Reporting Period: September to December 2008

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Progress report on action plan based on recommendations arising from the report of the HIQA investigation into the provision of services to Ms A by the Health Service Executive at University Hospital Galway in relation to her symptomatic breast disease, and the provision of Pathology and Symptomatic Breast Disease Services by the Executive at the Hospital Reporting Period: September to December 2008

1. The National Standards for Symptomatic 1.1 Assure compliance by all Breast Disease Services (2007) should designated centers funded or operated be applied to all centres providing by the HSE to key performance Symptomatic Breast Disease Services indicators in relation to national breast Irrespective of whether they are in the standards through audits conducted in public, private or voluntary sectors. association with HIQA on 6 monthly basis. authority and accountability see comments National Quality Assurance Standards Symptomatic Breast Disease 1.1 NCCP will coordinate audits in HSE operated or funded hospitals and HIQA will receive audit results. Authority regarding any necessary development required consequent to audits to be determined when Heads of Agreement signed between NHO and NCCP. Note: Private hospitals will not fall under the governance of the HSE. Where the care of patients is shared across more than one facility or institution, arrangements must be in place to ensure effective governance, management and review. 1.2 As 1.1 above. Wherein hospitalbased follow-up care has been provided outside a designated centre, this care must meet national breast standards and will be the subject of audit of designated breast centre where initial treatment was provided (see comment). 1.2 While initial treatment will be provided for women with breast cancer at a designated centre, subsequent pathway of care may see follow up provided at other hospital locations. The designated centre providing initial treatment will retain responsibility and assure the quality of follow-up care provided elsewhere. Care provided at private hospitals or in primary care cannot be assured by the NCCP. Regular multidisciplinary team meetings must be held (at least weekly) and in particular, clear leadership of care planning must be maintained. 1.3 This is a standard of care defined in the National Quality Assurance Standards Symptomatic Breast Disease. Assurance of compliance at all centre s will be provided through ongoing audit in association with HIQA. 1.3 Weekly MDT meetings currently in place in all centres with nominated clinical leader 1.4 See 1.1 above. Implementation of these standards should be subject to a co-ordinated process of quality review. 2. Where diagnostic services are provided by a third party facility (for example a HSE laboratory providing services for a private hospital), such an arrangement should be subject to a formal Service Level Agreement, or contract, which is effectively managed and regularly monitored to ensure appropriate governance and quality assurance of the service. The HSE and voluntary hospitals should undertake a review of all such arrangements to ensure appropriate service agreements and monitoring are in place. 1.4 See 1.1 above. 2.1 Review existing arrangements for diagnostic services provision between public and private sector in hospitals operated or funded by the HSE. 2.2 Convene a Working Group to examine review findings and to make recommendations regarding continuation of such services and the governance and quality assurance framework which should apply to them. 2.3 Direction from NHO to hospitals regarding diagnostic services provision between the public and private sector in hospitals operated or funded by the HSE based on recommendations of Working Group. Sept 08 Oct 09 NHO Ann 2.1 Arrangements reviewed 2.2 Draft Service Level Agreements have been prepared but are still undergoing consultation and review before final agreement and direction from NHO. 2.3 See 2.3 above 2.4 Audit compliance with this direction Oct 09 2.4 See 2.3 above Equally, private sector providers are strongly encouraged to review all relevant arrangements where care of their patients is shared between organisations. Private hospitals do not fall under the governance of the HSE. 2

