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Guidelines Part 6

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Guidelines Part 6 - Biological Agents

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G6.34-1 Exposure control plan

Issued August 1999; Editorial Revision July 2004; Editorial Revision February 2, 2006; Revised February 1, 2008

Regulatory excerpt
Section 6.34(1) of the OHS Regulation ("Regulation") states:

(1) If a worker has or may have occupational exposure, the employer must develop and implement an exposure control plan, based on the precautionary principle, that meets the requirements of section 5.54 and that includes the following:

(a) a risk assessment conducted by a qualified person to determine if there is a potential for occupational exposure by any route of transmission;

(b) a list of all work activities for which there is a potential for occupational exposure;

(c) engineering controls and administrative controls to eliminate or minimize the potential for occupational exposure;

(d) standard or routine infection control precautions and transmission-based precautions for all work activities that have been identified as having a potential for occupational exposure, including

(i) housekeeping practices designed to keep the workplace clean and free from spills, splashes or other accidental contamination,

(ii) work procedures to ensure that contaminated laundry is isolated, bagged and handled as little as possible, and

(iii) work procedures to ensure that laboratory or other samples containing a biological agent designated as a hazardous substance in section 5.1.1 are handled in accordance with the Laboratory Biosafety Manual issued by the World Health Organization, as amended from time to time, and the Laboratory Biosafety Guidelines issued by Health Canada, as amended from time to time;

(e) a description of personal protective equipment designed to eliminate or minimize occupational exposure;

(f) a program to inform workers about the contents of the exposure control plan and to provide them with adequate education, training and supervision to work safely with, and in proximity to, a biological agent designated as a hazardous substance in section 5.1.1;

(g) a record of all training and education provided to workers in the program described in paragraph (f);

(h) a record of all workers who have been exposed, while performing work activities, to a biological agent designated as a hazardous substance in section 5.1.1.

Purpose of guideline
The purpose of this guideline is to provide some examples of workplaces which are likely to require an exposure control plan (ECP).

Occupational exposure
The requirement to develop and implement an ECP applies to all workplaces where a worker has or may have occupational exposure. "Occupational exposure," as defined in section 6.33 of the Regulation, is the reasonably anticipated contact with a biological agent, that is designated as a hazardous substance in section 5.1.1, resulting from the performance of a worker's duties.

Most health care workers, lab workers, emergency responders, fire fighters and occupational first aid attendants in general industry, are likely to have occupational exposure. In addition some janitorial or custodial staff in hospitality industries in high risk areas, public utility or municipal workers with outside jobs in high risk areas, and social service agency workers in high risk areas may have such exposure.

Some workplaces in which workers typically have occupational exposure include, but are not limited to those listed in the table below.

Partial list of workplaces which are likely to require an exposure control plan

Physicians' offices Medical and dental laboratories Hospitals Hemodialysis centers Blood and tissue banks Nursing homes Home health care Fire and rescue Ambulance services Funeral homes and crematories Commercial laundries serving health care and public safety institutions Schools Workers employed in the woods involving potential exposure to ticks and Lyme Disease Workers who may have exposure to hantavirus when handling rodents or cleaning up dust contaminated with rodent urine and feces

Dental offices Medical & dental equipment repair Outpatient facilities (including renal dialysis clinics and cancer treatment centers) Drug treatment centers Research labs Residential care facilities Hospices Law enforcement Correctional institutions Health clinics in industrial facilities Personnel services Removal of regulated waste or sewage Workers in agriculture where there is potential exposure to mouldy hay, or who are exposed to zoonotic diseases (brucellosis, for example)

Elements of an ECP are listed in section 5.54 and section 6.34(1) of the Regulation. Required elements of an ECP will depend on the circumstances of the workplace and the outcome of the risk identification required by section 6.34(1)(a) of the Regulation.

G6.34-2 Risk assessment, engineering and administrative controls, and personal protective equipment

Formerly issued as G6.35, G6.36(1), and G6.36(2); Issued as G6.34-2 February 1, 2008. (Note: Former G6.34-2 on pandemic influenza has been renumbered as G6.34-6.)

Regulatory excerpt
Section 6.34(1) of the OHS Regulation ("Regulation") states:

(1) If a worker has or may have occupational exposure, the employer must develop and implement an exposure control plan, based on the precautionary principle, that meets the requirements of section 5.54 and that includes the following:

(a) a risk assessment conducted by a qualified person to determine if there is a potential for occupational exposure by any route of transmission;

(b) a list of all work activities for which there is a potential for occupational exposure;

(c) engineering controls and administrative controls to eliminate or minimize the potential for occupational exposure;

And section 6.34(1)(e) of the Regulation states:

(1) If a worker has or may have occupational exposure, the employer must develop and implement an exposure control plan, based on the precautionary principle, that meets the requirements of section 5.54 and that includes the following:

...

(e) a description of personal protective equipment designed to eliminate or minimize occupational exposure;

And section 5.55(3) of the Regulation states:

(3) The use of personal protective equipment as the primary means to control exposure is permitted only when

(a) substitution, or engineering or administrative controls are not practicable, or

(b) additional protection is required because engineering or administrative controls are insufficient to reduce exposure below the applicable exposure limits, or

(c) the exposure results from temporary or emergency conditions only.

Purpose of guideline
The purpose of this guideline is to provide information on what should be included in a risk assessment required under 6.34(1)(a), and discuss ways to control risks using engineering and administrative controls under section 6.34(1)(c). The guideline also discusses appropriate personal protective equipment (PPE) under section 6.34(1)(e).

Risk assessment
The objective of the risk assessment is to determine the jobs, tasks, and procedures for which occupational exposure is anticipated and to evaluate the likelihood that such exposure would occur. The factors to be considered will be dictated by the circumstances of the workplace and the type of biological agents designated as hazardous substances that workers are potentially exposed to.

A qualified person is required to conduct the risk assessment. A qualified person may be a medical or non-medical professional. This could include infection control practitioners, registered nurses, and physicians, occupational hygienists, microbiologists, or other individuals with specialized training in the area of biological agents designated as a hazardous substance under section 5.1.1 of the Regulation.

As part of the risk assessment, the job classifications should be reviewed within the workplace and categorized according to those jobs in which all workers have occupational exposure and those jobs in which some of the workers have occupational exposure. Where all workers have occupational exposure, such as scrub room nurses, clinical dental hygienists, and paramedics, it is not necessary to list individual work tasks, as long as it is made clear that all work activities have such exposure. Where only some workers have exposure, the specific tasks and procedures causing exposure need to be listed. All first aid attendants are considered to have occupational exposure.

When evaluating the potential for exposure, as well as the risk associated with exposure, the following sources of information should be considered:

• History of firm, including first aid records and accident/incident investigation reports
• WorkSafeBC claims records and statistics
• History of similar industries, similar exposure conditions, history of other firms in the same geographical area, and industries dealing with the same client group
• Information from other jurisdictions or agencies, such as Occupational Safety and Health Administration (OSHA) or National Institute for Occupational Safety and Health (NIOSH).

The potential for occupational exposure must be evaluated without regard to the availability or use of personal protective clothing and equipment. That is, the risk to an unprotected worker must be assessed.

If there is a question regarding the potential for exposure one should

• Determine whether the worksite requires an exposure control plan (refer to OHS Guideline G6.34-1)
• Consult the employers' risk assessment to determine if the occupation or task has been identified
• Evaluate the risk of occupational exposure. If necessary, contact the WorkSafeBC occupational health physicians for assistance
• If there is a risk of occupational exposure, determine whether the risk has been minimized with any of the following:
  • Engineering controls
  • Administrative controls
  • PPE
  • Adequate training and supervision of the workers

Engineering controls
Section 6.34(1)(c) requires an employer to use either engineering controls or administrative controls to eliminate or minimize the potential for occupational exposure. Part 1 of the Regulation defines "engineering controls" as follows:

the physical arrangement, design or alteration of workstations, equipment, materials, production facilities or other aspects of the physical work environment, for the purpose of controlling risk.

