National Quality Assurance Programme in Histopathology Information Governance Policy Version 2 Copyright Royal College of Physicians of Ireland 2013
Developed and approved by The Steering Group of the National QA Programme in Histopathology 2
Authors: Faculty of Pathology, RCPI, Working Group, National QA Programme in Histopathology Prof Kieran Sheahan (Chair) Prof J. Conor O Keane Dr Niall Swan Dr Julie McCarthy Consultant Pathologist, St. Vincent s University Hospital Consultant Pathologist, Mater Misericordiae University Hospital Dublin Consultant Pathologist, St Vincent s University Hospital Dublin Consultant Cytopathologist, Cork University Hospital Steering Group, National QA Programme in Histopathology Dr Mary Hynes Dr David Vaughan Mr Gerry O Dwyer Ms Kathryn Holly Mr Séamus Butler Prof J. Conor O Keane Prof Kieran Sheahan Mr John Magner Mr Kieran Tangney Dr Gerard Boran Dr Peter Kelly Dr Deirdre Mulholland Dr Niall Swan National Cancer Control Programme (Chair) Directorate Quality and Clinical Care Integrated Services Directorate Independent Hospital Association of Ireland HSE Information Communication Technology Faculty of Pathology, RCPI Working Group Chair, Faculty of Pathology, RCPI Royal College of Physicians Royal College of Surgeons National Clinical Care Programme Pathology Dean of Faculty of Pathology, RCPI HIQA (Observer) Faculty of Pathology RCPI (Observer) 3
Table of Contents 1. Summary... 5 2. Introduction... 6 3. Document Purpose... 7 4. Information Flow... 8 4.1. Encryption... 9 4.2. Roles & Responsibilities... 9 4.3. Data Originator... 9 4.4. Data Controller... 10 4.5. HSE ICT Directorate... 12 4.6. Health Information, Health Intelligence Unit, HSE... 12 4.7. ICT system & service providers... 13 5. Access... 14 5.1. Local Access levels... 14 5.2. National Access levels... 14 6. Reporting... 15 6.1. Locally generated reports... 15 6.2. Centrally generated reports... 15 7. Secondary use of Data... 15 8. Glossary and abbreviations... 16 9. References... 16 10. Appendix 1 User agreement online form... 18 11. Appendix 2 Clinical Lead user agreement Form... 19 12. Revision History... 20 4
1. Summary The Faculty of Pathology, Royal College of Physicians in Ireland (RCPI) launched the National Quality Assurance Programme in Histopathology in Jan 2009 in collaboration with the National Cancer Control Programme (NCCP) and Directorate of Quality and Clinical Care (DQCC). The fundamental aim of this QA Programme is to ensure patient safety and enhancement of patient care with timely, accurate and complete pathology diagnoses and reports. The Health Information and Quality Authority (HIQA) defines 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 Histopathology 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 3 and subsequent Data Protection (Amendment) Act 2003 4, as patient information will not be uploaded and Medical Record Numbers (MRNs) will be removed before data is entered in the central NQAIS database. This document 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 in this Information Governance Policy. As participating clinicians it is important to understand that this QA programme is not an exercise in individual performance management. Rather the purpose of the programme is to enable local Histopathology Laboratories to monitor, review and improve the quality of their work in the context of national norms and intelligently set national benchmarks (Q marks) and not to provide a basis for action against an individual or laboratory. The QA Reports in the Histopathology QA Programme will provide a standardised method of processing and displaying QA data locally for each laboratory across the country. The National Quality Assurance Intelligence System- Histopathology (NQAIS-Histopathology) is the central database that has been developed, for use by all participants to store and analyse QA data. This system allows individual laboratories to access their own data and analyse and generate reports using this data. It also allows individual laboratories to view national data with all hospitals summarised together and hospital Identifiers anonymised. The Faculty and Programme Steering Committee will have access to national data with all hospitals summarised together and hospital Identifiers anonymised within the following groupings: All laboratories, Cancer Centres and Non Cancer Centres. The Faculty, Programme Steering Committee and NCCP will have access to Cancer Centre data with Cancer Centres individually represented but with Hospital Identifiers anonymised i.e. Cancer Centre A, Cancer Centre B, Cancer Centre C. Consultant ID will not be accessible. There will be an opportunity for Non Cancer Centres to opt into the NCCP review. It will be the responsibility of the lead Pathologist and Clinical Director to drive continuous improvement locally based on QA data particularly in areas where results fall below the national average. 5
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 (Q marks) can be set for all key quality indicators. There has been much discussion around the issue of monitoring individual Consultant IDs as part of this programme and while there are benefits to adopting this approach, this data item will not be collated centrally at this time. The functionality to extract this data item has been built into the IT solution in order to avoid incurring unnecessary costs should this become a requirement in the future. Such a change would require an amendment to this Information Governance Policy. Amendments to this policy can only be approved with the agreement of all parties involved: Faculty, Steering Committee and following consultation with programme participants. This policy document will be maintained and controlled by the Project Manager of the National QA programme in Histopathology and will be subject to an annual review from the date of issue. 