Policy and procedural documents (development and management) policy – Rotherham Doncaster and South Humber NHS Foundation Trust (RDaSH)

1 Introduction

1.1 The importance and role of all procedural documents

This document and the underpinning suite of policies and procedures are in place to provide support and guidance to staff in fulfilling their roles at the trust and ensuring that they are carried out in a safe and effective manner. The objective of such documents is to provide clarity to the way in which staff are expected to perform and to highlight the authority and responsibility of those staff involved to allow for a smooth and efficient process to occur.

It is important for the trust to ensure through such documents that it also complies with any relevant legislation and external guidance and considers national best practice.

2 Purpose

2.1 Purpose and rationale for the development of the policy

The purpose of this policy is:

to provide an approved framework and template procedural document to facilitate a consistent, structured and systematic approach to the development and management, removal of, and extension to review dates of procedural documents which supports best practice
to set out the arrangements for the control of procedural documents essential for compliance with governance standards, and to promote standardisation in the provision of safe and effective care and the management of risk

These control measures will:

provide staff with access to up-to-date trust procedural documents
facilitate the review of all procedural documents within an agreed time frame, which will be a maximum of 5 years from the most recent date of approval, however, all new procedural documents should be reviewed within 24 months of issue to ensure they are working effectively
avoid duplication of procedural documents
facilitate cross referencing to associated documents
allow for the maintenance of a register or database of all ratified trust procedural documents
provide for the on-going maintenance of a procedural document library and archive, in which documents will be added to, have been replaced by a revised version or have been withdrawn
allow for the on-going monitoring of the use of, and compliance with procedural documents
identify and allow for a reduction in inequality through use of the equality impact assessment (EIA) screening tool

3 Scope

This document applies to and is relevant across the following services or departments:

Doncaster, Rotherham, North Lincolnshire and children’s care groups
all corporate services
other documents for example, collaborative or multi agency or regional policy documents to which the trust has adopted may be referred to in procedural documents (and via hyperlinks where available)

4 Responsibilities, accountabilities and duties

While the trust governance arrangements aim to provide a co-ordinated approach to the development of procedural documents throughout the organisation, there are individuals and committees who have specific responsibilities and duties in relation to the policy as detailed below:

4.1 Chief executive

The chief executive is accountable for there being a structured approach to procedural document development and management in place. Although responsibility for procedural document development may be delegated to other officers, accountability remains with the chief executive.

4.2 Accountable directors, policy groups with delegated authority for approval

Trust procedural documents are categorised as set out in the table below. Each category has an identified accountable director and an identified committee or group with authority or delegated authority from the board of directors for approval of procedural documents. These committees or policy groups are responsible for ensuring governance arrangements are in place for the review and approval of procedural documents for which they are accountable.

Accountable directors, policy groups with delegated authority for approval
Policy title or category	Accountable director	Policy committee or group with delegated authority for approval
Reservation of powers or scheme of delegation (including standing orders)	Finance and performance	Board of directors
Constitution	Finance and performance	Board of directors and council of governors
Standing financial instructions	Finance and performance	Board of directors
Procedural documents (development and management) policy	Corporate assurance	Board of directors
Risk management framework	Corporate assurance	Board of directors
Performance management framework	Corporate assurance	Board of directors
Learning from deaths policy, the right thing to do	Executive medical director	Board of directors
Clinical: Admissions Care, treatment and assessment Discharge or transfer End of life care Infection prevention and control Safeguarding Service specific Wound management	Nursing and allied health professionals Executive medical director	Clinical policies review and approval group
Mental health legislation	Medical director	Mental health legislation operational group
Prescribing and medicines management	Medical director	Clinical policies review and approval group
Emergency planning	Chief operating officer	Corporate policy approval group
Estates and facilities	Finance and performance	Corporate policy approval group
Finance	Finance and performance	Corporate policy approval group
Human resources (employment)	Workforce and organisational development	Corporate policy approval group
Health safety and security	Finance and performance	Corporate policy approval group
Information: Information technology Information governance Information management	Health informatics	Corporate policy approval group
Learning and development (education)	Workforce and organisational development	Corporate policy approval group
Patient experience	Nursing and nursing and allied health professionals	Corporate policy approval group
Patient safety	Nursing and nursing and allied health professionals	Clinical policies review and approval group or corporate policy approval group dependant on content
Records management	Health informatics	Corporate policy approval group
Research governance	Executive medical director	Corporate policy approval group

4.2.1 Accountable directors

The accountable directors are responsible for:

upholding the requirements set out in this policy
the development and management of the policies for which they are identified as the accountable director as set out above in line with this policy
identifying an author for the development or review of procedural documents
procedural documents being reviewed and ratified in accordance with the time scale specified at the time of approval (should not exceed 5 years), in order that all trust procedural documents remain current
scheduling procedural documents for approval to the relevant policy committee or group with delegated authority for approval

