Clinical Records Management Policy and Procedures Policy and procedures on clinical records management Page: Page 1 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 Recommended by Quality Committee Approved by Board of Directors Approval date 12.01.2015 Version number 4.1 Review date January 2017 Responsible Director Director of Quality Responsible Manager (Sponsor) Clinical Records Manager For use by All Trust employees Policy and procedures on clinical records management Page: Page 2 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 CHANGE RECORD FORM Version Date of Change Date of release Changed by Reason for change X1 1 May 2007 1 May 2007 Y Cutler Document Creation X2 30 May 2007 30 May 2007 Y Cutler Revised Draft to include service delivery feedback. X3 2 July 2008 2 July 2008 Y Cutler Amend contents in line with NHSLA Requirements X4 10 Nov 2008 10 Nov 2008 Y Cutler Amend contents in line with NHSLA Requirements X5 10 June 2009 10 June 2009 Y Cutler Amend ECG procedure 3.6 2.0 25 Aug 2010 25 Aug 2010 Y Cutler 3.0 May 2012 Y Cutler 4.0 Nov 2013 Y Cutler Amended job titles, grammatical errors and contents in line with NHSLA Requirements. NHSLA best practice template reviewed resulting in removal of redundant sections and inclusion of ‘best practice’ format. Amended to incorporate Lancashire’s Electronic Care System and Patient Transport Service Patient Report Form. Amended name changes within the Trust. Updated Section 7 Monitoring Compliance Amended to include 111 Clinical Records, updated acronyms, added the data.protection email address into section 5.3. Added “A PRF must be completed every time a clinician arrives at an incident, even if there is no patient as all information needs to be capture when the forms are scanned. It is vital the incident number is written legibly and is the correct number of digits” Page 19 4.1 Nov 2014 12 Jan 2015 Y Cutler Amended and updated the Responsible Director from Director of IM&T to Director of Quality. Also, removal of Assistant Director of Health Informatics and replaced with Head of Informatics Policy and procedures on clinical records management Page: Page 3 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 Foreword The objectives of this policy are as follows: To ensure that all staff are aware of and understand, the standards that NWAS expects and requires in relation to Clinical Records and to clarify the Trust’s position with regard to this environment To ensure consistent working practices throughout the Trust This policy will form part of the working practice of staff in order to avoid information security threats by promoting awareness and good practice. The Clinical Records Management Policy and Procedures (both documentation and practice) will be reviewed annually and updated where necessary to maintain currency and relevance. Staff wishing to discuss or have any questions about this policy should contact the Trust's Clinical Record Manager. Policy and procedures on clinical records management Page: Page 4 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 CONTENTS 1.0 INTRODUCTION AND SCOPE ..................................................................................... 6 2.0 OBJECTIVES .............................................................................................................. 7 3.0 DUTIES ..................................................................................................................... 7 4.0 PROCESS FOR CREATING RECORDS ......................................................................... 10 5.0 CLINICAL RECORD MANAGEMENT .......................................................................... 11 5.1 Security - Storage ................................................................................................................... 11 5.2 Security – Record Movement ................................................................................................ 11 5.3 Information Retrieval ............................................................................................................. 12 5.4 Retaining and disposing of clinical records ............................................................................ 12 5.5 Training .................................................................................................................................. 13 6.0 AUDIT .................................................................................................................... 13 7.0 MONITORING COMPLIANCE WITH THIS POLICY ............................................................ 14 APPENDIX A LEGAL OBLIGATIONS THAT APPLY TO RECORDS .................................... 15 Public Records Act ........................................................................................................................ 15 Public Records Act – Records Management Standard RMS1 ...................................................... 15 The Data Protection Act 1998 ...................................................................................................... 15 Human Rights Act 1998 ................................................................................................................ 16 The Caldicott Review.................................................................................................................... 16 Access to Health Records Act 1990.............................................................................................. 16 Crime and Disorder Act 1998 ....................................................................................................... 17 Audit Commission Report ............................................................................................................ 17 Information for Health ................................................................................................................. 17 APPENDIX B – CURRENT RETENTION GUIDELINES .............................................................. 17 APPENDIX C – THE PROCEDURE FOR THE MANAGEMENT OF CLINICAL RECORDS ................ 18 APPENDIX D EQUALITY IMPACT ASSESSMENT .................................................................... 