Official Statistics

Antenatal screening standards: data report 1 April 2018 to 31 March 2019

Published 28 October 2020

Applies to England

This is the second antenatal screening standards data report, covering 1 April 2018 to 31 March 2019. Antenatal screening is offered for 17 different conditions to approximately 700,000 pregnant women in England every year.

There are 3 NHS antenatal screening programmes. These are the:

• NHS Fetal Anomaly Screening Programme (FASP)
• NHS Infectious Diseases in Pregnancy Screening (IDPS) Programme
• NHS Sickle cell and thalassaemia (SCT) Screening Programme

We have improved the format of this report by moving from a PDF version to a more accessible HTML format. We have also for the first time made this report an official statistic. Official statistics are an essential public asset. They provide a window on society, the economy, and on the work and performance of government. They are fundamental to the judgements and decisions made by the public, by government, and by an enormous range of other organisations.

The report is a testament to the hard work of everyone involved in the programmes. We would like to thank all those involved in collecting and collating the data, producing the report, and most of all those from the NHS who deliver the screening services.

Data completeness has vastly improved for most indicators. The North region has made significant improvements in reducing the number of non-submitting providers. We would like to thank providers, commissioners and the screening quality assurance teams for their collaborative work in making this happen.

Looking ahead to 2019 to 2020, we would like to focus attention on 2 areas. These are:

• achieving complete coverage submissions (2 providers were unable to submit coverage data for IDPS-S01, IDPS-S02 and IDPS-S03 and SCT-S01, and 16 providers were unable to submit coverage data for FASP-S02)
• meeting the acceptable threshold (there are several providers not meeting the acceptable thresholds for some indicators and the system should support these providers as a priority to meet this minimum level)

And finally, we would like to acknowledge the important contributions of the National Congenital Anomaly and Rare Disease Registration Service (NCARDRS) and the Integrated Screening Outcomes Surveillance Service (ISOSS) in helping us to monitor and report on the outcomes for these screening programmes.

Further information

This report should be read in conjunction with the full standards datasets for 2018 to 2019 for the FASP, IDPS and SCT programmes.

Information about screening standards and service specifications are available for each programme.

For those standards that are also Key Performance Indicators (KPIs), the annual data presented in this report is calculated by adding together all 4 quarters of KPI submissions. Screening services are only included where valid KPI submissions were made in all 4 quarters of 2018 to 2019.

Please contact the screening helpdesk if you would like further information on screening data: phe.screeninghelpdesk@nhs.net

1. FASP summary

1.1 Coverage

Test	T21/T18/T13	Fetal anomaly ultrasound
Coverage %	85.0	99.1

1.2 Test: turnaround time

99.2% of T21/T18/T13 results reported within 3 working days of sample receipt.

1.3 Referral

Data shows that:

• 97.0% of women with higher chance results offered an appointment within 3 working days
• 76.5% of women with a suspected/confirmed anomaly referred and seen locally within 3 working days
• 88.4% of women with a suspected/confirmed anomaly referred to tertiary fetal medicine and seen within 5 working days

1.4 Test: completion of laboratory request forms

98.2% of laboratory request forms were complete.

1.5 Diagnosis or intervention: test results issued

Test	QFPCR ≤ 3 calendar days %	karyotype ≤ 14 calendar days %
T21/T18/T13	87.7	86.0
Fetal anomaly ultrasound	83.9	87.9

1.6 Test: performance

The standardised screen positive rate (SPR) for T21/T18/T13 was 3.1%.

In 2017 to 2018, the crude detection rate (DR) was 81.5% (95% CI 79.0 to 83.7) for the combined test, and 71.9% (95% CI 63.7 to 78.8) for the quadruple test.

2. IDPS summary

2.1 Coverage

Condition	Coverage %
HIV	99.7
Hepatitis B	99.7
Syphilis	99.7

2.2 Test: turnaround times

Condition	Results reported ≤ 8 working days of sample receipt %
HIV	99.3
Hepatitis B	99.3
Syphilis	99.3

2.3 Screen positive rates

Data shows that:

• 1.26 per 1,000 eligible pregnant women screened positive for HIV
• 3.89 per 1,000 eligible pregnant women screened positive for hepatitis B
• 1.52 per 1,000 eligible pregnant women screened positive for syphilis

2.4 Referral

Condition	Women with screen positive results attending a screening assessment ≤ 10 working days %
HIV	89.3
Hepatitis B	80.0
Syphilis	81.2

2.5 Diagnosis or intervention

86.2% of women with hepatitis B attended specialist assessment within 6 weeks.

2.6 Intervention or treatment

	%
Babies requiring hepatitis B vaccination receiving first dose ≤ 24 hours %	98.9
Babies requiring immunoglobulin receiving it ≤ 24 hours %	96.6

3. SCT summary

3.1 Coverage

99.7% of eligible pregnant women had SCT screening.

3.2 Test

	%
Timeliness of screening: results available ≤ 10 weeks +0 days %	57.3
Completion of FOQ: antenatal samples for SCT testing received %	97.7
Test turnaround time: ≤ 3 working days %	95.8

3.3 Referral

Data shows that:

• 48.6% of women at risk of having an infant with sickle cell disease or thalassaemia offered PND ≤ 12 weeks +0 days
• 57.3% of couples at risk of having an infant with sickle cell disease or thalassaemia offered PND ≤ 12 weeks +0 days

3.4 Diagnosis or intervention

43.2% of PND tests performed ≤ 12 weeks +6 days.

3.5 Test: results

	%
Women receiving PND results: ≤ 5 working days of PND test %	81.5
Newborn screen positive results to parents: ≤ 28 days of age %	72.7

3.6 Intervention or treatment

82.2% newborn infants with a positive screening result were seen at a paediatric clinic or discharged for insignificant results ≤ 90 days of age.

4. Coverage

This section covers standards FASP-S01, FASP-S02, IDPS-S01, IDPS-S02, IDPS-S03 and SCT-S01. See the 3 recommendations relating to coverage.

We measure coverage of the screening programmes to provide assurance that screening is offered to the eligible population. Low coverage should be investigated as it may indicate:

• eligible women are not being offered screening
• those offered screening are not accepting the test
• the test is not completed for those accepting screening

Figure 1: Antenatal screening – coverage standards, performance against thresholds, England, 2018 to 2019

Standard	Performance ≥ achievable	Performance ≥ acceptable and < achievable	Performance < acceptable	No return/data excluded	Total
FASP-S02	126	4	0	16	146
IDPS-S01	138	6	0	2	146
IDPS-S02	138	6	0	2	146
IDPS-S03	138	6	0	2	146
SCT-S01	139	5	0	2	146

FASP-S01 is not shown in figure 1 as there are no performance thresholds set for this standard.

Performance thresholds for FASP-S02 are:

• acceptable: ≥ 90.0%
• achievable: ≥ 95.0%

Performance thresholds for IDPS-S01, IDPS-S02, IDPS-S03 and SCT-S01 are:

• acceptable: ≥ 95.0%
• achievable: ≥ 99.0%

Figure 2: FASP-S01: Coverage: T21/T18/T13 screening, completeness, 2018 to 2019 by region

Region	Number of accepted returns	No return/data excluded	Total
London	23	3	26
Midlands and East	28	13	41
North	22	21	43
South	30	6	36

There is no intention to publish this standard by individual maternity service. Thresholds are not set for this standard, performance between providers should not be compared. FASP supports informed choice for women.

