Introduction

Ramnik  Sood; Najat  Rashid

IntroductionCHAPTER 1

BACKGROUND

In recent decades, scientific research has created new and unexpected knowledge and technologies that offer unprecedented opportunities to improve human and animal health and environmental, something evidenced in a small number of incidents of threats, but more particularly by the series of large-scale offensive biological warfare programs carried out by major states in the last century.

Scientists have a special responsibility when it comes to problems of “dual use” and the misuse of science and biotechnology.

Today the nation is facing a new challenge in safeguarding the public health from potential domestic or international threats involving the use of hazardous infectious pathogens and toxins, in addition to the risks from emerging and re-emerging disease. Existing standards and practices may require adaptation of a process of engagement between scientists and the security community and the development of strong ethical and normative frameworks to compliment legal and regulatory measures to ensure protection from such violent actions.

RISK ASSESSMENT

The laboratory director is ultimately responsible for identifying potential hazardous infectious pathogens and toxins, assessing risks associated with those hazards, and establishing precautions and standard procedures to minimize employee exposure to those risks. 2 It is necessary to conduct a risk assessment and threat analysis of the facility as a precursor to the security plan.

Threat and risk assessments are widely recognized as valid decision support tools for establishing and prioritizing security program requirements.

The first step in performing a risk assessment is a comprehensive approach for identifying hazardous infectious pathogens and toxins in the laboratory and will include information from a variety of sources. Methods to ascertain hazard information can include benchmarking, walkabouts, interviews, detailed inspections, incident reviews, workflow and process analysis, and facility design.

No one standard approach or correct method exists for conducting a risk assessment; however, several strategies are available, such as using a risk prioritization matrix, conducting a job hazard analysis; or listing potential scenarios of problems during a procedure, task, or activity. The process involves the following five steps:

Identify the hazards associated with an infectious pathogens and toxins.

The potential for infection, as determined by the most common routes of transmission (i.e. ingestion by contamination from surfaces/fomites to hands and mouth; percutaneous inoculation from cuts, needle sticks, non-intact skin, or bites; direct contact with mucous membranes; and inhalation of aerosols) (Table 1.1).
The frequency and concentration of organisms routinely isolated, as determined by specimen type, patient data (of individual or the hospital population), epidemiologic data, and geographic origin of the specimen.

Intrinsic factors (if agent is known)

Pathogenicity, virulence, and strain infectivity/communicability. Mode of transmission (mode of laboratory transmission may differ from natural transmission).
Infectious dose (the number of microorganisms required to initiate infection can vary greatly with the specific organism, patient, and route of exposure).
Form (stage) of the agent.
Invasiveness of agent (ability to produce certain enzymes).

Resistance to antibiotics.

Table 1.1 Laboratory activities associated with exposure to hazardous infectious pathogens and toxins

Routes of exposure/transmission	Activities/practices
Ingestion/oral	Pipetting by mouth Splashing infectious material Placing contaminated material or fingers in mouth Eating, drinking, using lipstick or lip balm
Percutaneous inoculation/non-intact skin	Manipulating needles and syringes Handling broken glass and other sharp objects Using scalpels to cut tissue for specimen processing Waste disposal (containers with improperly disposed sharps)
Direct contact with mucous membranes	Splashing or spilling infectious material into eye, mouth, nose Splashing or spilling infectious material onto intact and non-intact skin Working on contaminated surfaces Handling contaminated equipment (i.e. instrument maintenance) Inappropriate use of loops, inoculating needles, or swabs containing specimens or culture material Bites and scratches from animals and insects Waste disposal Manipulation of contact lenses
Inhalation of aerosols	Manipulating needles, syringes, and sharps Manipulating inoculation needles, loops, and pipettes Manipulating specimens and cultures Spill cleanup

Indicators of possible high-risk pathogens that may require continuation of work in a biological safety cabinet (BSC).

