Select Committee on Health Written Evidence


Supplementary evidence submitted by the Healthcare Commission (ISTC 36A)

INTRODUCTION

  1.  The Healthcare Commission was pleased to submit written and oral evidence to the inquiry. We hope that this supplementary submission will help to address the Committee's outstanding questions.

  2.  A principal reason for establishing the Healthcare Commission in 2004 was to create a single system of regulation that ensures high standards of care for patients wherever they are treated. Our focus is on assuring the same high standards of care for all. However, our responsibilities in the NHS and independent sectors still derive from different legislation (Health and Social Care Act 2003 and the Care Standards Act 2000 respectively), so drawing direct comparisons between our work in the two sectors at this stage is not always straightforward. For example, in the NHS we have a statutory role to deal with second stage complaints. In the independent sector, we have no such role, so the numbers of complaints received on a given issue are not comparable. It is also worth noting that the Care Standards Act 2000 confers responsibility on the Commission to pursue enforcement action against independent healthcare providers that do not to address failures of compliance with standards, but no such powers are available to us in the NHS.

  3.  We recently consulted on proposals for modernising the way we regulate independent healthcare. In particular, we asked for feedback on the way in which we will align it with our new system for assessing the NHS—the annual health check—and how (within the existing primary legislative framework) we plan to move towards aligned regulatory systems by 2008. These proposals are a major step forward in this work, however, directly comparable systems can never be achieved until there is a single legislative framework for healthcare. This will also be necessary to address anachronisms within the Care Standards Act that did not anticipate new technologies and service models in the rapidly changing healthcare environment.

  4.  Subject to the outcome of the current review of regulation and any subsequent legislation, we expect to integrate with the Commission for Social Care Inspection (CSCI) and the Mental Health Act Commission (MHAC) by 2008. We believe the drafting of primary legislation to create the new organisation will provide an excellent opportunity for more fundamental review of the legislative framework for regulating the NHS and independent sectors to allow more direct comparisons. We would welcome the Health Select Committee's views on this point.

  5.  Our long-term aim is for assessments to be based on a set of standards that have a stronger focus on the outcome of care.

  6.  The need for comparable data also needs to be addressed. We make secondary use of numerous data and information flows in our NHS work (eg routine reporting for statutory returns and hospital episode statistics (HES)), and such routine reporting does not exist for the independent sector. The ISTC contracts have requirements for the return of HES data, but this information flow is new and not yet matured. We are keen to redress this, and to have more routine data available from the independent sector for screening and surveillance, and have agreed a process with the providers for 2006-07. In the interim, we have been and will continue to work closely with the Department of Health and healthcare providers to move towards a system that allows direct comparison between providers from different sectors.

  7.  A more immediate aim for us, which is one of our three key strategic objectives for 2006-07, is to maximise opportunities to publish information for our target audiences in ways that are accessible and meet their needs. We will also aim to be more explicit, particularly for patients and the public, in designing our work in order to make publications as informative as we can. We want to improve our process for reporting findings on providers of the NHS and independent sector, achieving comparability wherever feasible and desirable, and to work with others to create more comprehensive sources of information for patients and the public.

  8.  Our consultation on alignment is now closed but the consultation document is available on our website at www.healthcarecommission.org.uk. We expect to publish the results shortly.

SPECIFIC QUESTIONS POSED BY THE COMMITTEE

(1)  Instances of good practice and innovation in ISTCs which the Healthcare Commission would hold up as exemplary

  9.  Instances of innovation that we have found in the ISTCs include:

    —  the use of mobile facilities, where the provider supplies clinical services from mobile units in a variety of settings (Netcare Healthcare UK Limited). The sites are agreed with the Healthcare Commission in advance and improve access for patients in remote areas (the "host" sites are included as a condition of the registration of the facility);

    —  construction of new facilities designed around the clinical flow of patients which supports increased productivity. These environments support a seamless experience for patients. For example, patients who require services from a variety of departments, such as pathology, imaging and cardiology, have a "one stop" experience in a designated area. An example of this is the Peninsula Treatment Centre in Plymouth, a surgical facility serving Devon and Cornwall operated by Partnership Health Group Limited (PHG).

  10.  Instances of good practice that we have found in the ISTCs, but which are not exclusive to ISTCs, include:

    —  blood conservancy and recycling techniques that reduce the need for transfusions;

    —  administering local anaesthetic instead of general anaesthetic for primary joint replacements, which reduces the anaesthetic risk and lengths of stay;

    —  using techniques for pain management to allow post-operative physiotherapy to commence earlier;

    —  improved use of stock, eg prostheses;

    —  introducing peer review of post-operative x-rays for orthopaedic patients as a quality control measure.

