Contaminated urine samples

Is dementia or a UTI causing confusion? Accurate diagnosis of urine samples is a MUST!

We’ve been an advocate for the MUST Campaign since they launched in May and this article explains why it is so important.

Read about it in this article published today on AgeSpace.com

Prevention, technology and how to unblock NHS adoption

The inaugural speech delivered by Mr Matt Hancock upon his appointment as Secretary of State for Health, focused quite rightly on the acceleration of preventative practice and the adoption of novel technology.  Forte Medical welcomes this approach … if it happens.  

It is high time to highlight and seriously consider the problems behind historic innovation adoption across the NHS because examples of what works – and just as importantly what doesn’t – can only serve to steer the powers that be to develop a better way. Our game-changing urine collection technology, which many rightly observe “has been around for years” is a prime example of how and why changes need to be made.

The NHS has long enjoyed international recognition for its vision and offering; yet Forte Medical has endeavoured to work with the NHS for over eight years – the outcomes of which more later – but the difference in our experiences of engaging in the US healthcare sector through the ABHI Trade Mission is palpable and there is much that could be learnt from their approach.

In the US, those of us attending with the ABHI are given the opportunity to present an “accelerator pitch” to leadership and key stakeholders of leading healthcare providers. Clinical, Medical and Nursing Directors, Patient Safety, Infection Control, Finance and Procurement will gather to meet us and listen to what we have to say. They get it – and are not afraid to try something new. In a few short months, Forte Medical has not only evaluations live with a number of leading providers, short-circuiting the equivalent process endemic here in the UK, but sales to laboratories that serve the health insurance market.

In the absence of NHS Leadership willing to accept an equivalent scheme where the AHSN Network may short-list and present the most compelling innovations every quarter, other steps must be taken to make such introductions seamless and effective.

Happily there have been successes for us over the past eight years. The excellent clinical results around Peezy Midstream are being recognised; thanks to the work of the ABHI, the AHSNs and a handful of diligent Healthcare Professionals, adoption is becoming a reality.

Meanwhile, I offer to those in the driving seat some examples of where, to the detriment of clinical outcomes, patient safety and yes, cost savings, inertia has proven easier to embrace than change. This in itself is where change is most needed.

2013: Pennine Acute Hospitals NHS Trust: A peer reviewed and published clinical trial of 104 male and female patients delivered a reduction in urine specimen contamination from a Trust average of 23% to 6%. The Abstract presented at the World Congress of Endourology and the Societe International de Urologie, surmised that: “Peezy is a welcome innovation by patients. The improvement in possible unreliable results was impressive, suggesting a significant financial saving due to the common nature of the investigation in LUTS assessments.”

At that time Peezy Midstream could have delivered direct savings to the Trust of £160,000 and indirect savings of £3.2m taking into account outlying costs of repeat appointments and tests. Procurement was disinterested, citing specimen collection as a non-priority and their position in Special Measures as prevention to the adoption of anything new (just when it was probably most needed).

2015: Barts Health NHS Trust: Professor Frank Chinegwundoh has Championed Peezy Midstream since he began a trial of 200 patients in his own clinic at the Royal London. He publicly presented interim results proving a reduction in historic contamination rates of 23% to 1.5% across 66 patients, pointing to significant clinical and cost improvements for the whole Trust. Despite his best efforts and support from the Trust’s Microbiology team, he has struggled to complete the evaluation. We have attempted to engage with antenatal to transfer the evaluation there but they, together with procurement and overall Trust leadership remain elusive. Are potential direct savings of £214k and indirect of £4.3m not worth investigating?

2016: Infection Control Director, Home Counties NHS Trust: The UK’s first Infection Control Director was familiar with Peezy Midstream, having spent 18 months setting up a trial that never happened at a London Teaching Hospital. On reading of his new appointment, we contacted him to see if he would implement his earlier work on this study at the new NHS Trust. The answer perplexed: if we sponsored his Conference at the RSM to the tune of £10,000 he would ensure the trial took place with good results. We thanked him and declined.

2018: A South West NHS Trust: The Head of Gynaecology and Obstetrics at this General Hospital was keen to trial Peezy Midstream to counter the 9% urine specimen contamination rate cited in antenatal, where screening accuracy is so important. A protocol was produced and trial conducted; the resulting paper citing tangible clinical improvements and cost savings with a potential for reduced broad spectrum antibiotic prescribing. This Abstract was peer reviewed, published and presented at a leading Conference earlier this year.

