Type of change. V02 Review Feb 13. V02.1 Update Jun 14 Section 6 NPSAS Alerts

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1 Document Title Reference Number Lead Officer Author(s) (name and designation) Ratified By Central Alerting System (CAS) Policy NTW(O)17 Medical Director Tony Gray Head of Safety and Patient Experience Trust wide Policy Group Date ratified March 2013 Implementation Date May 2013 Date of full implementation November 2013 Review Date August 2016 Version Number V02.2 Review and Amendment Log Version Type of change Date V02 Review Feb 13 Description of change Reviewed documentation changing from SABs to CAS Policy V02.1 Update Jun 14 Section 6 NPSAS Alerts V02.1 Update May 16 Extension to Review to Aug 16 This policy supersedes the following document, which must now be destroyed: Reference Number NTW(O)17 Version 02.1 Title Central Alerting System (CAS) Policy

2 Central Alerting System (CAS) Policy Section Contents Page 1 Introduction 1 2 Purpose 1 3 Scope 2 4 Duties and responsibilities 2 5 Central Alerting System (CAS) 3 6 NPSAS Alerts 4 7 CAS Administration Officer 5 8 Management of Alerts 5 9 Definition of Terms Used 7 10 Equality and Diversity Assessment 7 11 Training 7 12 Identification of Stakeholders 8 13 Implementation 8 14 Monitoring and Compliance 8 15 Standards Key/Performance Indicators 8 16 Fair Blame 9 17 Associated documents 9 Standard Appendices attached to policy Appendix A Equality and Diversity Impact Assessment Form 10 Appendix B Communication and Training Needs 12 Appendix C Monitoring Tool 14 Appendix D Policy Notification Record Sheet - click here Appendices listed separate to policy Appendix No: Description Issue No: Issue date Review date Appendix 1 Procedure for Assessment and Dissemination of CAS Alerts-Flowchart 2 Jun 14 Aug 16 Appendix 2 EXAMPLE - Response Form Overview 1 May 13 Aug 16

3 1 Introduction 1.1 National Health Service (NHS) organisations will receive Central Alerting System (CAS) bulletins; this information can vary widely from medical devices to product recall notices. The alerts describe in detail the specific item affected, what risk the item poses, whom may be affected and the course of action to take to protect the wellbeing of patients, staff and the general public. 1.2 The Central Alerting System bulletins are issued by agencies such as the Department of Health (DOH), Nice Guidance, NHS Estates the Medicines and Healthcare Products Regulatory Agency (MHRA), Chief Medical Officer and Field Safety Notices, Dear Doctors Letters (DDL) as well as many others. 1.3 (the Trust) also use an Internal CAS alerts system where the alerts are generated from incident activity and observations reported through the IR1 Incident Reporting system. 2 Purpose 2.1 The aims of the Central alerting system (CAS) are: To bring all alerts together into one electronic system and improve the way in which they are disseminated across the organisation Provide the Department of Health (DoH), Clinical Commission Groups (CCG s) and National Health Service Commissioning Boards (NHSCB) with the relevant assurances that the necessary action has been taken with reference to the recommendations detailed in the device alerts or guidance from the specific agencies To Communicate efficiently across the organisation by cascading all safety related information received from CAS, which may adversely affect patient, staff or the general public s safety and wellbeing allowing managers to take the necessary action to ensure that safeguards are in place Monitoring the performance of those managers and clinicians who receive the CAS alerts ensuring they respond in a timely manner providing details of whether the alerts are applicable to them, and their actions taken in respect of the recommendations contained in the alerts Maintain an acceptable level of risk through Northumberland, Tyne and Wear NHS Foundation Trust (the Trust). The risk management process ensuring any identified areas of concern are reflected in the organisation s risk register and dealt with accordingly through the allocation of resources and/or funding, and within acceptable time scales 1

