Information for people concerned about CervicalCheck

Information about the individual reports from the RCOG Expert Panel Review of cervical screening is available here

Information related to the CervicalCheck audit 2018 is available here

Update on CervicalCheck IT issue in Quest Diagnostic’s Chantilly lab

The HSE learned last week that Quest Diagnostics Chantilly lab had failed to send test results to the GPs of around 800 women.

The tests were on samples which were retested. These tests had been carried out outside of the recommended timeframe.

These women had previously had low-grade cytological changes from their smear test. Since 2015, CervicalCheck tests women with low-grade abnormalities for the HPV virus. This allows the programme to decide the appropriate clinical pathway for each woman.

Quest retested these samples using a DNA HPV test, which has a longer expiration period. This avoided the woman having to get another smear test. Both tests are acceptable and are used in international screening programmes.

mRNA testing is more specific than HPV DNA tests. It has a lower HPV positive rate because it is detecting active infections only.

As we would expect, there are a small number of women whose HPV status changed as a result of the more sensitive test. A total of 52 who previously tested negative tested positive.

• The GPs of the 52 women, whose status had changed, received their test results in February of this year.
• Over half of these women have been referred on for further investigation. We are confirming with GPs that all the women’s results have been discussed in full with them.

In terms of clinical risk, the women affected had shown low-grade cytological changes at a very low risk of progression.

We want to apologise to any woman affected by this issue. We are continuing to keep in contact with the women about what has happened and any action that they need to take. The delays in results being forwarded are not acceptable. The HSE’s independent review will be investigating this incident in full detail.

If your query is not answered here, call us on Freephone 1800 45 45 55 (+353 21 4217612 if calling from outside Ireland). This helpline is open from Monday to Friday, 9am to 6pm.

Response to the use of additional laboratory in Salford

Dr Lorraine Doherty, Clinical Director of CervicalCheck acknowledges the concerns of women following some of the findings in the latest report by Dr Gabriel Scally.

Following the report, Dr Doherty wants to assure women and their families of:

• the reliability of the laboratory services
• the ongoing commitment to improve the CervicalCheck screening programme
• the ongoing commitment to rebuild people’s confidence in our screening services

Dr Scally recently published his Supplementary Report of the Scoping Inquiry into the CervicalCheck Screening Programme.

Dr Doherty welcomes the further reassurance from Dr Scally about the quality of cervical screening in Ireland. She also acknowledges the issues raised over the use of extra laboratories.

Dr Scally found that the use of extra laboratories did not reduce the quality of the screening provided to women. His findings uphold the overall quality and performance of the laboratories.

The scoping inquiry team visited MedLab Pathology’s facility in Salford, Manchester to review:

• its quality systems
• the performance of the laboratory
• the individual screeners who provide cytology services in the Salford facility

We recognise Dr Scally’s concerns over the accreditation process of MedLab Pathology’s Salford facility.

But Dr Scally's report confirmed that:  "…on the basis of the information available to the Scoping Inquiry, the use of these additional laboratories did not in fact result in a reduction in the quality of the screening provided to Irish women and it is important to acknowledge this".

In addition to the work of the scoping inquiry team, we carry out on-going performance monitoring in relation to Medlab Pathology. This is done as part of the CervicalCheck programme's quality assurance process. This also did not identify any reduction in quality. 

The performance monitoring carried out included monitoring of

• the laboratory performance
• the individual screener’s performance

We have confidence in the performance of MedLab, including the Salford facility. 

The programme was made aware of the Salford facility in October 2018. Since then we have reviewed the data from this laboratory separately. Over the last two quarters, (Q4 2018 and Q1 2019) we can confirm that the performance gives us no cause for concern.

All of the professional aspects of the work carried out by the screeners in Salford is overseen by clinical governance arrangements from Medlab in Dublin. This includes:

• their continuing professional development activities
• multi-headed microscope sessions
• training feedback 

Copies of the NHS External Quality Assessment results and NHS update training are kept on record in Medlab.

