LAST UPDATE | 12 Sep 2018
DR GABRIEL SCALLY has said he is satisfied with the quality of testing done in the laboratories which provide CervicalCheck screening services.
These labs include CWIUH, Quest, and the Sonic Healthcare Laboratories, MLP and TDL.
Scally said he is also satisfied with the quality management in CPL in Texas, a laboratory which previously provided this service.
He made the comments in his review into the CervicalCheck controversy.
During the inquiry, Scally found out that some slides initially sent to CPL were outsourced to other labs in America for at least some of the screening process. This needs to be looked at further, he says.
“But I want to be clear that CPL is not a current provider, and has not been since 2013, nor are any of the other laboratories to which they distributed slides,” he notes.
The review also states:
Now and in the past, there is/has been insufficient understanding from CervicalCheck that work is being outsourced to laboratories other than the primary recipient, and only incomplete ascertainment of the quality parameters operating in the outsourced sites has been made.
“The Scoping Inquiry was satisfied with quality management processes in the current laboratory sites in Quest, MLP, TDL, CWIUH, and at the former provider CPL in Austin.
“The quality management, governance, regulatory, and operational management aspects of the other Sonic Healthcare sites in the US (San Antonio, Victoria, Las Vegas, Honolulu and Orlando) will be the subject of a supplementary report to be prepared by the Scoping Inquiry.
All of the laboratories visited by the Scoping Inquiry team are meeting the regulatory requirements current in their own country. There is abundant research evidence that screening sensitivity varies in different countries.
“As far as can be ascertained, all the laboratories have performance which is acceptable in their country,” he states.
He also says there is no reason to discontinue any contracts with the providers and that screening should continue as is until the introduction of the new HPV test.
Three million women
Over the course of the CervicalCheck programme, around 3.1 million samples have been provided by women who took part.
The report states: “Notably, CervicalCheck has not been able to provide this number broken down in detail by laboratory for the entirety of the programme.
“The percentages are very approximately apportioned:
Speaking about quality assurance techniques used in labs, Scally says: “Robust procedures and agreements are required to be in place and must be in line with international effective practice norms.
Quality assurance mechanisms are not designed to ensure a particular cancer detection rate, but they are concerned with the quality of the laboratory processes.
“Reliability and validity underpinned by sound processes and evidenced by data is the cornerstone of a modern standardised and predictable process.”
‘Serious gaps’
In the review, Scally says there are “serious gaps in the governance structures of the screening services”.
“In the specific case of CervicalCheck, there was a demonstrable deficit of clear governance and reporting lines between it, the National Screening Service and the higher management structures of the HSE. This confusion complicated the reporting of issues and multiplied the risks.
It is clear that there are also serious gaps in the range of expertise of professional and managerial staff directly engaged in the operation of CervicalCheck.
“There are, in addition, substantial weaknesses, indeed absences, of proper professional advisory structures. These deficiencies played no little role in the serious issues that concern this.”
‘Damaging, hurtful and offensive’
The review also examines details of the non-disclosure of information from CervicalCheck audits to patients and what various parties knew and when they knew it.
Addressing Health Minister Simon Harris, Scally says there should be two areas of focus: the families of the women impacted and making progress on the recommendations of this inquiry.
Scally says how the families of the women affected were eventually told about the audit was “damaging, hurtful and offensive”.
“The current policy and practice in relation to open disclosure is deeply contradictory and unsatisfactory.
In essence, there is no compelling requirement on clinicians to disclose. It is left up to their personal and professional judgement. I know, very well, from very many of the women themselves and the families, that the issue of non-disclosure is felt very intensely.
“They have expressed very clearly their anger at not being told at the time when the information from the audit became available, and they are equally as angry about how they were eventually told.
“In my view, the manner in which they were eventually told of their situation in many cases varied from unsatisfactory and inappropriate, to damaging, hurtful and offensive.”
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