POL 08:QP:003:02:NIBT PAGE 1 of 7

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1 POL 08:QP:003:02:NIBT PAGE 1 of 7 Northern Ireland Blood Transfusion Service POLICY DOCUMENT Document Details Document Number: POL 08:QP:003:02:NIBT Supersedes Number: 08:01:QP:003:NIBT No. of Appendices: NONE Document Title: NIBTS POLICY FOR INCIDENT MANAGEMENT ISSUE DATE: 11 JULY 2011 EFFECTIVE DATE: 8 AUGUST 2011 Document Authorisation Written By : Angela Macauley Regulatory Affairs & Compliance Manager Signature: Date: Authorised By: Geoff Geddis, Quality Manager Signature: Date: Authorised By: Dr Kieran Morris, Chief Executive Officer Signature: Date: CROSS REFERENCES This Policy refers to the following documents: Doc Doc. No. Title Type GUI RMS:002 Risk Management Guidelines POL PP:022 Claims Management Policy SOP QA:070 Procedure For Reporting And Management Of Quality Incidents SOP BD:017 Procedure For Processing Complaints And Other Contacts SOP HS:012 Procedure For Reporting And Managing Health And Safety Incidents FORM IR1 NHS Incident Record (Form IR1) FORM DD:260 Donor Contact Record Form.

2 POL 08:QP:003:02:NIBT PAGE 2 of 7 Key Change From Previous Revision: Addition of statement re non punitive nature of incident management systems. Addition of indication of NIBTS intent to use Q Pulse 5 as central recording system for all incidents. Addition of links to Risk Management and Claim Management. Targets for quality incidents updated to reflect agreed corporate targets and expansion of reporting arrangements for all incidents throughout policy.. Removal of detail re completion of IR1 form for Health and Safety Incidents. Expansion of reporting arrangements in several points. 1 STATEMENT It is NIBTS policy that any deviations (Incidents) from accepted practice will be reported (managed), investigated as appropriate and effective remedial action will be taken to prevent recurrence. All staff are expected to participate in the reporting of incidents, wherever they occur. Systems are in place in all areas of the service to permit the recording of incidents. These involve a combination of paper-based and electronic forms which are completed and where appropriate returned to Regulatory Affairs & Compliance Department for review and/or closure. The purpose of incident reporting is to help NIBTS improve quality and reduce risks to patients, donors and staff. NIBTS has a positive and non punitive approach to the reporting of incidents. Although staff are accountable for their actions it is also recognised that human error is understood to be frequently the consequence of failures in systems, and not necessarily of the individual. The purpose is not to lead to the disciplining of staff who make genuine errors. The reporting of incidents has several benefits: Firstly, to prevent defective components or products from being issued and placing patients at risk. Secondly, to ensure that faults in clinical test methods are identified and corrected. Thirdly, through the identification of a root cause, to permit remedial action to be taken to prevent a repetition of the incident. Fourthly, to provide data that can be used as a basis for continual quality improvements. Finally improved Health and Safety for patients, donors and staff. Data on NIBTS incidents is retained in appropriate database systems. The data held in these data bases will be analysed regularly for relevant management information e.g. time to incident closure, trending of similar incident types. Management information will be provided in regular reports. A review forum has been established to ensure that incidents are followed up effectively. The effectiveness of this policy will be assessed during the relevant management meeting and will be reviewed by the Senior Management Team through reports from the Quality and Regulatory Affairs & Compliance Departments.

