Terms of Reference of Scoping Inquiry

a) examine the facts including details of:

i. The non-disclosure of information to Ms. Phelan relating to a CervicalCheck standard case clinical audit carried out following her diagnosis of cervical cancer in July 2014;

ii. The apparent widespread practice of non-disclosure to patients relating to CervicalCheck standard case clinical audits;

iii. The management and level of knowledge of various parties including, but not limited to the HSE, the Department of Health or other public authorities and any relevant service provider of:

1) the Vicky Phelan case

2) any other cases concerning CervicalCheck

3) issues related to the non-disclosure of the clinical audit results

iv. The manner and means through which the relevant facts were shared, escalated, reported and communicated;

b) engage directly with Ms. Phelan and any other woman affected or her next of kin, who may wish to have an input;

c) examine all aspects of CervicalCheck;

d) examine the information provided by CervicalCheck to those receiving a service;

e) examine why the policy of open disclosure was not implemented by CervicalCheck;

f) examine the tendering, contracting, operation, conflict of interest arrangements, performance information and performance management, accreditation and quality assurance of contracted cytology laboratory services by CervicalCheck from initiation of the programme;

g) examine the other screening programmes operated by the National Screening Service particularly in relation to quality assurance and clinical audit, open disclosure and governance;

h) incorporate further elements if identified, including through engagement with stakeholders;

i) have flexibility to issue discrete reports or findings on particular matters if it is in a position to do so and provide a progress update in the first week of June;

j) report to the Minister for Health by the end of June 2018 setting out issues and recommendations to be addressed by means of a Commission of Investigation, which can take a modular approach, together with recommendations to address other issues by such other means as is considered appropriate.

Supplementary work

The attached Terms of Reference are in relation to the supplementary work required and have been agreed by the Minister. The Scoping Inquiry team are now undertaking this work.