EGALiTE

European Group for Accreditation and Liaison of Blood-Tissues and Cells Establishments

EGALiTE is an EU funded project endorsed by the leading scientific societies in Europe in the field of the Substances of Human Origin (SoHO).
It aims to promote the harmonization of practices among SoHO Entities, encourage sustainability and collaboration among stakeholders and the implementation of strategies required to improve accessibility and sufficiency of SoHO at European level.

Contingency Plans

This template is designed to assist stakeholders in the definition of contingency plans.

It serves as a facilitator for identifying and assessing various scenarios and their associated risks and consequences, summarizing the key aspects to consider when creating these plans. Therefore, this tool is a practical accessory for implementing the best practices outlined in the "Contingency Planning in SoHO Entities" defined by the EGALiTE Project. Users are advised to use the contents defined in the mentioned document to complete the definition of effective plans.

The outcome of this tool can be used as a report of the assessments performed and can be combined with other EGALiTE Outcomes, namely the BTC Database which can be used to search for collaborations required to address some contingencies.

A. Risk Assessment

Guidance:
Identify the failure scenario you wish to assess (A.1). Then choose which activity/activities may be affected by the failure scenario (A.2). Identify the (potential) effects of the failure scenario under evaluation (A.3), the stakeholders (A.4) and geographical scale of the failure (A.5). Estimate the likelihood of Occurrence (A.6) and estimated severity of the impact (A.7). Calculate the product (likelihood x severity) and evaluate in the figure under B the priority to develop a contingency plan to mitigate the impact.

Select then options to mitigate the effects of the failure scenario (B.1) taking into consideration the potential stakeholders (B.2) and the geographic scope (A.5).

Before implementing the contingency plan, reassess the Likelihood of Occurrence (C.1) and the Severity of Impact (C.2) considering that the Contingency Plan would be implemented. This will result in a new product for Occurrence X Severity. Subtracting this product from the initial product will result in a net effect of the contingency plan.

Depending on the initial priority and final priority for the definition of a Contingency Plan, the preparatory actions in the definition and real implementation of a Contingency Plan can be started (D).

It is evident that a failure scenario may affect multiple activities leading to multiple effects, involving multiple stakeholders and cover a larger geographical scope than service area of the establishment itself. One can than choose to analyse the severity of impact and likelihood of occurrence for each situation, which will lead to a magnitude of situations and contingency plans. This may be time consuming and lead to a complex collection of contingency plans. Alternatively, one could try to analyse all situations together in a more comprehensive way and design a contingency plan that addressed the potential failure scenario on multiple levels. Such an integrated approach may be more efficient and can lead to a more effective contingency plan, although it carries the risk of missing details.

1. Identify the potential type of failure scenario under analysis:












2. Identify the activity(ies) affected (or potentially affected):







3. Identify the (potential) effect(s) of the failure scenario under evaluation:














4. Select the stakeholders affected (or potentially affected) by the effect of the failure scenario:









5. Identify the geographical scope needed for the contingency plan:





6. Estimated Likelihood of Occurrence

(Please indicate an estimate of the likelihood that the contingency/catastrophic scenario foreseen in this exercise will occur)






7. Estimated Severity of Impact

(Please estimate the potential severity of impact that the specified contingency/catastrophic scenario may have on your system. Consider the overall impact, considering the probable effects on SoHO (availability, quality, and safety), the donation system, patient access to therapy, staff and financial consequences, etc.)






B. Priority for the definition of the Contingency Plan

(Estimated Likelihood of Occurrence x Estimated Severity of Impact = Range from 1 to 36):

1. Identify the potential stakeholders (to be) involved in the implementation of mitigation measures:










2. Select the feasible options to mitigate the effect(s) of the failure scenario(s) under evaluation:











C. Estimate the efficacy of the proposed Contingency Plan

In order to predict if the actions defined in “B. Preparatory actions for the definition and implementation of the Contingency Plan” are sufficient and efficacious to overcome the contingency under evaluation, please reassess the:

1. Estimated Likelihood of Occurrence

(Please indicate an estimate of the likelihood that the contingency/catastrophic scenario foreseen in this exercise will occur)






2. Estimated Severity of Impact

(Please estimate the potential severity of impact that the specified contingency/catastrophic scenario may have on your system. Consider the overall impact, considering the probable effects on SoHO (availability, quality, and safety), the donation system, patient access to therapy, staff and financial consequences, etc.)






(Estimated Likelihood of Occurrence x Estimated Severity of Impact = Range from 1 to 36):

D. Preparatory actions

Describe the actions and information required to implement the Contingency Plan, based on the criteria identified in the previous step A (Risk Assessment), using the recommendations included in the "Contingency Planning in SoHO Entities" defined by the EGALiTE Project

1. EGALiTE Database Contact and/or look for alternative collaborations in your network:

2. Communication Plan: Ensure effective communications systems, channels and protocols (by establishing Quality and Operative agreement with the selected partner):

3. Identify the Emergency Response Team (ERT):

4. Get the authorization from the Competent Authority if applicable:

5. Conduct a mock case to validate the plan if applicable:

6. Consider other steps identify in the Contingency Plan internal procedure:

Report

In order to store your Assement Report, press Print, and select Save as PDF.