CLINICAL PROCEDURAL DOCUMENT
DEVELOPMENT POLICY
Type of document
Please tick the relevant box:
Policy (must do)

Guidance (should do)
□
Protocol/procedure (must do)
□
Directorate Responsible for Policy:
Quality
Name of responsible board/committee:
Clinical Management Board
Post Holder Responsible for Policy:
Head of Clinical Effectiveness
Contact Details:
Ext 2033
Date Written:
September 2013
Approved By:
Clinical Management Board
Date Approved:
27 November 2013
Ratified by:
Joint Board of Directors
Date ratified:
Not required
Date Policy Becomes Live:
Last Review:
June 2016
Next Due for Review:
June 2019
Version
No.
Updated By
Updated
On
1.0
1.1
Head of Clinical Effectiveness
and Clinical Governance
Administrator
17 June
2016
Description of Changes
Policy developed as a separate document
from the Procedural Document
Development and Management Policy in
order to distinguish between corporate
and clinical documentation requirements.
4.3 Format – section removed. All
formatting will be undertaken by ICID
author.
New section (5) and References –
information added regarding the
Accessible Information Standard.
Remaining sections renumbered.
________________________________________________________________________________________
CLINICAL PROCEDURAL DOCUMENT DEVELOPMENT AND MANAGEMENT POLICY
VERSION 1.1
AUTHOR: CLINICAL GOVERNANCE ADMINISTRATOR
WRITTEN: SEPTEMBER 2013
REVIEWED:
JUNE 2016
Page 1 of 1
NEXT REVIEW DATE:
JUNE 2019
Contents
Section
1
Introduction
2
Purpose
3
Roles and Responsibilities
4
Style and Format of Clinical Documents
5
Accessible Information Standard
6
How to Develop a Clinical Procedural Document
7
Privacy Impact Assessment
8
Smartphone Apps
9
Approval and Ratification Process
10
Review and Revision Arrangements including Version Control
11
Dissemination and Implementation
12
Document Control including Archiving Arrangements
13
Monitoring and Compliance
14
References
15
Policy Privacy Impact Assessment
16
Appendices
Appendix A
Equality Analysis
________________________________________________________________________________________
CLINICAL PROCEDURAL DOCUMENT DEVELOPMENT AND MANAGEMENT POLICY
VERSION 1.1
AUTHOR: CLINICAL GOVERNANCE ADMINISTRATOR
WRITTEN: SEPTEMBER 2013
REVIEWED:
JUNE 2016
Page 2 of 2
NEXT REVIEW DATE:
JUNE 2019
1.
Introduction
It is important to ensure that any new clinical procedural document developed within the Trust is
based on sound evidence and follows an agreed process for approval and implementation.
To reduce the risk of out-of-date clinical information being unintentionally used and to reduce printing
costs, it is recommended that policies are not printed off and stored locally.
2.
Purpose
2.1
Staff Groups Affected
All clinical staff wishing to develop clinical procedural documents must adhere to this Policy.
2.2
Exceptions and Contraindications
There are no exceptions to this guidance. An Equality Analysis has been completed (Appendix A).
For advice and guidance on how to develop non-clinical procedural documentation, please refer to the
Trust’s Procedural Document Development and Management Policy.
3.
Roles and Responsibilities
3.1
Clinical Staff
Clinical staff have a responsibility for ensuring that they adhere to this Policy in the development of
new policies and maintenance of existing polices.
3.2
Local Committees, Forums or Groups
Once written, the clinical procedural document will be presented to the relevant local committee,
forum or peer group for approval. The relevant body must ensure that the document meets the
requirements set out in this Policy and that the approval, or any amendment requested prior to
publication, is recorded within the notes of the meeting.
3.3
ICID (Integrated Clinical Information Database) Author
The ICID Author, based in the Quality Directorate, will ensure that the document ratified by CMB is
put onto the ICID database and managed accordingly.
3.4
Head of Clinical Effectiveness
The Head of Clinical Effectiveness will undertake pre-publication review of the policy document prior
to submission to the Clinical Management Board and, where appropriate, make recommendations to
the author for change to ensure compliance with legal and ethical guidelines.
