PMLS BIORISK MANAGEMENT AND MEDTECH ETHICS
Risks when Working with Biological Materials?
- Accidental infection - Accidental release of toxic chemicals - Intentional theft and/or misuse - Physical Injuries
Laboratory Biorisk Management Standard
- CWA 15793:2008
Risk assessment strategy?
- Describe work activities - identify hazards - Determine risks - Decide whether or not risk is acceptable *if acceptable, proceed with work and monitor controls *if not, either revise or close project OR; - prepare risk control action plan - implement control measures - review adequacy of plan
Laboratory Biorisk Management Standard
- First internationally recognized management standard to specifically address hazards associated with microbiological laboratories at all containment levels · Provides a structured approach to managing risk associated with people, facilities, and working procedures in laboratory environments
Biorisk Management
- Integration of biosafety and biosecurity to manage risks when working with biological toxins and infectious agents (CWA 15793) - System or process to control safety and security risks associated with the handling or storage and disposal of biological agents and toxins in laboratories and facilities (CWA 15793:2011)
What Is Biorisk?
- It is the risk associated to biological toxins or infectious agents
Where does work with biological materials occur?
- Laboratories (academic, clinical, industrial) - Hospitals - Field work - Transport/Shipping (Packaging of samples) - Practically everywhere (biological materials are everywhere)
Biological Risk
- Likelihood that biological will cause harm under certain circumstances - Combination of the probable occurrence and the severity of harm - Relates to the environment and conditions of use (including control measures)
Biosafety Associations
- Network of individuals with interests in biosafety - Safety Resources
WHO Biosafety Guidelines (2004)
- No international standards - Difficult to develop a national standard or guidelines
Laboratory Acquired Infections
- Only 20% causative or defined event · 80% - human factors · 20% - equipment failure
Biological Hazard
- Relates to the intrinsic characteristics of the agents - Independent from the environment or conditions of use
Risk Assessment Questions: Pathogen
- Risk group? ROT/MOT? - Agent stability and ID50? - Concentration? - Availability of effective prophylaxis or therapy?Antibiotic resistance? - PSDSMSDS
Why do we need BRM?
- conform to prudent biosafety/biosecurity practices - Expand the research community/s awareness of the importance of biological safety - prevent employees and their families from acquiring laboratory-associated infectious diseases - prevent contamination of the environment and promote environmental quality - comply with all applicable National, International, and Local guidelines and regulations - Prevent loss, theft, or misuse of microorganisms biological materials, and research-related information - Protect proprietary materials and information - Protect the reputation and mission of the institute - Enhance emergency preparedness and response
Biorisk Assessment
- evaluation of the likelihood that biological agents or materials involved in a given activity or process will generate negative effects on the personnel, the community or the environment, and of the severity of those effects
Assessment
- identifying the hazards and evaluating the risks associated with biological agents and toxins, taking into account the adequacy of any existing controls - deciding whether or not the risks are acceptable
Assessing consequences
1 Insignificant No injuries, low financial loss 2 Minor First aid treatment, on site release, immediately contained 3 Moderate Medical treatment required, on site release contained w/ outside assistance, high financial loss 4 Major Extensive injuries, loss of production capability, off site release with no detrimental effects, major financial loss 5 Catastrophic Death, toxic release off site w/ detrimental effect, huge financial loss
Risk Evaluation Matrix - Likelihood rating
1 Rare Not expected to occur, but still possible 2 Unlikely Not likely to occur under normal circumstances 3 Possible Possible or known to occur once in a while 4 Likely Commonly occurring 5 Most likely Continuously or routinely occurring
Total LAI worldwide from 1979-2015?
