The Central Alert System - A Guide to Managing Safety Not Being Scanned

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1 Central Alert System (CAS) Policy Executive or Associate Director lead Policy author/ lead Feedback on implementation to Executive / Chief Nurse Joel Gordon (Health and Safety Risk Adviser) Joel Gordon (Health and Safety Risk Adviser) Date of draft May 2010 Dates of consultation period May-July 2010 Date of ratification 20 January 2011 Ratified by Executive Directors Group Date of issue January 2011 Date for review January 2013 Target audience All SHSC staff and the Board of Directors This policy is stored and available through the SHSC intranet and internet. This policy is an updated version of the 2006 Safety Alerts Broadcasting Systems (SABS). That policy which was based on the now obsolete system for issuing safety alerts to the NHS and should be removed from use. CAS Policy Page 1 of 20

2 Contents: Section Page 1 Introduction 3 2 Scope of this policy 4 3 Definitions 4 4 Purpose of this policy 5 5 Duties 5 6 Specific details - CAS process categories of alerts Action deadlines Key contact filter 8 7 Dissemination, storage and archiving 9 8 Training and other resource implications for this policy 9 9 Audit, monitoring and review 9 10 Implementation plan 9 11 Links to other policies, standards and legislation Contact details References 10 Appendix A Pathways for the CAS Liaison Officer 11 Appendix B Pathway for recipient of alerts 12 Appendix C CAS alert response form 13 Supplementary Sections: Section A Equality impact assessment form 14 Section B Human rights act assessment checklist 17 Section C Consultation process 19 CAS Policy Page 2 of 20

3 1. Introduction 1.1 What is the Central Alerting System? The Central Alerting System is a web-based system for issuing patient safety alerts and other safety critical guidance to the NHS and other health and social care providers. It brings together the Public Health Link (PHL) and the Safety Alert Broadcast System (SABS). Safety alerts, emergency alerts, drug alerts, Dear Doctor letters and medical device alerts will be sent through CAS IT system on behalf of the: Medicines and Healthcare Products Regulatory Agency (MHRA), National Patient Safety Agency (NPSA), Department of Health. CAS is flexible enough however to bring in new originating bodies as the need arises. 1.2 Why was it created? The Chief Medical Officer charged the Patient Safety & Investigations Branch with the development of a DH Central Alerting System merging the existing systems to provide a robust and streamlined means of distributing safety alerts to the NHS and other health and social care providers, with the potential to expand as needs arise. It provides other benefits such as much enhanced search facilities and better reporting systems. 1.3 What type messages are sent using CAS? CAS is a key means to communicate important safety information to the NHS, requiring action to address risks to patient safety. There is a distinction between the two types of alerts sent via CAS: Non-emergency alerts issued on behalf of MHRA Medical Devices, the NPSA and DH Estates and Facilities, have set deadlines for acknowledgment and completion of actions. NHS Trusts are required to submit responses on the action they have taken on alerts and are monitored on their compliance with completing such alerts within agreed deadlines. The Trust s nominated CAS Liaison Officer is responsible for cascading such alerts to the relevant groups and individuals and entering responses into CAS. Emergency alerts - are currently sent by the following originators MHRA Drug Alerts, MHRA Dear Doctor Letter and CMO Messaging. Although these alerts do have deadlines, these relate to how quickly the information contained should be cascaded onwards and do not require a response. As a matter of course they are sent to all Medical Directors and Chief Executives of NHS Trusts. 1.4 Care Quality Commission (CQC) requirements The Care Quality Commission (CQC) has specified their 2009/10 criteria for assessing Core Standards in all NHS Provider Trusts. The Core Standard that makes specific reference to alerts, notices and communication concerning patient safety is C1b: C1b: Healthcare organisations protect patients through systems that ensure that patient safety notices, alerts and other communications concerning patient safety which require action are acted upon within required timescales. CAS Policy Page 3 of 20

