INCIDENT REPORTING AND INVESTIGATION PROCEDURE

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1 INCIDENT REPORTING AND INVESTIGATION PROCEDURE Post holder responsible for Policy: Directorate / Department responsible for Policy: Governance Manager Governance Contact details: Noy Scott House ext Date written: August 2003 Date revised: October 2005 Approval route (names of committees): Governance Committee Board of Directors Date of final approval: 30 th November 2005 Date due for revision: November 2007 Date policy becomes live: 1 st December 2005 This document replaces: Incident reporting and investigation procedure 2005 Controlled Document This document has been created following the Royal Devon & Exeter NHS Foundation Trust Policy on the creation of policies, procedures, protocols, guidelines and standards. It should not be altered in any way without the express permission of the author or their representative. Page 1 of 21

2 1 INTRODUCTION 1.1 This procedure should be read in conjunction with The Royal Devon & Exeter NHS Foundation Trust s (hereby referred to as the Trust) Incident Reporting and Investigation Policy. The policy defines an incident and near miss and sets into context when this procedure should be used. 1.2 The Trust recognises its responsibility to report, record and investigate all appropriate incidents. Some incidents will not be serious and will therefore not require in-depth investigation. However, there will be incidents where detailed investigation is needed in order to ascertain the root causes of the incident and implement systems in order to reduce the likelihood of recurrence. This procedure details how this process is undertaken. 2 REPORTING INCIDENTS 2.1 All incidents must be documented on the Trust incident report form (a copy is available in the incident reporting books, available in all wards and departments). For those incidents directly related to equipment or defective medicine, an equipment/consumable/defective medicine report must also be completed (see incident reporting book) and the item withdrawn from service where appropriate. Defective medicines should be returned immediately to the Principal Pharmacist. Instructions for completion of the forms are outlined on the incident reporting books and on the forms themselves. Directorate Managers must ensure that the books are always readily accessible. 2.2 When Risk Management receives an incident form, it is graded for actual severity. Grading is broken down into four categories. These are: Red Incidents Orange Incidents Yellow Incidents Green Incidents Serious impact e.g. death, permanent harm Moderate impact e.g. semi-permanent harm Minor impact e.g. non-permanent harm No impact e.g. no harm. It is also important to stress that incidents may not just involve harm to patients, staff, visitors etc. Incidents may also be reported that relate to the potential for complaints, litigation, damage to property etc. In these cases, incidents will also be graded along similar lines as those outlined above. 2.3 It should also be noted that incidents shall be graded as moderate when there is a breach of statutory legislation or the incident is externally reportable. An example of this would be when an incident falls under the Reporting of Injuries, Diseases and Dangerous Occurrences Regulations (RIDDOR) Page 2 of 21

3 2.4 Following grading for actual severity, the incident will also be graded for potential future loss to the organisation. This grading will be along the same lines as those for actual severity but will also include an element of likelihood rating. The Royal Devon & Exeter NHS Foundation Trust Risk Assessment Policy and Procedure offers further information linked to incident grading. 2.5 The level of investigation required for an incident will depend on its actual impact or potential future loss to the organisation. The following table gives a breakdown of the level of investigation required. Where an incident is graded red, an initial investigation will be undertaken to determine whether a root cause analysis in required. Actual or Potential Future Loss Red Orange Yellow Green Level of investigation Full Root cause analysis May necessitate internal/external inquiry More in-depth investigation required Overview of circumstances surrounding incident Nil (but managers should routinely monitor these incidents) Personnel involved Risk Management / Directorate Manager / Clinical Director Risk Management / Ward Manager Ward / Department Manager 2.6 Investigations should be reported with 40 working days of the incident occurring. Details of how to conduct an investigation relating to Red actual incidents are contained within this procedure. This also applies to potential future incidents. 2.7 Directorate Managers are able to access all information relating to incidents reported in their area. This information is routinely supplied to them on a regular basis but ad hoc queries can also be made via Risk Management. The Governance Committee also receives regular information regarding reported patient incidents and the Health & Safety committee receives staff incident data. 2.8 Managers should take any immediate actions necessary following an incident in order to make the area safe and to impound equipment if necessary. Page 3 of 21

