In brief
Every clinic, frail care centre, dental surgery and veterinary practice in South Africa works under a set of health and safety regulations that most of them have never read in full. The Regulations for Hazardous Biological Agents, 2022 apply to every employer at a workplace where "exposure to an HBA may occur", and in a place that treats patients or residents that exposure is the normal working day. [1][2] The regulations do not stop at a risk assessment. They set four separate clocks, each running at intervals not exceeding 24 months: the risk assessment review, exposure monitoring, periodic medical examinations and the thorough examination of control measures. They add a 14-day deadline for a new employee's first health evaluation, require a clause in the waste contractor's contract, and keep the resulting records for 40 years. [1] None of these clocks is set by a gazette. Each one starts on the day the facility last did the work.
What the regulations are and when they started
The Regulations for Hazardous Biological Agents, 2022 were made under section 43 of the Occupational Health and Safety Act, 1993, published as Government Notice R. 1887 in Government Gazette 46051, and took effect on 16 March 2022. [1][2] They withdrew and replaced the Regulations for Hazardous Biological Substances, 2001, so a safety file that still cites the 2001 instrument is citing a regulation that has not existed for more than four years. [1] The Department published explanatory notes in the same gazette as Government Notice R. 1887A. [3]
A "hazardous biological agent", or HBA, is a biological agent classified into one of four risk groups by its ability to cause human disease, from Group 1 (unlikely to cause disease) to Group 4 (serious disease, readily transmissible, usually without effective treatment). [1] At publication, SARS-CoV-2 was listed in Group 3, which is why most commentary in 2022 read the regulations as a COVID-19 instrument. [2] They are much wider than that. Regulation 2 applies them to every employer or self-employed person at a workplace where an HBA "is produced, processed, used, handled, stored or transported" or where "exposure to an HBA may occur". [1] There is no sector list and no size threshold.
One limited carve-out exists. Where exposure is restricted to Group 1 agents only, regulations 8 (medical surveillance), 14 (labelling and transport) and 15 (disposal) do not apply. [1] A facility caring for sick people cannot plausibly claim that its exposure is restricted to agents unlikely to cause disease.
The four clocks
Each of the following runs at intervals the regulations cap at 24 months. [1]
- The risk assessment. Regulation 6 requires the employer to conduct and document a risk assessment, by a competent person, to determine whether any person could be exposed, taking into account among other things the effects on "pregnant, immunocompromised and vulnerable employees". The employer must then develop a documented action plan for the recommendations and inform employees and the health and safety representatives or committee of the results. Regulation 6(6) requires a review "at intervals not exceeding 24 months", and immediately if the assessment is no longer valid, if a process or the methods, plant or procedures change, if an incident involving an HBA occurs, or if medical surveillance reveals an adverse health effect. [1][2]
- Exposure monitoring. Regulation 7 requires an exposure monitoring programme representative of employees' exposure, conducted by a competent person, at intervals set in the risk assessment "but not exceeding 24 months", and again whenever a change may affect exposure, with its own documented action plan. [1][2]
- Medical surveillance. Where the risk assessment shows an employee is at risk of exposure, regulation 8 requires a documented system of medical surveillance overseen by an occupational health practitioner: an initial health evaluation "immediately before or within 14 days after" the person starts, periodic examinations at intervals the practitioner sets but not exceeding 24 months, and an exit examination. [1][2]
- Control measures. Regulation 12 requires documented, risk-based protocols for every control measure, item of plant and facility relied on, from ventilation to biosafety cabinets, and a thorough examination and test of each "at intervals not exceeding 24 months", with the results documented and available for inspection. [1]
The records run longer than any of the clocks. Regulation 9 requires risk assessments, exposure monitoring and medical surveillance records to be kept for at least 40 years, regulation 12 test and repair records for five years, and training records for as long as the employee remains at that workplace. [1][2] Personal medical records are excluded from what an inspector or representative may see, and the explanatory notes direct that health records and confidential medical records be kept apart, with the practitioner telling the employer only about fitness for work and any restrictions. [1][3]
Three duties that sit outside the clinical team
Three of the duties are routinely missed because they are not clinical work.
- Training before exposure. Regulation 4 requires every employee at risk of exposure, or of exposing others, to be informed, instructed and trained in both the practical and theoretical aspects, including the regulations themselves, the use and limits of protective equipment and what to do in an emergency. [1][2] Cleaners, porters, kitchen staff, laundry staff and administrative staff who enter patient or resident areas are all within that wording.
