Incident Management Policy and Guidance

Incident Management Policy and Guidance Version: Final v. 1.1 Ratified by: Governing Body Date ratified: 5 November 2014 Name & Title of originator/author(s): Name of responsible committee/individual: Richard Gibson Head of Governance Dianne Addison Governance Support Manager Governance Body Date issued: August 2014 Review date: August 2016 Target audience: All CCG Employees Leeds West CCG Incident Management Policy Version 1 August 2014 Page 1 of 27

Executive summary Leeds West CCG encourages and supports a positive and pro-active incident reporting culture that enables risks to be identified and lessons arising from incidents to be shared in order to promote continuous improvements in quality and safety. This policy requires that incidents are: reported using a standardised form; graded with a degree of harm score; investigated using a systems approach (e.g. the principles of root cause analysis (RCA)) as defined by the previous National Patient Safety Agency (NPSA), now transferred to the NHS Commissioning Board Patient Safety and an action plan put in place where change is required to reduce the risk of recurrence; and assessed for the need to be reported to external agencies (including statutory agencies) in the timescales imposed by those agencies. Leeds West CCG will: have systems for monitoring and reporting incidents to Governing Board; participate in the NPSA National Reporting and Learning System (NRLS); ensure that all individuals working for or on behalf of the Leeds West CCG are empowered to report incidents without fear of repercussions or disciplinary actions. Leeds West CCG Incident Management Policy Version 1 August 2014 Page 2 of 27

Contents The Policy Page 1 Introduction 4 2 Purpose 4 3 Scope 4 4 Definitions 4 4.1 Incident 4 4.2 Serious Incident 4 4.3 Near Miss 5 Duties and responsibilities 5 The Guidance 6 Incident reporting process 7 6.1 Being Open 7 6.2 Whistle-Blowing 7 6.3 Specialist review of incidents 8 6.4 Controlled Drugs 8 6.5 Incidents relating to commissioned services 8 6.6 Incident reporting and primary care providers 9 6.7 Learning 9 6.8 External reporting 9 6.9 Support for staff involved in traumatic/stressful incidents 11 6.10 Record keeping 11 6.11 Audit and reporting 11 7 Equality Impact Assessment 12 8 Implications and associated risks 12 9 Education and training requirements 12 10 Monitoring compliance and effectiveness 13 11 Associated documentation 13 12 References 15 Appendices Appendix A: Datix Web Incident Reporting Procedure Appendix B: The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR) Appendix C: Medicines and Healthcare products Regulatory Agency (MHRA) Appendix D: Information Governance Incidents Appendix E: Tools for Incident investigation and analysis Appendix F: NPSA Section A Decision Tree Leeds West CCG Incident Management Policy Version 1 August 2014 Page 3 of 27

The Policy 1 Introduction The aim of this policy is to outline the process stipulated by Leeds West CCG for reporting, managing, and learning from adverse incidents and ensuring that the organisation meets its legal responsibilities in respect of reporting to external agencies. 2 Purpose Incident management is an integral part of robust risk management and is included in both the NHS Litigation Authority s (NHSLA) Risk Management Standards and the Care Quality Commission s requirements. It enables organisations to learn from incidents and control risks and is essential to the maintenance of patient and staff safety. To translate into practice the aims of the risk management strategy, in relation to incident management. To introduce and ensure consistency in definitions, roles and responsibilities. To ensure that patient safety and other reportable incidents are appropriately managed within commissioned services. 3 Scope This policy applies to all adverse incidents including near miss incidents. It is applicable to all staff and contractors working within NHS Leeds West CCG 4 Definitions 4.1 Incident - An unintended or unexpected occurrence or event that could have led to or did lead to harm or damage (NPSA). 4.2 Serious Incident (SI) - Any incident or potential incident where the consequence is or could be assessed to be major or catastrophic in accordance with Leeds West CCG consequence grading. 4.3 Near Miss - Any event which had the potential to cause injury and/or damage and/or loss, but which was avoided by circumstances (Health & Safety Executive). The management of serious incidents should also be in accordance with the NHS Leeds West CCG Serious Incident Policy Leeds West CCG Incident Management Policy Version 1 August 2014 Page 4 of 27