4.2.2 The chairs of committees or policy groups with delegated authority for approval

The chairs of committees or policy groups with delegated authority for approval of procedural documents are responsible for:

confirming that consultation is conducted including the mandatory people identified on the tracking document for all procedural documents
clearly recording decision making in the minutes of meetings in respect of:
- the approval of procedural documents which meet the requirements set out within this policy
- the approval of procedural documents subject to recommendations
- the referral of procedural documents not ratified and which require further work back to the accountable director and the procedural document author with an indicative timescale for completion
- the approval of review date extensions
- removal of procedural documents from the procedural document library
- temporary adoption of urgent procedural documents in instances where a lack of immediate change to working practices can be detrimental to clinical, care, staff, or business continuity, the review should be completed retrospectively

4.3 Corporate assurance policy officer

The corporate assurance policy officer is responsible for:

the continuous monitoring of the implementation of this policy through:
- monitoring that new and revised procedural documents meet the requirements set out in this policy, informing accountable directors where this is not the case and advising on the changes required
- reviewing procedural documents as part of the consultation process, to ensure that they are in line with the requirements of this policy (see procedural document approval journey)
- monitoring that the procedural document approval process is in line with the requirements set out within this policy, liaising with chairs of committees or groups with delegated authority for approval as required
- maintaining an effective system for the control of procedural documents, including:
  - the electronic register or database of procedural documents.
  - the library archive on the trust shared L: drive
  - tracking documents system (see template appendix F) including version control process or to aid tracking and retrieval and archiving and retrieval arrangements
  - finalising the document control box on the front cover of all procedural documents submitted for publication on the trust website (this provides a key source of assurance for version control, archiving and approval)
- publication of procedural documents on the trust website following approval and the removal and archiving of previous versions
- liaising with the communications department at the earliest opportunity (on a monthly basis) to notify all staff via daily emails (all users) of the development and issue of:
  - new procedural documents
  - new versions of existing procedural documents
  - removal of procedural documents from the trust procedural document library
- monitoring procedural document review dates and providing the accountable director with a quarterly status report (which allows a minimum of 6 months’ notice) of documents requiring review.
- incorporating any procedural documents requiring approval or review by the board of directors into the trusts annual board cycle via the Corporate Assurance team.
- undertaking a yearly audit of the procedural document pages of the trust website and providing the results and any recommendations to the Executive Management team via the director corporate assurance.
providing advice and guidance to all staff on procedural document and in particular to corporate policy authors or leads or corporate staff on the development and review of corporate procedural documents as required

4.4 Clinical effectiveness lead

The clinical effectiveness lead is responsible for:

providing support, advice and guidance to clinical policy authors or leads or clinical staff on the development and review of clinical procedural documents as required
coordinating the reviews of clinical documents through to approval under the remit of clinical policies review and approval group (CPRAG), this includes the process prior to their approval, to approval and forwarding for publishing on to the policy website, checking the mandatory consultation has taken place, to ensure that they meet the requirements of this policy (see procedural document approval journey or flow chart)
providing status or exception reports to the care group, and CPRAG on clinical procedural document approval

4.5 Procedural document authors

All authors must comply with the guidance and templates contained in this policy.

Lead authors will be identified by the accountable director who will oversee the author undertaking the following tasks:

the development and, or review of procedural documents in line with the requirements of this policy, a procedural document approval journey is provided to support this process
before commencing development or review authors should assess whether:
- a procedural document does not already exist, and is not covered by the Royal Marsden suite of policies. The trust subscribes to this suite of policies which is primarily applicable to all areas of acute hospital inpatient care. Where applicable these policies should be used as opposed to the creation of new trust policies
- the document is still required or whether redundant and could be removed from the trust policy library or circulation?
- the content could be incorporated within an existing policy?
- if a new document is required could this be generated to fit across a broader scope than first anticipated? (could it fit across the whole organisation?)
- is this document purely for local practice, for example, a Local working instruction see section 2.1.1.8
authors are responsible for ensuring that the document is written in the approved style and format as detailed in section 5
using the track changes or similar function when reviewing an existing procedural document in order that changes can be identified and discussed when presented for approval or approval
being aware of any changes in legislation, practice or national guidance, and incorporating this into the procedural document (to note, where the legal position is not clear, the author will discuss this with the accountable director, who may decide to seek advice from the trust’s solicitors)
ensure that the content does not infringe copyright permissions
assess the procedural document considering any risk or potential adverse consequences for the trust and providing guidance on how to minimise these
test the robustness of the procedural document through a consultation process with as many relevant stakeholders as appropriate, see section 5.4.4
consider any training implications arising from the procedural document and discuss this with the head of learning, development and education
complete an equality impact screening assessment (opens in new window) (staff access only) (equality analysis) when required, and send to the head of equality and diversity to ensure they are sighted and approval can be obtained
seek advice from the local counter fraud specialist in relation to potential fraud issues to ensure the procedural document is robust and will be legally robust should any deviation from it be utilised in a fraud investigation, failure to ensure appropriate links will render the trust vulnerable in such circumstances and may lead to an inability to seek appropriate sanctions
contacting the relevant committee or group administrator to include the final document onto the next available approving committee or group agenda, along with a completed tracking document, equality impact assessment (and cover sheet for board of directors meetings only)
completing any amendments agreed subject to approval before submission to the corporate assurance policy officer for publication, document should be submitted for publication within 2 weeks of approval (clinical documents under the remit of CPRAG are provided via the clinical effectiveness support officer)
take remedial action to address issues where monitoring identifies failure of the controls in implementation and application of the policy

