Procedure For Processing Hazard Notices, Safety Action Notices, NHS QIS Patient Safety Alerts, Medical Devices Directives And Miscellaneous Alerts

Transcription

1 Procedure For Processing Hazard Notices, Safety Action Notices, NHS QIS Patient Safety Alerts, Medical Devices Directives And Miscellaneous Alerts Date Issued: April 2007 Review Date: April 2008 Responsible Officer: Head of Risk Management

2 Contents 1. Introduction Procedure Responsibilities...3 Appendix One - Procedure Flow Chart...5 Appendix Two - Risk Management Distribution Lists...6 Appendix Three - Suggested Flowchart for the Implementation and Documentation of Notices and Alerts Within Each Unit...7 Date Issued: April 2007 Review Date: April

3 1. Introduction NHS Forth Valley - Procedure for Processing Hazard Notices, Safety Action In order to discharge its governance responsibilities, NHS Forth Valley must ensure that appropriate action is taken (if deemed necessary), as specified in accordance with these Notices and Alerts. This reflects the responsibilities set out in the Risk Management Strategy and Health and Safety Policy, and is a mandatory requirement to meet our duty of care to staff, patients and visitors to our organisation. 2. Procedure Scottish Healthcare Supplies issue Hazard Notices and Safety Action Notices, as alerted by the Medical Device Agency, NHS Quality Improvement Scotland issue Patient Safety Alerts as notified by National Patient Safety Agency and Medical Suppliers issue medical device recalls, e.g. other safety bulletins. These Notices and Alerts are issued to a named contact within the Risk Management Department. The Risk Management Department will arrange for all Notices and Alerts to be circulated within NHS Forth Valley. The procedure to be followed by all identified individuals is contained within Appendix One. Hazard Notices will be issued for information, immediate action or for action within 14 days. Safety Action Notices will be issued for information or for action recommended with associated time scales as directed by the Risk Management Department. Medical Device Alerts will be issued for information or for action recommended with associated time scales as directed by the Risk Management Department. Patient Safety Alerts will be issued for information or for action recommended with associated time scales as directed by the Risk Management Department. 3. Responsibilities 3.1 Risk Management Department will: - Receive all Hazard Notices, Safety Action Notices, Medical Device Alerts and Patient Safety Alerts; Interpret the Notices and Alerts for detail, required action and timescale; If deemed necessary, provide additional guidance in consultation with appropriate Specialist Advisers; Where an NHS Forth Valley wide response is required, the Risk Management Department will coordinate the response with support from the units/departments as appropriate; Arrange the distribution list based on the guidance from Scottish Healthcare Supplies, Medicines and Healthcare products Regulatory Agency (MHRA) and NHS QIS and as determined through consultation (Appendix Two); Date Issued: April 2007 Review Date: April

4 Maintain a record of who the Notices and Alerts have been sent to for either information or actioning. The record will include a copy of the declaration form, to be signed and returned from the appropriate General Manager or named Senior Manager; Outstanding notices and alerts will be highlighted quarterly; Monitor the procedure through annual audit; Provide quarterly reports through the Governance Framework; Include an overview report within their annual report. The Risk Management Department will also be responsible for coordinating the reporting of all adverse incidents involving medical, laboratory and estates equipment, to Scottish Healthcare Supplies. An adverse incident is an event that causes, or has potential to cause, unexpected or unwanted effects involving the safety of patients, users or other persons. 3.2 General Managers and Named Senior Managers will: - Receive Hazard Notices, Safety Action Notices, Medical Device Alerts and Patient Safety Alerts for information or actioning as deemed appropriate; Will agree and establish a system for cascading Notices and Alerts to appropriate nominated named Managers for information or actioning (suggested flowchart Appendix Three); Ensure an investigation is carried out to determine if any of their areas of responsibility are affected; Identify the actions required (if any) in response to the Notice and/or Alert. If unable to action at a local level then ensure that a risk assessment with associated action plan is completed and placed onto the local risk register; Notify the appropriate General Manager/Executive Director if there is a significant risk to services and resources; Return a signed copy of the declaration form to the Risk Management Department detailing what actions undertaken and retain a copy for audit purposes; Where the required actions will exceed the timescale identified for returning the information to the Risk Management Department, agree a programme with the appropriate General Manager/Executive Director and advise the Risk Management Department of the revised deadline; Maintain a register containing details of the returns received (for audit purposes); Through their local Clinical Governance Framework, they will review the actions taken on the Notices and Alerts issued. Date Issued: April 2007 Review Date: April

