Risk Assessment Reduce the workers and Biosafety is an inexact - - PDF document

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Risk Assessment Reduce the workers and Biosafety is an inexact - - PDF document

Jun 20, 2023 386 likes •510 views

Risk Analysis Biosafety Risk assessment, Risk Risk analysis encom passes Management & risk risk assessm ent, risk communication m anagem ent, and risk com m unication. Ephy Khaemba International Livestock Research Institute

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1 Biosafety Risk assessment, Risk Management & risk communication

Ephy Khaemba International Livestock Research Institute

Risk Analysis

Risk analysis encom passes

risk assessm ent, risk m anagem ent, and risk com m unication.

What is Risk Assessment?

Risk: the probability that harm, injury, or

disease will occur; the probability of an adverse (health) effect

Assessment: The process of gathering

and judging evidence in order to decide whether a person has achieved a standard

  • r objective

Utilizing the Risk Assessment as a Deciding Factor

  • “The biosafety level assigned for

the specific work to be done is therefore driven by professional judgment based on a risk assessment” -WHO Laboratory

Biosafety Manual Risk Assessment

Reduce the worker’s and

environment’s risk of exposure

The Risk is never zero

Risk Assessment

“Biosafety is an inexact science, and

the interacting system of agents and activities and the people performing them are constantly changing.”

  • Every etiologic agent is different
  • Every laboratory is different
  • Every person is different
  • Biological Safety:Principles and Practices, 4th Ed. Fleming DO,

Hunt DL, eds., p. 81. Washington, DC. American Society for Microbiology, 2006

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2

RI SK MANAGEMENT PROCESS

I mplement Controls Make Risk Decision & Develop Controls Access Hazards I dentify Hazards Supervise and Evaluate

Risk Assessment steps Risk Management steps

Laboratory Hazards

  • Biological organisms
  • Animals
  • Chemicals
  • Radiation
  • Physical

Ways to mitigate RISK

Anticipate the issues Remove or reduce the hazard I ncrease familiarity with the hazard Train to deal with hazard I ncrease protection from the hazard Have a back up plan (in case all of the previous fail)

What hazard?

Biohazard: a biological agent or condition that constitutes a hazard to man or his environment; also a hazard posed by such an agent or condition.

From Webster’s 9th New Collegiate Dictionary, Miriam- Webster Inc. Publishers, Springfield, MA USA, 1985

The CDC/ NI H BMBL and the WHO

Laboratory Biosafety Manual

Outcome-oriented, not prescriptive, but ultimately based on risk assessment Laboratory director responsible for assessing risks and setting the biosafety level A participatory strategy works best

  • involve workers, safety professionals
  • develop training initiatives
  • vigilant review for effectiveness

Qualitative Risk Assessment

Identify all applicable risk factors

  • Biological agent
  • Work procedures and practices
  • Personnel
  • Facility

Review guidelines, regulations, publications Assess available epidemiological and field data Consult subject matter experts Recognize any available animal data

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3 Biohazard Risk Assessment

A biohazard risk assessment is a process which evaluates the risk posed by the agent, the procedure (s), and the worker to:

  • work
  • staff
  • environment
  • community

Over-arching Principles

  • Standard precautions are always advisable
  • Be conservative when insufficient information

forces subjective judgment

  • Everyone is responsible for the risk assessment

and management process – not just the “management”

Risk Assessment

FIVE STEP approach to Risk Assessment:

1.

Identify agent hazards

2.

Identify laboratory procedure hazards

3.

Determine preliminary Biosafety Level

  • 4. Evaluate staff for proficiency in laboratory and
  • ccupational health needs and use of safety

equipment.

  • 5. Review the risk assessment with a Biosafety

professional, subject matter expert and the Institutional Biosafety Committee.

