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Wednesday, 26 Sep 2018

Written Answers Nos. 156-180

Medical Consent

Ceisteanna (156, 157, 158)

Clare Daly

Ceist:

156. Deputy Clare Daly asked the Minister for Health if there is a State-wide policy in regard to obtaining written patient consent prior to the prescription of an unlicensed drug to that patient. [38918/18]

Amharc ar fhreagra

Clare Daly

Ceist:

157. Deputy Clare Daly asked the Minister for Health if a sanction applies to a clinician who prescribes an unlicensed drug to a patient without having first obtained that patient's written consent. [38919/18]

Amharc ar fhreagra

Clare Daly

Ceist:

158. Deputy Clare Daly asked the Minister for Health if it is the practice in the public health system to obtain written patient consent prior to that patient being prescribed an unlicensed drug [38920/18]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 156 to 158, inclusive, together.

Under the Medical Practitioners Act 2007, the Medical Council is the statutory body charged with responsibility for the registration and regulation of medical practitioners in the State. The Council's main role is to protect the public by promoting and better ensuring high standards of professional conduct and professional education, training and competence among doctors.  

The Council provides advice to doctors on consent in its Guide to Professional Conduct and Ethics.  It gives the general principles relating to consent at section 9 of the Guide, where it states at 9.2 that: "You must make sure that patients have given their consent before you provide any medical investigation, examination or treatment. Consent is required by law and is an essential part of respect for patients’ autonomy. Patients have the right to decide what happens to their own body."

Disciplinary matters concerning registered medical practitioners are a matter for the Council.  Under its legislation its role is to fully investigate any complaints made about registered practitioners and decide whether they are fit to practice.  Information about this process can be found on the Medical Council's website at: medicalcouncil.ie/Public-Information/Making-a-Complaint-/.

The Council may impose sanctions on medical practitioners where there is a finding of professional misconduct and the ultimate sanction for a medical practitioner is removal from the register.  

Medicines placed on the Irish market must be authorised by the Health Products Regulatory Authority (HPRA) or, in the case of centrally authorised products, by the European Commission. However, European regulations do provide for an exemption to this rule – this is via Article 5 of Directive 2001/83/EC. In this case, unauthorised medicines may be supplied where a registered doctor or dentist has prescribed the product for an individual patient under his or her direct responsibility. This is in order to fulfil the special needs of those patients. Such products are defined as ‘exempt medicinal products’

Exempt medicinal products are often used in clinical practice in Ireland and this reflects the fact that there are not always sufficient approved medicines to address every medical need.

The practice of a doctor, or healthcare professional with prescriptive authority, and the manner in which they counsel and undertake to get informed consent from their patients when initiating or continuing any form of treatment, is a matter for that healthcare professional and/ or their respective regulatory body.

Hospital Appointments Status

Ceisteanna (159)

Michael Healy-Rae

Ceist:

159. Deputy Michael Healy-Rae asked the Minister for Health the status of an operation for a person (details supplied); and if he will make a statement on the matter. [38923/18]

Amharc ar fhreagra

Freagraí scríofa

Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

The National Waiting List Management Policy, a standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, since January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.

In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.

National Treatment Purchase Fund

Ceisteanna (160)

John Curran

Ceist:

160. Deputy John Curran asked the Minister for Health if the newly established central validation function in the NTPF to centralise the validation of all waiting lists across the HSE has commenced; if so, if he will provide a progress report on this function; and if he will make a statement on the matter. [38928/18]

Amharc ar fhreagra

Freagraí scríofa

In June 2018 I approved the establishment of a Central Waiting List Validation function with the National Treatment Purchase Fund (NTPF) with the objective of delivering a standardisation of approach of validation across all waiting lists and all hospitals in line with the best patient-centred practices. The validation of waiting lists will better inform the true demand for hospital services and enable improved efficiency and patient scheduling.

The NTPF advise that the National Centralised Validation Unit was established on Monday 24 September 2018.  The Unit will commence the testing of validation reports, processes and systems prior to the validation of any patient on a waiting list.  A number of hospital sites have agreed to pilot the National Centralised Validation approach during October and a roll out plan is currently being coordinated for the rest of the year. A full Validation Programme will be agreed with every Hospital and Hospital Group for 2019.

Hospital Appointments Status

Ceisteanna (161)

Aengus Ó Snodaigh

Ceist:

161. Deputy Aengus Ó Snodaigh asked the Minister for Health if a person (details supplied) will be given an urgent date for an appointment to attend the ear, nose and throat department in either Tallaght or Crumlin children's hospitals. [38930/18]

Amharc ar fhreagra

Freagraí scríofa

Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

The National Waiting List Management Policy, a standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, since January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.

In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.

