Healthcare Governance Alert and Guidance Review Procedure

Transcription

1 Healthcare Governance Alert and Guidance Review Procedure Healthcare Governance Alert and Guidance Review Procedure Page: Page 1 of 20

2 Recommended by Approved by Quality Directorate/Medical Directorate Executive Management Team Approval date July 2014 Version number 2.0 Review date November 2014 Responsible Director Responsible Manager (Sponsor) For use by Director of Quality/Medical Director Head of Clinical Governance All Trust employees This policy is available in alternative formats on request. Please contact the Senior Clinical Quality Manager on Healthcare Governance Alert and Guidance Review Procedure Page: Page 2 of 20

3 Change record form Version Date of change Date of release Changed by Reason for change Oct Oct 2008 S Barnard Board approved version April 2013 M Peters Review 0.2 May 2014 M Peters Update and Review 0.3 June 2014 M Peters Feedback from EMT 2.0 July 2015 July 2015 M Peters EMT approved version Healthcare Governance Alert and Guidance Review Procedure Page: Page 3 of 20

4 Healthcare Governance Alert and Guidance Review Procedure Contents 1 Introduction Purpose Duties Scope Identification and Receipt of Alerts and Published Guidance Prioritisation of Alerts Impact Assessment and Action Planning Reporting Equality Impact Assessment (EIA) Review and Monitoring of the Procedure Appendix 1a: Clinical Alert Flow Chart Appendix 1b: Non-clinical Alert & Medical Device Flow Chart Appendix 2: Healthcare Governance Summary Review Record Appendix 3: MDLO SOP for Medical Device Alerts Appendix 4: Change Process Guidance Healthcare Governance Alert and Guidance Review Procedure Page: Page 4 of 20

5 1 Introduction 1.1 The monitoring, review and assessment of published clinical practice is critical in ensuring that the Trust delivers safe systems of care for patients and safe systems of work for staff. 2 Purpose 2.1 The purpose of this procedure is to ensure that the Trust has effective systems in place to monitor and assess published guidance and alerts received. The procedures ensure that alerts and guidance is reviewed with regards relevance and urgency to ensure safe systems of care for patients and safe systems of work for staff. 2.2 The procedure will ensure the Trust responds to published guidance and alerts through robust impact analysis, planning and implementation within appropriate timescales. Appendix 1 provides an overview of the process in flow chart form. 3 Duties 3.1 Duties within the organisation The Chief Executive of the Trust has the overall statutory responsibility to ensure the Trust has effective systems in place to identify and respond to alerts and published clinical guidance The Chief Executive of the Trust has delegated responsibility to the Trust s Medical Director and the Director of Quality, who are responsible for ensuring effective systems are in place The Chief Consultant Paramedic has responsibility for ensuring there are systems in place to monitor and respond to the relevant clinical guidance published (as described in section 4) including monitoring and performance management of the process. Healthcare Governance Alert and Guidance Review Procedure Page: Page 5 of 20

6 3.1.4 The Assistant Director Quality Governance has responsibility for ensuring that there are systems in place to monitor and respond to the relevant clinical and non-clinical safety alerts published (as described in section 4) including monitoring and performance management of the procedure The Heads of: Clinical Governance, Clinical Safety and Risk and Safety have responsibility for ensuring the Trust has access to or is communicated to regarding the publications or alerts as described in section 4. They are also responsible for the corporate development, implementation, and performance management and monitoring of the procedure The Senior Clinical Quality Manager and Health Safety and Security Manager have responsibility for ensuring that publications or alerts have been reviewed and the decision making rationale is held securely within the Trust. They are responsible for the implementation, performance management and monitoring of the procedure at a corporate level in addition to the day to day provision of local advice and support The Medical Devices Liaison Officer is responsible for the review of all alerts received through the Central Alerting System and advising the Health Safety and Security Manager of the impact to the Trust The Medicines Performance Facilitator is responsible for the review of clinical alerts and publications, and advising the Senior Clinical Quality Manager of the impact to the Trust The Clinical Governance Manager and the locality Health & Safety Practitioners are responsible for the performance management and the monitoring of the procedure at a local level; including the day to day provision of local advice and support The Clinical Governance Manager is responsible for co-ordinating the Clinical and non-clinical alerts and maintaining the review record and advising the Senior Clinical Quality Manager of the overall impact to the Trust Service Delivery management are responsible for supporting the operational implementation of the procedure; ensuring the correct actions are undertaken within the agreed timescales. Advanced Paramedics and Senior Paramedics have the lead responsibility for clinical guidance and clinical safety alert actions. Operational Managers and Assistant Operational Managers have responsibility for non-clinical actions and non-clinical safety alert actions. Healthcare Governance Alert and Guidance Review Procedure Page: Page 6 of 20

