Point Of Care Testing – The Supply Chain Crisis

Introduction

Global territories are currently experiencing shortages of multiple products essential for delivering effective healthcare. Having started with shortages of blood collection products such as blood sample tubes, needles and related consumables, the issue is now affecting products used to deliver point of care’s services.

In some cases, service delivery has been interrupted or restricted whilst procurement teams source products from alternative supply chains. The worry is this will not be alleviated in the immediate future, and service providers need to be proactive by introducing measures which assure the delivery of optimal patient care.

Why is the supply chain affected?

The supply chain has been affected in multiple ways and the major elements are shown below:

• Global production sites
• Raw materials
• Production capacity
• Cost of freight
• Customs delays
• Brexit (UK)
• Spiralling costs – fuel, raw materials, wages
• Quality Assurance
• Lack of staff (COVID and vacancies)
• Increased demand – patient backlogs
• Delays leading to cold chain breaches

Global Production Sites

Most products are produced across multiple global locations, having to meet regulations in a range of countries. Often the production of the item is in one country, quality assurance in another, and distribution centres in yet another country. The products are shipped between these locations meaning once they are produced there is a significant delay until the product is released for supply in any given territory.

An interruption at any stage of this chain will mean the customer waits for products, sometimes with little information about back orders or likely delivery times.

Raw Materials

A shortage of raw materials has been offered as a reason for delays, especially plastics, but now we are seeing increased disruption to the manufacturing of other products which do not rely on plastics production or availability. Sensors, test strips, and packaging have all become apparent in the last year. Even a misspelled word on product packaging or in the information for use (IFU) means that product cannot be issued for use and may lead to the product being destroyed.

Production Capacity

Even if raw materials are available, manufacturing has been hit hard by COVID absences and turnover. During the COVID pandemic, companies needed to increase production of certain point of care products to meet the demand often introducing new shift patterns heavily reliant on increased staff numbers.

The number of production sites also increased, with the need to increase the tooling and machinery required to continuously run the production lines. This was effective to meet the demand of the pandemic but may now be unsustainable with a tired, burned-out workforce now looking for alternative work. COVID has not gone away, so the impact of infections within the workforce is still an issue with company policies demanding isolation of staff even if asymptomatic.

Freight Costs

The price of fuel has undoubtedly hit the supply chain. The rise in costs has been attributed to processing crude oil, rather than the cost per barrel. The souring cost of energy is interlinked with the cost of fuel. Global manufacturing and distribution relies heavily on energy and fuel, in turn affecting the supply chain. Unfortunately, vendors are hit hard and those costs have to be passed on to the consumer, or novel supply routes have to be adopted either in the interim or long term. Either way, the customer and end user are likely to bear the impact of the disruption, either through delays or increased cost.

Customs Delays

With so much stock passing through multiple territories and their respective customs processes, the delays being experienced by end users is easily understood. A delay in production in one territory will lead to further delays in transport through subsequent territories. For instance, a product manufactured in the far east may travel through European distribution centres before reaching the intended country. Products requiring refrigeration or freezing during transport are then at risk due to the extended time taken to transport them. Primary providers need to ensure cold chain procedures are met, and if they aren’t met those items will be destroyed leading to further shortages. Additional checks such as those being experienced within the UK due to Brexit are likely to compound the issue.

Quality Assurance

With changes in raw materials comes the risk of quality assurance issues. We must also ask ourselves if products made from different raw materials are of the same specification that we first adopted. There have been many reports of products being manufactured that have not been released for market use, potentially indicating additional problems with quality acceptance.

Whole lot numbers of products have been destroyed pushing back availability dates and leading to back orders across multiple product lines.

Staffing Issues

During the pandemic we have seen an exceptional response from suppliers in trying to protect production and supply. From additional production sites to additional staff and 24 hour shift patterns, the response should be applauded. Covid has not gone away, nor has the expected absence rate due to other illnesses or personal issues. Therefore, some of these measures are now showing signs of ineffectiveness, and burnout cannot be ignored within these professions.

Similarly, measures taken to protect the healthcare workforce, each manufacturer will have measures implemented to preserve their workforce and the production line. This impacts on the productivity of manufacturing sites, the supply chain, and therefore the receipt of goods.

Minimising the risk

One way of minimising the risk of service interruption is mutual aid. Developing relationships with other service providers, either in the locality or part of a wider network, an agreement can be in place to share stock in times of crisis. This requires trust and a mechanism for reimbursement of the products shared.

Procurement teams can also identify alternative consumables to existing supplies. There may be some verification work on the performance of alternatives, but would result in additional options to preserve the service.

In discussion with clinical teams, managing demand for point of care tests affected by supply chain interruption might be necessary. Although this is a decision not taken lightly, it will ensure testing capacity is retained for the patients most in need. This requires good communication and potentially executive and/or medical director sign off, depending on responsibilities within the governance structure. Stock may be centrally controlled and issuing limited on a case by case basis.

Another way of limiting consumable use, especially with test strip/single use cartridge technology is to reduce the frequency of quality control testing. This must be done in a safe way by reviewing overall quality control performance within the service before making any changes. Devices that show stability may allow for a relaxing of the frequency of testing. A risk assessment should be produced and a narrative explaining the rationale.

Supply interruption may also offer an opportunity to re-educate users. Testing volumes can easily increase and go unchecked year by year unless the point of care service providers regularly review test numbers. This is often monitored throughout the year across the clinical landscape but is time consuming unless a sophisticated middleware is in use to compare activity over time.

As part of any testing frequency changes, service users could be reminded of why the test is performed and for which patients, whilst being directed to testing protocols or national guidance. This may serve as a reset and help control future testing activity with associated financial and clinical benefits.

Central Control

Where severe shortages of critical tests occurs, there is likely to be a level of control implemented by national bodies. For this to be effective, networks need to engage with the national body in their respective global territory. This may require each organisation or network to report their stock holding resulting in retrieval and reallocation to other services in greater need.

Reallocation also works internally where issued stock should be retrieved and provided to areas where critical stock levels exist.

National networks will be in constant communication with suppliers and alternative supply chains to source stock on behalf of care deliverers. Engaging in these national networks through service leads, procurement leads and quality managers is key to staying informed of evolving and resolving situations.

Communication from Suppliers

In recent supply crises the end users have been informed far too late to put adequate measures in place. Better communication from manufacturers and distributors is required to avoid catastrophic impact on areas of patient care. Not all point of care tests are available in the local laboratory, and when it comes to volumes of testing, for example glucose and urinalysis, reverting to laboratory testing will provide additional pressure on services and delays in clinical management of the patient.

It is recognised that all aspects of the supply chain are prone to supply interruption, and that vendors have done everything possible to increase production, obtain raw materials from new sources, manage workforce issues and absorb rising costs in year.

Ongoing Challenge

The factors affecting the supply chain are unlikely to be resolved in the coming months and some speculate that the problems will remain for the next two years, with current unaffected supplies experiencing similar frustrations in the future. Healthcare services are complex and heavily reliant on a stable supply chain to deliver optimised patient care.

Organisations, including point of care teams, should devise business continuity plans for their most critical services, develop mutual aid agreements and source alternative products that can be adopted rapidly to maintain services that must not be interrupted.