4 3 Scope The Trust is committed to protect patients through systems that ensure that patient safety notices, alerts and other communications concerning patient safety, which require action, are acted on within the required timescales. 4 Duties and Responsibilities 4.1 Chief Executive The Chief executive on behalf of the Trust retains ultimately accountability for the Health, Safety and Welfare of all patients, carers, staff and visitors; however key tasks and responsibilities will be delegated to individuals in accordance with the content of this policy. 4.2 Medical Director The Medical Director in their capacity as the Trust s nominated Board Lead for patient safety shall assume responsibility on behalf of the Board of Directors for all aspects of cascading and responding to CAS alerts. They will ensure that all management arrangements are in place to ensure compliance with this policy. 4.3 Deputy Director of Clinical Governance / Deputy Medical Director (Quality and Safety) The Deputy Director of Clinical Governance / Deputy Medical Director (Quality and Safety) shall on behalf of the Medical Director ensure a robust system of the management of CAS alerts is in place underpinned by sound clinical and corporate governance arrangements. 4.4 Head of Safety and Patient Experience The Head of Safety and Patient Experience is responsible for ensuring that the requirements of each alert is implemented, managed and monitored within the required time frames throughout the Trust. The Trust has a nominated CAS Administration Officer to support the Trust to comply with the required standards Will produce regular reports through the Patient Safety Group of ongoing CAS activity, and any areas of concern. 4.5 The Directors of Estates and Estate Managers Will receive and oversee the responses to Estates and Facilities related Alerts and assess whether compliance with individual alerts has been reached and have the responsibility of signing off the relevant Alerts when assurance has been gained. 2

5 4.6 The Trust Chief Pharmacist / Pharmacy Governance Lead Will receive and oversee the responses to Drug,Medication and Chief Medical Officer Drug related Alerts (EL) and assess whether compliance with individual alerts has been reached and has the responsibility of signing off the relevant Alerts when assurance has been gained. 4.7 Patient Safety Managers Will ensure that their respective Directorates respond to each CAS alert issued in a timely manner to monitor their responses and where necessary prompt and support any non responders. 4.8 Service Managers Are expected to have a robust and efficient management process in place within their area of responsibility. To Cascade the alerts received by them, to every area within their service To Monitor and collate the responses provided by the managers within their service using the CAS response procedure. To Ensure they provide adequate responses through the CAS address to the CAS Administration Officer only 4.9 Ward, Unit, Departmental managers are expected to provide assurance that they have done everything necessary to resolve or address the concerns raised within the CAS alert. 5 Central Alerting System (CAS) 5.1 The national CAS is an electronic web-based system, which holds copies of all alert notices together with statistics on responses from Trusts developed by the DoH, the NHS Estates the MHRA and from April 2014 NHS England NPAS alerts. 5.2 The system is the principle means by which the Department of Health circulates important safety and device alerts to NHS Trusts. 5.3 The Trust is required to acknowledge receipt of the alert and complete a feedback form within a designated time to the DoH identifying what has been done in response to the alert. 5.4 The responses are monitored externally and are available for public scrutiny via the national CAS web page. 3

6 6 NPSAS Alerts 6.1 NPSAS Alerts are issued through the CAS Alerts by NHS England on the basis of a set of agreed principles and may cover issues including the following. New or Under recognised patient safety issues: Widespread, common and challenging patient safety issues, not solved by alerts in isolation or Improving systems of clinical governance, reporting and learning. 6.2 Providers will be issued with required actions and signed off in accordance with the CAS sign off process where alerts will be tailored for each patient safety issue. 6.3 Alerts will be assigned with a staged process dependant upon the level of risk where part of the alert process for well known risk issues or all of the three stages for a major risk. 6.4 Failure to comply is likely to be used by the CQC in their intelligent monitoring system and by commissioners responsibilities for improving quality. 6.5 Failure to comply with a stage three alert ; Directive within the deadline will be a cause for significant concern on the part of regulators, commissioners and most importantly patients. 6.6 Alerts will be issued as narrowly as possible in order to keep them relevant to those receiving them. However in some cases where there is an absence of a definitive audience alerts may have to be issued to a wider audience. Stage One Alert - Warning o Warns organisations of the emerging risk, it can be issued very quickly once a new risk has been identified to allow rapid dissemination of information Stage Two Alert - Resource o Provision of resources, tools and learning materials to help mitigate risk identified in stage one Stage Three Alert - Directive o Organisations are required to confirm they have implemented specific actions or solutions to mitigate the risk 4

