The retention and storage of pathological records and specimens
(5th edition)
Guidance from The Royal College of Pathologists and the Institute of Biomedical Science
April 2015
Unique document number G031
Document name
The retention and storage of pathological records and specimens
Version number
5
Produced by
Dr Bridget Wilkins, on behalf of The Royal College of Pathologists’
Working Party on the Retention and Storage of Pathological
Records and Specimens
Date active
April 2015
Date for review
April 2019
Comments
This issue replaces all previous versions of
The retention and
storage of pathological records and archives/specimens.
In accordance with the College’s pre-publications policy, it was on
the College website for consultation from 21 October to 19
November 2014, following pre-consultation with SAC Chairs and
others. Over 260 items of feedback were received and the
guidance was amended accordingly. Please email
[email address] to see the responses.
Dr David Bailey, Vice-President for Communications
Dr Peter Cowling, Director of Clinical Effectiveness
The Royal College of Pathologists
4th Floor, 21 Prescot Street, London, E1 8BB
Tel: 020 7451 6700
Fax: 020 7451 6701
Web: www.rcpath.org
Registered charity in England and Wales, no. 261035
© 2015, The Royal College of Pathologists
This work is copyright. You may download, display, print and reproduce this document for your personal,
non-commercial use. Apart from any use as permitted under the Copyright Act 1968 or as set out above, all
other rights are reserved. Requests and inquiries concerning reproduction and rights should be addressed to
The Royal College of Pathologists at the above address. First published: 2015
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Contents
General principles of record and specimen retention ................................................................ 5
Introduction ................................................................................................................................... 6
Key updates and additions to this edition ........................................................................................ 6
Terms of reference, history and development of the guidelines ....................................................... 6
Contributors .................................................................................................................................... 7
Context ........................................................................................................................................... 7
Scope of the guidance .................................................................................................................... 8
The nature of pathology records ............................................................................................... 10
Clinical and diagnostic records and reports ................................................................................... 10
Laboratory and mortuary working records: reports and documentation for internal use ................. 11
Specimens .................................................................................................................................... 12
The management of records and specimen archives: general comments ............................. 12
A. Documents, electronic and paper records ........................................................................... 17
Request forms .............................................................................................................................. 17
Daily work logs (day books and electronic equivalents) and other records of specimens
received by a laboratory ................................................................................................................ 18
Mortuary registers ......................................................................................................................... 18
Protocols of standard operating procedures .................................................................................. 18
Worksheets ................................................................................................................................... 18
Laboratory file cards or other working records of test results for named patients .......................... 18
Records of telephoned or faxed reports ........................................................................................ 18
Report copies (physical or electronic) ........................................................................................... 18
Surgical (histological) reports ........................................................................................................ 19
Post-mortem reports ..................................................................................................................... 19
Correspondence on patients ......................................................................................................... 19
Point-of-care test data ................................................................................................................... 20
Bound copies of reports and records, if made ............................................................................... 20
Pathological archive or museum catalogues ................................................................................. 20
Photographic records .................................................................................................................... 20
Batch records ................................................................................................................................ 20
Internal quality control records ...................................................................................................... 21
External quality assessment records ............................................................................................. 21
Accreditation documents and records of inspections ..................................................................... 21
Temperature records for refrigerators and freezers (including those used for
post-mortem body storage) ........................................................................................................... 21
Equipment maintenance logs ........................................................................................................ 21
Records of service inspections and instrument maintenance ........................................................ 22
Records relevant to production of diagnostic products or equipment ............................................ 22
Records of assay validation and verification .................................................................................. 22
Research data .............................................................................................................................. 22
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Records relating to cell/tissue transplantation ............................................................................... 22
Records relating to retention of semen, spermatozoa, oocytes and tissues for
fertility assessment and use in assisted reproduction .................................................................... 22
B. Specimens and preparations ................................................................................................. 22
Legal issues .................................................................................................................................. 22
Plasma and serum ........................................................................................................................ 24
Newborn blood spot screening cards ............................................................................................ 25
Faecal occult blood screening cards and derived faecal suspensions ........................................... 25
Body fluids, aspirates and swabs (including liquid-based cytology specimens) ............................. 26
Whole blood samples, for full blood count ..................................................................................... 26
Donor lymphocyte preparations in cell or tissue transplantation .................................................... 26
Frozen tissue for immediate histological assessment (frozen section) .......................................... 26
Frozen tissue or cells for histochemical or molecular genetic analysis .......................................... 26
Paraffin wax or resin embedded blocks for histology ..................................................................... 26
Retention of specimens and records in the context of biosample banking for research ................. 27
Release and return of archived diagnostic samples for clinical trials purposes .............................. 28
Blocks for electron microscopy ...................................................................................................... 29
Grids for electron microscopy........................................................................................................ 29
Wet tissue (representative portion or whole tissue or organ) ......................................................... 29
Museum specimens, where these are generally accessible for undergraduate or
postgraduate study (teaching collections not accessible by members of the public) ...................... 30
Stained slides ............................................................................................................................... 30
Human DNA and RNA .................................................................................................................. 32
Microbiological cultures ................................................................................................................. 32
Freeze-dried or other permanently preserved cultures .................................................................. 33
Electrophoretic strips and immunofixation plates .......................................................................... 33
C. Documents, records, specimens and preparations: specific advice for
transfusion laboratories ............................................................................................................. 33
Documents and records ............................................................................................................. 33
Request forms for grouping, antibody screening and cross-matching ........................................... 33
Worksheets ................................................................................................................................... 33
Results of grouping, antibody screening and other blood transfusion-related tests ....................... 33
Blood Bank Register, blood component audit trail and fates ......................................................... 33
Refrigerator and freezer charts ..................................................................................................... 34
Records of serious events ............................................................................................................. 34
Annual reports (where required by The Blood Safety and Quality Regulations 2005) .................... 34
Specimens and preparations ..................................................................................................... 34
Blood for grouping, antibody screening and saving and/or cross-matching ................................... 34
Separated serum or plasma, stored for transfusion purposes ...................................................... 34
D. Forensic material .................................................................................................................... 35
Criminal cases .............................................................................................................................. 35
Autopsy reports, specimens, archived material and other, where the deceased has
been the subject of a Coroner’s autopsy ....................................................................................... 35
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E. Genetics .................................................................................................................................. 35
Storage of material following analysis of nucleic acids .................................................................. 36
a) Molecular genetics .................................................................................................................... 36
b) Molecular cytogenetics ............................................................................................................. 36
Retention of records and materials by providers of external quality assessment ................. 36
Additional records to be kept by EQA providers ............................................................................ 36
Other records ................................................................................................................................ 37
Retention times for materials stored by EQA providers ................................................................. 37
Cells, tissues and other materials stored prior to preparation and circulation ................................ 37
Disposal of human tissue ........................................................................................................... 37
General ......................................................................................................................................... 37
Fetal tissues .................................................................................................................................. 38
Medicolegal value of archived material ..................................................................................... 39
Specimens and records for teaching ........................................................................................ 39
Research data and records ........................................................................................................ 39
Confidentiality of records ........................................................................................................... 40
Long-term or permanent retention of records .......................................................................... 40
A note on veterinary pathology specimens and records ......................................................... 41
Bibliography and further guidance ............................................................................................ 42
Appendix 1: Summary of records guidance ............................................................................. 47
Appendix 2: Summary of specimens guidance ........................................................................ 53
Appendix 3: Schedule 1 of The Human Tissue Act 2004 ......................................................... 59
Scheduled purposes ..................................................................................................................... 59
Part 1: Purposes requiring consent: General ................................................................................. 59
Part 2: Additional purposes requiring consent: deceased person .................................................. 59
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General principles of record and specimen retention
Record/specimen type
Recommended retention period
Primary copy of record in patient’s paper or
30 years
electronic medical record
Information (paper or electronic) or
30 years
permanent specimens held in the laboratory
that may also be regarded as primary
components of the patient’s medical record
Records relating to cells and tissue used for
Lifetime of recipient
transplantation, including transfusion
Records and serum samples used for
Lifetime (recipient)
microbiological investigations prior to
At least ten years (donor)
transplantation
Tissue sections and other permanent
Minimum of 15 years
microscopy preparations replaceable from a
If from a child, until they reach the age of 25
primary specimen such as a tissue block
Working records (paper or electronic) needed Minimum of eight years (two accreditation
for laboratory accreditation
cycles)
Instrument and equipment performance logs
Lifetime of instrument/equipment plus
minimum of four years
Primary copy of record in patient’s paper or
Eight years
electronic medical record after death
Records (paper or electronic) or specimens
Eight years
held in the laboratory after death, that may be
regarded as primary
Non-permanent specimens, empty specimen
Until verification of completed report; an
containers and sampled material surplus to
additional margin may be advisable, depending
testing requirements
on specimen type and feasibility
Records of specimens stored with consent for Lifetime of specimen in storage
research/biobanking
Records of archived ‘surplus’ diagnostic
Five years from closure of study, or as
samples released for research
determined by study sponsor(s)
Please refer to Appendices 1 and 2 for more detailed information.
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Introduction
This is an update of the advice of The Royal College of Pathologists and Institute of Biomedical
Science on
The Retention and Storage of Pathological Records and Archives.
Key updates and additions in this edition
Revised advice for molecular genetics, reflecting the increasing use of genome-wide
sequencing technologies.
Expanded advice for point-of-care testing.
Adjusted document retention times reflecting move to ISO standards 15189 and I7043
accreditation.
Guidance for samples and records made available for research after diagnostic use.
Summary of general principles applicable to retaining key categories of records and
specimens.
Terms of reference, history and development of the guidelines
The original Working Party for this guidance was appointed in 1994 by the Council of The Royal
College of Pathologists, with the following terms of reference:
“To make recommendations on minimum retention times for pathology records, tissues and semi-
permanent or permanent pathological preparations, including those required for operational use,
for education, teaching, training and general scholarship, for research per se
, for historical
purposes and against the possibility of future litigation, audit or allegations of scientific fraud and to
report to Council”.
Following publication of the first version in that year, a second edition in 1999 additionally
considered ethical and practical implications relevant to genetic testing, especially those services
offered directly to the public, and the use of stored archives (specimens and records) in research,
education, audit and quality control. In 2005 and 2009, further editions included implications of the
Data Protection Act 1998, the Human Tissue Act 2004 and the Human Tissue Act (Scotland) 2006,
the increasing use of electronic records and molecular diagnostic tests for acquired disease, and
the requirements arising from participation in external quality assurance schemes.
For consideration in the 2015 edition, growth of molecular genetic testing continues apace, with
evolving data storage requirements as whole-genome sequence technologies gain prominence in
the diagnostic repertoire. Storage of electronic records also poses evolving challenges, particularly
for data security and continued availability in accessible formats at reasonable cost as hospitals’
information platforms are updated. Increased diversity of point-of-care testing has warranted
further advice. Guidance for bodies providing external quality assessment programmes has been
extended to reflect feedback since the introduction of this topic in the 2009 edition. Transition to
laboratory accreditation by UKAS against ISO standards 15189, 18025 and 17043 has implications
for the inspection cycle time over which some records should be held. A general principle in all
versions of this document has been to advise retention of relevant records for three inspection
cycles; this would lead to an extension from ten to 12 years, anticipating an overall cycle time of
four years to complete all elements of the cumulated annual inspections against ISO standards.
This is becoming an unreasonable and unnecessary burden and we therefore propose to
recommend retaining relevant records for two accreditation cycles (eight years). With increasing
experience of accreditation against these ISO standards, it may be possible, in the next iteration of
this guidance, to recommend reducing storage times for relevant documents to the length of a
single cycle plus a safety margin (say, five years). Lastly, with the increasing involvement of
diagnostic pathology archives as sources of biosamples for clinical trials and for research
biobanking, we have added guidance covering these activities.
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To date, medical records legislation has not been amended to extend retention requirements in line
with increased longevity in the general population. Should this change before publication of a
future revised edition of this guidance, references to 30-year retention of records and specimens,
where these constitute primary medical records, will need extending to match any new, legally
defined minimum period. A new EU data protection regulation is also currently under consideration
(January 2015), which may impose new consent requirements for patient data and sample sharing;
general principles arising from Article 8 of the Human Rights Act (1998) also require consideration.
Contributors
The names of the coordinators and the large number of individuals who have assisted with the
production of the original 1994 document and its revisions in 1999, 2005 and 2009 can be found
within the text of the relevant versions. This revision builds upon their work.
Contributors to the 2015 revision were:
Dr Jeff Adams
Forensic Science Regulation Unit, Home Office
Professor Gifford Batstone
Specialist Pathology Advisor, NHS England
Mr Christopher Birkett
Human Tissue Authority
Mr Clinton Blackburn
Institute of Biomedical Science, clinical chemistry
Ms Caroline Browne
Human Tissue Authority
Dr David Bullock
UK National External Quality Assessment Service
Dr Ian Frayling
Molecular pathology, genetics
Dr Danielle Freedman
Chemical pathology, clinical biochemistry
Dr Mike Galloway
Haematology, transfusion
Ms Alison Geddis
Institute of Biomedical Science, haematology and transfusion
Dr Jane Hair
Biobanking (Manager, Glasgow Biobank)
Dr Paul Johnson
Forensic pathology
Dr Nicholas Looker
Microbiology
Professor James Lowe
Forensic and non-forensic autopsy pathology
Ms Sarah May
Institute of Biomedical Science (Deputy Chief Executive)
Dr Ken Mutton
Public Health England, virology
Mrs Gail Norbury
Cytogenetics, molecular genetics
Dr Alison Parry-Jones
Biobanking (Manager, Wales Cancer Bank)
Dr Kay Poulton
Histocompatibility and immunogenetics
Mr Andrew Usher
The Institute of Biomedical Science, cellular pathology
Dr Bridget S Wilkins
Histopathology, molecular pathology
Dr Philip Wood
Immunology
Dr Bryan Woodward
Reproductive science
Key stakeholders were the Human Tissue Authority, Institute of Biomedical Science and all Chairs
of the College’s Specialty Advisory Committees.
Context
The 17 years since the 1998 edition of this document have seen major changes in attitudes
towards the use of personal data and human tissue. In 1998, following the guidance of the 1995
report from the Nuffield Council on Bioethics, most pathologists believed that human tissue
samples held in their laboratories could be used for any ethically acceptable purpose (as defined
by the Nuffield Council) without further consent from the patient, as long as the tissue was surplus
to diagnostic requirements.
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A similar view pertained to research and other work using confidential patient information.
Confidentiality should be maintained, but consent was not regarded as necessary. The Chief
Medical Officer of the time reinforced this view, and the preamble to the 1998 version of this
document quoted his opinion as:
“information which seems likely to provide material for medical research should be scrutinised with
a view to permanent preservation, and acknowledging the value to genetic services of retaining
informative medical records and biological samples where resources are available for this”.
This comment makes no mention of consent. The potential benefit to society of such work was
regarded as sufficient. Of course, the patient’s interests must not be harmed by such work, or the
patient would have had recourse to redress under common law. This situation has changed
radically, the most obvious manifestations being reflected in the implementation of the Data
Protection Act 1998 and the Human Tissue Act 2004.
In parallel, 17 years of technological development in laboratories and medical information systems
have passed, accompanied by rapidly increasing use of electronic media to store and share
information. These developments create new requirements relating to retention of new categories
of specimens and records; capacity and long-term accessibility are now pressing issues. The
revalidation of individual pathologists by the General Medical Council (GMC) also creates new
requirements to retain specimens, records and correspondence that may have an evidential role in
the revalidation process.
These changes justify ongoing modification of the advice of the College and the Institute of
Biomedical Science (IBMS) on the retention and storage of pathological records and specimens.
Scope of the guidance
In most cases, records and archived specimens are held primarily to benefit the medical care of
the patient concerned, as part of that patient’s medical record. Under the Human Tissue Act 2004,
consent is not needed for retention and use of tissue from living individuals for this purpose.
However, consent from a relative (or other appropriate third party), the authorisation of a Coroner
(a Procurator Fiscal in Scotland) or the police (Police and Criminal Evidence Act, 1984) is required
for retention of tissue obtained at post-mortem examination. In relation to data protection law, it is
reasonable to infer that the information held in pathological records was generated legitimately in
the first instance and that patients are aware of its continued existence within the confidential
archives of the hospital. Indeed, patients would have legitimate grounds for complaint if their future
healthcare was compromised because technical details of their previous investigations had been
erased without their knowledge. We can therefore assume that pathologists have legitimate
authority to retain records and archives for the benefit of individual patients, relying only on the
consent that was a clinical requirement for their original generation.
The updated guidance produced in 2005 and 2009 dealt in depth with altered consent and
licensing requirements relating to retention specifically for purposes
other than the direct benefit of
the patient concerned, in response to initial implementation of the Human Tissue Act 2004 and the
Human Tissue Act (Scotland) 2006. The principles of patient autonomy and consent are
fundamental to these Acts and so it follows that patients ought to know what data and samples are
held. In the unlikely event of a patient insisting on the destruction or return of a sample, the
pathologist should make all reasonable attempts to ensure that the patient understands the
possible adverse consequences of destruction. Laboratories should have established procedures
for informing patients of such consequences, and of the potential health hazards associated with
human tissue samples. However, if a patient so informed still insists on destruction or return,
consent has explicitly been withdrawn and laboratories must comply with the patient’s request.
