CervicalCheck controversy

Amirani

kaymin wrote: »

At the time a decision was taken to outsource, the QA unit resigned on mass because the outsourced service yielded 1/3 less positives than non-outsourced testing yet their concerns were dismissed. This does not seem to be a normal level of false negatives.

This hasn't been completely clarified yet. We're awaiting the publication of results between the different labs to see if there's any discrepancy.

You're correct in that there were resignations around the decision to outsource over testing thresholds. Whether these actually manifested and what the reasoning is is not completely clear.

Just speculating, but it may have been felt that outsourcing to a slightly less reliable lab would be preferable to having a backlog on smear tests that would take over a year to get through for example. This needs to be made clear and should come out in the inquiry being undertaken.

Amirani

Milkman.. wrote: »

Is it correct to say a false-negative only becomes a false-negative at a later stage and not at the time of reading the slide?

Not saying you're wrong

Well it will always be a false negative. But until you receive follow up information, it's just a "negative". You can only classify it as false if it gets re-examined differently.

kaymin

boombang wrote: »

Smears are inherently unreliable. If they went for a retest it would be with the same unreliable test. It was misleading for MLMcD to suggest that non disclosure damaged health.

That's not correct. The outsourcing screening service gave 1/3 less positive results than the non-outsourced screening service. That's the whole point - the US lab spends 5 minutes analysing each sample because the test is done every year and therefore a missed diagnosis is not as drastic. The screening service in Ireland spends far longer because it is done only every 3 years.

James Brown

glenfieldman wrote: »

...
But this tragic case affects all women in the Republic and not one pop up protest has been organised

What time are you starting and where? If they protest they're criminals, if they don't they are only self interested or something? Who'd be an Irish citizen..read my signature.

boombang wrote: »

I wish people could show some class and not throw statements like this around. The matter is too grave. No virtual death sentence has been given to that poor lady: she's the mostly likely simply the very unfortunate victim of probability.

You seem reluctant to have this even seen as any kind of abnormal, unacceptable process. Trying to find out what happened and ensure it doesn't again is the upmost respect you can give. Throwing claim money is nice but not a solution.

You should contact the media and explain there's virtually nothing to see here, also contact Harris;

Mr Harris also said he wants to get to the bottom of who knew what, and when, and said he had ordered a trawl of documents in the Department of Health.
https://www.rte.ie/news/politics/2018/0511/962713-cabinet-meeting-on-cervical-cancer-controversy/

Matt Barrett wrote: »

You've not shown how this is incorrect:

People died as a direct result of false readings. The company withheld false readings. We are investigating who knew what, when and why. We know Vicky Phelan only found out through her own due diligence.
If the errors were discovered sooner or when discovered patients were told immediately, could lives have been saved?

I'm not sure who you think you are protecting by downplaying this.
It's not merely fools baying for blood because the bias hyped media is pushing buttons. A litany of errors where made and a conscious cover up attempt. People died are dying. We want answers. Blithely suggesting errors happen and the rest is unfortunate, isn't good enough.

Milkman..

Amirani wrote: »

Well it will always be a false negative. But until you receive follow up information, it's just a "negative". You can only classify it as false if it gets re-examined differently.

It's only classified later as false negative

But it would be false -negative at the time of reading would it not

McMurphy

Amirani wrote: »

Mary Lou: "Women's lives were put in jeopardy by the Hse witholding information on false negative smears with the women."

That's disingenuous. Women's lives weren't put in jeopardy and women didn't die because of the HSE not sharing information. Her claim is false and misleading.

As I said, the interview is there if you want to listen back, she never said the HSE caused the deaths (that was your claim), she said that when someone gets a cancer diagnosis, the timing of when that diagnosis is disclosed is very important, she said a physician could lay out options for treatment upon a cancer diagnosis.

You complained about people being disingenuous, then went on to ascribe words to people that was never said.

kaymin

Amirani wrote: »

This hasn't been completely clarified yet. We're awaiting the publication of results between the different labs to see if there's any discrepancy.

You're correct in that there were resignations around the decision to outsource over testing thresholds. Whether these actually manifested and what the reasoning is is not completely clear.

Just speculating, but it may have been felt that outsourcing to a slightly less reliable lab would be preferable to having a backlog on smear tests that would take over a year to get through for example. This needs to be made clear and should come out in the inquiry being undertaken.

