This blog post is part of a series based on information presented at a biobank networking event hosted by Thermo Fisher Scientific earlier this year in the UK.
As we’ve mentioned before, any variation in how biobank samples are collected, processed and stored can have a significant impact on downstream analyses and/or applications.
Dr Nigel Westwood, Manager of the King’s College London Haemato-Oncology Tissue Bank, wholeheartedly agrees, and he underscored the point several times during his presentation at a Thermo Fisher Scientific networking event earlier this year.
For Nigel, the primary aim of any quality management system can be summed up in one word: Consistency.
How do you develop a consistent approach?
By focusing on these five areas: Policies and Procedures; Supporting Documents and Data Management Systems; Operational Procedures; Enabling Agreements; Compliance and Improvement.
Nigel shared more details about each of these areas, and he presented an outline, which you can use to evaluate and improve your current quality management system. As he explained, the five components of a robust quality management system are:
- Policies and Procedures
- Quality policy
- Adverse incidents policy and procedure
- Complaints policy and procedure
- Safety policy and procedures
- Tissue disposal policy and procedure
- User consultation policy and procedure
- Supporting Documents and Databases
- Quality manual
- Standard operating procedures
- Staff training manual
- Data management system
- Document management system
- Operational Procedures
- Management procedures
- Business continuity plan
- Quality procedures
- Sample processing protocols
- Enabling Agreements
- Service level agreements
- Material transfer agreements
- Compliance and Improvement
- Audit program
- Inspection program
- Management committee
- Clinical information
In addition, Nigel pointed out that the best sample collections are those accrued via clinical trials because these are linked to comprehensive and good quality coded data sets. Nigel asserted that biobanks can and must develop robust quality management systems for the conservation of the biospecimens they receive, but he was also of the view that the quality management of clinical data is often outside the control of the biobank. Nigel pointed out that a collection of good quality biospecimens without good quality clinical data is of little value to scientists and, in effect, represents buried treasure.
What hurdles do you have to overcome as you work to maintain the quality and consistency of your samples? What are the most important features of your quality management system?