Table 1: FASP-S02: Coverage: fetal anomaly ultrasound, performance, 2018 to 2019 by region

Region	Numerator	Denominator	Performance (%)
London	115,653	116,804	99.0
Midlands and East	151,532	153,194	98.9
North	116,378	117,475	99.1
South	136,327	137,219	99.3
England	519,890	524,692	99.1

Figure 3: FASP-S02: Coverage: fetal anomaly ultrasound, performance against thresholds, 2018 to 2019 by region

Region	Performance ≥ achievable	Performance ≥ acceptable and < achievable	Performance < acceptable	No return/data excluded	Total
London	25	0	0	1	26
Midlands and East	33	3	0	5	41
North	32	1	0	10	43
South	36	0	0	0	36

Performance thresholds are:

• acceptable: ≥ 90.0%
• achievable: ≥ 95.0%

Table 2: IDPS-S01: Coverage: HIV, performance, 2018 to 2019 by region

Region	Numerator	Denominator	Performance (%)
London	145,714	145,897	99.9
Midlands and East	197,326	198,047	99.6
North	177,894	178,505	99.7
South	155,608	156,155	99.6
England	676,542	678,604	99.7

Figure 4: IDPS-S01: Coverage: HIV, performance against thresholds, 2018 to 2019 by region

Region	Performance ≥ achievable	Performance ≥ acceptable and < achievable	Performance < acceptable	No return/data excluded	Total
London	26	0	0	0	26
Midlands and East	38	3	0	0	41
North	38	3	0	2	43
South	36	0	0	0	36

Performance thresholds are:

• acceptable: ≥ 95.0%
• achievable: ≥ 99.0%

Table 3: IDPS-S02: Coverage: hepatitis B, performance, 2018 to 2019 by region

Region	Numerator	Denominator	Performance (%)
London	145,728	145,898	99.9
Midlands and East	197,347	198,053	99.6
North	177,929	178,525	99.7
South	155,616	156,153	99.7
England	676,620	678,629	99.7

Figure 5: IDPS-S02: Coverage: hepatitis B, performance against thresholds, 2018 to 2019 by region

Region	Performance ≥ achievable	Performance ≥ acceptable and < achievable	Performance < acceptable	No return/data excluded	Total
London	26	0	0	0	26
Midlands and East	38	3	0	0	41
North	38	3	0	2	43
South	36	0	0	0	36

Table 4: IDPS-S03: Coverage: syphilis, performance, 2018 to 2019 by region

Region	Numerator	Denominator	Performance (%)
London	145,716	145,895	99.9
Midlands and East	197,311	198,046	99.6
North	177,934	178,525	99.7
South	155,621	156,155	99.7
England	676,582	678,621	99.7

Figure 6: IDPS-S03: Coverage: syphilis, performance against thresholds, 2018 to 2019 by region

Region	Performance ≥ achievable	Performance ≥ acceptable and < achievable	Performance < acceptable	No return/data excluded	Total
London	26	0	0	0	26
Midlands and East	38	3	0	0	41
North	38	3	0	2	43
South	36	0	0	0	36

Table 5: SCT-S01: Coverage: antenatal screening, performance, 2018 to 2019 by region

Region	Numerator	Denominator	Performance (%)
London	145,253	145,521	99.8
Midlands and East	197,342	198,101	99.6
North	178,031	178,643	99.7
South	155,592	156,290	99.6
England	676,218	678,555	99.7

Figure 7: SCT-S01: Coverage: antenatal screening, performance against thresholds, 2018 to 2019 by region

Region	Performance ≥ achievable	Performance ≥ acceptable and < achievable	Performance < acceptable	No return/data excluded	Total
London	26	0	0	0	26
Midlands and East	39	2	0	0	41
North	40	1	0	2	43
South	34	2	0	0	36

Performance thresholds are:

• acceptable: ≥ 95.0%
• achievable: ≥ 99.0%

We continue to see year on year improvement in data completeness and performance for the coverage standards.

Of those submitting data:

• no provider was below the acceptable threshold for any of the coverage standards
• the number of providers meeting the achievable thresholds increased compared to last year (2017 to 2018)

All regions had non-submitting providers for FASP-S01. We started monitoring this standard as the KPI FA3 in 2018 to 2019. More data fields were added to the data submission template which has improved data quality but may have contributed to a small increase in non-submitting providers.

Non-submitting providers include those who did not submit KPI data for all 4 quarters of the year. We are aware from communicating with some providers that they were only able to submit partial data because of the absence of key members of staff and there were no contingency arrangements in place.

The number of non-submitting providers for FASP-S02 has decreased for the third year. In 2016 to 2017, there were 72 providers who were unable to submit data. This decreased to 35 providers in 2017 to 2018 and we saw a further decrease this year to 16 providers, 10 of which are in the North. All providers in the South met the achievable threshold for FASP-S02.

Two providers in the North were unable to submit data for IDPS and SCT coverage standards. London met the achievable threshold for SCT-S01, and London and the South met the achievable threshold for IDPS-S01, IDPS-S02, and IDPS-S03.

5. Test

This section covers standards FASP-S03a, FASP-S03b, FASP-S04, FASP-S05, FASP-S06, IDPS-S04, SCT-S02, SCT-S03, SCT-S04, SCT-S07 and SCT-S08. See the 4 recommendations relating to test.

Timely analysis of the test is important in making sure women have their results or enter clinical services without delay.

Figure 8: FASP-S03a: Test: screen positive rate T21/T18/T13 screening, England, 2013 to 2014 to 2018 to 2019

Line graph showing a small decrease from 2.3% to 2.2% in tax years 2013 to 2014 and 2015 to 2016 before increasing from 2.2% in tax year 2015 to 2016 to 3.1% in tax year 2018 to 2019.

The reference maternal age distribution changed, resulting in an increase in the screen positive rate. The reference range for this standard was revised from 2.3% to 2.8%.

Table 6: FASP-S03b: Crude detection rates (%) and screening status (number): trisomy 21 by year, England, estimated delivery date (EDD) 2015 to 2016, to 2017 to 2018

Crude detection rate (95% CI)	2015 to 2016	2016 to 2017	2017 to 2018
Combined test	81.9% (77.6-85.5)	82.1% (78.8-85.1)	81.5% (79.0-83.7)
Quadruple test	61.7% (47.4-74.2)	66.3% (56.0-75.3)	71.9% (63.7-78.8)
Programme	79.0% (74.8-82.6)	77.4% (74.1-80.4)	77.2% (74.7-79.4)

PHE launched the National Congenital Anomaly and Rare Disease Registration Service (NCARDRS) in 2015. NCARDRS records people with congenital anomalies and rare diseases in England and is best placed to collect data on detection rates. This is vital for the ongoing monitoring and evaluation of the screening programme.

Figure 9: FASP-S04: Test: fetal anomaly ultrasound. Detection rates with and without early detections (%) for serious cardiac conditions, EDD 2017 to 2018 by region

The detection rate target is 50%. All regions and England overall had a detection rate over 75%.

Data from 95% of NHS maternity providers, for 5,321 babies with an expected date of delivery (EDD) between 1 April 2017 and 31 March 2018, shows detection rates were significantly above target for all cardiac conditions across England, with and without the inclusion of detections prior to 18⁺⁰ weeks gestation.

Figure 10: FASP-S05: Test: turnaround time T21/T18/T13 screening, performance by laboratory, 2018 to 2019

Of those submitting data, there were 2 screening laboratories that did not meet the acceptable target of 97.0%. These were Leeds and Portsmouth. Two screening laboratories met the acceptable target but did not meet the achievable target of 99.0%. These were Bolton, and Brighton and Sussex. The other 15 screening laboratories met the achievable target.