25 Policy and procedures on clinical records management Page: Page 5 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 1.0 Introduction and Scope Clinical Records Management is the process by which an organisation manages all the aspects of clinical records whether internally or externally generated and in any format or media type, from their creation to their eventual disposal. North West Ambulance Service NHS Trust (hereafter referred to as “NWAS” or “The Trust”) requires clinical records to: Support patient care and continuity of care; Assist clinical and other audits; Support improvements in clinical effectiveness through research; Protect the interests of the Trust and the rights of patients and employees, by providing evidence of patient care given. Current legislation has a significant effect on record keeping arrangements in public authorities. All records created and maintained by an NHS body are Public Records. NHS bodies must ensure that records management policies and procedures are fully compliant with legislation and Government policy on the management of information and take into consideration guidance on best practice, namely: Public Records Act; Public Records – Records Management Standard RMS1; The Data Protection Act 1998; Human Rights Act 1998; The Caldicott Report,; Records Management: NHS Code of Practice April 2006; Access to Health Records Act 1990; Crime and Disorder Act; Audit Commission Report, NHS Litigation Authority Standards; HSC 1998/168: Information for Health. (see Appendix A) The Data Protection Act 1998, describes the Clinical Record as “consisting of information about the physical or mental health or condition of an identifiable individual made by or on behalf of a health professional in connection with the care of that individual.” The following list is a guide only and is not exhaustive and refers to records in electronic and paper format Patient Report Form (PRF) includes Patient Transport Service PRF and the Electronic Care System (ECS) currently in use in Lancashire Diagnosis of Death (DoD) and associated ECG strip Hospital Thrombolysis Checklist (PHT) or Primary Percutaneous Coronary Intervention (PPCI), Vulnerable Adult and Child Forms Policy and procedures on clinical records management Page: Page 6 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 2.0 Urgent Care Desk (UCD) Clinical Records Emergency Operational Centre (EOC) Clinical Records 111 Service Clinical Records Objectives The main objectives of this policy are to ensure: Accountability – adequate records are maintained to account fully and transparently for all actions and decisions, in particular: To protect legal and other rights of staff or those affected by those actions; To facilitate audit or examination; To provide credible and authoritative evidence. Quality – records are complete and accurate and the information they contain is reliable and relevant. Security – records are secure from unauthorised disclosure or processing and that access and disclosure is properly controlled, and audit trails will track all use and movement. Accessibility – records and the information within them can be efficiently retrieved by those with a legitimate right of access, for as long as the records are held. Retention and Disposal - there are consistent and documented retention and disposal procedures to include provision for permanent preservation. Training – that all staff are made aware of their clinical record responsibilities through training programmes and guidance. Performance Measurement – that the application of clinical records management procedures are regularly monitored against agreed indicators and action taken to improve standards as necessary. 3.0 Duties Chief Executive The Chief Executive has overall responsibility for records management in the Trust, including the quality of those records. He delegates this responsibility to nominated Directors as follows. Trust Board Is ultimately responsible for ensuring that the Trust complies with relevant legislation in clinical records management Policy and procedures on clinical records management Page: Page 7 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 Executive Management Team Are responsible for ensuring that adequate resources are made available to support the management of clinical records and ensure compliance with relevant legislation and national guidance. Executive Directors The Lead Director accountable for clinical records management is the Director of Quality. The Lead Director should work closely with the Freedom of Information Lead and the Data Protection Lead where appropriate (currently these responsibilities are held by the Head of Corporate Communications and the Head of Informatics respectively). It is the Lead Directors’ responsibility to ensure adequate measures are in place to satisfy legal requirements and responsibilities i.e. developing and implementing policies and procedures, ensuring adequate resource commitment etc. The Lead Director will report any issues in the area of clinical records to the Executive Management Team and Trust Board. Caldicott Guardian Has responsibility for: Agreeing and reviewing internal protocols governing the protection and use of patient-identifiable information by Trust staff; Agreeing and reviewing protocols governing the disclosure of patient information across organisational boundaries; Ensuring adherence to Patient Confidentiality policies. The Information Governance Management Group Has responsibility for: Ensuring this policy is approved according to agreed Trust processes Monitoring effectiveness and completion of Trust wide action plans Monitoring all aspects of records management which includes clinical records, according to the Trusts Record Management Policy Annually reviewing the Training Programme with regard to clinical record keeping Reviewing and monitoring the KPIs Ensuring that a PRF is available for all patient contacts. Clinical Records Manager Is responsible for the overall development and maintenance of clinical records management practices throughout the Trust, in particular for drawing up guidance for good clinical records management practice and promoting compliance with this policy in such a way as to ensure the easy, appropriate and timely retrieval of clinical records. Policy and procedures on clinical records management Page: Page 8 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 Health Informatics Function Are responsible for: Ensuring all the systems are in place for the retrieval and reporting of clinical records. Heads of Service/Operational Managers Ensure that all their teams are aware of their obligations regarding the management of clinical records and comply with the stipulated procedures. It is also their responsibility to ensure that: There is an appropriate member of the operational management team who is the designated lead for the management of clinical records within each operational group; The Clinical Records Policy and Procedures are included in local induction programmes; All quality control processes and clinical audits are fully supported; Performance, in relation to clinical records, is managed locally, based on reports and audits; All requests for information are passed through the approved channels and not responded to locally. Health Professions Council (HPC) Requirements Each State Registered Paramedic has to comply with the following standard issued by the HPC surrounding record keeping. Registrant paramedics must Be able to keep accurate, legible records and recognise the need to handle these records and all other clinical information in accordance with