We asked the Clinical Lead if given the evidence and benefits she would now adopt Peezy Midstream? She demurred, saying by email that “Following the study, the way in which the wee is collected improved and the midwives and HCAs started to follow the right rules of sending off only the right urines. Not as good as with a Peezie [sic], but better than before.”

A new study has shown that Peezy Midstream reduces antenatal false positives by almost 70%; by implication the HCAs are still sending off too many “right urines” wasting time, money and possibly prescribing unnecessary broad spectrum antibiotics to pregnant women. Add to this the transient nature of staff, forgotten instructions … and in other words: Your innovation works but I am not prepared to make changes and although I don’t know what happens behind the closed toilet door, I am prepared to assume that patients will listen to verbal instruction … and be damned if they don’t. 

Innovation Managers in the South, North and Midlands: In 2014 and 2015, three “clinical innovation leads” from Trusts that boasted high urine contamination rates were presented with Peezy Midstream as a route to clinical excellence and cost savings. One manager refused outright to engage with an evaluation citing urine as “low priority”; the other two sat on the trial product for so long, the three-year use-by date expired.

Private providers who profit from inaccuracy and repeat testing: One of the largest private NHS laboratory providers assured us some time ago, that they would “never use or recommend use of your device; if it reduces retests to the extent you say, it will knock about half a million off our bottom line.” When I enquired as to their commitment to help the NHS treat its patients efficiently they observed “that’s the NHS’s problem, we have shareholders to answer to.”

Connecting the dots between clinician, trial, procurement and adoption

Every evaluation, every clinical trial must be conducted with the involvement and approval of all relevant stakeholders; without these interests being represented, evidence of prevention and improvements across the many facets of clinical and patient care stand not a chance of being translated into Good Practice. Thank heavens for the arrival of the AHSNs – would that they had existed in our earlier years.

The Future Operating Model (FOM) may also change things; our own Category Tower Manager Akeso&Co has visited almost every NHS lab in the country to understand their challenges. If this diligence has been mirrored across the other Consultancies involved, a more logical, efficient and pragmatic view of innovation being delivered to the NHS could become a reality.

Meantime, the money wasted for all parties in trials that go nowhere, not to mention the lost benefits that could have been delivered to patients and NHS Finances over the last five years from our own NHS GP created innovation, doesn’t bear thinking about. We believe we are nearly there; meantime, the USA calls. One way or another our perseverance will pay dividends for the one in four patients both here and across the pond, where diagnoses fail because of inconsistent urine collection methods. They deserve so much better.

  • Four steps to accelerating preventative innovation within the NHSWhere innovation has arrived outside of an AHSN introduction but is desirable, ensure the appropriate AHSN is involved to better cement protocols, stakeholder interest, deliverables and adoption
    • Incentivise clinical staff to embrace evaluations that, if successful will deliver tangible improvements to their work and working lives.
    • Appoint “adoption” managers who will oversee the implementation of new technology so that a more seamless approach is taken with wholesale acceptance by clinical teams
    • Reward private contractors on clear results and value, not volume; until then the NHS will fail to receive best endeavours in the interests of its patients – or balance sheets.
Giovanna Forte on TV

Disruptive TV: Giant Live Health Innovators

Barry Shrier, Founder of annual health innovation event Giant Live, presents the third Disruptor Giant Health Innovators TV interview featuring Giovanna Forte, CEO of Forte Medical, Francis White from AliveCor, Dr Sophie Bostoc​k of Sleepio and Etienne Bourdon from Healthy Health. Watch the half-hour programme here with Disruptive Live

UTIs in the elderly – and why it matters

In elderly patients, a UTI can induce behaviour that may be interpreted as “challenging”. As millions of us know, UTI is at best uncomfortable, at worst jolly painful.
Giovanna Forte was invited by Age Space to explain further.

Read the article in full here

 

Forte Medical News

Diagnosing UTIs is ‘a dog’s breakfast,’ and that’s affecting women

Symptoms of urinary tract infections can be acute and in many cases, very debilitating.   The need for a protocol around the collection of urine specimens to correctly diagnose and treat is critical.

Read this interesting news segment from CBC Radio.

Make sure your bladder is full | urine sample

Peezy Animation: instructions for use

How easy is Peezy? Very! Click here to see our new animation showing five simple steps that deliver right-first-time urine specimen collection. Any clinician will know that contamination can prevent or delay diagnoses; Peezy makes prompt analysis, diagnosis and treatment simple and cost effective.

Why is a contaminant-free urine sample is important?

Doctors can tell a lot about your health from your urine sample, if taken properly.

