NOTTINGHAM UNIVERSITY HOSPITALS NHS TRUST Documentation Control Central Alerting System (CAS) Dissemination Procedure Reference HS/SP/001 Approving Body Senior Management Team Date Approved 14 March 2017 Implementation Date 14 March 2017 Summary of Changes from Previous Version Reflects changes to the management of alerts and Field Safety Notices via the Datix Safety Alerts Module and the role of the Medical Devices Committee and Estates. Supersedes Consultation Undertaken Date of Completion of Equality Impact Assessment Date of Completion of We Are Here for You Assessment Date of Environmental Impact Assessment (if applicable) Legal and/or Accreditation Implications Central Alerting System (CAS) Dissemination Procedure October 2016 (v5) Key Stakeholders, Organisational Risk Committee, Clinical Risk Committee 11 November 2016 11 November 2016 11 November 2016 This is a key document for CQC assessment purposes because it sets out the requirements for all safety alerts received via the National CAS system. March 2017 1
Target Audience Clinical Directors, General Managers, Clinical Leads, Heads of Service, Division / Department CAS Leads, CAS Links, Trust CAS Officers (H&S team), Clinical Engineering Managers, Clinical Procurement Specialists, Infection Control Team, Theatre Manager, Clinical Quality, Risk & Safety Managers, Chair of Medicines Safety Group. Review Date March 2019 Lead Executive Medical Director Author/Lead Manager Neil Mart Head of Organisational Quality, Risk & Safety, extension 76018 Further Guidance/Information Neil Mart Head of Organisational Quality, Risk & Safety, extension 76018 March 2017 2
CONTENTS Paragraph Title Page 1. Introduction 4 2. Executive Summary 4 3. Policy Statement 4 4. Definitions 5 5. Roles and Responsibilities 7 6. Policy and/or Procedural Requirements 9 7. Training, Implementation and Monitoring 12 Arrangements 8. Impact Assessments 13 9. Monitoring Matrix 15 10. Relevant Legislation, National Guidance 16 and Associated NUH Documents Appendix 1 The management of Clinical Risk 17 Committee related alerts Appendix 2 The management of Medication related 19 alerts Appendix 3 The management of Estates & Facilities 25 related alerts Appendix 4 Implementation Plan Template 26 Appendix 5 Equality Impact Assessment 27 Appendix 6 Environmental Impact Assessment 30 Appendix 7 Here For You Assessment 32 Appendix 8 Certification Of Employee Awareness 35 March 2017 3
1.0 Introduction 1.1 This procedure outlines the route through which information received via the Central Alerting System (CAS) will be disseminated and managed within the Nottingham University Hospitals NHS Trust. The procedure also sets out how internally generated Alerts will be produced, disseminated and monitored and the process for reporting incidents and defects to external agencies such as the Medicines and Healthcare Products Regulatory Agency (MHRA). 2.0 Executive Summary 2.1 The introduction and maintenance of a robust centralised system for the management of safety alerts will serve to provide assurance to the Trust Board that such safety information is reviewed and where necessary enacted. It is therefore imperative that: Alerts are disseminated in a timely manner The alert recipient in the Division/Corporate Function responds within the designated timeframe (including Nil Returns) Where appropriate the information contained within the alert must be cascaded to relevant staff Alerts (including Field Safety Notices) received outside of the described process must be forwarded to the Trust CAS Officers for oversight, action and inclusion on the monthly CAS Log. There is a robust system for the monitoring of actions identified within alerts This procedure does not deal with staff alerts issued by SHA s on behalf of employers. These alerts are dealt with, and if required circulated, by the HR Department. 3.0 Policy Statement 3.1 The Trust will follow the Care Quality Commission (CQC) document in ensuring that patient safety notices, alerts and other communications concerning patient and staff safety are acted upon within required timescales. In addition, that there is a robust system for broadcasting and providing feedback on the implementation of the Safety Alerts. This procedure will ensure that the Trust has a: March 2017 4
Clearly defined alert communications system System for distributing alerts and obtaining responses from identified Responsible Officers System for monitoring that actions identified in the alerts have been taken, to ensure the safety of all those who deliver and receive services from the Trust. 4.0 Definitions There are 5 categories of CAS alerts which determine what action the Trust should take and therefore how the Trust should respond. These are defined as follows: 4.1 4.2 4.3 4.4 Immediate Action: This classification of alert is used in cases of actual death or serious injury, or where death or serious injury would have occurred but for fortuitous circumstances or the timely intervention of healthcare professional (or carer); and where the: Medical device is or is likely to be implicated Trust is expected to take immediate action on the advice Action: used where the Trust 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 modifications Update: used when the MHRA wish to update the Trust 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 to be beneficial. Information Request: Used to alert users about a specific issue that may become a problem and where the MHRA are requesting feedback. 4.5 Guidance Notes: These are generated by the National Institute of Clinical Excellence (NICE) and follow research and development by experts in specific fields. March 2017 5
