Policy for the Management of Alert Notices Generated via the DH Central Alert System (CAS)

Transcription

1 Policy for the Management of Alert Notices Generated via the DH Central Alert System (CAS) Version Number: V4 Name of originator/author: Risk Manager Name of responsible committee: Risk Committee Name of executive lead: Chief Executive Date V1 issued: January 2007 Last Reviewed: February 2014 Next Review date: February 2017 Scope: Trust wide MMHSCT Document Code CL04 Page 1 of 45

2 Document Control Sheet Document Title / Ref: Policy for the Management of Alert Notices generated via the DH Central Alert System (CAS) Lead Executive Chief Executive Officer Director Author and Contact Risk Manager Number Type of Document Policy Broad Category Broad Document Purpose The purpose of the document is to define the systems to be used for the dissemination of safety alerts, emergency alerts, drug alerts and medical device Alerts issued by the Medicines and HealthCare products regulatory agency, NHS Estates and Facilities, The National Patient Safety Agency and Department of Health. Scope Trust Wide Version number V4 Consultation Emergency Planning/Medicines Management Approving Committee Risk Committee Approval Date March 2014 Ratification and Date Trust Board Date of Ratification 24 April 2014 V1 Valid from Date January 2007 Current version is valid from approval date Date of Last Review February 2014 Date of Next Review February 2017 Procedural Documents to be read in Medical Devices Policy conjunction with this document: Training Needs Analysis Impact There are Training requirements for this procedural document. The training is required for the implementation of the policy Out of Hours which will be for Bleep holders and Night Managers Financial Resource Impact There are no Financial resource impacts Document Change History Changes to this document in different versions must be detailed below. Rationale for the change should also be given Version Number / Name of procedural document this supersedes Version 1 Type of Change i.e. Review / Legislation / Claim / Complaint Review Date December 2011 Details of Change and approving group or Executive Lead (if done outside of the formal revision process) To include the Lloyds Pharmacy and update the contact telephone numbers. Version 2 Review February 2013 To include process for on call Version 3 Review October 2013 To include the reporting of defects and Failures and Disseminating Estates and Facilities Alerts. Version 4 Review February 2014 To include an SOP in response to An Introduction to the NHS England National Patient Safety Alerting System. Page 2 of 45

3 External references used in the creation of this document: If these include monitoring duties upon the Trust for this policy the specific details should be recorded on the Monitoring and Compliance Requirements sheet Privacy Impact N/a Any issues? Choose an item. Assessment submitted Fraud Proofing N/a Any issues? Choose an item. submitted If not relevant to this procedural document give rationale: This is a Dept of Health System for Management of CAS Alerts Policy authors are asked to consider each of the nine protected characteristics under the Equality Act We expect you to demonstrate that throughout the policy process you have had regard to the aims of the Equality Duty: 1. Eliminate unlawful discrimination, harassment and victimisation and any other conduct prohibited by the Act; 2. Advance equality of opportunity between people who share a protected characteristic and people who do not share it; and 3. Foster good relations between people who share a protected characteristic and people who do not share it. Please provide a brief account of how you have done this, further work to be completed and any support you have had in considering the aims and working in compliance with the Equality Duty. If you are unclear on how to do this or would like further advice and support then you may contact quality.admin@mhsc.nhs.uk. It is the responsibility of the approving group to ensure this statement reflects the Trusts objectives and position with compliance as set out within the NHS Equality Delivery System This policy is broad and the scope is Trustwide so complies with the Trust s Equality Delivery System In line with the Trust values we may publish this document on our External Website. Is there any reason you would prefer this is not done? No It is the Authors responsibility to ensure all procedural documents comply with the Trust values If you are unclear on any of the requirements in the document control sheet then please quality.admin@mhsc.nhs.uk before proceeding Page 3 of 45

4 Monitoring and Compliance Requirements Sheet For audit, Registration and NHSLA purposes all procedural documents must have monitoring requirements or key performance indicators set by the authors, Committees or Lead Directors. This allows the Trust to routinely monitor the effectiveness and impact of their procedural documents on a regular basis. Procedural Document Title: Policy for the Management of Alert Notices Generated via the DH Central Alert System CAS Does this procedural document offer support or evidence for the Trusts registered activities and outcomes? Yes Primarily Outcome 11 Safety Availability and Suitability of Equipment Additional Outcome 4 Care and Welfare of People who use Services Additional Outcome 10 Safety and Suitability of Premises Is this an NHSLA Document? Yes Which Standard does this relate to? 1 Governance Which Criterion Not Applicable Choose an item. Choose an item. If other Monitoring requirements are necessary i.e. Health & Safety Act and you should include them here and record them in the External References section Specify where the requirement originates Minimum Requirement / Standard / Indicator to be monitored & Section of document it appears Level 1 Process to manage CAS Alerts (including Drug Alerts) during working hours Level 2 Process to Manage Drug Alerts out of hours Level 2 Monitor compliance with the Process to Manage CAS Alerts (including Drug Alerts) during working hours Level 2 Monitor Compliance with the process to manage Drug Alerts out of hours Level 3 Demonstrate with evidence of continuous improvement of the process for managing CAS Alerts (including Drug Alerts) Process for monitoring Responsible Individual / Group Additional Details i.e. Section number, Code of Practice Frequency of Monitoring Responsible Group for review of results / action plan approval / implementation Review Risk Manager/Risk Committee Yearly Risk Committee Review Risk Manager/Risk Committee Yearly Risk Committee Audit Risk Manager/Risk Committee Yearly Risk Committee Audit Risk Manager/Risk Committee Yearly Risk Committee Audit Risk Manager/Risk Committee Risk Committee Comments Page 4 of 45

