CervicalCheck has not inspected test labs for four years – says Scally report – Ireland



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CervicalCheck has not performed any of its own inspections of cervical cancer screening laboratories for four years.

No quality assurance site visits to any laboratories in the United States or Ireland has been performed since 2014.

The revelation is contained in the report of Dr. Gabriel Scally, who visited the labs as part of his investigation into the CervicalCheck scandal.

Although he says that, according to his evidence, there is no reason not to continue using the laboratories, he criticizes the level of monitoring services by CervicalCheck.

He said it's surprising that laboratory quality assurance inspections have not been conducted for so long.

"This is surprising and not in line with international best practices, which suggest visits every three years, unless there is a reason to actively change the schedule," he said.

"Any decision to move forward or back in quality assurance programs must be discussed and discussed at a high level within the organization."

He found that CervicalCheck's first rounds of laboratory quality assurance were limited in their governance, design and effectiveness.

"The missed opportunities to develop the quality assurance process and the lack of a new visit to all sites by 2017 have resulted in the failure of some aspects of the quality of services," he warned.

CervicalCheck should now carry out laboratory inspection visits in the coming weeks.

A separate investigation is also to begin with the decision of the PLC lab in Austin, Texas, which was used by CervicalCheck until 2013 to outsource tests of Ireland to Honolulu and Las Vegas.

In the meantime, it has become apparent that the number of complaints to the Medical Council by patients about suspected misconduct by doctors has been the main complaint for many years.

It follows the harrowing stories of women and families affected by the CervicalCheck controversy regarding the insensitive attitude of some doctors when they received the delayed copies of the audits, which shows that they had received a wrong result.

There were 151 such complaints in 2015 and 136 in 2016. Last year, the doctors' watchdog received 126 allegations against doctors.

Most never go to a full investigation and efforts are made to solve the problem, with doctors making excuses in many cases. Not all complaints are accepted and, in some cases, the patient may notify the Board due to other issues beyond his control.

In the case of CervicalCheck audit reports, it has already emerged that many doctors felt that it was not their job to talk about results to women and loved ones.

They thought that CervicalCheck should contact the people involved and organize an individual meeting explaining the context.

CervicalCheck has had several audit reports on its records for at least two years before sending them to physicians in 2016 to tell them to pass them on to patients.

In cases where a patient had died, it was suggested that the woman's treating physician simply record it in her file.

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