Update on the CervicalCheck Screening Programme: Discussion

The purpose of this morning's meeting is to give members of the committee an opportunity to receive an update on the CervicalCheck programme with officials from the Department of Health, representatives from the HSE and the Irish National Accreditation Board.

On behalf of the committee, I welcome all the witnesses to our meeting this morning. There are a large number of witnesses. I would firstly like to welcome Dr. Colm Henry, chief clinical officer of the HSE. I also welcome Dr. Lorraine Doherty, clinical director of CervicalCheck; Mr. Damien McCallion, interim national director of the National Screening Service; Ms Celine Fitzgerald, interim chief executive officer of the National Screening Service; and Dr. Peter McKenna, clinical director of the women and infants programme of the HSE.

From the Department of Health, we are joined by Ms Celeste O'Callaghan, principal officer on the CervicalCheck project team; Ms Tracey Conroy, assistant secretary of the acute care division; Dr. Ronan Glynn, deputy chief medial officer; and Mr. Stephen Brophy, principal officer in the governance and clinical indemnity unit.

I also welcome Dr. Sharon McGuinness, chief executive officer of the Health and Safety Authority; Dr. Adrienne Duff, programme manager at the Irish National Accreditation Board; and Ms Bríd Burke, senior accreditation officer of the Irish National Accreditation Board. I thank them all for attending this morning.

I draw the attention of witnesses to the fact that by virtue of section 17(2)(l) of the Defamation Act 2009, witnesses are protected by absolute privilege in respect of their evidence to the committee. However, if they are directed by the committee to cease giving evidence on a particular matter and they continue to so do, they are entitled thereafter only to a qualified privilege in respect of their evidence. They are directed that only evidence connected with the subject matter of these proceedings is to be given and they are asked to respect the parliamentary practice to the effect that, where possible, they should not criticise or make charges against any person, persons or entity by name or in such a way as to make him, her or it identifiable. I also advise the witnesses that any opening statements that they have made to the committee may be published on the committee's website after this meeting.

Members are reminded of the long-standing parliamentary practice to the effect that they should not comment on, criticise or make charges against a person outside the House or an official either by name or in such a way as to make him or her identifiable.

I ask Ms Tracey Conroy to make her opening statement.

Ms Tracey Conroy

I thank the Chairman for the opportunity to meet the committee. I am joined by my colleagues, Ms Celeste O'Callaghan, principal officer; Dr. Ronan Glynn, deputy chief medial officer; and Mr. Stephen Brophy, principal officer in the Department.

I am pleased to have the opportunity to update the committee on the ongoing work to ensure a sustainable and effective national cervical screening programme and to address that have arisen since April 2018. The Department's priority focus is on implementing the recommendations of Dr. Scally's scoping inquiry, overseeing the completion of the independent clinical expert review led by the Royal College of Obstetricians and Gynaecologists and working with the HSE to ensure capacity issues are addressed and to implement the switch to HPV primary screening.

A further focus is on improving support for patient representation and putting in place an ex gratia scheme for the women and next-of-kin affected by non-disclosure of retrospective audit results, as well as the promised CervicalCheck tribunal.

Following his final report in September last year, Dr. Scally carried out a supplementary report which was published in June of this year. As the committee is aware, the supplementary report identified a number of issues including contractual compliance and the use of additional sites for the screening of slides without CervicalCheck's knowledge. Crucially, the report also stated that, on the basis of the information available to the inquiry, the use of these additional laboratories did not result in a reduction in the quality of the screening provided to Irish women and that there is no evidence to suggest deficiencies in screening quality in any laboratory. This is, obviously, very welcome reassurance from the perspective of women's health.

Notwithstanding the reassurance on screening quality provided by Dr. Scally's report, he identified a significant range of issues in the cervical screening programme that must be addressed. Dr. Scally's recommendations have been accepted in full by Government and an implementation plan was published in December, setting out more than 160 actions to be undertaken by all organisations involved. The Department has overseen progress in this regard and it has been steady, with more than half of these actions completed by the end of quarter two of this year.

The supplementary report of the scoping inquiry added two further recommendations and actions to address these are being incorporated in the overall implementation plan which will be published together with the quarter three report in October.

Smear test turnaround times have been a cause of significant concern for many women and there has been very good progress in recent weeks in this regard. In early May, MedLab ceased to accept new slides in order to focus on processing the backlog of smears in that lab. The HSE has now confirmed that, last month, MedLab completed in full the processing of its smear test backlog.

All smears are now being processed either by the Coombe or by Quest Diagnostics and turnaround times have significantly improved. Colleagues in the HSE will provide more detail on turnaround times and what women can expect over the coming weeks and months.

The introduction of the HPV test as the primary screening test was approved by the Minister in early 2018 and its introduction will be a significant milestone for the programme. Notwithstanding the challenges faced over the past year and more, the staff in the National Screening Service have continued to make strong progress across the various work streams required to effect this change.

The Minister recently approved the HSE’s draft project plan for the switch to HPV testing early next year. Funding has been made available in budget 2019 to support the necessary work.

Recognising that colposcopy clinics are experiencing pressures, additional funding is being provided this year both to address the immediate pressures and to improve resourcing as part of the introduction of the HPV primary screening test, which is expected to lead to increased referrals to colposcopy after the first year.

The review led by the Royal College of Obstetricians and Gynaecologists, RCOG, will provide each woman, or her next-of-kin, who consented to participate, with an independent report to provide them with assurance about the timing of their diagnosis and treatment. The Department has been engaging on an ongoing basis with the RCOG and the HSE over the past number of months on the operational aspects of the review and the process for communicating individual reports to women. The HSE will provide further detail on preparations in this regard at this meeting.

The RCOG will prepare an aggregate report for the Minister, which will include recommendations, where appropriate, on improving care for women. The RCOG wrote to the Minister on 6 September last advising that the aggregated report will be provided in October. It also advised that, based on the provisional findings of its review, the performance characteristics of the CervicalCheck screening programme that fall within the scope of the review appear to be broadly in line with the experience in the UK.

A further focus for the Department this year has been the introduction of legislation to establish the CervicalCheck Tribunal, which became law on 23 July. The Department is working on the practical arrangements to be put in place, and on the rules, processes and procedures required. Work is also progressing on the legislative provision for restoration of trust meetings.

In addition, an ex gratia scheme has been put in place for women or next-of-kin affected by the non-disclosure of retrospective audit results. Most recent figures are that 156 applications have been made with 152 assessments made. The scheme remains open.

There is wide recognition in the health sector that patients have an important role to play in the development of health policy and the reform of health services. It is essential that the patient voice be at the centre of the work under way to address the range of issues arising in relation to CervicalCheck. Both the CervicalCheck steering committee and the HSE oversight group include patient representatives.

Recognising the issues that have been highlighted by Dr. Scally and others in regard to payment for patient representatives, the Department has recently commenced work on the development of a policy for the selection and payment of patient representatives within the Department of Health and the HSE.

The Department has also provided funding to the 221+ CervicalCheck support group to enable it to support the 221 women and families involved in this issue. Most recently, the Department has agreed in principle to provide further funding to enable the 221+ group to offer support to additional women identified through the RCOG review as having discordant smear test results.

To conclude, I have set out some of the key areas of progress so far. The Department intends to continue a strong focus on the key priorities of implementation of the recommendations of Dr. Scally, the completion of the RCOG review and introduction of HPV primary screening, ensuring this lifesaving programme continues to deliver improvements in women’s health.

Mr. Damien McCallion

I thank the Chairman and the committee for the invitation to attend this meeting. I am joined by my colleagues Dr. Colm Henry, chief clinical officer, HSE, Dr. Lorraine Doherty, clinical director, CervicalCheck, Ms Celine Fitzgerald, interim CEO of the National Screening Service, and Dr. Peter McKenna, clinical director of the women and infants programme.

We continue to address and manage a vast range of issues that have emerged as a result of the crisis in the CervicalCheck programme in April 2018. Our priority areas remain stabilising and strengthening our cervical screening programme; continuing to support women and families who were directly impacted by the CervicalCheck crisis; improving communications with women and increasing public engagement in our screening programmes; implementing Dr. Scally’s recommendations from each of his reports, supporting the independent external review being undertaken by the Royal College of Obstetrics and Gynaecology, RCOG; implementing the recent recommendations from the rapid review carried out by Professor Brian MacCraith; continued strengthening of the governance and resourcing within our screening programmes; and enhancing the quality assurance of the programmes and implementing HPV primary screening.

Our Information line and client services unit continues to provide information to women and their families. We also support women and their families in the provision of access to their records and ensuring women get their slides from laboratories, where required, for legal review. The client services unit in our national screening service continues to support this process. We have provided healthcare records to 631 women and have also provided 332 slides to women, families or their representatives. We continue to support the 221+ group through our community liaison officers. The community liaison officers support women and their families in provision of the support packages provided to the Government. We are also working closely with the 221 patient representatives across a wide range of areas and are very grateful for their guidance and input to the screening programmes. It is helping to make a real difference.

We have just completed a public and patient inclusion plan for our screening services. This was developed in conjunction with our patient representatives. This was also highlighted as an area to be strengthened in Professor MacCraith’s report and his recommendations have been incorporated in our plan.

Some key actions within the plan include appointment of a full-time patient inclusion officer, extension of the screening patient panel, putting patients on key committees and a model for patient inclusion. Our patient panel for cervical screening continues to operate and has already provided critical input into specific areas such as the information and communications materials provided to women and families. We also have patient representatives on a number of key project groups within screening services with the inclusion of two patient representatives on the HSE oversight group, which provides the governance over the implementation of Dr. Scally’s report and all other CervicalCheck related issues.

We are very grateful to the many patient representatives who voluntarily give up their time to support our screening programmes. We have made a start in this area and remain committed to having patients at the centre of our screening programmes.

The HSE continues to support the independent international expert panel review being undertaken by RCOG, which was established by the Minister for Health, following a Government decision, for women who were diagnosed with cervical cancer. The HSE supported the consent process; established a national helpdesk; developed an eligible dataset with the National Cancer Registry; and implemented a client management system to support RCOG, in addition to co-ordinating the release of slides culminating in the completion of RCOG's review. We are working closely with the Department of Health in supporting the RCOG where required.

Some 1,074 women consented to participate in the review. RCOG is now transferring the individual reports to the HSE for dissemination to women and their families. The dissemination of reports is commencing on a phased basis in the coming weeks. We expect this process to take up until the end of 2019 in order for all results to be provided and meetings to be held, where requested, by the women and their families.

Issues emerged regarding delays in notification letters being issued to women arising from the HPV expiration issue. The HSE CEO commissioned a rapid review to ensure that any lessons learned from the issue were identified and implemented, which was undertaken by Professor Brian MacCraith. The HSE has accepted all of these recommendations. An implementation plan has been developed to support the recommendations and many of the actions identified will be completed by the end of 2019. These have been incorporated into the implementation plan for Dr. Scally’s recommendations to ensure an integrated implementation plan within the HSE. While the issue represented a low clinical risk for the women involved, we would like to reiterate our apology for any upset they may have been caused.

In 2018 around 370,000 women presented to the programme, an increase from 280,000 in 2017. This was an increase of around 90,000 and caused significant backlog in reporting results to women. We have worked with existing private providers, other private providers and public service providers in other countries to try to grow our laboratory capacity to address this issue. Following a global search and complex negotiations we have managed to secure additional laboratory capacity that has enabled us to eliminate the backlog to ensure more reasonable turnaround times for women. The number of slides in the backlog was at approximately 81,346 which has largely been eliminated. We would normally expect that approximately 23,000 slides would be in the screening process at all times. The turnaround times for reporting of results were at one point taking up to six months and these have now reduced to an average of six weeks. We hope to sustain the turnaround times at this level. This will ensure that women and their GPs get their results in a reasonable time period.

A key risk to enable cervical screening to continue in Ireland was the extension of the laboratory contracts. The HSE reached agreement with both the Coombe and Quest to enable continuity of the programme. The HSE also made a decision to expand the public laboratory capacity and to develop a National Cervical Screening Laboratory, which is included in our recent HSE capital plan. This will provide a better balance between public and private laboratory capacity provision. A project steering group and project team are now in place with building and workforce plans developed. While we are planning for a rapid build programme it will still take a number of years to implement, primarily due to the challenge of recruiting suitably qualified staff.

Our colposcopy services remain under pressure with increased referrals and the requirement for increased consultation time. The HSE women and infants programme recently completed an impact assessment on colposcopy services that identified some immediate resource requirements. Funding has been allocated in the 2019 national service plan and this resource is currently being rolled out to the clinics to support additional service sessions, to increase capacity and improve waiting times.

We continue to implement our plan to introduce HPV primary screening. A project team has been in place since last year and there are seven work streams involved in the project. We have completed a review of international HPV primary screening implementations, including site visits, to ensure that the lessons learned from other jurisdictions can be applied in Ireland.

We have completed a review of international human papillomavirus, HPV, primary screening implementation, including site visits, to ensure that the lessons learned from other jurisdictions can be applied in Ireland. We remain committed to implementing HPV primary screening as soon as possible, with the aim for implementation in the first quarter of 2020. Since we last appeared before the committee, we have reduced some of the major risks to the project through the reduction in the backlog and securing laboratory providers that can provide the testing service. We still face significant challenges with the information technology system changes and to ensure sufficient availability of colposcopy services to address future demand from HPV primary screening on colposcopy services.

I advise the committee that we recently introduced the HPV vaccine for boys. Combined with the existing uptake of the HPV vaccine by girls will help reduce incidence of cervical and other cancers. Evidence from elsewhere in the world, including Australia and Scotland, demonstrates that this combination of HPV vaccine and HPV primary screening will have the impact of eliminating cervical cancer over the next two to three decades and in the shorter term ensuring that women present with the disease earlier, meaning they would be less likely to progress to cancer.

The HSE has contributed significantly to the development of an implementation plan in collaboration with other State agencies in response to the Scally scoping inquiry recommendations. A senior manager appointed in September 2018 continues to oversee and drive the implementation of the report by Dr. Scally, including the supplementary report published in June 2019. An oversight group was also established in the HSE to support and ensure continued implementation of the Scally report recommendations and other challenges in our screening services. The group is co-chaired by our chief clinical officer and the chief operations officer. In response to the reports from Dr. Scally, we have developed a set of 116 actions arising from recommendations that are the responsibility of the HSE to implement, and we are reviewing appropriate actions against each recommendation as the implementation progresses. As of today, a total of 78 actions have been completed, with the remainder in progress.

Examples of progress to date include key appointments and governance improvements in the National Screening Service and CervicalCheck. An organisational review of risk management structures has also been commissioned by the HSE, in addition to the establishment of an expert group within the National Screening Service to review clinical audit processes across all screening programmes. Reports from both these groups are expected in the coming weeks. A review of the HSE's healthcare records management policy has also been commenced.

One of Dr. Scally’s recommendations included setting out the future approach to interval cancer audit. The HSE established an oversight group for this project with expert groups. The expert groups are independently chaired and comprise patients, patient advocates, a patient ethicist, screening clinicians and international experts. The expert groups have considered international best practice as part of the work, and we expect them to report in the fourth quarter of 2019.

An interim revision of the open disclosure policy has been completed and was published in June 2019. The HSE remains committed to ensuring the operation of open disclosure throughout the organisation by continuing to roll out its national training programme and the establishment of a national open disclosure office. An open disclosure governance steering group has been established in the HSE, and the group is chaired by the national director of quality improvement. An open disclosure framework has been developed. The governance framework and the group will provide leadership for the evaluation of audit of compliance with the open disclosure policy. All recommendations relating to procurement in Dr. Scally's report have been implemented.

Recruitment and retention of staff remains a significant challenge for our screening services. We have progressed a review of the organisation design of the National Screening Service, and one of the key actions was the appointment of a permanent chief executive officer. I expect the advertisement for the permanent chief executive officer to issue towards the end of September. We have recently appointed an interim chief executive, Ms Celine Fitzgerald, for our screening services while we recruit a permanent chief executive for the service. We have appointed a permanent quality and risk manager for screening services and prioritised the recruitment of additional posts in quality and risk management. A deputy laboratory co-ordinator is now in place to strengthen the laboratory capacity in the programme. We have just completed a recruitment process for the CervicalCheck programme manager to work with the recently recruited deputy CervicalCheck programme manager.

We were unsuccessful in recruiting a programme colposcopy adviser and are commencing an international recruitment campaign for this role. In addition, we are preparing to go to recruitment for a CervicalCheck primary care adviser and a CervicalCheck colposcopy nurse, which will further strengthen the clinical input to the programme. We are also recruiting a permanent director of public health for the National Screening Service and additional public health specialist positions. This will strengthen the public health input to the programme. Posts in communications and human resources have also been advertised in addition to a number of other programme support roles. We will ensure that the recruitment of all posts from the National Screening Service workforce plan continue to be prioritised.

I assure members that the HSE is absolutely focused on continuing to stabilise and strengthen our screening services. All possible resources are being directed at this challenge.

Dr. Sharon McGuinness

I thank the committee for the invitation to attend today. I am the chief executive officer of the Health and Safety Authority, HSA, and I am joined today by my colleague, Dr. Adrienne Duff, programme manager of the Irish National Accreditation Board, INAB, and by Ms Bríd Burke, our senior accreditation officer. We welcome the opportunity to be here this morning. We have submitted a written document and will summarise that now.

INAB is the national body in Ireland with responsibility for the accreditation of laboratories, certification bodies and inspection bodies. It is also part of a wider international accreditation network. INAB was established in 1985 and has operated as a committee of the Health and Safety Authority since 2014. As an operating unit, its role was transferred to the HSA under the Industrial Development (Forfás Dissolution) Act 2014, which also dissolved Forfás as its original parent body at that time. The committee's invitation to us today arises from the second scoping inquiry report that includes references to INAB and MedLab Pathology Limited. I will ask my colleague, Dr. Adrienne Duff, to continue the presentation.