2. Introduction 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 5. Clinical audit is the central component of the National QA programme in Histopathology.To drive this QA programme the Faculty of Pathology has developed guidelines of Quality Assurance in a number of key performance areas of Histopathology 6. These guidelines have been implemented in public, private and voluntary hospitals in Ireland with Histopathology laboratories. Participating laboratories are collecting key quality data locally for ongoing review and improvement. As the QA programme is collecting and analysing information, an information governance policy is required 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 ensure that Medical Record Numbers (MRNs) are removed before cases are entered in the central NQAIS database. Key quality data is recorded on the local Laboratory Information System (LIS) at participating sites as part of normal laboratory workflow, and will be routinely exported, encrypted and securely transmitted to a central data repository. A local authorisation step is required before data is accessible to Faculty ensuring that local laboratories maintain ownership of data after it is transferred. The repository will primarily be used to facilitate local review and reporting of key quality data. This key quality data consists of essential data items associated with each case and includes general case details like case ID, case age, receipt date, details of case procedures, tissue types and details of quality activities applied to the case. A user-friendly central database for QA data storage, analysis and report generation called the National Quality Assurance Intelligence System (NQAIS)-Histopathology has been developed to support the QA programme. This NQAIS-Histopathology system was designed, developed, validated and deployed through collaboration between the RCPI, Health Intelligence Unit HSE, HSE ICT and the system developers OpenApp. It is based on the Health Atlas Ireland platform created by Health Intelligence Ireland. NQAIS is web-enabled, built using open source technologies and will enable each laboratory to review its clinical quality in both a local and national context at a glance. The NQAIS-Histopathology system is located at: http://www.healthatlasireland.ie/f1live 6
3. Document Purpose This Information Governance Policy has been developed in order to manage the confidential processing and communication of quality data pertaining to individual Histopathology departments. 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 Histopathology 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, as defined in the Data Protection Act 1988 3 and subsequent Data Protection (Amendment) Act 2003 4, as Medical Record Numbers (MRNs) will be removed before leaving the hospital site. It is recognised that to encourage participation in clinical audit, clinicians need to feel safe with the process and to be assured that it will not be used against them in a punitive manner 6. The programme s purpose is to enable local Histopathology Laboratories to monitor, review and improve the quality of their work in the context of national standards and set benchmarks (quality marks). Clear access levels to this local data have been established and are detailed further in section 6 of this document. This document 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 in this information governance policy (please see Appendix 1). An online version of this agreement must be reviewed and signed by all users of NQAIS-Histopathology on their initial log in to NQAIS. The Clinical Lead at each laboratory must also sign a paper copy of this user agreement and send it to the programme manager at the RCPI. 7
4. Information Flow Data required for the National QA programme in Histopathology is coded into the local Laboratory Information System (LIS) at each participating site. Data is extracted and encrypted at each site before it is securely transferred to the National QA Intelligence System (NQAIS) for Histopathology. The Patient ID will not be included in the QA data file transmitted to NQAIS. Each site maintains ownership of its own data at all times. Each site has access to its data on the 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 become accessible nationally for inclusion anonymously in national aggregate summary reports. This Sign Off step can only be completed by the Clinical Lead as detailed in (Section 6). Information Flow National QA Programme Histopathology Local LIS System National QA Intelligence System LOCAL ACCESS NATIONAL ACCESS STEP 1 STEP 6 STEP 7 STEP 12 Code Data into LIS System Maps Data Analyse Local Data Anonymised National Summary Reports available STEP 2 STEP 5 STEP 8 STEP 11 Extract Data from LIS System Validates Data Generate Local Reports Generate National Summary Reports STEP 3 STEP 4 STEP 9 STEP 10 Encrypt & Transmit Data Import Data Approve Local Data SIGN OFF Analyse National Data 8
4.1. Encryption Once data is extracted from the local LIS, sensitive data (i.e. Medical Record Number) will be encrypted locally and all data for that period will be saved and transmitted securely to the NQAIS. The Case ID can be used to identify the patient locally on the LIS if required. Access to this information locally must be controlled according to local procedure. In the event that a Unique Health Identifier is introduced the encryption process will ensure that records for the same patient in different laboratories are not linked together (i.e. they will not result in the same identifier following encryption). 4.2. Roles & Responsibilities The data originator is responsible for having a statement of information practices 2,7 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 is clearly displayed and accessible to all staff and service users. The appropriate, effective and efficient access to information within the Histopathology module of the HAI system 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 Histopathology QA Programme. Roles & responsibilities are defined as follows: 9 4.3. Data Originator The Data Originator is the entity from which data pertaining to National QA programme originates. The Data Originator is responsible for the integrity of data and can authorise or deny access to data. The Data Originators for the National QA Programme in Histopathology are the participating Histopathology departments under the direction and governance of hospital management. Although it is likely to be a rare occurrence the QA reports generated locally through NQAIS have the potential to identify histopathology departments who are underperforming in relation to national benchmarks. The ongoing regular review of QA data and subsequent management of poor performance identified by the QA programme sits firmly at a local hospital/department level. Appropriate Governance processes should be developed and in place locally to identify and manage poor performance. A Standard Operating Procedure outlining the participating hospitals responsibilities in relation to Monthly upload and local review of QA programme data has been prepared by the working group.
