Incident reporting policy National Chlamydia Screening Programme

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1 Incident reporting policy National Chlamydia Screening Programme Date of publication: November 2014 Date for review: November 2016

2 About Public Health England Public Health England exists to protect and improve the nation's health and wellbeing, and reduce health inequalities. It does this through advocacy, partnerships, world-class science, knowledge and intelligence, and the delivery of specialist public health services. PHE is an operationally autonomous executive agency of the Department of Health. Public Health England Waterloo Road Wellington House London SE1 8UG Tel: Facebook: Prepared by: Erna Buitendam For queries relating to this document, contact: Crown copyright 2014 You may re-use this information (excluding logos) free of charge in any format or medium, under the terms of the Open Government Licence v2.0. To view this licence, visit OGL or Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned. Published October 2014 PHE gateway number:

3 Contents About Public Health England 2 Contents 3 Introduction 4 Scope 5 Current incident reporting processes 5 Definitions and examples 7 NCSP incident reporting procedure 9 Responsibilities 11 Appendix 1. CQC table of notifications 12 Appendix 2. NCSP flow chart for reporting of incidents 13 3

4 Introduction 1.1 Chlamydia is the most common bacterial sexually transmitted infection (STI) in the UK, and affects men and women alike. The National Chlamydia Screening Programme (NCSP) aims to control chlamydia through opportunistic screening and treatment of sexually active people under 25 years old. 1.2 This document describes the NCSP s policy for responding to incidents that may occur across the country during delivery of the programme, and replaces the policy that was published in The screening programme is delivered locally in a variety of settings. Services are commissioned by local authorities, which are responsible for commissioning comprehensive sexual health services. It is important that the roles and responsibilities in the management of serious incidents are clear. The aim of this policy is to clarify the role of commissioners, providers and the NCSP within this process. 1.4 The management of serious incidents within the NCSP can be complex. This is because the patient pathway can include a number of organisations, including non NHS organisations. Local serious incidents could threaten the national reputation and therefore public participation in the programme. This policy clarifies reporting requirements, roles and responsibilities. 1.5 Providers are responsible for their own governance, and for investigating and resolving incidents in order to provide assurance of governance and safety, to prevent recurrence, improve services and share learning. Commissioners should ensure that effective clinical governance procedures are in place and monitor providers compliance with the contract specifications around incident reporting. This is particularly important in screening programmes, since more than one organisation may be involved and the commissioner may need to ensure that the wider implications of a serious incident in a screening programme are taken into account by the provider(s). 1.6 It is important for the national office of the NCSP to be informed about all serious incidents related to the programme, to enable collation of data at national level, to share learning, and to manage any national issues arising from the incidents. 1.7 The NCSP is committed to sharing lessons learnt in order to reduce as far as possible the number of serious incidents that may occur in the course of screening for chlamydia. 4

5 Scope 1.8 This policy covers all chlamydia screening providers in England. It will not duplicate local and national policies, but provides additional information regarding the process for involving and informing the NCSP about serious incidents. Commissioners and providers are requested to reference this document in their policies and contracts. 1.9 The NCSP national office is part of Public Health England (PHE). As such PHE s own adverse incident management procedure will be followed for incidents occurring within the team. Current incident reporting processes Care Quality Commission 1.10 All providers of health and social care services need to be registered under the Health and Social Care Act (HSCA) with the Care Quality Commission (CQC). This includes all NHS trusts, independent healthcare providers, adult social care, primary dental care and independent ambulance providers. From 1 April 2010 it became mandatory for NHS trusts in England to report all serious patient safety incidents to the CQC as part of its registration process. From April 2013 this requirement also applied for GPs and other primary care services (including community interest companies (CIC)), when they were required to register with CQC In March 2010, CQC published its guidance Essential standards of quality and safety to help providers to comply with the section 20 regulations of the Health and Social Care Act 2008, and the CQC (Registration) Regulations Of this guidance, section 5 on quality and management and its related outcomes 16 to 21 apply when considering incident reporting To avoid duplication of reporting, the regulations allow NHS trusts to submit most notifications about serious and untoward Incidents affecting people who use their services to the National Reporting and Learning System (NRLS), run by the former National Patient Safety Association (NPSA, see below). However, some notifications must be submitted directly to CQC. The process differs slightly for NHS trusts. Appendix 1 contains the overview produced by the CQC. This link explains it in more detail: 5