4.6 National Patient Safety Alerting System (NPSAS) In January 2014 the new National Patient Safety Alerting System (NPSAS) was launched to strengthen the rapid dissemination of urgent patient safety alerts to healthcare providers via the Central Alerting System (CAS). This three-stage alerting system also provides useful educational and implementation resources to support providers to put appropriate measures in place to prevent harm and encourage and share best practice in patient safety. The three stages of NPSAS alerts are: 4.6.1. Stage One Alert: Warning This stage warns organisations of emerging risk. It can be issued very quickly once a new risk has been identified to allow rapid dissemination of information. 4.6.2.Stage Two Alert: Resource This alert may be issued some weeks or months after the stage one alert, and could consist of: sharing of relevant local information identified by providers following a stage one alert; sharing of examples of local good practice that mitigates the risk identified in the stage one alert; access to tools and resources that help providers implement solutions to the stage one alert; and access to learning resources that are relevant to all healthcare workers and can be used as evidence of continued professional development. 4.6.3.Stage Three Alert: Directive When this stage of alert is issued, organisations will be required to confirm they have implemented specific solutions or actions to mitigate the risk. A checklist will be issued of required actions to be signed-off in a set timeframe. These actions will be tailored to the patient safety issue. March 2017 6
4.7 4.8 Estates & Facilities Notifications (EFNs) relating to high & low voltage equipment are now issued via the CAS system; more information is contained within Appendix 3 The management of Estates related alerts. Field Safety Notices (FSNs) It is imperative that if any alerts are received outside of the CAS process for example a letter sent direct by manufacturer, or an alert received via the NHS supply chain etc. that these are forwarded to the Trust s CAS Officers so that they can be recorded on the log and managed in accordance with this procedure. 5.0 Roles and Responsibilities 5.1 Committees 5.1.1 The Organisational Risk Committee (ORC) The Organisational Risk Committee (ORC) has overall responsibility for ensuring there is a robust alert process within the Trust. Each month a CAS Log is reviewed and monitored at ORC for assurance purposes; the log records all alerts, Field Safety Notices and drug alerts received that month and details any externally reported issues. ORC also oversees the management of alerts that fall outside of CRC s remit. 5.1.2 The Clinical Risk Committee (CRC) The Clinical Risk Committee are responsible for overseeing the management of clinical alerts which require a change in practice or are of a more clinical nature. The management of CRC alerts is described in Appendix 1. 5.1.3 The Medical Devices Safety Committee (MDSC) The Medical Devices Safety Committee March 2017 7
5.2 Individual Officers 5.2.1 Trust CAS Officer The Trust s Chief Executive has nominated the Head of Organisational Risk to act as the Trusts CAS Officer. The Trust s Health & Safety Manager will act as his deputy and provide support to the Head of Organisational Risk in this role (Hereinafter referred to as the CAS Officers). The CAS Officer is responsible for; acknowledging the receipt of a safety alert on the National system, disseminating alerts received to relevant areas of the Trust collating responses received from CAS Leads and recording these on the monthly CAS Log preparing and maintaining a monthly CAS Log for review by ORC updating and managing the National CAS Database administrated via MHRA Producing a bi-annual report for QuAC on Performance against this procedure Maintaining a record of action plans and supporting evidence of compliance 5.2.2 Divisional CAS Leads Each Division / Corporate function will identify a nominated CAS Lead who will act as the main conduit / contact for the dissemination and reporting back on action taken against alerts issued via this procedure. CAS Leads will identify CAS Links within each local Specialty / Department, to assist them in this process. CAS Leads will co-ordinate all response received via the CAS Links (within prescribed timeframes) for onward communication to the Trust CAS Officer via Datix. March 2017 8
