Written evidence submitted by Royal Society of Chemistry (CLL0083)
Introduction
The Institute of Biomedical Science (IBMS) is the professional body for the UK's workforce of 22,000 Health and Care Professions Council (HCPC) registered biomedical scientists.
This workforce is employed largely, but not wholly, in UK pathology laboratories. IBMS members are the UK’s expert scientific workforce in the safe and effective operation of pathology testing and form a key part of the government's testing programme for COVID-19 virus and antibodies.
From the outset of the pandemic, the IBMS, along with other organisations, has been concerned about the lack of a clear and comprehensive testing strategy. For the Health and Social Care Committee and Science and Technology Committee joint inquiry into lessons to be learned from the response to the coronavirus pandemic so far, the IBMS evidence focuses primarily on the testing aspects of the UK government’s COVID-19 response.
Key issues
As the number of cases in the community rose, it became clear that the UK’s limited testing capacity would be insufficient to meet demand. This lack of testing capacity was a key contributing factor to the UK government’s decision to end the ‘containment’ phase and shift to the ‘delay’ phase. Testing capacity was targeted and reserved for patients in hospital.
A number of factors contributed to the limited testing capacity:
On 2 April, the government published its response to address the continuing capacity limitations by launching its five-pillar strategy which signalled the establishment of additional ‘lighthouse laboratories’ and to announce its ambitious target of reaching 100,000 tests per day.
The creation of this additional standalone capacity prompted the IBMS to raise concerns regarding the development of a parallel testing system and its impact on the utilisation of staff, equipment and consumables in both systems.
The announcement of the ambitious testing target, whilst commendable in its ambition to galvanise effort and deliver much needed testing capacity, became a distraction and diverted resource from testing effort to the achievement of an arbitrary political target. Pillar 2 laboratories were incentivised to stockpile consumables which could have been used more effectively by Pillar 1 laboratories.
Pillar 1 and Pillar 2 laboratories have been working in parallel, not in collaboration. This has at times created unhealthy competition with laboratories competing for limited reagents and reducing the number of tests that could be carried out.
Testing capacity is only one element of an effective testing system. Matching capacity and demand has proved to be a challenge to all laboratories delivering COVID-19 testing but the focus on achieving large capacity numbers, such as 100k tests by end of April 2020, was unhelpful. Resources should have been used more effectively by, for example, focussing on IT issues to ensure the test results meet the 24-hour turnaround time target and that the data can be accessed to inform strategic decision making.
Testing capacity is a projection based on reports from laboratories on how many tests they could carry out each day based on availability of resources. Available testing capacity is not the same as utilisation and testing capacity not used on any one day cannot be carried forward for future use. There needed to be robust modelling of demand versus daily capacity across all providers and clear communication with the public where demand outstripped supply.
Whilst calling for greater alignment between Pillar 1 and Pillar 2 laboratories, both in terms of staffing and processes, the IBMS has promoted the importance of all laboratories having appropriately qualified/skilled staff to undertake the testing. Also, the IBMS called for adequate supervision by HCPC registered scientists to assure the quality of the testing and the result –the wrong test result is worse than no result at all. There should have been opportunities to second senior operational staff from UKAS (United Kingdom Accreditation Service) accredited laboratories into lighthouse laboratories and vice versa to share and accelerate learning for the benefit of those being tested.
As was to be expected with the start of the new academic term, staff returned to their universities and, therefore, reduced staffing capacity to deliver testing. On 3rd September the Prime Minister wrote to universities asking for their assistance in scaling up capacity for winter and for them to support the requirement for over 400 staff for lighthouse laboratories and the NHS Test and Trace team by sending back staff who had previously worked there. Since the universities were due to re-open, academics and researchers were expected to resume their normal duties.
With an increase in capacity within both Pillar 1 and 2 laboratories, it is vital that there is an integrated staffing plan to meet this need. The pool of available laboratory staff is limited and integration of staffing resource is vital to ensure that one testing stream does not destabilise the other through ‘poaching’ of staff. The autonomous nature of the individual lighthouse laboratories has led to competition for staff between Pillar 2 laboratories and the shortage of trained staff has led to led to a delay in opening the new lighthouse laboratories.