5 Duties and responsibilities Chief Officer or designated CE in absence Executive Directors / Senior Managers Managers: Line Manager The Chief Officer has overall responsibility for safety. It is the Executive Directors and senior managers responsibility to ensure implementation of the Incident Management Policy and ensure that incident reporting procedures are in place in each directorate. The line manager is responsible for: being the first point of contact for staff that have witnessed or been involved in an incident; assessing the situation to determine that the appropriate actions have been taken to ensure ongoing safety for staff and patients; if required, referring to the Incident Decision Tree (See appendix E) to establish if HR advice/consultation is required at this stage (Refer to HR Grievance Policy ). ensuring that relevant patients, carers, staff and others are kept informed. reviewing all incident submitted by their staff. They are responsible for ensuring follow-up of all incidents and documenting this in the investigation section. Line managers should develop and implement actions plans where this is necessary to reduce overall risk; frequently reinforcing the value of, and need for, incident reporting and providing feedback to reporting staff on the outcomes of the reports they have made; and ensuring that their managers and staff are clear about the deputising arrangements in their absence. Head of Governance (Governance Team) The Governance Team is responsible for ensuring that: the organisation has robust systems and processes in place to ensure effective incident management; staff receive appropriate advice in relation to incident management; compliance with the guidance is monitored and developed as necessary; and organisational analysis and learning is enacted Leeds West CCG Incident Management Policy Version 1 August 2014 Page 5 of 27

from incident reporting. Specialist Reviewers Other managers with remits for risk management in specialist fields will provide specialist input into the reporting, investigation, analysis and review of incidents pertinent to their field. Specialists include: Medicines Management; Health & Safety; Infection Control; Information Governance Employees All staffs have a duty to report all incidents in accordance with the Leeds CCGs Incident Management Policy. All employees have a duty to their patients, employer and fellow colleagues to co-operate fully with an investigation to ensure the most appropriate outcome. Leeds West CCG Incident Management Policy Version 1 August 2014 Page 6 of 27

The Guidance 6 Incident reporting process All incidents must be reported on the online Datix incident reporting system. An investigation must be completed and documented for all incidents. Refer to appendix A that details the incident reporting process. 6.1 Being Open In respect of the Being Open (NPSA) principles below, where a member of staff or public is harmed as a result of a mistake or error in their care, the Leeds West CCG believe that they, their family or those who care for them, should receive an apology, be kept fully informed as to what has happened, have their questions answered and know what is being done in response. This policy endorses the Leeds West CCG commitment to our patients and staff to follow these principles: apologise for the incident/experience explain, openly and honestly, what has happened; describe what will be done in response to the event to ensure the risk of recurrence is minimized; offer support and counseling services that might be able to help; provide the name of a person to speak to; and give timescale and updates on the results of any investigation 6.2 Whistle-Blowing All Leeds CCG employees can report incidents without fear of prejudice for doing so provided it is done in good faith. Incident reports should be focused on what went wrong and the consequences of the incident. Incident report forms should not be used to directly complain about service provision or performance of individual members of staff. The Whistle-Blowing policy should be followed to manage concerns regarding service provision. Incident investigations may give rise to concerns regarding staff performance and HR advice should be sought to ensure the appropriate policies are followed in this regard. Refer to incident decision tree (Appendix E). Leeds West CCG Incident Management Policy Version 1 August 2014 Page 7 of 27

