Special Report: Thousands of women affected by delays in their cervical smear test results

HSE chief executive Paul Reid has apologised to the thousands of women affected by delays in their cervical smear test results.

Special Report: Thousands of women affected by delays in their cervical smear test results

By Evelyn Ring, Joyce Fegan and Fiachra Ó Cionnaith

Reid ‘really sorry’ over concern caused

HSE chief executive Paul Reid has apologised to the thousands of women affected by delays in their cervical smear test results.

Mr Reid said he is “really sorry” for the undue concern caused to a lot of women: “I sincerely apologise to all of the women involved.”

He described the handling of the delayed reporting of cervical smear results as a “major communications failure.”

It emerged that 4,088 women were affected by an information technology problem that disrupted the distribution of smear test results from Quest Laboratories in the United States.

Mr Reid commissioned Brian MacCraith to conduct a “rapid review” of delays in issuing cervical screening HPV retest results.

His report found there was a decision not to communicate with women about the IT glitch for six months this year.

Between February and last week, there was no communication with most of the women involved.

Mr Reid said the HSE “accepts entirely” the findings of the MacCraith review and that the health authority will quickly and carefully implement each of the recommendations in full.

“The HSE wishes to reiterate its apology to all of the women impacted by the delays in issuing important information to them,” he said.

He also wants to “sincerely apologise” to patient advocates who felt “let down” by the health authority and “left out of the loop” in communications on the latest controversy.

Mr Reid promised to work hard with them to rebuild and continue to strengthen their trust in the HSE and their engagement and support for the health authority in the process.

Action to be taken includes strengthening the management, leadership and organisation of CervicalCheck and developing a culture of putting women first.

Also being prioritised is a clinical evaluation and assessment of the women impacted and to establish an audit of Quest’s IT processes and interfaces.

Patient advocate Stephen Teap, who is a key member of a committee established to drive change in the national cervical cancer screening programme, welcomed Mr Reid’s apology: “I do appreciate the apology but there is still a long way to go.”

Mr Teap and Lorraine Walsh are patient representatives on the CervicalCheck steering committee representing women and families.

They complained that the HSE was withholding information when it emerged last month that one of the women affected by the delays had contacted RTÉ.

Both Mr Teap and Ms Walsh said they are aware of “pre-meetings” before steering meetings, where they believe HSE and Department of Health officials agreed on what to tell them.

Mr Teap said they are both at “a very low point” because the matter was not mentioned to them at the steering committee meeting.

“We had a working relationship with the health authority as patient representatives but we were kept in the dark about this. It really crushed us.”

Mr Teap said he is glad that the HSE is going to continue to work with them.

“I would like to think that valuable lessons have been learned by the HSE on the importance of keeping us in the loop and the importance of putting patients, in this case, women, first." Mr Teap said it is “absolutely crucial” that all of Mr McCraith’s recommendations are implemented together with those of Gabriel Scally.

Dr Scally compiled a report on the CervicalCheck controversy that came to light in April 2018 after Vicky Phelan, terminally ill with cervical cancer, highlighted the scandal.

‘Sharon’ the reason public is aware of latest failure

Sharon's story

A woman by the name of ‘Sharon’ is the reason the country knows about the latest CervicalCheck failure, where 4,080 women failed to receive their result of a test for HPV (human papillomavirus).

For nearly 900 of them it meant their results were not issued to them, or their GP in many cases. For around 3,200 women, their doctors got the letters, but the women did not. Sharon is the reason why this information became public and here is her story.

Sharon had been diagnosed with pre-cancer cells 10 years ago and had been attending annual screening ever since. She was used to receiving a letter from the CervicalCheck (CC) with her results, usually within six weeks of the test having been carried out.

On December 3, 2018, she had her annual screening test done, but after the standard six-week mark passed and she was without her results, she contacted her GP.

What followed was months of communication between Sharon, CC, the HSE and the Department of Health (DoH).

After much frustration, Sharon eventually contacted the media on July 8, and her story, and the larger issue, was made public on July 11, a full seven months on from her screening test.

Before her story ever went public, Sharon first contacted her GP when she became concerned that her test results had not arrived in the post.

At this point, Sharon was advised by her GP that the current waiting time for smear test results was up to 14 weeks “due to issues over the past year”.

More time passed and Sharon escalated the matter to the CC screening programme.

On March 26, she called the CC helpline to enquire about her test. She was told that her results were not available. Her query was brought to the attention of a CC doctor, who called Sharon on April 3. However, this doctor was unable to tell her where her results were.

