ࡱ> O Mbjbj99 SWiSWi<Ph h 8L8F* $kmnhsuuuuuu$,vo,j|j|oo* Juuuo:j8* suosuuh* @)oG*_ġ0q"XqXTXoouooooos,oooooooXoooooooooh X :  INCIDENT REPORTING POLICY Document title: Reporting incidents To be read as an attachment to:Trust procedures: HYPERLINK "https://viewer.microguide.global/guide/1000000295/content/clinical-patient-safety-incident-response-policy-ALH3n9"Patient Safety Incident Response Framework (PSIRF) Policy HYPERLINK "https://viewer.microguide.global/guide/1000000295/content/clinical-datix-incident-reporting-policy-formerly-adverse-events-reporting-policy"DATIX Incident Reporting PolicyName of Trust policy/policiesPost Holder Responsible:Quality Manager, SFCDirectorate Responsible:Women and Newborn Contact Details:Quality Manager ɫ Fertility Centre ɫ District HospitalDocument identifier and versionPP038/2006v8Issue date:November 2006Authorised By:ɫ Fertility Centre Team Person Responsible Manager: Women and NewbornDate Policy Becomes Live:April 2007Legislation date and reference if applicableVersion InformationVersion No.Updated ByUpdated OnDescription of Changes1Quality ManagerDecember 2006Ensuring that the Centre complies with both Trust and HFEA policy for incident reportingMinor revisionsDateNotes on revision1April 08Register number changed from PR008, no revisions2April 09No change3April 10No change4April 20125Sept 2013Review again against HFEA code of Practice and Trust standards6March 2014 No change7Feb 2022No major changes. 8July 2024Addition of Patient Safety Summit details9October 2024Addition of PSIRF, redaction of staff member names in policy10Reissue document with new version number THIS IS A CONTROLLED DOCUMENT ISSUED BY THE QUALITY SYSTEM OF SALISBURY FERTILITY CENTRE WITHIN SALISBURY NHS FOUNDATION TRUST. 1. POLICY STATEMENT This policy details requirements for reporting adverse events and incidents, in line with Trust Policy and HFEA direction. 2. INTRODUCTION Trust policy (summary): NHS TRUST incident reporting is done via DATIXweb on the intranet. This is found by clicking the Datix button on the dashboard. ANYONE can report an incident. Trained staff can complete a new incident and this will be added to the SFC Incidents List. Lead Fertility Nurse and Quality Manager have completed DATIXweb Incident Management / Investigation (DIF2) training. Advice can be obtained from these staff members. Those that are named as; investigating manager (handler), manager of area, investigatoror 'who else needs to be informed' willreceive notification by e mail. These 'named' people will then be responsible to oversee / investigatethe incident. HFEA requirements for Serious/Major/Category A Incident/Reaction: Major adverse incidents occurring at ɫ Fertility Centre are reported to the HFEA by telephone within 12 working hours of the identification of the incident and an HYPERLINK "../../HFEA%20incidents%20and%20reports/BLANK%20Template%20HFEA%20Incident%20Reporting%20form.docx"Incident Report Form is submitted within 24 working hours. The Person Responsible is responsible for notifying the HFEA of any serious adverse incident or serious adverse reaction and providing a report analysing the cause and the ensuing outcome. The subsequent investigation, analysis and review of relevant procedures should minimise the risk of any reoccurrence of the incident. The HFEA is informed of the revised procedures. HFEA requirements for Minor Incident/ Reaction B &C and Near Misses Minor incidents or near misses occurring at ɫ Fertility Centre are reported to the HFEA by an Incident Report Form submitted within 24 working hours. Any member of staff can complete and submit an Incident Report Form to the HFEA See also: HFEA Incidents and Report folder in quality system:  HYPERLINK "\\\\Sdh-public\\public\\Ambulatory-Care-Directorate\\O&G\\SFC Quality\\HFEA incidents and reports" \\Sdh-public\public\Ambulatory-Care-Directorate\O&G\SFC Quality\HFEA incidents and reports 3. SCOPE This policy applies to all staff within the Fertility Centre. Incidents can and should be encouraged to be reported by any member of staff. 4. PURPOSE To ensure that SFC meets its requirements for reporting adverse events and incidents, in line with Trust policy and as set out in the HFEA 9th Code of Practice. DEFINITIONS An adverse incident is defined as: Any event, circumstance, activity or action which has caused, or has been identified as potentially causing harm, loss or damage to patients, their embryos and/or gametes, or to staff at a licensed centre. This includes serious adverse events, serious adverse reactions, breaches of confidentiality, anomalies or deficiencies in the obtaining or recording of consent, and ovarian hyperstimulation syndrome (OHSS) which has a severity grading of severe or critical. This includes any failure to protect the quality and safety of gametes or embryos during donation, procurement, testing, processing, preservation, storage and distribution processes. All breaches of the HFE Act and/or breaches of the HFEA Code of Practice. The HFEA will also investigate patient complaints that relate to adverse incidents. A serious adverse event is defined as: any untoward occurrence which may be associated with the procurement, testing, processing, storage or distribution of gametes or embryos intended for human application and which, in relation to a donor of gametes or a person who receives treatment services or non-medical fertility services might lead to the transmission of a communicable disease, to death, or life-threatening, disabling or incapacitating conditions, or might result in, or prolong, hospitalisation or illness, or any type of gametes or embryo misidentification or mix-up. A serious adverse reaction is defined as: an unintended response, including a communicable disease, in a donor of gametes intended for human application or a person who receives treatment services or non-medical fertility services, which may be associated with the procurement or human application of gametes or embryos and which is fatal, life threatening, disabling, incapacitating or which results in, or prolongs, hospitalisation or illness. A near miss is an occurrence that, but for luck, skill or judgment, would in all probability have become an adverse incident. 