**1. Introduction**

What can biobankers do to ensure that their biobank does not have to struggle in case of an emergency? The best activity plan could be as follows:

Implement risk assessment and risk determination processes specifically designed to address the needs of your biobank, come up with risk management and action strategies, and teach and train your staff in all these matters!

The management of risks is part of all business operations. However, for biobanking organizations, risk mitigation is unavoidably an overly critical element of day-to-day operations. The expensive nature of irreplaceable samples/cell lines, data, and other high-value products such as cell-based drugs and biologically active pharmaceutical ingredients calls for extremely accurate planning including the full spectrum of risks. These risks can be subdivided into the following categories:


Risk assessments and determination are essentially rather subjective; they are very individual and are based on personal perception of an employee. Hence, it is recommended to assess the risks in a workshop involving employees from each level and field of biobanking activities such as:

It is crucial to define the exact steps each biobank team member needs to follow in serious cases of emergency. A periodic review, update, and "walk-through" of the risk potential assessment are pivotal, and also the action plan should be renewed periodically. One of the most known and often implemented biobanking risk actions is the duplication of critical samples and their storage in multiple locations. This can be done on-site (same biobank, different storage locations) or off-site (an

Many biobanks are starting enthusiastically without thinking about risks and possible dangers that may occur during implementation and running of a biobank. The professional approach is not only to think about it and determine the risks but also to include risk management in the biobank budget. There is an old English saying on flyers of storage constructing companies: "Don't be penny-wise and pound-foolish." This saying applies exactly here, when speaking about risks. Too many biobanks neglect risk management because they "do not have the funds for it." This is unacceptable and above all irresponsible, especially in public biobanks, where using the taxpayers' money too much is invested without protective mechanisms, like risk management. Admittance and maintenance of risk management not only into biobanks' daily routine but also into budget is pivotal for longevity of the given biobank initiative, as every task in the biobank requires assets and capabilities

Cooperate, for collaborative exertion with supportive biobanks can be performed almost with every other biobank or biorepository in the world. Besides, a biobank can work with interventional research supportive organizations in their own country or area. Construct trusty collaborations with associates and encourage

and promote relations, which can build up the risk vindication plan of your biobank/lab. In the event of a crisis or a disaster, it is improbable that a team of a

and description of protection mechanisms to avoid dangers (which must be known). These risks must be predicted and managed to untroublesome issues. However, as is the case with natural disasters, not only a biobank but also any other institution is unable to always predict the future. If a biobank adopts a wide-ranging risk qualification and management plan, it can help to safeguard the protection of

Staying with the example of off-site storage: Choosing an offsite storage facility includes asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment of the location. The potential off-site storage provider should also provide an "emergency action plan (EAP)" in force as well as a plan for ensuring the safety of employees, for securing the facility, for addressing the media, and for notifying the relevant authorities following a disaster. Again, these plans should be written, reviewed at regular intervals independent of on-site or off-site storage solution in case changes are defensible, and tested via walk-through or table-top workouts to the extent possible and the employees trained on the procedures. Ideally, these trainings are also well documented, reviewed, reported, and repeated at least annually as well as every time if changes

There is a list of information that should be available for emergency cases in a

Risk susceptible infrastructures such as biobanks should have backup capacities well in addition to the minimum requirements. Thus, this may imply to have 100% redundant storage and supply (e.g., electricity) capacity. Fully redundant working

A respectable business managing and controlling plan comprises development

biobank can manage and recover alone—without associates.

extramural provider of storage in a different location).

for performing the work accurate.

*Risk Management in Biobanks*

*DOI: http://dx.doi.org/10.5772/intechopen.91463*

biobank bio specimens.

are made [1].

**73**

biobank (**Figure 1**).


Most risks that will be recognized in a workshop are of low probability. Years of mild weather are normal, while natural disasters are of low likelihood. Terrorism attacking biobanks is most probably also a minor aspect, except for sites that are near potential targets, such as governmental buildings and major airports. In the case of the abovementioned risks, occurrence of the damage will be irreparable. Thus, a biobank also needs an action plan for such unlikely events.

Further to evaluating the probability of a risk, the potential aftermath should also be considered in order to be able to calculate a real risk score. For example, a hurricane may be unlikely but could leave serious damage behind, including extended power outages.

