PROCEDURE FOR THE RETENTION AND DESTRUCTION OF PERSONAL HEALTH RECORDS

Transcription

1 PROCEDURE FOR THE RETENTION AND DESTRUCTION OF PERSONAL HEALTH RECORDS Document Control Date Version Contents/Changes Author October 31 st Initial draft. November 12 th 2007 December 20 th March 4 th April 11th Reviewed by ISG members informally Agreement to firm up reporting arrangements for document archiving. Retention schedule updated and archiving arrangements clarified Retention schedule updated and archiving arrangements finalised Kathleen Carolan, Service Improvement Manager ISG ISG ISG ISG Page 1 of 33

2 Table of Contents Chapter Item Page 1 Introduction 3 2 Associated Policies and Procedures 3 3 Aims and Objectives 4 4 Scope of this Procedure 4 5 The Definition of a Record 4 6 Accountability And Responsibilities 5 7 Confidentiality of a Record 6 8 Creation of a Record 6 9 Ownership of a Record - Health Records 6 10 Storage and Tracking of Personal Health Records 6 11 Audits of Records Management 7 12 Breaches to Information Security and Lost Records Reviewing, Archiving and Destruction of Closed Records Maintaining a register of patient records which have been archived or permanently destroyed 8 Appendix A Addendum 1 Appendix B NHS Shetland Health Records Retention and Disposal Schedule Principles to be used in Determining Policy Regarding the Retention and Storage of Essential Maternity Records Sources of Further Information Page 2 of 33

3 1. Introduction The purpose of this procedure is to provide a systematic and planned approach to the management, retention and archiving of personal health records produced and owned by Shetland NHS Board (the Board). Guidance on the retention and disposal of personal health records was last issued to NHS organisations in Scotland in New guidance has been produced to address developments, which include: Legislative changes (including the Data Protection Act 1998); The requests and views received from patients and the public; The Scottish Government Health Directorate s ehealth strategy which is to set up a single electronic health record for all patients in Scotland; The problems associated with the storage of paper records in many organisations within NHS Scotland. The new guidance on the retention and disposal of personal health records is set out in the draft Health Department Letter (HDL), The management, retention and disposal of personal health records. The draft HDL is currently subject to external consultation and due for publication at the beginning of NHS Boards have been granted permission by the Information Governance (IG) national team to implement the draft guidance as part of the work required to take forward the information governance standards in relation to health records management. This procedure sets out the local policy on the retention and disposal of personal records across the Board and is based on the guidance set out in the draft HDL and guidance on the disposal of administrative records (relating to the management and administration of healthcare organisations) recently issued in NHS HDL (2006) 28. The retention schedule for the Board can be found in Appendix A. 2. Associated Policies and Procedures This procedure should be followed in conjunction with other relevant and associated policies and procedures, which include: NHS Shetland Information Governance Policy 2 NHS Shetland Information Security Policy NHS Shetland Incident Reporting, Investigation and Management Policy 3 NHS Shetland Health Records Policy 4 NHS Shetland Patient Confidentiality Policy 5 1 The final draft was not available as of April The Board approved this policy in May The Clinical Governance Committee (CGC) approved this policy in February Currently being updated to follow national guidance and template (indicative approval date September 2008) Page 3 of 33

