Draft Health and Social Care Act 2008 (Regulated Activities) (Amendment) (Coronavirus) (No. 2) Regulations 2020 Draft Health Protection (Coronavirus, testing requirements and standards) (england) Regulations 2020

Alex Norris Excerpts

Thursday 10th December 2020 General Committees

[Alex Norris (Nottingham North) (Lab/Co-op)]

It is pleasure to debate these draft regulations under your chairship, Ms Rees. As we have heard, the two sets of regulations combine to replace the CQC registration requirements for covid-19 test providers with end- to-end accreditation through UKAS. The explanatory memorandum states that the change

“will allow testing providers to qualify for COVID-19 testing and analysis quickly and simply, allowing the market to expand more rapidly….it will also accredit a far wider range of COVID-19 testing-related activities”,

and will be cheaper. I have seen from the Government consultation feedback from stakeholders that that has been positively received, and have not heard of any strong reservations, so we do not intend to oppose the change; indeed, we support it. It is a good thing to do. It takes something quite complicated and newly emerging and makes it quite simple and effective.

I have points on which I seek assurance from the Minister. I am conscious that I tend to pepper my speech with these questions; it may be that not all of them can be addressed today, because some of them are granular, so I would appreciate it if those were followed up in writing.

As the Minister said, certain test providers were out of the scope of CQC regulation. If the service provider was taking blood samples via pinpricks or from veins, and the sample did not need lab analysis, it was out of scope; the same would apply if it was taking blood samples or external tissue with a swab, or just analysing or reporting such samples, and was already registered with the CQC for something else. There is quite a gap there, and an uneven playing field; it is possibly quite confusing.

With the market growing, and a growing number of technologies, a universal system is welcome. It also makes sense to broaden the system to cover all parts of these activities, end to end. That can only be of benefit, from a regulatory standpoint. Do the regulations mean that the end-to-end process will cover all entrants, and that all those undertaking those activities will be treated similarly? I wrote my speech before hearing what the Minister said; I think I heard her confirm that, but I want to make sure.

The staged process makes sense, in terms of ensuring quality at the beginning, and making sure that we do not have to wait long periods for providers to enter the market. Providers entering the accreditation process have to meet a range of standards, which include meeting Departments’ minimum standards for private testing, having a clinical director and meeting requirements under the Medical Devices Regulations 2002. I understand that the requirements were updated in November, a month after they were initially published. Is this the final list, or does the Minister intend to update them again?

Existing providers will need to achieve stage 1 by the end of the year. After that date, new providers must achieve stage 1 before they can deliver testing. Will the Minister give a sense of how long it will take a new provider to enter a market? Stage 2 will require existing providers to meet UKAS’s requirements to ensure that they are progressing towards full accreditation by the end of January, or new providers within four weeks of completing stage 1, if that is later. The 13 key requirements include having carried out a gap analysis in relation to the relevant International Organisation for Standardisation standard; having access to relevant clinical expertise; and having demonstrated meeting technical performance characteristics consistently. Can the Minister confirm that, having talked to providers, she feels that four weeks is adequate time to meet those requirements, particularly for new entrants to the market? What will happen if they do not? Will they get more time? Do they re-enter the system from the beginning? I would be interested to know what happens in the case of failure.

Stage 3 is full accreditation to the relevant ISO standard, whether for lab-based or point-of-care testing. Stage 3 must be met within four months or by 30 June next year, whichever is later. Of course, achieving the standard is really important, and goes a long way to assuring us about fundamental standards of quality and safety, but in such a fast-moving market, if the process takes about six months in total, that is quite a significant window.

Will the Minister share her assessment of the likelihood and the impact of testing providers entering the market at stage 1 or 2, and then failing to achieve stage 3? Are those stage 1 and 2 tests, in her judgment and that of the Department, robust enough to ensure that a risky product will not be out there for months? What safeguards prevent an unscrupulous or low-quality provider from re-entering the stage 1 process with a slightly different product, with no good-faith intention of ever achieving stage 3?

I have no doubt that those in the CQC will be the people who are most cheered by this. I suspect that, given the significant burdens on their time, they will not miss these responsibilities at all. Of course, every action has an equal and opposite reaction, so the regulations will bring more responsibilities to UKAS. Again, I wonder what assessment has been made of the capacity for UKAS to effectively deliver this scheme—certainly at the beginning, a lot of people could be making applications—and of the resourcing implications of ensuring that UKAS can act effectively, in terms of the business interests, and safely in all our interests.

I am conscious that I have peppered a good dozen questions into my remarks, as I always do. These are important points of clarity, however, because this is such an important area. As the Minister says, we all hope and pray for the vaccine every morning, but in the meantime testing is the significant aspect. It is right, as we wish to do more things, that private businesses—the Minister used the example of businesses—want to do testing, for staffing purposes. However, it is important that we proceed in an effective manner. This is a market that is growing and has little precedent. Even a year ago, we had no idea that we would now need such a market in this country. Risks can come with that. What the Government are doing today to put a shape around that is very sensible; we just need to make sure that it works.

[The Chair]

Minister, would you like to respond to those peppered points?