(2)  Any assessment made of the impact on local health economies of relaxing rules of additionally for Phase 2 ISTC contracts

  11.  We have not carried out a systematic, prospective assessment on this issue. Over the last year, the Commission has been setting up regional teams throughout the country, with offices in Bristol, Leeds, London, Manchester, Nottingham and Solihull. We believe that working locally will allow us to build relationships and work more closely with healthcare organisations, healthcare professionals, partners, patients and the public. This new local presence will allow us to gather information and knowledge to better understand local issues. We are happy to consider using our local teams to advise DH on the impact of relaxing the rule on additionality in the future if that would be helpful.

(3)  How many inspections of ISTCs has the Commission performed? Can you give an overview of the results of these inspections to date?

  12.  In the last year we carried out 7 routine inspections and 17 post implementation monitoring visits.

  13.  The Healthcare Commission registers ISTC facilities in England. A service must be considered fit before it can be registered. This means that the service must have satisfied a range of requirements covering such areas as:

    —  probity—all people associated with the service must be honest, truthful and be of professional and ethical standing;

    —  the service must be efficient and effective;

    —  it must be possible to hold the service accountable for its activities. It must be publicly visible—displaying transparency in its practices and procedures; and

    —  there must be good clinical governance, with systems in place to ensure that people are treated safely, effectively and appropriately.

  14.  Before registration is granted, the service is assessed by such means as site visits, interviews, checks through the Criminal Records Bureau and financial checks.

  15.  Once a service is registered it is included in a programme of annual inspections. These inspections are undertaken by teams of specialist inspectors and may include clinicians, nurses, pharmacists, and other health care professionals could be involved. The duration of the visit varies according to the type of facility being inspected. A large hospital may require several days of inspection involving four or more inspectors. By contrast a smaller facility may have a shorter visit from a single inspector who has specialist knowledge of the service in question.

  16.  Following an inspection, a report is published and made available to the public. The report summarises the results of the inspection and gives details of where regulations have been breached or standards have not been met. It also sets out guidance on the improvements needed, and the times by which changes should be made. In response, the providers must produce a detailed action plan showing how they will meet the requirements of the report. All reports can be accessed via the Healthcare Commission's website.

  17.  Where problems are identified in the course of our work, an action plan is agreed with the provider and implementation followed up through evidence (eg copy of a new policy or meeting minutes) or visit.

  18.  From our inspections to date, a strong theme that has emerged in the need for more robust risk management arrangements. These include areas such as:

    —  Improving and implementing policies and procedures across a range of topics;

    —  Establishing robust service audit programmes;

    —  Introducing shared governance arrangements where services are hosted by NHS trusts;

    —  Ensuring clear and well monitored service level agreements; and

    —  Improving arrangements for reporting untoward incidents.

  19.  Most ISTCs have been new facilities and many run by providers new to the UK. Inevitably there have been teething problems and this is why we initiated the six-month visits—a new approach adopted specifically for Phase 1 of this programme. From this body of experience our overriding impression has been that providers are keen to learn and improve; the vast majority been very willing to work with us to address any problems positively. Examples of responses have included improving operational policies and holding special staff meetings to ensure lessons are learned.

  20.  Detailed information on the outcome of our inspection activity is included in Appendix 1.[3]

Can you give a view on how the ISTCs compare with NHS providers and with other independent providers?

  21.  We will be moving towards providing this kind of information as our work becomes more aligned across different sectors. As mentioned in the introduction, routine data and information reporting does not exist for the independent sector in the same way it does for the NHS (where we make secondary use of numerous routine information flows). The ISTC contracts have requirements for the return of HES data, but this information flow is new and not yet matured. A further issue is that most NHS information is collected at institutional level, whereas ISTCs equate to sub-departments of hospitals. This further affects information comparability.

  22.  We are keen to redress this, and to have more routine data available from the independent sector for screening and surveillance, and have agreed a process with the providers for 2006/2007 to begin collecting these.

Can you give examples of the main problems that have been found, and how these were resolved?

  23.  The types of issues that been identified are summarised above. The broad process for follow-up has been described and the detailed actions for individual providers are set out in the table.

(4)  Can you provide a summary of the complaints made to ISTCs over the last 12 months, by type and nature, and how these were resolved?

