Implementation of NICE Guidelines 2
Dear Sir or Madam,
Further to your response to Mr Oakley, in that "Neither the Healthcare Commission nor the Care Quality Commission requires trusts to declare compliance with individual NICE guidelines"
Does this mean that they can only declare compliance if they have implemented ALL relevant NICE guidelines? If they have not, then surely action should be taken by the CQC with regards to the following Department of Health Statement?
"When NICE recommends a treatment, NHS organisations must provide funding for it. They have a maximum of three months from the date of publication of NICE final guidance to provide funding and resources. Local NHS organisations are expected to meet the costs of medicines and treatments
recommended by NICE out of their general annual budgets.
Where there is evidence that NHS Trusts are restricting access to NICE recommended treatments solely on cost grounds, the Department looks to Strategic Health Authorities (SHAs) to intervene. Trusts could ultimately
be exposed to legal proceedings if they have failed to meet their statutory obligations"
Yours faithfully,
L Cowling
Dear Sir/Madam,
Thank you for your email below which was received by the Commission on the same date.
We will respond as soon as we can but in any event within 20 working days following the date of receipt of your request. You can therefore expect a response by 12 October 2009.
Yours sincerely
Kim Lok
Information Governance Manager
Secretariat - Information Governance Team
Care Quality Commission
Finsbury Tower
103-105 Bunhill Row
London
EC1Y 8TG
Email: [email address]
Direct Tel: 020 7448 1765
Internal Tel: 3815
Statutory requests for information made pursuant to access to information legislation, such as the Data Protection Act 1998 and the Freedom of Information Act 2000, should be sent to: [Care Quality Commission request email]
Dear Lok, Kim,
Further to my request, could you provide me with a copy of the guidelines/assistance given to Trusts by the CQC in order for them to fill in the core standards declaration?
Yours sincerely,
L Cowling
Dear Sir/Madam.
I acknowledge receipt of your email below and the further request it contains. You shall receive a response by 15 October 2009.
Regards
Kim Lok
Information Governance Manager
Secretariat - Information Governance Team
Care Quality Commission
Finsbury Tower
103-105 Bunhill Row
London
EC1Y 8TG
Email: [email address]
Direct Tel: 020 7448 1765
Internal Tel: 3815
Statutory requests for information made pursuant to access to information legislation, such as the Data Protection Act 1998 and the Freedom of Information Act 2000, should be sent to: [Care Quality Commission request email]
Dear Sir/Madam,
Please find the Commission's response to your request below and your further request of the same date received at 21.24.
Your sincerely
Kim Lok
Information Governance Manager
Secretariat - Information Governance Team
Care Quality Commission
Finsbury Tower
103-105 Bunhill Row
London
EC1Y 8TG
Email: [email address]
Direct Tel: 020 7448 1765
Internal Tel: 3815
Statutory requests for information made pursuant to access to information legislation, such as the Data Protection Act 1998 and the Freedom of Information Act 2000, should be sent to: [Care Quality Commission request email]
Dear Lok, Kim,
Thank you very much for the information.
However, I have a number of concerns regarding the fact that a Trust has only to "reassure itself" and therefore I would suggest the following outcomes could possibly be in place.
1. The Trust has indeed conformed to the Technology Appraisals (TA) and has implemented all relevant NICE Guidelines and can duly tick that they have complied with Core Standard C5a.
2. The Trust has has taken into account all relevant NICE TA and rejected all or some of them and other Guidelines may or may not be in place and can duly tick that they have complied with Core Standard C5a.
3. The Trust has not taken into account NICE TA and therefore cannot tick that they have complied with Core Standard C5a and this is transparent.
However, with regard to scenario 2, what evidence is required to assess that the Trust has indeed taken into account NICE guidelines when they have not been implemented? Would Trust policies on conditions and treatments have to explicitly state that NICE guidelines have been taken into account and rejected? Would alternative guidelines have to be explicitly stated? Would this have to be clearly stated when treating patients in their medical records that NICE guidelines have not been followed and the reasons given or other guidelines followed? If this has not been done, would the fact that the Trust has "self assured" be considered to have been done in error as there is no audit trail as to the TA and reasons for non compliance to NICE Guidelines?
