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The proportion of pregnant women eligible for first trimester combined screening for Down’s syndrome (T21), Edwards’ syndrome (T18) and Patau’s syndrome (T13) for whom a conclusive screening result is available at the day of report. Rationale British Medical Ultrasound Society (BMUS) guidelines for the safe use of diagnostic ultrasound equipment
This standard provides assurance that the screen positive rate for the national programme remains within the defined range to minimise the number of women requiring an offer of an invasive diagnostic test. Definition Denominator: number of T21, T18, T13 screening samples received in the screening laboratory in the reporting period excluding samples received: perform the scan in accordance with the FASP handbook guidance for the combined and quadruple screening tests Sample did not arrive at the laboratory as specified in the specimen transport and storage section of the FASP laboratory handbook. Thresholds are set at 90.0% to allow for a number of samples where a result is not possible to give a diagnostic result due to slow growing cultures where, for example, insufficient sample was received by the laboratory for processing or sub-optimum samples (for example, maternal cell contamination).
make sure there is effective communication between maternity and ultrasound services, for example when interpreting services are needed A diagnostic test is offered where a woman has received a higher chance screening test result for Down’s syndrome and/or Edwards’ syndrome and Patau’s syndrome, and if there are unexpected findings at the time of the ultrasound scan. This could be:
Numerator: tested women is the total number of eligible women for whom a completed screening result was available from the 18 weeks plus 0 days to 23 weeks plus 0 days fetal anomaly scan at the day of report. FASP defines the national cut-off set at 1 in 150 at term for both first and second trimester screening tests. A woman with a result of 1 in 150 or greater (between 1 in 2 and 1 in 150), of having a pregnancy with T21 or T18 and T13 in the first trimester or T21 only in the second trimester will be considered to be in the ‘higher chance’ group and offered an invasive diagnostic test. National performance of ST4b (see standard STC-S05) in Q1 was 68.4%, higher than the previous quarter. The trend graph below shows England ST4b performance since the KPI was first published in Q1 2019 to 2020. Thresholds have not yet been set for this KPI. Denominator: number of confirmed cytogenetic diagnoses of T21 following any result (higher or lower chance) from the combined test Edwards’ syndrome, Patau’s syndrome (T18 and T13) combined test
Specific changes
We revised performance thresholds to greater than or equal to 95.0% acceptable level and greater than or equal to 99.0% achievable level. FASP-S03a test: screen positive rate T21, T18, T13 screening and FASP-S03b test: detection rate T21, T18, T13 screening
PHE has also published information about patient confidentiality in population screening programmes. Target population make sure all women with a ‘no result’ NIPT result attend an appointment in ≤ 3 working days of maternity services receiving the result to discuss the options of: Where the provider has a pathway in place to offer the 20-week screening scan between 18 weeks plus 0 days and 23 weeks plus 0 days, this pathway must: make sure a local pathway is in place for women who need more information at the point of screening
Summary of changes
Eligible women is the total number of pregnant women booked for antenatal care during the reporting period, excluding women who: present to the service (either dating scan or booking) with a CRL greater than 84.0mm (after 14 weeks plus 1 day) - some women may book and are thought to be before 14 weeks plus 2 days by last menstrual period ( LMP) but when scanned they are found to be at or after 14 weeks plus 2 days; these women can be excluded if there were no delays in the usual process of booking the dating scan Guidance is available on the FASP programme’s processes for ensuring seamless and safe screening across the whole pathway. All 142 screening services submitted data, including 50 services that reported zero couples at risk.
We have updated these standards in line with our national approach to setting screening standards and they will be valid for data collected from 1 April 2022. Hopefully this gives you lots of time to look at the standards and prepare for any changes before data collection starts.
We listened
Ultrasound departments may not always have the capacity to accommodate women presenting later in pregnancy and we have allowed leeway of 1 week. Therefore, if you are not able to offer and complete the fetal anomaly scan to women presenting to service between at or after 22 weeks plus 0 days and before or at 23 weeks plus 0 days they can be excluded. If you were able to offer these women the fetal anomaly scan they should be included in the denominator. Performance thresholds Denominator: eligible women is the total number of pregnant women booked for antenatal care during the reporting period, excluding women who: Tertiary referral is defined as a referral from one provider organisation to a fetal medicine service in another provider organisation. These do not require an application or notification form. The authorised firm can add the manager directly via their mySRA account.
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