4 2. Scope of this policy The policy encompasses the processes required for the management of alerts issued via CAS. This is a Trust-wide policy which applies to all Directorates and services without any exceptions. This policy also applies to staff that work in SHSC Trust services but are not employed by the Trust. Where staff employed by SHSC Trust work in services provided by other organisations they have a duty to follow the policies of the organisation they are working in, and comply with their processes. 3. Definitions The Medicines and Healthcare products Regulatory Agency (MHRA) - The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive agency of the Department of Health charged with protecting and promoting public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and that they are used safely. Medical Devices - Medical devices and equipment are items used for the diagnosis and/or treatment of disease, for monitoring patients, and as assistive technology. This does not include general workshop equipment such as power or machine tools, or general purpose laboratory equipment. Examples of medical devices can be found in the Trust s Medical Device Management Policy. Medical Device Alerts (MDAs) - Medical Device Alerts (MDAs) are the Medicines Healthcare products Regulatory Agency (MHRA) prime means of communicating safety information to medical device users in health and social care. Medical Device Liaison Officer (MDLO) - NHS trusts and primary care trusts in England have all designated a medical device liaison officer (MDLO). MDLOs encourage and train staff and users to report adverse incidents. In many organisations (including this Trust) the MDLO and the CAS Liaison Officer contact is the same person carrying out all functions of reporting, disseminating and feedback. CAS Liaison Officer (CASLO) The CAS Liaison Officer performs an important risk management role by disseminating safety alerts and completing electronic feedback forms to acknowledge alerts and indicate, where relevant, what action has been taken. The Department of Health (DH) The Department of Health is accountable to the public and the Government for the overall performance of the NHS, adult personal social services and the work of the Department itself. The Department itself does not directly deliver healthcare and social care services to the public. Instead the Department works, at both a national and a regional level, with many different external partners: other government departments, the NHS, local authorities, arm s length bodies and other public and private sector organisations. DH Estates and Facilities Alerts (EFA) A prime means of communicating safety information relating to non-medical equipment, engineering plant, installed services and building fabric. The National Patient Safety Agency (NPSA) - The National Patient Safety Agency are an Arm s Length Body of the Department of Health and lead and contribute to improved, safe patient care by informing, supporting and influencing organisations and people CAS Policy Page 4 of 20

5 working in the health sector. They have developed the following four formats to disseminate its advice and solutions to NHS staff: Patient safety alert (PSA) - requires prompt action to address high risk safety problems. Safer practice notice (SPN) - strongly advises implementing particular recommendations or solutions. Patient safety information (PSI) - suggests issues or effective techniques that healthcare staff might consider to enhance safety. Rapid Response Report (RRR) - may require prompt action or raise awareness of a current issue for which there may not currently be an identifiable resolution. 4. Purpose of this policy The purpose of this document is to give comprehensive and clear guidance in the effective, systematic, auditable approach to the distribution and action requirements of alerts, notices and other communication concerning safety that have been issued via the Central Alerting System (CAS). 5. Duties Trust Board The Trust Board has overall responsibility within the Trust for setting the strategic context in which organisational process documents are developed, and for establishing a scheme of governance for the formal review and approval of such documents. Chief Executive The Chief Executive has overall responsibility within the Trust for the strategic direction and operational management of the organisation, including ensuring that Trust process documents comply with all legal, statutory and good practice guidance requirements. The Chief Executive will also have overall responsibility for ensuring that the necessary management systems are in place to enable the effective management of CAS alerts. Executive Directors Executive Directors have responsibility for the professions; medical, nursing, allied health care and social work have joint responsibility for leadership of Governance. Executive Director/ Chief Nurse Executive Director/ Chief Nurse has lead responsibility for risk management in the Trust. This will include making sure that appropriate systems are in place to enable the effective management of CAS alerts. Executive Director for Operational Delivery Executive Director for Operational Delivery has responsibility for leading on Social Care and Health and Safety. Service and Clinical Director and Corporate Department Director Service and Clinical Director and Corporate Department Director is operationally responsible for all risk management issues within their service area, including significant risks identified as a result of issued alerts. CAS Policy Page 5 of 20

