Pathology tests involve taking and analysing samples of body fluids or tissues. They are crucial to the diagnosis of many conditions.
Unlike previous impact reports, this report does not follow a single pathway. Instead we have focused on our guidance where uptake data is available.
Published May 2021
Why focus on diagnostic pathology?
Diagnostic pathology impacts on all areas of healthcare. In particular, pathology tests play an important role in the prevention and early detection of cancer. Early detection improves the chances of successful treatment, saves lives and is more cost effective for the NHS.
- 1.2 billion pathology tests are estimated to be carried out each year in England
- around 95% of clinical pathways rely on access to pathology services.
Identifying and adopting new NICE diagnostics
Anyone can ask NICE to consider producing guidance or advice on a device, diagnostic or digital technology. Our diagnostics assessment programme produces guidance that evaluates innovative diagnostic technologies.
Our adoption team support the uptake of new technologies that we have recommended. They also support the NHS Accelerated Access Collaborative (AAC). The AAC brings together industry, government, regulators, patients, and the NHS to remove barriers and accelerate the introduction of new treatments and diagnostics.
Diagnostic pathology during the COVID-19 pandemic
We are supporting the NHS and social care during the COVID-19 pandemic by providing guidance and supporting efforts to get promising diagnostics and treatments to patients quickly.
Impact on primary care diagnostic pathology
Data taken between March and June 2020 showed that health tests, such as blood tests, fell by 80% in primary care compared to the previous year, but have since increased.
The decrease may have been because of people staying away to avoid putting pressure on NHS services, because they were afraid of catching COVID-19, or because they were advised to stay at home during the lockdown. The long-term effects of this reduction in tests are not yet clear.
Insight from Dr Michael Osborn
“The COVID-19 pandemic has led to a significant backlog of planned healthcare, particularly elective surgery. This is due to the pressures of the pandemic itself and through an inability and in some areas a reluctance to access healthcare.
Pathology-related guidance produced by NICE is helping address this backlog by signposting ways in which specialist services can be maintained while reducing the risks from COVID-19.
In addition, NICE advice on the use of pathology-based tests to help diagnose cancer in the primary care arena helps highlight patients who need to access urgent care despite the COVID situation.”
Key findings from the report
This page gives a summary of the uptake of 5 NICE-recommended pathology diagnostics. Two of these were originally identified by the AAC as rapid uptake products:
- high-sensitivity troponin tests
- placental growth factor (PIGF)-based tests for suspected pre-eclampsia.
We've included insights from Dr Michael Osborn, president of the Royal College of Pathologists, as well as shared learning examples from a number of NHS Trusts.
We owe it to our patients to provide a comprehensive, fast, accurate, pathology service and NICE is uniquely placed to help with this.
High-sensitivity troponin tests
- Hospital emergency departments use these tests when someone has acute chest pain. The tests show if someone is having a heart attack, the type of heart attack and the treatment needed. Older-style troponin tests take 10 to 12 hours, so people need to be admitted while they wait for the results.
- We recommend tests to help rule out a type of heart attack called a non-ST-segment-elevation myocardial infarction (NSTEMI) in 20 minutes or less. We also recommend a second test for people at low risk if the first test is positive.
- High-sensitivity tests can mean people with normal troponin levels do not need to be admitted to hospital, and those with a confirmed NSTEMI can get earlier treatment.
- 86% of eligible people had access to high-sensitivity troponin tests (estimated by the Accelerated Access Collaborative in 2019/20).
- We have produced an adoption support resource for high-sensitivity troponin testing. This provides practical information and advice to NHS organisations on adopting these tests.
Shared learning examples
The Royal Wolverhampton NHS Trust updated their chest pain pathway to incorporate the use of high-sensitivity troponin tests. The percentage of chest pain patients admitted to the hospital decreased from 61% to 38%, and the mean length of stay reduced from around 23 hours to 9.5 hours.
Results showed that this protocol was appropriate and safe for use in their trust. 70% of people tested during the pilot had NSTEMI ruled out and could be discharged more quickly.