Insightful piece by Rob Eley and Michael Sinnott from The University of Queensland

Read the full article: The Conversation

New Forte Medical Advisory Board

Encouraged by the growing national recognition of the value of urine in diagnostic medicine, health leaders are being approached to join a new Forte Medical Advisory Board. Three leading exponents of accurate basic medicine have so far been appointed: Mike Farrar (pic) who will Chair the panel, Dr Katherine Brown and Rachel Cashman

Mike Farrar is a management consultant with 15 years of CEO experience in the NHS, having stepped down as the Chief Executive of the NHS Confederation in September 2013.  Mike has been a member of the PwC Health Industries Oversight Board and has worked on major projects across the country. Mike has also built alongside this a successful business practice working with clients such as Celesio, ROGP, ABPI, NHS Quest, NHS Leadership Academy, Health Foundation, Vanguard Health Solutions, Pfizer, CIPFA and others, as well as starting up a number of small companies aimed at promoting health innovations, and links between health and sport.

He has been Chief Executive of North West England SHA, West Yorkshire, and South Yorkshire Strategic Health Authorities and Tees Valley Health Authority and Head of Primary Care at the Department of Health. Mike remains a prominent thought leader and consultant to the NHS throughout the UK

Dr Katherine Brown is an academic based in the UK and the US with over 100 peer-reviewed publications.  She is affiliated with Cambridge and Imperial Universities and the University of Texas. With over 25 years in medical applications, she has extensive expertise in biochemistry, biophysics, infectious disease and bio/nanotechnology.

Rachel Cashman is Managing Director, The Soircas Consultancy and former Head of Clinical and Scientific Policy and Strategy, NHS England

During her 20+ years in the healthcare and life sciences sectors, Rachel has delivered large-scale change and innovation through inter-sectoral collaboration and the development of networks. At NHS England, she led the establishment of Academic Health Science Networks (AHSNs) and the process to create the first nationally commissioned network of Genomic Medicine Centres, utilising the latest scientific techniques in understanding human DNA in order to better predict, precisely diagnose and personalise treatment of cancers and rare disease.

She has worked with NHS Trusts and CCGs and their local health and care system partners to develop appropriate governance and infrastructure in response to the NHS Five Year Forward View and the emergence of the Sustainability and Transformation Partnerships. As a Board member at University Hospitals Birmingham NHS Foundation Trust and Heart of England NHS Trust, Rachel designed the strategic business case and engagement process for the proposed merger. Rachel has played an integral role in helping the NHS utilise rapid assessment protocols to evaluate potential partnership opportunities such as hospital chains, franchise models, mergers, accountable care organisations and multi-specialty community provider organisations.

Preventing Infections and Reducing AMR

We have been talking prevention for some time so are pleased to see this report from Public Health England advocating right-first-time devices.

Read the full summary here

Urology Awareness Month

Review of the 2017 Forum

From AMR to UTIs, independent participants at this year’s Forum highlighted the clinical and financial case for a “gold standard” urine specimen collection process that would enable accurate analysis and diagnostics.

URINE TROUBLE : WHY A DIAGNOSTIC STANDARD IS OVERDUE

“It seems criminal to us that we are wasting so much time and money on bad sample collection and reading and re-readings, as this has a profound effect on the patient as well as the NHS.”                                                                     Louise de Winter, Chief Executive, The Urology Foundation

The Context of The Need For a Urine Diagnostic Standard 
Increased AMR will see areas of surgery and treatment, such as chemotherapy, unable to continue.    Antibiotics are being over prescribed and over used; it’s a global issue and if there is no progress in overcoming, it is estimated there will be a further 10 million deaths every year worldwide.

This was the stark context in which Philip Howard, NHS Improvement HCAI and AMR Project Lead and Consultant Antimicrobial Pharmacist, Leeds Teaching Hospitals NHS Trust opened proceedings at the Forte Medical Forum held last month at The Royal College of Physicians.

The Forum, convened to discuss “Urine Trouble: Why A Diagnostic Standard is Overdue” debated the importance of urine specimens in the diagnosing of illnesses and the need for the adoption – overwhelmingly supported by those present – of a gold standard that would ultimately save delayed diagnosis, patients’ lives and millions of pounds for the NHS and wider healthcare sector.

Research shows that of the 65m + urine specimens collected every year, up to 22.5% are unreliable.  This represents 14.6 million patients who cannot be diagnosed or treated from their urine specimen which in turn leads to inadequate treatment and increasing costs.   Research also shows contamination rates in the UK vary from 0.3% to over 70%.