4.6 Managers

Managers are responsible for:

implementing the requirement for new or revised procedural documents to be fully operational within their services within a period of 3 months
all staff they manage being aware of how to access the trust’s procedural documents
including any procedural documents relevant to their area of work in their local induction for new staff
identifying any staff training needs in relation to the implementation of new or revised procedural documents and bringing these to the attention of the head of learning, development and education
assisting in the monitoring and audit of procedural document implementation within their area of work

4.7 All staff (including those listed above)

All staff have a responsibility to work in line with the trust’s ratified procedural documents and should:

be aware of how to access them
be aware of those which are relevant to their area of work
act in accordance with them
attend any training which is offered in relation to them.
report to their manager any issues affecting compliance with them, in order that these can be taken account of
seek authorisation to develop a new procedural document from the accountable director before proceeding

4.8 Head of learning, development and education

The head of learning, development and education is responsible for:

considering any training implications identified by the procedural document author and planning the provision of an appropriate training programme, in close liaison with managers, authors have a responsibility of working with and liaising with the head of learning, development and Education to assess how best the learning needs may be addressed
including any completed training needs analysis which covers mandatory, statutory, safety training and training essential to role on the trusts training needs analysis matrix

4.9 Equality and diversity lead

The equality and diversity lead is responsible for:

advising document authors on completing an EIA
approving completed EIA’s before the document is presented for final approval
publication of approved procedural document EIA’s on the trust website

4.10 Communications department

The communications department is responsible for notifying all staff via the trust’s daily emails of the development and issue of:

new procedural documents
amended versions of existing procedural documents
procedural documents which have been removed from the trust policy library or archive

Contact details for queries about procedural documents will also be provided.

5 Procedure or implementation

5.1 Development of a new procedural document

The decision as to whether a new procedural document is developed rests initially with the relevant accountable director prior to approval by the relevant approval group. Individuals identifying a need for a particular procedural document should:

check against the Royal Marsden suite of policies for clinical procedural documents
check against any collaborative or multi agency or regional policy to which the trust has signed up to
check against national policy and recommendations.
contact the corporate assurance policy officer or clinical effectiveness lead to check against the trust electronic register or database of procedural documents, to ensure it is not duplicating other work locally
complete a procedural document request form and discuss with the accountable director the justification and support for:
- developing the new document
- how it links with service priorities
- the potential to extend this to cover across other services and or across the trust
- confirm that implementation is achievable within the resources of the service or organisation

In some cases the development of a procedural document will have been recommended by an external body (for example, Care Quality Commission) and this should be noted within the document in the introduction section.

5.2 Review arrangement with timescales

At least 6 months prior to the scheduled review date for procedural documents, the corporate assurance policy officer will notify the accountable director.

All trust procedural documents will be reviewed within a maximum period of 5 years.

Reviews or amendments of some procedural documents will be initiated earlier than this due to feedback received through monitoring processes and, or due to changes in the regulatory framework, national policy guidance, emerging best practice or the model of service provision etc.

Where the review process exceeds the agreed review date the published document remains the trust approved document until the review process is completed and the revised document ratified and published. Where the review of a procedural document breaches the agreed review date by 3 months the corporate assurance policy officer will notify the accountable director.

Patient group directives (PGD) supplied to cover seasonal sessions. These PGDs are generally supplied by Public Health England, are not to be tampered with other than to insert authorisation to use information and are set to cover a season start date and expiry date. These PGDs are to be removed from the trust Library on their expiry date following confirmation by the Pharmacy team.

5.3 Consultation process

The procedural document tracking document shown in appendix F will be used to record the development and consultation process and all responses received, including whether these have resulted in amendments to the policy and if not, why.

Drafts of procedural documents will be circulated to the identified stakeholders by the procedural document author identifying a timescale for response and a named contact to respond to.

Consultation must include:

anti-crime specialist
clinical effectiveness lead (for all clinical policies)
head of equality, diversity, inclusion and participation
head of learning, development and education
Mental Capacity Act lead
corporate assurance policy officer

The decision on other involvement of stakeholders will be taken on a case-by-case basis by the procedural document author in consultation with the accountable director or senior management, depending upon the nature of the procedural document being developed or reviewed.