Placental growth factor (PlGF)-based tests for suspected pre-eclampsia
- Pre‑eclampsia can be a serious pregnancy complication. It can need a referral to a specialist and hospital admission.
- Our updated guideline on hypertension in pregnancy, along with our diagnostics guidance on PlGF-based testing recommend a blood test for pregnant women with suspected pre-eclampsia who are between 20 weeks and 34 weeks plus 6 days. This could result in a faster and more accurate diagnosis of pre‑eclampsia. It could also allow pregnant women who have had pre‑eclampsia ruled out to return to community care instead of being admitted to hospital for observation.
- Only 1 hospital had access to PlGF-based tests in 2018/19 compared with 60 who had access to the tests in 2019/20.
- The rapid increase in uptake of PIGF-based tests means:
- quicker and more accurate diagnosis
- fewer unnecessary admissions
- This leads to reduced costs for the NHS.
Insight from Dr Michael Osborn
"These diagnostic tests highlight that through objective assessment and the championing of suitable pathology based diagnostics NICE has a pivotal role in improving pathology services, streamlining healthcare and so maximising the quality of patient care we can provide.
The path to NICE recommendation must however include close collaboration with the workforce to ensure any recommendations can be realistically implemented in a cost-effective manner.
Assessments made in isolation away from the real world setting may identify useful diagnostic techniques, but unless such diagnostics can be easily, economically and efficiently rolled out into day-to-day practice. they risk being challenging to implement."
Faecal immunochemical test (FIT) for colorectal cancer
- Our diagnostics guidance on faecal immunochemical tests helps primary care clinicians decide who to refer for a colonoscopy.
- We have produced an adoption support resource for faecal immunochemical testing.
- In June 2019 FIT became the primary test used in the bowel cancer screening programme for people aged 60 to 74 in England.
- Uptake of the screening test increased from 56% in 2015/16 to 66% in 2019/20.
- The NHS Long Term Plan highlights that use of the FIT has improved uptake rates. This includes groups with low participation rates such as men, people from black, Asian and minority ethnic groups, and people living in more deprived areas.
Insight from Dr Michael Osborn
"Tests such as faecal immunochemical test (FIT) for colorectal cancer are good examples of pathology diagnostics advocated by NICE. These tests can dramatically alter patient care.
On an individual patient-by-patient basis they can highlight at-risk groups and facilitate their rapid progression along the relevant care pathway.
They also reduce unnecessary escalations of care in patients who do not require it, and so help to focus limited resources on those who need them most. Having uptake data on such diagnostics helps identify barriers to their adoption so these can be addressed."
Prenatal testing for fetal RHD genotype
- A new prenatal test for fetal RHD genotype will help to ensure that only pregnant women who need anti-D prophylaxis receive it.
- Routine antenatal anti‑D prophylaxis for all women who are rhesus D negative is current practice in most NHS maternity services. However our diagnostics guidance on high-throughput non‑invasive prenatal testing (NIPT) for fetal RHD genotype states that about 40% of women who are rhesus D negative carry a rhesus D negative baby. Where the rhesus D status of the baby can be determined, anti‑D prophylaxis will not be needed.
- NIPT will prevent unnecessary treatment and protect stocks of anti-D immunoglobulin.
- We have produced an adoption support resource for prenatal testing for fetal RHD genotype to provide practical information and advice to maternity services.
Shared learning examples
University Hospitals Bristol NHS Foundation Trust implemented this test in 2017 and reduced anti-D immunoglobulin use by 29%.
Taunton and Somerset NHS Foundation Trust reported that adoption of prenatal testing resulted in a 40% reduction in anti-D immunoglobulin use in July to December 2015, compared with July to December 2016.
Yeovil District Hospital NHS Foundation Trust adopted prenatal testing and predicted that 40% of women would have a rhesus D negative result. From the 95 women who had their babies, 42% received a rhesus D negative result.
Natriuretic peptide testing for heart failure
- Natriuretic peptide testing - B‑type natriuretic peptide (BNP) or N‑terminal pro‑B‑type natriuretic peptide (NT‑proBNP) is an important tool for rapidly assessing adults presenting with possible heart failure.