5 NB: If you have selected audit you should complete the required audit registration form and standards document and submit these with your expected timescales for completing the audit to as soon as possible and no later than 4 weeks prior to the audit commencing. The Group / Committee should also ensure the monitoring work is added to their yearly schedule of monitoring and action logs as appropriate. Page 5 of 45

6 Contents Page Section Title Page Number 1 Executive Summary 7 2 Introduction 7 3 Purpose of the Policy 8 4 Medical Device Liaison Officer 8 5 Central Alert System 8 6 Dissemination Procedure Medical Device Alerts NHS Estates Safety Alerts and Hazard Notices National Patient Safety Agency Patient Safety Alerts Department of Health Guidance Documents Drugs Alerts via MHRA or Quality Control North West 11 7 Follow Up Procedure 11 8 Product Recalls from Companies and Organisations 12 9 Out of Hours South On Call Pharmacy Service Medical Device Bulletins What is a Medical Device? Dissemination Plan 15 Appx A Central Alerting System CAS 16 Appx B CAS Alert Policy Drug Alert Out of Hours 17 Appx C Standard Operating Procedure for Medicines CAS Alerts including 18 Reporting of Drug Defect Reporting (SOP 20) Appx D Standard Operating Procedure (SOP) for the Management of Stages 1, 2 and 3 Patient Safety Alerts issued by the National Patient Safety Alerting System (NPSAS) 28 Page 6 of 45

7 Policy for the Management of Alert Notices Generated via The DH Central Alert System (CAS) 1. Executive Summary The Central Alerting System (CAS) is a web-based cascading system for issuing patient safety alerts, important public health messages and other safety critical information and guidance to the NHS and others, including independent providers of health and social care. CAS was established in 2008, replacing the previous Public Health Link (PHL) and Safety Alert Broadcast System (SABS). Issued alerts are available on the CAS website and include safety alerts, CMO messages, drug alerts, Dear Doctor letters and Medical Device Alerts issued on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA), the National Patient Safety Alert System (NPSAS), and the Department of Health. On 1 June 2012 the key functions and expertise for patient safety developed by the National Patient Safety Agency (NPSA) transferred to the NHS Commissioning Board Special Health Authority. In January 2014 the NHS England Patient Safety Domain launched the National Patient Safety Alerting System (NPSAS), an improved three-level system for highlighting patient safety risks in NHS organisations, and implementing action to reduce risk. This policy will help Staff understand the CAS system along with the reporting mechanism for defects and failures in Estates and Facilities and the NPSAS. This policy will also provide support to staff to ensure the Trust is equipped to act on and implement each stage of the NHS England patient safety alerts. NHS England has a vital role in identifying, understanding and managing risks that pose a danger to patients. The major tool in identifying these risks is the National Reporting and Learning System (NRLS). Prior to June 2012, information regarding risk identified by NRLS was disseminated by various mechanisms developed and operated by the National Patient Safety Agency (NPSA), including issuing Patient Safety Alerts and Rapid Response Reports. This system was effective; however, the development process was lengthy often making it difficult to issue timely alerts. 2. Introduction The Trust is committed to having standards in place for managing CAS alerts, including patient safety risks. This policy and SOPs outlines the risk reduction strategies the Trust has in place to implement and manage alert notices issued by the DH CAS alert and the NPSAS three-stage system, for dissemination of patient safety information at different stages of development to staff providing care across all Care Groups and services provided by the Trust. Page 7 of 45

8 3. Purpose of the Policy The Trust supports the aims of the DH CAS alert system and the NHS England National Patient Safety Alert System in managing patient safety risks. This Policy emphasises the importance of the DH CAS alert system and the NHS England National Patient Safety Alert System in managing patient safety risks to all Trust staff. The policy sets out the standards to manage and implement all aspects of the DH CAS alert system and the NHS England National Patient Safety Alert System in managing patient safety risks. 4 Medical Device Liaison Officer The Medicines and Healthcare Products Regulatory Agency require the Trust to appoint a Liaison Officer (LO) who will act as the focal point for the dissemination of information between the MHRA and the Trust. The appointed person within the Trust is the Risk Manager who will ensure that his/her details have been forwarded to the MHRA. The Risk Manager will then receive an MHRA Liaison Officer information pack, which provides advice and guidance on the Medicines and Healthcare Products Regulatory Agency and the systems for the provision of CAS Alerts. The MHRA liaison officer is responsible for arranging prompt dissemination of all information and in particular, CAS Alerts comprising of: CAS Alerts Immediate Action Action Updates Information Requests 5 Central Alert System The Central Alerting System (CAS) is a web-based cascading system for issuing patient safety alerts, important public health messages and other safety critical information and guidance to the NHS and others, including independent providers of health and social care. CAS was established in 2008, replacing the previous Public Health Link (PHL) and Safety Alert Broadcast System (SABS). Issued alerts are available on the CAS website and include safety alerts, CMO messages, drug alerts, Dear Doctor letters and Medical Device Alerts issued on behalf of the Medicines and Healthcare products Regulatory Agency, the National Patient Safety Agency, and the Department of Health. On 1 June 2012 the key functions and expertise for patient safety developed by the National Patient Safety Agency (NPSA) transferred to the NHS Commissioning Board Special Health Authority. Page 8 of 45

