Mobilizing effective contingency plans for future health system threats: COVID-19 NHS case study

Tony Cambridge

Lead Biomedical Scientist, Pathology Management

Mobilizing effective contingency plans for future health system threats: COVID-19 NHS case study

15 April 2020

Quick Takes

  • In response to the rapid progression of SARS-CoV-2 transmission, contingency plans have been mobilized across healthcare systems

  • Initial key learnings from the NHS reveal that providing essential point of care services to help alleviate health system pressures relies on measures that include protecting staff, effective communication, and rapid expansion of testing accessibility

  • Implementation of these measures may support the more rapid mobilization of contingency plans for healthcare systems facing future pandemics

COVID-19 has sent a shockwave through healthcare systems all over the world. A pandemic of such scale, so rapid in its progression, has identified insufficiencies in healthcare that need serious review before another global threat is upon us.

In a direct response to the progress of the transmission of SARS-CoV-2, contingency plans have been mobilized to protect the NHS workforce, providing essential services within pathology laboratories and the point of care (POC) teams associated with blood sciences laboratories.

Initial planning indicated the following was required:

  • Protect staff through reducing the number of interactions with other staff members
  • Introduce physical distancing within the workplace
  • Reduce the number of staff working within each pathology team where workload supports this
  • Introduce a rotational system of working from home and working in the organization, ensuring more staff do not interact at all

Introducing these measures early sought to reduce the chance of transmitting coronavirus infection throughout the workforce, which would decimate the laboratory’s capability of providing a robust service to the NHS organization. Patient management would therefore remain at optimal levels during the COVID-19 crisis.

Emergency staffing measures protect and support workforce      

Workload monitoring showed a drop in general practitioner and outpatient samples being received in the laboratory, a direct result of the introduction of telephone and online consultations.  A decision was taken to introduce a system where the service would be delivered by smaller teams, alternating their work from home and in the laboratory.

The new rotas were reviewed and supported by senior NHS managers and the executive team of the organization. Particular care was taken to avoid disadvantaging any staff member by introducing these emergency measures.

The main considerations:

  • No staff member to lose out financially
  • No staff member to lose any annual leave if statutory annual leave had already been taken
  • There must be resilience in the rota where staff can be parachuted into a different team if necessary
  • Staff who planned to leave the trust or had recently retired should be retained where possible
  • Regular review of workload, pressure on staff, new absences impacting on service delivery
  • Changes could be made rapidly in response to the COVID-19 situation
  • May return to normal work practices at any time

Where staff were working from home, workload was planned in partnership with a supervisor, and output reviewed throughout the week to ensure appropriate progress was being made.

To enable home working, preparation was required involving the local IT teams who ensured laptops were assigned to key individuals, hospital assets were logged, and access to the necessary drives and applications assured.

Specific considerations for POC testing staff     

Although POC team staff members are mainly employed by the laboratory, there are special considerations when implementing change to work practices:

  • During a pandemic the need for POC testing (POCT) is likely to increase significantly
  • In the case of COVID-19, patients will present with varying levels of respiratory illness
  • Areas of the hospital will be repurposed as assessment areas, COVID-19 positive wards, and critical care
  • These areas will require an increase in POCT provision including blood gas analysis

The ability to introduce a new work pattern that allows working from home will be directly related to the number of staff in the team as well as the roles and responsibilities of each staff member.

Effective communication and national guidance

The success of such measures is fully dependent on effective communication between all levels of management within the organization. Lines of communication need to be quickly set up and key information shared between national institutes and local organizations.

Information required by teams delivering POCT support needs to be current and clear so that appropriate actions can be taken to support patient care. Early guidance was to restrict the use of POCT devices due to the potential for cross contamination of patients. This advice prevented early planning of POCT use. As more was understood about the transmission of the virus, and the realization that POCT solutions were integral to the management of these patients, the guidance was amended to indicate their widespread use with local risk assessments in place.

The impact of the pandemic in all countries presents each healthcare organization with unique challenges, not least providing care environments that meet the needs of the critically ill patient. The speed at which the capacity requirements are changing, based on the volume of patients confirmed as COVID-19 positive, indicates the need to expand the provision of point of care diagnostics in multiple areas.

  • Establish the line of communication with the senior management team
  • Implement local risk assessments for POC test use
  • POCT teams need to know at the earliest opportunity which hospital areas are being repurposed and what the POCT  requirement will be

Rapid expansion of POCT accessibility      

The accessibility and user friendliness of most POC tests makes them an excellent solution for accessing diagnostic information more rapidly than using the main laboratory.

