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1
Quality Assurance in Cancer Biobanking
Anne Carter1* and Fotini Betsou2
1Anne Carter
onCore UK
Devonshire House
Manor Way
Borehamwood
Herts
United Kingdom
2Fotini Betsou
Integrated Biobank of Luxembourg
6, rue Ernest Barblé
L- 1210 Luxembourg
*Corresponding author
E-mail [email protected]
Tel: +44 (0)208 731 4595
Fax: +44 (0)208 731 4587
2
Introduction
Biobanking is recognised as a critical area requiring development if progress is to be
made in identifying clinically useful markers of disease and disease progression,
discovering new drug targets and understanding the mechanisms of disease in cancer.
Researchers continue to report that they are unable to obtain sufficient high quality,
well annotated samples of diseased and control tissue, blood and other biological
materials1,2. At the same time, funders of research, and especially funders of
biobanks, are looking to obtain best value from their investments in sample and data
collection. There is a need to increase the availability to researchers of large numbers
of high quality, well annotated samples of diseased and control tissue, blood and other
biological materials and in this way accelerate cancer research.
Researchers report two major problems; the ability to get access to sufficient numbers
of samples and the fact that the available samples are not always suitable for their
research. The Cancer Genome Atlas (TCGA) group in the US, for example, reported
at a meeting of the International Cancer Genomics Consortium that biobanks typically
overestimated the quality of the cancer tissue samples they hold3.
Research by the European Commission’s Joint Research Centre and Institute for
Prospective Technological Studies4 recognised the need for improved collaboration
and networking amongst biobanks. Currently, networks of biobanks, such as the
Confederation of Cancer Biobanks in the UK, CNIO Tumour Bank Network in Spain,
the Danubian Biobank Consortium, Canadian Tumour Repository Network and the
Australasian Biospecimen Network, are working to develop harmonised methods and
3
quality assured procedures to address these issues. The ultimate aim of these
networks is to increase the numbers of high quality, well annotated samples that are
available to researchers and so accelerate cancer research.
The need for quality assurance is recognised as an essential part of any scientific
endeavour5,6 and it is especially important when different organisations work
together7. If donors, researchers, funders and the biobanks themselves are to be
assured that samples and data are of high quality, “inter-operable”, made available
and used in research there is a need to define sample and data quality, define best
practice for biobanks and set up a scheme to confirm that biobanks are following best
practice guidelines and achieving high quality.
This paper will discuss the components of a quality assurance system in a biobank,
the availability and usefulness of currently available written standards and guidelines
and will give some examples of work in this field. Whilst many of the examples used
come from cancer biobanking, the principles of quality assurance are applicable to all
biobanks storing human tissue or data for research. The paper will give an overview
of current thinking on the need for and use of quality assurance in biobanking of
human tissue and data.
What is quality assurance?
The simplest definition of quality is “fit for purpose”. The purpose of a biobank is to
collect, store and distribute high quality samples and data and it may, in addition,
process and test the samples. The way in which the biobank performs these tasks
4
needs to be controlled, so that all of the operations of the biobank, including the ways
in which the biobank is managed and in which legal and ethical requirements are met,
are “fit for purpose”.
Organisations control the quality of their activities by implementing a quality
management system (QMS). The QMS defines the organisation’s quality policy and
objectives and ensures that these are achieved through quality assurance (QA) and
quality control (QC). QA focuses on the processes through which the product is
obtained whereas QC focuses on the product.
Most scientists are familiar with QC, which is “that part of quality assurance that
focuses on fulfilling quality requirements” and perform QC as a routine part of their
day-to-day activities. QC consists of specific tests defined by the QA or QMS
programme to be performed to monitor procurement, processing, preservation and
storage, specimen quality and test accuracy. These tests may include but are not
limited to: performance evaluations, testing and controls used to determine the
accuracy and reliability of the biobank’s equipment and operational procedures as
well as monitoring of the supplies, reagents, equipment and facilities.
The concept of QA is less familiar than QC and often meets some resistance from
scientists who are proud of their scientific knowledge and achievements. So what is
QA, why is it important and what can a cancer biobank gain from implementing a QA
programme?
