Biosafety

Issues regarding biosafety can be directed to the institution´s Biosafety representatives, or to the KI´s Biosafety coordinator, or if you want to report your work with microorganisms or GMM to the Swedish Work Environment Authority. 

When working with infectious agents such as blood and human sample material, infectious microorganisms, or genetically modified microorganisms (GMM), risks must always be considered by conducting a risk assessment. Based on the risk assessment, necessary personal protective equipment and other protective measures are determined, as well as the required safety level in laboratories for the work.

Work with microorganisms that can cause infection in humans and all work with GMM requires approved notification or permission from the Swedish Work Environment Authority. 

Work with infectious agents and genetically modified microorganisms is primarily regulated by the following two regulations from the Swedish Work Environment Authority:

• AFS 2023:10 Chapter 11 Infectious Risks
• AFS 2023:13 Chapter 9 Contained Use of Genetically Modified Microorganisms

For more in-depth information, WHO has published an informative handbook in English.

Risk Assessment for Biosafety

Risk assessments must be conducted to ensure a safe working environment and to raise risk awareness. 

For risk assessments of blood and other human sample material, the Human Sample Risk Assessment (HUMRA) form can be used, and for risk assessment of microorganisms that can cause infection, the Biological Agent Risk Assessment (BARA) form is a useful tool. Both forms are developed by KI’s Biosafety Committee.

Work with genetically modified microorganisms always requires a risk assessment. However, the extent of the risk assessment depends on the level of risk associated with the work with GMM. Risk assessment of GMM is conducted using forms from the Swedish Work Environment Authority.

The Swedish Work Environment Authority’s regulation AFS 2023:10 Chapter 10 Infectious Risks describes how and when risk assessments should be conducted and documented for blood, human sample material, and microorganisms that are not genetically modified. For genetically modified microorganisms (GMM), see AFS 2023:13 Chapter 9.

Bloodborne Infections

Primarily, hepatitis B and C, as well as HIV, can be transmitted through handling human blood. Note that bloodborne infections can also be transmitted through materials contaminated with blood, such as tissue, wound fluid, spinal fluid, urine, pipette tips, and similar. Cell cultures can also transmit bloodborne infections.

Blood Handling

Handling blood can pose a risk in the laboratory environment, and all handling of human blood and other human sample material, such as tissue and primary cultures, is regulated by AFS 2023:10 Chapter 11 Infectious Risks. The main rule in this regulation is to handle all blood and blood-contaminated material as infectious. More information on how blood should be handled can be found in KI’s Blood Rules under documents.

Work with blood should only be performed by those who have received training on infectious risks, transmission routes, how to avoid infection, and protective measures. No special permission from the Swedish Work Environment Authority is required for handling blood, but the laboratory must be at least safety level 2 depending on the risk assessment. 

There must be written instructions on how the blood should be handled at each workplace. The written instructions should be based on a risk assessment. The risk assessment can be conducted using KI’s form for risk assessment of blood and other human sample material - HUMRA. See the Risk Assessment Form under Documents.

Blood from blood banks should also be handled as potentially infectious as it is often not tested before being released.

For microorganisms in risk class 2 and above, notification or permission is required.

Registration and Risk Assessment of Microorganisms

Microorganisms are classified into four risk classes, 1-4, based on their ability to cause infection and the severity of the consequences. The classification is based on work with biological agents in the laboratory, where work with agents in higher risk classes involves higher risk.

Microorganisms that normally do not cause infectious diseases are classified as risk class 1. They can still cause health issues due to hypersensitivity or toxin effects. The regulation AFS 2023:10 Chapter 11 Infectious Risks includes a classification list of the most common microorganisms in risk classes 2-4.

Microorganisms in risk classes 2-4 inherently pose a risk and must always be risk assessed, while microorganisms in risk class 1 only need to be risk assessed if the user believes the work may involve a risk. KI’s risk assessment form BARA can be used to assess the handling of microorganisms. The form is divided into two parts, where part A is used to characterize the microorganism and part B describes handling, exposure risks, and protective measures. 

Part B can be used for both laboratory work (B1) and handling of microorganisms in animal experiments (B2). 

Handling of non-genetically modified infectious microorganisms in risk classes 2-4 requires notification to the Swedish Work Environment Authority. 

If you have questions regarding risk classification, contact KI’s Biosafety Coordinator. 

Exceptions are made for diagnostic activities where handling only involves the use of the original patient sample, such as for chemical analysis where enrichment does not occur. Research activities on microorganisms in risk class 2 and above almost always require notification.

At a workplace that has received permission or approved notification to handle infectious microorganisms, the following applies:

• handling instructions established in connection with the notification must be followed
• only those who have been informed about the risks may work there
• work should only take place in the specified locations
• the premises must be marked
• documentation regarding the notification must be easily accessible, e.g., in the laboratory binder.