3.5
Clinical Management Board
The Clinical Management Board (CMB) has a duty to ensure that the appropriate steps have been
followed before ratifying new clinical procedural document. Following this approval, the policy will be
made ‘live’ on ICID.
________________________________________________________________________________________
CLINICAL PROCEDURAL DOCUMENT DEVELOPMENT AND MANAGEMENT POLICY
VERSION 1.1
AUTHOR: CLINICAL GOVERNANCE ADMINISTRATOR
WRITTEN: SEPTEMBER 2013
REVIEWED:
JUNE 2016
Page 3 of 3
NEXT REVIEW DATE:
JUNE 2019
4.
Style and Format of Clinical Documents
4.1
Language
All clinical procedural documentation must be written in a style which is concise and clear, using
unambiguous terms and language. If such documents are intended for use by the general public,
consideration must be given to the appropriateness of producing them alternative formats (large print,
easy read, brail) or in languages other than English, dependent on the population groups served by
the Trust.
Advice and guidance is available from Customer Care or email
[email protected].
4.2
Style
Any clinical document to be published on ICID should be forwarded to [email protected],uk
who will put it in the right template for ICID.
A
Clinical
Management
Information
template
http://icid/HowTo/pages/ICID_Help_v5/ICID%20Help.html
5.
form
is
available
on
ICID
at
Accessible Information Standard
The Accessible Information Standard has been published under section 250 of the Health and Social
Care Act 2012 to instruct organisations on how they should ensure that disabled patients receive
information in formats that they can understand, and that they receive appropriate support to help
them communicate.
All organisations that provide NHS or publicly funded adult social care must have fully implemented
and conform to the Standard by 31 July 2016.
If Trust staff are developing resources for patients they must ensure that these resources meet the
new Standard.
Further information can be obtained from the Trust’s Accessible Communication Policy which will be
available by autumn 2016.
6.
How to Develop a Clinical Procedural Document
6.1
The Process
A flow chart setting out the process to follow
http://icid/HowTo/pages/ICID_Help_v5/ICID%20Help.html.
is
available
on
ICID
at
Step 1 – Produce the draft Document
Write the document, in consultation with key stakeholders, using evidence-based research and
adopting the language, style and format set out in 4 above.
Step 2 - Responsibility
Determine who will be responsible for implementing the document and the risk of poor
implementation. Discuss and add this risk, where identified, to the relevant directorate’s risk register.
Step 3 - Method
Decide the most appropriate method of implementation.
________________________________________________________________________________________
CLINICAL PROCEDURAL DOCUMENT DEVELOPMENT AND MANAGEMENT POLICY
VERSION 1.1
AUTHOR: CLINICAL GOVERNANCE ADMINISTRATOR
WRITTEN: SEPTEMBER 2013
REVIEWED:
JUNE 2016
Page 4 of 4
NEXT REVIEW DATE:
JUNE 2019
Step 4 - Action Plan
Develop an action plan for implementation.
Step 5 - Local Approval
Obtain approval of the document, including action plan for implementation, from appropriate local
committee, forum or group.
If the document involves drugs, it must also be presented to the Drugs and Therapeutic Committee for
approval before proceeding to Step 6.
Step 6 - Submission to ICID
Submit the document via email to the ICID Author, based in the Quality Directorate, together with a
completed ‘New Clinical Management Information Approval Form’ available on ICID at
http://icid/HowTo/pages/ICID_Help_v5/ICID%20Help.html
The ICID Author will put the document into a format suitable for ICID and agree content prior to step
7.
Step 7 - Initial Review
The Trust’s Head of Clinical Effectiveness will review the draft document.
If they have any concerns or require amendments to the document, they will refer it back to the author
(step 1 above).
Step 8 - Ratification
When the Head of Clinical Effectiveness is happy with the document, it will be submitted to the
Clinical Management Board for ratification.
Step 9 - Publication
Once approved, the author of the document will be responsible for circulating it to all relevant parties
and publicising the action plan for implementation.
The ICID Author will publish the document on ICID. If the document replaces an existing one, the
ICID Author will archive the old document on ICID in line with the Trust’s information governance
policies and procedures. The author will receive automatic reminders when their document is due for
review.
Step 10 - Implementation and audit
The author of the document will be responsible for monitoring and auditing implementation, the results
of which will be fed back to the Trust’s 3:3 performance management meeting.
