, assist, control, emergency response

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Biosafety ProgramManagement

• Employees
• luxury, economy, SUVs, dragsters, stalled, etc.
• AAA
• Administrative support
• Active (pro-active biosafety program awareness)
• Accountability for compliance at all levels

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Biosafety ProgramManagement

• Adopt/mandate required policies
• Apply OSHA General Duty Clause elsewhere
• Establish policies where needed

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Rationale

• Control hazards
• Anticipate
• Identify
• Evaluate
• Prevent lab-acquired infections
• Interaction
• Proactive
• Assumption of responsibility

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Prevention

• Interaction
• Registration/reauthorization
• Initial and periodic training inspections
• Sanctions
• Evaluation
• Risk assessment/risk management
• Incidents/near misses

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Risk Assessment Risk Management

• Prior Planning
• Prevents Poor Performance

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Risk Assessment Risk Management

• Pathogen
• Procedures
• Personnel
• Place
• Protective Equipment

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Ineffective Program Management

• Morbidity/mortality
• Perceived lack of institutional control
• Regulatory visit/action
• Legal action (civil/criminal penalties)
• Bad press
• Low morale

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Biosafety ProgramManagement

• I go where Im towed to!
• Tell em where youre going to tow them
• Tow em where you want them
• Tell em why youve towed them there

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Identification of Biological Agents
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Identification of Agents

• Department
• PI/Lab Director
• Type of Lab
• Lab Supervisor
• Building(s)/room(s)
• Phone/fax/email/campus address

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Identification of Agents

• rDNA
• exempt/non-exempt, IBC, NIH-OBA registration
• Human material
• OSHA regulated, other
• Plants
• low risk, plant pests, pathogens, USDA APHIS
  requirements

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Identification of Agents

• Human Pathogens
• Risk group
• local, state, federal registrations
• Animals
• natural infections
• work with biohazards
• work with animal pathogens

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Identification of Agents

• Human subjects
• Healthcare/clinical locations
• Toxins of biological origin
• Shipping/transport of regulated agents
• Other?

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Identification of Equipment

• Autoclaves
• Biosafety cabinets, clean benches, glove boxes
• Eyewashes, showers
• Centrifuge containment

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Identification of Handlers

• Name, employee ID Number
• Campus address/contact information
• Identify work experience
• Observe work practices if necessary
• Refresher training as needed

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Biosafety Database Management
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Occupationally exposed workers

• Bloodborne Pathogen training (initial/annual)
• Biosafety Training (initial/periodic)
• HBV Vaccination program (other immunizations)
• TB Training, PPD Test
• Shipping/Transport Training (biennial)
• BSL3 Training/certification of researchers
• Select Agent registration/training/review

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Equipment Facilities

• Autoclave (location, testing)
• Clean air device (location, certification)
• biosafety cabinets, ventilated enclosures
• repairs, moves
• BSL3 facilities
• commissioning
• annual air balancing
• HEPA filter testing

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Research Registration

• Comprehensive Biohazard Registration Form (all
  biological materials used)
• rDNA protocols (new, updates, new personnel)
• Human pathogens (biennial)
• Select Agent transfers (inventory, tracking)
• Inspections (semi-annual, annual)
• BSL1, BSL2, BSL3, Animal, Select Agents

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Institutional Documentation

• IBC minutes (subcommittee deliberations)
• Approval letters
• Safety Manuals (periodic updates)
• Incidents
• Non-compliance reports
• Accidents, exposure investigations and
  recommendations
• Serious adverse events (human subjects)

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Biosafety Manual
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Biosafety Manual

• Introduction/Contact Info/Overview
• Responsibilities
• Chairperson
• Principal Investigator/Manager
• Researcher/Employee
• Safety Office
• IBC

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Biosafety Manual

• Requirements
• Annual registration
• Human etiologic agents/select agents
• rDNA
• Regulated human material
• Biohazards in animals/USDA Regulated agents
• Clean air device program
• Training

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Biosafety Manual

• Medical Surveillance/Employee Health
• Screening
• Immunization
• Medical restrictions
• Serum storage
• Incident reporting/evaluation/follow-up
• Counseling
• Records

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Biosafety Manual

• Risk Assessment/Risk Management
• Biosafety levels
• Routes of transmission
• Signs/labels
• Work practices
• Personal protective equipment
• Protective equipment/engineering controls

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Biosafety Manual

• Decontamination
• Disinfectants
• Sterilization methods
• Medical waste program
• Treatment of mixed wastes

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Biosafety Manual

• Spill/Emergency Response
• Spill kits/training/preparation
• BSL1, BSL2, BSL3 spill response
• Mixed spills

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Biosafety Manual

• Shipping/Transport
• Clinical, diagnostic specimens
• Etiologic agents, toxins of biological origin
• Packaging
• Shipping declaration forms
• Import/export requirements

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Biosafety Training
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Biosafety Training