Although the whereabouts of her results were unknown at the time of these calls, on the same day that Sharon called the CC helpline (March 26), her sample was transferred from the Quest Diagnostics (QD) Teterboro laboratory to the QD Chantilly laboratory.

The test was carried out in the Chantilly laboratory on March 27, but the test result report that is sent to GPs was not created at this time.

Sharon was still none the wiser as to her test results, despite the test now having been carried out.

On April 3, a full 17 weeks after Sharon had her smear taken, she emailed info@health.gov.ie outlining the delay in getting results back from her smear test. She explained that her GP had called QD and was told that there was currently a “20 week window for negative results and up to 27-30 weeks for positive” results to be issued.

In her email, Sharon also referred to her March 26 phone call to CC. In the email, she expressed her dissatisfaction and indicated her intention to bring her “concerns to the media”.

Later that day, Sharon received an email from the private secretary of the minister for health, acknowledging her email and advising that the issues raised would be examined and that she would receive a reply shortly.

When she had not received a reply within 11 days, she emailed the minister’s office on April 14, and again on April 28. She conveyed her frustration about the absence of the expected reply from the exchange on April 3, and also indicated that her almost five-month wait for her results was “totally unacceptable”.

On April 30, Sharon received an email response from the minister’s private secretary.

The email stated that the “HSE has advised that the natural history of cervical cancer indicates that the disease would normally develop over a period of 10 to 15 years. The HSE has advised that in this context, a delay in the return of cervical screening results, whilst undesirable, is not necessarily dangerous and poses a very low risk”.

On May 9, Sharon emailed the minister’s office expressing her dissatisfaction with the response of April 30, with particular reference to its “insensitivity” regarding her condition. Sharon contacted the DoH again on May 16, and June 4, seeking a response to the department’s email of April 30, and expressing her growing frustration with the time delay in obtaining her results.

On June 5, in a phone call to the DoH, Sharon was advised to contact CC directly. Sharon called CC customer services and was advised that the wait time for her results was 33 weeks. Sharon requested that her case be escalated.

On June 6, Sharon received an email from the minister’s private secretary in which the official acknowledged the call that Sharon had with a DoH colleague the previous day.

The official requested her personal details so that the DoH could engage directly with the National Screening Service on her behalf.

Using the personal details provided by Sharon to the DoH on June 7, CC contacted QD to request an update report on Sharon.

On June 17, Sharon’s sample was resulted and the report was sent to her GP. On June 25, CC confirmed to the DoH that Sharon’s test was processed and that the result was with her GP on June 17. They confirmed that, “due to an IT issue”, Sharon had not received a letter from CC, which would have been the normal process.

The letter stated that CC was addressing the issue with the laboratory in question and that they were writing to “all women who have been affected”.

On June 26, the CC doctor called Sharon with her results, to advise her of the IT issue and to inform her that her results were with her GP. When Sharon asked why she had not received the standard CC letter, she was told that there was an “IT issue”. On June 27, Sharon texted the CC doctor asking him to escalate the issue as her GP had no idea that letters “were not being sent to women”.

On July 8, Sharon phoned the DoH and raised a number of issues with the official whom she spoke with, including the delay in receiving her results, the non-issuing of letters to women, and the “rude” encounter with a staff member on the CC help-line. The DoH official confirmed that the department was still awaiting a report from the HSE arising from Sharon’s queries.

Later on July 8, Sharon emailed Fergal Bowers, RTÉ news correspondent, to advise him of the issues she had raised with the DoH.

This information was then made public on July 11, and a rapid review was subsequently commissioned.

Sharon’s story was fact checked by the authors of this review.

- Joyce Feegan

Patient advocacy groups hail report

The report into the latest CervicalCheck issue has been widely welcomed by patient advocacy groups.

Corkman Stephen Teap, whose wife Irene died from cancer more than two years ago, welcomed a key piece of the Rapid Review into the CervicalCheck Screening Programme, conducted by Brian MacCraith.

Irene had cervical cancer, which was missed by two smear tests. Had the illness been detected, her life could have been saved.

Mr Teap said it is “great to see” the key role of patient representatives being highlighted in yesterday’s report.

He was commenting on a statement made by the Midwives Association of Ireland.

“The issue of recognising the important role of patient representatives should be addressed with a view to placing it on a more stable footing and enhancing relationships with all relevant elements of the healthcare system,” read the association’s statement yesterday.

Also commenting on yesterday’s report was 221+, a patient support group.

The group said it welcomed the HSE’s promise of stronger structures and management of screening services. “The conclusion that there was no emphasis on putting ‘women first’ in the attempts to overcome the so-called ‘IT glitch’ that left about 800 women waiting over six months for the results of their cervical screening tests is a sad but succinct summary of the whole CervicalCheck debacle,” said a spokesman for the group.

