Organisational-wide Guidelines for the Development and Management of Controlled Documents
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1 Organisational-wide Guidelines for the Development and Management of Controlled Documents Policy Folder & Policy Number General 3.1 Version: 1 Ratified by: Governing Board Date ratified: 6 March 2013 Name of originator/author: Head of Governance Name of responsible committee/individual: Chief Financial officer Date issued: March 13 Review date: 31 March 16 Date Approved by CCG Board 6 March 13 Date of first issue 1 April 13 Target audience: All CCG staff 1 of 23
2 CONSULTATION AND RATIFICATION SCHEDULE Name and Title of Individual Date Consulted Chief Financial Officer February 2013 Name of Committee Date of Committee Governing Board Meeting 6 March 2013 VERSION CONTROL Policy Name: Version Valid from Valid to Document/Path 1.0 March March 2016 This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 2 of 23
3 Organisational wide guidelines for Development and Management of Controlled Documents Contents 1. Introduction 4 2. Scope of the Policy 4 3. Definition of Terms Used 4 4. Principles 5 5. Roles and Responsibilities 5 6. Policy Development 7 7. Equality Impact Assessment 7 8. Policy Language, Format and Content Consultation Policy Ratification / Approval Policy Implementation Archiving Review of Policies Monitoring and Compliance 12 Appendix A - Equality Impact Assessment Tool 13 Appendix B - Standard Format Template 14 Appendix C - Checklist for the Review and Approval of Procedural Document 18 Appendix D - Flowchart for the Creation and Implementation of Procedural Documents 21 Appendix E - Plan for Dissemination of Procedural Documents 23 This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 3 of 23
4 1. Introduction The purpose of this document is to set out a clear corporate framework for the development, consultation, approval and review of policies/standards. 2. Scope of the Policy This policy applies to all policies, procedures, guidelines and protocols, developed by the North Staffordshire Clinical Commissioning Group (CCG). Hereafter the word policy should be taken to mean all of the aforementioned. Policies should be approved by a delegated sub-committee of the Governing Board. If delegated to a sub-committee, then the policy needs to be included in the Clinical Accountable Officer s report to the Governing Board for ratification. 3. Definition of Terms Used Definitions of terms used in this policy are given below :- POLICY PROCEDURE GUIDELINE PROTOCOL CONSULTATION An organisational statement of intent. This means what, in general terms, the CCG intends to do about something. This includes statutory/legislative policies such as prime financial policies The mandatory steps taken to fulfil a policy. In other words precisely how the CCG is going to do something. A procedure does not have to be attached to a policy. It is a step by step plan of action who does what, where and when, A statement of principles giving practical guidance, allowing for professional initiative. The rules within which the CCG operates, i.e. the clinical guidance to be followed which is generally governed by professional advisory body. The process whereby a draft copy of a newly-created or amended document is circulated amongst key interested parties for comment and input prior to being finalised. RATIFICATION / APPROVAL The review and formal approval of a policy document, undertaken by a group or committee. This may be undertaken at different levels before ultimate ratification / approval is undertaken by the Governing Board. This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 4 of 23
5 4. Principles Policies will: Support the delivery of the CCG s vision and key objectives as set out in the Local Delivery Plan. Ensure the CCG meets its statutory and legal responsibilities whilst providing, wherever possible, a degree of flexibility for local application/interpretation. Be written in a standard format using easy to understand language (see Section 8 for details). Be developed and consulted on in an open and inclusive way with all relevant stakeholders. Avoid discrimination either explicit or implicit on the grounds of race, age, gender, disability or religion. Be based on the most up-to-date Department of Health, professional or other guidelines, directives or best practice. Ensure the CCG meets its legal responsibilities in relation to Information Governance Standards Legislation including Data Protection Act 1998, Freedom of Information Act 2000, Human Rights Act 1998 and the NHS Code of Confidentiality. This will be impact assessed (Section 7 refers). 5. Roles and Responsibilities 5.1. Clinical Accountable Officer The Clinical Accountable Officer is responsible for ensuring there is a clear and well communicated framework for policy development, control and review in the CCG Directors/ Heads of Service Directors/Heads of Service are responsible for ensuring that there are robust policies which reflect best practice and latest guidance to ensure safe practice. They are also responsible for identifying the appropriate lead person for each policy developed or reviewed Governing Board The Governing Board is responsible for approving corporate policies as defined within its statutory duties or directed by the Department of Health Organisation and Development Committee This committee is responsible for overseeing the policy review process ensuring that the dates for review are picked up and actioned. This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 5 of 23
