Scottish Government Records Management: NHS Code of Practice (Scotland) Version 2.0

Records Management Code of Practice


ANNEX D - 'THE MANAGEMENT, RETENTION AND DISPOSAL OF PERSONAL HEALTH RECORDS

Introduction

Scope of Schedule

This Annex sets out the minimum periods for which the various personal health records created within the NHS or by predecessor bodies should be retained (in line with Principle 5 of The Data Protection Act 1998), either due to their ongoing administrative value or as a result of statutory requirement. It also provides guidance on dealing with records which have ongoing research or historical value and should be selected for permanent preservation as archives and transferred to an appropriate archive.

The Annex provides information and advice about all personal health records commonly found within NHS organisations. The retention schedules apply to all the records concerned, irrespective of the format ( e.g. paper, databases, e-mails, X-rays, photographs, CD- ROMs) in which they are created or held.

This Annex does not provide specific guidelines on determining which documents are retained as part of a personal health record. However, in Addendum 1, principles to be used in determining policy regarding the retention and storage of essential maternity records are set out. In addition, NHS organisations are reminded that good practice suggests that a policy determining which documents should remain in the record after discharge (or culling) should be in place. The development of such a policy should include addressing any clinical requirements for completeness of information, as well as the legal requirements of the Data Protection Act 1998, which states that only personal information which is relevant and not excessive should be retained.

Guidance on corporate ( i.e. administrative, non-health) records commonly found within NHS organisations is given in Annex E

Responsibilities and Decision Making

NHS Boards are public authorities in terms of the Freedom of Information (Scotland) Act 2002, and their records are covered by the provisions of that Act and its Code of Practice on Records Management (under section 61 of the Act).

For an NHS organisation to manage its records effectively, wider records management responsibilities need to be considered, placed with the appropriate individuals and/or committees, and resourced. For example, organisations may require local records managers and/or a corporate records manager; a health or medical records manager and/or committee; and an archivist.

In addition, NHS Boards are required to comply with the Information Governance standards set out in the Clinical Governance and Risk Assessment standards specified by NHS Quality Improvement Scotland. These include standards applicable to administrative and patient records.

Retention Periods

Each organisation must produce its own retention schedule, specifying the locally agreed retention periods, in the light of its own internal requirements. Organisations must not apply to any records a shorter retention period than the minimum set out in this schedule, but there may be circumstances in which they need to apply a longer retention period. Organisations should ensure that they are able to justify, particularly in terms of the Data Protection Act when applicable, the retention of records for longer than the minimum period set out in this schedule. NHS Boards and GPs as producers of products and equipment, are affected by the provisions of the Consumer Protection Act 1987 covering the liability of producers for defective products. They may also be liable in certain circumstances as suppliers and users of products. An obligation for liability lasts for 10 years and within this period the Prescription and Limitation (Scotland) Act 1973, as amended by the Consumer Protection Act 1987, provides that the pursuer must commence any action within 3 years' from the date on which the pursuer was aware of the defect and aware that the damage was caused by the defect. This means that if a defective product was likely to have affected the health of a patient, then the patient's record would have to be retained for at least 13 years'. It will be for Boards and GPs to make their own judgement in such cases on whether any health records should be retained for this minimum period in order to defend any action brought under the Consumer Protection Act 1987 Organisations should ensure that they have mechanisms in place to identify records for which the appropriate minimum retention period has expired, in line with the 5th principle of the Data Protection Act 1998. It is acknowledged that organizations will have different mechanisms available to them in order to do this, and that these may vary depending on the medium on which the record is held. In relation to paper records in particular, it is acknowledged that organisations may 'batch' records together e.g. on an annual basis, in order to make disposal decisions. In such instances one approach to the calculation of minimum retention periods would be to base it on the beginning of the year after the last date on the record. For example, a file in which the first entry is in February 2001 and the last in September 2004, and for which the retention period is six years would be kept in its entirety at least until the beginning of 2011.

Disposal and Destruction of Personal Health Records

Decision Making

Staff in the operational area that ordinarily uses the records will usually be able to decide on their disposal and/ or destruction. Operational managers are responsible for making sure that all records are periodically and routinely reviewed to determine what can be disposed of or destroyed in the light of local and national guidance.

In respect of personal health records, the NHS Scotland Information Governance Standards require that NHS Boards establish a Patient Records Committee, which makes decisions on policy matters and which includes representation from clinical and non-clinical staff, and which is linked appropriately to other Information Governance Groups. Input from local healthcare professionals should be a key element of any records management strategy.

Once the appropriate minimum period has expired, the need to retain records further for local use should be reviewed periodically. Because of the sensitive and confidential nature of such records and the need to ensure that decisions on retention balance the interests of professional staff, including any research in which they are or may be engaged, and the resources available for storage, it is recommended that the views of the profession's local representatives should be obtained.