applicable legislation, protocols and guidelines Understand the need to use only accepted terminology (which includes abbreviations) in making clinical records. All staff Whether clinical or administrative, who create, receive and use clinical records have records management responsibilities. In particular all staff must ensure that they keep appropriate records of their work in the Trust and manage those records in keeping with this policy and with any guidance subsequently produced. Policy and procedures on clinical records management Page: Page 9 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 4.0 Process for creating records Clinical records are a vital part of the NHS professional standards and best practice should always be followed. Guidance for completion of a Patient Report Form is available on the intranet elearning site and also on the front cover of the PRF. Accurate, legible and clear notes taken at the time of treatment are often the key to successful defence of a clinical negligence case and important in the case of risk management. It is the responsibility of each individual member of staff to ensure that any records created by them are of an appropriate standard. Paper records must be written contemporaneously using a black pen that cannot be erased. They must be completed legibly in accordance with the instructions in the Trust ‘Guidance Notes on Patient Clinical Record Completion’. Erasers, liquid paper, or any other obliterating agents may not be used to cancel errors; a single line should be used to cross out and cancel mistakes or errors, and this should be signed and dated by the person who has made the error. Abbreviations should be kept to a minimum to aid understanding. The clinician completing the clinical record must ensure that the incident date, incident number, call sign and their identity number is included on the record. Records both paper and electronic shall be created and maintained in a manner that ensures that they are clearly identifiable, accessible and retrievable in order to be available when required. Records shall be credible, authoritative, and adequate for the purpose for which they are intended. Records shall be full and accurate to the extent necessary to: Provide evidence that an action was carried out; Prove that policies, procedures and rules have been followed in arriving at a decision; Defend against possible claims or future legal action; Pass information to those responsible for onward care to advise them what action occurred, when it occurred, who was involved and the sequence of events; Facilitate action by colleagues, successors and those responsible for ongoing patient care; Enable a proper scrutiny of the conduct of the Trust by anyone authorised; Respond to a request for information under the Freedom of Information Act; Respond to a request for information under the Data Protection Act. Policy and procedures on clinical records management Page: Page 10 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 Health care professionals have a responsibility to ensure that an accurate record is completed for every patient attended, and this responsibility is instilled in them during initial training and reinforced through ongoing training. 5.0 Clinical Record Management The storage, distribution and disposal of records will conform to the relevant legislation (e.g. Data Protection Act 1998, Human Rights Act 1998), guidance (e.g. Caldicott), Local Policies (e.g. the Trust Confidentiality Policy) and take into account best practice. Detailed procedures for each area are developed and approved and must be followed by all staff involved. Contractors and third parties carrying out NHS functions have the same responsibilities as any permanent member of staff. Their contracts must draw attention to obligations regarding confidentiality, including those specified by the Data Protection Act 1998. 5.1 Security - Storage On completion of a clinical record the document becomes a legal record detailing the clinical care delivered during the Ambulance Service element of the patient journey. It is the responsibility of all staff to ensure that completed clinical records are secure at all times and stored in such a way as to be easily retrievable when required. Storage accommodation for clinical records shall prevent environmental damage to the records and meet health and safety, and fire regulations (Fire Precautions Act 1971, Fire Precautions (workplace) Regulations 1997). Records shall be kept secure from unauthorised access but allow accessibility to the information for appropriate reasons. (Refer to the procedure for the management of clinical records and access to health records and subject access requests) Appropriate physical security measures will be in place to control access to areas where records are stored or used. Designated areas for the storage of clinical records must be away from areas frequently accessed or populated by non-NWAS staff. All members of staff responsible for clinical records storage (i.e. members of the operational management team), shall ensure that the standards regarding storage, as defined in this policy are adhered to and maintained. 5.2 Security – Record Movement The movement and location of records shall be controlled to ensure that a record can be easily retrieved at any time, that any outstanding issues can be dealt with, and that there is an Policy and procedures on clinical records management Page: Page 11 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 auditable trail of record transactions. Controls will include formalised station storage procedures, restricted access to completed records on station, controlled collection of records for scanning etc. Confidential records are a particularly high security risk when they are being transported between sites and both the method of transport and the storage of records during transport should reflect the requirement to maintain security and confidentiality. All movements of paper records should be tracked, preferably electronically. Tracking Information should include reference details of the document i.e. the title of the document, current date, the name of person who has withdrawn the record Contact details of the person/department to which the record has been sent. 5.3 Information Retrieval Under the Data Protection Act 1998, the right of “subject access” allows an individual to gain access to personal data held about them, subject to certain constraints and conditions. NWAS will review any requests for information relating to clinical records against the specific requirements of the Data Protection Act and the Access to Health Records Act 1990 before processing such a request. The Access to Health Records Act 1990 applies to requests for access to records of deceased patients by their personal representatives. Personal data may be shared with other people subject to conforming to the