6 5.5. Commissioning, Finance & performance Committee This Committee is responsible for approving all commissioning policies on behalf of the CCG Head of Governance The Head of Governance is responsible for co-ordinating the effective distribution of new and revised policies and communicating their existence in the CCG via the Portal and the shared drive. Lead officers will advise the Head of Governance of the existence of new/revised policies including the date/minute reference of the relevant Governing Board/sub-committee approval. The Head of Governance is responsible for maintaining the up-to-date database of named recipients and reminding policy authors of impending policy review dates. This will be performance managed through the Organisation and Development Committee (see 5.4) Policy Author Ensuring the correct language, format and content for policies is followed. The consultation process is as inclusive as possible and duly recorded. Ensuring that the contents of the draft policy are reviewed and impact assessed for their potential to discriminate on the grounds of race, gender, age, disability, religion or sexual orientation and to fail with the compliance of Information Governance Standards and Legislation, including Data Protection Act 1998, Freedom of Information Act 2000, Human Rights Act 1998, Mental Capacity Act 2005 and the NHS Code of Confidentiality. For each procedural document under development, the CCG may want to identify an individual, staff group or committee with responsibility for seeing the process through. If so, decisions about how this is agreed should be documented. That the start of the consultation process is communicated via internal communication and the website. Provide feedback to comments received where their views have not been incorporated in the redraft (including reasons). Ensure that the policy follows the necessary approval route. Ensure that the policy has a supporting implementation plan which is submitted for approval at the same time as the policy. Provide the Head of Governance with the final approved version for distribution. This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 6 of 23
7 Ensure that the policy is reviewed within the set timescales. Keep up-to-date with changes in legal, statutory or best practice guidance and revise the policy as necessary Directors/Heads of Directors/Heads of are responsible for: Communicating the existence of the change in policy within the team/site. Ensuring team members understand the policy and its implications. Ensuring Team members have access to policies. Provision of training where required. 6. Policy Development Each policy will have a lead person (policy author) identified for its development. The lead person will be determined by the Director responsible for the particular service or profession to which the policy relates. 7. Equality Impact Assessment All public bodies have a statutory duty under the Race Relation (Amendment) Act 2000 to set out arrangements to assess and consult on how their policies and functions impact on race equality. In effect to undertake equality impact assessments on all policies/guidelines and practices. see Appendix A - Equality Impact Assessment tool encompasses all areas of equality and should be completed and attached as an appendix to any document. The CCG will include a standard text such as: The organisation aims to design and implement services, policies and measures that meet the diverse needs of our service, population and workforce, ensuring that none are placed at a disadvantage over others. The Equality Impact Assessment tool is designed to help you consider the needs and assess the impact of your policy. 8. Policy Language, Format and Content Language - All policies must be written in easy to understand language. Where it is necessary to use technical terminology then this should be explained. Abbreviations can be used as long as the word(s) is written in full the first time it is used followed by the abbreviation. The author of the policy must think about the type of language used as the term patients, used as a catch all for the people served by the CGG may not be appropriate. This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 7 of 23
8 For some of the services of the CCG people work with and for people in different capacities than patients. Consideration must therefore be given to whether the use of local people, local community or general public may be more appropriate than patient Format - All north Staffordshire CCG policies must have:- the CCG corporate logo in the top right hand corner the title of the policy must be Arial size 24 The main content of the policy must be Arial 11, left justified Each section and, if appropriate, each subsection, should be numbered for ease of reference, e.g. :- 1. Heading 1.1. Sub Heading Text 1.2. Sub Heading Text etc. The footer of the policy must contain o o The footer of the policy must contain the filename/path (i.e. the name of the policy, policy folder and policy number) o Version number & date approved o Page x of x and the following statement This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. A standard format template is attached at Appendix B Content All policies must cover the following headings as a minimum:- Introduction/aim of the policy why do we need one? Scope of the policy who does it apply to? Definition of terms used Roles and responsibilities within the policy key players, where does accountability rest, what for and at what level Policy statement/principles Procedural/guidance detail (this may not be appropriate for all policies but should be considered when developing them). References a list of documents including associated documents (i.e. internal documents that the policy directly links to) and supporting references (i.e. external docs that informed the development of the policy). Monitoring and Compliance This needs to include the monitoring arrangements for compliance and effectiveness of the policy i.e. audit, review, etc.. Include the This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 8 of 23
