National Quality Assurance Programme in GI Endoscopy Information Governance Policy

National Quality Assurance Programme in GI Endoscopy Information Governance Policy Developed and approved by: The Steering Committee of the National QA Programme in GI Endoscopy CONJOINT BOARD IN IRELAND of the Royal College of Physicians and Royal College of Surgeons Copyright Conjoint Board RCPI and RCSI 2012

Authors: Working Group, National QA programme in GI Endoscopy Prof Steve Patchett (Chair) Dr Maeve Skelly Dr Chris Steele Dr Claire Smyth Prof John Hyland Ms Debbie McNamara Mr Joseph Duignan Ms Sharon Hough Consultant Gastroenterologist, Beaumont Hospital, Dublin Consultant Gastroenterologist, MWRH, Limerick & Hon Treasurer Irish Society Gastroenterology (2009-2011) Consultant Gastroenterologist, Letterkenny General Hospital Consultant Gastroenterologist, Connolly Hospital, Blanchardstown Consultant Surgeon, St Vincent s University Hospital, Dublin & President Irish Society Gastroenterology (2009-2011) Consultant Surgeon, Beaumont Hospital, Dublin, Irish Representative Association of Coloproctology of Great Britain and Ireland Council Member, Royal College of Surgeons in Ireland Advanced Nurse Practitioner, St. James s Hospital Steering Committee, National QA programme in GI Endoscopy Dr Alan Smith (Chair) Mr Eddie Byrne Ms Helen Byrne Mr Willie Anderson Ms Kathryn Holly Dr Jennifer Martin Mr John Magner Mr Kieran Tangney Prof John Hyland Dr Stephen Patchett Mr Art Cosgrove Dr Deirdre Mulholland Department of Health, Special Delivery Unit Integrated Services Directorate Quality and Patient Safety Directorate HSE ICT Independent Hospital Association of Ireland Department of Health and Children Royal College of Physicians of Ireland Royal College of Surgeons in Ireland Endoscopist Surgeon Endoscopist Physician Patient representative Health Information and Quality Authority (observer role) Page 2

Table of contents 1. Summary... 4 2. Introduction... 5 3. Document Purpose... 6 4. Information Flow... 7 5. Roles & Responsibilities... 8 5.1. Data Originator... 8 5.2. Data Controller... 9 5.3. HSE ICT Directorate... 11 5.4. Health Information Unit, Health Intelligence Ireland (HII), HSE... 11 5.5. ICT system & service providers... 12 6. Access... 12 6.1. Local Access levels... 13 6.2. National Access Levels... 14 7. Reporting... 15 7.1. Locally generated reports... 15 7.2. Centrally generated reports... 15 8. Secondary use of Data/Research... 15 9. References... 16 10. Glossary... 18 11. Revision History... 18 12. Appendix A... 19 Page 3

1. Summary The Conjoint Board of the Royal College of Physicians of Ireland (RCPI) and the Royal College of Surgeons in Ireland (RCSI) launched the National Quality Assurance Programme in GI Endoscopy in October 2011 in collaboration with the National Cancer Control Programme and the National Cancer Screening Service. The aim of this programme is to establish a quality assurance framework in each endoscopy unit that ensures the provision of a high quality, consistent and accurate service which will translate into a quality patient experience. The Health Information and Quality Authority (HIQA) define Information governance as follows: Information governance provides a means of bringing together all the relevant legislation, guidance and evidence-based practice that apply to the handling of information and offers a consistent way for people working in health and social care to deal with the many different legal provisions, guidance, and professional codes of conduct that apply to handling personal health information 1,2 Information Governance ensures necessary safeguards for, and appropriate use of, patient and personal information. This policy has been prepared to define how data collected for the National QA Programme in GI Endoscopy will be governed, processed, stored, accessed and reported on. The data collected centrally for this National QA Programme does not contain any personally identifiable information on the patient, as defined in the Data Protection Act 1988 8 and subsequent Data Protection (Amendment) Act 2003 9, as patient information will not be uploaded. Furthermore, there is a facility in the system to de-identify Medical Record Numbers (MRNs) before uploading to the central National Quality Assurance Intelligence System (NQAIS) database. However, the National QA Programme does contain personally identifiable information on the endoscopist as defined in the Data Protection Act 1988 8 and subsequent Data Protection (Amendment) Act 2003 9. Each endoscopist is required to sign a consent form prior to gaining access to NQAIS- Endoscopy. This Information Governance Policy includes a statement of agreement to be signed by all parties involved in the programme certifying that they have read, understood and agree with the principles set out. As participating clinicians it is important to understand that the purpose of this QA programme is to quality assure each participating endoscopy unit and to enable them to analyse and improve their performance. The QA Reports in the GI Endoscopy Programme will provide a standardised method of processing and displaying information from the Endoscopy Reporting Systems in each unit across the country. Its purpose is to enable local endoscopy units to monitor, review and improve the quality of their work in the context of national norms and set benchmarks (quality indicators) and not to provide a basis for action against an individual or a unit. The IT system developed for use by all participants to collect, store and analyse QA data will allow individual units to access, analyse and generate reports using their own data. The Conjoint Board and Programme Steering Committee will have access to centrally generated reports within the following groupings (e.g. all endoscopy units, Cancer Screening Units and other relevant groupings selected) It shall not be possible to determine any information on an individual hospital from centrally generated reports. It will be the responsibility of the Endoscopist Clinical Lead to drive continuous improvement locally based on QA data particularly in areas where results fall below the national average. Page 4