Disposal and Destruction

At the end of the relevant minimum retention period, one or more of the following listed actions will apply:

Review: records may need to be kept for longer than the minimum retention period due to ongoing administrative and/ or clinical need. As part of the review, the organisation should have regard to the fifth principle of the Data Protection Act 1998, which requires that personal data is not kept longer than is necessary. If it is decided that the records should be retained for a period longer than the minimum the internal retention schedules will need to be amended accordingly and a further review date set. Otherwise, one of the following will apply:

Transfer to or consult an NHS archivist or The National Archives of Scotland (see 'Archives' section below): if the records have no ongoing administrative value but have, or may have, long-term historical or research value. Organisations that do not have their own archivist should consult an NHS Archivist or the National Archives of Scotland for advice.

Destroy: where the records are no longer required to be kept due to statutory requirement or administrative or clinical need, and they have no long-term historical or research value. In the case of personal health records, this should be done in consultation with clinicians in the organisation and archivists, with the necessary arrangements made to protect patient confidentiality where appropriate. It is important that records of destruction of health records contained in this retention schedule are retained permanently. No surviving health record dated 1948 or earlier should be destroyed. Organisations should also remember that records containing personal information are subject to the Data Protection Act 1998.

Archives

All records management procedures with respect to NHS records, especially those that may be candidates for permanent preservation because of their wider medical or historical importance, should be informed by advice from the appropriate NHS Archivist or the National Archives of Scotland. (See the attached list of useful contacts in Annex B.)

Every NHS Board should have access to the services of a professional archivist. A number of NHS Boards employ qualified archivists to look after their non-current health records and to make them available both to staff of the employing authority and members of the public in consultation with the Keeper of the Records of Scotland. In the case of Boards that do not have their own archivist, an NHS Archivist or the National Archives of Scotland will offer advice on request.

Where possible, the Schedule identifies those records likely to have permanent research and historical value. Beyond this, some NHS organisations will have particular and individual reasons, which relate to their own history, for retaining particular records as archives. Conversely, it should also be borne in mind that some records may have a long-term research value outside the NHS organisation that created them ( e.g. both administrative and personal health records from a number of different hospitals have been used to study the 1918 influenza epidemic).

Interpretation of the Schedule

The following types of record are covered by this retention schedule (regardless of the media on which they are held, including paper, electronic, images and sound, and including all records of NHS patients treated on behalf of the NHS in the private health sector):

  • personal health records (electronic or paper-based, and concerning all specialties, including GP medical records);
  • records of private patients seen on NHS premises;
  • Accident and Emergency, birth and all other registers;
  • theatre, minor operations and other related registers;
  • xray and imaging reports, output and images;
  • photographs, slides and other images;
  • microform ( i.e. microfiche/ microfilm);
  • audio and video tapes, cassettes, CDROMS etc;
  • emails;
  • records held on computer; and
  • scanned Documents.

The layout and some of the content of the schedule is based on that published by the Department of Health on 30 March 2006 in its publication: 'Records Management: NHS Code of Practice' (270422/2/Records Management: NHS Code of Practice Part 2). Find out more here

The Schedule is organised into a table with 3 headings:

RECORD TYPE: lists alphabetically records created as part of a particular function.

MINIMUM RETENTION PERIOD: specifies the shortest period of time for which the particular type of record is required to be kept. This period of time is usually set either because of statutory requirement or because the record may be needed for administrative purposes during this time. If an organisation decides that it needs to keep records longer than the recommended minimum period, it can vary the period accordingly and record the decision on its own retention schedule. In this regard, however, organisations must consider the fifth principle of the Data Protection Act 1998, i.e. that personal data should not be retained longer than is necessary.

NOTE: - provides further information, such as whether the record type is likely to have long-term research or historical value.

The following 'standard' retention periods apply to the following record types:

Record Type

Minimum NHS Retention Period

Adult

6 years after date of last entry or 3 years after death if earlier

All types of records relating to Children and young people (including children's and young person's Mental Health Records)

Retain until the patient's 25th birthday or 26th if young person was 17 at conclusion of treatment, or 3 years after death.

If the illness or death could have potential relevance to adult conditions or have genetic implications, the advice of clinicians should be sought as to whether to retain for a longer period.

Mentally disordered person (within the meaning of any Mental Health Act )

20 years after date of last contact between the patient/ client/ service user and any health/ care professional employed by the mental health provider, or 3 years after the death of the patient/ client/ service user if sooner and the patient died while in the care of the organisation.

