Stephen Donnelly (Wicklow, Fianna Fail) | Oireachtas source

That is no problem. I thank the Acting Chair.

The overarching intention of the Bill, as colleagues will be aware, is to embed a culture of open disclosure in our health and social services. However, it is fair to say that many aspects of the Bill have been informed by the very serious learnings from what happened with CervicalCheck. This includes the need to ensure accountability by service providers and clinicians in carrying out open disclosure to patients and their families. In that regard, the Bill and its intended outcomes can be viewed as an important part of the legacy of reform and transformation arising from the issues in 2018 and how those issues have been addressed.

I flagged on Committee Stage that I would be introducing an amendment on Report Stage to ensure open disclosure applies to completed patient-requested reviews of cancer screening. The approach we are taking here is based on the report of the expert reference group, published in 2020, into interval cancers. The group was set up following on from the report by Dr. Scally. It was deemed appropriate to follow the group's recommendations in respect of individual patient-requested reviews as providing the basis for open disclosure provisions.

Amendment No. 19 is lengthy, comprising 21 sections. This is necessary to ensure full provision for mandatory open disclosure for patient-requested reviews of cancer screening. The provisions are similar to those already in the Bill in respect of mandatory open disclosure of notifiable incidences. This amendment will ensure that open disclosure applies to completed patient-requested reviews of cancer screening. This is key. It is one of the substantial amendments I am bringing forward on this Stage. I am now proposing that a patient-requested review of his or her cancer screening will be provided for in a new Part 5 of the Bill. This will ensure that current provision for open disclosure of a notifiable incident will be replicated in the new Part of the Bill for open disclosure of a patient-requested review of cancer screening. All reviews will have to be disclosed, irrespective of whether there is a discordance. This is the nub of it. All reviews must be disclosed to the patient where the patient has requested the review. Where there is a cancer diagnosis, all patients will be told the patient-requested review is available to them if they so choose. Our understanding is that in the UK, for example, approximately half of patients choose it. All patients will be informed that this is available to them. If they choose it, all patients will have that disclosed.

Amendment No. 19 provides for the insertion of a new Part 5 in the Bill to provide for the open disclosure of completed patient-requested reviews of HSE cancer screening services. Such a review will be defined in the body of the Bill and will involve statutory requirements similar to those prescribed for patient safety incidences. This includes an obligation to make an open disclosure of a review, procedures for making open disclosures of a completed review by the health service provider, and offences similar to those already prescribed in the Bill for patient safety incidences. Implementing mandatory open disclosure as provided for in the Bill is intended to afford patients and families the opportunity to understand what went wrong, and to receive an apology where appropriate.

Along with colleagues across the House, I have just come from a very useful discussion with officials, including the chief clinical officer. Very reasonable issues have been raised. One of those issues is the question of what would happen in the future in the case of the women affected by what happened with Cervical Check. The answer is that every woman who has a diagnosis of cancer would be informed that a patient review process is available to her should she want it. Every woman would be told. There would be mandatory open disclosure of that review should the woman choose to initiate a review. The reviews have been carefully designed with clinical and international experts, along with patient advocates and representatives. They have designed a review that works for the women, so that every woman will have this option, which was not available previously, available to them. That is the first important point.

A second question being asked relates to programmatic audits. The Madden report, published in 2018, stated that we must have these learning audits in order to be constantly improving the service for patients and constantly improving cancer detection rates. It stated that these learning audits, which need to go on all the time, should be anonymised. There are several reasons they should be anonymised. It is international best practice. It is the recommendation from the expert reference group. We are working closely with the WHO at the moment and expect it to publish a position on this shortly. We expect that it will be in line with anonymised programmatic audits. We have considered practice in this regard in the UK and other jurisdictions and we have concluded that anonymised audits are international best practice. Why is that? First, it means the health service providers have access to all the data. They are used right across the HSE at the moment. They are a really important learning tool in order to constantly improve care. The second reason is that if programmatic audits were done but were not anonymised, what would happen - this is what happened previously - is that a health service provider would be saying it is going to take all of a patient's information without his or her knowledge or consent, and do audits on the identifiable information of the patient without him or her having requested that. We know from the UK that only half of those who are offered it actually want it. Many of the patients did not ask for this, and in many cases did not want it. When discordant results are found, of course they would be disclosed to the patient, as they ought to be.

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