How to Produce a Procedural Document

Transcription

1 An Organisation-wide Policy for the Management and Development of Procedural Documents Also known as: How to Produce a Procedural Document Status (Draft/ Ratified): Ratified Date ratified: 15 th May 2013 Version: 3 Ratifying Board: Management Board for Quality & Risk Sponsor Group: Interim Policy Review Group Type of Procedural Document Policy Owner: Gillian Francis-Musanu Owner s job title Director of Corporate Affairs Author: Amanda Curnow Author s job title: Temporary Trust Policies Coordinator Equality Analysis completion date: 14/03/2013 Date issued: 08/07/2013 Review date: 14/05/2016 Replaces: Policy for Procedural Documents, v2.4 Key words (for intranet search purposes): Policy; Strategy; Guideline; Standard Operating Procedure; SOP; Policy for Policies; Procedural document. Unique Document Number: 0555

2 Equality statement This document demonstrates commitment to create a positive culture of respect for all individuals, including staff, patients, their families and carers as well as community partners. The intention is, as required by the Equality Act 2010, to identify, remove or minimise discriminatory practice in the nine named protected characteristics of age, disability, sex, gender reassignment, pregnancy and maternity, race, sexual orientation, religion or belief, and marriage and civil partnership. It is also intended to use the Human Rights Act 1998 to promote positive practice and value the diversity of all individuals and communities. This document is available in different languages and formats upon request to the Trust Procedural Documents Coordinator and the Equality and Diversity Lead. Page 2 of 49

3 Contents Preface (rationale, scope, objectives, outcomes and what this policy does) 1 Before you start Avoiding duplication: reviewing the evidence base 1.2 Consider the type of document required 1.3 Getting authorisation 1.4 Document definitions (Strategy, Policy, Guideline and Standard Operating Procedure) 2 Planning who needs to be involved NHSLA requirements 2.2 Responsibilities ratifying groups 2.3 Responsibilities - Sponsor Group 2.4 Responsibilities - other key posts 2.5 Alerting Stakeholders 2.6 Equality Analysis (formerly EIA) 3 Presentation and document control Use the relevant approved template and minimum content guidance 3.2 Style and presentation 3.3 Language and abbreviations 3.4 Completing the document control pages 3.5 Version numbering 3.6 Completing the Contents Page 4 Developing technical detail Overarching considerations 4.2 Defining Rationale and Scope 4.3 Objectives and outcomes 4.4 Building in Compliance Monitoring 4.5 Training to ensure compliance 4.6 Citing references and associated documents for credibility 4.7 Explaining terms used in your document (Glossary) 4.8 Controversial or difficult issues 5 Consultation Working with the Sponsor Group 5.2 Consulting subject experts 5.3 Consulting Stakeholders and User Groups 5.4 Incorporating feedback 5.5 Proof reading 5.6 Final preparation for approval 6 Approval, ratification & review Distinguishing between the approval process and ratification Page 3 of 49

4 6.2 Approval process for new and revised documents 6.3 Approval processes for key and minor changes 6.4 More about making minor changes 6.5 Chair s Action: what it is and its limitations 6.6 The review cycle 7 Dissemination, Publication and Archiving Dissemination arrangements 7.2 Steps to publication 7.3 Publishing locations 7.4 Archiving 8 Ensuring compliance with this Policy Building in Compliance Monitoring (for this policy) 8.2 Training to ensure compliance (for this policy) 9 References and associated documents (for this policy) Glossary/ explanation of terms used in this document (for this policy) Document Control (for this policy) 36 Figures 1 Before you start 6 2 Document selection guide (Strategy, Policy, Guideline and Standard Operating Procedure) 9 3 Full Ratification Pathway 25 4 Minor Change Pathway 26 5 Review cycles for different types of document 30 Appendices A Quick User Guide 39 B Approved Sponsor Groups 41 C Equality Analysis frequently asked questions 42 D Approval and Ratification Checklists 45 E Equality Analysis (EqA) for this Policy 47 F Minor Change Audit Pro-Forma (for use by Internal Audit) 49 Page 4 of 49

5 Preface Rationale for this policy This policy provides the framework for the development, approval, review, distribution and implementation of procedural documents at Surrey and Sussex Healthcare NHS Trust (referred to below as SASH or the Trust ). The provision of clear and accessible procedural documentation is essential in ensuring that SASH provides a safe, effective and consistent approach to the delivery of patient care and Trust processes. This policy also directs how NHSLA and CQC requirements will be embedded within procedural guidance so that they may be applied across the Trust. Scope of this policy This policy is mandatory and will apply to both Trust-wide and departmental Procedural documentation. It is relevant to all staff involved in the development, review, approval and archiving of procedural documentation. Objectives of this policy The objectives of this policy are to ensure that all SASH procedural documents: a) are developed in a robust and transparent manner by a multidisciplinary team b) provide a consistent procedural approach across specialties where appropriate c) have a clear content and format d) are measurable and contain a compliance monitoring plan Required outcomes The required outcomes of this policy are that each SASH procedural document is: i) correctly approved, disseminated and implemented ii) made accessible across the Trust iii) appropriately controlled iv) has a clear process for keeping procedural documents updated What this policy does The following pages detail the Trust s approach to the question how do I write a strategy/ policy/ clinical guideline/ standard operating procedure? This policy has been written to guide a potential author through a logical sequence of essential stages, beginning with the key question Is this document necessary? Page 5 of 49