If the audit results show compliance, a re-audit will be undertaken at the time the document is due for
review (maximum 3 years from implementation).
If the audit results show non-compliance, the author will need to amend the document accordingly,
starting at step 1 above.
________________________________________________________________________________________
CLINICAL PROCEDURAL DOCUMENT DEVELOPMENT AND MANAGEMENT POLICY
VERSION 1.1
AUTHOR: CLINICAL GOVERNANCE ADMINISTRATOR
WRITTEN: SEPTEMBER 2013
REVIEWED:
JUNE 2016
Page 5 of 5
NEXT REVIEW DATE:
JUNE 2019
6.2
Library of Clinical Procedural Documents
As outlined on step 9 above, the ICID Author will publish the document on ICID. The ICID Author is
responsible for the maintenance and archiving any clinical procedural documents in line with the
Trust’s information governance policies and procedures.
Ownership of the original document (together with any supporting documents such as implementation
action plans) will remain with the author.
7.
Privacy Impact Assessment (PIA)
When developing clinical information it must be established whether the personal information aspects
comply with the Principles in Schedule 1 of the Data Protection Act (DPA). Authors are encouraged
to seek guidance from the Information Governance Department and must complete the relevant PIA
documentation or gain formal confirmation that one is not required.
8.
Smartphone Apps
When developing clinical information for patients, it may be useful to provide a QR code linking to
additional information and/or the hospital website. Further advice can be sought from the relevant
Informatics team leader.
9.
Approval and Ratification Process
This Policy will be submitted to the Clinical Management Board for ratification.
10.
Review and Revision Arrangements including Version Control
This overarching Policy will be reviewed every three years or sooner should significant changes in
processes, external legislation or NHS central guidance arise.
Version control will be undertaken in line with ICID version control.
11.
Dissemination and Implementation
Staff will be advised of this Policy and any subsequent revisions via the Trust’s cascade brief process.
The Policy will be available on ICID.
12.
Document Control including Archiving Arrangements
This Policy will be held on ICID. Previous versions will be archived on ICID.
13.
Process for Monitoring Compliance and Effectiveness
The Head of Clinical Effectiveness will monitor compliance of this Policy and will report any
exceptions to the Clinical Management Board to agree further action.
14.
References
The process for implementing clinical procedural documents has been adapted from “Implementing
NICE Guidance, National Prescribing Centre 2001”.
________________________________________________________________________________________
CLINICAL PROCEDURAL DOCUMENT DEVELOPMENT AND MANAGEMENT POLICY
VERSION 1.1
AUTHOR: CLINICAL GOVERNANCE ADMINISTRATOR
WRITTEN: SEPTEMBER 2013
REVIEWED:
JUNE 2016
Page 6 of 6
NEXT REVIEW DATE:
JUNE 2019
SCCI1605 Accessible Information – the ‘Accessible Information Standard’
(Health & Social Care Information Centre – 3 July 2015)
https://www.england.nhs.uk/ourwork/patients/accessibleinfo/
15.
Privacy Impact Assessment (PIA)
This policy has been assessed against the Trust's PIA Policy Appendix C and as no fundamental
changes have been made to the processing of personal data, the Information Governance Manager
has determined that a PIA is not required.
16.
Appendices
Appendix A
Equality Analysis (see next page)
________________________________________________________________________________________
CLINICAL PROCEDURAL DOCUMENT DEVELOPMENT AND MANAGEMENT POLICY
VERSION 1.1
AUTHOR: CLINICAL GOVERNANCE ADMINISTRATOR
WRITTEN: SEPTEMBER 2013
REVIEWED:
JUNE 2016
Page 7 of 7
NEXT REVIEW DATE:
JUNE 2019
APPENDIX A
Equality Analysis (EA’s)
1.Title of policy, programme, framework or organisational change being analysed.
Clinical Procedural Document Development Policy
2. Please state the aims and objectives of this work and the intended equality outcomes. How does this
proposal link to the organisation’s business plan or Values and Beliefs?
The Clinical Procedural Document Development Policy sets out the process for staff to follow for the
production, approval and implementation of clinical procedural documentation within Salisbury NHS
Foundation Trust.
