National T21 screening programme standards 2013-2016 (DRAFT) · 2 National T21 screening programme...

1

National T21 screening programme standards 2013-2016 (DRAFT)

No. 1PS / GS(see

footnote)

Standard 2Criteria (see footnote)

Acceptable Achievable Level of monitoring

Policy and governance

1 PS All eligiblei pregnant women must be offered screening for Down’s syndrome(1-7)

The T21 screening window is from 10 weeks, 0 days to 20 weeks, 0 days. The Combined Screening Test must be undertaken when the crown rump length (CRL) measures from 45 mm to 84 mm (10 weeks, o days to 14 weeks, 1 day). It must include the ultrasound measurement of the nuchal translucency (NT) and measurement of maternal serum free beta hCG and PAPP-A biochemical markers. It is the UK-NSC recommended investigation pathway for both singleton and twin pregnancy regardless of maternal age. The Quadruple Screening Test which includes the measurement of maternal serum AFP, hCG, uE3 and Inhibin-A must be offered to women who are for whatever reason unable to have the Combined Screening Test and are

97% of eligible pregnant women offered screening for T21 in the first or second trimester of pregnancy

97% of eligible pregnant women offered the Combined Screening Test when the ultrasound CRL measures from 45 mm to 84 97% of eligible pregnant women offered the Quadruple Screening Test when the ultrasound CRL is greater than 84.0mm

100% of eligible pregnant women offered screening for T21 in the first or second trimester of pregnancy

97% of eligible pregnant women offered the Combined Screening Test when the ultrasound CRL measures from 45 mm to 84 mm 97% of eligible pregnant women offered the Quadruple Screening Test when the ultrasound CRL is greater than 84.0mm

Collected locally Collected regionally Collected nationally

1 PS (Programme standard) and GS (Generic standard)

2


No. 1PS / GS(see

footnote)



pregnant with either a singleton or twin pregnancy regardless of maternal age. The crown rump length (CRL) is greater than 84.0mm ( 14 weeks, 2 days to 20 weeks, 0 days)

2 PS Pregnant women should not be offered a diagnostic test on their age related risk alone(3)

There are systems in place to ensure that all service providers adhere to the requirements set out in national policy. There are systems in place to minimise the occurrence of unnecessary diagnostic intervention. There is a risk management system in place to monitor adverse practice.

Number (%) of eligible pregnant women accepting a diagnostic procedure for maternal age alone

Number (%) of eligible pregnant women accepting a diagnostic procedure for maternal age alone

Collected locally

3 PS

All hospital Trust imaging departments should allocate a minimum of 20 minutes to undertake the early pregnancy scan(8)

Healthcare professionals should adhere to the document, ‘A Practical Solution to Combining Dating and Screening for Down’s Syndrome’ (2011) Scan measurements are undertaken and recorded within the specific commissioned time frame.

95% allocation 20 minute time slots for the early pregnancy scan(10)

97% allocated 20 minute time slots for the early pregnancy scan

Collected locally

3


No. 1PS / GS(see

footnote)



4 PS All service providers must aim to meet the national programme centre’s aspirational population standard: a detection rate (DR) of greater than 90% for a screen positive rate (SPR) of less than 2%(2)

Healthcare professionals who undertake nuchal translucency (NT) are trained and fully competent to deliver the Combined Screening Test service. All healthcare professionals adhere to the NT quality assurance (QA) guidance set out in the NHS FASP Manual for Sonographers. There is a Screening Support Sonographer (SSS) in the ultrasound department. Laboratories to adhere to all QA standards and protocols as specified by the NHS FASP. There are systems in place to assess the quality, interpretation and reporting of screening performance

Provider performance is acceptable by DQASS 95% of service providers

The provider has reached the standard 97% of service providers

Collected locally Collected nationally

5 GS There should be a written policy for the screening programme(4)

All relevant stakeholders should be involved in establishing a local written policy for Down’s syndrome screening. These should include provider and commissioning organizations, as well as user and support groups. Key individuals responsible for each step in the T21 care pathway

95% of service providers have a written policy for the screening programme

97% of service providers have a written policy for the screening programme

Collected locally

4


No. 1PS / GS(see

footnote)



should be involved in the policy development process. Triennial review is undertaken by the hospital Trust Clinical Governance Group to ensure continued adherence to national and local expectations, recommendations and guidelines

6 GS

An executive of the provider organisation should be accountable for delivery of the screening programme

Governance at the highest level to ensure delivery of the required standards of care for the avoidance of harm Accountability for screening programmes should be included in the portfolio of an executive director of the provider organisation.

95% of provider services have in place an executive director who is accountable for the screening programme

97% of provider services have in place an executive director who is accountable for the screening programme director

Collected locally

7 GS The hospital Trust Clinical Governance Group (which oversees the T21 screening programme) is responsible for ensuring that inter-agency arrangements are in place and enable equity of access for all pregnant women(4)

Membership from all disciplines involved in screening including primary care colleagues, commissioner and parent/user representation.