5.2.3 Local Specialty / Departmental CAS Links Local Specialty / Departmental CAS Links will assist the CAS Lead in reviewing the relevance and in identifying and implementing any action required to comply with the requirements of any alerts issued via this procedure. 6.0 Policy and/or Procedural Requirements 6.1 Reporting of Incidents or Defects to External Agencies On occasion incidents or defects involving equipment or healthcare products that require external agencies to be notified, for instance the MHRA. For any such instances the CAS Officers must be informed and a copy of the reporting form forwarded for inclusion on the master CAS Log. 6.2 Procedure for the dissemination and management of alerts See flow chart overleaf 6.2.1 All alerts will be acknowledged within 24 hours of receipt 6.2.2 All alerts will be disseminated via the Safety Alerts Module on Datix by the CAS Officers within 48 hours of receipt 6.2.3 Each alert disseminated, will include a link to the alert on the Datix system which will contain details of the action taken to date, including any dialogue with internal specialists and any documents attached. This will be sent for action where a response is required on Datix or for information only, where there is no requirement for you to formally respond but the CAS Officer will be able to check that it has been read. March 2017 9
Alert Received via dedicated mailbox on the Trust network Automated e-mail sent from the Network system to the CAS Officer to flag that a new alert has been received CAS Officer acknowledges receipt of the alert on the National CAS system Alert added to monthly ORC CAS Log Alert added to Datix Safety Alerts Module CAS Officer with advice from internal specialists will decide if the alert is relevant to NUH Alert Relevant t o NUH Alert Not Relevant to NUH Any NPSA, Medical Devices, Medicines or general alerts requiring changes in Clinical Practice are sent to the Head of Clinical Quality, Risk and Safety for management via CRC (See appendices 1&2) For all other alerts CAS Officer identifies disseminates alert to relevant CAS Leads Alert reviewed by CAS Leads and disseminated to relevant CAS Links CAS Links review alert and communicate responses, actions taken or actions required back to the CAS Lead who collate all CAS Link responses and communicate back to the CAS Officer All CAS Lead responses are recorded and summarised on the monthly log to ORC Terms of alert met Terms of alert NOT met ORC log denoted accordingly and request made to close alert Action plan put in place to ensure remedial actions are taken, progress reviewed monthly Alert fully complied with Permission given by ORC to close alert - ALERT CLOSED ON NATIONAL SYSTEM Alert provisions met but action plan has remaining actions to complete. Alert added to monitoring log for ORC review in May and November. Permission given by ORC to close alert - ALERT CLOSED ON NATIONAL SYSTEM March 2017 10
6.2.4 On receiving an alert the CAS Lead must: Determine if the alert is relevant to receiving Division, Specialty, Department or Corporate Function. If it is, they must ensure that the recommendations contained within the notice and Datix notification are brought to the attention of relevant staff and implemented. Details of action taken / action required should be detailed on the response section on Datix within 1 week of receiving the notice. If the notice is not relevant then No Action Required should be selected on Dati x again within 1 week of receipt. 6.2.5 The CAS Officer will pull together all responses received on Datix and produce a monthly Master CAS Log, which will be submitted to the Trust s Organisational Risk Committee (ORC). Where alerts have been disseminated to the Clinical Risk Committee i.e. to ensure corporate action is taken following receipt of an alert, such alerts will be incorporated into the ORC monthly log detailing the delegation to CRC as appropriate. Any action taken through CRC will be communicated to the CAS Officer(s) who will update the master log for the Trust and also update the National CAS database to show progress / action taken. (Please see Appendix 1 and 2). 6.2.6 Performance against the management of CAS will form part of the monthly updates from ORC and CRC to the Quality Assurance Committee(QuAC). 6.2.7 An alert can only be recommended for closure once ALL returns have been received and the action taken fulfils the terms and wording of the alert or a risk assessment has been completed and agreed by ORC. Once the action taken is agreed as sufficient to close the alert this will be signed off by ORC or CRC and the CAS Officer will sign off on the National CAS database. 6.2.8 Any incomplete alerts from the monthly log will carry forward to the subsequent month. The CAS log will also be made available to Division / Corporate CAS Leads for dissemination within their areas as appropriate. The CAS Officer through the ORC will co-ordinate any across the Trust action as well as updates the CAS database detailing any actions required in order to meet the terms of the alert. March 2017 11
