document control policy - bolton nhs ft · version 9 policy document control policy page 3 of 15...

Version 9 Policy Document Control Policy of 15

Date March 2015 Next Review Date February 2018

Document Control Policy

Document type: Policy

Version: 9.1

Author (name and designation): Esther Steel, Trust Secretary

Validated by

Date validated

Ratified by:

Date ratified:

Name of responsible committee/individual: Esther Steel

Name of Executive Lead: Esther Steel

Master Document Controller: Caroline Swaby

Date uploaded to intranet:

Review date: March 2018

Version control

Version Type of Change Date Revisions from previous issues

V. 8 Full review Feb 2014 Major revision, changes to templates, updates to

reflect changes in governance structure.

V. 9 Full review March 2015 Major review following extensive consultation with

users. New document developed

Equality Impact

Bolton NHS Foundation Trust strives to ensure equality of opportunity for all service users, local people and the workforce. As an

employer and a provider of healthcare Bolton NHS FT aims to ensure that none are placed at a disadvantage as a result of its policies

and procedures. This document has therefore been equality impact assessed to ensure fairness and consistency for all those covered

by it regardless of their individuality. The results are shown in the Equality Impact Assessment (EIA).



Contents

Purpose of Policy

Content

Development of documents

Adoption of regional/national documents

Style and format of documents

Consultation

Equality Impact Assessment

Validation

Ratification/final approval

Review and revision

Dissemination and implementation

Document control

Version control

Monitoring Compliance

Appendices

1. Document development checklist

2. Approving/validating bodies

3. Equality Impact Assessment

4. Glossary of terms

5. Template



Purpose

1. All policies and procedural documents will conform to the standards set by the Trust in this document to ensure that:

• Documents are accessible and understood by all staff.

• Documents are developed and ratified by the appropriate bodies.

• Documents are underpinned by the appropriate education and training.

• Documents are kept up to date.

• That previous documents are archived for reference.

2. This policy applies to all staff who write or authorise procedural documents published in the name of the Trust.

3. The policy requires all staff to first determine the need for such a document or whether similar documents already exist.

4. This document shall apply from the date of publication to all new and revised documents.

5. The steps below are described in the following pages of the policy.

Identify need for new document or revision to existing

page

Develop or revise document - refer to

document development checklist

page

consult with relevant

stakeholders

page

Validation by appropriate body (see table page )

Final approval by relevant body

(see table page )

Publication and disemination

page

Audit of compliance

page

Review of document

page

return to step one



The Development of Documents

6. The Document development checklist at appendix 1 is provided as a guide for the development of documents.

Before developing a document authors should:

7. Justify the need for the document

8. Ensure the document is not duplicating other documents.

9. Consult with colleagues and stakeholders either individually or through designated groups in order to

Identify who will undertake and lead the work, who should be involved and how it will be done.

Ensure relevant expertise is used to ensure that the introduction of the policy reflects desired practice.

Consider external requirements pertinent to the contents of the policy.

Identify who will be responsible for what eg dissemination, implementation, training and review.

Advice on “fraud proofing” documents can be obtained from the local counter fraud specialist (LCFS).

Confirm that implementation is reasonably achievable

10. Identify how the document links with service priorities, NHS policy directives, legislation and best available evidence. Library Services staff are available to help with these aspects.

Adoption of Regional or National Documents

11. There are occasions when it may be appropriate to adopt regional or national procedural documents eg those prepared by NICE, Royal Colleges, Regulatory Authorities and Regional Networks.

The decision to adopt a regional or national procedural document should be made by the appropriate validating body - (please see appendix two)

a front cover, document tracking sheet and equality impact assessment should be completed in accordance with the document control policy and

The document should be submitted to the appropriate ratifying body and should be uploaded to the intranet in accordance with the policy.

Where a national or regional document is adopted the review date should be accordance with that set by the originating author/body.

Style and Format of Documents

12. All documents should be written in a style which is concise and clear using unambiguous terms and language.

13. The format and font of documents should be based on the template at Appendix 1 but reasonable minor variation may be acceptable at the discretion of the Chair of the ratifying committee.