95% of hospital Trusts have a Clinical Governance Group

97% of hospital Trusts have a Clinical Governance Group

Collected locally

8 GS An annual report should be submitted to the provider

The report should be approved by the hospital Trust Board before

95% of hospital Trusts provide an annual report

100% of hospital Trusts provide an report annual report

Collected locally

5


No. 1PS / GS(see

footnote)



organisation by the hospital Trust Clinical Governance Group(4)

dissemination. The report should be signed off by the hospital Trust Board of Governors and the hospital Trust Chief Executive (CE) ensuring that all recommended actions are taken and should oversee the resolution of any major risks identified within the screening programme including the appropriate management of serious incidents. The report should include (as a minimum):

Measures of performance against national and local standards for service provision(9)

Measures of performance against the NSC’s expectations for audit and performance monitoring.(10)

Laboratory (biochemistry and cytogenetic) audit reports.

Outcomes of user surveys

Outcomes of pregnancies

A copy of the report disseminated

6


No. 1PS / GS(see

footnote)



to:

The provider organisation’s Board of Governors

Clinical Commissioning Groups (CCGs)

All other stakeholders involved in service provision.

National Programme Director of the UK NSC and NHS Fetal Anomaly Screening Programme on request.

Care Quality Commission (CQC) on request

Service users on request.

9 GS Service providers should undertake regular audits against the standards and guidelines set out for the provision of the screening programme(4)

There are systems in place to audit with the appropriate tools to collect the data and information. There are technology management systems in place that link with appropriate data collection systems. There are systems in place to undertake regular audits against the standards and guidelines set out for the provision of the

95% of hospital Trusts undertake regular audits of the T21 screening standards

100% of Hospital Trusts undertake regular audits of the T21 screening standards

Collected locally Collected regionally

7


No. 1PS / GS(see

footnote)



screening programme. There are systems in place for specific hospital Trust directorates (maternity and gynaecology) to notify the screening laboratory about the pregnancy outcome of any woman who had T21 screening. Organizations must respond to the completion of the Care Quality Commission’s (CQC) triennial survey of women’s’ views and experiences of antenatal screening also cited as an indicator in the NHS Outcomes Framework.

10 GS All service providers involved in the T21 care pathway must be familiar, and comply with, the Government’s Equality Act (2010) and with the recommended guidelines for Government publications(11)

The hospital Trust adheres to, and monitors the Equality Act (2010) and protects the rights of women in relation to age, disability, marriage or civil partnership, pregnancy or maternity, ethnicity, religion or belief, sex or sexual orientation. For women with special requirements, service providers should take into account the environment and on-site facilities, appointment time and location to meet her individual needs as far as

MANDATORY 100% of service providers comply with the Equality Act .

MANDATORY 100% of service providers comply with the Equality Act

Collected locally

8


No. 1PS / GS(see

footnote)



is practical.(1;5-7) There are defined roles and responsibilities to meet specific or special needs of the pregnant population. There are systems in place to ensure that women are able to access special resources.

11 GS Information must be available in a range of formats and languages approved by the UK NSC for example, including visual (easy read) and Braille formats(4)

There are systems in place to ensure that women are provided with information within specified timescales about the screening and diagnostic process. Information must be provided in an accessible format. Trained interpreters and signers should be available if needed.

95% of information is accessible in a range of formats

97%of information is accessible in a range of formats

Collected locally

12 PS

Service providers must evidence use of the UK NSC and NHS FASP leaflets (or similar leaflets) and information must be offered to all pregnant women in an accessible format that can be understood(1;3;4;10-12)

Offer and documentation of offer of information in hospital notes. The offer of screening to all eligible pregnant women and any subsequent decision made must be clearly recorded in the woman’s hand held notes and the hospital trust’s clinical information system and/or in the hospital maternity records

95% of eligible women with documented evidence of receiving leaflets/information 95% of eligible women with documented evidence of receiving leaflets/information in the correct format

97% of eligible women with documented evidence of receiving leaflets/information 97% of eligible women with documented evidence of receiving leaflets/information in the correct format

Collected locally

9


No. 1PS / GS(see

footnote)



13 GS All pregnant women must have access to an interpreter (who is trained to discuss T21 screening) and a range of communication aids if they do not

Speak English and/or

Read English and/or

Understand English and/or

Have a hearing impairment (1;11;12)

There are systems in placed to ensure that women are able to access information in relevant formats. There are system in place to ensure pregnant women are aware who is present at and who is undertaking their examination /procedure. There are systems in place to ensure that the woman’s privacy and dignity are maintained.

95% of women can access an interpreter

97% of women can access an interpreter

Collected locally

14 GS All pregnant women that have special requirements should be offered additional support from other agencies or support groups (that are trained in T21 pregnancy screening)(1;11;12)

There are systems in place to access parent resources (in a range of formats) from relevant charities and agencies associated with T21.

95% of women are offered information to contact additional agencies or support groups

99% of women are offered information to contact additional agencies or support groups

Collected locally Collected nationally (support groups and charities)

15 GS The ‘offer’ of screening to all eligible pregnant women and any subsequent decision made must be clearly recorded(4;12)

In the woman’s hand held notes and the hospital Trust’s clinical information system and/or in the hospital maternity records

95% of maternity hand held notes contain a record of the screening offer and subsequent decisions

99% of maternity hand held notes contain a record of the screening offer and subsequent decisions

Collected locally

16 PS

Service providers should monitor any adverse practice

There are systems in place to explore the stepped processes of

97% of service providers review their risk

99% of service providers review their risk management

Collected locally

10


No. 1PS / GS(see

footnote)



within their T21 screening programme by reviewing the failsafe points and any incidents that occur as part of their risk management system

the T21 care pathway in terms of the:

Offer of screening

Screening undertaken

Sample journey from provider service to laboratory

Retrieval and dissemination of screening results

Referral from secondary to tertiary level fetal medicine services for specific indications

Offer and uptake of invasive testing

Pregnancy outcome

management system system

T21 screening - singleton pregnancy

17 PS All eligible women must be offered T21 screening during their pregnancy(1;2)

Regardless of maternal age Screening can be undertaken from 10 weeks, 0 days to 20 weeks, 0 days. Document of offer and maternal decision in hospital notes. Healthcare professionals should

95% of eligible pregnant women with a documented report of the offer of screening



11


No. 1PS / GS(see

footnote)



adhere to the NHS FASP Consent Standards (2012). Women must be given space and time to think and talk about their choices with an appropriately trained healthcare professional (or family/friends) about T21 screening. Midwives and clinicians are trained and competent to offer, discuss and undertake T21 screening. Midwives and clinicians keep abreast of national developments in policy, standards, guidance and technology.

18 PS

Where there is a history of significant vaginal bleeding, T21 screening must still be offered to the pregnant woman. ii

The Combined Screening Test where the crown rump length (CRL) measures from 45 mm to 84 mm (10 weeks, o days to 14 weeks, 1 day). CRL measurement should be recorded on the laboratory request form. The Quadruple Screening Test where the crown rump length (CRL) measures greater than 84mm. Head circumference (HC) and not CRL measurement should

95% of women with a history of vaginal bleeding offered T21 screening

97% of women with a history of vaginal bleeding offered T21 screening

Collected locally

12


No. 1PS / GS(see

footnote)



be recorded on the laboratory request form. Document of offer and maternal decision in hospital notes. All parts of the laboratory form must be filled in carefully when the screening test is undertaken. Without all of the information an accurate Trisomy 21 risk cannot be given(13)

T21 screening - multiple pregnancy

19 PS All eligible pregnant women with a multiple pregnancy must be offered T21 screening (1;2)

Healthcare professionals to inform women about the complexity of decisions they may need to make depending on the outcomes of screening, including different options according to the chorionicity of the pregnancy. Women must be given space and time to think and talk about their choices with an appropriately trained healthcare professional (or family/friends) about T21 screening.




13


No. 1PS / GS(see

footnote)



Midwives and clinicians are trained and competent to offer, discuss and undertake T21 screening. Midwives and clinicians keep abreast of national developments in policy, standards, guidance and technology. Regardless of maternal age Screening can be undertaken from 10 weeks, 0 days to 20 weeks, 0 days Combined Screening Test

Dichorionic diamniotic (DC/DA) twins

Monochorionic monoamniotic (MC/MA)

Monochorionic diamniotic (MC/DA) twins

Vanished twin pregnancy

Quadruple Screening Test

Monochorionic monoamniotic (MC/MA) twins

Monochorionic dichorionic (MC/DC) twins

Dichorionic Diamniotic (DC/DA) twins

14


No. 1PS / GS(see

footnote)



Nuchal Translucency (only)

Triplets or more

CD/DA surviving fetus Verbal and written information about the performance of screening for T21 and diagnostic testing including the complexities of acting on higher risk results or abnormal results offered to woman. Documented offer of appropriate test for multiple pregnancy and maternal decision Healthcare professionals should adhere to the NHS FASP Consent Standards (2012).

20 PS

All women who are having TWINS or a higher order multiple pregnancy should be given a leaflet which explains the complexity of T21 screening of multiple pregnancies so that they can make informed decisions about opting for screening and further tests(14)

A healthcare professional with experience of caring for women with twin and triplet pregnancies should offer information and counselling to women before and after every screening test(14) Healthcare professionals to inform women about the complexity of decisions they may need to make depending on the outcomes of

95% of women expecting TWINS given a specific T21 leaflet 95% of women expecting TRIPLETS or higher order multiple pregnancy given a specific T21 leaflet

97% of women expecting TWINS given a specific T21 leaflet 97% of women expecting TRIPLETS or higher order multiple pregnancy given a specific T21 leaflet

Locally collected

15


No. 1PS / GS(see

footnote)



screening, including different options according to the chorionicity of the pregnancy. Before screening for Down’s syndrome offer women with twin and triplet pregnancies information about:

the greater likelihood of Down’s syndrome in twin and triplet pregnancies

the different options for screening10 the false positive rate of screening tests, which is higher in twin and triplet pregnancies

the likelihood of being offered invasive testing, which is higher in twin and triplet pregnancies -the greater likelihood of complications of invasive testing

the physical risks and psychological implications in the short and long term relating to selective fetal reduction.(13)

There are systems in place

16


No. 1PS / GS(see

footnote)



to ensure that women are able to access information and that it is offered within specified timescales and in a range of formats.

21 PS

All service providers must offer eligible woman pregnant with TWINS the Combined Screening/Test(14)iii

Combined Screening Test (nuchal translucency, free beta-human chorionic gonadotrophin, pregnancy-associated plasma protein-A) regardless of maternal age T21 screening for DC/DA twins.

-Map (label) the twins, upper and lower or left and right

-Chorionicity must be recorded (both in writing and by a picture of the inter-twin septum where it joins the placenta showing either the T or lambda signs)

-Crown–rump length (CRL) measures from 45 mm to 84 mm (10 weeks, o days to 14 weeks, 1 day).