6 Figure 1 Before you start: Do you think SASH needs a new or revised procedural document? Check it does not duplicate national work (e.g. NICE Guidance, Royal College, etc) or procedural documents elsewhere at SASH (If unsure check with Chief of Service / Director and Trust Policies) Author New Will it be a new or revised document? Revised Is the document type correct (e.g. policy or guideline) according to the new definitions in this policy (see section 1.4)? Consider document type (Refer to Document Selection Guide, figure 2) Strategy Policy Clinical Guideline/ Pathway Standard Operating Procedure Executive director Executive director Chief of Service Service/ Speciality Lead Authoriser Authoriser confirms appropriate author in consultation with Speciality / Service Lead(s) AUTHORISER GIVES GO-AHEAD FOR AUTHOR TO PROCEED Page 6 of 49

7 1 Before you start 1.1 Avoiding duplication: reviewing the evidence base The author must ensure that new and revised documents do not duplicate other work, either nationally or locally by referring to relevant networking groups, pertinent websites and SASH Intranet. Figure 1 Before you start summarises the pathway for authorisation of different types of procedural documents. New documents: In consultation with their Authoriser (Figure 1), the author must be able to justify support for developing a new document. Decisions for developing new documents will be influenced by links to service priorities through the Trust s Board Assurance Framework, Corporate Risk Register, as well as requirements identified by, for example, external assessors such as Internal Audit, NHSLA, Care Quality Commission etc. Revised documents: Where an existing document is due to be revised the author must ascertain whether the old version has been superseded by similar local or national guidance. (Where a SASH document is considered to have become redundant the Lead Senior Manager must alert the Corporate Governance Officer via the Trust Policies internal address so that it can be removed from the intranet). Documents from other Trusts: Relevant procedural documents from outside the Trust can be used as a guide when developing new or revised SASH documents. However they should never be directly cut and pasted into a SASH document. This is because the reason for developing a SASH procedural document is because it must reflect the Trust s unique environment, approach and requirements. 1.2 Consider the type of document required It can be confusing when the terms policy, strategy and guideline are used interchangeably. Similarly, the terms guidelines, pathways and protocols can all be used to denote more concise forms of written advice. This policy defines the types of procedural document to be used at SASH and clarifies the differences between them. Whether producing a new document or revising an existing one, carefully consider the type of document that is needed at SASH. To help you decide, please refer to Figure 2 Document Selection Guide and section 1.4 Definitions of document types. Page 7 of 49

8 1.3 Getting authorisation The author, in consultation with their Authoriser (Figure 1), must evaluate whether the development of a new or revised document is achievable within available resources. If required resources are not currently in place for implementation, the authoriser must advise the author on the development of a business plan to accompany the procedural document. 1.4 Document definitions A Strategy contains high level, overarching objectives and long term aims for the Trust, designed to realise change, with an organisation-wide application. It evolves in response to changing circumstances. Life of the document usually covers three to five years. Document approval is undertaken at Trust Board level. (Format as defined by SASH template, available on the intranet). A Policy is a high level statement of approach detailing the way that national legislation or directives will be applied across the Trust with mandatory and organisation-wide application. A breach of policy may have serious consequences for the Trust and its staff. Life of the document usually covers three years. Document approval is undertaken at Management Board level. (Format as defined by SASH template, available on the intranet). A Clinical Guideline or Pathway contains evidence-based, detailed advice. Outlines accepted best practice. Has organisation-wide or division-specific application. Format can be mainly diagrammatic (with document control pages). It is expected that staff will follow guidelines in all but exceptional circumstances. Life of the document is 3 years or less as new evidence dictates. Document approval is undertaken at Management Board (for organisation-wide guidelines) or Divisional Board level (for division-specific guidelines). (Format as defined by SASH template, available on the intranet). A Standard Operating Procedure (SOP) contains detailed step by step instructions describing the appropriate method for carrying out tasks or activities at service-level. Its purpose is to achieve a stated outcome to the highest standards possible and to ensure consistency, safety and efficiency. Mandatory, service-level application. Life of the document is 3 years or less as methods change. Document approval is undertaken by Service Lead. Format is discretionary, with reference to recommended minimum content guidelines, available on the intranet. NB: If an existing or new SOP has implications for more than one Service, then it must be revised as a Clinical Guideline or Policy. Page 8 of 49

