Member Info for RegulatorUK

TWat's a Covidiot as well. Quelle surprise!

"but how would they know whose finger got pricked? You could get a mate who is immune to do it..."

There has to be a certain level of trust - and this could be backed up by significant penalties for cheating.

"I’m a web-developer by trade. I’ve had a quick look at the source code on GITHUB repository.

So, it looks like it’s an app that walks the user through how to take a blood sample, upload it and then get the result.

Steps involved start with “Check your kit”; I would assume: does your kit have all the bits.

Then there are app calls for “collect blood sample”, “prick finger”, “scan”, “wait”, “test complete”.

There’s also a reference to a TestKitID, so this is how they’d be able to tie the test to your phone. (I’m assuming it’s designed to be run on our phones.)"

Very similar to some of the apps that have been used elsewhere.

"Checkmate (often shortened to mate) is a game position in chess and other chess-like games in which a player's king is in check (threatened with capture) and there is no way to avoid the threat. Checkmating the opponent wins the game."

If you're going to copy and paste a quote from Wikipedia, can you please at least make sure it is relevant to the discussion?

*reporters... not 'reported'. Can't blame the spellchecker this time. :-(

I think you missed the wink ...

And Deeks is a twat. The Grauniad (not a typo) used to be a half decent paper but it went downhill under Rusbridger and Viner seems determined to kill it off. There are a few good reported and columnists on there still though (what would one do without e regular dose of Marina Hyde, eh?)

Depends on which Roll-Royce you are referring to. Roll-Royce (cars) are a subsidiary of BMW.

Rolls-Royce Holding plc (Aerospace, Defence, Energy and Marine) are an independent plc and the second largest manufacturer of aircraft engines in the world. it is the plc that is financially shaky at the moment, in part due to the knock-on impact from the significant decrease in aviation.

"The DHSC say they are absolutely on track for 500,000 tests a day."

Given that they've lied consistently and fudged the figures, and based on extensive experience of dealing with them, I think think I'll give assurances from DHSC the weight they truly deserve... ;-)

"Colin King, CEO of Omega, commented: “We’re very pleased that the self-test usability study has completed and that
we are progressing towards our goal of MHRA approval for self-test home use. We cannot give a timescale for when
this might be achieved but we look forward to updating shareholders on further developments.”
(From the RNS on 7 September)

Self-test use requires MHRA approval. Professional POC use doesn't (as the test is CE marked and registered). The thing to remembers is that the Government is likely to order both types of tests for different parts of the five pillars.

It is highly unlikely that the Government would order self-use tests without MHRA approval, as that would open them to potential liabilities (there is no blanket liability waiver under the current coronavirus regulations). They've already ****ed up with some of the current tests and are facing legal action - they can't afford to **** up again.

Indemnity* insurers for healthcare providers - both NHS and IS - require use of approved tests. These can either be those that are CE marked and registered (i.e. the UK-RTC professional POC AbC19 test) or self-use tests that have been subject to MHRA approval (which will be the UK-RTC AbC19 self-use test).

But the key take away from this all is: sit back and stop worrying. All will fall into place in due course and we have an exciting few months ahead of us.

* please note that in relation to NHS activity, either from NHS or IS providers, the indemnity being referred to is public and employer liability, as clinical negligence** indemnity for NHS activity is covered by the NHS Clinical Negligence Scheme for Trusts. In relation to private clinical activity, either by NHS or IS providers, the indemnity will also relate to clinical negligence as this cover has to be privately procured.

** as healthcare providers are required to have Covid-safe processes, arguably issues arising from the use of non-approved tests could be argued to be clinical negligence.

*

"The issue is with the lab based testing that BP Jo has promised to expand to 500k a day by end of October. That looks like it won't be met.

However, ODX can come to his rescue immediately. Once the tick in the box exercise is completed by MHRA."

The lab based testing is molecular and antigen. The UK-RTC test is antibody. At present, ODX doesn't have an antigen test. Mologic does have an ELISA test but that will be impacted by the same shortages as other lab based tests.

Let's stop fretting (It'll give us wrinkles) and just sit back and relax. Colin will deliver...

I've seen those figures and some of the initial responses to them. There is some scepticism about the accuracy, as the adjustments seem somewhat arbitrary and determinative.

That said, it won't really impact on the needs for the UK-RTC gold standard tests...

"Incorrect. All care homes must and will be registered. The owners of these care homes can then request tests on behalf of their staff, regardless of whether their staff are registered or not."

Wrong. CQC registration is *not * the same thing as registration as a healthcare professional (a registered healthcare professional is someone registered with one of the statutory healthcare regulators, e.g. the GMC, the NMC, the GPC, etc) . The CE marked professional use POC test can only be used by registered healthcare professionals.

Nursing homes are required to have registered healthcare professionals on their staff. Therefore, those staff will be able to undertake tests on colleagues and patients.