Dr. Adrienne Duff

In respect of the matters of interest to the committee, our role is specific. It is the accreditation of medical testing laboratories to ISO 15189 and assessing procedural and technical standards to demonstrate competence to perform cytology screening. The scoping inquiry’s report identified a procedural lapse that occurred within the INAB accreditation process, specifically relating to MedLab, and I will elaborate on how this took place. MedLab was first accredited by INAB in 2011 for cytology screening following an assessment by an independent team of technical assessors, and this has been verified annually. The company’s principal location for this operation has always been based in Dublin. In November 2016, MedLab contacted INAB by email, proposing to hire a cytology screening employee - a cytoscreener - and to locate that person at its laboratory in Manchester. At the time, INAB considered the information, consulted technical assessors, and was of the opinion that the activities, monitoring and controls that were understood for the cytoscreening in Manchester would be in line with ISO 15189. INAB informed MedLab by reply email that, in principle, such a proposal potentially would be acceptable.

The matter of cytoscreening at the Manchester laboratory was not subsequently raised directly again by MedLab with INAB. The procedural lapse that arose within INAB is that we did not subsequently and formally follow through on this information. From November 2016 onwards, INAB continued its usual annual assessments of MedLab in Dublin, which confirmed continued compliance to ISO 15189 each year. During the assessments of cytology screening, the INAB technical assessor, a consultant histopathologist, assessed the competency records of all MedLab screening staff. The lead assessor assessed the laboratory management system and no major findings for cytology screening were raised during these assessments.

It is worth noting that MedLab employees who were subsequently confirmed as based in the Manchester site were included in the INAB annual assessment. However, their exact location was not readily apparent to the INAB assessment team from the records examined. Following INAB’s engagement with the scoping inquiry earlier this year, it became apparent that cytology screening at the Manchester site - referred to in MedLab’s email to INAB in November 2016 - was in fact fully operational. We now understand from the scoping inquiry’s report that MedLab began cytology screening in the Manchester site in February 2016. We immediately conducted a review within INAB in conjunction with our technical assessors. The main outcomes of this were as follows.

The competence of all relevant MedLab staff to perform cytology screening was assessed in detail by our technical assessors each year since 2016. The Manchester site was under the direct control and management of MedLab. The staff at the Manchester site were employed by and under the direct supervision of MedLab. The Manchester site was using identical documentation, work instructions, information technology and reporting mechanisms issued and controlled from the Dublin site. Employees in the Manchester site were included in the overall MedLab quality system and were monitored exactly as employees based in Ireland. On completion of this review and based on the evidence, INAB confirmed to the scoping inquiry that the cytoscreening conducted at the Manchester site was within the scope of the accreditation of MedLab.

We followed up this review with a specific on-site visit to Manchester in April 2019 as part of our annual surveillance visit to MedLab in Dublin. The review satisfied us that the cytoscreening at the Manchester site was accredited under ISO 15189 and the management system of the MedLab Dublin office.

However, for the avoidance of any doubt, we do not think it acceptable to have been unaware of or not formally notified of, the specific external location of some of MedLab Pathology Limited’s cytoscreeners in the Manchester laboratory. Our review determined that a more specific, direct and robust level of communication should have taken place between INAB and MedLab Pathology Limited at the outset. It is clearly our responsibility to ensure that all applicants for accreditation and accredited bodies keep us fully and clearly informed about proposals to modify or extend their accredited activities in order that these proposals can be scrutinised as fully as is necessary before being implemented. We immediately put in place procedures to rule out any further such occurrence arising. This includes scrutiny of the exact locations of any personnel within organisations seeking accreditation, implementation of new technology to track all such matters through our system, and checks and balances to monitor our own systems and staff.

In summary, it is the case that MedLab continues to meet the requirements of ISO 15189. It is also very important to emphasise that nothing in our review and assessments or in the scoping inquiry report, suggests that the quality of cytoscreening conducted at the Manchester site was of a lower standard to that conducted at the Dublin site. I will now hand back to Dr. McGuinness to conclude our comments.

Dr. Sharon McGuinness

The overall matters being inquired into by the scoping inquiry are of the highest possible importance to women and society in general and we take them very seriously indeed. I can categorically reassure the committee that lessons have been learned, procedures were immediately reviewed and changed and system improvements have already been implemented. We were and are committed to having a strong and robust system, which provides confidence in accreditation. I am also deeply aware that this lapse on our part added further concern and worry for all the women involved. This is something I profoundly regret and unequivocally apologise for. I thank the Chairman and members of the committee.

We will now open the discussion to members. The first member to speak is Deputy Brassil, who is substituting for Deputy Donnelly.

I thank the witnesses for the presentations. A lot of information was passed over there and I welcome the fact that the waiting time has reduced significantly. For me, the issue was always about communication or the lack thereof. I want to concentrate my ten minutes on two specific issues. One issue relates directly to a constituent of mine, a lady called Claire Healy, who decided, because of the fact that she was a high risk patient, to get a private screening. On foot of the results of same, when she went to the public system she was advised and told she would not be seen as a public patient because her test had been obtained privately. Deputy Donnelly has been in constant contact with Ms Healy and I understand that as of last night, following months of being ignored, she received an email and a communication from the Minister's office to say the issue was resolved and people would have access to the public system whether they were tested privately or publicly. To get that call on a Tuesday night at 10 p.m. prior to the witnesses coming before the committee on Wednesday morning is the most crass attempt at media manipulation I have come across with this particular issue. I want to ask the witnesses a number of questions directly from Claire Healy because she has asked me to do so on her behalf and I am quite happy to do it. The first question is as follows:

In late August, Kerry Colposcopy Unit issued a reply to me stating that they were instructed by Cervical Check to prioritise public test results. Who then made the decision in Cervical Check to exclude every woman who decided to access private testing, in an attempt to alleviate the pressure on an already overburdened system?

The second question is as follows:

Cervical Check decided to prioritise public tests. Do you really feel refusing and ignoring private test results, refusing women, is an acceptable way to address the chronic waiting times in an effort to hide the numbers?

The third question is as follows:

When I was refused my test, I looked for answers at a time of great worry and stress for my young family. I was ignored by your Department. Why was it that I had to go to great lengths and go public in order to get very basic answers? Last night a late e-mail was sent to me from your office and that was the first acknowledgement of the awful situation I find myself in. It took over two months to get a reply from your office? Why are the lines of communication firmly shut?

The fourth question is as follows:

I now find myself in a situation awaiting biopsy results and waiting for further answers. The Colposcopy Unit in Kerry told me that as they are now processing both public and private test results, they are overwhelmed with those waiting for results. I am told I will be waiting for between 4-8 weeks minimum before I discover if I have cervical cancer! What is being done to shorten the waiting lists and provide extra services? When will the Minister start to make changes which puts Women First?

The final question is as follows, "Following all the revelations during the last year, why is there still no helpline, or central communications hub for women with concerns of this kind to ring?"

I have a second series of questions relating to the Sharon case and the IT glitch but I would like the witnesses to answer those first.

Mr. Damien McCallion

I will make one or two comments to the Deputy. On the wider public concern that was raised around private smears, my colleague Dr. Henry will talk on the historical reason private smears had not been included in the cervical screening in the public units. The decision was made a number of weeks back, given the delays women had and given the fact that women had used private smear testing services because of the pressures in the public system. A clear communication went out into the system, including with University Hospital Kerry, where I would have spoken to one person who had a concern, to ensure that people did have access to the public colposcopy units, given the delays that had been in place. I will ask Dr. Doherty to talk to the Deputy-----

Has that been in place for a number of weeks?

Mr. Damien McCallion

That is right. A memo was issued out directly through our acute hospital system two to three weeks ago on that.

It is most unfortunate that the patient who highlighted it was only contacted last night but that is not Mr. McCallion's remit.

Mr. Damien McCallion

I do not want to get into individual cases but I did directly speak to someone in Kerry who contacted me on it to make sure it was clear. I cannot recall if it was the individual Deputy Brassil has mentioned but I can check that and revert to him if needs be.

Dr. Lorraine Doherty

I will try to clarify the issue around screening tests and private tests. In Ireland, every woman within the eligible age group is entitled to a free cervical screening test. We maintain a register for that purpose and women are called regularly for their screening tests. All those tests are processed and if they are showing a result that requires referral to colposcopy, we have a contract with the colposcopy units around Ireland to provide that service. However, if a woman makes a decision to go to her GP and have an independent private smear, we have no knowledge of that individual. That woman does not appear on our records and that result does not come into our system so we do not know about these women. When we wrote to the clinics about the colposcopy services, we were highlighting the fact that we have women who are part of the screening programme, for whom we have a contract with the colposcopy services to provide colposcopy, and we reminded the colposcopy units that they needed to prioritise these women to deliver that particular service. All women who have a smear test done, irrespective of whether it is private or public, and who require colposcopy on the basis of clinical need, should have access to that service.

In this case I am specifically talking about, Ms Healy had a previous inconclusive smear test. That is why she wanted a second test and because of the delay she went for a private test. Surely she would have been in the system if she had a previous inconclusive test.

Dr. Lorraine Doherty

I cannot comment on individual cases but if a woman had an inconclusive test and was waiting for a repeat test, she could have the repeat test but like many women in this country she might have had to wait some time to get that result, which is regrettable and unfortunate. If she had her repeat test done privately, we do not receive that laboratory result. As I explained, those results do not come into CervicalCheck's system. It comes to the GP of that lady, the GP holds the result and makes a clinical decision as to where to send that lady for further care. At that stage of the woman's care pathway, CervicalCheck will be unaware that she has had a second test or what the result of that test is.

It has now been decided that a person who goes private because of the backlog will be treated in the public system.

Dr. Lorraine Doherty

I wish to make it clear that if a woman goes private for any reason, CervicalCheck will not have her result because it is a public, rather than a private, programme. The question of access to colposcopy services which do not sit primarily within CervicalCheck has been clarified. Women go to gynaecology or colposcopy clinics for a range of reasons. Of course, women who have a clinical need based on a public or private smear test result are entitled to a referral to a colposcopy unit.

I have spoken about the communication issue.

Ms Tracey Conroy

I might come in on it. I am very sorry that the patient who has been mentioned was not communicated with sooner. I am reluctant to discuss individual patients in this forum. The Department's priority was to communicate with the HSE on having the issue addressed. I understand it has been addressed.

If we go back to the very start of this issue, we will see that it was all about a lack of communication. It is important to have confidence in this important service. Many things have got lost in the ether. Issues have developed out of issues. At the end of the day, did anybody really know what the whole thing started about? For me, it was always about communication. The case I am raising, after 18 months, is another one in which the woman involved is not happy with the level of communication. That is obvious from the questions she has asked me to put on her behalf. We are still learning lessons. We need to highlight these issues. If we do not highlight them, we will never get this right. The line of communication on such a sensitive issue should be the first priority of the officials. Can I get an answer to the question I asked about the helpline?

Mr. Damien McCallion

An information line is available for each of the screening programmes. There are escalation points within that structure, for example, when clinical matters are raised. Queries can come into the programme from multiple sources. I accept that there is scope for improvement in bringing all of the communication channels together. They can be strengthened through the information line, the correspondence or various other means. While I accept what the Deputy said when he described Ms Healy's case, I would say things have improved over time. The CervicalCheck line which would have received a very small number of calls in previous years received tens of thousands last year. The number of calls has reduced this year. One of the key factors that, understandably, caused concern for women was the delays they encountered as they waited for their test results and tried to understand where they were at. That is something at which we are looking. We have seen a decline in the number of calls as a result of the improvement in turnaround times. It is hoped this will be of assistance as attempts are made to strengthen the communication loop. I accept the point that it needs to be improved. There is an information line in place. The challenge relates to the multiple sources that can be used to raise queries. We need to make sure they are brought together in a more unified manner. Our new CEO will look at trying to bring all of those areas together. People can communicate with the programme in five or six ways. I accept that there is a need to try to improve it.

Ms Healy also asked what was being done to shorten the waiting lists and provide extra services. She is in a critical period of waiting. I know that the delegates have made an extensive opening statement, but I ask them to summarise the position in this respect.

Mr. Damien McCallion

I will respond briefly before asking Dr. McKenna to speak.

There is a recognition that colposcopy services are under pressure. As Dr. Doherty said, the two sources of referral are through the screening programme and directly from GPs. We have seen increased demand for colposcopy services. Funding has been set aside this year to invest in them. Dr. McKenna might describe the process we went through to try to ensure additional resources were made available to address the concerns that had arisen.

Dr. Peter McKenna

At the start of this year we visited each colposcopy unit and asked those involved how they were coping with the crisis, how they would cope with the increased number of patients who would come on stream when the HPV arrangements were put in place and how they would cope when the increased pressure of the Royal College of Obstetricians and Gynaecologists disclosure arose. We discussed what was required under the headings of personnel and staff, equipment and minor infrastructural changes. These requirements have been collated; the plan has been submitted and funding allocated to approve them. One of the most striking things we found was a consistent increase across the country in the number of non-cytology referrals to colposcopy clinics. The colposcopy clinics are designed to deal with people with cytology abnormalities. Historically, a small proportion - between 5% and 10% - of those going to colposcopy clinics were women who had symptoms such as abnormal bleeding. In the last year that small proportion has increased to between 35% and 50%. The colposcopy clinics are finding it difficult to cope with the extra cohort of patients. The reason for the increase in the number of clinical referrals reflects an anxiety in the community and primary care services. Patients are very conscious of the need not to neglect symptoms. The number of patients being processed in colposcopy units has increased. Arguably, these clinical referrals are inappropriate for colposcopy units. With that in mind, we are seeking to find a method to take them out of colposcopy clinics. We are exploring how funding can be sourced to see them being dealt with more rapidly outside the colposcopy environment.

I understand I will get a second chance to contribute.

I want to revisit the IT glitch issue and the case of Sharon which was highlighted in the report.

I will let the Deputy in a second time.

Okay. I thank the Chairman.

Mr. Damien McCallion

If the Deputy wants to pass on the details, we will be happy to make direct contact with Ms Healy to hear about personal concerns she may have. We will speak to him outside.

I thank Mr. McCallion.

I seek clarification on Deputy Brassil's question. In normal circumstances, when a woman presents to a GP or another smear taker because she is concerned about the delay in obtaining a smear test result through the system, she may be referred to the private service to have the smear taken. The result normally comes back to the GP or the smear taker who acts on the result by referring the patient to a colposcopy clinic if it indicates that this should happen. Is it now the case that, regardless of whether the smear was taken in the public or private system, when the GP or smear taker refers the woman to a colposcopy clinic, there is no barrier to prevent her from being seen in that clinic? That seems to be the issue. The private smear was received by the smear taker who acted appropriately, but the colposcopy unit decided that it was not going to accept the result because it was a private smear. That is not going to be the case in the future.

Dr. Lorraine Doherty

No, that is not the case. If a woman has a smear taken privately and the result comes back to her GP, the GP can make a referral to a public colposcopy clinic on the basis of that result and based on clinical assessment and need. Patients should be seen on the basis of clinical need. The point I was trying to make earlier was that a woman who had a smear taken privately was not part of the cervical screening programme for that smear because we did not have those results, or we were not involved in her pathway of care.

Deputy Brassil is referring to a case in which a colposcopy referral was made but the referral was not accepted because it concerned a smear that had been taken privately.

Dr. Lorraine Doherty

At that stage, the clinics were focusing on trying to clear their waiting lists, which comprised a mixture of public and private patients. As my colleague Dr. McKenna has highlighted, the impact of such a sheer volume of patients being referred to colposcopy clinics has put intense pressure on the clinics. Attempts are being made to alleviate the pressure on them. Of course, women who have a clinical need for a colposcopy can be referred to a public clinic.

I want it to be clear that a woman who has a test done privately can be referred to the public system. There seems to be mixing and changing in that regard. As Dr. Doherty said, it was the case that such a woman could be referred to the public system. For some reason, that was not possible for some time, but it is now once more the case that such a woman can be referred to the public system.

Who made those decisions? We often hear that "CervicalCheck decided", "It was decided" or "The HSE decided" but, of course, these are not amorphous beings. A person made that decision and, presumably, the same person can reverse the decision just as easily, which is worrying because there is no transparency about how the decision was made. Who made that decision?

Dr. Lorraine Doherty

Let me be clear; I do not think a decision was ever taken to exclude women who had private smears from the colposcopy service. A decision was made by CervicalCheck when a large volume of women were waiting for results and women were being referred for a colposcopy. We have a memorandum of understanding with each colposcopy unit. We wrote to them reminding them to prioritise these women in fulfilling their obligation to the screening programme. We did not at any stage instruct them not to take private referrals or referrals from women who had private smears who were referred for a colposcopy.

As my colleague, Dr. McKenna, highlighted, because of the configuration for the delivery of services, when women go to their GP for a private smear and to have an investigation there is nowhere for them to be referred other than a private or public colposcopy clinic. The confusion arose because people felt that as we had asked clinics to prioritise the public patients from the screening programme to fulfil the contracts, that in some way women who had private smears were to be excluded. The exclusion came from the workload associated with the clinics when they were trying to keep up with the sheer volume of activity. A decision was never taken by CervicalCheck or the HSE to exclude women with private smears from the colposcopy clinics.

Dr. Doherty is confident they are not being excluded notwithstanding the fact she has said no decision was taken and that however that decision was arrived at it has now been reversed.

Dr. Lorraine Doherty

Absolutely. A woman who has a private smear and who has a clinical need for a colposcopy can be referred in the same way as any other woman to a public clinic or a private colposcopy clinic, whichever is appropriate for her.

Of course, it is an awful pity that she would feel the need to go private in the first place.

I have asked my next question previously as, I know, have many others. Will the HSE provide me with basic data showing the locations the 221 discordant results were read or misread? Who is responsible for producing these data? Who has had access to this information? My understanding is this information is available and people in the HSE have access to it but it is not being shared, for whatever reason. I ask the witnesses to explain this.

Mr. Damien McCallion

I will address this question. We asked a number of laboratory people, including our new laboratory quality assurance co-ordinator in conjunction with the laboratory quality assurance co-ordinator from Northern Ireland, to produce an assessment of the breakdown of the 221 cases by laboratory. We worked with the 221+ patient group on this in the same way as we produced an earlier report on the medical status of the 221 women impacted by the original audit. We committed that we would work with them on anything about them first and agree it with them. We have completed that report but there is some additional information they wish to have included and we are closing this out at present. It should have been done earlier but the pressures on the operational system for the laboratory people who had to do the work over the summer delayed it. We expect it to be done within the next two to four weeks. The data we have are there, as is the report, but the patient group has asked us to include some additional information and we are doing this at present. Once it is agreed with the patient group, we will be happy to issue it.