Engineering controls for occupational exposure include, but are not limited to

• Safety-engineered needles (e.g. syringes that include a needle retraction mechanism or other type of integral needle guard mechanism)
• Blunt tip sutures
• Needleless devices (devices that do not use a needle for the collection of body fluids, administration of medication or fluids, or any other procedures with potential exposure to a bloodborne pathogen; e.g. needleless intravenous connectors)
• Retracting lancets
• Automatic re-sheathing of disposable scalpels
• Puncture-resistant containers for sharps (sharps include anything that might produce a puncture wound that would expose a worker to blood or other potentially infectious material, such as broken glass, scalpels, contaminated ends of orthodontia wire, and suture needles)
• Splatter guards
• Biological safety cabinets
• Mechanical pipetting systems
• Negative pressure isolation, which is an isolation and ventilation control for biological agents that are transmitted via the airborne route and that pose an inhalation hazard. This involves isolating infectious patients in an isolation room under negative pressure through an independent air supply and exhaust system for the isolated area/room
• Triage stations - isolating medical staff from potentially infectious persons requiring medical attention through installation of protective barriers

Engineering controls must be properly selected, used, inspected, maintained, and replaced as needed to ensure their effectiveness. Selected engineering controls must eliminate or minimize the risk of an exposure incident. Section 4.3 requires that each tool be selected, used, and operated in accordance with the manufacturer's instructions (if available), safe work practices, and the requirements of the Regulation.

For other engineering controls necessary in the laboratory, see sections 30.12 (Biological safety cabinets), 30.13 (Centrifuges), 30.16 (Transport of containers), and 30.17 (Personal protection) of the Regulation. For ventilation of isolation rooms refer to sections 4.72 to 4.78.

Administrative controls
Section 6.34(1)(c) requires an employer to use either engineering controls or administrative controls to eliminate or minimize the potential for occupational exposure. Part 1 of the Regulation defines "administrative controls" as follows:

the provision, use and scheduling of work activities and resources in the workplace, including planning, organizing, staffing and coordinating, for the purposes of controlling risk.

Administrative controls for occupational exposure include, but are not limited to

• Adopting general infection control measures
• Washing hands with a suitable, non-abrasive cleansing agent and running water immediately after removal of gloves and as soon as possible after skin contact with blood or other potentially infectious material
• Disposing of contaminated needles immediately after use in a readily available sharps container specifically designed for such use
• Applying the "hands-free " method of passing scalpels during a surgical procedure, such as using a small hand tray to transfer scalpels and other sharps to and from the surgeon's hand
• Placing contaminated reusable sharps in containers that are puncture-resistant and leak-proof, such as stainless steel trays
• Using tongs or other suitable means, such as a dust pan and disposable brush, to pick up broken glass contaminated with blood
• Prohibiting the bending, manual recapping, or removing of contaminated needles
• Preventing the storage of food and/or drink in refrigerators or other locations where biological agents designated as hazardous substances under section 5.1.1 are present
• Keeping the number of workers potentially exposed to a biological agent to a minimum
• Restriction of visitors
• Restricting contact between workers and potentially infectious persons during an epidemic or pandemic outbreak - refer to OHS G6.34-6
• Limiting and controlling patient transportation/transfers
• Isolating infectious persons once hospitalized
• Medical surveillance for persons entering a medical facility
• Quarantining exposed staff
• Worker education and training, including drills

Personal protective equipment
The Regulation does not dictate what kind of PPE should be used for a given circumstance. This decision rests with each employer and must be based on the specific exposure circumstances in the workplace. The results of the risk assessment required under section 6.34(1)(a) and Part 8 of the Regulation can help the employer to determine appropriate levels of protection. Under section 8.4, the workplace evaluation to determine appropriate PPE must be done, where practicable, in consultation with the occupational health and safety committee or the health and safety representative, as applicable and with the worker who will use the equipment.

Workers must use appropriate PPE to prevent occupational exposure. Appropriate PPE may include, but is not limited to gloves, gowns, lab coats, coveralls, booties, face shields, eye protection, and respirators. For airborne or aerosolized occupational exposure, a NIOSH-approved, particulate respirator may be required.

Appropriate PPE for occupational first aid attendants includes an approved particulate face piece respirator and latex or other waterproof gloves to prevent accidental contact with blood or body fluids.

To evaluate compliance, the following questions should be considered:

• Under normal conditions and time of use, does the PPE prevent a biological agent designated as a hazardous substance under section 5.1.1 from
  • Passing through a worker's work clothes, street clothes, undergarments?
  • Reaching an employee's skin, eyes, nose, mouth, or other mucous membranes?
  • Being inhaled into the respiratory tract?
• Has the PPE been selected and used in accordance with the manufacturer's instructions and recognized standards? Does it provide effective protection? See section 8.3(1)(a) of the Regulation
• Does the PPE in itself create a hazard to the wearer? See section 8.3(1)(b)
• Does the PPE cause allergenic or other adverse health effects? See section 8.2(3)

Some workers may be allergic to natural rubber latex gloves. The WorkSafeBC pamphlet, Dealing with Latex Allergies at Work, should be consulted for more information and used as a resource by workers exposed to natural rubber latex products. The Laboratory Centre for Disease Control (a branch of Health Canada) considers disposable, good quality, non-latex gloves made of vinyl, nitrile, neoprene, copolymer, and polyethylene to be adequate barriers to bloodborne pathogens.

Additional resources
For additional information on the prevention of occupational exposure, refer to the WorkSafeBC website http://www2.worksafebc.com/Portals/HealthCare/Home.asp or http://www2.worksafebc.com/Portals/HealthCare/InfectiousDiseases.asp (e.g. this site contains information on common injuries and illnesses in the health care industry and a booklet entitled Controlling Exposure: Protecting Workers from Infectious Disease).

G6.34-3 Housekeeping and laundry practices

Formerly Issued as G6.36(3) and G6.36(4); Issued as G6.34-3 February 1, 2008

Regulatory excerpt
Section 6.34(1) of the OHS Regulation ("Regulation") states:

(1) If a worker has or may have occupational exposure, the employer must develop and implement an exposure control plan, based on the precautionary principle, that meets the requirements of section 5.54 and that includes the following:

...

(d) standard or routine infection control precautions and transmission-based precautions for all work activities that have been identified as having a potential for occupational exposure, including

(i) housekeeping practices designed to keep the workplace clean and free from spills, splashes or other accidental contamination,

(ii) work procedures to ensure that contaminated laundry is isolated, bagged and handled as little as possible, and

Purpose of guideline
The purpose of this guideline is to provide information on housekeeping and laundry practices.

Housekeeping practices
The requirements of section 6.34(1)(d)(i) of the Regulation apply to a broad range of fixed and non-fixed workplaces, including labs, operating rooms, accident scenes, ambulances, and refrigerated blood transfer vehicles.

To keep the workplace clean and sanitary, the employer must develop and implement appropriate methods of decontamination. This would include details on

• Location within the facility (indoor vs. outdoor)
• Type of surfaces to be cleaned
• Size of the spill (for example, gross, splatter, smear) or type of organism present
• Tasks or procedures to be performed, including
  • What kind of sterilant or disinfectant is to be used
  • How much should be used
  • How often it should be applied

Decontamination is the use of physical or chemical means to remove viable microorganisms from surfaces or materials. Three methods are available: sanitization, disinfection, and sterilization.