9 The most recently issued alerts are listed on the homepage along with a search alerts link to retrieve earlier alerts. Registered NHS users can access CAS reports using their login details. The Central Alert system is operated by the Department of Health and provides a mechanism for the swift despatch of a number of safety related alert and information notices, comprising of: Medical Device Alerts from the Medicines and Healthcare Products Regulatory Agency. (MHRA) MHRA drug alerts National Patient Safety Alerts. Safety Notices and Safety Bulletins from NHS Estates. Guidelines on specific subjects from the Department of Health. The alert system has an associated website, which holds copies of all alert notices, together with statistics on responses from Trusts. CAS alerts need to be acknowledged within 2 working days. Drug alerts and CMO alerts are circulated to the CAS Liaison officer, the Medical Director and the Director of Public Health. The Drug alerts and CMO alerts sometimes have to be acted within 6 hours, but no acknowledgement is required. The DH knows that Medical Directors and the Directors of Public Health already operate an on Call system. The CMO alerts will rely on the Medical Director on call system for dissemination and action. The Drug alerts will have to be dealt through a separate on call system for dissemination and action. The Risk Manager is the nominated Liaison Officer for CAS for the Trust and is responsible for: Receiving the documents on , via the CAS system. Promptly (normally the same day) forwarding the documents through the dissemination system described below, noting any priority action. Updating the CAS website to acknowledge receipt and necessary action rating for the notices. Collating returns from the identified addressees and finally closing down the notice on the CAS website when the issue has been completely dealt with. Holding a library copy of all CAS notices. Providing a list of all CAS notices to the Risk Committee and the Governance Committee. The Medical Director and the Chief Nurse and Director of Quality Assurance will ensure that the Risk Manager is provided with the necessary administrative support to ensure that the system continues to operate efficiently. 6 Dissemination Procedure Page 9 of 45

10 The procedure will be slightly different for each type of CAS notice: 6.1 Medical Device Alerts. On receipt of Medical Device Alerts, via the CAS system, the alert message will be forwarded by to all Responsible Officers for: Further dissemination and action through their area of responsibility. Notifying the Risk Manager of the actions taken, where applicable and within the timescale stated on the accompanying reply document. Notifying the Risk Manager where there is no action required, or that the Care Group concerned does not hold or operate any of the equipment. Note: Responsible Officers should ensure that CAS notices are actioned promptly they must therefore make arrangements for cover when they are on leave or away from the site. This may easily be done by auto-forwarding the CAS notice to one or more named deputies, who are authorised to carry out the duties of the Responsible Officer. Where the Responsible Officer (RO) delegates the action of providing the return information to the Risk Manager, then that RO must ensure that the Risk Manager is aware of the name of the nominated person. Therefore, return information will come from either the Responsible Officer or the nominated person. The Risk manager will hold a list of Responsible Officers, who are authorised to make returns for the Care Groups. Returns will not be accepted from any source other than those people on the list. All four classification of Safety Alert will be forwarded as soon as they are received in the Governance Office, it is the responsibility of the receiving officer, to note the priority on the front page of the Safety Alert and react accordingly. Returns to the CAS Liaison Officer should be made within one working week of receipt of the CAS notice, or earlier if so required by individual alerts. Safety alerts will sometimes require a Trust wide co-ordinated action. In these instances a Safety Alert Lead Person will be appointed to co-ordinate the actions necessary and report back to the CAS liaison officer. The lead person will be a senior manager or clinician with sufficient knowledge of the organisation and the problem, which the Alert message seeks to address. The selection of the lead person will be carried out in consultation with the Chief Nurse & Director of Quality Assurance the Medical Director, and the Risk Manager, (CAS Liaison Officer). (See flow chart). 6.2 NHS Estates Safety Alerts and Hazard Notices. It will often be fairly easy to determine any limited distribution list required by these notices, therefore, on receipt of the notices the Risk Manager will forward the notices by to the relevant Responsible Officer. Where there is any doubt or where the notice has relevance through several Care Groups, then the system described above for Safety Alerts will be used for dissemination to all Responsible Officers. Please also refer to the Medical Devices Policy, Local Site Handbook for reporting Estates issues and An Organisation wide Policy for the Management of Incidents including the Management of Serious Incidents Requiring Investigation (SIRI). In the interests of patients, staff and visitors safety, all staff working in a healthcare environment have a responsibility to report to the Department of Health defect or failures that occur at work. Defects and Failures should be reported on-line through the efm information module at In the interests of safety and to enable the sharing of information across all NHS service providers, it is important to ensure that the use of the local DATIX incident reporting and the Page 10 of 45