N.B.NHS organisations may wish to keep mental health records for up to 30 years before review. Records must be kept as complete records for the first 20 years in accordance with this retention schedule but records may then be summarised and kept in summary format for the additional 10-year period.

Social services records are retained for a longer period. Where there is a joint mental health and social care record, the higher of the two retention periods should be adopted.

When the records come to the end of their retention period, they must be reviewed and not automatically destroyed. Such a review should take into account any genetic implications of the patient's illness. If it is decided to retain the records, they should be subject to regular review.

Throughout this Schedule, where the 'standard' retention period specified above applies, the relevant record type has the entry 'Retain according to the standard minimum retention period appropriate to the patient/ specialty (see above)' in the 'Minimum Retention Period' column. Where it does not apply, the required minimum retention period is listed in the 'Minimum Retention Period' column.

Health Records Retention Schedule

TYPE OF HEALTH RECORD

MINIMUM RETENTION PERIOD

NOTE

A&E records (where these are stored separately from the main patient record)

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see above)

A&E registers (where they exist in paper format)

8 years after the year to which they relate.

Likely to have archival value- see footnote

Abortion - Certificates set out in Schedule 1 to the Abortion (Scotland) Regulations 1991

3 years beginning with the date of the termination

Admission books (where they exist in paper format)

8 years after the last entry

Likely to have archival value- see footnote

Ambulance records - patient identifiable

Component (including paramedic records made on behalf of the Ambulance Service)

7 years

Asylum seekers and refugees ( NHS personal health record - patient held record)

Special NHS record- patient held, no requirement on the NHS to retain.

Audiology records

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see above)

Birth registers (ie register of births kept by the hospital)

2 years

Likely to have archival value- see footnote

Body release forms

2 years

Breast screening Xrays

8 years

Cervical screening slides

10 years

Chaplaincy records

2 years

Likely to have archival value- see footnote

Child and family guidance

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see above)

Child Protection Register (records relating to)

Retain until the patient's 26th birthday

Clinical audit records

5 years

Clinical psychology

30 years

Clinical trials of investigational medicinal products - health records of participants that are the source data for the trial

For trials to be included in regulatory submissions: At least 2 years after the last approval of a marketing application in the EU. These documents should be retained for a longer period, however, if required by the applicable regulatory requirement(s) or by agreement with the Sponsor. It is the responsibility of the Sponsor/someone on behalf of the Sponsor to inform the investigator/institution as to when these documents no longer need to be retained. For trials which are not to be used in regulatory submissions: At least 5 years after completion of the trial. These documents should be retained for a longer period if required by the applicable regulatory requirement(s), the Sponsor or the funder of the trial, In either case, if the period appropriate to the specialty is greater, this is the minimum retention period.

Likely to have research value see footnote

Counselling records

30 years

Likely to have research/ historical value see footnote

Death - Cause of, Certificate counterfoils

2 years

Death registers - i.e. register of deaths kept by the hospital, where they exist in paper format

2 years

Likely to have archival value- see footnote

Dental epidemiological surveys

30 years

Dental, ophthalmic and auditory screening records

Adults: 11 years

Children: 11 years, or up to 25th birthday, whichever is the longer

Diaries - health visitors and district nurses

2 years after end of year to which diary relates.

Patient relevant information should be transferred to the patient record.

It is not good practice to record patient identifiable information in diaries.

Dietetic and nutrition

Retain according to the standard minimum retention period appropriate to the patient/ specialty(see above)

Discharge books

(where they exist in paper format)

8 years after the last entry

Likely to have archival value- see footnote

District nursing records

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see above)

Donor records (blood

and tissue)

30 years post transplantation

Likely to have research/ historical value see footnote

Family planning records

10 years after the closure of the case

For children retain until their 25 th Birthday

Forensic medicine records (including pathology, toxicology, haematology, dentistry, DNA testing, post mortems forming part of the Procurator Fiscal's report, and human tissue kept as part of the forensic record) See also Human tissue, Post mortem registers

For post mortem records which form part of the Procurator Fiscal's report, approval should be sought from the PF for a copy of the report to be incorporated in the patient's notes, which should then be kept in line with the specialty, and then reviewed.

In cases where criminal proceedings are anticipated documentation is not normally entered in to the patient records.

All other records retain for 30 years.

Likely to have research/ historical value see footnote

Genetic records

30 years from date of last attendance.

Likely to have research/ historical value see footnote

Genito Urinary Medicine ( GUM)

Store according to the standard minimum retention period appropriate to the patient/ specialty (see Above)

GP records, including medical records relating to HM Armed Forces

Retain for the lifetime of the patient and for 3 years after their death.