7 It is the responsibility of all Trust personnel to follow and support this procedure The Clinical Leadership Board is responsible for monitoring and reviewing the implementation of the procedure. They are responsible for reviewing and approving the Healthcare Governance Review Record (appendix 2) on a monthly basis The Clinical Leadership Board, relevant Trust management groups and Trust Executive Management Team are responsible for reviewing and approving any plans or project proposals relating to actions required as a result of an alert or published guidance; including monitoring progress of any approved plans or projects The Trust Clinical Governance Management Group is responsible for reviewing and approving the healthcare Governance Review Record on a bi-monthly basis; including monitoring compliance with the procedure The relevant Level 2 Service Delivery meetings are responsible for supporting and monitoring the local implementation of any identified actions required; including the provision of progress reports to the relevant Trust management groups 4 Scope 4.1 The procedure refers to the following publications and alerts received by the Trust, which can be broadly split into Clinical Alerts and non-clinical and or Medical Device Alerts. 4.2 Alert Systems National Institute for Health and Care Excellence: National Institute for Health and Care Excellence (NICE) publishes guidance in four areas of health: Interventional Procedures Technological Appraisals Clinical Guidelines Public Health Guidance NICE publishes updates and guidance on a weekly basis. Usually clinical interventions but may be on occasion related to non-clinical or medical devices. Healthcare Governance Alert and Guidance Review Procedure Page: Page 7 of 20

8 4.2.2 National Service Frameworks: National Service Frameworks (NSFs) cover some of the highest priority conditions such as cancer and coronary heart disease. The NSFs also cover other common conditions such diabetes and mental health. There are NSFs for key patient groups such as older people and those with long term conditions. The NSFs: Set clear quality requirements of care based on the nest available evidence of what treatments and services work most effectively for patients and Offer strategies and support to help organisations achieve these Published at irregular intervals and usually associated with a clinical intervention Joint Royal Colleges Ambulance Liaison Committee: The Joint Royal Colleges Ambulance Liaison Committee (JRCALC) produces clinical guidelines to support the development of clinical practice within UK ambulance services. The guidance is advisory and there is scope to modify guidance to suit the health needs of local populations. Publications and updates occur at irregular intervals and may relate to clinical intervention and or non-clinical medical devices National Confidential Enquiries/Inquiries: National Confidential Enquiries and National Confidential Inquiries are national defined audit programmes that ensure learning from serious incidents. Confidential Enquiry into patient Outcome and Death Confidential Inquiry into Suicide and Homicide Centre for maternal and Child Enquiries The audit programmes aim to improve clinical practice through the investigation of deaths in specific circumstances. Published at irregular intervals and usually associated with a clinical intervention High Level Enquiries: High Level Enquiries: address similar issues regarding serious incidents that cannot and should not be dealt with through the usual local procedures Drug Alerts: Drug Alerts occur when a defect is considered to be a risk to public health. The marketing authorisation holder withdraws the affected product form use and the Medicines and Healthcare Products Regulatory Agency issues a Drug Alert letter. This Alert is classified from 1 to 4 depending on the risk presented to the public health by the defective product. Class 1 is the most critical, for example serious mislabelling, microbial contamination or incorrect ingredients and requires immediate recall. Class 4 is the least critical and advises caution in use. Further procedural guidance on the management on the management of the drug alerts can Healthcare Governance Alert and Guidance Review Procedure Page: Page 8 of 20