4 This list is not exhaustive. For further guidance consult the local IG website on the intranet: 3. Aims and Objectives The purpose of the procedure is to meet the following aims and objectives: 1. To put in place a clear procedure for the use, storage, management, archiving and disposal of personal health records in line with national guidance, standards and legislation. 2. To maintain compliance with the Data Protection Act 1998, including the management of requests from patients or any other individual. 3. To maintain compliance with the Freedom of Information (Scotland) Act 2002, and records covered by the provisions of that Act and its Code of Practice on Records Management (under section 61 of the Act). 4. To ensure that the Board is compliant with the IG standards for health records management set out in the Clinical Governance and Risk Management Standards, NHS Quality Improvement Scotland (NHS QIS) and the national IG standards monitored by NHS National Services Scotland (NSS), Information Governance Team. 4. Scope of this Procedure This procedure relates to all personal health records that are created, maintained, stored or destroyed by staff working for, or on behalf of the Board. All staff that work for the Board, including those on temporary or honorary contracts, bank/agency staff and students, must follow this procedure 6. Breaches of this procedure may lead to disciplinary action being taken against the individual concerned. Independent Contractors are responsible for the management of their own records and ensuring compliance with relevant legislation and best practice guidelines. Scottish Clinical Information Management in Practice ( SCIMP ) Good Practice Guidelines on implementing the single scanning and document management system procured for Scottish general practices: is available at Separate guidance is also available from the professional bodies representing Optometrists, Dentists and Pharmacists, to support independent contractors where necessary, with compliance with the relevant legislation. 5. The Definition of a Record The following types of record are covered by this procedure and the retention schedule in Appendix A, (regardless of the media on which they are held, 5 The Clinical Governance Committee (CGC) approved this policy in February Staff working in General Practice under 17c contracts should also be aware of the SCIMP guidance as well as the instructions set out in this procedure. For additional advice regarding the implementation of this procedure in salaried Practices, contact the Primary Care Manager, Community Health & Care Partnership. Page 4 of 33

5 including paper, electronic, images and sound, and including all records of NHS patients treated on behalf of the NHS in the private healthcare sector): Patient health records (electronic or paper-based, and concerning all specialties, including GP medical records and other independent contractors who are part of the Community Health and Care Partnership); Records of private patients seen on NHS premises; Accident and Emergency, birth and all other registers; Theatre, minor operations and other related registers; X-ray and imaging reports, output and images; Photographs, slides and other images; Microform (i.e. microfiche/ microfilm); Audio and video tapes, cassettes, CDROMS etc; s; Records held on computer; and Scanned Documents. 6. Accountability And Responsibilities The Board as a public authority and corporate body The Board recognises that it has a specific corporate responsibility to ensure that personal health records are created, maintained and managed in accordance with current legislation, standards and guidance. The Chief Executive Has overall responsibility for patient safety, information governance (including records management) and clinical governance. Is accountable to the Board and the Scottish Government Health Directorate. Director of Service Improvement Is the lead director with Board level responsibility for records management. Operational responsibility for records management sits with the Medical Records Manager. Executive Directors and Senior Managers Responsible for driving forward the development and embedding of information governance (including policy associated with records management) across their areas of responsibility. Responsible for reviewing and recording risk to all corporate-level objectives. The Caldicott Guardian The Director of Public Health is the Caldicott Guardian and is responsible for ensuring that national and local guidelines and protocols on the handling and Page 5 of 33

6 management of confidential personal information are in place and acts as an advisor on such issues. The (ISG) is a strategic level steering group, which takes a lead role in the development of the Board information governance framework, IM&T strategies and records management. The ISG also plays a role in monitoring systems, commissioning, implementation and performance (including risk management). ISG reports directly to the Board through the DSI and other Directors with specific remit in respect of patient confidentiality, data protection and wider IG issues. The group membership includes stakeholders from across the organisation (CHP, joint posts with partner agencies and hospital based services etc). Establishes sub groups as required, to take forward specific projects such as new systems implementation. 7. Confidentiality of a Record All staff and those carrying out functions on behalf of the Board have a duty of confidence to patients and a duty to support professional ethical standards of confidentiality. The duty of confidence continues even after death of the patient or after an employee or contractor has left the NHS. Unauthorised disclosure of information may lead to a complaint against the Board or a disciplinary action against a member of staff for a breach of confidentiality. 8. Creation of a Record All records must be created in accordance with the procedure for the creation, structure and format of a record. 9. Ownership of a Record - Health Records Single Assessment Documentation Whilst contract and overview assessment documentation belongs to the patient, ownership of specialist documentation lies with the service delivering that episode of care. Patient Held Records Security of a record held by a patient during an episode of care is the responsibility of that patient. This responsibility reverts back to the Board after the care is completed and the record returned. Should a record not be returned to the Board or is lost, an incident reporting form should be completed and forwarded to the Medical Records Manager for investigation and advice. 10. Storage and Tracking of Personal Health Records Page 6 of 33