6 The Trust Chief Pharmacist The Trust Chief Pharmacist is the person responsible for safe use of medicines throughout the Trust. Nominated Risk Leads/Managers/Head of Departments/ Team Leaders Managers/Head of Departments/ Team Leaders will ensure that the teams within their sphere of responsibility respond to CAS alerts within the timescales detailed. They will ensure that their local procedures are adhered to in respect of distribution of alerts, required actions and compliance within required timeframes. They will ensure that all staff both current and new are aware of their responsibilities in relation to CAS and that the staff are confident and competent in the management and implementation of alerts. Any significant risks identified or unable to be compliant within the deadlines must be notified to the appropriate persons within their department or directorate, who will carryout a risk assessment and follow the Trust s risk management procedures (as detailed on the Trust s Risk Management Policy). CAS Liaison Officer The Chief Executive has nominated the Health and Safety / Risk Adviser as the CAS Liaison Officer. The CAS Liaison Officer is responsible for the management of non-emergency alerts issued via CAS and will liaise with key members of staff as part of the filtering process to ascertain if the alerts are applicable to the Trust; will ensure onward distribution of the alerts to the targeted areas for appropriate action or information and follow up to ensure action plans are developed and complied with within timescales set by the alerts. 6. Specific details - CAS Process Emergency alerts - are currently sent by the following originators MHRA Drug Alerts, MHRA Dear Doctor Letter and CMO Messaging. These alerts they can be sent out of office hours (24/7) and are issued directly by the alert originator. Although these alerts do have deadlines, as they are emergency alerts, they relate to how quickly the information contained should be cascaded onwards and do not require a response. The emergency alerts are sent to the Medical Director and Chief Executive and are cascaded onwards by their nominees. The CAS Liaison Officer is not involved with this process. Non-emergency alerts, the CAS Liaison Officer will liaise with Trust staff that are key contacts (see 6.3 Key Contact Filter) as part of the filtering process to ascertain if the alerts are applicable to the Trust and will ensure onward distribution of the alerts to the targeted areas for appropriate action or information (see appendix A). The alerts will then be disseminated by the CAS Liaison Officer to recipients via the Trusts system. Those recipients with managerial responsibility for alert compliance must consider action deadlines for each individual alert and make sure that all actions completed within the timeframes. The completed CAS Action Form (see appendix C) must be returned to the CAS Liaison Officer within 1 week of receipt of the alert. If further work/time is required to be compliant with the alert this should be stated on the form and an updated response form should be return before the alert deadline the return of the CAS Policy Page 6 of 20

7 CAS Action Form should not be delayed. The CAS Liaison Officer will update CAS as appropriate. Additional note: all medicines alerts (Emergency and Non-emergency) issued via CAS are sent to the Chief Pharmacist for appropriate action. Refer to the Medicines Management Policy for further information. The CAS process step by step (non-emergency alerts) Upon receiving the alert via CAS Liaison Officer The CAS Liaison Officer will acknowledge the alert within the prescribed time frame of 48 hours. Assess the relevance of the alert (see 6.1 Categories of Alerts) and consult other key contacts (see 6.3 Key Contacts Filter). If the alert is applicable, forward the alert to the either the specific department managers or nominated risk leads, as appropriate to the alert requirements, for their action (see appendix A). Recipient of the alert: Assess the relevance of the alert and consult other personnel if required or further disseminate the alert other people under your control as appropriate. Make sure that actions for the alert requirements are completed within the alert deadlines (see 6.2 Action Deadlines). Complete and return the CAS Alert Response Form to the CAS Liaison Officer within 1 week of the specified timescales. If you further disseminate the alert to areas under your control, then you must still manage the alert requirements and collate those responses and reply to the CAS Liaison Officer in one . If further work/time is required to be compliant with the alert this should be stated on the form and an updated response form should be return before the alert deadlines. CAS Liaison Officer: Monitor the responses are received within the specified timescales (initial response, within 1 week, subsequent responses before alert deadlines). Ensure the CAS website is updated within the specified timescales. Monitoring any action/implementation plans that may have been developed and advice of the appropriate risk management processes. Additionally, the CAS Liaison Officer will produce regular audits of responses for the Safety Sub-Group detailing the performance of the distribution system and identifying any operational issues or lack of compliance. 6.1 Categories of Alerts For non-emergency alerts, there are a number of categories that an alert might fall into, depending on its nature and urgency. The following outlines the categories found in alerts, which require a response: 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 on the advice. CAS Policy Page 7 of 20