The reason for the resignations are clear - the persons involved have been extensively quoted as to their reasons in the press i.e. 1/3 less positive results were coming from the outsourced screening lab.

It comes down to money - the backlog would be cleared if they invested in the testing. Instead they went with the lowest bidder who provided a completely inadequate service given smear tests are conducted every 3 years in Ireland (as opposed to every year in the US).

Amirani

Mr.H wrote: »

OK let's say I am your doctor. I test you for some sort of cancer. I then tell you after a long wait, that you are clear. You have nothing to worry about so go be with your family and enjoy life. Three years later you go for another check with a different doctor. You are told oh have very aggressive cancer and you've had it a while. In the mean time I realise I may have read our results wrong and I can't be sure that you were given the correct result three years ago. If I realised his three years ago you would have been retested. We may have found cancer and began treatment. Three years ago when it is not as aggressive and far along. In fact you may be clear of it by now. But because it doesn't change anything right now I choose to not tell you I made a mistake.

Are you telling me there is no malpractice, no conspiracy and no criminality in those actions?

Yes I would deserve jail time for that.

I think your analogy is fair and is similar to this situation. Once your actions as a doctor were taken in good faith, it would not be malpractice and there would be no criminality as far as I'm aware.

As regards telling me of your error, this is what we should be legislating around. It probably should be mandatory to inform patients of these errors (though there are conflicting views).

It's an unfortunate fact that one of the top 5 causes of death in Irish hospitals is human medical error. Once the doctor was acting in good faith and within clinical parameters, then it's not criminal or malpractice. A family member of mine died due to a surgeon's error, but their error was in no way criminal.

Red_Wake

Mr.H wrote: »

Amirani wrote:

It is wrong. But, you can't just subjectively call something criminal when there are no laws against it. There's no laws in Ireland that mandate the open disclosure of all health information. Maybe we should have such a law, but until then it's objectively not criminal.

OK let's say I am your doctor. I test you for some sort of cancer. I then tell you after a long wait, that you are clear. You have nothing to worry about so go be with your family and enjoy life. Three years later you go for another check with a different doctor. You are told oh have very aggressive cancer and you've had it a while. In the mean time I realise I may have read our results wrong and I can't be sure that you were given the correct result three years ago. If I realised his three years ago you would have been retested. We may have found cancer and began treatment. Three years ago when it is not as aggressive and far along. In fact you may be clear of it by now. But because it doesn't change anything right now I choose to not tell you I made a mistake.

Are you telling me there is no malpractice, no conspiracy and no criminality in those actions?

Yes I would deserve jail time for that.

So you'd jail a doctor who acted in good faith? 

I assume in your above scenario, you'd be in the position of being incapable of alerting the patient to their health problems, due to not being aware of them yourself.

Amirani

Johnny Dogs wrote: »

As I said, the interview is there if you want to listen back, she never said the HSE caused the deaths (that was your claim), she said that when someone gets a cancer diagnosis, the timing of when that diagnosis is disclosed is very important, she said a physician could lay out options for treatment upon a cancer diagnosis.

You complained about people being disingenuous, then went on to ascribe words to people that was never said.

I'm not discussing her radio interview, I'm discussing her tweets. She may well have changed her tune in the past few days, but her initial tweets were disingenous.

Mary Lou: "Women's lives were put in jeopardy by the Hse witholding information on false negative smears with the women."

Disingenuous.

Mary Lou:Precisely. You assert that witholding that information had no material affect on women's treatment.Vicky Phelan expresses a different view.

Also disingenuous.

kaymin

Amirani wrote: »

I'm not discussing her radio interview, I'm discussing her tweets. She may well have changed her tune in the past few days, but her initial tweets were disingenous.

Mary Lou: "Women's lives were put in jeopardy by the Hse witholding information on false negative smears with the women."

Disingenuous.

Mary Lou:Precisely. You assert that witholding that information had no material affect on women's treatment.Vicky Phelan expresses a different view.

Also disingenuous.

I don't see how it is disingenuous. If it is widely known that smear tests conducted by the US lab are not very accurate then women will get the test done by an Irish lab instead who detect 1/3 more positives. The withholding of the fact that testing conducted by the US lab is inaccurate has, most likely, cost lives.

Mr.H

Red_Wake wrote:

I assume in your above scenario, you'd be in the position of being incapable of alerting the patient to their health problems, due to not being aware of them yourself.