Identify the activities that might cause exposure to the agent or material.
1. The facility (i.e. Biosafety level 2 (BSL2), BSL3, open floor plan [more risk] versus separate areas or rooms for specific activities [less risk], sufficient space versus crowded space, workflow, equipment present).
2. 4The equipment (i.e. in the case of uncertified BSCs, cracked centrifuge tubes, improperly maintained autoclaves, overfilled sharps containers, Bunsen burners).
3. Potential for generating aerosols and droplets. Aerosols can be generated from many routine laboratory procedures but often are undetectable. The following procedures have been associated with generation of infectious aerosols.
4. Manipulating needles, syringes and sharps:
  1. Sub-culturing positive blood culture bottles, making smears
  2. Expelling air from tubes or bottles
  3. Withdrawing needles from stoppers
  4. Separating needles from syringes
  5. Aspirating and transferring body fluids.
5. Manipulating inoculation needles, loops, and pipettes:
  1. Flaming loops
  2. Cooling loops in culture media
  3. Sub-culturing and streaking culture media
  4. Expelling last drop from a pipette (including automatic pipettes).
6. Manipulating specimens and cultures:
  1. Centrifugation
  2. Setting up cultures, inoculating media
  3. Mixing, blending, grinding, shaking, sonicating, and vortexing specimens or cultures
  4. Pouring, splitting, or decanting liquid specimens
  5. Removing caps or swabs from culture containers, opening lyophilized cultures, opening cryotubes
  6. Spilling infectious material
  7. Filtering specimens under vacuum
  8. Preparing isolates for automated identification/susceptibility testing
  9. Preparing smears, performing heat fixing, staining slides
  10. Performing catalase test
  11. Performing serology, rapid antigen tests, wet preps, and slide agglutinations
  12. Throwing contaminated items into infectious waste
  13. Cleaning up spills.
7. 5Use of animals.
8. Production of large volumes or concentrations of potential hazardous infectious pathogens and toxins.
9. Improperly used or maintained equipment.
10. Working alone in the laboratory. No inherent biologic danger exists to a person working alone in the laboratory; however, the supervisor is responsible for knowing if and when a person is assigned to work alone. Because assigning a person to work alone is a facility-specific decision, a risk assessment should be conducted that accounts for all safety considerations, including type of work, physical safety, laboratory security, emergency response, potential exposure or injury, and other laboratory-specific issues.
Consider the competencies and experience of laboratory personnel:
1. Age (younger or inexperienced employees might be at higher risk).
2. Genetic predisposition and nutritional deficiencies, immune/medical status (i.e. underlying illness, receipt of immunosuppressive drugs, chronic respiratory conditions, pregnancy, non-intact skin, allergies, receipt of medication known to reduce dexterity or reaction time).
3. Education, training, experience, competence.
4. Stress, fatigue, mental status, excessive workload.
5. Perception, attitude, adherence to safety precautions.
6. The most common routes of exposure or entry into the body (i.e. skin, mucous membranes, lungs, and mouth).

Evaluate and prioritize risks (evaluate the likelihood that an exposure would cause a laboratory-acquired infection and the severity of consequences if such an infection occurs).

Risks are evaluated according to the likelihood of occurrence and severity of consequences (Table 1.2):6

Table 1.2 Risk prioritization of selected routine laboratory tasks

Task or activity	Exposure risk Potential hazard	Likelihood	Consequence	Risk rating
Sub-culturing blood culture bottle	Needle stick — percutaneous inoculation	Likely	Infection; medical treatment	High
	Aerosols — inhalation	Moderate	Infection; medical treatment	Medium
	Splash — direct contact with mucous membranes	Moderate	Infection; medical treatment	High
Centrifugation	Aerosols — inhalation	Likely	Infection; medical treatment	High
Performing Gram stain	Aerosols from flaming slides	Moderate	Colonization; infection	Moderate
Preparing AFB smear only	Aerosols from sputum or slide preparation	Likely	Illness; medical treatment; disease	High
Performing catalase testing	Aerosols — mucous membrane exposure	Unlikely	Colonization; infection	Low
AFB culture work-up	Aerosols — inhalation	Likely	Illness; medical treatment; disease	High

Likelihood of occurrence.
Almost certain: expected to occur.
Likely: could happen sometime.
Moderate: could happen but not likely.
Unlikely: could happen but rare.
Rare: could happen, but probably never will.
Severity of consequences: may depend on duration and frequency of exposure and on availability of vaccine and appropriate treatment. Examples of consequences for individual workers.
Colonization leading to a carrier state.
Asymptomatic infection.
Toxicity, oncogenicity, allergenicity.
Infection, acute or chronic.
Illness, medical treatment.
Disease and sequelae.
Death.