Philip Howard presented an overview of the global and national statistics around antimicrobial resistance (AMR) and actions being undertaken by the UK Government and the NHS to respond to the issue.    He said that whilst there had been a year on year reduction of c.difficile, MRSA and MSSA infections by around 80% – the big problem now is  e-coli blood infections.    47% of gram-negative blood infections are caused by UTIs and treating a UTI relies on accurate midstream urine collection.

The Clinical Evidence
Clinical research presented by Professor Frank Chinegwundoh MBE, Consultant Urological Surgeon, Barts Health NHS Trust, and Michael Adamczyk and Michelle Jie, Doctors of Obstetrics and Gynaecology at Royal Surrey County Hospital NHS Trust, about the use of MSU collection in their respective fields, highlighted the efficacy of the Peezy Midstream, as an alternative urine specimen collection process.

Interim results from the Barts Quality Improvement Study showed that contamination rates had been reduced from an historic 17.36% to just over 1.5%.   Prof Chinegwundoh said: “We have used Peezy Midstream with patients in clinic and found fewer repeats; the system also delivers accuracy, efficiency and hygiene.  This (on-going) Quality Audit is designed to substantiate our findings.”

Similar initial findings were shared in the Surrey study along with positive feedback on the usability of the device.  The latter point was further substantiated with the sharing of this year’s NIHR usability study demonstrating that patients liked the product, found it easy to use, hygienic and would prefer to use again if the option was available.

The Economics of Innovation
It was recognised that two of the greatest barriers to innovation adoption were cost, and with that value; and creating the right environment and culture in which change can happen.

Lord Carter’s review highlighted the need for £5 billion of savings within the NHS and this theme was picked up by Professor Trevor Williams, Economist and Visiting Professor at University of Derby.    The level of funding to the NHS, the second largest item of public spending, has decreased and one of its biggest risks is the ageing population; it costs nine times as much to look after someone aged 80-90 compared with someone aged 30.

The consensus that the NHS appears poor at adopting innovation and initiatives to expedite change are often in themselves the barriers to adoption.   SMEs in particular lack the leverage of ‘Big Pharma’ to get into the system – something that the Association of British Healthcare Industries (ABHI) has picked up and is championing on behalf of its SME members.

Using financial and economic data, Professor Williams laid out the case for devices such as Peezy Midstream generating savings of between £76-£138 million in direct savings.  The simplification of the urine collection process that allows direct transfer to an analyser cuts the cost of decanting, and other indirect costs such as cancelled operations, prescribing of broad-spectrum antibiotics, repeat appointments add to the benefits.

He concluded that “the evidence (for the adoption of Peezy) is compelling not just because the device has its own merits, but the backdrop to which its been developed and the need to have not just this device which is fantastic but other devices and other methodologies to effectively provide the care that an aging population requires in an affordable way. Cheaper is not automatically better!”

The Discussion For Change
On creating the culture/environment for change,  the Forum identified the need to change the culture of those working in the healthcare sector – and to provide the necessary education, at all levels, to help implement that change.   Whilst understanding the time pressures of nurses and those on the frontline, it was felt much could be done. Education on urine specimen collection would see less specimens going to labs.

The panel discussion raised a number of interesting facts around the need for improved specimen collection, the issues resulting from poor quality samples, and barriers that needed to be overcome

One delegate observed that over 800 million blood samples are taken every year to pathology model standards – a single universal method which sees the sample go straight into the analyser; the question then has to be ‘when will urine specimen collection and analysis follow a similar model?’  One attending microbiologist reiterated this need by reporting that the current diagnostic criteria is based on the 1965 Cass model which is antiquated and in need of urgent updating.

Adoption of any new innovation is difficult as Professor Chinegwundoh stated “The big challenge is to overcome the reluctance of those in the NHS unable to see the wide picture as not all the savings will hit their particular bottom line.”

In Conclusion
In closing proceedings, Philip Howard outlined the various actions and comments that had been expressed, these included:

  • the need for standardised urine collection supported by clinical and economic evidence
  • for urine specimen to be incorporated into existing initiatives such as Get It Right First Time, the Carter Model Hospital Matrix, Sustainability and Transformation Plans and the forthcoming new diagnostic strategy
  • the need for greater clarity on recurrent UTIs to support patients, GP and hospital specialists and in particular – an information portal for patients
  • more assistance for SMEs in innovation and supporting the pathways to adoption

There is much to be done and we look forward to working with you in ensuring all urine specimens collected in the future are trustworthy and fit for purpose.

Watch the Forum film