The situation in Scotland relating to tissue blocks and slides is different. The Scottish legal position
is that the blocks and slides become the property of the hospital, on the basis that they form part of
the individual’s medical record.
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It must be emphasised that this document is concerned with the retention and storage of
pathological records and archived specimens,
not their use.
Detailed guidance regarding the physical conditions (including security) of storage are also not
within the remit of this guidance, other than the general proviso that stored records and specimens
should remain intact and accessible for the full term of their retention. A few points of principle are
included relating to tissue storage conditions to optimise long-term specimen integrity for
biobanking purposes and for future molecular genetic testing.
This document does not cover material stored for therapeutic uses, such as transfusion or
transplantation, although the retention of laboratory records concerning such activities is included.
The fact that material has been retained for the benefit of the patient does not imply that other uses
are necessarily either legitimate or illegitimate. When using archives of specimens and records for
any other purpose, including the benefit of other patients, pathologists must consider whether their
actions are ethical and legal. In respect of research, the opinion of an appropriate Research Ethics
Committee must be sought. Further information, contacts for local committees and procedural
details can be found on the Health Research Authority website
(www.hra.nhs.uk), with the
Integrated Research Application System accessible directly
at www.myresearchproject.org.uk. In
respect of data, the hospital’s ‘Caldicott guardian’ and/or data protection officer should be able to
advise. The establishment of Clinical Ethics Committees in many UK hospitals is welcomed as a
further potential source of advice. In difficult cases, it may be necessary to seek advice from the
Information Commissioner’s Office
(www.ico.org.uk) in respect of data, or the Human Tissue
Authority
(www.hta.gov.uk) in respect of human biological samples.
Whenever such advice is sought, the presence and nature of consent, even if implied rather than
explicitly obtained consent, is likely to be important in whether the proposed use is regarded as
ethical or not. It is therefore hoped that hospitals will implement procedures to ascertain and record
the wishes of all patients in this regard. Current progress towards implementing such procedures is
highly variable across the NHS and remains incomplete. It is incumbent on laboratory staff to be
fully aware of the local arrangements in place in their hospitals and in other units (such as general
practitioner [GP] and dental surgeries) from which specimens may be received. A requirement to
re-contact patients for consent long after a clinical event is rarely practical or ethical. Consequently,
if initial consent is not requested and recorded, valuable work could be prevented. Informed patient
consent has become a requirement for some types of activity (especially the storage and use of
tissue and data for many research studies), even if the work produces no risk to the patient and is
intended for the benefit of all in society. Where consent procedures are not yet in place covering
retention and storage of patients’ tissue and data for future use, laboratory professionals have a
vital role in promoting these with hospital managers. Laboratory staff are also best placed to
implement tracking mechanisms to ensure retention or disposal in accordance with patients’ wishes.
Final y, a potential tension between retention of archived ‘surplus’ diagnostic material for the
patient’s benefit and for other uses, such as research, is highlighted by the increased
personalisation of treatment. Currently, this involves re-analysis of stored samples in a high
proportion of cases, sometimes after many years of ‘fallow’ storage. This thoroughly justifies
laboratories’ traditional practices in storing such material; its diversion into research use now needs
greater consideration. It is now no longer justifiable to make over-arching assumptions that
archived tissue or nucleic acid samples, after initial diagnosis, have completed their direct benefit
for the patient. This assumption has typically been the basis of allowing their use for research or
transfer to a research collection or biobank for future research use. Requirements for retrospective
genetic testing will undoubtedly evolve further (i.e. decline) as more proactive testing of samples
for germline mutations and predictive biomarkers is undertaken at diagnosis. However, the need to
re-investigate samples upon development of treatment resistance or emergence of new targetable
treatments will remain at least until whole-genome sequences are captured for such samples,
permitting reinvestigation of stored data rather than stored samples. Attention will need to be paid
to ease of specimen retrieval and to the alternative or additional storage of unfixed specimens to
avoid artefacts associated with formalin fixation and tissue processing.
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The nature of pathology records
Clinical and diagnostic records and reports
1.
These are hard copy or electronic records of the results of pathological investigation(s) sent
or made available to the requesting clinicians, with the expectation that they will be stored
within the patient’s individual clinical record. With respect to computer-generated, electronic
records, the same criteria that cover conventional records apply, unless they have been
converted to hard copy records and preserved as such. If held only on microfilm, microfiche
or original magnetic data files, extra care is needed to prevent corruption or deterioration of
data. Arrangements should be in place for frequent and secure back-up of electronic data.
These are usually administered centrally within hospitals for all laboratory sections
encompassed by their pathology IT systems. However, equivalent arrangements need to
cover point-of-care testing and tests undertaken in satellite venues such as GP surgeries. As
equipment becomes obsolete, re-recording may need to be considered. The minimum
periods of retention specified for records for certain categories of patients are embodied in
Records Management: NHS Code of Practice Part 1 (2006) and Part 2 (Second Edition,
2009), applying to the NHS throughout England (see Bibliography); additional records
guidance for Wales can be found at
www.nhswalesgovernance.com. In relation to patients in
the private sector in England, minimum retention times for medical records are specified in
Statutory Instrument 2001 No. 3968, Schedule 3(1). In Scotland, the position is set out in
MEL(1993)152, which was the subject of consultation in 2005 followed by publication in 2008
and revision in 2012, of a code of practice essentially equivalent to that applicable in
England:
Scottish Government Records Management: NHS Code of Practice (Scotland)
Version 2.1, 2012 (see Bibliography).
2.
The UK Departments of Health, in their published codes of practice covering records
management in the NHS referred to in paragraph 1 above, set the policy, standards and
retention periods for health and corporate NHS records, both paper-based and electronic.
However, concerns have been raised as to whether NHS electronic records are capable of
maintaining systems of retention as outlined in that guidance. The Department, together with
NHS Connecting for Health (disbanded in March 2013) and stakeholders have continued to
develop proposals for an appropriate electronic records retention policy for the NHS, to be
cost-effective, meet legal requirements and not compromise patient care. Current strategic
views, not yet enshrined in legislation or codes of practice, may be found via the Health and
Social Care Information Centre website
(www.hscic.gov.uk). The British Standards Institute
code BSI BIP 0008 encompasses legal standards for electronic records storage more
broadly (see Bibliography). In general, however, hard copy reports of pathological
investigations for patients should continue to be produced and incorporated into patients’
individual clinical notes for as long as hard copy remains the primary and comprehensive
form of record; see below with regard to electronic GP records. Although there is no
obligation to destroy them at all, patient records may not be destroyed until the minimum
period for retention has elapsed. Longer retention should be by authorisation from/transfer to
an approved place of deposit (
Records Management – NHS Code of Practice Part 2 [2nd
edition], 2009). Clearly, with increased longevity, 30 years is becoming too short a period but
medical records legislation has not yet been amended to change this. Hence, we still refer to
30 years throughout this document. It is primarily the responsibility of hospitals, surgeries,
etc. to ensure that filing of reports into patients’ records is performed in a comprehensive,
accurate and timely manner. Increasingly, GP surgeries are adopting electronic patient
records and have secure networking arrangements in place to receive pathology reports by
email or another directly transmitted electronic format. With explicit and formal agreement
between the hospital Trust, commissioners and GP practices involved, it is reasonable to
dispense with sending out secondary paper copies of such reports, providing procedures are
in place that ensure correct transmission and receipt of the electronic report occur and are
confirmed by both the laboratory and GP surgery. Transmission of electronic records that will
stand as final reports should be in an unalterable, ‘read-only’ format.
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3.
Point-of-care testing (POCT) services must be provided and operated in accordance with
recommendations from the Medicines and Healthcare products Regulatory Agency (MHRA)
(DB 2002(03)
Management and Use of IVD Point of Care Test Devices; with update in 2013
– see Bibliography) The guidelines on storage of specimens and records that apply to a
pathology (including genetics/genomics) laboratory should also, in general, apply to any
POCT service. Where no hard copy or electronic file is generated as output from POCT
analyses, the results must be transcribed as a contemporaneous record into the patient’s
clinical notes. Data security of information stored on hard drives of POCT instruments,
including those placed in community settings, must be assured. Increasing direct networking
of POCT services to laboratory information management systems is welcomed.
4.
POCT services are offered to generate a rapid result for guidance of immediate patient care.
These should be subject to accreditation and quality control procedures and should meet
standards equivalent to those which would be expected in a routine laboratory. Results from
POCT tests must be entered into a patient’s medical record and should include the name of
the POCT operator. The record should make it obvious to any user of the information that
those results are from a POCT system that is not necessarily fully compliant with routine
laboratory standards.
5.
Electronic records now take many forms and are used for a wide variety of purposes. Mostly,
these parallel the functions of paper records so that retention times can be deduced from
those suggested for equivalent physical records. However, their ease of access and
dissemination necessitates even more stringent security arrangements for transmission,
such as encryption and password protection. They also carry different risks of corruption or
loss from those of hard-copy records, and arrangements for regular and accurate back-up
are essential. The speed of change in IT provision for health services makes it essential to
ensure that such records remain accessible for the full period of their retention and possible
use. Laboratory professionals should ensure that electronic record-keeping and transfer are
encompassed by, and compliant with, their organisations’ overall IT security policies,
including the safe-keeping and regular updating of passwords and encryption keys, and
transfer to portable media.
Laboratory and mortuary working records: reports and documentation for internal use
6.
These include:
request forms
day books
worksheets
batch records (of reagent batches linked to series of specimens; also specimens
analysed as cohorts on automated instruments)
graphic output from instruments
refrigerator and freezer temperature records
photographic records
catalogues of the pathological archive or museum
bound copies of reports and records
point-of-care test data
correspondence
records of telephoned, faxed and emailed reports
equipment maintenance logs
quality control and quality assurance records
standard operating procedures
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accreditation documents
records of inspections.
(This list is not exhaustive.)
7.
Where these items are held in electronic form, often as digital image files, the same criteria
that cover conventional records apply. However, extra care is needed to ensure data security
and prevent corruption or deterioration of data (see paragraph 5 above). Suitable back-up
systems should be employed and, as equipment becomes obsolete, re-recording or the
production of durable hard copy may become necessary to maintain access.
8.
Use of a robust document management system is recommended, capable of providing a
secure repository for paper and electronic records with tracking of updates for procedural
documents such as standard operating procedures.
Specimens
9.
These include:
stored human biological specimens such as blood, serum, urine, faeces, cells and
tissue (including part or whole body organs)
tissue blocks
wet preparations including fixed tissue samples of any size
stained slides or other permanent or semi-permanent preparations including
electrophoretic strips, immunofixation preparations, nucleic acid and protein blots
museum specimens
test cards (e.g. neonatal screening [Guthrie test card] and faecal occult blood test
cards)
some POCT strips
microbiological swabs and cultures, freeze-dried or otherwise preserved
extracted nucleic acids of patient or cultured microbial origin.
10. When the term “tissue” is used in this document, it is used broadly in parallel with the
definition of “relevant material” in the Human Tissue Act 2004, i.e. material that consists of or
includes human cells. However, this document is not limited to such material, as it includes
reference to human biological material that is regarded by the Human Tissue Authority as
acellular (such as serum and plasma) and derived materials such as nucleic acids, including
naturally occurring cell-free DNA. In general, such material is not covered by the Human
Tissue Act 2004, although there are caveats in the Human Tissue Authority’s guidance
regarding plasma and serum. The professional requirement to adhere to relevant ethical
standards should be regarded as binding for all human tissue and derived materials. Further
advice concerning the definition of “relevant material” within the Act can be found at:
www.hta.gov.uk/legislationpoliciesandcodesofpractice/definitionofrelevantmaterial.cfm
The management of records and specimen archives: general comments
11. Diagnostic records are properly retained in individual patient notes or in electronic form. The
safekeeping of these records is primarily the responsibility of hospital records departments or
recipient general practitioners or private practitioners, once the pathologist has issued the
reports. Where pathologists have reason to doubt the reliability of systems of patient record
keeping, they should bring this to the attention of those responsible, rather than attempt to
rectify it by duplication with local and prolonged laboratory storage of diagnostic records. The
primary purpose of diagnostic records retention by laboratories is for internal use: correlation
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with results from previous and subsequent specimens, responding to queries from other
healthcare professionals, audit and quality assurance. When information relevant to clinical
care has been recorded in the laboratory, either formally or informally, the occurrence and its
content should be copied to the patient’s primary medical record or signposted in that record
for cross-reference if transcription is not feasible.
12. Where storage of material is no longer required for clinical purposes, but is desirable for
teaching, quality assurance, audit, research or other purposes of public benefit, the ethical
and legal acceptability of continued storage must be reviewed. The legitimacy of future
storage for such purposes is influenced by the presence or absence of appropriate consent.
This will depend on the intended future use; storage of relevant material for a scheduled
purpose under the terms of the Human tissue Act 2004 requires an appropriate licence, even
for de-identified specimens.
13. Research use will also require approval by a recognised Research Ethics Committee (REC)
or equivalent body. A Human Tissue Authority (HTA) licence will be required for storage of
relevant material removed after death, or for storage of relevant material from the living for
future research not covered by a current REC approval. Where a diagnostic archive of
specimens is used regularly as a source of material for research, advertises its availability or
invites applications as such a resource, the relevant material within it must be stored on
HTA-licensed premises. In many cases an existing HTA licence on the same premises,
which will most commonly relate to post-mortem or research storage activities, can be
extended.
(www.hta.gov.uk/legislationpoliciesandcodesofpractice/statementonextendingexistinglicence
stocovertheremovaloftissuefromthedeceasedforresear.cfm) The HTA should be consulted if extension to an existing licence is required to cover intended
storage for research use of relevant material within a primarily diagnostic specimen archive.
14. For compliance with requirements of current human tissue legislation, a recognised
Research Ethics Committee is either:
a Research Ethics Committee established under, and operating to, standards set out in
the governance arrangements issued by the UK Health Departments
or:
an ethics committee recognised by the UK Ethics Committee Authority (UKECA) to
review clinical trials of investigational medicinal products under the Medicines for
Human Use (Clinical Trials) Regulations 2004.
15. The statutory role of Designated Individuals in supervising suitable practices under the
authority of HTA licences is also crucial in relation to the above, as it is to all activities
undertaken for scheduled purposes licensed by the HTA. Indeed, many areas of the
guidance in this document align with the HTA standards for such suitable practices.
Designated Individuals can provide a valuable source of additional information regarding
acceptable conditions for storage and use of human cells and tissues, from living or
deceased individuals, regulated under the Act. More information about the roles and
responsibilities of Designated Individuals can be found via the HTA website; see
Bibliography.
16. There are reasons why individual pathologists or heads of departments may wish to retain
documents or materials for periods that are longer than the minimum times recommended
here. The following reasons for retention of tissue obtained from living individuals are legally
permissible without patient consent, largely because they are regarded as a necessary part
of the process of providing healthcare:
further diagnosis or ongoing clinical management
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clinical audit (this term should be interpreted selectively to encompass defined, planned
and documented audit activities rather than being used as a generic reason to retain
samples ‘just in case’)
quality assurance, including internal quality control and external quality assessment
teaching and training healthcare staff
epidemiology
analysis of data (such as case mix) for administrative or other purposes
direct evidence in litigation
individual, active research studies for which data or samples are suitably anonymised
and current approval is in place for the purpose, given by a recognised Research
Ethics Committee (REC). Specimens used for such research may continue to be held
for audit of the completed research but such storage must be under an HTA licence
unless there is continuing REC approval for the particular study or REC approval for
further use is pending. Consent is needed for the continued storage of specimens for
any of the scheduled purposes set out in Schedule 1, Part 1 of the Human Tissue Act
2004 (see Appendix 2 and Bibliography)
archives of specimens in hospital laboratories, for which the predictable diagnostic
purposes are complete, may in some circumstances be approved as tissue banks for
anonymous research use, by application to the National Research Ethics Service (for
further guidance see
www.hra.nhs.uk). This does, however, constitute a change in the
status of the archive (see paragraph 13 above) and requires HTA licensing; advice
should be sought from local Designated Individuals (see paragraph 15 above) and the
HTA to ensure compliance with their requirements. With exceptions for anonymised
use of archived samples in studies approved by an REC, appropriate consent for
research storage and use must be in place for material accrued after 1 September
2006).
17. It is nevertheless good practice, when practical, to check that the patient has not lodged a
specific objection to such use during the normal consent processes for the procedure(s) they
have undergone. Organisations within the NHS, and private clinical care providers operating
to equivalent standards, should have policies and procedures in place that allow patients to
register such an objection at any time after initial consent. To maintain public confidence, if
diagnostic archives are to be used even for anonymised research only, communication of
such decisions, and appropriate specimen tracking within laboratories, should operate to
ensure that patients’ wishes are respected in this regard.
18. Under the Human Tissue Act 2004, retention without appropriate consent of specimens
obtained at post-mortem examination is not permissible unless under one of the exclusions
specified in the Act, notably with the authority of the Coroner or for the requirements of the
criminal justice system. Under the Human Tissue Act 2004, authority to store human tissue
for a scheduled purpose without consent does
not persist after the Coroner’s work is
complete, unless under police authority. The situation in Scotland for Fiscal post-mortem
examinations is different; this is discussed below, as is the position regarding retention of
organs, tissue blocks and slides from a post-mortem examination instructed by a Fiscal.