3 POL 08:QP:003:02:NIBT PAGE 3 of 7 2 OVERVIEW The NIBTS recognises that it is inappropriate to manage all incidents in a single homogeneous system, as it is recognised that incidents may fall within various categories and this will determine the methods of investigation used and any follow up actions required. There are in effect 3 separate systems in operation, although these are all founded on the same principles as described in this policy. It is the intention of NIBTS that all 3 systems will be built around Q Pulse 5, an electronic data recording system. The processes are described in section 4. Incidents within these categories are defined as follows: Incidents related to quality An event which potentially has an adverse effect on the quality of NIBTS components, products or services or the safety of donors/patients. Incidents related to complaints A compliant is an expression of dissatisfaction from a donor or member of the public. The person may not always use the word complaint. Incidents related to health and safety An event which either causes or has the potential to cause harm or damage to either people (staff, donors, contractors, visitors, or members of the public) or equipment, NIBTS transport or the security of NIBTS premises or mobile sessions. It should be noted that in the definitions provided above the potential for an event to have caused an incident is grounds to raise the incident via the appropriate route therefore near miss events should also be reported as incidents. All reported incidents are graded according to severity of outcome and potential/future risk to users and/or the organisation. Guidance on the scoring of incidents is provided in the relevant procedures related to each category of incident and within GUI:RMS:002 - Risk Management Guidelines. Where incidents stem from, lead to or have the potential to lead to claims against NIBTS POL:PP:022 - Claims Management Policy will provide the basis for progressing this aspect of the incident. The basic principle under which all incidents are recorded and managed is that they should be investigated primarily within the area of NIBTS where the incident occurred. All incidents will be reviewed at an appropriate Management Forum. 3 RESPONSIBILITY Responsibility of all staff to report incidents. Responsibility of all Heads of Department and Senior Managers to ensure staff within their area comply with the requirements of this policy and related procedures.

4 POL 08:QP:003:02:NIBT PAGE 4 of 7 Regulatory Affairs & Compliance Manger responsible for maintaining the quality incident management system including provision of appropriate reports. Facilities Manager responsible for maintaining the incident management system dealing with those incidents related to Health & Safety/Transport/Security including provision of appropriate reports. Donor Services General Manager responsible for maintaining system for incidents related to donor complaints or complaints by members of the public including provision of appropriate reports. 4 POLICY 4.1 Quality Related Incidents: Personnel must ensure that all procedures are carried out in such a way that product/component quality is not placed at risk. This means that standard procedures must be followed, that staff are trained to perform tasks correctly, that appropriate checks are made of all operations, and that systems exist to help predict potential problems so that preventative action can be taken. However, despite all efforts to prevent problems, incidents will occur which have a potentially adverse effect on the quality of NIBTS components, products or services or the safety of donors/patients, these are classified as quality incidents. SOP:QA:070 Procedure For Reporting And Management Of Quality Incidents details the processes to be followed for Quality related incidents and the appropriate forms/templates that are to be used and is not covered under this policy. 4.2 Incidents Relating to Complaints: The 1996 (NI) Order which sets out the guidelines for dealing with complaints in Special Agencies. Further guidance was issued by DHSS PS in 2000 permitting the Chief Executive of Special Agencies to "delegate responsibility for responding to a formal complaint (to a) designated officer". Within NIBTS this responsibility was delegated to the Donor Services General Manager. All complaints resolved or not must be recorded on the Donor Contact Record FORM:DD:260 and copied to the Complaints Coordinator and Complaints Systems Manager and where potentially they may also constitute a quality incident the Regulatory Affairs & Compliance Department. Incidents relating to complaints received from donors or from members of the public will fall within this category. A complaint is an expression of dissatisfaction. The person may not always use the word complaint. They may offer a comment or suggestion that can be extremely helpful. However, it is important to recognise those comments that are really complaints and need to be handled as such. (Ref. SOP:BD:017 Procedure For Processing Complaints And Other Contacts )

5 POL 08:QP:003:02:NIBT PAGE 5 of Incidents related to Health and Safety/Transport/Security: An incident or near miss will be considered to fall into this category if it either causes or has the potential to cause harm or damage to either people (staff, donors, contractors, visitors, or members of the public) or equipment, NIBTS transport or the security of NIBTS premises or mobile sessions All Health and Safety, Transport, or Security Related Incidents must be reported using form IR Each department has access to the Incident Record form IR1 and following an occurrence or incident it is the responsibility of the line manager to complete this form appropriately See SOP:HS:012 Procedure For Reporting And Managing Health And Safety Incidents The Facilities Manager provides copies of all reported incidents to the Regulatory Affairs & Compliance Department to allow consideration as to the need to instigate a quality incident. 4.4 Analysis/Trending of Quality Related Incidents In addition to ensuring that all individual incidents are investigated and resolved effectively, it is imperative that data is collated and analysed. This analysis will include the following Monthly Incident Management Forum. The basic principle under which all incidents are recorded and managed is that they should be investigated primarily within the area of NIBTS where the incident occurred. All incidents will be reviewed at a monthly incident management forum. As part of the forum the following will be captured as a minimum: Monthly Incident Summary Report A monthly report with be prepared for the forum, listing of all incidents recorded within that month as well as all open incidents. Oversee the development and maintenance of the NIBTS incident report system. Ensure that training is available for staff in the principles and application of root cause analysis. Review the investigation of all category red incidents. Review of all Red and Amber Incidents to ensure that all applicable incidents have been entered on to SABRE. Initiate investigations of common, recurring incidents.