4 2 ACTION ON DISCOVERY OF A SERIOUS INCIDENT 2.1 Should a serious incident occur during normal working hours, then the Directorate Manager of the area involved will become the co-ordinating manager. If they are unavailable or the incident is out of hours, the on-call Manager will act as the co-ordinating manager. 2.2 Once more details of the serious incident are known the Directorate / on-call Manager will alert other senior staff as appropriate. He / she will be responsible for notifying the On-call Director. The incident checklist, detailed in Appendix A, should be used as a contemporaneous record of the immediate actions following the discovery of the incident. If the incident is deemed to be serious enough to warrant an internal / external emergency then the Emergency Preparedness policy should be followed. 2.3 In general terms, the most senior member of staff present at the time of the incident occurring is responsible for ensuring the following: The immediate safety/care of the people involved That emergency services have been contacted if necessary That the on-call manager has been alerted, whatever the time of day If necessary, that the area has been made safe. People should not jeopardise their own safety and should only act within their own capabilities That an incident form has been completed. Where equipment is involved, an equipment/consumables form should be completed and the equipment removed from service That, where circumstances permit, statements are taken from witnesses. If this is not possible at the time, names and contact details of all witnesses present must be recorded so statements can be obtained as soon as possible thereafter (see Appendix A, B, and C) That the scene is preserved, or the area/equipment involved is isolated and that there is no unauthorised entry to the area or tampering with the equipment The area/equipment is not re-used until authorisation has been obtained from Estates or MEM. 3 NOTIFICATION OF PATIENT AND NEXT-OF-KIN 3.1 In the event of death or serious injury, the patient and/or next-of-kin must be contacted as soon as possible and as a matter of priority (always before the media become involved). It should be remembered that a person-to-person meeting may be more appropriate in these circumstances. Page 4 of 21

5 3.2 The Police may be asked to assist in contacting the next-of-kin and whoever meets the relatives should provide all possible support and a sympathetic explanation of events. It is necessary, however, to be cautious, bearing in mind any possible legal implications for the Trust. 3.3 For a patient/next of kin: this should be carried out by the Consultant in charge of the patient and will be arranged by the Ward Manager on the ward that the patient was staying. The Directorate / On call manager should be present. 3.4 Member of staff, visitor or contractor: the Directorate / on call manager will be responsible for contacting and informing the next-of-kin in these circumstances. 4 INITIAL INVESTIGATION / MANAGER S ACTION 4.1 Initial investigation will take place when the Directorate / on-call Manager accepts responsibility for the incident and arrives on the scene. He / she will: Ascertain that all actions under Section 2.3 are complete or have been initiated and keep records of all actions taken thus far and those which he / she subsequently takes Where the incident involves a patient, the Consultant in charge of their care must be informed immediately (assistance from medical and/or other clinical staff may be necessary). He / she should be asked to attend the hospital to take any necessary clinical action to minimise the effect of the incident. If he / she is not available at once, another consultant in the same speciality should be advised of the situation and asked to attend immediately Inform the patient and/or any next of kin as a matter of priority and always before the media become involved (see section 3) Notify the Governance Manager or Risk Manager at the first available opportunity and liaise as necessary. The incident may trigger one or more procedures of the following: (a) (b) (c) Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 1995 (RIDDOR) Medical Device Alert procedure (Medicines and Healthcare Products Regulatory Agency) Drug recall procedure (d) External reporting of incidents involving radiation or radio isotopes - advice must be sought from the Trust s Radiation Protection Adviser or in Page 5 of 21