• Lab safety
• chemical, biological, fire, security, incident
  response
• Biosafety
• human/animal pathogens
• RG2/BSL2
• rDNA
• proficiency/competency

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Biosafety Training

• Bloodborne Pathogens
• Initial _at_ time of hire
• specific components of standard
• targeted to audience
• Annual retraining
• Sharps Safety Devices
• Evaluation training

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Biosafety Training

• BSL3 Training
• work practices, PPE, controls
• biosafety cabinet
• facility operations
• spill/incident response
• formal evaluation of proficiency
• inspection of proposed SOP

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Biosafety Training

• Shipping/Transport of Infectious Substances
• IATA (initial and every 2 years)
• DOT (initial and every 3 years)
• labs working with etiologic other regulated
  agents
• provide info to those handling clinical specimens
• Shipper/transporter/receiver
• general awareness
• function specific

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Biosafety Training

• Tuberculosis
• At time of hire, screening
• Infection control
• Proposed annual training requirement
• Respiratory protection
• Healthcare and beyond!

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Biosafety Training

• Effective Use of the Biosafety Cabinet
• recommended
• part of Biosafety training
• can require based on audit results

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Institutional Biosafety Committee
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Role of the IBC

• Established by highest administrator
• Oversight for potentially hazardous work
• Set policy for safe conduct of biohazard research
• Oversee rDNA projects ensure compliance
• Responsibilities not restricted to rDNA

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IBC Membership (NIH rDNA)

• varied disciplines (rDNA, microbiology, lab
  safety, engineering, lab technical staff, legal,
  community)
• gt 5 members (2 from community)
• plant pathogen/containment expertise
• animal containment expertise
• biosafety officer if BL3/BL4 or large scale

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IBC Membership

• consult with other scientists as needed
• annual report to NIH/OBA
• suggest opening meetings to public
• minutes available to public upon request

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Suggested IBC Subcommittees

• Human Gene Transfer Clinical Trials
• Xenotransplantation
• Medical Surveillance
• Biosafety Level 3
• All report back/through IBC

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IBC Function

• review rDNA research
• assess physical/biological containment level
• assess
• facilities
• procedures
• practices
• training/expertise of personnel

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IBC Function

• Infectious agents, toxins, other biohazards
• review PI written risk assessment
• perform risk assessment/assign RG or BSL
• train personnel, verify proficiency, retrain
• inspect proposed work practices/area
• periodically monitor
• Design/commissioning containment labs
• annual verification

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IBC Function

• periodically review rDNA research
• adopt emergency response plans
• report significant accidents/illnesses to state
  local public health agencies NIH/OBA
• report significant problems/violations of
  guidelines to NIH/OBA

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IBC Function

• communicate results of review to PI
• dont authorize initiation of work not covered by
  guidelines w/out NIH review
• ensure compliance with surveillance data
  reporting for human gene transfer projects

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IBC Function

• Sanctions
• establish framework in advance
• develop with related institutional entities
• acquire administrative backing
• perform case by case review
• work with prevent repeat
• document, file, and report to required bodies

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Communication with Related Committees/Groups

• NIH OBA, OHRP
• FDA CBER
• CDC, USDA
• IACUC
• IRB
• Grants Contracts

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OccupationalHealth Program
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Goals of Health Program

• prevention of occupational illness and injury
• early recognition of health alterations due to
  exposure
• prompt treatment and management of occupational
  illness/injury

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Occupational Health Program

• identify employees at risk
• medical history compared to hazards of position
• pre-placement medical evaluation
• baseline health information
• pre-existing conditions
• determine need for medical surveillance
• schedule update of work/health history

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Occupational Health Program

• understand the risks faced by employees
• inform of hazards and methods of protection
• educate on warning signals of illness (prompt
  visit to health clinic)
• clear procedure for reporting incidents and
  exposures

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Medical Evaluation

• BL3, BL4, non-human primate handlers, respirator
  users
• pre-assignment/periodic evaluations
• immunization status
• base-line tests (TB, biochemical analysis,
  serology)
• high risk medical conditions (GI disorders,
  pregnancy, immunosuppressive drugs, etc)

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Immunizations

• effective vaccine
• condition of employment?
• evidence of antibody response before starting
  work
• booster or revaccination as necessary

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Serum Storage

• potential to monitor serological changes
  resulting from employees exposure
• sample at time of hire, annually, after overt
  exposure, at termination
• test at time of collection if agent produces
  known serological response
• confidential
• informed consent (may decline)

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Report of seroconversion

• examine worker
• investigate procedures
• revise procedures to eliminate exposure

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Accidents Illnesses

• prompt reporting
• immediate medical assistance
• serum samples, stool specimens, nasal and skin
  washings
• investigate serious, unusual or extended illnesses

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Employee Health Records

• confidential
• exposure reports
• serious illnesses
• maintain for duration of employment plus 30 years