5.4 Identification of stakeholders

The involvement of staff, trade unions, relevant groups, committees and external stakeholders including service users and carers is central to the development and review of effective procedural documents, and to the success of their subsequent implementation. The following table provides guidance on relevant stakeholders that should be considered as part of the consultation process:

Identification of stakeholders
Document category	Type of stakeholder
Clinical: admission or access to services care treatment and assessment discharge or transfer end of life care infection prevention and control prescribing and medicines management safeguarding service specific wound management	Care groups (for wider circulation or consultation with operational staff) Health, Safety and Security team Human Resources or organisational Development team Infection Control team Information Governance team Medicines management Mental Health Act manager Patient Advice and Complaints team Patient Safety team Safeguarding Adults or Children team Psychological professionals
Emergency planning	Care groups (for wider circulation or consultation with operational staff) Estates and facilities
Estates and facilities	Care groups (for wider circulation or consultation with operational staff) Information technology
Finance	Care groups (for wider circulation or consultation with operational staff) Counter fraud specialists Health, Safety and Security team Information governance
Human resources	Care groups (for wider circulation or consultation with operational staff) Staff side Human Resources or Organisational Development team Information Governance team Patient Advice and Complaints team Patient Safety team
Health, safety and security	Care groups (for wider circulation or consultation with operational staff) Human resources or Organisational Development team
Information or records management	Care groups (for wider circulation or consultation with operational staff)
Learning and development	Care groups (for wider circulation or consultation with operational staff) Subject specific
Mental health legislation (including Mental Capacity Act)	Care groups (for wider circulation or consultation with operational staff)
Patient experience	Care groups (for wider circulation or consultation with operational staff)
Patient safety	Care groups (for wider circulation or consultation with operational staff) Health Safety and Security
Research governance	Care groups (for wider circulation or consultation with operational staff)

In addition to the list above the policy author must consider any other relevant department or service where the implementation of the procedural document will impact as part of the consultation process.

Drafts of a document may be circulated on more than one occasion, depending on the nature and complexity of the procedural document.

Consultation on policies that will have impact on working practices and patterns of work for employees will be consulted on with the trust staff council.

Consultation on policies that will impact particular groups of external stakeholders should be consulted upon with those concerned.

5.5 Procedural document approval process

All reviews to any procedural document, including those where a review confirms that no changes are required, must be ratified according to the process set out above.

Certain procedural documents require approval by the board of directors and the responsibility for these documents rests with the accountable director. See table in 4.2 accountable directors.

Responsibility for approval of procedural documents has been delegated by the board of directors to groups as set out in section 4.2 of this policy with the exception of those requiring approval by the board of directors.

A tracking document is to be completed recording the approval journey. This is to ensure a uniform approach to document development and management is maintained. When procedural documents are submitted for approval a completed tracking document should accompany it (see appendix F tracking document template).

The approving committee or group will either:

approve the procedural document
approve it subject to recommendations
not approve it

Ratified procedural documents, the procedural document author (for clinical documents this task is performed by the clinical effectiveness support officer will be forwarded to the corporate assurance policy officer to update the register or database and publish on to the trust library, archive and website. This action is to be completed within 2 weeks of the approval date.

Procedural documents ratified subject to recommendations, the procedural document will amend the procedural document and will then be forwarded to the corporate assurance policy officer for action as above.

Procedural documents not ratified will be returned to the procedural document author for further work supported by corporate assurance policy officer or clinical effectiveness lead or support officer as appropriate.

A minor amendment is defined as the correction of a small spelling mistake, expanding an acronym, amendment to contact person or details. This should be applied for by using a tracking document stating the change. Both the procedural document and the tracking document should be forwarded to the corporate assurance policy officer for recording and publishing. This change does not require formal approval.

A major amendment to a procedural document must be ratified by the responsible approving group. The review date of the policy will not change until a full review of the document is completed and approved by the committee or group responsible.

A major amendment is defined as any change to content of the document that would alter the previously approved procedure and, or defined roles and responsibilities.

5.5.6 Extension to review date

To apply for an extension to a review date, this should be requested using a tracking document detailing the:

request for extension and period of extension
why it is being requested
consultation if appropriate
associated risks

This is submitted to the appropriate group for approval.

5.5.7 Removal of document from trust library or archive

To apply for a document to be removed, this should be requested using a tracking document detailing the:

the request for removal
why it is being requested
the consultation
where content has been incorporated elsewhere (if appropriate)
any associated risks

This is submitted to the appropriate group for approval.

5.5.8 Version control

Once ratified all procedural documents will be version numbered to aid tracking and retrieval and, or specific version. Version numbers must be included in the document control box on the front cover of the procedural document.

The corporate assurance policy officer will manage the version control process via the electronic register or database, version control and archiving and retrieval arrangements.

5.5.8.1 Draft procedural documents

The first draft of a document must start at 0.1 and then progress through revisions by incrementing the number to the right of the point for example, 0.2, 0.3 and so on.

5.5.8.2 Ratified procedural documents

Once ratified the version number of a new procedural document must start at version 1.0. A revised document must follow in numerical order from the last ratified version for example, version 1.0 become version 2.0.

5.5.8.3 Amendments

If a minor amendment to a procedural document (not a full review) is required the corporate assurance policy officer must be notified by the procedural document author (for clinical documents this task is performed by the clinical effectiveness lead), the version number will be amended to indicate the change by incrementing the number to the right of the decimal point, for example, version 2.1 and the document re-published.

If the amendment is a major change involving a major amendment which is defined as any change to content of the document that would alter the previously approved procedure and, or defined roles and responsibilities, the version number is amended to indicate the change by incrementing the number to the left of the decimal point, for example, version 1.0 becomes version 2.0.