19. Separate regulatory arrangements apply to retention and use of donor material (from living or
deceased individuals) for the potential benefit of transplant recipients. These are explained in
paragraphs 52–58 of the HTA guidance document
The Quality and Safety of Organs
Intended for Transplantation – A documentary framework (July 2012; see Bibliography).
20. The following reasons for retention were listed in early versions of this guidance, but they are
no longer acceptable as primary reasons to retain samples and data unless appropriate
consent has been given (unless the material is for some reason exempt from the
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requirements of the Data Protection Act, e.g. by adequate anonymisation, and the Human
Tissue Act, e.g. as a result of procurement before the Act came into force).
research (other than that covered in paragraph 16 above).
historical purposes.
holding of pathological material and records in dedicated tissue banks.
21. What form of consent is ‘appropriate’ is defined by the Information Commissioner in respect
of data, and by the Human Tissue Act 2004 and the HTA in respect of tissue. It is not
necessarily the case that consent must be written and individually signed, although it must be
documented. The nature of consent in different circumstances may range from generic to
highly specific.
22. The need to store specimens and data will vary according to the discipline of pathology that
is practised. Where specimens or permanent or semi-permanent preparations are kept, they
should be appropriately labelled, indexed and catalogued, so that the record remains
accessible, usable and under professional control and guidance.
23. However, if the material is not needed for clinical purposes but continued retention is
desirable, in some circumstances anonymisation will be necessary. If information is rendered
‘not identifiable’, this removes it from the remit of the Data Protection Act 1998 (as does the
death of the patient). Under some circumstances, secure coding of data may have the same
effect but expert advice should be sought, usually from an institution’s Data Protection
Officer.
24. In the case of human biological samples, information on the nature of any consent pertaining
to each sample should be retained even after irreversible anonymisation, as this will
influence the uses to which a sample can be put after anonymisation. For example, consent
for research use of individual tissues sampled at post-mortem examination may be specified
in detail by relatives of the deceased; it is important to retain a clear record of which tissues
may or may not be stored for research use. Patients, and relatives on behalf of the
deceased, may also specify objections to use of tissue in research involving animals while
permitting other research uses. Where the retention of human tissue would be unlawful,
anonymisation does not override this and cannot make continued retention lawful.
25. The recommendations that follow refer to the minimum times of retention that are consonant
with acceptable practice. If any of our recommendations indicate a shorter time for retention
than those required by recognised systems of good laboratory practice, the UK Blood
Services (NHS Blood and Transplant Service, Scottish National Blood Transfusion Service,
etc.), Public Health England laboratories, the Home Office or any other relevant regulatory
body, we recommend that the latter be followed by subscribing laboratories. Many laboratory
professionals will have good and cogent reasons for retaining records and materials for much
longer periods. Increasing longevity, although not yet reflected in a change of medical
records legislation, provides justification for considering the retention of primary records and
permanent specimens beyond the current statutory 30 years.
26. Where laboratories or hospitals are to be closed, or where a contract to provide a pathology
service is transferred to another provider, pathologists, laboratory and hospital managers
must consider the need to retain and relocate certain records and materials, so that
continuity of essential data storage is maintained and the records remain accessible at all
times for clinical purposes. There should be an explicit agreement as to which organisation
assumes responsibility for the retained records and materials; access procedures should be
defined clearly and made known to users. Also, depending on the nature of the material
being transferred, the receiving organisation may require an HTA licence. This will all
necessitate careful organisation but provides opportunity for disposal of records that are no
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longer needed. Any records for disposal that contain patient-identifiable data should be
disposed of by incineration or shredding as confidential waste.
27. It has been established legally that the mere possibility of pathological material or related
documentation constituting material evidence in future litigation is not a sufficient ground for
the imposition of a duty to store indefinitely (Dobson
versus North Tyneside HA [1996]). As
litigation can arise very many years after the relevant treatment is complete, maintaining
records for extended periods sufficient to satisfy all potential medicolegal interests is
unrealistic. It should be noted, however, that once particular legal proceedings have
commenced, or there is a reasonable expectation that they are about to commence, any
archive destruction policy should be suspended in respect of all documents or specimens
relevant to that matter (Criminal Procedure and Investigations Act 1996).
28. This document does not discuss maximum retention times. If a patient dies, it may be that
data and samples taken during life are held in the archives but now have no foreseeable
future use, and the wishes of the patient in relation to retention are not known. Such data and
samples may be disposed of although their identification within a large archive may be
laborious. If samples are taken
before death and the patient
subsequently dies, that death
does not alter the status of the samples under the Human Tissue Act 2004. In contrast with
samples obtained
after death, there is no legal requirement to dispose of data and samples
from patients who have
subsequently died.
29. In early versions of this guidance, the word “permanently” was used widely, with an
explanation that this was not intended to enforce retention for longer than 30 years. For
greater clarity, this version continues to use the phrase “for at least 30 years”, which was
introduced in the 3rd edition in 2005. However, this is intended to have the same meaning,
i.e. “without limit of time”. Furthermore, to preserve material of potential historical importance,
records earlier than 1948 should not be destroyed and hard copy reports made to patients’
notes should be kept by records departments in accordance with UK Departments of Health
guidance (see Bibliography). Wherever possible, pathological preparations and any
documentation pertaining to them should be kept for the same period of time, but see above.
The NHS Code of Practice cited above anticipates that medical records held for more than
30 years, or pre-1948, will be achieved by transfer to an approved Place of Deposit or to The
National Archive; individual institutions may apply to be recognised as approved Places of
Deposit.
30. Previous versions of this guidance have not considered in detail the conditions under which
cells, tissues, derived materials, reagents and records are kept. With regard to reagents,
there is clear guidance from Control of Substances Hazardous to Health (COSHH)
(www.hse.gov.uk/coshh). With regard to records, hospitals and other institutions generally
have local policies and procedures to ensure appropriate back-up and secure data storage,
with which pathology laboratories should comply. Where specific requirements are needed
for particular specimens, e.g. refrigerated or frozen storage, appropriate arrangements
should be in place to ensure maintenance of the correct storage temperature, including
emergency arrangements in case of power supply failure. Appropriate light, temperature and
humidity conditions should be provided for temporary storage of ‘transient’ preparations such
as fluorescently labelled cells and tissue sections, and for other ‘wet’ preparations. These
requirements are all encompassed by accreditation standards now incorporated under the
umbrella of UKAS
(www.ukas.com) used by diagnostic laboratories, including ISO 15189 to
which NHS diagnostic laboratories are currently in transition. Institutions that may not require
such accreditation are recommended to meet equivalent standards if they are not governed
by other arrangements such as those of GCP applicable to research laboratories.
(www.mhra.gov.uk/Howweregulate/Medicines/Inspectionandstandards/GoodClinicalPractice)
31. Currently, there are no specific requirements that materials, designated for storage under
ambient conditions, should be stored with controlled levels of ventilation, light or temperature.
However, laboratory managers should be aware that, as potential uses of stored materials
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change, guidance in these areas may evolve; for example, where research biobanking of
paraffin wax-embedded tissue blocks (and derivatives such as tissue microarrays) is
undertaken, it may emerge that temperature and/or humidity control are important new
considerations for long-term preservation of sample integrity.
A
Documents, electronic and paper records
(See also Sections C [blood transfusion laboratories], D [forensic material] and
E [certain genetic services])
32. Note that storage of data relating to identifiable individuals is likely to be an offence under the
Data Protection Act 1998 unless there is appropriate registration with the Office of the
Information Commissioner. If in doubt, consult your institution’s Data Protection Officer.
33. Unless stated otherwise, minimum retention periods are not influenced by whether
information is in electronic or paper form, although measures to ensure the security and
integrity of the information will differ.
Request forms
34. It is prudent to keep request forms until the authorised report, or reports on investigations
arising from it, have been received by the requester. As this period of time may vary with
local circumstances, we do not recommend a minimum retention time but believe that,
ordinarily, request forms need not be kept for longer than one month after the final checked
report has been despatched. For many uncomplicated requests, retention for one week
should suffice. Where paper copy directly duplicates an electronic request (e.g. many order
comms systems), there is no absolute requirement to retain the paper copy.
35. Where the request form contains clinical information not readily accessible in the patient’s
notes but used in the interpretation of test data (as in screening for alpha fetoprotein,
cytogenetic and molecular genetic testing), the request should be kept for at least 30 years.
Similarly, where the request form is used to record working notes or as a worksheet, it should
be retained as part of the laboratory record (see paragraphs 40 and 41 below for guidance
regarding such working documents), unless the information is transcribed to another source
(such as a computer record). Where regarded as minor financial documents for accounting
purposes, the advice of the local finance department should be sought.
36. It is not the purpose of this document to specify acceptance criteria for documentation and
labelling of specimens received in laboratories. However, without certain minimum data,
receipt is unsafe and reporting is rendered inefficient or impossible. Laboratories are
recommended to operate policies according to locally agreed criteria, with a clear
understanding between themselves and their users that items found to be non-compliant with
the agreed acceptance policy will be disposed of. What constitutes a reasonable enquiry for
missing information, if a replacement specimen cannot easily be provided, should be part of
this local agreement. It is the responsibility of individual laboratories to decide whether or not
inadequately identified specimens should undergo the requested analyses or be discarded
without analysis. Records of specimens disposed of without analysis should be kept for a
minimum of four years, to facilitate audit over at least one full accreditation cycle, together
with the primary request documentation and explanation of the reason for discard. Standard
practice for adequate identification is to require two or three unique patient identifiers plus
identifiers of the date and nature of sample. Where records or samples are transferred
between organisations, it is important that these identifiers are retained and cross-referenced
by information tracking systems. Further guidance on specimen identification and
acceptance
criteria
is
available
from
the
Institute
of
Biomedical
Science
(www.ibms.org/go/media/publications/professional-guidance and see Bibliography).
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Daily work logs (day books and electronic equivalents) and other records of specimens
received by a laboratory
37. Eight years from specimen receipt, to ensure availability for review through at least two full
cycles of laboratory accreditation.
Mortuary registers
38. Retain for 30 years.
Protocols of standard operating procedures
39. Both current and outdated protocols should be dated and kept in a catalogued, accessible
format for at least 30 years. Use of a document management system capable of
administering records in electronic and paper formats is strongly recommended, with
maintained access to the legacy of previous versions.
Worksheets
40. Keep for same length of time as related permanent or semi-permanent specimens or
preparations. For temporary specimens (such as serum, body fluid and faecal samples) that
are not suitable for retesting, keep at least until the final report has been authorised.
Laboratory file cards or other working records of test results for named patients
41. One year from specimen receipt if all results transcribed into a separately issued and stored
formal report. Otherwise, they should be kept as for worksheets above. The diversity of these
types of working record is very wide; within individual specialties and departments,
consideration should be given to the potential audit or medicolegal value of storing such
working records for 30 years, as for other primary records. We recommend that results of
tests undertaken by external laboratories, where records are held by those laboratories and
the results are transcribed locally into a cross-referenced report, are regarded as such
working documents.
Records of telephoned or faxed reports
42. Note of the fact and date/time that a telephoned or faxed report has been issued should be
added to the laboratory electronic record of the relevant report, or to hard copies, and kept
for a minimum of five years. Where management advice is discussed in telephone calls, a
summarised transcript should be retained long term, as for the retention of other
correspondence (see paragraph 49). Clinical information or management advice provided by
fax, in addition to pure transmission of a report, should also be kept as correspondence filed
in the patient’s notes and/or stored with a laboratory copy of the specimen request/report for
30 years. Further guidance on the reporting of results by telephone is available from the
IBMS and there is also RCPath guidance on the related issue of ensuring appropriate
transmission of urgent results (see Bibliography).
Report copies (physical or electronic)
43. Six months, or as needed for operational purposes. The primary record, which must be
retained in line with legal requirements for all components of a patient’s medical record, is
the copy placed in their notes. Reports communicated between laboratories (e.g. resulting
from analysis of a sample forwarded from a local laboratory to a reference laboratory) must
be placed directly or transcribed into the patient’s medical record. Copies should be retained
in the local laboratory for at least six months; identifying information sufficient to re-access
the original reference laboratory results must be retained long term (minimum of eight years,
as for day books, batch records, etc).
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44. Where copies represent a means of communication or
aide memoire, for example at a
multidisciplinary team meeting or case conference, they may be disposed of when that
function is complete.
45. Copies of reports sent by fax may also be disposed of after sending; a record should be kept
for audit purposes detailing the date and time of transmission, patient and specimen
identifiers and the intended recipient.
45A. Report copies generated to substitute for an original report (e.g. if an original is misplaced)
should be retained as for the original.
46. Report copies assembled as components of training portfolios by individual pathology trainee
clinicians and scientists should be anonymised and retained by the individual, in the context
of the intact portfolio, for a minimum of five years after completion of training. Report copies
assembled into revalidation portfolios should be anonymised and kept by the individual, in
the context of the intact portfolio, for at least the full length of one revalidation cycle (currently
five years for clinical consultants).
Surgical (histological) reports
47. Copy lodged in patient’s notes. Electronic or hard copy to be kept for at least 30 years by the
laboratory, with maintained accessibility of e-copies when laboratory computer systems are
upgraded or replaced.
Post-mortem reports
48. The report should be lodged in patient’s record; in the case of Coroner’s or Fiscal’s reports,
this is dependent on the Coroner’s or Fiscal’s approval. Electronic or hard copy should be
kept for at least eight years with maintained accessibility (see also Section D). In cases of
violent or suspicious death, we recommend that post-mortem reports are retained for 30
years. In addition to accessible indexing of paper copies, there must be continuation of
access to e-copies when laboratory computer systems are upgraded or replaced. This
guidance applies equally to rapid, short reports that may be prepared for the Coroner,
summarising cause of death, and to the final reports of post-mortem examinations.
Correspondence on patients
49. This should be lodged in the patient’s record, if feasible. However, this is often beyond the
control of the laboratory, particularly for cases referred distantly. Ensuring entry into the
patient’s notes is not primarily the responsibility of laboratory staff (although those with direct
ward-based responsibilities, such as haematologists and microbiologists, will have direct
responsibilities for this). Otherwise, keep for at least 30 years; this may be most conveniently
done in association with stored paper or scanned copy of the relevant specimen request
and/or report kept by the relevant laboratory. Paper documents, once scanned, may be
disposed of as long as security and accessibility of the derived electronic records are
assured. The practicalities of storing email correspondence have yet to be fully addressed
within the NHS. Logically, such communications should be retained as for correspondence
on paper. Individual Trusts retain back-up copies of email correspondence but the times may
vary according to local policy. Some laboratory information management systems can store
email correspondence linked to specimen records and this – or alternative systems for
comprehensive storage (and retrieval, when required) of emails – should be explored. Until
explicit guidance is available from the UK Departments of Health, laboratories should ensure
that they comply with their institution’s medical records and IT policies with regard to the
status of email correspondence.
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Point-of-care test data
50. Results should be entered into the patient’s record; the log of specimens analysed should be
retained for at least the lifetime of the instrument. With increasing POCT at venues outside
healthcare establishments, the overseeing laboratories should implement governance
arrangements to ensure equivalent protection of patient confidentiality to that pertaining to
hospital-based tests. Particular consideration should be given to the security and integrity of
patient-identifiable data stored on the hard drives of POCT equipment housed in non-clinical
environments. Patients should be advised regarding the primary importance of any self-held
records as a component of their overall medical record.
Bound copies of reports and records, if made
51. At least 30 years.
Pathological archive or museum catalogues
52. For as long as the specimens are held or until the catalogue is updated, subject to consent
where required (with maintained and accessible documentation of consent).
Photographic records
53. Where images represent a primary source of information for the diagnostic process, whether
conventional photographs (+/- negatives; e.g. for electron microscopy) or digital images, they
should be kept for at least 30 years. In practice, most such circumstances are rare; they may
include, for example, some macroscopic specimen records and images from post-mortem
examinations.
54. In increasingly frequent circumstances, images of pathological specimens are being
produced as an alternative to storing the specimen itself. At present, this should be done only
where it is possible to be confident that the image contains all the diagnostic information in
the original specimen, and that its storage will satisfy any possible future requirements, of a
medicolegal as well as of a clinical nature. In such circumstances, the images should be
stored for at least as long as is recommended for the specimens from which they are
derived, with continued accessibility and assured storage conditions to avoid deterioration in
quality over time. They must be linked to the patient’s electronic clinical records and
appropriately backed up. This is a rapidly developing field and the need for new, specific
guidance on digital images in pathology practice in the near future should be anticipated.
55. In genetics laboratories, large numbers of digitised images are routinely generated as part of
the testing protocol (e.g. digital representations of molecular cytogenetic and nucleic acid test
results). See Section E. As above, where such images represent the primary source of
information for the diagnostic process, the details should be transcribed and interpreted into
a report that is entered into the patient’s record. They can then be regarded as semi-
permanent preparations or working documents, depending on context. If they are not
transcribed, they should be kept for at least 30 years, with security of storage and maintained
accessibility guaranteed.
56. Where images represent a means of communication or
aide memoire, for example at a
multidisciplinary meeting or case conference, they may be disposed of when that function is
complete.
Batch records
57. At least eight years.
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Internal quality control records
58. At least eight years.
External quality assessment records
59. Subscribing laboratories or individuals: minimum of eight years, to ensure continuity of data
available for laboratory accreditation purposes over two inspection cycles (see paragraph 60,
following) and equivalence with performance records for the equipment used.