The screeners in Salford are identified by their screener numbers. This forms part of the Medlab data already reviewed by the scoping inquiry during the previous visit. It is also part of the ongoing performance monitoring data received by the HSE.

Dr Doherty said: “We welcome that Dr Scally has upheld the quality of cervical screening in Ireland, notwithstanding the issues raised in relation to the use of additional laboratories. We are fully committed to implementing Dr Scally’s recommendations and rebuilding confidence in our screening programme. We are committed to delivering the best possible cervical screening service for the people in our care and their families.”

The HSE continues to strengthen governance, quality assurance and management in the CervicalCheck programme and the wider National Screening Service. This is in line with the recommendations of Dr Scally in his final report. 

Of the 105 actions assigned to the HSE:

• 42 are complete
• 52 are in progress
• 7 are due to start later this year

Most actions will be completely implemented by the end of 2019.

The extra recommendations from this supplementary report will also be put in place.

We hope this will restore women's confidence in our cervical screening programme. This programme plays a key role in reducing cervical cancer in Ireland.

Dr Doherty said: “Cervical screening can prevent 75% of cervical cancer cases. As a result of our national cervical screening programme one woman is diagnosed with cervical cancer every two days, while thousands of abnormalities are detected every year.

"We understand women and their families concerns and we are committed to delivering a high quality cervical screening programme for the women of Ireland."

MedLab HPV tests on smear test samples reaching 6-month storage limit

We have agreed with MedLab Pathology Ltd, one of our contracted laboratories, that they carry out a HPV test before cytology on smear test samples that are reaching a storage limit of 6 months. This is because of the delays in reporting on smear test samples. MedLab Pathology Ltd is the laboratory with the largest number of smear tests waiting to be processed.

This laboratory serves women in the south and west of Ireland.  

Contact CervicalCheck if you have any questions about this.

Cytology

Cytology is where the lab examines your screening test sample under a microscope. They do this to look for any abnormalities (changes) in the cells of your cervix. These can range from low-grade (minor) changes to higher grade (more serious) changes.

HPV testing

HPV is a very common virus. Most people will have had it at some time in their lives. It usually clears without treatment. But some types of HPV can cause changes in the cells of the cervix that can later develop into cervical cancer.

We expect approximately 15% of the total samples taken to be HPV positive. These samples will be prioritised for cytology by the laboratory.

If your HPV test is positive

If your HPV test is positive, your test will be prioritised by the laboratory for cytology. This is because these women are considered to have the highest clinical needs.

If your cytology test finds changes, we will recommend you have an examination called a colposcopy. A colposcopy is a more detailed look at your cervix. You will have it done in a hospital free of charge. They will give you advice on whether you need any treatment and when to have your next screening test.

If your cytology test does not find changes, we will recommend you have a repeat smear test in 12 months as many HPV infections will clear in this time

If your HPV test is negative

Samples that are HPV negative are at a much lower risk of developing cervical cancer.

If your HPV test is negative, your test will go through cytology, but at a later stage and not immediately. This because these women are considered less at risk.

This means that if you have negative HPV results, you may experience a further delay in getting your final result. This is because the laboratory is prioritising HPV positive tests for cytology. This is so that results and recommendations can be given more quickly to those women most at risk.

We have communicated this measure to GPs and smeartakers registered with MedLab Pathology Ltd.

Read our letters to GPs and smeartakers about this

Repeat screening tests recommended for some women

About 4,000 women have been invited for a repeat cervical screening test (smear test).

This is because one of our labs has told us that some HPV (human papillomavirus) tests were carried out beyond the manufacturer’s recommended time-frame of 30 days. HPV tests have been a routine part of cervical screening tests since 2015. 

We have written to women affected by this issue. If you are affected by this issue, we will issue a letter to you by the end of this week (8th February 2019).

Not everyone who is affected by this issue will need to have a repeat test.

If you do need a repeat test, we will let you know. The repeat test will be free and will be processed as a priority.

Patients who are currently awaiting cervical screening test results are not affected by this issue. If you are affected, we will contact you.

We are sorry about this issue and any inconvenience or concern this may cause you.

