Technical Writing - The Control Procedure DN1 Staff

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DN1 Document Control Procedure Version: 2.1 Review due: 07/2015

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Document title:

Document number:

Document Control Procedure

DN1

Staff involved in development:

Head of Corporate Affairs

FOI & Document Control Officer Clinical Governance Manager Clinical Audit Manager

Document author/owner: FOI & Document Control Officer

Directorate: Chief Executive

Department: Chief Executive

For use by: All staff

Review due: 07/2015

This is a controlled document. Whilst this document may be printed, the electronic version maintained on the Trust’s Intranet is the controlled copy. Any printed copies of this document are not controlled. ©Papworth Hospital NHS Foundation Trust. Not to be reproduced without written permission.

Key points of this document

It is the only document which sets out the framework for the content, format and style for Papworth Hospital’s Trust Documents - Strategies, Policies, Procedures and Guidelines.

• It sets out the administrative process for creating, reviewing and archiving the documents.

• This document covers documents which have a DN prefix. It does not cover documents for purely local/team procedures or other categories of documents such as Consent, Competency, Nursing, CaseNotes, etc.

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Page 2 of 15 Contents

Section no. Page no.

Key points of document 1

1 Introduction 3

2 Purpose of this document and rationale for development

4

3 Categories of document 4

4 Duties 5

5 Content, format and style 6

6 Counter-Fraud 7

7 Arrangements for review 8

8 Dissemination and implementation 8

9 Control and archiving arrangements 9

10 Process for Monitoring Compliance 9

11 Equal Opportunities 13

12 Supporting References 13

13 Questions and queries 13

14 Flowchart showing document control process 14

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Page 3 of 15 1. Introduction

This document sets out the procedure for the creation and control of strategy, policy, procedure, guidelines and similar documents which are made available on the

intranet and for use either Trust-wide or across directorate/departmental boundaries. These documents play a vital part in the efficient running of the Trust and in fulfilling the criteria of the many external bodies which guide, monitor or audit the work of the Trust.

The Trust also has key documents in other categories: External & joint documents, Competency documents, Consent documents, Death documents, CaseNotes

documentation, Nursing documents, and Terms of Reference for committees. These are not covered by the DN1 document. The other categories, and their named lead person, are as follows:

External/Joint (documents created outside the hospital or shared with other institutions)

Document number begins with EJ

This category is overseen by Kate Merrell, FOI & Document Control Officer. Contact Kate on ext 4776 or by email if you have any queries concerning these documents

Competency

(documents setting out how to do something and the way in which doing it will be assessed) Document number begins with CP

This category is overseen by Sheila Turner, Lead of Core and Clinical Education. Contact Sheila on ext 4840 or by email if you have any queries concerning these documents

Consent

The Trust’s general and procedure-specific consent guidance and forms

Document number begins with CONSENT

This category is overseen by Helen Munday, Lead Nurse - Practice Development. Contact Helen on ext 4508 or by email if you have any queries concerning these documents

Nursing Documents Document number begins with ND

This category is overseen by Jane French, Nurse Consultant. Contact Jane on ext 4855 or by email if you have any queries concerning these documents.

Casenotes Document number begins with CN

This category is overseen by Janet Chapman, Patient Services Manager.

Contact Janet on ext 4485 or by email if you have any queries concerning these documents.

Death Documents Document number begins with DD

This category is overseen by Brenda Bush, PALS Manager. Contact Brenda on ext 4896 or by email if you have any queries concerning these documents.

Terms of Reference of the Trust’s

Document number

This category is overseen by (tbc) Mary MacDonald, Trust Secretary. Contact Mary on

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Page 4 of 15 Committees begins with

TR

ext 4555 or by email if you have any queries concerning these documents.

The process, which is set out in this document (DN1 Document Control Procedure), is subject to review at least every three years and is also adapted when necessary to meet the needs of the Trust, of National Health Service Litigation Authority (NHSLA) risk management standards, and of external regulatory bodies such as Monitor and the Care Quality Commission (CQC).

2. Purpose of this document and rationale for development

As a requirement for Corporate Governance, the Board of Directors has an agreed framework in place for the writing, approval, implementation, monitoring, revision and archiving of strategies, policies, procedures, protocols, and guidelines. The purpose of this document is to set out this framework.

Consultation Process

Staff creating or revising documents must, first and foremost, consider, and consult with colleagues and other stakeholders, to see if the creation of a new document is necessary. They must check whether a suitable document already exists, either among the Trust’s Documents or if appropriate, at an external source. Failing that, it might be possible to add a section to an existing related document. However, to comply with good practice, Policies and Procedures should not be combined: where both are necessary they should be separate documents.