Responsibilities of all members of the Data Originator: Identify a designated Clinical Lead locally with overall responsibility for the programme, e.g. Lead Pathologist, Clinical Director Develop local protocol regarding data access and reporting, report circulation and storage Adhere to local policies and procedures with regards to information governance, along with this policy Report and manage patterns of practice with the potential to affect patient safety, uncovered as part of National Histopathology QA Programme activities, in compliance with local policy Process data according to local protocol and in compliance with this Information Governance Policy Responsibilities of the designated Clinical Lead: Identify a designated person locally with responsibility for the operational management of the programme on an ongoing basis (the Local Operational Manager) Authorise local user access rights and access levels to the NQAIS for this programme Identify centrally generated report recipients e.g. all Pathologists within department Review and verify the accuracy and completeness of local QA data by utilising local report and analysis tools provided Approve and sign-off QA data for each relevant period, allowing status of data to change from local to national (this should be conducted on a monthly basis) Review and manage local performance relative to National Benchmarks provided Report and manage patterns of practice with the potential to affect patient safety, uncovered as part of National Histopathology QA Programme activities, in compliance with local policy Report on any breaches to this Information Governance Policy, locally through the established clinical governance structure and also on a national level through the Steering Committee for the Programme Responsibilities of the Local Operational Manager: Ensure all QA activity is accurately recorded on the Laboratory Information System (LIS) Provide accurate list(s) of locally implemented codes to Data Controller to facilitate mapping to agreed national codes Maintain local code mapping tables on the NQAIS Ensure data extracted from the LIS is accurate and complete Encrypt sensitive data (i.e. Medical Record Number, Consultant ID) before QA data leaves the laboratory using encryption facilities provided Routinely transmit QA data to the NQAIS using secure data transfer facilities provided, ensuring that it is imported and updated successfully Develop and maintain Standard Operating Procedures (SOPs) for all QA programme related processes to ensure a consistent approach and facilitate local user training Supply and maintain up to date mailing list for the receipt of National reports and communications 10 4.4. 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 Histopathology is the Faculty of Pathology, RCPI under the direction of the Programme Steering Committee
In the context of this programme the Faculty of Pathology, RCPI is defined as the Dean of the Faculty with advisory Faculty members as follows: the Chair of the Histopathology Subgroup and members of the National QA Programme in Histopathology Working Group. The Dean of the Faculty is responsible for final decisions. 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 HSE Health Information Unit 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 Histopathology QA programme on an ongoing basis Authorise national user access to the NQAIS for this programme Review national QA data and agreed metrics Use data in the setting of National Benchmarks 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 enhancement of patient care with timely, accurate and complete pathology diagnoses and reports 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 Histopathology department level. Any poor performance identified at a local level which cannot be adequately managed within local governance arrangements should be referred to the Faculty of Pathology or Medical Council as appropriate. Local governance arrangements should include procedures for such escalation. Responsibilities of designated National Operational Manager (QA Project Manager): Support the ongoing development and use of the NQAIS (e.g. additional analyses/reports & laboratories), liaising with the System Manager and HSE ICT Directorate as necessary Monitor compliance with the Information Governance Policy and report any noncompliance with to the Data Controller Maintain list of national codes (e.g. quality, procedure, tissue codes) Assist Data Originators with the mapping of local / national codes Liaise with local laboratories to ensure that QA data is uploaded as scheduled, in a timely manner Develop Standard Operating Procedures (SOPs) for all QA, user setup and ICT support related processes to ensure a consistent approach and facilitate national user training 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 11