We continue to update our website with information on this issue.

Here we have information which may answer some of your questions: 

• What has happened to date
• Accuracy of your HPV test if done after the recommended date
• Women whose samples are affected 
• If you are affected by this issue
• If you need a repeat cervical screening test
• Repeat cervical screening test results
• If you are told you do not need any follow-up
• If you are waiting for a result on a test you had in 2018
• If you are pregnant or have recently given birth
• Testing for HPV – how your cervical screening test is processed
• Labs affected by this issue
• Contacting CervicalCheck 

What has happened to date

About 4,000 women have been invited for a repeat cervical screening test (smear test). This is because one of our labs has told us that some HPV (human papillomavirus) tests were carried out beyond the manufacturer’s recommended time-frame of 30 days.

These HPV tests were carried out on test samples where low-grade (minor) abnormalities or changes in the cells of the cervix were detected. When low-grade changes are found, the test samples are then also tested for HPV. This HPV testing has been a routine part of cervical screening since 2015. 

There is no issue with the first findings of the cervical screening tests. This is the part of the test (known as cytology) where low-grade abnormalities were found. 

The issue is only to do with secondary HPV tests that were done between 2015 and 2018. The lab that told us about the issue is run by Quest Diagnostics. It is 1 of 3 labs used by CervicalCheck.

Accuracy of your HPV test if done after the recommended date

HPV tests are still likely to be accurate even if carried out after the recommended date. But, in order to provide complete reassurance, we will ask some women to go for a repeat cervical screening test.

Women whose samples are affected

The women affected by this issue had their cervical screening tests processed by Quest Diagnostics between 2015 and 2018. This issue does not affect all women who had a cervical screening test during this time. It only affects women whose sample was tested for HPV. This is about 56 in 1,000 women screened.

If you are affected by this issue

If you are affected by this issue, we will write to you. We will also write to your GP. 

We will tell you if any follow up is needed. Most women will not have to have any follow up or do anything. Some women will need to have a repeat cervical screening test. We will tell you if you need to have a repeat test.

If you are affected by this issue, you and your GP should receive a letter from us by 8th February 2019.

If you need a repeat cervical screening test

If we ask you to have a repeat cervical screening test, you can have it free-of-charge with any GP or smeartaker registered with CervicalCheck. 

You will need to:

• make an appointment with a GP or smeartaker
•  bring all the information we have sent you about this issue — the letter and the separate insert with the letter to your GP

The insert will be put with your sample. This is to let the lab know that your cervical screening test sample needs to be done as a priority. If you lose your insert or forget to bring it with you, don’t worry. Your GP will send your cervical screening test in the usual way. When your sample arrives in the lab, it will still be identified and processed as a matter of priority.

Some women had their cervical screening test in a colposcopy clinic. If you are one of those women, the clinic you attended will contact you to arrange an appointment for a retest. We will let you know in your letter if you should expect the clinic to contact you.

Repeat cervical screening test results

Results for repeat cervical screening tests will be processed within around 4 to 6 weeks after your smear test is carried out. We will send you a letter when your results are ready. Your GP will also get a copy of your results.

Some women are waiting longer than 6 weeks for their results. We’re very sorry about this. This delay is due to an administration issue. This issue has now been resolved. But it took longer to resolve than we expected.

The lab we use has told us that results for all repeat tests they have received so far will be issued within the next two weeks. Any future tests will have results issued within around 4 to 6 weeks.

Your HPV retest results are unlikely to be different from your original test result. Evidence shows that HPV tests are still effective outside the manufacturer’s recommended timeframe. But as a precaution, we are asking some women to have a repeat cervical screening test to confirm the original result.

If you are told you do not need any follow-up

We are writing to all women affected by this issue. Not all women will need to take any action or have any follow up. Only some women need to have a retest. But we wanted to let you know what has happened. Your HPV test results are likely to be accurate even though the test was done after the manufacturer’s recommended time-frame.