9 be found in the Trust Medicine Management policy. Published as a change occurs and associated with a change to clinical intervention Central Alerting System The Central Alerting System (CAS) provides safety alerts issued by the Medicines and Healthcare Products Regulatory Agency (MHRA), DH Estates & Facilities, the Chief Medical Officer Public Health Link, and patient safety specific guidance from the Department of Health. The alerts received are classified in 4 ways: Immediate action Action Update Or information request. Published as a change occurs and associated with a change to clinical intervention and or non-clinical or medical device alert Other Sources: There is also additional clinical guidance or health related acts published from a number of different sources and circulated through a number of different communication channels and networks. 5 Identification and Receipt of Alerts and Published Guidance The Trust will identify alerts and published guidance by the following methods: 5.1 Clinical Alerts NICE: registration with NICE to receive newly published guidance by . The Head of Clinical Governance and the Senior Clinical Quality Manager will, as a minimum, be registered to receive the guidance. It is acknowledged that the Chief Executive Officer and Medical Director will also receive copies of NICE guidance as part of the national dissemination process NSFs: Notification of NSFs and other published guidance will be received through the Chief Executive Bulletins, which the Medical Director will be responsible for passing onto the appropriate corporate lead for further assessment. It is also acknowledged that the Chief Executive Officer will also receive copies of NSFs as part of the national dissemination process. Healthcare Governance Alert and Guidance Review Procedure Page: Page 9 of 20

10 5.1.3 JRCALC: Updates or additions to JRCALC will be received through the Trust Medical Director and Assistant Clinical Director for review and communication to the appropriate corporate lead for further assessment Drug Alerts: The Trust will register with Quality Control North West who is responsible for the dissemination of drug alerts at a regional level. The Head of Clinical Governance, Senior Clinical Quality Manager and Medicines Performance Facilitator will be registered to receive the alerts by and fax. Out of hours arrangements are also in place. (See Trust medicine management toolkit) CAS Alerts: are received via by the Health, Safety and Security Manger, Senior Clinical Quality Manager, Medicines Performance Facilitator, and the Medical Devices Liaison Officer (MDLO). These alerts are reviewed for their relevance to the Trust. The CAS web based system along with the Trust Healthcare Governance review record is updated to record the action taken. If any of the alerts appear to have significance these are disseminated by the MDLO to the Health, Safety and Security Manager for information and to Operational management for action where they are required to report back to the Health, Safety and Security Manager the action taken. 5.2 Monitoring of Alerts The alerts are monitored on a bi-monthly basis at the Clinical Governance Management Group and monthly by the Clinical Leadership Board The Trust will monitor Confidential Enquiries/Inquiry through Chief Executive Bulletins, which the Medical Director will be responsible for passing on to the Head of Clinical Safety. The Head of Clinical Safety will also check the Confidential Enquiry/Inquiry website on a quarterly basis for any updates The Trust will receive High Level Enquiry reports through the Chief Executive who will be responsible for ensuring communication to the Medical Director. The Medical Director will be responsible for forwarding the report to the relevant corporate lead for further assessment All alerts and publications received must be recorded on the Healthcare Governance Review Record (Appendix 2). Healthcare Governance Alert and Guidance Review Procedure Page: Page 10 of 20

11 6 Prioritisation of Alerts This section is also supported by a flowchart see Appendix Prioritisation of alert Upon receipt of the alert or published guidance an assessment/review should be undertaken by the relevant Head of Clinical Governance/Clinical Safety and Risk and Safety; Senior Clinical Quality Manager, Clinical Governance Manager, MDLO or Medicines Performance Facilitator The relevant person (identified in 6.1.1) will be determined initially by the nature of the alert or publication and secondly by availability If no further action is required then the decision must be recorded on the Healthcare Governance Review Record If immediate action is required then the Clinical Leadership Board should be ed to confirm action required and or provide further advice If further action is required it must be identified if the action is immediate i.e. within 24/48 hours. 6.2 Immediate Action Identified Any immediate action required must be communicated to the relevant members of the Healthcare Governance and the Service Delivery Management and Advanced Paramedic team with clear timescales for completion. The communication should be undertaken by the relevant person as per Confirmation of the actions being completed must be fed-back to the relevant person as defined in and recorded on the Healthcare Governance Review Record Any immediate action is required then the relevant person (6.2.1) should complete a summary report of the alert or guidance in the preparation of a Trust impact assessment. Healthcare Governance Alert and Guidance Review Procedure Page: Page 11 of 20