If a biobank has not performed a realistic, well-researched risk assessment, then the risk mitigation strategy is based on guesswork, is not professional, and is just not acceptable compared to the efforts of collecting and storing samples and data. It is very important to have a comprehensive risk management plan in place that is up to date. It is easy to start with a well-researched and/or well-known risk assessment.

#### *Risk Management in Biobanks DOI: http://dx.doi.org/10.5772/intechopen.91463*

• Human resources risks

*Risk Management and Assessment*

• Infrastructural risks

• IT risks

• Strategic risks

• Management

• Public relation

• Human resources

• Financial officers

• Lab technicians

• Researchers

• IT specialists

• Ethics specialists

• Medical doctors

extended power outages.

**72**

• Infrastructure specialists

• Strategy developer and network coordinator

Thus, a biobank also needs an action plan for such unlikely events.

• Natural disasters

and field of biobanking activities such as:

Risk assessments and determination are essentially rather subjective; they are very individual and are based on personal perception of an employee. Hence, it is recommended to assess the risks in a workshop involving employees from each level

Most risks that will be recognized in a workshop are of low probability. Years of mild weather are normal, while natural disasters are of low likelihood. Terrorism attacking biobanks is most probably also a minor aspect, except for sites that are near potential targets, such as governmental buildings and major airports. In the case of the abovementioned risks, occurrence of the damage will be irreparable.

Further to evaluating the probability of a risk, the potential aftermath should also be considered in order to be able to calculate a real risk score. For example, a hurricane may be unlikely but could leave serious damage behind, including

If a biobank has not performed a realistic, well-researched risk assessment, then the risk mitigation strategy is based on guesswork, is not professional, and is just not acceptable compared to the efforts of collecting and storing samples and data. It is very important to have a comprehensive risk management plan in place that is up to date. It is easy to start with a well-researched and/or well-known risk assessment.

It is crucial to define the exact steps each biobank team member needs to follow in serious cases of emergency. A periodic review, update, and "walk-through" of the risk potential assessment are pivotal, and also the action plan should be renewed periodically. One of the most known and often implemented biobanking risk actions is the duplication of critical samples and their storage in multiple locations. This can be done on-site (same biobank, different storage locations) or off-site (an extramural provider of storage in a different location).

Many biobanks are starting enthusiastically without thinking about risks and possible dangers that may occur during implementation and running of a biobank. The professional approach is not only to think about it and determine the risks but also to include risk management in the biobank budget. There is an old English saying on flyers of storage constructing companies: "Don't be penny-wise and pound-foolish." This saying applies exactly here, when speaking about risks. Too many biobanks neglect risk management because they "do not have the funds for it." This is unacceptable and above all irresponsible, especially in public biobanks, where using the taxpayers' money too much is invested without protective mechanisms, like risk management. Admittance and maintenance of risk management not only into biobanks' daily routine but also into budget is pivotal for longevity of the given biobank initiative, as every task in the biobank requires assets and capabilities for performing the work accurate.

Cooperate, for collaborative exertion with supportive biobanks can be performed almost with every other biobank or biorepository in the world. Besides, a biobank can work with interventional research supportive organizations in their own country or area. Construct trusty collaborations with associates and encourage and promote relations, which can build up the risk vindication plan of your biobank/lab. In the event of a crisis or a disaster, it is improbable that a team of a biobank can manage and recover alone—without associates.

A respectable business managing and controlling plan comprises development and description of protection mechanisms to avoid dangers (which must be known). These risks must be predicted and managed to untroublesome issues. However, as is the case with natural disasters, not only a biobank but also any other institution is unable to always predict the future. If a biobank adopts a wide-ranging risk qualification and management plan, it can help to safeguard the protection of biobank bio specimens.

Staying with the example of off-site storage: Choosing an offsite storage facility includes asking the right questions to determine if the storage provider has the appropriate risk mitigation infrastructure in place, beginning with a realistic threat assessment of the location. The potential off-site storage provider should also provide an "emergency action plan (EAP)" in force as well as a plan for ensuring the safety of employees, for securing the facility, for addressing the media, and for notifying the relevant authorities following a disaster. Again, these plans should be written, reviewed at regular intervals independent of on-site or off-site storage solution in case changes are defensible, and tested via walk-through or table-top workouts to the extent possible and the employees trained on the procedures. Ideally, these trainings are also well documented, reviewed, reported, and repeated at least annually as well as every time if changes are made [1].