  24.  The Commission does not have a statutory role in handling the private sector second stage complaints as we do in the NHS. The focus of our inspections in the independent sector is on how providers themselves deal with complaints. We do not routinely record the nature of those complaints. There are detailed requirements under the National Minimum Standards for complaints handling and these are assessed as part of the inspection regime. Our work has indicated there are no particular problems with complaints handling within ISTCs. There is a statutory duty on providers to notify the Commission of any serious incidents under regulation 28 (see Para 27 below).

  25.  However, the Healthcare Commission does received written complaints about independent healthcare providers where providers have been unable to satisfy complainants. In any given year we receive around 200 complaints relating to the acute sector as a whole. To date the Commission has received one complaint about an ISTC, as we noted in our submission.

  Is it possible to compare these with complaints made about other independent providers and NHS providers?

  26.  As noted above we do not have comparable roles regarding complaints within the independent healthcare and NHS sectors. We do not collect details of all complaints made to providers but rather focus on complaints handling. Only one formal complaint has been received by the Commission regarding ISTCs and hence no generalisable lessons can be drawn from complaints.

(5)  Can you provide a summary of the number of notifiable events received from ISTCs, by organisation, and by type of event, over the last 12 months, and whether these were followed up (indicating how long each organisation has been registered with the Commission)?

  27.  In the last year we received 84 notifications of events from ISTC providers under Regulation 28. Regulation 28 covers:

    —  the death of a patient—in an establishment; during treatment provided by an establishment or agency; or as a consequence of treatment provided by an establishment or agency within the period of seven days ending on the date of the death—and the circumstances of the death;

    —  any serious injury to a patient;

    —  the outbreak in an establishment of any infectious disease which, in the opinion of any medical practitioner employed in the establishment, is sufficiently serious to be notified; and

    —  any allegation of misconduct resulting in actual or potential harm to a patient.

  28.  The reporting system is new for some ISTC providers; with some needing to adjust to the requirements. This means the types of events deemed notifiable have varied between providers. Where events have been notified, we have followed up as required and this has included feedback about the appropriateness of the notification. This means the absolute numbers of notifications is not yet a good indicator of safety or quality.

  29.  Analysis of the notifications shows a spectrum of seriousness (see Appendix 2), but taking account of the variations noted above, this is not thought to represent an abnormal pattern for services of this sort. We will, however, keep this under review.

  Is it possible to compare the number of notifiable events recorded by ISTCs with those recorded by other independent providers and by NHS providers?

  30.  Currently, NHS trusts do not directly report these kinds of incidents to the Healthcare Commission. Details are sent to strategic health authorities for non-foundation trusts or to Monitor for foundation trusts. This is because historically this has been dealt with as an aspect of performance management rather than regulation. Even if this information were collected in one place, at this point comparing it would be complicated as the two sectors use different definitions.

  31.  Clearly, with more patients moving between sectors we need to address this. Identifying this anomaly has been a key learning point from Phase 1 and we plan shortly to open discussions with the Department of Health and other stakeholders to explore how we can work to bring together this type of notifiable information into a format that allows inferences to be drawn across sectors.

(6)  How many ISTCs have you investigated? Have you been asked to carry out any investigations into ISTCs, and, if you decided not to, what were the reasons for this?

  32.  Where the Healthcare Commission has serious concerns about the provision of healthcare it will consider whether it needs to conduct an investigation. Triggers that might alert the Healthcare Commission to the potential need for an investigation include:

    —  direct contact from patients, the public, NHS staff or the media;

    —  issues brought to light during Healthcare Commission's screening processes, reviews or visits;

    —  trends or issues highlighted in the monitoring of complaints which reach the independent stage; and

    —  requests from the Secretary of State and Welsh Assembly Government in respect of cross border special health authorities, or from other inspectorates.

  33.  The criteria used to determine whether to instigate an investigation include:

    —  a higher number than anticipated of unexplained death(s);

    —  serious injury or permanent har million, whether physical, psychological or emotional;

    —  events which put at risk public confidence in the healthcare provided, or in the NHS more generally;

    —  a pattern of adverse effects or other evidence of high-risk activity;

    —  a pattern of failures in service(s), or team(s), or concerns about these; and

    —  allegations of abuse, neglect or discrimination against patients (particularly those less able to speak for themselves or assert their rights).

  34.  In determining whether to investigate, the Healthcare Commission will consider the extent to which local resolution, referral to an alternative body, or other action might offer a more effective solution.

  35.  We have received no requests for an investigation into an ISTC. Furthermore, we have been satisfied any concerns coming to light in the course of our work have been addressed appropriately by providers and are subject to monitoring by our inspectors.

Anna Walker

Healthcare Commission

April 2006





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