9 Figure 2 Document selection guide Document type Organisational Strategy Policy Clinical Guideline/ Pathway Content and purpose High level, overarching objectives and long term aims of the Trust High level statement of approach detailing the way that national legislation or directives will be applied across the Trust. Evidence-based, detailed advice. Outlines accepted best practice. Format can be mainly diagrammatic (with document control pages). Standard Operating Procedure (SOP) Detailed step by step instructions describing the appropriate method for carrying out tasks or activities at service-level. Application Organisation-wide Organisation-wide Organisation-wide or Division- specific Service-level Implementation SASH commitment Mandatory Mandatory Mandatory Implications of non-compliance The document will evolve in response to changing circumstances A breach will have serious consequences for the Trust and its staff Staff are expected to follow except in exceptional circumstances. A breach will have (potentially serious) consequences for specific services Document duration 3 to 5 years 3 years 3 years or less as new evidence dictates 3 years or less as methods change Authorising Officer Ratification level Format Executive Director Trust Board Strategy template (on SASH intranet) Executive Director Management Board Policy template (on SASH intranet) Chief of Service Management Board or Divisional Management Board Guideline template (on SASH intranet) Service/ Speciality Lead Service Lead Recommended minimum content guidelines (on SASH intranet) Publishing location Main Intranet Policies page Main Intranet Policies page Main Intranet Policies page or Division web page (only if division-specific) Service web-page Page 9 of 49

10 2 Planning who needs to be involved Before you start work on the document it is important to be clear about who you need to consult at various stages during the development process. 2.1 NHSLA requirements Authors must liaise with the Corporate Governance Manager prior to commencement to check whether specific NHSLA requirements relate to your document. All NHSLA policies must be ready for assessment at least four months in advance of NHLSA assessor s visit, to allow sufficient time for the management board reporting schedule and final amendments (see 2.4 below). 2.2 Responsibilities ratifying groups: Organisation-level Strategies: The Trust Board has responsibility for the approval and ratification of Organisation-level Strategies. Policies (and service-level strategies): The Trust s three overarching Management Boards for Quality and Risk, Strategy and Performance have delegated responsibility for the approval and ratification of policies and service-level strategies. Clinical Guidelines: Management Boards and Divisional Boards have delegated authority to approve and ratify clinical guidelines, depending on whether the guideline is organisation-wide or division-specific application. Standard Operating Procedures (SOP): Service Leads are responsible for the format, publication, management and archiving arrangements of Standard Operating Procedures. NB: if an existing or new SOP has implications for more than one Service, then it must be revised as a Clinical Guideline or Policy and approved at the appropriate level (see above). A ratifying group must be quorate in order to ratify a procedural document, as defined by its Terms of Reference. All ratifying groups are responsible for ensuring that the procedural documents that they approve: Have been reviewed in light of ensuring patient safety and staff safety Are fit for NHSLA, Monitor, CQC and NHS Constitution purposes, Have incorporated compliance monitoring and include an audit tool or plan (consult with your Divisional clinical audit facilitator). Has been subject to appropriate levels of consultation via a Sponsor Group. Page 10 of 49

11 Are in Trust format and have document control pages attached and appropriately completed Meet the basic requirements outlined in the Ratification Checklist at the end of Appendix D. 2.3 Responsibilities - Sponsor Groups Approved Sponsor Groups are responsible for ensuring that the planning, development and consultation advice within the Policy for Procedural Documents has been followed and for approving it as suitable to be sent to Trust, Management or Divisional Boards for ratification. In particular, a Sponsor Group must confirm that the appropriate level of consultation has taken place with relevant experts, other stakeholders and user groups prior to approving the document as ready to go forward for consideration by a ratifying body. The Sponsor Group may wish to refer to Appendix D Approval and Ratification Checklists, to aid their consideration of the final draft document. (The author should also refer to section 5.1 Working with the Sponsor Group ). Approved Sponsor Groups have been identified in this Policy (Appendix B). This policy gives Approved Sponsor Groups an enhanced and pivotal role in the development and approval of draft procedural documents. In particular: 1) Helping to identify appropriate stakeholders and ensuring that the draft document has been subject to appropriate levels of consultation. 2) Providing scrutiny as to how an author has incorporated stakeholder feedback (including questioning reasons why comments have been incorporated in some instances and have not been incorporated in others). 3) Advising on technical detail, including building in compliance monitoring and the development of an audit tool or plan 4) Advising on arrangements for undertaking Equality Analysis (formally EIA) at an early stage and integrating it into the document 5) Advising on dissemination and training following publication 6) Using the Approval and Ratification checklists (appendix D) to assess the readiness of and approve the draft document for consideration and ratification by management board. It is important that an author engages with a Sponsor Group prior to starting work on the document. This will ensure that the advice of the Sponsor Group can be incorporated into the document from the outset. It is essential to choose a Sponsor Group whose purpose is aligned with the requirements of the procedural document that you are writing. Documents with clinical content, for example, should be sponsored by a Group that is Page 11 of 49

