Title

Determine which biosafety level(s) the facilities need to comply with

Why

Besides the essential biosafety requirements that apply to every TB laboratory regardless the type of procedures being performed, there are also additional requirements that do depend on the procedures being performed at the laboratory. This variable, plus the fact that the state of the facilities and safety situation varies from laboratory to laboratory, makes provision of a fixed facilities and safety improvement plan for all laboratories impossible. Therefore the choice was made in this tool to follow a risk-based approach. This means that the laboratory first has to determine the risk level of each room of the laboratory and develop a facility and safety improvement plan based on this risk level.

What

In chapter 1 of the WHO TB Laboratory Biosafety Manual the different risk levels of TB laboratories are described. Determine for every laboratory room the risk level based on the information from this chapter. Chapter 3 to 5 of the TB Laboratory Biosafety Manual provide the requirements related to the different risk levels. Develop an improvement plan to get each laboratory room to comply with the requirements related to the risk level of that room.

How & who

Biosafety Officer:

  1. Determine the risk level of laboratory room using the information from chapter 1 of the WHO TB Laboratory Biosafety Manual.
  2. Discuss the results with the Laboratory Manager and determine which activities are needed to get into compliance with the risk group requirements of each laboratory room.
  3. Make an action plan together with the Laboratory Manager to execute the activities under point 2 and achieve compliance with the safety requirements related to the risk group of each room.
  4. Store this action plan in the dedicated Action Plan folder and monitor timely execution of action plans. Discuss the progress of implementation of the action plan during the bimonthly meetings with the Laboratory Manager.


Laboratory Manager:

  1. The Biosafety Officer will determine the risk group of each laboratory room based on information from the WHO TB Laboratory Biosafety Manual. Discuss the results and determine which activities are needed to get into compliance with the risk group requirements of each laboratory room.
  2. Develop a planning together with the Biosafety Officer to execute the activities under point 2 and achieve compliance with the essential safety requirements for TB laboratories. Discuss progress of execution of this plan during the bimonthly meetings with the Biosafety Officer.


Note that it is better to develop a multiyear action plan that is realistic (SMART!) than an over-ambitious plan that cannot be adhered to.

Back to Roadmap Activity Overview
This activity belongs to the QSE Facilities & Safety

 

ISO15189:2007: 5.2.1 5.2.2 5.2.4
ISO15189:2012: 5.2.1 5.2.2
ISO15190:2003: 4