The Policy does not link to the organisation’s business plan. It does reflect the Trust’s values and beliefs
particularly in relation to the safety and wellbeing of patients.
3. Who is likely to be affected? Eg: staff, patients, service users (please refer to appendix 1)
This Policy is primarily for the use of clinical staff although other staff groups may be involved when a
clinical procedural document is being initiated or reviewed.
4. Using the ‘Equality Definitions’ template - What evidence do you have of the potential impact
(positive or negative)? Include any supporting evidence eg: research, data or feedback from
engagement activities
4.1 Disability
The Policy has no positive or negative impact on people with disabilities.
________________________________________________________________________________________
CLINICAL PROCEDURAL DOCUMENT DEVELOPMENT AND MANAGEMENT POLICY
VERSION 1.1
AUTHOR: CLINICAL GOVERNANCE ADMINISTRATOR
WRITTEN: SEPTEMBER 2013
REVIEWED:
JUNE 2016
Page 8 of 8
NEXT REVIEW DATE:
JUNE 2019
4.2 Sex (Male or Female)
The Policy relates to any gender.
4.3 Race
The Policy highlights the need for staff to consider whether their clinical procedural documentation is
intended for use by the general public and, if so, to consider the appropriateness of producing the
document in languages other than English, dependent on the population groups served by the Trust.
Section 5 of the Policy highlights the importance of complying with the Health & Social Care Accessible
Information Standard by 31 July 2016, and the Trust’s Accessible Communication Policy which will be
available from autumn 2016.
4.4 Age
The Policy relates to staff of any age.
4.5 Transgender
The Policy has no positive or negative impact on transgender.
4.6 Sexual Orientation (this will include lesbian, gay and bi sexual as well as heterosexual people)
The Policy has no positive or negative impact on the various sexual orientations.
4.7 Religion or belief (includes religion, beliefs or no religion or belief)
The Policy has no positive or negative impact on staff’s religion or beliefs.
________________________________________________________________________________________
CLINICAL PROCEDURAL DOCUMENT DEVELOPMENT AND MANAGEMENT POLICY
VERSION 1.1
AUTHOR: CLINICAL GOVERNANCE ADMINISTRATOR
WRITTEN: SEPTEMBER 2013
REVIEWED:
JUNE 2016
Page 9 of 9
NEXT REVIEW DATE:
JUNE 2019
4.8 Marriage and civil partnership
The Policy has no positive or negative impact relating to marriage and civil partnership.
4.9 Pregnancy and maternity (this can include impact on working arrangements and infant caring
responsibilities)
The Policy has no positive or negative impact on staff relating to pregnancy and maternity.
5.0 This table
should
be
completed with
all
actions
identified
to
mitigate
any
negative effects
Action Plan
Target
Date
Review Date
Person
Responsible
List of Actions:
No actions
required.
are
6.0 Sign off
Name and signature of person who carried out this analysis:
Gill Sheppard, Clinical Governance Administrator
________________________________________________________________________________________
CLINICAL PROCEDURAL DOCUMENT DEVELOPMENT AND MANAGEMENT POLICY
VERSION 1.1
AUTHOR: CLINICAL GOVERNANCE ADMINISTRATOR
WRITTEN: SEPTEMBER 2013
REVIEWED:
JUNE 2016
Page 10 of 10
NEXT REVIEW DATE:
JUNE 2019
Date analysis completed:
22 August 2013
Reviewed June 2016 – reference made to the Health and Social Care Accessible Information Standard
and Trust’s Accessible Communication Policy
Name and signature of line manager:
Claire Gorzanski, Head of Clinical Effectiveness
Date analysis approved by line manager:
21 November 2013 Amendments approved 30 June 2016
Copy forwarded to Equality and Diversity Department:
21 November 2013 Revised version 30 June 2016
________________________________________________________________________________________
CLINICAL PROCEDURAL DOCUMENT DEVELOPMENT AND MANAGEMENT POLICY
VERSION 1.1
AUTHOR: CLINICAL GOVERNANCE ADMINISTRATOR
WRITTEN: SEPTEMBER 2013
REVIEWED:
JUNE 2016
Page 11 of 11
NEXT REVIEW DATE:
JUNE 2019