4.5. 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 the NQAIS, and standardised LIS interfaces, in collaboration with the National Programme Manager and HSE Health Intelligence Unit Procure software development services (as necessary) to facilitate the enhancement of the HAI and LIS applications 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 detailed design, development, testing and implementation of the NQAIS Lead the detailed design, development, testing and implementation of all necessary LIS interfaces to facilitate the routine export of detailed QA data, in collaboration with the National Programme Manager and participating laboratories Manage the ongoing relationships and contracts with LIS vendors for the provision of essential ICT services (e.g. software development, maintenance & support, database/systems administration) Advise the Data Controller and National Programme Manager 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 the Health Information Unit and the Operational Manager on an ongoing basis Process data only on and subject to the instructions of the Data Controller (i.e. potential data processor role) 4.6. Health Information, Health Intelligence Unit, HSE The Health Information Unit, HSE, in collaboration with the National Programme Manager, HSE ICT Directorate, OpenAPP and other stakeholders will lead the development of the NQAIS, which builds upon the existing Health Atlas Ireland functionality and infrastructural design. Responsibilities: Identify a designated System Manager with overall responsibility for the ongoing management of the HAI system, enhanced to include the NQAIS Lead the detailed design, development, testing and implementation of the NQAIS (e.g. user interfaces, analyses, displays and report formats) based on the existing HAI system and supporting infrastructures, in light of the specified QA requirements and in collaboration with the National Programme Manager and HSE ICT Directorate Manage the ongoing relationship and contract with OpenAPP for the provision of essential ICT services (e.g. software development, maintenance & support service levels, database/systems administration) Manage the ongoing relationship and contract with HEAnet for hosting the 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) 12
Responsibilities of designated System Manager: Support the ongoing management and security of the NQAIS, liaising as necessary with OpenAPP, HEAnet, 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 the NQAIS in collaboration with the Data Originators Handle technical calls/queries relating to the NQAIS on an ongoing basis Support the ongoing development of the NQAIS (e.g. additional reports and analyses) 4.7. ICT system & service providers Existing ICT system and service providers (i.e. LIS/HAI system vendors, HEAnet) will be contracted by the HSE 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, ICT Project Manager, HSE Health Information Unit and participant Laboratories. 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 of the Data Controller (i.e. potential data processor role) 13
5. Access The existing Health Atlas Ireland application and supporting infrastructure was enhanced to facilitate the NQAIS-Histopathology. Existing information security mechanisms to safeguard data confidentiality, integrity and access were modified to meet the needs of this programme. Access to data in the NQAIS 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. 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 Access Controller. 5.1. Local Access levels Role on NQAIS Manager Sign Off Manager Analyst Upload Export Local Access Right User Management - set up of users (once authorised by the clinical lead) who can access the lab s QA data and what access rights each user has Mapping tables access- can create, update and delete sections of mapping tables. Review, approve and sign off local QA data. This sign off allows data to be included within the national QA dataset. Create reports based on QA data that has been uploaded or signed off Delete reports Add and remove comments Upload local encrypted QA data for the lab to NQAIS Histopathology. Use the KQI Export function to produce a spreadsheet listing all the cases that contribute to a KQI Expected Users Local Operational Manager Clinical Lead Local Operational Manager, Clinical Lead, Other local lab Users Local Operational Manager Any user with Analyst and KQI export access rights 5.2. National Access levels National Standard Access : Members of the Data Controller will have access to anonymised data and reports only. National Administrator Access : The National Operational Manager designated by the Data Controller will have access to data from all participating Hospitals including Hospital IDs, but MRN will remain encrypted. This access is for the purposes of programme administration only (e.g. troubleshooting, addressing participant queries). 14