Sanitization: Reduces microbial contamination to levels judged safe by public health authorities.

Disinfection: Destroys specific infectious microorganisms. There are three levels of disinfection.

• High: Destroys all forms of microbial life except high numbers of bacterial spores
• Intermediate: Destroys Mycobacterium tuberculosis, vegetative bacteria, most viruses, and most fungi. It does not kill bacterial spores
• Low: Destroys most bacteria, some viruses, some fungi, but not Mycobacterium tuberculosis or bacterial spores

A high level of disinfection should be used for items that contact mucous membranes during use but do not usually penetrate normally sterile areas of the body. Intermediate and low level disinfection should be used for items that contact only intact skin during routine use.

Sterilization: Destroys all forms of microbial life including high numbers of bacterial spores. This method of decontamination should be used for items that routinely penetrate the skin or mucous membranes, enter normally sterile areas of the body or come into direct contact with recirculating body fluids, such as blood.

When used at recommended dilutions, chemical germicides approved for use as "hospital disinfectants" that are capable of killing Mycobacterium tuberculosis can be used to decontaminate spills of blood and other body fluids. Workers must ensure the recommended disinfectant is used according to the manufacturer's instructions. The frequency with which housekeeping practices are performed will vary depending on the nature of the spill and the type of organism and may be

• Immediate (for example, blood spilled on laboratory bench)
• After specific procedures involving patient care (for example, surgical operation)
• At the end of the work shift (for example, routine department cleaning)

Laundry
Section 6.34(1)(d)(ii) of the Regulation, requires worker exposure to contaminated laundry be prevented by isolating the laundry and minimizing manual handling. This section applies to all contaminated laundry whether provided by the employer or personal laundry (such as contaminated work clothes).

The material will be considered as "isolated" if laundry is

• Effectively bagged or containerized at the location of use
• Not sorted or rinsed in the location of use
• Handled as little as possible

When contaminated laundry is wet and there is a reasonable likelihood of soak-through or leakage, the laundry should be placed and transported in other leak-resistant bags or containers.

Bags and other containers containing laundry contaminated with a biological agent designated as a hazardous substance in section 5.1.1 must be labelled according to section 6.37(1).

Where laundry contaminated with a biological agent designated as a hazardous substance in section 5.1.1 is sent for processing to a laundry or dry cleaning facility, the employer sending the articles (the supplier) and the employer receiving the articles (the operator) must follow the requirements of sections 12.157 and 12.158 of the Regulation.

G6.34-4 Program to inform workers of the exposure control plan

Formerly Issued as G6.38; Issued as G6.34-4 February 1, 2008

Regulatory excerpt
Section 6.34(1)(f) of the OHS Regulation ("Regulation") states:

(1) If a worker has or may have occupational exposure, the employer must develop and implement an exposure control plan, based on the precautionary principle, that meets the requirements of section 5.54 and that includes the following:

...

(f) a program to inform workers about the contents of the exposure control plan and to provide them with adequate education, training and supervision to work safely with, and in proximity to, a biological agent designated as a hazardous substance in section 5.1.1;

Purpose of the guideline
The purpose of this guideline is to provide information on what should be included in a program to inform workers about the exposure control plan, required under section 6.34(1)(f). This guideline updates content from former G6.38 Education and training following amendments to the Regulation.

Program to inform workers about the exposure control plan (ECP)
Section 6.34(1)(f) of the Regulation requires the employer to inform workers about the contents of the ECP and to provide them with adequate education and training to work safely with and in proximity to a biological agent designated as a hazardous substance in section 5.1.1.

This section applies to any worker (including part-time, full-time, temporary, and casual) who has or may have occupational exposure. No worker with potential occupational exposure is exempt from this section. The instruction requirement for lab workers who handle biohazardous materials is covered under section 30.14 of the Regulation.

Education and training must be provided before a worker begins work with or in proximity to a biological agent designated as a hazardous substance in section 5.1.1. Specifically, training needs to be given when a worker is initially assigned to the task and when changes are made that affect a worker's occupational exposure, such as when a task is modified or new procedures are being instituted. Education and training is an element of an ECP, as required by section 5.54(2). To comply with the requirements of section 5.54(3) of the Regulation, the employer must review the ECP at least annually and update it as necessary. Consequently, the employer may need to provide refresher training annually or whenever the ECP is updated.

Education and training material must be appropriate to the educational level, literacy, and language of workers. The content will generally include discussion and explanation of the following items:

• Applicable sections of the Regulation - applicable sections include section 3.19(1); sections 5.2, 5.54, and 5.55; sections 6.33 to 6.41; sections 8.2 and 8.3; sections 12.157 and 12.158; Part 30
• Applicable sections of the Workers Compensation Act - including section 173 on incidents that must be investigated
• Definition of a biological agent designated as a hazardous substance in section 5.1.1
• Occupational exposure
  • How it occurs, such as modes of transmission
  • How to identify tasks and other activities, such as routine and emergency spills, that may involve worker exposure to a biological agent designated as a hazardous substance in section 5.1.1
  • Effects of exposure
  • What to do in the event of exposure, such as emergency procedures to be followed, and post-exposure treatment
• Use and limitations of control measures to prevent or minimize exposure
  • Engineering controls
  • Work practice, or administrative, controls
  • Personal protective equipment (PPE). This element should address selection, care, use, storage, limitations, maintenance, inspection, decontamination, and availability of PPE
• Employers ECP and where to access it
• Required labels and identification for a biological agent designated as a hazardous substance in section 5.1.1
  • When necessary, information on the vaccines required under section 6.40 of the Regulation

The training session should also include the opportunity for an interactive question and answer period.

The person providing the education and training must have knowledge about a biological agent designated as a hazardous substance in section 5.1.1, particularly in the context of workplace exposure and control. Trainers may be medical or non-medical professionals. Medical professionals could include infection control practitioners, registered nurses, and physicians. Non-medical professionals could include occupational hygienists or other individuals with specialized training in the area of biological agents designated as a hazardous substance in section 5.1.1. In some workplaces, such as medical and dental offices, the employer, who is often a physician, may do the training, provided he or she is familiar with exposure control measures.

To evaluate compliance with this section, it needs to be verified that education and training was provided before a worker was placed in a position where occupational exposure may occur. A WorkSafeBC prevention officer should, by observation and interviews, determine if workers work safely with and in proximity to a biological agent designated as a hazardous substance in section 5.1.1. Informed workers can be identified by their ability to answer the following questions:

• Do you work with biological agents designated as a hazardous substance? If so, what are they?
• What precautions are required for preventing exposure?
• What do you do in case of an emergency?
• Where would you go for further information?

G6.34-5 Record keeping requirements

Formerly Issued as G6.41-2 and G6.41-3; Issued as G6.34-5 February 1, 2008

Regulatory excerpt
Section 6.34(1) of the OHS Regulation ("Regulation") states:

(1) If a worker has or may have occupational exposure, the employer must develop and implement an exposure control plan, based on the precautionary principle, that meets the requirements of section 5.54 and that includes the following:

...

(g) a record of all training and education provided to workers in the program described in paragraph (f);

(h) a record of all workers who have been exposed, while performing work activities, to a biological agent designated as a hazardous substance in section 5.1.1.

Purpose of the guideline
The purpose of this guideline is to provide information on what should be included in a record of training and a record of exposure referred to in section 6.34(1)(g) and (h) of the Regulation. This guideline consolidates and updates content from former G6.41-2 Records of exposure and G6.41-3 Records of training following amendments to the Regulation.