Records relating to those serving in HM Armed Forces - The Ministry of Defence (MoD) retains a copy of the records relating to service medical history. The patient may request a copy of these under the Data Protection Act ( DPA), and may, if they choose, give them to their GP. GPs should also receive summary records when ex-Service personnel register with them. What GPs do with them is a matter for their professional judgement, taking into account clinical need and Data Protection Act requirements- they should not, for example, retain information that is not relevant to their clinical care of the patient.

GP records of serving military personnel in existence prior to them enlisting must not be destroyed. Following the death of the patient the records should be retained for 3 years.

*Electronic Patient Records ( EPRs)- GP only- must not be destroyed, or deleted, for the foreseeable future

*The rationale for this is explained in ' SCIMP Good Practice Guidelines for General Practice Electronic

Patient Records - section 6.1'

Health visitor records

10 years

Records relating to children should

be retained until their 25th birthday

Homicide/ 'serious untoward incident' records

30 years

Likely to have research/ historical value see footnote

Hospital acquired infection records

6 years

Human fertilization records, including embryology records

Treatment Centres

1. If a live child is not born, records should be kept for at least 8 years after conclusion of treatment

2. If a live child is born, records shall be kept for at least 25 years after the child's birth

3. If there is no evidence whether a child was born or not, records must be kept for at least 50 years after the information was first recorded

Storage Centres

Where gametes etc have been used in research, records must be kept for at least 50 years after the information was first recorded.

Research Centres

Records are to be kept for 3 years from the date of final report of results/ conclusions to Human Fertilisation and Embryology

Authority ( HFEA)

Likely to have research value see footnote

Human tissue (within the meaning of the Human Tissue (Scotland) Act 2006) (see Forensic medicine above)

For post mortem records which form part of the Procurator Fiscal's report, approval should be sought from the Procurator Fiscal for a copy of the report to be incorporated in the patient's notes, which should then be kept in line with the specialty, and then reviewed.

Likely to have research value see footnote

Intensive Care Unit charts

Retain according to the standard minimum retention period appropriate to the patient/specialty (see above)

Joint replacement records

For joint replacement surgery the revision of a primary replacement may be required after 10 years to identify which prosthesis was used.

Only need to retain minimum of notes with specific information about the prosthesis.

Likely to have research value see footnote

Learning difficulties -(records of patients with)

Retain for 3 years after the death of the individual.

Macmillan (cancer care) patient records -community and acute

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see Above)

Maternity (all obstetric and midwifery records, including those of episodes of maternity care that end in stillbirth or where the child later dies)

25 years after the birth of the last child

Medical illustrations (see Photographs below)

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see Above)

Mentally disordered persons (within the meaning of any Mental Health Act )

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see Above)

Microfilm/

microfiche records relating to patient care

Retain according to the standard minimum retention period appropriate to the patient/ specialty

(see Above)

Likely to have archival

value- see footnote

Midwifery records

25 years after the birth of the last child

Mortuary registers (where they exist in paper format)

10 years

Likely to have research/ historical value see footnote

Music therapy records

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see Above)

Neonatal screening records

25 years

Notifiable diseases book

6 years

Occupational Health Records (staff)

6 years after termination of employment

Health Records for classified persons under medical surveillance

50 years from the date of the last entry or age 75, whichever is the longer

Likely to have research/ historical value see footnote

Personal exposure of an identifiable employee monitoring record

40 years from exposure date

Likely to have research/ historical value see footnote

Personnel health records under occupational surveillance

40 years from last entry on the record

Likely to have research/ historical value see footnote

Radiation dose records for classified persons

50 years from the date of the last entry or age 75, whichever is the longer

Likely to have research/ historical value see footnote

Occupational therapy records

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see Above)

Oncology (including radiotherapy)

30 years

N.B. Records should be retained on a computer database if possible.

Also consider the need for permanent preservation for research purposes.

Likely to have research value see footnote

Operating theatre registers

8 years after the year to which they relate

Likely to have historical value- see footnote

Orthoptic records

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see Above)

Out of hours records ( GP cover), including video, DVD and tape voice recordings

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see Above)

Outpatient lists (where they exist in paper format)

2 years after the year to which they relate

Parent held records

There should be a copy kept at the NHS organisation responsible for delivering that care and compiling the record of the care.

The records should then be retained until the patient's 25th birthday, or 26th birthday if the young person was 17 at the conclusion of treatment, or 3 years after death

Pathology records: Documents, electronic and paper

TYPE OF HEALTH RECORD

MINIMUM RETENTION PERIOD

NOTE

Accreditation documents; records of Inspections

10 years or until superseded

Batch records results

10 years

Bound copies of reports / records, if made

30 years

Correspondence on patients

This should be lodged in the patient's record, if feasible. However this is often beyond the control of the laboratory, particularly for case referred distantly, and ensuring entry into the patients notes is not primarily the responsibility of laboratory staff. 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.