Step 1

Identify Agent

Biological Hazard Recognition

Biological organism Pathogenicity Mode of transmission Work practices Animal work Training Personnel Workplace surveys Publications/research

Risk Assessment: Agent Basis

►What is known about the agent (Category, Amount of agent, Transmissibility)? ►What information is in the literature? ►Is an LD50, ID50 or TCID50 given? ►Is the agent/material known to cause infectious or toxigenic disease?

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4

Agent Based Risk Assessment

►Ordinary work procedures and type of work to be done (clinical samples, research, large scale, concentration) ►Is the host range limited or broad? ►Is post-exposure treatment, vaccine or prophylaxis available?

Agent Based Risk Assessment

Potential outcome of exposure Natural route of infection/other routes of

infection (parenteral, airborne, ingestion)

Stability in the environment

Agent Based Risk Assessment

Information available (animal studies,

laboratory-acquired infections, clinical reports

Laboratory activity (sonication,

aerosolization, centrifugation, etc.)

Genetic manipulation

Agent Based Risk Assessment

Ordinary work procedures and type of work to be done (clinical samples, research, large scale, concentration) Worker (host) factors (training, health) Other agent related questions?

Step 2

Evaluate Lab Activities to Identify Potential

Hazard

Risk Assessment: Lab Activity Basis

Conduct a protocol based biohazard

risk assessment

I nclude laboratory activities that may

not be listed in protocols

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5

Potential routes of transmission for LAIs:

What: Investigate potential routes of transmission for Laboratory Acquired Infections How? Identify activities which could release the

  • rganism and expose the worker, co-workers

and/or the environment

Risk Assessment for the Clinical Lab

Assessment of risk focuses primarily on the prevention of laboratory- acquired infections (LAI )

  • Spills/ Splashes
  • Aerosol

exposures

  • Cuts/ Lacerations
  • Needle sticks
  • Animal bites

Factors Necessary for Transmission

Presence of agent Stability of agent Sufficient virulence of agent Mechanism of transmission to host Correct portal of entry Susceptible host

CHAI N OF I NFECTI ON

route of entry provided: scratch, blood, ingestion, mucous membrane, or respiratory exposure

Pathogen/ Infectious organism

proper training, use proper PPE

I mproper practices, training or equipment allows

  • rganism to escape from vial

Exposure/ Incident Route of transmission Infectious dose Host Susceptibility INFECTION P R O P E R R I S K A S S E S S M E N T & A P P R O P R I A T E T RAI NI NG x x x x x

surveillance available treatment

Compromised immune status

vaccination

effective disinfection, proper ventilation, PPE, reduce aerosols resistance in environment, improper disinfection

Aerosol Issues

  • Procedures that impart energy into a

microbial suspension are a potential source of aerosol (Chatigny, 1974)

  • Laboratory procedures having potential of

releasing aerosols are ubiquitous

  • pening vials, centrifugation, mixing, sonication,

blending, grinding, shaking, vortexing, spills, pipetting, etc.

Agent Considerations

AEROSOL I NFECTI OUS DOSE*

  • Agent

–

Ebola virus

–

  • M. tb

–

Tularemia

–

Brucella

–

Anthrax

–

Cholera

–

Salmonella typhi

–

  • E. coli

–

  • E. coli O157:H7

–

Shigella spp.

  • Estimated I nfectious Dose

–

1

–

1 – 10

–

10

–

10 – 100

–

2,500-55,000 viable spores

–

10^ 8

–

10^ 3

–

10^ 8

–

10 – 100

–

10 – 100

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6

Viable Particles Recovered from Air

Procedure

  • sonic oscillator
  • mixing w/ pipette
  • verflow from mixer
  • pening lyophilized vial
  • top removed after blending
  • dropping flask of culture
  • dropping lyophilized culture

# Particles/ft3 of air

  • 6
  • 7
  • 9
  • 135
  • 1500
  • 1551
  • 4839

(from Chatigny 1974

Microbiological procedures presenting risk of aerosol in lab

  • streaking plates
  • spreading material on slides
  • cooling loop in media
  • “sniffing plates”
  • Catalase tests
  • Pipetting
  • Inoculating blood tubes
  • heating loop in bunsen burner flame
  • Rapid test kits/automated liquid dispensing