The group welcomed the professor’s report “whose work highlights further the critical need for ‘well structured, strongly led’ management of screening services in Ireland”.

The spokesman said the latest report highlights the “negative knock-on impact” of the shortcomings in the current screening system.

The group also noted Mr MacCraith’s observation that “the culture of engagement between patient representatives and the Department of Health is not positive”.

Political reaction to the report was not as positive, with Sinn Féin’s health spokeswoman Louise O’Reilly saying that “nothing has been learnt from the crisis”.

“The findings of the Independent Rapid Review of Specific Issues in the CervicalCheck Screening Programme which showed that a lab was added to the CervicalCheck programme without proper checks or operational due diligence shows that nothing has been learnt from the crisis to date.

“Previously when it was announced that additional capacity had been secured to reduce the backlog of smear tests and delays in results, I publicly called on the minister [Simon Harris] to publish the quality assurance assessments they carried out on the new labs.

“It beggars belief that this quality assurance was not carried out,” she added.

Fianna Fáil’s health spokesman Stephen Donnelly said he is “flabbergasted” that CervicalCheck controversies continue after all that happened in 2018.

“The report carried out by Professor Brian MacCraith rightly highlights ‘a constant theme of women frustrated by poor service and lack of information, their information’.

Given the failures to communicate in previous years how could this situation be allowed to develop again?

“It is simply outrageous and frankly incomprehensible. It is symptomatic of a complete aversion to open disclosure.”

Speaking before the report was officially launched, Taoiseach Leo Varadkar said he still has confidence in CervicalCheck.

“I do have confidence in the service. CervicalCheck, BreastCheck, our colorectal cancer screening programme work,” he said.

“We know that those programmes have saved a lot of lives and they have also helped pick up a lot of cancers early, meaning that people got treated earlier.

“But it is never the case that any screening programme can pick up all abnormalities — they almost always miss somewhere around a third.”

- Joyce Fegan and Fiachra Ó Cionnaith

CervicalCheck timeline

How did we get here?

  • November 5, 2018: Quest Diagnostics Teterboro laboratory, in New Jersey, USA, a lab used by the HSE’s CervicalCheck screening programme made a significant discovery: a number of samples for HPV (human papillomavirus) RNA (ribonucleic acid) testing were performed beyond the manufacturer’s recommended room temperature stability period of 30 days
  • November 20, 2018: Quest Diagnostics tried to identify how many samples could be rescued using DNA testing and to identify the positive samples and to determine where women are in their screening
  • November 28, 2018: Quest Diagnostics identified it had about 700 samples in Teterboro that can still be tested for HPV DNA in its Chantilly laboratory, in Virginia, USA. These were known as ‘rescue samples’. At final analysis, there were 871 such unique samples
  • November 30, 2018: CervicalCheck in Ireland then granted permission for Quest Diagnostics to use its Chantilly laboratory for HPV DNA testing. The granting letter stipulated that a condition was the HPV DNA results from the Chantilly laboratory “can be transmitted back to CervicalCheck using the existing electronic methodology”
  • December 13, 2018: The CervicalCheck national screening service established a serious incident management team to address the expiration issue
  • December 14, 2018: The first HPV DNA testing is conducted at the Chantilly laboratory
  • December 17, 2018: The expiration issue was formally communicated to the National Patient Safety Office
  • December 18, 2018: Quest Diagnostics disclosed to CervicalCheck that the HPV expiration issue goes back to 2015. The analysis by Quest Diagnostics showed the number of samples impacted between 2015 and 2018 is now 11,577
  • December 21, 2018: CervicalCheck categorised the 11,577 samples to identify what action is required for the women impacted by the sample expiration problem
  • January 10, 2019: Quest Diagnostics wrote to national screening service outlining the problems with the original testing in New Jersey and the revised process to address these
  • January 11, 2019: There was initial engagement between CervicalCheck and Quest Diagnostics on the issue of transferring results electronically on to the cervical screening register
  • January 24, 2019: The CervicalCheck’s clinical director wrote to all GPs to inform them of the expiration issue that has arisen on some HPV tests carried out on samples between 2015 and 2018, and that up to 6,000 women will likely be called for a repeat smear test
  • January 31, 2019: Serious incident management team discussed the IT issue for the first time and possible solutions to this. CervicalCheck clinical director and national screening service’s director of public health both wrote to some categories of women affected by the expiration issue
  • April 3, 2019: The first email representation was sent from ‘Sharon’ to the Department of Health, which triggered the information being put into the public domain on July 11, and a subsequent review into the entire affair

- Joyce Fegan

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