Day books and other records of specimens received by a laboratory

2 years from specimen receipt

Equipment/ instruments maintenance logs, records of service inspections

Lifetime of instrument; minimum of 10 years

Procurement, use, modification and supply records relevant to production of products (diagnostics) or equipment

Comprehensive records relevant to procurement, use, modification and supply: 10 years.

External quality control Records

Subscribing laboratories or individuals, 5 years to ensure continuity of data available for laboratory accreditation purposes. Records will be kept for longer periods by organisations providing external quality assessment schemes.

Internal quality control Records

10 years

Lab file cards or other working records of test results for named patients

1 year from specimen receipt if all results transcribed into a separately issued and stored formal report. Otherwise, they should be kept as for worksheets over. The diversity of these types of working records is very wide; within specialties and departments, consideration should be given to the potential audit or medico- legal value of storing such working records for 30 years, as for other primary records.

Mortuary Registers

30 years

Near-patient test data

Result in patient record, log retained for lifetime of instrument

Pathological archive/museum catalogues

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

Where images represent a primary source of information for the diagnostic process, whether conventional photographs or digital images, they should be kept for at least 30 years.

Records of telephoned Reports

Note of the fact and date/ time that a telephone or fax report has been issued should be added to the laboratory electronic records of the relevant report, or to hard copies and kept for a minimum of 5 years. Where management advice is discussed in telephone calls, a summarised transcript should be retained long term, as for the retention of other correspondence. Clinical information or management advice provide by fax, in addition of pure transmission of report, should also be kept as correspondence in the patient note and/ or stored with a laboratory copy of the specimen request/ report for 30 years.

Records relating to cell/ tissue transplantation

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.

Records relating to investigation or storage of specimens relevant to organ transplantation, semen or ova

30 years if not held with health record

Reports and copies (physical or electronic)

6 months or as needed for operational procedures. Where copies represent a means of communication or aide memoire, for example at a multi- disciplinary meeting or case conference, they may be disposed of when that function is complete. Copies of reports sent by fax, with accompanying details of the date and times of transmission, and the intended recipient, should be retained in conjunction with the matching specimen reports and stored long-term by the laboratory. Any such copies generated to substitute for an original report ( e.g. if an original is misplaced) should be retained as for the original.

Reports, copies Post mortem reports

The report should be lodged in patient's record; in the case of Procurator Fiscal reports this is dependant on the PF's approval. Electronic or hard copy should be kept at least 30 years with maintained accessibility. 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 maybe prepared for the PF, summarising cause of death and to the final reports of post-mortem examinations.

Request forms that are not a unique record

Request forms should be kept until the authorised report, or reports on investigation arising from it, have been received by the requestor. As this period of time may vary with local circumstances, no minimum retention time is recommended, request forms need not to be kept for more than one month after the final checked report has been despatched. For many uncomplicated requests, retention of 1 week will suffice.

Request forms that contain clinical information not readily available in the health record

30 years

Where the request form is used to record working notes or as a worksheet, it should be retained as part of the laboratory record.

Standard operating procedures (both current and outdated protocols)

30 years

Surgical (histological) reports

Copy lodged in patients 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.

Pathology Records: Specimens and Preparations.

TYPE OF HEALTH RECORD

MINIMUM RETENTION PERIOD

NOTE

Body fluids/ aspirates/ swabs

Keep for 48 hours after the final report has been issued by the laboratory, unless sample deterioration precludes storage.

Blocks for electron microscopy

30 years

Electrophoretic strips and immunofixation plates

Keep for 5 years, unless digital images are taken, if digital images of adequate quality for diagnosis are taken, then the original preparations my be discarded after 2 years. The images should then be stored under "photographic records" bearing in mind the need to maintain the ability to read archived digital images when equipment is updated.

Foetal serum

Because of it's rarity and value for future research, wherever possible foetal serum should be kept for at least 30 years.

Frozen tissue for immediate histological assessment (frozen section)

Stained microscope slides should be kept for a minimum of 10 years.

Frozen tissues or cells for histochemical or molecular genetic analysis

10 years and preferably longer if storage facilities permit.

Grids for electron microscopy

Requirements in different specialties differ. Grids prepared for human tissue diagnosis ( e.g. renal, muscle, nerve, or tumour) should be kept for 10 years; preferably longer if practicable. Grids prepared for virus identification maybe 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.