Care homes are not required to have registered healthcare professionals on staff if they are not providing nursing care (which the majority don't). Registered managers (who are registered with CQC) are not registered healthcare professionals unless they are also registered with one of the statutory health profession regulators.

Care home staff who are not registered health care professionals *cannot* administer professional use POC tests to colleagues or residents. They would be able to assist residents with undertaking a self-test, as and when self-tests are authorised by MHRA and the care homes are able to procure them.

My colleagues in care homes are telling me they are not currently able to access relevant tests and they have not been issued with clear guidance from HMG. That doesn't surprise me, as HMG have a habit of issuing guidance at the last minute and it being garbled nonsense.

"Incorrect. Abingdon Health are the only ones at this present moment manufacturing the ABC-19 test. If they cannot meet demands, then ODX will be called in to help out. You can email Colin for confirmation"

Colin confirmed to me the position I put forward earlier.

"Thanks again for repeating what I stated, Hospitals can order these tests through whichever supply chains they normally use."

I didn't repeat what you said. I pointed out you don't know what the actual position is. As some will be aware (if you look back at my posts) I was in a briefing with our pathology team yesterday... guess what we were discussing? Take a peek at the Health Service Journal as well.

"Absolutely incorrect. Pharmacy staff fall under key Health workers so are eligible for the test as well. They are not available to members of the public. This is clearly stated on Abingdon Health website. These Pharmacies have not received any orders asking them to hold off selling to the public. There are no tests available to the public as of yet."

You're conflating things again. I made no comment on who will be eligible for testing - I was talking about who was placing pre-order for tests. The large pharmacy chains are doing just that, as they will be offering professional use POC tests to the public. They've been asked not to roll those services out yet.

"Why doesn't ODX have any orders yet? They have capacity for 200k a weel, have sent us all a picture for expanding to 500k. They have their test signed sealed and ready to go, but not sold. Whats the verdict here?"

All orders for the AbC19 antibody test are going through CIGA, who are leading on that for the consortium. They are not going direct to the individual manufacturer (e.g. ODX).

"Tricky.
As with the previous Test and trace app and failures will there not be a lapse period to see how this goes. Just because the App is launched surely there will be a week to see how it works."

The app has already been rolled out to select users (in the Isle of Wight, the London Borough of Newham and amongst NHS volunteers), to test its functionality. I understand that there have been some issues identified that have been fed back to the developers - and which have supposedly been addressed (not holding my breath though). I don't think anything will be allowed to hold up the much vaunted launch tomorrow - even if it doesn't work perfectly they'll push it out, otherwise it will be yet another private sector/government failure (to add to the catalogues of failures to date)...

"For Professional use only means for doctors, nurses, dental surgeons, and people that work in care homes"

For 'professional use' means by a registered healthcare professional, where it falls within their sphere of competence. That would include doctors, nurses, dentists and pharmacists - it would not include those working in care homes unless they are also a registered healthcare professional.

"Abingdon Health are currently the only ones producing this test. If demand increases to the point where they cannot cope, this is when ODX will be called in to help out with manufacturing."

As I understand it, all the UK-RTC manufacturing partners are currently manufacturing to enable them to deal with any government order and the professional use pre-orders currently being gathered on behalf of the consortium by CIGA.

"The current tests for Professional use are not ordered by the Govt, they are ordered independently through Hospitals and the other Health care settings mentioned earlier."

It's not quite that straightforward. Hospitals (in England) have been told that they should not ordering directly but via NHS supply routes... it's tied in with a somewhat bizarre instruction from DHSC about them not testing staff and patients (I know - bonkers!) GPs have been told something similar.

At present, dentists and pharmacists are ordering. The big chains (Boots, Superdrug, etc) will be offering professional POC tests alongside their other testing/vaccination services. They've been asked to hold off rolling it out at the moment.

From what I gather from colleagues, care and nursing homes have (once again) been left in the dark about how they will access POC test - particularly if they have no registered healthcare professionals on the staff.

Thanks to HMRC...

Because the professional sales will be from spare capacity once any government order is confirmed. They have to find out what any government order will be *before* they know what capacity will be available for professional sales.

They are taking pre-orders for professional sales. Once any government order is confirmed they'll then be able to let those buyers know when delivery will be.

I have a fundamental problem with charging people for public health testing... which is what this is. There is a significant proportion of the population for which the cost of a test - even if subsidised - may be prohibitive. This runs the risk of excluding people from participating in areas of public life nd creating 'second class citizens'.

Moreover, it fundamentally undermines the basic principle that this sort of access to public health measures should be free at the point of use - just as other public health measures are - and it runs the risk of leading people to participate in public events without the necessary testing.

I think this would be a cynical - and ultimately foolish - move by the government.

I'm going to have to stop watching the statement as I've got call with our testing leads (which could be interesing)...

Oof! The Ben Bradshaw question rattled him... and he avoided the point by waffling on about freedom.