7 7 CAS Administration / Safeguard System Administrator 7.1 The Trust s Safety and Patient Experience Department has a nominated CAS Administration Officer who acts under the instruction of the Head of Safety and Patient Experience. Monitoring the CAS and NPSAS Alerts received in the organisation The onward distribution of the alert as appropriate Updating and feedback on the action taken by the Trust ensuring it is logged on the CAS website. 7.2 When the CAS Administration Officer is unavailable, arrangements are in place to cover the CAS Administration Officer function. 7.3 The CAS Administration Officer will monitor the procedures to ensure that they are effective and being followed. 7.4 CAS Administration Officer contact telephone numbers: 8 Management of Alerts (ex 56662) (ex 56663) or (ex 56664) 8.1 Most alerts will be self-explanatory, however, where queries exist regarding a particular device, the CAS Administration Officer will seek advice from the specialist functions within the Trust as to whether the Alert needs to be cascaded further e.g. Supplies department, Pharmacy, Estates Department, Patient Safety or the Medical Devices Inventory. 8.2 If the Safety Alert is deemed to be applicable or any doubt exists, the alert will be disseminated to Service Manager(s) and administrators. across the relevant areas within the Trust. 8.3 The nominated Department leads will determine what level of action is necessary and respond appropriately to their service manager using the defined process. Please see section (Deadline Action Completion) 8.4 Service Managers and Clinical lead(s) are responsible for collating responses and sending a cumulative response to the CAS Administration Officer by the date specified on the response sheet using (Appendix 2) normally within 14 days of receipt of the alert or earlier if so required by the individual alerts. 5

8 8.5 The CAS Administration Officer reports the Trust s position to the national database on behalf of the Trust. 8.6 The responses are the following: We acknowledge that we have received and read the alert Categories of Alerts Immediate action: used in cases where there is a risk of death or serious injury and where the recipient is expected to take immediate action Action: used where the recipient is expected to take action on the advice, where necessary to repeat warning on long standing problems, support or follow-up manufacturers field modifications Update: used to update the recipient about previously reported incidents or series of incidents and where further follow-up safety information is judged to be beneficial Information Request: used to alert users to specific issues that may become a problem and where the DOH requests feedback information. These alerts are sent out with additional questions for organisations to answer, e.g. drug alerts, where no formal response is required Action Deadlines All CAS alerts are issued with action deadline requirements which relate to the seriousness of the identified safety issue. The CAS Administration Officer is responsible for updating the CAS website in relation to all action deadlines. Deadline: Action underway: at the time of acknowledgment of the alert the Trust registers that it is assessing relevance, after it has been established the Trust is responsible for the issues raised. Deadlines are set by the DOH for this part of the process Deadline: Action completed: the date the DOH requires the Trust to have completed any necessary action. o Assessing the relevance of alert o Action is necessary, not started o Action is necessary and on going o No action is required because (state reason e.g. not applicable) o Action is complete and the matter resolved 6