9 responsibilities for conducting the monitoring/audit, the methodology to be used, the frequency i.e. quarterly, on a rolling basis, etc. and the process for reviewing results and ensuring improvements in performance occur. A template for policies is attached at Appendix C. A checklist for Review and Approval of Procedural Documents is attached at Appendix D. A Flowchart for the Creation and Implementation of Procedural Documents is attached at Appendix E. 9. Consultation It is the responsibility of the lead person for the policy s development to ensure that the consultation on the policy is as inclusive as possible, including contractor services and partner organisations where appropriate. As a minimum consultation must include:- All policies will be clearly marked as draft during the consultation period with a version number so that people know what draft they are being asked to comment on. Publication of the start of the consultation process through appropriate briefings. This will include details of where to obtain a copy, to whom to send comments and by when. The length of the consultation period must be no less than 4 weeks from the announcement of the consultation process. Relevant staff side representatives are sent a personal copy of the policy, preferably electronically. Circulation of the draft policy to members of relevant CCG Groups, again preferably electronically. Circulation of the draft policy to members of relevant patient/public groups, e.g. Stoke on Trent Community Health Voice. Comments received from the consultation process must be incorporated in the draft policy wherever possible. Where comments are not incorporated into the redraft then the lead person for the policy must give feedback to the commenter as to why. If significant redrafting of the policy is required as a result of comments received from consultation, then the revised policy must be reissued for a further period of consultation of no less than 2 weeks. Ensure that policies that will or have the potential to affect partner organisations are circulated to Chief Executive s( or equivalent) of those organisations for inclusion in the consultation process. This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 9 of 23
10 10. Policy Ratification / Approval Different types of policies will require different levels of approval before issue (see earlier definition, formal policies must be approved/ratified by the Governing Board). A degree of common sense must be exercised by the lead person for the policy when deciding the appropriate approval route for a policy. It is the lead person s responsibility to ensure that the necessary approval processes are followed. They will need to give thought to:- Is there any statutory or legal directive which stipulates the level at which the policy must be approved? e.g. Board, Audit Committee Does the policy need professional approval? If so, is it one or more? Does the policy need Staff Side consultation/approval? Does the policy require other organisation s approval, including agency services? Does the policy need operational level approval? This list is not exhaustive and is meant only as a prompt for the kind of questions a lead person must ask themselves when determining the appropriate approval route for their policy. All policies must be signed off by the Governing Board or a designated sub-committee e.g. Audit Committee, Quality Committee, Organisation and Transition committee, Executive Group. Examples of the types of documents that will be approved by the CCG s Groups/Committees are listed below. This is not an exhaustive list :- Types of Documents Committee for overseeing and approving policy Quality Quality Committee Patient Safety Quality Committee Clinical Effectiveness Quality Committee Scheme of Delegation/Prime financial policies Audit Committee Commissioning Commissioning, Finance & Performance Committee Corporate Commissioning, Finance & Performance Committee Health & Safety Organisation and Development HR Organisation and Development 11. Policy Implementation It is the responsibility of the lead person for the policy to notify the Head of Governance of the need to issue the policy. Once approved, all policies will be stored electronically on the CCG s shared network. This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 10 of 23
11 All policies will be marked on the front cover with the following; Policy Folder Number Policy Number Author Version Number Approval date Review date Version control details are as follows: Use a unique version number to distinguish one version from another. Use this procedure for all documents where more than one version exists, or is likely to exist in the future. The version numbering system uses version numbers with points to reflect major and minor changes, such as version 1.0 (first version), version 2.0 (second version with a major change), version 2.1 (third version with a minor change). Put the version number on the document name itself. The existence of new policies or the revision of existing policies, following final approval, will be communicated via . Following approval by the relevant group(s), relevant employees will be informed of the policy existence within two weeks of final approval. Any new or revised policy will be found on the CCG s server or web site. Previous or superseded versions of the same policy will be retained electronically. Any documents appearing in paper form are not controlled and should be checked against the service file version prior to use. A Plan for Dissemination of Procedural Documents is attached at Appendix E. 12. Archiving All policies will be stored electronically on the Trust s shared network. Once a new version of a policy is approved, this will be stored in a folder appropriate to the policy type. If a previous version of the policy exists, the Head of Governance will ensure that this is moved to a separate folder for previous versions. 13. Review of Policies All policies will be reviewed no less than every 3 years from the date of approval. The lead person for the policy will be responsible for ensuring that the review is undertaken and where changes are required that the process of consultation on the revised policy This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 11 of 23
