Evidence submitted by the Healthcare Commission
(ISTC 36)
1. INTRODUCTION
The Healthcare Commission exists to promote
improvements in the quality of healthcare and public health in
England and Wales.
1.1 In England, we are responsible for assessing
and reporting on the performance of both the NHS and independent
healthcare organisations, to ensure they are providing a high
standard of care. We also encourage providers, in both the public
and independent sectors, to continually improve their services
and the way they work. In Wales, our role is more limited and
relates mainly to working on national reviews that cover England
and Wales, as well as to our annual report on the state of healthcare.
1.2 In the first part of this submission
we set out the role the Healthcare Commission plays in regulating
independent sector treatment centres (ISTCs). In the second part
of our submission we go on to cover some of the specific points
raised by the Committee in its terms of reference.
2. THE REGULATION
OF INDEPENDENT
SECTOR TREATMENT
CENTRES
In April 2004, the Healthcare Commission took
over responsibility for regulating the independent healthcare
sector, which was previously the responsibility of the National
Care Standards Commission (NCSC). [45]
2.1 As we move from an NHS very largely
provided by NHS suppliers to one in which at least 15% of services
are likely to be provided in the independent sector, it is important
that the opportunities for mutual learning within the ISTC programme
are seized. It is important too that the different elements of
the two regulatory regimes which the Commission operates, covering
both the NHS and the independent sector—including NHS care
by providers in the independent sector—are deployed to the
greatest benefit of patients.
2.2 There are currently 19 ISTCs registered
and running, with 11 more due to be registered as part of the
first phase of ISTCs. A complete list of Phase 1 ISTCs is available
in appendix A. The regulatory regime for ISTCs will need to develop
as the learning from the first phase is drawn out.
2.3 The Healthcare Commission has a number
of mechanisms for regulating quality of care in ISTCs. ISTCs are
subject to the same regulation and inspection regimes as all other
independent healthcare providers. Currently, our work in this
area is undertaken by a specialist central team. Over time, the
registration and inspection process will pass into the mainstream
regulatory activity of our regional teams. The Healthcare Commission
uses the Department of Health's national minimum standards, [46]and
the statutory requirements that accompany them, as the basis for
regulating ISTCs. In addition, ISTCs are subject to two further
procedures. Our specialist team undertakes an additional post-registration
monitoring visit (see paragraph 2.7); and NHS patients treated
in ISTCs can access both the NHS and the independent sector complaints
procedures.
2.4 Our mechanisms for regulating ISTCs
are set out in the linked processes below.
2.5 Registration
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:
— compliance with regulations;
— demonstration that national minimum
standards are met;
— probity—all people associated
with the service must be honest, truthful and be of professional
and ethical standing;
— it must be possible to hold the service
accountable for its activities. It must also display transparency
in its practices and procedures; and
— there must be good clinical governance,
with systems in place to ensure that patients are treated safely,
effectively and appropriately.
2.6 Before registration, the service is
assessed on these issues by examination of the organisation's
self-assessment form and by site visits, policies and documentation
review, interviews and checks through the Criminal Records Bureau.[47]
2.7 Post-registration monitoring visit
Our specialist team undertakes a monitoring
visit to ISTCs, usually within three months of registration, in
order to review how systems are bedding in. This visit is supplementary
to the usual inspection process for independent sector providers.
The clinical teams working in ISTCs will often be new, and many
include internationally recruited doctors and nurses, due to the
"additionality" rule, [48]ISTCs
must not recruit clinicians who have been working in the NHS for
the last six months. Such teams may not be used to working together
or to complying with current guidance. These visits assist providers
by offering advice to help them comply with the standards. It
supports our commitment to working with providers to identify
problems and find solutions.
2.8 Inspection
When a service is registered it is included
in a programme of annual inspection. [49]This
is undertaken by a team of specialist inspectors appropriate to
the particular service and could include nurses, pharmacists and
other health professionals. The duration of the inspection visit
varies according to the facility being inspected. Following an
inspection, a report is published and made available to the public
via the Healthcare Commission's website.
2.9 The report summarises the results of
the inspection and gives details of where we believe regulations
have been breached or standards have not been met. It also sets
out recommendations on the improvements needed and the times by
which changes should be made. In response, the providers are asked
to produce a detailed action plan showing how they will meet the
requirements and recommendations of the report.