In response to the challenge of monitoring patients confirmed COVID-19 positive, who will present with respiratory illness of varying degrees, blood gas analysis has been the initial focus of expansion plans. Monitoring acid base disorders, electrolyte disturbances and co-oximetry will be essential in assessing the progression of the disease and effectiveness of treatment. Ventilated patients in particular, will need regular blood gas measurements. Hospitals will struggle to cover all newly created COVID-19 areas with a blood gas analyzer.

Suppliers have been inundated with orders for additional devices and healthcare organizations are working hard to repurpose existing blood gas analyzers in their service. Where sites have a blood gas analyzer with relatively low use, they have been redeployed. Lower throughput devices such as handheld analyzers used as an option for backfill. This back-up plan could expand further to provide additional analytical resources at the bedside.

Normal procurement obstacles have been removed in most cases with financial approval delegated to high ranking officials in the organization. Records of COVID-19 related spend will be kept in order to seek reimbursement from central funds.

The following must be established to ensure that POCT solutions are adopted effectively:

  • Implement a re-purposing plan
  • Keep a record of device redeployment – they will need to return to their rightful place
  • Establish the requirements for rapid set up of devices
  • Ensure the POCT leads are informed of the changing plans for critical care expansion
  • Use the organization’s critical incident control center to raise POCT related issues
  • Establish a mechanism for daily feedback

Regular review of POC activities must continue to understand the impact decentralized diagnostics is having on patient care.

Supply chain evaluation to help plan ahead where possible      

Many suppliers have long lead times for analyzer delivery. This is understandable, but also a learning point for manufacturers. However, the scale of the pandemic is like nothing the healthcare system has seen before.

Actions for healthcare organizations to take now:

  • Evaluate the analytical requirements across the service
  • Check lead times and place orders as applicable
  • Record COVID-19 related spend
  • Ensure the supply chain is sound, including delivery of consumables and testing materials such as quality controls
  • Consider multiple devices from different suppliers in order to meet demand. This will increase validation and verification processes, and introduce variation in results

The emergence of the NHS Nightingale hospitals – the newly created 4000 bed temporary hospital based at the ExCel Centre in London, with more across England planned – may have an impact on availability of devices to regional hospitals. Due to the scale of the care being delivered, activities must be backed up by the availability of diagnostics.

Adequate training

The training burden has never been greater. Staff are being moved between teams and may never have performed POC tests before. The resources available in POCT teams are stretched. Use of clinical educators is essential to meet the demand. 

Considerations for healthcare organizations:

  • Review the number of clinical educators and where they are deployed
  • If staff are moving around, ensure a clinical educator is backfilled appropriately
  • Ensure POCT devices are adequately covered in induction training if new staff, or returning staff are being brought in
  • Hospitals are grading wards as red (COVID-19 cases), amber (suspected COVID-19 cases) and green (no COVID-19 cases). POCT staff may not be able to enter red or amber areas to train, and staff deployed in red areas may not be able to leave these areas for training
  • Training should cover simple troubleshooting, maintenance and possibly first fixes

Quality Assurance

Normal quality processes must be followed as closely as possible during this pandemic. This will include internal quality control programs, external quality assurance testing, and review of service performance. POCT leads should ensure the following:

  • Continue to perform and review internal quality control data
  • Ensure the supply chain of quality materials is uninterrupted
  • Plan for interruption to external quality assurance schemes and introduce measures to assure performance
  • Enroll all new devices in external quality assurance schemes
  • Service users must be able to perform the testing in COVID-19 areas as POCT staff will not routinely be able to access the devices

Infection control

Public Health England have provided guidance on handling biological specimens but a local risk assessment is required in order to inform the processes to be introduced. The laboratory is a level 2 containment facility and normal laboratory processes are appropriate for most sample types, however there are exclusions. For POC users, the following applies:

  • Use full personal protective equipment (PPE) when in COVID-19 designated areas
  • Use appropriate PPE whilst in assessment areas
  • Provide infection control measures if service users are moving between “dirty” and clean areas
  • Restrict the movement of devices between these areas. If possible they must remain static
  • Wearing full PPE may restrict users from accessing their operator ID for device log on – consider open access of devices in controlled areas where training is known to have been given to all staff
  • Consider traceability of results if open access is adopted
  • Consult the infection control team and manufacturers regarding decontamination and cleaning of devices

Maintenance, troubleshooting and repairs

The current extension of wards and care units dealing with COVID-19 positive patients has created additional challenges when ensuring maximum uptime of equipment. Many suppliers’ engineers will only make site visits for service critical call outs.