Records of training
The intent of section 6.34(1)(g) of the Regulation is to provide a way to document compliance, to determine who attended each training session and, when necessary, to assess the adequacy of the training. Accurate and sufficiently detailed records of education and training should be maintained by the employer and should include

• Date(s) of training
• Content or a summary of the training sessions
• Type of education and training (for example classroom, video, interactive, or on-the-job)
• Names and qualifications of those conducting the training
• Names, job titles, and work locations (departments) of workers attending the sessions

Education and training records should be kept for at least 3 years after the training session. Unlike medical records, training records are not confidential and can be inspected and copied as required by a WorkSafeBC prevention officer.

Records of exposure
Under section 6.34(1)(h), employers must keep a record of all workers who have been exposed to a biological agent designated as a hazardous substance under section 5.1.1. Incidents of occupational exposure may be documented in the following ways:

• Accident/incident reports (such as an incident report regarding a needlestick injury)
• First aid treatment records - see section 3.19 of the Regulation
• Medical records (including documentation of post-exposure medical evaluation, treatment, and counselling, as well as records of hepatitis B and other vaccinations)
• Inspection reports of documented exposures
• Claim forms
• Worker complaints
• Results of the risk assessment performed in compliance with section 6.35
• Records required as part of the exposure control plan, as per section 6.34, regarding risk identification, assessment, and control

The employer must ensure that records are kept as required. A physician usually maintains such records (some large firms may have their own on-site occupational physician). Worker medical records are to be kept confidential and not disclosed or reported without the worker's written consent to any person within or outside the workplace except as required by law.

Records of vaccination and other exposure records should be kept for the period of employment plus 10 years or such earlier time if the employer ceases to do business. (Note that section 3.19(2) of the Regulation specifies that the first aid record of an injury or illness must be kept for at least 3 years. First aid records are distinct from records of occupational exposure section 6.34(1)(h).)

Under section 179 of the Workers Compensation Act, a WorkSafeBC prevention officer has the authority to inspect and inquire with respect to health and safety matters at any workplace and may make inquiries and inspect documents considered necessary. Sections 3.19(3), (4), and (5) of the Regulation specify the conditions for access to first aid records and maintaining their confidentiality. A prevention officer should consult with a WorkSafeBC occupational health physician before any worker medical records are requested. Prevention officers must protect the confidentiality of such records or any other personal medical information received.

G6.34-6 Exposure control plan - Pandemic influenza

Issued February 8, 2007 as G6.34-2; Revised February 1, 2008 and renumbered as G6.34-6; Revised April 27, 2009

For some time, health authorities have advised of the possibility of an influenza pandemic arising from a mutated strain of a virus currently found primarily in birds (technically referred to as the H5N1 virus). WorkSafeBC has issued this guideline to assist with workplace planning in the event of such an influenza pandemic. It addresses the expectations for exposure control plans to protect workers from possible exposure to such a virus in B.C. workplaces.

The guideline has been developed following consideration of recent documents adopted by agencies such as the US Center for Disease Control and the World Health Organization. Also, it is intended to be consistent with the primary themes of the SARS Commission Report by Justice A. Campbell (January 2007), and with the report on the role of personal protective equipment on influenza transmission issued by the Council of Canadian Academies (December 2007).

This guideline was initially issued in February 2007 in consultation with workplace stakeholders and following a period of consultation with other parties. It was revised, primarily to reflect regulatory amendments that became effective on February 1, 2008 following public hearings. As is the case with other guidelines, it may be revised from time to time based on evolving evidence on the nature of the virus and appropriate means of control.

Regulatory excerpt
Section 6.34(1) (Exposure control plan) of the OHS Regulation ("Regulation") states:

(1) If a worker has or may have occupational exposure, the employer must develop and implement an exposure control plan, based on the precautionary principle, that meets the requirements of section 5.54 and that includes the following:

(a) a risk assessment conducted by a qualified person to determine if there is a potential for occupational exposure by any route of transmission;

(b) a list of all work activities for which there is a potential for occupational exposure;

(c) engineering controls and administrative controls to eliminate or minimize the potential for occupational exposure;

(d) standard or routine infection control precautions and transmission-based precautions for all work activities that have been identified as having a potential for occupational exposure, including

(i) housekeeping practices designed to keep the workplace clean and free from spills, splashes or other accidental contamination,

(ii) work procedures to ensure that contaminated laundry is isolated, bagged and handled as little as possible, and

(iii) work procedures to ensure that laboratory or other samples containing a biological agent designated as a hazardous substance in section 5.1.1 are handled in accordance with the Laboratory Biosafety Manual issued by the World Health Organization, as amended from time to time, and the Laboratory Biosafety Guidelines issued by Health Canada, as amended from time to time;

(e) a description of personal protective equipment designed to eliminate or minimize occupational exposure;

(f) a program to inform workers about the contents of the exposure control plan and to provide them with adequate education, training and supervision to work safely with, and in proximity to, a biological agent designated as a hazardous substance in section 5.1.1;

(g) a record of all training and education provided to workers in the program described in paragraph (f);

(h) a record of all workers who have been exposed, while performing work activities, to a biological agent designated as a hazardous substance in section 5.1.1.

Section 5.54 (Exposure control plan) states:

(1) An exposure control plan must be implemented when

(a) exposure monitoring under section 5.53(3) indicates that a worker is or may be exposed to an air contaminant in excess of 50% of its exposure limit,

(b) measurement is not possible at 50% of the applicable exposure limit, or

(c) otherwise required by this Regulation.

(2) The exposure control plan must incorporate the following elements:

(a) a statement of purpose and responsibilities;

(b) risk identification, assessment and control;

(c) education and training;

(d) written work procedures, when required;

(e) hygiene facilities and decontamination procedures, when required;

(f) health monitoring, when required;

(g) documentation, when required.

(3) The plan must be reviewed at least annually and updated as necessary by the employer, in consultation with the joint committee or the worker health and safety representative, as applicable.

Purpose of guideline
The purpose of this guideline is to discuss the application of the Regulation to the protection of workers in the event of an influenza pandemic. It provides background information on regulatory context, the nature of pandemic influenza, routes of transmission, and adverse health effects.

It also provides information on exposure control plans in the workplace, and guidance on specific types of controls, including engineering measures, work procedures, and personal protective equipment.

The guideline does not specifically address issues related to the health of the public and any medical procedures used for the treatment of patients, which are within the mandate of public health and medical authorities. Internet locations for accessing further information on pandemic planning, whether for the workplace or the community, are provided at the end of this guideline.

Regulatory context
Sections 6.34 and 5.54 of the Regulation are basic requirements that apply in the circumstances of a pandemic influenza. However, they operate in the context of other requirements.

For example, Part 3 of the Workers Compensation Act ("Act") and Part 3 of the Regulation address issues such as employer and worker responsibilities, occupational health and safety programs, correction of unsafe conditions, undue risk, and the procedures related to any work refusals. The general requirements for chemical and biological safety in Part 5 of the Regulation help round out the framework.

What is pandemic influenza?
Pandemics are worldwide outbreaks of disease such as influenza. Three outbreaks of pandemic influenza (as opposed to seasonal influenza) occurred in the 20th century: 1918 (Spanish influenza), 1957 (Asian influenza), and 1968 (Hong Kong influenza).

Predicting the impact of an influenza pandemic on people is difficult until the time the actual outbreak occurs. Some pandemics have had a relatively minor impact, usually affecting the very old and young, and immuno-compromised persons. Others such as the Spanish influenza pandemic have involved exceptionally high morbidity and death among normally healthy persons. The concern with a pandemic based on a virus such as the H5N1 variety is the possibility of a new and highly virulent form of the virus for which the general population has no immunity, capable of effective person-to-person transmission, and causing high morbidity and mortality.

