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Just in time

A look at how and why the blood tubes shortage happened, the implications and if a procurement overhaul is needed.

On 10 August this year NHS England announced: “We have been notified of a supply disruption in relation to Becton Dickinson (BD) on their Blood Specimen Collection Portfolio.”

The tubes affected by the shortage were 5 mls yellow top – SST II – clotted sample and purple top – EDTA. 

A guidance document from NHS England and NHS Improvement stated: “All primary care and community testing must be halted until 17 September 2021, except for clinically urgent testing” and that “acute and mental health trusts must reduce their demand by a minimum of 25% for the three-week period up to 17 September 2021. We are asking laboratories to help you in documenting this change.”

The IBMS contributed to the guidance document, and on 20 August IBMS Chief Executive David Wells said: “Our members are involved in performing over 1 billion tests a year in the UK and hundreds of millions of blood tubes are used for several thousand different blood tests. Whilst this could have serious ramifications, we urge our members to follow the guidance set out in this document, should issues arise from any supply disruptions.”

Why did it happen?

BD attributed the shortage to the COVID-19 pandemic creating an unprecedented demand, with the company highlighting difficulties, such as customers attempting to predict the types and amounts of blood tubes they anticipated using on a month-to-month basis. BD also said that global transport delays had further complicated the issue, resulting in more products being held up “than is normal, creating additional delays in deliveries. Raw material suppliers are also challenged to keep up with demand for materials and components”.

However, the IBMS stated that pathology services in England, Scotland and Wales – Northern Ireland is unaffected as it uses a different supplier – experienced major disruptions to their supplies of blood test tubes because of “the ‘just-in-time’ manufacturing model and an over reliance on a limited number of suppliers of the test tubes. Therefore, the routine maintenance closure of the BD factory, along with the increased global demand for blood test tubes, had a knock-on effect for the supply chain, resulting in potential disruption for patients. As pathology services seek alternative products, this will also lead to disruptions in other supply lines, widening the issue.”

Working in partnership

Tony Cambridge is Lead Biomedical Scientist working in pathology management at a busy UK acute care hospital. He says that his department has been involved in managing the supply of blood tubes to their pathology services users: “This has meant that many working hours have been spent on devising strategies for managing the issue of stock and managing demand for pathology tests.” He highlights the national and regional calls that have been made to ensure a standardised approach across networks and “put sufficient oversight in place to review stock levels and ensure continued supply to those services close to depletion. Measures have been taken to recall stock from those sites that have overstock, to advise GPs on prioritising their patient investigations, and combining tests into one tube being requested rather than individual tubes. This has meant a redesign of some workflows and electronic ordering guidance”.

“Many working hours have been spent on devising strategies for managing the issue of stock”

Has patient care been affected? Cambridge says: “Acute and urgent care have been maintained, in my opinion, whereas non-urgent reviews, follow-up testing, and ongoing monitoring of chronic conditions may well see the highest impact.”

Gordon Beattie, National Procurement Director at NHS National Services Scotland (NSS), tells The Biomedical Scientist: “Production issues with one major supplier required NSS to activate our established resilience measures. These measures have successfully assured supplies for NHS Scotland in the short term. By working in partnership with colleagues across the four nations, we also ensured we could continue to fully meet demand through the medium term and beyond.”

He continues: “We work closely with clinical colleagues and the wider laboratory and healthcare science community. NHS Scotland guidance has been collaboratively developed to ensure demand optimisation and builds on best practice in diagnostic test use.” Beattie adds that NSS was “not aware of any negative clinical impact as a result of this temporary supply challenge”, but would “continue to work closely with the clinical and scientific community to ensure that our supply chain remains robust, resilient and responsive to emerging challenges”.

Clearing the backlog

Dr Pablo Millares Martin is a GP and Senior Partner at the Whitehall Surgery in Leeds. He says that the blood tube shortage has occurred at a time when there was a “backlog of monitoring of long-term conditions, as many people did not attend over previous months for their check-up, because of concerns over their safety. Yet the Government is still clear that Quality and Outcomes Framework payments will be dependent on these tests being carried out, even when there is an expected delay on many of the tests, and furthermore, when there are concerns that this crisis is going to last longer. We must be careful on what tests we order.”

Dr Martin said that he and his colleagues are doing more than just urgent tests, as some are needed for the safety of patients. “But for how long are we going to be able to continue doing this limited service? The consequences are simple,” he explains, “we are not able to clear our backlogs; we are criticised for not doing our part on behalf of our patients; and we are expecting financial penalties.”

Weather any storm

On the Isle of Man, however, the blood tube emergency has not had the same ramifications as on the mainland. Charlie Houston is Chief Biomedical Scientist (Biochemistry) for Manx Care, based within the pathology department at Nobles Hospital on the Isle of Man.