12 7 Impact Assessment and Action Planning Applicable whether the alert requires action within 24/48hrs or otherwise 7.1 Impact Assessment A summary report should be forwarded to the relevant members of the Healthcare Governance and Clinical Governance Teams for a local impact assessment to be completed within an agreed timescale Wherever possible summary report should include consultation with local stakeholders An outline of the process followed by the MDLO in the management of CAS alerts is located in Appendix Where action is limited to just communication of information, checking of equipment or simple precautionary measures then a full impact assessment with subsequent approval may not be required. The relevant Head of, Senior Clinical Quality Manager or Health and Safety Security Manger can decide this. 7.2 Action Planning Upon receipt of the feedback the relevant Head of, Senior Clinical Quality Manager or Health and Safety Security Manager should develop a report and action plan; including identification of resources required, training needs and other issues such as an impact on commissioning arrangements. Consideration should also be given to the size and scope of the action(s) required and whether a formal project should be developed through the Trust project management process. Appendix 4 provides guidance on the process to be followed for the implementation of change The report and action plan/project proposal should be presented to the Clinical Leadership Board for review and approval. Where time constraints require more urgent action then the Trust Executive Management Team should be utilised for review and approval Progress of the action plan or project should be monitored through the Clinical Leadership Board, relevant Trust management groups and Level 2 Service Delivery operational meetings The Healthcare Governance Review Record should be updated to include confirmation of action taken. Healthcare Governance Alert and Guidance Review Procedure Page: Page 12 of 20

13 7.3 Alternative Actions The Clinical Leadership Board retains the right to challenge the contents of the report and the subsequent action plan If the guidance is not to be followed the Clinical Leadership Board will provide assurance to the Trust Board or Executive Management Team of the: the rationale quality impact assessment and any impact on regulatory requirements such as TDA, Monitor or the CQC, risk assessment and proposed mitigating actions (if any), an alternative action plan Progress of the alternative action plan or project should be monitored through the Clinical Leadership Board, relevant Trust management groups and Level 2 Service Delivery operational meetings The Healthcare Governance Review Record should be updated to include confirmation of action taken The alternative actions will be reviewed on an at least annual basis to ensure no adverse incidents have occurred. Any adverse incident will be brought as evidence for re-consideration of the alternative action by the Clinical Leadership Board The review will contribute to the annual Healthcare Governance audit report submitted to the trust Clinical Governance Management Group. 8 Reporting 8.1 Responsibility The Clinical Governance Manager and the Health and Safety Security Manager are responsible for managing the reporting process Lead persons, responsible for progressing identified actions, will be required to submit a monthly update report to the appropriate corporate lead or Senior Clinical Quality Manager. Healthcare Governance Alert and Guidance Review Procedure Page: Page 13 of 20

14 8.2 Dissemination The Healthcare Governance Review Record will be presented to the Clinical Leadership Board on a monthly basis for review and approval; including the identification of any action required and the monitoring of any action agreed The Healthcare Governance Review Record will be presented to the level 2 as a standard agenda item basis for information The Trust Board will receive notification of the Healthcare Governance Review record being reviewed through receipt of the Trust Clinical Governance Management Group minutes The Trust Annual Report will include a summary report of the guidance and alerts received during each financial year. 9 Equality Impact Assessment (EIA) 9.1 An Equality Impact Assessment has been performed and the results are that the procedure is considered as having an overall positive effect. The EIA documentation is available on request. 10 Review and Monitoring of the Procedure 10.1 Review This procedure will be reviewed every two years; however, should national guidance or legislation change then the policy may be reviewed earlier As part of the procedure review process, the effectiveness of the procedure and its application will be assessed. Information and results from audit systems, adverse incidents, user feedback and external audits/reviews will be used to inform this assessment. Healthcare Governance Alert and Guidance Review Procedure Page: Page 14 of 20

