Biosafety ProgramManagement

EMD Lecture #3

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

Related Compliance Entities

• IRB

• IACUC

• ICC

• Grants & Contracts

• Police, Security

• Other

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

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

Information to Employees

• Hazard awareness

• Risk (toxicity/disease), signs/symptoms

• Exposure limits/infectious dose

• Employer’s responsibilities

• Protective measures (controls)

• Medical surveillance/monitoring

• Emergency response procedures

Biosafety Program Management

I GO WHERE

I’M TOWED TO!

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

Biosafety ProgramManagement

• Employees– luxury, economy, SUV’s, dragsters, stalled, etc.

• AAA– Administrative support– Active (pro-active biosafety program =

awareness)– Accountability for compliance at all levels

Biosafety ProgramManagement

• Adopt/mandate required policies

• Apply OSHA General Duty Clause elsewhere

• Establish policies where needed

Rationale

• Control hazards– Anticipate– Identify– Evaluate

• Prevent lab-acquired infections– Interaction– Proactive– Assumption of responsibility

Prevention

• Interaction– Registration/reauthorization– Initial and periodic training & inspections– Sanctions

• Evaluation– Risk assessment/risk management– Incidents/near misses

Risk Assessment &Risk Management

Prior Planning

Prevents Poor Performance

Risk Assessment &Risk Management

• Pathogen

• Procedures

• Personnel

• Place

• Protective Equipment

Ineffective Program Management

• Morbidity/mortality

• Perceived lack of institutional control

• Regulatory visit/action

• Legal action (civil/criminal penalties)

• Bad press

• Low morale

Biosafety ProgramManagement• “I go where I’m towed to!”

– “Tell ‘em where you’re going to tow them”

– “Tow ‘em where you want them”

– “Tell ‘em why you’ve towed them there”

Identification of Biological Agents

Identification of Agents

• Department

• PI/Lab Director

• Type of Lab

• Lab Supervisor

• Building(s)/room(s)

• Phone/fax/email/campus address

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

Identification of Agents

• Human Pathogens– Risk group– local, state, federal registrations

• Animals – natural infections– work with biohazards– work with animal pathogens

Identification of Agents

• Human subjects

• Healthcare/clinical locations

• Toxins of biological origin

• Shipping/transport of regulated agents

• Other?

Identification of Equipment

• Autoclaves

• Biosafety cabinets, clean benches, glove boxes

• Eyewashes, showers

• Centrifuge containment

Identification of Handlers

• Name, employee ID Number

• Campus address/contact information

• Identify work experience

• Observe work practices if necessary

• Refresher training as needed

Biosafety Database Management

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

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

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

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)

Biosafety Manual

Biosafety Manual

• Introduction/Contact Info/Overview

• Responsibilities– Chairperson– Principal Investigator/Manager– Researcher/Employee– Safety Office– IBC

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

Biosafety Manual

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

Biosafety Manual

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

Biosafety Manual

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

Biosafety Manual

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

Biosafety Manual

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

Biosafety Training

Biosafety Training

• Lab safety– chemical, biological, fire, security, incident

response

• Biosafety– human/animal pathogens– RG2/BSL2 – rDNA– proficiency/competency

Biosafety Training

• Bloodborne Pathogens – Initial @ time of hire

• specific components of standard

• targeted to audience

– Annual retraining– Sharps Safety Devices

• Evaluation & training

Biosafety Training

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

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

Biosafety Training

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

Biosafety Training

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

Institutional Biosafety Committee

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

IBC Membership (NIH rDNA)

• varied disciplines (rDNA, microbiology, lab safety, engineering, lab technical staff, legal, community)

• > 5 members (2 from community)

• plant pathogen/containment expertise

• animal containment expertise

• biosafety officer if BL3/BL4 or large scale

IBC Membership

• consult with other scientists as needed

• annual report to NIH/OBA

• suggest opening meetings to public

• minutes available to public upon request

Suggested IBC Subcommittees

• Human Gene Transfer Clinical Trials

• Xenotransplantation

• Medical Surveillance

• Biosafety Level 3

• All report back/through IBC

IBC Function

• review rDNA research

• assess physical/biological containment level

• assess:– facilities– procedures– practices– training/expertise of personnel

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

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

IBC Function

• communicate results of review to PI

• don’t authorize initiation of work not covered by guidelines w/out NIH review

• ensure compliance with surveillance data reporting for human gene transfer projects

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

Communication with Related Committees/Groups

• NIH OBA, OHRP

• FDA CBER

• CDC, USDA

• IACUC

• IRB

• Grants & Contracts

OccupationalHealth Program

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

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

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

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)

Immunizations

• effective vaccine

• condition of employment?

• evidence of antibody response before starting work

• booster or revaccination as necessary

Serum Storage

• potential to monitor serological changes resulting from employee’s 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)

Report of seroconversion

• examine worker

• investigate procedures

• revise procedures to eliminate exposure

Accidents & Illnesses

• prompt reporting

• immediate medical assistance– serum samples, stool specimens, nasal and skin

washings

• investigate serious, unusual or extended illnesses

Employee Health Records

• confidential

• exposure reports

• serious illnesses

• maintain for duration of employment plus 30 years