6.2.9 Any alerts that are met in terms of action taken but have an ongoing implementation e.g. annual maintenance, regular checks etc. these will be added to an ongoing monitoring log which will be considered by ORC in May and November each year. In monitoring the log ORC will be seeking the necessary assurances from the appropriate Departments / Lead Managers that ongoing actions are being adhered to. 7.0 7.1 Training, Implementation and Monitoring Arrangements Training Arrangements Awareness sessions for key stakeholders can be arranged via the Organisational Quality, Risk and Safety Team. 7.2 Implementation Arrangements The procedure will be circulated to the target audience and if necessary awareness sessions delivered. The procedure will be available via the Trust s Intranet for staff s perusal. 7.3 Monitoring Arrangements In order to provide the Trust with the Assurances that a robust system for managing alerts is in place the Organisational Risk Committee will undertake regular performance monitoring through Key Performance Indicators (KPI s). The KPI s to be used are as follows; a) Percentage of alerts acknowledged within 24 hours b) Percentage of alerts disseminated within 48 hours of receipt. c) Division return rate against NUH specified deadline; d) Percentage of alerts completed within DH specified deadlines. A bi-annual CAS report will be presented to the Quality Assurance Committee (QUAC) & Trust Board indicating the alerts received and an explanation as to why any of the alerts have breached the deadline. March 2017 12
Additionally Open safety alert information features within the SHA Performance Monitoring Regime on a monthly basis. Where any significant risks are identified through the CAS Process these will be added to the Trusts Risk Register and managed in accordance with the NUH Risk Management Policy. If the CAS Officers have any concerns regarding the action taken locally or where there is a consistent failure to meet the deadlines set, these will be conveyed to the relevant Division CAS Lead / Clinical Director / Executive Director for immediate action, and reported to QUAC via the monthly update process. 7.4 Audit In order to provide additional assurance that alerts are adequately implemented and monitored as necessary a programme of audits will take place. Inclusion of four audits (two ORC alerts and two CRC alerts) within the NUH Clinical Audit programme will take place annually in addition to an independent Internal Audit of the entire CAS process which is undertaken by the Internal Audit department on a bi-annual basis. 8.0 Trust Impact Assessments 8.1 Equality Impact Assessment An equality impact assessment has been undertaken on this draft and has not indicated that any additional considerations are necessary. 8.2 Environmental Impact Assessment An environmental impact assessment has been undertaken on this draft and has not indicated that any additional considerations are necessary. March 2017 13
8.3 Here For You Assessment A Here For You assessment has been undertaken on this document and has not indicated that any additional considerations are necessary. March 2017 14
9.0 Policy / Procedure Monitoring Matrix Minimum requirement to be monitored Procedure KPI s are achieved Management of CRC delegated alerts Audit of two ORC alerts & two CRC managed alerts Audit of CAS Process & System Management of on-going actions such as patient follow-ups. Monitoring of EFM Notifications Monitoring Performance Responsible individual/ group/ committee Head of Organisational Quality, Risk & Safety Clinical Risk Committee CAS Officer 360 Internal Audit Organisational Quality, Risk & Safety team Carillion plc ORC Process for monitoring e.g. audit Monitoring of CAS Log Monitoring of CRC related alerts NUH Clinical Audit Programme Audit of procedure compliance Monitoring of ongoing actions Monitoring of status Performance Report Frequency of monitoring Responsible individual/ group/ committee for review of results Responsible individual/ group/ committee for development of action plan Responsible individual/ group/ committee for monitoring of action plan Monthly ORC ORC Quality Assurance Committee Monthly CRC CRC Quality Assurance Committee Annual ORC ORC / CRC Quality Assurance Committee Every two years ORC ORC / CRC Quality Assurance Committee Every six months ORC ORC Quality Assurance Committee Quarterly ORC ORC Quality Assurance Committee Every six months ORC ORC Quality Assurance Committee 15
10.0 Relevant Legislation, National Guidance and Associated NUH Documents 10.1 Medical Devices Agency. Equipped to Care The safe use of medical devices in the 21 st century. Medical Device Regulations 2003 Nottingham University Hospitals NHS Trust - Trust Policy and Protocol for the Management of Medical Devices. 16
APPENDIX 1 The management of Clinical Risk Committee related alerts Introduction This procedure details the specific arrangements that have been established for alerts managed by the Clinical Risk Committee (CRC) received via CAS. Procedure 1. Alerts relating to clinical issues are received by Head of Organisational Quality, Risk and Safety/Organisational Quality, Risk and Safety Manager (the nominated Trust s CAS Officers ) and forwarded to the: Deputy Medical Director (Chair of Clinical Risk Committee), Head of Patient Safety and the Clinical incident & Risk Lead. 2. The CAS Officers will record on the CAS website and the Trusts CAS Log that the Alert is being managed by CRC. The Clinical Incident & Risk Lead will ensure the alert is added to the CRC CAS Monitoring Log which is discussed at CRC monthly. 3. For each new alert CRC will either disseminate to the allocated lead in each Division or assign a Lead/ Task and Finish group as deemed appropriate to take forward the actions. In accordance with the deadline alerts may be circulated outside of the CRC meeting. 4. For each new alert CRC will agree a reporting timetable, commensurate with the completion timescale identified in the alert. 5. The assigned Leads will provide updates to CRC in accordance with the agreed timescale and a summary portfolio of evidence to support sign off of the alert prior to the deadline being reached. 6. Any problems / issues of non-compliance with the alert that cannot be solved by the Lead/ Task & Finish group must be immediately referred to the Clinical Risk Committee for action. Where CRC are unable to 17