8 Action: Used where the recipient is expected to take action on the advice, where it is necessary to repeat warnings on long-standing problems, or to support or follow-up manufacturers' field modifications. Update: Used to update the recipient about previously reported incidents or series of incidents, possibly on a topical or device group basis, and where further follow-up safety information is judged beneficial. Information Request: Used to alert users about a specific issue that may become a problem and where we are requesting feedback. These alerts may be sent out with additional questions to be completed. Other alerts will have these categories: Immediate: Cascade within 6 hours. To be used infrequently in exceptional cases where potentially serious health risks are implicated. Urgent: Cascade within 24 hours. The most common category. Non-urgent: Cascade within 48 hours. For information: This is used in circumstances where there is no need to cascade the information and only those who receive the message directly need to be aware of its contents. 6.2 Action Deadlines All non-emergency CAS alerts are issued with action deadline requirements which relate to the seriousness of the identified safety issue. The CAS Liaison Officer is responsible for updating the CAS website in relation to all action deadlines. Further details of the actions 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 had completed any necessary action. 6.3 Key Contact Filter CAS Liaison Officer to liaise with key contacts to establish if the alerts are applicable: MHRA Medical Device Alerts: Procurement and Supplies SCELS Managers Senior Nurse - Patient Safety Chief Pharmacist or nominee (for pharmacy related devices) DH Estates and Facilities Alerts: Estates Managers NPSA (PSA, PSN, PSI, RRR): Senior Nurse - Patient Safety Clinical Risk Manager Chief Pharmacist or nominee CAS Policy Page 8 of 20

9 Other types of alerts: Relevant Executives, specialists/leads will be consulted when required. 7. Dissemination, storage and archiving This policy will be available to staff on the Trust Intranet website, alongside other policies. When updated/revised a copy of this policy will be archived by the Integrated Governance Department. 8. Training and other resource implications for this policy Within all the Trust Directorates managers at all levels must ensure that appropriate staff (including new staff) are aware of their responsibilities in relation to the management of CAS alerts. Safety alert arrangements are detailed within the Trust s Risk Management training programme. The implementation of this policy should have no additional resource requirements. The revised policy should improve the management of safety alerts throughout the Trust and streamline previous processes, therefore saving time and positively contribute to our statutory duty and common law duty of care requirements. 9. Audit, monitoring and review The policy will be regularly audited monitored and reviewed for compliance with the key performance indicators. These are: Appropriate recipients in place to receive and actions alerts Appropriate awareness training in dealing with alerts Alerts are to be acknowledged on the CAS website within all specified timescales All alerts issued in a timely manner All responses received from the recipients within the alert deadlines All actions are appropriate to the alert requirements All actions have been completed to the alert requirements Actions with significant risks are assessed and escalated as per the Risk Management Policy requirements The CAS Liaison Officer will produce regular audits of responses for the Safety Sub- Group detailing the performance of the distribution system and identifying any operational issues or lack of compliance. This Policy will be reviewed in 2 years, or earlier if needed due to changes in national guidance, lessons learned or incidents. 10. Implementation plan Action / Task Put revised policy onto intranet and Responsible Person Health and Safety Risk Adviser Deadline 07/02/2011 Progress update CAS Policy Page 9 of 20

10 remove old version Make team aware of new policy Inform all Trust staff of the revised policy via Trust-wide Reference revised policy in Risk Management training Health and Safety Risk Adviser Health and Safety Risk Adviser Health and Safety Risk Adviser Clinical Risk Manager 07/02/ /02/ /02/ Links to Other Policies Risk Management Policy Manual Incident Reporting & Investigation Policy Medical Devices Management Policy Medicine Management Policy Risks and Processes 12. Contact details Title Name Phone Health and Safety / Risk Joel Gordon Joel.gordon@shsc.nhs.uk Adviser CAS Helpdesk safetyalerts@dh.gsi.gov.uk 13. References DH Central Alerting System Recipients Manual MHRA, (DB2010(01) Device Bulletin: Reporting adverse incidents and disseminating medical device alerts Care Quality Commission (CQC), 2009/10, Core Standards C1b: Safety Notices Medical Devices (Amendment) Regulations 2008 CAS Policy Page 10 of 20