Develop, implement, and evaluate controls to minimize the risk for exposure:
1. Engineering controls:
  1. Primary containment: BSC, sharps containers, centrifuge safety cups, splash guards, safer sharps7 (i.e. autoretracting needle/syringe combinations, disposable scalpels), and pipette aids.
  2. Secondary containment: Building design features (i.e. directional airflow or negative air pressure, hand washing sinks, closed doors, double door entry).
2. Administrative and work practice controls:
  1. Strict adherence to standard and special microbiological practices.
  2. Adherence to signs and standard operating procedures.
  3. Frequently washing hands.
  4. Wearing personal protective equipment (PPE) only in the work area.
  5. Minimizing aerosols.
  6. Prohibiting eating, drinking, smoking, chewing gum.
  7. Limiting use of needles and sharps, and banning recapping of needles.
  8. Minimizing splatter (i.e. by using laboratory "diapers" on bench surfaces, covering tubes with gauze when opening).
  9. Monitoring appropriate use of housekeeping, decontamination, and disposal procedures.
  10. Implementing "clean" to "dirty" work flow.
  11. Following recommendations for medical surveillance and occupational health, immunizations, incident reporting, first aid, post-exposure prophylaxis.
  12. Training.
  13. Implementing emergency response procedures.
3. PPE (as a last resort in providing a barrier to the hazard)
  1. Gloves for handling all potentially contaminated materials, containers, equipment, or surfaces.
  2. Face protection (face shields, splash goggles worn with masks, masks with built-in eye shield)
  3. At BSL2 and above, a BSC or similar containment device is required for procedures with splash or aerosol potential (Table 1.3).
  4. Laboratory coats and gowns to prevent exposure of street clothing, and gloves or bandages to protect non-intact skin.
  5. Additional respiratory protection if warranted by risk assessment.
4. 8Job safety analysis one way to initiate a risk assessment is to conduct a job safety analysis for procedures, tasks, or activities performed at each workstation or specific laboratory by listing the steps involved in a specific protocol and the hazards associated with them and then determining the necessary controls, on the basis of organism suspected (Table 1.3). Precautions beyond the standard and special practices for BSL2 may be indicated in the following circumstances:
  1. Test requests for suspected Mycobacterium tuberculosis or other mycobacteria, filamentous fungi, bioterrorism agents, and viral hemorrhagic fevers.
  2. Suspected high-risk organism (i.e. Neisseria meningitides).
  3. Work with animals.
  4. Work with large volumes or highly concentrated cultures.
  5. Compromised immune status of staff.
  6. Training of new or inexperienced staff.
  7. Technologist preference.
5. Monitoring effectiveness of controls Risk assessment is an ongoing process that requires at least an annual review because of changes in new and emerging hazardous infectious pathogens and toxins and in technologies and personnel:
  1. Review reports of incidents, exposures, illnesses, and near-misses.
  2. Identify causes and problems; make changes, provide follow-up training.
  3. Conduct routine laboratory inspections.
  4. Repeat risk assessment routinely.

Standardization of the risk assessment process at an institution can greatly improve the clarity and quality of this process. Training staff in risk assessment is critical point in achieving the objectives.

RISK MANAGEMENT METHODOLOGY

A risk management methodology can be used to identify the need for a biosecurity program through the following approaches:

Table 1.3 Example of job safety analysis for employees working in diagnostic laboratories: infectious pathogen hazards and controls

Task or activity	Hazards and recommended controls
	Potential hazard	Engineering controls	Administrative/work practices	PPE
Sub-culturing blood culture bottle	Needle stick—percutaneous inoculation	Safer sharps; retractable needles; puncture-resistant sharps container	No recapping; immediate disposal into sharps container	Gloves; gown or lab coat
	Aerosols—inhalation	BSC or splash shield	Work inside BSC or behind splash shield	Face protection if not in BSC; gloves; gown or laboratory coat with knit cuffs
	Splash—direct contact with mucous membranes	BSC or splash shield	Work inside BSC or behind splash shield	Face protection if not in BSC; gloves; gown or laboratory coat
Centrifugation	Aerosols—inhalation	BSC; removable rotors; safety cups; O-rings on buckets; plastic tubes; splash shield	Spin in BSC, or load and unload rotor in BSC; check O-rings and tubes for wear; no glass tubes; wait for centrifuge to stop before opening	Face protection if not in BSC; gloves; gown or laboratory coat with knit cuffs
Performing Gram stain	Aerosols from flaming slides	Slide warmer	Air dry or use slide warmer	Laboratory coat; gloves (optional)
Preparing AFB smear only	Aerosols from sputum or slide prep	Work in BSC; sputum decontaminant; slide warmer	Use slide warmer in BSC; dispose of slide in tuberculocidal disinfectant	Laboratory coat; gloves
Catalase testing	Aerosols— mucous membrane exposure	BSC; disposable tube	Work in BSC or perform in disposable tube	Laboratory coat; gloves; eye protection
AFB culture work-up	Aerosols—inhalation	BSL3 laboratory optimal; BSL2 laboratory with BSC minimal	All work in BSC using BSL3 practices	Solid-front gown with cuffed sleeves; gloves; respirator if warranted

10Establishes biosecurity measures to prevent loss, theft, diversion, or intentional misuse of any hazardous infectious pathogens and toxins.
Ensures that the protective measures provided, and the costs associated with that protection, are proportional to the risk.

The need for a biosecurity program should be based on the possible impact of the theft, loss, diversion, or intentional misuse of the hazardous infectious pathogens and toxins, recognizing that different agents and toxins will pose different levels of risk. Biosecurity policies and procedures should not seek to protect against every conceivable risk. The risks need to be identified, prioritized and resources allocated based on that prioritization. Not all institutions will rank the same agent at the same risk level. Risk management methodology takes into consideration available institutional resources and the risk tolerance of the institution.

Chapter Notes

IntroductionCHAPTER 1