6.3 Specialist Review of Incidents To ensure an appropriate response to particular incidents a number of specialist reviewers have been identified who will receive notification of incidents in their sphere of responsibility. Specialist reviewers are required to review all incidents passed to them and advise on appropriate action where it is necessary within prescribed timescales. 6.4 Controlled Drugs Any serious incident relating to controlled drugs (as defined by the Misuse of Drugs Regulations 2012) should be reported to the Leeds West CCG Medical Director as a matter of urgency. All other incidents relating to controlled drugs should be reported in the normal way clearly indicating that the medicine concerned was a controlled drug. Member practices must report any incident relating to the use of controlled drugs to NHS England on line at www.cdreporting.co.uk This is in addition to their internal procedures and/or the local datix system on http://nww.incidentreportform.nhsleeds.nhs.uk/index.php. CCG staff should encourage member practices to meet their legal and contractual obligations in this regard. CCG staff who identify an incident relating to controlled drugs (or other drugs with a propensity for abuse) must report it using DATIX and inform the CCG Medicines Optimisation Lead or Medical Prescribing Lead. It is the responsibility of the CCG Medicines Optimisation Lead to ensure that where there are concerns about the use of controlled drugs in any setting that these concerns are shared with NHS England (West Yorkshire) Controlled Drugs Accountable Officer and the West Yorkshire Local Intelligence Network for Controlled Drugs either using www.cdreporting.co.uk or e-mailing england.westyorkshire-cd@nhs.net in accordance with the information sharing agreement principles. All incidents relating to controlled drugs will be followed up by a medicines management support/team. 6.5 Incidents Relating to Commissioned Services Where there is a contract agreement between the CCG and any service provider, the provider will be responsible for responding to and reporting incidents occurring in respect of any services provided under the agreement. Commissioners must be satisfied that the service provider operates within a sound incident management policy. Leeds West CCG Incident Management Policy Version 1 August 2014 Page 8 of 27

6.6 Incident Reporting and Primary Care Providers The incident reporting system is available to all General Practices in the city to use to record, manage and analyse incidents that occur within practice. The system provides practices with a systematic tool to evaluate accurate information about the quality and safety of the care, treatment and support the practice provides and its outcomes for patients. Benefits of using Datix: Provides practices with a systematic tool to evaluate accurate information about the quality and safety of the care, treatment and support the practice provides and its outcomes for patients. Facilitates sharing of incident data and lessons learned across the health economy and nationally to improve quality & safety for patients Regular and accurate use of the Datix incident reporting system can provide practices with evidence of compliance with CQC registration (Outcome 4, 16, 18 & 20). Use of Practice Data: The data is primarily for the use of the practice to actively manage and analyse its own systems and processes. The CCG is not responsible for monitoring practice incident reporting systems. This responsibility now lies with the commissioner for primary care (NHS England) and the regulator (CQC). These two organisations do not have access to the Datix system and will be required to ask providers for access to their incident reporting data. The CCG Governance Team is alerted to any incident entered on the system graded as serious in accordance with the National Framework for Managing Serious Incidents. The CCG Medicines Management Team reviews all incidents relating to medicines as part of their support for practice prescribing systems. The CCG will collate themes and trends identified from the reporting data and share this across the city for learning and development purposes. This data is anonymous of patient, practice and staff information. 6.7 Learning Learning from experience is critical to the delivery of safe and effective services in NHS Leeds West CCG. Each incident and ensuing findings from the investigation are a learning opportunity. These lessons will be shared across the organisation using the following methods: Leeds West CCG Incident Management Policy Version 1 August 2014 Page 9 of 27

Articles will be published in the CSU quarterly Governance & Risk Newsletter Immediate lessons learned shared at the Team Brief where appropriate Learning to be shared in the GP locality development sessions Articles will be published in the Pharmfax newsletter Articles will be published in the Leeds West CCG Bulletin Leeds West CCG will take the opportunity to share lessons learnt across the health economy through professional and care pathway networks and consortiums, cooperation with partner organisations where appropriate. 6.8 External Reporting In addition to internal reporting certain categories of incident require reporting to external agencies. The following table describes the incident types and the receiving agency. Incident Type Reportable to Responsibility Patient Safety Incidents National Patient Safety Agency Governance Team RIDDOR Injuries to staff sustained in the course of work e.g. Any accident (including acts of violence) which result in being away from work for more than seven consecutive days as the result of their injury. This seven day period does not include the day of the accident, but does include weekends and rest days. The report must be made within 15 days of the accident. Major injuries e.g. fracture, amputation, loss of sight, electric shock Diseases contracted in the course of work e.g. occupational dermatitis, asthma, hepatitis, tuberculosis, tetanus etc. http://www.hse.gov.uk/riddor/ Medical Device Incidents http://www.mhra.gov.uk/index.htm Health & Safety Executive Refer to appendix B for further details. Medicines and Healthcare Products Regulatory Agency (MHRA) Refer to appendix C for further details Line Manager with support from Health & Safety Advisor Line Manager Medication suspected adverse drug MHRA Line Manager Leeds West CCG Incident Management Policy Version 1 August 2014 27 Page 10 of