Data Protection Act. Formal requests should be made in writing to the Legal Department by emailing data.protection@nwas.nhs.uk and a fee may be payable. Patient information shall not be passed on to others without the patient’s consent, except as permitted under Schedule 2 and 3 of the Data Protection Act 1998 or, where applicable, under the common law where there is an overriding public interest. Further guidance on disclosing patient information can be gained from NWAS Patient Information Confidentiality Policy. Anonymous clinical records will be released where appropriate, if the request is deemed to be reasonable, but where it does not conform to the specific purposes of the Data Protection Act. 5.4 Retaining and disposing of clinical records The Trust has adopted the retention periods set out in the Records Management: NHS Code of Practice. (Appendix B) Policy and procedures on clinical records management Page: Page 12 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 It is the responsibility of the Trust to satisfy itself that records are destroyed in a way that safeguards against accidental loss or disclosure of content. See the destruction of confidential waste policy available on the Trust intranet. It is vital that confidentiality is safeguarded at every stage in the clinical records process and that the method used to destroy such records is fully effective and secures their complete illegibility. Normally this will involve shredding, pulping, or incineration under secure and controlled conditions. The Trust maintains a third party contract with a document management company, who destroy all paper clinical records once they have been imaged onto another media for long term archive. Destruction follows documented procedures and is logged and certificated. The third party company assure the confidentiality of patient information in accordance with the Data Protection Act and a confidentiality agreement is in place. Any work undertaken by a third party will comply with ISO standards. Where copies of clinical records are not required (i.e. Duplicate copies not required for onward patient care where patient refuses treatment etc. or copy designated for clinical audit is not required), destruction should be carried out by NWAS staff. The appropriate procedures (The procedure for the management of clinical records Appendix C) must be followed to ensure a suitable method of destruction is used. Advice can be sought from the Clinical Records Manager. (Also see Destruction of Confidential Waste Policy) Any records in electronic format must either be placed onto a server or archived to disc and placed in a secure box marked with contents, department, and review date. And either stored in a lockable room with access restrictions to staff or transferred to an appropriate and Trust approved storage company/site. (See Appendix B for Retention period) 5.5 Training Induction training for all new staff and mandatory training for existing staff that may create or come into contact with clinical records covers the Clinical Records Policy and Procedures and the requirement to maintain confidentiality will be emphasised. This will be reinforced with internal communications and e-learning on the Trust intranet. This will include Operational staff, administrative and support staff who work with clinical records. Periodic reviews and audits of practice will confirm adherence to documented requirements and highlight any deficient areas. Re-fresher training will target areas requiring improvement or corrective action. 6.0 Audit A Clinical Performance Indicator (CPI) has been developed to audit the standard of PRF completion across the Trust. A minimum sample of 30 PRFs will be audited each month from every station. This will be managed locally by designated clinicians. With regards to the ECS Policy and procedures on clinical records management Page: Page 13 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 system in Lancashire all records are available for audit using the database but only a sample will be used to ensure consistency. The Healthcare Governance Department will be responsible for the collection of clinical audit data and the production of subsequent CPI reports. In order to provide reassurance of clinical records existing for all patients attended, the Emergency Operation Centre incident data will be reviewed against completed clinical records held. Where a missing record is identified an investigation will be initiated. The appropriate responsible service delivery manager will regularly monitor all the procedures to ensure compliance. 7.0 Monitoring Compliance with this Policy What Duties Legal obligation that apply to records Process for tracking records Process for creating records How Monitored through appraisals and identification of weaknesses are reviewed until compliance is achieved Frequency Annual By whom Line managers including Trust Board level Evidence Appraisal form and training needs identified to Education and Training. As a result of concerns raised following an investigation of a complaint or incident Serious untoward incidents reporting As required Line managers including Trust Board level Documented on Datix Risk Management System Monthly Healthcare Governance STEISS reporting EMT Information security breach reporting Audit trail reporting available on the incident search facility and all electronic systems Clinical record availability report Quarterly Information Governance Team KPI and policy and procedure review By exception Clinical Records Manager Audit Bi-annually Health Informatics Service Delivery Information Governance Management Group Policy and procedures on clinical records management Page: Page 14 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 Process for retrieving records Process for retention, disposal and destruction of records Clinical Performance Indicator completion of clinical records Hit/miss function on incident search facility. Monthly Clinical Record availability report Subject access request log in sheet Quarterly DoH Retention Schedule adopted Annually Clinical audit team Local Clinical Performance Indicator Reports Bi-annually Health Informatics Information Governance Team Clinical Records Manager Hit/miss audit & Subject Access Request KPI Information Governance Management reporting, Organisational Performance Group and IM&T Senior Management Retention schedule amended if changes made APPENDIX A LEGAL OBLIGATIONS THAT APPLY TO RECORDS Public Records Act The Public Records Act relates to all records produced by NHS and Government Organisations. The Act discusses a framework for record storage and archive in an agreed Public Records depository. The Act does not provide procedures to be followed, but merely provides the scope of what should be considered a public record. Public Records Act – Records Management Standard RMS1 The Records Management Standard provides