Pipetting

  • no mouth pipetting
  • disposable plastic pipettes
  • don’t expel last drop
  • all samples handled in biosafety cabinet
  • collect pipettes inside biosafety cabinet

Sharps Hazards

Syringes and needles, scalpels and broken glass

  • Auto-inoculation
  • mishandling
  • separation from syringe
  • Inoculating blood tubes and bottles
  • inappropriate disposal
  • poor work practices

Sharps Precautions

  • Specific locations for sharps in lab
  • Never fill sharps containers all the way
  • Use self-retracting needles and other

engineering controls

  • no recapping, bending, breaking, etc.
  • Substitute plastic for glass when possible
  • Avoid glass Pasteur pipettes and capillary

tubes

  • Practice “infectious spill with glass” clean-up

procedures

  • immediate collection/disposal

Laboratory Considerations

Facility Laboratory work practices PPE Resources Procedures culture large volumes animals diagnostics

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No Problem Here… Right? Risk Assessment Considerations

  • Pathogen (Agent)
  • Procedures

(Protocol)

  • Protective

Equipment

  • Place (lab facility)
  • Personnel (host)

the 5 P’s of Risk

Assessment)

Step 3

Preliminary Determination of Biosafety

Level

Establishing a “Starting Point”

Determining the

  • 1. preliminary biosafety level
  • 2. additional precautions

Requires a comprehensive understanding of the practices, safety equipment, and laboratory facility safeguards involved in the work to be undertaken

Step 4

Worker Assessment

Worker Assessment

Worker assessment must focus on

identifying gaps: 1) Worker experience 2) Occupational health and safety (includes prophylaxis and fit testing)

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8

Worker Assessment

Should include:

Previous training and experience Expertise in specific protocols Good microbiological practices Attitude toward use of safe practices, PPE New worker and medical surveillance

program

Work Hazard Analysis

  • List major procedure or process
  • Break procedure down into individual components
  • Determine hazard(s) associated with individual

component

  • Identify way to deal with each hazard (hazard

mitigation)

Work Hazard Analysis

Host (Worker) Considerations

I mmunocompromised because of drug therapy or illness I mmunocompromised due to a primary infection; more susceptible to secondary

  • pportunistic infections

Age Pregnancy Fatigue and stress Worker proficiency and training Attitude Recent medical procedures Chronic illness/ infection

Immunization Considerations for Clinical Situations

Hepatitis B virus,

Hepatitis A virus

Rabies Tetanus Meningococcal

Immunization

Vaccinia Typhoid Botulinum Yellow Fever, EEE

Considerations for Assessing Risk in the Clinical Laboratory Environment

Clinical Lab

  • Demanding constant workload
  • Crowded
  • Specimen workload and “stat requests”
  • Unfamiliar with agent (if not endemic)
  • May be first to encounter BT agent
  • PTs may not be treated like patient specimen
  • Lack of time for training
  • Limited staff
  • Many “routine” samples leads to complacency
  • “Assume” that BSC and PPE are effective
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9

Clinical Lab (Continued)

  • Lack of “hands-on” training
  • Lack of communication/information flow between PHL and

hospital labs

  • How to track training for staff on off-shifts
  • Part-time staff
  • New and automated technology
  • Lack of policies, occupational health programs
  • Lab left out of routine hospital surveillance -- not represented
  • n committees
  • Lack of skilled MT/ microbiologists in small labs
  • Laboratory may not receive patient information
  • Potentially more emphasis on patients (Infection control), not

lab (LAIs)

  • Difficult to differentiate between LAI and community acquired
  • Incorrect facility design, BSC type and placement

I s there a risk here?

Lowenstein-Jensen Mycobacterium Medium

BLOOD CULTURE BOTTLES Perform catalase tests in biosafety cabinet if possible Blood tubes Gram – , or nonspecific staining, cocci Positive oxidase test Colony morphology 24 / 48 hr

Establish Trigger Points

Would this raise a flag?