14. Each paragraph should be numbered to ensure ease of reference.

15. Each page must be numbered and should use the standard footer as shown in the document template in appendix five

16. The ratifying committee should not decline to ratify otherwise appropriate documents on the basis of minor deviations from style or format alone.

Consultation

17. After the initial draft of a document is produced to the satisfaction of the author, the author should consult with key personnel and any appropriate stakeholders.

Equality Impact Assessment

18. The Trust aims to design and implement services, policies and measures that meet the diverse needs of our service population and workforce, ensuring that none are placed at a disadvantage over others. The Equality Impact Assessment (EIA) is designed to help you consider the needs and assess the impact of your document.

19. All strategies and policies must have an EIA completed and included in the appendix of the document. The table at appendix 2 shows which documents require a completed EIA and which are considered exempt from this requirement.

20. The author of the document is responsible for carrying out an Equality Impact Assessment using the assessment tool (appendix 3).

Validation

21. A Trust wide committee, expert committee or working group should peer review and validate the document. Where specialist knowledge is required it may be necessary to seek external advice. In the case of policies and protocols this must all be done prior to seeking ratification.

22. This stage involves checking that the process undertaken during the development of the document has considered:

The relevance to the organisation.

Readability and ease of comprehension.

That all relevant people have been consulted.

That the document has been peer reviewed.

That it conforms to Trust guidelines and format.

That methods of dissemination have been identified and, where necessary,

supported by a planned educational and training programme.

That if required, an Equality Impact Assessment has been carried out.

Ratification/final approval

23. The type of document determines the forum for final approval (ratification) of a document (see table in appendix two). The ratification of a document must be included in the minutes of the ratifying committee



24. After consideration of the document the chair or secretary of the ratifying committee should return the completed tracking document to the document author.

Review and Revision

25. Authors are expected to keep their documents up to date to reflect changing practices, legislation, demands and expectations. Documents must be reviewed once every three years and should be reviewed earlier if there is a significant change in practice eg revised NICE guidance.

26. The document management system will flag up review dates. The Master Document Controller should remove/archive out of date documents from the intranet and replaced with the new version of the document.

27. If a document has been updated and there is no change in practice, final approval can be granted by the validating body without the need to re-consult.

28. Amendments to documents should be recorded within the version control schedule at the beginning of the document.

29. A document will not be invalidated or removed from the Trust intranet solely on account of the review date passing. The document shall remain in force until replaced or decommissioned.

Dissemination and Implementation

30. Dissemination - The “Master Document Controller” is responsible for ensuring that, once approved, the document goes onto the intranet in the relevant section.

31. For policies and strategies, the author will notify the Head of Communications that the document has been approved. Staff will be notified of relevant new or revised Trust documents in the monthly Team Brief.

32. Implementation into practice should be supported by planned management of change, education and training activities, and allocation of resources if required. The responsibility for arranging this rests with the relevant division/directorate.

Document Control Including Archiving Arrangements

33. All Trust wide current ratified documents shall be freely available on the Trust’s intranet. They must be put on the intranet whether or not they are also held in storage systems such as QPulse. Authors must retain a Microsoft Word master copy of each of their documents.

34. Where a document or series of documents - usually local standard operating procedures and guidelines are specific to one department, the department may

seek the approval of the Procedural Document Group to maintain the documents locally and not upload to the internet.

35. All previous versions of trust wide procedural documents are maintained in an archive on the Trust intranet. This should include the date of archiving and version number. Master document controllers will be responsible for maintaining an archive of the original documents.



Version control

36. In order to provide clarity of the status of documents that are in circulation, all documents are to be clearly annotated with version numbers and must include a change record.

37. The first draft of the document should be labelled ‘Draft version 0.1’ and dated. Further draft versions should be labelled ‘Draft version 0.2, 0.3’ etc. and dated.

38. The final original version of the document should be labelled ‘Final Version 1.0’ and dated. This version will be submitted for the appropriate approvals.

39. Subsequent versions should be labelled ‘Draft Version 1.1, 1.2’ whilst being drafted and reviewed and the version re-submitted for approval should be labelled ‘Final Version 2.0’ and dated.

Monitoring Compliance with the Document

40. All Trust policies, guidelines and protocols should be monitored for compliance and have an appropriate monitoring section this may be a table as used below, or a narrative description of how the policy will be monitored.