5.5.8.4 Review of procedural documents

When a procedural document has undergone a complete review (review of the contents, roles and responsibilities, procedure, equality impact assessment, consultation etc.), and has been ratified by the responsible approval group the version number will be amended to indicate the change by incrementing the number to the left of the decimal point, for example, version 1.0 becomes version 2.0.

5.5.9 Communication, dissemination and implementation

All procedural documents will be publicised via the communications daily emails on a monthly basis and made available to staff via the trust website in read only files.

It is accepted that following approval of a procedural document there needs to be an allowance of time before it becomes fully operational in order to allow appropriate dissemination within the trust. It is therefore expected that any procedural document will be fully operational within 3 months of the date of approval unless otherwise notified.

Implementation issues and training needs should be identified for each new, amended and reviewed procedural document as an integral part of the review process.

Where it has been identified by the procedural document author that relevant groups of staff require training, a training needs analysis is to be completed to detail how these training needs will be addressed. Where this affects mandatory or statutory or essential to role training, the document author should inform the head of learning, development and education.

5.5.10 Procedural document control and archiving arrangements

All obsolete and, or superseded procedural documents will be removed and archived from the trust website and replace with a revised version where appropriate, with a new version number.

The electronic register or database of trust procedural documents, library and archive will be stored on a shared drive.

5.5.11 Retrieving procedural documents from archive

Documents due review or amendment can be retrieved from the archive when required by contacting the corporate assurance policy officer or another member of the Corporate Assurance team at rdash.corporate-assurance@nhs.net.

6 Training implications

There are no specific training needs in relation to this policy, but the following individual and groups need to be familiar with its contents:

board of directors
accountable directors
procedural document authors
chairs of trust policy and planning committees or groups with delegated authority for approval of procedural documents
any other individual or group with a responsibility for, developing procedural documents

7 Monitoring arrangements

7.1 Monitoring compliance

Monitoring compliance with:
- style and format
- explanation of any terms used
- consultation process
- approval process
- associated documents
- supporting references
How: An audit of procedural document tracking documents for a sample of approved documents.
Who by: Corporate assurance policy officer.
Reported to: Clinical leadership executive groups or board of directors.
Frequency: Annually.

7.2 Monitoring compliance

Monitoring compliance with:
- style and format
- explanation of any terms used
- consultation process
- approval process
- associated documents
- supporting references
How: Review of all procedural documents as part of the consultation process.
Who by: Corporate assurance policy officer.
Reported to: Document policy authors.
Frequency: On-going.

7.3 Control of documents, including archiving arrangements

How: Audit of register or database of documents against trust website pages.
Who by: Corporate assurance policy officer.
Reported to: Clinical leadership executive groups or board of directors.
Frequency: Annually.

7.4 Review arrangements

How: Report on the management of procedural documents detailing, documents reviewed and approved, scheduled for review, exception report on policies exceeded their review date.
Who by: Corporate assurance policy officer.
Reported to: Clinical leadership executive groups committees or board of directors.
Frequency: Quarterly.

8 Equality impact assessment screening

To access the equality impact assessment for this policy, please email rdash.equalityanddiversity@nhs.net to request the document.

8.1 Privacy, dignity and respect

The NHS Constitution states that all patients should feel that their privacy and dignity are respected while they are in hospital. High Quality Care for All (2008), Lord Darzi’s review of the NHS, identifies the need to organise care around the individual, ‘not just clinically but in terms of dignity and respect’.

As a consequence the trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided).

8.1.1 How this will be met

No issues have been identified in relation to this policy.

8.2 Mental Capacity Act

Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individuals capacity to participate in the decision making process. Consequently, no intervention should be carried out without either the individual’s informed consent, or the powers included in a legal framework, or by order of the court.

Therefore, the trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act (2005). For this reason all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act (2005) to ensure that the rights of individual are protected and they are supported to make their own decisions where possible and that any decisions made on their behalf when they lack capacity are made in their best interests and least restrictive of their rights and freedoms.

8.2.1 How this will be met

All individuals involved in the implementation of this policy should do so in accordance with the Principles of the Mental Capacity Act (2005).

9 Links to any other associated documents

10 References

11 Appendices

11.1 Appendix A Definition of terms

11.1.1 Types of procedural documents

The term procedural document is used as a global term to cover the various types of documents commonly developed and used within the trust. Procedural documents must be ratified by a trust group with delegated authority for approval and once implemented all staff are to work to them.