Would the Care Quality Commission consider that a Therapy, for example Cognitive Behaviour Therapy recommended under NICE Guidelines for Bipolar Disorder, be considered a treatment that is required to be implemented as per the Department of Health stipulation of 3 months after publication of a NICE final guidance?
I look forward to your response in due course.
Lee Cowling
Yours sincerely,
L Cowling
Dear Lok, Kim,
With regard to the definition of a Therapy;
Therapy (in Greek: θεραπεία), or treatment, is the attempted remediation of a health problem, usually following a diagnosis. In the medical field, it is synonymous with the word "treatment".
Therefore would the Care Quality Commission agree with this definition?
Yours sincerely,
L Cowling
Dear Sir/Madam,
Thank you for your email containing an information access request in accordance with the Freedom of Information Act 2000, which the Commission received on 26th October 2009.
We will respond to your request as soon as is possible, but in any event, within 20 working days following the date of receipt of your request as outlined by the Act. You can therefore expect a response by 20th November 2009. We will write to you before the deadline for response if we are unable to meet it.
Please note that the information you have requested may be subject to an exemption. Should this occur, you will be notified accordingly when we write to you next.
If you have any queries please do not hesitate to contact me.
Yours sincerely,
Adenike Ojo
Information Governance Officer
Secretariat - Information Governance Team
Care Quality Commission
Finsbury Tower
103-105 Bunhill Row
London
EC1Y 8TG
Email: [email address]
Direct Tel: 020 7448 1766
Internal Tel: 3816
Statutory requests for information made pursuant to access to information legislation, such as the Data Protection Act 1998 and the Freedom of Information Act 2000, should be sent to: [Care Quality Commission request email]
Dear Sir/Madam,
Our Ref: Information Request CQC IG 204
Thank you for your email containing an information access request in
accordance with the Freedom of Information Act 2000, which the Commission
received on 26th October 2009.
The Information Governance Team has now processed your request and I am
pleased to enclose the recorded information that the Commission holds in
relation to this matter.
You requested for the following information:
1. What evidence is required to assess that the Trust has
indeed taken into account NICE guidelines when they have not been
implemented?
In line with the Department of Health’s Standards
for Better Health, the Care Quality Commission (CQC) expects that NHS
trusts conform to NICE technology appraisals
where they are relevant to its services and that
compliance is regularly monitored. We also expect NHS organisations to
take account all relevant NICE guidelines and other
nationally agreed guidance and implement them
where they are applicable to the services delivered, unless there are good
reasons for not doing so.
2. Would Trust policies on conditions and treatments have
to explicitly state that NICE guidelines have been taken into account and
rejected?
We ask organisations to make an annual self
declaration of their assurance processes and to declare whether they are
meeting each standard, including C5a, which is the
standard relating to NICE and other national
guideline implementation. Organisations are not required to make a
declaration of the implementation of each individual
guideline or technology appraisal.
3. Would alternative guidelines have to be explicitly
stated?
No.
Organisations do not make a declaration in respect of
every piece of NICE guidance. The declaration they make relates to the
whole standards (Standards for Better Health,
C5a) and they declare that they are assured that they
'take account of NICE guidelines'.
Fundamentally, the accountability for ensuring
implementation rests with the NHS organisation. Following
declarations we use nationally available information to test
declarations of assurance in relation to NICE
clinical guidelines, interventional procedures guidance and technology
appraisal guidance and other national guidance. We
inspect approximately 20% trusts after they have made
their annual declarations. A proportion of these will be selected randomly
but the majority will be selected on the basis
of information suggesting that further questions need
to be asked about aspects of the trust’s declaration. If it was found
on inspection that a trust was not taking account of
NICE or any other evidence based guidelines we would
deem that it had not met the standard. However, a trust may have decided
not to implement a specific NICE
guideline; this may be because it has decided that it
will follow other nationally recognised, evidence based guidance and is
perfectly acceptable - CQC would require
assurance that the trust had an appropriate process
in place for making that decision
4. Would this have to be clearly stated when treating
patients in their medical records that NICE guidelines have not been
followed and the reasons
given or other guidelines followed?
It is expected that all care delivered to patients is
based on what is known to be current best practice or evidence based
practice. It is the trusts responsibility to ensure
clinicians keep detailed records of care and
treatment (patient notes). Clinicians receive regular review of their
practice to ensure their practice, skills and knowledge is up to
date, if a clinicians was found to be delivering
care/treatment that was not in keeping with evidence based practice then
the trust must take appropriate action to ensure that
clinician does so. However, there are no specific
requirements to specifically state that NICE guidelines or other
guidelines have been followed - it is more likely that a
description of the total care and treatment would
be given in the patients notes.