6 his / her absence an emergency radiation physicist (contact numbers available from Switchboard) (e) (f) (g) Reports to other external NHS organisations Disciplinary procedures. The disciplinary procedure requires proper investigation and consultation with the Human Resources department is required. The reporting of incidents implies no blame on the persons concerned. Further details regarding this are contained in the Trust s Incident Reporting and Investigation Policy and on the front cover of the incident reporting book. The incident may include notification to HM Coroner, preparation for handling Public Relations and in due course notification to statutory bodies (NMC, GMC, etc.). The requirements at (a) to (e) are for immediate notification in appropriate cases, including out of hours. Penalties for failure to notify may be severe and so if the Risk Manager is unavailable, the Directorate / On-call Manager should ensure that the appropriate agencies are informed Depending on the severity of the incident and the time of day, notify the on call Director and pass on the completed incident form(s) and other documentation to them. The relevant Directorate Manager and/or Clinical Director should be informed at the first available opportunity, together with the patient s GP and other individuals /agencies concerned with the patient s care Following the initial investigation, the manager in charge should ensure that the Local PCTs are informed of the incident. This should only be undertaken following consultation with an Executive Director If necessary, initiate any media handling arrangements (including the preparation of a statement) in consultation with the Head of Corporate Affairs. The Trust Policy on Confidentiality should be noted. The Directorate / on-call Manager must remember to keep a copy of any statements given to the media. The movement of reporters and photographers on site must be supervised. 4.2 Where appropriate, the Directorate / on-call Manager should formulate an initial report for consideration at the earliest possible time by the on-call Director and provide a briefing on the circumstances known to date. This should be done within 24 hours of the incident occurring and will then determine whether the next stage (Section 5) of the procedure is implemented. 4.3 It may also be appropriate to consider briefing the Chief Executive, other Executive and Non-Executive Directors and the Trust s solicitors, dependant on the circumstances. 4.4 Where relevant, the incident must be reported to the appropriate National Confidential Inquiry. Page 6 of 21

7 5 FURTHER ACTION 5.1 Following submission of the initial report as detailed in 4.2 the on-call Director will decide whether an internal or external inquiry is required. Guidelines for establishing Internal Enquires can be found in Appendix D. 6 SERIAL INCIDENTS 6.1 Under certain circumstances an incident may be regarded as a serial incident. The definition of a serial incident is one that impacts upon a number of patients or staff. In order to deal with this situation, a strategy has been developed. This can be seen in Appendix E. 7 RECORD KEEPING 7.1 Written evidence, in the form of statements, forms, etc. is important information. Records must be kept during and after a serious incident as the incident will have a momentum of its own and it is easy to forget the sequence of events and significant details, especially when a number of people are involved over a period of intense activity. Any member of staff writing a statement must keep a copy for his or her own records. 7.2 Any written evidence may become "disclosable" in the event of subsequent legal action and care should be taken in its formulation to include only relevant facts of what actually happened, not what people thought happened. There should be no opinion on who is at fault or any speculation on causes. Forms should be fully completed and all information requested completed. Statements and reports should only contain relevant information, giving a full and detailed account of what actually happened, including times, circumstances leading up to the event, people involved and action taken. 7.3 Statements should be taken from all involved parties independently, and may be given in the presence of a friend, relative, or representative. 7.4 Staff are referred to Appendix B & C for guidelines on statement writing. Page 7 of 21

8 Royal Devon & Exeter NHS Foundation Trust APPENDIX A Serious Incident Checklist TO BE COMPLETED BY THE DIRECTORATE MANAGER OR ON-CALL MANAGER AS APPROPRIATE. Name of person completing form: Telephone ext. / bleep no. Date of Incident: / / Date of completion: / / Time.. Brief details of the incident Location of Incident Action Comments Complete Y / N 1. Record name of person who reported the incident 2. If incident involves a patient, record name of their consultant and contact him / her 3. If appropriate ensure Emergency Services contacted 4. Consider whether any immediate action needs to be taken to minimise risk to other patients, staff or anyone else affected by the Trust 5. Consider whether the on-call Director needs to be informed 6. Contact Risk Management at the earliest opportunity. Record action taken and advice given Page 8 of 21

9 Action Comments Complete Y / N 7. Consider whether anyone else needs to be informed, i.e. Communications, HSE, Police, Coroner etc. If so record actions taken 8. Ensure an incident form is completed and record number 9. Record names of individuals involved directly or as witnesses 9. If possible take brief statements. If this is not possible at the time ensure that individuals make statements within 48 hours using the Trust proforma and forward them to you 10. Identify and record any other key individuals 11. Detail any equipment involved; make a record of any settings, etc. Impound and label if possible 12. Identify any relevant documentation and if necessary impound it. Record any such documentation 13. Identify whether staff require any support and if so who can best provide this. Record actions taken Any other comments: Page 9 of 21