You may not need any follow up because:

• you’ve had another HPV test since and that test was processed within the recommended time-frame
• you’ve attended a colposcopy clinic or are due to attend — HPV is one of the tests done in colposcopy so you’ll have been given advice on any treatment, if needed
• you had a cervical screening test in the last 6 months and the lab still has your sample. They will retest it with a different HPV test. Your GP will be sent the result.

If you are waiting for a result on a cervical screening test you had in 2018 

If you are currently awaiting results for a cervical screening test you had last year, you shouldn’t be affected by this issue.

The screening test samples affected are ones that have already been processed and the results sent out. Any cervical screening test that has not been processed and where the results have not sent out is not affected by this issue.

But, you may still be contacted by us if a cervical screening test you had in the last few years is affected. If you are affected, we will let you know.

If you are pregnant or have recently given birth

A screening test isn't usually recommended while you're pregnant. Your GP will usually tell you to wait until 3 months after the birth before having another screening test.

The risk to your health and the health of your baby is very low if you decide to wait until 3 months after the birth.

The HPV test previously carried out on your smear test is still likely to be accurate even if it was carried out after the recommended date. The CervicalCheck Clinical Management team are confident of this. 

We are offering some women a repeat smear test in order to provide complete reassurance. We also want to make sure we have an accurate record of their results on file.

Having a screening test while you are pregnant will not increase your risk of having a miscarriage. But, you may have slight bleeding afterwards.

If you are very concerned and wish to have a repeat test, talk to your GP.

Testing for HPV – how your cervical screening test is processed

When you have a cervical screening test your test sample is sent to 1 of 3 labs that we use. The lab then follows a standard process as they test the samples. All samples are examined for changes in the cells of the cervix. This stage is called cytology. Only some tests then need to be tested for HPV.

Step one – cytology

Cytology is where the lab examines your screening test sample under a microscope to look for any abnormalities (changes) in the cells of your cervix. These can range from low-grade (minor) changes to higher grade changes.

If no changes are detected, you are told to continue to go for routine screening tests when they are due. This is usually every 3 or 5 years depending on your age.

If high-grade changes are found, you are recommended to go for a colposcopy. A colposcopy is more detailed examination of the cervix.

Step two – HPV test

If low-grade changes are found, the lab also tests your sample for HPV. These HPV tests have been routine since 2015.

HPV is a very common virus. Most people will have had it at some time in their lives. It usually clears without treatment. But some types of HPV can cause changes in the cells of the cervix that can later develop into cervical cancer.

If the HPV test is negative, the low-grade changes are not a cause for concern. You are at a low risk of developing cervical cancer before your next screening test. You are recommended to go for your routine screening when invited. This is usually every 3 or 5 years depending on your age.

If the HPV test is positive, you will need to have an examination called a colposcopy. A colposcopy is a more detailed look at your cervix. It's free of charge. You will have it done in a hospital. You will be given advice on whether you need any treatment and when to have your next screening test.

Labs affected by this issue

The lab affected by this issue is run by Quest Diagnostics Inc, Teterboro, New Jersey, USA.

We are working with Quest Diagnostics to ensure this issue does not happen again.

We have also contacted the other 2 labs we use to ensure this issue does not occur with them.

Contacting CervicalCheck

We continue to update our website with information on this issue.

If your query is not answered here, you can call us on Freephone 1800 45 45 55 (+353 21 4217612 if calling from outside Ireland) and an advisor will take your details. This helpline is open from Monday to Friday, 9am to 6pm.

Delays in screening test results

Almost 350,000 screening tests were carried out during 2018. There are usually about 250,000 cervical screening tests each year. This increase in 2018 was due to understandable concerns about cervical screening.

This increased workload has led to long and very regrettable delays in the reporting of results. Currently, results are taking an average of 6 weeks from the time you have your smear test. In some cases, this is taking longer. In the past, results would have been available in about 4 to 6 weeks.

Due to this delay, a very small proportion of the overall samples expired before they were transferred to slides for testing. Repeat testing was required in about 1,000 cases.
CervicalCheck has been in touch with women about this and with their GPs.

We are sorry about these delays. We are making every effort to improve the situation.