If it is necessary to create a new document, staff should – again, in consultation with colleagues - make sure that they choose the most appropriate document category for their purpose. Its purpose must be stated clearly and succinctly on the front sheet of the document. The rationale for its development should be included in the ‘key points’ bullet list on the front sheet.

The legislation, objectives, and guidance which the document supports, and the other documents (internal and external) which relate to it, must be listed in the table at the end of the document. In particular, if the document supports CQC and/or NHSLA standards, these should be stated in full: eg ‘NHSLA Risk Management Standard 2.9’ not just ‘NHSLA Management Standards’.

The responsibility for ensuring that all stakeholder groups are consulted as

appropriate throughout the creation and revision of documents lies with the document author/owner(s) and their local managers.

3. Categories of document

Strategies are formal documents required by the Department of Health or other bodies or simply to direct organisational good practice. Strategies define where the Trust aims to be, or what is aims to achieve, in a particular area over a specified period of time. A strategy may be supported by a number of Trust policies. Policies are formal documents and provide a “statement of intent” about how the Trust complies with legislation, directives or good practice. They can also set out the Trust’s position on a specific subject. As such, policies rarely need to exceed five pages. It is mandatory for all staff to comply with Trust policies and non-compliance

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Page 5 of 15 may result in disciplinary action. A policy may be supported by a number of other documents.

Strategies and policies can be created or reviewed by local committees but they must also be approved by the Board of Directors or a Committee of the Board.

Other documents - procedures and guidelines - do not have to undergo formal approval by the Board or a Committee of the Board. Creation and review of these documents are to be approved by the relevant local committee. In exceptional circumstances, they can be approved by Chair’s Action by the Chair of the local committee or by an appropriate Executive or Non-Executive Director.

All these documents must contain a section explaining how compliance with the document will be monitored (see section 10).

4. Duties

Overall responsibility for the implementation and compliance of this Procedure, and all other Trust Documents, lies with the Board of Directors.

It is the duty of the author/owner of documents to:

• consider if the creation of a new document is necessary: they should check whether a document already exists, either among the Trust’s Documents or if appropriate, at an external source, which already fulfils the intended function or could do so if suitably amended.

• consult their colleagues and other stakeholders both internally and externally on the creation and content of documents. Wide consultation, both initially and at draft stage, it vital to ensure that the document will be fit for purpose and not require frequent early revisions after it has come in to use.

• revise or organise the revision of the document in good time for its formal review date and before that date when necessary (for example, to reflect legislative changes).

• make sure that the document is seen by the relevant committee(s) and, where this is requested, amend the document until it receives committee approval. Ratification Process

It is the duty of the relevant local committee to: • review the documents and:

 approve them for use; or

 approve them for progress to a Committee of the Board of Directors for further ratification (if Strategies or Policies); or

 refer them back to the author/owner for modifying, and then  approve them for use; or

 approve them for progress to a Committee of the Board of Directors for further ratification (if Strategies or Policies); or

• in exceptional circumstances, review of documents other than Strategies or Policies can be carried out by Chair’s Action by the Chair of the local

committee, or by a relevant Executive or Non-Executive Director. It is the duty of the relevant Executive Director to:

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Page 6 of 15 • ensure that every new or revised document is forwarded to the Document

Control Officer (after undergoing committee approval, where appropriate). It is the duty of the Document Control Officer to:

• check that documents received, both new and revised, comply with the rules set out in this framework, including those on content, format and style, and return to source any documents which are non-compliant;

• check that the appropriate evidence of approval has been received;

• assign each document with a unique identifying number and version control number; log the changes; archive any existing version;

• ensure that the documents are converted into PDF format and added to the intranet.

Other duties are identified elsewhere in this document and are stated in bold. 5. Content, format and style for DN Documents

Trust Documents must be written in a clear, concise and unambiguous way. All staff must follow the approved Trust rules on format, content and style when creating or reviewing Trust Documents. This uniformity makes documents more accessible and also projects a professional, ‘corporate’ approach.

DN must start with the front page table, fully completed: any sections not applicable should be marked ‘n/a’. This must be followed by an introduction which sets out the rationale for the development of the document, explains how it links with the Trust’s service priorities, and states its objectives and intended outcomes.

The document must have a stated author/owner (personal name optional but job-title mandatory): this is the person who organises the creation/review of the document and can deal with any queries about the document. This must be the name of an individual (or where appropriate, two) not the name of a department or a committee. All DN documents must have a header stating the document number (a unique DN number assigned by the Document Control Officer) and title on the left and with the Trust logo on the right.