3. UHG s experience in responding to this incident, including the process adopted for patient management, should be captured and used to inform the development and implementation of national guidelines for handling adverse incidents. 4. Units using breast Fine Needle Aspiration (FNA) as a diagnostic modality should do so only in an appropriate triple assessment context and with robust quality assurance. This should include: Clarifying the role of FNA cytology in the investigation of breast disease and applying agreed patient selection criteria Auditing the service against the minimum standards set by the United Kingdom NHS Breast Screening Programme (BSP). Audit should calculate sensitivity, specificity, positive predictive value of C5, false negative rate, false positive rate, inadequate rate, inadequate rate from cancers and suspicious rates Using the C1-C5 classification system to ensure reports are clear and unambiguous 5. A clearer direction is needed for the development and quality assurance of the diagnostic cytology service in UHG Pathology Department. 3.1 Workshop to be held by SIMT with key staff from UCHG involved in responding to this incident to identify learning for future incidents. 3.2 Incorporate this learning in the next iteration of SIMT policy and incident management policy, procedure and guideline. 4.1 Review current role of FNA in assessment of women with symptomatic breast disease including patient selection criteria and reporting of results 4.2 Prioritise laboratory accreditation where FNA is provided by benchmarking against UK standards. 5.1 Diagnostic cytology services at UCHG to secure INAB accreditation In line with document control Nov 2008 Jan 2009 Dec 2008 June 2009 SIMT Anne Carrigy NCCP Professor Tom Keane NHO Ann National Quality Assurance Standards Symptomatic Breast Disease 3.1 Initial meeting to plan workshop held. Master class to share learning on response to serious incidents be delivered in Q2 2009. 3.2 Learning from this Masterclass will be incorporated in the next revision of the SIMT policy and incident management policy, procedure and guideline. 4.1 Current role established. 4 centres use FNA in primary diagnosis of breast cancer. Mater is fully accredited; St James s fully accredited; Galway University Hospital working towards accreditation; Limerick service not on site and centre is developing a service with an accredited laboratory. All 4 centres use C1-C5 classification system. 4.2 See 4.1 There has been a national decision to cease processing of new cervical screening cytology in all laboratories at hospitals funded or operated by the HSE. No new samples will be accepted after October 2008 and laboratories will continue processing of historic backlog to completion. The Service is now governed by the National Cancer Screening Service. UCHG is currently working towards accreditation of its laboratory. 6. All pathology departments should implement the recommendations of the Faculty of Pathology s guidelines on programmes in pathology laboratories. This incorporates, among other things: Intra-departmental consultation/peer review Multidisciplinary case discussion Incident reporting Vertical case review/audit Cytology quality assurance 6.1 The NHO and NCCP will facilitate the implementation of the Faculty of Pathology s guidelines on Programmes in pathology laboratories in hospitals operated or funded by the HSE through a series of workshops 6.2 Direction from NHO to all hospitals to implement these guidelines in pathology laboratories in hospitals operated or funded by HSE. April 09 March 09 April 09 NHO - Ann Faculty of Pathology s guidelines on histopathology quality assurance programmes in pathology laboratories 6.1 An information day was held in July 2008. The NCCP has provided the Faculty of Pathology with funding for 1 year to appoint a person (0.5 whole time equivalent) to support the Faculty s guidelines who will facilitate workshops. This post commenced in January 2009 and will include the development and roll out of the programme. 6.2 This is dependent upon the completion of guideline development 6.3 Audit implementation of Faculty of Pathology s guidelines on Sept 09 6.3 Initial development work looks likely to lead to the definition of a set of Key Performance Indicators which will 3