10 STATEMENT WRITING APPENDIX B GUIDELINES FOR STAFF 1 PURPOSE 2 AIMS A statement will normally be requested in connection with an incident at work and may form part of the investigation into a formal complaint or legal claim. You cannot be compelled to write a formal statement but this will be encouraged to help the Trust manage any incidents that arise. To explore the facts and to establish the truth of allegations. 3 RESPONSIBILITY OF STAFF 3.1 The Trust stands vicariously liable for the actions of their employees during the course of their duties. 3.2 All members of staff are therefore expected to co-operate by supplying information where necessary. 3.3 Ex-employees may also be approached for statements and the Trust relies upon them having a responsible attitude and assisting in any investigations. 3.4 It is extremely unlikely that legal action will be brought by a Trust against an individual employee. However, there could be disciplinary action against an existing member of staff in the event of serious misconduct or gross negligence, amounting to breach of contract. 3.5 Everyone makes mistakes and it is better to be honest and report problems instead of trying to cover them up. The truth will usually come out and the consequences may be more serious if this is delayed. 3.6 Remember the need for confidentiality. Do not offer comment to anyone, e.g. the Police or media, without first checking with your Directorate Manager. 4 HELPING TO WRITE STATEMENTS 4.1 Your manager or Trade Union Representative will normally be willing to help in preparing a statement and if appropriate, you may wish to involve a professional organisation such as the NMAC, MDU, MPS or IHSM. If this statement is needed for the investigation of a complaint or legal action against the Trust, the Risk Management or Legal Departments will be happy to advise. Page 10 of 21

11 5 HOW TO WRITE A STATEMENT 5.1 Before providing a written statement, particularly if it relates to an incident that occurred some time ago, make sure that you have access to any relevant records. The Trust has a statement proforma available on the Intranet. This should be used to record a statement. 5.2 A statement should begin with your full name, work address, position, grade and location at the time of the incident or allegation, and the name of your employer at the time. (You might have moved and be requested to write a statement long after you have left.) 5.3 It should confirm the date (including day of the week, time and location of the incident in question). 5.4 It should give the full name of any person(s) involved: patient, visitor, colleague, etc. 5.5 You should describe your period of duty and specific responsibilities at the time. 5.6 If possible, say who else was on duty and who was in charge. Was it a particularly busy time? 5.7 Give a full description of the sequence of events, including the actions of others involved, and conversations held if appropriate. 5.8 Your account must be as accurate as possible and, above all, factual. Do not express opinions and avoid using hearsay (i.e. someone else's view or version of events). 5.9 State whether what you have described is your actual memory of the incident or whether you have relied entirely on records made at the time, or a combination of the two. This is when good record keeping will prove invaluable The text should be concise, whilst containing all the relevant details. Highlight anything unusual, e.g. a departure from normal practice for whatever reason Avoid jargon, clichés, and abbreviations (unless you have already explained the meaning and the need to use a particular abbreviation frequently) Statements should be legible, preferably typed, and carefully checked before being signed Sign and date your statement at the end Remember to keep a copy in a safe place. Page 11 of 21

12 STATEMENT PROFORMA APPENDIX C Writing a statement can often appear a daunting task. This guidance aims to make it as easy as possible. The purpose of writing a statement is so that you can provide a detailed chronological step-by-step account of your involvement. A statement is not a list. It should explain your involvement in a particular incident. It is not something to be rushed and it is often easier to write down everything you remember and then put into chronological order for the statement. It is important to remember that although your statement will be used to assist in investigating an incident it may well be used for other purposes such as a Coroners Inquest, Legal Claim etc. This is not something that should cause you any concern; rather it reinforces the importance of taking care in compiling it. Your statement does not need to be typed, however it does need to be legible. An electronic version of this form is available on the Risk Management section of the Trusts Intranet should you wish to type it. Using this form you should write: i. a step-by-step chronological account of your involvement. Include details (names) of patients, staff and others involved. ii. Include actual or approximate times where you know them. iii. Keep to the facts: What you saw, what you did, what you heard iv. Stick to facts, not opinions. Consider: i. When were you involved? At the beginning or part way through? ii. What were you told about the incident? Who told you? iii. What did you actually see and hear? iv. What exactly did you do? If necessary explain why you did this. v. Did you give information to patients or relatives? If so what? vi. What was documented and where? Include the incident form number where you know it. Page 12 of 21

13 ROYAL DEVON & EXETER NHS FOUNDATION TRUST Statement Proforma Incident form No Title First name Surname Job Title Grade (if relevant) Statement re: Statement Details I believe that the facts stated in this witness statement are true. Signed Date This statement consists of pages Page 13 of 21