It will be two to four weeks.

Mr. Damien McCallion

Yes. I do not expect it to take any longer. People have been working on it for the past number of weeks with regard to the additional information requested through the patient representatives of the 221+ group.

How long has the HSE had the information on where the results were read?

Mr. Damien McCallion

The patients are looking for broader information and this has been pulled out for us.

Specifically on that.

Mr. Damien McCallion

Many months. With regard to its release, we committed to agreeing it with the patient representatives first because it is information about them.

This is information with regard to laboratories. Nobody is looking for names. This is a question I have asked previously as have other Deputies. To be fair, whenever it is asked, the answer we get is that there will not be any bother with it but we never seem to be able to get it. Mr. McCallion has stated it will be two to four weeks.

Mr. Damien McCallion

Absolutely, yes. The constraint has been that we have agreed with the patients to include some additional information. We expect this to be done and people are finishing it off at present.

The HSE has had it for months and we will know in a month.

Mr. Damien McCallion

Yes.

The challenge of recruiting staff was mentioned and we are aware there are issues in this regard. Will Mr. McCallion outline the steps that are being taken to repatriate the testing? We will not go back over it but we know it was a political decision to outsource it. I am very proud that I opposed it at the time, although I was not a politician. Other politicians did. I do not believe it was best practice but it was done. Are any efforts being made? There is a long lead-in time for repatriating. Owing to the fact it was outsourced, we do not have a lot of the clinical expertise. What efforts are being made?

Mr. Damien McCallion

On the wider recruitment and retention problems, we have made some progress in recruitment. Ms Fitzgerald and others have joined in recent times. There is a wider recruitment challenge. There are specific challenges in laboratories and in trying to resource colposcopy. Each part of the pathway presents different challenges.

We made a decision towards the tail end of last year to develop a national cervical screening laboratory. An agreement was reached with the Coombe Hospital that it would be provided there. We believe this will take some time. The planning permission application is being made this week for the new build for the new facility. The design is completed and the Coombe has signed off on it. The building is expected to be finished by the end of 2021 and it was in the capital plan announced recently.

The challenge I alluded to in my opening statement relates to trying to attract and retain the staff we need to operate the laboratory. We also have a challenge with the fact that the Coombe Hospital has a very small base with regard to the programme. It has only been involved in it for a short period. Currently, it processes approximately 10% of the slides. It is a very important laboratory because in recent months it has also taken on additional colposcopy work, which is more complex with regard to the smears and the multidisciplinary meetings that need to follow. We have developed a workforce plan and a steering group to develop the project, which is jointly chaired by the Coombe and the HSE. We have people working full-time on developing it. We have identified 22 resources needed over coming years. Immediate approval has gone out for ten resources to be recruited and competitions are running for them. We are trying to be opportunistic with regard to where we can source some of these scarce resources, be they consultants or medical scientists. Currently, one permanent consultant and another locum consultant are working in the hospital. We have sanctioned a number of additional consultant posts but our challenge is trying to attract medical consultants into what is a specialised and quite a challenging area. We have had some success in identifying possible candidates and we are trying to work them through for additional posts. Up to four consultant posts will be authorised for the hospital but, as I have said, the challenge will be trying to fill them. There is also the scalability issue with regard to when we will be able to have growth in the Coombe. We believe we can get it to 40% to 50% over the next 18 months of the programme. Beyond this, it is contingent on being able to attract the right type of people.

Surely it will also be contingent on being able to train the right people. Many courses were discontinued by virtue of the fact the Government took away the need for them. Mr. McCallion mentioned 2021 and a degree programme of four years. Are people in training at present? Have the numbers been ramped up? Has the HSE liaised with colleges? Is this work being done?

Mr. Damien McCallion

The Coombe has an existing arrangement with one of the Dublin institutes and is utilising it. We are also trying to recruit people with experience from outside. One of the challenges with cytology as a career is that the numbers are dropping significantly because of the new testing model. People are leaving the profession. In the UK, there are huge delays as a result of people leaving prior to moving to new testing models. It has a different form of backlog pressure . We are also looking at where we can broaden the range of specialties people might have so they are not just dedicated to a single specialty that might, perhaps, present problems for them from a career perspective. On the medical science side, the Coombe has an arrangement that it is looking to extend. It is also trying to identify people coming out of medical science training programmes and generic programmes who might be interested in working in the field and offering them broader opportunities.

It sounds lovely when Mr. McCallion says they are looking to extend it but are they doing anything practically? That aspiration is all very well but I did not support outsourcing at the time and nor do I now. I refer to much of what has happened, such as how tests have been carried out in other jurisdictions. There has been talk of mad stuff like retrospective accreditation and so on. I speak as someone who uses the service. I am not happy that smear tests are bouncing all over the world. My instinct is that the best defence is to have the smear tests read here in this jurisdiction. It is one thing to say we all would like this to be happening and that it is being looked into and discussed but it does not seem as though much is being done. I respect that it is an aspiration but to make it a reality, it will require personnel, trained people and those who are in training now to come to work in the laboratory. I do not think that is being prioritised in any way.

Mr. Damien McCallion

I will try to reassure the Deputy. A workforce plan has been developed which looks at all aspects. Critical within the laboratory is the logistics and the operation is where much of the heavy numbers are in staffing. Equally, there are medical scientists and consultants. If one does not have medical consultants, one cannot provide the service or one is constrained in the volume and scale that can be provided.

The workforce plan has been agreed, the Coombe has ten posts, which it is now advertising and recruiting. On the medical side, we have identified additional posts. They are in the middle of trying to look for those posts. Some are going through the recruitment process but it will be very challenging to recruit people. We have tried to broaden out the nature of the role to make it more attractive to consultants. On the medical scientist side, the Coombe has a programme running with the institutes in Dublin. It is also recruiting and ran a campaign in recent months to recruit people. We are actively trying to increase capacity within the Coombe. There is also a sensible growth volume. Moving from 10% to a larger amount requires that it be done in a very safe, sustained way to ensure that one does not create difficulties for the existing laboratory. Finally, the new facility will go to planning this week. The money is in the capital plan. It will be completed, if on target, by the end of 2021. Very significant steps are being taken. I take the point that we need to try to accelerate the process but we are trying to push it across each of the three staff categories of medical, medical scientist and the logistics and operation piece.

Finally in this round, I believe Ms Conroy spoke of extra money being provided. It might have been in Mr. McCallion's submission. What is the amount of extra money?

Ms Tracey Conroy

A sum of €5.8 million was provided this year for CervicalCheck for the broad range of issues, including €2 million for colposcopy. It is to address the pressures, including those of staffing so there are extra posts and equipment, and so on. There will be ongoing requirements in this regard.

There was nothing in addition to the €5.8 million which was already announced.

Ms Tracey Conroy

That was the additional money.

Okay, that was the additional money. That is fine. I thank Ms Conroy.

I call Deputy Kelly.

I apologise that I will not be here for the second round as I must be in the House for Leaders' Questions. Last night I had the pleasure of being at the official book launch of Vicky Phelan's amazing book, which I am pleased to say is number one in the non-fiction chart. I met a range of people there who are very much affected by this crisis. I took the opportunity to scan their views and to listen to them for hours with a view to the questions I would pose this morning. The seven questions I will ask are based on doing this. I will ask them together, as it will make the best use of time. I ask that everyone answer them fully and directly, not in a generic fashion, as they are quite specific.

I listened to Mr. McCallion provide the basic information on the 221 and the laboratories, what labs were used and on what dates, etc. I have good time for Mr. McCallion but I just do not buy this and I am not sure that Mr. McCallion does himself. Tony O'Brien, to be fair to him, said in May last year that this information should be available within weeks. The 221 have asked for this information in that detail since last December. It is now September. There is a reason why this information is not being given out. Will Mr. McCallion be honest and tell us?

If we have learned anything over the past year or so, it is that we must be open and honest with the 221 campaign and the patient representatives, Lorraine Walsh and Stephen Teap. Mr. McCallion is saying that it will take another four weeks to collate this information. The information is available to him. I can guarantee that. If the patient representatives write to Mr. McCallion today and ask for the information, as he currently has it, in whatever state it is, will he give it to them? That is my first question. That information is available and Mr. McCallion should not tell me that it is not. If it is not collatable and available, there is a level of incompetence in the HSE that means that we have bigger issues than those about which we already know. This is a very simple desktop exercise. It could be done in one hour, never mind a year and a half. I ask Mr. McCallion to answer this very directly. We need to know the information. I have information from my own sampling, which suggests certain trends but we need the real facts.

My second question is specifically for the Irish National Accreditation Board, INAB, and the Department. I acknowledge the apology and regret for what happened by the representatives from INAB. What happened is very unprofessional and unacceptable. I have been trying to piece together a jigsaw around Dr. Scally's second report and what happened. The report was due in the middle of February but was suddenly postponed for many months. Responding to several of my questions and at committee meetings, Dr. Scally has stated there was no exact date when he discovered the laboratory in Salford was unaccredited. I have listened to him dance around the issue and I have listened to INAB do the same. On what date did INAB find out that this laboratory was not accredited and by whom? Will INAB provide the committee with all communication, written in any format, electronic or otherwise, from its parent Department, namely, Health, the HSE or the Scally inquiry or both, as well as from any members of its team, to this committee in respect of the issue of this lab? I want to know the date when they found out this was not accredited. Moreover, in a question to which many people want an answer, how can a lab be accredited retrospectively? I could read out a dictionary definition of quality assurance. How can INAB guarantee that everything that went on in that lab was to the standard required? We ought not forget that between 2016 and 2018, 91,000 smear tests went through there, not counting the free smears as we do not have those figures.

The third question is probably for Dr. McKenna or whichever representative on that side wishes to take it. On colposcopy waiting times, we are told that CIN 3 should be four weeks. The target is 90% in four weeks; it is now 70% and getting worse. CIN 1 should be eight weeks. The target is 90% at that level, but is also at 70% and getting worse. This is a serious problem. What is being done to address this? Given that HPV screening is being introduced, which I greatly wish to see, and accuracy levels will improve and so on, how will we deal with that as the number of referrals should increase in a good way? What plans are being put in place to deal with that?

My next question is for the representatives from the Department of Health. Dr. Scally visited seven of the 16 laboratories. He accidentally gave us misinformation regarding his visit to the laboratories, which, in fairness, he corrected. We now know that there was retrospective accreditation of one laboratory. He also stated that it was surprising and disturbing. I have the schedule of all of the non-visits to all of the other laboratories. How can we be guaranteed that there was not outsourcing, in any capacity, in any of the other laboratories ever over that period? I have a real concern on that issue and I would like to get some answers.

My next question concerns the RCOG review. I have to acknowledge, first, that there has been some learning in the area of communications. The HSE believes that 40% of all slides will have some form of different outcome. Some 1,047 women are involved in that review. Using that 40% percentage means that 430 women will have a different outcome. That seems high but 40% is referenced in the steering group minutes of July 2018. How can that percentage be explained? I ask the representatives from the Department of Health to please not insult me by stating that it is down to site review, bias or anything like that. Why do the representatives from the Department think that it is going to be 40%, as referenced in the minutes?

My next question is interconnected. This 40% is referenced the July minutes. Regarding the current position, I have raised for the past year and a half the fact that I believe it is wrong that the audit has just stopped. That is going to cause serious issues in the future. I do not have time to discuss this now, but it will cause serious issues and that must be faced up to now. The quicker this issue is dealt with the better. The trajectory of discordance of sampling, I have heard, is continuing post the audit. I want to know when the audit will be brought back, what proposal there is to do that and why the Department of Health continues to ensure that it is stopped. I ask that because, if we look at this based on what is going to come out in the RCOG review, the Department is going to have a much more serious problem, given the statistics it has stated itself.

Regarding what happened with the accreditation of the laboratory in Manchester, it is obvious that there was a breach of contract in some way. The Department of Health found out about this some significant time ago. I am not fully sure of the dates because they seem confusing. I have been given multiple dates. The Department, however, found out about this in January or February of this year. I presume it was before 14 February. That was when Dr. Scally was meant to publish his report but the date was pushed back following questions of the Secretary General of the Department at this committee. He stated that it was imminent but then the publication date suddenly changed. Obviously, that had something to do with the laboratory in Manchester and other quality assurance issues.

There is, however, a contractual issue in this regard. Any competent organisation will deal swiftly with a contractual issue of this seriousness and magnitude, which is causing such public concern. Will the representatives from the Department of Health provide the committee with all the details, in writing, of the efforts that the Department has made, and contact it has, with the organisation I referenced in trying to deal with that contractual issue? Will they also update this committee now on what has been done with company concerning that contract? This is an issue that the Department would have to have dealt with swiftly by now.

I thank Deputy Kelly and I call Mr. McCallion.

Mr. Damien McCallion

I will address the information on the laboratories. I have spoken to the patients about this issue in the past couple of weeks. I have no issue releasing the information once we have the agreement of the patients. We have, as the Deputy said, the overall breakdown. Additional information is being requested after discussions with Ms Lorraine Walsh and Mr. Stephen Teap. With their agreement, I have no hesitation in releasing the information. I spoke to Mr. Teap yesterday-----

Mr. McCallion has that agreement in writing today.

Mr. Damien McCallion

That is fine. We are happy to work with them on that.

That is fine. The information will be released today or tomorrow. That is grand and I thank Mr. McCallion.

Mr. Damien McCallion

I will ask Dr. McKenna to deal with the question of colposcopy.

Dr. Peter McKenna

I think this is mostly dealing with the fifth question from Deputy Kelly.

That is fine.

Dr. Peter McKenna

The HSE has taken the disclosure of the RCOG audit as a matter of the utmost importance. There were many unknowns involved. We did not know when the reports were going to come through and we did not know the discordant rate. Consequently, our plans were based around a discordance rate of 40%. We had to plan for something and so we picked something at the upper end of the likely range. Other audits like this would have shown a discordance rate of 25% to 35%, so we decided that we would plan for the worst case, which would be 40%.

We have not got all of the reports back yet, but the evidence we have suggests that the discordance rate is going to be substantially lower. The total number in the priority group, consisting of all of the discordant smears, the 221 patients who were a part of the RCOG review, patients who have died, patients who had an interface with colposcopy and patients whose slides have been either lost or broken, comes to approximately 400. Based on that fact, it is reasonable to state that the discordant rate is likely to be substantially less than the 40% for which we were planning. That is how we arrived at that figure and we did that so that we could get our plans in motion. I am not in a position to give the Deputy the absolute discordant rate yet, but the hope and the expectation is that the planned percentage was on the high side.

That is fine.

Mr. Damien McCallion

Dr. McKenna might also inform the committee about the plans regarding colposcopy, the pressures there and the impact assessment undertaken.

Dr. Peter McKenna

The colposcopy waiting time has been addressed locally by people putting on extra clinics. There are now three or four a week where previously there were two or three. That is what they can do quite easily.; what they cannot do is deal with the number of increased clinical referrals. The expectation, as I stated earlier, is that we will be planning to take those out of the colposcopy clinics and let them deal with abnormal cytology and positive HPV. If we can reduce that number of referrals by what we know to be 30% to 40% of the colposcopy workload, the HPV work generated can be accommodated relatively easily.

I do not know if many people will agree with that.

Dr. Peter McKenna

Well, I am interested to know of which element the Deputy is sceptical.

Dr. Peter McKenna

The increased referral in respect of HPV is variable. Some people have reported increased rates of 10% to 15% and others increased rates of 40%. If we can take the clinical referrals out of the colposcopy clinics, which currently account for 35% to 40%, the increased rate of HPV work should be accommodated.

Let us see if Dr. McKenna is right.

Mr. Damien McCallion

As Dr. McKenna said, no one is stating that this is not a challenge. There is a significant piece of work going on-----

I am sorry, but we have had time to prepare for it.

Mr. Damien McCallion

We have investment going out at the moment in respect of additional funding for the service plan this year. We think that it will need more and we will work that through.

The figures I quoted are accurate and are going south.

Mr. Damien McCallion

That is correct.

A miracle is needed and I am taking Dr. McKenna's word that the miracle is going to be performed.

Mr. Damien McCallion

I will allow Dr. McKenna to come in shortly. There are two challenges. One concerns current pressures. The funding is being targeted to address that and the hospitals have been engaged as well. The second challenge then relates to HPV work. Dr. McKenna has visited all or most of the sites and he may wish to speak to that issue.

Dr. Peter McKenna

I would like to give some clarification in case the Deputy thinks I am claiming that we are going to work miracles. I am grateful to him for his interest in this issue because additional resources will be required to address the problem. It is not going to be resource-neutral. Any help we can get in procuring these resources will be entirely welcome.

It will be particularly welcomed by the colposcopy community, who are very conscious of these waiting times. This is a group of individuals who are committed to dealing with their patients in the appropriate length of time and they would certainly be appreciative of the Deputy's interest should it help to resolve-----

This is not the first time I have raised this matter. I have been raising it for some time.

Dr. Peter McKenna

Pardon?

I have been raising this matter for some time.

Dr. Peter McKenna

I thank the Deputy.

My concerns are on the record and we will see what will happen in the future. I am conscious of time and the other questions I have asked.

Mr. Damien McCallion

I will take the Deputy's question about the contract arrangement with MedLab in Manchester.

Mr. Damien McCallion

My colleague, Dr. Henry, will pick up on the point about interval cancers.

MedLab has ceased as a provider with the programme and there is no further work going through Manchester or Sandyford. In that regard, the contract has concluded.

I understand that, but there was obviously a breach of contract so what did the HSE do about it?

Mr. Damien McCallion

We were locked in negotiations over the continuation of the contract with MedLab and that was one of the factors in the negotiations and how we dealt with it. It was dealt with in a composite way around the termination of that work.

No, there is a breach of contract here and there is a consequence. We were paying, as taxpayers. There is a breach of contract and, obviously, something must have come back from this. What did the HSE do about it?