11 Appendix A Pathway for the CAS Liaison Officer The nominated CAS Liaison Officer receives a CAS Alert via . The alert must be acknowledged on CAS online database within 48 hours. Filter: CAS Liaison Officer to liaise with key contacts to establish if the alerts are applicable: MHRA Medical Device Alerts: Procurement and Supplies SCELS Managers Senior Nurse - Patient Safety Chief Pharmacist or nominee (for pharmacy related devices) DH Estates and Facilities Alerts: Estates & Facilities Managers NPSA (PSA, PSN, PSI, RRR): Senior Nurse - Patient Safety Clinical Risk Manager Chief Pharmacist or nominee Other types of alerts: Relevant Executives, specialists/leads will be consulted when required. Is alert applicable to the Trust? NO Update CAS website: Action not required YES OR MAYBE Issue alert and response form to assessed recipients via Review returned CAS Response Forms CAS website is updated as required Monitor progress and liaise and advise with alert recipients for compliance within deadline timescales. Issue reminders and follow up if: CAS Alert Response Form is not returned within specified timescales (1 week) Follow up Response Forms are not returned in good time before the final deadline date Action not started Action required: Ongoing Action not required Action complete The CASLO will also produce regular audit responses for the Safety Sub- Group detailing the performance of the distribution system and identifying implementation plans and any operational issues or lack of compliance. CAS Policy Page 11 of 20

12 Appendix B Pathway for recipients of alerts (Non emergency alerts) Alert received via Alert initially sent by the CAS Liaison Officer (Joel Gordon, Health and Safety Risk Adviser) to either the Directorate Risk Leads or Departmental managers directly (dependant on each alert). Nominated Directorate Risk Leads Must review the alert decide where to further disseminate the alert within their Directorate. Departmental managers Alert received from your Directorate Risk Lead: Review the alert, action as required Complete and return the CAS Alert Response Form to your Nominated Directorate Risk Lead within 1 week. Follow up Response Form to be sent when actions are complete (before the alert deadline). Departmental managers Alert received directly from the CAS Liaison Officer Review the alert, action as required Complete and return the CAS Alert Response Form to the CAS Liaison Officer within 1 week. Follow up Response Form to be sent when actions are complete (before the alert deadline). Nominated Directorate Risk Leads Collate responses for the areas under your control within timescales, review the compliances and analyse the risks. Return the CAS Alert Response Form to Joel Gordon, Health and Safety Risk Adviser within 1 week of initial receipt. Follow up Response Form to be sent when actions are complete (before the alert deadline). If further work/time is required to be compliant with the alert that may take it beyond the deadline dates or pose a significant risk, then this should be highlighted as a risk to your department/directorate and you should follow your local risk management processes. You must also inform the CAS Liaison Officer as soon as possible and keep up to date with progress. CAS Policy Page 12 of 20

13 Appendix C CAS Alert Response Form dd/mm/yyyy From: Joel Gordon, Health and Safety / Risk Adviser, CAS Liaison Officer (CASLO), Medical Device Liaison Officer (MDLO). Integrated Governance Department Fulwood House Tel: Departmental alert recipient, Ref: Please note: (action dates set by the alert) Action underway: Action complete: Would you please refer to the attached Alert and ensure that all necessary checks and actions are undertaken in relation to the activities controlled by yourself concerning the detailed above. Please complete the section below detailing the required actions and return by to: within 1 week. Subsequent updates must be returned before the specific alert deadlines (as above). If you distribute this notice to your subordinate departments please collate your departmental returns and reply as to the CAS Liaison Officer as one response. If you have any concerns or require advice please contact the CAS Liaison Officer (Joel Gordon, Health and Safety / Risk Adviser), as soon as possible. Further guidance is detailed in the Central Alert System Policy Department: Name: Location: Designation: Action status No action necessary Action not yet started Action ongoing Action complete, matter is resolved Additional comments (if required) Tick as appropriate Brief comments on required actions. (if alert is not applicable, you must state why) CAS Policy Page 13 of 20

