Standard Operating Procedure for Development, Implementation, Management and

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1 Standard Operating Procedure for Development, Implementation, Management and Review of Documents produced by NSAG (NOSCAN Systemic Anti-Cancer Therapy Advisory Group) Lead Author/Co-ordinator: Mark Parsons, NHS Tayside Reviewer: NOSCAN Systemic Anti- Cancer Therapy Advisory Group (NSAG) Approver: Mark Parsons, NHS Tayside Signature: Signature: Signature: Identifier: (to be provided after sign-off) Approval Date: April 2015 Review Date: April 2017 Uncontrolled When Printed Version [1]

2 Contents Page No. 1. Outline of Procedure 3 2. Area of Application 3 3. Objective 3 4. Stages of the Process 3 5. Responsibilities 7 6. Definitions/ Abbreviations 7 Page 2 of 9

3 Standard Operating Procedure for Development, Implementation, Management and Review of Documents produced by NSAG (NOSCAN Systemic Anti-Cancer Therapy Advisory Group) 1. Outline of Procedure This standard operating procedure (SOP) sets out the development, implementation and management of regionally developed SOPs. 2. Area of Application This SOP will apply to all adult oncology and haematology settings across NOSCAN, excepting for the administrative areas of Argyll and Bute in NHS Highland which are linked to the WOSCAN CEL (2012) 30 governance framework. 3. Objective The purpose of this document is to ensure a consistent approach to the development, implementation, management and review of regional documents approved by NSAG. 4. Stages of the Process Document Development Process Governing Concepts For the purposes of this SOP documents can include; operational processes, supportive treatment guidelines, protocols to manage complications of SACT and procedural processes. There is an expectation that the SACT lead clinician, nurse and pharmacist act through NSAG to present the informed service position for each of the participating Boards. NSAG will prioritise and agree which documents should be developed on a regional basis based on clinical need, practice variation and SACT related risks to patient care. For operational reasons, the aim will be to develop, implement and manage documents in a way that brings the update timetable across the contributing boards into phase. Stages Stage 1 NSAG identifies and agrees a need for the development of a shared regional operational process, supportive treatment guideline or protocol to be developed. NSAG should incorporate such work within its work plan. The NOSCAN work plan should be approved by each member Board through local SACT groups. This approval commits the NHS Board and local SACT teams to delivery of the NOSCAN work plan. Page 3 of 9

4 Where there is disagreement over the work plan this should be discussed within NSAG to find resolution. It is recognised that whilst all NOSCAN Boards are committed to the development of shared regional approaches to care there will be occasions when the timing of aligning local and regional approaches may meant that an individual Board has to delay implementing a regional approach. Where this happens it should be the exception, have reasons for delay/ not operating within the regional approach documented and signed off by local SACT governance group and the local SACT Clinical Lead. Each of the boards will be required to nominate members of staff to participate in a document development short-life working group SLWG. Each document SLWG should have representation and input from all composite Boards. However, it is recognised that due to work pressure, capacity and spread of expertise that there will occasions where an NHS Board is unable to nominate an individual. Where this occurs it is paramount that the NHS Board is explicit, both internally and externally with NOSCAN colleagues as to how local processes of clinical engagement and signoff will be undertaken and who the lead individual responsible for ensure these processes are undertaken is. The SLWG will have a lead nominated by NSAG. Stage 2 The SLWG will identify the key standards; national guidance where appropriate, existing documents from across the region and beyond, or if necessary, undertake a review of the literature, and the degree of variation in practice present across the region. The SLWG will identify at an early stage whether the existing documentation can form the basis of a shared regional policy, guidance or protocol as appropriate. SLWG to identify and document the proposed development milestones, responsibilities, timelines and key contacts in each Board. Stage 3 A nominated lead author(s) from within the SLWG will undertake the development of a first draft document which will be shared, reviewed and amended from comments by colleagues within the SLWG. Stage 4 The document developed by the sub-group will then be circulated to the members of NSAG and circulated through established consultation procedures in each Board. The Board SACT leads will assure that the document is widely circulated within their services for further consultation as deemed appropriate. Stage 5 The SLWG will collate comments and assess the development required based on the scale of amendments needing to be made. Where there are significant barriers to progress the SLWG will escalate to the NSAG for support and advice. Stage 6 At final draft stage the SLWG will provide a copy to the local Board SACT Lead who will confirm that the relevant consultation for the regional policy, guidance or protocol has taken place and there are no significant barriers to the NHS Board implementing the regional policy, guidance or protocol once approved by NSAG. Page 4 of 9