11 Trust risk management systems does not result in the reporting of relevant defects and failures being overlooked. If a relevant incident report is submitted to another body (for example the Health & Safety Executive), a report should also be entered onto the efminformation system. by the Estates Manager. 6.3 National Patient Safety Alerting System. On receipt of a Patient Safety Alert, the Risk Manager will consult with the Medical Director (in her/his absence, the Chief Nurse & Director of Quality Assurance), and determine the distribution of the Alert Notice. When the distribution has been determined the alert notice will be forwarded by to the nominated addressees, who must action and disseminate as necessary. A Safety Alert Lead Person will be appointed as necessary.(for details of the process please see the SOP for the Management of Stages 1, 2, and 3 of Patient Safety Alerts issues by the National Patient Safety Alerting System (NPSAS). 6.4 Department of Health Guidance Documents. On receipt of a Department of Health Guidance Document, the Risk Manager will liaise with the Chief Executives Department to determine the correct distribution and priority of actions necessary. 6.5 Drug Alerts via MHRA or Quality Control North West. These are received via the CAS system by the CAS Liaison officer who contacts the chief pharmacist. There is a backup system which is a separate fax from Quality Control North West to the medicines management team at Park House and the Lloyds pharmacy on the north site. During working hours these are dealt with under the management of the chief pharmacist. Outside working hours these are dealt with through a separate operating procedure (See below). The period of time that they should be responded to is defined within the alert, as Class level, e.g. Level 1, Action Now including Out of Hours and giving the level of recall, eg. Patient Level, Hospital Pharmacy Level. The Trust pharmacy services deal with the alert as required within the defined timescales. The information regarding relevant Drug alerts may also be disseminated via Trust Communications of very urgent CAS alerts. Please refer to the Drug Defect Reporting procedures on the intranet to find out how to report faults to the MHRA. 7 Follow Up Procedure In the event that any Responsible Officer or other addressee fails to reply to the covering letter, which accompanies the CAS Alert, the Risk Manager will send a reminder to the Responsible Officer one week after the CAS Alert was despatched and a final reminder and phone call one week later. It is a fundamental facet of this procedure that Responsible Officers ensure that they have a robust system in place to action all CAS notices in a timely manner, including arranging for a prompt, consolidated reply to the CAS Liaison Officer. The Risk Manager will maintain a record, which highlights the pattern of responses, in order to verify the efficacy of the system and assist in the reminder process to Responsible Officers. Addressees should note the response timescales on individual alerts and ensure that actions taken are commensurate with the timeframe specified. Whilst the whole process may be carried out electronically the Responsible Officers should ensure that they maintain a record locally to act as an audit trail of their actions for all CAS alerts. The CAS website is situated within the public domain, therefore members of the public may log onto the system and will have access to the alert information, including the time taken for Page 11 of 45

12 the Trust to action and close down the relevant notice. Please see the AvMA reports February 2010 and February The AvMA URL link is below. Update&utm_source=AVMA&utm_medium= 8 Product Recalls from Companies and Organisations Information received from suppliers and manufacturers, which require immediate action, are forwarded to Responsible Officer and separately to Storekeepers, through the supplies system via the Trust internal mail system (where an electronic copy is not available). Addressees should take the actions detailed on the information supplied and advise the Risk Manager of the outcome. Note that supplier information and recall notices will not fall under the remit of the CAS system. The Risk Manager will normally liaise closely with the supplies manager. 9 Out Of Hours 9.1 South on Call Pharmacy Service: The Trust will receive Drug Alert from the Quality North West through a pharmacy on call for South via Wythenshawe pharmacy. The on call pharmacist will alert the South bleep holder of an MHRA drug alert. Quality Control North West (QCNW) will contact South Pharmacy on Call who will inform the South Bleep Holder of the Drug Alert and Actions to be taken. The Bleep Holder at South will respond by forwarding the Drug alert to the clinical areas at South, CRHTs (South & Central), A & E Liaison (South & Central) and Anson road for actions and receipt of feedback. Each Ward, CRHT South & Central, A&E Liaisons at South & Central and Anson act on the Drug alert and feedback to the Bleep Holder on actions taken. Quality Control North West will inform the Bleep Holder at North of a drug alert and the action to be taken. The Bleep Holder at North will respond by forwarding the drug alert to the clinical areas, North CRHT, A&E Liaison North and Station Road for action and receipt of feedback. 10 Medical Device Bulletins From time to time the Medicines and Healthcare Products Regulatory Agency issue information bulletins on specific subjects. These bulletins are a very useful and informative means of expanding knowledge on a myriad of related subjects relating to the use of medical devices. A library of all relevant bulletins will be held in the Governance Office on the S- Drive and copies forwarded to equipment users as necessary. All MHRA Device Alerts and Device Bulletins can be accessed and downloaded from the MHRA website at: 11 What is a Medical Device? Page 12 of 45