6 POL 08:QP:003:02:NIBT PAGE 6 of 7 Provide reports for NIBTS Senior Management. Review all overdue incidents and incidents that are still open over 90 days. Incidents over 90 days the incident owner/investigator shall be invited to the monthly meeting to discuss why the incident is still open. This will recorded in the minutes of the meeting. Note: Incidents which are over the 90 days will be treated as serious and will be brought to the attention of the Senior Management Team. The monthly report shall be circulated to the Senior Management Team and the NIBTS Board Time to Closure Data will be collated on time from initiation to investigation completion and then to closure. The target is that 95% of all incidents investigations with associated CAPA should be agreed within 30 days and 75% of incidents are closed i.e. all CAPA completed and review stage carried out within 60 days from initiation to closure. A further target of a maximum of 5 incidents open over 90 days at any one time will be monitored. Data will be reported to the relevant management forum on performance against this KPI. If data shows that all or part of the organisation fails to meet this target, then this will be reviewed actively. With time, the intention will be to tighten the target for closure Trend Analysis The NIBTS will use the data available to analyse for recurring incidents. This trend analysis data will be presented to relevant Management forums where action will be taken to understand the root cause of these incidents and to initiate strategies for preventative action. Where relevant, this will involve the creation of appropriate project teams Annual Reports An annual report will be prepared for NIBTS incidents and this will be provided to the NIBTS Board and to regulatory bodies as required. 4.5 Analysis/Trending of Incidents related to Health and Safety/Transport/ Security The facilities manager will provide regular monitoring updates to the Health and Safety group and Governance & Risk Management Committee. 4.6 Analysis/Trending of Incidents related to Complaints Each month the Complaints Coordinator will record the number, general nature and processing time of all complaints and provide a

7 POL 08:QP:003:02:NIBT PAGE 7 of 7 copy to the Donor Services General Manager, Business Continuity & Risk Manager and Quality Manager An interim review and report is undertaken at the end of each quarter, and presented: At each Governance and Risk Management meeting. As appropriate, at BTS Communities Partnership meetings At the end of each year a summary report on complaints will be established. This report will detail the number and type of complaints received, and the Agency s performance against targets for processing each complaint All complainants will be written to, in order to determine their satisfaction/dissatisfaction with the way their complaint was handled. This survey will normally be conducted mid-year following that in which the complaint was made In addition, a further review of complaints will be undertaken to determine how many complainants, if eligible, actually returned to a donor session. 4.7 Reporting of Serious Adverse Incidents Serious Adverse Incidents regardless of their source will be reported to the Chief Executive Officer, the Board and where appropriate the relevant Regulatory Body and DHSSPS in accordance with DHSSPS Guidelines. 5 EQUALITY SCREENING OUTCOME This policy has been drawn up and reviewed in light of the statutory obligations contained within Section 75 of the Northern Ireland Act (1998). In line with the statutory duty of equality this policy has been screened against particular criteria. If at any stage of the life of the policy there are any issues within the policy which are perceived by any party as creating adverse impacts on any of the groups under Section 75 that party should bring these to the attention of the Head of HR& Corporate Services. 6 TRAINING REQUIREMENTS Senior Managers/Department Managers/Section Heads must read and understand this policy. Facilities Manager and Deputy must read and understand this policy. Complaints Co-ordinator must read and understand this policy. Regulatory Affairs & Compliance Lead must read and understand this policy.