GLOUCESTERSHIRE HOSPITALS NHS FOUNDATION TRUST

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1 GLOUCESTERSHIRE HOSPITALS NHS FOUNDATION TRUST REGISTERING WITH THE CARE QUALITY COMMISSION IN RELATION TO HEALTHCARE ASSOCIATED INFECTION 1.0 Purpose To inform the Board of a new requirement for NHS Trusts to register with the Care Quality Commission between 12th January and 6 th February Background 2.1 The new Care Quality Commission (CQC) has been established under the Health and Social Care Act 2008 to bring together independent regulation of health, mental health and adult social care from April The first stage in this process is a new system for registering and assessing NHS organisations against requirements concerning healthcare associated infections (HCAI). The final submission will need to be endorsed by the Trust s board, and the Chief Executive must sign the final application. There will be no fee for HCAI registration in : Te 3.0 Summary of the new arrangements 3.1 The new NHS HCAI registration system is underpinned by a restructured hygiene code. The code sets out compliance criteria that the CQC will use to monitor whether trusts are complying with the regulations. The CQC assert that trusts which already meet the existing code s good practice, or that have credible plans to deal with any shortcomings in a timely fashion, will not have to undertake any major new, extra work relating to HCAI in order to apply for registration under the new system. 3.2 The key difference is that trusts must, by law, comply with one overarching regulation about HCAI, which requires them to operate in a way that, as far as practicable, protects patients, workers and others from identifiable risks of acquiring an HCAI. Trusts must publicly state, in their application form, whether they comply (and will continue to do so). If the CQC determine that a trust does not meet this registration requirement then they may not be able to register it. An unregistered trust that continues to provide healthcare would be committing a criminal offence and may be prosecuted. 3.3 The CQC may require a trust that they register to make changes and there will different classes of registration. The CQC will use available information to cross-check trusts applications - similar to the way that the Healthcare Commission cross-checks annual health check declarations. The outcome of the new registration system, however, will be different. The CQC will tell trusts what registration classification they have decided upon ( registered, registered with conditions and not registered ). 3.4 The response to any subsequent failure to meet the legal requirement or any imposed conditions will also be different under the new system of regulation. The CQC new powers range from warning notices through to prosecution for trusts with the most serious failings. 3.5 The CQC will encourage trusts to publish their registration applications, in a similar way to the Healthcare Commission s current expectation that trusts will publish their annual health check declarations and the CQC will publish the register. Registering With The Care Quality Commission Page 1 of 6

2 4.0 What trusts can do before applying 4.1 These regulations are underpinned by the nine compliance criteria of the revised code. These are attached at appendix 1. The Trust can therefore prepare for registration by considering the documents issued for consultation by the DH. 4.2 The Healthcare Commission is publishing a mid-term briefing on the emerging findings of the 2008/09 round of acute trust HCAI inspections. This report will give trusts an idea of the most common shortcomings measured against the current hygiene code, and what trusts should be doing to rectify them before applying for HCAI registration. 4.3 During November and December 2008, the CQC will be holding a series of events to help explain to trusts what is involved in HCAI registration. The Director of Corporate Governance & Facilities and Director of Nursing are attending an event in November Registering with the Care Quality Commission in relation to healthcare associated infection The CQC will use available information to identify trusts that are most at risk of failing to protect patients from HCAI and will then systematically target their registration assessment activity. The information available to the CQC includes: The views of local people about their experiences of healthcare (drawn, for example, from the national patients surveys). Trusts most recent declaration for the core standards relevant to HCAI. Evidence from the Healthcare Commission s current HCAI inspection programme. Data about HCAI rates supplied by the Health Protection Agency. Patient Environment Action Team reports. Issues raised by Monitor in relation to foundation trusts declarations. Issues raised by strategic health authorities. A screening dataset of outcome and other information. 6.0 Registration decisions 6.1 The application form will ask trusts to state whether they meet each of the nine criteria described in the revised hygiene code. Based on this (cross-checked against the other available information above, plus follow-up enquiries with trusts where necessary), the CQC will make their registration decisions. A summary of the proposed registration categories are set out in Appendix Examples of conditions under conditional registration might include: A condition to produce a plan. a statement of action to comply addressing the issues that the CQC are concerned about and detailing the specific actions that the trust will take within an agreed time to rectify the shortcomings. The CQC might specify that a report be produced describing progress against an action plan. The trust will need to have discussed the plan and progress with the strategic health authority or Monitor (and, when appropriate, with those commissioning services) A more specific condition, such as having to close a problematic isolation ward or decontamination unit until improvements have been carried out. It could even be to close a service or site. 6.3 The CQC might choose to visit a trust to verify that the necessary actions set out in any conditions have been taken. Once the problems are resolved and the CQC is assured Registering With The Care Quality Commission Page 2 of 6