The World Health Organization (WHO), Health Canada and in British Columbia, the BC Centre for Disease Control (BCCDC), have recommended that all jurisdictions and workplaces develop influenza pandemic preparedness plans to reduce the potential for adverse effects arising from a pandemic. The WHO has advised that there is a risk of pandemic influenza that could cause widespread illness and death in humans.

Seasonal, pandemic, and avian influenzas can be differentiated as follows:

• Seasonal influenza - A disease caused by influenza viruses carried and spread among humans, typically on a seasonal basis.
• Pandemic influenza - A disease caused by a new strain (or subtype) of influenza virus that quickly spreads among humans worldwide because humans have little or no pre-existing immunity against it.
• Avian (Bird) influenza - A disease caused by influenza viruses carried and spread among birds. There are some cases where the virus has been transmitted from birds to humans.

There are a number of phases that a pandemic is likely to go through, as shown in the following Table.

Table 1: Pandemic influenza phases (adapted from the WHO global Pandemic Influenza Preparedness and Response 2009 guidance document)

Phase	Characteristics
Phase 1 - Pre-Pandemic	No animal influenza virus circulating among animals has been reported to cause infection in humans.
Phase 2 - Pre-Pandemic	An animal influenza virus is known to have caused infection in humans and is therefore considered a specific potential pandemic threat.
Phase 3 - Pandemic Alert	An animal or human-animal influenza virus has caused sporadic cases or small clusters of disease in people, but has not resulted in human-to-human transmission sufficient to sustain community-level outbreaks.
Phase 4 - Pandemic Alert	Human-to-human transmission of an animal or human-animal influenze virus able to sustain community level outbreaks has been verified.
Phase 5 - Pandemic Alert	The same identified virus has caused sustained community level outbreaks in two or more countries in one World Health Organization region.1
Phase 6 - Pandemic	In addition to the criteria defined in Phase 5, the same virus has caused sustained community level outbreaks in at least one other country in another WHO region.
Post-Peak Period	Levels of pandemic influenza in most countries have dropped below peak levels.
Possible New Wave	Level of pandemic influenza activity in most countries is rising again.
Post-Pandemic Period	Levels of influenza activity have returned to levels seen for seasonal influenza in most countries.

¹World Health Organization regions can be found at http://www.who.int/about/regions/en/

What are the symptoms of pandemic influenza?
The effects of a future pandemic influenza are expected to be much more severe than for seasonal influenza, due to a lack of immunity to the virus. Seasonal influenza affects people to varying degrees, with symptoms including headache, fever, fatigue, sore throat, and runny nose. In some cases secondary infections such as pneumonia may develop. Symptoms of pandemic influenza are likely to include high fever (higher than 38 degrees Celsius), chest pain, and difficulty breathing.

In its materials on pandemic influenza, the BCCDC advises influenza is communicable for 24 hours before onset of symptoms, and 3 - 5 days afterwards (but may be longer in some children and some adults).

How can pandemic influenza be spread?
Pandemic influenza would be spread in the same way that seasonal influenza is spread, typically by exposure to ill persons or contact with surfaces that an infected person has handled or touched.

Exposure to a pandemic influenza virus may occur in a variety of ways such as

• Breathing airborne droplets or particles containing influenza viruses (generated, for example, from coughing, sneezing, and aerosol-generating medical procedures used with infected patients)
• Infectious droplets (from a coughing or sneezing infected person) landing in the eye or onto the mucosa (moist inner surface) of the nose or mouth
• Shaking hands with an infected person or touching a surface contaminated with the virus followed by touching one's eyes, nose, or mouth
• Sharing food items or utensils with an infected person

Is there a vaccine or a treatment for pandemic influenza?
At present, there is no vaccine for the prevention of a future pandemic influenza. It is only possible to develop a vaccine after the actual pandemic influenza virus has been identified. In addition, it typically requires 4 to 6 months to produce a new influenza vaccine.

Antiviral drugs (that slow down or kill the virus) have been shown to be beneficial against seasonal influenza. However, their effectiveness against a pandemic influenza virus is not known. There is evidence that some of these products can reduce or stop influenza viruses from spreading throughout the body and improve the prospects of survival.

What is "occupational exposure" to pandemic influenza?
"Occupational exposure," as defined in section 6.33 of the Regulation, is the reasonably anticipated contact with a biological agent that is designated as a hazardous substance, resulting from the performance of a worker's duties. A pandemic virus is likely to be a hazardous substance under section 5.1.1 of the Regulation.

The possibility of contact varies depending on the specific organism and its route of transmission. For a virus causing pandemic influenza, contact resulting from the performance of a worker's duties may occur, for example, when caring for, or having other close contact with a person who has pandemic influenza. Examples of workplaces where contact may occur include hospitals, community care facilities, group homes, private homes, and ambulances.

What do you need in an exposure control plan (ECP)?
An ECP is a plan for preventing harmful exposure of workers to a pandemic influenza virus in the workplace.

Section 6.34 requires that if a worker has or may have occupational exposure, then an exposure control plan must be developed and implemented, based on the precautionary principle.

The precautionary principle, as defined in section 6.33 of the Regulation, means adopting provisional precautions covering all routes of transmission, based on a higher level of protection when the identity, causation, or routes of transmission of the biological agent designated as a hazardous substance have not been established. The use of this principle was one of the key recommendations of the Justice Campbell SARS Commission Report released in January 2007. The Commission recommended that in any future infectious disease crisis including pandemic influenza, the precautionary principle should guide the development, implementation, and monitoring of the means of protecting workers. In practical terms, the application of the precautionary principle to the protection of workers in an influenza pandemic will mean that in some cases respirators meeting an N95 standard or equivalent will need to be worn.

The ECP must incorporate the applicable elements outlined in section 5.54 of the Regulation, and be consistent with the provisions listed in section 6.34. In many workplaces of lower risk, the ECP may involve relatively few types of protective measures, such as provision and use of hand washing facilities and use of cough/sneeze etiquette. More extensive measures will be required for protection of workers in higher risk circumstances, such as health care personnel involved in direct patient care, emergency response personnel, and first aid attendants.

Elements of the ECP
An ECP will need to incorporate the following elements, as specified in section 5.54 of the Regulation:

• A statement of purpose and responsibilities
• Risk identification, assessment, and control
• Education and training
• Written work procedures, when required
• Hygiene facilities and decontamination procedures, when required
• Health monitoring, when required
• Documentation, when required

Section 5.54(3) requires that the ECP be reviewed at least annually and updated as necessary by the employer, in consultation with the joint OHS committee or worker health and safety representative, as applicable. To assist with communication and understanding, it is recommended the employer consult with workplace parties in the initial development of the ECP.

The elements of the ECP are discussed below.

1. Statement of purpose and responsibilities: While individual workplaces may state the purpose of this ECP in different ways, an underlying purpose of the ECP is to prevent harmful exposure of workers to a pandemic influenza virus in the workplace. Assignment of responsibilities for implementation of the ECP in a small workplace is likely to be straightforward, typically involving one person. In a larger workplace, there may be some division of responsibilities for implementing aspects of the ECP.



2. Risk identification and assessment: The extent of control measures included in the ECP will depend on the level of risk to worker health and safety. Thus a key step in assembling the exposure control plan is the proper identification and assessment of risk.

   Section 6.34(b) requires that the risk assessment be conducted by a qualified person to determine the potential for occupational exposure by any route of transmission. Under section 1.1 of the Regulation "qualified " means being knowledgeable of the work, the hazards involved, and the means to control the hazards, by means of education, training, experience, or a combination.