9 8.8 Responses are monitored and reports provided to the Patient Safety Group. Specific medical device alerts will be reported to the Safety, availability and suitability of equipment group. 8.9 The alerts received will be discussed at all Directorate Group ward and departmental managers meetings to ensure an efficient response to the alerts is maintained. 9 Definition of Terms Used 9.1 The Definitions used within this Practice Guidance Note refer to the responsible government offices or information systems used to cascade alerts across the NHS nationally. Central Alert System (CAS), Body set up to Cascade alerts across the NHS Department of Health (DOH), Government Department for Public Health National Health Service (NHS), Providing free Health care for all National Health Service Commissioning Board (NHSCB), Modernising the NHS Medicines and Healthcare Products Regulatory Agency (MHRA),DoH Quality and safety Dear Doctors letters, Physicians safety alerts Drug Alerts, Alerts issued relating to Medication and Treatments Internal Alerts, Alerts generated from Lessons learnt and Incident activity. 10 Equality and Diversity Assessment 10.1 In conjunction with the Trust s Equality and Diversity Officer this policy has undergone an Equality and Diversity Impact Assessment which has taken into account all human rights in relation to disability, ethnicity, age and gender. The Trust undertakes to improve the working experience of staff and to ensure everyone is treated in a fair and consistent manner. 11 Training See Appendix B 11.1 Trust Directorate Groups are all subject to receiving CAS alerts, managers at all levels must ensure that appropriate staff, (including newly appointed staff), are aware of their responsibilities in relation to their response and management of CAS alerts. 7

10 11.2 Advice and support in relation to any specific alert can be obtained from the specialist advisors in the departments mentioned in section Identification of Stakeholders 12.1 This is a reviewed policy document which has been circulated for a four week consultation period to those listed below: Senior Management Team Local Negotiating Committee Consultant Psychiatrists Planned Care Specialist Service Urgent Care Psychological Services Clinical Governance and Medical Directorate Safeguarding Trust Allied Health Profession Services Finance, IM&T, Estates and Performance Staff-side Trust Pharmacy Workforce Communications 13 Implementation 13.1 Each Directorate Group will ensure that they have effective systems in place to ensure that CAS Alerts are managed effectively at ward and department level and that all staff are aware of the need to respond to the Alerts in a timely manner Taking into consideration all the implications associated with this policy, it is considered that a target date of November 2013 is achievable for the contents to be implemented within the organisation 14 Monitoring compliance (See Appendix C) 14.1 The Head of Safety and Patient Experience will ensure that all identified areas are monitored for their responses to CAS alerts within the required time frames. Reports on compliance will be sent to the Trust wide Patient Safety Group on a monthly basis. The Patient Safety Managers will also report any related compliance issues to the monthly Quality and Performance Groups to demonstrate the efficient management of alerts within the Trust. 15 Standard/Key Performance Indicators 8

11 15.1 The Trust maintains a register of responses from the Groups within the Safeguard Risk management Alerts module which ultimately informs us whether the Trust can close off the Alerts within the National Alerts system. 16 Fair Blame 16.1 The Trust is committed to developing an open learning culture. It has endorsed the view that, wherever possible, disciplinary action will not be taken against members of staff who report near misses and adverse incidents, although there may be clearly defined occasions where disciplinary action will be taken. 17 Associated documentation NTW(C)21 - Medical Devices Policy 9

12 Appendix A Names of Individuals involved in Review Equality Analysis Screening Toolkit Date of Initial Screening Review Date Chris Rowlands V02 Dec 12 February 2016 Trust wide Service Area / Directorate Policy to be analysed Central Alerting System(CAS) Policy V02 Is this policy new or existing? Existing What are the intended outcomes of this work? Include outline of objectives and function aims NHS organisations receive safety related information from many sources. This information can vary widely from medical devices to product recall notices. The format of the reports is generally in an official Safety Alert format and describes in detail the specific item affected, what risk the item poses, who may be affected and the course of action to take to protect the wellbeing of patients, staff and the general public Communicate efficiently across the organisation by cascading all safety related information received from the various sources, which may adversely affect patient, staff or the general public s wellbeing Who will be affected? e.g. staff, service users, carers, wider public etc Staff Protected Characteristics under the Equality Act The following characteristics have protection under the Act and therefore require further analysis of the potential impact that the policy may have upon them Disability Sex Race Age Gender reassignment (including transgender) Sexual orientation. Religion or belief Marriage and Civil Partnership Pregnancy and maternity 10