13 Medical devices consist of a whole range of equipment used for the diagnosis and treatment of disease or for monitoring of patients. Such as: (NB this is not an exhaustive list). X-Ray systems. Ultrasound Imagers and CT/MR Scanners Patient monitoring equipment. E.g., Cardiac Monitors. Anaesthetic equipment Sphygmomanometers Examination Gloves Endoscopes Dressings Chiropody Equipment. Physiotherapy Equipment Blood warming cabinets Powered and unpowered surgical implants (e.g. implantable defibrillators, pacemakers, heart valves, orthopaedic prostheses, bone cements). Radiotherapy equipment (brachytherapy, external beam). Vaginal spatulae. Catheters. IV administration sets and pumps Dental equipment and materials Thermometers Syringes and needles Surgical Instruments and equipment For Critical Care Ventilators. Defibrillators For the care of disabled people. Wheelchairs and special support seating Walking aids Orthotic and prosthetic appliances Pressure relief equipment Patient Hoists By Ambulance Services (but not including ambulance vehicles) Stretchers and trolleys Resuscitators For Daily Living Commodes Urine drainage systems Incontinence Products Prescribable footwear Bathing and shower equipment Page 13 of 45

14 Hearing aids Special Chairs In-vitro Diagnostic Equipment and Accessories. Devices for blood glucose measurement Pregnancy test kits. Urine test strips Intra- uterine devices (IUDs) Condoms Hepatitis and HIV test kits Blood gas analysers Specimen collection tubes Contact lenses and care products The Agency are also interested in products which whilst not themselves medical devices, are used closely in conjunction with these devices. Disinfecting and sterilizing equipment. Chemical and Biological Indicators used in sterilization process Blood and tissue storage systems Bench top sterilizers Medical devices do not include general workshop equipment such as power tools or machine tools, or general-purpose laboratory equipment. Further information on reporting Adverse Incidents involving medical devices may be found in the Serious Untoward Incident Reporting Policy. The MHRA provide an annual update on the reporting procedure within a Device Alert. (Action). The latest copy of this Alert is available from the MHRA website Reference No: DB2006(02) March Dissemination Plan Title of document: Date finalised: POLICY FOR THE MANAGEMENT OF ALERT NOTICES GENERATED VIA THE DH CENTRAL ALERT SYSTEM (CAS) TBC Dissemination lead: Risk Manager Previous document already being used? Yes Page 14 of 45

15 If yes, in what format and where? Proposed action to retrieve out-of-date date copies of the document: To be disseminated to: How will it be disseminated, who will do it and when? Electronic, available on the Intranet Archive previous version on SharePoint All Directors, Senior Managers, General Managers, Service Managers and Team Leaders. A group will be sent by the Risk Manager, alerting teams to download the Policy for local use, once it has been formally ratified by the Trust Board. Paper or Electronic? Electronic Useful links: o o o o The Medicines and Healthcare products Regulatory Agency: Patient safety website: The Chief Medical Officer (for England): Action against medical accidents (AvMA) News+Update&utm_source=AVMA&utm_medium= Page 15 of 45

16 (Working Hours) Liaise with the Hosts Trusts if appropriate. Page 16 of 45

17 Appendix B to CAS alert policy- Drug Alert Out of Hours Step One Quality Control North West (QCNW) will contact South Pharmacy on Call who will inform the South Bleep Holder of the Drug Alert and Pharmacy Actions to be taken. on call South Quality Control North West Quality Control North West will inform the Bleep Holder at North of a drug alert and the action to be taken. Step Two The Bleep Holder at South will respond by forwarding the Drug alert to the clinical areas at South, CRHTs (South & Central), A & E Liaison (South & Central) and Anson road for actions and receipt of feedback. Bleep Holder (South) Bleep Holder (North site) The Bleep Holder at North will respond by forwarding the Drug alert to the clinical areas, North CRHT, A&E Liaison North and Station Road for action and receipt of feedback. Step Three Clinical areas at Each Ward, CRHT South & South, CRHTs, Central, A&E Liaisons at South & Central and Anson act on AOTs (South & the Drug alert and feedback to the Central), A&E Bleep Holder on actions take Liaisons (South & Central) and Anson Road. Clinical areas at North, North A&E Liaison, CRHT (North), AOT and Station Road. Prison Health Care Manager on Call Each Ward, CRHT North, A&E Liaison at North and Station Road act on the Drug alert and feedback to the Bleep Holder Page 17 of 45

18 Appendix C Standard Operating Procedure for Medicines CAS Alerts including reporting of Drug Defect Reporting (SOP 20) Version Number: 2 Name of originator/author: Petra Brown, Chief Pharmacist Name of responsible Medicines Management Committee committee: Name of executive lead: Medical Director Date V1 issued: February 2011 Last Reviewed: December 2013 Next Review date: December 2016 Scope: Trustwide including HMP Manchester MMHSCT Document Code Page 18

19 Document Control Sheet Document Title / Ref: SOP 20: Medicines CAS alerts including reporting of Drug Defect Reporting Lead Executive Director Medical Director Author and Contact Chief Pharmacist, tel: Number Type of Document Trust Wide Broad Category Document Purpose This SOP provides information on the system relating to a central drug defect reporting system is managed by Stepping Hill Quality Control laboratories and the National Medicines Information Centre in Liverpool. Scope Trustwide Version number 2 Consultation Guidelines Committee/ Governance Approving Committee Guidelines Committee Approval Date December 2013 Ratification and Trust Board TBC Date V1 Valid from Date February 2011 Current version is valid from approval date Date of Last Review December 2013 Date of Next Review December 2016 Procedural Documents to be read in conjunction with this document: Medicines Policy dicines%20management/medicines%20policy.p Training Needs Analysis Impact There Training requirements for this procedural document which is dealt with during Local Induction in the Local Service provider. df Financial Resource Impact There are no ffinancial resource impacts Document Change History Changes to this document in different versions must be detailed below. Rationale for the change should also be given Version Number / Name of procedural document this supersedes Version 1 Type of Change i.e. Review / Legislation / Claim / Complaint Review Date December 2011 Details of Change and approving group or Executive Lead (if done outside of the formal revision process) To include the Lloyds Pharmacy and update the contact telephone numbers. Version 2 Review February 2013 To include process for on call Version 3 Review October 2013 To include the reporting of defects and Failures and Disseminating Estates and Facilities Alerts. Version 4 Review February 2014 To include an SOP in response to An Introduction to the NHS England National Patient Safety Alerting System. External references used in the creation of this document: If these include monitoring duties upon the Trust for this policy the specific details should be

