National Reporting and Learning Service (NRLS) Data Quality Standards Guidance for organisations reporting to the Reporting and Learning System (RLS) September 2009
Introduction to the NRLS The are designed to improve the quality, accuracy and timeliness of patient safety incident data submitted to the Reporting and Learning System (RLS). This document sets out the and provides guidance on their use. It is aimed at NHS staff (such as risk managers and governance managers) responsible for submitting their patient safety incidents to the RLS via local risk management systems (LRMS) or eform. The National Reporting and Learning Service (NRLS), part of the National Patient Safety Agency (NPSA), recommends that all NHS healthcare organisations comply with these standards so that the NRLS receives the best quality information possible for issuing patient safety guidance. Evidence suggests that organisations that follow the, and have high reporting, also have a good safety culture and sound risk management processes. These standards will also aid the improvement of data analysis for local organisations and ensure that they meet their obligations under the Data Protection Act (1998). Organisations that are unable to comply with these standards should seek further assistance from the NRLS, as a matter of urgency. Feedback reports are available via the NRLS website. These reports highlight areas of compliance with some of the standards. The NRLS provides a team of reporting improvement leads covering the whole of England and Wales. Organisations should stay in regular touch with these contacts for updates, feedback or support. RLS enquiries and support The NPSA has appointed a dedicated team to provide local support for NHS organisations submitting to the RLS. For information on using the data quality standards please contact your designated RLS improvement lead or patient safety manager. If you do not know who your contact is please email support@npsa.nhs.uk For IT support and RLS reporting queries please contact the NPSA IT Helpdesk on support@npsa.nhs.uk NRLS National Reporting and Learning Service Address: 4-8 Maple St, London W1T 5HD Telephone: 020 7927 9500 Website: www.npsa.nhs.uk/nrls 2 NRLS September 2009
The NRLS Information on the are set out as follows: 1. A list of the standards in poster-format (Table 1). 2. A list of the standards including a quick audit tool (Table 2). 3. Background and rationale for the standards (Table 3). Networking and benchmarking between organisations on progress against these standards can help to improve the quality and quantity of reporting to the NRLS. This in turn helps the NRLS improve understanding of key patient safety issues. Organisations may wish to publish information relating to their progress against these standards on their own public websites. In publishing information, organisations have a duty to ensure the accuracy of such information. Organisations should be auditing their incident reporting processes against these standards and implement action plans to address any weak areas. A basic audit tool is provided as Table 2. Defining a patient safety incident A patient safety incident (PSI) is defined by the NRLS as: Any unintended or unexpected incident(s) that could have or did lead to harm for one or more person(s) receiving NHS funded healthcare. Notes on the definition of a PSI: Unintended includes known and unexpected complications of treatment or side effects of medication. Unintended would not include harm where this is an inevitable effect of a treatment, e.g. transplant anti-rejection medication affecting the immune system. Unexpected includes unexpected outcomes and unexpected deaths. Local organisations should investigate these to determine if a PSI contributed to the unexpected outcome or unexpected death. Organisations should not enter a harm grading of severe or death on a PSI report unless they believe that permanent harm or death actually resulted and was directly attributable to a PSI. Incidents include both acts and omissions. Could have extends to situations that could realistically lead to harm or cause significant concern for patient safety. This includes incidents that occurred but, through luck or intervention, led to no harm to the patient. Harm includes mental or psychological harm as well as physical harm. NHS funded healthcare includes healthcare that is partially or fully funded by the NHS, regardless of the location in which it is provided. PSIs should be reported whether currently considered preventable or not. In addition to improving safety around preventable incidents, we aim to also identify incidents currently considered unpreventable. With improvements in knowledge, practice, and/or technology; together we can work to ensure that more of these become preventable too. Judging preventability at the point of reporting or before investigation can be difficult but PSI reports can be updated as this becomes clear. NRLS September 2009 3
