As the United Kingdom, and many other countries, slowly emerge from the primary wave of SARS-CoV-2 infections, the time is right to reflect on the measures taken to support the NHS acute care response.
Key Article Elements
- Reflect on the measures taken to support COVID-19 patient care
- Consider the options for decentralised diagnostics
- Address the challenges that POCT users face in delivering care for infected patients
- Develop partnerships with diagnostics companies
- Logistical points for consideration
- Adopt innovative technology and informatics
As the pandemic traversed the globe, the media focus was on procuring ventilators, personal protective equipment (PPE) and preparing clinical areas to care for patients with COVID-19. Whilst healthcare leaders and care providers mobilised extensive plans in anticipation of the critical care surge, pathology clinicians, managers and healthcare scientists devised solutions to provide the essential diagnostic tools required to support this respiratory illness. Patients with underlying health conditions would present as the highest risk for critical care and ventilation.
The response evolved on a day by day basis, with the rapid introduction of molecular RT-PCR testing in the clinical laboratory. Huge flexibility was shown by healthcare scientists and technical assistants to provide 24 hour laboratory analysis. All hospitalised patients were eventually tested for COVID-19 with isolation areas created for assessing infection status and providing high dependency care to those patients exhibiting advanced symptoms of the disease.
It was clear from the outset that one of the fundamental tools required to manage patients effectively would be blood gas analysis, electrolyte and metabolite measurements, and co-oximetry. These parameters are readily available from a number of vendors distributing blood gas analysers. The challenge facing point of care teams across secondary care was simple; which blood gas system would best meet the needs of care providers in areas where access would be restricted, full PPE worn, and time constraints evident.
The assessment of the key factors indicated a cartridge based system with high performance, high throughput, wide testing panel, and minimal user intervention would be preferable over any other system. The GEM Premier 5000 critical care analyser met the brief, with additional features assuring the quality of results, improved governance and operational oversight.
The GEM Premier 5000 offered great flexibility with a range of cartridge sizes (75 rising to 600 tests per cartridge). This proved ideal for low and high use areas where cartridge changes performed by users could be minimised and waste vastly reduced.
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The system consists of one consumable; the cartridge named GEM PAK, which is stored at room temperature and is ready for use in around 40 minutes from installation. In COVID-19 positive areas where staff are in full PPE which includes gloves, gown, face mask and visor/goggles, minimising the interaction expected of the user is paramount. With minimal training any user can change a GEM PAK meaning point of care team members are not called upon to provide continuous analytical uptime.
Changing a GEM PAK once every 600 tests in a high dependency or critical care area has a positive impact on the time healthcare providers spend with infected patients. Storing consumables at room temperature, with no warm up time, is attractive for many reasons including the removal of the need for large refrigerated storage areas.
The system is easy to clean, disposal of used consumables (the GEM PAK) is simple, and all infection control guidelines are met without any special considerations even in COVID-19 areas.
GEMWeb Plus 500, the custom connectivity solution which connects to the GEM family of devices offers added benefits to point of care team members. Where access to devices became problematic in COVID-19 areas, the operational oversight was still provided through the middleware. The number of tests performed, operator management, informatics and quality assurance data can all be managed through this one stop solution.
GEM Premier 5000 analysers feature Intelligent Quality Management (iQM2), featuring IntraSpect™ technology. iQM2 ensures the validity of every result by testing the suitability of each sample for analysis. In essence the quality assurance is automated, detecting errors in the sample in real time by analysing 5 solutions before, during and after sample analysis.
Clots, microbubbles and other anomalies are detected automatically. Where clots have been detected the analyser will flush the obstruction to waste, ensuring the continued availability of the remaining tests in the PAK. Where a clot is unable to be removed automatically, the validity of subsequent samples is assured by rejecting the PAK, prompting a change for a new cartridge.
All interventions and automated processes are logged for complete traceability, and recalled through the GEMWeb Plus solution. IntraSpect™ technology detects transient errors that other traditional QC methods can miss, detecting the presence of compounds known to interfere with the methodologies employed in these solutions. The potential benefit of iQM2 is illustrated below.
The intelligent corrective actions initiated by iQM2 is a novel feature, supporting the healthcare professional by ensuring GEM Premier 5000 analysers are optimised for use every time they are accessed. The accuracy and precision of results is paramount during a health crisis such as the SARS-CoV-2 pandemic.
A diagnostics solution can only be effective when the vendor can meet the demands of the customer in a health crisis. Werfen have scored top marks during this unprecedented period, ensuring short lead times for analysers, scaling up manufacturing to meet increased GEM PAK demand, and preserving the supply chain and logistics. Increasing testing capacity could have been a significant challenge had Werfen not responded to the challenge and I congratulate the teams in manufacturing, export and implementation for their efforts in ensuring healthcare workers can provide uninterrupted clinical services.
We are now seeing a relaxation of lockdown across many countries where movement of people will bring a risk of a second wave of infections. Some geographical areas which have managed to minimise the level of infection in the local populations could be worst hit, and the critical care surge could be greater than the initial wave of infections.
Maintaining capacity is key to reacting rapidly to those prospective infections. Many hospitals will have procured more analytical capacity than subsequently needed during the first wave. This may lead to cancelled orders with vendors who have not yet delivered those units due to long lead times. The risk here is that those cancelled orders may ultimately be required, and it will be too late to reverse the decision if an order is withdrawn by the time the tests are required. My advice is to stockpile diagnostic solutions for future escalation.
Criticism of the diagnostics sector has been widespread during this pandemic. Some vendors have been better positioned to react to the challenge than others, but there is no blame here. A lack of investment in different territories has reduced the ability to upscale production in response to a crisis we are now experiencing. Some countries have little or no investment in their own diagnostics landscape which requires immediate review.
The popular opinion is that we will be living with this coronavirus for years where it will settle into the community, with infections spiking from time to time in different geographical areas. We need to be prepared for additional waves of infections, meaning the plans to rapidly expand critical care capacity must remain in place. Partnerships and associations with trusted vendors will ensure that these plans can be effectively implemented with no impact on the quality of care received by our patients.
This is uncharted territory, but we have seen how this virus can disrupt our day to day lives, many have paid the ultimate price, so we must be ready to escalate contingency plans for the future. Adopting the best diagnostics solutions is paramount. The GEM Premier 5000 critical care analyser could be a welcome addition to your diagnostics portfolio.
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Tony Cambridge is the Managing Director of Thornhill Healthcare Events and Consultancy, and former Lead Biomedical Scientist in the Pathology Management team of a busy acute care hospital in England. He frequently speaks at national and international healthcare events, and is a key opinion leader for point of care testing. He is also a member…