Area to be monitored methodology Who Reported to frequency

The development and management of procedural documents as set out within the policy to include the ratification process.

Continuous monitoring of documents submitted for publication on website

Procedural

Document Group Accountable Directors

Continuous

Control of documents and archiving arrangements

‘snapshot’ audit of current and archived documents

Trust Secretary Quality Assurance

Committee Annual

Table 1 - Monitoring of the Document Control Policy



Appendix One Document Development checklist Type of document

Lead author:

Is this new or does it replace an

existing document?

What is the rationale/ Primary

purpose for the document

[Motivation for developing the

document]?

What evidence/standard is the

document based on?

Is this document being used

anywhere else, locally or nationally?

Who will use the document?

Has a pilot run of the document

taken place?

Has an evaluation taken place? What

are the results?

What is the implementation and

dissemination plan? [How will this

be shared?]

How will the document be

reviewed? [When, how and who will

be responsible?]

Are there any service implications?

[How will any change to services be

met? Resource implications?]

Keywords [Include keywords for the

document controller to include to

assist searching for the policy on the

Intranet]

Validated by

Date

Ratified by

Date



Appendix Two - Approving/Ratifying Bodies

Type of procedural document Validating Body Final approval/ratification EIA

Strategies

Executive Directors Board of Directors

Policies

Appropriate Trust wide committee or expert group

Executive Directors

Protocols

Appropriate expert group Clinical Governance & Quality Committee

Non- Clinical Guidelines

Appropriate expert group Lead Executive Director or Divisional Board

-

Clinical Guidelines/Pathways Appropriate expert group Clinical Governance & Quality Committee. If guideline also pertain to medicines will need ratifying at D & T committee

Formulary/Prescribing Guidelines

Appropriate expert group Drugs and therapeutics Committee -

Patient Group Directions (PGDs)

signed off by head of nursing, medical director and chief pharmacist

Drugs & Therapeutics Committee -

Patient Specific Directions (PSD)

Appropriate expert group Individual care documents -

Care Plans and associated care provision documents such as NEWS

Appropriate expert group Professional Advisory Group -

Standard Operating Procedures (SOPs)

Appropriate expert group Departmental Manager/Head of Service

Pharmacy Fact Sheets

Appropriate expert group Drugs & Therapeutics Committee -



Appendix Three

Equality Impact Assessment Tool

To be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval.

Yes/No Comments

1. Does the document/guidance affect one group less or more favourably than another on the basis of:

Race No

Ethnic origins (including gypsies and travellers) No

Nationality No

Gender (including gender reassignment) No

Culture No

Religion or belief No

Sexual orientation No

Age No

Disability - learning disabilities, physical disability, sensory impairment and mental health problems

No

2. Is there any evidence that some groups are affected differently?

No

3. If you have identified potential discrimination, are there any valid exceptions, legal and/or justifiable?

4. Is the impact of the document/guidance likely to be negative?

No

5. If so, can the impact be avoided?

6. What alternative is there to achieving the document/guidance without the impact?

7. Can we reduce the impact by taking different action?

If you have identified a potential discriminatory impact of this procedural document, please refer it to your divisional E and D lead together with any suggestions as to the action required to avoid/reduce this impact.



Appendix Four Glossary of Terms Strategies are formal documents which provide a corporate framework or plan of action as to how

certain broad aims will be addressed by the Trust.

A policy is a statement of intent, describing the approach or course of action the Trust is taking in

respect of a particular issue.

Protocols a protocol addresses the key questions of what should be done, when, where and by

whom. It provides a framework for working in multi-disciplinary teams to standardise practice and

reduces variation in the treatment of patients.

Guidelines provide a recommended process for delivering an outcome which affects a broad group

within a flexible framework. For the purpose of classification guidelines should be described as

Clinical, non-Clinical or Formulary/prescribing.

Standard Operating Procedures - Is a defined way or method of undertaking a task or series of

actions.

Patient Group Direction (PGD) - PGDs provide a legal framework that allows the supply and/or

administration of a specified medicine(s) by named, authorised, registered health professionals, to a

pre-defined group of patients needing treatment or prophylaxis for a condition described in the PGD,

without the need for a prescription or an instruction from a prescriber. A PGD is for limited situations,

usually in acute care, where it offers an advantage for patient care without compromising patient

safety.