2.10 Monitoring of complaints
The Healthcare Commission deals with complaints
about registered independent sector providers. Anyone can raise
concerns with us about a service (for example, by contacting our
helpline staff who will refer issues to our complaints team).
In the first instance, if a complaint is made to the Healthcare
Commission, we ask the provider to investigate the problem, respond
to the complainant and inform us of its response. We then consider
the provider's response and determine whether further action is
required. We may, for example, undertake an inspection to establish
whether there has been any breach of regulations and to assist
in the appropriate resolution of the complaint.
2.11 We also monitor how ISTCs and other
independent providers deal with complaints themselves. Regulations
require registered providers to supply a summary to the Healthcare
Commission annually of the complaints made during the previous
12 months and the action taken in response to these. Prior to
inspection, in the case of all acute providers, we ask about resolution
(timescales and whether complaints have been upheld) as well as
numbers of written and verbal complaints. Providers are also required
to keep records of the details, investigation and outcome of each
complaint, which the Healthcare Commission can access if appropriate.
2.12 All NHS patients treated in ISTCs also
have access to the NHS complaints system in addition to the independent
healthcare process outlined above. The Healthcare Commission has
a specialist team based in Manchester that deals with the independent
review of NHS complaints.
2.13 To date, the Healthcare Commission
has received one complaint against an ISTC, which may indicate
that any complaints made to the provider are successfully resolved
locally.
2.14 Monitoring of notifiable events
reporting
The Healthcare Commission monitors the reporting
of serious events. Providers are required to inform us within
24 hours of the following incidents:
— 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.
2.15 When a notification is received, the
lead assessment manager determines if the event requires any further
information to be submitted or followed up. Where necessary, an
inspection or investigation may be undertaken.
Our new and developing methodology is designed
to ensure better targeting of inspections. As part of this, we
are working with experts in the field on the development of more
detailed performance indicators looking at patient outcomes. This
will include the notifiable events above, and will also cover
other clinical and non-clinical indicators. These indicators will
be drawn from information already collected by providers; however
we will be working with them to ensure that it is collected in
a consistent and comparable way. We anticipate this information
being submitted on a quarterly basis. Notifiable incidents will
still need to be reported within 24 hours.
2.16 Investigations
All concerns raised with the Healthcare Commission
are given an initial consideration before a decision is made whether
to investigate. During the initial consideration process we gather
information about the service from a range of sources including
strategic health authorities, primary care trusts, the Department
of Health and professional bodies. The Healthcare Commission can
make recommendations without an investigation having to be carried
out, and undertake announced and unannounced visits.
2.17 Enforcement
If providers do not make the necessary improvements
following an inspection or where the Healthcare Commission thinks
there is a risk to the health and welfare of patients and users
of services, we have legal powers to act appropriately to safeguard
patients. The Healthcare Commission has a range of enforcement
options available to it.
2.18 Enforcement notices are issued where
it is considered that a service has failed to comply with the
regulations, and the risk to patients is such that the provider
should be compelled to take action. The provider is given time
to remedy the problem, but if the problem is not resolved, prosecution
for breach of the regulations may follow. Our other enforcement
mechanisms include a power to impose conditions on a registration
and, on certain grounds, to cancel a registration.
2.19 The regulatory system enables the Healthcare
Commission to act on behalf of patients and users of ISTCs to:
— monitor the protection of vulnerable
people using these services;
— ensure that patients and their families
know what standards to expect;
— ensure that arrangements to assure
safety and quality are in place; and
— bring together standards and criteria
that will enable a similar approach to assessments and inspections
to be adopted across all sectors of the health system.
2.20 The ISTC programme is part of a broader
initiative to create additional capacity within the NHS to reduce
waiting times and to introduce greater choice for patients. PCTs
and strategic health authorities define the requirements set out
in their contracts. The first wave of activity was arranged through
the general supplementary (GSupp) procurement process and this
contract was let by the Secretary of State for Health. These GSupp
contracts operated slightly differently to the formal first wave
of ISTCs. Independent sector providers involved in the GSupp contracts
remain subject to the Commission's regulatory regime.
3. ISSUES OUTLINED
IN THE
COMMITTEE'S
TERMS OF
REFERENCE
3.1 What is the main function of ISTCs?
ISTCs are designed to deliver a limited selection
of low risk, high volume elective surgery and diagnostic procedures.