Accreditation documents and records of inspections
60. Minimum of eight years, or at least two inspection cycles (anticipating a four-yearly cycle for
accreditation against ISO 15189), whichever is the longer.
Temperature records for refrigerators and freezers (including those used for post-mortem
body storage)
61. Plots of continuous records, where made, should be summarised regularly to provide
summated statistics (including occurrence and duration of any variation outside an agreed
acceptable range). The primary traces or other raw data should be retained for a reasonable
period: a minimum of two months is recommended for these, if transcribed regularly into
summary format. If continuous or intermittent daily records are retained as the primary
record, without transcription or derivation of summary statistics, retention should be as
described below:
62. If storage is of blood for transfusion, the Blood Safety and Quality Regulations 2005 provide
the appropriate standard, which is a minimum of 15 years (see paragraph 152 below).
63. For refrigerators and freezers used for long-term storage of specimens for purposes other
than human application (e.g. for research, quality control, assay validation or potential future
retesting), automated or summarised manual temperature data should be regarded as a type
of internal quality control record (paragraph 58) and retained for at least eight years.
64. If storage is of analytical reagents and/or ‘temporary’ specimens that are used and replaced
rapidly, retention should allow continuity of data availability between UKAS (or equivalent)
inspection cycles; five years is recommended. This is the scenario that probably best
matches the pattern of use of a mortuary refrigerator.
65. When a freezer is being used for potentially very long term storage, e.g. in biobanking, data
summarised from daily temperature records should be kept for at least the lifetime of the
equipment. The records of all affected individual specimens should be annotated with, or
linked accessibly to details of, any temperature deviation beyond ‘normal’ variance. These
details should remain accessible as a component of the specimen record, following transfer
to a new freezer, for the lifetime of the specimen.
66. Temperature records for freezers used to store forensic samples for potential medicolegal
use should be retained for at least as long as the oldest sample held. There is general
guidance from the Metropolitan Police regarding the retention and storage of frozen exhibits:
www.met.police.uk/foi/pdfs/policies/handling_of_frozen_exhibits_policy.pdf
Equipment maintenance logs
67. Lifetime of instrument plus a minimum of four years (to encompass at least one full
accreditation cycle after lifetime complete).
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Records of service inspections and instrument maintenance
68. Lifetime of instrument plus a minimum of four years, as above.
Records relevant to diagnostic products or equipment
69. Comprehensive records relevant to procurement, use, modification and supply: at least eight
years.
Records of assay validation and verification
70. Performance claims are required by UKAS to be verified prior to introduction. Records should
be kept of the methods used and results obtained: at least eight years.
Research data
71. See below.
Records relating to cell/tissue transplantation
72. Records not otherwise kept or issued to patient records that relate to investigations or
storage of specimens relevant to cell/tissue transplantation, including donated organs from
deceased individuals, should be kept for at least 30 years or the lifetime of the recipient,
whichever is the longer. Identification should link these records and specimens unequivocally
to the recipient but also maintain traceability to the donor. Records and specimens arising
from testing of donor tissues not subsequently used for transplantation should be kept as for
equivalent samples/records for a patient and should be identified by the donor’s details.
There are also requirements to retain data specifically relating to activities in the human
application sector licensed by the HTA (see
www.hta.gov.uk/_db/_documents/Annex_-
_Guide_to_Quality_and_Safety_Assurance_for_Tissues_and_Cells_for_Patient_Treatment.
pdf).
Records relating to retention of semen, spermatozoa, oocytes and tissues for fertility
assessment and use in assisted reproduction
73. Records not otherwise retained or issued to patient records that relate to investigation or
storage of specimens of semen, spermatozoa, testicular tissue, oocytes, ovarian tissue,
embryos created by IVF/ICSI, biopsied polar bodies, blastomeres and trophectoderm should
be kept for at least 30 years.
B
Specimens and preparations
(See also Sections C [blood transfusion laboratories], D [forensic material] and
E [certain genetic services])
Legal issues
74. With a few exceptions, the Human Tissue Act 2004 prohibits the removal and/or storage of
any material obtained after death and containing human cells, including fluid samples, for a
scheduled purpose (see Appendix 2) unless undertaken on premises that have an
appropriate licence from the Human Tissue Authority and with appropriate consent in place.
There are also licensing requirements for storage of tissue removed from the living; detailed
advice on licensing may be obtained from the Human Tissue Authority. The Human Tissue
Act 2004 applies in England, Wales and Northern Ireland, replacing previous legislation.
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For a brief summary see:
www.hta.gov.uk/legislationpoliciesandcodesofpractice/legislation/humantissueact.cfm. The position in Scotland is somewhat different and is set out at the end of this section.
75. Under the Human Tissue Act 2004, neither consent nor a licence is required for the storage
of material for diagnostic purposes for the benefit of the person from whom the tissue was
removed during life. This exemption includes genetic testing carried out for the same
purposes.
76. Appropriate consent (as defined in the Act and elaborated in the relevant Human Tissue
Authority
Codes
of
Practice,
www.hta.gov.uk/legislationpoliciesandcodesofpractice/
codesofpractice.cfm) is required for storage for purposes listed in part 1 of Schedule 1 of the
Act if the samples came from the body of a living person, and for any of the purposes listed
in Schedule 1 if the samples were obtained from a deceased person (see Appendix 2).
77. Post-mortem samples of human tissue (including fluids) may be retained by the Coroner
without consent for as long as they are required to fulfil the Coroner’s duties. The Coroner,
not the pathologist, should decide when these duties are complete and hence for how long
the retention of relevant tissue samples should be authorised. The instructions of the
Coroner should therefore be obtained and followed in regard to retention of tissue samples
from all post-mortem examinations conducted under the Coroner’s authority.
78. Note that the Coroner has no power to authorise retention of tissue after the coronial
investigation is complete (e.g. following the conclusion of an inquest). The Human Tissue
Authority has issued guidance for pathologists to follow in circumstances when the Coroner’s
authority has expired but instructions have not been received regarding what to do with the
tissue (see HTA Code of Practice 5). Where the period of retention authorised by the
Coroner is insufficient to allow the pathologist to address the issues raised by the death, the
pathologist should make this known to the Coroner but must not keep the tissue beyond the
authorised period. The police may authorise further retention for evidential purposes, if
required, under the remit of the Police and Criminal Evidence Act 1984.
79. Samples and accompanying records, from living or deceased individuals, may be retained for
as long as they are required for the purposes of investigation of crime or for the criminal
justice system. In effect, this may in some cases require storage in perpetuity and,
depending on individual circumstances, may involve retention on the premises of the original
hospital laboratory, those of a forensic specialist service provider or elsewhere. Storage as
potential criminal evidence includes maintenance of a chain of custody consistent with
requirements of the Police and Criminal Evidence Act 1984.
Guidance on the retention of exhibits for use in criminal investigation and prosecution has
been
published
by
the
National
Policing
Improvement
Agency
(2012;
see
www.acpo.police.uk/documents/FoI%20publication/Disclosure%20Logs/Crime%20%20FOI/2
012/199%2012%20Att%2001%20of%201%20Forensic%20Exhibit%20Retention%20Guidan
ce.pdf).
Further advice may be obtained from the Forensic Science Regulator (see Bibliography),
from the Crown Prosecution Service or the Home Office. Pathologists are also advised to
seek from the police the precise legal authority underlying any request for retention which
they initiate, to ensure that provisions of the Human Tissue Act are not breached.
80. As soon as post-mortem samples are no longer required by the Coroner or the criminal
justice system, appropriate consent will be needed for storage for any of the purposes listed
in Schedule 1 of the Human Tissue Act (see Appendix 2). If the function of the Coroner has
been completed but for some reason the pathologist has not been informed of the wishes of
the relatives in relation to retention or disposal, continued retention of the material is not
permissible. The Human Tissue Authority has provided advice, in the form of a Code of
Practice (Code 5; see paragraph 77 above and
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www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice.cfm), on the length of
time for which such material should be retained pending clarification of the wishes of the
relatives.
81. Similarly, as soon as samples from living patients are no longer required by the criminal
justice system, appropriate consent (as defined by the Human Tissue Act) will be needed for
storage for any of the purposes listed in part 1 of Schedule 1 of the Human Tissue Act (see
Appendix 2).
82. Section 45 and Schedule 4 of the Human Tissue Act 2004 applies in Scotland, relating to the
non-consensual analysis of DNA. The position in Scotland is otherwise defined by the
Human Tissue (Scotland) Act 2006, in which “authorisation” has the same fundamental
status and importance as “consent” in the Human Tissue Act 2004. Section 39 of the 2006
Act provides that once the necessary notice has been received from the Fiscal, all tissue
blocks and slides from the examination automatically become part of the medical records of
the deceased person. They can be used, without the need to obtain authorisation, for the
purposes of:
providing information about or confirming the cause of death
investigating the effect and efficacy of any medical or surgical intervention carried out
on the person
obtaining information which may be relevant to the health of any other person
(including a future person)
audit.
83. It should be noted, however, that storage and use of cells or tissue for human application,
whether from a living or deceased donor, are regulated under the Human Tissue (Quality and
Safety for Human Application) Regulations 2007, which apply throughout the UK including
Scotland (see
www.legislation.gov.uk/uksi/2007/1523/resources).
84. Only once the necessary authorisation has been given will it be possible for the blocks and
slides to be used for purposes such as medical education, training and research.
85. Larger specimens (such as whole organs) retained at a Fiscal post-mortem examination do
not automatical y become part of the medical record once the Fiscal’s purposes have been
satisfied. In order for these to be retained for any purpose, the necessary authorisation would
have to be given by the family.
86. The provisions of the COSHH Regulations 2002 and of current Health and Safety at Work
legislation must be observed.
Plasma and serum
87. Keep for 48 hours after the final report has been issued by the laboratory, unless there is a
reasonable expectation that additional testing will be required, e.g. if the final report has
requested that a follow-up test is done in parallel with retesting of the original sample. If there
is a requirement to store for longer, specimens that have been centrifuged but not separated
should be separated to prolong stability. Cell-free nucleic acids from plasma are increasingly
useful as analytes (e.g. in non-invasive antenatal diagnosis and in cancer monitoring);
storage should be in a suitable form for such analyses, where relevant.
88. In transplant centres, serum samples obtained from recipient(s) for the purposes of matching
in cell/tissue transplantation, and their accompanying records, must be kept for the lifetime of
the recipient. For transplant-related virology/microbiology samples, a minimum of ten years
for donor material, and 30 years for recipient material is recommended, which is consistent
with SaBTO (Safety of Blood, Tissues and Organs) guidance on the microbiological safety of
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human
organs,
tissues
and
cells
used
in
transplantation;
the
associated
virology/microbiology
records
should
be
stored
retrievably
for
30
years.
(www.gov.uk/government/publications/guidance-on-the-microbiological-safety-of-human-
organs-tissues-and-cells-used-in-transplantation).
89. Serum from the first booking visit for pregnancy should be kept for two years by
microbiology/virology and other laboratories offering antenatal screening, to provide a
baseline for further serological or other tests for infections or other disease during pregnancy
and the first 12 months after delivery. Further guidance and more detailed standards have
been developed by the National Screening Committee for the Infectious Diseases in
Pregnancy Screening Programme. See their
Handbook for Laboratories (2nd edition), 2012
(listed in Bibliography) and
infectiousdiseases.screening.nhs.uk/standards.
89A. Sera for virological assessment of individuals dialysed overseas should be retained for one
year (see
www.gov.uk/government/publications/smi-v-10-bloodborne-virus-testing-in-dialysis-
patients).
90. Because of its rarity and value to future research, wherever possible, fetal serum (from
cordocentesis) should be kept for at least 30 years. Although plasma and serum are not
covered by the Human Tissue Act 2004 in the absence of cellular content, it is recommended
that systems are set in place prospectively to request consent for such long-term storage for
potential future research.
91. Serum taken after needlestick injury or other hazardous exposure should be kept for a
minimum of two years.
92. Other left-over sera or plasma should be stored for as long as practicable, to provide an
array of material for future research and disease surveillance purposes. While long-term
storage may be impractical in many settings, virology centres and laboratories involved
routinely in public health activities should retain sera for a minimum of one year to facilitate
‘look-back’ exercises, identification of emerging infections and vaccine programme
monitoring. Samples that do not contain human cells are not regulated as human tissue by
the Human Tissue Act, although ethical constraints on appropriate storage and use
nevertheless apply; consent should be sought where appropriate. Storage of samples of
cellular material with the
intention of human DNA analysis without appropriate consent may
be an offence under the Human Tissue Act:
www.hta.gov.uk/licensingandinspections/sectorspecificinformation/dna.cfm
Newborn blood spot screening cards
93. A minimum of five years’ storage is mandated as part of quality management, with longer-
term storage recommended in accordance with the Public Health England NHS Newborn
Blood Spot Screening Programme’s
Code of Practice for the Retention and Storage of
Residual Spots (2005) – see ‘Residual Spots’ page
at newbornbloodspot.screening.nhs.uk.
Controversy persists regarding the legal status of blood-spot screening cards held long term
and their use for additional testing without specific and individual consent. An EU
recommendation is anticipated favouring requirement for such consent. Revised storage
guidance is anticipated once the EU opinion and its implication for UK law are clear.
Faecal occult blood screening cards and derived faecal suspensions
94. The primary specimens (test cards) should be kept for a minimum of 48 hours after report
authorisation, to allow answering of queries regarding receipt etc. The derived faecal
suspensions in buffer may be required for retesting of equivocal results and should be stored
for at least two weeks, frozen at –20°C.
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Body fluids, aspirates and swabs (including liquid-based cytology specimens)
95. Keep for 48 hours after the final report has been issued by the laboratory, unless sample
deterioration precludes storage. Examples of the latter include joint fluids examined for
crystals and semen specimens examined for spermatozoa, which may be discarded
immediately after analysis, and coagulation samples, which may be discarded after 24 hours.
Samples that are easily and non-invasively repeated, such as most urine samples, may be
destroyed once the examination is concluded and the final report has been authorised.
Reference laboratories receiving all or part of a specimen of this sort from another laboratory
should follow the same guidance.
Whole blood samples, for full blood count
96. Retain specimens for 24 hours.
Donor lymphocyte preparations in cell or tissue transplantation
97. Donor lymphocytes and relevant identifying documentation should be retained for the lifetime
of all recipients of cell or tissue grafts from that donor (see Blood Safety and Quality
Regulations 2005 and HTA Code of Practice 6: Donation of allogeneic bone marrow and
peripheral blood stem cells for transplantation).
Frozen tissue for immediate histological assessment (frozen section)
98. Stained microscope slides should be kept as described below for sections from fixed
specimens. Residual tissue should be processed as a normal, fixed specimen once the
frozen section is complete.
Frozen tissue or cells for histochemical or molecular genetic analysis
99. Keep for at least ten years and preferably longer if storage facilities permit. This advice
includes EBV-transformed and fibroblast cell lines. Retention for at least three months
(longer if space permits) is recommended for cytogenetic cell suspensions in fixative.
Paraffin wax or resin embedded blocks for histology
100. Storage for at least 30 years is recommended, if facilities permit. If not, review the need for
archiving at ten years (and at similar intervals thereafter) and select representative blocks,
showing the relevant pathology, for permanent retention. Blocks representing rare diseases
and those (including representative normal tissue) from patients with diseases known, or
thought likely, to have an inherited genetic predisposition should be particularly considered
for permanent retention. The labour, cost and potential risk involved in selection of
representative material to retain in this way should not be underestimated by employers and,
wherever possible, storage of all histology blocks should be for at least the current minimum
of 30 years. As an alternative to destruction, transfer to an HTA-licensed research biobank
should be considered, at least for selected samples and data.
101. Where destruction of blocks at less than 30 years is being considered, blocks that provided
the basis for a diagnosis of malignancy should be identified and retained until three years
after the patient’s death.
102. Early destruction of blocks from paediatric cases is inappropriate; these should not be
destroyed until the child has reached adulthood and is at least 25 years old. Permanent
retention should be considered in all cases and is particularly recommended for all cancers
(including material representing normal background tissue) arising in children. Specimens
representing other conditions known or thought likely to be associated with inherited genetic
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abnormalities should also be retained permanently. Special considerations apply in forensic
practice (see Section D).
103. Post-mortem tissue blocks must only be taken, stored and used in accordance with the
consent given for post-mortem examination. The Human Tissue Act 2004 does not specify
minimum or maximum retention times for such material stored with consent of a relative or
other authorised individual, and no specific legislation applies to post-mortem blocks stored
before September 2006. We recommend applying the principles described in paragraph 100
above. In the case of tissue taken during an autopsy performed for the Coroner or Fiscal, the
guidance under ‘Legal issues’ at the head of this section must be followed. It should be noted
that the situation in Scotland differs from that in the rest of the UK. The details of consent for
retention of all post-mortem tissue should be documented, and that documentation should be
retained for as long as any specimens are retained.
104. Care must be taken that the chain of custody for tissue blocks is not broken when material is
referred between hospitals for additional testing and/or specialist review. Dispatch, receipt,
temporary storage, long-term retention or return must be tracked and documented by audited
systems, operating in both the sending and receiving hospitals, to minimise risk of loss at any
stage. The Royal College of Pathologists’ guidance on inter-hospital referral of cases
includes relevant advice on this subject
(www.rcpath.org/Resources/RCPath/Migrated%20Resources/Documents/G/G137_Interdept
dispatch_Mar14.pdf).