7 Each health care team must follow the Boards filing procedure and all documentation must be store in the appropriate filing system when not in use. The basic filing of documents is the responsibility of the person who last made an entry in the record. Multiple documents belonging to an individual service and which constitutes a record should be filed together. Paper documents should be securely attached to each other. Any complaints or litigation correspondence should be filed separately from the clinical case notes. 11. Audits of Records Management An audit programme is in place to measure compliance with this procedure. There are two types of record keeping audit, which are in place as part of the annual record keeping programme: 1. Organisation of the health record 2. Clinical record keeping review against professional standards (e.g. NMC record keeping standards etc). 12. Breaches to Information Security and Lost Records Any incident or near miss relating to a breach in the security regarding the use, storage, transportation or handling of records must be reported using the Boards Incident Reporting Form (IR1). A serious breach of security (e.g. theft of records, media holding personal health information or fire etc) must be managed in accordance with the Boards policy guidance for investigation a serious incident 7. A lost record (hard copy) is defined as any record that cannot be located within 2 working days of first attempt to access the record, or any record that has been stolen from a known place, for example the boot of a car. Any suspected thefts must be reported to the Police. The Caldicott Guardian must be informed immediately of any loss or misplacement of any document that is used to record patient information, including diaries. When all efforts to locate the record have been exhausted, an incident form must be completed giving clear details of all actions including: When and where record was last seen, with date if known If stolen, from where and Police Incident Number Actions taken to locate file It is the responsibility of the line manager, liasing with and taking advice as necessary from the Medical Records Manager, to investigate such incidents and identify any learning points that must be implemented in order to prevent a recurrence. 7 Page 7 of 33

8 If portable devices with patient information are lost or misplaced, the Head of IM&T and the Caldicott Guardian must be informed immediately. Refer to the data protection procedure, the computer user procedure and the IT security policy for more detail guidance on data protection and storage of personal information 8. This includes devices such as laptop computers, pen drives, smart phones and consumables such as floppy disks, CDs and capture cards. 13. Reviewing, Archiving and Destruction of Closed Records All records will be reviewed annually to determine if they have been used within the minimum record retention period 9. For the central file, this process will be managed by the Medical Records Department. Where it is found that a record has not been used within the minimum retention period, the Medical Records Manger will contact the Consultant responsible for the last episode of care to make a decision regarding archival preservation or destruction of the records. Where this is not possible the Director of Service Improvement, the Medical Director or the Caldicott Guardian will make the decision as to whether the record can be closed and destroyed, or archived. Where necessary, this decision will be taken with advice from NHS Archivists. Other departments, which hold patient records, separately from the main health record (e.g. Maternity, Therapists, Community Nursing etc) are responsible for ensuring that records are appropriately reviewed, retained, archived or destroyed as per the schedule. The Head of Department is responsible for ensuring that processes are put in place to review these records for compliance with the schedule and the Data Protection Act The Medical Records Manager, Director of Service Improvement or Caldicott Guardian can provide additional advice on this subject. Where the decision is to destroy the record, the Medical Records Manager will ensure that all closed records are securely archived until such time as they can be destroyed in accordance with the retention and destruction schedule set out in Appendix A Maintaining a register of patient records which have been archived or permanently destroyed The destruction is an irreversible act. A record must be kept of everything that has been destroyed, when and by whom. The process for logging the destruction of patient identifiable information for records stored in the central file (Medical Records Department) is to include a note on the patient administration system that a record has been destroyed or archived. Other departments that hold patient identifiable information that need to destroy or archive records must set up a process for logging and registering materials to identify the date of destruction. It is suggested that a secure file is created to act See Appendix A for the full retention schedule. Page 8 of 33

9 as a register in departments not using the central medical records department filing system. Paper waste containing patient and identifiable information must be treated as confidential waste and shredded or incinerated. If there is any ambiguity regarding the retention, destruction or archiving of a set of health records, contact the Medical Records Manager for guidance. The retention schedule and supplementary guidance is described in Appendix A. Page 9 of 33