The footer should contain the document number, title, review due date; and page numbering (in the style “page x of y”) - all as shown in this document and in DN1A Trust Document Exemplar. The Document Control Officer will add the version control number to the footer.

All documents must finish with the ‘Further Document Information’ table, fully completed; any sections not applicable should be marked “n/a”.

• Documents must be in Microsoft Word or Excel • The document title must be in Arial font size 14;

• The main body of the document must be t in Arial 12 (not Arial narrow). A smaller font size may be used where this is necessary to fit text in a table or diagram, but it must never be so small that readability is compromised; • Header & footer are to be in Arial 11.

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Page 7 of 15 • Where acronyms or abbreviations are used, the meaning must be stated in

full at first time of use. Similarly, any terms should be explained where these are unlikely to be generally understood.

• Text to be aligned to the left-hand margin (full justification not to be used) • Margins to be set at 2.5 cm

• Legislation, objectives, and guidance which the document supports must be listed in the table at the end of the document. In particular, if the document supports CQC and/or NHSLA standards, these should be noted, with the specific standards, outcomes etc stated in full..

• Key associated documents (internal and external) which relate to the Trust Document in questions must be listed in the table at the end of the document. For example, DN89 Isolation Procedure would list DN15 Infection Prevention and Control Policy; DN226 Clostridium difficile Procedure, etc.

The above points are all mandatory. The following points are for additional guidance: • Unless use of colour is essential to make the meaning clear, colour should not

be used, and use of the Trust logo in black is acceptable in these documents. • Section headings (also in Arial) should to be no greater than size 12 bold, and

numbered where appropriate.

• Capitalisation of entire phrases is to be avoided - even for headings. • Over-use of underlining is to be avoided.

• A contents page should be included for any document which is eight or more pages long (excluding the front and back page document information tables). • Open punctuation should be used eg Dr not Dr., 23 August not 23rd

August, ext 4776 not ext. 4776, etc.

Hyperlinks are to be avoided as these quickly ‘break’ – give web home page addresses instead.

Staff are reminded that, while most documents appear on the intranet rather than the public-facing website, these documents are still held to be in the public domain, and may be used, for example, in responses to enquiries under the Freedom of Information Act.

The exemplar document - DN1A Trust Document Exemplar – is available as a guide.

6. Counter Fraud

Whenever a document is created or revised, staff should consider if it would be useful to invite the Local Counter Fraud Specialist (LCFS) to review the document to ensure it is robust and fraud proof.

This applies especially but not exclusively to documents of the Finance, Operations and HR directorates. Staff should ensure that all relevant organisational documents are reviewed and fraud-proofed by the LCFS. The LCFS will review documents and advise whether there are any inherent weaknesses in the document in terms of fraud, theft, corruption and any other illegal acts involving dishonesty. The LCFS’s expertise might highlight areas of concern that might not be evident to staff. This review will identify any inherent risks or weaknesses in the document in terms of possible fraud,

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Page 8 of 15 theft, corruption or other illegal acts; advise of any changes to minimise these risks; and ensure that the document is able to withstand evidential scrutiny in the event of a criminal investigation.

The LCFS can be contacted on 01223 216019 or 07929 207174. Contact details for the LCFS are also available via the Document Control Officer and on the Trust’s intranet.

7. Arrangements for review

All documents must be reviewed and revised whenever necessary as circumstances or good practice change, but in any case must be fully reviewed at least every three years, and more frequently if guidelines or legislation dictate.

While the reminder that a document is due for review is sent three months in advance to the document author/owner, it remains the duty of the relevant Executive Director to ensure that documents are reviewed both routinely and whenever the need arises.

At the time of review, the opportunity should be taken by the owner/author to ask: • Is this document still needed?

• Is it working effectively in its current format?

• Could it usefully be amalgamated with another document to reduce the number of controlled documents?

• Should it be reclassified (eg as a Procedure or Guideline rather than a Policy)?

Requests for advice on this are welcomed by the Corporate Affairs Department at [email protected] or ext 4240.

It is the duty of the Document Control Officer to assign each document a new version control number each time it is revised, and to monitor the version control as part of the overall Document Control process. The Document Control Officer also ensures that, while the documents are held on the electronic archive in Word format, they go onto the intranet in PDF format. This ensures that they cannot be altered or edited other than via the formal review and version control process.

