The Retention And Storage Of Pathological Records And .

The retention and storage of pathological records and specimens(5th edition)Guidance from The Royal College of Pathologists and the Institute of Biomedical ScienceApril 2015Unique document numberG031Document nameThe retention and storage of pathological records and specimensVersion number5Produced byDr Bridget Wilkins, on behalf of The Royal College of Pathologists’Working Party on the Retention and Storage of PathologicalRecords and SpecimensDate activeApril 2015Date for reviewApril 2019CommentsThis issue replaces all previous versions of The retention andstorage of pathological records and archives/specimens.In accordance with the College’s pre-publications policy, it was onthe College website for consultation from 21 October to 19November 2014, following pre-consultation with SAC Chairs andothers. Over 260 items of feedback were received and theguidance was amended accordingly. Please emailpublications@rcpath.org to see the responses.Dr David Bailey, Vice-President for CommunicationsDr Peter Cowling, Director of Clinical EffectivenessThe Royal College of Pathologists4th Floor, 21 Prescot Street, London, E1 8BBTel: 020 7451 6700Fax: 020 7451 6701Web: www.rcpath.orgRegistered charity in England and Wales, no. 261035 2015, The Royal College of PathologistsThis 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, allother rights are reserved. Requests and inquiries concerning reproduction and rights should be addressed toThe Royal College of Pathologists at the above address. First published: 2015PUB2704151V11Final

ContentsGeneral principles of record and specimen retention . 5Introduction . 6Key updates and additions to this edition . 6Terms of reference, history and development of the guidelines. 6Contributors . 7Context . 7Scope of the guidance . 8The nature of pathology records . 10Clinical and diagnostic records and reports . 10Laboratory and mortuary working records: reports and documentation for internal use . 11Specimens . 12The management of records and specimen archives: general comments . 12A. Documents, electronic and paper records . 17Request forms . 17Daily work logs (day books and electronic equivalents) and other records of specimensreceived by a laboratory . 18Mortuary registers . 18Protocols of standard operating procedures . 18Worksheets . 18Laboratory file cards or other working records of test results for named patients . 18Records of telephoned or faxed reports . 18Report copies (physical or electronic) . 18Surgical (histological) reports . 19Post-mortem reports . 19Correspondence on patients . 19Point-of-care test data . 20Bound copies of reports and records, if made . 20Pathological archive or museum catalogues . 20Photographic records . 20Batch records. 20Internal quality control records . 21External quality assessment records . 21Accreditation documents and records of inspections . 21Temperature records for refrigerators and freezers (including those used forpost-mortem body storage) . 21Equipment maintenance logs . 21Records of service inspections and instrument maintenance . 22Records relevant to production of diagnostic products or equipment . 22Records of assay validation and verification. 22Research data . 22PUB2704152V11Final

Records relating to cell/tissue transplantation . 22Records relating to retention of semen, spermatozoa, oocytes and tissues forfertility assessment and use in assisted reproduction . 22B. Specimens and preparations. 22Legal issues . 22Plasma and serum . 24Newborn blood spot screening cards . 25Faecal occult blood screening cards and derived faecal suspensions . 25Body fluids, aspirates and swabs (including liquid-based cytology specimens) . 26Whole blood samples, for full blood count . 26Donor lymphocyte preparations in cell or tissue transplantation . 26Frozen tissue for immediate histological assessment (frozen section) . 26Frozen tissue or cells for histochemical or molecular genetic analysis . 26Paraffin wax or resin embedded blocks for histology . 26Retention of specimens and records in the context of biosample banking for research . 27Release and return of archived diagnostic samples for clinical trials purposes . 28Blocks for electron microscopy. 29Grids for electron microscopy. 29Wet tissue (representative portion or whole tissue or organ) . 29Museum specimens, where these are generally accessible for undergraduate orpostgraduate study (teaching collections not accessible by members of the public) . 30Stained slides . 30Human DNA and RNA . 32Microbiological cultures . 32Freeze-dried or other permanently preserved cultures . 33Electrophoretic strips and immunofixation plates . 33C. Documents, records, specimens and preparations: specific advice fortransfusion laboratories . 33Documents and records . 33Request forms for grouping, antibody screening and cross-matching . 33Worksheets . 33Results of grouping, antibody screening and other blood transfusion-related tests . 33Blood Bank Register, blood component audit trail and fates . 33Refrigerator and freezer charts . 34Records of serious events. 34Annual reports (where required by The Blood Safety and Quality Regulations 2005) . 34Specimens and preparations . 34Blood for grouping, antibody screening and saving and/or cross-matching . 34Separated serum or plasma, stored for transfusion purposes . 34D. Forensic material . 35Criminal cases . 35Autopsy reports, specimens, archived material and other, where the deceased hasbeen the subject of a Coroner’s autopsy . 35PUB2704153V11Final