Pharmacy Fact sheet - A summary of a drug, drug class, or related group of drugs, covering the key

points that support safe and effective prescribing, administration and monitoring. Primarily used for

drugs that are deemed to carry a high-risk for error or where an error is likely to be severe in nature.

Care Plans - Care plans are documents that identify specific interventions for a patient and serve as

a guide to care delivery, for example a nursing care plan. This policy relates to the development of

the template not the individual care plan

Patient Specific Direction (PSD) - A PSD is a written instruction by a prescriber for a named

individual, this policy relates to the development of the template not the individual PSD

Algorithms / Flowcharts these are diagrams which show a step-by-step approach to performing a

task or clinical activity. These will invariably be a part of a protocol, SOP or guideline.

Operational policies - These provide a description of a particular service, ward or department and

illustrate how that service operates in relation to other services.

Standards - a statement which outlines an objective, with guidance on how to achieve it, including

the required resources, activities and predicted outcomes.

Ratification – for the purpose of this policy is the final approval of a procedural document by the

appropriate body.

Validation - for the purpose of this policy is the review and approval of a document by an expert

committee or working group prior to submission for final validation.

Keywords - Keywords are used to ensure the document is easy to find when searching the intranet.

Authors should select words associated with the document that are not in the title.

Version Document Page x of y

Date Next Review Date

Appendix Five - Document Template

Title of Document

Document type:

Version:

Author (name and designation):

Validated by

Date validated

Ratified by:

Date ratified:

Name of responsible committee/individual:

Name of Executive Lead:

Master Document Controller:

Date uploaded to intranet:

Review date:

Version control

Version Type of Change Date Revisions from previous issues

Equality Impact

Bolton NHS Foundation Trust strives to ensure equality of opportunity for all service users, local people and the workforce. As an employer

and a provider of healthcare Bolton NHS FT aims to ensure that none are placed at a disadvantage as a result of its policies and

procedures. This document has therefore been equality impact assessed to ensure fairness and consistency for all those covered by it

regardless of their individuality. The results are shown in the Equality Impact Assessment (EIA).



Contents

1 Purpose of Policy

2 Content

3 Monitoring

4 Appendices

5 References



Purpose

1. Use this section to briefly introduce your document

2. Consider who the document is for and what you want them to do as a result of reading it

Content

3. This section should be the body of your document outline the key facts using headings to highlight key areas if appropriate.

4. Structure this section to give a logical flow to your document and make it easy to read/digest

5. Use straightforward language, avoid buzz words

6. Font should be 12pt Arial with headings in bold; avoid capitals and italics

7. Use bullet points for short lists

8. Include flow charts if it will help the reader of the policy

9. Number paragraphs but not headings

10. Keep to the key facts, use appendices for definitions and references

11. Avoid footnotes

12. All pages should have a page number and footer as the example on this template

Monitoring Compliance

13. This should be a short section on how compliance with the document will be monitored. A table like the one below or narrative can be used.

Area to be monitored methodology Who Reported to frequency

Appendices

Use numbered appendices to provide supplementary information eg forms and flow charts. The Equality Impact Assessment must also be included in the appendices.

If relevant, a reference list and further reading can be included in the appendices.



Equality Impact Assessment Tool

To be completed and attached to any procedural document when submitted to the appropriate committee for consideration and approval.

Yes/No Comments

1. Does the document/guidance affect one group less or more favourably than another on the basis of:

Race

Ethnic origins (including gypsies and travellers)

Nationality

Gender (including gender reassignment)

Culture

Religion or belief

Sexual orientation

Age

Disability - learning disabilities, physical disability, sensory impairment and mental health problems

2. Is there any evidence that some groups are affected differently?

3. If you have identified potential discrimination, are there any valid exceptions, legal and/or justifiable?

4. Is the impact of the document/guidance likely to be negative?

5. If so, can the impact be avoided?

6. What alternative is there to achieving the document/guidance without the impact?

7. Can we reduce the impact by taking different action?

If you have identified a potential discriminatory impact of this procedural document, please refer it to your divisional E and D lead together with any suggestions as to the action required to avoid/reduce this impact.