Two screening laboratories did not submit data. These were Kings College Hospital and University Hospitals Coventry and Warwickshire.

Overall performance for England for those laboratories submitting data was 99.2%, meeting the achievable threshold.

Table 7: FASP-S06: Test: completion of laboratory request forms T21/T18/T13 screening, performance, 2018 to 2019 by region

Region	Numerator	Denominator	Performance (%)
London	104,149	105,355	98.9
Midlands and East	143,753	146,263	98.3
North	110,875	113,252	97.9
South	122,097	125,064	97.6
England	480,874	489,934	98.2

Figure 11: FASP-S06: Test: completion of laboratory request forms T21/T18/T13 screening, performance against thresholds, 2018 to 2019 by region

Region	Performance ≥ achievable	Performance ≥ acceptable and < achievable	Performance < acceptable	No return/data excluded	Total
London	0	23	2	1	26
Midlands and East	0	33	8	0	41
North	0	35	7	1	43
South	1	25	10	0	36

Figure 12: FASP-S06: Test: completion of laboratory request forms T21/T18/T13 screening, performance trends, England, April 2014 to March 2019

Line chart showing a steady increase from tax years 2014 to 2015 and 2018 to 2019. The percentage of completed laboratory request forms was below the acceptable threshold of 97.0% in tax years 2014 to 2015 (96.6%) and 2015 to 2016 (96.8%). The overall performance in England has been above the acceptable threshold since tax year 2016 to 2017 (97.4%) and was 98.2% in tax year 2018 to 2019.

Two providers did not submit data on this standard. Twenty-seven of the providers submitting data did not meet the acceptable threshold. Only one provider submitting data met the achievable threshold.

Although national performance has improved on this long-standing indicator, most providers were not able to meet the achievable threshold. NHS FASP has reviewed and introduced a new standard, FASP-S06 (KPI FA4) for data submissions starting April 2020.

Table 8: IDPS-S04: Test: turnaround times HIV, hepatitis B, syphilis, performance, 2018 to 2019 by region

IDPS-S04a: HIV

Region	Numerator	Denominator	Performance (%)
London	119,877	120,065	99.8
Midlands and East	188,536	190,024	99.2
North	174,384	176,308	98.9
South	154,382	155,148	99.5
England	637,179	641,545	99.3

IDPS-S04b: hepatitis B

Region	Numerator	Denominator	Performance (%)
London	120,619	121,109	99.6
Midlands and East	188,608	190,026	99.3
North	174,696	176,707	98.9
South	154,471	155,280	99.5
England	638,394	643,122	99.3

IDPS-S04c: syphilis

Region	Numerator	Denominator	Performance (%)
London	118,085	118,493	99.7
Midlands and East	188,504	190,029	99.2
North	174,328	176,257	98.9
South	154,467	155,225	99.5
England	635,384	640,004	99.3

Figure 13: IDPS-S04: Test: turnaround times HIV, hepatitis B, syphilis, performance against thresholds, 2018 to 2019 by region

Region	Performance ≥ acceptable	Performance ≥ acceptable and < achievable	Performance < acceptable	No return/data excluded	Total
London S04a	22	0	0	4	26
London S04b	22	0	0	4	26
London S04c	22	0	0	4	26
Midlands and East S04a	34	1	2	4	41
Midlands and East S04b	34	1	2	4	41
Midlands and East S04c	34	1	2	4	41
North S04a	37	2	1	3	43
North S04b	37	1	2	3	43
North S04c	38	1	1	3	43
South S04a	32	2	0	2	36
South S04b	32	2	0	2	36
South S04c	32	2	0	2	36

Performance thresholds are:

• acceptable: ≥ 95.0%
• achievable: ≥ 97.0%

All regions had non-submitting laboratory providers, but the number has decreased compared to 2017 to 2018 (37 to 13). The largest decrease was seen in the North where there were 14 non-submitters in 2017 to 2018 and only 3 in 2018 to 2019. Of those submitting data, 4 laboratories did not meet the acceptable threshold.

Figure 14: SCT-S02: Test: timeliness of antenatal screening, performance trends, England, April 2014 to March 2019

A line graph showing the overall England performance at 51.2% in tax year 2014 to 2015, which is above the acceptable threshold of 50%, increasing to 57.3% in tax year 2018 to 2019.

Due to inconsistencies in the way that SCT-S02 is reported, we do not recommend that this standard is used to compare performance between maternity services. A regional comparison of performance against thresholds is therefore not presented in this report. However, the 5-year trend for England performance is shown above.

Table 9: SCT-S03: Test: completion of family origin questionnaire (FOQ), performance, 2018 to 2019 by region

Region	Numerator	Denominator	Performance (%)
London	133,712	136,619	97.9
Midlands and East	188,871	193,313	97.7
North	172,561	177,061	97.5
South	146,503	149,663	97.9
England	641,647	656,656	97.7

Figure 15: SCT-S03: Test: completion of family origin questionnaire (FOQ), performance against thresholds, 2018 to 2019 by region

Region	Performance over achievable	Performance between acceptable and achievable	Performance less than acceptable	No return/data excluded	Total
London	15	5	5	1	26
Midlands and East	12	22	4	3	41
North	11	25	5	2	43
South	11	22	1	2	36

Performance thresholds are:

• acceptable: ≥ 95.0%
• achievable: ≥ 99.0%

The thresholds for SCT-S03 were changed in 2015 to 2016. Eight providers (every region had at least one provider) did not submit data despite this being a long-standing indicator. Of those providers submitting data, 15 did not meet the acceptable threshold. 36% of those that submitted data met the achievable threshold.

Table 10: SCT-S04: Test: turnaround time (antenatal screening), performance, 2018 to 2019 by region

Region	Numerator	Denominator	Performance (%)
London	119,943	121,820	98.5
Midlands and East	162,853	173,306	94.0
North	164,462	172,588	95.3
South	101,177	104,930	96.4
England	548,435	572,644	95.8

SCT-S04 was a new standard introduced in April 2017. Just under 96% of tests were turned around in 3 working days; an improvement from 93.9% in 2017 to 2018. The number of non-submitting laboratory providers decreased from 31 in 2017 to 2018, to 16 in 2018 to 2019.

Some data submissions were excluded as the data did not meet the definition of the standard; for example, some laboratories only currently report data by calendar days instead of working days. Of those laboratories submitting data, 17 did not meet the acceptable threshold.

The way antenatal screening laboratories are set up varies considerably across the country. In some areas, large centralised laboratories perform screening for several providers, which is particularly common in London. Due to this variation, a graphical representation of performance against thresholds is not shown in this report. Performance for individual screening laboratories is shown in the accompanying data tables.

Table 11: SCT-S07: Test: timely reporting of prenatal diagnosis (PND) results to parents, performance, 2018 to 2019 by region

Region	Numerator	Denominator	Performance (%)
London	183	205	89.3
Midlands and East	27	55	49.1
North	37	40	92.5
South	22	30	73.3
England	269	330	81.5

Figure 16: SCT-S07: Test: timely reporting of PND results to parents, performance against thresholds, 2018 to 2019 by region

	Performance over achievable	Performance between acceptable and achievable	Performance less than acceptable	No cases identified	No return/data excluded	Total
London	16	4	4	2	0	26
Midlands and East	7	1	14	19	0	41
North	7	2	1	33	0	43
South	8	1	3	24	0	36

Performance thresholds are:

• acceptable: ≥ 70.0%
• achievable: ≥ 90.0%

This is a small number standard and it should be noted that all regions had providers with no cases in 2018 to 2019. There were no non-returns which is an improvement from 2017 to 2018 when there were 18 providers that did not submit data.