reactions (yellow card scheme) Serious Adverse Blood Reactions & Events (SABRE) Physical Assault on Staff Information Governance Incidents MHRA NHS Security Management Service Health & Social Care Information Centre Refer to Appendix D for further details Line Manager Local Security Management Specialist (LSMS) via CSU NHS Protect Line Manager Incidents requiring reporting to the HSE and MHRA should be reported by the line manager of the staff reporting the incident. Staff should report the incident internally as described in section 6 as well as via the external agencies own mechanism for reporting the incident. A copy of the externally filed report must be linked to the incident report form via the documents section in Datix web. The Governance Team reports all patient safety incidents to the NPSA via a dedicated weblink between the Datix database and the NPSA. This is performed on at least a monthly basis. The Governance Team can advise further with regards external reporting. The Governance Team monitors all reported incidents and will ensure all externally reportable incidents are identified. 6.9 Support for staff involved in traumatic/stressful incidents Line Managers must ensure all staff involved in a traumatic/stressful incident is offered support following the incident. In the first instance a debrief session should be held as soon after the event as possible to allow staff the opportunity to reflect on the situation and explore how it has made them feel. The exact nature of the support mechanisms used will be dependent on the type and severity of the incident and the needs of the individual involved and will always follow the principles of being open. The manager may consider actions to protect the individual s wellbeing at this time. As appropriate, staff will be offered reasonable access to: Immediate Medical treatment if required Occupational Health Services Leeds West CCG Incident Management Policy Version 1 August 2014 27 Page 11 of

Advice from Human Resources Independent and Confidential Counselling Legal advice (at the discretion of the CCG) Time away from work (nature of leave to be agreed on a case by case basis) Time out to consult with their Union and/or professional body Subsequently managers should ensure staff can access ongoing peer support within and/or external to the team. Further debrief sessions may be required for particular incidents/staff. In the event that a member of staff is called as a witness in relation to an incident then the line manager must ensure that the staff member has access to appropriate advice in this regard. The Governance Team must be contacted in the first instance. In the event that a member of staff is required to be interviewed to give witness statements to the Police, they must comply with this request and their line manager will ensure the staff member receives the appropriate advice and support. If the staff member is experiencing continuing difficulties with the event then professional advice must be sought from the Occupational Health Service and Human Resources Department in the first instance. 6.10 Record Keeping Datix is a secure computer system. All records are kept in line with the CCG Leeds Records Management Policy. 6.11 Audit and Reporting The Governance Team is responsible for producing assurance reports to the Board and associated committees that demonstrate that the systems and processes implemented are effective. The incident reporting process will be reviewed annually by the Governance Team to determine the following: Incident forms are completed correctly. Regular data quality checks of the CCG s risk management system (DATIX) to identify coding errors, under-reporting and inappropriate reporting. Action plans are produced and objectives are specific, measurable, achievable, realistic and timely (SMART) and implemented with outcomes monitored. Persons throughout the incident reporting process understand their roles and responsibilities and have the capabilities to contribute effectively to the incident reporting process. Leeds West CCG Incident Management Policy Version 1 August 2014 27 Page 12 of

Relevant timescales, both internal and external, are adhered to. 7 Equality Impact Assessment (EIA) This document has been assessed to ensure consideration has been given to the actual or potential impacts on staff, certain communities or population groups. The CCGs aim to design and implement services, policies and measures that meet the diverse needs of our service, population and workforce, ensuring that none are placed at a disadvantage over others. Whilst there is no requirement for an Equality Impact Assessment for this policy the CCG will monitor any themes and trends to identify, understand and address any incidents linked to a particular building, staff group or people with an Equality Act protected characteristic (age, disability, gender reassignment, marriage or civil partnership, pregnancy and maternity, race, religion or belief, sex, sexual orientation). This document has been assessed, using the EIA toolkit, to ensure consideration has been given to the actual or potential impacts on staff, certain communities or population groups, appropriate action has been taken to mitigate or eliminate the negative impacts and maximise the positive impacts and that the and that the implementation plans are appropriate and proportionate. Based on the screening tool an equality impact assessment is not necessary. 8 Implications and associated risks There are no implications or risks associated with this policy. 9 Education and training requirements All New Starters: An introduction to incident reporting is included in the CCGs induction programme. Local induction processes must include incident reporting processes. Existing Staff: As the incident management policy and processes are developed staff will be kept updated and where necessary undertake appropriate training to meet their needs. 10 Monitoring compliance and effectiveness The incident reporting process is governed through the Leeds West CCG formal committee structure: Leeds West CCG Incident Management Policy Version 1 August 2014 27 Page 13 of

