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Healthcare Associated Infections - Inspection, Assurance and Public Confidence Consultation Paper



1. This consultation paper proposes arrangements to build public confidence in the NHS through further development of scrutiny and inspection arrangements with a particular focus on the quality of the clinical care environment and its impact on healthcare associated infections. The aim of the consultation is to seek views on the nature and scope of the proposed inspections; the related public engagement mechanisms; and reporting and publication arrangements.


Vale of Leven Inquiry

2. The report of the Independent Review Team, set up to review the outbreak of Clostridium Difficile (C.diff) at the Vale of Leven Hospital, was published in August 2008. The report identified a number of shortcomings in terms of governance, infrastructure, professional practice and leadership. The Scottish Government considers that the current arrangements to review infection outbreaks at all levels are not sufficiently sensitive to detect the issues which created the environment for the C.diff outbreak. Accordingly, The Cabinet Secretary for Health and Wellbeing has identified a need for a more transparent process of external assurance that will provide reports to the public that the care environment is clean and safe; that processes are in place to detect and tackle Healthcare Associated Infection ( HAI) and related issues; and that the necessary governance, infrastructure, professional practice and leadership arrangements are robust.

Wider Scrutiny Context

3. The Crerar Review considered how Scotland's system of external scrutiny in the public sector could be improved. The outcome of the review suggested that the core purpose of external scrutiny is to provide independent assurance within a wider performance management and reporting framework. Independent assurance is intended to demonstrate that services are well managed, safe and fit for purpose, and that public money is being used properly. Five guiding principles were described as follows:

  • public focus
  • independence
  • proportionality
  • transparency
  • accountability

4. In considering how best to strengthen NHS inspection, it will be important to have regard to Crerar's principles and guidance, and to the Scottish Government's ongoing work to simplify the wider public sector landscape. In the healthcare context, these factors translate to a scrutiny model which is:

  • focused on areas requiring public assurance,
  • based on self assessment,
  • located in an existing scrutiny body,
  • targeted rather than based on cyclical inspection,
  • placing a strong emphasis on transparent and accessible public reports, and
  • accountable to Scottish Ministers and reporting to the Scottish Parliament

Scope of Strengthened Inspection

5. Having examined a number of international inspection models as well as looking at existing inspection arrangements in Scotland such as the Mental Welfare Commission and the Care Commission, we have identified seven dimensions where checks against standards of care may be of value:

  • safety
  • clinical and cost effectiveness
  • governance
  • patient focus
  • accessible and responsive care
  • care environment and amenities
  • public health.

6. In Scotland each of the seven dimensions above is the subject of scrutiny through NHSScotland accountability and performance management arrangements; existing NHS Quality Improvement Scotland ( NHSQIS) reviews; and other approaches such as the work done by the Scottish Health Council. For example, NHS performance on access is actively managed through the Scottish Government performance management arrangements and the Scottish Patient Safety Programme is starting to deliver real improvement.

7. However, the Scottish Government takes the view that, in the area of the care environment, the disaggregated nature of the existing approaches and the variety of reporting arrangements make a coherent model spanning the NHS difficult to achieve. It is also difficult for the public to determine how well their NHS Board or local hospital is performing, not least in relation to cleanliness and infection control. This suggests that while we should continue to address all of these areas in the round, we require a particular focus on the quality of the care environment and application of hygiene and cleanliness standards.

8. This approach is intended to ensure that healthcare organisations meet basic expected levels of performance; and to assess whether organisations are improving. The aim is to measure the things that matter to patients. The information from HAI Inspection will be publicly available. In addition, there will be added leverage for ensuring compliance and improvement through requirements set out by Scottish Ministers. The proposed approach will build on learning from previous scrutiny in this area and will supersede that scrutiny. The aim will be to bring together more effectively the various strands of compliance activity; including work on cleaning and hand hygiene. It will sit alongside the complementary work of the Scottish Patient Safety Programme.