All regions had providers that did not meet the acceptable threshold. Midlands and East did not meet the acceptable threshold but shows some improvement since 2017 to 2018. The North region met the achievable threshold.

Table 12: SCT-S08: Test: reporting newborn screen positive results to parents, performance, 2018 to 2019

Numerator	Denominator	Performance (%)	Exclusions from the denominator due to missing data
194	267	72.7	37

Figure 17: SCT-S08: Test: reporting newborn screen positive results to parents, England, 2018 to 2019

Measure	Where parents received newborn screen positive results ≤ 28 days of age	Where parents received newborn screen positive results > 28 days of age	Total
Number of infants	194	73	267

Performance thresholds are:

• acceptable: ≥ 90.0%
• achievable: ≥ 95.0%

Please note that data for SCT-S08 does not include any infants with screen positive results for whom the blood spot sample was tested at Liverpool Newborn Screening Laboratory (< 5 infants).

We identified data quality issues with the submitted data; therefore, only England level data is shown, and this must be interpreted with caution as it may not be reflective of true performance.

We also do not have enough information on 37 infants to determine performance for this standard. We will review the methods of data collection and the standard definition to improve data quality and completeness in future.

6. Referral

This section covers FASP-S07, FASP-S08, IDPS-S05, and SCT-S05. See the 5 recommendations relating to referral.

These standards give us assurance that women with higher chance/screen positive results have a timely opportunity to discuss their results and further options with an appropriately trained health professional.

Table 13: FASP-S07: Referral: time to intervention T21/T18/T13 screening, performance, 2018 to 2019 by region

Region	Numerator	Denominator	Performance (%)
London	3,236	3,342	96.8
Midlands and East	3,973	4,052	98.1
North	3,043	3,220	94.5
South	3,820	3,900	97.9
England	14,072	14,514	97.0

Figure 18: FASP-S07: Referral: time to intervention T21/T18/T13 screening, performance against thresholds, 2018 to 2019 by region

Region	Performance ≥ achievable	Performance ≥ acceptable and < achievable	Performance < acceptable	No return/data excluded	Total
London	15	2	8	1	26
Midlands and East	25	9	7	0	41
North	25	6	11	1	43
South	25	7	4	0	36

Performance thresholds are:

• acceptable: ≥ 97.0%
• achievable: ≥ 99.0%

There were 2 non-returns this year which is an improvement from 2017 to 2018 when there were 18 non-submitting providers. There were 9 non-submitting providers in the North in 2017 to 2018 and only 1 in 2018 to 2019.

There is also less variation in performance from 2017 to 2018 and 2018 to 2019. The interquartile range has reduced from 3.2 to 2.3.

Although the number of submitting providers meeting the acceptable threshold has increased from 30 in 2017 to 2018 to 34 in 2018 to 2019, there are still 30 data submitting providers not meeting this threshold.

The number of submitting providers achieving 100% increased from 61 in 2017 to 2018 to 77 in 2018 to 2019 but no region met the achievable threshold in either year. There is a need to better understand the reasons why providers find it challenging to meet the achievable threshold for this long-standing indicator.

Table 14: FASP-S08a: Referral: time to intervention 18⁺⁰ to 20⁺⁶ fetal anomaly ultrasound, local referral, performance, 2018 to 2019 by region

Region	Numerator	Denominator	Performance (%)
London	997	1,088	91.6
Midlands and East	1,476	2,131	69.3
North	1,285	1,682	76.4
South	751	992	75.7
England	4,509	5,893	76.5

Figure 19: FASP-S08a: Referral: time to intervention 18⁺⁰ to 20⁺⁶ fetal anomaly ultrasound), local referral, performance against threshold, 2018 to 2019 by region

Region	Performance ≥ acceptable	Performance < acceptable	No cases identified	No return/data excluded	Total
London	13	8	3	2	26
Midlands and East	7	26	5	3	41
North	15	17	9	2	43
South	11	15	7	3	36

Performance threshold: Acceptable: ≥ 97.0%

Table 15: FASP-S08b: Referral: time to intervention 18⁺⁰ to 20⁺⁶ fetal anomaly ultrasound, tertiary referral, performance, 2018 to 2019 by region

Region	Numerator	Denominator	Performance (%)
London	498	530	94.0
Midlands and East	838	940	89.1
North	1,050	1,231	85.3
South	792	893	88.7
England	3,178	3,594	88.4

Figure 20: FASP-S08b: Referral: time to intervention 18⁺⁰ to 20⁺⁶ fetal anomaly ultrasound, tertiary referral, performance against threshold, 2018 to 2019 by region

Region	Performance ≥ acceptable	Performance < acceptable	No cases identified	No return/data excluded	Total
London	13	7	4	2	26
Midlands and East	9	22	7	3	41
North	7	26	7	3	43
South	17	10	5	4	36

Performance threshold: Acceptable: ≥ 97.0%

The acceptable threshold was not met for England, with no region meeting the acceptable threshold for either FASP-S08a or FASP-S08b.

The number of non-submitting providers improved from 31 non-submitters in 2017 to 2018 to 10 this year, but there are concerns about data quality and some submissions were excluded where:

• it was clear that some providers were using the same denominator for parts a and b
• some providers reported their women in the wrong part of the standard and therefore measured against the wrong timeframe
• some tertiary providers were including referrals made to their service, resulting in double counting
• providers included women who had a suspected condition not listed in the 11 auditable conditions defined by NHS FASP

Further work is also required to understand why all regions had providers reporting no cases for a whole year (2018 to 2019).

Table 16: IDPS-S05: Referral: timely assessment of screen positive and known positive women, performance, 2018 to 2019 by region

IDPS-S05a: HIV

Region	Numerator	Denominator	Performance (%)
London	303	326	92.9
Midlands and East	220	247	89.1
North	152	173	87.9
South	85	105	81.0
England	760	851	89.3

IDPS-S05b: hepatitis B

Region	Numerator	Denominator	Performance (%)
London	822	1,032	79.7
Midlands and East	545	735	74.1
North	434	502	86.5
South	311	371	83.8
England	2,112	2,640	80.0

IDPS-S05c: syphilis

Region	Numerator	Denominator	Performance (%)
London	257	312	82.4
Midlands and East	239	307	77.9
North	233	270	86.3
South	94	125	75.2
England	823	1,014	81.2

Figure 21: IDPS-S05: Referral: timely assessment of screen positive and known positive women, performance against thresholds, 2018 to 2019 by region

Region	Performance ≥ achievable	Performance > acceptable and < achievable	Performance < acceptable	No cases identified	No return / data excluded	Total
London S05a	14	0	10	2	0	26
London S05b	6	1	19	0	0	26
London S05c	13	0	13	0	0	26
Midlands and East S05a	25	0	11	4	1	41
Midlands and East S05b	16	1	23	1	0	41
Midlands and East S05c	23	0	15	2	1	41
North S05a	23	0	9	11	0	43
North S05b	26	0	16	1	0	43
North S05c	21	0	18	4	0	43
South S05a	18	0	10	8	0	36
South S05b	15	0	20	1	0	36
South S05c	12	0	17	7	0	36

Performance thresholds are:

• acceptable: ≥ 97.0%
• achievable: ≥ 99.0%

All providers submitted data for this standard. This is an improvement as there were 19 non-submitting providers in 2017 to 2018. The data from one provider in the Midlands and East region was excluded as genitourinary appointments were counted instead of appointments with the screening team.

