Scally report on smear tests published today

A report examining the scale of outsourcing of smear tests by laboratories contracted to do the work by the HSE will be brought to the Cabinet today.

Scally report on smear tests published today

A report examining the scale of outsourcing of smear tests by laboratories contracted to do the work by the HSE will be brought to the Cabinet today.

The report, by Gabriel Scally, is expected to be published in the afternoon, pending Cabinet’s approval.

Whether the HSE and CervicalCheck, the national screening service, were aware that US laboratories contracted to read smear tests subcontracted work out to other sites has been examined as part of a wider analysis of the issues that gave rise to the CervicalCheck controversy.

While it had been anticipated that the report would be complete in February, Dr Scally advised the Department of Health that the breadth and complexity of the issues involved in the supplementary report required further time for analysis.

A spokesperson for the department said Dr Scally had “also advised that he has found no reason to revise the view taken in his earlier report, that as far as can be ascertained, all the current laboratories have performance which is acceptable in their country”.

Dr Scally’s additional work — supplementary to his Scoping Inquiry into CervicalCheck — examined the “facts and details” of the additional laboratories involved in CervicalCheck work which came to light during the work of the Inquiry — their nature, ownership, extent of activity, quality and accreditation arrangements, governance structures, “and other relevant matters”.

The HSE had used Quest Diagnostics in New Jersey, USA, the Coombe Hospital in Dublin, and laboratories owned by Sonic Healthcare, including MedLab Pathology in Dublin, Clinical Pathology Laboratories in Austin, Texas, and the Doctors Laboratory of London to do cytology reviews.

However, the scoping inquiry identified a further five laboratories which had been used by Sonic Healthcare as part of the CervicalCheck contract held by CPL between 2010 and 2013 — in San Antonio and Victoria, Texas, Las Vegas, Honolulu, and Orlando.

Sonic Healthcare argued there was no breach of contract under “schedule 13” of the 2010 contract which states that: “In the event that CPL in Austin unexpectedly is unable to provide cytology services, workload can reliably be handled at other Sonic Group laboratories in the United States”.

However, Dr Scally has said there is “no record available” to suggest that CPL advised CervicalCheck about the use of additional laboratories.

Dr Scally also examined the circumstances which led to these additional laboratories undertaking work for CervicalCheck; the effectiveness and operation of procurement and contracting of laboratory-based cervical cytology services.

And furthermore, he also examined standards the laboratories operated to and whether they were equivalent to the standards of ISO 15189, an international standard particular to medical laboratories.

He had said he would broaden his inquiry if other “relevant elements” were identified and would report back to Health Minister Simon Harris with recommendations.

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