The two main laboratories, which examine more than 260,000 smear tests a year under the national CervicalCheck screening programme, have not yet agreed to sign new contracts with the Health Service Executive, RTÉ News has confirmed.
With the existing contracts due to expire this month, intense negotiations are continuing involving the HSE and two key laboratories, Quest Diagnostics in the US, and MedLab Pathology in Dublin.
It is understood that a key issue is the laboratories securing new insurance to cover the backlog of CervicalCheck tests to be done and for future testing, given the controversy involving CervicalCheck and legal claims and settlements.
The laboratories are reporting difficulties in securing indemnity or claim that the cost of securing new indemnity is significantly higher and would have to be passed on to the State.
Laboratories have argued that a key issue involves some legal settlements and/or claims where false negatives are regarded as negligence, something they say is not occurring elsewhere.
Quest conducts more than 132,630 tests for CervicalCheck each year, while MedLab performs more than 131,750.
A spokeswoman for the Minister for Health, Simon Harris, said the HSE remains in intensive negotiations with the two laboratories, with the talks at a crucial stage.
She added that the minister believes it would be inappropriate to comment further at this juncture, saying the HSE should be given space to conclude the discussions.
The HSE said that talks were ongoing with both firms but would not comment further.
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It has declined to comment on what contingency measures it has in place, should one or both of the laboratories not agree to a new contract or a contract extension.
The situation is serious as such a scenario could possibly lead to a slowdown in CervicalCheck screening, or in an extreme measure, a suspension of the programme for a period.
MedLab said it had no comment on the issue, while Quest has not commented.
The Coombe Laboratory also does tests for CervicalCheck but handles around just 10% of the total, amounting to a maximum of 35,000 checks a year.
It would not be in a position to take on a major amount of extra work.
The previous contracts with Quest and MedLab were extended past their duration, pending a new competition this year.
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The recent Scally Review expressed satisfaction with the quality management processes in the current laboratories being used.
It also emphasised the importance of continuing the cervical screening programme.
The planned introduction of HPV testing next year is expected to significantly improve the accuracy of the cervical screening process and increase the chance of more cancers being prevented, due to the detection of early changes.
However, it remains unclear when exactly HPV testing will be introduced.