While improvements can and will inevitably be made almost immediately, it is acknowledged that a considerable period of time will be required before this system is validated, QA data has stabilised and intelligent, evidence-based national benchmarks (Quality Indicators) can be set for all quality measures. However, some Quality Indicators have already been set based on international evidence where possible and are stated clearly in the QA GI Endoscopy Guidelines. These QIs may be adjusted over time to reflect performance and goals suitable to GI Endoscopy practice in Ireland. It is envisaged that day to day central management of the QA programme will be redefined once the initial programme implementation phase is complete. This will trigger a review of this Information Governance Policy. Amendments to this policy can only be approved with the agreement of all parties involved: Conjoint Board RCPI & RCSI, Steering Committee and a majority of Programme participants. This policy document will be maintained and controlled by the Project Lead of the National QA programme in GI Endoscopy and will be subject to an annual review from the date of issue. 2. Introduction Clinical audit is a central component of the National QA programme in GI Endoscopy. A clinical audit is a quality improvement process within the clinical environment. Clinical audit is arguably the single most important method that any healthcare organisation can use to understand and assure the quality of the service that it provides 3. To drive this QA Programme the Conjoint Board has developed guidelines of Quality Assurance in a number of key performance areas of Oesophago-gastro-duodenoscopy (OGD) and Colonoscopy. These guidelines are currently being implemented in all participating public, private and voluntary hospitals in Ireland with GI Endoscopy units. Once implemented, participating endoscopy units will be expected to collect key quality data (KQD) locally for ongoing review and improvement. This key quality data consists of essential data items associated with each procedure and includes general details such as Hospital ID, Endoscopist ID, Procedure ID and details of quality activities applied to the case. Key quality data will be recorded at participating sites at detail level on Endoscopy Reporting Systems (ERS), and encrypted data extracts from the ERS of all KQD will be securely transmitted to a central data repository. A local authorisation step is required before data is accessible outside of the hospital ensuring that local units maintain ownership of data after it is transferred. The repository will primarily be used to facilitate local review and reporting of KQD. As the QA programme is collecting and analysing information, an information governance policy needs to be put in place to ensure appropriate use of patient and personal information. It should be noted that patient information will not be uploaded and there is a facility in the system to de-identify Medical Record Numbers (MRNs) before uploading to the central repository. An existing application, National Quality Assurance Intelligence System (NQAIS) for use by the National QA Programme in Histopathology was adapted from the HSE Health Information Unit system by Health Intelligence Ireland (HII) and this NQAIS system will be the central data repository for the programme. NQAIS will be enhanced to store, analyse, access and report on key quality data locally and nationally for the QA Programme in GI Endoscopy. Essentially a GI Endoscopy module within HII will be configured to facilitate analysis of GI Endoscopy key quality data this module will be referred to as the National QA Intelligence System (NQAIS) for GI Endoscopy within the broader context of the National GI Endoscopy QA Programme. Page 5