address the problem the issue will be referred to the Quality Operational Group (QuAC) for action. 7. The implementation of any changes required by the alert must be clearly communicated to all healthcare professionals affected by the alert. 8. The Clinical Incident & Risk Lead and the Organisational Quality, Risk & Safety Manager will liaise regularly to ensure that the National CAS System is updated. 9. Once an alert is signed off at CRC, The Clinical Incident & Risk Lead will inform the Organisational Quality, Risk & Safety Manager in order to close the alert on the National System and on Datix (supported by relevant evidence). 18
APPENDIX 2 Central Alerting System (CAS) Dissemination Procedure -HS/SP/001 Procedure for completing Medication Safety related External alerts Introduction This procedure details the specific arrangements that have been established to manage medication alerts received via CAS. This excludes MHRA drug recall alerts. Procedure 1. Receipt of medication alerts 1.1. External Alerts relating to medication issues are received by the nominated Trust s CAS Officers and forwarded to: Medicines Safety Officer (Secretary to Trust Medicines Safety Group (MSG)) Deputy Medical Director, Chair of Clinical Risk Committee (CRC) and Clinical Incident & Risk Lead Head of Pharmacy & Clinical Director for Medicines Optimisation. The CAS Officers will record on the CAS website and the Trusts CAS Log that the Alert is being managed by CRC. The Clinical Incident & Risk Lead will ensure the alert is added to the CRC CAS Monitoring Log which is discussed at CRC monthly. 2. Action following receipt of a medication alert 2.1. The Medicines Safety Officer will assess: 2.1.1. The scope of the alert including the patient groups & healthcare professionals likely to be affected, interface issues, and drugs involved. 2.1.2. Current position (e.g. review of relevant incidents from DATIX). 19
2.1.3. Identify clinician(s) / other healthcare professional & specialist pharmacists who could provide information on the current level of compliance and/or contribute to implementation of the alert. 2.1.4. Ability to deliver the actions within the timescales prescribed within the Alert. 2.2. NHS Improvement Patient Safety Alerts Stage One Alert: Warning Warns organisations of emerging risk. It can be issued very quickly once a new risk has been identified to allow rapid dissemination of information 2.2.1. These alerts have a short timescale, usually one month for a Trust to declare compliance. Due to the sort timescale, the Medicines Safety Officer will scope the alert as described in section 2.1 and advise the Chair of the Medicines Safety Group of any further action required. 2.2.2. The Medicines Safety Officer will produce a portfolio of evidence to demonstrate that the actions have been met. 2.2.3. The Chair of MSG will advise the Chair of CRC whether they recommend the alert can be closed within the timescale. 2.2.4. If agreed by CRC, the Deputy Medical Director, Chair of Clinical Risk Committee (CRC) will inform the nominated CAS Officers who will formally close the Alert on CAS. 2.3. NHS Improvement Patient Safety Alerts Stage Two Alert: Resource. Provision of resources, tools and learning materials to help mitigate risk identified in stage one 2.3.1. The Medicines Safety Officer will table a discussion on the agenda at the next Medicines Governance Committee meeting to agree appropriate delegation to Trust medicines sub-committees to manage implementation of the alert e.g. Medicines Safety Group, Medicines Education Group. 2.3.2. The Medicines Safety Officer will facilitate production of a portfolio of evidence to demonstrate that the actions have been met. 20
2.3.3. The Chair of MGC will advise the Chair of CRC whether they recommend the alert can be closed within the timescale. 2.3.4. If agreed by CRC, the Deputy Medical Director, Chair of Clinical Risk Committee (CRC) will inform the nominated CAS Officers who will formally close the Alert on CAS. 2.4. NHS Improvement Patient Safety Alerts Stage Three Alert: Directive Organisations are required to confirm they have implemented specific actions or solutions to mitigate the risk. 2.4.1. The Medicines Safety Officer will forward the Alert to Medicines Safety Group (MSG) members and table a discussion on the agenda at the next MSG meeting. 2.4.2. The Medicines Safety Officer and Chair of MSG will identify a Division who could take the lead on the alert and will ask the appropriate Divisional team for a nomination. The lead for the alert will be responsible for convening a multidisciplinary Task & Finish Group to devise and implement a plan to action any relevant recommendations contained within the Alert. 