Governing Body Leeds West CCG Governing Body has overall accountability for safety. Leeds West CCG Governing Body is corporately accountable for the risk management strategy, systems and processes including incident reporting. Assurance Committee This committee is accountable for ensuring that the Board is assured of the effectiveness of the systems and processes for ensuring clinical safety. Approves the policy and procedure for the Quality Surveillance Group (city wide) Health & Safety Committee (city wide) Information Governance Committee (city wide) management of incidents. Receives reports regarding risk areas identified from clinical incident data. Receives reports regarding risk areas identified from non-clinical incident data. Receives reports regarding risk areas identified Information Governance Incidents Leeds West CCG s Information Governance Committee will ensure that this policy and guidance is monitored and evaluated by the Governance Team. 11 Associated documentation This policy is linked to the following Leeds West CCG policies and strategies: Risk Management Strategy 2013 Serious Incident Policy and Guidance Health and Safety Policy Compliments, concerns, comments & complaints policy and procedure Claims management policy and procedure for clinical negligence; liabilities to third parties; and property expenses scheme claims Hearing staff concerns - Whistleblowing Records Management Policy Leeds Multi-agency Safeguarding Adults Partnership Policy Part One Leeds Multi-agency Safeguarding Adults Partnership Policy Part Two Leeds West CCG Incident Management Policy Version 1 August 2014 27 Page 14 of

This policy and procedure takes into account: National Patient Safety Agency Guidance The Health & Safety at Work etc Act 1974 The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 Guidance from the NHS Counter Fraud Security Management Service Management of Health & Safety at Work Regulations 1999 Care Quality Commission Essential Standards of Quality and Safety 2009 NHSLA Risk Management Standards for Acute Trusts, Primary Care Trusts and Independent Sector Providers of NHS Care 2014/15 NHS Commissioning Board Serious Incident Framework 2013 Leeds West CCG Incident Management Policy Version 1 August 2014 27 Page 15 of

12 References NPSA, Seven steps to patient safety for primary care, full reference guide, May 2006: http://www.npsa.nhs.uk/health/resources/7steps NHS Litigation Authority Risk Management Standards, Jan 2011 http://www.nhsla.com Care Quality Commission Essential Standards of Quality and Safety 2009 http://www.cqc.org.uk/ Medicines and Healthcare products Regulatory Agency website (MHRA) http://www.mhra.gov.uk/ Health & Safety Executive, Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) http://www.hse.gov.uk/riddor/ National Patient Safety Agency (2005); Building a Memory: Preventing Harm, Reducing Risks and Protecting Patient Safety. London: National Patient Safety Agency. The Data Protection Act 1998 London: Office of Public Sector Information. Available at: www.opsi.gov.uk Freedom of Information Act 2000 London: Office of Public Sector Information. Available at: www.opsi.gov.uk Health Act 2006 London: Office of Public Sector Information. Available at: www.opsi.gov.uk Controlled Drugs (Supervision of management and use) Regulations 2006 London: Office of Public Sector Information. Available at: www.opsi.gov.uk Leeds West CCG Incident Management Policy Version 1 August 2014 Page 1 of 27

APPENDICES Appendix A: Datix Web Incident Reporting Procedure Accountability Process Line Manager and/or investigator receive a incident notification email Confirmation email sent to sender Automatic email informing specialist reviewers and/or the Governance Team if appropriate Incident occurs Grade Incident Complete IRFWEB1 Form SUBMIT FORM WITHIN 3 DAYS Incident number generated Stage One To be completed within 3 days (Escalate immediately if this is a Serious Incident (SI). Line Manager/ investigator will assess incident Line Manager/ investigator must review all sections of the incident form. Specialist Reviewers to provide guidance/support if appropriate Those involved in the incident investigation can review at any time. Governance Team to performance manage expired incidents Line Manager/Investigator to review the IRFWEB2 Form Line Manager to choose investigator if it is not them. Enter investigation start date Approval status to be changed to Being reviewed Contacts to be authorised Investigation underway. Investigations must be completed within 30 working days. Investigator to complete all relevant sections on the investigation page Investigator to enter an investigation closed date Investigator to change approval status to Awaiting final approval Stage Two An IRFWEB1 becomes an IRFWEB2 at the point of submitting incident form Trends can be identified by running Reports Final Approval The Investigator will review the incident investigation. The Investigator will change the status of the incident to Incident has final approval and click save Stage Three This must be completed for all incidents. The incident is now completed and saved on the DATIX system for reference. Leeds West CCG Incident Management Policy Version 1 August 2014 Page 2 of 27