1,753
10 Most Frequently Reported LAI Worldwide of 1930-1979?
1. Brucella esp 2. Coxiella burnetti 3. Hepa B 4. Salmonella enterica Typhi 5. Francis 6. M. tuberculosis 7. Blsatomyces dermatitidis 8. VEE 9. Chlamydia psittacosis 10. Cocciciodes immus
Overall risk analysis methodology
1. Define the activity or specific steps 2. Identify all the events that may lead - A personnel exposure - A release either in normal operation or in case of failure or accident 3. Evaluate likelihood of occurrence 4. Evaluate the impact (consequences) of exposure or release
Approach to Assess Risks and Select Appropriate Safeguards
1. Identify agent hazard, perform an initial assessment of risk 2. Identify laboratory procedure hazards 3. Determine of appropriate biosafety level, select additional precautions indicated by the risk assessment 4. Evaluate proficiency of staff regarding safe practices and the integrity of safety equipment 5. Review the risk assessment with a biosafety professional, subject matter expert, and the IBC.
LAI Incident Rate in Public Health Clinical Laboratory
1.4/1,000
LAI Incident Rate in Clinical Laboratory with more than 25 employees
1.5/1,000
Total LAI worldwide from 1930-1979?
2,168
LAI Incident Rate in Public Health Microbiology Laboratory
2.7/1,000
LAI Incident Rate of Neisseria meningitidis
25.1/1,000 in Microbiology Lab 0.6/1,000 in General population
LAI Incident Rate in Hospital Laboratory
3.5/1,000
LAI Incident Rate in Clinical Laboratory
3/1,000 employees
LAI Incident Rate in Hospital Microbiology Laboratory:
4/1,000
LAI Incident Rate in Clinical Laboratory with less than 25 employees
5/1,000
LAI Incident Rate in Research Laboratory
6-7x higher than Hospital and Public Health Laboratory
LAI Incident Rate of E coli
83/1,000 vs 0.96/1,00
Hazard Group 4
Agents causing severe disease; - High hazard for the individual and the community · Agents presenting a serious hazard to laboratory workers with high mortality · Agents with a high risk transmission in the community or the environment · Agents likely to cause significant harm, including possibly economical · No medical prevention or treatment available
Hazard Group 2
Agents likely to cause mild to moderate disease in healthy individuals; - Hazard moderate for the individual, low for the community and the environment · Agents that are not likely to spread into the community (or the environment) · A number of those agents are commonly present in populations, with limited harm · Existence of efficient medical prevention or treatment
Hazard Group 3
Agents likely to cause severe disease; - Hazard severe for the individual, moderate to severe for the community and the environment · Agents likely to spread into the external community or the environment (animals, plants) in case of release · Agents likely to cause significant harm in the community or the environment · Efficient medical prevention or treatment not always available
Hazard Group 1
Agents not likely to cause disease in healthy individuals; - No or negligible hazard for the individual, the community and the environment. - opportunistic organisms hazard group 1 agents are likely to produce infection in non-healthy individuals or immunodepressed people
Risk Assessment Questions: PPE
Appropriate combination of personal protective clothing and safety equipment?
Risk Assessment Questions: Place
Appropriate facility and equipment for work to be done?
Three Primary Components of BRM: AMP Model
Assessment Mitigation Performance
Biosafety Level 3: Laboratory Facilities (Secondary Barriers)
BSL-1 and 2 Facilities PLUS: - Separate building or isolated zone - Double door entry - Directional inward airflow - Single pass air; 10-12 air changes/hour - Exposures for aerosol generating equipment - Room penetrations sealed - Walls, floors and ceilings are water resistant for easy cleaning
Biosafety Level 3: Special Practices
BSL-2 Special Practices PLUS: - Work in certified BSC - Use of bioaerosol-containing equipment - Decontaminate spills promptly
Biosafety Level 4 - Maximum containment
BSL-3 Practices PLUS: · Clothing change before entering laboratory · Shower on exit · All materials decontaminated on exit from facility· · Safety Equipment : · Class III Biosafety cabinet · Class I or II biosafety cabinet · w/ full-body, air supplied, positive personnel suit