The performance for those submitting data shows that HIV performs better than hepatitis B and syphilis. This likely reflects long established pathways for HIV.

No region met the acceptable threshold for IDPS-S05a, IDPS-S05b or IDPS-S05c in 2017 to 2018 or in 2018 to 2019. There is a need to better understand the reasons why providers find it challenging to meet the acceptable threshold for this long-standing indicator.

Table 17: SCT-S05: Referral: timely offer of PND to women (a) or couples (b) at risk of having an infant with sickle cell disease or thalassaemia, performance, 2018 to 2019 by region

SCT-S05a: The proportion of women at risk offered PND by 12 weeks + 0 days gestation

Region	Numerator	Denominator	Performance (%)
London	300	661	45.4
Midlands and East	391	727	53.8
North	93	225	41.3
South	73	150	48.7
England	857	1,763	48.6

SCT-S05b: The proportion of couples at risk offered PND by 12 weeks + 0 days gestation

Region	Numerator	Denominator	Performance (%)
London	306	540	56.7
Midlands and East	166	297	55.9
North	101	164	61.6
South	51	88	58.0
England	624	1,089	57.3

Figure 22: SCT-S05: Referral: timely offer of PND to women at risk (a) or couples at risk (b) of having an infant with sickle cell disease or thalassaemia. data completeness, 2018 to 2019 by region

Region	Data included	One or more return missing	Total
London S05a	25	1	26
London S05b	26	0	26
Midlands and East S05a	41	0	41
Midlands and East S05b	41	0	41
North S05a	42	1	43
North S05b	42	1	43
South S05a	36	0	36
South S05b	36	0	36

This standard was collected for the first time in 2017 to 2018, and performance thresholds have not yet been set. The above figure presents the data completeness for this standard.

This standard is now KPI ST4 so data will be collected every 3 months. New KPIs are not published in the first year of data collection. This time is used to improve the data quality and completeness, by revising the definition, adding clarity and/or setting thresholds as required. After this time, PHE Screening will review the data with the aim of publishing it from the following year. We have identified data quality issues, therefore the submitted data may not reflect true performance. Performance between regions should not be compared.

Data completeness has improved in 2018 to 2019 with only 3 non-submitting providers (one service closed and the other 2 did not submit 1 of 4 quarters KPI data) compared to 19 non-submitting providers in 2017 to 2018.

7. Diagnosis or intervention

This section covers FASP-S09, IDPS-S06, and SCT-S06. See the 2 recommendations relating to Diagnosis or intervention.

These standards provide assurance that women with screen positive or higher chance results or known to have a condition, who wish to have a diagnostic procedure or intervention, have these in a timely manner.

Table 18: FASP-S09: Diagnosis or intervention: diagnostic tests fetal anomaly screening, England performance, tax years 2015 to 2019

Standard	2015/16	2016/17	2017/18	2018/19
9a – QFPCR testing for higher chance T21/T18/T13	97.1	89.8	90.1	87.7
9b – Karyotype testing for higher chance T21/T18/T13	82.1	82.7	81.0	86.0
9c – QFPCR testing for fetal anomaly ultrasound	91.3	84.0	84.2	83.9
9d – Karyotype testing for fetal anomaly ultrasound	82.2	86.2	86.8	87.9
Number of submissions	15/18	16/18	15/18	15/18

Figure 23: FASP-S09: Diagnosis or intervention: diagnostic tests fetal anomaly screening, 2018 to 2019

Standard	Performance ≥ acceptable	Performance < acceptable	No cases identified	No return/data excluded	Total
9a	6	7	2	3	18
9b	4	11	0	3	18
9c	7	5	3	3	18
9d	4	10	1	3	18

Performance threshold:

• Acceptable: ≥ 90.0%

The Association of Clinical Genomic Science (ACGS) collects data on behalf of NHS FASP. Standards FASP-S09a and FASP-S09b measure the turnaround times for results from either QF-PCR or karyotype following a higher chance screening result for Down’s syndrome, Edwards’ syndrome and Patau’s syndrome.

An increasing number of diagnostic laboratories report that they are more likely to perform micro-array than karyotype following an unexpected finding at the 18 to 20 weeks screening scan. It should be noted that the current NHS FASP standards and service specification recommends karyotype.

There were 3 genomic laboratories that did not submit data. Several laboratories did not meet the acceptable threshold.

Table 19: IDPS-S06: Diagnosis or intervention: timely assessment of women with hepatitis B, performance, 2018 to 2019 by region

Region	Numerator	Denominator	Performance (%)
London	222	259	85.7
Midlands and East	305	345	88.4
North	142	168	84.5
South	105	126	83.3
England	774	898	86.2

Figure 24: IDPS-S06: Diagnosis or intervention: timely assessment of women with hepatitis B, performance against thresholds, 2018 to 2019 by region

Region	Performance ≥ achievable	Performance ≥ achievable and < acceptable	Performance < acceptable	No cases identified	No return/data excluded	Total
London	15	9	2	0	0	26
Midlands and East	21	11	5	4	0	41
North	20	6	8	8	1	43
South	16	6	9	5	0	36

Performance thresholds are:

• acceptable: ≥ 70.0%
• achievable: ≥ 90.0%

Figure 25: IDPS-S06: Diagnosis or intervention: timely assessment of women with hepatitis B, performance trends, England, April 2014 to March 2019

The England overall performance has steadily increased from 68.4% in tax year 2014 to 2015, which was below the acceptable target of 70.0%, to 86.2% in tax year 2018 to 2019, which remains below the achievable target of 90.0%.

Since 2016 to 2017, IDPS-S06 counts only women with hepatitis B who are either newly diagnosed or known positive with high infectivity markers.

Of those submitting data, the number of providers not meeting the acceptable threshold has decreased from 31 in 2017 to 2018 to 24 in 2018 to 2019. The number of providers submitting data that met the achievable threshold has also increased from 66 in 2017 to 2018 to 72 in 2018 to 2019.

There was one provider in the North that did not submit data for 1 of 4 quarters KPI data submissions.

All regions met the acceptable threshold.

Table 20: SCT-S06: Diagnosis or intervention: timeliness of PND, England, 2018 to 2019 by region

Region	Numerator*	Denominator	Performance (%)	Exclusions from the denominator due to missing data
London	99	189	52.4	1
Midlands and East	20	65	30.8	0
North	14	49	28.6	0
South	14	37	37.8	0
England	147	340	43.2	1

*The numerator relates to PND fetal samples that are taken ≤ 12 weeks + 6 days gestation.

Figure 26: SCT-S06: Diagnosis or intervention: timeliness of PND, England, 2018 to 2019

Measure	Performed ≤ 12 weeks + 6 days gestation	Performed > 12 weeks + 6 days gestation	Where gestation at PND test is unknown	Total
Number of PND tests	147	193	1	341

This standard was collected at the national level for the first time in 2017 to 2018. We are not able to report this standard by maternity service at the time of publishing and have improved data collection processes to enable us to do this in future.

8. Intervention or treatment

This section relates to standards IDPS-S07 and SCT-S09. See the 2 recommendations related to Intervention or treatment.

These standards provide assurance that babies who require treatment receive it in a timely manner.