About the Reporting and Learning System To drive improvement in patient safety, the NRLS established the Reporting and Learning System (RLS). This is a unique, national system which collects, reviews, analyses and feeds back data, learning, and action relating to patient safety risks. Due to the commitment of frontline staff who report incidents, and the central risk or governance teams that upload these reports to the RLS, we have a database of over three million incidents. Through the use of both incident categories and a keyword search function, we can focus in on almost any patient safety concern, even where it makes up only a handful of the three million incidents, for example, identifying all cases of harm to patients during the insertion of chest drains. The data from the RLS are used in a number of ways to improve patient safety; for example to: Scrutinise all incidents reported as causing death and severe harm to identify any new or under-recognised risks to patient safety that may need national action. The most important safety issues identified lead to the issue of Rapid Response Reports (RRR). Search the RRRs at: www.npsa.nhs.uk/nrls/alerts-and-directives/ Produce feedback reports. These help organisations to compare their reporting and learning practice with other organisations providing similar healthcare services. See: www.npsa.nhs.uk/nrls/patient-safety-incident-data/ Provide themed reports that help organisations prioritise their patient safety work. Examples include overviews of patient safety incidents affecting children, and incidents involving medication. Improvements in the quality of data submitted to the RLS will help us to be more effective in supporting local patient safety improvement activities. We help the NHS to understand why and how patient safety incidents happen, to learn from these incidents and take action to prevent the occurrence of future harm to patients. About the National Reporting and Learning Service The National Reporting and Learning Service (NRLS) is one of the three divisions of the National Patient Safety Agency (NPSA). The NPSA is a special health authority, established by the Department of Health in 2001 following the publication of An organisation with a memory (2000). Its remit covers healthcare services in England and Wales. The NPSA s overarching role is to drive, implement and support a programme of change across the NHS which leads to a reduction in the number of serious patient safety incidents and a consequent improvement in patient safety. Further reading Department of Health. An organisation with a memory. London: The Stationary Office. (2000). Available at: www.dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_4065083 Department of Health. Safety First: a report for patients, clinicians and healthcare managers. London: The Stationary Office. (2006). Available at: www. dh.gov.uk/en/publicationsandstatistics/publications/publicationspolicyandguidance/dh_062848 NPSA and The NHS Confederation Briefing. Act on reporting: Five actions to improve patient safety reporting. Issue 161. (2008). Available at: www. npsa.nhs.uk/nrls/reporting/five-actions-to-improve-reporting/ National Patient Safety Agency. Seven steps to patient safety. (2004). Available at: www.npsa.nhs.uk/sevensteps/ Information Commissioner s Office. Data Protection Technical Guidance. Determining what is personal data. (2007). Available from: www.ico.gov.uk Contact National Reporting and Learning Service National Patient Safety Agency 4 8 Maple Street London W1T 5HD T 020 7927 9500 F 020 7927 9501 www.npsa.nhs.uk/nrls Reference: 1101 September 2009 National Patient Safety Agency 2009. Copyright and other intellectual property rights in this material belong to the NPSA and all rights are reserved. The NPSA authorises UK healthcare organisations to reproduce this material for educational and non-commercial use. 4 NRLS September 2009
Table 1: Poster NRLS 2009 No. Criterion title Minimum standard 1 Reporting to the National Reporting and Learning Service (NRLS) NHS organisations should submit all their reported patient safety incidents (PSIs) to the NRLS s Reporting and Learning System (RLS). 2 Regularity of reporting should submit reported PSIs regularly to the RLS regularly is defined by the NRLS as at least monthly. 3 Exclusion of person identifiable information should ensure that PSIs reported to the RLS do not contain person identifiable information in free text fields. 4 Recording actual degree of harm as a result of the PSI should ensure that the degree of harm recorded for each PSI describes the actual harm to the patient as a direct result of the PSI. 5 Speed of reporting of the most serious PSIs to the NRLS should report PSIs with an actual degree of harm of either severe or death (as described in 4) to the RLS within two working days of the incident occurring. NRLS September 2009 5
Table 2. NRLS 2009 Organisation name: Start date: No. Criterion title Minimum standard Status Date 1 Reporting to the National Reporting and Learning Service (NRLS) NHS organisations should submit all their reported patient safety incidents (PSIs) to the NRLS s Reporting and Learning System (RLS). 2 Regularity of reporting should submit reported PSIs regularly to the RLS regularly is defined by the NRLS as at least monthly. 3 Exclusion of person identifiable information should ensure that PSIs reported to the RLS do not contain person identifiable information in free text fields. 4 Recording actual degree of harm as a result of the PSI should ensure that the degree of harm recorded for each PSI describes the actual harm to the patient as a direct result of the PSI. 5 Speed of reporting of the most serious PSIs to the NRLS should report PSIs with an actual degree of harm of either severe or death (as described in 4) to the RLS within two working days of the incident occurring. 6 NRLS September 2009