3. Document Purpose The Information Governance Policy has been developed in order to manage the confidential processing and communication of quality data pertaining to individual endoscopy units. This document is not intended to constitute a legal document. It has been prepared to define how data collected for the National QA Programme in GI Endoscopy will be governed, processed, stored, accessed and reported on. It is recognised that to encourage participation in clinical audit and quality assurance activities, Endoscopists need to feel safe with the process and to be assured that it will not be used against them in a punitive manner. The purpose of collecting data is to record key areas of quality assurance in the endoscopic procedure to facilitate improvement in clinical practice. The QA Report does not provide any information on an individual Endoscopist which does not already exist in the local ERS but standardises the way this data is displayed and analysed for all participating units. Clear access levels to this detailed data have been established and are detailed further on in this document (Section 6). This document includes a statement of agreement and consent form to be signed by all parties involved in the programme certifying that they have read, understood and agree with the principles set out in this information governance policy (please see Appendix 1-to be included). An online version of this agreement must be reviewed and signed by all users of NQAIS-Endoscopy before their initial log in to NQAIS. Page 6

4. Information Flow Data required for the National QA Programme in GI Endoscopy will be entered into the local ERS as part of workflow at each participating site. Data is extracted at each site and securely transferred to the National QA Intelligence System (NQAIS) for GI Endoscopy. The Patient ID will not be included in the QA data file extracted to NQAIS. This de-identifying step is there as an additional security measure. Each site maintains ownership of its own data at all times. Each site has access to its data on NQAIS in order to review it using the reporting functionality provided and sign it off as being complete and accurate within the agreed time limits. It is only after this sign-off that the data is included in the aggregated data. The Sign Off Manager indicated below should be the Clinical Lead (Section 6) Page 7

5. Roles & Responsibilities The data originator is responsible for having a statement of information practices 2,6 for their service outlining how data may be disclosed in the future for the benefit of the service user, or for purposes not directly related to, or completely separate from the service user s own treatment. The benefits of any proposed secondary uses and their rights in this regard should be clearly explained to service users for example by outlining the importance of the clinical audit function within a hospital. This statement of information practices should be clearly displayed and accessible to all staff and service users. The appropriate, effective and efficient access to information within NQAIS-Endoscopy requires a clear definition of the roles and responsibilities of the different parties involved in the National QA programme and a definition of access rights based on those roles. Representatives of each organisation involved in this programme (e.g. stakeholders, participants, contractors), and staff members likely to access QA data, analyses or reports, will be asked to read, agree and observe the rules set out in this Information Governance Policy. Before such access is permitted, these individuals must sign a statement of agreement & compliance with this Information Governance Policy, which will remain applicable even after cessation of involvement in National GI Endoscopy QA Programme. Roles & responsibilities are defined as follows: 5.1. Data Originator The Data Originators for the National QA Programme in GI Endoscopy are the participating endoscopy units They are responsible for the integrity of data pertaining to the National QA Programme and can authorise access to data They should adhere to local policies and procedures with regard to information governance, along with this policy A Clinical Lead must be identified locally with overall responsibility for the programme Clinical Lead Responsibilities: The below responsibilities concerning sensitive data must be assigned to the Clinical Lead Routinely run extract of QA data from ERS using software provided Transmit QA data to the central repository using secure data transfer facilities provided, ensuring that it is imported and uploaded successfully Review and verify the accuracy and completeness of local QA data by utilising local report and analysis tools Approve and sign-off QA data for each relevant period, allowing status of data to change from provisional to approved Review and manage local performance relative to Quality Indicators provided and nationally aggregated data Authorise local user access rights and access levels to the QA Extracts from the ERS Identify centrally generated report recipients e.g. all Endoscopists within the unit Identify all trainees within the units and their designated training lead Develop local protocol regarding data access and reporting, report circulation and storage Page 8