5. If this has not been done, would the fact that the
Trust has "self assured" be considered to have been done in error as there
is no audit trail as to the TA and
the reasons for non compliance to NICE Guidelines?
We have strengthened the way we look at how NHS
trusts assure themselves that they have are conforming to NICE technology
appraisals (where relevant) and considered
the use and implementation of NICE guidance.
During our follow up visits to trusts in 2008/09, we have ‘traced’ the
process of assurance from decision making to
implementation: that is, from board level to
service level delivery.
In 2008/09 32 trust received follow visits in
respect of C5a; more than any other standard. Information about how an
organisation is performing is reported publicly in the
Annual Health Check. These results are available on
our website.
We also work closely with NICE. A joint programme
of work has been developed with several different strands; one of which is
looking at how to deal with poor uptake of
NICE guidelines and how this can be improved
through regulatory activities.
6. Would the Care Quality Commission consider that a
Therapy, for example Cognitive Behaviour Therapy recommended under NICE
Guidelines for Bipolar
Disorder, be considered a treatment that is
required to be implemented as per the Department of Health stipulation of
3 months after publication of a NICE
final guidance?
CQC will implement a new regulatory framework from
1^st April 2010. One of the main changes to the current system of
regulation is the requirement on organisations
(including the NHS, local authorities, private
companies and voluntary organisations that have responsibility for the
provision of that care) to register with CQC based on the
kind of activity they provide (for example surgical
procedures, diagnostics and screening etc.) rather than the organisation
or setting in which an activity is provided.
In this new system if an organisation fails to
comply with the registration requirements CQC will be able to take
appropriate action; from placing conditions on the registration
through to suspending services. Therefore, if
organisations are not delivering effective and safe care by not conforming
to NICE technology appraisals or implementing NICE
guidelines appropriately then CQC will be able to
take appropriate action (proportionate to the risk to people who use
services).
We will also carry out periodic reviews of
organisations and undertake a series of special reviews and studies using
a thematic approach. All will take into consideration the
implementation of NICE and other national evidence
based guidelines.
7. With regard to the definition of a Therapy;
Therapy (in Greek:
θεÏαπεία), or treatment, is the attempted
remediation of a health problem, usually following a diagnosis. In the
medical field, it is
synonymous with the word "treatment".
Therefore would the Care Quality Commission agree
with this definition?
CQC only provide definitions where terms are used
in documents that it publishes - thus describing what CQC means when it
uses a specific term. CQC does not have any
current documents in publication where it has
provided a definition of therapy.
If you have any queries about the handling of this request, you may
complain to the Commission, by requesting for an internal review of the
Commission's decision. Please contact:
The Information Governance Team
Care Quality Commission
Finsbury Tower
103-105 Bunhill Row
London
EC1Y 8TG
Alternatively, you may complain via email to:
Please clearly indicate that you wish for an internal review.
Further rights of appeal exits to the Information Commissioner's Office
(www.ico.gov.uk) once the internal appeals process has been exhausted.
The contact details are:
Information Commissioner's Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF
Telephone: 01625 545 700
If you have any queries please do not hesitate to contact me.
Yours sincerely
Adenike Ojo
Information Governance Officer
Secretariat - Information Governance Team
Care Quality Commission
Finsbury Tower
103-105 Bunhill Row
London
EC1Y 8TG
Email: [email address]
Direct Tel: 020 7448 1766
Internal Tel: 3816
Statutory requests for information made pursuant to access to information
legislation, such as the Data Protection Act 1998 and the Freedom of
Information Act 2000, should be sent to: [Care Quality Commission request email]
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D. Speers left an annotation ()
It seems that guidance is optional and whilst guidance is often quoted, its rarely implemented. SHA do not implement the guidance because trusts fail to implement policy........aka if an SUI is investigated as a CIR then SHA will not record as an SUI and will not question things further. It seems that unless matters of concern are brought to the regulators attention, questions will not be asked and lessons will not be learnt!The most worrying aspect of this is that it seems CQC will lose all regulation powers in 2009/2010......and who will then regulate healthcare?