10 Appendix A NHS Shetland Health Records Retention and Disposal Schedule Introduction Scope of Schedule This Appendix sets out the minimum periods for which the various personal health records created within the NHS or by predecessor bodies should be retained, 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. Principles to be used in determining policy regarding the retention and storage of essential maternity records are set also set out in the schedule. The guidance does not include s for administrative records commonly found within NHS organisations. Guidance on corporate (i.e. administrative, non-health) records is given in NHS HDL (2006) 28 The Management, Retention and Disposal of Administrative Records ( At the end of the relevant, one or more of the following listed actions will apply: 1) 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: 2) 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, or they have some administrative value but are more appropriately held as archives. Organisations that do not have an NHS Archivist should consult an NHS Archivist or the National Archives of Scotland for advice. 3) Destroy: where the records are no longer required to be kept due to statutory requirement or administrative or clinical need, and they have no longterm historical or research value. In the case of health records, this should be done in consultation with clinicians in the organisation and 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. Page 10 of 33

11 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. Interpretation of the Schedule This retention schedule details a Minimum Retention Period for each type of health record. Records (whatever the media) may be retained for longer than the minimum period. However, where a period longer than 30 years is required (e.g. to be preserved for historical purposes), an NHS Archivist or the National Archives of Scotland should be consulted. 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 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). The Schedule is organized 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. Page 11 of 33

12 The following standard retention periods apply to the following record types: Record Type Adult All types of records relating to Children and young people (including children s and young person s Mental Health Records) Mentally disordered person (within the meaning of any Mental Health Act) Minimum Retention Period 6 years after date of last entry or 3 years after death if earlier Retain until the patient s 25 th birthday or 26 th 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. 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 Page 12 of 33

13 specialty (see above) in the Minimum Retention Period column. Where it does not apply, the required is listed in the Minimum Retention Period column. Notes: 1 Record is likely to have permanent research and historical value, consult archivist or National Archives of Scotland. Health Records Retention Schedule *** = Work still outstanding TYPE OF HEALTH RECORD A&E records (where these are stored separately from the main patient record) A&E registers (where they exist in paper format) Abortion Certificates set out in Schedule 1 to the Abortion (Scotland) Regulations 1991 MINIMUM RETENTION PERIOD specialty (see above) 8 years after the year to which they relate 3 years beginning with the date of the termination NOTE Likely to have archival value- see Note 1 Admission books (where they exist in paper format) Ambulance records patient identifiable component (including paramedic records made on behalf of the Ambulance Service) Asylum seekers and refugees (NHS personal health record patient held record) Audiology records 8 years after the last entry Likely to have archival value- see Note 1 7 years Special NHS record- patient held, no requirement on the NHS to retain specialty (see above) Page 13 of 33

14 Birth registers (i.e. register of births kept by the hospital) Body release forms 2 years Likely to have archival value- see Note 1 2 years Breast screening X- rays Cervical screening slides Chaplaincy records Child and family guidance Child Protection Register (records relating to) Clinical audit records Clinical psychology Clinical trials of investigational medicinal products health records of participants that are the source data for the trial Page 14 of 33 8 years 10 years 2 years specialty (see above) Retain until the patient s 26 th birthday 5 years 30 years 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. Likely to have archival value- see Note 1 See Note 1

15 Counselling records CreutzfeldtJakob Disease (hospital and GP) Death Cause of, Certificate counterfoils 30 years See Note 1 30 years from date of diagnosis, including deceased patients See Note 1 2 years Death registers i.e. register of deaths kept by the hospital, where they exist in paper format Dental epidemiological surveys Dental, ophthalmic and auditory screening records Diaries health visitors and district nurses 2 years 30 years Adults: 11 years Children: 11 years, or up to 25 th birthday, whichever is the longer 2 years after end of year to which diary relates. Patient relevant information should be transferred to the patient record. Likely to have archival value- see Note 1 It is not good practice to record patient identifiable information in diaries. Dietetic and nutrition Discharge books (where they exist in paper format) District nursing records Donor records (blood and tissue). Family planning records specialty (see above). 8 years after the last entry Likely to have archival value- see Note 1 specialty (see above). 30 years post transplantation See Note 1 10 years after the closure of the case. For children retain until their 25 th birthday. Page 15 of 33

