CervicalCheck: is 'absolute confidence' setting the bar too high?

The HSE organises free cervical smear tests for women between certain ages through CervicalCheck and has contracted out the testing of samples to various multinational firms including Quest Diagnostic Incorporated and Medlab Pathology Limited. Earlier this year, the High Court issued a judgment in the Ruth Morrissey and Paul Morrissey v Health Service Executive, Quest Diagnostic Incorporated and Medlab Pathology Ltd case relating to interpretation and reporting of tests. 

The judgment in this case caused some debate, in that it included the determination that screeners must have “absolute confidence” that a sample is adequate and contains no abnormalities before it can be reported negative. This article is intended to set out the current position. An appeal against the High Court judgment is listed for hearing shortly and is expected to clarify matters further. 

The first plaintiff’s smear tests

The first plaintiff, Ms Morrissey, had a cervical smear test done in 2002, which was negative. She had another cervical smear test done in August 2009, by her GP. The sample was sent to Quest Diagnostics laboratories in the US for analysis. They reported that the sample was adequate and that the result was “negative for intraepithelial lesion or malignancy”. Ms Morrissey was informed of the satisfactory result and scheduled for standard recall three years later.

Her next cervical smear test was done in August 2012. This sample was sent to Medlab Laboratories in Ireland for analysis. Again, it was reported that the sample was adequate and that the endocervical component was absent but there was no evidence of neoplasia, ie. no evidence of abnormal growth tissues.

Cancer diagnosis

The first plaintiff presented to her GP in 2014 with post-coital bleeding and upon examination, her GP discovered a lesion in her cervix. Subsequent investigations disclosed cervical cancer. 

The first plaintiff had treatment including surgery in 2014 and it was thought that the cancer had been successfully eradicated. However, in October 2017 it was discovered that her cancer had returned and spread and at the time of this High Court case, her prognosis was terminal.

Audit

In the first plaintiff’s case and in others, where cancer was diagnosed after a previous negative smear test, the laboratories audited patients’ previous smear tests with the objective of educating screeners, reviewing quality and standards and of making improvements.  

The first plaintiff’s 2009 slide was reviewed by a senior staff pathologist in Quest who reported that the original test result was incorrect. Nothing was recorded under the heading “Factors likely to lead to false negative results”.

Her 2012 slide was reviewed by the medical director in Medlab who reported that the original result was incorrect and recorded under the heading “Factors likely to lead to false negative results”, that the sample was “scanty”.

By 2015, the results of the audit were communicated to CervicalCheck. Neither the fact of the audit or its results were disclosed to the first plaintiff until national publicity concerning another patient in 2018.

The first plaintiff’s case

Ms Morrissey argued that if the 2009 test had been correctly reported, she would have been referred for investigation within three months or more probably, for immediate colposcopy which as a matter of probability, would have disclosed a precancerous condition, resulting in a LLETZ procedure, leading to complete excision of the malignant cells.

The first plaintiff contended that the 2012 sample was inadequate for testing and that a second sample should have been taken from the liquid container or that she should have been recalled for re-testing. She argued that, although it was scanty, if the original sample had been correctly analysed, it would not have been a negative result. 

She argued that if it had been correctly read, she would have been recalled immediately or within six months and that on the balance of probabilities, colposcopy at that time would have shown a high-grade lesion in early development that could have been treated again with a LLETZ procedure, leading to complete excision of the malignant cells.

She also argued that the HSE was negligent for failing to inform her of the audit and its results. She maintained if she had been informed, she would have insisted on imaging in 2016 or 2017, that she probably would then have been alerted at that earlier stage that her cancer had returned and that her treatment and prognosis could have been different. 

Defendants’ cases 

The defendants denied liability and causation, arguing that even if Ms Morrissey’s smear tests were negligently reported, any alarming feature found in the samples in 2009 and 2012 were unrelated to her ultimate diagnosis of cancer. The defendants argued that, on the balance of probabilities, her cancer was not developing in 2009 or 2012 or that if it was, it would not have been detected on re-screening or colposcopy. The HSE admitted breach of duty insofar as it failed to inform Ms Morrissey about the audit results.