14 I believe that the facts stated in this witness statement are true. Signed Date This statement consists of pages Page 14 of 21

15 APPENDIX D GUIDELINES FOR ESTABLISHING INTERNAL INQUIRIES FOLLOWING SERIOUS INCIDENTS Following an incident it may be necessary to hold an inquiry to ascertain the facts regarding the incident and establish what, if any, lessons need to be incorporated into future practice. Inquiries are intended to be fact-finding and conducted formally. All inquiries will be held in accordance with Royal Devon & Exeter NHS Foundation Trust Incident Reporting and Investigation Procedure. The decision to hold an inquiry will depend on the nature and severity of the incident and will be made by the Chief Executive. The inquiry panel will be established within 2 weeks of the incident decision and will aim to report within 6 weeks. A typical inquiry panel will consist of: A Chairman (who may be an executive director, non-executive director as appropriate). The chairman s role is to chair the panel, oversee the inquiry, agree the final report and submit it. Directorate Manager Medical Director / Clinical Director / Consultant as appropriate Governance Manager External advisor as appropriate Panel secretary The decision as to the composition and seniority of the panel will depend on the nature of the incident and will be made by the Chief Executive. Panel members will be drawn from outside the speciality / directorate where the incident occurred. The Trust Management Secretariat will provide the administrative support for the panel. A clear set of terms of reference agreed by the chairman will be produced. Appendix D1 provides a model set. The appropriate Directorate Manager should produce a synopsis of the facts surrounding the incident, obtain any statements available and prepare a list of witnesses who should be asked to attend the inquiry. The on-call manager / duty nursing manager who dealt with the incident initially, or the Governance Manager should be able to help. This should then be agreed with the panel chairman. Page 15 of 21

16 Those individuals who are required to attend the inquiry should be given at least 3 working days notice of the inquiry date and asked to attend. A standard letter inviting them will be sent out by the inquiry panel secretary. Staff must be advised that they can be represented by their trade union or professional association, or simply be accompanied by a colleague. At the commencement of each interview the panel chairman will advise each person of the purpose of the inquiry. At the chairman s discretion, the proceedings may be suspended if in his / her view the person being interviewed is under undue pressure or issues are disclosed that are of such significance as to fundamentally alter the remit of the inquiry. Where the latter is the case the panel chairman will suspend the enquiry and seek advice from the Chief Executive. The chairman and panel may, having heard the evidence, decide it is necessary to interview additional individuals. Where this is necessary the panel secretary will arrange for this to happen at the earliest convenient date. In some instances it may be appropriate to interview the individual involved in the incident, their relatives or carers, to gain their views and opinions regarding what happened. This decision needs to be carefully considered and where it is thought appropriate the panel chairman will write to the individual and arrange a suitable time and place to meet. Once the panel has finished hearing evidence a formal report, in the agreed format, should be produced within 10 working days. This format is detailed in Appendix D2. Once agreed by the chairman and panel members, the report should formally be sent to the Chief Executive for consideration. The Medical Director will send copies of the report to the relevant Clinical Director and Directorate Manager, who will be responsible for producing an action plan to address any recommendations made in the report. The report may also need to be made available to other external agencies such as the Coroner, HSE, GMC, NMC etc. The format of the action plan is detailed in Appendix D3 and must be produced within 3 weeks of the finalised report being issued and a copy sent to the Governance Manager. The Governance Manager will formally report it to the Trust s Governance Committee and monitor its implementation. It is the Trust s policy to make available to staff the findings of the inquiry and the Directorate Managers will be responsible for briefing their staff regarding this and where appropriate, distributing copies of the final report. This may be achieved via a briefing meeting so that all relevant staff receive a common message. It is important that Directorate Managers ensure support is provided to individuals. Where the inquiry report is to be made available to the individual / relatives / carers or made publicly available, the question of anonymity for individuals needs to be considered. However it must be borne in mind that in the event of, for example, a subsequent Coroners inquest, individuals will be identified. Page 16 of 21

