Liz McManus (Wicklow, Labour)
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Question 146: To ask the Minister for Health and Children the number of pathology laboratories here that hold recognised accreditation; if she has plans to introduce legislation to require accreditation; her views on concerns that laboratories in the US that are carrying out tests for patients here have different codes of practice; and if she will make a statement on the matter. [24015/07]

Mary Harney (Dublin Mid West, Progressive Democrats)
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Prior to the establishment of the Health Information and Quality Authority (HIQA) this year, accreditation was carried out by the Irish Health Services Accreditation Board. This has now been taken over by HIQA. The bulk of work on accreditation has been carried out in the acute hospital sector, for which an Acute Care Assessment Scheme was developed. This scheme provides a quality and safety framework involving standards of excellence, self assessment and skills of trained peer review and service user surveyors and covers all aspects of each participating hospital — including laboratories within the hospital. The scheme is voluntary. However currently over 95% of public acute hospitals have applied for accreditation.

There are a number of other accreditation schemes available for the private sector. There are also a number of agencies which provide accreditation for medical laboratories such as the Irish National Accreditation Board which accredits medical laboratories to ISO 15189, which is the internationally recognised standard of best practice in medical laboratories. This, too, is a voluntary process.

In January 2007, I established the Commission on Patient Safety and Quality Assurance to develop proposals for a health service wide system of governance based on corporate accountability for the quality and safety of all health services. One of its terms of reference is to specifically examine and make recommendations in relation to a statutory system of licensing for public and private health care providers and services.

In relation to the use of US laboratories for carrying out testing, I understand from the Health Service Executive that the National Hospitals Office outsourced the backlog of cervical smears earlier this year. The tests were conducted at fully accredited laboratories in Quest's Houston and Chicago. All Quest's Diagnostics' testing locations are subject to Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) certification and maintain current CLIA licenses. Quest Diagnostics' main laboratories are accredited by the College of American Pathologists (CAP) and the above labs have CAP and CLIA approval.

Quest laboratories use the internationally accepted Bethesda methodology for reporting pap smears. This methodology is utilised world wide with the exception of Ireland and England which uses the British Society of Cytology standards. As the Besthesda method is the dominant world wide, the EU requires that the British standards be fully translatable with Bethesda.