and identifying roles in the department with permission to access individual Endoscopist data (from NQAIS) Report on any breaches to this Information Governance Policy, locally through the established clinical governance and also on a national level through the Steering Committee for the programme The Clinical Lead may delegate the below responsibilities to another individual within the unit. In cases where another individual is not identified, all responsibilities remain with the Clinical Lead. Provide accurate list(s) of locally implemented codes to Data Controller to facilitate mapping to agreed national codes e.g. comfort scales Maintain local code mapping tables on the NQAIS Process data according to local protocol and in compliance with this Information Governance Policy Develop standard operation procedures (SOPs) for all QA programme related processes to ensure a consistent approach and facilitate local user training Ensure QA data is accurately recorded on ERS and in NQAIS-Endoscopy Supply and maintain up to date mailing list for the receipt of National reports and communications Individual Endoscopist responsibilities: Ensure QA data is accurately recorded on ERS and in NQAIS-Endoscopy Each endoscopist will have access to their Endoscopy Unit Report, Endoscopist Report and also an Endoscopist combined report in cases where the Endoscopist works across different hospitals. All access levels are clearly set out in Section 6 of this document. Trainer/Training Lead responsibilities: Ensure QA data is accurately recorded on the ERS and in NQAIS-Endoscopy Ensure a list of trainees is maintained and available on NQAIS-Endoscopy and that the Trainer:Trainee relationship is defined All issues relating to the competence or performance of a trainee must be dealt with through the established RCPI/RCSI training programme 5.2. Data Controller The Data Controller is the entity that determines the purposes for which and the manner in which data pertaining to the National QA Programme are to be processed. The Data Controller for the National QA Programme in GI Endoscopy is the Conjoint Board of the RCPI & RCSI under the direction of the Programme Steering Committee. In the context of this programme the Conjoint Board of the RCPI & RCSI is defined as the Presidents of the RCPI & RCSI with advisory members as follows: the Chair of the QA GI Endoscopy Steering Committee and members of the National QA Programme in GI Endoscopy Working Group. The presidents of the RCPI & RCSI are responsible for final decisions. Page 9

Responsibilities of Data Controller: Define the Information Governance Policy for this programme Oversee the development and implementation of the ICT solutions necessary to support the needs of this programme, in collaboration with the HSE ICT Directorate and Health Intelligence Ireland (HII) Ensure that adequate technical & organisational security measures are put in place to safeguard against unauthorised access, alteration, disclosure and destruction of data Ensure that all NQAIS users receive appropriate training prior to using the system Identify a designated National Operational Manager with responsibility for the operational management of the National QA programme on an ongoing basis Authorise national user access to NQAIS for this programme Review national QA data and agreed metrics Use data in the setting of National Benchmarks in response to requests through the Conjoint Board Ensure data is not disclosed to any third party without consent of the Data Originator Ensure data is used only for the purpose intended i.e. to facilitate the provision of a high quality, consistent and accurate service which will translate into a quality patient experience. The data controller has no role or responsibility in the identification, investigation or reporting of poor performance and persistent poor performance highlighted by the QA programme. As previously stated, this responsibility rests at the local endoscopy unit level. Any poor performance identified at a local level, which cannot be adequately managed within local governance arrangements, should be referred to the Conjoint Board or Medical Council as appropriate to advise on resolution options. Local governance arrangements should include procedures for such escalation. Responsibilities of designated National Operational Manager (QA Programme Lead): Support the ongoing development and use of NQAIS-Endoscopy (e.g. additional analyses/reports & units), liaising with the HII Project Manager and HSE ICT Directorate as necessary Ensure that all stakeholders and participants comply with the Information Governance Policy for this programme Assist Data Originators with the mapping of local / national codes Liaise with local endoscopy units to ensure that QA data is uploaded as scheduled, in a timely manner Develop standard operation procedures (SOPs) for all QA, user setup and ICT support related processes to ensure a consistent approach and facilitate national user training Co-ordinate the ongoing setup and removal of authorised national and local NQAIS users for this programme Handle QA programme related calls/queries on an ongoing basis Review national QA data and agreed metrics Generate and circulate national QA reports to the agreed list of recipients Page 10