Testing platforms
As the UK diagnostic industry was starting from a low baseline at the beginning of the pandemic, there was limited availability of instruments and shortages of consumables to support the testing regime.
The government has supported the testing regime through the purchase of analysers, and this is to be welcomed. However, it should be noted that funding needs to be extend beyond the initial equipment purchase to cover the cost of reagents, maintenance of the equipment, staff to operate and integration with clinical IT systems. Reliance on a single provider of analysers and consumables should be avoided as it builds in further risk to the resilience of the testing system.
While a single supplier solution may support consistency in user familiarity and comparability of test results, the risks of security of the supply chain outweigh these benefits. The IBMS, therefore, supports a multiplicity of testing platforms to improve the resilience of the supply chain and advocates for the involvement of HCPC registered scientists, who understand the differences in analyser performance and limitations, ease of use and outputs, as an integral component of the testing regime.
Key to the success of the testing programme is the speed with which results are produced and made available to those who need to know to make clinically informed decisions. The international standard is for all tests to be turned around within 24 hours. In the early stages of the testing programme there were widely reported issues in the turnaround times in the Pillar 2 stream of the programme with performance figures showing that the percentage of 24-hour test turnaround time dropped.
Turnaround time targets and performance against these targets needed to be equitable, well defined and clear across all testing streams. This would have allowed for accurate comparison, early identification of infection ‘hot spots’ and targeted support at both national and local levels.
Linked to turnaround times is the provision of the test result to those who need to know and who can take appropriate action. When the lighthouse laboratories were first established there were concerns that result data from Pillar 2 tests were not getting into all the relevant patient health records fast enough and, in some cases, were not being entered into the patient record at all.
Additionally, local authorities complained that they had not been provided with the data either in sufficient detail or quickly enough to support a local response. Whilst these data issues are reported to have been resolved, future provision of testing in any setting must include integration with existing clinical systems as part of the service specification to ensure that IT links are in place to record rapid testing results.
Raising the public’s expectation in this way needs to be carefully managed otherwise it can raise unreasonable expectations and demands for testing that is not clinically appropriate. Laboratory scientists need time to evaluate new technologies and make considered judgments about the most appropriate implementation of them in diagnosis and management of patients.
Access to rapid testing in the UK has been set up to support whole communities and to complement the national COVID-19 testing strategy for PCR testing across NHS and lighthouse laboratories. The most challenging elements of this arrangement are to now ensure that the most appropriate test is used for the most appropriate population and phase of the pandemic. The use of rapid testing needs to consider the purpose of the test, whether those being tested are symptomatic or asymptomatic, the resource intensity of the test and the cost, the clinical requirement and the balance between rapid turnaround and accuracy of result.
The IBMS has published a statement to support its members and other laboratory professionals in selecting and advising on the most appropriate rapid testing route for patients. This document outlines and assesses the principal rapid testing options currently available for COVID-19 - www.ibms.org/resources/news/sars-cov-2-rapid-testing-options/.
It is important to understand the limitations of rapid tests for infectious diseases in general. For SARS-CoV-2 they are less sensitive than PCR and therefore, are not as effective at detecting the virus in patients who are at the beginning of the infection.
The absence of economies of scale means that decentralised rapid testing can be prohibitively expensive (reports of £140 per test for reagents only), especially when compared to large scale laboratory testing (typically £20 per test for reagents). Rapid testing is also labour intensive and, combined with the cost of consumables, makes it the most expensive modality of testing. There are also issues with rapid testing platforms as they are often difficult to link to existing clinical IT systems to transfer the results to the requesting clinician.
Mass testing provides testing for screening purposes in the wider population. Swabs are collected at sampling centres from symptomatic and asymptomatic individuals. Samples are then processed on a large scale in a laboratory setting which enables thousands of tests to be processed each day. Results for these samples are expected to be reported within 24 hours.
Due to the scale of the testing operations any failures in the system can cause a delay to thousands of sample results being available in a timely manner. Lateral flow devices are being used for rapid mass testing of asymptomatic people. While this may be useful to make assessments about incidence at population level, these devices are not designed to inform definitive diagnoses for individual patients.
Nov 2020