Human DNA

4 weeks after final report for diagnostic specimens. 30 years for family studies for genetic disorders (consent required)

Microbiological cultures

24-28 days after final report of a positive culture issued. 7 days for certain specified cultures- see RCPath document

Museum specimens (teaching collections)

Permanently. Consent of the relative is required if it is tissue

Newborn blood spot screening cards

A minimum of 5 years storage is indicated for quality assurance purposes, with longer term storage recommended in accordance with the Code of Practice of the U.K Newborn Screening Programme Centre (2005). See here for more information.

Paraffin blocks

Storage for at least 30 years is recommended, if facilities permit. If not, review the need for archiving at 10 years (and at similar intervals thereafter) and select representative blocks, showing the relevant pathology for permanent retention. Blocks representing rare pathologies and those (including representative normal tissue) from patients of diseases known or thought likely to have an inherited genetic pre-disposition should be particular considered for permanent retention. Wherever possible, storage of all histology block should be for the full minimum of 30 years.

Plasma and serum

Keep for 48 hours after the final report has been issued by the laboratory.

Records relating to donor or recipient sera

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.

Serum from first pregnancy booking visit

Should be kept by microbiology/ virology and other relevant laboratories to provide a baseline for further serological or other tests for infections or other disease during pregnancy and the first 12 months after delivery. Because of rarity and value to future research, wherever possible, foetal serum (from cordocentesis) should be kept for at least 30 years.

Stained slides

Appropriate retention times depend on there nature and purpose. Relevant guidance on minimum retention periods can be found here.

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; further information can be found here.

Wet tissue (representative aliquot or whole tissue or organ)

For surgical specimens from living patients, keep for 4 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.

Whole blood samples, for full blood count

24 hours

Pathology Records: Transfusion Laboratories

TYPE OF HEALTH RECORD

MINIMUM RETENTION PERIOD

NOTE

Annual reports (where required by EU directive)

15 years

Autopsy reports, specimens, archive material and other where the deceased has been the subject of Procurator Fiscals autopsy

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. It is good practise to lodge copies of the autopsy report in the deceased patients health record but the consent of the procurator fiscal should be obtained.

Blood bank register, blood component audit trail and fates

30 years to allow full traceability of all blood products used.

The data may be held in electronic form if robust archiving arrangements are in place. For hospital laboratories the records 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)

Blood for grouping, antibody screening and saving and/or cross-matching

1 week at 4° C

Forensic material - criminal cases

Permanently- not part of the health record.

In cases where criminal proceeding can be anticapted, all recording made at the autopsy, be the hand written 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). They must be available to all involved throughout the lifetime of the case, including appeals and other re-investigations.

Refrigeration and freezer charts

15 years

Request forms for grouping, antibody screening and cross-matching

1 month

Results of grouping, antibody screening and other blood transfusion-related tests

30 years to allow full traceability of all blood products used, in compliance with the Blood Safety and Quality Regulations 2005.

Separated serum/plasma, stored for transfusion purposes

No minimum storage time is recommended for recipient patient samples. Storage of donated serum/ plasma should optimally be at -30 degrees Centigrade or colder. These materials may be stored for up to 6 months, but guidelines for the timeline of sample collection prior to blood transfusion must be followed. Archived blood donor samples should be stored by blood services for at least 3 years, and preferable longer if it is practicalable, in order to facilitate 'look back' exercises.

Storage of material following analyses of nucleic acids

Developing technologies mean that there are now a variety of hard copy and / or electronic outputs associated with the analysis and interpretation of diagnostic tests using nucleic acid. It is recommended that all such outputs should be stored for at least 30 years unless the information is transcribed into permanently accessible report formats authorised by senior clinical laboratory staff or pathologists. The later reports should be kept for at least 30 years, as for other pathology reports may be regarded as reporting documents. For such working documents storage for at least the instrument , with a minimum of 10 years is recommended.

Worksheets

30 years to allow full traceability of all blood products used

End of Pathology Records

Patient Held Records

Patient held records

At the end of an episode of care the NHS organisation responsible for delivering that care and compiling the record of the care must make appropriate arrangements to retrieve patient-held records. The records should then be retained for the period appropriate to the patient/ specialty (see Above).

Pharmacy Records: Prescriptions

TYPE OF HEALTH RECORD

MINIMUM RETENTION PERIOD

NOTE

Chemotherapy

2 years after last treatment

Clinical drug trials (non-sponsored)

2 years after completion of trial

GP10, TTO's, outpatient, private

2 years

N.B. Inpatient prescriptions held as part of health record.

Immunoglobulin's/ blood products

30 years

To allow full traceability of all blood products used

Parenteral nutrition

2 years

Original valid prescription to be held with the health record.