Mr. Damien McCallion

This was part of a wider negotiation and we could not look at this issue in isolation. We were negotiating a contract for the future of the programme. The programme, at that stage, was on the verge of collapse so we looked at that in the whole. Our priority for the Manchester facility was to get assurance that the performances of the screeners in the laboratory were included within the MedLab screening performance which we are assured they were. We looked at it in that context to ensure there were no issues from a performance perspective.

In a wider context, we had to negotiate around-----

To save time, I will say that what I am reading into Mr. McCallion's reply is that nothing happened.

Mr. Damien McCallion

No, there was-----

There was no consequence to the breach of contract.

Mr. Damien McCallion

It was a factor in the overall negotiations. We could not look at that in isolation.

I do not accept that.

Mr. Damien McCallion

The contract negotiation was more complex.

I do not accept that one bit. I am sorry, but I am conscious of time.

Mr. Damien McCallion

Sure. I will ask Dr. Henry to talk about interval cancers.

Dr. Colm Henry

I entirely agree with Deputy Kelly. Interval cancer audit is one component, but a critical component, of quality assurance measurements of screening programmes, not just in Ireland but internationally.

I know all about interval cancers but I did not ask a question about it. Is Dr. Henry trying to get around to the audit issue?

Dr. Colm Henry

Yes, if the Deputy will give me time to answer his questions.

That is no problem.

Dr. Colm Henry

I will be brief but I need the Deputy to give me some time to answer.

It is not that at all, it is purely about the audit and I am conscious that the Chairman may wish to move on.

Dr. Colm Henry

In international screening systems, interval cancer rate is often measured because there are population-based screening programmes. For example, our own breast screening programme has an interval cancer rate which compares very favourably internationally. The events of last year and Dr. Scally's report showed and characterised the existing audit as flawed in design, implementation and the way in which it engaged with clinicians. Following the publication of the Scally report, we committed to design, and are well advanced in designing, interval cancer audit for all three cancer screening programmes. We have expert groups led by independent chairs. We are scoping out international best practice. For example, in Canada, all audit or quality assurance clinical activities are protected in legislation while, in England and Wales, a duty of candour legislation was introduced in 2014 making it almost unique in bringing in not only open disclosure with regard to certain elements of false negativity.

We do not want to just reintroduce what was characterised as a flawed audit. The works of these three groups is coming to a conclusion. Input into that work came not only from international experts but from patient representative and advocacy groups and I am confident we will have an output from those groups towards the end of this year.

When will the audit commence? When will the audit be back in place retrospectively to 2016?

Dr. Colm Henry

We will not have last year's audit back in place.

I know that. When will there be an audit?

Dr. Colm Henry

We need an audit that everybody can stand by-----

That is fine. When will it be in place?

Dr. Colm Henry

-----and the work of these groups will come to fruition towards the end of this year.

When will the audit be in place?

Dr. Colm Henry

After the work of the groups comes through, the HSE and Department will validate it.

I agree with all of that.

Dr. Colm Henry

We want to get it back up as soon as possible.

That will go back to 2016.

Dr. Colm Henry

We are looking at a prospective designed audit as to what we do from here on out.

So, the HSE is going to skip the years 2016 to 2019.

Dr. Colm Henry

There is no intention of skipping. We do not need to implement what is characterised as a flawed audit.

What is going to happen to the years 2016 to 2019 or 2020? This is new information to everyone here. If the audit will run from 2020 onwards but there is a gap dating back to 2016, what is going to happen?

Dr. Colm Henry

We are designing something prospectively which includes open disclosure in certain circumstances and scoping best international practice.

Will 2016 to 2019 be covered?

Dr. Colm Henry

There are existing quality assurance mechanisms in place.

Will there be an audit for the years 2016 to 2019? Please answer "Yes" or "No".

Dr. Colm Henry

We will look at each individual programme. There is no intention not to perform audit or carry out quality-----

So, there will be an audit for the years 2016 to 2019.

Dr. Colm Henry

We will look at each-----

There will be an audit. That is what I am taking from that and, if I am wrong, contradict me.

The last question was to the lads from the Irish National Accreditation Board, INAB; I am conscious they are waiting with bated breath to answer.

Dr. Adrienne Duff

I intend to be as exact as possible on the questions the Deputy has asked. As I said at the outset, MedLab has been accredited by INAB to ISO 15189 standard since 2011. In order to confirm its accreditation on an annual basis, INAB carries out on-site assessments with consultant histopathology, specifically in relation to cyto-screening.

To directly answer the questions the Deputy asked about our communications as part of the scoping inquiry, in November 2016, MedLab emailed us about information regarding recruitment of a cyto-screener and it intended to locate that cyto-screener in the Manchester office. As we said in our opening statement, we should have followed up more robustly at that stage on that information that was provided.

On 8 February this year, Dr. Scally sent to me a copy of that email which we received from MedLab at the time with the specific-----

Has all that documentation been supplied to the committee?

Dr. Adrienne Duff

It has. On that basis, we carried out a thorough internal review at the time, in conjunction with our technical assessors. Based on the evidence and the facts in the MedLab file at the time, we confirmed, and confirm now, that the cyto-screening carried out at the Manchester site is accredited by INAB.

What date was that? Was it 30 May 2019?

Dr. Adrienne Duff

Which date is the Deputy asking about?

The date accreditation was given.

Dr. Adrienne Duff

We are confirming that accreditation is in place for MedLab under ISO 15189 based on the review and the annual assessments we undertook to MedLab from 2011 right through to 2019.

That is not what I asked. There was no accreditation according to Dr. Scally's letter to me. The schedule was numbered and dated as edition two. The accreditation of 23/10/2018 just said Unit 3, Sandyford Business Park and did not mention Manchester. By 30/5/2019, it had Manchester. That is according to INAB's own schedule.

Dr. Adrienne Duff

That is right.

This is an important and specific question. INAB was notified in writing by Dr. Scally on 8 February. I want to know on what date INAB gave accreditation to this lab.

Dr. Adrienne Duff

May I put it in a different way?

I am sorry, but this is a specific question and I am caught for time.

Dr. Adrienne Duff

I understand.

This is a very specific question. I have asked this question many times and in many different ways to Dr. Scally and his team, to the Department of Health, to the HSE and to everyone else. I want to know on what date INAB gave accreditation to this lab.

Dr. Adrienne Duff

Based on the evidence from the assessments that we carried out on an annual basis to ISO 15189 standards, which reviewed the competency of all the cyto-screeners, all the equipment involved in the cyto-screening testing, the release and issue of results, we confirmed to Dr. Scally in an email of 13 February that the cyto-screening activities carried out by MedLab Pathology at the Dublin and Manchester sites are accredited.

So, accreditation was given on 13 February?

Dr. Adrienne Duff

No. We confirmed to Dr. Scally that accreditation was for both the Manchester and Dublin sites based on the evidence and factual information we had and the depth of the assessments we carried out on an annual basis.

That did not answer my question. Dr. Duff has now thrown another date in here. On 13 February, did INAB confirm that the Manchester site was accredited or not? For everyone watching - and I ask Dr. Duff to remember that some very senior people are watching what we are saying - what is the difference between what INAB wrote to Dr. Scally on 13 February and the schedule, edition two, 30 May 2019 which is where INAB next says that lab is accredited, as distinct from 23/10/18 when INAB just stated Sandyford was accredited? I want to know the difference in what INAB stated on those occasions. We are focusing in now; I do not know why my question cannot be answered directly and I must zone in. What is the difference between 13 February and 30 May?

Dr. Adrienne Duff

It goes back to what we said in our opening statement. We accept there was a lapse in our procedures in terms of the depth of follow-up and the timeliness of our follow-up. Following our engagements with the scoping inquiry, we carried out an on-site assessment of MedLab Pathology, which included the Dublin and Manchester sites.

What date was that?

Dr. Adrienne Duff

It was 17 and 18 April 2019 and a third date in May 2019. That is part of the annual assessment of MedLab that assesses its entire scope of accreditation with technical experts. Following that on-site assessment we regularised our paperwork. We accept there were gaps in our procedures which we should have identified in the Manchester site.

I understand that. We now know there was an email in November 2016 and there was no follow-up, for which Dr. Duff has apologised. I accept that and it is not a major issue for me. We now know that on 8 February, Dr. Scally wrote to Dr. Duff when he found out about this. I have already asked Dr. Duff to provide all communication from Dr. Scally, his team, either department, including the parent department, and-or the HSE or cervical teams to the committee. I ask the witnesses to tell us now if they have any issue with any of that.

I cannot be any more direct or specific. I want to know on what date INAB, as the accreditation body responsible, gave MedLab's Manchester operation accreditation. We have heard several dates, namely, 13 February, 17 or 18 of April, another date in May and 30 May. Unless I hear a specific date on which INAB gave MedLab accreditation, I want to say on the record that INAB is unable to provide us with a date on which it accredited the Manchester lab. I want to be contradicted here and now by being told the exact date on which the Manchester lab was accredited. It is a basic thing and the public deserves to know that information. Furthermore, it is incredible if there is no date. It is not believable that there is not a date on which the accreditation was given by an accredited body in this State.

Dr. Adrienne Duff

As part of our review and engagement with the scoping inquiry, and based on a full technical review of the evidence we gathered over our annual assessments to MedLab and the fact it was operating a common system of management across its sites, we reviewed the competence and quality assurance of the cytoscreeners involved in the testing. We reviewed the application of its common management system, control of the laboratories and the staff involved. The cytoscreening activities performed at the Manchester site have been accredited since they started.

They have always been accredited.

Dr. Adrienne Duff

Based on the evidence and technical review we conducted, we are satisfied that there is a common system of management in the laboratory, that we did assess the competency-----

A lab that nobody knew about, including the HSE, and that was not part of the contract was always accredited by INAB. This is scary stuff.

In the history of INAB, has it ever retrospectively accredited any lab for any purpose, either in Ireland or outside of the jurisdiction? Is this situation unique to CervicalCheck? Has it happened in the veterinary sector or any other area of healthcare? Is this a new phenomenon? Is this flaw or failing just a moment in time? It requires a "Yes" or "No" answer. Has INAB ever retrospectively accredited a lab?

Dr. Adrienne Duff

Retrospective accreditation is not a term which is used under international accreditation rules.

Has INAB ever done what it did in this case before, whatever the witnesses want to call it?

Dr. Adrienne Duff

The situation which arose in this particular instance was unique to this set of circumstances.

Was it unique in the history of INAB?

Dr. Adrienne Duff

Yes.

On the basis of the information given here, I will write to INAB because this raises concerns way beyond what we thought we knew about.

I will be very brief because many of my issues have been raised. I refer to private screening and people being referred to public colposcopy clinics. I saw a letter from a consultant to a patient over four months ago. The patient's GP became concerned about her and felt her screening needed to be fast-tracked. The results came back and concerns were raised in the screening process. The GP referred the patient to a public clinic in Cork and a consultant in the clinic wrote to state that because the patient went for a private screening, the clinic would not be able to assess her.

I gave advice to the patient to the effect that the GP should write to another public clinic and a second public clinic had no difficulty in accepting the patient. Two weeks after the patient had been seen in the public clinic, the clinic received a circular advising it could not take any patient who had had screening privately. The same letter was sent to public clinics. I understand that is now not the position and a further letter has been sent to public clinics stating that if a medical practitioner is concerned about a result, regardless of whether the patient is public or private, the clinic will be able to take the patient. I would like clarification on that.

Mr. Damien McCallion

That is correct. The acute hospitals division issued a note a number of weeks ago to clarify the situation, as I mentioned to Deputy Brassil. There is no issue.

I raised the matter with the Minister four months ago. I showed him the letter which was issued to the patient by the medical consultant in the public clinic. It was a case where a GP had a very genuine concern and results from the private screening were forwarded to the public clinic. That was the response the GP received. The patient has been dealt with in another public clinic. Everything has worked out for that patient, but I was concerned, and that is why I raised the matter with the Minister over four months ago. Mr. McCallion has clarified the situation. He has said that when a patient has been identified as having an abnormal result, she will be taken on board by the public system.

Mr. Damien McCallion

The acute hospitals division wrote to all of the hospitals for the avoidance of doubt to ensure that, if a private smear result was referred to, as Dr. Doherty said, a public colposcopy clinic, the patient would be treated based on clinical need and priority.

I thank Mr. McCallion. The roll-out of lab facilities in Ireland was mentioned. Reference was made to a planning process. The programme will be dependent on the recruitment of suitably qualified staff who can provide an adequate service. Is there a plan in terms of the timeframe? It is not something which can be developed over six or 12 months. It will obviously have to happen over a period of time. Is there a three-year or five-year target?

The IDA has paid significant sums to attract foreign investment into this country to create jobs. We are exporting a major service to other countries when we should have been developing it here. What is the overall plan for carrying out the vast majority of lab work required in Irish labs? Will it take three, five or ten years? Is there adequate training available to train people in Ireland to ensure that they are suitably qualified to staff the lab as it develops? Do we need to talk to the various training bodies about how we can increase the number of people working in the area?

Is there an overall plan relating to training and the development of this facility?

Mr. Damien McCallion

There is a very clear timetable on the construction project. As I said earlier, it is going to planning this week and is scheduled to be completed by the end of 2021. That is the plan in terms of the building aspect of it. A workforce plan has been developed concerning what is needed to operate a national cervical screening laboratory. Approval was given this year for ten posts through the funding that was mentioned earlier by colleagues in the Department and those people, including medical scientists, are being recruited. The Coombe is working with the institutes in Dublin in terms of the training piece for medical scientists but our biggest challenge will probably involve medical consultants - the appropriate consultant cytopathologists. There are significant challenges. We have one permanent person and one locum person in the country. In order to develop a laboratory, we do not just require a building, medical science and logistics. The medical piece that provides the oversight and engages in multidisciplinary meetings with the colposcopy units for patients who are referred to colposcopy is critical. We have sanctioned the posts and the funding so that is not an issue. We are going through the normal consultants approval process. That is one of the areas where we are working with our medical manpower people. There is a national lead for medical workforce planning in the HSE and we are trying to utilise those to look at opportunities for how we could grow that. There is a clear plan regarding how that will work but we also face a challenge that is part of the ongoing work around looking at international evidence where we need a level of resilience alongside that. If everything is in one laboratory and there is a spike and we lose staff, the danger is that we get back into backlogs. Difficulties can arise if there is an issue in a laboratory. We must look at that balance. Most jurisdictions have found some balance between having some options around resilience as well as part of it and that is also being considered. There is a very clear timetable for the building and a workforce plan has been agreed and has started with regard to recruitment. The Coombe, which has kindly agreed to take on this facility within the hospital, is working with the institutes to develop that and I am confident that they will address that part but there are very significant challenges involving the consultant workforce and trying to develop it. We are looking at a range of options around how we can do that. It goes beyond training in the sense that there is a number of people we need in the country. If we have a small number of people and someone leaves or falls ill, we have no resilience in what we are offering so we need a significant number, which is why we have grown the number of consultant posts within the model for the national cervical screening laboratory, but there are challenges there.

Have we looked at other jurisdictions such as the UK, New Zealand or Australia to see whether we have people working in that area and to try to encourage them to come back to Ireland or even to go down the road of that training?

Mr. Damien McCallion

On the medical side, we are trying to attract qualified people. It is a much longer journey and is very difficult for a single specialty. Discussions are ongoing with the medical workforce people about how we might try to create roles. That might mean that they have to be broader than just this specialty so we offer a number of specialties and might attract someone that way. That is one of the things we are doing around one post in the Coombe without getting into the international search. We are carrying out international searches and have one or two leads we are following up regarding people who may be interested in returning to this country on the medical side but they take time and must be harnessed and worked through to persuade someone to make that career choice to come back. The crisis brings additional challenges but we are working through them and are trying to attract people to those positions, particularly the medical posts.

My final question concerns the roll-out of the HPV vaccine to boys. Will there be provision for parents of boys who will not be included in this year's vaccine programme? Will these parents be able to have their sons included in the programme? This also applies to girls whose parents may have had concerns 12 months ago but no longer have them and are anxious that their daughters be vaccinated. Is there a way for those parents to have their children vaccinated or will it be confined to a particular age group?

Dr. Colm Henry

We will find out the details. I cannot give the Senator the exact answers but we will furnish him with them when we consult with our public health colleagues.

Parents have raised this issue with me. Their sons will not be included in this year's programme because they are a year or two older but they want them to be included and they want to know if they can avail of that service. Likewise, parents who had concerns 12 or 18 months ago and did not have their daughters vaccinated have approached me. These parents now want their daughters to have the vaccine. Can provision be made for children in this situation?

Ms Tracey Conroy

I will ask Dr. Ronan Glynn, who has policy responsibility for that area in the Department, to answer that question.

Dr. Ronan Glynn

There is an opportunity for girls who missed out in previous years as the HSE will be running mop-up clinics. A teenage girl who has gone beyond first year and had access to the programme in previous years but for whatever reason, did not avail of it can still avail of it. The introduction of the new vaccine this year for girls and boys was based on a recommendation from HIQA, which performed a health technology assessment. Based on its advice and that of the national immunisation advisory committee, which is the source of the advice upon which we base our decisions, a decision was taken with the introduction of the new vaccine not to introduce a catch-up programme for boys. However, that will depend on uptake over the coming years of the vaccine so that is something the national immunisation advisory committee will keep under review and is, therefore, something we in the Department would keep under review over time as well.

Dr. Glynn said there would be availability for girls. Will information on that be rolled out because many parents would not be aware of that?

Dr. Ronan Glynn

That facility is in place. There should be information on the national immunisation office's website, www.immunisation.ie, but I will follow that up afterwards to make sure information on that is available. That facility has been in place for years because, obviously, with the low uptake, there have been parents of older girls who, for whatever reason, chose not to take up the vaccine in a given year and subsequently changed their minds.

Would it be worth doing some work on social media to get that information out there because many parents are not aware of that?

Dr. Ronan Glynn

I will liaise with the national immunisation office on that.

I appreciate that.

To return to an issue raised by me, Senator Colm Burke and Deputy Brassil regarding private smears entering the system, could the witnesses supply the committee with all the circulars relating to that, including the initial circular suggesting that public smear results should be prioritised over private ones and the recent circular rescinding that recommendation?

Mr. Damien McCallion

Yes.

