Health Education England
It is recommended that Health Education England develops and publishes a national standardised competency-based training programme for NG tube placement and confirmation by pH testing.
The model may include simulation, observed practical assessment and ongoing competency assessment. The competency-based training programme would need to be defined, developed, and tested using a human factors approach prior to any widespread implementation. The competency based training programme will lead to a recognised accreditation which will be transferable across the NHS care providers in England.
HSIB has closed this recommendation response following the merger of Health Education England and NHS England on 3 April 2023. HSIB has confirmed the closure to the Department of Health and Social Care and that this area may be explored further on the establishment of the Healthcare Services Safety Investigations Body (HSSIB).
NHS England and NHS Improvement
It is recommended that NHS England and NHS Improvement works with the Department of Health and Social Care and others, to identify the process by which the NHS can identify and commission necessary research to support improvements in patient safety. This would include research to confirm NG tube placement.
Summary: We welcome HSIB’s investigation report into placement of nasogastric tubes, and its many helpful recommendations directed at royal colleges and other national bodies.
Patient safety research is an important part of safety improvement, including for areas where the safety and effectiveness of new technology or new interventions needs to be tested. There are already processes for how the NHS’s research needs, including patient safety needs, are identified and commissioned, and the complementary responsibilities of DHSC, NIHR, and NHS England and NHS Improvement have been set out. This reply summarises the process by which NHS can identify and commission necessary research to support improvements in patient safety and explains how the DHSC, NIHR, and NHS England and NHS Improvement work together to achieve this. Because of this, we do not believe a new action plan to deliver this safety recommendation is needed.
The overall research commissioning system is complex, and the DHSC, NIHR, and NHS England and NHS Improvement have systems and support that means research needs can be navigated to the right part of the system. We will undertake to jointly produce a brief guide to help HSIB direct any future research-related recommendations to the body best placed to take them forward. We expect to be able to provide this to HSIB by 31 May 2021.
We are confident these systems will work for future nasogastric tube research needs. As we know HSIB appreciates through the summaries provided for its investigation, there has been substantial research investment in new methods of nasogastric tube placement confirmation, and companies have also conducted their own clinical trials. When current early stage trials are published it will be clearer whether these are or are not likely to have a lower error rate than current testing methods, and therefore whether we have a research need for larger scale safety and efficacy trials.
Full response: We welcome HSIB’s investigation, and its many helpful recommendations directed at royal colleges and other national bodies.
Patient safety research is an important part of safety improvement, including for areas where the safety and effectiveness of new technology or new interventions needs to be tested. There are already processes for how the NHS’s research needs, including patient safety needs, are identified and commissioned, and the complementary responsibilities of DHSC, NIHR, and NHS England and NHS Improvement are already set out. These responsibilities in summary are:
DHSC via NIHR works in partnership with NHS England & NHS Improvement to systematically support the identification, prioritisation and exploration of opportunities for commissioning research to address the NHS’s research needs. This also includes the funding and commissioning research infrastructure and research delivery, such as the NIHR collaboration with the Academic Health Science Networks.
NHS England and NHS Improvement supports and engages in these processes, and has specific responsibilities to improve NHS commissioner input into identifying research needs in the NHS, and to identify the strategic research needs of its own national programmes, including the NHS Long Term Plan.
Patient safety research needs are best met as an integral part of these systems rather than separated, as aspects of quality are frequently intertwined; for example, many areas of research whose primary focus is patient experience or clinical effectiveness also demonstrate safety benefits.
Some of the ways DHSC, NIHR, and NHS England and NHS Improvement work together to ensure patient safety research needs are met include:
- DHSC’s policy research funding stream, which is a vital and valued route for NHS England & NHS Improvement to propose major new research to influence patient safety policy.
- Jointly hosting national workshops to bring all potential players in the patient safety research landscape together to streamline the patient safety research journey.
- DHSC and NIHR seeking NHS England & NHS Improvement advice and input when recommissioning major patient safety research streams, such as the Patient Safety Translational Research Centres.
These are just some of many examples in an overall operational relationship that is very positive, supportive and productive for patient safety research.
Because of these existing strategic and operational processes, we do not believe a new action plan to deliver this safety recommendation is needed.
We acknowledge the overall research commissioning system is complex, and the DHSC, NIHR, and NHS England and NHS Improvement have systems and support that means colleagues with research needs do not need to understand the complexity, but can be navigated to the right part of the system. We will undertake to jointly produce a brief guide to help HSIB direct any future research-related recommendations to the body best placed to take them forward. We expect to be able to provide this to HSIB by 31 May 2021.
We are confident these systems will work for future nasogastric tube research needs. As we know HSIB appreciates through the summaries DHSC and NIHR provided for its investigation, there has been substantial research investment in new methods of nasogastric tube placement confirmation, and companies have also conducted their own clinical trials. We appreciate the key research need is to identify a testing methodology less likely to fail to detect lung misplacement than current methods of x-ray and pH checks, where ‘never events’ are occurring in around one in 30,000 placements. When early stage trials are published it will be clearer whether any new technologies are, or are not, likely to have a lower error rate than current testing methods, and therefore whether we have a research need for larger scale safety and efficacy trials. Any future potential research needs can be taken forward through the systems described above.