There is a list of information that should be available for emergency cases in a biobank (**Figure 1**).

Risk susceptible infrastructures such as biobanks should have backup capacities well in addition to the minimum requirements. Thus, this may imply to have 100% redundant storage and supply (e.g., electricity) capacity. Fully redundant working

The direct citation of the definition is as follows: "Risk Management is the process of identifying, assessing, responding to, monitoring, and reporting risks. Therefore, a risk management plan defines how risks associated with the organization will be identified, analyzed, and managed. It outlines how risk management activities will be performed, recorded, and monitored using templates and practices

The aim of risk management is to prevent that risks become a problem or to minimize the damage, which could occur because of risks. By consistently searching and analyzing possible risks, a possible operational blindness is eliminated

One of the methods that can be used when identifying risks is a Strengths and Weaknesses, Opportunities, and Threats (SWOT) analysis. When using this tool, internal factors (Strengths and Weaknesses) and external factors (Opportunities and Threats) are analyzed. As the risks for a biobank are very comprehensive, an

Risks will be actively identified, analyzed, and managed periodically. They will

accomplishing this are outlined in the following sections. One defined responsible

Risk identification involves the management team and includes evaluation of environmental factors, organizational culture, and the strategic plan of a biobank. Careful attention needs to be given to the business plan and the stakeholder analysis cost/effort estimates, resource plans, and other key project

All recognized existing and probable risks must be evaluated in a matter of classification of the potential variety of consequences in the real case. Criterion must be implemented and discussed for definition, categorization, and regulation of risks. The recognized top risks must be followed and reacted immediately, and there will be some risks which in the given period of development can be

The likelihood and influence of manifestation for individually recognized risks should be evaluated by the team of the given biobank under the moderation of risk manager. The important criteria for this consideration are probability and

• Medium—over <30%> but under <70%> likelihood of incidence

• High—over <70%> likelihood of incidence

• Low—under <30%> likelihood of incidence

own risk management strategy should be implemented for each biobank.

be identified as early as possible to minimize their impact. The steps for

person should serve as the risk manager for the organization.

for recording and prioritizing risks."

*DOI: http://dx.doi.org/10.5772/intechopen.91463*

*Risk Management in Biobanks*

as well.

**2.1 Process**

documents.

ignored.

impact.

**75**

**2.3 Risk analysis**

*2.3.1 Risk analysis*

Probability

**2.2 Risk identification**

#### **Figure 1.**

*Information emergency cases in a biobank. Adapted from: http://blog.fisherbioservices.com/bid/286295/ Defense-in-Depth-Off-Site-Storage-for-Biological-Specimens-and-Biopharmaceuticals-Risk-Mitigation.*

#### **Figure 2.**

*Risk matrix adapted for use in qualitative risk analysis.*

allows one unit to maintain accurate facility temperatures, while the other is serviced or repaired and at the same time may deliver extra cooling capacity for unexpected events [1].

Risk mitigation occurs at all levels of operations. Hence, in the following chapters, we will discuss and explore the possible risks and action strategies, if a risk occurs (**Figure 2**).

#### **2. Risk management plan**

In general a risk is an event or condition that, if it occurs, could have a negative effect on an organization.

#### *Risk Management in Biobanks DOI: http://dx.doi.org/10.5772/intechopen.91463*

The direct citation of the definition is as follows: "Risk Management is the process of identifying, assessing, responding to, monitoring, and reporting risks. Therefore, a risk management plan defines how risks associated with the organization will be identified, analyzed, and managed. It outlines how risk management activities will be performed, recorded, and monitored using templates and practices for recording and prioritizing risks."

The aim of risk management is to prevent that risks become a problem or to minimize the damage, which could occur because of risks. By consistently searching and analyzing possible risks, a possible operational blindness is eliminated as well.

One of the methods that can be used when identifying risks is a Strengths and Weaknesses, Opportunities, and Threats (SWOT) analysis. When using this tool, internal factors (Strengths and Weaknesses) and external factors (Opportunities and Threats) are analyzed. As the risks for a biobank are very comprehensive, an own risk management strategy should be implemented for each biobank.

#### **2.1 Process**

Risks will be actively identified, analyzed, and managed periodically. They will be identified as early as possible to minimize their impact. The steps for accomplishing this are outlined in the following sections. One defined responsible person should serve as the risk manager for the organization.