As an addendum to that, with regard to referrals coming from private patients entering the system or requiring urgent treatment, is there a culture in the public health sector to refer these patients elsewhere rather than deal with them in the event that their condition requires urgent and necessary treatment because I have come up against that and would like some clarification? I believe the health of the patient should be paramount regardless of whether he or she is private or public and if it is possible to give him or her the attention he or she requires and deserves, it should be done.

Mr. Damien McCallion

Is the Deputy talking in the context of screening or in a wider context?

I am speaking in a wider context.

Mr. Damien McCallion

Is the Deputy asking whether private referrals are treated differently in the public health system?

Dr. Colm Henry

We have a hospital system that into which private practice is knitted.

I know that. If a private patient is in a difficult or dire situation requiring urgent treatment that is available in the public system, will that private patient be referred to the public system or will he or she be told "Sorry, you're a private patient. Go through the private sector"?

Dr. Colm Henry

The question is very broad in scope. For example, some private hospitals may not have all the facilities needed to deal with the level of acuteness or complexity of illness some patients may have.

For example, some patients may be referred to a private hospital, receive treatment there, develop dialysis needs, in the case of renal failure, that may not be provided in a private hospital setting, and then require transfer to a public hospital. There are long-standing practices in private hospitals and public hospitals for transfer of patients based on clinical need. Ultimately, I hope the behaviour of clinicians is guided by clinical priority, irrespective of whether the source of the referral is public or private.

My question was whether there is a culture of referral elsewhere in the event of a patient in a serious condition requiring urgent treatment. Such a patient, being a private patient elsewhere, deserves and requires treatment of an emergency nature immediately, not when somebody has decided that the patient is private and will be dealt with differently.

Dr. Peter McKenna

In the case of the sickest patients in the country, such as those who need intensive care therapy, I have never in many years of practice heard the patient's insurance status referred to.

I have great respect for Dr. McKenna and I accept he genuinely believes that, but I have evidence to the effect that that is not the case. I am aware of a patient who was transported to this country from abroad in an emergency but who was refused access to the public health sector even though the expertise required to deal with the patient was in the public sector.

Dr. Peter McKenna

That might be best dealt with on an individual basis. As a general principle, I have never heard a person's insurance status referred to when he or she was critically unwell.

I strongly support that principle. The condition of the patient should be paramount in the determination of where, how and when treatment is given.

I return to the issue of accreditation. INAB deals with accreditation and has a series of stages, although I will not list them. When tests were first referred to the Manchester laboratory, was its status sought? When did the first referrals take place? Was there a request at that stage for the laboratory's ISO status to be clarified? I would have presumed it was requested, given that it is required according to the information we have but, in light of the information that has emerged, it seems there was no such request. In such a situation, how was it decided to make referrals if there was no clarification as to the status of the laboratory at the time?

Dr. Sharon McGuinness

I might answer initially before passing to my colleague as appropriate. Accreditation is very much an independent and impartial service. To answer Deputy Kelly's question, we are not affiliated with the Department of Health and there is no connection between INAB and the Department.

We were asked whether the laboratory was accredited. The question can be answered based only on the evidence, the standard we work to, namely, ISO 15189, and the ability to have what we call satellite laboratories - that is my expression and I apologise if it is not the correct one - in that situation. That was the question we were asked by the scoping inquiry in February and it is the one we answered. Every year, there was an additional approach in respect of accreditation, which took place in April and May.

Accreditation is part of a bigger picture. We perform one element, namely, accreditation, but other elements, such as quality control and ongoing checks and balances in the system, are involved. We assess the competency, the management systems, and the suitability and so on of the service being provided.

I would have provided that context earlier but Deputy Kelly was in a bit of a rush.

Dr. Adrienne Duff

To respond specifically to Deputy Durkan, on accreditation and the requirements of the ISO standard, the screening performed at the Manchester site is not considered to be referral under the accreditation definitions. The samples were being screened by MedLab Pathology at two locations in Dublin and Manchester. There are other mechanisms by which laboratories can outsource and refer samples but those that were screened in Manchester were not referred out. They were MedLab samples, fully under its control, and their screening was performed by competent staff who were authorised, trained and fully under the supervision of MedLab. The results were issued from Dublin. The common system of management has been confirmed and verified by INAB annually since the awarding of accreditation in 2011.

How often might it occur that samples are sent to a laboratory without the referrer having clear prior knowledge of its standard and whether it has accreditation? My presumption was that if a hospital, the HSE, a consultant or even a GP sent a sample in some direction, somebody would know what the capabilities and the standard in a professional capacity of the laboratory were, and whether it had a standing in accordance with the relevant ISO standards. Given the sensitive nature of healthcare in general, there is a capacity for matters to go wrong if the appropriate standards do not apply at the laboratory to which the samples are sent.

Ms Bríd Burke

When samples were sent to the laboratory, the user of the service was aware that MedLab was accredited.

Ms Bríd Burke

Yes, that MedLab was accredited. MedLab included both the Manchester and the Dublin sites. The former was under the direct control of MedLab in Dublin, not under that of any other entity. The laboratory and screening activity in Manchester were under the direct control of the laboratory in Dublin, which is the entity we accredit.

The Dublin laboratory was accredited whereas the Manchester one was not.

Ms Bríd Burke

It was accredited. It is the same company, which is why we-----

It is not in the same location, however.

Ms Bríd Burke

That is correct and we have acknowledged that fact. Nevertheless, the system in use in Manchester was identical. The IT systems were the same, the employees were direct employees of MedLab in Dublin and they were under the direct supervision of the Dublin management. The samples were not sent to another entity but remained within the entity we accredited.

There was no discrepancy between results from the two places.

Ms Bríd Burke

No.

I accept that the following question was asked previously and that an answer was given but it has slipped from my memory. In general, from which laboratories did the results that were returned but had question marks over them come? Did the authorities monitor the laboratory to which the case was referred and which subsequently had questions raised about its authenticity? Could the results be traced to the relevant laboratory in each case, whether in the US, Manchester or Dublin?

Mr. Damien McCallion

I will deal with that, given that I replied on it to Deputies Kelly and O'Reilly earlier. There is a breakdown of the 221 women in the original audit and with the patients we have worked through some additional, broader information they wish to see.

We have spoken to the patient representatives on that, and effectively we are committing to complete it within the next two to four weeks. If, as Deputy Kelly has said, the patient representatives have already had sight of this, and if they would wish to release part of the information earlier, then we would have no issue with that. We are working with the patient group to do that. We have the information.

The HSE has that information already.

Mr. Damien McCallion

Yes, that is correct, so we would know-----

How long has the HSE had that information?

Mr. Damien McCallion

That information is in the system. The final draft report on that probably was earlier in the summer. During the process with the patient representatives, they had requested additional information to be put into the report around the breakdown and we have looked to do that. We have had resource-----

As a result of the review, is the HSE now satisfied that each laboratory paid equal attention to the requirements, that the National Screening Service could rely on the results emanating from each lab and that there was no difference between them? Is this what Mr. McCallion is saying?

Mr. Damien McCallion

The Deputy is asking a much broader question on the assurance around the laboratories. That has come from the ongoing performance monitoring being undertaken through the programme and through the independent review that was done by Dr. Gabriel Scally and Dr. Karin Denton on the performance of the laboratories. They have given that assurance over and above the assurance that is ongoing through the programme. Dr. Scally was very clear on the overall performance of the laboratories in the programme, notwithstanding the individual issues.

From the results and from the inquiries and questions raised with regard to the authenticity or otherwise of the results afterwards, can we be assured that each of the laboratories was operating on the same level playing pitch and that they were capable of dealing with the cases accurately and quickly? Do the results show that?

Mr. Damien McCallion

On performance assurance, Dr. Scally and Dr. Denton have given the independent assurance that the laboratories are performing in the context of the metrics one looks at for a cervical cancer screening laboratory.

I am not talking about performance assurance. I am referring to the numbers in respect of which difficulties arose subsequently. Has the National Screening Service checked from which laboratories those particular tests were referred?

Mr. Damien McCallion

Sure. That is the breakdown we have committed to provide to the committee with regard to those reports; to the 221 women whose slides were in that original audit.

The slides did not all go to the one laboratory.

Mr. Damien McCallion

No. Over the 13 plus years of the CervicalCheck programme, a number of laboratories have been involved at different stages. It would be a breakdown by all of the laboratories.

Deputy Durkan raised the issue of the laboratory in Manchester. How many cytopathology screeners were in that laboratory?

Dr. Adrienne Duff

There were two permanent cytoscreeners in the laboratory and MedLab Pathology had two locum cytoscreeners also. That is four in total.

In her opening statement Dr. Duff said "In November 2016, MedLab contacted INAB by email, proposing to hire a cytology screening employee - a cytoscreener - and to locate that person at its laboratory in Manchester." Will the witnesses expand on that?

Ms Bríd Burke

I have some of the detail on that. The operation in Manchester had started in February 2016 and we were not aware of it at that time. MedLab had decided to hire a cytoscreener. It is a slightly different qualification, and this had been agreed with the National Screening Service. MedLab was informing us that it was hiring a cytoscreener for the laboratory in Manchester. This is what that communication was about. Subsequently, MedLab hired two locum staff, but the laboratory would not necessarily have let us know about that because it is not a requirement. Laboratories frequently change staff and add on new members of staff without informing us. That would be normal.

Are there different levels of qualification for staff who would look at smear slides?

Ms Bríd Burke

Slightly different, but there are all deemed competent by the technical assessments and by the requirements as laid out in the quality assurance programme issued by the National Screening Service. They were agreed with the National Screening Service also.

Is it up to each individual laboratory to be satisfied that those whom they employ are properly accredited?

Ms Bríd Burke

Yes.

It does not come back to CervicalCheck to check this.

Ms Bríd Burke

The laboratory deems its own staff to be competent, and this is subject to an annual assessment by the Irish National Accreditation Board.

CervicalCheck would not have been aware of the existence of those people until 2019.

Ms Bríd Burke

I am sorry but perhaps the representatives from CervicalCheck could answer that question more clearly.

Mr. Damien McCallion

We became aware of Manchester at the tail end of last year, and we advised Dr. Scally at the time because he was in the middle of his scoping process around the additional laboratories.

If the HSE and CervicalCheck had been aware of the existence of the Manchester laboratory would it have checked on the competency of the individual screeners? Would this have been part of the brief?

Mr. Damien McCallion

I understand that it is part of the quality assurance standard to look at the screeners and the individual performance, which would have been monitored. The point was made earlier that the Manchester screeners were in the returns for all of MedLab. That gave us assurance, at least, that the performance of the laboratory and of the screeners was being monitored and looked at as part of the ongoing process.

My first query is for INAB. Does the board accredit the person, the tester, or the laboratory? When INAB gives an accreditation such as the ISO 15189, is it to the laboratory, to the kit or to the person? Will the witnesses tell me the answer to that please?

Dr. Adrienne Duff

Yes. The accreditation is awarded to an organisation to carry out a range of activities. In this instance it is for cytology screening. To meet the standard for accreditation and to meet the requirements for ISO 15189, it covers a whole range of elements including: personnel; competence of personnel; equipment calibration, maintenance and traceability; the release and authorisation of reports and so on. The ISO 15189 standard covers in detail very technical requirements for any laboratory to meet, and covers management systems requirements for any laboratory to meet.

The accreditation is to the organisation in a particular spot. Will Dr. Duff talk me through it? If I wanted to open a laboratory tomorrow or this year what do I do? Do I set up my laboratory first and then make the phone call to INAB, or do I contact INAB first and set up my laboratory next?

Dr. Adrienne Duff

The organisations that apply to INAB to be accredited are established. They are working and providing testing activities over the-----

I ask that Dr. Duff would pause it there. There is a bit of confusion here. Let us say that Deputy Durkan has a laboratory and he is testing for other things, perhaps to do with other human or animal health. He is not doing cervical screening but he decides he wants to branch out, add this to his workload and add cervical screening. His laboratory applies for ISO. Does he pick up the phone and ask for INAB to come out?

Dr. Adrienne Duff

The organisation would make an application to us and provide us with a certain amount of information including the scope of activities and the type of testing they want to be involved in.

Is there a form or does the applicant just notify INAB? What is the process?

Dr. Adrienne Duff

Currently the process is online through our IT system, which we implemented and is fully operational since 2018.

When INAB is satisfied there is a laboratory, somebody from INAB goes out to give the ISO certification.

Dr. Adrienne Duff

We will evaluate the application. The accreditation is a peer assessment of organisations. INAB will match its technical expertise and technical assessors to the scope of technical activity that is being applied for. In this instance of cytology screening, and on each INAB assessment conducted every year, we bring consultant histopathologists with us as part of the assessment-----

Where does INAB get these people from? Does the board have them or does it have to get private people in by putting it out to tender, perhaps from other countries?

Dr. Adrienne Duff

We have a very robust process, which we are required to have as an accreditation body, in order to qualify people to become technical assessors. They will go through that rigid process. There is an open call on our website for people who might be interested in working with INAB. We would also approach people, perhaps where we have particular expertise gaps we need to fill, depending on the organisation.

That is what I am really getting at. The man in Salford in Manchester was conducting tests for nine months before there was mention of the second cytoscreener. That is when MedLab Pathology got in contact with the Irish National Accreditation Board, INAB. INAB was not in any way aware of the Manchester laboratory until the application was received for the second employee. Deputy Harty mentioned the number of people who worked in the laboratory. Is there any scope for practitioners to carry out tests before they are accredited? Could Deputy Durkan start doing tests and receive accreditation when he got round to looking for it? My apologies to the Deputy. That does not seem to make any sense. For instance, in all of the contracts the State has concluded for the provision of any screening, the guidelines and precursor documents require the meeteing of the International Organisation for Standardisation, ISO, standard. We have spoken about equivalence between the ISO standard and that of the College of American Pathologists, CAP, to which we will get back in the future. It seems a bit handy that they are now equivalent. If the contract for the provision of services specifically states the practitioner has to be ISO or CAP-accredited, how could there be a situation where somebody performs tests and then receives accreditation afterwards? If a person opens a laboratory and is operational for several months before he or she receives accreditation, surely it is a breach of contract and standards?

Dr. Sharon McGuinness

Let me answer that question in a general sense. Accreditation is impartial and independent, but it is voluntary. Not every laboratory or testing facility in the country-----

I understand that. However, in the case of State contracts, specifically the contracts for cervical and bowel screening, the ISO standard is specified. The contracts have been signed with the companies. MedLab Pathology had a laboratory in Manchester, with a guy working on his own, of whom INAB was blissfully unaware for nine months, until the laboratory applied for accreditation for the second employee. Then, in a unique moment in INAB's history since 1985, it retrospectively, a word the delegates do not like, granted accreditation based on certain information, which I assume consisted of laboratory files, calibration documents, humidity information, etc. As I have worked in a laboratory, I have an idea of what goes on. When INAB's agents went there, they were able to see the files, the logs and the qualifications. INAB is an organisation that is independent of the Department of Health and I imagine it has a European boss because the ISO standard is a European standard. Why, for the first time ever, would it do this for a private company? It just does not seem to add up. Why would INAB, a group funded by the Health and Safety Authority, go back and accredit a person's work retrospectively? Why not just say MedLab Pathology did not fill in the form correctly or make the telephone call and conclude that it would have to deal with its contractor by itself?

Dr. Sharon McGuinness

With respect to the ISO 15189 international standard, we evaluate according to the evidence and information available to us. Our contention is that the laboratory was accredited because it was part of the overall system controlled from Dublin. We are not happy with the way the communication happened and acknowledge that there was a lapse. However, while we might not have been aware of it, this is where our independence and impartiality comes in. Let us be very clear that we did not do anybody a favour. We proceeded according to the evidence, the information we had available and our own assessments in previous years and made that decision.

Page 26 of the supplementary report of the Scally inquiry specifically states a process is in place for INAB to accredit outside the Irish jurisdiction. It is stated in smaller print:

In a very small number of cases, if an Irish organisation decided to set up a branch office in the UK, then that could fall under the remit of INAB accreditation. This information would be clearly documented on the INAB published scope of the lab.

That seems strange. The one time INAB dealt with a laboratory in another country it did not follow its own rules and then retrospectively accredited it. Something does not add up. I do not understand why INAB would do that for a private company.

Dr. Adrienne Duff

Perhaps I misunderstood the question the Deputy asked previously. INAB does deal with Irish-based organisations and laboratories that have sites in other countries. This is not the only instance. It is perfectly acceptable-----

In those other cases did INAB accredit them the moment they opened? Let us imagine Deputy Durkan has a laboratory in the United Kingdom. Are there other examples where a laboratory in the Irish jurisdiction opened a satellite laboratory in the United Kingdom and INAB followed its own processes to accredit it?

Dr. Adrienne Duff

In those other cases we performed on-site assessments of the laboratories as part of their accreditation evaluation.

INAB carries out an annual audit. When it audited the Sandyford facility annually since 2016, did it ever notice that MedLab Pathology was sending material to Manchester? Did MedLab Pathology ever mention the laboratory in Manchester during the audits? When INAB was performing its annual audit which I imagine is supposed to keep us all safe, did it notice that the Manchester laboratory existed? Did anyone make any mention of anything to do with the laboratory in Manchester?

Dr. Adrienne Duff

It was not apparent in the documentation provided for us by MedLab Pathology that-----

Women were having smears taken in Ireland. They were supposed to be sent to Sandyford. INAB is in charge of accreditation to ISO standards, independently of the HSE. Somehow a laboratory was operating and testing women's smears in Manchester without accreditation and INAB never noticed when it was auditing. There is no purpose to the audit if INAB cannot see what is right in front of it, especially when it continues for such a long time. It continued for three years. What is the point of auditing a company if the auditing body does not find anything when it goes in? Does INAB have records on its annual audits?

Dr. Adrienne Duff

Yes.

Can the committee have them? Can we have a copy of the procedures which outline what INAB checks during an audit?

Ms Bríd Burke

Absolutely. We can provide that evidence. To follow up on what Dr. Duff was saying, our records on those audits show that our technical assessors went through the competency files of all of the cytoscreeners.

Was the competency file of the fellow from Manchester in Sandyford when INAB carried out the audit?

Ms Bríd Burke

Yes. Actually our-----

MedLab Pathology kept all of his work files in Sandyford.