But being aware of my error later is not acting in good faith

James Brown

kaymin wrote: »

The reason for the resignations are clear - the persons involved have been extensively quoted as to their reasons in the press i.e. 1/3 less positive results were coming from the outsourced screening lab.

It comes down to money - the backlog would be cleared if they invested in the testing. Instead they went with the lowest bidder who provided a completely inadequate service given smear tests are conducted every 3 years in Ireland (as opposed to every year in the US).

I'd be interested in the details of the bidding process too. It's not beyond the realms of imagination that there may be a conflict of interest there.

Amirani

kaymin wrote: »

The reason for the resignations are clear - the persons involved have been extensively quoted as to their reasons in the press i.e. 1/3 less positive results were coming from the outsourced screening lab.

It comes down to money - the backlog would be cleared if they invested in the testing. Instead they went with the lowest bidder who provided a completely inadequate service given smear tests are conducted every 3 years in Ireland (as opposed to every year in the US).

Yep, there's a very good chance that money is involved. Countless decisions within our health service come down to money; should HPV vaccine be rolled out to girls and boys, should drug X be provided at a cost of €y per year, should we outsource or hire more medical professionals.

People will always lose out in these sorts of decisions, and it's tragic, but it's the nature of not having an unlimited health budget.

The question really is how adequate was the outsourced service and whether it was a reasonable alternative to investing here. These are exactly the sorts of questions that need to be asked.

HeidiHeidi

kaymin wrote: »

I don't see how it is disingenuous. If it is widely known that smear tests conducted by the US lab are not very accurate then women will get the test done by an Irish lab instead who detect 1/3 more positives. The withholding of the fact that testing conducted by the US lab is inaccurate has, most likely, cost lives.

Is it an option though for women to choose who tests their smear samples?

Genuine question, as I was never given that choice, nor was aware of who was doing the testing.

boombang

HeidiHeidi wrote: »

Is it an option though for women to choose who tests their smear samples?

Genuine question, as I was never given that choice, nor was aware of who was doing the testing.

It's divided up on a regional basis. If you live in Dublin and get yours done at the Well Woman centres theirs go to the Coombe.

James Brown

HeidiHeidi wrote: »

Is it an option though for women to choose who tests their smear samples?

Genuine question, as I was never given that choice, nor was aware of who was doing the testing.

It's trust in the state healthcare provider. You don't expect the tests to be sent to a barn in Chechnya either.
Initially the HSE wasn't able to say which lab themselves.

The HSE has been unable to clarify which of the laboratories it contracts to process cervical smears produced inaccurate test results in relation to 206 women.
https://www.irishexaminer.com/ireland/hse-cant-say-which-lab-linked-to-errors-470023.html

boombang

kaymin wrote: »

I don't see how it is disingenuous. If it is widely known that smear tests conducted by the US lab are not very accurate then women will get the test done by an Irish lab instead who detect 1/3 more positives. The withholding of the fact that testing conducted by the US lab is inaccurate has, most likely, cost lives.

Take care not to conflate the issue of which labs to contract with non disclosure. We're taking issue with MLMCD's claims re non disclosure.

boombang

kaymin wrote: »

That's not correct. The outsourcing screening service gave 1/3 less positive results than the non-outsourced screening service. That's the whole point - the US lab spends 5 minutes analysing each sample because the test is done every year and therefore a missed diagnosis is not as drastic. The screening service in Ireland spends far longer because it is done only every 3 years.

TOB has stated that the required Quest to reconfigure their processes for Irish requirements and that the evidence put forward by Dr Gibbons doesn't relate to Quest's performance with CervicalCheck since 2008. Of course, that's not evidence that Quest has worked as well as the others. That evidence still needs to be seen.

McMurphy

Amirani wrote: »

I'm not discussing her radio interview, I'm discussing her tweets. She may well have changed her tune in the past few days, but her initial tweets were disingenous.

Mary Lou: "Women's lives were put in jeopardy by the Hse witholding information on false negative smears with the women."

Disingenuous.

Mary Lou:Precisely. You assert that witholding that information had no material affect on women's treatment.Vicky Phelan expresses a different view.

Also disingenuous.

Her tweets don't state that the hse caused anyone's deaths, that was your claim, and it was in itself disingenuous.

You don't seem to be able to distinguish the difference in putting a life in jeopardy, and causing the loss of a life.


We'll leave it there.

