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 NHSthe annual health checkand
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:
probityall 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 visibledisplaying
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
visitsa 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 patientin 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 deathand 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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