Ms Bríd Burke

Yes.

His results were assessed as being normal.

Ms Bríd Burke

There is evidence that our assessor looked at-----

However, no one from INAB ever stepped into the laboratory in Salford.

Ms Bríd Burke

We assessed the competency file of one of the cytoscreeners there.

That is, the paperwork on the work of the man in Manchester was assessed in Ireland, assuming that the work at that point was being carried out in Sandyford.

Ms Bríd Burke

Yes. At the time it was not apparent that it was being done in Manchester. However, the location would not have affected the performance of the cytoscreener, which is the important part to remember in all of this.

There are many important parts.

Ms Bríd Burke

I know.

I refer to the bowel screening programme which, by the looks of things, is operated by MedLab Pathology. Who can talk to me about it?

Mr. Damien McCallion

That is correct. MedLab Pathology provides the testing service for the BowelScreen programme.

I had a look on its site. I printed this off before the summer, for our last meeting. In May 2010 MedLab Pathology was given the contract to the be sole provider of the national colon cancer programme. It opened the laboratory in August 2010. It received ISO 15189 accreditation in December 2011. Perhaps I am reading it all wrong, but it seems that we have another example of a laboratory that was open and received a contract to carry out the national bowel screening programme. At the point it was awarding the contract it did not have ISO accreditation, which is fine because it may have been conducting other tests.

Was the company providing services relating to colon cancer testing on behalf of the State before the point at December 2011 when it received its ISO accreditation from INAB? Are companies allowed to do testing before they are accredited?

Mr. Damien McCallion

I will have to revert to the Deputy on the matter of bowel screening. I do not have the information with me today.

There are very specific questions and perhaps Mr. McCallion has a different answer from what is on MedLab's website. In May 2010, the company was awarded a contract but it did not receive its ISO accreditation until 2011. I am wondering whether between May 2010 and December 2011, there was a laboratory in Dublin operating without ISO accreditation. Was there ISO accreditation for a specific test?

There were two tender documents for bowel screening. A colleague asked questions over the summer about this. The proper tender document has no mention of ISO accreditation. The answer provided by the national screening service was that this is catered for in the pre-qualification questionnaire but there is no mention of it there. Is it a case of the cart being put before the horse? Should accreditation be gained before applying for a contract or are companies winning contracts before they have accreditation? It seems a bit strange that accreditation would come down the track.

Mr. Damien McCallion

I will have to check that with the procurement unit. I do not know about the wider context of the contracting side with respect to accreditation for other laboratory services. I will have to revert on it.

It is not that I do not believe Mr. McCallion but rather that I do not understand it. Has there been a sanction from a European body because of the breach? One accreditation in INAB's history has been given to a laboratory in this way. Has the European body been in contact about INAB's procedures and the way it does its work? There is an ISO standard and if a company or state is seeking to get work done, this ISO accreditation seems to be the gold standard. Are these being handed out willy-nilly or given out retrospectively to suit different ends? Has anybody been in contact or has INAB been audited by its "big boss"?

Dr. Adrienne Duff

As recently as September 2018, we were subject to our latest peer evaluation. We are subject to these once every four years by the European association of accreditation bodies. That evaluation takes place in our offices and it is a combination of an office assessment and an assessment of our implementation of ISO standards onsite. With specific reference to ISO 15189, we had two European colleagues who are experts in accreditation and ISO 15189 evaluating our systems on-site for a week.

That was last September.

Dr. Adrienne Duff

It is the normal frequency.

What was the report?

Dr. Adrienne Duff

The report was very satisfactory. There were some minor findings relating-----

Was this specific incident highlighted at all?

Dr. Adrienne Duff

This specific incident was not highlighted.

It did not come up and did not feature in the assessment. This once-off incident of INAB applying accreditation retrospectively did not come up in the assessment by the European boss. We did not know at that stage. Has INAB reported this to the European body in light of this? Is that normal practice? From the opening statement, it seems this is a bit of a mess. Would INAB go to its European counterparts and say it made a bags of this and how could it learn from it? Has INAB evaluated how this happened?

Dr. Adrienne Duff

We have certainly evaluated this in depth within INAB and identified precisely where our lapse in procedures arose. We identified a number of steps, which we have implemented and will continue to monitor in terms of checks and balances for our system. As I said, we are subject to routine peer evaluations as they occur and four years is the normal cycle for all accreditation bodies. We will welcome our colleagues back again in 2022.

Has the HSE been in contact with the European bosses of INAB to indicate there may be an issue if accreditation is being given out and procedures may not necessarily be followed? Is that a concern? There is an expected standard with ISO accreditation and if that is being breached in any way, even with retrospective accreditation, is that an issue? Are there any concerns about INAB?

Mr. Damien McCallion

It would not be a role for us to link with any oversight body.

Surely if the HSE is issuing contracts with a necessary standard and the independent organisation that is supposed to be giving the accreditation has done something that is not orthodox, would it not be a concern for all contracts and all the stuff done by INAB? INAB was auditing a company and did not notice the fellow in Salford, and it was prepared to make a one-time retrospective accreditation. Would the HSE, as service providers, not be concerned as to whether all the labs to which it is sending stuff are okay? Whose job is that?

Mr. Damien McCallion

Our concern is to ensure the labs are appropriate assured in terms of performance and accreditation status. When we became aware of the Manchester case, we became aware of the issue and informed Dr. Scally, who was in the middle of his review.

I understand that. Is the HSE concerned about this issue with INAB? I am concerned that a laboratory has been operational for this length and its audits did not notice it. It was prepared to retrospectively accredit work based on paperwork. Is the HSE worried about standards?

Mr. Damien McCallion

We rely on various accrediting bodies for all sorts of services in the HSE and our role is just to ensure that whatever departments-----

So the role is to write the cheque and not ask the questions while hoping for the best.

Mr. Damien McCallion

It would not necessarily be that all. We put significant steps in place and we are clearly trying to strengthen these with respect to both contracts that we have with laboratories-----

I feel like writing to the European body and asking if it has looked on the lads in Ireland as something dodgy, or at least not 100% right, is going on if they can retrospectively accredit a company. If it happened every day, I could see that it is done that way but we are talking about one fellow in Salford. Why would the accreditation body act in this way? I have gone at this every way and I cannot understand why the box was ticked. Before I came, somebody asked for all correspondence between INAB, the Department of Health, CervicalCheck, MedLab and anybody else involved. This was anything to do with the fellow in Salford and the correspondence should include emails, text messages and whatever is available.

We dealt with quality assurance at our previous meeting, which before the recess. INAB was doing quality assessment of laboratories but it did not notice that slides were going elsewhere. Did anybody in this room go on such a visit? Dr. Doherty was on such a visit. Was it recently?

Dr. Lorraine Doherty

I was in a party of visitors to Quest Diagnostics in the United States in April this year.

I am wondering about prior to that. We knew there was a problem in April this year but what about before all this came out?

Dr. Lorraine Doherty

I joined the service in February this year so I was not party to any visits prior to that time.

Was there a procedure on Dr. Doherty's visit? How many were on the team if she was the lead? Was there an external histopathologist? Who was on the team that went over?

Dr. Lorraine Doherty

I chaired the visit but I am not a formal laboratory inspector. The laboratory quality assurance consultant from CervicalCheck was on the team and we had an external quality assurance-----

What about those people?

Do the employees of CervicalCheck who are quality assurance experts work in cervical screening all the time?

Dr. Lorraine Doherty

They work part-time for CervicalCheck and part-time for another organisation in the same role of quality assurance. We had an independent quality assurance-----

Can Dr Doherty say for what organisation they work in their second role? Does somebody work for the State and a private company engaged in quality assurance at the same time?

Dr. Lorraine Doherty

Not a private company. I do not think I can name other companies for which an individual works. Suffice it to say, the person in question is a fully accredited laboratory inspector, our lead in the area of laboratory quality assurance and that on that visit we had an independent consultant pathologist from-----

Was it a different person from the one who would not come and give evidence?

Dr. Lorraine Doherty

Yes, a different person who is not part of CervicalCheck.

My understanding is that before Dr. Doherty's time, there was an independent doctor, an assistant pathologist who did not deal with Dr. Scally at all and who has not formed any part of the report. It was a new independent doctor.

Dr. Lorraine Doherty

I am not sure to which individual the Deputy is referring, but the individual on this visit was an independent consultant who undertook quality assurance work.

We need to move on. There will be an opportunity to come in on a second occasion.

I believe I am still behind Deputy Kelly's time. I would have to go on for half the day. Will the Chairman let me finish? I am nearly there.

One final question.

Dr. Doherty travelled over with the independent consultant, the QA person, and who else? Dr. Doherty was leading the team.

Dr. Lorraine Doherty

There was an administrative assistant to help in co-ordinating the visit and all of the logistics.

In respect of the paperwork, did the doctor go over with a file and tick boxes? Is there a formal process and does the doctor come back with a report?

Dr. Lorraine Doherty

Yes, there is a formal process and a formal report.

Was the process created by Dr. Doherty, or did she just pick up the empty file and travel over? Did she set up this new way of engaging in quality assurance?

Dr. Lorraine Doherty

There was an existing set of laboratory quality standards against which units could be assessed. We took the standards and updated them and developed an evaluation questionnaire to take to the laboratories based on the standards to make the evaluation. We are returning to the laboratories in November for a further visit.

Did anybody here today make quality assurance visits before Dr. Doherty came on board?

Mr. Damien McCallion

No, I do not think there is anybody here who would have been involved.

Can we have the list of the names of people who made quality assurance visits in the past 12 years and be told when they went, for how long the trip was and who paid for it?

Mr. Damien McCallion

All of the visits would have been funded by the HSE directly.

That is fine. How many went because Dr. Doherty was able to manage with three or four people, but prior to that, there does not seem to have been any quality assurance expert. I do not think I am wrong in saying the assistant pathologist doctor who was externally employed has not engaged with the Scally inquiry. When will we receive that information? It must be very clear from the diaries.

Mr. Damien McCallion

We can pull it together fairly quickly.

We have been here for two and a half hours and I am obliged to offer delegates an opportunity to take a break for ten minutes, if they wish to avail of it before we move to the second round of questioning. Are they happy to continue?

Mr. Damien McCallion

Yes, we are happy to continue.

Before I bring in Deputy Brassil for the second round of questions, I would like to ask some of my own.

On Quest Diagnostics now being involved in 90% of screenindg, is that a substantial risk to the service because if anything happens to it, the cervical screening programme will be in serious trouble. How is that risk being managed?

Is Quest Diagnostics involved in HPV testing, in addition to cytology? When doctors received results from MedLab Pathology, not only did they receive the cytology report, they also received a HPV report in conjunction with it. Will the delegates clarify what Quest Diagnostics has been contracted to do? What is the waiting time for samples that go to it? Is it back to four to six weeks or longer than that?

There was a suggestion in the McGrath report that there be a tracking system for smears in order that women would be able to track where their smear was in the system to identify how long it would take for them to get the result. Has that tracking system been put in place?

We have spoken about when HPV screening will start. It will now be the primary test or should be, while the cytology test will, I presume, be a secondary test. That will reduce substantially the load on cytopathology. Will it speed up the repatriation of cytological screening?

It was the audit and interval cancers that brought this controversy to the fore when it became apparent that an audit had been carried out but women had not been informed of the results. Audit is a very important part of quality assurance. There are two elements to the audit. Was a misreading of a smear negligent or was it purely a built-in difficulty in screening, that it is not possible to be 100% accurate in the screening system? Errors are inherent within screening. The High Court judgment on absolute confidence in any cytologist looking at a smear was that if he or she had any doubt whatsoever, he or she would have to apply the absolute confidence principle. Will it be built into any new audit process to be introduced?

To come back to Deputy Kelly's question, to which we did not receive a clear answer, when a new audit process is put in place, will it pick up from where the last audit stopped or will there be a gap in the audit process?

Dr. Peter McKenna

I will answer on one facet of the questions about the audit process and how a slide for a patient who turns out to have an interval cancer is reviewed. To date, all of the reviews have been made in an unblinded manner. They include the Royal College of Obstetricians and Gynaecologists, RCOG, review where the people looking at the slide know that the patient has developed cancer. The environment in which the review is taking place is very important. It also depends on who a person asks. If, for example, the slide is shown to a consultant cytologist and they are given unlimited time, in telling the doctor that the woman has cancer and asking them if they can, please, find the abnormal cells, that is an entirely different environment from that of a screener who has received many slides that day to go through and who has to pick out the abnormal cells. None of the reviews about which we have spoken, whether they have been in court, at the RCOG or the original review, has been carried out in an unblinded manner. It appears to us that the only fair way to do it is in a blinded manner, that a panel of individuals be included which would include a number of primary screeners, in addition to more senior ones, and that the abnormal smear be mixed in with a number of normal ones, for example, ten or 20. There would then be an individual report from each of the people who had looked at it and an aggregate and agreed report.

The reason we believe it is so important to go into this detail is that it does not really matter how one looks at a slide if the patient is not to be told. In many countries patients are not informed of the result of a review; therefore, the slide can be given to ten professors who will have a week to look at it for one of them to find the abnormal result. That will have no implications if the patient is not to be told the result. Similarly, it will have no implications if the patient is to be told and there will be no financial repercussions for the system. In Ireland, up to now, the patient has been told and it appears as if it will have financial repercussions. That is why it is very important to design a review system that will be entirely fair to the programme, the screener and the patient's expectations.

That is only a small element of the questions asked by the Chairman. There were many others.

Mr. Damien McCallion

I will take one or two points and might ask my colleague Ms Fitzgerald to talk about the tracking system. Dr. Henry may speak to the wider questions of the audit and timing and about the retrospective element. Dr. Doherty might speak about HPV screening.

On the question on the balance between Quest Diagnostics and the Coombe, in the first quarter of this year we faced not having a cervical screening programme. We had done a global trawl for capacity for the laboratories. That was limited as people moved to HPV and there was little to no appetite for companies to come into this country to provide a service. It was clear, as we have discussed earlier, that it would take a significant time, notwithstanding the effort and investment that has gone into the Coombe to build that up. Following three months of long and protracted negotiations with the two existing providers, we managed to get an agreement. That is the context for where we are and in terms of understanding that, it is important to note that while the Coombe did not grow, it took on much more complex work with the colposcopy smears. Both the Coombe and Quest Diagnostics have stepped up in that regard. Our strategies were clear, namely to build up the capacity of the Coombe, and to rebalance between public and private testing. As I said earlier, we believe we can make some progress on that over the next number of years. On where we can ultimately get to, we have challenges in defining a point that the Coombe can grow to but we are putting everything behind that to try to strengthen it. On the risk with that, it is the same whether it is 90% or 10%. The Coombe will be subject to the same quality assurance that Dr. Doherty has talked about, as will Quest Diagnostics. As members can see, there has been one QA visit already. An additional QA visit is planned and those are increasing in frequency from the three to five year reviews that would have been undertaken heretofore to partially restore public confidence for people and alongside the other steps that are in place within the programme.

I will ask Ms Fitzgerald to talk to the tracking system and the efforts to improve how information is put together.

Ms Celine Fitzgerald

The introduction of a tracking system was part of the Dr. Scally recommendations and we have been looking at the best way to do that. As a first step, we have agreed with the procurement team in the HSE to issue a request for information, RFI, and to allow all relevant suppliers to come back to us with details of the system that they supply. That will allow us to assess the compatibility of those systems with our systems because it is not a simple matter of buying a system. It is critical that it can be fully integrated and that we can track the samples from when they are taken by the smear taker to the conclusion. That would have to be closely integrated with our existing systems to avoid any further potential confusion or breakdowns. It is under way and it is an important feature that would be welcomed by women and users because it would be a further assurance around the process.

Does CervicalCheck have a timeline for its introduction?

Ms Celine Fitzgerald

The RFI and the tender process would take several months and then one might consider whether the best time to do it would not be with our existing system but as we move forward with HPV, which provides us with an entirely new process. That might be the best time to introduce it rather than trying to introduce it now and then moving it over to a new system.

Dr. Lorraine Doherty

The Chairman asked a question about what was happening with HPV testing now and what would then happen in the future. On current HPV testing, we are a cytology-based primary screening programme. If a woman goes for a smear, she has cytology. She only has a HPV test if there is some abnormality on her cytology that warrants further investigation. Where there was additional HPV testing, we have called it co-testing, which arose in the context of managing the backlog that developed in recent months, which we have now resolved. At that time, we allowed our service providers to co-test the cytology samples for HPV to identify those which may be at a slightly higher risk and which should proceed to cytology immediately. That happened in MedLab Pathology Limited and in Quest Diagnostics for a time. MedLab Pathology Limited is no longer contracted to work with us and Quest Diagnostics has now resolved its backlog issues so we are back to being primarily a cytology based programme with reflex HPV where there is a need. When we move to HPV primary screening we will turn that around where the first test will be a HPV test and those who have a positive HPV test will then proceed to have a cytology test.

Dr. Colm Henry

I want to emphasise the accuracy of interval cancers. They do not constitute errors per se. All screening programmes internationally have interval cancer rates because we are dealing with a healthy population and we are applying a relatively simple and quick test to identify some of that population who are at risk of going on to develop cancer in the case of cancer screening programmes. They are not diagnostic programmes. For example, in our breast screening programme, for every 1,000 people screened, there are two interval cancers. When one looks at interval cancers and breast screening programmes internationally, that breaks down to where nothing is seen, even in unblinded retrospective review, and in a small number of cases there will be something very clear in retrospective review. As I said earlier, programmes tend to measure interval cancer rates as a measure of the quality of a programme.

On the Chairman's question on an audit, the primary purposes of an audit are learning, education and improvement. These values are so strongly felt in many jurisdictions that the whole process of an audit is in itself protected to ensure that it can carry on unhindered so that people can learn, improve and further develop programmes.

The final question the Chairman put was on the Cross judgment and absolute confidence. At the time there was disquiet in the screening programmes and in many other disciplines, including primary care, applying a test of absolute confidence to clinical scenarios where judgement is being used, which, as the Chairman knows, is not necessarily absolute in all clinical scenarios. My understanding is that if that is gone, the State Claims Agency is appealing that judgment and that is proceeding in November. Beyond that I cannot say much at this stage.