For the purpose of this policy the following definitions apply:

Definitions
Term	Definition
Business continuity plans	Business continuity plans are a framework to ensure the resilience of an organisation and business to any eventuality, to help ensure continuity of service to key users; patients or service users and the protection of the NHS brand and reputation.
Framework	A framework is a set of ideas, principles, agreements or rules that provide the basis or outline for the management of a particular issue
Strategy	A strategy is a long term plan of action (usually covering three to five years) which is designed to achieve stated goals or objectives. It is usually a broad statement which outlines how the organisation plans to reach the intended outcome. The trust policies and procedures are in place to support the achievement of the strategy
Patient group direction (PGD)	PGDs are documents permitting the supply of prescription-only medicines (POMs) to groups of patients, without individual prescriptions. Healthcare workers using PGDs should be sufficiently trained to be able to supply and administer POMs
Policy	policy is a statement of intent, describing the approach or course of action the trust is taking with regard to a particular issue. Policies are underpinned by relevant evidence based procedures and guidelines and enable managers and staff to make correct decisions, work effectively and comply with relevant legislation and trust aims and objectives. Policies must be achievable and must demonstrate how they are to be implemented. Each policy should have a purpose and specific steps (procedures) as to how the policy is to be implemented
Standard operating procedure (SOP)	A SOP is an agreed set of instructions for performing a particular task. SOPs require to be overarched by one trust ratified policy
Local working instructions	A local working instruction is a document that is not ratified through the corporate approval process and is not retained on the procedural document web library or archive. The use of this document is at local level where a matter or subject or process only relates locally to one service or is specific internally to a department, for example, finance procedures that are only applicable to the Finance team. Management of a local working instruction is the responsibility of the accountable director or designated senior manager with approval being recorded through a designated approving group. The review of this document is recorded and maintained at this designated level in line with the formulation of operational policies or local working instructions SOP. Any document that is to be used more broadly, across more than one service, or where there is a statutory or legal requirement, should be retained within the corporate approval process and be included within the procedural document web library or archive. Any such document would not be titled a local working instructions
Policy manual	A policy manual is an overarching (web based) policy where procedures are hyperlinked within section 5 and appendices are hyperlinked within section 11 of the overarching policy. This method has been devised to reduce duplication and make accessing subject detail quicker (see section 5.3)
Procedure	A procedure is a series of actions conducted in a certain order or manner. A procedure sits within a policy manual
Acceptable terms for people accessing trust services	The term patient is most commonly used within trust procedural documents in order to be consistent with the national approach, however service user may also be used as an alternative. Use of either of these terms should be restricted to either one, not both within a document
Care groups	Where the term care groups is used this includes the care group director, the care group medical director (lead consultant, children’s care group) and care group nurse director

11.2 Appendix B Development of procedural documents

11.2.1 The style and format of procedural documents

All procedural documents will be:

Written in a style which is concise and clear, using unambiguous terms and language.

Presented in a standard template for use with all procedural documents is provided as appendices.

Referenced using the Harvard referencing system.

11.2.2 Content of a policy (see appendix C)

11.2.2.1 Front cover

This should be set out as shown in appendix C. The document control box provides a key source of assurance for version control, archiving and approval.

11.2.2.2 Contents page

This may not be required depending on the length and complexity of the document. If it is a short document it can be deleted from the template.

11.2.2.3 Introduction (section 1)

This section must be completed for all documents. It is used to introduce the topic and includes references to and applicability of any relevant legislation, national policy guidance and external agency recommendations.

11.2.2.4 Purpose (section 2)

This section must be completed for all documents and should outline the objectives and intended outcomes of the process or system being described.

11.2.2.5 Definitions or explanation of terms used (section 2.1)

Include a list of definitions or explanation of any terms used that may require an explanation or clarification.

11.2.2.6 Scope (section 3)

This section must be completed for all documents and the target audience and the activities covered by the document clearly stated. When completing this section, procedural document authors should bear in mind that there will be some procedural documents developed for a specific service or staff group. Where different aspects of a topic are covered by more than one policy, it will be helpful to indicate this in this section.

11.2.2.7 Responsibilities, accountabilities and duties (section 4)

This section must be completed for all documents and should be divided into subsections, providing an overview of the individual, departmental and committee duties including levels of responsibility for document development. Duties may include accountabilities of:

directors
committees
specialist staff
authors with responsibility for procedural documents

11.2.2.8 Procedure or implementation (section 5)

This section must be completed for all documents and is the section where the actual procedural guidance is set out. For some documents this may only be a brief section. More lengthy procedural guidance should be presented in subsections to make it easier for the user of the document to refer to.

11.2.2.9 Training implications (section 6)

This section must be completed for all documents:

where training needs are identified in relation to the procedural document, a training needs analysis (TNA) must be completed, using the agreed template shown in appendix C
mandatory and statutory training
procedural documents in key subject areas in relation to risk which incorporate aspects of training must be included within the organisations training needs analysis. Details are provided in the trust mandatory and statutory training policy and associated training needs analysis (TNA)
where training is not required, the procedural document author should provide details of how staff will be made aware of the policy and its implications for their working practice as detailed below

11.2.2.9.1 Standard statement where no training is required, but where awareness is required

There are no specific training needs in relation to this policy, but the following staff will need to be familiar with its contents:

board of directors
accountable directors
procedural document authors
chairs of trust policy and planning committees or groups with delegated authority for approval of procedural documents
any other individual or group with a responsibility for, or an interest in, developing procedural documents
any other individual or group with a responsibility for implementing the contents of this policy

As a trust policy, all staff to be made aware of the key points that the policy covers. Staff can be made aware through (examples below, Please amend as appropriate):

continuous professional development sessions
one to one meetings or supervision
local Induction
posters
group supervision
team meetings
practice development days
communications daily email
special meetings

11.2.2.10 Monitoring arrangements (section 7)

A model template for the monitoring section of procedural documents is shown in section 7 of appendix B and must be completed for all documents. This section should set out how implementation of the procedural document will be monitored.

