SH IG 07 Clinical Record Keeping Policy Amending Inaccuracies in Clinical Records Procedure Version 2 Summary: Procedure attached to Clinical Record Keeping Policy. Keywords (minimum of 5): (To assist policy search engine) Target Audience: Inaccurate; inaccuracies; amendments, removal; paper records, electronic records; OpenRiO All staff who contribute to or manage clinical information both paper and electronic. Next Review Date: March 2018 Approved and ratified by: Information Governance Group Date of meeting: 13 th July 2015 Date issued: Author: Rachel Lloyd, Records Manager Sponsor: Helen Reading, Associate Director of Technology 1
Change Record Date Author Version Page Reason for Change 15/08/2011 L Barrington DV0.1 All Developed from HPFT and HCHC guidance and merged into SHFT document 29/12/2011 L Barrington DV0.2 All Minor amendments following consultation 29/04/2012 L Barrington FINAL 5 Take out embedded doc and include as appendix 17/06/2015 R Lloyd V2 D1 4,5&6 Data Change process updated 14/06/2016 L Barrington V2 Para 1.6 Updated process for information recorded/uploaded into EPRs 22/08/2016 L Barrington V2 Para 1.6 Sections 2 & 3 Update of process to request removal of information from OpenRiO 29.6.17 2 Review date extended from June to September 2017 16.8.17 2 Review date extended to December 2017 4.1.18 2 Review date extended to March 2018 Reviewers/contributors Name Position Version Reviewed & Date MH&LD Records Group members Various service records leads V0.1 15/08/2011 ICS Records Group members Various service records leads V0.1 15/08/2011 Clinical Info Assurance Stg Group Senior Clinical Leads for Records V0.1 15/08/2011 Clinical Info Assurance Stg Group Senior Clinical Leads for Records V0.2 29/11/2011 Lisa Crome System Support Team Manger V2 D1 17/06/2015 IGG Membership consulted V 2 26/06/2015 2
Contents Page 1. Introduction 4 2. Data Subject Requesting Amendments to Clinical Records 4 3. Removing information from the Electronic Patient Record 5 Procedure to request removal of data from OpenRiO 6 4. Action to be taken for other EPR Systems 6 5. Appeals/Review process 7 6. Compensation 7 7. References 7 Appendix 1 Appendix 2 Request for approval from Caldicott Guardian Form 8 Servelec Data Change form (for System Support Team use only) 9 3
Procedure for amending inaccuracies contained in clinical records 1. Introduction 1.1 Under the Data Protection Act 1998 (DPA) individuals (Data Subjects) have the right to view and receive copies of their clinical records. If during this process, the Data Subject considers any information contained within his or her records to be inaccurate, he/she can request the information be corrected. It should be noted, however, that diagnosis and clinical opinion is a matter of clinical judgement and cannot be changed solely at the patient s request. 1.2 The Data Subject may choose to either a) write a letter to the Trust (Clinician, Manager or Complaints Manager); b) instruct a solicitor to act on his/her behalf; or c) take action via the Courts. Whichever route the matter is raised, it should be brought to the immediate attention of the relevant Service Manager who will be responsible for ensuring the following procedure is implemented. He/she will inform the Complaints Manager or Head of Legal and Insurance Services as appropriate. 1.3 Under the DPA, a Data Subject may apply to the Court for an order requiring the data controller (the Trust) to rectify, block, erase or destroy such data relating to them as is inaccurate as well as any other personal data which contain an expression of opinion which the Court finds is based on the inaccurate data. Data is inaccurate if it is incorrect or misleading as to any matter of fact. 1.4 Considering requests of this nature will involve a certain amount of time and effort on the part of the Consultant or Senior Healthcare Professional (HCP) and/or Manager. However, it is important that the Trust can demonstrate to the Data Subject, their legal representative or the Court that it has taken the matter seriously and responded in accordance with the Data Protection Act 1998. 1.5 Further guidance is available from the Information Commissioner s Office website and the Trust s Information Assurance Team. 1.6 Staff may also become aware that information has been included in error in a patient s electronic record. If this is the case they must follow the Standard Operating Procedure associated with that EPR. See sections 3 and 4 for detail. 2. Data subject requesting amendments to clinical records: 2.1 If not already done so, the Data Subject must be asked to put in writing the matters he/she considers to be inaccurate. A request received by email is acceptable. 2.2 The Service Manager must ask the Consultant or Senior HCP to review the clinical records and consider each entry which the Data Subject has identified as inaccurate. 2.3 The Consultant or Senior HCP should provide a written response to the Manager identifying: a) which entries (if any) he/she considers to be inaccurate and noting the correction that needs to be made. In some cases it may be that the Data Subject has suggested alternative wording to appear in the records and this should be considered by the Consultant or Senior HCP; 4
