‘We Are Very Sorry’

at

CervicalCheck; Dublin City University president Prof Brian MacCraith

The Irish Times is reporting that a woman, who wants to be identified as Ms Scullion, made contact with the newspaper in the wake of Dublin City University president Prof Brian MacCraith’s report on delays in the issuing cervical screening HPV retest results to women.

The delays related to a Quest Diagnostics’ laboratory based at Chantilly in Virginia, USA, and Prof MacCraith found that 4,088 cases were affected by an IT problem.

Some 873 women who had repeat HPV tests were not sent results while, in the case of the remaining 3,215 women, results were sent to GPs but not to the women themselves.

Ms Scullion told The Irish Times that she was one of the 873 women and that she received a letter on Tuesday, August 6, telling her that she tested negative for HPV in her HPV retest.

But, Ms Scullion told the the newspaper, she is HPV positive – and she knows this from a previous test.

Further to this…

Marie O’Halloran reports in The Irish Times:

…The HSE on Wednesday confirmed that almost half of the 873 women received a letter in the last week from CervicalCheck that “contained an inaccuracy”.

…In a statement, the HSE said in the letters sent out, “we also confirmed that the result of these women’s HPV re-test was unchanged ‘and remains HPV negative’. However, for some women, this should have read ‘and remains HPV positive’. This was an error on our part and we are very sorry for any confusion it may have caused.”

*Thud*

CervicalCheck sends letter with incorrect test results to 400 women (Marie O’Halloran, The Irish Times)

Previously: No Checks

10 thoughts on “‘We Are Very Sorry’

  1. eoin

    So

    (1) the tests which were done at an unapproved lab
    (2) and which are up to a year late being sent by the lab to the patient

    are turning out to be

    (3) wrong (ie clear diagnosis given by the lab when the patient knows otherwise)

    Apart from Simon Harris personally taking a taxi round to the patient, ringing the doorbell and spitting in her face, is there anything else that can be done to exacerbate this unholy mess?

    1. Cian

      (1) false. if you actually read the report (or the media were in any way fair) you would know that CC experienced a 30% increase in smear tests (because Harris offered free retesting to all). One of the two contracts for testing expired, and the company decided not to renew, leaving only one company to do twice as many tests. This created a huge backlog. the company said it could only do additional tests by using another lab. CC said okay, but it needs to be seamless (Narrator: it wasn’t) .

      (2) a year late. see (a)

      (3) they weren’t wrong, per se, they were confusing.
      The women initially were told their results were positive, and further testing was required. They later got this confusing letter that said “your HPV re-test result is unchanged and remains HPV negative”. The first bit “your HPV re-test result is unchanged” is correct – they are still positive, the second “and remains HPV negative” is the exact opposite to the first – confusing.

        1. Cian

          Read of Brian MacCraith’s report.

          From section 2 Context (my emphasis) .
          In 2018, around 370,000 women presented to the CC programme, an increase from 280,000 in 2017. This >30% increase created significant challenges for testing laboratories with a consequent impact on ‘turnaround time’ (TAT) and the creation of a backlog of samples. In normal circumstances, the target TAT from the receipt of a sample for testing is about 4 weeks. Currently, over half of samples received into the CC programme are being processed within 7 weeks, although it can take up to 33 weeks for the report to be provided.

          At a time when there was a clear need to identify increased capacity to deal with increased demand in the screening programme: one of the laboratories contracted by the programme did not renew its contract with CC. With limited capacity in the Coombe Women and Infants University Hospital Laboratory at the time, protracted negotiations with the one remaining laboratory provider (QD) became a major focus. An extension to the contract with QD, which
          was due to expire in October 2018, was signed in November 2018 and a second extension was signed on June 7th 2019 after intensive negotiations involving senior CC and NSS personnel.

          In November 2018, CC agreed with QD to use an additional, quality-assured QD in Chantilly, Virginia to process cervical screening tests. The decision was made in order to address the substantial increase in tests caused by the high demand for cervical screening in 2018 (for the reasons outlined above). In November 2018, QD advised CC of a problem (the Expiration issue) related to expiration of samples for HPV testing at its Teterboro facility. The HPV test used at the QD Teterboro laboratory is an RNA test, which needed to be completed within the manufacturer’s room temperature stability period of 30 days from the sample collection date. The HPV test used at the QD Chantilly laboratory, on the other hand, is a DNA test which has a sample expiration window of up to 6 months, depending on sample treatment. This meant that the QD Chantilly laboratory could also be used to retest samples from the Teterboro laboratory (thereby ‘rescuing’ expired samples) or to test ‘backlog’ samples that were close to expiry.

          https://static.rasset.ie/documents/news/2019/08/independent-rapid-review-of-specific-issues-in-the-cervicalcheck-screening-programme.pdf

          1. eoin

            “When Quest Diagnostics (QD) was given approval to conduct HPV DNA testing at its Chantilly
            Laboratory, it was specified by CC that permission would be granted on the basis that the
            30
            samples were within the 6 month stability period for DNA testing, the Chantilly Laboratory
            would meet the tenets of the current contract, and that the HPV DNA results “can be transmitted
            back to CC using the existing electronic methodology”.
            As the electronic transmission of results was critical to the automated process, it was essential
            that this was in place, hence its inclusion in the granting conditions. The electronic transmission
            of results does not appear to have been verified by CC in advance of commencement of testing
            and delivery of samples to Chantilly. From a risk management perspective, there was no
            evidence of assurance being provided for such a critical process. In any event, it should have
            been verified in advance by testing. Without such testing, the risk of failure of report generation
            and letter generation was not identified at this time. ”

            It was approved subject to a precondition which it failed to meet.

            that’s where you get “unapproved”

  2. GiggidyGoo

    Keystone Kops. The daily ritual of incompetence in the HSE, Department of Health, and Simon Harris. Not forgetting of course Varadkar who was a Health Minister, but who checked with his staff to see if he knew anything when he was in Health.
    “Another day, another headache” as the Muppaphones say on The Muppet Show”

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