6. RESPONSIBILITY All members of staff within ɫ Fertility Centre have a responsibility to read and enact this policy. 7. PROCEDURE Flow Chart for Reporting  Procedures for the identification, investigation, control and recording of serious adverse events and reactions: a) There are defined responsibilities and authorities for personnel responsible for the management of incidents within individual job descriptions at the Fertility Centre and within the Trust b) All Fertility Centre staff receive induction into Incident Reporting on joining the staff; c) All Trust staff have access to additional training and support in all aspects of Risk Management and Incident reporting; d) Identification and investigation of incidents includes reactive root cause analysis of actual incidents and proactive identification through risk assessment and internal audit, which is undertaken following Trust policy and procedures; e) Recording of incidents includes analysis of cause, corrective action taken and ensuing outcome; f) The option to cease assisted conception processes may need to be a consideration as required, g) If a donor might have contributed to the incident, then this is identified and appropriate action taken. h) If an incident calls for the control and verifiable recall of any gametes or embryos procured or applied this will be put into motion within 24 working hours or as soon as is reasonably practical; i) If any consignee and recipients of gametes from the same donor may have been put at risk, they are identified and notified with due consideration of the needs of the individuals concerned. j) Investigation may require the control and verifiable recall of any material, and the investigation of any equipment used in association with the incident; k) Investigation includes evaluation of all assisted conception processes directly related to the incident and all processes involving the management of resources, training and competence of personnel, equipment, materials, information systems and control of environment l) All records pertaining to the adverse incident, including those of gametes and embryos procured or materials applied, are retained; m) Relevant information is reported to parties including: all personnel within the Centre involved in assisted conception processes other centres engaged in the donation, procurement, testing, processing, storage and distribution of gametes or embryos, to facilitate traceability and ensure quality and safety control notification of the HFEA, by the Person Responsible, of the adverse incidents and the subsequent provision of a confirmation/conclusion report. The Trust reporting as detailed in Trust policies and procedures The Medical Devices Agency (if medical devices are at issue) Reporting Adverse Incidents (Events/Reactions) to the HFEA HFEA Directions require centres to report all adverse incidents and near misses to the HFEA. This includes adverse incidents occurring at third party premises, where there is a third party agreement in force between the centre and that third party. The HFEA will grade submitted incidents as A (the most serious), B, C or as a near miss using the incident grading matrix, which assesses the severity of incidents and the likelihood of their recurrence (see Appendix A). Major adverse incidents (grade A) occurring at ɫ Fertility Centre are reported to the HFEA within 12 working hours of the identification of the incident. All adverse incidents (grades A, B, and C) and near misses are submitted via an Incident Report Form within 24 working hours to incident.reporting@hfea.gov.uk. The initial notification of a major (Grade A) adverse event/reaction to the HFEA includes at a minimum: a) centres name b) HFEA centre identification number c) contact details of the person responsible d) date of the initial notification or report e) name of any individual affected f) date and time of the serious adverse event or reaction g) details of gametes or embryos involved in the incident, and h) type of incident, including any transmission of infectious agents. To be followed by a confirmation report including, items a) c) above and: a) date of confirmation report b) confirmation of the type of reaction(s) OR a change in type of reaction (s) c) clinical outcome, if known, and classified: complete recovery minor sequelae serious sequelae death d) Investigation report with details of causes, corrective actions taken, and final conclusions. Patients/donors must be informed of any adverse incidents that may have resulted in harm to them, their gametes or their embryos (HFEA 27.11). Adverse events arising from equipment or materials The documented procedure for the management of equipment and materials includes requirements for adverse incident reporting. For these events, the competent authority is the Medicines and Healthcare products Regulatory Agency (MHRA). An adverse incident in this context is defined as incidents which produce, or have the potential to produce, unwanted effects involving the safety of patients, users and others. For example: someones injured (or almost injured) by a medical device, either because its labelling or instructions arent clear, its broken or has been misused a patients treatment is interrupted because of a faulty device someone receives the wrong