-Results provide risks for each fetus

95% of eligible women pregnant with TWINS with a documented report of offer of the Combined Screening Test

97% of eligible women pregnant with TWINS with a documented report of offer of the Combined Screening Test


17


No. 1PS / GS(see

footnote)



T21 screening for (MC/DA) and (MC/MA) twins.

-map (label) the twins, upper and lower or left and right

-Chorionicity must be recorded (both in writing and by a picture of the inter-twin septum where it joins the placenta showing either the T or lambda signs)

-Crown–rump length (CRL) measures from 45 mm to 84 mm (10 weeks, o days to 14 weeks, 1 day).

-Calculate the risk of T21 per pregnancy in monochorionic twin pregnancies

-Results provide risks per pregnancy

Healthcare professionals should adhere to the document, ‘A Practical Solution to Combining Dating and Screening for Down’s Syndrome’ (2011). Document of offer and maternal

18


No. 1PS / GS(see

footnote)



decision in hospital notes. Midwives and clinicians are trained and competent to offer, discuss and undertake T21 screening. Midwives and clinicians keep abreast of national developments in policy, standards, guidance and technology.

22 PS

T21 screening should be offered in DC/DA twin pregnancies where one fetus has miscarried

Maternal age and the NT measurement of the surviving fetus must only be used for screening purposes(15) Women must be given space and time to think and talk about their choices with an appropriately trained healthcare professional (or family/friends) about T21 screening. Document of offer and maternal decision in hospital notes. Midwives and clinicians are trained and competent to offer, discuss and undertake T21 screening. Midwives and clinicians keep abreast of national developments in policy, standards, guidance and technology.

95% of pregnant women offered T21 screening that have a DC/DA twins but one has miscarried

Number (%) of pregnant women with DC/DA twins where one has miscarried who have T21 screening

97% of pregnant women offered T21 screening that have a DC/DA twins but one has miscarried

Collected locally

19


No. 1PS / GS(see

footnote)



23 PS

Pregnant women with a twin pregnancy (with one sac is empty) should be offered the Combined Screening Test to screen the remaining fetus.iv

If a second sac is seen on scan but with no fetus visible the Combined Screening Test can be offered(16) If a second sac is seen containing a dead fetus T21 can be offered but only using maternal age and nuchal translucency(15) Women must be given space and time to think and talk about their choices with an appropriately trained healthcare professional (or family/friends) about T21 screening. Document of offer and maternal decision in hospital notes. Midwives and clinicians are trained and competent to offer, discuss and undertake T21 screening. Midwives and clinicians keep abreast of national developments in policy, standards, guidance and technology.

95% of pregnant women with a twin pregnancy (and one empty sac) who are offered the Combined Screening Test Number (%) of pregnant women with a twin pregnancy (and one empty sac) who have the Combined Screening Test

95% of pregnant women with a twin pregnancy (and one empty sac) who are offered the Combined Screening Test

Collected locally

20


No. 1PS / GS(see

footnote)



24 PS

All MC/DA twins should be monitored regularly for monochorionic complications regardless of the T21 syndrome screening risk by a tertiary level fetal medicine centre specialist.

The hand-over of care for MC/DA twins after diagnosis from a clinician (i.e. Obstetrician, midwife or sonographer) to a fetal medicine specialist should be seamless. There are systems in place to refer MC/DA twins to a tertiary level fetal medicine centre specialist if either or both fetuses are found to have:

Discordant fetal growth

Fetal anomaly

Discordant fetal death

Feto-fetal transfusion syndrome.

Appointment and scans should be undertaken approximately 11 weeks 0 days to 13 weeks 6 days* and 16, 18, 20, 22, 24, 28, 32 and 34 weeks Minimum contacts with core multidisciplinary team - 9 (including 2 with specialist obstetrician)(14)

MANDATORY 100% pregnant women with MC/DA twins should be monitored in a tertiary level fetal medicine centre.

MANDATORY 100% pregnant women with MC/DA twins should be monitored in a tertiary level fetal medicine centre.


21


No. 1PS / GS(see

footnote)



25 PS

MC/MA twins must be referred to a tertiary level fetal medicine centre after T21 screening due to the additional risks of monoamnionicity complications.

The hand-over of care for MC/MA twin pregnancies for clinical serial management and treatment (if required) by a competent and trained fetal medicine specialist from a clinician (i.e. Obstetrician, midwife or sonographer should be seamless. Document of offer of referral and maternal decision in hospital notes.

MANDATORY 100% pregnant women with MC/MA twins must be monitored in a tertiary level fetal medicine centre.

MANDATORY 100% pregnant women with MC/MA twins must be monitored in a tertiary level fetal medicine centre.


26 PS

All women pregnant with TRIPLETS (or more) who request T21 screening must be offered referral to a fetal medicine specialist in a tertiary level fetal medicine centre (14)

The hand-over of care for triplets (or more) for clinical serial management and treatment (if required) by a competent and trained fetal medicine specialist from a clinician (i.e. Obstetrician, midwife or sonographer should be seamless. Document of offer of referral for T21 screening and maternal decision in hospital notes. T21 screening by nuchal translucency (NT) assessment and measurement with maternal age.