detailed guidance on best practice relating to the storage of public records. The applicability of these guidelines will depend on the records to be stored. The standard covers storage facilities, access security, environmental issues – humidity and damp, and fire protection. The Data Protection Act 1998 The Data Protection Act 1998 defines the rules for processing personal information. It requires any organisation processing personal information about a living individual to respond to requests from that person regarding how the information may be used, who it may be shared with and on what basis. It also gives the individual the right to see that information, subject to certain conditions, and under some circumstances the right to prevent processing. Policy and procedures on clinical records management Page: Page 15 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 Human Rights Act 1998 This Act binds public authorities to respect and protect an individual’s human rights. This includes an individual’s right to privacy and a patient’s right to expect confidentiality of their information at all times. The Caldicott Review In March 1996, guidance on The Protection and Use of Patient Information was published by the Department of Health. This guidance required that when the use of patient information was justified, only the minimum necessary information should be used and it should be anonymous wherever possible. In the light of that requirement the Chief Medical Officer established the Caldicott Committee to review the transfer of all patient-identifiable information from NHS organisations to other NHS or non-NHS bodies for purposes other than direct care, clinical research or where there is a statutory requirement, to ensure that current practice complies with the Departmental guidance. The Caldicott committee’s report, published in December 1997, included 18 recommendations, which related to ensuring best practice in the use of information flows between organisations. Freedom of Information Act 2000 The act creates a general right of access, on request, to information held by public authorities. Requests by individuals for access to their own personal information will fall outside the act, and will continue to be dealt with under the Data Protection Act 1998. Records Management: NHS Code of Practice Records Management: NHS Code of Practice was published in March 2006 by the Department of Health as guide to the required standards of practice in the management of records for those who work within NHS organisations in England. It is based on legal requirements and professional best practice. This guidance document replaces and supersedes HSC 1999/053 For the Record. The new code of practice provides clear and concise records management guidance in an updated format, but does not introduce any new concepts. The retention guidelines have been updated and affect both the length of time organisations are required to retain clinical records and also permanent preservation issues. Access to Health Records Act 1990 The Access to Health Records Act 1990 provides rights of access to the health records of deceased individuals for their personal representatives and others having a claim on the deceased’s estate. In other circumstances, disclosure of health records relating to the deceased should satisfy common law duty of confidence requirements. All other requests for access to information concerning living individuals are provided under the access provisions of the Data Protection Act 1998. Policy and procedures on clinical records management Page: Page 16 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 Crime and Disorder Act 1998 This Act allows disclosures of information to the Police, Local Authorities, Probation Service or Health service where disclosure is necessary or expedient for the purposes of any provision of the Act. Audit Commission Report The 1995 Audit Commission report, ‘Setting the Record Straight – A study of hospital clinical records’, criticised the poor standard of NHS record keeping and strongly recommended that corrective action should be taken. The key issues to be addressed are the: Legacy of low priority given to records management and related facilities; Lack of awareness of the importance of good record keeping; Lack of information sharing between professions and work units; Tendency to treat records as personal rather than corporate assets; Lack of co-ordination between paper and electronic information strategies; Need to maintain confidentiality whilst legitimately freeing information. Information for Health Information for Health, an information strategy for the Modern NHS 1998-2005 (HSC 1998/168) sets out an information strategy for the introduction of Electronic Patient Records (EPR) to eventually replace paper records, which means that the NHS will require effective Records Management policies to cover electronic as well as paper records. APPENDIX B – CURRENT RETENTION GUIDELINES Records Management: NHS Code of Practice Ambulance 10 years (applies to ALL Ambulance records – Clinical Records)NB Where a patient patient is transferred to the care of another identifiable NHS organisation all relevant clinical component information must be transferred to (including the patients’ health record held at paramedic that organisation) records made on behalf of the Ambulance Service) Limitation Act Destroy under confidential conditions N Policy and procedures on clinical records management Page: Page 17 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 APPENDIX C – THE PROCEDURE FOR THE MANAGEMENT OF CLINICAL RECORDS Introduction Purpose The purpose of this Procedure Note is to provide a robust system for the handling of the paper PRF used by NWAS Paramedic Emergency Service. Scope and Definitions The term ‘Clinical Records’ refers to clinical information that has been created and gathered as a result of the work of the NWAS Paramedic Emergency Service including Community First Responders, Patient Transport Service and the ECC. NWAS have a number of Clinical Records in use A paper Patient Report Form (PRF) which is completed for every patient attended and supplementary records for example: Diagnosis of Death (DoD) Child Protection (CP), Vulnerable Adult (VA) and Pre-Hospital Thrombolysis checklist (PHT) or Primary Percutaneous Coronary Intervention (PPCI) will stay as separate forms. An electronic care system (ECS) is in use by PES in the Lancashire Area Urgent Care Desk clinical records are added into C3. A paper Patient Report Form (PRF) is in use by the Patient Transport Service C3 and Pro QA are the electronic records in the Emergency Operational Centres (EOC) 111 Service use electronic and paper clinical records. The above list is not exhaustive and this Procedure Note applies to all employees of the Trust who handle clinical records in any format. Responsibility It is the responsibility