Table 3. Background information and rationale for the NRLS No. Criterion title Minimum standard Background information and rationale 1 2 3 4 5 Reporting to National Reporting and Learning Service (NRLS) Regularity of reporting Exclusion of person identifiable information Recording actual degree of harm as a result of the PSI Speed of reporting of the most serious PSIs to the NRLS NHS organisations should submit all their reported patient safety incidents (PSIs) to the NRLS should submit reported PSIs regularly to the RLS regularly is described as at least monthly. should ensure that PSIs reported to the RLS do not contain person identifiable information in free text fields. should ensure that the degree of harm recorded for each PSI describes the actual harm to the patient as a direct result of the PSI. should report PSIs with an actual degree of harm of either severe or death (as described in 4 above) to the RLS within two working days of the incident occurring The publication An Organisation with a memory led to the creation of the National Patient Safety Agency (NPSA) to collect information on PSIs to ascertain the national picture in relation to patient safety. This can only be an accurate picture when all NHS organisations report to the Reporting and Learning System (RLS). Seven Steps to Patient Safety defines a patient safety incident as any unintended or unexpected incident(s) that could have or did lead to harm for one or more persons receiving NHS funded healthcare. It is an umbrella term which is used to describe a single incident or a series of incidents that occur over time. Reporting to the NRLS is a requirement of the healthcare standards in Wales. Experience has shown that many internal and external factors can affect reporting patterns throughout an organisation s reporting history. However, sustaining regular reporting allows problems to be detected early and resolved quickly. Experience has also shown that organisations uploading from local risk management systems (LRMS) find file sizes (batches) containing less than 100 incidents to be most efficient and reliable when reporting to the RLS. In England, the Care Quality Commission (CQC) will monitor this and expects to see regular reporting at least on a monthly basis. In Wales, Health Inspectorate Wales (HIW) will require evidence of this to be submitted in the annual returns. If a local risk management system is not available, then the NHS organisation should report via the NRLS eform. Available at: https://www.eforms.npsa.nhs.uk/staffeform/ The Data Protection Act (1998) requires that person identifiable information is processed (e.g. held, used and disclosed) fairly and for a specified purpose only. The NRLS does not require or use person identifiable information from PSI reports and therefore no staff or patient identifiable information should be included in incident reports uploaded to the RLS. The NRLS currently uses specialist software to cleanse as much person identifiable information as possible from PSI reports but it is not possible to identify every type of variable. Where organisations are still working to achieve this standard they should inform patients and staff about the information they hold in PSI reports and with whom they may share it. This standard refers solely to free text fields submitted to the RLS. This does not apply to person identifiable information in patient and employee sections of LRMS as they are not submitted to the RLS. Organisations unsure about which free text fields are included in their LRMS should contact support@npsa.nhs.uk When reporting by NRLS eform, person identifiable information should not be included in any free text boxes. The degree of harm on PSI reports should relate to the actual harm resulting directly from the PSI itself. It is therefore incorrect to record potential harm rather than actual harm as a result of the PSI. Similarly it is inaccurate to record the degree of harm in relation to the outcome of the medical condition rather than the direct result of the PSI itself, e.g. severe should only be recorded when the patient has been permanently harmed as a result of the PSI and death should only be recorded when the PSI has resulted in the death of the patient. For England, the Department of Health publication Safety First placed a requirement on NHS Organisations to report the most serious PSIs to the NRLS within 36 hours of the initial report, to ensure that national learning occurs in a timely fashion. However, as the date and time of initial report is not routinely captured and therefore not measurable from most systems; a period of two working days from the incident occurring has been adopted as the rapid reporting standard. The two working day period will be considered to: o Exclude weekends and bank holidays; o Run from 23:59 on the day the incident occurred to 23:59 on the day the incident is received in the RLS. The method of reporting to the RLS within two days should be via the usual reporting system. For Wales, the Welsh Assembly Government s serious patient related incident reporting process also requires that the Regional Office is informed within 24 hours. NRLS September 2009 7