6 National Reporting and Learning System 1.13 NRLS, established in 2003, enables patient safety incident reports to be submitted to a national database. Data is analysed to identify hazards, risks and opportunities to improve the safety of patient care. This information is used to develop tools and guidance to help improve patient safety at a local level. Most incidents were submitted to NRLS electronically from local risk management systems. Responsibility for NRLS has now transferred from NPSA to the Imperial College NHS Trust (under contract to the NHS England), and is expected to continue to run on a voluntary basis. Notifications submitted to NRLS through a local risk management system are forwarded on to CQC. NCSP 1.14 We strongly encourage providers and commissioners of chlamydia screening and treatment services to share any incidents in the programme with the national chlamydia screening team because we: can ensure that any risks identified or lessons learnt are shared with other programme areas in order to continue to improve performance and minimise risk across the country may need to update national guidance to include learning points identified through incidents reported to the programme may need to support accurate reporting on the NCSP or respond to queries from other external parties as a result of the incident 1.15 The following two Department of Health documents support the reporting of incidents in sexual health services: the non-mandatory pro forma Public Health Services Contract for integrated sexual health services contains a section that allows for commissioners to agree processes and procedures for reporting incidents (appendices C and G, the latter includes the requirement to report to the NCSP) 1 Sexual health: clinical governance, key principles to assist service commissioners and providers to operate clinical governance systems in sexual health services. Particularly paragraphs on incident management, and paragraphs 26 and More details on the required procedures for the NCSP are provided below. 1 Department of Health 2013/14 non mandatory pro forma Public Health Services Contract for integrated sexual health services. 2 Department of Health, Sexual health: clinical governance, key principles to assist service commissioners and providers to operate clinical governance systems in sexual health services, October

7 Definitions and examples Definitions 1.17 This policy adheres to the following definitions: 3 An incident is an event or circumstance that could have resulted, or did result, in unnecessary damage, loss or harm such as physical or mental injury to a patient, staff, visitors or members of the public. An incident investigation is a process to determine the underlying reason for an incident and to identify actions to minimise the likelihood of the event recurring. A root cause analysis investigation should be undertaken. A serious incident requiring investigation is defined as an incident that occurred in relation to NHS-funded services and care resulting in one of the following: unexpected or avoidable death of one or more patients, staff, visitors or members of the public serious harm to one or more patients, staff, visitors or members of the public or where the outcome requires life-saving intervention, major surgical/medical intervention, permanent harm or will shorten life expectancy or result in prolonged pain or psychological harm (this includes Incidents graded under the NPSA definition of severe harm) a scenario that prevents or threatens to prevent a provider organisation s ability to continue to deliver healthcare services, for example, actual or potential loss of personal/organisational information, damage to property, reputation or the environment, or IT failure allegations of abuse adverse media coverage or public concern about the organisation or the wider NHS one of the core set of never events as updated on an annual basis 1.18 Even though the definitions refer to NHS-funded services, they are equally applicable to clinical services commissioned by bodies with new responsibilities, including local authorities. 2 In addition, the NCSP classifies anything as a serious incident that might have a damaging effect on the reputation of the NCSP or PHE. Providers and commissioners are asked to report all such incidents to the NCSP as outlined below. 3 World Health Organisation The Conceptual Framework for the International Classification for Patient Safety. Version