16 Forensic medicine records (including pathology, toxicology, haematology, dentistry, DNA testing, post mortems forming part of the Procurator Fiscals report, and human tissue kept as part of the forensic record) See also Human tissue, Post mortem registers. Genetic records Genito-urinary Medicine (GUM) GP records, including medical records relating to HM Armed Forces Page 16 of 33 For post-mortem records which form part of the Procurator Fiscals 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 the pathology laboratory, and then reviewed. All other records retain for 30 years. 30 years from date of last attendance. Store according to the standard specialty (see Above). 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. See Note 1 See Note 1

17 10 years Health visitor records Homicide/ serious untoward incident records Hospital acquired infection records Records relating to children should be retained until their 25 th birthday. 30 years See Note 1 6 years Treatment Centres Human fertilisation records, including embryology records Human tissue (within the meaning of the Human Tissue (Scotland) Act 2006) (see Forensic medicine above) Page 17 of 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). For post mortem records which form part of the Procurator Fiscals 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. See Note 1 See Note 1

18 Intensive Care Unit charts Joint replacement records Learning difficulties (records of patients with) Macmillan (cancer care) patient records community and acute Maternity (all obstetric and midwifery records, including those of episodes of maternity care that end in stillbirth or where the child later dies). Medical illustrations (see Photographs below) Mentally disordered persons (within the meaning of any Mental Health Act) Microfilm/microfiche records relating to patient care Midwifery records Mortuary registers (where they exist in paper format) Music therapy records Neonatal screening records Notifiable diseases book Page 18 of 33 specialty (see above). 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. Retain for 3 years after the death of the individual. specialty (see Above) 25 years after the birth of the last child specialty (see Above) See Above specialty (see Above) 25 years after the birth of the last child See Note 1 See Addendum Notes May have archival value- see Note 1 10 years See note 1 specialty (see Above) 25 years 6 years

19 Occupational Health Records (staff) Health Records for classified persons under medical surveillance Personal exposure of an identifiable employee monitoring record Personnel health records under occupational surveillance Radiation dose records for classified persons Occupational therapy records 6 years after termination of employment 50 years from the date of the last entry or age 75, whichever is the longer. See Note 1 40 years from exposure date See Note 1 40 years from last entry on the record 50 years from the date of the last entry or age 75, whichever is the longer specialty (see Above) 30 years See Note 1 See Note 1 Oncology (including radiotherapy) Operating theatre registers Orthoptic records Out of hours records (GP cover), including video, DVD and tape voice recordings Outpatient lists (where they exist in paper format) N.B. Records should be retained on a computer database if possible. Also consider the need for permanent preservation for research purposes. 8 years after the year to which they relate specialty (see Above). specialty (see Above). 2 years after the year to which they relate. See Note 1 Likely to have archival value- see Note 1 Page 19 of 33

20 Parent held records Pathology records Documents, electronic and paper records Accreditation documents; records of inspections Batch records results Bound copies of reports/records, if made Day books and other records of specimens received by a laboratory. Equipment/ instruments maintenance logs, records of service inspections Procurement, use, modification and supply records relevant to production of products (diagnostics) or equipment External quality control records Internal quality control records Lab file cards or other working records of test results for named patients Near-patient test data 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 25 th birthday, or 26 th birthday if the young person was 17 at the conclusion of treatment, or 3 years after death. 10 years or until superseded 10 years 30 years 2 calendar years Lifetime of equipment 11 years 2 years 10 years 2 calendar years Result in patient record, log retained for lifetime of instrument Page 20 of 33

21 Pathological archive/museum catalogues Photographic records Records of telephoned reports Records relating to investigation or storage of specimens relevant to organ transplantation, semen or ova Reports, copies Post mortem reports Request forms that are not a unique record Request forms that contain clinical information not readily available in the health record Standard operating procedures (current and old) Specimens and preparations Blocks for electron microscopy Electrophoretic strips and immunofixation plates Foetal serum Frozen tissue for immediate histological assessment (frozen section). Frozen tissues or cells for histochemical or molecular genetic analysis. Grids for electron microscopy 30 years, subject to consent 30 years where images present the primary source of information for the diagnostic process 2 calendar years 30 years if not held with health record 6 months Held in the patient s health record for 8 years after the patient s death 1 week after report received by requestor 30 years 30 years 30 years 5 years unless digital images taken, in which case 2 years and stored as a photographic record 30 years Stained microscope slides- 10 years Residual tissue- kept as fixed specimen once frozen section complete 10 years 10 years Page 21 of 33