b) which entries he/she considers to be accurate and should stand as originally recorded; c) which entries should be blocked, erased or destroyed. 2.4 The Manager should then make a new entry in the clinical record (to be signed and dated) which states that the Data Subject has raised concerns about the accuracy of the records as set out in the relevant document (e.g. letter from the Data Subject dated dd/mm/yy). This document needs to be filed on the clinical record. Depending upon whether there are corrections, the entry should then confirm that, where applicable, corrections have been made in the relevant parts of the records and that otherwise the records are confirmed as not requiring correction and have been noted as such. 2.5 Where the Consultant or Senior HCP agrees that an entry is inaccurate, the correction should be noted alongside the relevant entry. In paper records, care should be taken not to obliterate the original entry and the correction should be signed and dated by the Consultant or Senior HCP. Correction fluid must not be used. 2.6 In cases where the Consultant or Senior HCP believes that the entry in the records is accurate, the notes should be marked as ''correct'' and should refer to the new entry made in accordance with as above. For example, see entry dated dd/mm/yyyy''. 2.7 Where there is a dispute of accuracy, the most appropriate course of action is often to insert the patient s opinion alongside that of the clinical professional. 2.8 The Manager should then ensure that a copy of the Data Subject s concerns and the Consultant s or Senior HCP s response are inserted into the Data Subject s clinical record. 2.9 Once this has been done, the Manager should make copies of each page/entry of the clinical records which the Manager has noted upon plus copies of the Data Subject s concerns and the Consultant s or Senior HCP s response. These copy documents should be provided to the Data Subject free of charge. 2.10 For paper records, where it has been determined that the records should be blocked or erased, this should be done using a permanent marker pen. For electronic records see section 3 below. 2.11 Where it has been determined that the records should be destroyed, the relevant sheets should be removed from the record and shredded. Extreme care should be exercised before any records are destroyed. The Information Assurance Team must be informed before such action is instigated. 2.12 Where it is reasonably practicable to do so, the Manager must also consider notifying any third parties to whom the data has been disclosed of the rectification, blocking, erasure or destruction. 2.13 If information has been included/filed/written/uploaded/entered in the wrong patient s record, the incident should be reported using Ulysses Safeguard, the Trust s reporting system. The erroneous information/entry needs to be removed from the primary record and inserted into the correct record and an explanatory note entered. 3. Removing information from the electronic patient record 3.1 Refer to the relevant Standard Operating Procedure/guidance. 5
3.2 Procedure to request removal of data from OpenRiO 3.3 There may be exceptional occasions where it is agreed that information recorded in a patient s case record, or a whole clinical record held within OpenRiO, is to be amended or removed. Examples: An entry is made in a patient s record, that does not pertain to that patient, and may put either the patient and/or family members and/or staff at risk A Data Subject (patient) has requested an amendment to their record, and the Senior HCP/Consultant agrees (see above) 3.2 These cases will be exceptional and agreement must be sought within the appropriate Division and from the Trust s Caldicott Guardian 3.3 The must evidence the decision making process regarding the removal of the information. This must highlight the risk to the individual or family or staff if the information is left in the record. If there is insufficient evidence to do this then the entry must be marked entered in error and left in the record. 