- The waste contract. Regulation 15(f) requires that where a waste disposal contractor is used, "a provision is incorporated into the contract stating that the contractor must comply with the provisions of these Regulations". [1] The duty is the facility's, and the evidence is a clause in a contract usually held by procurement or finance.
- Signage and prohibitions. Regulation 13 prohibits eating, drinking, smoking and applying cosmetics where an HBA is handled, and leaving a controlled area without removing potentially contaminated protective clothing, and requires a notice of those prohibitions to be posted in a conspicuous place. [1]
Contravention of most of the regulations is an offence, punishable on conviction by a fine or imprisonment of up to 12 months, with an additional fine of R200 for each day a continuous offence continues. [1][2]
Where the clocks usually stop
The difficulty in a healthcare setting is rarely the first assessment. It is that each clock is reset by an event that belongs to someone else.
A new hire triggers the 14-day initial evaluation, and hiring happens in human resources. A new procedure, a new piece of equipment or a change to a ward's use triggers a review of the risk assessment, and those are decided by clinical leadership, procurement or the board. [1] A needlestick or splash incident triggers a review as well, and is usually handled as a clinical event rather than a compliance one. The thorough examination of extraction or ventilation sits with facilities, and the waste contract with procurement. The occupational health practitioner holds the medical records, and is often an outside provider. None of these people holds the risk assessment, and none of them is required by the regulations to tell the person who does.
Five questions for a healthcare employer
Each has a yes or no answer.
- Does your current safety file cite the Regulations for Hazardous Biological Agents, 2022 rather than the withdrawn 2001 regulations, and is the HBA risk assessment dated within the last 24 months?
- Was the assessment reviewed after the last procedure change, equipment change or exposure incident, and can you show the action plan that followed it?
- Did the most recent person to join a patient-facing or resident-facing role have an initial health evaluation within 14 days of starting, and HBA training before exposure?
- Does your contract with your healthcare risk waste contractor contain a clause requiring the contractor to comply with the regulations?
- If your occupational health provider changed tomorrow, where would the 40-year surveillance and monitoring records be, and who would hold them?
A facility that answers yes to all five is ahead of most of its peers.
GRC Shop view
This section is opinion and interpretation, not a statement of law.
In our view the Hazardous Biological Agents Regulations are the most underestimated instrument in South African healthcare compliance, because they were introduced in the language of the pandemic and many facilities filed them away when the pandemic ended. The text does not depend on COVID-19 at all. It reaches every agent in Annexure A, and a frail care centre, a day clinic or a dental practice meets those agents every working day. We read regulation 4's training duty as reaching non-clinical staff who work in clinical areas, and regulation 6's "vulnerable employees" as a reason to revisit the assessment whenever a pregnant or immunocompromised employee is placed, though each employer should take its own advice on both.
Compliance files go stale. Our system keeps yours current. The assessment a facility commissioned is usually sound on the day it is signed, and the occupational health provider usually does good work. What fails is afterwards: people are hired, procedures change, an incident happens, the waste contract is renewed, and none of it reaches the file, so a year later the assessment still reads well and no longer describes the facility. The GRC Shop platform does one thing, and its OHS app is currently the only app on it: it keeps a single managed, live record of a business's OHS obligations, assessments, training and evidence, with the dates that matter attached, so that the person the Act holds accountable can see the current position without asking anyone to send it.
If you would like to see what that looks like for your facility, request a quote at https://www.grcshop.co.za/get-a-quote
Abbreviations
- HBA: hazardous biological agent
- OHS: occupational health and safety
References
[1] Department of Employment and Labour, "Regulations for Hazardous Biological Agents, 2022", Government Notice R. 1887, Government Gazette 46051, 16 Mar 2022, as published by the Southern African Legal Information Institute's Law Library. https://lawlibrary.org.za/akn/za/act/gn/2022/r1887/eng@2022-03-16
[2] Bowmans, "South Africa: New hazardous biological agents regulations further regulate employers' responsibilities for managing COVID-19 exposure in the workplace", 18 Mar 2022. https://bowmanslaw.com/insights/south-africa-new-hazardous-biological-agents-regulations-further-regulate-employers-responsibilities-for-managing-covid-19-exposure-in-the-workplace/
[3] Department of Employment and Labour, "Explanatory notes to the Regulations for Hazardous Biological Agents, 2022", Government Notice R. 1887A, Government Gazette 46051, 16 Mar 2022. https://lawlibrary.org.za/akn/za/act/gn/2022/r1887a/eng@2022-03-16