5.3. HSE ICT Directorate The HSE ICT Directorate has overall responsibility for the successful delivery of the necessary ICT solution(s) to support the needs of this programme, and is accountable for the approved ICT capital budget. Responsibilities: Identify a designated ICT Project Manager to assume overall responsibility for the delivery of the necessary ICT solution(s), and for the approved ICT capital funding Lead the initial specification and design of NQAIS-Endoscopy, and standardised ERS extracts and interfaces, in collaboration with the National QA Programme Manager and Health Intelligence Ireland Procure software development services (as necessary) to facilitate the enhancement of the HII and ERS extracts and interfaces, to meet the needs of this programme, and to facilitate the ongoing maintenance, support and development of these systems to meet ongoing and evolving needs Assist with the development, testing and implementation of NQAIS-Endoscopy Work with vendors during implementation, provide technical advice, lead acceptance testing and implementation of all necessary ERS extracts and interfaces, to facilitate the routine export of detailed QA data, in collaboration with the National QA Programme Lead and participating endoscopy units Manage the ongoing relationships and contracts with ERS vendors for the provision of essential ICT services (e.g. software development, maintenance & support, database/systems administration) Advise the Data Controller and National QA Programmes Lead on appropriate technical & organisational security measures to safeguard against unauthorised access, alteration, disclosure and destruction of data Identify a designated person with responsibility for liaison with Health Intelligence Ireland and the National QA Programme Lead on an ongoing basis Process data only on and subject to the instructions and agreement of the Data Controller (i.e. potential data processor role) 5.4. Health Information Unit, Health Intelligence Ireland (HII), HSE The Health Information Unit, HSE, in collaboration with the National QA Programme Lead, HSE ICT Directorate, and other stakeholders will lead the enhancement of NQAIS for the GI Endoscopy QA Programme, which builds upon the existing NQAIS functionality and infrastructural design. Responsibilities: Identify a designated HII Project Manager with overall responsibility for the ongoing management of the NQAIS system, enhanced for QA GI Endoscopy functionality and the QA Modules Lead the detailed design, development, testing and implementation of NQAIS (e.g. user interfaces, analyses, displays and report formats) based on the existing NQAIS and supporting infrastructures, in light of the specified GI Endoscopy QA requirements and in collaboration with the National QA Programme Lead and HSE ICT Directorate Manage the ongoing relationship and vendor contract for the provision of essential ICT services (e.g. software development, maintenance & support service levels, database/systems administration) Page 11

Manage the ongoing relationship and contract with HEAnet for hosting NQAIS (e.g. access/security, disaster recovery, network management) Process data only on and subject to the instructions of the Data Controller (i.e. potential data processor role) Responsibilities of designated HII Project Manager: Support the ongoing management and security of NQAIS, liaising as necessary with the approved vendor(s) of the various QA ICT systems described in this document, HII, the National Operational Manager and the HSE ICT Directorate (e.g. system configuration, user setup, issuing of security certificates) Set up and maintain authorised users on NQAIS and QA Modules in collaboration with the Data Originators System Managers Handle technical calls/queries relating to NQAIS on an ongoing basis Support the ongoing development of NQAIS (e.g. additional reports and analyses) 5.5. ICT system & service providers Existing ICT system and service providers (i.e. ERS and NQAIS) will be contracted by the HSE ICT to develop and maintain the necessary ICT solutions and infrastructures to support this programme. These providers will work in collaboration with the National Programme Manager, HSE ICT Project Manager, HSE Health Intelligence Unit and participant endoscopy units. Responsibilities of each provider: Identify a designated person to lead and co-ordinate all necessary development work, within their own organisation Enhance their existing solution/infrastructure(s) to meet the needs of this programme Maintain, support and develop the enhanced solution/infrastructure(s) to meet ongoing and evolving needs Assist with the design and implementation of appropriate technical security measures to safeguard against unauthorised access, alteration, disclosure and destruction of data Process data only on and subject to the instructions and agreement of the Data Controller (i.e. potential data processor role) 6. Access It has been agreed that the existing Health Intelligence Ireland NQAIS application and supporting infrastructure will be enhanced to facilitate NQAIS for the QA GI Endoscopy Programme. Existing information security mechanisms to safeguard data confidentiality, integrity and access will be modified as necessary to meet the needs of this programme. Access to data in the NQAIS central repository will be restricted to authorised local and national users who must be members of the defined Data Originator, Data Controller, HSE ICT Directorate and HSE Information Unit entities. Authorised users will be granted appropriate access to specific functionality, and will be appropriately restricted to local or national views of the data on the NQAIS. Authorisation for the granting of user access accounts and for the associated data access rights is required from the specified Clinical Lead (local access) or the National Operational Manager (national access). Page 12

6.1. Local Access levels Role Access Expected Users Hospital Analyst Execute an Endoscopy Unit Report based on the hospital s QA records All clinicians Clinician Analyst Clinical Lead Analyst QA Data Upload Execute an Endoscopist Report based on the hospital s QA records for the logged on user and any trainees Execute an Endoscopy Unit Report based on the hospital s QA records and drill-down into KQDs to show endoscopist level KQDs. Execute an Endoscopist Report for all endoscopists working at this hospital Upload the hospital s QA records All clinicians Export QA Data Export the set of cases that contribute to a KQD to a CSV file Sign Off Manager Approve the hospital s QA records endoscopy unit clinical lead NQAIS Manager Create, modify or delete user accounts for the hospital Assign user roles for the hospital Modify or delete identifier values and mapping tables for the hospital Manage trainer/trainee relationships Access to hospital QA data as required for ICT support purposes Page 13