Palliative Care Services Provision

Ceisteanna (162)

Bríd Smith

Ceist:

162. Deputy Bríd Smith asked the Minister for Health the capital funding application received by the HSE for the project to redevelop the palliative care unit at Our Lady’s Hospice, Harold’s Cross; if the application has been approved; and if HSE funding was allocated to this project. [38938/18]

Amharc ar fhreagra

Freagraí scríofa

As the Health Service Executive is responsible for the delivery of healthcare infrastructure projects, I have asked the HSE to respond to you directly in relation to this matter.

Voluntary Hospital Sector

Ceisteanna (163)

Bríd Smith

Ceist:

163. Deputy Bríd Smith asked the Minister for Health the costs to date of suspensions of staff at Our Lady’s Hospice, Harold’s Cross; and the cost of external investigators hired by the hospice over the past five years to conduct disciplinary or other inquiries into staff. [38939/18]

Amharc ar fhreagra

Freagraí scríofa

I have asked the HSE to respond to you directly on this matter.

Voluntary Hospital Sector

Ceisteanna (164)

Bríd Smith

Ceist:

164. Deputy Bríd Smith asked the Minister for Health if section 38 and 39 organisation such as Our Lady’s Hospice, Harold’s Cross are covered by the procurement guidelines that govern the hiring of external investigators to examine industrial relations of staff-related issues in their organisations. [38940/18]

Amharc ar fhreagra

Freagraí scríofa

In addition to the health and social care services which it directly provides the HSE also enters into arrangements with service providers for the provision of health and personal social care services on its behalf.

The Health Act 2004 provides the legal framework for the HSE to enter into arrangements or agreements with two distinct categories of agencies/groups:

Section 38 (1) states that:

The Executive may, subject to its available resources and any directions issued by the Minister under section 10, enter, on such terms and conditions as it considers appropriate, into an arrangement with a person for the provision of a health or personal social service by that person on behalf of the Executive and

Section 39 (1) states that: The Executive may, subject to any directions given by the Minister under section 10 and on such terms and conditions as it sees fit to impose, give assistance to any person or body that provides or proposes to provide a service similar or ancillary to a service that the Executive may provide.

The HSE enters into Service Arrangements regarding the funding which it provides to Section 38 and section 39 bodies and public procurement is defined in the Service Arrangement documentation. 

The HSE has confirmed that section 38 and section 39 bodies must adhere to procurement guidelines where the goods or services being procured relate to Exchequer funding.    Our Ladys Hospice in Harolds Cross is a Body funded under section 38 of the Health Act and therefore if the external investigator services which were being procured by it related to Exchequer funding they should have been procured in accordance with procurement guidelines.

Cancer Screening Programmes

Ceisteanna (165, 166, 171)

Bríd Smith

Ceist:

165. Deputy Bríd Smith asked the Minister for Health the reason his reply to two previous parliamentary questions on the ISO accreditation of US-based labs stated that these labs had ISO status while the Scally report states they did not. [38941/18]

Amharc ar fhreagra

Bríd Smith

Ceist:

166. Deputy Bríd Smith asked the Minister for Health if screeners in US labs have the same or comparable levels of qualifications to screeners who examine cervical check slides here. [38942/18]

Amharc ar fhreagra

Bríd Smith

Ceist:

171. Deputy Bríd Smith asked the Minister for Health his views on the reference in the Scally report to the plans of a CervicalCheck provider to use laboratories in Australia to conduct future tests; if a risk assessment of such a practice will be conducted; and if he will make a statement on the matter. [38947/18]

Amharc ar fhreagra

Freagraí scríofa

I propose to take Questions Nos. 165, 166 and 171 together.

Earlier this year in response to Parliamentary Questions, I stated, as was my understanding then, that laboratories contracted by CervicalCheck met the programme’s standards and had ISO accreditation, certified by the relevant national authorities. The Report of the Scoping Inquiry established by Government has clarified that only some laboratories have ISO accreditation.

Dr Scally is providing me with a supplementary report which will investigate the matter of accreditation. I look forward to receiving this report.

However, it is important to be clear that Dr Scally's Report, published on 12 September, has provided welcome reassurance in relation to the laboratories currently contracted by CervicalCheck. He is satisfied with the quality management processes in the labs currently contracted by CervicalCheck, and he is clear that he has found no reason why the contracts with existing providers should not be extended pending the switch to HPV testing as the primary screening test.

The Report is a comprehensive and robust assessment of CervicalCheck, based on engagement with women and families involved, review of documentation, interviews with key personnel and visits to the laboratories involved. It makes fifty recommendations, including a significant number in relation to laboratories and procurement, the implementation of which I expect to provide all necessary assurance in relation to the services on an ongoing basis.

The Government has accepted all 50 of Dr Scally’s recommendations and I have asked the State bodies involved to move swiftly in relation to implementation.