Appendix B: The Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013(RIDDOR) In addition to completion of an incident form, some staff related incidents also require reporting to the Health & Safety Executive (HSE) under the RIDDOR regulations 1995. It is the responsibility of the line manager to report these incidents to the HSE. A RIDDOR reportable incident is a staff related incident that is either: a death; a major injury; or an over-seven-day injury. Below is a summary of the criteria for reporting. Reportable major injuries include: fracture, other than to fingers, thumbs and toes; amputation; dislocation of the shoulder, hip, knee or spine; loss of sight (temporary or permanent); chemical or hot metal burn to the eye or any penetrating injury to the eye; injury resulting from an electric shock or electrical burn leading to unconsciousness, or requiring resuscitation or admittance to hospital for more than 24 hours; any other injury leading to hypothermia, heat-induced illness or unconsciousness, or requiring resuscitation, or requiring admittance to hospital for more than 24 hours; unconsciousness caused by asphyxia or exposure to a harmful substance or biological agent; acute illness requiring medical treatment, or loss of consciousness arising from absorption of any substance by inhalation, ingestion or through the skin; acute illness requiring medical treatment where there is reason to believe that this resulted from exposure to a biological agent or its toxins or infected material. Over-seven-day injuries You must report accidents connected with work (including acts of physical violence) which result in an employee, or a self-employed person working on your premises being away from work or unable to do their normal duties for more than three days (including non work days). Leeds West CCG Incident Management Policy Version 1 August 2014 Page 3 of 27

Diseases You must report any case in which a doctor notifies you in writing that one of your employees is suffering from a disease specified in RIDDOR which is linked with the corresponding activity. Self-employed people need to make their own arrangements to notify any reportable diseases they suffer. Reportable diseases include: Some skin diseases, such as occupational dermatitis. Occupational asthma or respiratory sensitisation. Infections such as hepatitis, tuberculosis, legionellosis and tetanus. Any other infection reliably attributable to work with biological agents; exposure to blood or body fluids or any potentially infective material. Other conditions, such as occupational cancer and certain musculoskeletal disorders. Infections For the purposes of RIDDOR, an infection is the entry and multiplication of an infectious agent in the body causing a damaging reaction in the tissue. The infection and the damage caused may give clinical signs and symptoms of disease ( clinical or symptomatic ), or may not be evident ( sub-clinical or asymptomatic ). You need to report a case of infection only when you can reliably attribute it to the work that a person does. Infections which could have been acquired equally easily at work or in the community are not reportable. Colonisation, in other words the presence and multiplication of infectious agents in or on the body, without a damaging reaction in the tissue, is not the same as infection and is not reportable as a disease. Dangerous occurrences Dangerous occurrences are certain listed near-miss events. Not every nearmiss event must be reported. Here is a list of those that are reportable: collapse, overturning or failure of load-bearing parts of lifts and lifting equipment; explosion, collapse or bursting of any closed vessel or associated pipe work; failure of any freight container in any of its load-bearing parts; plant or equipment coming into contact with overhead power lines; electrical short circuit or overload causing fire or explosion; Leeds West CCG Incident Management Policy Version 1 August 2014 Page 4 of 27