2.4.3. Where a lead for the alert cannot be easily identified or there is concern about meeting the timescale defined within the alert this must be immediately (or a soon as identified) be referred to the Deputy Medical Director (Chair of CRC). 2.4.4. The Task & Finish group will: 2.4.4.1. write to Divisional Directors & Divisional Nurses to inform them of the alert, what action needs to be taken at a local level at this stage, and where appropriate, request the Divisional Governance Lead in each department to table the alert at the next Governance meeting in order to provide the Task & Finish Group with essential background information to aid their work. 2.4.4.2. Assess the level of risk for NUH through e.g. review of incident data, Divisional risk registers, information from health professionals working in relevant areas and feedback from local Governance forums. It may be necessary at this 21
initial stage to collect data to fill in any gaps in information. Once complete, an initial risk assessment must be completed and forwarded to the Medicines Safety Group. The risk assessment must be recorded on the Trust s Datix System. 2.4.4.3. Assess the level of compliance of the Trust against the criteria set out in the Alert. It may be necessary at this initial stage to collect data to fill in any gaps in information. 2.4.4.4. Develop an action plan to address the risks identified and set out work required to move the Trust to full compliance with the requirements stated in the alert. This action plan must include clear timescales and named individuals and differentiate between the actions to be taken at a Trust wide level by the Task & Finish Group and the actions to be taken at a local level by the Division. 2.4.4.5. Complete actions to be taken at a Trust wide level by the Task & Finish Group. 2.4.4.6. Communicate the action plan for Divisions to Divisional Directors, Divisional Nurses and Divisional Governance leads. Request them to provide assurance that their Division are aware of, and compliant with the required actions. 2.4.4.7. Where appropriate, develop an audit template for the alert. 2.4.4.8. The Lead for the Task and Finish Group will produce a portfolio of evidence to demonstrate that the alert actions have been met. 3. Management of the implementation of medication alerts 3.1. The Medicines Safety Group will monitor progress of all Task & Finish groups. The Medicines Safety Officer (secretary to MSG) will request a regular update from all Task & Finish groups. 3.2. The Medicines Safety Officer, Secretary to the Medicines Safety Group will provide a monthly progress report on all Alerts being managed by MSG to the Clinical Risk Committee. The Deputy Medical Director, Chair of Clinical Risk Committee (CRC) will ensure that copies of the 22
CRC discussion around such Alerts are forwarded to the nominated CAS Officers who will update progress on the National CAS System. Timescales for delivery of actions will be monitored. 3.3. Any problems / issues of non-compliance with the alert that cannot be solved by the Task & Finish group / MSG must be immediately referred to the Clinical Risk Committee for action. 3.4. The implementation of any changes required by the alert must be clearly communicated to all healthcare professionals affected by the alert. 3.5. Following the implementation of the alert, the risk assessment must be re-scored by the Task & Finish group and forwarded to the Medicines Safety Group for sign off. The Medicines Safety Officer will update the Datix Risk Management system to record the mitigation put into place. 3.6. Once signed off by MSG a recommendation to close the alert will be submitted to CRC. If agreed by CRC, the Deputy Medical Director, Chair of Clinical Risk Committee (CRC) will inform the nominated CAS Officers who will formally close the Alert on CAS. 3.7. Following sign off, details of the alert and actions taken will be included in the Patient Safety Newsletter to demonstrate organisational learning. 4. Assurance of continued compliance 4.1. The Medicines Safety Group will ensure that following closure of the Alert, the identified risk will continue to be monitored by the group. Incidents relevant to the medication alert will be reviewed every 6 months in the Trust wide biannual medication incident report and risk assessments updated as appropriate. 5. Responsibilities 5.1. Some alerts require Trust wide actions in the form of a new policy, risk assessment or new documentation. Alerts may also require action at a local level e.g. introduction of new equipment, education of staff. 5.2. Task & Finish Groups are responsible for the development of 23
recommendations to move the Trust to full compliance with the alert. This will ensure standardisation of changes made across the Trust. The Task and Finish Group will complete Trust wide actions e.g. new documentation, new policy. 24
