The Scally Review into the CervicalCheck screening programme has found serious gaps in the governance and expertise of the programme.
Dr Gabriel Scally found a whole system failure and said the open disclosure system was unsatisfactory.
The full report is available to read here, but below are the 50 recommendations:
Method of Approach
1) The Department of Health and the HSE should revise their policies in respect of document management. This should ensure that good quality records are created and maintained which are authentic, reliable, and complete in searchable format. They should be protected and preserved to support future actions and ensure current and future accountability.
Listening to the Voices of the Women and Families Affected
2) The Minister for Health should give consideration to how women’s health issues can be given more consistent, expert and committed attention within the health system and the Department of Health.
3) The Department of Health should examine the current arrangements for patients to have access to their hospital medical records so that such access can be achieved in a timely and respectful way.
CervicalCheck – Organisation and Governance
4) The Minister for Health should consider seriously the appointment of two patient advocates to the proposed new Board for the HSE.
5) A National Screening Committee should be constituted to advise the Department of Health and the Minister on all new proposals for screening and revisions to current programmes.
6) The NSS, whatever its location within the HSE, should be able to access senior levels of the organisation and be located close to strategically and logically linked services.
7) A far greater component of professional and public health expertise should be deployed across the screening services, not as external advisors but with significant roles within the screening programmes.
8) The implementation of new governance arrangements for the HSE should include a substantial revision to the organisational approach to risk management and its reporting.
CervicalCheck – Laboratory Services
9) CervicalCheck should revise its programme standards to clarify what is mandatory, and to clarify the level of reliance on external accreditation processes. This is particularly important in respect of laboratory service providers in other jurisdictions.
10) As a priority all providers should fully implement a single agreed terminology for the reporting of results and ensure that criteria for defining the different grades of abnormality are consistently applied.
11) Based on revised programme standards, a specification for a new and more robust quality assurance procedure should be documented and form part of the contract for services with cytology providers.
12) CervicalCheck should adopt a formal risk management approach to parameters which do not reach acceptable standards despite full intervention and monitoring.
13) CervicalCheck should document which organisation (e.g. CervicalCheck, HSE, Providers) has responsibility for pursuing issues of continued non-compliance and the consequences thereof. An advisory group of cytopathologists and other laboratory based staff should be established to advise on this process, and this should include input from those who work for non-State providers.
14) CervicalCheck should collate and publish annual data on reporting rates for all categories broken down by provider.
15) In order to obtain comparable data CervicalCheck should amend data specifications to exclude samples taken from colposcopy, and analyse and publish all performance statistics on samples taken in primary care, or equivalent, only.
16) When this change to comparable data is made further epidemiological investigation is required to establish whether the differential rates of abnormality persist and, if so, to what extent they can be attributed to underlying population differences.
17) The different rates of sensitivity for Scoping Inquiry into the CervicalCheck Screening Programme
18) The different inadequate rates are not a cause for immediate concern. The Scoping Inquiry recommends that the findings of the English health technology assessment (HTA) study referenced in Appendix 1 are implemented across all providers to try to obtain more consistency.
Procurement of Laboratory Services
19) Winning proposals should be appended to the relevant contract and not destroyed until at least one year following the termination of the contract (and any extension thereof).
20) A system should be put in place for proactive contract governance in order to safeguard the future of the service and the relationship of the service with the market place.
21) Procurement processes for external laboratory services should be designed to test the market at reasonable intervals (e.g. every four years), to ensure that CervicalCheck does not become overly reliant on a small number of incumbent suppliers, and to ensure that innovative approaches and added value can be formally captured within the procurement process.
22) CervicalCheck should ensure that its procurement approach maintains a balanced focus on qualitative factors, supplier experience, and innovation, alongside cost considerations.
23) CervicalCheck should ensure that future procurements incorporate measures to test performance in the current contract.
24) External professional assistance should be sought in the construction of any future RFP, and the evaluation of proposals in order to ensure that best practices developed across the public sector since 2012 are incorporated into key areas such as development of RFP documents, supplier briefings, construction of award criteria, construction of evaluation panels, establishment of governance and continuous improvement programmes, etc.
25) Assurances should be sought with respect to the capability to deliver the service as specified and without material change. Where change is possible, robust change management procedures, which include approval by the procuring authority, should be defined.
Auditing Cervical Screening
26) Audits should continue to be an important component of cervical screening as this complies with all good clinical practice. Common, robust and externally validated approaches to the design, conduct, evaluation and oversight of audits should be developed across the screening services.
27) There should be a minimum of two patient advocates involved in the oversight of clinical audits for the screening services.