Retention of specimens and records in the context of biosample banking for research
105. The types of sample and records are fundamentally the same as those discussed elsewhere
in this guidance and the same general principles apply. Differences in approach arise where
the longevity of data and biosample availability for research exceeds legal requirements
applicable to medical records kept for purposes of supporting clinical practice. There is no
maximum retention time for biosamples (including their linked clinical information and
biological data) stored with consent for research use, unless otherwise specified as a
condition of the donor’s consent. Variations may also arise where biosample processing and
storage occur in facilities that are not within or closely linked to a clinical laboratory
environment
106. Operational records kept to ensure that equipment, facilities and processes work
appropriately, and that faults and remedial actions are recorded, should be kept in the same
way as those kept for clinical governance in relation to diagnostic specimens.
107 It is particularly important, as far as possible, to link specimens with details of their pre-
analytical handling, such as warm/cold ischaemic times, methods of freezing and frozen
storage, duration of fixation, processing schedule and any non-standard details of
preservation (alternative fixatives, cold storage of paraffin blocks, etc.).
108. If biosamples issued for research are not exhausted by an end-user and are returned to the
biobank, records should be cumulated to document their movements and the conditions of
storage while under the custodianship of the researchers.
109. A material transfer agreement (MTA) will be in place between the biobank and the
researcher or researcher’s institution and this should include definition of the storage
conditions for any biosample that will be returned. This MTA, with linked details of the studies
and biosamples to which it relates, should be kept by the biobank for at least as long as any
of the included biosamples remains available for further study. The researcher should keep
an equivalent record in relation to their study in accordance with their institution’s
requirements for research records retention (see ‘Research data and records’, paragraphs
184 and 185 below). If the end-user is required by the MTA to dispose of, rather than return
to the biobank, any surplus material from the biosample at the end of their study, they must
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keep auditable records of the date and method of disposal, for a minimum period of time
compliant with their institution’s requirements.
110. The biobank should keep records of internal and external quality assurance performance and
audits for at least 12 years (see paragraphs 58 and 59). This is particularly important for
those banks not housed physically in clinical laboratory premises subject to regular
inspection by bodies such as CPA or UKAS. Alternative or additional regulatory review may
be required by the Human Tissue Authority, other accreditation bodies and research funding
organisations.
111. A biobank will keep the biosamples and records of any adopted sub-collection for the same
length of time and, as far as possible, to the same standard, as their ongoing collections.
Such legacy collections may arise, for example, following closure of another biobank or
adoption (with appropriate consent and ethical approvals) of biosamples after the completion
of a specific research project or clinical trial.
Release and return of archived diagnostic samples for clinical trials purposes
112. Translational research using diagnostic samples traditionally regarded as ‘surplus’ is an
increasingly frequent component of clinical trials and it can be anticipated that this trend will
continue for the foreseeable future. Molecular or immunohistological testing of a pre-existing
specimen as a component of selection for trial entry or allocation to a specified trial arm is
another increasing requirement. These types of study now predominate greatly over
traditional observational studies within clinical trials involving review and return of the original
diagnostic material (such as stained histological sections). They are often accompanied by a
request to retain material for future, unspecified, studies by the academic institution or
commercial company coordinating the trial.
113. Hospital pathology laboratories with diagnostic specimen archives should endeavour to
support the decisions of patients who have given consent for their samples to be used for
such research purposes. However, they have a duty to maintain the patient’s diagnostic
record and consider the potential future value for the patient of retaining samples to be
available for future diagnostic tests. With the advance of ‘personalised medicine’, the
retention of diagnostic samples after completion of their initial purpose is becoming
increasingly justified in anticipation of future needs and the definition of ‘surplus’ now
requires assessing on a case-by-case basis.
114. Clinical trial protocols, and the patient information accompanying them, should acknowledge
that availability of ‘surplus’ material cannot be guaranteed for all patients (e.g. when tumour
is represented in a single tissue block or the original specimen was a small needle core or
endoscopic sample). Pathologists have a responsibility to engage with the design of
protocols and patient information materials, to ensure that expectations among patients and
researchers are accurate. The patient’s potential current and future diagnostic need is
paramount while they remain alive and the sole source of testable material must not be
consumed for research without full understanding, on the patient’s part, of the implications of
this being done.
115. Where minimal diagnostic sampling (such as endoscopy and needle biopsy) is the norm,
clinicians undertaking these investigations may be encouraged to consider obtaining multiple
cores/fragments at diagnosis to anticipate generating sufficient ‘surplus’ for future clinical
trials. Cellular pathology department protocols should incorporate the possibility of
maximising this potential by embedding needle cores and endoscopic fragments individually
in separate blocks where feasible. For larger excision and resection specimens that are not
usually processed in their entirety, pathologists should consider preparing additional tissue
blocks at the time of macroscopic sampling; these can then be flagged in the laboratory
information management system (LIMS) and the specimen report as being available for
research.
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116. Wherever possible, derived materials from a stored tissue block (e.g. tissue sections,
extracted nucleic acids) should be provided, rather than the block itself, unless multiple
representative blocks exist. Arguably, even in the latter circumstance, provision of sections
rather than release of a block ensures that material is available for the greatest possible
number and range of research studies. This approach upholds the general ethical principle of
maximising the research benefit to be gained from any sample ‘gifted’ by a patient for
research.
117. Small biopsy samples may generate no surplus. There is cost but no scientific value in
sending away, or preparing sections from, a depleted block for clinical trial use; in these
circumstances the researchers should be informed that no material is available. Clinical
research staff need to bear this In mind, particularly when considering recruitment of patients
into trials requiring additional research tests for initial trial entry and stratification.
118. Pathology staff should note that the supply of ‘surplus’ material for clinical trials or other
defined research studies undertaken with the patient’s specific consent is not subject to
regulation under the Human Tissue Act 2004. Where trial protocols include long-term
biobanking for future unspecified studies, the biobanking arrangements in England and
Wales must be HTA compliant and subject to appropriate research ethics committee
approval; an accreditation scheme in Scotland provides an equivalent governance structure;
evidence of similar standards should be sought when considering release of diagnostic
biosamples for research biobanking overseas. Retention of surplus diagnostic samples by
researchers as a biobank resource requires specific patient consent for that storage, in
addition to their consent to the specific biological studies covered by the current clinical trial
protocol.
119. If research will involve non-return or destruction of a primary resource such as a tissue block,
destruction must not occur before expiry of the legal minimum retention term for medical
records (30 years). The material should be returned to its hospital source rather than being
destroyed if earlier destruction would otherwise occur. The patient information must make
these aspects of specimen governance clear for potential research participants.
Blocks for electron microscopy
120. Keep for at least 30 years.
Grids for electron microscopy
121. Requirements in different specialties differ. Grids prepared for human tissue diagnosis (e.g.
renal, muscle, nerve or tumour) should be kept for ten years; preferably longer, if practicable.
Grids prepared for virus identification may be discarded 48 hours after the final report has
been issued, provided that all derived images are retained and remain accessible for at least
30 years.
Wet tissue (representative portion or whole tissue or organ)
122. For surgical specimens from living patients, keep for four weeks after issue of final report.
For cases in which a supplementary report is anticipated after additional tests (such as
various molecular investigations or referral for expert opinion), which may occasionally
exceed this period, arrangements should exist to ensure that individual specimens are
retained until the additional report has been finalised.
123. For post-mortem specimens, appropriate consent for a scheduled purpose under the Human
Tissue Act must have been obtained if any retention (other than that legitimately authorised
by the Coroner or Fiscal) is to be legal. The terms of that consent must be complied with in
relation to storage and use.
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124. Whole organs, wet tissue samples or fetal specimens retained before the implementation of
the Human Tissue Act 2004 should be kept only if there is genuine interest and intention to
use them for a scheduled purpose or for education/training in relation to human health. If this
is not the case, they should be disposed of in line with HTA Code of Practice 5
Disposal of
Human Tissue:
www.hta.gov.uk/legislationpoliciesandcodesofpractice/codesofpractice/code5disposal.cfm
125. In England and Scotland, for a five-year period from 18 April 2002 until 2007, families were
entitled to reclaim organs, tissue blocks and slides retained under past post-mortem practice,
by which was understood cases from before 2000 where there was doubt about the extent to
which families were involved in agreeing to retention. Following formal review of this process,
the Scottish Executive accepted the recommendation of the Review Group on Retention of
Organs at Post-Mortem that organs and tissue unclaimed at the end of the five years should
be legally deemed to come under the authority of the relevant hospital, which should be able
to make use of it for legitimate research or educational projects. Where organs or tissues are
not considered necessary or suitable for those purposes, the hospital should ensure their
respectful disposal. The Executive also accepted the Review Group’s recommendation that
there should be no moratorium on existing research involving organs or tissue retained under
past post-mortem practice, including material from Fiscal post-mortem examinations. It has
been possible to start new research projects since 18 October 2002 using material retained
under past practice. All such projects must be non-destructive (i.e. sufficient tissue for
potential future diagnostic review must remain in the block after study) and be likely to
contribute significantly to diagnosis or therapy. They must also have the approval of a
Research Ethics Committee.
Museum specimens, where these are generally accessible for undergraduate or
postgraduate study (teaching collections not accessible by members of the public)
126. These may be retained permanently (provided there is no deterioration, or until replaced by a
better specimen). Since 1 September 2006, appropriate consent has been a legal require-
ment under the Human Tissue Act for the retention of tissue for teaching purposes, only if the
tissue was obtained after death. Nevertheless, it is good practice to obtain consent from
living patients before entering preserved surgical specimens into a museum.
127. There is no consent requirement for museum specimens obtained before the implementation
of the Act on 1 September 2006, although a licence is required for storage of tissue obtained
from a deceased person to use for teaching purposes, unless the material is more than 100
years old. With regard to historic and ancient specimens, the Department of Culture, Media
and Sport has produced guidance on the care of human remains held in museums and
equivalent institutions (see Bibliography).
128. If specimens are stored under conditions that can be regarded as representing public
display, the Human Tissue Act requires that consent must be given. If the specimens are
from a deceased person, the consent must have been given in writing by the person in life
and witnessed. The consent of a relative is not adequate to sanction public display. Public
display of paediatric specimens is therefore invariably illegal unless the child has attained
‘Gil ick competence’ and has given consent during life. A licence from the HTA is also
required if displayed specimens are from a deceased person who consented for their display
to occur after death.
Stained slides
129. Appropriate retention times depend on their nature and purpose. Note that where sections
are likely to contain intact human cells, or are intended to be representative of whole cells,
they constitute “relevant material” under the Human Tissue Act 2004; see
www.hta.gov.uk/legislationpoliciesandpractice/definitionofrelevantmaterial.cfm
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130. Microbiological (e.g. cerebrospinal fluid preparations, malarial blood films, blood culture films,
acid-fast bacilli cultures) and slides from easily repeatable investigations such as semen
analysis for fertility testing: seven days after final report. Standard Gram-stained preparations
from culture plates may be discarded immediately after use.
131. Blood films, routine: seven days after final report. Note that increasing storage of digital
images is anticipated (see Sections 53 and 54 above).
132. Cytogenetic preparations: two years after final report, if photographic or digitised record kept;
five years otherwise. If photographed or digitised, the image should be stored with
maintained accessibility for 30 years, if feasible. The RCPath and IBMS recognise that,
particularly in genetics, increasing data complexity and frequency of IT system replacement
may confound this ideal. The key principle to observe, before destruction of any such images
or other primary test data, is transfer of descriptive information and appropriately authorised
interpretation into a report placed in the patient’s medical record, with secure back-up of that
report.
133. Molecular genetic and molecular cytogenetic preparations (e.g. microarray slides,
fluorescence
in-situ hybridisation [FISH] slides). A representative photographed or digitised
image should be captured for all patients and stored with maintained accessibility for 30
years, with the proviso expressed in paragraph 55 above. Long-term storage of fluorescently
stained slides is problematical; these should be retained at least until the final written report
has been authorised and issued.
134. Bone marrow films: Stained films used for diagnosis, 30 years minimum. Surplus unstained
films may be discarded upon completion of the clinical report, including the reports for any
accompanying flow cytometry, cytogenetic, molecular genetic and trephine histology
specimens. Increasing storage of digital images as an alternative to the original slides is
anticipated (see paragraphs 53 and 54 above).
135. Cytology, including population screening: ten years minimum, and longer if possible, for audit
purposes. Note that cytoblock preparations should be retained as for other paraffin-
embedded tissue blocks described above, and the cytoblock sections should be retained for
the same period as their accompanying cytological slides.
136. Histology: at least ten years, in general (but see comments below regarding scanned digital
images) and longer if practicable. It should be realised that retention of the paraffin block
alone does not always guarantee the retention of relevant diagnostic material, especially with
small biopsy specimens or specimens with only focal representation of disease. If the
disposal of slides at ten years is contemplated, it may be appropriate, although extremely
laborious, to select slides from small specimens and those difficult or impractical to replace
(e.g. slides representing focal involvement by disease or
essential
additional
stains,
including immunostains) for longer retention. Retention for a minimum of 30 years is
recommended for stained slides where re-cutting the fixed tissue block cannot be regarded
as a robust means of replacement. The reservations stated in paragraphs 100–102 regarding
selection of material for earlier disposal apply equally to diagnostic slides. However, the use
of digital slide scanning and the potential for retention of images as an alternative to retaining
the physical slides has advanced considerably since the 2009 edition of this guidance. In
centres with robust scanning and digital archiving arrangements, this may be considered as
an acceptable alternative to long-term storage of glass slides; the physical slides should
remain available for two cycles of laboratory accreditation (eight years). All of the principles
applying to other electronic record formats must apply to the digitised images in this
circumstance (safety and security of storage, legacy arrangements etc.).
137. Chain of custody for cytology and histology slides referred between hospitals, for purposes
such as specialist review, should be assured as for tissue blocks (see paragraph 104).
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138. Semi-permanent preparations such as direct immunofluorescence slides, used in a variety of
pathology disciplines, should be kept at least until the final specimen report has been issued.
Human DNA and RNA
139. Keep for a minimum of eight weeks after final report for diagnostic specimens. As the range
of acquired mutations relevant as targets for stratified medicine approaches is expanding
rapidly, requirement for considerably longer storage should be anticipated in some
circumstances, to avoid the need to re-extract nucleic acid from (sometimes limited) paraffin-
embedded samples. Retain samples for at least 30 years if needed for family studies in those
with genetic disorders or if stored as donor/recipient material in the context of cell or tissue
transplantation. With some exceptions it is an offence under the Human Tissue Act merely to
possess human tissue with the intention of analysing its DNA without consent. Exceptions
include analysis for diagnosis/treatment of the person whose body manufactured the
DNA/RNA; see
www.hta.gov.uk/licensingandinspections/sectoRspecificinformation/dna.cfm
140. The need for retention of diagnostic specimens should be assessed at the time of sampling,
and appropriate consent obtained; see The Joint Committee on Medical Genetics report
Consent and Confidentiality in Clinical Genetic Practice: Guidance on genetic testing and
sharing genetic information (2011; see Bibliography). Once DNA/RNA has been legitimately
extracted from the tissue, this material does not fall under the remit of the Human Tissue Act,
because it no longer contains human cells; but ethical requirements impose a duty to apply
similar restrictions to use and storage. Storage conditions must be suitable for preservation
of the integrity of the material. Specimens used in research should be kept indefinitely if the
consent status permits this.
141. Long-term storage of extracted DNA and RNA in increasing volumes as molecular pathology
expands raises logistical and environmental concerns. Laboratories of all sub-specialties
within pathology have differing needs to address providing appropriate storage facilities. To
guarantee maintenance of specimen quality, nucleic acids may be stored in ultra-low
temperature (–80°C) freezers with systems in place to ensure continuity of power supply at
all times. However, this is costly and incurs risk of freezer failure. Long-term storage may be
achieved more practically by freeze-drying samples or by simple drying of DNA onto filter
paper. Records of the identity and tissue source of the specimen must be retained.
Microbiological cultures
142. Microbial cultures are derived from patient specimens, but they do not come under the scope
of the Human Tissue Act unless they contain residual human cells and the intention of their
storage is for use for a ‘scheduled purpose’ as defined in the Act.
143. Most positive cultures, including viral cultures, can be discarded within 24–48 hours of
issuing a final authorised report. Specified cultures of clinical importance (e.g. blood culture
isolates, cerebrospinal fluid isolates, enteric pathogens, multiple antibiotic resistant or
meticillin resistant
Staphylococcus aureus, ‘outbreak’ strains,
M. tuberculosis, Group A
streptococci and unusual pathogens of clinical significance) should be retained for at least
seven days. Where isolates have been referred to reference laboratories, they should be
retained until receipt of the reference laboratory’s final report; longer retention local y, with
potential for hazard, is not needed under these circumstances and the reference sample in
most cases remains available as a reserve.
144. Whenever cultures are stored, pathology staff have a duty to ensure that specimens are held
safely and securely, to guard against accidental or non-accidental mishap. Some cultures of
viable organisms and other preparations deemed hazardous may need to be stored in locked
containers and in secure laboratory premises with restricted and controlled access.