Monitoring provides assurance that prescribed systems are working and involves collecting information that will help answer questions about the trust’s systems, including:

are we managing the risk?
how well are we doing?
are we doing the things we said we should?
are we making a difference in doing those things?
where can we find the evidence?

For some, but not all procedural documents, audit will be used to monitor implementation. Other methods of monitoring which may be used are:

annual reports
complaints analysis
compliance with legislation and national standards, for example, Care Quality Commission
dashboards or adherence to key performance indicators (KPIs)
focus groups
health record checks
health and safety inspections and environmental audits
incident reports
routine data collection
spot checks
staff record checks
staff surveys
training evaluation
training records

11.2.2.11 Equality impact assessment screening (section 8)

The Equality Act 2010 replaces the previous anti-discrimination laws with a single act. One of the key measures of the act was the public sector equality duty (PSED) which came into force on the 5 April 2011. The equality duty is a duty on public bodies and others carrying out public functions, it ensures that public bodies consider the needs of all individuals in their day to day work, in shaping polices, in delivering services and in relation to their own employees. The equality duty is supported by specific duties set out in regulations which came into force on 10 September 2011; these specific duties require public bodies to publish relevant, proportionate information demonstrating their compliance with the equality duty. To this end trust staff complete and publish the equality impact assessment (EIA) on all policies, services, strategies and events taking into consideration not only the 9 protected characteristics but also a category to consider other people who may be disadvantaged for other reasons (disadvantaged groups).

The protected characteristics covered by the equality duty are:

age
disability
gender reassignment
marriage and civil partnership (but only in respect of eliminating unlawful discrimination)
pregnancy and maternity
race (includes ethnic or national groups, colour or nationality)
religion or belief (includes lack of religion or belief)
sex
sexual orientation

Not included in the act but included for people who fall into ‘Inclusion Health’ groups who experience difficulties in accessing and benefitting from the NHS. Inclusion health was defined in a Social Care Task Force and Department of Health publication of 2010.

These other disadvantaged groups typically include but are not restricted to:

people who are homeless
people who live in poverty
people who are long-term unemployed
people in stigmatised occupations (such as women and men involved in prostitution)
people who misuse drugs
people with limited family or social networks
people who are geographically isolated

The overall aim of an assessment is to identify where the service, policy, strategies or event has an adverse impact upon any particular group or community so that action can be taken to minimise or remove the detrimental impact if deemed necessary. Or if there is a positive impact which can be shared in order to spread best practice and lessons learnt across the organisation.

An EIA should be completed for all policies and strategies and when any of these are revised or reviewed. Completed EIA’s must be approved by the equality and diversity department before the document is presented for formal approval to the approving committee or group.

For assistance and additional guidance on completing the EIA, please contact the equality and diversity department on 01302 796473.

The completed equality impact assessment will be published alongside the corresponding policy on the trusts policy webpage.

11.2.2.11.1 Privacy, dignity and respect (section 8.1)

As a consequence, the trust is required to articulate its intent to deliver care with privacy and dignity that treats all service users with respect. Therefore, all procedural documents will be considered, if relevant, to reflect the requirement to treat everyone with privacy, dignity and respect, (when appropriate this should also include how same sex accommodation is provided). The wording of the procedural document should indicate how this will be met.

11.2.2.11.2 Mental Capacity Act statement (section 8.2)

Central to any aspect of care delivered to adults and young people aged 16 years or over will be the consideration of the individual’s capacity to participate in the decision-making process. Consequently, no intervention should be carried out without either the individual’s informed consent, or the powers included in a legal framework, or by order of the court.

Therefore, the trust is required to make sure that all staff working with individuals who use our service are familiar with the provisions within the Mental Capacity Act (2005). For this reason, all procedural documents will be considered, if relevant to reflect the provisions of the Mental Capacity Act (2005) to ensure that the rights of the individual are protected and they are supported to make their own decisions where possible and that any decisions made on their behalf when they lack capacity are made in their best interests and least restrictive of their rights and freedoms.

11.2.2.12 Links to any associated documents (section 9)

This section should provide details of any documents which are referred to at any point in the document, in order that the user can refer to these for further guidance as required.

The full title of the associated document and where it can be located should be recorded.

11.2.2.13 Referencing (section 10)

References provide an evidence base for procedural documents. The Harvard style will be used to provide a uniform approach to referencing, as set out in the table below:

Referencing
Type of literature referenced	Reference style
Books	Books are listed by Author, date, title and publisher, for example, Stewart R (2002) Evidence-based Management, a practical guide for health professionals Radcliffe Medical Press
Journals	Journals are listed by author, date, title of article, title of journal, part number, page number (beginning of article, end of article) for example, Moore S and Munro M (1990) The Newman System Model Applied to the Mental Health Nursing of Older Adults Journal of Advance Nursing 15, 293-299
Chapters in edited books	Quote the author and date of the chapter then follow it with the book reference for example, Samson C, 1970 Problems of Information Studies in History. In S Store, ed Humanities information research. Sheffield CRUS 1980, pp 44 to 68
Electronic information	The referencing of a CD-rom or website is similar to a book or journal. The author, date and title are used with the full address of the web page. (This can be copied from the address box). At the end of the web address the date you accessed the page should be included as web pages are often modified or removed
Copyright	If using content from other sources copyright permission should be checked prior to its inclusion. If obtained reference should be made alongside the copyrighted content

11.2.2.14 Appendices (section 11)

List the appendix numbers and titles of any appendices.