5
Quality assurance is defined as “that part of quality management that focuses on
providing confidence that quality requirements will be fulfilled”8. QA requires the
systematic monitoring and evaluation of all aspects of the biobank’s processes; it
covers the way in which the biobank is operated as well as the quality of the samples
and data held.
The quality of any product or process can be demonstrated by comparison with a
quality standard and organisations who can show that they meet the requirements of
the standard can gain certification or accreditationi. The international standard, ISO
9001:20089 (ISO 9001), sets out the internationally accepted requirements for a QMS
that can be applied to any type of organisation. It is based on Deming’s Shewhart
cycle of “plan, do, check, act” (figure 1) and covers management requirements as
diverse as defining quality objectives, documenting procedures, controlling
documents and records, contracting, purchasing, handling complaints, correcting and
preventing problems, internal auditing, training and committing to improvement.
The organisation is able to set its own quality objectives and decide for itself (and its
stakeholders) what its product or service should look like. Compliance with ISO 9001
does not, by itself, ensure that scientifically valid methods are used and samples and
data are “fit for purpose” because this standard does not give any technical
requirements for the quality of the samples or the scientific aspects of a biobank’s
work. It does not cover, for example, qualification of equipment, validation of
methods, measurement traceability, use of control and reference materials,
participation in proficiency testing schemes and handling of samples and data. As
well as having a management system that ensures that the biobank’s core processes
6
are “fit for purpose”, a biobank must ensure that the samples and data it provides are
“fit for purpose” (figure 2).
Quality standards
There is no international standard for technical quality in a biobank, so the Marble
Arch Working Group on International Biobanking (MAWG) studied the requirements
of the available ISOii standards containing technical requirements that could be
applied to biobanks as well as available guidelines/best practice documents. The
standards selected were ISO 17025:2005 (ISO 17025), the standard for testing and
calibration laboratories10, and ISO guide 34, for reference material producers11, which
contain the quality management system requirements present in ISO 9001 and
additional technical requirements relevant to the subject area. The MAWG looked
also at biobanking “best practice” guidelines published by the OECD12, NCI13 and
ISBER14 to determine what additional technical requirements are needed for
biobanking. ISO standards contain technical requirements but do not mandate how
those requirements should be met, whereas best practice guidelines give detail on the
best ways to achieve such requirements. Best practice guidelines are not compulsory
for organisations seeking certification or accreditation if the organisation can justify
why they have taken an alternative approach.
None of the guidelines/best practice publications examined by the MAWG was found
to be sufficient as an international standard for biobanking so the MAWG compiled
i Certification is the procedure by which a third party gives written assurance that a product, process or service conforms to specific requirements. Accreditation is the procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks. iiISO is the Geneva-based International Organisation for Standardisation. This organisation produces and publishes written standards according to the perceived needs of the international community.
7
elements from them into the format of an ISO standard specific for biobanks15. The
document produced contains the requirements for an international standard for
biobanking. However, a biobanking standard has not been adopted as a “work item”
by an ISO Technical Committee yet.
The only existing national biobank-specific standard is the French standard, NF S 96-
900 Quality of biological resource centres (BRC) – Management system of a BRC and
quality of biological resources of human and microbial origin, published in July
2008. Its design was based on ISO 9001, and it includes some additional specific
technical requirements. It is applicable to the wide activities of research tissue banks
and is suitable as a certification, but not as an accreditation, standard. Certification
against either ISO 9001 or NF S 96-900 is requested of research tissue banks by the
French research infrastructures funding organisation (IBISA) and so far 47
organisations have been certified against NF S96-900, of which a majority are
research tissue banks. The French standard has not been used outside of France but
its application in France shows that a specific standard designed for research tissue
banks is useful and applicable.
In the absence of a widely applicable biobank-specific standard, many biobanks have
obtained certification of their quality management systems against the requirements of
ISO 9001 (for example UK Biobank, UK DNA Banking Network, Spanish HIV
Biobank, Invidumed (Hamburg), Norwegian Mother and Child Cohort Study biobank,
Biobanque de Picardie, Biobank Graz (Austria), Singapore Bio Bank and others).