14 Supplementary Section A - Stage One Equality Impact Assessment Form 1. Have you identified any areas where implementation of this policy would impact upon any of the categories below? If so, please give details of the evidence you have for this? Grounds / Area of impact People / Issues to consider Negative (it could disadvantag e) Type of impact Race People from various racial groups (e.g. contained within the No No census) Gender Male, Female or transsexual/transgender. Also consider No No caring, parenting responsibilities, flexible working and equal pay concerns Disability The Disability Discrimination Act 1995 defines disability as a No No physical or mental impairment which has a substantial and long-term effect on a persons ability to carry out normal day-today activities. This includes sensory impairment. Disabilities may be visible or non visible Sexual Lesbians, gay men, people who are bisexual No No Orientation Age Children, young, old and middle aged people No No Religion or belief No No People who have religious belief, are atheist or agnostic or have a philosophical belief that affects their view of the world. Consider faith categories individually and collectively when considering possible positive and negative impacts. Positive (it could advantage Description of impact and reason / evidence 2. If you have identified that there may be a negative impact for any of the groups above please complete questions 2a-2e below. 2a. The negative impact identified is intended OR 2b. The negative impact identified not intended 2c. The negative impact identified is legal OR 2d. The negative impact identified is illegal OR (see 2e) (i.e. does it breach antidiscrimination legislation either directly or indirectly?) 2e. I don t know whether the negative impact identified is legal or not (If unsure you must take legal advice to ascertain the legality of the policy) CAS Policy Page 14 of 20

15 3. What is the level of impact? HIGH - Complete a FULL Impact Assessment (see end of this form for details of how to do this) MEDIUM - Complete a FULL Impact Assessment (see end of this form for details of how to do this) LOW - Consider questions 4-6 below N/A 4. Can any low level negative impacts be removed (if so, give details of which ones and how) N/A 5. If you have not identified any negative impacts, can any of the positive impacts be improved? (if so, give details of which ones and how) 6. If there is no evidence that the policy promotes equality and equal opportunity or improves relations with any of the above groups, could the policy be developed or changed so that it does? The policy does not need to be changed but in terms of implementation please see below. 7. Having considered the assessment, is any specific action required - Please outline this using the pro forma action plan below (The lead for the policy is responsible for putting mechanisms in place to ensure that the proposed action is undertaken) Issue Action proposed Lead Deadline Assessing ongoing impact Safety alerts to be notified also to the SHSC equality lead in order for the alert to be reviewed for any potential specific negative impact of an alert on a protected group. CAS Policy Page 15 of 20

16 8. Lead person Declaration: 8a. Stage One assessment completed by : Joel Gordon. (name). (signature) 25/08/2010 (date) 8b. Stage One assessment form received by Patient experience and Equality Team..(date) 8c. Stage One assessment outcome agreed. (sign here).... (Head of Patient Experience and Equality) OR (date agreed) 8d. Stage One assessment outcome need review.. (sign here).... (Head of Patient Experience and Equality).. (date returned to policy lead for amendment) (if review required please give details in text box below) If a full EQIA is required the stage 1 assessment form should be retained and a completed EQIA report submitted to the relevant governance group for agreement by the chair. The chair will forward the completed reports to the Patient Experience and Equality team for publication. Any questions relating to the completion of this form should be directed to the Head of Patient Experience and Equality. CAS Policy Page 16 of 20

17 Supplementary Section B - Human Rights Act Assessment Form and Flowchart You need to be confident that no aspect of this policy breaches a persons Human Rights. You can assume that if a policy is directly based on a law or national policy it will not therefore breach Human Rights. If the policy or any procedures in the policy, are based on a local decision which impact on individuals, then you will need to make sure their human rights are not breached. To do this, you will need to refer to the more detailed guidance that is available on the SHSC web site (relevant sections numbers are referenced in grey boxes on diagram) and work through the flow chart on the next page. 1. Is your policy based on and in line with the current law (including caselaw) or policy?. No further action needed. No. Work through the flow diagram over the page and then answer questions 2 and 3 below. 2. On completion of flow diagram is further action needed? No, no further action needed., go to question 3 3. Complete the table below to provide details of the actions required Action required By what date Responsible Person CAS Policy Page 17 of 20