   Risk identification and assessment for exposure to the pandemic influenza virus should be based on factors such as routes of transmission, work activities, and workers who may be at risk.

   a. Routes of transmission by which the virus can infect a worker: In the case of pandemic influenza it is anticipated there will be three primary routes of transmission, all of which need to be controlled. Based on the use of traditional terminology, the routes are

   • Airborne transmission: Airborne (inhalable) particles can be generated from coughs and sneezes. They can also be generated from some medical procedures such as endotracheal intubation, bronchoscopy, nebulizer treatment, or airway suctioning.

     Both coughs and sneezes produce large droplets and smaller airborne particles. The smaller particles remain suspended in air for longer periods, and can be inhaled. In addition, large droplets can evaporate quickly to form inhalable particles. As the distance from the person coughing or sneezing increases, the risk of infection from airborne exposure is reduced, but can still be a concern in smaller, enclosed areas, especially where there is limited ventilation. As the number of infected people in a room increases, all things equal, the risk of infection can increase.

   • Droplet transmission: Large droplets may be generated by an infected person through coughing or sneezing, and also through medical procedures such as cough induction. Droplets travel a short distance through the air and can be deposited on inanimate surfaces, or in the eyes, nose, or mouth.
   • Contact transmission, both direct and indirect: Direct contact involves direct skin-to-skin contact, such as when a worker performs patient care or emergency response activity that requires direct personal contact (such as turning or bathing a patient). Indirect contact involves a worker's contact with a contaminated intermediate object such as a contaminated table top, door knob, or a computer keyboard used by an infected worker and then touching the eyes, nose, or mouth. Contact transmission is important to consider because influenza viruses can persist for minutes on hands and hours on surfaces.

   Note: The above discussion is based on the use of traditional terminology to describe routes of transmission. While the terms have general utility it should be noted that a report of the Council of Canadian Academies issued in December 2007 advises that it may be useful to update terminology. For example, the report notes that the diameter of a particle determines its ability to enter the respiratory tract. It advises that particles/droplets with diameters up to 100 µm (0.1 mm) can be inhaled, terming these as "inhalable particles." Particles larger than 100 µm are considered non-inhalable, and are termed "ballistic particles." The report also concludes that the current weight of evidence suggests that transmission of influenza by inhalation is more probable than by indirect contact. The report can be accessed at http://www.scienceadvice.ca/influenza.html

   b. Work activities that may result in exposure: The potential for workplace exposure will vary from sector to sector, and will also depend on work activities in a sector. For example, in the health care sector, direct patient care involves a higher potential for exposure to the virus than activities which involve work at a distance, such as delivery of supplies, or maintenance in areas where patients are not present. In the former case, all routes of transmission are possible; in the latter, the routes are more likely to be restricted to avenues such as indirect contact.
   Note: Section 6.34(b) requires that a list be assembled of all work activities for which there is a potential for occupational exposure.

   c. Identification of the workers at risk of exposure: Appropriate protective measures will vary according to the kinds of activities the workers perform and the relationship of those activities to routes of transmission and proximity to sources of infection.

3. Risk control: The required controls may range from simple hand washing and cough/sneeze etiquette, to more extensive measures requiring administrative and engineering controls as well as personal protective equipment (PPE). Control measures need to address all possible routes of transmission. Exposure controls must meet the requirements of section 6.34 (c), (d), & (e) of the Regulation.

   Engineering and administrative controls: Section 6.34(c) requires engineering and administrative controls to eliminate or minimize the potential for occupational exposure. An example of an engineering control in a hospital could include a well-ventilated isolation room with a directed airflow that ensures the safety of workers. An example of an employer's administrative work practice control is a policy of encouraging sick workers to remain at home. Work practices would also include the procedures established in the workplace to eliminate or minimize the potential for exposure. Such work practices may be substantial in higher risk workplaces (see Table 2).

   Standard precautions: Section 6.34(d) requires the implementation of both standard infection control and transmission-based precautions, to address issues such as housekeeping practices to keep the workplace free from accidental contamination, as well as measures to ensure safety when handling laundry or samples of biological agents. Ensuring the workplace is free from accidental contamination is a fundamental measure for protection against the pandemic influenza virus. Procedures for safety with laundry or diagnostic samples will be needed where applicable, for example, in health care facilities that provide such services.

   Personal protective equipment (PPE): Section 6.34(e) requires a description of PPE designed to eliminate or minimize occupational exposure. Depending on the circumstances of risk and the effectiveness of other controls, required PPE may include respirators, gloves, gowns, goggles, surgical masks, and face shields. The proper donning, fit checking, doffing, and disposal of the PPE and training in these practices must also be considered. Requirements for PPE are also found in Part 8 (Personal protective clothing and equipment) of the Regulation.Table 2 at the end of this guideline provides information on basic measures related to personal hygiene and PPE for several types of work circumstances.

4. Education and training: Under section 6.34(f) the employer must ensure that workers are informed about the content of the ECP and provided with adequate education, training, and supervision to work safely with and in proximity to the pandemic influenza virus. Information provided should ensure an understanding of the means of transmission of the virus and applicable control measures. Information on the use of PPE should include instruction on the means of donning and doffing the equipment.

   Supervisors need to ensure that instruction has been provided to workers in procedures, and that procedures are followed, including the use of PPE. Where PPE is required, supervisors need to lead by example.

5. Written procedures, hygiene/decontamination facilities, health monitoring, and documentation: Section 5.54 requires these elements of the ECP where necessary to protect workers. In the event of a pandemic influenza, the expectations are as follows:

   Written procedures would be required if the complexity of the procedure and risks involved, or the size of the workplace merit instructions being written. For example, written procedures might be required for a hospital isolation ward, but not in a small workplace of low risk as long as worker education and training addresses basic issues of worker protection.

   Hygiene facilities to permit proper hand washing whenever needed are a basic expectation under all ECPs. Decontamination procedures will be needed in some higher risk workplaces, for example, when cleaning re-usable personal protective equipment such as gowns, aprons, face shields, and goggles.

   In all workplaces workers should be monitored for possible symptoms of pandemic influenza. If a worker develops symptoms, appropriate measures should be taken to minimize exposure of other workers, and the worker should be referred to the appropriate medical authority.

   Sections 6.34(g) and (h) of the Regulation establish requirements for documentation of worker training and education, and of exposure to the virus when performing work activities. It is expected that documentation of the job positions that would involve exposure to the pandemic influenza virus coupled with the identity of workers who are in those positions will meet the intent of the requirement for records of worker exposure.

   Where to get more information
   Both WorkSafeBC and various public health authorities have web sites with further information on infectious diseases, pandemic planning, and protection from exposure.

   • WorkSafeBC - www.worksafebc.com
   • The BC Centre for Disease Control - www.bccdc.ca/default.htm
   • The Public Health Agency of Canada - www.phac-aspc.gc.ca
   • The World Health Organization - www.who.int
   • The US Centers for Disease Control - www.pandemicflu.gov

Table 2: Personal protective measures for pandemic influenza

This Table provides basic information for personal protection of workers in some but not all types of work situations.¹ A risk analysis will need to be done in all cases, including those covered by this Table, to ensure that control measures properly protect workers. The Table focuses on PPE and personal hygiene, but does not address work procedures or engineering controls, which also need to be considered in the exposure control plan.