Interestingly, the Karolinska Institute biobank and the National Reference Cell
Standards are sponsored by a national standardisation body (the British Standards Institute in the UK,
8
Culture Centre of Instituto Zooprofilattico Sperimentale della Lombardia dell’Emilia
Romagna – Brescia, have been accredited to ISO17025 and the ATCC has been
accredited to both ISO17025 and ISO Guide 34. No such example exists for a cancer
biobank yet. ISO 9001 is described in the Molecular Medicine Ireland’s (MMI)
Guidelines for standardised biobanking16 as “the recognised international quality
standard that biorepositories are working to implement”. The MMI guidelines have
been accepted by BBMRIiii as a first version of a BBMRI Laboratory Manual, thus
giving increased authority to this publication.
The MAWG publication and the French biobanking standard provide an excellent
starting point for the development of an ISO standard specifically for biobanks. ISO
standards are aimed primarily at reducing barriers to international trade and co-
operation, thus development and implementation of an ISO for biobanks will ensure
that samples and data collected in any biobank which conforms to the ISO
requirements are suitable for use in local, national and international research projects.
Harmonisation, standardisation and best practice.
Biological materials and their derivatives are fragile, they can change rapidly when
removed from the living host, they need to be conserved ex vivo with as little
modification as possible in relation to their in vivo state, and they need to correspond
to the researchers’ needs. Standardisation of procedures is an essential part of quality
assurance; a biobank will determine and document its ways of working in standard
for example) and agreed, by consensus, with representatives of the community to which they relate. iii BBMRI is the European Biobanking and BioMolecular Resources Research Infrastructure, currently in its preparatory phase. It is supported by the European Union Framework Programme 7 and aims to
9
operating procedures (SOPs) to ensure that samples and data are collected and
handled consistently. If researchers are to be able to use samples and data from more
than one biobank, however, samples and data sets held by different biobanks must be
comparable. If they are not comparable, differences discovered during the research
may be due to the ways in which the samples and data have been obtained and
handled, rather than to physiologically relevant differences in vivo.
Harmonisation is a process through which procedures and practices are aligned so that
they are compatible with one another. This would allow researchers to have
knowledge of the differences between samples and take these into account during
their research. Standardisation is the process of defining and agreeing upon technical
standards, so that samples and data obtained from one biobank are equivalent to those
from other biobanks using the standardised methods. Both rely upon biobanks having
a common aim and willingness to work together and adapt pre-existing practices.
The definition of a high quality specimen or dataset can be a problem for a biobank.
A researcher working on a specific project, using specific sample types and
experimental techniques, can determine which factors will affect his work and ensure
that samples and data are collected appropriately to suit his needs. A biobank, in
contrast, is collecting samples and data for future, unspecified research and does not
know what techniques will be used, what factors will affect the suitability of the
samples or what data will be needed. Samples that are suitable for one technique may
not be suitable for a different technique – there is no single way of handling samples
that will suit all users. The biobank must decide which factors are most important to
lay the basis for unified biobanking across the EU. It brings together some 250 biobanks from
10
control, and select procedures that provide a balance between the predicted needs of
any potential researchers and the available resources within the biobank. There is
little scientific evidence supporting one protocol over another thus it is difficult to
find justification for the methods chosen and equally difficult to persuade a biobank to
change so that it is in line with others.
There is a need for biospecimen research to define evidence-based best practices.
This need is recognised by the biobanking community but funding for this type of
research is hard to come by; much of the current research is funded in the USA by the
National Cancer Institute (NCI) through the Office of Biorepositories and
Biospecimen Research (OBBR) where it is a strategic priority17 and in the EU through
an FP7 project, SPIDIAiv. Few institutions, like the Integrated Biobank of
Luxembourg or the Van Andel Research Institute have an internal biospecimen
research focus. To achieve inter-operable samples and data, practices must, as a
minimum, be standardized inside each biobank and harmonised between biobanks. In
the meantime, the best that can be done is to validate procedures and keep meticulous
records so that any differences between samples can be attributed to the sample itself
rather than the way in which it was collected, processed and stored.