programmes in pathology laboratories Commencement date Finish date provide ongoing assurance of histopathology quality rather than audit of implementation. Implementation of these recommendations must be supported by appropriate Information Technology systems. 7. The HSE should review workforce planning at national and local levels to ensure that recruitment of consultants is more responsive to changing service needs and reliance on temporary staff is minimised. This should include measures to reduce the time-lag between authorisation to appoint and staff taking up post. 6.4 Establish a Working Group to examine strategic development of ICT to support histopathology laboratory quality assurance and to make recommendations for service planning. 7.1 Finalise and publish workforce planning strategy for the HSE 7.2 Align workforce planning with service and financial planning in annual service plan 7.3 Develop and implement a monitoring system to ensure approved vacant consultant posts are advertised and filled in a timely manner April 09 June 09 Mar 09 June 09 6.4 Among wide stakeholder engagement for this work, the HSE will welcome input from HIQA s Health Information Function 7.1 The workforce planning strategy is in final draft stage and is expected to be finalised by the end of February 2009. 7.2 Alignment of workforce planning with service and financial planning is on schedule to commence in March 09 following finalisation of the workforce planning strategy. 7.3 Work has commenced and is on schedule in relation to the development of a monitoring system to ensure approved vacant consultant posts are advertised and filled in a timely manner. 7.4 Undertake audit of monitoring system Nov 09 7.4 Audit will commence following implementation of the system. 8. It is recommended that the HSE Risk Sub- Committee progress and publish their work on mitigating risks associated with the employment of permanent and locum consultant staff. In the meantime, all local service providers should review recruitment policies and procedures to ensure robust verification and assessment processes are in place. 9. A formal policy for the recruitment of locum and temporary consultant staff should be established and implemented nationally to ensure more robust and effective arrangements and quality assurance mechanisms. This should include: Formalised agreements with specialist recruitment agencies which will include; their role, responsibility and area of accountability in the recruitment process. These agreements should be regularly monitored The provision for appointment panels to view and discuss all written references as part of the assessment process and before recommendation for appointment Account to be taken of existing competency levels of applicants as well as arrangements for their ongoing development and support as temporary employees An agreed programme of audit against compliance 8.1 Finalise, publish and implement end to end procedural instructions booklet for all employers to mitigate risks associated with recruitment. 8.2 Audit compliance with procedural instructions booklet. 9.1 See 8.1 9.2 Initiate and complete the procurement of a national contract for the provision of locum consultants. 9.3 Procedural instructions booklet to issue to all employers to ensure that applicants are considered on the basis of abilities, qualifications and suitability for the post in question. 9.4 Regular audit of locum and temporary consultant recruitment and selection process to be carried out in line with the HSE s recruitment licence. in place Mar 09 in place 8.1 Procedural instructions booklet, including audit documents, have been drafted by HR in consultation with the NHO, PCCC & Quality and Risk. Draft documents expected to be finalised and implemented in Q1 09. 8.2 Audit will commence in following implementation of procedural instructions booklet. 9.1 see 8.1 9.2 The procurement process is underway and the target date of March 09 for completion of the process is on schedule. 9.3 Procedure instructions booklet sets out the criteria / processes for selection and assessment. 9.4 Audit ongoing in line with the HSE s recruitment licence 4

10. The recommendations of the Lynott Report 10.1 Deliverable 8.1 addresses the (2002) should be implemented by the HSE recommendations of the Lynott Report and other service providers and compliance relevant to the HSE should be audited regularly. 10.1 See 8.1 10.2 Engage with Irish Medical Council in relation to appropriate systems ongoing liaison 10.2 Liaison ongoing 11. The role of independent advocacy services should be developed in all hospitals. These advocacy services should facilitate patients coming forward to raise concerns and have them addressed. Hospitals should encourage such services as part of a helpline and/or as part of patients hospital attendance. 11.1 Support, facilitate and engage with independent advocacy groups. Consumer Affairs Mary Culliton 11.1 The first meeting of the Implementation Group took place on 25th November 2008. In partnership with NCCP, Consumer Affairs have a number of initiatives in line with the HSE Strategy for Consumer Participation in designated centres: Patient satisfaction surveys are being planned in eight designated centres. This will provide standardisation and build on surveys already undertaken in centres. A charter for patient rights is being developed. 12. The corporate HSE executive management team should nominate a specific Director accountable for ensuring the development of an implementation plan for these recommendations. This should include a clear timeframe with milestones. Progress against the plan should be made public and reported to the Board of the HSE. 11.2 A hospital appointed patient liaison person (at a senior level) identified as part if the complaints structure. 12.1 Nominate specific accountable Director for development of Implementation plan 12.2 Develop an implementation plan for recommendations. 12.3 Publish implementation Oct 08 Aug 08 Sept 08 Aug 08 Oct 08 NHO - Ann A number of designated centres have engaged in discussions and planning to establish a patient involvement forum. 11.2 Designated complaints officers in place across hospitals operated or funded by the HSE in line with legislative requirements of Part 9 of the Health Act 2004. complete 5