12 predominantly attended by clinicians who operate at an appropriate level and within a relevant subject area. If you are unsure as to which Sponsor Group to approach, check with The Corporate Governance Officer via Trust Policies internal address and/ or your Authoriser (as identified in Figure 1). 2.4 Responsibilities - other key posts In addition, the following posts have particular responsibilities in relation to the production of SASH procedural documents: Executive Directors may be called upon to authorise the development of Strategies and Policies, in consultation with Service Leads and the potential author. Chiefs of Service may be called upon to authorise the development of Clinical Guidelines, in consultation with Service Leads and the potential author. Specialty and Service Leads are responsible for authorising the development of Standard Operating Procedures (SOP) and approving them. In particular: Ensuring the necessary resources are in place to implement the SOP e.g. finance, staff, and equipment. Confirming who will help to develop and implement the document, including assistance with research and responsibility for dissemination, implementation and monitoring. NB: if an existing or new SOP has implications for more than one Service, then it must be revised as a Clinical Guideline or Policy). Specialty and Service Leads are also responsible for overseeing the development and review of other types of procedural documents, including policies and clinical guidelines, in consultation with Executive Directors and Chiefs of Service. In particular: Ensuring that policies that are relevant to their Speciality are kept up to date Ensuing that relevant members of their staff are aware of policies that they are due to write, review and revise Raising awareness of this SASH Policy for Procedural Documents amongst their staff Keeping information up to date regarding division-specific guidelines on Divisional and Departmental Web Pages. Page 12 of 49

13 Authors are responsible for: Technical content and ensuring that the document is developed in line with this policy. Ensuring that the content is appropriate for an acute Trust and fits with SASH unique profile and overall strategic direction. Ensuring the document is correctly formatted and that the relevant template has been used Organising Equality Analysis (EqA - see section 2.5 for further details) and building into the procedural document any changes proposed as a result of the analysis. In particular, gathering evidence and consulting with appropriate groups to identify the impact that the policy document may have on them. (Involve service users where possible and get their opinion, use demographic / census data available from public health and other sources, surveys (past or maybe carry one out), talk to staff in PALS and Complaints or HR). Organising proof-reading of the draft document (technical and presentation) prior to consultation. Building compliance monitoring into their procedural document, in consultation with their Divisional Clinical Audit Facilitator Identifying, in conjunction with their Service lead, the relevant ratifying body that will approve a new or revised document (refer to figure 3 Full Ratification Pathway to determine details of ratifying bodies for different types of document). Organising dissemination, ensuring links with relevant training and CPD Arranging for the final ratified document to be published on the intranet (for correct publication route and procedure, see Figure 3 Full Ratification Pathway ). The Corporate Governance Officer, based within Corporate Affairs, is responsible for advising on the planning, development and approval of SASH Procedural Documents. All matters relating to procedural documents must be sent to them via the Trust Policies internal address. The Corporate Governance Officer is also responsible for: The publication of Strategies, Policies and organisation-wide Guidelines on the Main Policies Intranet page and keeping this webpage up to date Maintaining a database of currently published (and recently archived) procedural documents that links to the main Policies Intranet page Archiving out of date versions. Notifying owners of review dates for organisation-wide procedural documents published on the main Policies Intranet page (normally 6 months in advance of expiry) The Corporate Governance Manager, based within Corporate Affairs, is responsible for the implementation and monitoring of this policy and Page 13 of 49

14 producing an annual monitoring report to MBQR. They are also responsible for Preparation for NHSLA assessment. To include: Ensuring all NHSLA policies are ready for assessment at least four months in advance of assessment, to allow sufficient time for final amendments. Preparing a report to Management Board to confirm readiness for assessment four months prior to NHSLA assessment. (E.g. report to management board in October prior to assessment in February of the following year). 2.5 Alerting Stakeholders Stakeholders are those who will be directly or indirectly affected by the development and/ or implementation of the procedural document. They are likely to include staff from relevant specialties and external representatives, including service user and community groups. Stakeholders must be involved in the development, review and monitoring of procedural documents to ensure that they reflect the requirements of the wider organisation. Stakeholders may be identified through discussion with a Sponsor Group and specialists that will be involved in reviewing and/ or approving the draft document. This discussion must consider the level of involvement of each stakeholder and the process for incorporating their comments. Contact stakeholders at an early stage to request their assistance in principle and to alert them to your timeframe for consultation. Use and, if necessary extend, the Consultation Record on the Document Control page to plan and record consultation on your draft document. 2.6 Equality Analysis (formerly EIA) The Trust is required to have due regard for the Equality Act 2010 and to provide evidence to support the Public Sector Equality Duty. One of the ways that the Trust manages this requirement is to ensure that each of its procedural documents is subject to an Equality Analysis (EqA) prior to publication. Equality Analysis (EqA) was formally known as an Equality Impact Assessment, (EIA). It is essential to consider EqA and the evidence that you need to collect before you start writing so that any necessary changes are built into the document as it is developed. The new EqA process is a streamlined process. Usually the EqA tool can be carried out by you and at a minimum one other person who will check your analysis and help challenge any assumptions you may be making. Other Page 14 of 49