At present, many researchers validate the samples they receive from biobanks because
they are not able to rely upon the suitability of samples that they have not collected
European Union (EU) member and associated states. See: www.bbmri.eu. iv SPIDIA is a 4-year project, funded by the European Union FP7 which aims to tackle the standardisation and improvement of pre-analytical procedures for in-vitro diagnostics. The proposed research and standardisation activities cover all steps from creation of evidence-based guidelines to creation of tools for the pre-analytical phase to testing and optimisation of these tools through the development of novel assays and biomarkers.
11
themselves. The purpose of harmonisation and standardisation is to ensure that
samples are collected, transported, processed, tested and stored in ways which gives
consistently high quality samples and consistently accurate data. This makes the
samples and data acceptable to researchers without further testing.
Harmonisation with respect to sample variability
The differences between samples are multi-factorial. Pre-analytical factors affecting
the samples occur in-vivo, due to differences between the donors, and after the
samples have been removed from the donors, during transport, stabilisation,
processing and storage. Examples of pre-analytical variables are shown in figure 3.
Pre-analytical factors are often outside the control of the biobank. To allow such
samples to be used by researchers it is necessary to keep meticulous records and make
them available to the researcher. A system for annotating samples with data about
pre-analytical factors has been developed by the ISBER Working Group on
Biospecimen Science and published as a standard pre-analytical coding for
biospecimens (SPREC)18. The criteria used to annotate solid tissue samples are
shown in figure 4. This system allows samples to be annotated by a code that
describes how they have been obtained and processed, allowing pre-analytical factors
to be compared by the researcher. The application of a pre-analytical sample code can
not only facilitate a more effective inter- and intra- laboratory specimen utilization by
scientists from different biobanks supplying samples for common research and
validation exercises, but also allow more effective reporting of research results.
Validation
12
Validation of biobank’s methods, samples and data
Validation can be defined as “establishing documented evidence which provides a
high degree of assurance that a specific process will consistently produce a product
meeting its pre-determined specification and quality attributes”19. Validation of
methods, samples and data will enable biobanks, funders and researchers to have
confidence in sample quality and so give added credence and reproducibility to the
results of research.
Validation can be applied to the “raw” biological material or data, the processing
methods used and any quality control testing performed. The objective of validation
is to demonstrate that the samples, data and methods are suitable for their intended
purpose. Equipment, also, needs to be validated (validation of equipment is usually
referred to as equipment qualification). Information and guidance about validation is
available from IUPAC20, the International Committee on Harmonisation21, NIST22,
ISO 572523 and ISO 17025, covering validation of the methods of performing
analyses, traceability of measurements, evaluating uncertainty of measurement and
defining the accuracy and precision of results. Elements to consider when validating
testing methods are shown in figure 5.
Validation of processing methods looks at pre-analytical variables that have the
potential to affect the outcome of results but are not related to the inherent sample
differences of interest to researchers. Validation aims to design methods that
minimise and control these differences. The problem for biobanks is that whilst
potential confounding factors can be postulated, their effect on research results is not
known. This makes it essential to carry out biospecimen research to identify which
13
processing steps are critical to sample quality, which sample attributes are important
and so develop appropriate quality control assays24.
Some of the elements of biospecimen research that can support QA in biobanking are
already within the scope of biobanks and/or associated laboratories. Indeed, it is
possible to evaluate the uncertainty of measurements that biobanks may be
performing. It is also possible to evaluate the impact of several pre-analytical
variables on downstream analyses25 . However, some of the elements which might be
essential to the implementation of an integral quality assurance program are still
missing. One such element is international Proficiency Testing programs for the
evaluation of the accuracy and precision of the different types of measurements that
biobanks often carry out for the characterization of their samples. Another missing
element is reference materials. Reference materials are necessary for validation of the
accuracy of a testing method11.
Validation of data requires verification of all clinical and biological annotations, use
of standard ontologies, checks on accuracy of transcription, eventually through double
entries, and implementation of data security systems, for example compliance with
the EU Directive on the protection of personal data and the EU-US Safe Harbour
principles26,27.