12 commences as set out in section 8. This will be performance managed through the Organisation and Development Committee. All policies will be marked with the date for review on the front cover before being distributed. Legal or statutory directives may require that policies are reviewed more regularly than every 3 years. It is the lead person s responsibility to ensure that they keep up-to-date with relevant directives to ensure the CCG meets its responsibilities. 14. Monitoring and Compliance The effective implementation of individual policy documents shall be monitored as appropriate to that individual policy. The effective implementation of this policy will be monitored by the Organisation and Development Committee on review and approval of the policy documents developed in line with this policy. In addition, a report will be prepared by the Head of Governance and submitted to the Organisation and Development Committee on a minimum 6-monthly basis, showing the status of all current policies including those currently in development, consultation, or ratification, and identifying any that are overdue for review. This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 12 of 23
13 Appendix A - Equality Impact Assessment Tool Guidelines for Completing Equality Impact Assessments (EqIA) An equality impact assessment (EqIA) must be completed for all new and reviewed policies, strategies, services and commissioned services. When completing the EqIA consider whether the document could have any potential positive, neutral or negative impacts on groups from any of the protected characteristics (or diversity strands) listed. 1. Does the policy/guidance affect one group less or move favourably than another on the basis of: Age Disability Gender Reassignment Marriage and Civil partnership Pregnancy and Maternity Race Religion or Belief Sex Sexual orientation 2. Is there any evidence that some groups are affected differently? 3. If you have identified potential discrimination, are any exceptions valid, legal and/or justifiable? 4. Is the impact of the policy/guidance likely to be negative? 5. If so can the impact be avoided? 6. What alternatives are there to achieving the policy/guidance without the impact? 7. Can we reduce the impact by taking different action? 8. Has the Mental Capacity Act been considered in the development of the policy? Yes/No Comments If you have identified a potential discriminatory impact of this procedural document, please refer to you immediate manager together with any suggestions as to the action required to avoid/reduce this impact. This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 13 of 23
14 Appendix B - Standard Format Template Policy Title (Arial, Bold 24) Policy Folder & Policy Number General 3.1 Version: 1 Ratified by: Date ratified: Name of originator/author: Name of responsible committee/individual: Date issued: Review date: Date of first issue Target audience: This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 14 of 23
15 CONSULTATION AND RATIFICATION SCHEDULE Name and Title of Individual Date Consulted Name of Committee Date of Committee VERSION CONTROL Version Date Author Detail of Change This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 15 of 23
16 Contents This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 16 of 23
17 1. Introduction / Aim of the Policy Add here a brief background to why we need the policy. 2. Scope of the Policy Add here the details of the key players, where does accountability rest, what for and at what level. 3. Definition of Terms Used Add here a definition of all terms used in the policy 3. Principles Add here details of the guiding principles associated with the policy 4. Roles and Responsibilities Add details here of specific individual or team responsibilities within the policy. 5. Procedural / Guidance If appropriate, add here any specific procedures or guideline required to implement the policy. 6. Equality Impact Assessment All policies must have the completed Equality Impact Assessment Tool form included (Appendix A). This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 17 of 23
18 Appendix C - Checklist for the Review and Approval of Procedural Document To be completed and attached to any document which guides practice when submitted to the appropriate committee for consideration and approval. 1. Title Title of document being reviewed: Is the title clear and unambiguous? Is it clear whether the document is a guideline, policy, protocol or standard? 2. Rationale Are reasons for development of the document stated? 3. Development Process Is the method described in brief? Are people involved in the development identified? Do you feel a reasonable attempt has been made to ensure relevant expertise has been used? Is there evidence of consultation with stakeholders and users? 4. Content Is the objective of the document clear? Is the target population clear and unambiguous? Are the intended outcomes described? Are the statements clear and unambiguous? 5. Evidence Base Is the type of evidence to support the document identified explicitly? Are key references cited? Are the references cited in full? Are supporting documents referenced? Yes/No/ Unsure Comments This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 18 of 23