3.4 Process to gain approval, and removal: Caldicott Guardian Completes Appendix 1 Request for approval to remove clinical information from OpenRiO Sends the completed form and supporting evidence, including risk assessments if required, via NHS Mail to the Caldicott Guardian for approval Responds with approval or rejection If rejected to review the circumstances and follow amendment procedures If approved - raises an IT service desk call with the request detail: please remove data from OpenRiO Sends the approval and supporting documentation, with the IT service desk number to the System Support Team via NHS Mail hp-tr.sst@nhs.net System Support Team Will manage the removal process, and will inform the (c.c. Caldicott Guardian and Records Manager) once the process is complete. 3.5 If the removal of the information is approved, the will be responsible for any charges that may be incurred, and will be asked for a Cost Centre and Code if needed. 4. Action to be taken for other electronic systems Refer to relevant SOP and/or contact the IT service desk. 6
5. Appeals/Review Process 5.1 Should the Data Subject remain dissatisfied with the outcome and the action taken by the Trust, if they have not already done so, they may choose to make a formal complaint. In an effort to resolve the matter, the Trust may consider asking the Lead Consultant for the Service to independently review the request for amendments. 5.2 Finally, the Data Subject may raise their dissatisfaction with the Information Commissioner and ask for an assessment to be undertaken regarding the outstanding matter. Alternatively, the Data Subject may take legal action. If they choose the latter, the Act requires that they first write to the Data Controller stating their reasons for believing the data to be inaccurate or incomplete. 6. Compensation 6.1 A Court has the power to award compensation to the Data Subject if they are satisfied that the Data Subject has suffered damage by reason of any contravention by a data controller of any of the requirements of the Act and that there is a substantial risk of further contravention. 7. References Information Commissioner s Office https://ico.org.uk Standard Operating Procedures http://www.southernhealth.nhs.uk 7
Appendix 1 SH IG 07: REQUEST FOR APPROVAL TO REMOVE CLINICAL INFORMATION FROM OPENRIO All fields are mandatory and must be completed. Additional/supporting information must be supplied as required. Service details: Manager s name / role / contact details: Name of Service/Team: Date: Patient details: Patient s full name: Address: Date of birth: NHS Number: OpenRiO number: Details of request to remove information from OpenRiO Record: Include specific information relating to: progress notes; assessment forms; care plans; uploaded documents, including referrals, reports (internal and external; care plans; discharge summaries. Reason/rationale for request: Include details of risk assessment, and supporting documentation: Send the form and additional information to the Caldicott Guardian via NHS Mail. Caldicott Guardian: Request is rejected (detail): Request is approved (detail): Caldicott Guardian to return form to the Operational Manager via NHS mail 8
Appendix 2 SYSTEM SUPPORT TEAM USE ONLY Data Change Form Please email to healthsupport@servelec-healthcare.com Telephone No: 01246 437450 In the interest of data integrity and security it is Servelec Healthcare s policy not to alter patient data. In the rare situation that this may be required, we request that you complete the following form so that we can audit this process in recognition of the sensitivity of data changes. In the situation where changes are required due to a user inputting data incorrectly, we request that you use the reversal functionality in the software. Where this is not possible there may be a charge for the alteration. We reserve the right to refuse the change eg: in the event of clinical safety. Incident/Unique Number : Customer Name Customer Contact Reason for the change Date Tel. no. Full details of the change requested Is there a reversal process available in the area in which you wish to change data? Yes/No If Yes, please state why is a data change is preferable to reversing the existing data Please indicate the urgency of the change and the business impact of not having this change : Note however that there are no SLAs for change requests and that these are outside of the support contract. Urgency Low Medium High Business impact Low Medium High Customer Signature Servelec Healthcare Internal Notes Servelec Healthcare Internal notes, for completion by Servelec Healthcare Please indicate our assessment on the urgency and impact of performing the change : Urgency Low Medium High Impact Low Medium High Authorised Yes/No Reason for decline Name 9