Biological Agents in Healthcare: Employer Duties in Ireland

Healthcare workers can be exposed to biological agents (such as bacteria and viruses) simply by doing their jobs, and Irish health and safety law places specific duties on the employer when that happens. Those duties are in the Safety, Health and Welfare at Work (Biological Agents) Regulations 2013 (S.I. No. 572 of 2013), as amended by S.I. No. 539 of 2020. This guide explains what the regulations require of employers in healthcare and social care, how they connect to occupational health, and what we could and could not confirm from the official pages. It sits next to, but is different from, clinical infection control; for that side, see our overview of infection prevention and control training for healthcare staff.

This is a compliance guide for employers and managers. It gives no medical advice and does not describe how to treat any condition.

What the regulations are and what the HSA says about healthcare

According to the Department of Enterprise, Tourism and Employment's page (dated 20 December 2013), the regulations transpose Directive 2000/54/EC on the protection of workers from risks related to exposure to biological agents at work. The Health and Safety Authority (HSA) page "Biological Agents in Health and Social Care" (no date shown) says exposure can be intentional, as in a microbiology laboratory, or unintentional, as during patient care, and can arise through direct contact with service users or through contaminated materials such as waste, laundry and surfaces. It names norovirus, influenza A, SARS-CoV-2 and hepatitis B virus as common agents.

The HSA is also clear about what it does not do: it enforces the regulations but does not handle clinical infection control, which is addressed elsewhere. In other words, the employer duty to protect workers is a health and safety matter, separate from the clinical standards your service follows.

Who and what is covered

We read the regulations on the HSA's website (the text as made in 2013). Regulation 3 applies them to activities where exposure to a biological agent has occurred or may occur. If a risk assessment shows exposure only to a group 1 agent, with no identifiable health risk, several duties do not apply, though good occupational safety and hygiene principles must still be observed. The obligations are in addition to those under other enactments, which is why they sit alongside the Safety, Health and Welfare at Work Act 2005 and, for sharps, the 2014 sharps regulations.

The main employer duties

The following summary reflects the regulation headings and wording as we read them. Check the current consolidated text before relying on any detail.

General duties and risk assessment (Regulations 5 and 7)

Employers must apply the regulations and any relevant code of practice, avoid use of a harmful agent where a less dangerous one can be substituted, and, where exposure cannot be prevented, apply the Schedule 2 measures so that exposure is reduced as far as technically practicable. Risk assessment under Regulation 7 must cover any existing or potential risk to employees' health and safety, be in writing, use all available information, and be reviewed when conditions change. Your general safety statement and risk assessment process is the natural home for it.

Information, training and consultation (Regulation 8)

Employees must be given training before work involving contact with a biological agent begins, and repeated as needed. It covers the risks, precautions, hygiene, protective equipment and the steps to take in an incident. Written instructions are required for serious incidents and for group 4 agents, employees must be told immediately of incidents that could cause severe infection, and they must be consulted on risk assessment matters.

Hygiene and protective equipment (Regulations 9 and 10)

Employers must prohibit eating and drinking where contamination is a risk, provide adequate washing and toilet facilities, and set procedures for handling samples of human or animal origin. They must also supply work clothing, protective clothing and personal protective equipment, and make sure contaminated items are removed when leaving the work area, kept separately, and checked, cleaned, decontaminated or destroyed as needed.

Vaccination and health surveillance (Regulations 11 and 12)

Employers must make effective vaccines available, when necessary, to employees who are not already immune. Schedule 4 requires that vaccination be offered free of charge and that employees be told of its benefits and drawbacks. For health surveillance, Regulation 12 requires appropriate surveillance, as provided for in section 22 of the 2005 Act, for employees at risk, carried out by a responsible medical practitioner and available before exposure and at necessary intervals. Individual health records must be kept for at least 10 years after exposure ends. The HSA's separate vaccination and health surveillance pages were menu-only when we opened them, so we cannot summarise their guidance.

