LAI - Monitoring of Laboratory-Acquired Infections

Laboratory-acquired infections (LAIs) refers to all direct or indirect human infections, regardless of whether they are symptomatic or asymptomatic, following occupational exposure to biological agents in a bio-containment facility. This study aimed at providing insight in the legal options for specific preventive measures (in particular vaccination and exclusion of candidate employees) and LAI monitoring, as well as their value and feasibility. 

The monitoring of LAIs aims at:

• (rapid) detection of the occurrence of an adverse event with risk of human infection.
• prevention of consequences for human health and the environment
• creation of evidence in effectiveness of the required containment measures (evidence-based biosafety).

In the project, a conceptual model has been developed to position different monitoring levels, as stated in the image below:

1. potential exposure
2. the employee who is exposed to biological agents
3. the occupational infection, thereby possibly starting with or without the indication of an exposure (e.g. bio-incident). 

The general lack of information on LAIs today, due to incomplete notifications of LAIs, prevents an in-depth analysis of the efficiency and effectiveness of the implemented protective measures (legal biosafety framework). The project report (CGM 2018-01) suggests that, in addition to focussing on monitoring, a centralised ‘open’ LAI reporting system should be developed with respect for privacy and confidentiality. The information collected through this system will be useful in evaluating whether similar situations can happen elsewhere, as well as how they can be avoided. This should result in a more evidence-based bio-risk management and in less biological accidents that can be harmful to the public or the environment.

Results

The key findings of the project are that:

• directives 2009/41/EC and 2000/54/EC are complementary and provide for monitoring possibilities
• monitoring of LAIs could lead to more knowledge of risks and better management 
• although legislation derived from Directives 2009/41/EC and 2000/54/EC is complementary, distinct government authorities might be involved in their implementation, causing fragmentation of authority. As a result notification obligations and follow-up might be overlooked
• the potential for adverse biological effects from activities with biological agents, including GMOs, for the environment and population:
  • is considered low, based on the limited data, thus it is socially not a priority
  • cannot be completely ruled out, mainly caused by non-GMOs from R&D (and relatively less from diagnotics activities)
  • the share of GMOs is marginal as GMOs are often intrinsically contained with regard to the risk for the population and the environment (e.g. auxotrophy, nonreplicative, attenuation, …)
  • there is no centralised reporting system for LAIs and accidents involving biological agents
  • there is only a limited number of ‘lessons learnt’, which leads to
    • incomplete and fragmented data on LAIs
    • no optimal risk management for avoiding similar accidents and the pragmatic organisation of the legal requirements.

This project was commissioned by COGEM. The contents are the sole responsibility of the authors and may in no way be taken to represent the views of COGEM.