9. The inspections will focus on the care environment in its widest sense. That should include:

  • infection control practice (from screening to discharge arrangements);
  • application of hygiene and cleanliness standards;
  • waste management;
  • the physical fabric of the accommodation (including design and quality of the built environment);
  • standards and configuration of essential equipment;
  • access arrangements for visitors etc;

It is also proposed that the inspections will also seek to test clinical governance related to these areas and the levels of understanding and compliance of all healthcare workers.

Inspectorate and Model of Inspection

10. In the context of the principles for effective public sector scrutiny and the intention for the delivery of an enhanced, more independent and more transparent model of scrutiny focused on the quality of the care environment, the proposed arrangements will be delivered by a new Inspectorate based in NHSQIS. The Inspectorate will comprise a core team of Inspectors plus a number of co-opted experts. The functions of the Inspectorate will be to:

  • develop a proactive and assertive approach to NHS Board self assessment and supporting evidence requirements,
  • establish a robust methodology for the analysis of that evidence for the purposes of validation, risk assessment and targeting for scheduled and random inspections,
  • ensure rigorous inspections, drilling-down from NHS Board level to hospital level down to ward / clinical level,
  • provide continuous oversight of NHS Board improvement plans,
  • make its findings public,
  • make recommendations to Scottish Ministers.

11. Annex A sets out a proposed process. Scottish Ministers will require NHS Boards to co-operate with the Inspectorate including the completion of self assessment, making arrangements for any visits, publishing improvement plans and acting on recommendations. These arrangements will also require NHS Boards to fully involve their Public Partnership Forums ( PPFs) in providing a mechanism for public engagement. Boards will be required to involve their PPFs in self-assessments and to agree the basis of their improvement plans with their PPFs.

12. In summary, the proposed Inspection process would be as follows:

(a) Inspectorate issues annual self assessment template based on best practice standards and local and national intelligence;

(b) NHS Boards complete self assessments for each hospital involving their PPF in the process;

(c) Inspectorate analyse self assessment and identify risks;

(d) Inspectorate carries out 'unannounced' visits on the basis of identified risks. Every Board will be visited. Every acute hospital will be visited at least once in any 3 year period;

(e) Inspectorate prepares reports for each board and a national overview with an annual report provided to Ministers and the Scottish Parliament);

(f) Each Board publishes an improvement plan and uses this as a basis for demonstrating continuous improvement in managing HAI; and

(g) Inspectorate carries out follow-up visits within specified timeframes to review progress, delivery and compliance with improvement plans.

13. While this will ensure a more robust and finer grain review and inspection of NHS processes and facilities there remains a need to strengthen the independence of such arrangements. This will be addressed by NHSQIS providing reports from the Inspectorate to Scottish Ministers; and by copying those reports to the Scottish Parliament. Follow up action required would be through the existing Scottish Government Health Directorates performance management and accountability review processes. It will be for the Health Directorates, acting on behalf of the Scottish Ministers, and having regard to advice from the Inspectorate, to determine what action to take against Boards where there is a failure to improve.


14. While additional resources will be necessary in terms of setting up and running the Inspectorate, these costs will be found within existing NHS resources, and will be offset by savings made in the prevention of infectious disease outbreaks.


15. These proposals are based on a more developed, coherent and integrated use of existing arrangements in response to the findings of an independent Review commissioned by Scottish Ministers. While we are now consulting on the practical implications of the model described above, the focus of this consultation is on implementation (as compared to consultation about whether to implement). Given that this approach is based on an enhancement of existing arrangements, consultation responses are sought from NHS Boards, and through them from each Public Partnership Forum; and the Scottish Consumer Council. Consultation questions are set out at Annex B. Consultation responses should be sent to Colin Brown at colin.brown3@scotland.gsi.gov.uk by Friday, 12 December 2008.


16. The aim of the proposed new inspection arrangements is to enhance scrutiny, assurance and public confidence through more rigorous and more integrated processes, and through those processes to reduce risk to patients. These proposals offer the opportunity to introduce inspection arrangements which are more transparent with greater coherence, oversight and direction than is the case at present.

Healthcare Policy & Strategy Directorate
11 November 2008