Table 21: IDPS-S07: Intervention or treatment: timely neonatal hepatitis B vaccination and immunoglobulin, performance, 2018 to 2019 by region

IDPS-S07a: vaccination

Region	Numerator	Denominator	Performance (%)
London	831	833	99.8
Midlands and East	570	584	97.6
North	418	422	99.1
South	293	296	99.0
England	2,112	2,135	98.9

IDPS-S07b: immunoglobulin

Region	Numerator	Denominator	Performance (%)
London	73	75	97.3
Midlands and East	61	61	100.0
North	43	46	93.5
South	22	24	91.7
England	199	206	96.6

Figure 27: IDPS-S07: Intervention or treatment: timely neonatal hepatitis B vaccination (a) and immunoglobulin (b), performance against thresholds, 2018 to 2019 by region

Region	Performance ≥ achievable	Performance ≥ acceptable and < achievable	Performance < acceptable	No cases identified	No return / data excluded	Total
London S07a	24	2	0	0	0	26
London S07b	21	0	2	3	0	26
Midlands and East S07a	29	1	10	1	0	41
Midlands and East S07b	24	0	0	17	0	41
North S07a	37	0	4	2	0	43
North S07b	15	0	2	26	0	43
South S07a	30	0	3	3	0	36
South S07b	10	0	2	24	0	36

There were no non-returns which is an improvement from 2017 to 2018 when there were 19 non-submitting providers for at least one part of IDPS-S07.

All regions met the acceptable threshold for IDPS-S07a with 3 of the 4 regions (London, North, and South) meeting the achievable threshold.

Midlands and East achieved 100% for IDPS-S07b for the last 2 years. North and South did not meet the acceptable threshold for IDPS-S07b.

Table 22: SCT-S09: Intervention or treatment: timely follow-up, diagnosis and treatment of newborn infants with a positive screening result, performance, 2018 to 2019 by region

Region*	Numerator	Denominator	Performance (%)	Exclusions from the denominator due to missing data
London	110	140	78.6	6
Midlands and East	58	68	85.3	7
North	52	57	91.2	1
South	16	21	76.2	1
Unknown	0	1	0.0	0
England	236	287	82.2	15

*Region relates to the region of the haemoglobinopathy centre (medical) in which the infant was seen or referred to and thus may not reflect the infant’s region of residence.

Figure 28: SCT-S09: Intervention or treatment: timely follow-up, diagnosis and treatment of newborn infants with a positive screening result, England, 2018 to 2019

Measure	With positive screening result who were seen at paediatric clinic or discharged for insignificant results ≤ 90 days of age	With positive screening result who were seen at paediatric clinic or discharged with insignificant results > 90 days	Total
Number of infants	236	51	287

Please note that data for SCT-S09 does not include any infants with screen positive results for whom the bloodspot sample was tested at Liverpool Newborn Screening Laboratory (< 5 infants).

We do not have enough information on 15 infants to determine performance. As the SCT newborn outcomes system is implemented, the quality of the data is expected to improve.

9. IDPS: screen positive rates

The data collection for IDPS-S05: referral: timely assessment of screen positive and known positive women includes the collection of the breakdown of women who screen positive. These breakdowns are shown below. Please note that due to data exclusions the absolute numbers reported here may differ from those reported elsewhere.

Table 23: Breakdown of women who screen positive for HIV, England, 2018 to 2019

Breakdown of screen positives	n	% of total
Newly screened positive women	94	11.0
Previously known positive women, not re-tested	112	13.0
Previously known positive women, re-tested in this pregnancy	654	76.0
Total screen positive women	860	100.0

Known false positives were excluded from the above. The above includes data submitted by all 146 maternity services in England.

Table 24: Breakdown of women who screen positive for hepatitis B, England, 2018 to 2019

Breakdown of screen positives	n	% of total
Newly screened positive women	608	23.0
Previously known positive women, not re-tested	32	1.2
Previously known positive women, re-tested in this pregnancy	2,000	75.8
Total screen positive women	2,640	100.0

The above includes data submitted by all 146 maternity services in England.

Table 25: Breakdown of women who screen positive for syphilis, England, 2018 to 2019

Breakdown of screen positives	n	% of total
Newly diagnosed requiring treatment	324	31.2
Previously diagnosed requiring treatment	149	14.4
Previously diagnosed not requiring treatment	554	53.4
Other treponemal infections	6	0.6
Unknown	4	0.4
Total screen positive women	1,037	100.0

Known false positives were excluded from the above. The above includes data submitted by all 146 maternity services in England.

Screen positive rates are calculated using a combination of indicators and are expressed as the total number of screen positive women (newly positive or previously known diagnosed) per 1,000 women tested.

Data are only included if the provider had complete data for both standards. This means that the absolute numbers reported here are lower than those reported for individual standards.

Please note that the below screen positive rates are based upon 2 separate data collections relating to the number of women who were booked for antenatal care in the reporting period and subsequently tested (including women who were known positives and not retested), and the number of women with screen positive results or known positive status reported in the reporting period. The 2 cohorts of women may therefore differ slightly, and the below should therefore be interpreted with caution.

For HIV and hepatitis B, the number of screen positive women is the total number of women who screen positive during antenatal screening which comprises: women newly diagnosed and those previously diagnosed. Previously known diagnosed women may not be retested in the pregnancy, but will still appear in the women tested and screen positive women totals.

All women are offered screening for syphilis in every pregnancy regardless of history of previous infection. For syphilis, the number of screen positive women is the total number of women who screen positive during antenatal screening. This will include women who are later found to have a treponemal infection that is not syphilis.

For all infections, the rates are calculated based on the total number of women tested.

Table 26: Screen positive rates for HIV in pregnant women, England, 2018 to 2019

Screen positive women†

Region (returns included/expected)	Women tested	n*	Rate/1000 women tested
London (26/26)	145,714	325	2.23
Midlands and East (41/41)	197,326	255	1.29
North (41/43)	177,894	170	0.96
South (36/36)	155,608	105	0.67
England (144/146)	676,542	855	1.26

Newly diagnosed women

Region (returns included/expected)	Women tested	n	Rate/1000 women tested
London (26/26)	145,714	24	0.16
Midlands and East (41/41)	197,326	33	0.17
North (41/43)	177,894	22	0.12
South (36/36)	155,608	15	0.10
England (144/146)	676,542	94	0.14

†Known false positive results are not included in the number of screen positives.

*The number of screen positive women has been rounded to the nearest multiple of 5 to prevent disclosure by comparison with other published data.

Table 27: Screen positive rates for hepatitis B in pregnant women, England, 2018 to 2019

Screen positive women†

Region (returns included/expected)	Women tested	n	Rate/1000 women tested
London (26/26)	145,728	1,030	7.07
Midlands and East (41/41)	197,347	735	3.72
North (41/43)	177,929	490	2.75
South (36/36)	155,616	370	2.38
England (144/146)	676,620	2,630	3.89

Newly diagnosed women

Region (returns included/expected)	Women tested	n	Rate/1000 women tested
London (26/26)	145,728	223	1.53
Midlands and East (41/41)	197,347	193	0.98
North (41/43)	177,929	111	0.62
South (36/36)	155,616	78	0.50
England (144/146)	676,620	605	0.89

†The number of screen positive women has been rounded to the nearest multiple of 5 to prevent disclosure by comparison with other published data.