5 Stage 7 SLWG will submit the final document, including appropriate checklists to demonstrate consultation etc. to NSAG, with each Board SACT lead represented will sign off the regional policy, guidance or protocol. Stage 8 Document finally approved by NSAG. NSAG SACT leads will ensure the documents are sent to participant Boards for Board level sign off and implementation. Stage 9 Generic copy of the document placed on the NOSCAN website. Stage 10 It is the responsibility of participant Boards to develop the sign off, implementation and governance arrangement. It is expected that documents can be amended with Boards to add to local service details e.g. wards, contact details, storage sites etc. but not to develop further. It is anticipated that any review is limited to ensuring the Board has had the opportunity and participated in the development and consultation phases of the development of the document, not to look to amend the content of the regional documents. Stage 11 The Documents then enter the Management and Review Phase. The document approved by the NSAG group will be held on the NOSCAN website with monitored expiry/ review dates assigned to them. Where documents have been amended to include local Board information required for Board implementation, these documents will be managed within the Board through local document management arrangements. Page 5 of 9

6 Stage 1 NSAG agrees document requirement, Boards nominate short-life working group members. SLWG lead nominated by NSAG. Stage 2 SLWG undertakes collation of existing documentation and literature review. Document type identified e.g. SOP, policy or guideline. Timescale and responsibilities identified. Stage 3 First draft by lead author(s) submitted to SLWG for review and comments. Stage 4 Draft document circulated to NSAG members for Board review. SACT Leads distribute within local service areas as appropriate. Stage 5 SLWG collate comments and assess level of amendments required. Refer to NSAG if required. Stage 6 Final draft presented to NSAG, SACT leads confirm all local consultation has taken place and no barriers to implementation. Stage 7 Final document presented to NSAG with Board SACT Lead sign off. Stage 8 Approval by NSAG. SACT leads present to local boards for sign of and implementation. Stage 9 Generic copy published on NOSCAN website Stage 10 Local Boards sign off and implement. Local service details added where appropriate. Stage 11 Document Management and Review Phase Page 6 of 9

7 Document Management and Review Process Once a regional policy, guidance, SOP or protocol document has been drafted, consulted on, reviewed and approved by NSAG, it will be distributed to the NOSCAN NHS Boards by the Board SACT Leads. An original generic copy of the SOP will be stored and managed by NOSCAN for review purposes at 2 yearly intervals (unless otherwise stated). The NHS Boards can either choose to:- Adopt the SOP as it stands OR Adapt the SOP with minor changes to suit local requirements or configurations Adopted SOPs NHS Boards will hyperlink the copy of the current version of the SOP within the NOSCAN website into their document management system (e.g. QPulse). Reviews will be carried out at NSAG level and updated versions distributed through NSAG. Adapted SOPs NHS Boards may choose to adapt regional SOPs to suit local requirements/ configurations. NHS Board must inform NSAG if problems occur with implementation of agreed SOPs. As well as the NOSCAN logo, these SOPs must additionally include the NHS Board logo to identify them as local versions. NOSCAN logo on the left and Board logo(s) on the right. A local lead should be identified on the local version for reviewing purposes. The review dates for local versions will be the same as the main version (2 years from publication date). The local lead is responsible for ensuring local information is up-to-date. The NHS Board in NOSCAN will be required to participate in review of the main version of the SOP within NSAG and ensure that local versions reflect any changes made. 5. Responsibilities Documents adopted by NHS Boards (i.e. without any changes) will be managed by NOSCAN and reviewed by NSAG. NHS Boards are required to ensure that within their document management system there is a hyperlink to the NOSCAN website. SOPs adapted by NHS Boards (i.e. local changes made) will be managed by the local SACT team (identified on the SOP). Reviews will be carried out at local level to ensure local data is correct, main document will be reviewed at NSAG level. NHS Boards are required to ensure the current version is stored appropriately within local document management system. 6. Definitions/Abbreviations SOP Standard Operating Procedure NSAG NOSCAN SACT Advisory Group Page 7 of 9

8 CEL 30 (2012) definitions:- GUIDELINE A document containing best practice advice. May be used to develop specific local policies and procedures. POLICY- A plan of action adopted by a group or organisation. PROCEDURE - A document giving detailed instructions on how to carry out a task, based on good practice. Page 8 of 9

9 Replaces: Lead Author/Co-ordinator: Responsibilities of the Lead Author/Co-ordinator Key word(s): Document application: Purpose/description: (detail previous unique identifier if applicable) Mark Parsons Ensuring registration of this document on Document and Information Silo Disseminating document as per distribution list Retaining the master copy of this document Reviewing document in advance of review date Document; development; implementation; review NOSCAN (purpose of document) Policy statement: It is the responsibility of all staff to ensure that they are working to the most up to date and relevant clinical process documents. Responsibilities for implementation: Organisational: Operational Management Team and Chief Executive Sector General Managers, Medical Leads and Nursing Leads Departmental: Clinical Leads Area: Line Manager Review frequency and date of next review: (Include a statement that indicates that in the absence of any obvious changes review should occur every 2 years) Revision History: Revision Date Previous Revision Date Summary of Changes (Descriptive summary of the changes made) Changes Marked (Identify page numbers and section heading ) Page 9 of 9