Cervical smear tests are not diagnostic. The tests are screening tests and in the course of his judgment, Mr Justice Kevin Cross said that this is an important distinction as to the duty of the laboratories in relation to the analysis of the samples. He accepted the evidence of all the relevant experts involved in the case that in the event of any ambiguity, a laboratory should report a smear test result as abnormal because otherwise the purpose of the screening programme would not be achieved. 

Laboratory procedures

In the laboratory, all samples are prepared using what is known as the Thin Prep Image System to make a slide, which is examined by a screener (who may be a technician or a degree scientist). The screener must first assess adequacy of the sample. If any abnormal cells are detected, the slide must be classified as abnormal regardless of the adequacy of the sample. The two defendant laboratories had different systems in place to provide for second or confirmatory review of slides. Areas of suspicion on slides are marked and sent to a laboratory pathologist for reporting. 

Judge Cross noted: “there is room in the analysis for genuine and non-negligent divergence as to whether particular cells are negative or potentially alarming” and it was common case that not every erroneous analysis would constitute negligence. There was no agreement between the parties on what kind of errors would not be negligent. 

Key issues 

Judge Cross had to deal with the following issues, among others:

Questions of fact – on the balance of probability, what was on the slides?

Judge Cross agreed with the following observations from the English case of Penney Palmer & Canon v East Kent Health Authority:

“The standard of care which I have to apply is that of a reasonably competent screener exercising reasonable care at the time when the screening took place. …  Equally important, I must bear constantly in mind that in cases where an exercise of judgment is called for, the fact that with the benefit of hindsight that judgment was exercised wrongly is not itself proof of negligence.”

Judge Cross adopted the approach set out in the Penney Palmer case, when it came to making findings of fact and asked:

• What was to be seen in the slides? 
• At the relevant time could a screener exercising reasonable care have failed to see what was on the slide? 
• Could a reasonably competent screener, aware of what a screener exercising reasonable care will observe on the slide, treat the slide as negative?

Judge Cross noted that the Penney Palmer judgment endorsed the view that if there was any doubt in the mind of a screener as to whether a slide was normal, (s)he should not classify it as negative.

He then commented: “a slide should not be classified as negative unless the screeners had ‘absolute confidence’ that it was so.”

The legal standard to be applied to the issue of liability 

The Judge commented that the legal standard of care and the factual standards and criteria to which screeners must adhere are different but interlinked issues.

Judge Cross stated that standard of care in medical negligence cases remains as per the principles set out in the case of Dunne v National Maternity Hospital [1989]. Those principles can be summarised as follows: 

• The true test for establishing negligence in diagnosis or treatment on the part of a medical practitioner is whether (s)he is proved guilty of such failure as no medical practitioner of like specialisation and skill would be guilty if acting with ordinary care
• Deviating from a general and approved practice does not establish negligence, unless no other medical practitioner taking ordinary care would have done likewise
• It is no defence to an allegation of negligence to have followed a general and approved practice if that practice is inherently defective
• An honest difference of opinion between medical practitioners as to the better way of treating a patient is no basis for a finding of negligence
• A judge does not decide which course of management is preferable in the circumstances – (s)he decides whether the defendant medical practitioner complied with the careful conduct of a medical practitioner of like specialisation and skill.

The laboratories had contracted to conduct their tests in accordance with “good laboratory practice” which was defined as “the exercise of that degree of skill, diligence, prudence and operating practice, which will be considered as good practice from a skilled and experienced laboratory of a similar scale and professional standing engaged in the provision of cervical cytology screening and related services”. Judge Cross said that he did not consider that the contractual obligations altered the standard of care required by the Dunne case.