Just a few risks found in the Clinical Lab…

  • Dealing with many types of infectious organisms (at the same time)
  • Set ups
  • Fixing slides over a bunsen burner
  • Any other aerosol generating manipulation

(inoculating blood culture bottles, sterilizing loops)

  • Training and use of PPE
  • Leaking or broken specimen containers
  • Identifying isolates
  • Face too close to open plates (sniffing cultures?)
  • Suspicious plates not sealed
  • Catalase tests
  • Using automated systems
  • Crowded lab
  • Equipment and PPE shortages
  • Cracked hands from latex or multiple hand washing
  • Workload, stress
  • Routine. Complacency
  • Lack of training
  • New personnel / rotating trainees

Considerations for Assessing Risk in the Clinical Laboratory Environment

Microorganisms

  • Most organisms seen spread by hand-mouth, bloodborne, and

aerosol

  • Poor technique can contribute to large LAI outbreaks
  • Trusting automated Dx equipment with slow growing isolates
  • Training for techs and laboratorians needs to be focused and fit
  • schedule
  • PPE available, used properly? Containment equipment training and

use

  • Understand aerosol generating manipulations, how to

reduce/ eliminate

  • Reinforce hand washing and disinfectant procedures
  • Sickness, I njury, exposure reporting
  • Reminders to clinicians and pathologists to notify lab if dangerous
  • rganism is suspected

Risk Management Responsibilities

Top management

Overall safety policy Resource allocation

Supervisor

I mplement policies Training, practices & procedures, access

Laboratory Personnel

Strict & rigorous attention to details of

practices and procedures

Report incidents and exposures, and “near

misses”

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10

Biological Agent Risk Assessment Tools

Risk Assessment Review

  • There is risk in everything that we do
  • Never underestimate biological organisms
  • Don’t underestimate the value of good training
  • Assume that any unknown illness in your lab is a

potential LAI until proven otherwise

  • Have a plan to deal with unrecognized illness
  • Be conservative when dealing with unknowns or

unfamiliar agents

  • Develop an overall communication plan

Bottom Line Risk Management Recommendations

  • When in doubt, be conservative
  • Use Standard Precautions as a starting point
  • Complacency and routine can be deadly
  • Constantly remind clinicians and pathologists to

notify lab personnel if suspicion exists

  • Risk Assessment requires information about the

agent and the work along with good judgment

  • Acknowledge and make aware of “close calls”

Risk Management

Does your risk management solution: Make Scientific Sense? Make Logical Sense? Make Practical/ Common Sense?

RISK COMMUNICATION

Risk communication refers

specifically to the process of communicating information about risks with the objective of changing or consolidating the recipients views about the issue.

COMMUNICATION

Three elements of communication:

Communicator (status, credibility, appeal,

trust and presentation)

Message (verbal/non verbal, appeal/fear,

presentation style)

Recipient (attitude, education,

environment and persuasibility)

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The effectiveness and efficiency

  • f communication process

depends on the level of attention provided to the communicator by the receiver, the interpretation of the message by the reciver, the situation context the information is provided and the trust of the receiver has in the provider of the information.

COMMUNICATION STRATEGY

An effective communication strategy requires a plan within which responsibilities have been defined. The plan should address 4 desired objectives:

Define the key goals of the communication

exercise by identifying what the main issues are and what messages must be communicated.

Adopt an open multidisplinary approach to

communication process by involving where possible all stakeholders.

Include information from all relevant

sources and avoid presenting an obviously

  • ne sided or biased viewpoint.

Prepare a balance presentation for

messages being communicated and avoid making claims that are clearly difficult to support.

An effective communication strategy should achieve an increased level of knowledge and understanding of the issues among stakeholders who should all feel that they have participated in the communicating process and have been provided

  • pportunity to present their views on

the issue

Questions?