18 Human Rights Assessment Flow Chart Complete text answers in boxes and highlight your path through the flowchart by filling the YES/NO boxes red (do this by clicking on the YES/NO text boxes and then from the Format menu on the toolbar, choose Format Text Box and choose red from the Fill colour option). Once the flowchart is completed, return to the previous page to complete the Human Rights Act Assessment Form. 1.1 What is the policy/decision title? Central Alert System Policy What is the objective of the policy/decision? To disseminate safety alerts issued via CAS Who will be affected by the policy/decision? Trust employees 1 Flowchart exit Will the policy/decision engage anyone s Convention rights? YES Will the policy/decision result in the restriction of a right? 2.2 YES 2.1 NO NO There is no need to continue with this checklist. However, o Be alert to any possibility that your policy may discriminate against anyone in the exercise of a Convention right o Legal advice may still be necessary if in any doubt, contact your lawyer o Things may change, and you may need to reassess the situation Is the right an absolute right? 3.1 YES NO 4 The right is a qualified right Is the right a limited right? YES 3.2 Will the right be limited only to the extent set out in the relevant Article of the Convention? 3.3 NO YES 1) Is there a legal basis for the restriction? AND 2) Does the restriction have a legitimate aim? AND 3) Is the restriction necessary in a democratic society? AND 4) Are you sure you are not using a sledgehammer to crack a nut? YES NO Policy/decision is likely to be human rights compliant BUT Policy/decision is not likely to be human rights compliant please contact the Head of Patient Experience, Inclusion and Diversity. Get legal advice Regardless of the answers to these questions, once human rights are being interfered with in a restrictive manner you should obtain legal advice. You should always seek legal advice if your policy is likely to discriminate against anyone in Access to legal advice MUST be authorised by the relevant Executive Director or Associate Director for policies (this will usually be the Chief Nurse). For further advice on access to legal advice, please contact the Complaints and the exercise of a convention right. Litigation Lead. CAS Policy Page 18 of 20

19 Supplementary Section C - Consultation process Name of Policy Central Alert System Date 16 July 2010 Name of Policy Lead Joel Gordon Health and Safety Risk Adviser Contact Details Integrated Governance Department Consultation Plan: Who will be significantly affected by the policy (or need to implement it?): This policy was issued to those who will play a significant part of the processes of distributing and action safety alerts issued via CAS or have managerial responsibilities to make sure that safety are appropriately managed under their remit. Typically these are: nominated Risk Leads, Chief Pharmacist, Estates Managers/Head of Departments, Senior Nurse / Patient Safety, Clinical Risk Manager, Director of Quality, Head of Integrated Governance. Is this a big change to a current policy or a new policy? NO If NO If YES Consultation via and discussion at relevant governance groups is sufficient Consider a wider consultation process eg with focus groups, attendance at team or directorate meetings RECORD OF CONSULTATION (interactive) Group or individual consulted The revision of the policy discussed at Risk Lead link meeting Sent to nominated Risk Leads/Managers/Head of Departments Date of consultation/ response received Comments on draft policy 23 rd April Not required at this stage N/A Sent 28 th May 2010 As below As below Chief Pharmacist 28 th May 2010 Add Chief Pharmacist responsibilities Add or nominee in appendix A next to Pharmacist Samantha Brazier 3 rd June 2010 Amend ratification group Clearer detail on the role of the Chief Nurse. Amend responsible person for uploading onto internet. Supp Section A - Referencing details and box alignment. Add record of consultation appendix Your response (say if policy amended if not, say why not) CAS Policy Page 19 of 20

20 Helen Payne 2 nd June 2010 In 6.3 and appendix A - change name to Estates & Facilities Managers. Requested to consider to include internal generated alerts Giz Sangha 15 th June 2010 Requested to consider to include alerts generated from commissioners (Drug, Alcohol Action Team (DAAT)) Tina Ball 16 th July 2010 Grammar errors identified. To include clearer information on the difference of emergency alerts and non-emergency alerts in the introduction. Appendix A - to include follow up/monitoring arrangements. Appendix B - to include follow up/monitoring arrangements with a link to the risk management processes. No. Policy aimed at alerts issued via CAS only. No. Policy aimed at alerts issued via CAS only. Peter Pratt and Margaret Rotchell 7 th December 2010 Hyperlink Medicines Management Policy. Include Pharmacy Dept in the initial filter process for pharmacy related devices. CAS Policy Page 20 of 20