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145. Although non-human in derivation, nucleic acids derived from microbiological cultures, and
the molecular diagnostic outputs from microbiology/virology laboratories relating to these,
represent integral components of the patient’s diagnostic record and should be retained in
line with the general guidance provided for human DNA and RNA (minimum of four weeks
after final report unless with consent in a research context; see paragraphs 139 and 140).
Freeze-dried or other permanently preserved cultures
146. These should be retained permanently where archived in collections accessible for reference
and research, such as those nationally or locally recognised. Security must be assured for
hazardous samples, as outlined above.
Electrophoretic strips and immunofixation plates
147. Keep for five years, unless digital images are taken. If digital images of adequate quality for
diagnosis are taken, then the original preparations may be discarded after two years. The
images should than be stored as discussed above under ‘Photographic records’, bearing in
mind the need to maintain the ability to read archived digital images when equipment is
updated.
C
Documents, records, specimens and preparations: specific advice for
transfusion laboratories
(Minimum requirements for retention times may differ from those detailed in
Sections A and B. In all instances, the longer period is recommended.)
Documents and records
Request forms for grouping, antibody screening and cross-matching
148.
Retain for one month.
Worksheets
149. Documentation to allow full traceability of all blood components, whether used or discarded,
must be kept for at least 30 years (The Blood Safety and Quality Regulations 2005,
incorporating previous EU Blood Directives into UK law; see Bibliography). The requirement
for traceability extends from initial collection to ultimate fate (transfusion or discard); for most
hospital laboratories, this will start from receipt of products from the NHS Blood Transfusion
Service. The data may be held in electronic form if robust archiving arrangements are in
place. According to the 2005 Regulations, some worksheets in paper format may be
discarded after 15 years although the expectation for electronic equivalents would be 30
years; therefore, we recommend retaining documents of this type, whatever their format, for
30 years.
Results of grouping, antibody screening and other blood transfusion-related tests
150. Retain records for 30 years, in compliance with the Blood Safety and Quality Regulations
2005.
Blood Bank Register, blood component audit trail and fates
151. Documentation to allow full traceability of donor and recipient must be kept for at least 30
years. The data may be held in electronic form if robust archiving arrangements are in place.
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For hospital laboratories, this record should include:
blood component supplier identification
issued blood component identification
transfused recipient identification
for blood units not transfused; confirmation of subsequent disposition (discard/other
use)
lot number(s) of derived component(s) if relevant
date of transfusion or disposition (day, month and year).
Refrigerator and freezer charts
152. These should be kept for 15 years.
Records of serious events
153. Records of any serious events which may affect the quality or safety of blood or blood
components must be retained for at least 15 years, as required by The Blood Safety and
Quality Regulations, 2005.
Annual reports (where required by The Blood Safety and Quality Regulations, 2005)
154. These should be kept for 15 years.
Specimens and preparations
(Note that the following requirements may need modification in the case of high-risk samples,
where the risk of storage is deemed to outweigh the potential benefits.
Blood for grouping, antibody screening and saving and/or cross-matching
155. Keep for a minimum of seven days from group and screen, stored at 4°C. Samples must be
available for a minimum of three days post-transfusion for investigation of acute transfusion
reactions. Practically, requirements for paragraph 156 below will dictate keeping for 14 days
in most circumstances. Recently revised guidance from the British Committee for Standards
in Haematology (BCSH) covers this topic in their
BCSH Guidelines for Pre-Transfusion
Compatibility Procedures in Blood Transfusion Laboratories, 2012 (see Bibliography and
www.bcshguidelines.com
Separated serum or plasma, stored for transfusion purposes
156. Recipient plasma/serum samples should be stored for up to 14 days post-transfusion for
investigation of a delayed transfusion reaction; see
BCSH Guidelines for Pre-Transfusion
Compatibility Procedures in Blood Transfusion Laboratories, 2012,
as referenced in
paragraph 155, above
. Storage of donated serum/plasma should optimally be at –30°C or
colder. These materials may be stored for up to three months and guidelines for the timing of
sample collection prior to blood transfusion must be followed. Archived blood donor samples
should be stored by blood services for at least three years, and preferably longer if it is
practicable, in order to facilitate ‘look-back’ exercises.
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D
Forensic material
Criminal cases
157. In cases where criminal proceedings can be anticipated, all recordings made at the autopsy,
be they handwritten notes (by everyone, i.e. pathologist, technician, trainee, etc), tape
recordings, drawings or photographs, are all documentary records and as such their
existence must be declared (disclosed) and they must be kept permanently. They must be
available to all involved throughout the lifetime of the case, including appeals and other re-
investigations. They are not normally entered in the patient records.
Autopsy reports, specimens, archived material and other, where the deceased has been the
subject of a Coroner’s autopsy
158. HM Coroners or Procurators Fiscal have absolute dominion over autopsy reports. They are
confidential to them and may not be released without their consent to any third party. We
believe that it is good practice to lodge copies of autopsy reports in the deceased’s notes but
the consent of the Coroner or Procurator Fiscal should be obtained. Guidance relating to
retention of tissue specimens, and the operation of the Human Tissue Act 2004/Human
Tissue Act (Scotland) 2006 in respect of such materials, are covered in earlier parts of this
document.
159. Independent pathology practitioners undertaking post-mortem examinations on behalf of
Coroners or Procurators Fiscal must ensure that they use facilities to store records and
specimens that have governance arrangements equal to those pertaining in NHS and
academic institutions used for these purposes, Indeed, all practices regarding retention and
disposal of post-mortem records and specimens by such practitioners in the UK must be
directly comparable to those applicable to practitioners directly employed by HTA-licensed
NHS or academic institutions.
E
Genetics
160. The College endorses the
Code of Practice and Guidance of the Advisory Committee on
Genetic Testing (1997) and its recommendations on storage, archiving and disposal of
specimens and records related to Human Testing Services (Genetics) offered and supplied
direct to the public. Those who intend to offer such services should follow its guidance.
Additional recent guidance in this area can also be found in the report of the Joint Committee
on Medical Genetics’
Consent and Confidentiality in Clinical Genetic Practice: Guidance on
genetic testing and sharing genetic information’ (2nd edition), 2011 (see Bibliography).
161. The House of Lords’ Select Committee on Science and Technology (2009) has
recommended that the provisions of the Data Protection Act 1998 should be the primary
means of regulating human genetic databases. The response of the Human Genome
Strategy Group (HGSG) is contained in their report
Building on Our Inheritance: Genomic
technology in healthcare (2012):
www.gov.uk/government/publications/genomic-technology-in-healthcare-building-on-our-
inheritance
Their recommendation is that the UK Departments of Health, in partnership with the HGSG’s
Bioinformatics Subgroup and other relevant partners, should develop proposals to establish
a central repository for storing genomic and genetic data, plus relevant phenotypic data from
patients, with the capacity to provide biomedical informatics services and an open-data
platform that small and medium-sized enterprises can build upon.
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Storage of material following analyses of nucleic acids
162. Developing technologies means that there is ever-increasing variety of hard copy and/or
electronic outputs associated with the analysis and interpretation of diagnostic tests using
nucleic acids. It is recommended that such outputs should be stored for at least 30 years
unless the technical details and interpretation are transcribed into permanently accessible
report formats authorised by senior clinical laboratory staff or pathologists. The latter reports
should then be kept for at least 30 years, as for other pathology reports, and the machine
outputs may be regarded as working documents. For such working documents, storage for at
least five years (one accreditation cycle plus a safety margin) is recommended. Further
challenges to this approach are posed by the development of next-generation sequencing
(NGS) technologies, which generate files of many terabytes. Immediate needs can be met by
transcription of specific results into conventional diagnostic reports. However, much of the
efficiency of these technologies will be compromised if the raw data files are discarded,
requiring repeat sampling and re-sequencing when analysis of new biomarkers is required.
personalised data storage strategies will be needed as NGS methods become routine unless
massive data storage capacity can be assured for collective holdings.
163. The following is a list of current outputs, which is not meant to be comprehensive as new
technologies and outputs are evolving continually.
a) Molecular genetics:
storage of dHPLC/Wave profiles
storage of quantitative PCR data
storage of sequence, mutation and polymorphism information
storage of dosage profiles (MAPH/MLPA)
storage of autoradiographs, SSCP, PTT DGGE (heteroduplex) gels
other agarose gels.
b) Molecular cytogenetics:
storage of all FISH imaging data both qualitative (e.g. microdeletion test) and
quantitative (e.g. CGH)
storage of array data (Array-CGH, cDNA micro-array, etc.)
all other diagnostic outputs associated with detection of genomic dosage imbalances.
Retention of records and materials by providers of external quality assessment
164. Most external quality assessment (EQA)/proficiency testing providers maintain the capacity
to regenerate reports of participants’ performance rather than the individual records
themselves. This capacity should be maintained for at least five years to allow retrospective
review in the event of an official enquiry into performance and as a back-up for retrieval of
data needed by participants’ for their next cycle of UKAS accreditation. This should apply
equally to laboratory technical EQA schemes and schemes addressing clinical competence.
Updating of electronic records with any change of IT systems should be assured as
described above (paragraphs 1–2).
Additional records to be kept by EQA providers
165. Participants’ returns (electronic or hard copy) received for data entry. These should be kept
for at least three months (or one month after the report has been sent to the participant, if
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longer), as working documents, to facilitate identification, checking and correction of
discrepancies.
166.
Other records
Performance surveillance records including communications with, and complaints from,
participants.
Ethical approval and consent records for donated material.
Quality assurance and safety documentation relating to circulated materials, including
virus testing, where relevant, and homogeneity results from third-party suppliers
Records of contractual agreements with commercial and NHS suppliers.
Storage of such records is recommended for at least five years.
Retention times for materials stored by EQA providers
167. The usual reasons for retention of materials after distribution are to provide further samples
for participants to use in troubleshooting or verification of new or amended procedures,
equipment or reagents, and to assist in investigating or resolving anomalous performance
data. As most materials have limited stability no universally applicable recommendation is
appropriate. Retention of degraded material has limited value.
168. Appropriate retention periods should therefore be determined through risk assessment,
based primarily on consideration of:
the stability of the material in storage
the expected uses of such material
the risk of not retaining such material
any special features of some samples (eg clinical specimens, reference method
values)
Relevant materials comprise:
reference samples of the materials distributed to participants, if any remain (e.g. liquid
or freeze-dried plasma/serum, whole blood, urine, slides, tissue blocks, bacteriological
cultures, DNA, digital images)
reference samples tested ‘in house’ in preparation or in parallel with EQA distributions
Storage is recommended for at least five years if the material represents, or can be
converted to a valid “permanent” preparation. Retention should not take precedence over
legitimate use. Degradable materials should be kept, if possible, for one month after the
relevant circulation has been assessed.
169. Cells, tissues and other materials stored prior to preparation and circulation
Such materials will be stored until used, or disposed of if surplus to requirements.
Disposal of human tissue
General
170. Disposal of human biological samples must be carried out in a respectful manner. Exactly
what constitutes a respectful manner will vary with the specimen type. The Human Tissue
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Authority has issued Codes of Practice relevant to this subject, particularly Code 5; the
current versions of the codes are available from the Authority’s website
(www.hta.gov.uk/legislationpoliciesandcodesofpractice.cfm).
171. Disposal of liquid specimens is unlikely to cause concern as long as misuse of samples or
residues is made impossible. Solid tissue samples from surgical or biopsy specimens can
usually be incinerated, but the samples and the process of destruction should not be visible
to the public and they should not be mixed with other forms of clinical or general waste.
Disposal should be in keeping with requirements of the Environment Agency.
172. Where patients have indicated, within the normal time limits for retention of samples, a wish
for the return of unprocessed or surplus material, such requests should be complied with. In
such cases, it is the responsibility of the laboratory to indicate any hazards that may be
present in the returned material. A record of the transfer must be placed in the patient’s notes
and correspondence relating to the transfer should be kept by the laboratory for at least ten
years.
Fetal tissues
173. Currently fetal remains of less than 24 weeks’ gestation are not defined as human remains
but are regarded as components of the mother’s tissue. Hospital systems for the sensitive
disposal of such tissue should comply with Human Tissue Authority guidance (‘
Guidance on
the disposal of pregnancy remains following pregnancy loss or termination’, March 2015).
See also paragraph 175 below.
174. Clinical staff should ask the mother to provide consent for histological examination of
products of conception, including ectopic gestations. The surgical consent process is not
directly controlled by pathologists but it should include information about (and consent for)
histological examination, and options for disposal, in line with HTA guidance. The option of
taking away the material for a private funeral should be offered. Where the wishes of parents
are known, they should be followed.
175. Laboratories should have a policy for the disposal of samples containing fetal parts. It should
comply with guidance issued by The Royal College of Obstetricians and Gynaecologists
(
Good Practice No. 5: Disposal following pregnancy loss before 24 weeks gestation)
published in 2005, guidance from The Royal College of Nursing (2007) and guidance from
the Human Tissue Authority (2015).
176. It is acknowledged that crematoria are licensed for the cremation of human remains only, but
it is considered quite reasonable for such remains to be buried or cremated if this is the wish
of the parents. Communal burial or cremation is acceptable where parents do not wish to
make their own arrangements, provided that the guidance of the Institute of Cemetery and
Crematorium Management is adhered to
(www.iccm-uk.com). This guidance includes a
requirement that hospitals maintain a register of the disposal of fetal remains and that this
register, with all other documentation relating to the disposal of fetuses, is kept for a
minimum of 50 years (
ICCM: The Sensitive Disposal of Fetal Remains 2011 – see
Bibliography).
177. Procedures for handling material from terminations of pregnancy may differ, as histological
examination should rarely be required and the Abortion Act 1967 imposes a requirement to
maintain confidentiality. Nevertheless efforts should be made to comply with any known
wishes of the parents, as set out in the HTA’s guidance of March 2015.
178. Where doubt exists, guidance should be sought. The advice of the hospital chaplaincy
service or a clinical ethics committee (if available) may be of value. The Human Tissue
Authority can also advise on such matters.
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Medicolegal value of archived material
179. For forensic purposes (whether civil, criminal or coronial), documents consisting of original
and contemporaneous notes are the most desirable. Handwritten working records are
regarded as the best documentary evidence. Hard copy reports lodged in the patient’s
medical records are preferable to records held electronically in the laboratory or in integrated
electronically held patient information systems. This is especially applicable to autopsy and
surgical pathology reports but applies to laboratory reports of all kinds. The primary value of
direct witness testimony on oath should not be forgotten.
180. However, courts are prepared to accept computerised records in civil cases and, provided
additional safeguards are complied with, also in criminal cases. In criminal and civil cases,
statements contained in documents that are received in evidence may be proven by copies
of the original documents, provided that such copies are adequately authenticated. Thus,
although original records are desirable, this must be balanced against the convenience and
practicality of making copies or preserving them in computerised or microfilm form. However,
as a matter of practice, it is necessary to maintain records of the fact of computerisation or of
the copying process in relation to any documents, to facilitate subsequent authentication and
admissibility.
181. Archived material is important for ‘look-back’ exercises, where a historical risk (say of a
blood-borne infectious agent in the case of transfusion practice) is being sought, or reviews
of alleged reporting errors or misjudgements are being commissioned. In such
circumstances, the material used must usually be patient-identifiable, but precautions should
be taken to secure appropriate confidentiality. Under the GMC’s powers to regulate fitness-
to-practise of individual pathologists, both documentary and specimen archives may be
scrutinised.
Specimens and records for teaching
182. Selected photographs, preserved cultures, mounted specimens and stained slides, with the
relevant tissue blocks in the case of surgical pathology, are an invaluable resource and
should be lodged, adequately indexed, described and catalogued, in collections either in the
laboratory of first instance or in local, central or national archives. If diagnostic requirements
have been fulfil ed and the integrity of patients’ clinical records wil not be compromised,
patient identity should be protected by irreversible anonymisation or, as a minimum, a secure
coding process for linked anonymisation. Digital images, which are being used increasingly,
should be treated in an equivalent manner.
183. Under the Human Tissue Act 2004, the public display of human biological samples from a
deceased person, even if anonymised, is unlawful unless the person (not a relative) has
given consent; if the person has died, they must have given consent in writing and this must
have been witnessed. These requirements do not apply to material already held before 1
September 2006. A Human Tissue Authority licence is required for public display of human
biological samples that have been taken from the body of a deceased person.
Research data and records
184. Confidential named patient data (documentation) collected in the course of investigation and
held separately from patients’ records should be destroyed or anonymised six months after
the research has been completed, the data have been analysed and final publication of
findings has been made. If further recourse to identifiable information is anticipated, it should
be kept for as long as such a need may exist, if this is permissible under the Data Protection
Act (1998); advice should be sought.
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185. Working records and other research data should be retained for at least ten years to rebut
allegations of scientific fraud but, wherever possible, these records should not include
patient-identifiable data unless consent for such retention has been obtained. Records and
clinical trial data on medicines must be kept for at least 15 years. The provisions of the Data
Protection Act (1998) must be observed for these as for other pathological records. The
Medical Research Council’s
Good Research Practice (2000) and
Human tissue and
Biological Samples for Use in Research: Operational and Ethical Guidelines (2001) contain
further advice; see Bibliography. Universities and other academic institutions will also have
their own rules, which may involve longer storage of such information, and local guidance
should be sought as appropriate.