10 Most Frequently Reported LAI Worldwide of 1979-2015?
Brucella esp M. tuberculosis Arboviruses Salmonella spc. Coxiella burnetti Hantavirus Hepa B Shigella spp. HIV N. Meningitidis
Hazard Groups
Classification of biological agents in 4 hazard groups reflecting the global level of hazard they present
Risk Mitigation Control Measures
Elimination - Removing the risk Substitution - Substitution of a serious pathogen w/ one this is much less pathogenic Controls: Engineering - Physical changes to work stations, equipment, materials, production facilities, or any other relevant aspect of the work environment that reduce or prevent exposure to hazards Administrative - Policies, standards and guidelines Practices and procedures - Processes and activities PPE - Devices worn by the worker to protect against hazards *Last control in hierarchy of control · Should be used w/ other controls · However, in many laboratories it is the first control implemented, and sometimes the only control
Advantages and Disadvantages of each Risk Mitigation Control Measure
Elimination or Substitution - Immediate reduction of risk - Not always available or possible Engineering - Efficient, eliminates hazard - Cost, complexity Administrative - Authority approach - Indirect approach, primarily addresses the human factor Practices & Procedures - SOP based (standardized approach) - Training and supervision requirements PPE - Ease of use, relative cost - Does not eliminate hazard, PPE fails exposure happens, uncomfortable, limits ability, only protects the user
LAI Incident Rate of Salmonella
General Population (17.9/1,000) Microbiology: (1/1,000)
Risk Evaluation Matrix - Risk Scoring
Green <5 score Low Acceptable -Routine procedures -No additional control measures necessary Amber 5-14 Medium Acceptable with Mitigation -Additional control measures needed (adaptation of work practices, protective equipment, administrative control) -Need to re-evaluate risk after implementation. Red >15 High Not Acceptable -No start of/stop activities -Consider elimination or suppression of hazard -Definition of drastic control measures in order to reach acceptable risk level before starting activity -High level periodic review.
Biosafety Level 2: Safety Equipment (Primary Barriers)
In addition to BSL - 1: Use biosafety cabinets (class II) for work w/ infectious agents involving : · Aerosols and splashes · Large volumes · High concentrations
Risk formula
LC L = Likelihood; probability of an event occurring C = Consequences; the severity of an event
Hazard identification and characterization of biological agents; Factors to consider:
Main biological characteristics; Infectious potential; Severity of infection; Hazard Groups - Main Classification Criteria
Who got Infected, Where & How? (Singapore)
Male graduate student; BSL3 Lab, Environmental Health Institute; appropriate lab procedures and cross-contamination of West Nile virus SARSCoV
Who got Infected, Where & How? (Taiwan)
Male lab scientist; BSL4 Lab, Inst. Of Preventive Medicine, National Defense Medical Center; Was working on SARSCoV. Found a spillage of material disinfected with 70% ethanol and cleaned manually; SARS obtained from Environmental samples from handle of alcohol spray bottle and switch panel of cabinet
Risk Assessment Questions: Personnel
Skill level and vulnerability of at-risk personnel?
Biological Risk Assessment and Management
Step 1. Hazard group and characteristics of the biological agents (or materials) Step 2. Risk class of the activity (or process) (Biological Risk Assessment) Step 3. Define and implement appropriate control measures. Biosafety level and possibly some additional specific measures. (Biological Risk Management)
Biological risk assessment methodology
Step 1. Hazard identification and characterization of the biological agents (for materials) Step 2. Risk analysis of the activity or process
LAI Incident Rate of TB for lab workers
TB 3x higher for lab worker than non-worker.
Hazard
an object that can cause harm; intrinsic ability to cause adverse effects; ·physical (facility); material (chemical); activity (procedure)
risk
be based on either a hazard and/or a threat; likelihood that adverse effects (harm) will occur; a function of both the Likelihood of something happening and Consequences of that occurrence.'
Severe Acute Respiratory Syndrome (SARS) in 2003
infected over 8000 people and killed almost 800
5PS OF RISK ASSESSMENT
o Pathogen o Procedure o Personnel o PPE o Place
threat
person who has intent and/or ability to cause harm to other people, animals or the institution.