Indirect validation of biobank’s impact
Whilst this section has concentrated on the quality of samples and data, this is only
one aspect of the quality issues in biobanking. The funders of biobanks seek to
maximise the return on their investment. Ensuring the quality of the sample and its
suitability for use by the researcher is one way that this investment can be maximised,
14
but the funder is interested, also, in ensuring that samples reach the researcher, and so
has an interest in the access policies and scientific review procedures that are used
when biobanks grant access to samples and data to researchers. From the funders’
perspective, numbers of samples used in research and numbers of publications from
those samples are also markers of the quality of a biobank. Best practice guidelines
are broad based and cover every aspect of running a biobank, considering, for
example, legal and ethical issues, sustainability of funding, appropriate levels of
anonymisation and methods of determining who has access to samples and data.
These are often the areas where best practices devised in one country may not be
applicable elsewhere, since legal and ethical requirements differ between countries,
but their control is essential to give confidence to donors, funders and researchers.
Benchmarking of biobanks
Once standards and best practices are defined, it is possible to benchmark biobanks.
In 1999, the OECD suggested that national governments “should support the
development of an accreditation system for biobanks based upon scientifically
acceptable objective international criteria for quality, expertise and financial
stability”. This is one way in which biobanks can be benchmarked but there are
several options for benchmarking of biobanks, namely self-assessment, peer review or
through a formal certification or accreditation procedure.
Self assessment is the simplest and least expensive route. A series of questions can be
drawn up based on the required standards and the biobank can rate itself against the
questionnaire. ISBER members, for example, have access to a web-based self-
assessment tool designed to allow biobanks to assess their compliance with the
15
ISBER best practice guidelines. The main drawback to self assessment is the lack of
consistency and transparency in assessments.
Peer review consists of inspection and assessment of compliance with the required
standards by experts in the field, such as staff from another biobank or associated
organisation. This system is more expensive, requiring staff to be released from their
normal work to visit the biobank that is seeking assessment. Its advantage over self
assessment is that the assessors can be trained so that assessments are consistent and
the relative independence of the assessors gives greater assurance of the validity of
the results of the assessment. The assessors, however, are not truly independent since
they assess one another’s banks; there is a natural “professional courtesy” between
such assessors that is to the detriment of the perception of independence since the
person whose bank you are assessing today may come to assess your bank next time.
In addition, there are problems with ensuring confidentiality and protecting
intellectual property if the assessors are your “competitors”. This is handled in most
instances by requiring assessors to sign confidentiality agreements but some
commercial organisations are not willing to permit peers from competitor
organisations on site. Great care is needed when using competitors as assessors.
Certification and accreditation are widely recognised as the “gold standard” ways to
assess organisations. The terms certification and accreditation tend to be used
interchangeably by “lay” people, however they have different meanings.
Certification is the proof of consistency in the procedures followed. Accreditation is
the proof of the competence, the impartiality and the independence of a certification
body or laboratory in view of existing norms. Thus an organisation can be certified as
16
having a quality management system that conforms to the requirements of ISO 9001
and can seek accreditation against ISO 17025 to demonstrate its competence in
carrying out specific testing or calibrations (as defined in its “Scope of
Accreditation”). Organisations that gain accreditation against ISO 17025 are
recognised as complying with the requirements of ISO 9001 since a quality
management system is an integral requirement of ISO 17025. Formal certification
and accreditation are expensive to implement and maintain. They depend upon an
international consensus to devise appropriate standards but grant international
recognition to organisations that are certified or accredited.
There are several national and international initiatives looking at certification and
accreditation schemes to assess biobanks but, as discussed above, only in France is
there an official national standard. The need for a certification and accreditation
working group was proposed and strongly supported at the ISBER 2010 meeting, held
in Rotterdam last May. The Canadian Tumour Research Network is launching a
certification scheme for Canadian tumour biobanks at a meeting in Vancouver in
January 2011. The National Centre for Tumor Diseases (NCT) in Heidelberg has
obtained accreditation against ISO 17020:2004 General criteria for the operation of
various types of bodies performing inspection. ISO 17020 is not an obvious choice as
a standard for a biobank; it was used to accredit the competence of pathologists to
examine tissue but does not cover other biobank activities28. Its use is another sign of
the need for a biobank-specific ISO standard. Work Package 3 of the BBMRI project
aims “to provide support for the development of a European framework facilitating
harmonization of standards through certification and accreditation procedures”
(http://www.bbmri.eu/index.php/workpackages/wp-3). The American Association of
17
Tissue Banks offers “accreditation” to research tissue banks based on its own criteria
(http://www.aatb.org/accreditation). The College of American Pathologists is
exploring the possibility of developing an accreditation scheme for American tumour
banks. These schemes are not interchangeable, therefore whilst biobanks within a
scheme will have confidence in each others’ samples and data others outside the
scheme, or in a different scheme, will not have the same assurance. The need for an
international (ISO) standard for accreditation of research tissue banks is long overdue.