15 10.2 Monitoring The procedure will be monitored through the following systems: Area for Monitoring Fulfilment of duties/responsibilities Process for identifying relevant documents Process for disseminating relevant documents Process for conducting an organisational gap analysis Process for ensuring that recommendations are acted upon throughout the organisation Reporting Process Monitoring Process Review and approval of the Healthcare Governance Review Records by the Trust Clinical Governance Management Group as per section 8. Auditing of the review process for 5% of guidance and alerts received annually. Auditing of the dissemination process for 5% of guidance and alerts received annually. Auditing of the impact assessment process for 5% of guidance and alerts received annually. Review and approval of the healthcare Governance Review Records by the Trust Clinical Governance Management Group as per section 8. The Head of Clinical Governance will be responsible for ensuring that an audit report of the review process is presented annually to the Trust Clinical Governance Management Group. Healthcare Governance Alert and Guidance Review Procedure Page: Page 15 of 20

16 Appendix 1a: Clinical Alert Flow Chart Drug Alerts NICE Guidance, NSFs, Clinical Guidance, Health related Acts etc Confidential Enquiries/ Confidential Inquiry Clinical Governance Manager (CGM) / Medicines Performance Facilitator (MPF) Review all guidance received for relevance to Trust Summary report and guidance to relevant members of Clinical & Healthcare Governance teams for an impact assessment Where possible involve relevant staff forums YES Is the guidance/alert relevant to the Trust and/or is further action required? Feedback to CGM & MPF YES Immediate Action Required within 24/48hrs NO Development of report & action plan, feedback on resources required, training needs, impact on commissioning arrangements Notify Clinical Leadership Board via for confirmation of action required Relevant Directorate SMT(s) to review & approve plan Action managed via relevant members of Clinical Governance Teams, Service Delivery & Clinical Leadership Relevant Trust management group(s) to review & approve plan Confirmation of Actions complete fed back to CGM & MPF Action recorded on Trust Healthcare Governance Review Record Project development & Implementation process monitored through monthly appropriate SMT(s) and Trust Management Group(s) A monthly summary report is presented to the Clinical Leadership Group for review. A Bi-monthly summary is presented to the Trust Clinical Governance Management Group. Alternative Actions If the Guidance is determined not to be followed : Any adverse incidents will be used as evidence for re-consideration of the alternative action by the Clinical Leadership Board Clinical Leadership Board must provide to the Trust Board or EMT: Rationale, Quality Impact Assessment and impact on regulatory requirements such as TDA, Monitor or CQC Risk assessment and proposed mitigating actions (if any) Alternative action plan Alternative Actions will be reviewed on an at least annual basis to ensure no adverse incidents have ocurred Healthcare Governance review record updated Progress of the plan will be monitored through the Clinical Leadership Board, relevant Trust management Groups and Level 2 Service delivery operational meetings Healthcare Governance Alert and Guidance Review Procedure Page: Page 16 of 20

17 Appendix 1b: Non-clinical Alert & Medical Device Flow Chart Medical Device Alerts (MDA)/ Central Alerting System (CAS) Health & Safety Security Manager (H&SSM) / Medical Devices Liaison Officer (MDLO) Review MDA/CAS for relevance to Trust Summary report and guidance to relevant members of Clinical & Healthcare Governance teams for an impact assessment Where possible involve relevant staff forums Feedback to H&SSM YES Is the guidance/alert relevant to the Trust and/or is further action required? YES Immediate Action Required within 24/48hrs NO Notify Clinical Leadership Board via for confirmation of action required Development of report & action plan, feedback on resources required, training needs, impact on commissioning arrangements Action managed via relevant members of Healthcare & Clinical Governance Teams, Service Delivery & Clinical Leadership Relevant Directorate SMT(s) to review & approve plan Confirmation of Actions complete fed back to H&SSM Action recorded on CAS Relevant Trust management group(s) to review & approve plan AND Project development & Implementation process monitored through monthly appropriate SMT(s) and Trust Management Group(s) Action recorded on Trust Healthcare Governance Review Record A monthly summary report is presented to the Clinical Leadership Group for review. A Bi-monthly summary is presented to the Trust Clinical Governance Management Group. Alternative Actions will be reviewed on an at least annual basis to ensure no adverse incidents have ocurred Any adverse incidents will be used as evidence for re-consideration of the alternative action by the Clinical Leadership Board Alternative Actions If the Guidance is determined not to be followed : Healthcare Governance review record updated Progress of the plan will be monitored through the Clinical Leadership Board, relevant Trust management Groups and Level 2 Service delivery operational meetings Clinical Leadership Board must provide to the Trust Board or EMT: Rationale, Quality Impact Assessment and impact on regulatory requirements such as TDA, Monitor or CQC Risk assessment and proposed mitigating actions (if any) Alternative action plan Healthcare Governance Alert and Guidance Review Procedure Page: Page 17 of 20