20 recorded on the Monitoring and Compliance Requirements sheet Privacy Impact Assessment N/a Any issues? Choose an item. submitted Fraud Proofing submitted N/a Any issues? Choose an item. If not relevant to this procedural document give rationale: Policy authors are asked to consider each of the nine protected characteristics under the Equality Act We expect you to demonstrate that throughout the policy process you have had regard to the aims of the Equality Duty: 1. Eliminate unlawful discrimination, harassment and victimisation and any other conduct prohibited by the Act; 2. Advance equality of opportunity between people who share a protected characteristic and people who do not share it; and 3. Foster good relations between people who share a protected characteristic and people who do not share it. Please provide a brief account of how you have done this, further work to be completed and any support you have had in considering the aims and working in compliance with the Equality Duty. If you are unclear on how to do this or would like further advice and support then you may contact quality.admin@mhsc.nhs.uk. It is the responsibility of the approving group to ensure this statement reflects the Trusts objectives and position with compliance as set out within the NHS Equality Delivery System This SOP is broad and the scope is Trustwide so complies with the Trust s Equality Delivery System In line with the Trust values we may publish this document on our External Website. Is there any reason you would prefer this is not done? It is the Authors responsibility to ensure all procedural documents comply with the Trust values If you are unclear on any of the requirements in the document control sheet then please quality.admin@mhsc.nhs.uk before proceeding

21 Monitoring and Compliance Requirements Sheet For audit, Registration and NHSLA purposes all procedural documents must have monitoring requirements or key performance indicators set by the authors, Committees or Lead Directors. This allows the Trust to routinely monitor the effectiveness and impact of their procedural documents on a regular basis. Procedural Document Title: SOP 20: Medicines CAS alerts including reporting of Drug Defect Reporting Does this procedural document offer support or evidence for the Trusts registered activities and outcomes? Primarily Additional Additional Choose an item. Is this an NHSLA Document? Which Standard does this relate to? Which Criterion?? Choose an item. Choose an item. If other Monitoring requirements are necessary i.e. Health & Safety Act and you should include them here and record them in the External References section Specify where the requirement originates Additional Details i.e. Section number, Code of Practice Minimum Requirement / Standard / Indicator to be monitored & Section of document it appears Process for monitoring Responsible Individual / Group Frequency of Monitoring Responsible Group for review of results / action plan approval / implementation Comments Level 1 Process to manage CAS Alerts (including Drug Alerts) during working hours Level 2 Process to Manage Drug Alerts out of hours Level 2 Monitor compliance with the Process to Manage CAS Alerts (including Drug Alerts) during working hours Review Risk Manager/Risk Committee Yearly Risk Committee Review Risk Manager/Risk Committee Yearly Risk Committee Audit Risk Manager/Risk Committee Yearly Risk Committee

22 Level 2 Audit Risk Manager/Risk Committee Yearly Risk Committee Monitor Compliance with the process to manage Drug Alerts out of hours Level 3 Audit Risk Manager/Risk Committee Risk Committee Demonstrate with evidence of continuous improvement of the process for managing CAS Alerts (including Drug Alerts) NB: If you have selected audit you should complete the required audit registration form and standards document and submit these with your expected timescales for completing the audit to quality.admin@mhsc.nhs.uk as soon as possible and no later than 4 weeks prior to the audit commencing. The Group / Committee should also ensure the monitoring work is added to their yearly schedule of monitoring and action logs as appropriate.

23 Contents Page Section Title Page Number 1 Introduction Drug Defect noted by member of MMHSCT Staff Drug Defect noted by Central Defect Reporting System 7 2 During Work Hours 7 3 Outside Normal Working Hours North North Pharmacy on Call Service South Pharmacy on Call Service Community Service 8 4 Individual Responsibilities Mental Health Trust Chief Pharmacist Lloyds Pharmacy Services Mental Health Trust Executive Director Mental health Trust Senior Manager on Call Mental Health Trust Bleep-holder MMHSCT Medicines Management Committee MMHSCT Staff 9 Appendix 1 Depot Clinics 10

