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.