Confidentiality of records
186. The General Medical Council instructs that “doctors carry a prime responsibility for the
protection of information given to them by patients or obtained in confidence about patients.
They must therefore take steps to ensure, as far as lies in their control, that the records,
manual or computerised, which they keep, to which they have access, or which they transmit
are protected by effective security systems with adequate procedures to prevent improper
disclosure”. The operation of laboratory information management systems, and local
implementation of aspects of the NHS National Programme for Information Technology,
should be conducted in accordance with this general principle, paying particular attention to
data security.
187. Confidential information on patients may be transmitted by fax or from one computer to
another. With increasing access to secure electronic transmission via the internet, routine
use of fax communication should be questioned and substituted with a more secure method
where feasible. It is important to ensure that the information is sent to the correct location
and that only the intended recipient will be able to access it. Both sender and recipient must
establish arrangements to allow this. The primary responsibility lies with the sender. With
regard to fax transmission, a key step is to establish that the receiving fax machine is
physically located where it is accessible only to individuals who have a right to see the
information transmitted.
188. Confidential data transmitted electronically, especially over the internet, for example by
email, must be assumed to be liable to interception and therefore must be encrypted unless
the addresses of both sender and recipient are within the secure NHS network (e.g. email
addresses with an “nhs.net” suffix and NHS network links established between GP surgeries
and hospitals). Where data are shared via web-based access to information held on a
remote server, security of access must be assured. The most suitable methods of ensuring
data security will vary with the circumstances and over time. Institutional policy should be
followed and, with increasing requirements for such transmission, pathologists should remain
vigilant in ensuring that confidential information (including information regarding deceased
persons) is not accessed by unauthorised individuals.
189. In the case of specimens and preparations, the pathologist has a duty to ensure that they are
kept not only confidentially, but also safely and securely, so as to guard against accidental or
non-accidental mishap. Some specimens and derived materials may need to be stored in
locked containers and in secure laboratory premises with restricted and controlled access.
Back-up procedures for electronic records must be robust and secure; copies of particularly
valuable records, whether paper or electronic, may need to be kept in fireproof containers.
Long-term or permanent retention of records
190. Retention of records and specimens for historical purposes beyond 30 years, other than in
the case of recognised historical or teaching or research archives already kept in approved
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Places of Deposit (which may include the premises of medical institutions), requires an
application to the Lord Chancellor through the Keeper of Public Records, if there is a need
for them to be retained by a Health Authority rather than transferred to a place of deposit or
destroyed. In practice, the Officer appointed by health authorities (HC[89]20) deals with
these matters. The statutory position of health records in Scotland is different (MEL[1993]152
and the subsequently updates code of practice on records management for Scotland [v2.1,
2012]). There is equivalent guidance for Wales and Northern Ireland; see Bibliography.
191. Pathologists and other laboratory professionals should be prepared for records, including
stored pathological material, to be destroyed after 30 years unless they wish to state a case
for their further retention (e.g. for teaching or research) as outlined in paragraph 190 above,
or unless the records under their immediate care are already secured in an approved place
of deposit. Records logging authorised destruction may be helpful and are recommended as
good practice but are not mandatory.
192. Property in pathological records, as in other Health Service (NHS) records and items, is
ultimately vested in the Secretary of State for Health or in NHS Trusts, and in Scotland in
Health Boards. Human tissue samples can accrue property rights if skill has been used to
modify them. The level of skill needed is not defined in law, but this argument is likely to
apply to fixed and processed tissue samples, so these too could be argued to be the property
of the NHS Trust where the work was done. However, in practice, this property right will in
almost always be ceded to the patient if requested. In private practice, ownership is vested in
the maker of the records. In both instances, it is subject to the restraints of professional
regulation and to statutory and common law. Property in records, reports and materials
relating to procedures within the jurisdiction of an appointed and legally competent authority
(Coroner, Procurator Fiscal) is not vested in the same way. The long-term retention of
documentary material is subject to the guidance of the Keeper of Public Records and, in the
NHS, also to that of the Officer appointed in accordance with the 2005
Records
Management: NHS Code of Practice (other than in Scotland, where MEL(1993)152 and the
Records Management NHS Code of Practice (Scotland) 2008 applies).
193. Use of pathological archives for research, teaching, training, scholarship, disease
surveillance or quality control raises important socio-political, ethical and legal issues. Long-
term retention of material of potential value in genetic or other medical research is desirable,
but its use and access to it must be subject to the law, professional guidance and ethical
standards.
A note on veterinary pathology specimens and records
194. Storage of records and specimens is not an issue that has been addressed systematically in
veterinary pathology clinical practice to date. Diagnostic services are mainly provided by
commercial laboratories and each laboratory has its own policy on retention of tissues. Most
will dispose of formalin-fixed biopsy tissue within 30 days. There is wide variation in retention
practices with regard to histology blocks and slides. It is not uncommon for requests for
immunohistochemistry or reassessment of histology specimens up to two years old to be
required and this need should be anticipated, so that retention of blocks for at least two years
would be advisable as good practice. Not many laboratories offer a post-mortem examination
service and there is no consistency on whether any tissue is retained from such
examinations in the form of blocks or slides. Bodies are cremated or disposed of as clinical
waste unless the post-mortem examination is undertaken for legal purposes. If the latter, the
body and all tissues are retained, usually frozen, by the litigating body (almost always the
RSPCA) until the legal process is complete.
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Bibliography and further guidance
Note regarding PDFs: External
PDF links provided below may well become outdated before this
document is revised, so if any references can no longer be located, readers can access an archive
folder (crated by the College in March 2015) by emailing
[email address], stating which
references they wish to view. Readers should also contact the documents’ publishers directly to
ensure they follow the latest guidance.
Medical records management
Department of Health (England).
Records Management: NHS Code of Practice,
2005.
www.gov.uk/government/publications/records-management-nhs-code-of-practice
Department of Health (England).
Records Management: NHS Code of Practice, Part 2 (2nd edition),
2009.
www.gov.uk/government/uploads/system/uploads/attachment_data/file/200139/Records_Manage
ment_-_NHS_Code_of_Practice_Part_2_second_edition.pdf NHS Scotland.
Records Management: NHS Code of Practice (Scotland) 2008, updating
Guidance
for the Retention and Destruction of Health Records. NHS MEL(1993)152.
www.show.scot.nhs.uk/sehd/mels/1993_152.htm National Assembly for Wales.
Managing Records in Trusts and Health Authorities. WHC(2000)71.
www.wales.nhs.uk/document/74159/info NHS Wales Governance e-Manual. Standard 20: Records management.
www.wales.nhs.uk/governance-emanual/standard-20-records-management Health and Social Care Services in Northern Ireland:
Good Management, Good Records,
HSS(MD)44/04.
The Private and Voluntary (England) Regulations 2001.
Statutory Instrument 2001 No. 3968,
Schedule 3(1): Period for which medical records must be retained.
www.legislation.gov.uk/uksi/2001/3968/made
British Medical Association Guidance on Health Records Retention.
bma.org.uk/practical-support-at-work/ethics/retention-of-health-records Data protection, information governance and electronic records
The Data Protection Act 1998.
www.legislation.gov.uk/ukpga/1998/29 Information Commissioner’s Office.
Guide to Data Protection.
www.ico.org.uk/for-organisations/guide-to-data-protection Institute of Biomedical Science.
IBMS Professional Guidance: Giving results over the telephone,
2011.
www.ibms.org/go/media/publications/professional-guidance
Institute of Biomedical Science.
IBMS Professional Guidance: Patient sample and request form
identification criteria, 2010
. www.ibms.org/go/media/publications/professional-guidance
Department of Health (England).
Information for Health: An Information strategy for the modern
NHS 1998–2005, 1998. HSC1998/168. Now archived.
www.dh.gov.uk
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The National Archives. Guidance on preservation and management of digital records.
www.nationalarchives.gov.uk/information-management/manage-information/preserving-digital-
records/guidance British Standards Institution.
Evidential Weight and Legal Admissibility of Information Stored
Electronically: Code of Practice for the Implementation of BS 10008, December 2014.
shop.bsigroup.com/ProductDetail/?pid=000000000030296631 The Royal College of Pathologists.
Communication of unexpected findings, urgent reports, delayed
reports and the use of Alert systems in diagnostic cellular pathology, November 2013.
www.rcpath.org/Resources/RCPath/Migrated%20Resources/Documents/G/G133_Alert_Nov13.pdf Human tissue and research
Medical Research Council.
Good Research Practice, July 2012. MRC, London.
www.mrc.ac.uk/research/research-policy-ethics/good-research-practice Medical Research Council:
Human Tissue and Biological Samples for Use in Research:
Operational and Ethical Guidelines, November 2014. MRC, London.
www.mrc.ac.uk/news-events/publications/human-tissue-and-biological-samples-for-use-in-
research NHS Health Research Authority (encompasses the National Research Ethics Service, NRES).
www.hra.nhs.uk
Laboratory accreditation
United Kingdom Accreditation Service (UKAS).
www.ukas.com Clinical Pathology Accreditation (UK) Ltd.
Standards for the medical laboratory, 2009.
www.ukas.com/Library/Services/CPA/Publications-CPA-
accreditation/Standards%20for%20the%20Medical%20Laboratory.pdf Clinical Pathology Accreditation (UK) Ltd.
Additional standards for point-of-care testing (POCT),
2010.
www.ukas.com/Library/Services/CPA/Publications-CPA-
accreditation/Additional%20Standards%20for%20Point_of_Care%20Testing_POCT_Facilities.pdf International Standards Organisation (ISO). For more information about ISO 15189 (medical
laboratories), ISO 17043 (proficiency testing) and ISO 18025 (point-of-care testing), see
www.iso.org. Copies of the standards may also be purchased from ISO.
Summary of comparisons between CPA standards and those of ISO 15189, 2012.
www.ukas.com/Library/Services/CPA/Summary%20of%20Idifferences%20betwen%20ISO%20151
89%20&%20CPA.pdf Clinical genetics
Department of Health Advisory Committee on Genetic Testing.
Code of Practice and Guidance on
Human Genetic Testing Services Supplied Direct to the Public, 1997.
www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_400
5565?IdcService=GET_FILE&dID=9335&Rendition=Web
Human Genetics Commission.
Inside Information. Balancing interests in the use of personal
genetic data, 2002.
webarchive.nationalarchives.gov.uk/20061023110946/http://www.hgc.gov.uk/UploadDocs/DocPub/
Document/insideinformation_summary.pdf
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UK Newborn Screening Programme Centre.
Code of Practice for the Retention and Storage of
Residual Newborn Blood Spots, 2005.
newbornbloodspot.screening.nhs.uk/residual-spots#fileid12538 Building on Our Inheritance: Genomic technology in healthcare. A report by the Human Genomics
Strategy Group, January 2012.
www.gov.uk/government/publications/genomic-technology-in-
healthcare-building-on-our-inheritance
The Royal College of Physicians, The Royal College of Pathologists, British Society for Human
Genetics.
Consent and Confidentiality in Clinical Genetic Practice; Guidance on genetic testing and
sharing genetic information. A report of the Joint Committee on Medical Genetics (2nd edition),
2011.
www.rcpath.org/Resources/RCPath/Migrated%20Resources/Documents/C/consent_and_confident
iality_2011.pdf
Point-of-care testing
Medicines and Healthcare Products Regulatory Agency.
Management and Use of Point of Care
Test Devices. MDA DB 2002(03), 2002.
www.mhra.gov.uk
MHRA guidance,
Management and use of IVD point of care test devices, December 2013.
www.mhra.gov.uk/home/groups/dts-bi/documents/publication/con071105.pdf Transfusion and transplantation
Blood Safety and Quality Regulations, 2005, incorporating into UK law Directive 2002/98/EC of the
European Parliament and Council of 27 January 2003. (
Setting standards of quality and safety for
the collection, testing, processing, storage and distribution of human blood and blood
components).
www.legislation.gov.uk/uksi/2005/50/pdfs/uksi_20050050_en.pdf British Committee for Standards in Haematology. Guidelines for pre-transfusion compatibility
procedures in blood transfusion laboratories, 2012.
www.bcshguidelines.com/4_HAEMATOLOGY_GUIDELINES.html Serious Hazards of Transfusion (SHOT) guidanc
e. www.shotuk.org/resources SaBTO guidance on the Microbiological Safety of Human Organs, Tissues and Cells used in
Transplantation, 2011.
www.gov.uk/government/publications/guidance-on-the-microbiological-
safety-of-human-organs-tissues-and-cells-used-in-transplantation
Post-mortem retention of organs and tissue
Disposal of existing holdings of post-mortem material. Department of Health, 2007.
webarchive.nationalarchives.gov.uk/20080910134953/dh.gov.uk/en/Policyandguidance/Healthand
socialcaretopics/Tissue/Tissuegeneralinformation/DH_4137493
Scottish Executive Health Department.
Independent Review Group on Retention of Organs at
Post-Mortem, Report on Phase 3, 2003.
www.scotland.gov.uk/library5/health/romp3-00.asp See also the Scottish Review Group’s main report.
www.sehd.scot.nhs.uk/scotorgrev Institute of Cemetery and Crematorium Management.
The Sensitive Disposal of Fetal Remains:
Policy and guidance for burial and cremation authorities and companies, November 2014.
www.iccm-uk.com/iccm/library/FetalRemainsPolicyNOV2014ReviewFINAL.pdf Royal College of Nursing.
Sensitive Disposal of All Fetal Remains: Guidance for nurses and
midwives, 2007.
www.rcn.org.uk/__data/assets/pdf_file/0020/78500/001248.pdf
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Human Tissue Authority.
Guidance on the disposal of pregnancy remains following pregnancy loss
or termination, March 2015.
www.hta.gov.uk/sites/default/files/Guidance_on_the_disposal_of_pregnancy_remains.pdf
The Department for Culture, Media and Sport.
Guidance for the Care of Human Remains in
Museums, 2005.
www.britishmuseum.org/pdf/DCMS%20Guide.pdf The Police and Criminal Evidence Act 1984.
www.legislation.gov.uk/ukpga/1984/60/contents
Forensic Science Regulator. Codes of Practice and Conduct for forensic science providers and
practitioners in the Criminal Justice System, Version 2.0, August 2014.
www.gov.uk/government/uploads/system/uploads/attachment_data/file/351197/The_FSR_Codes_
of_Practice_and_Conduct_-_v2_August_2014.pdf
Metropolitan Police.
Policy on the Handling and Storage of Frozen Exhibits and Samples within
Operational Command Units.
www.met.police.uk/foi/pdfs/policies/handling_of_frozen_exhibits_policy.pdf
National Policing Improvement Agency.
Exhibit Retention Guidance, 2012
www.acpo.police.uk/documents/FoI%20publication/Disclosure%20Logs/Crime%20%20FOI/2012/1
99%2012%20Att%2001%20of%201%20Forensic%20Exhibit%20Retention%20Guidance.pdf
The Human Tissue Act and Human Tissue Authority
The Human Tissue Act 200
4. www.legislation.gov.uk/ukpga/2004/30/contents Explanatory not
es: www.legislation.gov.uk/ukpga/2004/30/notes/contents
The Human Tissue Act (Scotland) 2006.
www.opsi.gov.uk/legislation/scotland/acts2006/asp_20060004_en.pdf
Guide to the implications of the Act for NHS Scotland, 2006.
www.show.scot.nhs.uk/sehd/mels/HDL2006_46.pdf The Human Tissue Authority.
www.hta.gov.uk
The Human Tissue Authority.
