The procurement and implementation of a new information management system for CervicalCheck will be a significant but essential undertaking. Catherine Reilly reports
CervicalCheck has secured significant funding to procure and implement a new information management system (IMS), the Medical Independent (MI) has learned.
The current IMS, which is over 20 years old, represents the “highest area of programme risk”, according to a business case obtained by this newspaper under Freedom of Information law. The document, which was redacted in parts, was dated June 2022.
The IMS, known as the Cervical Screening Register (CSR), is “the fundamental enabler of programme operation and management”, outlines the business case.
It notes: “The reliance on a functionally-outdated CSR leads to avoidable clinical risk for screening participants, missed opportunities for innovation, a host of administrative inefficiencies through manual workarounds and their associated risks, and a lack of confidence in the current CervicalCheck system to effectively manage a complex cancer screening programme to the highest standards.”
Speaking to MI in December, CervicalCheck Programme Manager Ms Gráinne Gleeson said funding for a new IMS was secured in the fourth quarter of 2022. The amount is commercially sensitive. Ms Gleeson said the programme aimed to initiate a procurement process in March following a market engagement exercise. This process is expected to be completed by the end of 2023.
“The development piece will start then into 2024,” she said. “We see it as a two-year project, so we are looking at finalising [implementation] at the end of 2025, because it is a very complex project.”
Ms Gleeson said the CSR is recorded as high-risk due to the “complexity of the system” and potential impact if there was a malfunction. However, she said there was no evidence to suggest any failure of the CSR leading to women not receiving screening invites or results (GPs also receive screening results from the testing laboratory via Healthlink. If a woman is under the care of a colposcopy unit, the screening result letter goes to the colposcopy unit).
“We don’t get a lot of complaints from women [in this regard]. The system actually does what it needs to do, which is fundamentally a call/re-call system,” stated Ms Gleeson. “[The CSR] is on the risk register because potentially it could be a big issue, but it’s not [currently].”
The issues covered in the 2019 MacCraith rapid review, following non-receipt of screening results by women and GPs, were not related to any failure of the CSR.
Ms Gleeson, who joined CervicalCheck in June 2019, said she wanted to place a strategic focus on quality improvement and drive the programme forward.
“In 2020 one of the big projects that came out of our numerous workshops was our new IMS,” she outlined.
However, the Covid-19 pandemic impacted on capacity to develop and finalise a business case. The programme was also undertaking extensive work to roll-out primary HPV screening nationally in 2020. Ms Gleeson said the CSR was placed on the risk register in summer 2022 when the “full scope” of the project was identified.
Separately, Ms Gleeson took the opportunity to encourage women to update the programme when they move address. There is no data agreement for information transfer between CervicalCheck and the Department of Social Protection after the initial transfer of information when the woman turns 25. A request for women to check their details on the register is included in the programme’s advertising campaign messages.
However, it is a principle of the programme that an eligible woman does not need an invite letter to attend for screening and can check the register online and attend for screening when due.
CervicalCheck commenced in 1999 in the mid-west and was rolled out nationally in 2008. The aim of the screening programme is to reduce the number of women who develop cervical cancer and ultimately to contribute to the elimination of cervical cancer in Ireland (in tandem with the HPV vaccination programme). Between September 2008 and March 2020, some 64,110 women had high-grade precancerous changes detected and treated and 1,786 cancers were detected following participation in the programme.
Currently screening is offered to all eligible women aged 25-to-65 (approximately 1.3 million individuals). The programme is responsible for the call, recall and management of the eligible women through the screening pathway, as well as ensuring the follow-up of women referred for further care.
The programme has 78 per cent coverage between the ages of 25 and 60 (coverage is defined as the proportion of women who have had at least one satisfactory screening test taken within the defined screening interval). Screening eligibility was extended to age 65 in 2020.
In providing background about the programme, the IMS business case refers to recent “significant challenges”, most notably “the news in 2018 that women with cervical cancer were not given the results of an audit of cytology slides done as part of the quality assurance process”. As a result, “trust in CervicalCheck was severely eroded and there was significant public anger and reputational damage.”
“The findings and recommendations of the subsequent inquiry by Dr Gabriel Scally continue to be subject of intense public interest and political scrutiny. A separate Rapid Review was conducted by Prof Brian MacCraith in 2019 following an incident whereby a batch of letters was not issued by a screening laboratory to GPs. This resulted in further damage to the programme.”
The language is stark on the potential ramifications of not replacing the IMS.
To not fund the business case “is to risk another high-profile crisis in CervicalCheck, brought about due to a failure in the current CSR. The reputational damage to CervicalCheck, the National Screening Service (NSS) and the HSE would be catastrophic and the viability of CervicalCheck and other screening programmes in Ireland would be jeopardised.”
According to the business case, the key functions of the CSR include “cohort, invitations, and pathway management”; securely holding complete client screening histories and a record of past engagements with the programme; information transfer between the programme and external partners (eg, screening laboratories, histology laboratories, colposcopy clinics, outsourced printing company); results provision to women; facilitated referrals to colposcopy (via GPs); issuing of ‘failsafes’; and programme monitoring and reporting to enable quality assurance.
The CSR, which was bought in 1999, is “functionally outdated and inherently risky with legacy technologies that are coming to, or past, their end-of-support lifecycles”.
The main issues with the system include the number of manual processes and workarounds in place and associated risks; the inflexibility or inability to respond to changes in screening practice or to avail of new innovations, eg, new communication modalities; the absence of key data fields (eg, HPV vaccination status), which cannot easily be added; the difficulties associated with quality assuring the ‘call/recall’ function and reliance of “exception processes to mitigate known issues”; and the difficulties associated with quality assuring the results provision function.
According to the business case, the CSR has also been “severely stretched at every level for many years”. However, these pressures had been compounded by “recent challenges”, including then Minister for Health Simon Harris’s invitation to all women for an out-of-cycle screening test in 2018 (circa 100,000 additional tests undertaken); the introduction of new screening pathways and eligibility rules with the transition to primary HPV cervical screening in 2020; the pause and subsequent restart of the screening programme in 2020 due to Covid-19, which resulted in the controlled rescheduling of over 1.2 million letters by the end of 2021; and the cyberattack in May 2021 and subsequent lengthy delays in obtaining colposcopy updates from acute hospitals nationwide.
The new system will “mitigate the risks and overcome the limitations” of the existing CSR system; address specific recommendations of the Scally and MacCraith reports – particularly around data, quality assurance and reporting; and ensure compliance with data protection and privacy regulations, national health policies, and the national e-health agenda.
The new system will also “introduce new, advanced innovations through improved accessibility and a woman centred approach”. It will enable “robust quality assurance across the programme through the collection of high-quality data and the generation of accurate and timely reports”.
Ms Gleeson said the CSR requires a number of supportive systems. The programme uses a separate reporting tool that pulls information from the CSR as opposed to having built-in performance monitoring tools. Currently, the extraction and compilation of this data is highly time-consuming.
The current system also requires an external document imaging management system, whereas a new IMS would enable all information related to a participant to be readily accessible via a single source.
Ms Gleeson said implementing a new information system for CervicalCheck was a significant undertaking, but is the correct approach.
“I am guaranteed the funding for this, which I say with great delight…. We have done really good workshops, I have got a dedicated team, we have got really strong governance around this group, we have a steering group, we have a project team…. There is no question this is the right way to go, but I also feel confident in my team’s ability to be able to deliver this.”