6.2. National Access Levels Role Access Expected User Hospital Group Analyst Execute a Hospital Group Report based on the aggregated QA records Conjoint Board RCPI/RCSI; Steering Committee; National Operational Manager Hospital Group Clinical Lead National Administrator Execute a Hospital Group Report based on the aggregated QA records and drilldown into KQDs to show endoscopy unit and endoscopist level KQDs. Execute an Endoscopy Unit Report for any hospital within the group Execute an Endoscopist Report for any endoscopist working at an endoscopy unit within the group System configuration National clinical lead for endoscopy National Operational Manager Page 14

7. Reporting The NQAIS (central repository) will provide functionality for the development of standard and ad hoc reports using National GI Endoscopy QA data. 7.1. Locally generated reports Participants will have the facility to access and analyse their own local data at all times in order to facilitate local review and quality improvement. An Endoscopist Combined Report will also be available to clinicians that work across different hospitals. Information governance around the generation, storage and circulation of reports produced using local endoscopy performance data should be consistent with this national policy but governed according to local protocol. The following locally generated reports are available: Endoscopy Unit Report Endoscopist Report Endoscopist Combined Report The designated Training Lead in the hospital will also have the facility to access and analyse any trainees that have been allocated to them. The review of these reports should be covered under the governance of the training programme delivered by the Conjoint Board. 7.2. Centrally generated reports Centrally generated reports will be made available to participants, the Conjoint Board and the Programme Steering Committee. Reports made available to the Conjoint Board and Programme Steering Committee will contain national data with all hospitals summarised together and hospital ID s anonymised within the following suggested groupings: Hospital Group Report All Participants Cancer Screening Units Other relevant Hospital Groups Reports cannot be published to, or shared with any other party without prior approval of the Data Originator. Reports generated or received by participants containing any reference to other participants, albeit anonymous, must not be published outside of the hospital without prior approval. This includes reference to position on any scale of measure with inferred reference to other participants (e.g. Hospital X has the highest Completion Rate). 8. Secondary use of Data/Research Access to data in NQAIS can be granted by the Data Controller for approved research purposes. Clinicians wishing to apply for access must follow the Research Access Application Procedure. Access will be granted based on the criteria set out in this procedure. In the cases where access is granted, hospital and endocopist identities will remain anonymous. Ethical approval must also be sought before any research activity is undertaken. Page 15

9. References 1) The Health Information and Quality Authority. National Standards for Safer Better Healthcare. 2012 2) The Health Information and Quality Authority Guidance on information governance for health and social care services in Ireland. 2012 3) The Commission on Patient Safety and Quality Assurance. Building a Culture of Patient Safety. 2008. 4) The Department of Health and Children. Discussion Document on Proposed Health Information Bill. June 2008. 5) The Department of Health and Children. Proposed Health Information Bill. 2009. 6) The Health Information and Quality Authority. An As Is Analysis of Information Governance in Health and Social Care Settings in Ireland. 2010. 7) The Health Information and Quality Authority. International Review of Information Governance Structures. 2009. 8) The Data Protection Act 1988. 9) The Data Protection (Amendment) Act 2003. 10) FOI Central Policy Unit, The Department of Finance. A Short Guide to the Freedom of Information Act 1997 and Freedom of Information (Amendment) Act 2003. 2004. 11) The Office of the Data Protection Commissioner. Data Protection Guidelines on Research in the Health Sector. 2007. 12) The National Cancer Registry, Ireland. Data Confidentiality in the National Cancer Registry - General policy, procedures for release of data and staff guidelines. 2007. 13) Health Intelligence Unit, HSE. Health Intelligence Initiatives - Population Health, Knowledge Management and Health Informatics. 2009. 14) The Office of the Data Protection Commissioner. Data Protection Acts 1988 and 2003 - A Guide for Data Controllers. 2008. 15) HSE Incident Management Policy and Procedure 2008. Health Service Executive 16) Flowers L, Riley T. State-based mandatory reporting of medical errors. An analysis of the legal and policy issues. Portland, ME, National Academy for State Health Policy, 2001. 17) World Alliance for Patient Safety, WHO Draft Guidelines for adverse event reporting and learning systems. World Health Organisation 2005 Page 16