any unintentional explosion, misfire, failure of demolition to cause the intended collapse, projection of material beyond a site boundary, injury caused by an explosion; accidental release of a biological agent likely to cause severe human illness; failure of industrial radiography or irradiation equipment to de-energise or return to its safe position after the intended exposure period; malfunction of breathing apparatus while in use or during testing immediately before use; failure or endangering of diving equipment, the trapping of a diver, an explosion near a diver, or an uncontrolled ascent; collapse or partial collapse of a scaffold over five metres high, or erected near water where there could be a risk of drowning after a fall; unintended collision of a train with any vehicle; dangerous occurrence at a well (other than a water well); dangerous occurrence at a pipeline; failure of any load-bearing fairground equipment, or derailment or unintended collision of cars or trains; a road tanker carrying a dangerous substance overturns, suffers serious damage, catches fire or the substance is released; a dangerous substance being conveyed by road is involved in a fire or released. The following dangerous occurrences are reportable except in relation to offshore workplaces: unintended collapse of: any building or structure under construction, alteration or demolition where over five tonnes of material falls; a wall or floor in a place of work; any false work; explosion or fire causing suspension of normal work for over 24 hours; sudden, uncontrolled release in a building of: 100 kg or more of flammable liquid; 10 kg of flammable liquid above its boiling point; 10 kg or more of flammable gas; or of 500 kg of these substances if the release is in the open air; accidental release of any substance which may damage health. Examples: Reportable diseases Examples: Dangerous occurrences A nurse contracts TB after nursing a patient with TB. A laboratory worker suffers from typhoid after working with specimens containing typhoid. A nurse suffers asthma and becomes sensitised to glutaraldehyde after working in a gastroenterology unit. A secretary suffers from work-related upper limb disorder. A surgeon suffers dermatitis associated with wearing latex gloves A patient hoist falls, due to overload. Asbestos is released from ducting during maintenance work. A nurse suffers a needlestick injury from a needle and syringe known to contain Hepatitis B positive blood. A laboratory worker spills a container of formaldehyde. A container of a TB culture is broken and releases its contents. Leeds West CCG Incident Management Policy Version 1 August 2014 Page 5 of 27

during surgery. A paramedic becomes Hepatitis B positive after contamination with blood from an infected patient. Keeping records You must keep a secure/confidential record of any reportable injury, disease or dangerous occurrence. This must include the date and method of reporting; the date, time and place of the event; personal details of those involved, and a brief description of the nature of the event or disease. The record must be kept for three years from the date you record the details. You can keep the record in any form you wish, for example by keeping copies of completed report forms in a file or recording the details on a computer. RIDDOR Contact Details All incidents should be reported online via the HSE website. A telephone service still remains, however should only be used for the reporting of fatal and major injuries only - Incident Contact Centre - 0845 300 9923 (opening hours Monday to Friday 8.30 am to 5 pm). The HSE and local authority enforcement offices are not an emergency service and only the most serious of incidents require reporting outside normal working hours. The types of circumstances where the HSE may need to respond out of hours are: following a work-related death, or where there is strong likelihood of death following an incident at or connected with work; following a serious accident at a workplace, to gather details of physical evidence that would be lost if you waited until normal working hours; following a major incident at a workplace where the severity of the incident, or the degree of public concern, requires an immediate public statement from either HSE or Government ministers. If you feel that your incident fits these descriptions, or if you are not sure, then ring the duty officer on 0151 922 9235. For Internet report please go to: www.riddor.gov.uk Or alternatively link via the HSE website: www.hse.gov.uk Leeds West CCG Incident Management Policy Version 1 August 2014 Page 6 of 27

Appendix C Medicines and Healthcare products Regulatory Agency (MHRA) The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. More details can be found on their website: http://www.mhra.gov.uk/index.htm In addition to the completion of an incident form the following incidents are reportable to the MHRA, this can be done via their website; A side effect with a medicines or vaccine (Yellow Card) The Yellow Card Scheme is run by the MHRA and the Commission on Human Medicines (CHM), and is used to collect information from both health professionals and the general public on suspected side effects or ADRs to a medicine. Its continued success depends on the willingness of people to report suspected ADRs. We collect Yellow Card reports from anyone from the UK on both licensed and unlicensed medicines including: prescription medicines vaccines over-the-counter (OTC) medicines herbal remedies swine flu antiviral medicines (Tamiflu or Relenza) swine flu vaccines (Pandemrix, made by GSK or Celvapan, made by Baxter). MHRA also collect reports on ADR s suspected to be cause by unlicensed medicines in cosmetic treatments. Adverse Incidents Involving Medical Devices Extract from MDA Notice MDA/2007/001 Reporting medical device related adverse incidents: Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients, and as assistive technology. This does not include general workshop equipment such as power or machine tools, or general purpose laboratory equipment. An adverse incident is an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons, for example: the design or manufacture problems inadequate maintenance inappropriate local modifications user error, poor user instructions or training unsuitable storage and use conditions. Any adverse incident involving a medical device should be reported, especially if the incident has led to or, were it to occur again, could lead to: Leeds West CCG Incident Management Policy Version 1 August 2014 Page 7 of 27