-Map the fetal positions

MANDATORY 100% of eligible women pregnant with TRIPLETS referred to a fetal medicine specialist

Number (%) of eligible women pregnant with TRIPLETS seen by a fetal medicine specialist

MANDATORY 100% of eligible women pregnant with TRIPLETS referred to a fetal medicine specialist


22


No. 1PS / GS(see

footnote)



-Use nuchal translucency and maternal age to screen for Down’s syndrome

-Crown–rump length (CRL) measures from 45 mm to 84 mm

Calculate the risk of Down’s syndrome per pregnancy in MC triplet pregnancies Calculate the risk of Down’s syndrome for each fetus in DC and trichorionic triplet pregnancies. Healthcare professionals should adhere to the document, ‘A Practical Solution to Combining Dating and Screening for Down’s Syndrome’ (2011) Clinicians are trained and competent in NT scanning. Verbal and written information about the performance of screening for T21 and diagnostic testing including the complexities of acting on higher risk results or abnormal results offered to woman.

23


No. 1PS / GS(see

footnote)



27 PS

The second trimester Quadruple Screening Test should be offered to all women pregnant with TWINS(2;17)v

Women must be given space and time to think and talk about their choices with an appropriately trained healthcare professional (or family/friends) about T21 screening. Document of offer and maternal decision in hospital notes. When the Combined Screening Test cannot be offered to a woman with a twin pregnancy (for example, if the woman books too late in pregnancy) Healthcare professionals to inform women about the complexity of decisions they may need to make depending on the outcomes of screening such as the increased likelihood of pregnancy loss associated with double invasive testing because the risk of Down's syndrome cannot be calculated separately for each baby. Offer regardless of maternal age T21 screening using the Quadruple Screening Test - Beta-hCG, Inhibin-A,

95% of eligible women pregnant with TWINS with a documented report of the offer of the Quadruple Screening Test Number (%) of women pregnant with TWINS who have the Quadruple Screening Test

97% of eligible women pregnant with TWINS with a documented report of the offer of the Quadruple Screening Test

Collected locally

24


No. 1PS / GS(see

footnote)



unconjugated oestriol (uE3) and alphafetoprotein (AFP).

Map (label) the fetal positions

Undertaken only where the crown rump length (CRL) is greater than 84mm

Head circumference (HC) and not CRL measurement should be recorded on the laboratory request form.

-Calculate a total pregnancy risk result

If the chorionicity cannot be determined the pregnancy should be managed as if monozygotic. This will result in a single risk being given to the whole pregnancy irrespective of its chorionicity. Women should be made aware about the higher false positive rate and the implications regarding invasive testing, miscarriage and selective reduction. Healthcare professionals should adhere to the document, ‘A

25


No. 1PS / GS(see

footnote)



Practical Solution to Combining Dating and Screening for Down’s Syndrome’ (2011)

28 PS

All service providers must offer women pregnant with TWINS (MC/MA) or TRIPLETS, referral to a tertiary level fetal medicine centre specialist(14)

Twin (MC/MA) and triplet pregnancies should be offered individualised care from a consultant in a tertiary level fetal medicine centre Twins or triplets with one or more fetuses found to have an increased NT of greater than or equal to 3.5mm regardless of the T21 risk

MANDATORY 100% of women pregnant with either TWINS or TRIPLETS referral to a fetal medicine specialist in a tertiary level fetal medicine centre 95% of fetuses with an increased NT that measures greater than or equal to 3.5mm on ultrasound

MANDATORY 100% of women pregnant with either TWINS or TRIPLETS referral to a fetal medicine specialist in a tertiary level fetal medicine centre 97% of fetuses with an increased NT that measures greater than or equal to 3.5mm on ultrasound


29 PS

When the woman has had the Combined Screening Test and DCDA TWINS are diagnosed service providers must be give a risk for T21 for each fetus(14)

There are systems in place to ensure that women, pregnant with twins know how, when and by whom results/reports will be communicated.

MANDATORY 100% MANDATORY 100% Collected locally

30 PS

When the woman has had the Combined Screening Test for MC twins then a single pregnancy risk result should be given

There are systems in place to ensure that women know how, when and by whom results/reports will be communicated.


26


No. 1PS / GS(see

footnote)



31 PS

Where a woman with a TWIN or TRIPLET pregnancy is given a risk result which is greater than 1 in 150 for either one or more fetuses, invasive testing must be offered (14)

Documented offer of invasive test and testing if undertaken Healthcare professionals to inform women about the complexity of decisions they may need to make depending on the outcomes of screening, including different options according to the chorionicity of the pregnancy Women must be given space and time to think and talk about their choices with an appropriately trained healthcare professional (or family/friends) about diagnostic testing.


32 PS

Any woman with a MULTIPLE pregnancy who agrees to the offer of invasive testing or wishes to discuss this option further, must be referred to, and have this undertaken by a fetal medicine specialist in a tertiary level fetal medicine centre who is able to offer selective termination if the karyotype is abnormal(18)

There are systems in place to offer and refer a woman to a fetal medicine specialist proficient in invasive testing and treatment

MANDATORY 100% MANDATORY 100% Locally collected

27


No. 1PS / GS(see

footnote)



Quality assurance of CRL and NT

33 PS

CRL and NT images and measurements must be reported on and archived

In the woman’s hand held notes and the hospital Trust’s clinical information system and/or in the hospital maternity records

97% of CRL and NT images are reported. 95% of CRL and NT images are archived

99% of CRL and NT images are reported. 97% of CRL and NT images are archived

Collected locally

34 PS

All service providers should collate the number (%) of failed NT scans in women who wanted the Combined Screening Test