Cancer Screening Programmes

Ceisteanna (167)

Bríd Smith

Ceist:

167. Deputy Bríd Smith asked the Minister for Health the reason HSE documents that relate to the procurement and tendering of contracts for CervicalCheck were destroyed in 2017; and the steps he will take to ensure all such documents are retained and available for scrutiny in the future. [38943/18]

Amharc ar fhreagra

Freagraí scríofa

On 12 September, the Report of the Scoping Inquiry into the CervicalCheck programme, led by Dr Gabriel Scally, was published on the website of my Department following the Government meeting.

Dr Scally has emphasised in his Report that the continuation of cervical screening in the coming months is of crucial importance. In that context, I very much welcome the fact that he has found no reason why the existing contracts for laboratory services should not continue until the new HPV testing regime is introduced. The Report provides very welcome reassurance in regard to the quality management processes in place in the laboratories currently contracted by CervicalCheck.

As stated in the Report, the destruction of some of the original material relating to the CervicalCheck tender competitions in 2017 was in line with HSE policy for document retention and disposal. The Report sets out fifty recommendations, including a number in relation to laboratories and procurement, and the Government has committed to implementing these in full. They include a recommendation that "Winning proposals should be appended to the relevant contract and not destroyed until at least one year following the termination of the contract (and any extension thereof)" and this will be implemented.

Cancer Screening Programmes

Ceisteanna (168)

Bríd Smith

Ceist:

168. Deputy Bríd Smith asked the Minister for Health the reason the identity of the labs involved in the false negative results that affected 221 women, as sought in previous parliamentary questions, has not been revealed; and his plans to ensure this information is made available. [38944/18]

Amharc ar fhreagra

Freagraí scríofa

Screening tests are a balance of sensitivity and specificity and therefore include both false negative and false positive results which could affect the screening outcome and treatment of a person who may or who may not have a disease. It would be expected that they would have occurred in all labs contracted by CervicalCheck since its inception.

The Deputy may wish to be aware that according to Dr Scally’s report, conducting an audit or review of interval cancers is a good thing to do for the purposes of quality control and, particularly, learning. Dr Scally does point out that it is not without problems when it comes to comparability.

His review has summarised that, “no matter how closely the review panel tries to reproduce the original screening conditions, the conditions of a review are different – the fact that a review includes records of a patient known to have a serious condition, such as cancer, will heighten vigilance and increase reports of abnormality.”

Dr Scally is clear that finding discrepancies on review does not imply that the same findings should have been made under routine conditions. His report states that in a cervical screening programme the result is based on interpretation of appearances on a scan, slide or mammogram in circumstances where the boundary between normality and abnormality is not firmly drawn and this may result in debate between experts as to the appropriate classification of the sample or the interpretation of the image.

Cancer Screening Programmes

Ceisteanna (169)

Bríd Smith

Ceist:

169. Deputy Bríd Smith asked the Minister for Health his plans to build up the capacity of public labs based here to conduct all CervicalCheck screening in the future on foot of the Scally report; if he will initiate a program of university graduate and undergraduate classes necessary to train the required number of medical scientists for such a scenario; and if he will make a statement on the matter. [38945/18]

Amharc ar fhreagra

Freagraí scríofa

My priority is and will remain the provision of services of the highest quality. It is important to be clear that the Report of the Scoping Inquiry into CervicalCheck, published on 12 September on the website of my Department, provides welcome reassurance on the quality of all laboratories currently contracted to provide services for CervicalCheck, including the private laboratories contracted both in Ireland and America (Medlab Pathology and Quest Diagnostics, respectively) and the Coombe Women and Infants University Hospital in Dublin.

Switching to HPV testing as the primary screening mechanism will require a reconfiguration of laboratory services. While it is likely that a tendering process will be needed to meet at least some of the HPV testing requirement,  the potential to use public laboratories in Ireland to carry out testing for the programme is being carefully assessed as part of the planning of this major project.

Cancer Screening Programmes

Ceisteanna (170)

Bríd Smith

Ceist:

170. Deputy Bríd Smith asked the Minister for Health if future contracts or procurement arrangements with a provider for CervicalCheck services will place the emphasis on awarding such contracts on criteria other than costs on foot of the Scally report; and if he will instruct the HSE to examine the workplace conditions, qualifications and workload of such screeners or examiners of slides. [38946/18]

Amharc ar fhreagra

Freagraí scríofa

On 12 September, the Report of the Scoping Inquiry into the CervicalCheck programme, led by Dr Gabriel Scally, was published on the website of my Department following the Government meeting.

Dr Scally has emphasised in his Report that the continuation of cervical screening in the coming months is of crucial importance. In that context, I very much welcome the fact that he has found no reason why the existing contracts for laboratory services should not continue until the new HPV testing regime is introduced. The Report provides very welcome reassurance in regard to the quality management processes in place in the laboratories currently contracted by CervicalCheck.