Unlicensed medicines dispensing record

5 years

Pharmacy Records: Clinical trials

TYPE OF HEALTH RECORD

MINIMUM RETENTION PERIOD

NOTE

Destruction records

2 years after end of trail

Dispensing records

2 years

Production batch records

5 years after end of trial

Protocols

2 years

Pharmacy Records: Worksheets

TYPE OF HEALTH RECORD

MINIMUM RETENTION PERIOD

NOTE

Chemotherapy, aseptics worksheets,

5 years

Extemporaneous dispensing records

5 years

Parenteral nutrition, production batch records

5 years

Production batch records

5 years

Raw material request and control forms

5 years

Resuscitation box worksheet

1 year after the expiry of the longest data item Applies only to re-packaged items.

Paediatric worksheets

As per Children and Young People (see Above)

Pharmacy Records: Quality Assurance

TYPE OF HEALTH RECORD

MINIMUM RETENTION PERIOD

NOTE

Analysis certificates

5 years or 1 year after expiry date of batch (whichever is longer)

Environmental monitoring results

1 year after expiry date of products

As electronic record in perpetuity

Equipment validation

Lifetime of the equipment

Operators validation

Duration of employment

QC Documentation,

5 years or 1 year after expiry date of batch (whichever is longer)

Refrigerator temperature

1 year

Refrigerator records to be retained for the life of any product stored therein particularly vaccines

Standard operating procedures

15 years after superseded by revised version

As electronic record in perpetuity

Pharmacy Records: Orders

Adhoc forms (dispensing requests forms to store)

3 months

Invoices

6 years

Order and delivery notes, requisition sheets, old order books

Current financial year plus one

Picking tickets/ delivery notes

3 months

Ward Pharmacy requests

1 year

Pharmacy Records: Controlled Drugs, Others

TYPE OF HEALTH RECORD

MINIMUM RETENTION PERIOD

NOTE

Aspectic controlled drugs worksheets (paediatric)

26 years

Controlled drugs, Clinical trails

5 Years

Controlled drug destruction records (pharmacy based)/ destruction of patients' own CD's

7 years

Controlled drug prescriptions ( TTOs/ OP)

2 years

Controlled drug order books, ward orders and requisitions

2 years from date of last entry

Controlled drug registers (pharmacy and ward based)

2 years from date of last entry, but if contain record of destruction of CD, keep for 7 years

Copy of signature for CD ward order or requisition

Duration of employment

Copy of signature of each authorised signatory should be available in the pharmacy department

Extemporaneous controlled drugs preparation worksheets

13 years

External controlled drug orders and delivery notes

2 years

Pharmacy records: others

Destruction of patients' own drugs

6 months

Dispensing errors

1 year plus current

Doctors/ nurses signatures

Duration of contract plus one year

Medicines information enquiry

8 years (25 years for child obstetrics and gynaecology enquiries)

Minor clinical interventions

2 years

Recall documentation

5 years

Stock check list

1 year plus current

Superseded group directions

10 years

Superseded intravenous drug administration monographs

5 years

(end of Pharmacy)

Other Health Records

TYPE OF HEALTH RECORD

MINIMUM RETENTION PERIOD

NOTE

Photographs (where the photograph refers to a particular patient it should be treated as part of the health record)

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see Above)

Physiotherapy records

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see Above)

Podiatry records

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see Above)

Post mortem records (see Pathology records

Post mortem registers (where they exist in paper format)

30 years

Likely to have archival value- see footnote

Private patient records admitted under section 57 of the National Health Service (Scotland) Act 1978 or section 5 of the National Health Service (Scotland) Act 1947 (now repealed)

It would be appropriate for authorities to retain these according to the standard minimum retention period appropriate to the patient/ specialty (see above)

Psychology Records

30 years

Likely to have research/ historical value see footnote

Records/documents related to any litigation

As advised by the organisation's legal advisor. All records to be reviewed.

Likely to have research/ historical value see footnote

Records of destruction of individual health records (case notes) and other health related records contained in this retention schedule (in manual or computer format)

Permanently

Likely to have research/ historical value see footnote

Research records

1. Other than clinical trials of investigational medicinal products, health records of participants that are the source data for the research

30 years

See Footnote Review patient identifiable records every 5 years to see if they need to be retained or if their identifiably could be reduced.

2. Research records and research databases (not patient specific)

Clinical trials of investigational medicinal products

At least 2 years after the last approval of a marketing application in the EU. These documents should be retained for a longer period, however, if required by the applicable regulatory requirement(s) or by agreement with the sponsor. It is the responsibility of the sponsor/ someone on behalf of the sponsor to inform the investigator/ institution as to when these documents no longer need retained.

Research records other than for clinical trials of investigational medicinal products

As above.

