II. NORMAS ORGÁNICAS
7. Ley de Colegios Profesionales (Autonómica de Ma-
2.31 Building a safer NHS for patients3 proposed a new
national reporting system for learning and envisaged that by December 2001, 60 per cent of trusts would be able to provide information to the system and that by the end of 2002 all NHS trusts, and a significant proportion of primary care trusts, would be providing information to the system. The system was envisaged as being:
n mandatory for individuals and organisations; n confidential, but open and accessible; n generally blame free and independent;
n simple to use but comprehensive in coverage and
data collection; and
n allow systems learning and change at local and
national levels.
Healthcare organisations in other countries, having compared the merits of anonymous and confidential reporting, have generally opted for confidential reporting (Appendix 4). Other industries have also opted for confidential and not anonymous reporting systems (Appendix 3). Over time, as the aviation industry and some hospitals in the United States of America have embedded their systems, they have moved towards an open system of reporting.
2.32 Following publication of Building a safer NHS for patients3 (and prior to the formation of the National
Patient Safety Agency in July 2001) the Department conducted an Official Journal of the European
Communities procurement exercise to establish a pilot project for the national reporting system for learning. This resulted in the Australian Patient Safety Foundation being awarded a contract to develop software for a central repository and Safecode (United Kingdom supplier of risk management systems to trusts) being engaged to work with the Australian Patient Safety Foundation to develop software to allow patient safety incident data (both the details of the incident and root cause analysis) to be extracted from local reporting systems. The pilot commenced in September 2001 in 28 trusts; an interim report was published in April 2002 and a final report in June 2002.
2.33 The report on the pilot concluded that it had been successful in identifying implications for the
implementation of a national reporting system for learning across the NHS, although trusts had some difficulties capturing the root cause analysis data. The National Patient Safety Agency considered that the roll out of the pilot would be neither optimal nor cost effective due to the complexity of data extraction and data mapping problems. It therefore developed a Business Case with options ranging from “Do Nothing” to an in-house developed computerised national reporting and learning system. This latter option, with a revised, phased, implementation timetable between summer 2003 and December 2004, was subsequently agreed by the Department and approved by the Treasury in February 2003 (subject to close scrutiny of the e-Form integration with local risk management systems and the carrying out of peer reviews as suggested by the Office of Government Commerce).i
2.34 The approved option was to collect comprehensive data on patient safety incidents in NHS trusts and identify national trends in incidents, from which the National Patient Safety Agency could develop practical solutions for application across all local organisations. The National Reporting and Learning System either extracts information directly from trusts’ own incident reporting systems, which is then de-identified, or collects information from an anonymous electronic reporting form (e-Form). The cost in the business case was £9.4 million over seven years. As at March 2005, £5.5 million had been spent from a revised lifetime budget of £10.4 million (June 2004).
2.35 The National Patient Safety Agency’s decision to devise an anonymous reporting e-Form was based on the belief that assurances of confidentiality would not be enough to encourage clinicians too frightened to report and that there was a need for a safety net. Experience, at trusts where both anonymous and confidential systems work in parallel, has showed that less than ten per cent of all reported incidents are submitted anonymously. Some trusts told us that the potential for incidents to by-pass their own reporting systems would in their view undermine the progress they had made in establishing an open and fair culture.
2.36 The National Patient Safety Agency believe the initial indications are that the e-reporting system will be a rich source of information for learning. Ninety-four per cent of the 108 reports received between September 2004 and March 2005 had the agreement of the reporter to share the information with the trust involved. Although still early, 13 per cent of reports are from medical staff who generally may be less likely to report incidents locally.
2.37 Building a safer NHS for patients3 stated that the data
requirements at local and national levels are different. Trusts need to know who reported the incident, to ensure no misinterpretation and to validate the information. In contrast, national reporting systems gather information about what, where, when, how and why things are likely to go wrong, what action is taken, the impact of the incident and what could have been done to prevent it, rather than identify the people involved. The majority of the data captured by the National Reporting and Learning System has come from local incident reporting systems and all trusts told us that it had already been analysed to identify learning. Ninety-nine per cent provided examples of such learning. Therefore the National Patient Safety Agency could have collected aggregate information on commonly occurring incidents that trusts knew about and used it to promulgate learning nationally, whilst focusing on the collection of information on less frequent incidents.
2.38 An organisation with a memory1 envisaged the
national collection of certain categories of data and Building a safer NHS for patients3 that definitions of
incidents should gradually move to internationally agreed standards. To meet its objective of identifying and disseminating patient safety learning the National Patient Safety Agency decided not to limit its dataset and
consequently the National Reporting and Learning System receives data on all incidents, regardless of their potential for national learning. And despite the existence of well developed international incident classification, the National Patient Safety Agency decided to define its own taxonomy for national reporting and produce tailored versions for use in nine different healthcare settings. However, reporting fields, which identify the contributory factors to the incident, are optional, and compliance is variable, even though the learning of lessons is most likely to come from this information.
14
Organisations involved in collecting reports on patient safety incidents and near misses and encouraging learning from these incidentsNOTES
1 The Department has now taken over NHS Estates responsibilities for the health and safety and environmental reporting. 2 Only for patients detained under the Mental Health Act.
3 Will only receive reports, conduct investigations, issue guidelines and alerts if there is significant risk or a claim has been received.
4 From November 2005 the Medicines and Healthcare products Regulatory Agency assumes responsibility for Haemovigilance. The new system will provide a single data entry point for Medicines and Healthcare products Regulatory Agency and Serious Hazards Of Transfusion reports.
5 Data on those incidents involving licensed medicines or where a medical device is involved and a device fault needs to be ruled out.
Source: National Audit Office
There is duplication in the reporting and investigation of patient safety incidents.
Patient injury Adverse drug reactions Equipment failure or malfunction Blood transfusion errors Communicable disease outbreaks Suicides Violence and aggression Absconsion Unexpected death Trust incident reporting system (plus close-call) Medicines and Healthcare products Regulatory Agency Health Protection Agency NHS Litigation Authority NHS Estates1 National Patient Safety Agency Health and Safety Executive l l l l l l l l l l l l 4 l 5 l l l 3 3 3 3 3 l l l l l l l l l l l l l
Key Receive reports Conduct investigations Issue guidelines Issue alerts
l Required to be reported l Depends on underlying cause and severity 4 ? G ! 4 ? G ! 4 ? G 4 ? G ! 4 ? G ! 4 G ! 4 ? G 4 ? G !
2.39 The full roll out of the National Reporting and Learning System commenced in September 2004, nearly two years later than the headline target in Building a safer NHS for patients3 (see paragraph 2.28). By end of
December 2004, all trusts had the technology to link to the National Reporting and Learning System but not all had finished mapping their data sets. The revised target for all trusts to begin sending their data to the System was June 2005. By August 2005, at least 35 trusts still had not submitted any data to the National Reporting and Learning System.
2.40 Trusts have invested considerable time and resources to develop individual data mapping schemes in order to comply with, and to send data to, the National Reporting and Learning System (Appendix 5). Our survey in 2005 showed that 12 per cent of trusts had no problems in linking to the National Reporting and Learning System. Eighty-two per cent of trusts reported problems, of which 36 trusts said these were major, and these were due to time and resource issues (64 per cent and 46 per cent respectively) and software compatibility issues (39 per cent). We found that there was a significant relationshipj between the manufacturer of the trust’s
incident reporting system and the ease with which the local and national data sets were integrated.