When registration notifying, it is defined which microorganisms will be used. If you want to handle additional microorganisms in the same laboratory, or otherwise want to supplement/change, an update of the notification is required. 

The regulation and the Swedish Work Environment Authority’s website also provide information on the required details for notification. At KI, all notifications are sent to the Biosafety Coordinator for review. The Biosafety Coordinator then sends the documentation to the Swedish Work Environment Authority. 

Note that the institution should be aware of which microorganisms at safety level 2 and above are handled, via the institution’s Biosafety delegates. Read more about this on the page “Biosecurity”.

During safety rounds or inspections from the Swedish Work Environment Authority, documentation regarding the permit, as well as all routines included in the notification such as risk assessments/handling instructions, should be available.

Registration, Permission, and Risk Assessment for GMM

The definition of a genetically modified microorganism (GMM) is a microorganism whose genetic material has been altered in a way that does not occur naturally through mating or natural recombination (SFS 2000:271). 

All activities with GMM must be risk assessed and notified to or receive permission from the Swedish Work Environment Authority. This is done through KI’s Biosafety Coordinator and in consultation with the institution’s biosafety representatives. For GMM that may pose a risk, each use must also be notified to the Swedish Work Environment Authority. 

Information about GMM can be found on the Swedish Work Environment Authority’s website and in AFS 2023:13 Chapter 9 Contained Use of Genetically Modified Microorganisms. 

More information is available on the page Registration, Permission, and Risk Assessment of GMM.

Protective Measures 

The protective measures to be taken when handling biological material depend on how the material is transmitted. Often, both chemical and biological materials are handled simultaneously, which needs to be considered. The choice of protective measures should be defined during the risk assessment. Remember to define the choice of protective measures and when they should be used in written routines so that everyone in the laboratory works in the same way to avoid infection.

Gloves

The risk assessment determines whether gloves need to be used, and if so, what type of glove. When choosing gloves for microbiological work, both penetration ability and resistance to cuts should be considered. 

Hand washing and hand disinfection should always be performed after removing gloves during microbiological work. Disinfectants destroy the protective properties of the gloves. Remember that gloves become infectious and should therefore be changed often. Note that not all microbiological work needs to be conducted with gloves on. 

More detailed information about protective gloves.

Protective Clothing

During microbiological work at KI, protective clothing, such as a laboratory coat, should always be worn. This should be removed when leaving the work area. When transporting microorganisms, e.g., within the institution, but where public areas are accessed, microorganisms should be stored in a transport box or equivalent, and the protective clothing should be removed. 

More information is available on the page Transport of biological specimens and chemical products.

Ventilated Workplaces

Whether ventilated workplaces need to be used, and what type should be used, should be determined by the risk assessment for the experiments. More information is available on the page Ventilated Workplaces.

Other Methods for Protection Against Infection

When only splash protection is required, such as often during blood handling, no ventilation is needed. In these cases, a plexiglass screen, visor, or goggles and a face mask may be used. The risk assessment determines which protection should be used. In these situations, a fume hood often works well as protection.

Vaccinations

When working with specific microorganisms for which vaccines are available, and when there is a risk of bloodborne infection, vaccination should be offered to the laboratory worker, following a risk assessment/medical evaluation. More information is available on the page Vaccination.

Spills

In the event of a spill of biological material, it is important to quickly take action to prevent harm to personnel or the environment:

1. isolate the area to avoid exposure to aerosols
2. read the risk assessment
3. contact a specialist for advice, such as occupational health services, an infection clinic
4. clean up yourself if possible. Never let the cleaning staff clean up! They do not have the competence for this.

The risk assessment determines how the cleanup should be performed. It takes several minutes for aerosols to settle. Usually, the area should be covered with paper towels or equivalent, then a disinfectant chemical should be poured onto the paper towels. It is important that the chemical has sufficient contact time, such as 5-10 minutes.

After that, the material should be handled as infectious. The surface is disinfected again and then washed with a non-oxidizing chemical, such as ethanol or detergent.

Note that the disinfectant chemical must be proven effective against the biological material in question.

In the event of a spill in a microbiological safety cabinet, point 1 can usually be omitted. In the case of a contaminated centrifuge or incubator, the lid/incubator door should instead be closed so that any aerosols settle before cleaning according to points 2-4 above. Blood has a buffering capacity, and in the event of a spill, ethanol is not sufficient; instead, Virkon, hypochlorite, or equivalent should be used.

An incident should be reported to KI’s Incident Reporting System, read more on the page Report Incidents.

For chemical spills, read instead on the page “Chemical Safety”.

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