On 10 December 2020, the Grand Committee of the House of Lords is due to debate together the draft Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020 and the draft Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020. Both instruments were laid under the draft affirmative procedure. This means they must be approved by both Houses before they can be brought into force.
Current regulatory regime
In 2014, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 defined the activities that are subject to regulation by the Care Quality Commission (CQC). The CQC is the body that monitors, inspects and regulate care services to make sure they meet fundamental standards of quality and safety. Under these regulations as they stand, the treatment of providers seeking to offer coronavirus testing is complex: some would fall under the regime and some would be exempt. For example, the Government says testing bodies:
- would need to be regulated if their method involves the “removal of bodily cells, tissues or fluid samples” (such as saliva or mucus from a mouth or nose swab); but
- would not need to be regulated if they use a blood sample taken through a pin prick or from a vein, and that sample does not need to go to a laboratory for analysis.
The Government argues the complexity of the 2014 instrument means that “it can be difficult for new entrants into the Covid-19 testing market to navigate their way through the regulations, resulting in delays and costs being incurred”. In addition, it states that registration with the CQC can take “up to ten weeks”.
There are no mandatory standards that regulate or assure end-to-end testing services under the existing regime. End-to-end testing means “the process from booking patients in, sample collection, transporting samples and tests for analysis, to test analysis and communication of the results”.
Purpose of the regulations
In proposing the new regulatory regime, the Government argues that its intention is to simplify the existing regulations and remove barriers to entry into the market for private Covid-19 test providers. It seeks to do this by:
- removing all coronavirus testing from the CQC regulatory requirements through the Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020; and
- establishing a replacement system for organisations that offer end-to-end Covid-19 testing services on a commercial basis. This would be achieved through the draft Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020.
The Government intends that the existing regime will lapse and the new one come into force on the same day.
Proposed new regulatory regime
The proposed new regulatory regime, implemented though the draft Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020, involves accreditation through the United Kingdom Accreditation Service (UKAS). UKAS is an existing government body that assesses and provides accreditation to organisations, including medical laboratories and point of care testing services. Under the proposal, UKAS would provide a national accreditation service on wider aspects of testing, including the processing, analysing and reporting of tests.
The regulations would apply to private organisations that offer end-to-end Covid-19 testing to the general public on a commercial basis. The regulations would not apply to charities or to organisations that have set up their own, free of charge, testing capabilities for use on their employees only.
Certain parts of the end-to-end process can be sub-contracted to different organisations. The draft explanatory memorandum acknowledges this and confirms that the regulations would only apply to organisations that have overall responsibility for the service. A subcontracting organisation would be responsible for ensuring that any subcontractors worked in line with the regulations.
The proposed regime would require private organisations to follow the three-stage process for UKAS accreditation:
- Stage 1: UKAS application: organisations would make a self-declaration against the Department of Health and Social Care’s minimum standards.
- Stage 2: UKAS appraisal: organisations would be required to meet a set of requirements as set out by UKAS.
- Stage 3: UKAS accreditation: this is the final stage of the process and would see organisations receive UKAS accreditation.
The regulations provide for timeframes within which applicant organisations must have completed all three stages.
The secretary of state would be required to review the new regime within six months from the day that the regulations come into force.
Potential benefits of the proposed regime
The Government contend that benefits of the new approach would include:
- allowing providers to enter the market more quickly and at lower cost;
- providing more comprehensive oversight of the entire market;
- assuring quality of testing standards; and
- ensuring “novel, non-clinical testing technologies and methods” do not need to be individually exempted from regulation.
Without these measures, the Government believes that the general public could lack assurance about any private tests they choose to purchase. As the number of private testing services increase, ministers contend the more difficult it would be for the public to determine which providers offer the best and most appropriate testing. The Government argues that regulations will assure the general public about the standards of commercial testing and its ability to tell individuals that they should isolate following a positive test result or comply with other legal obligations.
The Government reported that it had consulted a range of test providers and industry groups on the new measures. It said that “overall, the feedback from stakeholders was largely in favour of this approach”. However, it reported concerns about the UKAS system being able to respond to innovative approaches to test provision. In response, UKAS has agreed to allow new providers to apply for Covid-19 testing accreditation, while in parallel applying for “a flexible scope that allows providers to make changes to their accredited procedures within an agreed remit”. UKAS said this procedure could “reduce assessment timelines to a matter of days”.
The regulations were laid before Parliament on 23 and 25 November 2020. The Joint Committee on Statutory Instruments has considered the draft Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020 and did not raise any concerns. At the time of writing, the committee had not considered the Health Protection (Coronavirus, Testing Requirements and Standards) (England) Regulations 2020. The House of Lords Secondary Legislation Scrutiny Committee has not yet considered either set of regulations.
The House of Commons is due to consider both instruments in a delegated legislation committee on 10 December 2020, the same day as the House of Lords debate.
Summaries of the CQC’s current regulatory system, and the UKAS accreditation process, can be found at:
- Care Quality Commission, ‘Regulating coronavirus (Covid-19) testing’, 27 November 2020
- United Kingdom Accreditation Service, ‘The route to accreditation’, accessed 3 December 2020
Cover image by Colin D on Unsplash.