- It can be used to rule out a diagnosis of heart failure or to decide if further investigation with echocardiography is needed.
- It can save time and distress for people presenting with suspected heart failure.
- Our guideline on chronic heart failure recommends that people with suspected chronic heart failure should have NT‑proBNP measured. In addition, our guideline on acute heart failure and quality standard on acute heart failure recommend measuring either BNP or NT‑proBNP in people presenting with new suspected acute heart failure.
- There is a lack of uptake data. The British In Vitro Diagnostics Association have data showing a rapid increase in the sales of BNP tests. This suggests an increase in use. But our discussions with stakeholders and local data collection says that availability is variable.
- We published a chronic heart failure: diagnosis visual summary to help clinicians decide which tests to offer when diagnosing heart failure. We will continue to focus our implementation efforts on increasing uptake of NT-proBNP in primary care.
Shared learning example
Brighton and Sussex University Hospitals NHS Trust describes their quality improvement project to reduce inappropriate use of NT-proBNP in the heart failure diagnostic pathway in secondary care.
Education sessions were carried out, including posters, slide packs, real-world data and practical examples of how these tests fits into our diagnostic pathway for heart failure.
Audit data from April to August 2019 showed that 46% of NT-proBNP tests were not following the appropriate pathway.
Unnecessary echocardiograms were carried out when NT-proBNP test results were normal. The tests were repeated in hospital when heart failure had already been diagnosed. This ongoing project has raised awareness of how to use NT-proBNP and helped to embed it in practice.
Improving pathology data
There is no single national data collection for pathology services.
The national pathology quality assurance dashboard (PQAD) will report on pathology services month by month to help understand how services are performing and drive improvement. NHS England and NHS Improvement will collect this data quarterly for benchmarking. Data collection will include adherence to our guidelines on sepsis and guidelines on neutropenic sepsis.
Getting It Right First Time: pathology
The Getting It Right First Time (GIRFT) programme is developing a pathology specialty report using:
- clinical data
- current best practice
- clinical experience of providing pathology services to both primary and secondary care in the NHS and other settings.
GIRFT pathology clinical leads have gathered emerging themes and developed recommendations and actions to help improve pathology services.
One of the recommendations in the GIRFT pathology report is likely to be for a pathology data repository. The NHS England Diagnostics: recovery and renewal report also calls for standardised data collection across all diagnostics. We support these views and will work with system partners on the development of a national data collection based on our guidance.
Pathology networks and GIRFT working with NICE will help develop and improve pathology services leading to better patient care. Accurate data is vital to this process and the pathology quality assurance dashboard (PQAD) will help to provide this.
However, to achieve the best results the system must encompass the whole of healthcare, including primary care and specialised services. And there needs to be easy secure transferability of data across the NHS for treatment and research purposes, to prevent tests having to be repeated.
It is also important that data is not assessed in isolation but is related to real healthcare practice. In addition, it must be remembered that in all areas of pathology sufficient numbers of appropriately skilled staff are needed to achieve good outcomes.
What we're doing next
While developing this report we engaged with external stakeholder organisations and individual clinical biochemists. We worked to identify implementation challenges and available support across the healthcare system.
Gap in uptake
A gap was identified in uptake of the appropriate use of N-terminal pro-B-type natriuretic peptide (NT-proBNP) testing when diagnosing heart failure.
Areas that could enable system change
- Make pathways consistent across providers, in line with our guidance.
- Improved data collection, to identify gaps in uptake.
To help support implementation in these areas, we will work with:
- GIRFT to address any joint actions arising from their pathology workstream.
- Association for Clinical Biochemistry and Laboratory Medicine to explore collaborative working.
- NHS England and NHS Improvement to support pathology priorities in the NHS Long Term Plan.
- British Society for Heart Failure to explore collaborative working.
We would like to thank Dr Michael Osborn for his contributions. We would also like to thank The British In Vitro Diagnostic Association and NHS Blood and Transplant.