of all Trust employees to ensure that they are conversant with and follow the guidance contained within this Procedure Note. Managers should bring the procedure to the attention of all new employees on commencement of their role. 1. NWAS PES Patient Report Form and associated clinical records. A standardised patient report form has been designed by the Medical Directorate. This incorporates the Patient Report Form (PRF), Required Not Conveyed (RNC) Capacity to Consent and Pathways. Diagnosis of Death (DoD), Child Protection (CP), Vulnerable Adult (VA) and Pre-Hospital Thrombolysis checklist (PHT) or Primary Percutaneous Coronary Intervention will stay as separate forms. Policy and procedures on clinical records management Page: Page 18 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 A PRF must be completed every time a clinician arrives at an incident, even if there is no patient as all information needs to be capture when the forms are scanned. It is vital the incident number is written legibly and is the correct number of digits. Completion guidance for the PRF is included on the covers of the PRF booklets and on the intranet as an eLearning package. 2. Storage 2.1 On Vehicle 2.1.1 To comply with Department of Health Code of Practice and Data Protection, opaque courier pouches should be on all vehicles, and completed clinical records need to be stored in these pouches until they can be deposited into the deposit box (see below) 2.1.2 All completed forms remain in the pouch until the crew return to station, when they should be emptied and go into the on-station storage box. Best practice is for the pouch to be emptied on every return to station to reduce the number of forms held at any one time and therefore reduce the risk of confidentiality breaches or forms going missing. 2.1.3 The pouch should be stored in lockable cupboard on the vehicle, where this is not possible it should be stored in the cab. 2.1.4 Vehicles must be locked at all times when unattended, with any completed PRFs stored out of direct vision. 2.2 On Station 2.2.1 The sector manager will assign a member of their management team the responsibility for clinical records, that person must ensure that the standards regarding storage of records, defined in this document, are adhered to and maintained. 2.2.2 Upon each return to station all completed clinical records held must be transferred from the courier pouch to the clinical records deposit box on station. To allow maximum storage the PRF should only be folded once making an A4 size before being deposited. Where it is found that a weeks worth of clinical records will not fit into the box a second box can be obtained from the Clinical Records Manager. Policy and procedures on clinical records management Page: Page 19 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 2.2.3 On completion of a shift it is the responsibility of the ambulance crew, finishing duty, to ensure that all completed clinical records are removed from the vehicle and placed in the deposit box. 2.2.4 The designated area for the storage of all clinical records at station level should fulfill the following criteria: The deposit box must be fixed to a table using the holes in the bottom of the box Service Delivery will make the necessary arrangements in each Area. Station security must be maintained at all times to ensure that the storage of clinical records remains safe and secure Designated areas for the storage of clinical records must be away from areas frequently accessed or populated by non-NWAS staff Clinical records must not be stored on the floor due to risk of flood damage; Clinical record storage areas must not be in basements, attics or other areas which may pose a risk of environmental damage due to humidity, damp etc. Completed originals of clinical records must be deposited as soon as possible in a secure metal storage box which does not allow unauthorised retrieval of documents once deposited Clinical record storage areas must be easily accessible to required staff and not pose any health & safety risk. 3. Process 3.1 All top copies (white) of the PRF will be deposited in the deposit box on station. Keys will be held by the Clinical Records Manager, appropriate operational managers and couriers. For emergency access, this should be a very rare occurrence; NWAS Patient Information Confidentiality Policy must be adhered to (available on intranet) 3.2 The green (middle) copy that contains patient identifiable information that has not been passed on to a healthcare professional providing continued care (i.e. A&E, GP etc.) because it was not appropriate, should be left with the patient for an RNC/Refusal. If it is not appropriate to leave with a patient this copy should be shredded on station by the member of staff that created the record. 3.3 Clinical audit copies (yellow) which are not patient identifiable and therefore do not pose any risk to confidentiality requirements should be filed according to existing clinical audit processes. 3.4 Copies not required for a specific audit must be collected on station and held for 6 weeks before being shredded. Audit copies not required for clinical audit are kept on station in a box file or ring binder for reference and disposed of by shredding after 6 weeks. It is recommended that shredding take place every week for the appropriate batch to reduce the time it should take to shred a batch. Policy and procedures on clinical records management Page: Page 20 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 3.5 DoD & ECG strip, and PHT/PPCI forms are part of NWAS’ record of care and as such should be managed in the same way and available for retrieval if required. All of these forms, where used, should also be deposited in the records deposit box and sent for scanning. 3.6 ECG strips should be stapled to DoD or PHT/PPCI forms and should have the incident number clearly written. Other ECG strips do not need to be kept and should be shredded. 3.7 Child Protection, Vulnerable Adult and PTS PRF these should continue to follow existing procedures and processes. 3.8 All of the supplementary forms should have the incident number clearly written and be stapled behind the corresponding PRF before being deposited. Any audit copies should be filed in the clinical audit files. 