6. Reporting The NQAIS will provide functionality for the development of standard and local reports using National Histopathology QA data. 6.1. Locally generated reports Through NQAIS participants have the facility to access and analyse their own local data at all times in order to facilitate local review and quality improvement. Information governance around the generation, storage and circulation of reports produced using local Histopathology performance data should be consistent with this national policy but governed according to local protocol. 6.2. Centrally generated reports Centrally generated reports will be made available to participants, the Faculty and the Programme Steering Committee only. Reports made available to the Faculty and Programme Steering Committee will contain national data with all hospitals summarised together and hospital Identifers anonymised within the following groupings: A) All Participants B) Cancer Centres C) Non Cancer Centres Reports made available to the Faculty, Programme Steering Committee and NCCP will also contain Cancer Centre data with Cancer Centres individually represented but with hospital Identifers anonymised i.e. Cancer Centre A, Cancer Centre B, Cancer Centre C. 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. This includes reference to position on any scale of measure with inferred reference to other participants (e.g. Hospital X has the shortest turnaround time). 7. Secondary use of Data Access to data in the 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 identities will remain anonymous. Ethical approval must also be sought from the RCPI Research Ethics Committee before any research activity is undertaken. 15
8. Glossary and abbreviations HII Health Intelligence Ireland HIQA Health Information and Quality Authority ( MRN Medical Record Number NCCP National Cancer Control Programme NQAIS-Histopathology National Quality Assurance Intelligence System-Histopathology SOP Standard Operating Procedure RCPI Royal College of Physicians of Ireland 9. References 16 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 Data Protection Act 1988. 4. The Data Protection (Amendment) Act 2003. 5. The Commission on Patient Safety and Quality Assurance. Building a Culture of Patient Safety. 2008. Department of Health and Children. 6. Guidelines for the Implementation of a National Quality Assurance Programme in Histopathology. Faculty of Pathology, RCPI 7. The Health Information and Quality Authority. What you should know about information governance a guide for health and social care staff. 8. The Department of Health and Children. Discussion Document on Proposed Health Information Bill. June 2008. 9. The Department of Health and Children. Proposed Health Information Bill. 2009. 10. The Health Information and Quality Authority. An As Is Analysis of Information Governance in Health and Social Care Settings in Ireland. 2010. 11. The Health Information and Quality Authority. International Review of Information Governance Structures. 2009. 12. 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. 13. The Office of the Data Protection Commissioner. Data Protection Guidelines on Research in the Health Sector. 2007.
14. The National Cancer Registry, Ireland. Data Confidentiality in the National Cancer Registry - General policy, procedures for release of data and staff guidelines. 2007. 15. Health Intelligence Unit, HSE. Health Intelligence Initiatives - Population Health, Knowledge Management and Health Informatics. 2009. 16. The Office of the Data Protection Commissioner. Data Protection Acts 1988 and 2003 - A Guide for Data Controllers. 2008. 17. HSE Incident Management Policy and Procedure 2008. Health Service Executive 18. 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. 19. World Alliance for Patient Safety, WHO Draft Guidelines for adverse event reporting and learning systems. World Health Organisation 2005 20. 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 21. Data Processing Agreement between Caredoc Limited and the Health Service Executive, 2005. 17
10. Appendix 1 User agreement online form 18
11. Appendix 2 Clinical Lead user agreement Form 19
12. Revision History Version Date Editor(s) Changes Draft 1.0 17/06/10 Gillian Walsh & Fergus Murray Original Draft Draft 1.1 30/06/10 Gillian Walsh First review with Programme Steering Committee Draft 1.2 23/07/10 Gillian Walsh Reviewed with Health Information/Intelligence Unit Draft 1.3 23/08/10 Fergus Murray Include changes agreed at meeting of RCPI, HSE ICT, HSE HIU and OpenAPP on 4 th August Draft 1.4 06/09/10 Gillian Walsh Reviewed with QA Programme Working Group Draft 1.5 10/09/10 Gillian Walsh Second review with Programme Steering Committee Draft 1.6 13/10/10 Gillian Walsh Comments received at Programme Update day Draft 1.7 05/11/10 Gillian Walsh Input from Faculty of Pathology Executive & Programme Steering Committee Draft 1.8 16/11/10 Gillian Walsh Reviewed with Working Group & Steering Committee Draft 1.9 21/11/10 Gillian Walsh Second review at Faculty of Pathology Executive Draft 2.0 14/12/10 Gillian Walsh Approved by Histopathology Working Group and Programme Steering Committee 1.0 11/02/11 Gillian Walsh 1 st formal release following 30 day consultation period with Faculty Fellows Draft 2.1 23/07/12 Judy Gannon First review with QA programme Working group Draft 2.2 28/08/12 Judy Gannon Changes made following review with Working Group Draft 2.3 08/10/12 Judy Gannon Changes made following review with Reference Panel and Steering Committee. Version for consultation with Programme participants 2.0 11/01/13 Judy Gannon 2 nd formal release following consultation period with programme participants 20