17 Model Terms of Reference APPENDIX D1 i. To review the care of (the patient) whilst an inpatient/ outpatient on Ward / Department. ii. To consider whether all Trust policies and procedures were followed. iii. To make recommendations for any changes in policies and procedures, training or support to improve standards and reduce risks as appropriate. iv. To make a report for consideration by Trust s Governance Committee and if appropriate external NHS agencies. v. To ensure relevant support was provided to those involved vi. To make any other recommendations to the Trust regarding the incident, action taken, conduct of the inquiry or any other relevant issues that may be identified. Page 17 of 21

18 APPENDIX D2 Model Report Format Royal Devon & Exeter NHS Foundation Trust Royal Devon and Exeter Hospital (Wonford) Barrack Road, Exeter EX2 5DW Internal Enquiry re 1. The Panel : Who they were 2. The Proceedings 3. Terms of Reference for the Panel 4. Background 5. Summaries of interviews with relevant staff 6. Conclusions 7. Recommendations and Action to be taken Page 18 of 21

19 Proforma Action Plan APPENDIX D3 Royal Devon & Exeter NHS Foundation Trust Royal Devon and Exeter Hospital (Wonford) Barrack Road, Exeter, EX2 5DW Internal Enquiry:, Hospital No Action Plan No. 1. Recommendation Action Responsibility and completion date Page 19 of 21

20 APPENDIX E STRATEGY FOR DEALING WITH SERIAL INCIDENTS HELPLINE ARRANGEMENTS 1. INTRODUCTION 1.1 In certain circumstances, the discovery of an incident and subsequent investigation may lead to the realisation that the incident may affect multiple individuals. The following strategy is designed to deal with such a situation. 2. STRATEGY 2.1 The level of support needed to deal with multiple enquiries is dependent on the type of incident. Some incidents may only require minimal support whereas others will need considerable resources over a long time frame. The Director of Operations will decide on the level of support needed for such incidents. 2.2 The following process should be followed in the event of helpline arrangements needing to be in place. 1. The incident should to be brought to the attention of the Chief Executive, Director of Operations, Director of Nursing and Service Improvement, Medical Director, and other Executive Directors as necessary. 2. The Executive team will review the nature of incident with the specialities providing the service and estimate the numbers of patients potentially involved. 3. The Executive team will decide whether or not a helpline is necessary and if this best provided by the Trust or by NHS Direct. 4. The Executive team will notify the Trust Chairman, Primary Care Trust and the local Director of Public Health. 5. In the event that a helpline is considered necessary the responsibility for setting it up will be passed to the Director of Operations or a nominated deputy. 6. The Director of Operations will notify the Head of Communications. Page 20 of 21

21 7. The Major Incident Control Room will be used as a base of operations. The room currently has a maximum of five lines, four of which are dedicated major incident lines but which can be used under one published number. A PAS link and terminal will also be provided. Further IT arrangements will be agreed with the IT department. 8. At the earliest possible opportunity after the decision has been made for helpline arrangements to be in place, the Telecommunications Manager will be contacted. It may be necessary to arrange additional telephone lines in conjunction with BT and brief hospital switchboard operators. 9. The postal services manager will be contacted to ensure that any mail that is delivered to the Trust in relation to the incident is delivered to the Major Incident Control Room. 10. Staffing of the telephone lines needs to be considered carefully, and may require either clinical or non-clinical staff as appropriate. One Executive Director will be nominated as co-ordinator for staffing arrangements and to provide supervision and support. 11. The press may wish to film in the room, therefore careful consideration should be given to the dress of helpline staff. Experience shows that nurses in uniform appear to be the most reassuring to the public. 12. The telephone lines will be staffed in a flexible way including the number of hours that the lines will be manned. In the absence of a manned line, a suitably recorded answerphone message will be available. 13. The helpline number and the operation of the helpline will be coordinated with the Head of Communications so that the media can be briefed appropriately. 14. Arrangements will be put in place to ensure that the details of each call are recorded. The minimum information required will be the date, time, name of patient, and contact number. Other information may be required depending on the nature of the incident. Proformas for logging calls and log call sheets can be found in the Major Incident Control room in a folder marked Helpline. 15. The Director of Operations, or nominated deputy, will review helpline activity with the co-ordinating manager at a minimum every four hours. This will include number of callers and staffing arrangements. 16. The decision to cease the helpline, or alter its arrangements in any way, will be discussed with and agreed by the Chief Executive. Page 21 of 21

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