15 people including stakeholders may be involved in the EqA as appropriate and proportionate to the scope of the document. Note that it is the responsibility of the author to implement any changes proposed as a result of an EqA. EqA must be applied, in the main, to all procedural documents. When a document is being revised, a procedural document will need an EqA for changes that require ratification at Management Board. The EqA will then be valid until the procedural document is reviewed or changed. The EqA tool is found in the appendices of each template. Refer to Appendix C Equality Analysis Frequently Asked Questions, for more details. If you require further advice, contact the Head of Equality and Diversity in Human Resources. By completing the EqA tool in full you will have gathered evidence to ensure documentation, service design, delivery and organisational decisions have due regard for the Equality Act This will also support the Public Sector Equality to provide evidence of: an understanding that there are differing complexities for each protected characteristic group a dialogue occurring wider engagement and involvement the impact of the document or process on each protected characteristic group data and information from consultations, routine data collection (highlighting areas where this is not collected) agreement regarding the impact of the evidence agreement on the remedial actions required identification of a lead to take the action forward, with timescales Page 15 of 49

16 3 Presentation and document control 3.1 Use the relevant approved template and minimum content guidance All SASH Strategies, Policies and Guidelines must be written using the approved Procedural Documents templates. The use of approved templates ensures that procedural documents are created in a clear and consistent manner that aids ease of reference and version control. Templates for policies, strategies, clinical guidelines are located on the Intranet (click on the Policies tab). The layout of SASH strategy and policy templates is well defined. In contrast, the SASH template for clinical guidelines, in particular, allows more room for customisation according to topical requirements. Variations in the templates reflect the purpose and format of the documents (see Figure 2, Document Selection Guide for further details). All templates contain document control pages, which must be completed and kept up to date. The format or layout of Standard Operating Procedures (SOP) is determined by the preference of the Service or Speciality Lead and is subject to recommended guidelines on minimum content, available on the intranet (main Policies page). The minimum content guidelines help to clarify standard information that may be required in the event of incident investigations and legal searches. 3.2 Style and presentation Default language in MS Word is to be set to English (UK) and normal style to Arial 12 point. To ensure consistency in appearance, all SASH procedural documents should comply with the following (templates will be set up using this style): Title (front page) Main Headings Subheadings Body text Header: (front page) Arial, font size 16, Mixed Case, Bold, Centred Arial, font size 14, Mixed Case, Bold, left-aligned Arial, font size 12, Mixed Case, Bold, left-aligned Arial, font size 12, Mixed Case, left-aligned Trust logo, top right corner Page 16 of 49

17 Headers: remainder of document Footers: page numbers Section numbers Lists & bullets All text Name of the document, Arial, font size 10, mixed case, leftaligned None on front page Page 2 onwards: page number expressed as x of x (as in this policy), right-aligned. Sections should be numbered to 1 decimal point only (e.g. 5.1 not 5.1.1). Bullets points will generally be avoided (except where they are very short). Lists should be outline numbered instead of bullets for ease of reference. E.g. (i),(ii),(iii) or (a), (b), (c). The use of outline numbers avoids confusion with section numbers. Use plain, jargon free English and avoid acronyms unless they are first explained 3.3 Language and abbreviations Keep statements simple and unambiguous. Be succinct and use plain, jargon free English. Automatically spell-check the document prior to proof reading. Avoid acronyms unless they are first explained. Where acronyms are used, the phrase must be written in full on the first occasion, followed by the acronym in brackets. For example, Management Board for Quality and Risk (MBQR). Further reference to this management board can be abridged to MBQR. 3.4 Completing the document control pages Every procedural document produced by SASH must contain a document control page. Document control aids the tracking and retrieval of documents and is vital for legal searches and governance purposes, enabling the Trust to be sure exactly which document was in place at any one point in time. The Document Control page records the timing and manner in which the document changes through the course of its life. It also contains information about key standards (such as NHSLA and CQC Outcomes) that the document supports and who has been consulted. Updating the front of the document: Each approved or ratified version of a procedural document must be carefully numbered on the front page and the Change History box updated accordingly. Prior to publication on the intranet the Corporate Governance Officer will allocate the approved document a unique reference number (on the cover page) and from an associated record within the Trust Policies database. Completing the standards, change history and consultation record: The information required for each of these boxes is self-explanatory. Each Page 17 of 49