Designated Individuals and Licence Holders under the Human
Tissue Act, 2006.
www.hta.gov.uk/licensingandinspections/peopleatlicensedestablishments/disandlicenceholdersund
erthehumantissueact2004.cfm Human Tissue Authority Codes of Practice and information about licensing can be found under
‘Guidance’.
www.hta.gov.uk/legislationpoliciesandcodesofpractice.cfm The current HTA codes of practice are:
Code of Practice 1: Consent
www.hta.gov.uk/_db/_documents/Code_of_practice_1_-_Consent.pdf
Code of Practice 2: Donation of solid organs for transplantation
www.hta.gov.uk/_db/_documents/Code_of_practice_2_-
_Donation_of_solid_organs_for_transplantation.pdf
Code of Practice 3: Post-mortem examination
www.hta.gov.uk/_db/_documents/Code_of_practice_3_-_Post-mortem_examination.pdf
Code of Practice 4: Anatomical examination
www.hta.gov.uk/_db/_documents/Code_of_practice_4_-_Anatomical_examination.pdf
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Code of Practice 5: Disposal of human tissue
www.hta.gov.uk/_db/_documents/Code_of_practice_5_-_Disposal_of_human_tissue.pdf
Code of Practice 6: Donation of allogeneic bone marrow and peripheral blood stem cells for
transplantation
www.hta.gov.uk/_db/_documents/Code_of_practice_6_-
_Donation_of_allogeneic_bone_marrow_and_PBSC_for_transplantation.pdf
Code of Practice 7: Public display
www.hta.gov.uk/_db/_documents/Code_of_practice_7_-_Public_display.pdf
Code of Practice 8: Import and export of human bodies, body parts and tissue
www.hta.gov.uk/_db/_documents/Code_of_practice_8_-
_Import_and_export_of_human_bodies,_body_parts_and_tissue.pdf
Code of Practice 9: Research
www.hta.gov.uk/_db/_documents/Code_of_practice_9_-_Research.pdf HTA position statement on extension of existing licences to cover removal of tissue from the
deceased for research, 2014.
www.hta.gov.uk/legislationpoliciesandcodesofpractice/statementonextendingexistinglicencestocov
ertheremovaloftissuefromthedeceasedforresear.cfm
HTA position statement on diagnostic archives releasing tissue for research, 2009.
www.hta.gov.uk/legislationpoliciesandcodesofpractice/positionstatementondiagnosticarchivesrelea
singtissueforresearch.cfm
HTA position statement on consent for genetic testing.
www.hta.gov.uk/licensingandinspections/sectorspecificinformation/dna.cfm
Definition of relevant material, 2014.
www.hta.gov.uk/legislationpoliciesandcodesofpractice/definitionofrelevantmaterial.cfm
Supplementary list of relevant materials, 2008.
www.hta.gov.uk/_db/_documents/Supplementary_list_of_materials_200811252407.pdf
Supplementary list of relevant materials for human application sector.
www.hta.gov.uk/_db/_documents/Supplementary_list_for_HA_Sector.pdf
Guidance on the disposal of pregnancy remains following pregnancy loss or termination, March 2015.
www.hta.gov.uk/sites/default/files/Guidance_on_the_disposal_of_pregnancy_remains.pdf
Additional relevant reports and guidance
Building on our Inheritance: Genomic technology in healthcare. A report by the Human Genomics
Strategy Group, 2012.
www.gov.uk/government/uploads/system/uploads/attachment_data/file/213705/dh_132382.pdf Institute of Biomedical Science’s professional guidance.
www.ibms.org/go/media/publications/professional-guidance The Human Tissue (Quality and Safety for Human Application) Regulations, 2007.
www.legislation.gov.uk/uksi/2007/1523/resources NHS Infectious Diseases in Pregnancy Screening Programme Standards.
infectiousdiseases.screening.nhs.uk/standards Faecal occult blood testing within the UK Bowel Cancer Screening Programme.
www.cancerscreening.nhs.uk/bowel/index.html
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Appendix 1
Summary of records guidance
Record type
Paragraph
Minimum retention unless stated otherwise
Related
Related guidance
paragraphs
‘Simple’ request form (see below for variations)
34
Until report authorised, longer than one month
not required. If uncomplicated, 1 week is
sufficient
Request form containing clinical information not
35
30 years
transcribed into report or otherwise readily
accessible in patient’s notes
Request form used as laboratory worksheet
35
Retain as part of the laboratory record
40, 41
Minor financial document used for accounting
35
Seek local advice from accounts department
purposes
Records of specimens disposed of without
36
4 years
www.ibms.org/go/me
analysis, together with primary request
dia/publications/profe
documentation and reason for discard
ssional-guidance
Records of specimens received by a lab
37
8 years from specimen receipt
Mortuary registers
38
30 years minimum
SOP protocols
39
30 years minimum
Worksheets for permanent/semi-permanent
40
Retain as for related specimens
specimens
Worksheets for temporary specimens (serum,
40
At least until final report has been authorised
body fluid and faecal samples)
Working records of test results for named
41
1 year from specimen receipt
patients, if all results included in separate stored
report
Working records of test results for named
41
At least until final report has been authorised –
patients, if results are NOT in separate stored
possibly up to 30 years for audit or medicolegal
report or undertaken by external laboratories
reasons
Records of telephone/faxed reports
42
5 years minimum
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Record type
Paragraph
Minimum retention unless stated otherwise
Related
Related guidance
paragraphs
Records of telephone calls re. management
42
Long term, as for other correspondence
advice
Records of faxes re. clinical advice
42
30 years, as for other correspondence
49
IBMS/RCPath
guidance:
Communication of
unexpected findings,
urgent reports,
delayed reports and
the use of Alert
systems in
diagnostic cellular
pathology
Report copies (electronic/physical)
43
6 months, or as needed for operational
purposes
Report copies (electronic/physical)
43
6 months
communicated between laboratories
Identifying information of report copies (physical
43
8 years to re-access original results
or electronic) communicated between
laboratories
Report copies for communication/
aide memoire
44
Disposed when function complete
Report copies sent by fax
45
Disposed after sending. Transmission details
recorded
Report copies to replace original
45A
As original
Report copies as part of training portfolios
46
5 years after training completion
Report copies in revalidation portfolios
46
Length of 1 revalidation cycle (currently 5
years)
Surgical (histological) reports
47
30 years
(electronic/physical)
Post-mortem report copies (electronic/physical)
48
8 years
Section D
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Record type
Paragraph
Minimum retention unless stated otherwise
Related
Related guidance
paragraphs
Post-mortem report copies of violent/suspicious
48
30 years
deaths
Patient correspondence not lodged in patient's
49
30 years
record
Patient correspondence by email
49
See local medical records and IT policies
POCT specimens log
50
Instrument lifetime
Bound copies of reports and records
51
30 years
Pathological archive or museum catalogues
52
Time specimens held or until catalogue
updated
Photographs as primary source for diagnosis
53
30 years
Images of pathological specimens
54
As long as recommended for original
specimens. New guidance anticipated
Digitised images in genetics testing protocols
55
Treated as semi-permanent preparations or
Section E
transcribed into report
working documents
Digitised images in genetics testing protocols
55
30 years
Section E
NOT transcribed into report
Photographic images for communication/
aide
56
Disposed when function complete
memoire
Batch records
57
8 years
Internal quality control records
58
8 years
External quality assessment records
59
8 years or 2 accreditation cycles against ISO
15189 (currently 4-year cycle), whichever is
longer
Accreditation documents and records of
60
As paragraph 59
inspection
Primary traces of temperature records for fridges 61
2 months (unless used for paragraphs 62–66)
BSQR 2005
and freezers
As 61. Summarised data, if blood for transfusion
62
15 years
152
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Record type
Paragraph
Minimum retention unless stated otherwise
Related
Related guidance
paragraphs
As 61. Summarised data, if long-term storage of
63
8 years
58
specimens not for human application
As 61. Summarised data, if storage of analytical
64
5 years
reagents/temporary specimens
As 61. Summarised data if for very long-term
65
Lifetime of equipment
storage
As 61. Summarised data, if for biobanked
65
Lifetime of specimen
specimens
As 61. Summarised data, if for forensic samples
66
As long as oldest sample held
www.met.police.uk/fo
for potential medicolegal use
i/pdfs/policies/handli
ng_of_frozen_exhibit
s_policy.pdf
Equipment maintenance logs
67
Instrument lifetime plus one full accreditation
cycle (4 years)
Service inspection and instrument maintenance
68
Instrument lifetime plus one full accreditation
records
cycle (4 years)
Records relevant to diagnostic products or
69
8 years
equipment
Assay validation and verification records
70
8 years
Records of specimens relevant to cell/tissue
72
30 years/lifetime recipient whichever longer
transplantation not in patient records
Records from donor tissues not used for
72
Same as equivalent samples/records for a
www.hta.gov.uk/_db/
transplantation
patient
_documents/Annex_-
_Guide_to_Quality_a
nd_Safety_Assuranc
e_for_Tissues_and_
Cells_for_Patient_Tr
eatment.pdf
Records of fertility specimens not in patient
73
30 years
records
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Record type
Paragraph
Minimum retention unless stated otherwise
Related
Related guidance
paragraphs
Transplant-related virology/microbiology records
88
30 years
www.gov.uk/govern
ment/publications/gui
dance-on-the-
microbiological-
safety-of-human-
organs-tissues-and-
cells-used-in-
transplantation
Operational records in biosample banking
106
As for clinical governance in diagnostic
specimens
Biobank records of internal and external quality
110
12 years
58, 59
assurance performance
Biobank records of adopted sub-collection
111
As for ongoing collections
Request forms
148
1 month
Worksheets (electronic/physical)
149
30 years
The Blood Safety
and Quality
Regulations 2005,
incorporating
previous EU Blood
Directives into UK
law
Results of transfusion-related tests
150
30 years
The Blood Safety
and Quality
Regulations 2005
Blood Bank Register blood component audit trail
151
30 years
records (electronic/physical)
Refrigerator and freezer charts
152
15 years
Records of serious events
153
15 years
The Blood Safety
and Quality
Regulations 2005
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Record type
Paragraph
Minimum retention unless stated otherwise
Related
Related guidance
paragraphs
Annual reports
154
15 years
Criminal case records in any medium
157
Permanently
Machine outputs from diagnostic tests using
162
5 years (1 accreditation cycle plus safety
nucleic acids
margin)
Ability to regenerate records of external quality
164
5 years
assessment (EQA) proficiency testing
Participants' returns (electronic/physical) from
165
3 months or 1 month after report sent to
EQA providers
participant if longer
Performance surveillance records in EQA
166
5 years
Confidential patient documentation held
184
Destroyed/anonymised 6 months after
separately from patient records
completion of research
Working records and other research data
185
10 years
Records and clinical trial data on medicines
185
15 years
The Medical
Research Council’s
Good Research
Practice (2000) and
Human tissue and
Biological Samples
for Use in Research:
Operational and
Ethical Guidelines (2001)
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Appendix 2 Summary of specimens guidance
Specimen type
Paragraph
Minimum retention unless stated otherwise
Related
Related guidance
paragraphs
Material containing human cells obtained post
74
Prohibited unless licence from HTA and
Appendix 2
www.hta.gov.uk/leg
mortem
consent
islationpoliciesandc
odesofpractice/legi
slation/humantissu
eact.cfm
Post-mortem samples of human tissue retained
77
As long as required to fulfil Coroner's duties
by Coroner
Samples for criminal investigations
79
As long as required for investigation
www.acpo.police.u
k/documents/FoI%
20publication/Discl
osure%20Logs/Cri
me%20%20FOI/20
12/199%2012%20
Att%2001%20of%2
01%20Forensic%2
0Exhibit%20Retent
ion%20Guidance.p
df
Post-mortem samples no longer required by
80
Consent needed in Schedule 1 of HTA
Appendix 2
www.hta.gov.uk/leg
Coroner or criminal justice system
islationpoliciesandc
odesofpractice/cod
esofpractice.cfm
Sample from living patient no longer required by
81
Consent needed in Schedule 1 of HTA
Appendix 2
criminal justice system
Plasma and serum
87
48 hours after final report
Plasma and serum with expectation of follow up
87
Retained until follow-up tests
Serum for transplantation matching
88
Lifetime of recipient
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Specimen type
Paragraph
Minimum retention unless stated otherwise
Related
Related guidance
paragraphs
Transplant virology/microbiology serum samples
88
10 years donor material, 30 years recipient
www.gov.uk/gover
material
nment/publications/
guidance-on-the-
microbiological-
safety-of-human-
organs-tissues-
and-cells-used-in-
transplantation
Serum from first pregnancy booking visit
89
2 years
infectiousdiseases.
screening.nhs.uk/st
andards
Sera for virological assessment of patients
89A
1 year
www.gov.uk/gover
dialysed overseas
nment/publications/
smi-v-10-
bloodborne-virus-
testing-in-dialysis-
patients
Fetal serum from cordocentesis
90
30 years
Serum after needlestick injury/hazardous
91
2 years
exposure
Left-over sera or plasma
92
1 year
www.hta.gov.uk/lic
ensingandinspectio
ns/sectorspecificinf
ormation/dna.cfm
Newborn blood spot screening cards
93
5 years
‘Residual Spots’
page at
newbornbloodspot.
screening.nhs.uk
Faecal occult blood screening test cards
94
48 hours after report authorisation
Derived faecal suspensions in buffer
94
2 weeks
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Final
Specimen type
Paragraph
Minimum retention unless stated otherwise
Related
Related guidance
paragraphs
Body fluids, aspirates and swabs
95
48 hours after final report
Deteriorated body fluids, aspirates and swabs
95
Discarded immediately after analysis
Coagulation samples
95
24 hours
Easily and non-invasively repeated samples
95
Destroyed once examination concluded and
final report issued
Whole blood samples for FBC
96
24 hours
Donor lymphocyte preparations
97
Lifetime all recipients
Blood Safety and
Quality Regulations
2005 and HTA
Code of Practice 6
Microscope slides of frozen sections
98
As fixed specimens
Residual tissue of frozen sections
98
As normal fixed specimens once section
complete
Frozen tissue/cells for histochemical or genetic
99
10 years preferably longer
analysis
Cytogenic cell suspensions in fixative
99
3 months (longer if space permits)
Wax/resin embedded blocks for histology
100
30 years. If no facilities, 10 years, retaining
most relevant blocks permanently
Wax/resin embedded blocks for histology with
100
Considered for permanent retention, otherwise
rare pathology
at least 30 years or transfer to licensed biobank
Wax/resin embedded blocks for histology
101
Blocks that provided basis malignancy
considered for destruction <30 years
diagnosis retained 3 years after patient death
Paediatric wax/resin embedded blocks for
102
Until child >25 years old. Consider permanent
histology
particularly cancers, inherited abnormalities
Paediatric wax/resin embedded blocks for
102
Special considerations apply
Section D
histology in forensic practice
Post-mortem wax/resin embedded blocks for
103
According to consent given for examination
100, 74-86
histology
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Final
Specimen type
Paragraph
Minimum retention unless stated otherwise
Related
Related guidance
paragraphs
Adopted sub-collection of biosamples by
111
As for ongoing collections
biobank
Research involving non-return/destruction of
119
30 years or returned to hospital source if
primary resource
earlier
Electron microscopy blocks
120
30 years
Electron microscopy grids for human tissue
121
10 years, preferably longer
diagnosis
Electron microscopy grids for virus identification
121
48 hours after final report if images are
accessible for 30 years
Wet tissue surgical specimens from living
122
4 weeks after final report issued. Longer if
patients
anticipating report on further tests
Post-mortem wet tissue specimens
123
As authorised by Coroner
Whole organs, wet tissue, fetal specimens
124
Only kept if intention to use for human health
retained before HTA 2004
education
Teaching collections
126
Can be retained permanently
Microbiological and easily repeatable stained
130
7 days after final report
slides
Gram-stained preparations from culture plates
130
Discarded immediately after use
Blood films
131
7 days after final report
53, 54
Cytogenetic slide preparations
132
2 years after final report
Digitised/photographed cytogenetic slide
132
30 years, if feasible
preparations
Digitised/photographed molecular
133
30 years
55
genetic/cytogenetic slide preparations
Fluorescently stained slides
133
At least until final report issued
Stained bone marrow films
134
30 years minimum
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Final
Specimen type
Paragraph
Minimum retention unless stated otherwise
Related
Related guidance
paragraphs
Surplus unstained bone marrow films
134
Discarded after report complete
Cytology slides including population screening
135
10 years, preferably longer
Cytoblock preparations
135
As for other tissue blocks. Sections as long as
accompanying slides
Histology slides
136
At least 10 years. If longer not possible, retain
selected slides
Histology slides where cannot replace by re-
136
30 years
cutting block
Histology slides scanned and digitally archived
136
Physical slides for 2 accreditation cycles
(8 years)
Semi-permanent preparations
138
At least until final report issued
Human DNA and RNA
139
8 weeks after final report
Human DNA and RNA for family studies with
139
30 years
genetic disorders/ context of transplantation
Positive microbiological cultures
143
Discarded within 24–48 hours of final report
Positive microbiological cultures of clinical
143
7 days
importance
Positive microbiological cultures referred to
143
Until receipt of reference laboratory's final
reference laboratories
report
Nucleic acids from microbiological cultures
145
4 weeks after final report unless consent in
139, 140
research
Permanently preserved cultures
146
Permanently retained
Electrophoretic strips and immunofixation plates
147
5 years
Digitised electrophoretic strips and
147
30 years, original preparations discard after
immunofixation plates
2 years
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Final
Specimen type
Paragraph
Minimum retention unless stated otherwise
Related
Related guidance
paragraphs
Blood for grouping, Ab screening, saving/
155
7 days from group and screen. Available for
156
BCSH Guidelines
X-matching
3 days post-transfusion. Practically will be
for Pre-Transfusion
14 days
Compatibility
Procedures in
Blood Transfusion
Laboratories, 2012
(www.bcshguidelin
es.com)
Stored separated serum or plasma from
156
14 days post-transfusion
155
recipient
Stored separated serum or plasma from donor
156
Up to 3 months
Archived blood donor samples
156
3 years
Materials stored by EQA providers if can be
168
5 years
converted to permanent preparation
Degraded material stored by EQA providers
168
1 month after relevant circulation assessed
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Appendix 3
Schedule 1 of the Human Tissue Act 2004
Scheduled purposes *
Part 1: Purposes requiring consent: general
1.
Anatomical examination.
2.
Determining the cause of death.
3.
Establishing after a person’s death the efficacy of any drug or other treatment administered
to him/her.
4.
Obtaining scientific or medical information about a living or deceased person which may be
relevant to any other person (including a future person).
5.
Public display.
6.
Research in connection with disorders, or the functioning, of the human body.
7.
Transplantation.
Part 2: Additional purposes requiring consent: deceased person
8.
Clinical audit.
9.
Education or training relating to human health.
10. Performance assessment.
11. Public health monitoring.
12. Quality assurance.
*
Scheduled purposes relate to
“relevant material” as defined within the Act. The Human
Tissue Authority has now also produce
d a supplementary list of relevant material for
guidance.
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