	Low risk: Workers who typically have no contact with pandemic influenza-infected persons2	Moderate risk: Workers who may be exposed to infected persons from time to time in relatively large, well ventilated workspaces3	High risk: Workers who may have contact with infected patients, or with infected persons in small, poorly ventilated workspaces4
Hand hygiene	Yes (washing with plain or antimicrobial soap and water; or use of hand wipes that contain effective disinfectant)	Yes (washing with plain or antimicrobial soap and water; or use of hand wipes that contain effective disinfectant)	Yes (washing with plain or antimicrobial soap and water; or use of hand wipes that contain effective disinfectant)
Disposable gloves	Not required	Not required (unless handling contaminated objects on a regular basis)	Yes in some cases- e.g. when working directly with pandemic influenza patients
Apron, Gown, or similar body protection	Not required	Not required	Yes in some cases- e.g. when working directly with pandemic influenza patients
Eye protection - Goggles or Face shield	Not required	Not required	Yes in some cases- e.g. when working directly with pandemic influenza patients
Airway Protection - respirators	Not required	Not required (unless likely to be exposed to coughing and sneezing)	Yes (minimum N95 respirator or equivalent)

1. For example, lab work is an activity not covered by the Table. Lab workers will require appropriate hand, body, and eye protection when handling specimens that are or may be contaminated with the pandemic influenza virus. Also, approved respiratory protection would be required where there may be exposure to contaminated aerosols.
2. This category would typically apply to workers who do not have contact with the public, for example, in locations such as production facilities or administrative clerical areas.
3. This category would typically include workers who routinely deal with the public, some of whom may be infected with the pandemic influenza virus, in circumstances where typically the contact is of a short duration, and the workspace is relatively large and well ventilated. Examples include cashiers, tellers, receptionists, and sales persons. Protective measures may be required if workers handle, on a regular basis, objects that may be contaminated (e.g. money, paperwork, or ticket stubs), or are exposed to coughing or sneezing.
4. High risk activities typically involve workers (e.g. health care, first aid, and emergency response) who treat patients with pandemic influenza, or who do other work in isolation wards, rooms, or home settings where such patients are present. They may also include other circumstances where there is extensive contact with the public in small enclosed areas where ventilation is poor.

G6.36(1.1) Safety engineered needles

Issued January 1, 2007; Editorial Revision October 2, 2007; Editorial Revision February 1, 2008

Regulatory excerpt
Section 6.36(1.1) of the OHS Regulation ("Regulation") states:

(1.1) On and after January 1, 2008, a needleless device or safety-engineered hollow bore needle must be used for the following procedures performed to care for or treat a person:
(a) withdrawal of body fluids;
(b) accessing a vein or artery;
(c) administration of medications or fluids;
(d) any other procedure involving the potential for an exposure to accidental parenteral contact for which a needleless system or safety-engineered hollow bore needle system is available.

Purpose of guideline
This guideline explains the implementation period under section 6.36(1.1) and provides some examples of workplaces where the s. 6.36 requirements apply.

Implementation period
The requirements of sub-section 1.1 as well as the requirements in sub-sections 1.3, 1.4, 1.5, and 1.6 that apply to subsection 1.1, are effective on and after January 1, 2008, to provide sufficient time for employers to commit funds, adopt safety-engineered devices, change workplace policy and practices, and educate and train workers.

Definition of "workplace"
Section 106 of the Workers Compensation Act defines a workplace as any place where a worker is or is likely to be engaged in any work and includes any vessel, vehicle, or mobile equipment used by a worker in work. Some examples of workplaces where section 6.36(1.1) may apply include, but are not limited to

• Hospitals
• Ambulances
• Homecare sites where a community health nurse visits
• Blood collection clinics
• Correctional institutes
• Dental offices
• Medical and dental laboratories
• Health clinics, including those located in industrial facilities
• Outpatient facilities (including renal dialysis clinics and cancer treatment centers)
• Hemodialysis centers
• Drug treatment centers
• Blood banks
• Hospices
• Residential care facilities
• Assisted living residences
• Physicians' offices
• Naturopaths' offices
• Acupuncture clinics
• Tattoo parlours

G6.36(1.3) Not clinically appropriate

Issued October 2, 2007; Editorial Revision February 1, 2008

Regulatory excerpt
Sections 6.36(1.1) to (1.3) of the OHS Regulation ("Regulation") state:

(1.1) On and after January 1, 2008, a needleless device or safety-engineered hollow bore needle must be used for the following procedures performed to care for or treat a person:
(a) withdrawal of body fluids;
(b) accessing a vein or artery;
(c) administration of medications or fluids;
(d) any other procedure involving the potential for an exposure to accidental parenteral contact for which a needleless system or safety-engineered hollow bore needle system is available.

(1.2) On and after October 1, 2008, any medical sharp used to care for or treat a person must be a safety engineered medical sharp.

(1.3) Subsections (1.1) and (1.2) do not apply if

(a) use of the required device, needle or sharp is not clinically appropriate in the particular circumstances, or
(b) the required device, needle or sharp is not available in commercial markets.

And section 6.36(1.6) of the Regulation states:

Safe work procedures and practices relating to the use of a safety-engineered hollow bore needles and safety-engineered medical sharps must be developed and implemented before use of these devices.

And section 6.33 of the Regulation states:

"medical sharp" means a needle device, scalpel, lancet, or any other medical device that can reasonably be expected to make parenteral contact;

"safety-engineered medical sharp" means a medical sharp with a built-in safety feature or mechanism that eliminates or minimizes the risk of accidental parenteral contact while or after the sharp is used.

And section 6.34(1)(c) of the Regulation states:

(1) If a worker has or may have occupational exposure, the employer must develop and implement an exposure control plan, based on the precautionary principle, that meets the requirements of section 5.54 and that includes the following:

...

(c) engineering controls and administrative controls to eliminate or minimize the potential for occupational exposure

Purpose of guideline
The purpose of this guideline is to explain the term "not clinically appropriate" under section 6.36(1.3) and highlight that the s. 6.34(1)(c) requirements for engineering controls and administrative controls apply even where sections 6.36(1.1) and 6.36(1.2) do not apply.

Not clinically appropriate
A person who makes the determination of whether the use of a required device, needle, or sharp is clinically inappropriate should

• Be qualified. Under section 1.1 of the Regulation, "qualified" means being knowledgeable of the work, the hazards involved, and the means to control the hazards, by reason of education, training, experience, or a combination thereof
• Have expertise in the procedure in question
• Have knowledge of the devices that are commercially available for the procedure

The reasons why the use of a device required under section 6.36(1.1) is not clinically appropriate should be well documented for each procedure or type of procedure where that determination is made.

Note: Use of device required under s.6.36(1.1) may necessitate modification of a medical procedure. This circumstance alone does not necessarily mean that the use of the device will compromise patient care or safety, or worker safety. It may be clinically appropriate to use the required device even though its use in turn requires modification of a medical procedure.

Safe work practice controls
Section 6.34(1)(c) requires that engineering controls and work practice controls be established to eliminate or minimize the potential for occupational exposure. Therefore, even if a device, needle, or sharp required under s. 6.36(1.1) is not commercially available or not clinically appropriate to use, engineering controls (for example, puncture-resistant containers for sharps) and work practice controls must still be in place.

Where a required device, needle, or sharp is used, section 6.36(1.6) requires that safe work procedures and practices relating to its use be developed and implemented before use.

For further information on other engineering controls and work practice controls that may be appropriate for use under section 6.34(1)(c), see OHS Guideline G6.34-2 Risk assessment, engineering and administrative controls, and personal protective equipment.