The positioning of POCT analyzers in “dirty” areas makes access difficult, not just for engineers but also the POCT team members who would normally troubleshoot problems. It quickly became apparent that POC team members would be required to enter COVID-19 areas to support the uptime of analytical devices. This required staff to undergo full PPE fitting 

POCT leads should consider:

  • Provision of equipment that needs minimal intervention, for instance cartridge based blood gas analyzers where consumables can be changed by users if a problem occurs i.e. failure due to lodged blood clots
  • Retain a stock of devices that can be exchanged easily such as glucose meters and urinalysis analyzers
  • Cover simple troubleshooting in user training
  • Establish an area where decontaminated equipment can be left for collection
  • Consider establishing a 24 hour support rota for troubleshooting equipment in critical areas

Validation and verification

Due to the rapid adoption of new equipment, there will be a significant amount of verification work to be conducted before first use. If the equipment procured is considered industry standard, or has an appropriate level of published data supporting its safe use, then a simple verification may be sufficient to support the introduction of the device or test. This will require clinical oversight and approval.

New tests or equipment that does not have a strong user base will require wider verification or full validation, depending on the intending use.

Refer to ISO standards 15189:2012 and 22870:2016 for guidance on validation and verification of clinical devices.

IT requirements

It is essential to ensure adequate capture of data whilst rolling out multiple devices in new locations. In order to achieve this, full connectivity should be considered where possible. This ensures results are captured in the electronic patient record (EPR) and full traceability of testing is recorded in related informatics solutions for review.

The following must be considered:

  • Raise the requirement for IT support with senior management in the organization 
  • Ensure IT resources in the organization can support the introduction of new devices
  • Identify data ports, Wi-Fi connections, accessibility
  • Obtain driver details and software release notes from suppliers
  • Use informatics solutions to critically review the provision of POC services

COVID-19 testing at POC

The emergence of COVID-19 testing has been problematic, especially outside of the laboratory. Molecular testing within microbiology laboratories has been expanded quickly across healthcare organizations. As with the supply of POCT devices, there has been a shortage in the availability of the kits and reagents required to meet the testing challenge introduced by governments.

There has also been confusion over who to test and when, to have maximum impact on progression of virus transmission.

There has been an explosion of POC tests coming to market, often with CE marking and performance characteristics derived from small studies involving either patient samples or spiked samples.

These tests are mainly lateral flow IgM and IgG tests with varying specificity and sensitivity for these antibodies.1,2 There is little guidance around when to test patients so that antibody levels are above the detectable levels. There is therefore an increased risk of false negatives, which may lead to increased infection rates in the community. 

There are also antigen tests on the way although details are not readily available at this point in time. Rapid molecular POC tests are also being released often with the caveat of ‘for emergency use only’. These tests would be preferable if performance is deemed adequate, but throughput is low and not fit for mass testing.

Consideration is required for the following:

  • Adopt POCT molecular tests for areas requiring low volume testing
  • Use antibody tests to establish the level of immunity in the community
  • Use data from antibody testing to inform future vaccination programs when a vaccine becomes available
  • Adopt a combination of tests to meet the testing challenge, following a clinically led testing program
  • No one test is appropriate for mass screening due to low throughput, long assay times, and additional resources required

Future global healthcare response

It is clear that the world was not prepared for a global healthcare response. Existing contingency plans for a pandemic on this scale have been inadequate when it comes to staffing, personal protective equipment, testing capabilities and healthcare facilities falling short of what is required.

There is no blame here. The world has not had to deal with such a healthcare crisis of this magnitude in modern times. However, the lessons learned following the emergence of SARS-CoV-2 in late 2019 present an opportunity for the global healthcare community to reflect upon the challenges faced and take measures to improve future responses.  

Key learnings from the NHS that can support the more rapid mobilization of contingency plans for healthcare systems facing future pandemics include:

  • Share information from the international community with NHS leads at the earliest opportunity
  • Develop resilience and redundancy in the healthcare service to deal with the impact of a global pandemic on the NHS service
  • Work closely with the diagnostics industry to ensure supply can be optimized rapidly
  • Engage with manufacturing to ensure production can be maximized for key items such as PPE
  • Develop the NHS workforce to be ready for a similar global challenge. This requires a continuous flow of new healthcare workers into emergency and critical medicine
  • POC testing must be supported to establish well governed, safe and effective services including equipment, staff resources and a complete national electronic patient record capturing all POC results
  • Carefully consider the communication of national testing availability and capability in order to control the message being perpetuated

Tony Cambridge is the Managing Director of Thornhill Healthcare Events and Consultancy, and 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 recently co-wrote the British Society of Haematology’s point of care testing guideline for general hematology and remains active across healthcare platforms offering advice and guidance. He is also a member of a global diagnostics company’s scientific advisory committee.

References

  1. Okba et al. (2020). Emerg Infect Dis 26, https://doi.org/10.3201/eid2607.200841 [Accessed April 2020]
  2. Bell. (2020). Article available from https://www.research.ox.ac.uk/Article/2020-04-05-trouble-in-testing-land [Accessed April 2020]