Red_Wake

Mr.H wrote: »

Red_Wake wrote:

I assume in your above scenario, you'd be in the position of being incapable of alerting the patient to their health problems, due to not being aware of them yourself.

But being aware of my error later is not acting in good faith

But by the time you were aware of the error, the patient would be diagnosed with cancer, and receiving treatment. That is how you would have been made aware of your initial error.

In your view, how would notifying the patient of the inevitable statistical error improve their outcome?

kaymin

HeidiHeidi wrote: »

Is it an option though for women to choose who tests their smear samples?

Genuine question, as I was never given that choice, nor was aware of who was doing the testing.

I doubt it especially if going through the public health system - knowing what I know now though and if I was a woman, I'd pay privately if necessary to have it done by an Irish lab.

boombang

Johnny Dogs wrote: »

Her tweets don't state that the hse caused anyone's deaths, that was your claim, and it was in itself disingenuous.

You don't seem to be able to distinguish the difference in putting a life in jeopardy, and causing the loss of a life.


We'll leave it there.

I noted she used very careful language when speaking on this in the Dáil. She didn't say it outright, but the implication was clear. I'm pretty sure she knew what she was doing. She's no fool.

kaymin

boombang wrote: »

TOB has stated that the required Quest to reconfigure their processes for Irish requirements and that the evidence put forward by Dr Gibbons doesn't relate to Quest's performance with CervicalCheck since 2008. Of course, that's not evidence that Quest has worked as well as the others. That evidence still needs to be seen.

Yes, but I wouldn't believe a word that comes from Tony O'Brien. The reasons given for the resignations by the persons who resigned was quite clear. TOB claims the issues were dealt with but just not in the way that others might like - I somehow doubt this.

givyjoe

Red_Wake wrote: »

But by the time you were aware of the error, the patient would be diagnosed with cancer, and receiving treatment. That is how you would have been made aware of your initial error.

In your view, how would notifying the patient of the inevitable statistical error improve their outcome?

I thought the point/problem with these errors and not disclosing the errors... was that if the patients had of been notified, then they would not now be left with terminal cancer, i.e. if the mistake had of been notified when it was discovered.

boombang

kaymin wrote: »

Yes, but I wouldn't believe a word that comes from Tony O'Brien. The reasons given for the resignations by the persons who resigned was quite clear. TOB claims the issues were dealt with but just not in the way that others might like - I somehow doubt this.

I understand your suspicion. I'm going to wait to see what the review says.

Interestingly, I think it's less about how the screen performance panned out and more about what could reasonably be claimed at the time regarding getting the system up to scratch.

Although, ongoing monitoring for poor performance is also an important part of the process for sure.

boombang

givyjoe wrote: »

I thought the point/problem with these errors and not disclosing the errors... was that if the patients had of been notified, then they would not now be left with terminal cancer, i.e. if the mistake had of been notified when it was discovered.

Others in this thread have also been under that impression. Read back over some of the previous posts in reply to Matt and Mr H.

McMurphy

boombang wrote: »

I noted she used very careful language when speaking on this in the D. She didn't say it outright, but the implication was clear. I'm pretty sure she knew what she was doing. She's no fool.

That clears that one up so.

Was there a suggestion about people being disingenuous here?

Red_Wake

givyjoe wrote: »

Red_Wake wrote: »

But by the time you were aware of the error, the patient would be diagnosed with cancer, and receiving treatment. That is how you would have been made aware of your initial error.

In your view, how would notifying the patient of the inevitable statistical error improve their outcome?

I thought the point/problem with these errors and not disclosing the errors... was that if the patients had of been notified, then they would not now be left with terminal cancer, i.e. if the mistake had of been notified when it was discovered.

No this is utterly false. The errors were only discovered when the initial smears were retested following the women in question receiving a diagnosis of cancer. By the time they were aware of the errors in the smear[the false negatives], they were already receiving treatment for cancer.

This is explained several times a page in this topic.

kaymin

boombang wrote: »

Take care not to conflate the issue of which labs to contract with non disclosure. We're taking issue with MLMCD's claims re non disclosure.

Regardless of the lab, non-disclosure of the fact testing gave inaccurate results meant women inappropriately relied on those results to their detriment and possibly their lives. You claim inaccurate results are within normal ranges - all the indications says otherwise - the fact they are settling multi-million lawsuits and what the QA team that resigned have to say about the matter.