19 6. Approval Does the document identify which committee/group will approve it? If appropriate have the joint Human Resources/staff side committee (or equivalent) approved the document? 7. Dissemination and Implementation Is there an outline/plan to identify how this will be done? Does the plan include the necessary training/support to ensure compliance? 8. Document Control Does the document identify where it will be held? Have archiving arrangements for superseded documents been addressed? 9. Process to Monitor Compliance and Effectiveness Are there measurable standards or KPIs to support the monitoring of compliance with and effectiveness of the document? Is there a plan to review or audit compliance with the document? 10. Review Date Is the review date identified? Is the frequency of review identified? If so is it acceptable? 11. Overall Responsibility for the Document Is it clear who will be responsible for coordinating the dissemination, implementation and review of the document? This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 19 of 23
20 Individual Approval If you are happy to approve this document, please sign and date it and forward to the chair of the committee/group where it will receive final approval. Name Signature Date Committee Approval If the committee is happy to approve this document, please sign and date it and forward copies to the person with responsibility for disseminating and implementing the document and the person who is responsible for maintaining the organisation s database of approved documents. Name Signature Date Acknowledgement: Cambridgeshire and Peterborough Mental Health Partnership NHS Trust This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 20 of 23
21 Appendix E Appendix D - Flowchart for the Creation and Implementation of Procedural Documents Acknowledgement: Cambridgeshire and Peterborough Mental Health Partnership NHS Trust Rationale and Priority Development Plan Content Evidence Base Read An organisation-wide policy for the development and management of procedural documents before commencing Identify: Who will do the work Who should be involved How will it be done? Identify clear, focused objectives Identify what type and source e.g. research, expert pinion, clinical consensus, patient views Undertake prioritisation - is the document needed? Identify all relevant stakeholders including service users Target population e.g. service users, staff groups for whom the document is intended Is it based on a national document? If yes, is local information needed? Ensure proposed document does not duplicate national work Ensure relevant expertise is used Intended outcome - what you want it to achieve Include references cited in full in agreed organisational format Ensure it does not duplicate work elsewhere in the organisation (see local register/library of procedural documents) Consult with service users and stakeholders Keep statements simple and unambiguous Agree the need for document with relevant committee if necessary Identify who will be responsible for what e.g. dissemination, implementation, training and review Plan to develop any necessary support information, leaflets, etc Use organisation s template How will the organisation measure compliance? Set measurable standards and design methods for monitoring compliance and effectiveness Continue to Consultation and Approval (next page) This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 21 of 23
22 Consultation and Approval Dissemination, Implementation and Access Monitoring, Compliance and Review Responsibility Consult with all relevant stakeholders including service users Identify: Who will do this How will it be done Period of implementation, including start date Implement the monitoring arrangements contained within the procedural document Who (clinical or service manager) will be responsible for co-ordinating the ongoing development, implementation and review of the document? All procedural documents with HR implications must be taken to the staff side/human resources committee (or equivalent) Link with induction training, continuous professional development, and clinical supervision as appropriate Consider findings from monitoring arrangements at an appropriate committee Complete document review processes, including Equality Impact Assessment Tool and Checklist for the Review and Approval of Procedural Documents How and where will staff access the document (at operational level)? Implement changes to improve compliance of, and effectiveness with the procedural document Approve document as outlined in the Organisation-wide policy for the development and management of procedural documents including completion of the Checklist for the Review and Approval of Procedural Documents Plan to remove old copies from circulation Review document in accordance with planned review date Log document on the organisation s register/library of procedural documents Ensure staff are aware the document is logged on the organisation s register/library of procedural documents Content - is there new evidence of best practice to be incorporated into the document? Re-approve procedural document at the appropriate committee/group Archive old versions of the document according to organisation s procedure for archiving This is a controlled document. Any documents appearing in paper form are not controlled and should be checked against the servicer file version prior to use. Page 22 of 23
23 Appendix E - Plan for Dissemination of Procedural Documents To be completed and attached to any document which guides practice when submitted to the appropriate committee for consideration and approval. Acknowledgement: University Hospitals of Leicester NHS Trust. Title of document: Date finalised: Previous document already being used? If yes, in what format and where? Proposed action to retrieve out-of-date copies of the document: Yes / No (Please delete as appropriate) Dissemination lead: Print name and contact details To be disseminated to: How will it be disseminated, who will do it and when? Paper or Electronic Comments Dissemination Record - to be used once document is approved. Date put on register / library of procedural documents Date due to be reviewed Disseminated to: (either directly or via meetings, etc) Format (i.e. paper or electronic) Date Disseminated No. of Copies Sent Contact Details / Comments 23 of 23
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