diagnosis because of a medical device This reporting is distinct but complimentary to that required by the HFEA, and can be reported on the gov.uk website - https://www.gov.uk/report-problem-medicine-medical-device. The MHRA does not require patient names or other identifying information in order to carry out an investigation. Investigating Adverse Incidents If an adverse incident or near miss occurs, centres are expected to: a) review relevant procedures to minimise the risk of the incident happening again, and b) Inform the HFEA of the revised procedures. Serious adverse events and reactions should be thoroughly investigated. When investigating serious adverse events and reactions, the centre should evaluate all assisted-conception processes directly related to the adverse event or reaction, and all relevant processes involving the: a) management of resources b) training and competence of staff c) equipment d) materials e) information systems, and f) control of environment. A copy of the investigation report should be submitted to the HFEA. Reporting a moderate and/or above event to the Trust Once a Datix has been submitted, it will be investigated by the Investigating Manager and then reviewed by a member of the DMT before closure. If the incident affects patients and has been graded with a moderate or above outcome, the incident will go through the Trust Patient Safety Incident Response Framework (PSIRF) which is a compassionate system approach in how patient safety incidents are investigated, and must be presented at the Patient Safety Summit by the Quality Manager. This is done by completing the HYPERLINK "../../Emma Elliott/quality docs/Non-Conformance Work & Improvements/PSR Reporting Template. Final. 30 Apr 24.docx"PSR Reporting Template and emailing to HYPERLINK "mailto:sft.weekly_pss@nhs.net"sft.weekly_pss@nhs.net where a member of the Trust Clinical Executive team will be present. This ensures transparency and Trust monitoring of moderate and above incidents, as well as being a useful platform to gain support concerning the handling and investigation of incidents. 8. MONITORING COMPLIANCE AND EFFECTIVENESS OF POLICY Review of Adverse events An ongoing non-conformance work spreadsheet is maintained by the Quality Manager on the shared drive and can be located at SFC Quality > Quality06> quality docs > Non conformance work and improvements > Non conforming work ongoing. This spreadsheet holds a list of all incidents within the department, as well as non conformances arising from audits, and quality improvements as a result of near misses. Within the spreadsheet, trending analysis of incidents can take place, with catagorisation of incident type and length of time the incident remained open. Root causes and CAPA details are also recorded here. At the Annual Quality Review, there is a review of the identification, investigation, control, recording and notification of serious adverse events and reactions, and the results of continual improvement activities including current status of corrective and preventive actions. 9. REFERENCES HYPERLINK "https://viewer.microguide.global/guide/1000000295/content/clinical-patient-safety-incident-response-policy-ALH3n9"Patient Safety Incident Response Framework (PSIRF) Policy HYPERLINK "https://viewer.microguide.global/guide/1000000295/content/clinical-datix-incident-reporting-policy-formerly-adverse-events-reporting-policy"DATIX Incident Reporting Policy HFEA Code of Practice 9th Edition Guidance note 27: Adverse incidents 10. APPENDIX Appendix A HFEA Risk Matrix: for use in incident and near-miss grading (CREF-11)          Author: SFC  FILENAME\p \* MERGEFORMAT  FILENAME \p \\Sdh-public\public\Ambulatory-Care-Directorate\O&G\SFC Quality\quality06\policies procedures\Incident Reporting Policy.doc Issue date: December 2006 Reviewed: October 2024 Next Review date: October 2026 Document identifier: PP038/2006v9 Authorised by Quality Manager: October 2024 Page  PAGE \* MERGEFORMAT 1 /  NUMPAGES \* Arabic \* MERGEFORMAT 12 Any adverse incident (major and minor) or near miss occurs Major/Serious Adverse Incident Minor Adverse Incident or Near Miss Report to HFEA within 12 working hours Submit an HYPERLINK "../../HFEA%20incidents%20and%20reports/BLANK%20Template%20HFEA%20Incident%20Reporting%20form.docx"Incident Report Form to the HFEA at  HYPERLINK "mailto:incident.reporting@hfea.gov.uk" incident.reporting@hfea.gov.uk within 24 working hours. The initial notification of an adverse incident to the HFEA includes at a minimum: centres name HFEA centre identification number contact details of the person responsible date of the initial notification or report name of any individual affected date and time of the serious adverse event or reaction details of gametes or embryos involved in the incident, and type of incident, including any transmission of infectious agents. Submit a DATIX incident report to the Trust (can be done by ANY member of staff) Incidents affecting patients graded moderate or above to follow PSIRF, see below Adverse incident/near miss related to a Medical Device? If yes, a report must also be sent to the MHRA through the gov.uk website -  HYPERLINK "https://www.gov.uk/report-problem-medicine-medical-device" https://www.gov.uk/report-problem-medicine-medical-device. HFEA Incident Report to be followed up by a confirmation/conclusion report (if not already covered in initial incident report): date of confirmation report confirmation of the type of reaction(s) OR a change in type of reaction(s) clinical outcome, if known, and classified: complete recovery minor sequelae serious sequelae death Investigation report with details of causes, corrective actions taken, and final conclusions. 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