The Department of Health's intention was for the independently
run clinics to deliver services for NHS patients with the advantage
that they would be unaffected by the seasonal and emergency demands
of the NHS. Primarily the ISTCs perform hip and knee replacement
surgery and cataract operations.
3.2 What arrangements are made for the follow
up of treatment provided to patients and for the management of
complications?
Arrangements for follow ups are part of the
discharge planning protocol which should be included in the integrated
care pathway for individual patients, as set out in the national
minimum standards. Under these standards the patient should be
advised of follow up arrangements prior to them being discharged
from the ISTC. Details should be recorded in the patient's health
record and a summary of this record sent to the patient's GP within
a locally agreed timescale (no more than four weeks). The provider
should have a policy in place outlining the management of complications
which includes transfer to another hospital where required. The
written information given to patients should include general risks
and risks specific to certain procedures, and complications associated
with the surgery or other treatments. Documented post-operative
instructions should be given to patients to take home after the
procedure. [50]
3.3 The Healthcare Commission checks these
arrangements by examining organisations' self-assessments and
through our inspection process. Our work with providers indicates
that a number of improvements are being made in follow up care.
For example, after a query from the Healthcare Commission one
provider has improved links with local trusts and formed an agreement
with consultants regarding the management of complications after
surgery. Patients now have the option of either returning to the
independent provider or to their local hospital for follow up.
The patients themselves are given written post-operative information
and staff now provide a follow up telephone call to patients the
day after surgery.
3.4 We believe it would be helpful to build
on this good practice by requiring ISTCs to draw up clearly defined
protocols on transfer arrangements, stating explicitly who is
responsible for making decisions and arrangements for transfers,
with clear time frames agreed. Both the ISTC and local NHS providers
must agree the arrangements and the protocol should be circulated
widely.
3.5 What role have ISTCs played and should
they play in training medical staff?
It is vital that nursing and medical students
receive appropriate experience and training. If it is anticipated
that ISTCs are to carry out a significant proportion of surgical
procedures, (primarily hip and knee replacements and cataract
surgery) then it will be important for nursing and medical students,
specialist nurses and junior doctors to receive training in ISTCs
in order that the education opportunities are optimised. While
this is happening in part we would like to see it rolled out to
all appropriate ISTCs.
3.6 We understand the Medical Royal Colleges
and Deaneries are currently considering introducing accreditation
for training in ISTCs and this would be a further welcome development.
3.7 Are the accreditation and appointment
procedures for ISTC medical staff appropriate?
ISTC providers are responsible for ensuring
that the people who provide treatment and care in their establishments
or on their behalf are appropriately skilled, qualified and competent.
Regulations require providers to have a written HR policy in place,
covering recruitment, induction and retention of employees and
their employment conditions. Detailed guidance relating to recruitment
of staff includes pre and post employment procedures, including
interview records, qualifications, employment references and appraisal.
[51]
3.8 Consultants who work in ISTCs have to
be on the Specialist Register of the General Medical Council.
The appointments procedure should include a recommendation by
the Medical Advisory Committee of the hospital where they have
applied to practise.
3.9 The Healthcare Commission checks these
arrangements during the registration process, by examining organisations'
self-assessments and through our inspection process. Consideration
should be given to aligning the recruitment procedure for ISTCs
with those for the NHS, including introducing an equivalent to
the advisory appointment committee system, which exists in the
NHS. We know that one independent provider of NHS care[52]
has reviewed its recruitment policy and taken the decision to
strengthen its appointments system. This good practice should
be encouraged.
3.10 Are ISTCs providing care of the same
or higher standard as that provided by the NHS?
This comparative information is difficult to
assess as the programme has been running for a relatively short
time with only 19 facilities registered to provide services to
date. A preliminary report by the National Centre for Health Outcomes
Delivery (NCHOD) in October 2005 suggested that the four ISTCs
studied provided a good level of care. [53]However,
anecdotally concerns have been expressed that ISTCs have excluded
some frail patients from surgery. We look forward to the final
report from the NCHOD, which will need to ensure that there has
not been such "cherry-picking"' of patients.
3.11 The Healthcare Commission is undertaking
a study looking at how best to gather information on the experiences
of patients in treatment centres and we will make the preferred
method available to all treatment centres in the near future.
3.12 What implications does commercial confidentiality
have for access to information and public accountability with
regards to ISTCs?
Due to the commercial sensitivity around the
tendering process, the Healthcare Commission has no formal involvement
until the preferred bidders are announced by the Department of
Health.
