Title

Appoint a Biosafety Officer

Why

Medic al laboratories are potentially dangerous places to work due to chemical, electrical, mechanical, physical, but above all biological hazards, especially in tuberculosis laboratories due to the high contagiousness of TB. As such it is important to always minimize every risk in the laboratory. A method to achieve this is to develop procedures for safe behavior. Examples are procedures for safe handling of samples, safety rules for personnel and visitors in the facility, safe handling of equipment, etc. The facility should also permit safe handling of microorganisms.


ISO 15189 contains only one requirement on safety, merely stating that the laboratory must be safe and should comply with good practice and applicable requirements. This requires much staff time and specialized training. The process of controlling and improving the safety of the laboratory needs good coordination. For this a Biosafety Officer must be appointed.


In the right-hand column the WHO Laboratory Quality Management System (LQMS) handbook chapter on facilities and safety is provided. This gives easy to read and understandable information on all the safety aspects related to laboratory practice and should be read by all laboratory staff members. The WHO has also published a Laboratory Biosafety Manual especially for TB laboratories. This gives more specialized information on TB laboratory biosafety and should at least be read by the Biosafety Officer (although it is highly recommended that all personnel members read this manual).

What

The first step in the safety improvement process is to appoint a Biosafety Officer. This person is responsible for all the topics related to safety and he/she will be the one planning and managing the safety improvement process. It is, off course, important that the Biosafety Officer receives the full support from the Laboratory Management so that the Biosafety Officer is fully recognized by all the staff members and can perform his/her work with full cooperation from everybody.


The Biosafety Officer has an advisory function to the Laboratory Management. Examples of tasks of the Biosafety Officer are (note that these are just a few examples, more tasks may be added when needed):

  • Developing the safety policy and procedures (in consultation with the Laboratory Manager)
  • Orientation and training of all laboratory staff in biosafety
  • Providing safety advice
  • Ensuring staff compliance with safety policies and procedures by performing regular safety inspections, and documenting and submitting reports of such inspections to the Laboratory Manager for review and action
  • Investigating laboratory accidents and documenting accident reports

How & who

Laboratory Manager:

  1. Start with making a "profile" of the position Biosafety Officer. This means: make a description of the tasks and responsibilities for the Biosafety Officer.
  2. After this, choose a staff member that is willing to, and competent to be the Biosafety Officer. Appoint this staff member as Biosafety Officer and discuss with him/her the tasks and responsibilities belonging to this position.
  3. After appointing the Biosafety Officer explain to all staff members who the Biosafety Officer is and what his/her tasks and responsibilities are.

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This activity belongs to the QSE Organization
ISO15189:2007: 4.1.5
ISO15189:2012: 4.1.2.5
ISO15190:2003: 5.17.1