Response received on 15 March 2021.
NHS Supply Chain |
British Standards Institution
It is recommended that NHS Supply Chain and the British Standards Institution work together (engaging other system leaders as appropriate, such as the Medicines and Healthcare products Regulatory Agency and NHS England and NHS Improvement), to develop and publish an agreed standard to minimise the risks relating to human errors in the use of pH strips designed for testing human gastric aspirate at the bedside. The standard should consider product design, regulatory standards, procurement practices and human factors engineering to provide a consistent approach that can be embedded within NHS Supply Chain product specifications.
Summary: BSI, as the UK’s National Standards Body (NSB), fully supports the Safety Recommendation 2020/108 made by the HSIB in report I2019/006, covering placement of naso-gastric tubes. We fully recognize the problem highlighted in the draft report that there is little that can be changed in terms of existing products that are placed on the market, and that the variation in pH strips from different manufacturers will remain a risk for patient safety. We are committed to work with NHS Supply Chain and wider partners to develop and publish an agreed standard to minimize the risks relating to human errors in the use of pH strips designed for testing human gastric aspirate at the bedside. Detailed actions and timescales for completing this are outlined below. We will keep the HSIB informed of the results of these meetings and discussions.
Action: NHS Supply Chain are taking immediate action to mitigate the risk of error in the use of inconsistently manufactured strips which will need to be endorsed by NHS England and Improvement (NHSE/I) along with agreement of a plan of implementation being agreed in respect of narrowing the products available in Trusts and supporting such an approach with guidance and/or training. NHS Supply Chain will work with NHSE/I to achieve this, as required, including on products supplied through the Supply Chain but noting that direct purchasing by Trusts would also need to be addressed in line with any agreed approach. MHRA will also need to endorse the new standard and include as a requirement in future regulations for products supplied for the identified indication. Timeline: Q2 2021.
Action: BSI and NHS Supply Chain will collaborate with NHSE/I and MHRA to facilitate a forum that will address how industry can provide a standardized approach as part of a wider solution that mitigates the risk and ensure all products supplied for this indication meet the defined standard to ensure consistent application of the standard by suppliers/manufacturers with an interest in this product category. The stakeholders working directly with BSI’s invitro-diagnostic standards committee represent industry professional bodies, regulators, NHS, charities and patient groups (via our consumer network). For the purposes of the forum BSI will draw on their expertise where appropriate. This initiative will be cognisant of user need, changing UK regulations and industry capacity given the international nature of manufacturing. This is likely to require changes in manufacturing process, supply chain procurement frameworks and potentially also have cost impacts which will equally need to constitute key elements of the consideration of the forum. Timeline: Q3 2021.
Action: Based on the outcomes, BSI, NHS Supply Chain and other relevant stakeholders will work to develop and publish a national standard addressing the safety issues highlighted in this recommendation, ensuring robust and rigorous process and timeframe. Where possible we will align to international standardization activities that are relevant to this topic. Timeline: from Q4 2021.
Response received on 13 March 2021.
NHS Supply Chain
It is recommended that NHS Supply Chain develops essential specifications to support the clinically-led procurement of devices to include devices to confirm NG tube placement, for example, pH testing strips.
The essential specifications should set out a range of factors critical to inform the selection by NHS Supply Chain of a product including, but not limited to: clinical output requirements; design and ergonomics; human factors and intended use; and limitations on use and usability. Critically, these specifications should ideally be established in partnership across the healthcare system with clinicians, healthcare professionals and safety leads, while maximising best practice.
NHS Supply Chain is actively engaged in the development of essential specifications for clinically-led future procurement as part of its wider engagement with DHSC, MHRA, customers and users. We are committed to delivering on the need to maximise the quality of products supplied by NHS Supply Chain to meet clinical and patient need, mitigate the risk of harm and prevent future harm.
Fundamental to this is our understanding that regulatory requirements for market placement are merely a baseline for market access and that a much more holistic approach to product selection and product review is required, on which our proposals would deliver. We therefore fully support the HSIB recommendation and look forward to engaging further on this recommendation as our work is rolled out across a range of clinical specialities in the medium term.
Response received on 26 April 2021.
British Society of Gastrointestinal and Abdominal Radiologists |
Health Education England |
Society and College of Radiologists
It is recommended that the British Society of Gastrointestinal and Abdominal Radiologists, working with Health Education England and the Society and College of Radiographers, develops and publishes a national standardised competency-based training programme for X-ray interpretation to confirm NG tube placement. The competency-based training programme will include the referral process for X-ray to confirm NG tube position and the subsequent reviewing, recording and communication of the clinical evaluation of the X-ray findings prior to initiation of feed. The standards must meet the Ionising Radiation (Medical Exposure) Regulations IR(ME)R requirements. The competency-based training programme will lead to a recognised accreditation for those qualified to clinically evaluate and record their findings, for example doctors, radiographers and advanced care practitioners. The accreditation certificate will be transferable across NHS care providers in England.
HSIB has closed this recommendation response following the merger of Health Education England and NHS England on 3 April 2023. HSIB has confirmed the closure to the Department of Health and Social Care and that this area may be explored further on the establishment of the Healthcare Services Safety Investigations Body (HSSIB).