Open Disclosure and the HSE
28) The HSE’s open disclosure policy and HSE/SCA guidelines should be revised as a matter of urgency. The revised policies must reflect the primacy of the right of patients to have full knowledge about their healthcare as and when they so wish and, in particular, their right to be informed about any failings in that care process, however and whenever they may arise. The revision process should be overseen by a working party or committee with a minimum of two patient advocates amongst its members.
29) The option of a decision not to disclose an error or mishap to a patient must only be available in a very limited number of well-defined and explicit circumstances, such as incapacity. Each and every proposed decision not to disclose must be subject to external scrutiny and this scrutiny process must involve a minimum of two independent patient advocates.
30) A detailed implementation programme must be developed that ensures the principles and practice of open disclosure are well understood across the health service. In particular, medical staff must be required, as a condition of employment, to complete training in open disclosure.
31) A governance framework for open disclosure must be put in place that includes evaluation and audit.
32) An annual report on the operation of open disclosure must be presented in public session to the full Board that is to be appointed to govern the HSE.
Open Disclosure and the Medical Council
33) The Department of Health should enter into discussions with the Medical Council with the aim of strengthening the guide for registered medical practitioners so that it is placed beyond doubt that doctors must promote and practice open disclosure.
Open Disclosure and CervicalCheck
34) A statutory duty of candour must be placed both on individual healthcare professionals and on the organisations for which they work.
35) This duty of candour should extend to the individual professional-patient relationship.
36) NCRI should urgently negotiate and implement data sharing agreements with all major providers and users of registration data. This is necessary in order to meet the requirements of the new EU General Data Protection Regulation but also, and more importantly, represents good governance. Where such an agreement is with an overarching statutory body, such as the HSE, there should also be individual MoUs in place with distinct organisational users of data, such as the cancer screening programmes.
37) Timely data is important to assure the effectiveness of both cancer screening and treatment services. This is a patient safety issue. To fulfil its role properly as a cancer registry:
(a) NCRI must be given additional support to recruit cancer registration officers and strengthen its public health medicine capacity.
(b) The Department of Health and the HSE should commit to make progress on electronic data capture by NCRI from hospitals, and set clear targets for its achievement.
38) NCRI should review data definitions related to cervical cancer and CIN (cervical intra-epithelial neoplasia) cases to ensure that the screening flags are meaningful for analysis of the effectiveness of the CervicalCheck programme
39) The need to duplicate the collection of patient level details of cervical cancers by both NCRI and CervicalCheck should be reviewed. It is notable that both CervicalCheck and NCRI have identified patients that the other has not. If it is determined that both systems should continue then properly functioning data sharing agreements must be put in place.
40) The Department of Health must review the composition of the Board of NCRI in order to ensure more robust governance, in particular in QA, data sharing and patient safety.
41) Any future consideration of the governance of the NSS needs to acknowledge, and contribute to the effective oversight of, the specific role played by NCRI in working in conjunction with the cancer screening programmes.
42) The Department of Health should work with the Board of NCRI to commission an annual peer review, for at least the next three years, by external cancer registration and cancer control experts. The report of each review and the response to it by NCRI should be forwarded to the Minister for Health.
43) NCRI should establish stronger and more regular contacts with external clinical and public health experts to ensure scrutiny of, and advice on, outputs from NCRI so as to enhance the level of its clinical and public health interpretation, importance and impact.
44) One of the requirements for the establishment and good management of a screening programme is that health services should be of a good standard to manage those people detected with disease by the screening programme. NCRI, through links with the clinical community, should seek to engage actively in the assessment of the quality of cancer services, comparing these for screen and non-screen detected cases.
Other Screening Programmes
45) Considering the clinical and technical differences that characterise the different screening programmes, NSS needs to advance its thinking on cross programme learning, external QA, and governance oversight of the QA programmes.
46) The composition and duration of appointments for all QA Committees should be reviewed, in conjunction with emerging clinical advisory committee structures.
47) The QA Committees should review and confirm the adequacy of the arrangements within their respective screening programmes for introductory training and continuing staff development, as well as the arrangements at all levels in the quality system for identifying and appropriately responding to inadequate technical or clinical performance.
48) NSS should consider, with external assistance, the relevance of the HSE policy on ‘Open Disclosure’ as it develops in light of this Scoping Inquiry, for all of its screening programmes.
49) The Department of Health should consult with interested parties as to how women and families who wish to, can be facilitated in meeting with the clinician who was involved with their care and/or disclosure.
50) The Department of Health should encourage and facilitate (but not necessarily participate in) a meeting involving the presidents of the Medical Council, the Royal Colleges and their faculties, leaders of other leading medical organisations and representatives of the women and families involved with the cervical screening problems.