Exposure lists and notification (Regulations 14 and 15)

Employers must keep a list of employees exposed, or potentially exposed, to certain agents (group 3 and group 4, and certain group 2 agents as specified in a code), noting the work done and the agent where possible. Records are kept for at least 10 years after the last known exposure and up to 40 years for certain persistent, latent or long-term illnesses. Employees can access their own entries. Regulation 14 sets out notification to the HSA, including immediate reporting of accidents or incidents that could release an agent and cause severe infection, and notification before first use of certain agents. How the first-use notification applies to incidental exposure in a care setting is a question for the HSA's notification guidance, which we could not read.

Healthcare facilities (Regulation 16)

Regulation 16 applies specifically to health care and veterinary care facilities other than diagnostic laboratories. As we read it, the employer must give particular attention in the risk assessment to the nature of the work, uncertainties about biological agents in patients, and the hazard from agents known or suspected to be present; take appropriate measures to protect employees, including specifying decontamination and disinfection procedures and procedures for handling and disposing of contaminated waste; and apply appropriate containment measures at isolation facilities where patients are infected or suspected of being infected with certain agents.

The 2020 amendment (S.I. No. 539 of 2020, made on 22 November 2020) implements two EU directives, including one on SARS-CoV-2, removes one listed activity from Schedule 1 (work in biotechnology, including the production of pharmaceutical products), and deletes a subparagraph of Regulation 16(c). The 2020 instrument states that Regulation 16(c) is amended by deleting subparagraph (i), which in the 2013 text referred to group 2 agents specified in a code of practice, so check the current text of Regulation 16 directly.

What employees must do (Regulation 6)

Employees must report immediately to their employer any accident or incident involving exposure, risk of exposure or release of a biological agent that could affect health or safety. Make sure your induction tells staff how and to whom.

Where pregnancy and other circumstances come in

Individual circumstances matter in risk assessment. We do not give advice on individual cases here, but our guide on pregnant employees and workplace risk assessment covers the separate employer duties that apply when an employee notifies you of pregnancy.

A practical approach for managers

The following points are our suggestions, not legal requirements.

• Map your service: which roles may have contact with patients, service users, waste, laundry or surfaces, and which tasks add risk?
• Keep the written risk assessment where managers can find it, and diarise a review after any change in service, equipment, or staffing.
• Agree who owns occupational health referral, vaccination offers and exposure lists, and where records are stored securely.
• Include biological agent reporting in induction and refresh it when procedures change.
• Keep records of training with dates so you can show what was given and when.

What we could not confirm

Several HSA pages (the biological agents legislation page, vaccination, FAQs and notification) were menu-only, and the Code of Practice on the HSA site could not be read in an official form, so we have not described its detail. We read the 2013 text as published by the HSA, not a consolidated version, and we did not check for amendments beyond the 2020 instrument. No penalties provision was in the text we read, so we state none.

Learnsignal's offices are off Baggot Street in Dublin, and we offer in-person training from there. For current details, see our CPD pages.

Frequently asked questions

Does the HSA regulate infection control in hospitals?

No. The HSA says it enforces the biological agents regulations but does not handle clinical infection control, which is addressed elsewhere.

Must employers offer vaccination?

The regulations require employers to make effective vaccines available, when necessary, to employees not already immune, and Schedule 4 requires that it be free of charge. Whether it is necessary depends on the risk assessment.

How long are exposure records kept?

As we read Regulation 15, the exposure list is kept for at least 10 years after the last known exposure, and up to 40 years for certain long-term illnesses. Health records under Regulation 12 are kept for at least 10 years after exposure ends, and for a longer period of up to 40 years for the exposures covered by Regulation 15(c).

Do these duties apply to care homes and home support?

The regulations apply to activities where exposure to a biological agent has occurred or may occur, and the HSA page covers health and social care generally. Whether a given task creates exposure is for your risk assessment.

A written, regularly reviewed risk assessment is the foundation for every other duty in these regulations.