8 Examples of serious incidents 1.19 The National Screening Committee s guidance (2010) clarifies the definition of an serious incident for screening programmes as: An actual or possible failure at any stage in the pathway of the screening service, which exposes the programme to unknown levels of risk that screening, assessment or treatment have been inadequate, and hence there are possible serious consequences for the clinical management of patients. The level of risk to an individual may be low, but because of the large numbers involved the corporate risk may be very high. Complex screening pathways often involve multidisciplinary teams working across several NHS organisations in both primary and secondary care, and inappropriate actions within one area, or communication failures between providers, can result in serious incidents Some examples of serious incidents within the NCSP might include: serious harm to a patient, member of staff, visitor or member of the public breach of confidentiality fabrication of results or data allegations of young people being coerced into providing a sample or of under 16 year olds being asked to take the test without Fraser competence being assessed loss of test samples or results failure to inform patients of their test results mix up of data, ie, informing patients of the wrong test result incorrect treatment of positives adverse national media coverage 8

9 NCSP incident reporting procedure Identifying and reporting incidents 1.21 When an incident (or near miss) occurs the individual who has identified it should follow the local/regional incident reporting policy, including reporting to commissioners. In addition to normal reporting requirements the organisations are encouraged to inform the NCSP national office. Send reports to as soon as key details of the incident become clear. The NCSP head of quality assurance and standards will log the serious incident on the NCSP s serious incident database Due to the varied nature of incidents reported to the NCSP, and to avoid duplication, the NCSP does not provide a specific report format for serious incidents. Providers and commissioners may wish to forward their local incident report documentation to the NCSP, or provide an summary of the details. In exceptional circumstances where the incident is deemed to be extremely serious (eg, patients have been harmed, a service is suspended, or the reputation of the programme is seriously compromised), and the local programme or services from one or more providers need to be suspended, we request that the NCSP director be informed within two working days. The NCSP will also inform the local PHE centre as appropriate If an NCSP sexual health facilitator (SHF) or any other member of the national office becomes aware of an event that should be classified as an incident they should speak immediately to the local provider and advise them to report the incident locally as per their organisation s incident reporting policy. (Similarly, if the national office receives a complaint, the patient will be referred to the commissioner or provider, in line with information governance policies.) Look backs 1.24 If the service cannot be confident that results are reliable, and disease may have been missed or wrongly diagnosed, a recall exercise may be necessary. This would only be considered if a systematic failure had led to performance well below published standards or norms and warranted a review of work. The commissioner should discuss any such move with the director of public health (DPH), local PHE centre and inform the NCSP national office before taking action The head of QA and standards will inform the NCSP director, clinical champion and communications manager and other senior staff if deemed necessary, and escalate through PHE s reporting system as appropriate. 9

10 Investigating and closure 1.26 Each organisation will have its own process for investigating incidents. The duty of investigation is with the local programme, not the NCSP national office. It is important that incidents are appropriately investigated so that the root cause is identified, and any learning recognised and improvements implemented. The outcome of the investigation, including follow-up action, should be fed back to the NCSP national office, when the entry in the database will be closed. Where there is a decision not to investigate an incident further, the director of the NCSP may request through the DPH that this is done where deemed necessary. Dissemination of learning 1.27 Where risks or learning relevant across the NCSP have been identified, either by the commissioner, the provider or the NCSP national team, these will be disseminated so that learning is shared across the country. This will be the responsibility of the head of QA and standards and will be done at a minimum through the SHFs and their provider and commissioner s networks. Where appropriate a lessons learnt report will be circulated by the NCSP s head of QA and standards. As the main purpose is to prevent similar incidents, reports will be published anonymously. Monitoring of incidents 1.28 The head of QA and standards will monitor serious incidents reported to the NCSP and provide reports at regular intervals and issue lessons learned reports when deemed necessary by the NCSP management team. Communications 1.29 Communication with patients will be the responsibility of the organisation where the incident occurred. Where communications with the media are needed as the result of a serious incident, the NCSP communications manager will work with the commissioner or provider communications team to facilitate an appropriate and timely strategy All media enquiries will be dealt with by the NCSP communications manager, and should be forwarded to the communications manager via or 10