The breadth and depth of interest in biobanking at present make exciting times for
cancer biobanks. Donors, funders, researchers and governments are showing that the
need for high quality, well annotated samples of human tissue and its derivatives are
widely recognised as a key to enhancing cancer research. Quality assurance is the key
to providing confidence in the quality of samples and data, enabling collaboration
between biobanks and furthering the research effort.
Acknowledgments:
The authors wish to express their thanks to Dr Sabine Lehmann, Quality Manager at
IBBL, for critically reading and making helpful comments on the manuscript.
19
Figure 2 Requirements for a quality management system and technical
requirements for quality assurance in a biobank
Standard Norm
Technical require-ments
Manage-ment
require-ments
• Scope• Terms and definitionsIntroduction
Biobank norm
• Supply• Ethics
• Privacy• Informed consent• Access• Custodianship• Intellectual property
Additional require-ments
Solid samples Liquid samples Derivatives
• cell lines• nucleic acids• microbial strains• protein extracts• …………….
• Accommodation and environmental conditions
• Test and calibration methods/method validation
• Equipment• Measurement traceability• Sampling• Handling of test and calibration
items• Assuring the quality of test and
results• Reporting of results
• Biobank management issues
• Ethical, Social governance issues
• IT issues
• Organization• Management system• Document control• Review of requests, tenders,
contracts• Subcontracting• Purchasing services and supplies• Service to the customer• Complaints• Control of non conformity testing• Improvement• Corrective actions• Preventive actions• Control of records• Internal audits• Personnel
20
Figure 3 Potential pre-analytical variables affecting samples collected by a
cancer biobank.
Patient information • Gender • Age • Diet • Genetics • Medical background • Health background • Special conditions (pregnancy,
medications) • Social history (alcohol; smoking) • Type of anaesthesia • Position • Fasting • Smoking • Stress • Circadian rhythms • Menstrual cycle • Pregnancy • Physical exercise
Collection • Biopsy • Surgery • Aspiration • Autopsy
Clamping • Vessel clamping • Wedge resection • Ultrasonic shears
Collection device • Tube or bag • If tube, glass or plastic • Gel or non-gel separator • Other additives • Manufacturer and device information
Tissue derivative and processing • Sample type frozen vs. fixed • If frozen, milking • If fixed, fixative used • Details of processing (protocol)
Storage • Frozen before analysis • Elapsed time and temperature, prior
to freezing • Short or long term storage • Storage temperature • Expiration dating • Storage materials (glass vs. plastic) • If plastic, type of plastic
21
Figure 4. SPREC for solid tissue samples
Data originally published in Cancer Epidemiol Biomarkers Prev 2010;19:1004-1011
22
Figure 5. Elements to consider during method validation
Quantitative testing methods
Qualitative testing methods Processing methods
Specificity Accuracy Sensitivity Contamination between samples Robustness Reference values precision Linearity Domain of analysis Stability Interferences Correlation with reference method
Specificity Sensitivity Contamination between samples Robustness Stability Interferences Correlation with reference method
Reproducibility Robustness Stability Domain of application
23
References:
1 Hewitt, RE. Biobanking: the foundation of personalized medicine. Curr Opin Oncol 2010 Nov 11.
[Epub ahead of print] doi: 10.1097/CCO.0b013e32834161b8
2 NCRI: A Review of Research in Mesothelioma and other Asbestos- Related Diseases November
2010. www.ncri.org.uk/includes/Publications/reports/mesothelioma_and_ards_report.pdf
3 Moore HM, Compton CC, Lim MD, Vaught J, Christiansen KN, Alper J. Biospecimen research
network symposium: advancing cancer research through biospecimen science. Cancer Res
2009;69:6770–72.