Proportion of pregnancy scans with CRL 45-84mm where the NT could not be measured (for whatever reason) in women who wanted the Combined Screening/Test. Pregnancy scan for the Combined Screening/Test must include measurement of the CRL and NT. NT is undertaken only when the CRL is between 45.0mm and 84.0mm(19)

95% of NT scans successfully undertaken

97% of NT scans successfully undertaken

Collected locally Collected regionally Collected nationally

35 PS

All hospital Trust imaging departments that provide a first trimester scan (fetal surveillance, CRL and NT scan) must take part in external evaluation by the DQASS

CRL, NT and laboratory data are sent every six months to DQASS (cycles running from April to September and October to March)

MANDATORY 100% hospital Trust ultrasound practitioners participate in DQASS

MANDATORY 100% hospital Trust ultrasound practitioners participate in DQASS


28


No. 1PS / GS(see

footnote)



quality assurance programme.(20)

36 PS All sonographers undertaking the NT component of Combined Screening/Test within the NHS should review their distribution curves with the SSS at least twice a year(21)

Sonographers to use the diagnostic plot self-assessment tool to enter their 25 paired measurements.

95% of ultrasound practitioners review their distribution curves with the SSS at least twice a year

97% of ultrasound practitioners review their distribution curves with the SSS at least twice a year

Collected locally

37 PS

Completion of the Combined Screening Test i.e. serum biochemistry must be encouraged, even when the NT measurement is greater than or equal to 3.5mm

Midwives and clinicians are trained and competent to offer, discuss and undertake T21 screening. Midwives and clinicians keep abreast of national developments in policy, standards, guidance and technology.

Number (%) of eligible women that do not have maternal serum biochemistry when the NT measurement is greater than or equal to 3.5mm


CommunicatingT21 screening test results

38 PS All pregnant women must be notified of their screening test result (4;22)

Within 10 working days from the time of sampling. There are systems in place to ensure that women know how, when and by whom results/reports will be communicated.

97% of pregnant women notified of their screening test result within 10 working days from the time of sampling

99% of pregnant women notified of their screening test result within 10 working days from the time of sampling

Collected locally

29


No. 1PS / GS(see

footnote)



All service providers should inform women about their ‘higher’ or ‘lower risk’ screening test result and specific numerical risk. All service providers must avoid the terms, ‘screen positive’ and ‘screen negative’ when talking about T21 screening explaining test results to pregnant women. Instead, ‘higher risk’ and ‘lower risk’ together with the laboratory numerical value (e.g. 1: 200) must be used instead. All service providers must provide supplementary information (including relevant informative/supportive websites or details of support organisations) to all pregnant women who after screening receive a higher risk test result. All pregnant women must be given the option to discuss their screening test results and if they decide to do, this should be undertaken in a suitable

30


No. 1PS / GS(see

footnote)



environment.

39 PS All T21 screening test results are filed in the woman’s hand held notes and recorded on the hospital Trust’s clinical information system(23;24)

There are systems in place to file laboratory reports in hand held notes and record on the hospital IT system

97% of T21 screening test results within the woman’s hand held notes. 97% of T21 screening test results are available on the hospital Trust’s clinical information system

99% of T21 screening test results within the woman’s hand held notes. 97% of T21 screening test results are available on the hospital Trust’s clinical information system

Collected locally

40 PS Women who receive a ‘ higher’ risk test result must have access, to an appropriately trained healthcare professional in order to discuss the result and options for further management(4)

Within three working days (of the result being issued by the laboratory) All service providers must record the woman’s decision following her higher risk result in the Trust’s clinical information system and/or in the maternity notes. All pregnant women must be given the time they need to consider their choices and to discuss them with other people should they wish to. All pregnant women must be given the choice to discuss their decisions with a trained and competent healthcare professional about T21 screening and the

95% of women with ‘higher risk’ T21 results offered referral to an appropriately trained healthcare professional.

97% of women with ‘higher risk’ T21 results offered referral to an appropriately trained healthcare professional

Collected locally

31


No. 1PS / GS(see

footnote)



possible long-term health issues of the condition.

41 PS All discussions and decisions between the service provider and the woman must be clearly recorded/filed in the woman’s hand held record and hospital Trust’s clinical information system(23;24)

There are systems in place to record and file the T21 counselling consultation in the woman’s hand held notes and hospital Trust IT system.

95% of maternal hand held notes include the T21 counselling consultation between the woman and healthcare professional. 95% of T21 counselling consultations are recorded on the hospital Trust IT system.

97% of maternal hand held notes include the T21 counselling consultation between the woman and healthcare professional. 97% of T21 counselling consultations are recorded on the hospital Trust IT system.