Likely to have research value see footnote

Scanned records relating to patient care

Retain in main records and retain for the period of time according to the standard minimum retention period appropriate to the patient/ specialty (see above)

School health records (see Children and young people)

Retain in Child Health Records

Speech and language therapy records

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see above)

Telemedicine records (see also Video records)

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see above)

Transplantation records

Records not otherwise kept or issued to patient, records that relate to investigations or storage of specimens relevant to organ transplantation should be kept for 3 years

Likely to have research value see footnote

Ultrasound records ( e.g. vascular, obstetric)

Retain according to the standard minimum retention period appropriate to the patient/ specialty (see Above)

Video records/ voice recordings relating to patient care/videoconferencing records (see also Telemedicine records and Out of hours records)

6 years subject to the following exceptions:

Children and Young People- Records must be kept until the patient's 25th birthday, if the patient was 17 at the conclusion of treatment until their 26th birthday, or until 3 years after the patient's death if sooner.

Maternity- 25 years

Mentally disordered persons- Records should be kept for 20 years after the date of last contact between patient/ client/ service user and any healthcare professional or 3 years after the patient's death if sooner.

Cancer patients- Records should be kept until 6 years after the conclusion of treatment, especially if surgery was involved. The Royal College of Radiologists has recommended that such records be kept permanently where chemotherapy and/ or radiotherapy was given.

The teaching and historical value of such recordings should be considered, especially where innovative procedures or unusual conditions are involved. Video/ video-conferencing records should be either permanently archived or permanently destroyed by shredding or incineration (having due regard to the need to maintain patient confidentiality)

Ward registers, including daily bed returns (where they exist in paper format)

2 years after the year to which they relate

Likely to have archival value- see footnote

Xray films (excluding PACS images)

The minimum retention period for these can continue to be determined locally by the NHS organisation responsible. In setting the minimum retention period, appropriate recognition should be given to current professional guidance, clinical need, special interest groups, cost of storage and the availability of storage space.

Xray - PACS images

National:

PACS images captured as part of the national PACS programme are stored in a central national archive in accordance with the National PACS for Scotland Image Retention/ Storage Policy, which is subject to annual review by the PACS Clinical Advisory Group.

Local:

Locally set minimum retention periods can continue to apply to PACS images that are not captured as part of the national PACS programme.

As eHealth strategic developments progress, this guidance, along with that for other record types affected, will be reviewed.

Xray registers (where they exist in paper format)

30 years

Likely to have archival value- see footnote

Xray reports (including reports for all imaging modalities)

To be considered as part of the patient record. Retain according to the standard minimum retention period appropriate to the patient/ specialty (see above)

Foot Note - record is likely to have permanent research and historical value, consult NHS archivist or National Archives of Scotland.

Principles to be used in Determining Policy Regarding the Retention and Storage of Essential Maternity Records

Reproduced below is the joint position on the retention of maternity records as agreed by the British Paediatric Association, the Royal College of Midwives, the Royal College of Obstetricians and Gynaecologists and the then

United Kingdom Central Council for Nursery, Midwifery and Health Visiting. This is specified in the Department of Health publication: 'Records Management: NHS Code of Practice' (270422/2/Records Management: NHS Code of Practice Part 2).

Joint Position on the Retention of Maternity Records

All essential maternity records should be retained. 'Essential' maternity records mean those records relating to the care of a mother and baby during pregnancy, labour and the puerperium.

Records that should be retained are those that will, or may, be necessary for further professional use. 'Professional use' means necessary to the care to be given to the woman during her reproductive life, and/or her baby, or necessary for any investigation that may ensue under the Congenital Disabilities (Civil Liabilities) Act 1976, or any other litigation related to the care of the woman and/or her baby.

Local level decision making with administrators on behalf of the health authority must include proper professional representation when agreeing policy about essential maternity records. 'Proper professional' in this context should mean a senior medical practitioner(s) concerned in the direct clinical provision of maternity and neonatal services and a senior practising midwife.

Local policy should clearly specify particular records to be retained AND include detail regarding transfer of records, and needs for the final collation of the records for storage. For example, the necessity for inclusion of community midwifery records.

The policy should also determine details of the mechanisms for the return, collation and storage of those records, which are held by mothers themselves, during pregnancy and the puerperium.

List of Maternity Records to be retained

Maternity Records retained should include the following:

  • documents recording booking data and pre-pregnancy records where appropriate;
  • documentation recording subsequent antenatal visits and examinations;
  • antenatal inpatient records;
  • clinical test results including ultrasonic scans, alphafeto protein and chorionic villus sampling;
  • blood test reports;
  • all intrapartum records to include initial assessment, partograph and associated records including cardiotocographs;
  • drug prescription and administration records;
  • postnatal records including documents relating to the care of mother and baby, in both the hospital and community settings.
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