“The Isle of Man is not part of the UK, but is a crown dependency,” says Houston. “We have our own NHS, Manx Care, and on the Isle of Man, we’ve always tried to ensure healthy stock levels of all our consumables due to our remote location, and we have enough blood sample collection tubes to last for a number of weeks by which time the situation should have eased.

“Being an island means that we are generally better prepared to deal with shortages of equipment and consumables as we tend not to use the ‘just-in-time’ ordering system.” Houston points out that they keep around two months’ supply “which helps us weather any storm, actual or metaphorical. Also, we do not use the NHS supply chain for blood tubes, although we do use it for some other consumables”.

At present, he says, “there are no restrictions on testing that can be carried out. However, it’s certainly a good time to remind our users to carefully consider whether a test is appropriate and essential as this issue may run for a number of months.”

Can lessons be learned?

Tony Cambridge is clear that the issues seem to be multi-factorial, with everything from a lack of raw material to the logistics chain being blamed for the shortage. Workforce issues, such as the impact of COVID-related isolation cannot be discounted, he says, nor the changes affected by Brexit and withdrawal from the EU. Should any changes be made to the current model of NHS procurement? Cambridge says: “Any procurement service will be looking for value for money in any contract they enter into with a vendor. However, this should not be to the detriment of competition in the marketplace. There are too few suppliers of these essential products, and when one vendor ascends to market leader without adequate competitors in the sector, there is an inevitable loss of flexibility and a risk to service delivery.”

Cambridge also thinks that vendors need to be quicker to respond to challenges such as this, informing customers at the earliest opportunity as to the likelihood of supply disruption: “Measures could have been taken earlier by service providers to limit the impact on patient care, and preserve tubes for the patients most in need.”

Acting Chief Officer of the HealthCare Supply Association (HCSA) Simon Walsh says that the NHS, over many years, has placed a greater emphasis on cost efficiency, driving initiatives that were focused on supplier aggregation and rationalisation. “This example highlights the importance of also investing in supply chain resilience and supplier relationship management to better manage these risks,” he says.

Mark Roscrow, Chairman of the HCSA, highlighted a need for “more supply that is directly under NHS control”. He describes BD as the “dominant force”, thus creating difficulty in bringing on other suppliers: “It’s a problem of their own creation,” he says. “Anyone who is shutting their factory down should do something to plug the gap,” he says, adding, “we had a lot of these procurement problems during the pandemic and we, the NHS, need to consider storing more of these products in the UK so we can be more resilient.”

Too many tests?

Offering a view from general practice, Leeds-based Dr Martin says the shortage of blood tubes “should serve as a catalyst to reconsider the need for so many blood tests”. He adds that it has served to trigger fundamental questions – Are we efficient? Are we sharing information, like results of blood tests, among the different organisations that form part of the NHS?

Dr Martin makes the point that patients and clinicians expect digital information to be shared, but, unfortunately, it is not necessarily the case. He says: “Blood results done in a hospital are not always available to other units. The result is that many tests are duplicated, which is not only an inconvenience to patients with risk of missing relevant details that could change their management, but further additional work for healthcare workers, and, finally, a waste of blood tubes.”

We need to consider storing more of these products in the UK so we can be more resilient

Dr Martin looks back to the origins of digitalisation in the NHS. “There was an aspiration for all information related to a single patient to be available to anyone looking after that individual.” However, due to the many challenges that this approach generated, it was eventually dismantled. Tests are performed and repeated unnecessarily, says Dr Martin. “Considering that each patient in the UK has a unique 10-digit NHS identifier, why is it so hard to hold at least the last tests done in a common repository for the benefit of all? We need one efficient digital NHS, not a million software products lacking sufficient interoperability.”

Engagement

A 2019 study in the journal Nursing Management noted that an aim of the NHS in England is “to work more efficiently and reduce variation and waste in the use of clinical products”. Entitled “An exploration of NHS clinical staff perceptions of changes to clinical products and their procurement”, the study cites the 2016 Carter Report on unwarranted variation in productivity and efficiency in the NHS, which advocated greater collaboration, cooperation and economies of scale, thought to underpin the new 2017 Future Operating Model: “It is designed to change how clinical products are procured as trusts face increasing financial pressure and reconfiguration of services.”

Study author Clare Donohoe notes that while there is a critical role for finance managers “in engaging clinicians in finance decisions, nurses and other clinicians are the ones who commit NHS resources and need a greater understanding of the financial consequences of their actions”.

Donohoe acknowledges, however, that “engaging clinical staff in procurement can be challenging and it is often regarded as a low priority due to clinical staff’s focus on clinical priorities, service delivery and staffing. Engagement can also be affected by resistance to change, organisational culture and structure, personalities, decision-making, aversion to risk and complex governance processes. Improving clinical engagement, therefore, requires good relationships between clinicians and procurement departments.” And, one might add, laboratories.  

Image credit | Neil-Webb

 

 

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