8. Dissemination and implementation

It is the duty of the Document Control Officer to ensure that new/revised Trust documents are added to the intranet in a timely manner and that the version number/date of addition shows on the Trust Document web pages. Where this is required, the Document Control Officer can provide further help in dissemination by, for example, arranging for the document to be highlighted in the staff publications NewsBeat and/or NewsBites.

It is the duty of all executive directors and managers to:

• have in place a plan whereby all their staff are alerted to the existence of documents relevant to them, including any revisions, and are able to access these documents;

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Page 9 of 15 • have in place a plan to ensure implementation by they themselves and their

staff of the content of the documents.

In addition, it is the duty of all staff joining the Trust to familiarise themselves with, and implement, all the Trust‘s documents (of any category) which are relevant to them. This duty is made clear to them as part of the general induction course mandatory for new employees.

Evidence of implementation and dissemination of all Trust Documents is required by the Care Quality Commission and the NHS Litigation Authority (NHSLA).

9. Control and archiving arrangements

When a Trust document is created or revised, it is sent to the Document Control Officer who assigns it a document number (“DN” number) if it is new and gives all documents a version number. S/he then places the document, whether new or revised, in a secure electronic archive, and asks the Digital Media Co-ordinator to convert the Word version of the document into PDF format before adding it to the Trust Documents pages of the intranet and (where this has been requested) to the relevant departmental webpage.

The current versions of documents appear on the Trust Documents pages of the Intranet, in PDF format, under “A-Z All Documents”. There are several simple methods of searching for these documents, and these are outlined at the top of the webpage. Some documents are also accessible by direct link from the departmental webpage of the department owning the document.

The Document Control Officer holds both current and previous versions of documents, in their original formats within the Trust’s shared directory at

S:\shared\Document Control. Document author/owners requiring their document in Microsoft Word format rather than PDF format version for purposes of revision etc can obtain this by contacting the Document Control Officer or in her/his absence, the Digital Media Co-ordinator. Earlier versions can be obtained by the same route. In order to minimise the risk of out-of-date documents being used, electronic copies of Trust Documents should not be held in the originating department.

All staff are reminded that these documents are not controlled in hard (printed) copy format and they are expected to go to the current version, available on the Trust Documents page of the intranet, rather than to use any existing hard copy which may well be obsolete. For the same reason, hard copies of documents are not to be kept either centrally by the Document Control Officer or locally in the originating department. Documents should not be photocopied and should only be printed (where this is necessary) at point of use.

10. Process for Monitoring Compliance

Monitoring and compliance with the document control process is the

responsibility of the Executive Directors and senior managers, with assistance from the Document Control Officer.

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Page 10 of 15 • When a document is approved, either the Minutes of the approving

committee, the relevant Minute, or an email from the approving director or manager, should be sent to the Document Control Officer. The full date (day, month, year) must be stated. This helps to ensure compliance with, and monitoring of, the ratification process.

• The overall process is monitored by a monthly spot-check by the Document Control Officer of six Trust documents chosen at random, to check that: they all comply with the guidelines set out in DN1 as follows:

that the style and content are broadly compliant.

• That the record, the documents on the intranet, and the document in the current archive tally.

• That all earlier versions are held in the archive.

• That evidence is held of the document having been approved

• Where any errors or anomalies are identified, there will be corrected by the Document Control Officer, with the involvement if necessary with the

document author/owner, identifying where possible how the mistake arose and how recurrence might be avoided.

• To aid compliance, document author/owners are contacted by the Document Control Officer with a reminder three months in advance of their document(s) becoming due for routine review.

• Regular reports are made to Executive Directors; to the Quality & Risk Committee of the Board of Directors.

In addition to the above, all documents which go to the Quality and Risk Committee of the Board of Directors for renewal must be accompanied by a report, prepared by the author/owner of the document, showing how the policy/procedure has been implemented and how compliance has been monitored since its creation or latest revision.

The effective implementation of all procedural documents should be monitored as appropriate and this is the responsibility of the author/owner, together with the appropriate manager(s). The process of monitoring must be set out in the document. Where appropriate, the table on the following page should be used to set out the monitoring process. (The generic table also appears in DN1A Document Control Template, with some sample wording).

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DN1 Document Control Procedure Version: 2.1 Review due: 07/2015 Page 11 of 15 Table 1 – Monitoring the requirements of this procedure

Element to be monitored from relevant CNST Standard

Lead Tool

Audit / Report etc

Frequency Reporting arrangements for the monitoring Acting on monitoring recommendations Change in practice and lessons to be shared

Style and format Document

Control Officer

Spot check of representative sample of Trust documents chosen at random to check they conform with DN1. Summarised in report.