The Report includes fifty recommendations, many relating to the laboratories and approach to procurement. The Government has committed to implementing these in full. In particular, Recommendation 22 sets out that the procurement approach should maintain a balanced focus on qualitative factors, supplier experience, and innovation, alongside cost considerations and this will be implemented.

More broadly, the recommendations encompass proactive contract governance, measures to test performance and revision of programme standards. I am confident that the full implementation of the recommendations will ensure continuation of an effective, high quality service.

Question No. 171 answered with Question No. 165.

Primary Care Centres Provision

Ceisteanna (172)

John Brady

Ceist:

172. Deputy John Brady asked the Minister for Health the services that will be available in the new primary healthcare centre in Bray, County Wicklow; and if he will make a statement on the matter. [38964/18]

Amharc ar fhreagra

Freagraí scríofa

As this question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply.

Occupational Therapy Provision

Ceisteanna (173)

John Brady

Ceist:

173. Deputy John Brady asked the Minister for Health if a cognitive occupational therapy service will be available for persons in the new primary healthcare centre in Bray, County Wicklow; and if he will make a statement on the matter. [38965/18]

Amharc ar fhreagra

Freagraí scríofa

As this question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply.

Hospital Appointments Status

Ceisteanna (174)

Michael Healy-Rae

Ceist:

174. Deputy Michael Healy-Rae asked the Minister for Health the status of an assessment for a person (details supplied); and if he will make a statement on the matter. [38967/18]

Amharc ar fhreagra

Freagraí scríofa

Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

The National Waiting List Management Policy, a standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, since January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.

In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.

Hospital Appointments Status

Ceisteanna (175)

Michael Healy-Rae

Ceist:

175. Deputy Michael Healy-Rae asked the Minister for Health the status of a cataract operation for a person (details supplied); and if he will make a statement on the matter. [38968/18]

Amharc ar fhreagra

Freagraí scríofa

Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

The National Waiting List Management Policy, a standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, since January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.

In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.

Hospital Appointments Status

Ceisteanna (176)

Michael Healy-Rae

Ceist:

176. Deputy Michael Healy-Rae asked the Minister for Health the status of a cataract operation for a person (details supplied); and if he will make a statement on the matter. [38969/18]

Amharc ar fhreagra

Freagraí scríofa

Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

The National Waiting List Management Policy, a standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, since January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.

In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.

Hospital Appointments Status

Ceisteanna (177)

Seán Fleming

Ceist:

177. Deputy Sean Fleming asked the Minister for Health when an operation will be carried out for a person (details supplied); and if he will make a statement on the matter. [38979/18]

Amharc ar fhreagra

Freagraí scríofa

Under the Health Act 2004, the Health Service Executive (HSE) is required to manage and deliver, or arrange to be delivered on its behalf, health and personal social services. Section 6 of the HSE Governance Act 2013 bars the Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

The National Waiting List Management Policy, a standardised approach to managing scheduled care treatment for in-patient, day case and planned procedures, since January 2014, has been developed to ensure that all administrative, managerial and clinical staff follow an agreed national minimum standard for the management and administration of waiting lists for scheduled care. This policy, which has been adopted by the HSE, sets out the processes that hospitals are to implement to manage waiting lists.

In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.

Occupational Therapy Provision

Ceisteanna (178)

Róisín Shortall

Ceist:

178. Deputy Róisín Shortall asked the Minister for Health the waiting times for an occupational therapist appointment in Dublin 11; when a person (details supplied) will be seen by an occupational therapist; and if he will make a statement on the matter. [38980/18]

Amharc ar fhreagra

Freagraí scríofa

As this question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply.

Home Help Service Provision

Ceisteanna (179)

Robert Troy

Ceist:

179. Deputy Robert Troy asked the Minister for Health if additional home help hours have recently been put in place for a person (details supplied). [38998/18]

Amharc ar fhreagra

Freagraí scríofa

The Government is committed to providing services and supports for people with disabilities which will empower them to live independent lives, provide greater independence in accessing the services they choose, and enhance their ability to tailor the supports required to meet their needs and plan their lives. This commitment is outlined in the Programme for Partnership Government, which is guided by two principles: equality of opportunity and improving the quality of life for people with disabilities.

As the Deputy's question relates to service matters, I have arranged for the question to be referred to the Health Service Executive (HSE) for direct reply to the Deputy.

Hospital Consultant Recruitment

Ceisteanna (180)

Eamon Scanlon

Ceist:

180. Deputy Eamon Scanlon asked the Minister for Health when the two remaining consultant radiologist posts will be filled in Sligo University Hospital; and if he will make a statement on the matter. [39003/18]

Amharc ar fhreagra

Freagraí scríofa

In relation to the particular query raised, as this is a service matter, I have asked the HSE to respond to the Deputy directly.

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