SARS
severe acute respiratory syndrome
Examples of at risk activities and operations
· All aerosol generating activities or operations · Large-scale production · Use of open culture systems · Sampling on pressurized equipment (bioreactors) · Inoculation of animals with pathogenic agents · Handling of infected animals · Use of a large diversity of biological agents · Maintenance activities · Storage (from a biosecurity point of view) · Transport outside laboratories (biosafety and biosecurity) · Emergency situations
Biosafety Level 3: Safety Equipment (Primary Barriers)
· BSL-1 and 2 Safety Equipment Plus - BSC Class II or III to manipulate infectious material - Respiratory protection may be indicated
- Safety Resources
· Biosafety in Microbiological and Biomedical Laboratories · Laboratory Biosafety Manual
Main biological characteristics considerations
· Classification · Morphology and dimensions · Replication and reproduction models · Genetic material (DNA, RNA) · Genetic stability and mutation potential · Existence of sub - types (variants, serogroups) · Existence of spores or other survival forms · Environmental preferences and tolerances
Biological Waste Types
· Cultures, stocks, isolates · Materials containing or contaminated w/ blood · Sharps · Pipettes, wrappers, tips · All materials used in the lab · Specimen Disposal · Decontamination - Sterilization - Disinfection
Purposes of risk activity analysis
· Decide whether or not the risk is acceptable · Define and implement appropriate control measures
Main Classification Criteria of hazard groups
· Degree of pathogenicity · Level of hazard for the exposed personnel · Level of hazard for the community in case of exposure · Existence of appropriate medical prevention and/or treatment means
Risk analysis of the activity
· Evaluation of the risks linked to the activity
Biological safety cabinet - class I: Standard practices
· Keep work areas uncluttered and clean · No food in lab refrigerator · Minimize splashes and aerosols · Decontaminate work surfaces daily · Maintain insect & rodent control program
Biosafety Level 2: Facility design (secondary barriers)
· Laboratories have lockable doors · Sink for handwashing · Work surfaces easily cleaned · Bench tops are impervious to water · Sturdy furniture
Biosafety Level 2: Facility construction (secondary barrier)
· Location - separated from public areas · Structure - normal construction · Ventilation - directional
Severity of infection considerations
· Pathology, type, diversity and severity of symptoms · Existence of asymptomatic or latent infections · Incubation period, period of infectiousness · Possibility of chronic and long term effects · Mortality
Lab Procedures that Can Produce Aerosols
· Pippeting · Mixing · Shaking · Centrifugation · Grinding · Blending · Vortexing · Pouring · Loading syringes · Harvesting tissue, eggs · Lasers, cell sorters · Injecting/intranasal inoculation of animals · Sonic Disruption · Opening Lyophilized Cultures · Flaming bacteriologic loops · Opening vessels at non-ambient pressures, fermenters, freezer vials · Changing animal bedding · Homogenizers
Aerosol generating activities
· Pouring, blending and mixing of liquids · Accidental spill and splashes · Leaks on pressurized equipment · Break of tubes inside a centrifuge · Pipetting, opening of completely filled vials
Network of individuals with interests in biosafety
· Promote biosafety · Share biosafety knowledge · Develop and exchange resources and guidance material · Training & workshops
Biosafety Level 1: Standard Microbiological Practices
· Restrict or limit access when working · Prohibit eating, drinking and smoking in the laboratory · Pipetting by mouth strictly forbidden
Laboratory acquired SARS outbreaks
· Singapore - September 2003 · Taiwan - December 2003 · Mainland China (Beijing and Anhui) - March 2004
Top 4 accident resulting in infection
· Spillages & splashes · Needle & syringe · Sharp object · Bite or scratch
Risk Assessment Questions: Procedures
· Type of laboratory procedures?
Biosafety Level 2 Special Practices
· Use sharps containers · DON'T break, bend or reuse syringes or needles · DON'T place needles or sharps in office waste containers · DON'T touch broken glass w/ hands · Identify "clean" and "contaminated" areas · Use appropriate warning signs · Decontaminate work surfaces · Report spills and accidents · Remove gloves, lab coats before leaving work area · No animals in the laboratories
Infectious potential considerations
· Virulence and infectious dose · Transmissibility · Natural modes of transmission - Infectious potential
The source of biorisk
· unintentional exposure to unauthorized access · accidental release or loss, theft, misuse, diversion · intentional unauthorized release of biohazard