22 Human DNA Microbiological cultures Museum specimens (teaching collections) Stained slides Newborn blood spot screening cards Body fluids/ aspirates/swabs Paraffin blocks Records relating to donor or recipient sera Serum following needlestick injury or hazardous exposure Serum from first pregnancy booking visit. Wet tissue (representative aliquot or whole tissue or organ) Whole blood samples, for full blood count Transfusion laboratories Annual reports (where required by EU directive). 4 weeks after final report for diagnostic specimens. 30 years for family studies for genetic disorders (consent required) days after final report of a positive culture issued. 7 days for certain specified cultures- see RCPath document. Permanently. Consent of the relative is required if it is tissue obtained through post mortem Depends on the purpose of the slide- see RCPath document for further details. ( pdf/retention- SEPT05.pdf ). 5 years- parents should be alerted to the possibility of contact from researchers after this period and a record kept of their consent to contact response. 48 hours after the final report issued by lab. 30 years and then appraisal for archival value 11 years post transplant. 2 years 1 year 4 weeks after final report for surgical specimens 24 hours 15 years Page 22 of 33

23 Autopsy reports, specimens, archive material and other where the deceased has been the subject of Procurator Fiscals autopsy. Blood bank register, blood component audit trail and fates. Blood for grouping, antibody screening and saving and/or cross-matching. Forensic material criminal cases. Refrigeration and freezer charts. Request forms for grouping, antibody screening and cross matching. Results of grouping, antibody screening and other blood transfusion-related tests. Separated serum/plasma, stored for transfusion purposes. Storage of material following analyses of nucleic acids. Worksheets These are Procurator Fiscals records- copies may only be lodged on the health record with the PF s permission. 30 years to allow full traceability of all blood products used. 1 week at 4 C Permanently- not part of the health record 11 years 1 month 30 years to allow full traceability of all blood products used Up to 6 months 30 years See RCPath document for further guidance pdf/retention-sept05.pdf 30 years to allow full traceability of all blood products used End of Pathology records Page 23 of 33

24 Patient held records Pharmacy Records Prescriptions Chemotherapy Clinical drug trials (non-sponsored) GP10, TTO s, outpatient, private Parenteral nutrition Unlicensed medicines dispensing record Worksheets Raw material request and control forms Resuscitation box Chemotherapy, aseptics worksheets, parenteral nutrition, production batch records Page 24 of 33 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 patientheld records. The records should then be retained for the period specialty (see Above). 2 years after last treatment 2 years after completion of trial 2 years 2 years 5 years 5 years 1 year after the expiry of the longest data item Applies only to re-packaged items. 5 years N.B. Inpatient prescriptions held as part of health record. Original valid prescription to be held with the health record. NHS organisations should be aware of product liability which 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 (Prescription and Limitation (Scotland) Act 1973 as amended by the Consumer Protection Act 1987 )

25 Paediatric Quality Assurance Environmental monitoring results Equipment validation QC Documentation, certificates of analysis Refrigerator temperature Standard operating procedures Orders Invoices Order and delivery notes, requisition sheets, old order books Picking tickets/ delivery notes Ward Pharmacy requests Controlled Drugs Controlled drug destruction records (pharmacy and ward based) Controlled drug prescriptions (TTOs/OP) Controlled drug order books, ward orders and requisitions Controlled drug registers (pharmacy and ward based) Other Medicines information enquiry (End of Pharmacy) Photographs (where the photograph refers to a particular patient it should be treated as part of the health record). As per Children and Young People (see Above) 1 year after expiry date of products Lifetime of the equipment 5 years or 1 year after expiry of batch (whichever is longer) 1 year 5 years after superseded by revised version 6 years Current financial year plus one 3 months 1 year 2 years 2 years 2 years 2 years 10 years specialty (see Above) Refrigerator records to be retained for the life of any product stored therein Page 25 of 33