Table 28: Screen positive rates for syphilis in pregnant women, England, 2018 to 2019

Screen positive women†

Region (returns included/expected)	Women tested	n	Rate/1000 women tested
London (26/26)	145,716	312	2.14
Midlands and East (41/41)	197,311	330	1.67
North (41/43)	177,934	261	1.47
South (36/36)	155,621	125	0.80
England (144/146)	676,582	1,028	1.52

Confirmed syphilis positive women‡

Region (returns included/expected)	Women tested	n	Rate/1000 women tested
London (26/26)	145,716	309	2.12
Midlands and East (41/41)	197,311	329	1.67
North (41/43)	177,934	259	1.46
South (36/36)	155,621	125	0.80
England (144/146)	676,582	1,022	1.51

Screen positive women, requiring treatment

Region (returns included/expected)	Women tested	n	Rate/1000 women tested
London (26/26)	145,716	128	0.88
Midlands and East (41/41)	197,311	152	0.77
North (41/43)	177,934	127	0.71
South (36/36)	155,621	63	0.40
England (144/146)	676,582	470	0.69

†Known false positive results are not included in the number of screen positives.

‡Confirmed syphilis positive excludes women who are found to have a treponemal infection that is not syphilis.

The trends in screen positive rates in England in the 3 years since the IDPS programme began data collection in 2016 to 2017 are shown in tables 29 to 31. The number of maternity services for which data on screen positive rates could be included increased between 2016 to 2017 and 2018 to 2019. This must be considered when interpreting the year on year screen positive rates.

Table 29: Trends in screen positive rates for HIV in pregnant women, England, 2016 to 2017 to 2018 to 2019

Measure	2016 to 2017	2017 to 2018	2018 to 2019
Returns included/expected	110/145	125/147	144/146
Screen positive women†: rate/1,000 women tested	1.32	1.36	1.26*
Newly diagnosed women: rate/1,000 women tested	0.13	0.16	0.14

†Known false positive results are not included in the number of screen positives.

*The rate for total screen positive women in tax year 2018 to 2019 is based on a count that has been rounded to the nearest multiple of 5 to prevent disclosure by comparison with other published data.

Table 30: Trends in screen positive rates for hepatitis B in pregnant women, England, 2016 to 2017 to 2018 to 2019

	2016 to 2017	2017 to 2018	2018 to 2019
Returns included/expected	90/145	125/147	144/146
Screen positive women†: rate/1,000 women tested	3.79	4.16	3.89*
Newly diagnosed women: rate/1,000 women tested	0.89	0.96	0.89

*The rate for total screen positive women in tax year 2018 to 2019 is based on a count that has been rounded to the nearest multiple of 5 to prevent disclosure by comparison with other published data.

Table 31: Trends in screen positive rates for syphilis in pregnant women, England, 2016 to 2017 to 2018 to 2019

Measure	2016 to 2017	2017 to 2018	2018 to 2019
Returns included/expected	91/145	124/147	144/146
Screen positive women†: rate/1,000 women tested	1.31	1.39	1.52
Newly diagnosed women: rate/1,000 women tested	0.56	0.53	0.69

†Known false positive results are not included in the number of screen positives.

10. IDPS: outcomes

10.1 Background

Data analysed through the Integrated Screening Outcomes Surveillance Service (ISOSS) allows PHE to assess the impact of the IDPS programme on:

• prevention of vertically acquired HIV, hepatitis B and syphilis
• protecting the health of women with HIV, hepatitis B and syphilis during and after pregnancy
• protecting the health of any children born to women with HIV, hepatitis B and syphilis
• protecting the health of infants and children diagnosed with HIV, hepatitis B, syphilis and congenital rubella syndrome

The IDPS programme has commissioned the ISOSS team at Great Ormond Street Institute of Child Health (ICH) to collect data on screening programme outcomes. The service helps the screening programme to meet the national requirements for high quality public health disease surveillance.

HIV screening outcomes

Data on pregnancies to women living with HIV are requested on a quarterly basis via a secure online reporting portal with named respondents in every maternity unit. The team conducts comprehensive surveillance of:

• all pregnancies in women diagnosed with HIV prior to or during their current pregnancy in the UK
• all infants with in utero HIV exposure
• all children diagnosed with HIV in the UK (under 16 years of age), including those born abroad

There are over 1,000 pregnancies to women living with HIV in the UK every year. The vertical (mother to child) transmission rate among diagnosed women has remained at under 0.3% since 2012.

Since 2015, 89% of pregnancies were to women who were aware of their HIV status at conception, and over 76% of women conceived on combined antiretroviral therapy (Figure 29). Overall, 93% of women delivered with undetectable viral load (< 50 copies/ml).

This reflects over 99% coverage of antenatal screening of HIV in the UK, improved HIV testing outside of pregnancy, and treatment advances with more efficacious and less toxic drugs.

The team also continues to conduct enhanced surveillance of any cases of supported breastfeeding by mothers living with HIV in accordance with the British HIV Association (BHIVA) guidelines. To date, there have been 135 (1.9%) reports of planned supported breastfeeding among approximately 7,000 live births (up to March 2019).

Figure 29: Timing of HIV diagnosis among pregnant women between 1998 and 2019.

Bar chart showing that the number of women diagnosed with HIV before their current pregnancy peaked in 2010 and has since been declining. The number of women finding out their diagnosis in their current pregnancy has reduced in recent years.

**Reporting delay for recent years.

10.2 Syphilis screening outcomes

Data collection on pregnancies to women who screen positive, or who are subsequently diagnosed during pregnancy with syphilis will commence in 2020. Data requests will be made on a quarterly basis via the same secure online ISOSS reporting portal as used for HIV surveillance.

The team will conduct comprehensive surveillance of:

• all women who screen positive for syphilis during pregnancy
• all women who are subsequently diagnosed with syphilis during their pregnancy
• all infants who are born to women who required treatment for syphilis in pregnancy
• all infants who are tested and confirmed to have congenital syphilis

This surveillance will be limited to England only whilst governance arrangements are sought with the devolved nations.

A national review of all congenital syphilis cases born in England dating back to 2015 is currently underway. Approximately 30 infants have been reported with confirmed congenital syphilis and an additional 30 infants with suspected congenital syphilis.

10.3 Clinical expert review panels

Where a confirmed vertical transmission has taken place, the ISOSS team conducts detailed enhanced data collection. Interviews are carried out with the clinicians involved with the care of the woman and infant. Clinical Expert Review panels (CERPs) have been established for all 3 screening programmes to determine:

• likely timing of maternal infection in women
• any missed opportunities for identifying undiagnosed women as early as possible during their pregnancy
• any missed opportunities for preventing vertical transmission in women known to be syphilis positive or living with HIV or hepatitis B during their pregnancy
• recommendations to strengthen policy and practice at a national level to improve the prevention of vertical transmission
• recommendations to the IDPS programme and update service specifications, standards and handbooks where required
• factors to be addressed to avoid further missed opportunities, and to strengthen local policies and practices for preventing vertical transmissions
• share relevant clinical issues with the clinical bodies, such as BHIVA, the British Association for Sexual Health and HIV (BASHH), and the British Association for the Study of the Liver (BASL)

The CERPs are multidisciplinary groups of clinicians with a specialist interest in preventing paediatric infections. They consist of paediatric specialists, obstetricians, specialist midwives, and specialist clinicians, with regional representation from across the country.

Recommendations from the CERP are reviewed by the IDPS infection specific task groups who determine appropriate actions to address any recommendations.

The task group is accountable to the IDPS Programme Advisory Group and updates are presented to the group on their recommendations. Advisory groups advise the National Screening Programme Team and the UK NSC, and are accountable to Dr Anne Mackie, Director of Screening, PHE.

10.4 Congenital rubella surveillance

The IDPS programme also supports the continued monitoring of congenital rubella cases. Rubella is a notifiable disease and cases of congenital rubella are notified to the ISOSS team via the PHE National Infection Service and British Paediatric Surveillance Unit rare conditions active reporting scheme. Any reported case is then investigated by the ISOSS team to confirm diagnoses and contributing factors. There continues to be no reported cases.