Annual Quality & Risk

Committee of the Board of Directors Document author and local committee/group who signed off document

Required changes to practice will be identified and actioned within a specific time frame. A lead member of the team will be identified to take each change forward where

appropriate. Lessons will be shared with all the relevant

stakeholders. Ratification Process Document

Control Officer

Review of committee/ group minutes for evidence of ratification in relation to 6 Trust documents chosen at random

Summarised in report.

Committee of the Board of Directors Document author and local committee/group which signed off document

stakeholders.

Document control Document

Control Officer

Spot-check of representative sample of Trust documents chosen at random, to check the documents appear on the Trust Documents pages of the Intranet in PDF format; all current and earlier versions are stored in archive with an

Committee of the Board of Directors Document author and local committee/group which signed off document.

Document Control Officer

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DN1 Document Control Procedure Version: 2.1 Review due: 07/2015 Page 12 of 15

assigned document number and version number.

appropriate. Lessons will be shared with all the relevant stakeholders. Archiving of documents Document Control Officer Spot-check of representative sample of Trust documents chosen at random, to check both current and previous versions of documents, in their original formats are within the Trust’s shared directory at

S:\shared\Document Control.

Committee of the Board of Directors Document author and local committee/group which signed off document.

Document Control Officer

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Page 13 of 15 11. Equal Opportunities

It is the responsibility of authors/owners of Trust Documents to make sure that an equality impact assessment is carried out in line with the guidance document on this (available via the Human Resources pages on the intranet) and that this is

appropriately documented and available for inspection. 12. Supporting References

This section should contain the details of any reference materials drawn on in the development of the document. References should be cited in full and follow the conventions for referencing.

This document drew on the NHSLA’s template document, An Organisation-wide Document for the Development and Management of Procedural Documents, accessed on 02/12/2010 at the NHSLA website at www.nhsla.com/publications, under Risk Management Publications followed by Document Templates.

13. Questions and queries

Questions about the DN1 document control process, format of documents, review, etc should be directed to the Document Control Officer in the Corporate Affairs Department, on ext 4776.

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Page 14 of 15 14. Flowchart summarising procedure for the Trust Document Control process

Need for new Trust Document (Strategy, Policy, Procedure or Guidelines) identified or revision of existing document required.

Author/owners write or revise document in consultation with colleagues, conforming to the rules on content, format and style set out for Trust

Documents (‘DN’ documents) in DN1 Document Control Procedure.

Document goes to relevant local committee for approval (in exceptional circumstances, approval can be given by Chair’s Action or by an

appropriate Executive or Non-executive Director).

Strategies and Policies only:

After any recommended changes have been made, document goes to the Board of Directors or a Committee of the Board for further approval. Approval recorded in

Minutes and a copy of the Minutes or relevant Minute is sent to the Document

Control Officer.

After any recommended changes have been made, the document is emailed to the Document Control Officer, with a copy of the Minutes or

relevant Minute (or where approval was by Chair’s Action or ED/NED, confirmation of this).

Document Control Officer logs new document/new version and stores it on electronic archive, and publishes it on the intranet in PDF format.

Senior Managers alert all relevant staff to the need to familiarise themselves with the new/revised document.

Document Control Officer alerts owner of documents three months in advance of routine review date and the process begins again.

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Page 15 of 15 Further document information

Approval – this is required for all documents. Approval should be by the relevant committee(s)*. State the name(s) of the

committee(s) and the full date(s) of the relevant meeting(s):

*In exceptional circumstances only, approval can be by Chair’s Action or by appropriate ED or NED – state full date of

approval:

Quality and Risk Committee – see below

Approval date (this version) (Day, month, year):

See below Approval by Board of Directors

or Committee of the Board (required for Strategies and Policies only):

Quality and Risk Committee

Date (Day, month, year): July 2012 This document supports:

standards and legislation – include exact details of any CQC & NHSLA standards supported

CQC compliant

NHSLA Risk Management Standard 1.2 Public Records Act 1958

Freedom of Information Act 2000 Section 46 NHS Code of Practice Records Management IG Toolkit V8 2010/11 Standard 601

Key associated documents: Trust Document Exemplar DN1A Records Management Policy DN260 Counter Fraud and Corruption Policy and Procedure for Reporting DN203

Counter Fraud In creating/revising this document, the contributors have considered and minimised any risks which might arise from it of fraud, theft, corruption or other illegal acts, and ensured that the document is robust enough to withstand evidential scrutiny in the event of a criminal investigation. Where appropriate, they have sought advice from the Trust’s Local Counter Fraud Specialist (LCFS).