Vol. 503 No. 5
2 Ms McManus asked the Minister for Health and Children the control or supervision, if any, his Department exercises over laboratories checking cervical smear tests; his views on health boards subcontracting examination of the test to third parties; and if he will make a statement on the matter. [10586/99]
Each subspeciality in pathology operates to its own professional standards and guidelines. For example, the Irish Association of Clinical Cytology has produced guidelines for cytology testing which are available to all pathology laboratories. Laboratories are staffed by qualified personnel and ultimate responsibility for the quality of the work lies with the consultant pathologist. Quality control procedures currently in place include primary screening by trained cytotechnicians, rapid rescreening of all smears by another cytotechnician and double screening of abnormal screens.
Ireland, in common with most other EU member states, is currently developing a formal laboratory accreditation scheme in consultation with the relevant professional interests. I understand that only the UK and Holland have such schemes at the moment. My Department proposed on 9 March last a number of accreditation models to the joint working group involved and has requested a response to the proposals as a matter of urgency.
When health boards enter into contracts with third parties it is a matter for the health board to satisfy itself regarding the services to be provided. In this case the North-Western Health Board contracted the private laboratory in 1997 to read a backlog of 2,115 smears on the basis that the laboratory would adhere to accepted clinical practice. The health board was assured that quality control practices such as primary screening of all smears, rapid rescreen of smears and review of abnormal smears above borderline by a consultant pathologist would be adhered to.
The possibility of a problem was identified by the North-Western Health Board during its routine quality control process. The board is carrying out its own investigation into what happened and has not ruled out legal action against the laboratory involved.
Why has it taken since 1996, when the joint working group submitted its report to the Department, until 9 March this year for the Department to put forward models for an accreditation system and to look for an urgent response? It seems anomalous that there is such a different attitude now.
I would like to ask the Minister about two aspects of the North-Western Health Board experience and his response. He said that in terms of controls a pathologist must review tests which show any abnormalities. In the instances where a technician was working outside her normal working hours and doing this privately, will the Minister assure the House that any tests which should have been referred to a pathologist were referred? Will he also reassure us that, where a consultant pathologist reviewed those smears, public facilities were not used by her or him to support a private laboratory which was being paid for by a health board? Will the Minister make that commitment? The understanding is that the procedures were correct in so far as the checks and balances required by the Department were in place. The question is how those checks and balances were applied. Were public facilities in a public hospital used?
The Minister has carried out a review of the smear tests which were conducted and has gone one step further in relation to the 5,000 smears in St. Vincent's Hospital and the Bons Secours. Has he found a laboratory willing to undertake those tests? Is he ensuring a control is included in the review so we know for definite that there were inaccuracies and mistakes were made, other than the normal inaccuracies which exist? We all understand that this form of screening is inexact in its nature. We need to know if there have been inaccuracies over and above the normal margin of error. Has the Minister put a control system in place so we can assess the true nature of what has happened?
That process is ongoing. Reviews of smear test results are being undertaken as a result of the instructions which have been given to the various institutions where we believe it is prudent that that should be done as a precautionary measure.
By whom?
By independent people.
Has the Minister found a location for the 5,000 smear tests to be carried out?
In the same way as Our Lady of Lourdes Hospital, Drogheda, and Beaumont Hospital have been asked to carry out reviews, those reviews will be carried out. The same instructions have been given as regards the 5,000 smears.
We are currently developing a formal laboratory accreditation scheme in consultation with the relevant professional interests. It is because of the need for this consultation that we have not yet reached agreement on those issues despite the fact that we suggested accreditation models last March, which predated this issue entering the public domain. The idea that no proactive action is being taken on accreditation does not stand up to scrutiny. Work on this matter is ongoing.
The relevant professional interests concerned are clinical pathologists, medical laboratory technicians and biochemists. They are represented by a joint working group comprising of representatives from the Faculty of Pathology, the Academy of Medical Laboratory Science and the Association of Clinical Biochemists. The objective of these discussions is to develop and implement a formal accreditation system for pathology laboratories.
As regards consultant pathologists looking at borderline smear tests, I understand that was the case. There are legal issues involved in exactly how that happened and there are disputed versions of events by individuals, which must be resolved by the employer concerned before a final report can come on that matter.
On accreditation, I accept that 9 March predates this information about the North Western Health Board coming into the public domain. However, can the Minister state it predates any information coming to anybody in his Department?
I am intrigued there are legal problems relating to this because nobody has heard of it before. Is the Minister saying he cannot assure us that public facilities were not used to, in effect, make profit for a private laboratory?
The facts in relation to the circumstances regarding the involvement of people in this issue are disputed by the parties concerned and must be resolved. In regard to accreditation, the consultation with the professional interests also predates 9 March, which was the date when accreditation models were suggested to them as a result of a great deal of ongoing discussions to see if we could bring this matter to a conclusion.
In regard to the information being made available to the Department, the Department would have been informed about the quality review proceedings which went on in the North Western Health Board and that 2,115 smears would have to be re-examined. The question of what to do about it did not arise until that was assessed by an independent laboratory in Glasgow – as the Deputy said, it is an inexact science. Those results came back the week before last.
When was the Department informed initially? That is all I want to know.
We were informed of the results of the smear testing the week before last.
When was it informed that there was an issue?
The issue arose in the review which took place in late January.
The time for Priority Questions has expired and we must proceed to Ordinary Questions. We can transfer Questions Nos. 4 and 5 to Ordinary Questions, although I must call Question No. 4 first. I should add, for the information of the House, that Question No. 15 in ordinary time is similar to Question No. 3. With the co-operation of the House, we can still deal with the subject matter of Question No. 3 before the end of Question Time, but that is a matter for the Members.