10.5 Future

The IDPS programme and ISOSS team continue to implement and expand the service with:

• annual CERPs on outcomes for all 3 infections and confirmed congenital cases of rubella
• inclusion of outcomes data as part of annual data reports across PHE
• inclusion of outcomes data in data reports and strategy reviews worldwide
• a feedback process to submitting trusts and stakeholders
• established relationships and data agreements with devolved assemblies in Wales, Scotland, Northern Ireland, the Channel Islands and the Isle of Man
• include reporting of maternal hepatitis B and linkage to paediatric outcomes for women who screen positive from 1 January 2021

11. SCT: screen positive rates

The sickle cell and thalassaemia screening programme collects annual data from antenatal screening laboratories. This data is used to determine the proportion of pregnant women who are screen positive for a significant haemoglobinopathy condition or who have haemoglobin variant or thalassaemia carrier status. When women are screen positive, testing of the biological father is recommended. Based on the results of both parents, it can be determined whether the pregnancy is at risk of a haemoglobin disorder.

The table below presents the proportion of women that screened positive, and the proportion of the screen positive women that were found to have a pregnancy at risk of a clinically significant haemoglobin disorder, which requires referral for counselling. These pregnancies are represented by the orange boxes in the breakdown table and include all pregnancies where there is a 1 in 4 chance or higher of the fetus having a clinically significant haemoglobin disorder. Whilst referral for counselling is required for all of these pregnancies, PND must be offered for the serious conditions, as described in the inheritance risk table within the sickle cell and thalassaemia screening handbook.

Please note that data returns are only included in Table 31 if data for the number of samples, the number of screen positive women, and the number of pregnancies at risk of a clinically significant disorder could all be accepted. Data returns are based on the maternity provider served by the laboratory. The number and proportion of pregnancies at risk of a clinically significant disorder shown in Table 31 is likely to be an underestimate due to pregnancies where the baby’s biological father’s status is unknown.

Table 32: Numbers screened and proportion of screen positive women and pregnancies at risk of a clinically significant disorder, antenatal sickle cell and thalassaemia screening, England, 2018 to 2019

Screen positive women

Region (returns included/expected)	Antenatal screening samples n	n	% of samples
London (24/26)	136,354	5,764	4.23
Midlands and East (40/41)	202,629	3,649	1.80
North (37/41)	176,516	2,295	1.30
South (35/37)	144,571	1,588	1.10
England (136/145)	660,070	13,296	2.01

Pregnancy at risk of a clinically significant disorder, referral for counselling required

Region (returns <included/expected)	Antenatal screening samples n	n	% of samples
London (24/26)	136,354	374	6.49
Midlands and East (40/41)	202,629	229	6.28
North (37/41)	176,516	132	5.75
South (35/37)	144,571	96	6.05
England (136/145)	660,070	831	6.25

The sickle cell and thalassaemia screening programme also collects annual data from newborn screening laboratories. This data is used to determine the rate of infants screening positive for significant conditions and specified carrier results during newborn blood spot screening. Significant conditions comprise FS, FSC, FS-other and FE results. Carrier results comprise FAS, FAC, FAD, FAE and other haemoglobin variants. Data presented is from all thirteen newborn screening laboratories in England.

Table 33: Numbers and rates of significant conditions and carrier screening results, newborn blood spot screening for sickle cell disease, England, 2018 to 2019

Significant conditions

Region	Babies tested n	n	Rate/1,000 babies screened
London	123,121	143	1.16
Midlands and East	185,215	67	0.36
North	165,264	47	0.28
South	142,859	25	0.17
Unknown region	10,196	8	0.78
England	626,655	290	0.46

Carrier results

Region	Babies tested n	n	Rate/1000 babies screened
London	123,121	3,463	28.13
Midlands and East	185,215	2,105	11.37
North	165,264	1,222	7.39
South	142,859	1,008	7.06
Unknown region	10,196	138	13.53
England	626,655	7,936	12.66

Region is based upon the maternity provider, clinical commissioning group or child health information service of the baby. The geography used differs according to the submitting laboratory.

For 2 laboratories in England, data provided is based on samples received rather than babies tested.

12. Recommendations

12.1 Recommendations on coverage

Recommendation 1:

Providers not yet submitting data for coverage must have an action plan in place to enable them to do so (FASP-S01, FASP-S02, IDPS-S01, IDPS-S02, IDPS-S03, SCT-S01).

Recommendation 2:

Public health commissioning teams should continue to monitor exception reports for coverage standards (FASP-S01, FASP-S02, IDPS-S01, IDPS-S02, IDPS-S03, SCT-S01).

Recommendation 3:

Providers must make sure there are contingency arrangements for data collection and submission to cover periods of staff absence (all indicators).

12.2 Recommendations on test

Recommendation 4:

NHS FASP should review the performance threshold for FASP-S04 in the major review of standards planned for 2020 to 2021.

Recommendation 5:

Public health commissioning team should review reasons for low performance in the Midlands and East region and develop an improvement action plan (SCT-S07).

Recommendation 6:

Public health commissioning teams must make sure that the contracts or subcontract of screening laboratories include the timely submission of data to PHE screening (FASP-S05, IDPS-S04a, IDPS-S04b, IDPS-S04c, SCT-S03, SCT-S04).

Recommendation 7:

Providers and public health commissioning teams should review performance and develop and action plan to meet thresholds where these are not met. Priority should be given to meeting the acceptable threshold in the first instance (FASP-S05, IDPS-S04a, IDPS-S04b, IDPS-S04c, SCT-S03, SCT-S04, SCT-S07).

12.3 Recommendations on referral

Recommendation 8:

Providers not yet submitting data for FASP-S07 must have an action plan in place to enable them to do so.

Recommendation 9:

Providers that have not met 100% for FASP-S07 should participate in the PHE Screening national audit 2019 to 2020.

Recommendation 10:

NHS FASP should include FASP-S08a and FASP-S08b in the major review of standards planned for 2020 to 2021.

Recommendation 11:

Providers not yet submitting data for IDPS-S05 must have an action plan in place to enable them to do so.

Recommendation 12:

Providers that have not met 100% for IDPS-S05 should participate in the PHE Screening national audit 2019 to 2020.

12.4 Recommendations on diagnosis or intervention

Recommendation 13:

The ACGS should work with genomic laboratories not submitting data for FASP-S09 to achieve complete data submission.

Recommendation 14:

Providers not meeting the acceptable threshold for IDPS-S06 should develop plans to meet the threshold.

12.5 Recommendations relating to Intervention or treatment

Recommendation 15:

Providers not meeting the acceptable threshold for IDPS-S07a and IDPS-S07b should develop plans to meet the threshold.

Recommendation 16:

Public health commissioning teams should make sure all centres treating babies implement the SCT newborn outcomes system (SCT-S09).

13. SCT antenatal data return form

Antenatal data return form part 2 – breakdown of screen positive women

A matrix grid for use to determine pregnancies at risk of a clinically significant disorder. Mother’s antenatal results are matched the father’s antenatal result and inputted into the grid.

The matrix was changed for the 2018 to 2019 return form (see screenshot above) to include orange (for pregnancies at risk of a clinically significant disorder – PND should be offered) or white (minimal risk of a clinically significant disorder). The blue boxes indicate that the biological father is not a carrier. The yellow boxes indicate that the biological father was unavailable for testing or declined testing. The current return form is available on GOV.UK.