I ask Deputy Brassil to come to his second round of questions.

Before going onto the IT glitch issue I want to raise, I refer back to this morning and to Dr. Doherty's reply on the question of those who would go for a private test when she said that CervicalCheck would not have that information. I want to make it clear because Claire Healy is watching proceedings here and is extremely upset. She was a public patient who was invited by CervicalCheck to take a test and the only difference was that it could not give her a test in a timely manner and because of her concerns she went and got a private test. That test proved positive for precancerous cells and when she went for a colposcopy she was told they could not test her because it was a private test. Those are the facts of the matter. I understand the system is under pressure but let us be honest about it - the system was under pressure because of free out-of-cycle repeat smear tests that were offered by the Minister in the middle of this crisis, which put the whole system under strain. It was a poorly thought out strategy. For anybody who is caught up in the issue and whose case has a negative outcome, the system should be reaching out to those people. That is why my constituent is so upset by all of this. If this case was not highlighted publicly, it would not have been resolved. I want to make it clear that Claire Healy was a public patient who was called in by CervicalCheck. It is not acceptable to say that CervicalCheck would not be aware of the findings because Ms Healy would have made them aware, as would hundreds of other women. I have to highlight that. The system should have reached out to all those women in the circumstances. I do not know if the witnesses want to comment on that or not.

Dr. Peter McKenna

I will make one observation for the sake of completeness. I would like to take it away from an individual patient into the abstract. If an individual patient has a private smear that shows a high grade abnormality, and attends the colposcopy clinic where they do not see that much and they take a biopsy, which shows only a minor degree of abnormality, the correct procedure would be that the patient would then be subject to a multidisciplinary meeting or tele-call and part of the condition of the State laboratories is that they make themselves available for this.

This facility may not be available in the case of a private laboratory, and consequently, important elements of decision-making for an individual patient - that is, colposcopy, cytology and pathology - may not be able to be taken into consideration. I am not speaking about an individual patient, but that is why all the components of cytology, colposcopy and pathology should be available for consideration at a multidisciplinary meeting, and that is why it is better for smear tests to be done within the public health system. Clearly, the public system has not been functioning appropriately for the last year or so, which is why, in the particular case the Deputy referred to, the woman went for a private smear. Given the emergency circumstances, this should have been accommodated.

Why would Dr. McKenna suggest the system was not functioning appropriately?

Dr. Peter McKenna

As we all know, the system was under a lot of strain from increased clinical referrals and an increased number of smear tests, which is multifactorial, so-----

From the free out-of-cycle smears recommended off the cuff by the Minister.

Dr. Peter McKenna

That was a factor, but it certainly was not the only factor in why the system was under pressure.

I know that individual cases make it difficult, but I am quite sure there are others like this out there. My client was advised to go back into the public system. That has now been resolved and has been moved on from, but it would be far more beneficial for the committee to hear that this is not how it should have happened, for my particular constituent or for many others, I am sure.

Dr. Peter McKenna

I am not disagreeing with that. I am merely trying to explain why in general terms it is better for individual people who have a significant abnormality that the three components of colposcopy, cytology and pathology can be discussed in an interdisciplinary manner in cases of diagnostic dilemma, which does arise from time to time. It is just a general observation.

I refer to the IT error, which initially involved one person, then 856 people, and finished up at nearly 3,000 people. A report was commissioned on this issue and was presented in July. A case called "Sharon's case" is specifically referred to in the report, and it is stated that the Minister for Health, Deputy Harris, corresponded with Sharon on 6 June. On 9 July an official stated that the Minister was fully briefed, however, the Minister stated that he was not briefed until 10 July. That does not seem to add up. Who is not telling the truth here?

Ms Tracey Conroy

The issue was the subject of consideration by Professor MacCraith in his report, and he is clear that the report was received on 10 July. He has accepted that.

Okay, but the-----

Ms Tracey Conroy

That is the factual position.

On 6 June, the Minister's office wrote to Sharon and stated: "The Minister for Health, Simon Harris, T. D. has asked me to thank you for your correspondence concerning CervicalCheck and would like to again apologise for any distress this delay has caused you and reassure you that this is a priority for his Department and the Health Service Executive". That is a factual email on 6 June to Sharon, the person referred to in the report.

Ms Tracey Conroy

I will ask Ms O'Callaghan to come in on that.

Ms Celeste O'Callaghan

I believe that was a communication via the Minister's office which sought this lady's details so that her individual case could be followed up on.

As I stated earlier in my contribution, the issue for me is about proper communication and letting people know. Errors and IT glitches happen, but when this came into the public domain initially it was about one person. It then transpired that 856 women did not have letters sent to them or their GPs and for an additional 2,150 women the letter was sent to their GPs but not to them. Are the witnesses satisfied that systems have been put in place to ensure the issue will not recur, or that if it does recur, people will be told about it? The witnesses need to communicate and let people know if there has been some form of error or glitch. Nobody will be punished if something happens in error, as long as it is communicated to the people involved.

Ms Tracey Conroy

The IT issue has been referred to as being the subject of significant consideration in the context of the MacCraith report and Professor MacCraith makes very specific recommendations on addressing some of the issues there. Perhaps some of my colleagues from the HSE might be in a position to discuss that implementation plan and some of the progress being made there.

Mr. Damien McCallion

I ask Dr. Doherty to give an update on that.

Dr. Lorraine Doherty

I can update the committee on the IT issue which arose in relation to the Quest laboratory in Chantilly. An issue arose in February of this year when the laboratory had taken on an additional workload for the HSE and was trying to issue results in the normal way to our IT system. If a result comes into our IT system, the woman who has had the test is automatically notified that her GP has her result and her GP receives her result. When the IT system in Chantilly was unable to interface with the CervicalCheck system, they used a manual system for issuing results to the GPs. However, because the results were being issued manually, they did not come into our system electronically, and so our system did not generate letters to the women. We wrote to GPs in April, when the manual system was finalised, to tell them they would be receiving the results manually and that they should inform their patients. We did not write to all the women in the programme at that time because we did not know exactly who was coming or who had been screened. We had not communicated with the women and we have learned from that. Though we had a temporary arrangement in place and communicated with the health professionals on the issue while trying to resolve the IT glitch, we did not communicate with the women. I take the Deputy's point. That is a lesson for us and it has been picked up in the MacCraith report.

The IT system upgrade took longer than we expected and it affected this large group of women. However, I can assure the committee that the IT issue has been resolved. The results are now coming electronically into CervicalCheck and the system is working in the normal way, in that the GP gets the result and the woman gets a letter to tell her she has received her result. We have categorised all the women who have been involved or affected in any way by this IT glitch into different groups based on the action we needed to take, and all of them have been contacted. There is a small group of women who are working with their clinicians and whose clinicians had been in contact with them about some of the test results. The IT issue has been resolved, the system is now functioning normally, and everybody who had been affected by this over the last number of months has had a communication from CervicalCheck.

Dr. Doherty said she would follow up for me, but am I correct in saying that she has requested the circular on the decision to exclude women who had private testing, and the subsequent circular around reversing that decision? Yes? I thank the witnesses.

Mr. Damien McCallion

What is important is that there was not necessarily an original decision to exclude private smear tests, but some clinics perhaps interpreted it that way. What went out in the circular was an unequivocal clarification to ensure that all colposcopy units, whether public or private, would be treated accordingly based on clinical need. We will send that correspondence to the committee.

Before we move on, regarding Sharon's case, which was the basis of the MacCraith report, one of her problems in respect of communication was that she had her smear test before Christmas. When she had not received her results by the beginning of April, she contacted CervicalCheck. It did not communicate with her despite her making several contacts with it. It was only when she threatened to go to the media on 6 June that the Department of Health responded to ask for her details. No action was taken between the beginning of April and the beginning of June regarding getting her results. At that time, nobody was aware that there was an IT glitch, at least not in the public domain. Her problem was that despite contacting CervicalCheck at the beginning of April, the first meaningful response was on 6 June when she threatened to go to the media. It took another three weeks, I understand, for her GP to get the report of her testing, which all revolved around HPV secondary testing.

Mr. Damien McCallion

I need to check the chronology in respect of Sharon's case. I have spoken to her on a number of occasions and I know she spoke to our clinical doctor, who provides support and clinical advice, about a number of aspects of her care. I believe he may have contacted her in the first instance when her results were released. Her results were caught in the overall backlog. The learning from Sharon's case has been taken on board in terms of communication. It is one of the priorities, as Ms Fitzgerald said, around improving communication. I mentioned the multiple channels people can come through in terms of representation, whether that concerns delays or whatever else, and bringing that together in a more harmonised way, not just in terms of the IT systems for tracking, to which Ms Fitzgerald referred, but also in terms of the general communications system.

Has CervicalCheck met Sharon?

Mr. Damien McCallion

I have spoken to her on a number of occasions, both during the issue and in the past couple of weeks.

Mr. McCallion has not met her in person.

Mr. Damien McCallion

No, but we have spoken at length on the phone on a number of occasions.

Ms Tracey Conroy

There was a reference to the Department not having been in contact with this patient until it became an issue in the media. In fact, she made contact with the Department in April regarding the delay in respect of her smear test results. That was not an unusual letter for the Department to receive at the time, given the context of the long turnaround times for smear tests. We responded at that time to explain the general delay in turnaround times. There was a series of communications, and I will ask Ms O'Callaghan to outline the situation very briefly.

Ms Celeste O'Callaghan

Without talking too much about an individual patient's communications, this lady contacted the Department in early April with concerns about the delay in her smear test results. As my colleague has said, that was not an unusual letter for us to receive because turnaround times have been long. Our initial judgement was that that was the issue that arose for this woman. We wrote back to her to explain what was causing the delay in the hope that would provide some reassurance.

She came back to the Department with further concerns, and when it became apparent the delay could not be explained by the normal turnaround times that applied at the time, we sought her details to follow up on the case with CervicalCheck. We had quite a number of communications with her in the course of that being assessed until, I believe, 25 June when CervicalCheck responded to us to say there had been an IT issue and, as a result, the woman's results had not been issued. We sought further detail on the IT issue, its implications, and the number of other people who may have been affected.

That detail was provided on-----

Ms Celeste O'Callaghan

On 10 July.

Was it 9 or 10 July?

Ms Celeste O'Callaghan

On 10 July.

I thank everyone for their patience. I appreciate this is a very long morning for the witnesses. To return to the issue of communication with Sharon, she raised a very serious issue, which we have all now accepted. Some did not accept that initially, but it turned out to be an incredibly serious issue. She was fobbed off with a standard response. I am certain she was not the only person who raised the issue with the Department. As witnesses have said, there was a huge volume of correspondence from women who were very concerned about issues relating to their health, so concerned that they felt it necessary to escalate that. In the normal course of things, people get a smear test done and wait for the results. It is not unusual to wait, and generally people do not panic when they do not hear anything because they believe they will be contacted if something is wrong. We now know that clearly that was not the case.

A large number of women raised concerns. Did they all receive within a couple of weeks the same fob-off letter explaining the delay to them? In reference to what the Chairman said, it does seem that only when the threat of going to the media raised its head was any sort of meaningful response given. I am perfectly willing to accept that was not the case if the witnesses can demonstrate that to be so.

A number of women raised concerns, and so concerned were they that they raised their concerns to the level of the Minister for Health. It appears they were being fobbed off, with the people concerned thinking it was just another letter from another woman who was just concerned because she probably read something in the newspapers or something, and they were just given a letter to explain what would happen in a generic delay-type situation. Clearly, this was not a generic delay-type situation.

Do the witnesses have any idea how many women contacted the Department directly about this particular issue? I hesitate to call it an IT glitch because that is very disrespectful to those on the business end of what was a complete mess. Nobody checked if these women had legitimate concerns or if they were just part of the overall mess, for want of a better word, or part of the overall delay. How many communications were there before a meaningful response was given? The witnesses know what I mean by a meaningful response - not the one that explains what a delay is, because the woman was clearly living that at that time. How many other women with a similar experience were in contact with the Department before they were listened to, taken seriously and any action taken?

Ms Tracey Conroy

While I am reluctant to talk about individual patients in this forum, the Deputy may have missed some of the previous interaction, so at the risk of repeating it, this patient got in contact with the Department in early April regarding the delay in her smear test results. It was not unusual to receive that kind of letter at that time, given the delays in smear test results. The context for saying that is that, of course, the Department and HSE were at the time and continue to be intensively engaged in addressing the capacity issues. We have had some considerable success in that regard, as the HSE has outlined today.

Ms O'Callaghan outlined the series of communications with this patient that took place over the period of time concerned. When it became apparent to the Department that the turnaround in her case was moving beyond what had been expected in that context, we then got in contact with her regarding getting her personal details so that we could ask CervicalCheck to follow up on it. There was intensive engagement between the Department and CervicalCheck on this particular case leading up to the receipt of the report on the matter on 10 July.

On the broader question of how many representations we receive, we receive about 4,000 representations in the Department every year. I do not have the specific figure in respect of CervicalCheck, but we can come back to the committee on that.

That would be an important figure for us to know. When a serious issue like this is raised and people are being fobbed off - others can call it any word they like but that is the one I am choosing to use - women want to know how many emails it takes before they are taken seriously. How serious does the volume have to be? I fully appreciate that the Department would have been in receipt of a lot of representations, but women were making representations to the Office of the Minister for Health on the basis that they were concerned, notwithstanding the massive and unacceptable delays that meant they were already outside of that timeframe. They were concerned that, if they were not outside that timeframe, they were heading in that direction. It seems like they knew something was wrong.

They were trying to alert senior people that there was something wrong. It took an awful lot of effort. As the Department has had contact with the individual woman to whom we are referring, the witnesses will know the stress this caused her through her constantly banging on the door trying to raise a case and feeling as though she was being ignored. What was at the heart of what led us here was the fact that women were treated disgracefully within the system. This appears throughout the Scally report. It is very hard for people in my position to understand how any lessons have been learned. The witnesses say that lessons have been learned but in the immediate aftermath, it appears that no lessons were learned.

Ms Tracey Conroy

There is no question of women being fobbed off. The Department places the highest priority on representations from members of the public. With regard to CervicalCheck, a small team of dedicated people in the Department respond to these representations. With regard to this case, the record demonstrates the timely and intensive engagement between the Department and the HSE in terms of following up on this issue.

Ms Conroy and I have a very different view of it. I have one technical question involving the Royal College of Obstetricians and Gynaecologists, RCOG, review. I am neither a scientist nor a doctor but my understanding is that in order to be effective, a review of this nature should be done blind. Was the RCOG review a blind review and if not, why not? If it was a blind review, that is fine but I am not sure it was.

Dr. Peter McKenna

I was the one who alluded to the RCOG review. As I understand it, the RCOG review is not blinded The reviewers would have known that the individuals at whom they were looking had developed cancer. What they did not know was how the smear had been interpreted by the previous smear reader. They were not informed what the previous person had thought but they knew the patient had developed cancer.

Is it international best practice for reviewers not to have any of that knowledge in advance of conducting the review? People have appeared before us to tell us about the potential for review bias and we are aware that this is an issue. In this case, would I be right in suggesting there is an increased chance of review bias in the RCOG review by virtue of the fact that while the reviewers would not necessarily have all of the information, they have some of it? Does that in some way undermine the result? I apologise, as "undermine" is probably the wrong word. Dr. McKenna knows what I mean. If it is best practice that a review be completely blinded, will the fact a review is not cause an issue?

Dr. Ronan Glynn

They are not completely blinded in the RCOG review. As Dr. McKenna has said, they are aware that every case at which they are looking is a case of someone who went on to develop cervical cancer so that will lead to what we call hindsight bias, which is why we are constantly at pains to emphasis that this is a feature of this review. Again, this is why it will be so important that the results are placed in that context. Given the fact that the reviewers know what subsequently happened to the participants in the review, their review of the slides will, obviously, be influenced by that. That is a common feature of many reviews. The key element of that is that it is acknowledged and factored into the analysis of the results that emanate from the review.

Is there a way of factoring that in, in order that the Department can get the best result from the review? Are the witnesses saying it is common practice for that knowledge to be with the reviewer in any event? Given where we are, let us differentiate between common practice and best practice.

Dr. Peter McKenna

That is a very interesting question. The answer is that there is no internationally accepted best practice as to how one conducts one of these reviews. As I said earlier, it depends entirely on the use of the result of the review. If it is being used for purely educational and quality improvement purposes, one can set the bar extremely high. If one is trying to mimic the situation in which the normal screener works, the bar clearly comes down a bit. There are time restraints. The person may only have ten or 15 minutes to look at it. There is no internationally accepted best way of doing this. We have explored how they do it in some parts of the world where they would mix one abnormal smear in with 50 normal ones and see how a panel of screeners would interpret that. That is why, as I said earlier, we are going to some lengths to come up with a system that is robust and fair to the patient and the system.

I apologise if I missed this. My next question is for the representatives from INAB. I understand they do not like to use the term "retrospective accreditation" but I think we all know what I mean when I say it. There is no other circumstance in which what I am referring to as retrospective accreditation would be done. The witnesses will understand that it seems to stretch credibility that they would be able to do that but it would not be done in any other case. It is not something that would be-----

Dr. Adrienne Duff

I reiterate that our confirmation that the cytoscreening in Manchester was accredited was based solely on the evidence and facts garnered from assessments from 2011 onwards, on an annual basis with a team of experts. The evidence we reviewed would have reviewed the cytoscreeners who were performing all the cytoscreening testing located in Dublin and Manchester, the equipment being used, the pre-examination procedures, the screening processes, the checks and quality assurances on the cytoscreeners and the authorisation and release of results. Our statement confirming that the cytoscreening testing in Manchester was accredited is based solely on evidence, which is the basis on which we make all decisions on accreditation.

I know. This question has already been asked. I am not sure whether this was answered 100%. Under normal circumstances, someone would get accreditation and start to do the work. These people were doing the work and accreditation was given afterwards. The best we can get is we see no reason why there would have been any problem because we do not necessarily believe that there was a problem and we have not had all the reviews etc., yet. What is worrying is the notion that this can be applied after the work has started and I seek an assurance from the Irish National Accreditation Board. It happened and we cannot change that without a time machine. It is not ideal, which is the kindest way of putting it. How do we know it will not happen again and we or other people will not be back here at some point saying "yes, but we then applied the accreditation to them"? Can Dr. Duff give an assurance that from now on, notwithstanding what happened previously, where this work is being carried out, the accreditation will be in place before the work is carried out?