4. Document Transportation The courier service should have access to all stations and access to the clinical records deposit boxes. The courier will collect from stations and deliver to a document management company for scanning. The courier should access each station and open the deposit box. Collected forms will be placed in individual mail pouches, the pouch will then be delivered direct to a document management company. The courier should sign the log/occurrence book to evidence they have visited each station. Cumbria Area The local courier will collect the PRFs from stations and deliver to Salkeld Hall. Transport Logistics courier will collect from Salkeld Hall on a fortnightly basis and deliver to the document management company for scanning. Greater Manchester, Cheshire and Merseyside Areas The courier will collect weekly from all stations and deliver to the document management company. Lancashire Area As Lancashire has an ePR system, an electronic PRF needs to be completed for every patient. Each PRF is uploaded and stored electronically. A paper PRF should only be used as a fall back if the receiving unit does not have a web viewer or if a fault has been reported with the electronic system. The forms that need collecting from Lancashire will be collected on a monthly basis. 5. Process for retrieving records In order to comply with the Data Protection Act 1998, Chapter 29, Section 4, Principle 7: “Appropriate technical and organisational measures shall be taken against unauthorised or Policy and procedures on clinical records management Page: Page 21 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 unlawful processing of personal data and against accidental loss or destruction of, or damage to, personal data”, Crews will not generally have access to the forms once deposited. Operational staff are not permitted to remove any clinical records from the box once deposited. Staff should direct any requests for prfs through their management team. The clinical records will be scanned by a document management company and the image will be captured and indexed by incident number and date. The images are downloaded onto a server. An interface through the intranet incident screen allows an incident search to also provide the facility to retrieve the corresponding clinical records image (This will be a PRF, but also DoD/Capacity to Consent etc where applicable). As this is done through the intranet, permissions are configured to restrict access to authorised staff. Individuals accessing patient data will be requested to justify the reason for the request before the information is displayed 5.1 Third Party Requests All requests for copies of patient report forms made by police and other official bodies must be validated against data protection requirements before any information is released. (See Access to Health Records and Subject Access Request Policy and the Patient Information Confidentiality Policy on the intranet) 5.2 Emergency Operation Centre Requests Should information be required by the Emergency Operation Centre for jobs completed in the previous week then the audit copy should be available. Should this not be the case then authorisation will be given by the appropriate Operational Manager to locate the NWAS copy from the clinical records box in order to provide the required information. The appropriate Operational Manager will then be responsible for ensuring that the form is returned to the box as soon as possible. 5.3 Crew Requests Police Should copies of PRFs be requested by crews for reference where the Police are requesting an interview or statement, then the audit copy should be available and should be used. In cases where patient identity is required (where multiple patients have been attended) the Operational Management Team should be contacted and requested to provide access to the deposit box. The Operational Management Team will then be responsible for ensuring that the form is returned to the deposit box as soon as possible. Under no circumstances should patient records be viewed by other NWAS staff or by third parties (i.e.: the Police), unless appropriate authorisation is granted. This should be a written request for information under section 29 of the Data Protection Act. (NWAS Patient Information Confidentiality Policy available on the NWAS intranet) Policy and procedures on clinical records management Page: Page 22 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 Continual Professional Development Audit copies contain no patient identifiable information and do not present a confidentiality risk. Should crews require copies of PRFs for personal development programmes they should obtain a photocopy of an audit copy. Should the audit copy not be of adequate quality for photocopying and where it is not required for clinical audit the appropriate supervisor may authorise the use of the audit copy itself. Under no circumstances should the top or middle copies be given to crews or photocopied. 5.4 Other requests Should access to clinical records be required by an employee from NWAS (who does not have access to the incident search facility) then a written request must be sent to the Clinical Records and Electronic Care System Manager (contact details are at the end of this document) stating the records required and the reason for access. These requests should be evaluated and where appropriate access to specific PRFs will be granted. 6 Process for tracking records 6.1 Missing Records To ensure that NWAS can track the clinical record process the Health Informatics department will issue a regular “Clinical Records Availability Report” This report will show that for every patient where an ambulance has arrived scene there should be a PRF image. Service Delivery, will ensure, where at all possible, that missing prfs are located or an A&E copy retrieved where applicable and where feasible, put back into the forms collection process. Where missing forms are not located after initial searches, the appropriate service delivery managers will be notified of the details of missing forms, including incident number, date, crew, summary of incident. The Advanced Paramedic will then discuss this issue with the crew involved and an incident report will be raised. The managers will monitor incidents of missing prfs involving ambulance crews and escalate any ongoing issues. 7 Retention & destruction 7.1 Top Copies All original documents should be put into the clinical record deposit box which will be collected and delivered by the courier to the document management company for imaging and they will destroy them on their site once approval to do so has been confirmed by the Health Informatics department and the Clinical Records Manager. Policy and procedures on clinical records management Page: Page 23 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 7.2 Audit Copies All audit copies not required for clinical audit will be kept on station for a minimum of 6 weeks and will then be shredded on station. As these copies are not patient identifiable, there is no requirement to document their destruction. 7.3 Surplus Carbon Copies Carbon copies that have not be passed on to the healthcare professional providing continued care (i.e. A&E, GP etc.), as this was not appropriate, will then be shredded on station by an appropriate member of the operational management team and a record kept of the clinical records destroyed. 