24 Standard Operating Procedure for Medicines CAS alerts including reporting of Drug Defect Reporting (SOP 20) 1. Introduction A central drug defect reporting system is managed by Stepping Hill Quality Control laboratories and the National Medicines Information Centre in Liverpool. The system alerts all primary and secondary care trusts to drug defects and recalls and operates 24 hours a day, 7 days a week. This is in addition to the national CAS alert system and is in place to ensure that drug alerts are managed outside of working hours. These alerts will continue to arrive via with the Trust s CAS officer also. Each Trust must ensure that using in house on call systems, any urgent recalls can be actioned at all times. The full system is available from the Chief Pharmacist on Drug defect noted by member of MMHSCT staff Staff should notify the pharmacies, Chief Pharmacist or, out of hours, the bleep holder should they be aware of a defect in a medicinal product e.g. intravenous fluid bags leaking. The drug defect reporting procedure is updated regularly by QCNW and the most up to date version is on the intranet. Prior to contacting QCNW please contact the on call pharmacist for South or North to discuss the need to report. 1.2 Drug defect notified by central defect reporting system Any fault recognised in a marketed drug such as labelling, stability, concentration or shelf life. Usually the system will recall a full batch of the product. This product may already however be in use by the general public and therefore needs to be recalled from individual units and patients. 2. During Working Hours (7am to 6pm weekdays) All urgent faxes are brought immediately to the attention of the Chief Pharmacist and the medicines management team. These faxes are received by Medicines Management Office on and the Lloyds Pharmacy on and are always marked urgent. They are then distributed by fax to the R&D office, the Prison pharmacy and the pharmacy team at North and South. The pharmacy team will ensure that the acitons required are completed within the timeframes required. If a fax is received by anyone other than the pharmacy team all attempts should be made to contact the Chief Pharmacist either in Park House on or by mobile on or one of the pharmacists are available on: Karen Bennett (North) David O Reilly (South) Emma Street (Lead Nurse) Pharmacy Technicians

25 3. Outside Normal Working Hours 3.1 North The alert will still arrive via with the CAS officer however in addition QCNW will activate the out of hours cascade system due to the lack of cover out of hours for the CAS system. QCNW will contact the bleep holder at North who has a separate procedure within the bleep holder pack on how to deal with CAS medicines alerts. Most are self explanatory with a specified response time and therefore the bleep holders only need to manage any alerts that need actioning before pharmacy next opens. In practice this would be predominantly 48 hour or immediate recalls. Each area will act CAS alert and feedback to the Bleep Holder at North on the actions taken. 3.2 North Pharmacy on Call Service The on call mental health pharmacist can be contacted by the North bleep holder via switchboard for added advice. 3.3 South Pharmacy on Call Service The Trust will still receive a pharmacy on call for South via Wythenshawe pharmacy. The on call pharmacist will alert the bleep holder of an MHRA drug alert and help with any actions needed. 3.4 Community Service Using current systems it is very difficult to action an urgent recall within the community. Primary care trusts will fax alerts to community pharmacists and GP practices however this will generally only account for alerts occurring during normal working hours. MMSHCT will attempt to reach all community mental health teams should an alert of particular relevance to the teams be initiated. This will usually only be possible during normal working hours. Should a very urgent alert be cascaded out of hours the on call pharmacists would be able to contact the mental health chief pharmacist or other members of the team. 4. Individual Responsibilities 4.1 Mental Health Trust Chief Pharmacist To ensure that all urgent drug alerts during normal working hours are implemented as appropriate To ensure systems are in place should the Chief Pharmacist not be available To ensure systems are in place out of hours 4.2 Lloyds Pharmacy Services To action recalls occurring during normal working hours with the aid of the site mental health pharmacist and mental health trust chief pharmacist To action Saturday recalls including mental health in-patient units To supply any specific information required to the mental health service such as drug implicated and the likely urgency of the recall, names of patients prescribed the

26 treatment, patients consultants and any other relevant details such as home addresses or GP details. 4.3 Mental Health Trust Executive Director To provide support to the senior manager on call if a situation should arise that the on call pharmacist / bleep holder and senior manager were unable to manage 4.4 Mental Health Trust Senior Manager on Call To liaise with bleep holder if contacted To ensure recall is actioned satisfactorily by bleep holder as per this procedure. 4.5 Mental Health Trust Bleep-holders: To action the alert as per instruction To contact the on call pharmacist for advice if needed at North To liase with the on call pharmacist at South if contacted by them and agree appropriate actions To take advice from the senior manager if needed To feedback the actions to the chief pharmacist 4.6 MMHSCT Medicines Management Committee To monitor and audit the ability of the recall system to cascade and action any alerts relevant or specific to the mental health service. 4.7 MMHSCT Staff To be aware of the policy and act within it should they be made aware of a drug defect. To report any suspected defects through this system

