Biosafety Program Management EMD Lecture 3 Biosafety Program

Biosafety Program Management 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, Et. O, Labels, HAZWOPER, etc. • NIH Guidelines (r. DNA) – Applicability, scope • Transport – DOT, IATA, USDA, CDC/PHS, Do. C, 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 Program Management • Employees – luxury, economy, SUV’s, dragsters, stalled, etc. • AAA – Administrative support – Active (pro-active biosafety program = awareness) – Accountability for compliance at all levels

Biosafety Program Management • 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 Program Management • “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 Supervisor Building(s)/room(s) Phone/fax/email/campus address

Identification of Agents • r. DNA – 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) BSL 3 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 • BSL 3 facilities – commissioning – annual air balancing – HEPA filter testing

Research Registration • Comprehensive Biohazard Registration Form (all biological materials used) • r. DNA protocols (new, updates, new personnel) • Human pathogens (biennial) • Select Agent transfers (inventory, tracking) • Inspections (semi-annual, annual) – BSL 1, BSL 2, BSL 3, 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 – r. DNA – 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 – BSL 1, BSL 2, BSL 3 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 – RG 2/BSL 2 – r. DNA – 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 • BSL 3 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 r. DNA projects; ensure compliance • Responsibilities not restricted to r. DNA

IBC Membership (NIH r. DNA) • varied disciplines (r. DNA, microbiology, lab safety, engineering, lab technical staff, legal, community) • > 5 members (2 from community) • plant pathogen/containment expertise • animal containment expertise • biosafety officer if BL 3/BL 4 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 r. DNA 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 r. DNA 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

Occupational Health 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 • BL 3, BL 4, 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