Reporting/ Action Reporting/ Action Record/Log Event Alert & Report The management of estates related alerts APPENDIX 3 Procedure for Estates and Facilities Notification (EFN) Alerts This procedure details the specific arrangements that have been established for alerts managed by the Estates Team received from Nottingham University Hospitals (NUH) Trust via the Central Alerting System (CAS) EFN alerts are received by NUH Trust s Head of Organisational Risk / Health and Safety Manager; (the nominated NUH Trust s CAS officers) which are then forwarded to the Head of Estates. The Estates CAS coordinator will ensure each alert is assigned to a Estates officer. The CAS coordinator will confirm rescript of each alert by an read receipt email back to the nominated NUH trust officers. The CAS coordinator will record on Datix, receipt of each CAS, track the progress of each CAS, any areas of non-compliance and the date of completion. The log will also record any recommendations and follow on works. Where remedial action may be deemed necessary, the alert will not be considered complete until such action has either been approved the Authorised Engineer or Responsible Person or the Authorised Engineer or Responsible Person has stated such remedial action is not deemed necessary. The CAS coordinator will monitor the status of every current CAS alert in the monthly report to ORC. NUH CAS Officer will submit the CAS log in time for the NUH trust s Organisational Risk Committee (ORC) Meeting. Non-compliance notifications will formally be reported by the Estates Representative at ORC under the CAS Log Agenda. 25
Document Reference Title Version Date Lead officer for implementation Target Audience Training and Education Requirements POLICY / PROCEDURE IMPLEMENTATION PLAN HS/SP/001 Central Alerting System Dissemination Procedure 6 March 2017 Head of Organisational Risk APPENDIX 4 Key stakeholders as identified in the document control page Key Stakeholder general awareness of their responsibilities. Implementation Plan Submit procedure to Directors Group for approval. Arrange to place a copy of the procedure on NUH Intranet and internal Governance. Publicise through usual Trust media. Raise awareness at other Trust Committees and Forums. Timetable for Completion of Implementation 31 March 2017 26
APPENDIX 5 Equality Impact Assessment (EQIA) Form (Please complete all sections) Q1. Date of Assessment: 11 November 2016 Q2. For the policy and its implementation answer the questions a c below against each characteristic (if relevant consider breaking the policy or implementation down into areas) Protected Characteristic a) Using data and supporting information, what issues, needs or barriers could the protected characteristic groups experience? For example, are there any known health inequality or access issues to consider? The area of policy or its implementation being assessed: b) What is already in place in the policy or its implementation to address any inequalities or barriers to access including under representation at clinics, screening c) Please state any barriers that still need to be addressed and any proposed actions to eliminate inequality Race and Ethnicity Availability of this policy in languages other than English Alternative versions can be created on request. None Gender None Not applicable None Age None Not applicable None Religion None Not applicable None 27
Disability Visual accessibility of this document Already in font size 14. Use of technology by end user. Alternative versions can be created on request. None Sexuality None Not applicable None Pregnancy and None Not applicable None Maternity Gender None Not applicable None Reassignment Marriage and None Not applicable None Civil Partnership Socio-Economic None Not applicable None Factors (i.e. living in a poorer neighbour hood / social deprivation) Area of service/strategy/function Q3. What consultation with protected characteristic groups including patient groups have you carried out? None for this version. Q4. What data or information did you use in support of this EQIA? Trust policy approach to availability of alternative versions. Q.5 As far as you are aware are there any Human Rights issues be taken into account such as arising from 28
surveys, questionnaires, comments, concerns, complaints or compliments? No. Q.6 What future actions needed to be undertaken to meet the needs and overcome barriers of the groups identified or to create confidence that the policy and its implementation is not discriminating against any groups What By Whom By When Resources required Not applicable Q7. Review date Not applicable 29
Environmental Impact Assessment APPENDIX 6 The purpose of an environmental impact assessment is to identify the environmental impact of policies, assess the significance of the consequences and, if required, reduce and mitigate the effect by either, a) amend the policy b) implement mitigating actions. Area of impact Waste and materials Soil/Land Water Environmental Risk/Impacts to consider Is the policy encouraging using more materials/supplies? No Is the policy likely to increase the waste produced? No Does the policy fail to utilise opportunities for introduction/replacement of materials that can be recycled? No Is the policy likely to promote the use of substances dangerous to the land if released (e.g. lubricants, liquid chemicals) No Does the policy fail to consider the need to provide adequate containment for these substances? (for example bunded containers, etc.) No Is the policy likely to result in an increase of water usage? (estimate quantities) No Is the policy likely to result in water being polluted? (e.g. dangerous chemicals being introduced in the water) No Does the policy fail to include a mitigating procedure? (e.g. modify procedure to prevent water from being polluted; polluted water containment for adequate disposal) No Action Taken (where necessary) Not applicable Not applicable Not applicable 30
