The Immensa loophole: Exploring the government’s role in the Dante lab scandal

News of the Immensa false negative lab scandal broke on the same day as Conservative MP David amesswas murdered, and understandably disappeared quickly from the headlines. In the 10 days since then, the plot has thickened considerably.

First, there’s the possible impact. One estimate is that the false negative results will lead to somewhere between 500 and 1,000 additional deaths. That in itself is reason to pursue exactly what happened and why.

Second, we were soon reminded that the same laboratory had been, or still is, under some kind of DHSC investigation surrounding alleged irregular behaviour at the lab (Sun on Sunday, so no link I’m afraid), and that the parent company also had a questionable record of performance pre-dating Covid.

Third, it also soon came to light that the new head of the new UK Health & Security Agency (UKHSA) and therefore head of so-called NHS Test & Trace, was confused about the Covid testing and laboratory accreditation process that started in January 2021; while she thought filling in the relevant self-accreditation forms as stage 1 in the United Kingdom Accreditation process counted as being accredited by UKAS, UKAS issued a stiff correction to the effect that being accredited involves the tricky process of getting accredited, and that neither Immensa or parent company Dante Labs had done that.

Fourth, it looks very much as though while laboratory work for the NHS Test & Trace programme may have been suspended by the UKHSA, the same laboratory may be continuing to offer its testing services for travel purposes, possibly on the basis that it is not the laboratory itself that has been suspended, but just the contract between Immensa and UKHSA for non-travel testing.

Again, UKHSA looks confused, not least because Dante Labs appears now to have been quietly removed from the list of its private providers of Covid testing (note that this list is not the same as UKAS’s list of accredited providers, because it includes stage 1 self-accredited and stage 2 organizations as well as fully accredited, stage 3 ones).

So there are lots of questions to ask about this firm, and how it is suspended but not suspended. Independent Sage has asked some of them, but there is one big issue, tying together the third and fourth confusions, which seems to have eluded both Indie Sage and mainstream journalists so far: the question of the government’s own role in all of this.

To get a better grasp of where the confusions over Immensa’s non-suspension come, we need to go back to December 17th 2020, when two new pieces of secondary legislation on Covid testing processes came into force.

The first piece exempted Covid testing and laboratory work from the list of regulated activities set out in Schedule 1 of The Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. This means that the kind of work done by Immensa no longer needs to be regulated by the Care Quality Commission (CQC), the body given regulation and enforcement powers to that point.

The second piece of legislation, coming into force on the same day, established UKAS as the accreditation body, with the three stage process described, although UKAS’s new role did not, mysteriously, extend to cover testing:

provided or administered under the National Health Service Act 2006; [or]

provided by a person (P) solely to(i)P’s employees (ii) persons contracted to provide services to P.

Without access to all the details of the Immensa case, it is hard to be sure what has happened, but a plausible scenario, based on an understanding of this legislative change is that Immensa’s contract for Test & Trace work has been suspended commercially, but that, because a) the government exempted labs like Immensa for CQC regulation; and b) allowed a period of self-certification before UKAS accreditation, while still calling it accreditation, there is now a gaping hole in the legal power to stop the Immensa lab from operating, however dangerous or not that operation may be.

That is, CQC no longer has any power to inspect and close, and nor does the UKHSA (or DHSC before its formation) because in the legislation establishing the UKAS accreditation process it did not reserve itself this power.

Moreover, this may explain why the investigation promised by DHSC back when the Sun on Sunday supplied the photos has seemingly never been concluded, or perhaps never even started.

If so, then this looks like more than a government own goal; it looks like the government decision to outsource regulation to UKAS, under terms it now looks like UKAS may have dsagreed with, may be the direct cause of 500 to 1,000 deaths.

But then, a question still remains; why, as the second wave developed, did the government feel the need to tinker with the regulation process at all? What was wrong with the CQC-led process of registration, inspection and enforcement, such that this loophole-creating change in the law had to be rushed through?

Back in January 2021, when I first came across this weird legislative tinkering that made no clinical sense, my conclusion was that it was probably down to intense lobbying by private providers, keen that what they then thought would be the commercial opportunities of Spring 2021 should come their way should come their way, and keen that little encumbrances like the CQC should be set to one side in favour of heavy upfront application fees and then an accreditation process that they could fudge just long enough for them to cash in, at the expense of more reputable organizations:

So this latest government chicanery is on brand: a cynical systematization of profit-making opportunity for firms enabled to form a cartel, though it important to stress that, in contrast to the earlier PPE scandal, they will be conducting more legitimate business (and indeed some organizations on the accredited list are new new get-rich-quick entrants, but established providers who have no choice but to jump through the new regulatory hoops, and manage to do so).

Maybe, I was right, but the prospect of 500 to 1,000 extra, needless deaths brings me anger, not pleasure at my maybe being right.

Legal note: I am not accusing Dante Labs or Immensa of acting illegally at any point.