13 Carers Other identified groups - STAFF Increased awareness of equipment defects How have you engaged stakeholders in gathering evidence or testing the evidence available? Through standard policy process How have you engaged stakeholders in testing the policy or programme proposals? Through standard policy process For each engagement activity, please state who was involved, how and when they were engaged, and the key outputs: Appropriate policy review via author/groups Summary of Analysis Considering the evidence and engagement activity you listed above, please summarise the impact of your work. Consider whether the evidence shows potential for differential impact, if so state whether adverse or positive and for which groups. How you will mitigate any negative impacts. How you will include certain protected groups in services or expand their participation in public life. Increased awareness of staff in the organisation of any equipment defects which may affect their clinical work Now consider and detail below how the proposals impact on elimination of discrimination, harassment and victimisation, advance the equality of opportunity and promote good relations between groups. Where there is evidence, address each protected characteristic Eliminate discrimination, harassment and victimisation Advance equality of opportunity Promote good relations between groups What is the overall impact? Does not unlawfully discriminate against equality target groups Increased awareness of staff in the organisation of any equipment defects which may affect their clinical work Addressing the impact on equalities Does not unlawfully discriminate against equality target groups From the outcome of this Screening, have negative impacts been identified for any protected characteristics as defined by the Equality Act 2010? If yes, has a Full Impact Assessment been recommended? If not, why not? Manager s signature: Chris Rowlands Date: Nov 12 Information transferred to new template May 14 11

14 Appendix B Communication and Training Check list for policies Key Questions for the accountable committees designing, reviewing or agreeing a new Trust policy Is this a new policy with new training requirements or a change to an existing policy? If it is a change to an existing policy are there changes to the existing model of training delivery? If yes specify below. Are the awareness/training needs required to deliver the changes by law, national or local standards or best practice? Please give specific evidence that identifies the training need, e.g. National Guidance, CQC, NHSLA etc. Please identify the risks if training does not occur. Please specify which staff groups need to undertake this awareness/training. Please be specific. It may well be the case that certain groups will require different levels e.g. staff group A requires awareness and staff group B requires training. Is there a staff group that should be prioritised for this training / awareness? Please outline how the training will be delivered. Include who will deliver it and by what method. The following may be useful to consider: Team brief/e bulletin of summary Management cascade Newsletter/leaflets/payslip attachment Focus groups for those concerned Local Induction Training Awareness sessions for those affected by the new policy Local demonstrations of techniques/equipment with reference documentation Staff Handbook Summary for easy reference Taught Session E Learning Please identify a link person who will liaise with the training department to arrange details for the Trust Training Prospectus, Administration needs etc. Reviewed document No Training No Training No Training No Training No Training Not applicable 12

15 Appendix B continued Training Needs Analysis Staff/Professional Group Type of training Duration of Training Frequency of Training Not applicable Copy of completed form to be sent to: Training and Development Department, St. Nicholas Hospital Should any advice be required, please contact: (internal 32216) 13

16 Monitoring Tool Appendix C Statement The Trust is working towards effective clinical governance and governance systems. To demonstrate effective care delivery and compliance, policy authors are required to include how monitoring of this policy is linked to auditable standards/key performance indicators will be undertaken using this framework. NTW(O)17 Central Alerting System Policy - Monitoring Framework Auditable Standard/Key Performance Indicators Frequency/Method/Person Responsible Where Results and Any Associate Action Plan Will Be Reported to, Implemented and Monitored; (this will usually be via the relevant Governance Group). 1. CAS Alert Trust Overview Monthly Reports from the Safeguard System Head of Safety and Patient Experience 2. CAS Alert Group Overview Monthly Reports from the Safeguard System Head of Safety and Patient Experience. Patient safety group. Group Quality and Performance meetings The Author(s) of each policy is required to complete this monitoring template and ensure that these results are taken to the appropriate Quality and Performance Governance Group in line with the frequency set out. 14

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