Judge Cross held that ‘absolute confidence’ is the screeners’ practical duty in relation to their analysis of what is on the slide including the adequacy of the sample and that the legal issue is whether or not they have carried out that duty in accordance with the Dunne principles. He said: “a screening programme cannot operate safely if screeners are left to judge the slides and whether they are safe merely on the balance of probabilities” and commented that the dangers of false positives are far outweighed by the dangers of false negatives.

He said that if there is any room for doubt that a slide is normal, it would be a breach of the Dunne principles to report it as normal. As a consequence, if a screener is in any doubt regarding the adequacy of a sample or the result, it must be marked positive or abnormal and followed up.

To summarise, Judge Cross dealt with questions of fact on the balance of probabilities and adopted the approach set out in the Penny Palmer judgment. Judge Cross applied the Dunne principles as the legal standard on the question of the defendants’ liability.  

Were the defendants negligent as regards the 2009 and 2012 smear tests?

Judge Cross found that the defendants were negligent and in breach of duty in relation to the reading of the August 2009 smear test. Judge Cross found that although the 2012 slide contained abnormal and non-negative cells, the nature of those cells was such that the failure to record them as abnormal was not a breach of duty or negligent.

He found that the third named defendant was negligent and in breach of duty for failing to conduct an adequacy review of the 2012 sample and that had it done so, the slide would, as a matter of probability, have been reported as inadequate and Ms Morrissey would have been retested between one and three months later.

The consequences of the established negligence

Judge Cross found that if there had not been negligence in the reporting of the 2009 smear test, the serious consequences for the plaintiff’s health would not have arisen.

He found that her claim for injuries and loss was caused by the negligent failure to report the 2012 sample as inadequate and the consequent failure to ensure that the plaintiff was re-tested.

Ms Morrissey was awarded €500,000 general damages and special damages in the sum of €247,508. She was also awarded €10,000 damages in respect of the failure to inform her about the audit. Paul Morrissey was awarded €60,000 general damages and special damages in the sum of €1,345,000 which included the future loss of Ms Morrissey’s income and the future costs associated with childcare arrangements for their daughter. 

Commentary and concerns

The High Court judgment provoked debate and reaction which centres on the finding that screeners must have “absolute confidence” that a sample is adequate and contains no abnormalities before it can be reported negative. 

Stakeholders and commentators have highlighted that “absolute confidence” as a standard may be unattainable and unworkable in practice. It has been suggested that if false negative results breach the required standard of care, the viability of screening programmes may be called into question.

There has been discussion around the judgment leading to more cautious reporting of samples if there is any doubt whatsoever about a result or the adequacy of a sample and this could increase pressure on the different screening systems and have cost implications.

Queries and concerns have also been raised about potential implications for other areas of medical practice and whether the “absolute confidence” requirement applies only to screeners or in a wider context and the general consensus seems to be that clarification is required.

All three defendants filed appeals with the Court of Appeal but also applied for what is known as a ‘leap-frog appeal’ from the High Court jurisdiction directly to the Supreme Court (ie. bypassing the Court of Appeal).

The urgency of the case was the primary reason put forward for justifying the request for ‘leap-frog appeal’ status. The judgment has potential implications for other cases, including those going through the recently established CervicalCheck Tribunal. 

More than 200 women affected by the CervicalCheck controversy can now apply for ex-gratia payments in respect of distress and psychological suffering but for so long as debate continues about the appropriate test to determine legal liability, that Tribunal may be constrained in its ability to progress its work.

The appeal is expected to focus on the standard of care that should apply in cervical cancer screening and whether the HSE is potentially liable, either primarily or vicariously, for acts or omissions of laboratory screeners. The award of damages made against the HSE in the High Court was nominal at €10,000 but the finding that the HSE carried primary responsibility, rather than the defendant laboratories, would have implications for other cases brought by women involved in the CervicalCheck controversy.

It appears that the Government made arrangements through the Chief State Solicitor’s Office for the full award determined by the High Court to be paid to the Morrisseys, irrespective of the outcome of the appeal.