18 approved version (as a result of key changes or minor amendments being made to the document) must include an update of the information contained on this page. Tracking of unapproved drafts can be recorded on temporary Draft Control pages at the end of the document (see next paragraph). You can add a temporary draft control page onto the end of an existing document to help you keep track of amendments at different stages (copy and paste this from the relevant document template on the intranet). Draft control: It is important not to confuse draft documents with approved versions. Therefore, each template also contains a temporary draft control page, which will be deleted by the Corporate Governance Officer after ratification and before publishing. This page helps to track the development of different drafts during consultation. (The development of the document, in terms of approved versions, is recorded in the Change History and Approval box, within the Document Control Pages, which will remain part of the procedural document at all times). Technical proof reading: The technical content proof reading box records that the final draft has been examined for technical accuracy by an expert other than the author. This box should not be completed until the document is in its final draft stage. 3.5 Version numbering Add appropriate version numbers to the document control pages in anticipation of approval. (All changes to existing documents require formal approval - see Figure 3, Full Ratification Pathway for further details). Whole numbers are used to denote an approved version ratified by Management Board. Decimals denote a minor change. For example: New documents: When a new document has been formally ratified it will be published as version 1.0. Full review: Major changes to an existing procedural document must be formally ratified by management board. The amended and ratified version will be identified by the next whole number, e.g Minor changes: all changes, including very minor changes to an existing document, require approval. (See section 6 and Figure 4, Minor Change Pathway for further details). Documents that contain minor changes should be outline numbered and recorded in the Change History box on the Document Control page. For example, a ratified version number 2 would change to 2.1 following a minor (approved) change. Drafts: It is important to differentiate unapproved drafts from ratified versions. Accordingly, draft numbers are recorded in the Draft Status box on the Document Control Page. In addition, the title and status box on the front page will be clearly identified with the word DRAFT in capital letters. Where Page 18 of 49

19 possible, the remainder of the document should also be identified as a draft using a watermark. 3.6 Completing the Contents Page Add section and subsection headings and numbers to the Contents Page as your document develops. Please be sure to number each heading and subheading (to a maximum of one decimal place, e.g. 3.1, 3.2, etc). The new templates are set up so that the contents page automatically updates as the document changes. You do not need to do this manually. As and when you make changes to your document, just right click on the contents page and select update field. The Contents page will automatically update. Page 19 of 49

20 4 Developing technical detail 4.1 Overarching considerations The technical detail of each SASH procedural document should be unique. Ensure that the technical detail within your document is: a) Fit for purpose at SASH - avoid copying and pasting from other documents and if you do ensure that the source is properly referenced. b) Easy to find ensure your text is logically divided into subsections that reflect the key topics. Title subsections carefully. Ensure that key subsections are listed on the Contents Page. c) Credible sources of best practice must be well referenced in footnotes of both text and diagrams and also at the end of the document. d) Deliverable - are the required resources in place to implement the procedure and if not, is there a business plan to accompany it? 4.2 Defining Rationale and Scope Rationale defines why the document is necessary. Here you need to describe the underlying aims, regulations, standards and guidance on which the document is based. Scope defines to whom the document applies. Here, you need to describe where & when the document should be applied. 4.3 Objectives and outcomes Objectives and Outcomes are normally applied within strategy documents. Be clear about what you want the document to achieve and be sure that this is reflected in both the objectives and required outcomes. Objectives: Objectives are essentially aspirational but must also be realistic. They must be set within a stated timeframe for their completion. Outcomes: Ensure that required outcomes of the document are clearly stated and that provision for their implementation and monitoring are unambiguous. 4.4 Building in Compliance Monitoring All documents are to include provision for monitoring compliance. (For Clinical procedural documents, contact the relevant Divisional Clinical Audit Facilitator for advice and ensure it is added to your annual clinical audit programme if appropriate). Page 20 of 49

21 The document author must identify Key Performance Indicators (KPIs) and/ or measurable standards associated with the implementation of the document and the person responsible for monitoring them. The process and frequency for monitoring the identified KPIs must be stated within the document. The process for reviewing the results of monitoring and ensuring improvements in compliance occur must also be stated. Monitoring minor changes: An annual internal audit will randomly select 20% of procedural documents (minimum of 20) and use the Minor Change Audit Pro-Forma (appendix F) to review whether the minor change process as defined by this policy has been followed. A score of zero will demonstrate compliance with this policy. Where the audit scores greater than zero, this policy has not been followed and the author will be informed of the need for their procedural document to be re-ratified as soon as possible. The results of the audit will be presented to management board as part of the annual review of procedural documents. Areas of noncompliance will be considered and appropriate actions taken as required. It is recommended that authors consult the Minor Change Audit Pro-Forma (appendix F) to see how minor changes will be monitored. (Refer to section 6 and figure 4 for further information about approval of minor changes). Monitoring Ratification and Document Control: Ratification and document control processes will be monitored via the Trust Policies database, to ensure that this policy has been followed and that the Trust meets NHSLA requirements beyond level 1. The database will record this information gathered during the course of communication between Corporate Affairs and document authors. Trends will be collated and reported to management board. Ratification process and document control issues will also be traceable to individual policies via the database. (Refer to sections 3.4, and figure 3 for further information about document control and the full ratification process). 4.5 Training to ensure compliance It is essential to identify how compliance with the procedural documentation can be improved via training. Produce an outline plan within your document to identify how it will link with induction training, continuous professional development and clinical supervision, as appropriate. As stated in section 2.3, Specialty and Service Leads are responsible for ensuring the necessary resources are in place to implement the procedure e.g. finance, staff, equipment. If resources are not yet secured for necessary training, a business plan must be developed to accompany the procedural document when it is presented to Management Board for ratification. The Page 21 of 49