7.4 Responsibilities for Clinical Records ‘All individuals who work for a NHS organisation are responsible for any records which they create or use in the performance of their duties any record that an individual creates is a public record.’ Records Management: NHS Code of Practice There are therefore INDIVIDUAL, STATUTORY & MANAGERIAL responsibilities for all NHS records, including health records. Creating and maintaining clinical records is vital to patient care if records are inaccurate then future decisions regarding care could be detrimental to the patient. If information recorded is inconsistent, then records are harder to interpret, resulting in delays and possible errors. The information entered onto clinical records may be needed for the immediate treatment of the patient, but also for future research that could lead to improvements in patient care. For NWAS the Patient Report Form and associated forms make up the clinical record used by NWAS to document treatment given and this should be fully completed for every incident where we arrive at scene even if there is no patient. A PRF does not have to be completed when cancelled enroute to a call. The only exception to this is when an RRV arrives on scene together with an ambulance, as only one record is required for each incident/patient. Any information from the RRV clinician should be incorporated into the ambulance PRF. In the event of an RRV only response the RRV clinician must complete a PRF if they have arrived at scene. Please note that it is the responsibility for a Paramedic or EMT2 to countersign any PRFs which have been completed by the EMT1, as they are the responsible clinician. Policy and procedures on clinical records management Page: Page 24 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 APPENDIX D EQUALITY IMPACT ASSESSMENT Name of Policy, Service or Function Clinical Records Policy and Procedure. Equality Impact Assessment carried out by Chris Gresty, Head of Informatics Date of Equality Impact Assessment May 2012 Step 1: Description and Aims of Policy, Service or Function Overall aims The aims of this policy and associated procedures • Establish a framework for Clinical Record Management; • Define responsibilities for Clinical Record Management; • Clarify applicable legal requirements. Who does the policy, service or function affect? All Trust staff, whether clinical or administrative, who create, receive and use clinical records How do you intend to implement the policy or service change (if applicable)? Induction training for all new staff that may create or come into contact with clinical records shall cover the Clinical Records Policy and Procedures. Clinical Records is part of the Mandatory Training Programme This will be reinforced with internal publications. This will include Ambulance staff, administrative and support staff who work with clinical records i.e.: Community First Responders, IM&T, Health Informatics, Claims & Complaints, PTS, Clinical Governance, PALS etc. Periodic reviews and audits of practice will confirm adherence to documented requirements and highlight any deficient areas. Re-fresher training will target areas requiring improvement or corrective action. Policy and procedures on clinical records management Page: Page 25 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 Step 2: Data Gathering Summary of data available and considered Key data assessed and reviewed: The document complies with mandatory legal requirements, best practice for handling of patient information and clinical records management. The document has been written in line with the NHSLA requirements. Exemplar documents have been gathered and utilised from other NHS Trusts in the creation of this document set. Outcomes of data analysis Equality Group Evidence of Impact Gender No impact, affects all genders equally Race/Ethnicity Potential for language barriers. Disability No impact, (not a patient carrying vehicle) Sexual Orientation No impact, affects all sexual orientation groups equally Religion or belief No impact, affects all religions and beliefs equally Age No impact, (not a patient carrying vehicle) General (Human Rights) No impact on areas covered by the Human Rights Act Step 3: Consultation Summary of consultation methods The policy and procedures document has been presented to stakeholders, service delivery teams, clinical governance and the project team for input. Service delivery had input and the document was amended accordingly to reflect this. Policy and procedures on clinical records management Page: Page 26 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 Outcomes of consultation Equality Group Evidence of Impact Gender No impact, affects all genders equally Race/Ethnicity No impact, affects all race/ethnicity equally Disability No impact, (not a patient carrying vehicle) Sexual Orientation No impact, affects all sexual orientation groups equally Religion or belief No impact, affects all religions and beliefs equally Age No impact, (not a patient carrying vehicle) General (Human Rights) No impact on areas covered by the Human Rights Act Steps 4 & 5: Impact Grid Relevant Equality Area Areas of impact identified Is the impact positive or negative? Key issues for action No impact, affects all genders equally Gender Race/Ethnicity Potential for language barriers. Disability No impact, (not a patient carrying vehicle) Sexual Orientation Religion or belief Age General (Human Rights) Negative The policy and procedure is available in all languages on request. No impact, affects all sexual orientation groups equally No impact, as the procedure affects all religions and beliefs equally No impact, (not a patient carrying vehicle) No impact on areas covered by the Human Rights Act Policy and procedures on clinical records management Page: Page 27 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017 Step 6: Action Plan Issue identified and Action equalities group or communities affected Potential for language Translation barriers for staff services to be accessed When Who Expected Outcome As required Clinical Records Manager Resolved issue Progress Summary of decisions and recommendations Access translation service as required and monitor frequency of translation requirements in order to establish if further action is required to take place. Step 7: Monitoring arrangements Periodic reviews and audits of practice will confirm adherence to documented requirements and highlight any deficient areas. Re-fresher training will target areas requiring improvement or corrective action Step 8: Date of next Equality Impact Assessment This equality impact assessment will be reviewed and a subsequent assessment carried out at the first of the following occasions: On review date of the policy and procedure which is detailed as January 2014. Policy and procedures on clinical records management Page: Page 28 of 28 Author: Clinical Records Manager Version: 4.1 Date of Approval: 12.01.2015 Status: Final Date of Issue: 12.01.2015 Date of Review January 2017