Air Is the policy likely to result in the introduction of procedures and equipment with resulting emissions to air? (For example use of a furnaces; combustion of fuels, emission or particles to the atmosphere, etc.) No Does the policy fail to include a procedure to mitigate the effects? No Does the policy fail to require compliance with the limits of emission imposed by the relevant regulations? No Energy Does the policy result in an increase in energy consumption levels in the Trust? (estimate quantities) No Nuisances Would the policy result in the creation of nuisances such as noise or odour (for staff, patients, visitors, neighbours and other relevant stakeholders)? No Not applicable Not applicable Not applicable 31
We Are Here for You Policy and Trust-wide Procedure Compliance Toolkit APPENDIX 7 The We Are Here for You service standards have been developed together with more than 1,000 staff and patients. They can help us to be more consistent in what we do and say to help people to feel cared for, safe and confident in their treatment. The standards apply to how we behave not only with patients and visitors, but with all of our colleagues too. They apply to all of us, every day, in everything that we do. Therefore, their inclusion in policies and trust wide procedures is essential to embed them in our organisation. Please rate each value from 1 3 (1 being not at all, 2 being affected and 3 being very affected) If your document generates a score of 16 or more, you are required to review the document and make changes to ensure the values are reflected in the document. Value 1. Polite and Respectful Whatever our role we are polite, welcoming and positive in the face of adversity, and are always respectful of people s individuality, privacy and dignity. 2. Communicate and Listen We take the time to listen, asking open questions, to hear what people say; and keep people informed of what s happening; providing smooth handovers. Score (1-3) 1 2 32
3. Helpful and Kind All of us keep our eyes open for (and don t avoid ) people who need help; we take ownership of delivering the help and can be relied on. 4. Vigilant (patients are safe) Every one of us is vigilant across all aspects of safety, practices hand hygiene & demonstrates attention to detail for a clean and tidy environment everywhere. 5. On Stage (patients feel safe) We imagine anywhere that patients could see or hear us as a stage. Whenever we are on stage we look and behave professionally, acting as an ambassador for the Trust, so patients, families and carers feel safe, and are never unduly worried. 6. Speak Up (patients stay safe) We are confident to speak up if colleagues don t meet these standards, we are appreciative when they do, and are open to positive challenge by colleagues 7. Informative We involve people as partners in their own care, helping them to be clear about their condition, choices, care plan and how they might feel. We answer their questions without jargon. We do the same when delivering services to colleagues. 8. Timely We appreciate that other people s time is valuable, and offer a responsive service, to keep waiting to a minimum, with convenient appointments, helping patients get better quicker and spend only appropriate time in hospital. 1 2 1 1 1 1 33
9. Compassionate We understand the important role that patients and family s feelings play in helping them feel better. We are considerate of patients pain, and compassionate, gentle and reassuring with patients and colleagues. 10. Accountable Take responsibility for our own actions and results 11. Best Use of Time and Resources Simplify processes and eliminate waste, while improving quality 12. Improve Our best gets better. Working in teams to innovate and to solve patient frustrations 1 2 1 1 TOTAL 15 34
CERTIFICATION OF EMPLOYEE AWARENESS APPENDIX 8 Document Title Central Alerting Safety (CAS) Dissemination Procedure Version (number) 6 Version (date) 14 March 2017 I hereby certify that I have: Identified (by reference to the document control sheet of the above policy/ procedure) the staff groups within my area of responsibility to whom this policy / procedure applies. Made arrangements to ensure that such members of staff have the opportunity to be aware of the existence of this document and have the means to access, read and understand it. Signature Print name Date Division/ Directorate The manager completing this certification should retain it for audit and/or other purposes for a period of six years (even if subsequent versions of the document are implemented). The suggested level of certification is; Clinical Divisions Divisional General Manager or nominated deputy Corporate Directorates- deputy director or equivalent. The manager may, at their discretion, also require that subordinate levels of their Division / department utilise this form in a similar way, but this would always be an additional (not replacement) action. 35 March 2017