27 AM Monday Tuesday Wednesday Thursday Friday Central North South Central North South Central North South Central North South Central North South Clozapine Clinic 9am to 4pm Park House (Maria Hayward) Clozapine Clinic 9am to 1pm Laureate House (Jackie Brammer / Paula King) Clozapine Clinic 9am to 3pm Rawnsley Building / (Jackie Brammer) Physical Health Clinic 12pm to 1pm Pink Suite, Longsight Health Centre (Paul Duckworth, Central Central CMHT) ECT Clinic 9am to 1pm Park House (Maria Hayward) ECT Clinic 9am to 1pm Laureate House (Jackie Brammer / Paula King) Clozapine Clinic 9am to 3pm Rawnsley Building (Jackie Brammer) Depot Clinic 9am to 4pm Park House (Maria Hayward/ Audrey McCarroll) Depot Clinic (Alternate Weeks) 9am to 12pm Ancoats Primary Care Centre (Chris Peters CMHT North East) Clozapine Clinic 9am to 1pm Laureate House (Jackie Brammer / Paula King) Depot Clinic 9am to 4pm Park House (Maria Hayward/ Audrey McCarroll) Depot Clinic 9am to 12pm Newton Heath Health Centre (Dave Nugent CMHT North East) Depot Clinic 9am to 12pm Laureate House (Jackie Brammer / Paula King) ECT Clinic 9am to 1pm Park House (Maria Hayward) Depot Clinic 9am to 12pm Openshaw Health Centre (Chris Peters CMHT North East) ECT Clinic 9am to 1pm Laureate House (Jackie Brammer / Paula King) PM Clozapine Clinic 9am to 4pm Park House (Maria Hayward) Clozapine Clinic 9am to 3pm Rawnsley Building (Jackie Brammer) Depot Clinic 1pm to 3pm Pink Suite, Longsight Health Centre / (Jonathan Dodd/ Anna Womack Central Central CMHT) Clozapine Clinic 9am to 3pm Rawnsley Building (Jackie Brammer) Depot Clinic 9am to 4pm Park House (Maria Hayward/ Audrey McCarroll) Depot Clinic 1.30m to 3.30pm Harpurhey Health Centre (Sheila Cadman/ Maureen Thomas CMHT North West) Depot Clinic 1pm to 3pm Levenshulme Health Centre (Katie Godbehere Central East Team) Depot Clinic 9am to 4pm Park House (Maria Hayward/ Audrey McCarroll) Depot Clinic 1pm to 2pm Withington Community Hospital / (Jackie Brammer)

28 Appx D Standard Operating Procedure (SOP) for the Management of Stages 1, 2 and 3 Patient Safety Alerts issued by the National Patient Safety Alerting System (NPSAS) Version Number: V1 Name of originator/author: Risk Manager Name of responsible committee: Risk Committee Name of executive lead: Chief Executive Officer Date V1 issued: New Document Last Reviewed: April 2014 Next Review date: July 2017 Scope: Trust wide MMHSCT Policy Code CL04b Page 28

29 Document Control Sheet Document Title / Ref: Standard Operating Procedure (SOP) for the Management of Stages 1, 2 and 3 Patient Safety Alerts issued by the National Patient Safety Alerting System (NPSAS) Lead Executive Chief Executive Officer Director Author and Contact Number Risk Manager Type of Document Standard Operating Broad Category Broad Procedure Document Purpose The Trust is committed to having standards in place for managing patient safety risks. This SOP outlines the risk reduction strategies the Trust has in place to implement the NPSAS three-stage system, for dissemination of patient safety information at different stages of development to staff providing care across all Care Groups and services provided by the Trust. Scope Trust Wide Version number V1 Consultation Emergency Planning/Medicines Management/Quality Board Approving Committee Risk Committee Approval Date Ratification Trust Board Date of Ratification and Date V1 Valid from Date April 2014 Current version is valid from approval date Date of Last Review New document Date of Next Review April 2017 Procedural Documents to be read in conjunction with this document: This document needs to be reads in conjunction with the Medical Devices Policy Policy for the Management of Alert Notices generated via Training Needs Analysis Impact There are Training requirements for this procedural document. The training is required for the implementation of the SOP Out of Hours which will be for Bleep holders and Night Managers the DH Central Alert System (CAS) Burt SOP20? Financial There are no Financial resource impacts Resource Impact Document Change History Changes to this document in different versions must be detailed below. Rationale for the change should also be given Version Number / Name of procedural document this supersedes New Document Type of Change i.e. Review / Legislation / Claim / Complaint Date Legislation April 2014 Details of Change and approving group or Executive Lead (if done outside of the formal revision process) External references used in the creation of this document: If these include monitoring duties upon the Trust for this policy the specific details should be recorded on the Monitoring and Compliance Requirements sheet

30 Privacy Impact N/a Any issues? Choose an item. Assessment submitted Fraud Proofing N/a Any issues? Choose an item. submitted If not relevant to this procedural document give rationale: Policy authors are asked to consider each of the nine protected characteristics under the Equality Act We expect you to demonstrate that throughout the policy process you have had regard to the aims of the Equality Duty: 4. Eliminate unlawful discrimination, harassment and victimisation and any other conduct prohibited by the Act; 5. Advance equality of opportunity between people who share a protected characteristic and people who do not share it; and 6. Foster good relations between people who share a protected characteristic and people who do not share it. Please provide a brief account of how you have done this, further work to be completed and any support you have had in considering the aims and working in compliance with the Equality Duty. If you are unclear on how to do this or would like further advice and support then you may contact quality.admin@mhsc.nhs.uk. It is the responsibility of the approving group to ensure this statement reflects the Trusts objectives and position with compliance as set out within the NHS Equality Delivery System This SOP is broad and the scope is Trustwide so complies with the Trust s Equality Delivery System In line with the Trust values we may publish this document on our External Website. Is there any reason you would prefer this is not done? It is the Authors responsibility to ensure all procedural documents comply with the Trust values If you are unclear on any of the requirements in the document control sheet then please quality.admin@mhsc.nhs.uk before proceeding