11 Responsibilities In summary: 1.31 When an incident occurs, the organisation s reporting policy should be used. The serious incident policy of every commissioner and provider should include reference to these guidelines as we request that the NCSP is included in the reporting process of any incidents Following local investigation, the NCSP asks to be informed of the outcome of the findings and any local follow-up action. The NCSP will ensure that sharing the learning from incidents will be disseminated through the sexual health facilitators and their networks of commissioners and providers Commissioners should: ensure that the requirement for any provider (NHS and non-nhs) to comply with local/regional governance arrangements is part of the service specification when tendering for services and in subsequent contracts ensure that the requirement to inform the NCSP of serious incidents forms part of the service specification monitor providers compliance with this requirement ensure that the NCSP national office has a current name and contact details for the sexual health/chlamydia screening lead in their organisation 1.34 Commissioners and providers should: maintain proper incident reporting policies and procedures, ensuring that all incidents are properly dealt with, reported and investigated where necessary ensure that the NCSP national office has a current name and contact details for the sexual health/chlamydia screening lead in their organisation The NCSP head of QA and standards will: log all serious reported incidents to the NCSP s local database, together with their status and outcomes, and keep this updated as necessary provide updates as appropriate on the frequency and type of serious incidents ensure that learning is shared with the sexual health facilitators and their local provider and commissioners networks, as well as the relevant PHE centre 1.36 The NCSP communications manager will: work with the communications teams in the commissioning and provider organisations to implement a suitable and coherent strategy as required, and facilitate accurate reporting ensuring that appropriate information is shared when necessary 11

12 Appendix 1. CQC table of notifications Table of statutory notifications under the Health and Social Care Act 2008 This list is a summary. Please see the essential standards document and the guidance on the NHS, adult social care or independent healthcare pages for full details of what must be notified. Regulation Essential standards Notification outcome Changes to the provider s statement of purpose Absence (and return from absence) of registered persons Changes affecting a registered person Death of a person who uses the service Deaths and unauthorised absences of people who are detained or liable to be detained under the Mental Health Act Serious injuries to people who use the service Application to deprive a person of their liberty (under the Mental Capacity Act) Abuse and allegations of abuse involving people who use the service Events that prevent or threaten to prevent the provider from carrying on regulated activities safely and properly Incidents reported to or investigated by the police* 20 n/a Death of a woman after a termination of pregnancy* 21 n/a Death of a service provider (including a personal representative s plans for a service following the death of a provider) 22 n/a Appointment of liquidators * Does not apply to NHS trusts These notifications are not part of an essential standards outcome. Please see the relevant regulation in the Care Quality Commission (Registration) Regulations The process for submitting notifications is different for NHS and non-nhs service providers. Non-NHS Service providers submit directly to CQC, but NHS service providers can also still submit to the former NRLS. CQC s guidance on notifications from NHS service providers can be found here. 12

13 Appendix 2. NCSP flow chart for reporting of incidents Individual in provider or commissioner organisation identifies incident / near miss Incident is reported by individual outside of provider or commissioner organisation directly to NCSP Incident reported to local provider/ commissioner for investigation and action OR patient referred to correct organisation Individual follows process as per local incident serious incident policy as applicable: CQC notification, local risk management procedure, etc Incident reported to NCSP via: phe.gov.uk. NCSP: NCSP head of quality assurance logs incident Incident is investigated locally Findings from investigation fed back to NCSP Actions from investigation are implemented locally. NCSP is kept informed on progress NCSP: database is updated with findings from investigation and actions taken. Incident closed NCSP: Learning from incident is shared through sexual health facilitators and their provider and commissioner networks, and other media if necessary NCSP: Serious incidents are reviewed monthly (and by the sexual health programme board as appropriate) 13

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