Results 681-700 of 3,336 for speaker:Kate O'Connell

Public Accounts Committee: Bord na gCon Financial Statement 2017 (19 Sep 2019)

Kate O'Connell: Okay. I think that is it now. I thank the witnesses for their time.

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: 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...

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: Has INAB ever done what it did in this case before, whatever the witnesses want to call it?

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: Was it unique in the history of INAB?

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: 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?

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: 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?

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: 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...

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: Is there a form or does the applicant just notify INAB? What is the process?

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: When INAB is satisfied there is a laboratory, somebody from INAB goes out to give the ISO certification.

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: 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?

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: 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...

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: 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...

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: 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...

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: 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?

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: 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...

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: 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,...

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: Can the committee have them? Can we have a copy of the procedures which outline what INAB checks during an audit?

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: Was the competency file of the fellow from Manchester in Sandyford when INAB carried out the audit?

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: MedLab Pathology kept all of his work files in Sandyford.

Joint Oireachtas Committee on Health: Update on the CervicalCheck Screening Programme: Discussion (18 Sep 2019)

Kate O'Connell: His results were assessed as being normal.