3 that the trust meets the registration requirements, they will review the classification with a view to making the trust registered without conditions. 6.4 All applications that may potentially be in categories other than unconditional registration will be further reviewed by a team of HCAI risk assessors. The team may contact trusts to discuss the evidence with a view to understanding the extent of any risk of non-compliance and obtaining the trust s agreement to any remedial action considered necessary. 7.0 Surveillance and selective inspection 7.1 The CQC will continue to monitor information about trusts throughout the year, and will use this information to help target our further inspection activity, including visiting. The CQC will continue the inspections of acute trusts that the Healthcare Commission is carrying out during 2008/09. Higher risk trusts, the ones where it is more likely that things could go wrong and where the screening analysis at the time of registration indicates that some systems may be relatively weak, are likely to be visited first. There will also be an element of random sampling, and therefore some fully registered trusts might also be visited early in 2009/ Information arising from surveillance and inspection after the initial registration decisions have been published on 1 April 2009 will be used for ongoing monitoring of compliance with the criteria set out in the Code of Practice and the regulations. The registration classification of trusts is therefore subject to change. 8.0 Enforcement 8.1The CQC will encourage improvement wherever possible, but if a Trust fails to meet the legal requirements of its registration, they may take enforcement action. The CQC is consulting on their overall policy on enforcement and a separate document provides more detail on how it intends to use the enforcement powers. 8.2 In summary, the CQC will have the power to: Issue a warning notice. Issue a penalty notice, in lieu of prosecution. Prosecute for specified offences (for example, failure to be registered, failure to comply with registration requirements, failure to comply with conditions). Impose, vary or remove conditions of registration (by either the normal or urgent process). Suspend registration for a period of time (by either the normal or urgent process). Cancel registration outright (by either the normal or urgent process). 9.0 Recommendation The Board is asked to: NOTE the requirement for registration with the Care Quality Commission 10.0 Next Steps The Directors of Corporate Governance & Facilities and Nursing will review the Trust s position in relation to the published criteria Author and Presenter: Graham Lloyd Director of Corporate Governance & Facilities November 2008 Registering With The Care Quality Commission Page 3 of 6

4 GLOUCESTERSHIRE HOSPITALS NHS FOUNDATION TRUST Appendix 1 CRITERIA SET OUT IN THE CODE OF PRACTICE Trusts will be required to state whether each criterion is: Met Partly met Not met Criterion 1: The trust has in place and operates effective management systems for the prevention and control of HCAI that are informed by risk assessments and analysis of infection incidents Criterion 2: The trust provides and maintains a clean and appropriate environment that facilitates the prevention and control of HCAI Criterion 3: The trust provides suitable and sufficient information on HCAI to patients and the public and to other service providers when patients move to the care of another healthcare or social care provider Criterion 4: The trust ensures patients presenting with an infection or who acquire an infection during treatment are identified promptly and receive appropriate treatment and care to reduce the risk of transmission Criterion 5: The trust gains the co-operation of staff, contractors and others involved in the provision of healthcare in preventing and controlling infection Criterion 6: The trust provides or can secure adequate isolation facilities Criterion 7: The trust secures adequate access to laboratory support Criterion 8: The trust has, and adheres to, appropriate policies and protocols for the prevention and control of HCAI Criterion 9: The trust ensures, so far as is reasonably practicable, that healthcare workers are free of and are protected from exposure to communicable infections during the course of their work, and that all staff are suitably educated in the prevention and control of HCAI Registering With The Care Quality Commission Page 4 of 6

5 GLOUCESTERSHIRE HOSPITALS NHS FOUNDATION TRUST Appendix 2 Proposed registration categories The evidence Core Quality Commission s conclusions Registration Category 1. A trust states that it complies with the HCAI regulations and has robust systems in place to meet the nine compliance criteria of the hygiene code. 2. The Commission determines that minor weaknesses in relation to the criteria exist (which the trust may or may not have itself declared). 3. Evidence provided by the trust in its application or otherwise available to the Commission leads us to determine that there are significant weaknesses relating to compliance criteria resulting in a significant risk that the registration requirements are being or may be breached The Care Quality Commission s cross-checking does not reveal any information to challenge the trust s application The Commission concludes that there is little likelihood of the registration requirement being breached leading to actual harm to patients. An agreement with the trust will provide a proportionate resolution because we are confident (in partnership with the strategic health authority or Monitor) that the necessary improvements will be achieved in a timely fashion. The agreement would normally be backed up by a trust statement (available publicly) setting out how it is strengthening its systems and by when. We conclude that the imposition of registration conditions or formal enforcement action will not achieve those improvements any faster or make them more likely to happen. The commission determines that a significant risk of harm to patients exists and that action is required. There might be specific issues, such as the adequacy of isolation facilities. Or there might be a large number of ongoing minor breaches demonstrating cumulatively that a trust s general management systems are failing to protect people, requiring further investigation. There is a risk that the trust may not achieve the necessary improvements in a timely fashion and therefore safeguard patients - unless we attach conditions to registration Registered Registered (It is agreed that an area of concern will be improved, but the concern is NOT listed on the registration certificate) Registered with conditions Registering With The Care Quality Commission Page 5 of 6

6 Proposed registration categories The evidence Core Quality Commission s conclusions Registration Category 4. Evidence exists of significant weaknesses and there is a serious risk to life, health or well-being of patients 5. A trust fails to submit an application before the deadline, or submits an incomplete application. If the Commission determines that the safety of patients cannot be assured, then we may refuse registration. This is extremely serious because a trust will not be able to continue providing services without being registered. As described further below, depending on the circumstances, we may allow the trust to continue providing services while alternative arrangements are put in place. In making this decision, we will focus on the needs of patients and balance the risk of threatening service continuity against the risk of allowing these services to continue in such circumstances. An incomplete application means that the Commission may not be able to assure itself that the trust is complying reliably with the registration regulation. We will seek the missing information when possible. If sufficient information becomes available, then it may be appropriate for us to register with conditions. 6. As (5) The Commission can only reach a decision based on what is available to us and therefore, depending on what has been omitted from the application, we may not be able to register the trust. Where the Commission is unable to make a registration decision, then from 1 April 2009 the trust is committing the offence of not being registered. As described under (4), this is extremely serious. To help ensure this scenario does not arise due to administrative oversight by a trust, we will be in regular contact with NHS providers between now and February 2009 to help ensure that trusts have all the information they need to provide a complete and accurate application. Not Registered Registered with conditions Not registered Registering With The Care Quality Commission Page 6 of 6

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