E. Genetics . 35Storage of material following analysis of nucleic acids . 36a) Molecular genetics . 36b) Molecular cytogenetics . 36Retention of records and materials by providers of external quality assessment . 36Additional records to be kept by EQA providers . 36Other records . 37Retention times for materials stored by EQA providers . 37Cells, tissues and other materials stored prior to preparation and circulation . 37Disposal of human tissue . 37General . 37Fetal tissues. 38Medicolegal value of archived material . 39Specimens and records for teaching . 39Research data and records . 39Confidentiality of records . 40Long-term or permanent retention of records . 40A note on veterinary pathology specimens and records . 41Bibliography and further guidance . 42Appendix 1: Summary of records guidance . 47Appendix 2: Summary of specimens guidance . 53Appendix 3: Schedule 1 of The Human Tissue Act 2004 . 59Scheduled purposes . 59Part 1: Purposes requiring consent: General. 59Part 2: Additional purposes requiring consent: deceased person . 59PUB2704154V11Final

General principles of record and specimen retentionRecord/specimen typeRecommended retention periodPrimary copy of record in patient’s paper orelectronic medical record30 yearsInformation (paper or electronic) orpermanent specimens held in the laboratorythat may also be regarded as primarycomponents of the patient’s medical record30 yearsRecords relating to cells and tissue used fortransplantation, including transfusionLifetime of recipientRecords and serum samples used formicrobiological investigations prior totransplantationLifetime (recipient)Tissue sections and other permanentmicroscopy preparations replaceable from aprimary specimen such as a tissue blockMinimum of 15 yearsWorking records (paper or electronic) neededfor laboratory accreditationMinimum of eight years (two accreditationcycles)Instrument and equipment performance logsLifetime of instrument/equipment plusminimum of four yearsPrimary copy of record in patient’s paper orelectronic medical record after deathEight yearsRecords (paper or electronic) or specimensheld in the laboratory after death, that may beregarded as primaryEight yearsNon-permanent specimens, empty specimencontainers and sampled material surplus totesting requirementsUntil verification of completed report; anadditional margin may be advisable, dependingon specimen type and feasibilityRecords of specimens stored with consent forresearch/biobankingLifetime of specimen in storageRecords of archived ‘surplus’ diagnosticsamples released for researchFive years from closure of study, or asdetermined by study sponsor(s)At least ten years (donor)If from a child, until they reach the age of 25Please refer to Appendices 1 and 2 for more detailed information.PUB2704155V11Final

IntroductionThis is an update of the advice of The Royal College of Pathologists and Institute of BiomedicalScience 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-widesequencing technologies. Expanded advice for point-of-care testing. Adjusted document retention times reflecting move to ISO standards 15189 and I7043accreditation. Guidance for samples and records made available for research after diagnostic use. Summary of general principles applicable to retaining key categories of records andspecimens.Terms of reference, history and development of the guidelinesThe original Working Party for this guidance was appointed in 1994 by the Council of The RoyalCollege of Pathologists, with the following terms of reference:“To make recommendations on minimum retention times for pathology records, tissues and semipermanent or permanent pathological preparations, including those required for operational use,for education, teaching, training and general scholarship, for research per se, for historicalpurposes and against the possibility of future litigation, audit or allegations of scientific fraud and toreport to Council”.Following publication of the first version in that year, a second edition in 1999 additionallyconsidered ethical and practical implications relevant to genetic testing, especially those servicesoffered 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 theData 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, andthe requirements arising from participation in external quality assurance schemes.For consideration in the 2015 edition, growth of molecular genetic testing continues apace, withevolving data storage requirements as whole-genome sequence technologies gain prominence inthe diagnostic repertoire. Storage of electronic records also poses evolving challenges, particularlyfor 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 warrantedfurther advice. Guidance for bodies providing external quality assessment programmes has beenextended to reflect feedback since the introduction of this topic in the 2009 edition. Transition tolaboratory accreditation by UKAS against ISO standards 15189, 18025 and 17043 has implicationsfor the inspection cycle time over which some records should be held. A general principle in allversions of this document has been to advise retention of relevant records for three inspectioncycles; this woul

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.