26 Physiotherapy records Podiatry records Post mortem records (see Pathology records) Post mortem registers (where they exist in paper format) 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) specialty (see Above) specialty (see Above) 30 years It would be appropriate for authorities to retain these according to the standard specialty (see above) Likely to have archival value- see Note 1 Psychology records 30 years See Note 1 As advised by the organisation s Records/documents legal advisor. All records to be See Note 1 related to any litigation reviewed. Records of destruction of individual health records (case notes) and other health - related records contained in this retention schedule (in manual or computer format). Research records 1. Other than clinical trials of investigational medicinal products, health records of participants that are the source data for the research. Permanently See Note 1 30 years See Note 1 Review patient identifiable records every 5 years to see if they need to be retained or if their identifiability could be reduced. Page 26 of 33

27 2. Research records and research databases (not patient specific) Scanned records relating to patient care School health records (see Children and young people) Speech and language therapy records 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. 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) Retain in Child Health Records specialty (see above) See Note 1 Suicide notes of patients having committed suicide Telemedicine records (see also Video records) 10 years See Note 1 specialty (see above). Transplantation records Page 27 of 33 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. See Note 1

28 Ultrasound records (e.g. vascular, obstetric) Video records/ voice recordings relating to patient care/videoconferencing records (see also Telemedicine records and Out of hours records) Ward registers, including daily bed returns (where they exist in paper format) X-ray films (excluding PACS images) specialty (see Above) 8 years subject to the following exceptions: Children and Young People- Records must be kept until the patient s 25 th birthday, of the patient was 17 at the conclusion of treatment until their 26 th 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 8 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. 2 years after the year to which they relate The 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. 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) Likely to have archival value- see Note 1 Page 28 of 33

29 X-ray PACS images X-ray registers (where they exist in paper format). X-ray reports (including reports for all imaging modalities) 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. 30 years To be considered as part of the patient record. specialty (see above) As ehealth strategic developments progress, this guidance, along with that for other record types affected, will be reviewed. Likely to have archival value- see Note 1 Page 29 of 33

30 Addendum 1 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, Royal College of Midwives, Royal College of Obstetricians and Gynaecologists and the United Kingdom Central Council for Nursery, Midwifery and Health Visiting and 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, which 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. Policy should also determine details of the mechanisms for return and collation for 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, alpha-feto protein and chorionic villus sampling; Blood test reports; Page 30 of 33

31 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. Page 31 of 33

32 Appendix B Sources of Further Information Contacts Patricia Ruddy ehealth Scottish Executive Health Department St Andrews House Regent Road EDINBURGH Tel: There are at present four NHS archivists providing archive services to NHS Boards in Scotland. They can provide advice on the selection and preservation of healthcare records and the management of current records. Mike Barfoot Lothian Health Services Archive Edinburgh University Library EH8 9LJ Tel: lhsa@ed.ac.uk Alistair Tough Greater Glasgow and Clyde NHS Board Archive University of Glasgow Archives Dumbarton Road GLASGOW G11 6PW Tel: Fax: A.tough@Archives.gla.ac.uk Fiona Watson Northern Health Services Archives Victoria Pavilion Woolmanhill Hospital Aberdeen AB25 1LD Tel: f.watson@nhs.net Morag Williams Dumfries and Galloway NHS Board Crichton Royal Hospital DUMFRIES DG1 4TG Tel: National Archives of Scotland (NAS) HM General Register House 2 Princes Street Page 32 of 33

33 EDINBURGH EH1 3YY Tel: Archival advice about moving images can be obtained from: Scottish Screen Archive 1 Bowmont Gardens GLASGOW G12 9LR Tel Sources of Further Information Information Commissioner Scotland Office (Data Protection Act 1998) 28 Thistle Street Edinburgh EH2 1EN Tel/ Fax: Scotland@ico.gsi.gov.uk Website: NHS National Services Scotland Information Governance Programme Information Governance Team NHS National Services Scotland Information Services Division Area 074A Gyle Square 1 South Gyle Crescent EDINBURGH EH12 9EB Tel: infogov@isd.csa.scot.nhs.uk Website: Scottish Information Commissioner (Freedom of Information (Scotland) Act 2002) Kinburn Castle Doubledykes Road St Andrews Fife KY16 9DS Tel: Fax: enquiries@itspublicknowledge.info Website: Page 33 of 33