Collected locally

Biochemistry and cytogenetic laboratory governance, analysis and reporting

42 GS All biochemical screening and cytogenetics laboratories must be accredited by an appropriate body e.g. Clinical Pathology Accreditation (CPA UK Ltd)(4;25)

Full CPA Accreditation of host Biochemistry Department and Cytogenetics Lab viewed on CPA website

Full CPA Accreditation Full CPA Accreditation Collected nationally

43 GS All biochemical screening and cytogenetics laboratories must participate in an accredited external quality assessment scheme e.g. UK NEQAS, and be able to demonstrate their

Evidence of participation in scheme with demonstration of unsatisfactory performance External quality assurance (EQA) scheme registered with CPA

MANDATORY 100% participation

MANDATORY 100% participation

Collected nationally

32


No. 1PS / GS(see

footnote)



satisfactory performance in an annual report.(4;26)

44 GS All biochemical screening and cytogenetics laboratories shall be directed by a person or persons who have executive accountability and the competence to assume responsibility for the service. The laboratory director would be expected to have Medical Consultant status or equivalent and have competence at the level of Fellowship of the Royal College of Pathologists (RCPath) or equivalent(4)

Nominated director of service name held at programme centre who cross checks with RCPath web site for appropriate qualifications


Biochemical screening

45 PS All biochemical screening laboratories must submit screening data in the specified format to DQASS and the UK NSC on request(20)

CRL, NT and laboratory data are sent every six months to DQASS (cycles running from April to September and October to March)

MANDATORY 100% MANDATORY100% Collected locally Collected nationally

33


No. 1PS / GS(see

footnote)



46 PS A stand-alone biochemical screening laboratory must have a workload of at least 10,000 screening specimens per annum to have sufficient confidence in the quoted screen positive rates, and to have sufficient specimens to calculate reliable, median values for the biochemical markers(4;20)vi

Monitored by DQASS and by FASP program centre in terms of DQASS 6 monthly reports

MANDATORY 100% MANDATORY 100% Collected locally Collected nationally

47 PS All biochemical screening laboratories with a workload of less than 10,000 specimens a year must be part of a ‘managed network’ of laboratories.(4;20)

Each having a minimum workload of 5,000 specimens per year and identical screening policies, risk calculation software and analytical procedures in force. Monitored by DQASS and by FASP program centre in terms of DQASS 6 monthly reports


48 PS All Biochemical Screening laboratories must undertake and document appropriate internal quality assurance procedures (20)

There are systems in place to undertake weekly or monthly checks of screen positive rates, results of the analysis of internal QC specimens and regular checks


34


No. 1PS / GS(see

footnote)



of median MoM marker values Monitored by DQASS and by FASP program centre in terms of DQASS 6 monthly reports

49 Serum screen reports must be issued from the screening laboratory to the hospital Trust within 3 working days of receipt of the specimen

There are systems in place to issue reports from the laboratory to a named professional securely in accordance with the Data Protection Act.(27) Within 3 working days

97% of reports issued within 3 working days of receipt of the specimen

99% of reports issued within 3 working days of receipt of the specimen

Collected locally

50 PS Serum screen reports must be

issued to all screened women

(4)

There are systems in place to issue

‘higher’ and ‘lower’ risk results to

all screened women within 10

working days of having the T21

screening test.

95% of screened women notified about their T21 risk result within 10 working days of the specimen being taken. 95% of women with a ‘higher’ risk are notified of their test result within 3 working days (of the date of the laboratory report)

97% of screened women notified about their T21 risk result within 10 working days of the specimen being taken. 97% of women with a ‘higher’ risk are notified of their test result within 3 working days (of the date of the laboratory report)

Collected locally

Cytogenetic diagnosis

35


No. 1PS / GS(see

footnote)



51 PS Results from karyotyping should be reported within 14 calendar days of receipt of sample in the laboratory (4;28)

Within 14 calendar days of receipt of sample in the laboratory. There are systems in place to ensure that the ACC ‘Prenatal diagnosis best practice guidelines’ (2009) v1.00 December 2009 are adhered to and results delivered within the specific commissioned time frame.

95% of karyotype results reported within 14 calendar days of receipt of sample in the laboratory to the reporting hospital Trust

97% of karyotype results reported within 14 calendar days of receipt of sample in the laboratory to the reporting hospital Trust

Collected nationally

Pre-test information and offer of invasive testing

52 PS All higher risk pregnant women should be informed about and offered invasive testing (appropriate for their specific gestation in pregnancy) (28)

Within 4 working days of the diagnostic test result. There are systems in place to ensure that all women are informed about their results, know how, when and by whom results/reports will be communicated. Midwives and clinicians are competent to offer, discuss and undertake T21 screening. Midwives and clinicians keep abreast of national developments

95% of women contacted and offered invasive testing

97% of women contacted and offered invasive testing

Collected locally

36


No. 1PS / GS(see

footnote)



in policy, standards, guidance and technology. All pregnant women should be informed that the procedure – related risks for amniocentesis and chorionic villus sampling (cvs) are similar

53 PS As a minimum, a rapid test should be offered to women(4)

Women with an T21 increased risk result but normal scan findings

95% of women with an increased T21 serum screen risk result but normal scan findings who have a rapid test

97% of women with an increased T21 serum screen risk result but normal scan findings who have a rapid test

Collected locally (laboratory) Collected regionally Collected nationally

54 PS

A rapid test and karyotyping should be offered to women found to have a fetal anomaly detected by ultrasound scan or where other clinical indications justify.