G6.36(1.4) and (1.5) Highest level of protection

Issued October 2, 2007; Editorial Revision February 1, 2008

Regulatory excerpt
Sections 6.36(1.4) and 6.36(1.5) of the OHS Regulation ("Regulation") state:

(1.4) If more than one type of safety-engineered hollow bore needle or safety-engineered medical sharp is available in commercial markets, the needle or sharp that provides the highest level of protection from accidental parenteral contact must be used.

(1.5) For purposes of subsection (1.4), an employer must make a determination of the highest level of protection available based on information provided by manufacturers, independent testing agencies, objective product evaluation, or other reliable sources.

Regulation section 6.33 includes the following definitions:

"medical sharp" means a needle device, scalpel, lancet, or any other medical device that can reasonably be expected to make parenteral contact;

"parenteral contact" means piercing of mucous membranes or the skin;

"safety-engineered medical sharp" means a medical sharp with a built-in safety feature or mechanism that eliminates or minimizes the risk of accidental parenteral contact while or after the sharp is used;

Purpose of guideline
The purpose of this guideline is to discuss the requirements and considerations for selecting safety-engineered medical sharps (SEMS), including safety-engineered hollow bore needles, that provide workers the highest level of protection. The guideline also highlights some of the obligations of suppliers of these devices.

Considerations for "highest level of protection"
SEMS with similar or different engineering controls may provide comparable levels of protection. However, where evidence suggests that one device provides a higher level of protection than another in a particular circumstance, the employer is required to select the SEMS affording the highest level.

To determine which SEMS provides the highest level of protection, consideration should be given to

• Evidence that other devices would reduce accidental contact in that workplace and for that task more effectively
• Consideration and review of the different types of engineering controls that are commercially available for the relevant devices
• Information provided by manufacturers, independent testing agencies, "objective product evaluation" (see below), or other reliable sources, as specified in section 6.36(1.5)
• Conducting a periodic review to ensure that the devices selected are appropriate based on the most current scientific knowledge of protection from sharps injuries. For example, a review may identify technological developments that may eliminate or reduce exposure to a biological agent designated as a hazardous substance under section 5.1.1, as well as any new information on the efficacy of the selected devices.


Note: Review of exposure control plans
• Section 6.34 requires the employer to develop and implement an exposure control plan (ECP) meeting the requirements of section 5.54 if a worker has or may have occupational exposure.
• Section 5.54(3) requires the employer to review the ECP at least annually and update the ECP as necessary in consultation with the joint health and safety committee or the worker's health and safety representative as applicable.
• Section 5.54(2)(b) requires that the ECP incorporates the element of risk control, which includes the selection of devices under section 6.36(1.5) where applicable.

Objective product evaluation
Section 6.36(1.5) allows an employer to make a determination of the highest level of protection available based on an objective product evaluation. An objective product evaluation should enable the employer to assess the extent to which the SEMS eliminates or minimizes the risk of parenteral contact while or after the device is used. An objective product evaluation should assess the factors that are relevant to determining the effectiveness of SEMS and be applicable to the groups of devices and procedures under consideration. Anecdotal evidence alone is not sufficient to determine that a device provides the highest level of protection.

The following are examples of criteria for employers to consider when using an objective product evaluation to determine which SEMS provide the highest level of protection:

• The device includes built-in protection of the needle or other sharp
• The user can easily tell whether the safety feature is activated
• The device performs reliably
• The device is easy to use and is self-evident
• The safety feature is in effect before disposal and remains in effect after disposal

Sample evaluation forms for safety engineered needles and IV systems were developed through the training for Development of Innovative Control Technologies (TDICT) Project and are available at at http://www.osha.gov/. Type in the search term "TDICT" and click on the document noted as the 2001 -- 11/27/2001 CPL 02-02-069 ]CPL-2-2-69] - Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens.

Consideration of both "highest level of protection" and "clinically appropriate"
Section 6.36(1.3) recognizes that the use of SEMS affording the highest level of protection to a worker may not be clinically appropriate for certain clinical situations.

Consider the following example where an employer is initially considering three SEMS for use in a procedure:

	What level of protection from accidental parenteral contact does the SEMS provide the worker?	Is the SEMS clinically appropriate for the procedure in question?
SEMS #1	High	No
SEMS #2	Medium	Yes
SEMS #3	Low	Yes

In this case, although SEMS #1 may provide the highest level of protection to the worker, it has been determined that it is not clinically appropriate to use it in the procedure in question. Therefore, for the purposes of section 6.36(1.4), SEMS #2 must be used because it provides the highest level of protection among those SEMS that are commercially available and clinically appropriate to use in the procedure in question.

Suppliers' OHS obligations and highest level of protection
Section 120 of the Workers Compensation Act ("Act") places obligations on suppliers. For example, section 120 requires that every supplier must

Ensure that any tool, equipment, machine, or device, or any biological, chemical, or physical agent, supplied by the supplier is safe when used in accordance with the directions provided by the supplier and complies with Part 3 of the Act and the Regulation

Provide directions respecting the safe use of any tool, equipment, machine, or device, or any biological, chemical, or physical agent, that is obtained from the supplier to be used at a workplace by workers

For example, if a supplier fails to provide directions respecting the safe use of SEMS, then the supplier is in contravention of section 120. In this case, even if the SEMS could potentially provide the highest level of protection, the workers may not receive the highest level of protection because they are without adequate directions from the supplier.

Health Canada is the federal regulator that administers the Medical Devices Regulations, issued under the Food and Drugs Act. The Medical Devices Regulations apply to the sale and advertising for sale of a medical device and the importation of a medical device for sale or use on individuals. Under the Medical Devices Regulations, manufacturers have obligations regarding the safety and effectiveness of the devices. Manufacturer's compliance with this regulation alone does not guarantee that the use of the device provides the highest level of protection in general or in particular circumstances.

G6.40 Medical evaluation

Issued August 1999; Revised February 1, 2008

Regulatory excerpt
Section 6.40 of the OHS Regulation ("Regulation") states:

If a worker may have been exposed to the human immunodeficiency virus (HIV), hepatitis B virus or any other biological agent designated as a hazardous substance in section 5.1.1, the employer must advise the worker to seek immediate medical evaluation.

Purpose of guideline
The purpose of this guideline is to provide suggested management protocol in the event a worker is exposed to HIV, hepatitis B, or other biological agent designated as a hazardous substance under section 5.1.1. The guideline also provides information about the confidentiality of test results.

Management protocol
In the event that a worker has been, or may have been, exposed to HIV, hepatitis B, or any other biological agent designated as a hazardous substance in section 5.1.1, the management protocol typically will include immediate first aid, reporting, and documentation of the incident, followed by medical assessment at a hospital emergency department as soon as possible. The times in which a worker should receive a medical assessment for various types of occupational exposure should be included in the exposure control plan under section 6.34(1). For HIV, for example, this would be preferably within two hours of the incident.

Confidentiality
Medical personnel need informed consent in writing before blood tests are taken and before results regarding either the source or the exposed worker can be released. Blood tests include those for HIV, hepatitis B and C, and/or liver function status. Because all results are confidential, a WorkSafeBC prevention officer must respect the confidentiality of any information received in this regard from any source.

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Disclaimer: The Worker and Employer Services Division issues Guidelines to help with the application and interpretation of sections of the Occupational Health and Safety Regulation and with divisions of the Workers Compensation Act that relate to health and safety. Guidelines are not intended to provide exclusive interpretations but to assist with compliance. WorkSafeBC ("Workers' Compensation Board of B.C.") does not warrant the accuracy or the completeness of the online version of the Guidelines and neither WorkSafeBC nor its board of directors, employees or agents shall be liable to any persons for any loss or damage of any nature, whether arising out of negligence or otherwise, which may be occasioned as a result of the use of the online version of the Guidelines.