3.13 Members of the Healthcare Commission's
ISTC team provide informal guidance to potential providers relating
to compliance with national minimum standards and regulations.
Our relationship is with the individual provider and all information
is treated in the strictest confidence. Occasionally information
is shared with Concordat[54]
partners with the provider's consent.
3.14 What changes should the Government make
to its policy towards ISTCs in the light of experience to date?
It would be useful to see a formal evaluation
of Phase 1, identifying areas of learning. Our feedback from stakeholders
suggests the following areas could be considered:
— early discussion with local NHS trusts,
PCTs and clinicians to ensure a "no surprises" policy
and enable better planning across the local health community;
— further consideration of training
arrangements, which should include discussion with the medical
royal colleges and deaneries; and
— review of the additionality rule.
While this was initially introduced to counter fears of ISTCs
"poaching" staff from the NHS, anecdotally we hear it
has limited the opportunity for the exchange of staff and sharing
of good practice and experiences between ISTCs and the NHS. The
Department of Health has stated that this will be relaxed for
the second wave and we would welcome this.
3.15 It would be helpful to explore mechanisms
for ensuring that information and learning is being shared between
all relevant directorates within the Department of Health, especially
as there has been a high turnover of staff in this area.
3.16 What factors have been and should be
taken into account when deciding the location of ISTCs?
Geographical capacity gaps should be identified
by specialty within a clearly defined timescale, taking into account
the proposed date of the commencement of the service. This exercise
should involve the current NHS providers in consultation with
PCTs and strategic health authorities.
3.18 Consideration should be given to how
the addition of a new facility will impact on the local provision
of services. The interface with the local health community and
stakeholders needs to be considered. Such consideration should
include:
— location of ISTCs in relation to
local NHS providers;
— suitability of a "host"
site with a range of shared facilities;
— impact on training and recruitment
of staff;
— the need for specialist supporting
services;
— specific requirements for specialist
services such as paediatrics; and
— the potential involvement with and
inclusion in local networks such as cancer networks.
4. CONCLUDING
COMMENTS
The regulatory regime for ISTCs is still new
and developing and we anticipate that a broader picture of performance
will be built up over time. The Healthcare Commission is committed
to working with all providers of services to drive improvements
in patient care.
Healthcare Commission
February 2006
45 45 Our duty to regulate independent healthcare is
laid out in the Care Standards Act 2000 (as amended by the Health
and Social Care (Community Health and Standards) Act 2003). Details
of what we regulate are given in the Care Standards Act and Private
and Voluntary Healthcare (England) Regulations 2001. Back
46
The Department of Health's National Minimum Standards and Regulations
for Independent Healthcare TSO February 2002. Back
47
47 The self-assessment form is available from www.healthcarecommission.org.uk Back
48
The additionality rule is a term of the ISTC's contract with the
Department of Health. Back
49
The Healthcare Commission is currently consulting on the alignment
of our regulatory regimes for the NHS and independent sectors.
One of our proposals is to move to a more proportionate and risk-based
approach, which would mean that some organisations might not routinely
receive an annual inspection in the future, in conjunction with
the Department of Health proposals to decrease the minimum requirement
for inspections to once every five years. Further information
can be found it our consultation document Aligning our assessment
of the NHS and independent healthcare sectors December 2005,
available on our website www.healthcarecommission.org.uk Back
50
Further information regarding these policies is available in Regulation
9 of the Private and Voluntary Healthcare Regulations 2001 ("the
PVH Regulations"), and Core Standard C30 and Acute Standard
A1 of the National Minimum Standards. Back
51
Further information regarding these policies and procedures is
available in Regulations 9, 18 (Staffing), 19 (Fitness of Workers),
20 (Guidance for Healthcare Professionals) and Schedule 2. Specific
elements are also identified for example in Core Standard C10
and Acute Standards A3, A4, A5 and A8. Back
52
NB this concerned the provision of services under the General
Supplementary Procurements arrangements rather than an ISTC. Back
53
National Centre for Health Outcomes Development ISTC Performance
management Analysis Service: preliminary overview report for schemes
GSUP1C, OC123, LP4 and LP5 October 2005 www.dh.gov.uk Back
54
The Healthcare Commission is the lead organisation in the Concordat
between ten bodies inspecting health services. The Concordat partners
work together to deliver a more consistent and coherent programme
of inspection. Back
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