If no appendices are to be included, please state none. This reflects that all sections of the document have been addressed and or included as opposed to the document being incomplete.

11.2.3 Standard operating procedures

A standard operating procedure (SOP) is an agreed set of instructions for performing a particular task that is overarched by an approved policy or procedure. In some instances the overarching policy or procedure may be a regionally agreed collaborative document to which the trust has signed up to.

Responsibility for approval of standard operating procedures has been delegated by the board of directors to committees or groups as set out in section 4.2 of this policy.

Standards operating procedures will include as a minimum:

11.2.3.1 Title of the standard operating procedure (procedure for use in policy manual)

11.2.3.2 Document control box

version number
approved by, name of approval group
Date of approval, date of approval
name of originator or author
name of responsible committee or individual
date issued
review date
target audience

11.2.3.3 Aim of the procedure (section 1)

To outline the objectives and intended outcomes.

11.2.3.4 Scope (section 2)

Detail any specific area the SOP applies to.

Include the target audience, relevance to specific services or staff group and the activities covered and exclusions (if any).

11.2.3.5 Link to overarching policy or other appropriate document (section 3)

Only one document can overarch a SOP and the overarching details should be reflected within the policy or document. Should the overarching policy or procedure be a regionally agreed or collaborative document this should be referenced.

If the overarching document has an associated equality impact assessment (EIA) the SOP does not require its own. If the overarching document does not have an associated EIA then one should be created.

11.2.3.6 Procedure (section 4)

State procedural instruction detailed in a basic step by step process. SOPs are by definition a basic description of instructions to be taken. More lengthy procedural guidance should be considered for inclusion in the overarching procedural document.

11.2.3.7 Appendices (section 5)

Any appendices should be inserted in this section. If there are no appendices, please state so.

See appendix D, template for the development of a standard operating procedure.

11.2.3.8 Policy manual

A policy manual is an overarching mainly web based policy where procedures are hyperlinked within section 5 of the overarching policy. This method has been devised to reduce duplication and make accessing detail quicker. The content of the overarching policy will be common across all section 5 procedures. The manual procedure template is based on a SOP template but may contain section headings from a policy which are subject specific.

All appendices within the manual will be given consecutive numbering and be listed within section 11 appendices within the overarching policy. Only appendix titles or hyperlinks will be stated in the procedure.

The overarching policy and procedures will have their own version numbering and be reviewed independently.

11.3 Appendix C Template policy document

Template in word format: Template for policy.
Template including guidance: Template for the development of policy documents guidance.

11.4 Appendix D Template standard operating procedure or procedure for use in policy manual

Template in word format: Template for standard operating procedure.
Template including guidance: Standard operating procedure guidance.

11.6 Appendix H Flow chart (approval journey)

11.6.1 New document

New document, author send procedural document request from approval group.
Document approved?
- No, no further action. End process.
Yes, author advised to create procedural document.
Author to complete equality impact assessment.
Author to send out procedural document with equality impact assessment for consultation.
Author to finalise procedural document and complete tracking document.
Author to send procedural document, equality impact assessment and tracking document to approval group.
Approved?
- No, author to make requested changes. Go to step 7.
Yes, author to send procedural document, equality impact assessment and tracking document to corporate assurance policy officer.
Procedural document is published.

11.6.2 Full document review

Author to review procedural document.

11.6.3 Extension or removal

Author to complete tracking document.

11.6.4 Major change

Author to amend procedural document or tracking document.

11.6.5 Minor change

Author to amend procedural document.

11.6.6 Urgent publishing

Author to amend procedural document.
Author to obtain interim approval.
Yes, author to send procedural document, equality impact assessment and tracking document to corporate assurance policy officer.
Procedural document is published.
Author to arrange retrospective approval. Go to 11.6.1 new document, step 5.

11.6 Appendix I Abbreviations, approved by clinical approval group September 2023

Please contact Lisa Elder with any enquiries regarding abbreviations. See appendix E healthcare record keeping policy.

Document control

Version: 9.4.
Unique reference number: 270.
Approved by: Board of directors.
Date approved: 29 January 2024.
Name of originator or author: Director of corporate assurance.
Name of responsible individual: Director of corporate assurance.
Date Issued: 07 February 2024.
Review date: September 2024.
Target audience: Board of directors, accountable directors, procedural document authors, chairs of policy approval groups with delegated authority for approval of procedural documents and, any other individual or group with a responsibility for developing procedural documents.

Page last reviewed: May 17, 2024
Next review due: May 17, 2025

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