4 Zika E, Paci D, Baumen TS, et al. Biobanks in Europe: Prospects for Harmonisation and Networking
EUR 24361 EN – 2010 ISBN 978-92-79-15783-7 DOI: 10.2791/41701.
5 Biotechnology and Biological Sciences Research Council, the Department for Environment, Food and
Rural Affairs, the Food Standards Agency and the Natural Environment Research Council. Joint Code
of Practice for Research 2003. http://www.defra.gov.uk/evidence/science/how/quality/index.htm
6 DOE Standard, Implementation guide for Quality Assurance programs for basic and applied research.
DOE-ER-STD-6001-92
7 PHJ Riegman, MM. Morente, F. Betsou, P. deBlasio, P. Geary and the Marble Arch International
Working Group on Biobanking for Biomedical Research. Biobanking for better healthcare. Mol Oncol
2008;2:213-222.
8 ISO 9000:2005- Quality Management Systems-Fundamentals and Vocabulary.
9 ISO 9001:2008-Quality Management Systems-Requirements.
10 EN ISO/IEC 17025 – General Requirements for the competence of testing and calibration
laboratories (ISO/IEC 17025:2005 E). Geneva: International Organization for
Standardization/International Electrotechnical Commission.
24
11 ISO Guide 34, General Requirements for the Competence of Reference Material Producers. Second
edition. Geneva: International Organization for Standardization, 2000.
12OECD. OECD Best Practice Guidelines for Biological Resource Centers – General Best Practice
Guidelines for all BRCs. Paris: OECD, 2007. DSTI/STP/ BIO(2007)9/REV1
13 National Cancer Institute. First-Generation guidelines for NCI-supported Biorepositories. Federal
Register 2006; 71(82): 25184–25203. Available from:
http://epi.grants.cancer.gov/documents/Bulletins/NCI-Supported_Biorepositories.pdf.
14 International Society for Biological and Environmental Repositories. Best Practices for Repositories:
Collection, Storage and Retrieval of Human Biological Materials for Research, 2008. Available from:
http://www.isber.org/Pubs/BestPractices.pdf.
15 Betsou F, Luzergues A, Carter A et al. Towards norms for accreditation of biobanks for human
health and medical research : Compilation of existing guidelines into an ISO certification/accreditation
norm-compatible format. Qual Assur J 2007;11:221-294.
16 Guerin JS, Murray DW, McGrath MM, Yuille MA, McPartlin JM, Doran PP. Molecular Medicine
Ireland Guidelines foe standardized biobanking. Biopreservation and Biobanking 2010;8:3-63.
17 http://biospecimens.cancer.gov/about/overview.asp
18 Betsou F, Lehmann S, Ashton G, et al. Standard Preanalytical Coding for Biospecimens: Defining
the Sample PREanalytical Code. Cancer Epidemiol Biomarkers Prev 2010;19:1004-1011.
19 FDA. www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm124720.htm
20 IUPAC Technical Report: Harmonized Guidelines for single-laboratory validation of methods of
analysis. Pure Appl Chem 2002;74:835-855.
21 The International Committee on Harmonisation Validation of Analytical Procedures : text and
methodology (Q2 (R1)), ICH
25
22 NIST Guidelines for evaluating and expressing uncertainty of NIST measurement results (NIST
technical note 1297, 1994 edition)
23 ISO 5725, Accuracy and precision of results and measurement methods, 1994/1996
24 Betsou F, Barnes R, Burke T et al. Human Biospecimen research: Experimental Protocol and Quality
Control Tools. Cancer Epidemiol Biomarkers Prev 2009;18:1017-1025.
25 Spruessel A, Steimann G, Jung M et al. Tissue ischemia time affects gene and protein expression
patterns within minutes following surgical tumor excision. BioTechniques 2004;36:1030-1037.
26 EU Directive 95/46/EC
27 http://www.export.gov/safeharbor/eu/index.asp28 Carter A, Betsou F, Clark BJ. Quality
management and accreditation of research tissue banks (Letter to the editor). Virchows Arch 2010, in
press.