18 Appendix 2: Healthcare Governance Summary Review Record Period Alerts reviewed (date commencing date ending) Summary Review Completed By: Date of Clinical Leadership Board: Record Span Record Number Date Received Ref. no Class Title Impact Assessment Results Actions Recommended Actions Completed Y/N Date Actions completed Record Number Date Received Ref. no Class Title Impact Assessment Results Review Completed by (Designation ) Date Review Completed Healthcare Governance Alert and Guidance Review Procedure Page: Page 18 of 20

19 Appendix 3: MDLO SOP for Medical Device Alerts Background Information: Medical Devices Agency makes contact with the Trust via automated through The Central Alerting System which brings together CMO s Public Health Link (PHL) and the Safety Alert Broadcast System (SABS) MDA alerts are issued when an adverse incident has occurred which involves a piece of medical equipment. This includes both consumable/disposable items and also pieces of mechanical/electrical equipment. Objectives: The safe and accurate assessment of MDAs and their impact on NWAS Scope: The Trust is informed of all such alerts regardless of whether they affect NWAS or not. Procedure: 1. Nominated members receive electronic alerts and assess the content to determine whether the alert is applicable to the Trust. 2. In the event that recipients of the Alert are unable to determine whether it is applicable, the recipients must seek specialist advice for clarification from the relevant department within the Trust. Where an alert is applicable to the Trust: 1. Support Services must liaise with Operational Management team to alert them to the issue/problem 2. Corrective measures and action plan to be devised to resolve issue 3. Identification of location(s) of problematic item(s) (Supplies and support services) 4. Arrange withdrawal of the item(s) from service where necessary (Supplies & Service Delivery leads) 5. Production of operational notices to educate operations of issue as and when required 6. Update Health Security and Safety Manager (HS&SM) of action taken and progress 7. Receipt alert and update CAS system of progress (HS&SM) 8. Update CAS system once necessary action complete (HS&SM) Where an alert is not applicable to the Trust: 1. Support Services Department Manager to inform the nominated Risk and Safety Manager that the alert is not applicable to the Trust 2. Supplies Department Manager to inform the nominated Risk and Safety Manager that the alert is not applicable to the Trust 3. Risk and Safety nominated manager to close of the alert on the CAS alerts electronic system. Policy on the development and management of SPP documents Page: Page 19 of 20 Author: HQ Corporate Governance Manager Version: 2.3 Date of Approval: 23 February 2011 Status: Final Date of Issue: 4 March 2011 Date of Review September 2012

20 Appendix 4: Change Process Guidance PROPOSED CHANGE This includes any new services or planned changes to service delivery WHAT IS THE REASON FOR CHANGE/NEW SERVICE Where and what is the evidence? What are the identified risks? WHAT IS THE EVIDENCE THAT SUPPORTS CHANGE/NEW SERVICE AS SAFEST/ BEST PRACTICE? This includes evidence reviews, policy or guidance documents. Options Appraisal should also be considered. Clinical & Cost Effectiveness Summary required. STAKEHOLDER CONSULTATION Has the proposed changes been discussed with patients, staff and other groups RISK ASSESSMENT A full risk assessment must be completed and included as part of the proposal TRAINING NEEDS ANALYSIS Proposed changes/new services must be mapped against existing competencies to identify: 1. Suitability to existing level(s) of practitioner(s) and; 2.Training requirements to ensure competency COST OF CHANGES/NEW SERVICE Full costing must be calculate and included as part of the proposal. Commissioning arrangements should be considered. AUDIT/PERFORMANCE MONITORING How will the change /new service be monitored and how will its impact be measured INCIDENT REPORTING How will adverse incidents be managed and reported? REVIEW How will the change/new service be reviewed? What will be the timescales? EVALUATION How will the change/new service be evaluated? Is it a pilot for a fixed timescale? What will be the timescales? Healthcare Governance Alert and Guidance Review Procedure Page: Page 20 of 20