5 Appendix One - Procedure Flow Chart Procedure for Processing Hazard Notices, Safety Action Notices, Medical Device Alerts and NHS QIS Patient Safety Alerts Risk Management Department Receive Notices and Alerts and determine circulation and if additional guidance is required Hazard Notice Safety Action Notice Medical Device Alert Patient Safety Alert Miscellaneous Alerts Circulate to General Managers and Named Senior Managers for actioning or information Actioning Only Within designated timeframe (where applicable) General Manager and named Senior Manager to circulate notice to all relevant individuals within their area of responsibility Actions at local level, (nominated named Manager) to complete tear off slip declaration form detailing action (s) taken and return to General Manager or named Senior Manager Information Only General Manager and named Senior Manager to complete and sign declaration form detailing who Notice/Alert distributed to and return a copy to the Risk Management Department, retaining copy for own audit purposes General Manager and named Senior Manager to return copy of the completed signed declaration form detailing all actions undertaken, to the Risk Management Department, retaining copy for own audit purposes If unable to action at local level, complete a Risk Assessment Form with associated Action Plan and return to General Manager or named Senior Manager The General Manager or named Senior Manager will ensure the Risk Assessment and associated Action Plan are entered onto the appropriate Risk Register Only Hazard Notices and Safety Action Notices that are specific for Estates will be actioned by Estates although all notices will be circulated to Estates for information only. Date Issued: April 2007 Review Date: April

6 Appendix Two - Risk Management Distribution Lists Responsible Officer Designation Location For Info Fiona MacKenzie Chief Executive Carseview Margaret Duffy Chief Operating Officer FDRI Gareth Davies Medical Director Carseview Angela Wallace Director of Nursing FDRI Helen Kelly Director of Human Resources Carseview Fiona Ramsay Director of Finance Carseview Jonathan Procter Director of Access and Associate Finance Director FDRI Beverly Finch Head of Corporate Services Carseview Elaine McRae Head of Performance Management Carseview Monica Inglis Head of Clinical Governance FDRI Neil McCormick Head of Strategic Projects and Property FDRI Kate Lancaster Head of Communications Carseview Scott Jaffrey Head of ICT SRI Deirdre Coyle Head of Information Governance FDRI Jack Watson Head of Medical Physics FDRI Kathy O Neill General Manager - Clacks CHP Bungalow 5 Larbert Sue Dow General Manager - Falkirk CHP FDRI Eddie McDonald General Manager Stirling CHP Gladstone Place David McPherson General Manager - Forth Valley Facilities FDRI Jim Sinclair General Manager - Clinical Facilities/Surgery FDRI Ian Aitken General Manager - Med & Rehab/Emerg. Care FDRI Gillian Morton General Manager - W&C/Clinical Services SRI Tom Redfern General Manager - Projects FDRI Maureen Goggins General Manager - Projects FDRI Linda Donaldson General Manager - Pay Modernisation FDRI Neil Houston Clinical Lead - Clacks CHP Euro House James King Clinical Lead - Clacks CHP Tillicoultry H/C Leslie Cruickshank Clinical Lead - Falkirk CHP FDRI Stuart Cumming Clinical Lead - Stirling CHP Gladstone Place Jan Jamieson Service Manager - Mental Health Bungalow 5 Larbert James Cassidy Service Manager - Learning Disabilities & Older FDRI People Services Dorothy Bell Service Manager Occupational Health FDRI Lorraine Scott Service Manager - Surgery/Clinical Facilities FDRI/SRI Lorna Henry Service Manager - Medicine SRI Sue Phillips Service Manager - ICR FDRI Karen MacLure Service Manager - Emergency Care SRI Mary Millar Service Manager - Women and Children SRI Andrene Dickins Service Manager - Clinical Services FDRI Janett Sneddon Clinical Co-ordinator - Women and Children SRI Effie Rodger Lead Nurse - Falkirk CHP FDRI Steve Oakley Supplies Manager Colquhoun Street Conrad Binnie Estates Manager - PC Colquhoun Street Dan Doherty Estates Manager - Acute FDRI David Paterson Medical Equipment Manager - PC Bungalow 5 Larbert Marjory MacKay Matron Strathcarron Hospice Brian Telfer Manager J.L.E.S Unit 9 Westmains Industrial Grangemouth Estate Paul Hopson RCN Representative FDRI Marlene Ferguson Amicus Representative SRI Please ensure distribution and actioning (if applicable) by the relevant individuals within your area of responsibility e.g. Consultants, Medical, Nursing Staff, Pharmacists etc. For Action The Risk Management Department will share all Hazards and Alerts with its Department members and will provide specialist advice and input as indicated from: Health and Safety Manager/Advisers Infection Control Adviser/Nurses Management of Violence and Aggression Co-ordinator Manual Handling Advisers Fire and Security Advisers Clinical and non-clinical Risk Advisers Date Issued: April 2007 Review Date: April

7 Appendix Three - Suggested Flowchart for the Implementation and Documentation of Notices and Alerts Within Each Unit Procedure to be followed in each Unit to process Safety Action Notices, Hazard Notices and NPSA alerts. Electronic notice received from Risk Team to identify Unit Lead for action Notice distributed by admin support to Heads of Department within Unit as identified by Unit Lead for action or information as required by specified date Electronic log of distribution maintained in Unit office for audit purposes Head of Department or designated person prints out notice and addresses actions required within requested time limit Hazard Notices to be printed in Yellow and Safety Action Notices in Green If there is to be a delay in reply or difficulties arise in obtaining required information Development Nurse to be contacted Head of Department or designated person returns copy of achieved/completed actions to Unit office by to Unit secretary When all actions are received and appropriately recorded, answers are collated by Unit Lead and returned to the Risk Management Team by office staff A paper copy of all replies returned to Unit office whether by or fax is filed to allow for audit purposes at Unit level Date Issued: April 2007 Review Date: April