22 purpose of the Business plan is to ensure implementation and compliance with the policy. Where possible link measures of training success with Key Performance Indicators and the monitoring arrangements for your document (refer to section 4.4). 4.6 Citing references and associated documents for credibility The evidence on which the procedural document is based underpins its credibility. References must accompany all procedural documents, even diagrammatic clinical guidelines and pathways. See Clinical Guideline/ Pathway Template (appendix I). List references in a single location (spreadsheet/ word document) as you come across them, so that a full list can be cited in detail when the document is drafted in the approved format. Two separate tables are provided in the References and associated documents section of the template. In the first table, list references in full and cite sources of diagrams, illustrations and quotes within the text. In the second table, list sources that are related to or have implications for your document but which are not directly quoted within it. If a source can be classified as both a reference and an associated document, list it in both tables. 4.7 Explaining terms used in your document (Glossary) Update the glossary as you develop your document. Any commonly used acronyms used within text, pathways or illustrations should be explained within the glossary. If there is any doubt as to whether the meaning of a term is clear, explain it within the glossary. 4.8 Controversial or difficult issues The author must ensure that controversial or difficult issues addressed within a procedural document are: i) discussed with the Sponsor Group at an early stage ii) agreed prior to the development of the final draft iii) highlighted in the cover sheet to their policy when it is presented to Management Board. Page 22 of 49

23 5 Consultation 5.1 Working with the Sponsor Group One of the key roles of the Sponsor Group is to ensure that appropriate consultation has taken place. (See section 2.2 The Role of the Sponsor Group for further details) At this stage in the document development process, the Sponsor Group will: a) Provide advice on contacting relevant experts and stakeholders and incorporating their comments. b) Confirm that the Approval and Ratification checklists (appendix D) have been completed appropriately and in full prior to submission for approval. Where possible, individual stakeholders that are not part of an identified sponsor group should be invited to attend relevant meetings, as appropriate, to enable round-table discussion of a draft document. 5.2 Consulting subject experts It is vital that all relevant subject experts are consulted. For example, Pharmacy should be consulted on any Standard Operating Procedure (SOP) that includes information on medicines. Procedural documents relating to A&E are likely to be relevant to other specialities, and vice versa. 5.3 Consulting Stakeholders, User and Community Groups Communication arrangements with key stakeholders must be robust and inclusive. It is vital for future reference and review purposes to capture these details in the Consultation section of the Document Control pages. Ensure that the relevant Speciality and Divisional Groups are consulted on the full draft document. Consultation with other stakeholders will vary according to the subject being considered. It may, for example, include unions and representatives from different divisions, as well as external stakeholders, including service users, community groups and equality and diversity groups. It is also important to consider different forms of communication with user groups to enable the capture of views of those with differing needs. For example, it may be beneficial to arrange a personal meeting with a user group to discuss how a new procedure may affect staff or patients with learning difficulties. Where possible, make consultation invitations in writing and follow up with a phone call or verbal request for a group or individual to review your draft Page 23 of 49

24 document. Ensure that your contact information is up to date. Record in a single location the date when the invitation was sent and whether a response was received. Do not assume that a null response means that your contact is not interested in being involved (your contact might have moved desks or be on leave, for example). Make a follow-up call to make sure. Please note that major stakeholders (or their representatives) must respond. 5.4 Incorporating feedback The author must be able to explain to the Sponsor Group and, if required, the ratifying management board, how individual comments have been incorporated into the draft document. Some authors find highlighting changes in a different colour a useful way of illustrating changes that have been made. The author must also be prepared to justify instances in which comments have not been incorporated. This should be discussed by the Sponsor Group and it may be queried by Management Board at a later stage. (See section 2.2 Role of the Sponsor Group and appendix D Approval and Ratification Checklists for further details). Consultation and feedback is also used as evidence in the Equality Analysis (EqA) process and will be identified on the EqA appended to the document. 5.5 Proof reading Technical proof reading must be undertaken by someone other than the author who is suitably qualified to identify potential inconsistencies, errors or omissions. Proof reading by an administrator for English usage, correct formatting and clarity must be organised by the author after the technical proof reading stage and prior to submission for approval. 5.6 Final preparation for approval An author can use the Approval and Ratification Checklists (included in this policy in appendix D) to help them decide whether they have completed all the necessary steps for their document to be approved by a sponsor group and later ratified by Management Board. A copy of this checklist is also included within each template. Page 24 of 49