18) Implementation Steering Group for the Report of the Commission on Patient Safety and Quality Assurance First Quarterly Progress Report End September 2009. Department of Health and Children 19) Data Processing Agreement between Caredoc Limited and the Health Service Executive, 2005 20) Guidelines for the implementation of a National Quality Assurance Programme in GI Endoscopy, 2011 Page 17

10. Glossary RCPI RCSI ERS OGD NQAIS SOP HII Royal College of Physicians Royal College of Surgeons Endoscopy Reporting System Oesophago-gastro-duodenoscopy National Quality Assurance Intelligence System Standard Operating Procedure Health Intelligence Ireland 11. Revision History Version Date Editor(s) Changes Draft 0.1 07.12.11 Project Team (S Boyle) Draft 0.2 17.05.12 Project Team (G Farr & S Boyle) Draft 0.3 05.07.12 Project Team (G Farr) Draft 1.0 14.12.12 Project Team (G Farr) First draft Updated to reflect the ICT Requirements Specification. First provisional draft, sent to Steering Committee for approval Updated to reflect comments from Steering Committee review and HIQA guidance Updated to align with changes made to the Histopathology Info Gov Policy and the inclusion of trainer/training lead responsibilities Page 18

12. Appendix A Field Description Required? Hospital ID Unique code for the hospital in which the procedure place Case ID Patient ID Identifier associated with the procedure; unique within each hospital Identifier for the patient; values are unique within the hospital Blank expected Patient Gender Patient s gender Optional Patient Age Patient s age in years on the procedure date Optional Procedure Date Date on which the procedure was carried out Endoscopist ID Procedure ID Intubate To ID Successful Intubation Identifier for the endoscopist; values are local to each hospital Identifier for the endoscopy procedure; values are local to each hospital Identifier for the organ/site that was intubated to; values are local to each hospital Indicator that there was a successful intubation to the oesophagus Optional Sedative 1 ID Identifier for sedative 1; values are local to each hospital Optional Sedative 1 Quantity Quantity of the sedative 1 used Optional Sedative 2 ID Identifier for sedative 2; values are local to each hospital Optional Sedative 2 Quantity Quantity of the sedative 2 used Optional Sedative 3 ID Identifier for sedative 3; values are local to each hospital Optional Sedative 3 Quantity Quantity of the sedative 3 used Optional Sedative 4 ID Identifier for sedative 4; values are local to each hospital Optional Sedative 4 Quantity Quantity of the sedative 4 used Optional Sedative 5 ID Identifier for sedative 5; values are local to each hospital Optional Sedative 5 Quantity Quantity of the sedative 5 used Optional Page 19

Sedative 6 ID Identifier for sedative 6; values are local to each hospital Optional Sedative 6 Quantity Reversal Agent 1 ID Reversal Agent 2 ID Quantity of the sedative 6 used Identifier for reversal agent 1 used; values are local to each hospital Identifier for reversal agent 2 used; values are local to each hospital Optional Optional Optional Retroflexion Indicator that a retroflexion (J-manoeuvre) was performed Gastric Ulcer Indicator that a gastric ulcer was detected Repeat Request Indicator that a repeat endoscopy has been requested Comfort Score Suspect MPT Tattooing Identifier for the patient comfort score; values are local to each hospital Indicator that suspected malignant polyps or tumours were detected Indicator that tattooing of suspected malignant polyps and tumours occurred Polyps Detected Indicator that polyps were detected Polyps Excised Number of polyps excised Polyps To Histology Bowel Prep Score Diarrhoea Level Number of polyps for which histology was requested Identifier for bowel preparation score; values are local to each hospital Identifier for diarrhoea level; values are local to each hospital Mucosal Biopsy Indicator that mucosal biopsies were taken Colonic Perforation Indicator that colonic perforation occurred Poly Performed Indicator that a polypectomy was performed Post Poly Perforation Post Poly Bleeding Indicator that a post-polypectomy perforation occurred Indicator that post-polypectomy bleeding requiring transfusion occurred Page 20