death or serious injury medical or surgical intervention (including implant revision) or hospitalisation unreliable test results. Other minor safety or quality problems should also be reported as these can help demonstrate trends, such as highlighting inadequate manufacturing or supply systems. Report all adverse incidents to the MHRA as soon as possible. Serious cases should be reported by the fastest means possible. Initial incident reports should contain as much relevant detail (e.g equipment type, make and model) as is immediately available, but reporting should not be delayed for the sake of gathering additional information. Serious Adverse Blood Reactions and Events (SABRE) The UK Blood Safety and Quality Regulations 2005 and the EU Blood Safety Directive require that serious adverse events and serious adverse reactions related to blood and blood components are reported to the MHRA, the UK Competent Authority for blood safety. These incidents are reported via the MHRA website Leeds West CCG Incident Management Policy Version 1 August 2014 Page 8 of 27

Appendix D Information Governance Incidents Information Governance incidents include any incident involving personal data or the actual or potential corruption or loss of equipment that is used to store personal data. This includes: Any incident which involves actual or potential failure to meet the requirements of the Data Protection Act 1998 The unlawful disclosure or misuse of confidential data, recording or sharing of inaccurate data Information security breaches Any breaches the Common Law of Confidentiality. All information governance breaches should be considered as a potential Information Governance Serious Incident and managed in accordance with the Health & Social Care Information Centre s Checklist Guidance for Reporting, Managing and Investigating Information Governance Serious Incidents Requiring Investigation. Where incidents relate to information governance issues they should be reported within the Information Governance (IG) toolkit, in line with the Health and Social Care Information Centre guidance All level 2 information governance incidents are Serious Incidents and must be reported to the IG reporting toolkit and managed in accordance with the NHS England Serious Incident Framework which requires recording the incident on STEIS (the Strategic Executive Information System). These incidents must be managed under the NHS Leeds West CCG Serious Incident Policy. Health and Social Care Information Centre (2013) Checklist Guidance for Reporting, Managing and Investigating Information Governance Serious Incidents Requiring Investigation version 2. Leeds West CCG Incident Management Policy Version 1 August 2014 Page 1 of 27

Appendix E Tools for Incident investigation and analysis All incidents require some level of investigation in order to identify the underlying causes of why the incident has occurred. The level of the investigation will depend upon the degree of harm of the incident. All incidents require a risk scoring by the line manager when completing the incident form. Leeds West CCG is committed to improving safety in a systematic and fair blame manner. Therefore the model for all investigations, no matter what level, will be based on the theory and principles of root cause analysis (RCA) technique. The underpinning theory behind RCA is that systems and processes are reviewed to identify the potential causes of failure. Corrective actions are then taken to prevent reoccurrence. See Appendix E: Incident decision Tree Further information and advice is available from the Governance Team. http://www.nrls.npsa.nhs.uk/, Leeds West CCG Incident Management Policy Version 1 August 2014 Page 1 of 27

Appendix F Incident Decision Tree To refer to the complete document follow the link below: www.ahrq.gov/professionals/quality-patient Leeds West CCG Incident Management Policy Version 1 August 2014 Page 2 of 27

Consultation Process Title of Document Document Type New/ Revised Document If the document is revised what revisions were required and for what reasons e.g. change in medical procedures or change in legislation Lists of persons involved in developing the policy List of persons involved in the consultation process Incident Management Policy Policy Revised Updated to include information of web based reporting and organisational structure changes. Richard Gibson Head of Governance Dianne Addison Governance Support Manager Health & Safety Team WSYBCSU Leeds CCG s Governance Team List any declarations of interest from commercial sponsors (if applicable) Nil Leeds West CCG Incident Management Policy Version 1 August 2014 Page 3 of 27