Dr. Adrienne Duff

Generally speaking, when organisations engage with us, they can carry out testing long before a need to become accredited arises and they make an application. We confirm and award accreditation to organisations on the basis of the assessments we perform. The matter before this committee today is of significant concern to the Irish National Accreditation Board and we have critically reviewed our own processes and procedures and have identified a number of steps and improvements we have made. They already have been implemented and we will continue to check to ensure those processes continue to be implemented and improved.

That is good to know.

It seems very generous to apply that lookback for whatever reason. I can fully understand they could be carrying out all the accreditation they like and then when they apply to the INAB for that accreditation only then does that process start and they get it from whenever they get it. However, in this instance effectively what Dr. Duff is saying is, "They did not have accreditation but we're going to grant it with some degree of retrospection." It seems very generous. Obviously, Dr. Duff is saying the INAB was not specifically asked to do that. In the absence of anyone asking it or pressuring it to do it, it seems exceptionally generous that the organisation would do that.

Some years ago, a company for which I worked was applying for ISO 9000 accreditation. There was considerable work involving late nights and early mornings to get ourselves shipshape and all the rest of it. Had I known at that stage that a facility could have been extended allowing us to continue doing what we were doing and have it applied to us, it would have saved us many 60 and 70-hour weeks. I am not necessarily asking Dr. Duff to comment on this, but it seems an exceptionally generous thing that the organisation has extended in very public circumstances.

In cases where a GP or a consultant refers requests for tests to a lab how common is it for there to be no contact with the consultant or GP thereafter? Is it uncommon, very rare or whatever? We have all come across cases where the patient needs to ring up to find out what has happened, notwithstanding that we have modern technology and that all these things can be linked into the communications system effectively.

My next question relates to the Salford issue. Why would it not have been possible to deal with the tests that were referred to Salford here in Dublin? It might have meant taking on an extra specialist in that area. Would it not have been simple to say, "Okay tests have been carried out here in the city and we have a bit of an overload. Can you take on extra staff to clear it?"

Mr. Damien McCallion

I will take the second question first. It would be a matter for MedLab as to why it went to Manchester. It may help to give the general context. There has been serious shortage of screeners, of medical scientists, who can do cytopathology. That has been a serious challenge in this country and others as people move to HPV. As I mentioned earlier, people regard it as a very narrow career path. When people go from doing 100% of something to only doing 15% of something, clearly that has an impact on the resource that is there in many of the NHS facilities. I am giving that as context. It would be a matter for MedLab as to why it went to Manchester rather than staying in Dublin.

Dr. Henry will speak about laboratories' contact with GPs and consultants.

Dr. Colm Henry

The ordering of tests whether through labs or radiology is a staple of the assessment of patients and it is increasingly computer-mediated now. From primary care to hospital care tests are ordered through computers. The results come back through computers to a consultant or GP and the sign-off is done in the same way.

Despite all that, the clinical judgment has not changed. Depending on the context or urgency of the case, there would often be discussion for more complex or urgent cases between a general practitioner or a consultant directly with a lab consultant or a radiologist because at the end of the day despite all the developments we have had, the assessment of a patient is essentially one of clinical judgment supported by clinical tests.

I am somewhat uneasy about some of that. Of course, the most urgent cases should receive the most urgent attention, but the less urgent cases ultimately could become very urgent cases because of deferral. I wonder if any system is in place to catch those cases and ensure they are not pushed aside to become part of a waiting list. The waiting lists have become endemic; in almost everything we do there is a waiting list for it. A waiting list costs more in administration etc. There are greater risks involved with it. I am not referring entirely to the health system. The waiting lists are everywhere and are costly.

If someone goes into the office in the morning and leaves part of the day's work behind for the next morning, that becomes part of a waiting list which becomes unmanageable and cannot be done. As the Chairman knows, in our own business it cannot be done. I would be concerned that it could lead to difficulties at a later stage. I ask for something to be done to ensure that those less urgent cases that are not a question of life or death today should not be left to wait for six months to have their returns.

Dr. Colm Henry

I entirely agree with the Deputy. As medical knowledge constantly evolves we can develop scoring systems to identify patients who are more urgent. For example, in the world of endoscopy we can select out patients with particular symptoms that we know merit more urgent endoscopy and likewise with those who come through screening programmes who need more urgent endoscopy. That is not to say that among those people who do not fulfil those scoring systems within that larger of groups of routines there are not people who have more serious illness. I entirely agree that in addressing urgent cases we cannot lose sight that serious illness can happen in something that is initially styled as routine, based on the initial assessment.

In response to my earlier questioning Ms Burke said that the ISO accreditation was to the organisation, but that is not true. It is to the test; is it not? I just had a look and it is specifically to a test. I was confused about it when she was giving me answers before the break. The INAB, does not give ISO accreditation to Durkan Limited; it is specifically for tests taken on.

Ms Bríd Burke

Yes, it is according to the test.

The INAB website shows the schedule of accreditation. What Ms Burke said earlier was incorrect. It is not the organisation; it is for a specific test that the organisation will carry out. There is a distinct difference there.

Ms Bríd Burke

Yes, we accredit the system for the testing that it completes.

Therefore, the INAB accredits the company to perform X test.

Ms Bríd Burke

Exactly.

If it wants to take on Y test it must reapply.

Ms Bríd Burke

Yes.

In the case of the Salford lab, no one phoned the INAB to get accredited. It did not notice when it was doing its annual audit in Sandyford. The guy in Salford was operating for nine months before the second guy was taken on. It must be lucrative. When I read the report for what must have been the fifth time last night, I found out that the lab guy relocated from Sandyford to Manchester for personal reasons, which is none of our business. However, to set up a new lab for one guy, he must have been some employee despite shortages or it must have been extremely lucrative to support that level - the price we are paying, a matter we will probably get to at another meeting.

The information Ms Burke gave us earlier was incorrect. An organisation does not hold ISO accreditation. In ISO accreditation it states somewhere that if a company is ISO accredited to a particular standard, the onus is on the company to have its satellite labs ISO accredited. Is that true?

Ms Bríd Burke

I will just go back to clarify where the Deputy said I had given just the information. Yes, we accredit the entity for a specific set of tests.

That is on day one.

Ms Bríd Burke

Yes. The testing that was being carried out in Manchester was the same as the testing carried out in Dublin. That would form one of the-----

That is how the INAB justified it.

Ms Bríd Burke

It was one of the ways.

It justified it by saying that the lab in Dublin that was accredited was accredited to do that test in Dublin and therefore the INAB retrospectively deemed it acceptable that it was accredited to do it in Manchester.

Ms Bríd Burke

Before we said that, we assessed our own documentation.

No, we have been through that.

Ms Bríd Burke

We assessed quite closely that they had managed it.

It was based solely on evidence.

Ms Bríd Burke

Yes.

I would argue that the evidence in question is the evidence the board has today. If it went back, perhaps the evidence would have been different. It is an informed historical accreditation based on the documentation that the board has.

Ms Bríd Burke

But it was-----

As Ms Burke said earlier, the board "deemed" the operator to be competent.

Ms Bríd Burke

At that time, yes.

Ms Bríd Burke

Yes, but we were looking at historic records. Absolutely.

The fact is that the laboratory was not accredited through the standard or normal route. It did not apply to be accredited. It piggy-backed off its Dublin accreditation. The board did not step into that laboratory until last May.

Ms Bríd Burke

Does Dr. McGuinness want to respond to that point?

There were smears. The board was auditing. America is far away. Sandyford is only up the road.

Ms Bríd Burke

Yes.

Manchester is not too far away.

Ms Bríd Burke

Yes.

I do not understand one aspect of what happened when the quality assurance people - this predates Dr. Doherty - were going over. If they had been sending off a truckload of smears to a woman in Honolulu or wherever, one might be able to see how they got away with it. I cannot understand how the accreditation body, in its official remit under the HSA, was able to go to Sandyford without noticing that smears were going to the guy in Salford. I cannot understand how it was able to look at documentation - as I explained earlier, I assume that files and standards, etc., were examined - before retrospectively deeming him competent solely on the basis of the evidence it had to hand. This happened in the middle of an absolute crisis in cervical screening. It all seems generous, which is one way of describing it. I do not know what the best word to use is. I find it unorthodox. I find it very strange. Would there be any reason a private company would think it was okay? Why would it not bother getting accreditation for a test? Is that common? I know that one does not need to be accredited in order to open a laboratory. All the guidelines I have read regarding what we were going to do under CervicalCheck or BowelScreen are great. We were going to do great things. When those guidelines are whittled down into a tender document, it is often the case that ISO accreditation is required. When the accreditation body goes into a laboratory, does it have a remit to point out that it was not accredited yesterday when it did a test on behalf of the State? Is that its business?

Ms Bríd Burke

Yes.

If someone from the accreditation body was auditing a laboratory in Sandyford or Kildare that was applying for accreditation for a new test, and he or she noticed that the laboratory had no accreditation for doing that test on behalf of the State the previous week, would that be the accreditation body's problem or would it be a matter for someone else? Does the accreditation body have a remit-----

Ms Bríd Burke

No, we just look at our own accreditation system.

Dr. Sharon McGuinness

I would like to add to the points that have been made. As I have said, accreditation is an independent and impartial system. We assess it on the basis of the merits, the evidence and the standards we look at across the board with regard to a laboratory, a certification body or a notification body. That is why I said earlier that it is very much part of a bigger system. There is accreditation, but there is also quality assurance. Ongoing assurance steps are also involved. More people are involved in that. Therefore, the site visit element of accreditation takes place once a year. We provide accreditation for a year. If we are made aware of inconsistencies, or if we find out ourselves about such matters, we can address them.

No, I get all that. If the guy in Salford had not been historically accredited, what would the impact have been? What would have happened if the accreditation body had declined to provide accreditation on the basis that he did not apply for it when he opened his laboratory and he did not get in contact. If the accreditation body had said "No" on the basis that this was the first mention of this laboratory - it was not mentioned in the audit - what would the impact have been? I ask Dr. McGuinness to talk me through what the impact would have been if the accreditation body had not been as generous. What would that have meant for cervical screening? What would it have meant for the accreditation body?

Dr. Sharon McGuinness

I reiterate that we answered a question that was asked about whether this laboratory was accredited.

Dr. Sharon McGuinness

The impact of making a "Yes" or "No" statement in response to that question is not something that compels us to make a decision. Our approach is based on the information, the evidence, the standard and the normal accreditation process.

Okay. There is a second edition of the accreditation list on the website. Where is the first edition? I cannot seem to get it. We can see that at the time the May 2019 list was made, the Salford laboratory was accredited. The list does not say when the Salford laboratory became accredited. I know Deputy Kelly was hammering on about this earlier. If there is a second edition, there must have been a first edition. As the Salford laboratory is included in the second edition, we know it was accredited in May 2019, but we do not know how long it had been accredited for at that stage. Where is the first list? Where is the first edition?

Dr. Adrienne Duff

I think this goes back to what we have been saying. Based on the evidence we have-----

Dr. Adrienne Duff

I would like to clarify the matter. Based on the evidence we have assessed over the years with MedLab for the cytoscreening testing, which was the precise activity that was being carried out in Manchester-----

Was it a kind of "trusted trader" thing? The accreditation body decided to trust the laboratory because it had dealt with it for years. I am trying to get to it. It is either technical or it is not. If the accreditation body is going to accredit a company - historically, retrospectively or otherwise - why would it do it in this way? Would it do so on the basis of corporate knowledge, for example if it had dealt with the laboratory for 12 years? Why would it take this approach to a private company?

Dr. Adrienne Duff

We were asked whether the cytoscreening in Manchester was accredited. We reviewed all our assessments from 2011 right through our engagement with MedLab. As I have said, a full onsite assessment is done every year with consultant histopathologists in the cytoscreening area. Based on that review, we told the scoping inquiry that the activities in Manchester were accredited. With regard to the information that is publicly-----

Yes, we have been there. This might be our fourth time around the block on this issue. I have asked a specific question. In May 2019, the Salford laboratory appeared in the second edition of the accreditation list. I want the first edition of the list.

Ms Bríd Burke

We will provide that. We have it.

I asked earlier for any paperwork relating to how this decision was made. It does not make sense that the accreditation body would do this. It would make sense to me if it were done all the time, because then I could say it was part of a standard approach. The accreditation body has been in operation since 1985. It seems that in the middle of a serious health crisis involving cervical cancer screening, it decided to tick this box for a private company, thereby deeming that in the accreditation body's expert opinion - looking back - the laboratory was competent and everything was suitable. I do not buy it on the basis of what would happen if I operated a laboratory like this. As a pharmacist, my understanding is that if the contract says "ISO accreditation", that is what we pay for and that is what we get. My understanding was that the accreditation board, under the care of the HSA, was independent. I am not saying it is not independent. It is supposed to accredit. I understood it would accredit what was in front of it, and that there would be no scope for any flexibility or generosity with regard to accreditation. When the State signs a contract with a specific standard in it, I assume that is what we get and what the people get. We have found out that the stuff in the US was going to Honolulu and the stuff in Sandyford was going to Manchester. The guys who were auditing did not notice. We do not know what these lads were doing when the quality assurance people were going over. I am bewildered regarding what they did during the quality assurance visits. It seems that a massive amount was going to Honolulu and other places. I assume the service providers who are in charge of the contracts are supposed to make sure the people are getting what they are paying for. Is that Mr. McCallion's job? Whose job is it?

Mr. Damien McCallion

Each of the contracts has contract management systems. Dr. Scally has made recommendations with regard to how they might be strengthened. Those recommendations will be incorporated into future contracts. I refer not only to cervical screening contracts, but also to other contracts that the HSE will have with providers. We said earlier that the quality assurance process that still underpins accreditation is one arm of an overall quality service. The quality assurance process is a key aspect of our efforts to provide some extra assurance.

There is no point in having processes and accreditation if people are not ticking the boxes and checking. There is no point going in with one's file to do quality assurance and going off for a cup of tea. One has to go in and check. That is the job.

Mr. Damien McCallion

I think-----

Their job is to accredit. I cannot understand why Mr. McCallion has not been in touch with the Department of Education and Skills, which is responsible for the HSA, as I understand it. I think it falls within the remit of the Minister of State, Deputy Halligan. I cannot understand why Mr. McCallion has not been in touch with the other Department to point out that there is an issue because those who are responsible for accreditation are able to able to accredit generously and flexibly when it suits them. When that is combined with the lack of accreditation, does Mr. McCallion not see why we would all be concerned? If the standard in the contract is not being met in the US or in Ireland, we might as well be dropping it down to Deputy Durkan to screen in Kildare.

Mr. Damien McCallion

What is important is that in the overall quality of a laboratory, accreditation is one facet while the overall quality assurance-----

Mr. McCallion is suggesting that accreditation is not so important.

Mr. Damien McCallion

No, I am saying it is one facet. What is important for us is to give assurance to people in respect of the laboratories used and the programme, retrospectively and prospectively, as well as we can-----

There is no point having a cheap, fast whatever, with the results being returned, if the standard of the basic test is not what it should be. The rest of it is pointless in that case.

Mr. Damien McCallion

For assurance to people whose samples are screened by the laboratories in question it was not only we, but also Dr. Scally and Dr. Denton, who examined the performance of the laboratories in detail to ensure they were within the ranges-----

They repeatedly said they could not find any evidence. They never said the laboratories were all perfect and that there was no need to worry about accreditation.

Mr. Damien McCallion

If I might move away slightly from that point to give assurance to people who had tests, Dr. Denton and Dr. Scally stated that when examining the performance, they examined not only the overall performance of the laboratories but also the individuals. It is a small number in this case. That is important to state because we do not want to cause anxiety-----

I understand that Dr. Scally examined the matter and stated there did not seem to be any issue with any individual screener or individual laboratory. Nevertheless, if samples were sent to a non-accredited laboratory, that is completely wrong.

Mr. Damien McCallion

We were unhappy we were not made aware of that and alerted Dr. Scally, who did his work in examining it. Our primary concern is------

Since CervicalCheck was started and the contracts went out, there was first the College of American Pathologists accreditation, which has now been said to be an equivalent. In 12 years, nobody checked whether the ISOs were always up to date. I cannot understand how nobody considered it vital to go to step 2 of the process.

Mr. Damien McCallion

In the case of the Manchester laboratory, we were not aware of the scenario at the time-----

I know. That case is worse again.

Mr. Damien McCallion

It is a slightly different scenario, as I am sure the Deputy will appreciate.

It is 1 p.m.

Before I finish, I wish to clarify a question that I asked Mr. McCallion earlier about the bowel screening contract.

Mr. Damien McCallion

I stated I would revert to the Deputy.

We need to observe the time, Deputy.

I will clarify to ensure that Mr. McCallion will revert with the correct information. MedLab was awarded the tender for CervicalCheck in May 2010. The laboratory did not open until August 2010 and did not obtain ISO accreditation for cervical screening until December 2011. I want to know whether it was testing smears without accreditation before December 2011. The same company - MedLab - secured the bowel screening contract, as the sole provider, in May 2012. It obtained HPV accreditation in June 2012 for the Roche 4800 machine. How were private companies able to secure tenders when they did not have the accreditation standard? Is that normal?

Mr. Damien McCallion

I will revert to the Deputy on the matter.

I was just clarifying the question because I may not have been clear before the break.

Mr. Damien McCallion

Sure.

That concludes our proceedings. On behalf of the committee, I thank Dr. Henry, Mr. McCallion, Dr. Doherty, Ms Fitzgerald and Dr. McKenna, who appeared on behalf of the HSE, CervicalCheck and the National Screening Service; Ms O'Callaghan, Ms Conroy and Dr. Glynn from the Department of Health, as well as Mr. Brophy, whom we ignored completely throughout the three and a half hours; and from the Health Safety Authority and INAB, Ms Burke, Dr. Duff and Dr. McGuinness.

The joint committee adjourned at 1.04 p.m. until 10.30 a.m. on Wednesday, 25 September 2019.