Human Samples in Research

<Project Name>

Contingency Plan

Document History
Version / Review Date / Comment / Replaces / Reviewed by

1.Purpose

This contingency plan outlines the actions to be taken in the event of failure of (describe storage facility/unit/area or equipment) located in (insert location details). The tissue types covered in this contingency plan are (insert details of all tissues at risk).

2.Scope

The arrangements set out in this plan apply to (insert personnel/research group/department details)

3. Responsibilities

The following persons are responsible for ensuring that this contingency plan is followed during (insert details of storage unit(s) / equipment) failure:Insert names

Where a storage unit containing Relevant Material fails, the following persons are responsible:Insert names

4.Procedure

4.1 Existing Arrangements

Describe the current arrangements for storage of samples in the storage units for the project / tissue to which the contingency plan refers. Include current routine maintenance procedures, maintenance contracts and location of storage units – refer to the unique identifiers for each storage unit.

And / Or

Describe the non-storage equipment for which the contingency plan refers (e.g essential centrifuges)

4.2 Failure conditions

For each piece of critical equipment, describe the conditions for failure (e.g. temperature deviation limits and duration outside limits)requiring the contingency arrangements to be invoked. The type of tissue and extent of deterioration caused by temperature fluctuations should be considered.

4.2 Location of back up freezers / equipment

Describe the exact location and unique identifiers of back-up facilities

4.3 Contact Personnel

Insert a hierarchy of contact details for personnel who can be contacted in the event of failure of each piece of critical equipment.4.4 Steps to be taken in the event of storage unit failure outside normal working hours.

4.4 Actions to be taken in the event of equipment failure

Insert details of actions to be taken when equipment fails, include specific locations of designated contingency storage units. Tissue transferred to temporary storage locations should be labeled in accordance with HTA-10-SOP-Equipment Maintenance i.e.

4.5 Recording an Adverse Event (HTA Relevant Material Only)

Following the failure of a storage unit used to store human tissue (relevant or non-relevant), or any instance where tissue integrity is compromised, an adverse event report will be completed in line with HTA-11-SOP-Adverse Event Reporting.

Insert additional steps as required

For additional guidance on completion / HTA regulatory requirements please contact:

Dr Lisa Wakeman

Governance Officer - Human Tissue Act | Research & Development | ABMU Health Board

Swyddog Llywodraethu – Deddf Meinweoedd Dynol | Ymchwil a Datblygu | Bwrdd Iechyd PABM

Swansea University/PrifysgolAbertawe

Room 104, Institute of Life Science 2/Ystafell 230, Athrofa Gwyddor Bywyd 1

Singleton Park/Parc Singleton

Swansea/ Abertawe

SA2 8PP

01792 530891|or

To be signed by all members of the research team:

Read by (Print) / Signature / Date
Uncontrolled when printed
HTA-10-Form-Contingency Plan Version 1.0 / Page 1 of 5