25 Figure 3 Full Ratification Pathway Consider type of document Organisation-wide Division-specific Service-level Type of Document Strategy Policy Guideline Divisional Guideline Sponsor Group Sponsor Group Sponsor Group Sponsor Group Standard Operating Procedure (SOP) Approval & Ratification Executive Team Meeting Trust Board Sub-Committee SASH Management Board: Quality & Risk Performance Strategy Sponsor Group or Divisional Management Board decides Guideline has SASH-wide significance Divisional Management Board: Surgery Medicine WaCH CSS Service Lead Trust Board Publication Main Trust Intranet Policies page Divisional Intranet Page Service Intranet Page Page 25 of 49

26 Figure 4 Minor Change Pathway Change in: Contact details Department names Change in: Clinical procedure Management practice Other change National requirement / guidance SASH need New resource needed? No Yes Minor Change More than 2 changes in one year Key Change Update Document Control pages (Ref: section 3.4) Follow figure 3 Full Ratification Pathway amended document to Authorising Officer Executive Director (Organisation-wide Strategies and Policies) Chief of Service (Clinical Guidelines) Service/ Speciality Lead (Standard Operating Procedures) For further information on: Chair s Action on amendments recommended by Management Board: refer to section 6.3 Publishing locations for different types of document: refer to figure 3 and section 7.3 Page 26 of 49

27 6 Approval, ratification & review 6.1 Distinguishing between the approval process and ratification The Approval Process describes the journey of a draft document towards ratification. It starts with a Sponsor Group confirming that the draft document has been subject to sufficient and appropriate consultation, approving it to go forward for to Management Board for ratification. See Figure 3, Full Ratification Pathway for further details. Occasionally changes to a document are sufficiently minor that a document does not need to go through the full ratification process. Refer to Figure 4 Minor Change Pathway and section 6.4 below for further details. Ratification occurs when Management Board (and occasionally Trust Board) records that a procedural document has being approved as an official Trust document. The minutes of the meeting must record that a procedural document has been ratified. Please note that only after a document has been approved by the sponsor group, can it be ratified. 6.2 Approval process for new and revised documents All new procedural documents must be ratified via the Full Ratification Pathway (figure 3). All changes to existing procedural document must also be formally approved. Refer to section 6.3 below for further details. In order for both new and revised documents to be approved they must have been developed using the planning, development and consultation advice contained in sections 1 to 6 above. Authors, Sponsor Groups and Ratifying Groups should refer to Appendix D Approval and Ratification Checklists, to aid their consideration of draft documents. 6.3 Approval processes for key and minor changes Figure 3 illustrates the Full Ratification Pathway required for key changes and figure 4 illustrates the Minor Change Pathway. Generally, a key change is defined as any amendment to a procedural document that leads to change in clinical procedure or management practice. Generally, a minor change is strictly limited to changes in contact details or department names. However, before choosing a pathway, the reason for making the change must be taken into account together with any resource implications, as outlined below. Local need for change: Where there is a local SASH need for change in clinical procedure or management practice then the Full Ratification Pathway Page 27 of 49

28 (figure 3) must be followed, irrespective of whether additional resources will be required. This is so that management board can be assured that full consultation has been undertaken and agreement secured on local changes to clinical procedures or practices that may have implications for more than one division or speciality within the hospital. National requirement for change: Where changes in management practice or clinical procedure are required at a national level (e.g. NICE directive), then such changes can be dealt with via the Minor Change Pathway (see figure 4 and section 6.4 below), as long as the changes do not incur new financial or infrastructure resources. Where new resources are required as a result of national directive, then the Full Ratification Pathway (figure 3) must be followed. National guidance or national advice recommending change: Where changes in management practice or clinical procedure are recommended at a national level (e.g. NICE guidance), and the advised changes have financial or infrastructure implications for the Trust, the Full Ratification Pathway (figure 3) must be followed. Where there are no new resource requirements, an authorising officer (as defined in figure 4) may agree that the recommended change can be dealt with as a minor change. Refer to section 6.4 below and figure 4 Minor Change Pathway for further details. When the Full Ratification Pathway (figure 3) is being followed, the author must amend the version number on the front of the document using the next whole number. (For example, a previous version number of 2.0 or 2.1 would change to version number 3 following the approval and ratification of a key change). The author must also update the Change History box on the Document Control Pages, adding the new version number, date the change was approved, the author responsible and summary of the key change(s) made. When the Minor Change Pathway (figure 4) is being followed, the author must change the version number on the front of the document using a decimal point. See section 3.5 Version numbering. For example, a ratified version number 2 would change to 2.1 following a minor change; version 2.4 would change to version 2.5, and so on). The author must also update the Change History box on the Document Control Pages, adding the new version number, date the minor change was approved, the author responsible and summary of the minor change(s) made. 6.4 More about making minor changes Minor changes will be audited: Please note that minor changes to a policy will be monitored via internal audit. National Directive references must be stated within the Document Control pages Change History box. See section 4.4 Building in compliance monitoring and appendix F Minor Change Request Audit Pro-Forma (for use by Internal Audit) for more details. Page 28 of 49