Examples include:

Fetal anomaly detected by ultrasound

NT greater than or equal to 3.5mm

A family history of chromosomal abnormality

Chromosomal rearrangement in one parent

95% of women who are offered a rapid test and karyotyping 95% of women who have a rapid test and karyotyping

97% of women who are offered a rapid test and karyotyping 97% of women who have a rapid test and karyotyping

Locally collected (laboratory) Collected regionally Collected nationally

37


No. 1PS / GS(see

footnote)



55 PS Rapid test results should be ready and available to give to the woman

Rapid test results, e.g. rapid trisomy screen (by CVS direct/short term chromosome analysis, FISH or QF-PCR) reported within 3 working days of receipt of sample in the laboratory

95% of rapid test results reported

95% of rapid test results reported


Abnormal results, management and follow up

56 PS

An increased nuchal translucency (NT) of greater than or equal to 3.5mm must be must be referred to a tertiary level fetal medicine centre (29;30)

Singleton pregnancy Multiple pregnancy (one of more than one fetus with an increased NT) Regardless of T21 risk result Document of offer and maternal decision for referral in maternal notes. The hand-over of care after diagnosis from a clinician (i.e. Obstetrician, midwife or sonographer) to a fetal medicine specialist or obstetrician for a termination of pregnancy should be seamless.

97% singleton pregnancies with an NT of greater than, or equal to 3.5mm (regardless of the T21 risk result) 97% of twin pregnancies (either fetus) with an NT of greater than, or equal to 3.5mm (regardless of the T21 risk result)

MANDATORY 100% singleton pregnancies with an NT of greater than, or equal to 3.5mm (regardless of the T21 risk result) MANDATORY 100% of twin pregnancies (either fetus) with an NT of greater than, or equal to 3.5mm (regardless of the T21 risk result)


38


No. 1PS / GS(see

footnote)



Fetal echo undertaken before 23 weeks gestation.

57 PS All women with a fetus affected by T21 (diagnosed by amniocentesis or CVS) should be offered the opportunity to discuss the findings with an appropriately qualified specialist or external body/agency(31)

There are systems in place to offer the woman referral to a number of qualified specialists and/or external bodies for (e.g. Clinical geneticist, Antenatal Results and Choices (ARC), the Down’s Syndrome Association (DSA) or Genetic Alliance (GAUK) Document of offer and maternal decision for referral in maternal notes.

95% of women offered specialist counselling 95% of women offered information about external body/agency

97% of women offered specialist counselling 97% of women offered information about external body/agency

Collected locally

58 GS Following a confirmed diagnosis, clear accurate information and support should be offered to all women whether or not, they choose to continue with their pregnancy(4)

Communication with the woman should be clear, sensitive and honest, and should be tailored to meet individual needs. The hand-over of care after diagnosis from a clinician (i.e. Obstetrician, midwife or sonographer) to a fetal medicine specialist or obstetrician for a termination of pregnancy should be seamless.

95% of women offered information and support about T21

97% of women offered information and support about T21

Collected locally

39


No. 1PS / GS(see

footnote)



There are systems in place that ensure all women are looked after by healthcare professionals that are specifically trained to deal not only with her clinical care and physical needs but also with her their emotional needs and given information about what the termination process involves, and should be supported and encouraged to make her own decisions about the future of her pregnancy. The woman must always be treated with respect and dignity and should be supported with genuine sensitivity and empathy about her decision to continue or end her pregnancy.

Education and training of staff

59 GS All new staff involved in screening should work through an appropriate T21 screening induction(23;24;32)

which outlines the policy and practice recommendations of the UK National Screening Committee(4)


40


No. 1PS / GS(see

footnote)



60 GS

All healthcare professionals involved in the screening pathway for singleton and multiple pregnancies must undertake training suitable to their role (23;24)

The hospital Trust screening co-coordinator (or equivalent) of Independent Provider should ensure that education and training for T21 screening is accessible and accessed by all relevant staff involved in the Trust’s antenatal and newborn screening programmes at regular (at least annual) intervals so that the pregnant women they see are able to make decisions based on the most up to date information. All service providers must provide staff with the opportunity to access an educational programme to ensure that consistent, up-to-date information is being given to women to enable them to make informed choices regarding screening for T21. This training programme should include use of the NHS FASP/UK NSC freely available resources to ensure learning is up-to-date and congruent with policy and practice standards


41


No. 1PS / GS(see

footnote)



There are systems in place for healthcare professionals to gain appropriate communication and counselling skills that they are able to give all pregnant women up to date, unbiased and correct information about screening. There are systems in place to ensure that on-going learning is up-to-date and congruent with policy and practice standards. There are systems in place to ensure that healthcare professionals are competent to undertake the role to which they have been appointed, including a process for remedial action if concerns around staff competency are raised.

61 PS All obstetric ultrasound practitioners undertaking any type of antenatal scan must possess the minimum qualifications as recommended and advised by the NHS FASP(17;21;29)

Ultrasound practitioners performing fetal screening for Trisomy 21 must hold a minimum of Postgraduate Certificate in Medical Ultrasound (Pg. Cert.) or the academic equivalent. Pg. Cert. is the Recommended level of qualification, a period of training


42


No. 1PS / GS(see

footnote)



and certification of competency in 1st trimester ultrasound scanning (ideally to include NT) is acceptable for those who already have a health professional qualification and wish to undertake the Measurement of NT as part of combined screening. This should be provided by a CASE accredited University ‘focused’ course, taught at Master Level and externally assessed. Specifically for NT scanning two online resources must be undertaken which contain current Recommendations on NHS policy and guidance on screening for Trisomy 21. Sonographers with current FMF accreditation practising within an NHS Trust framework should Familiarise themselves with the two NHS FASP theoretical modules to ensure they have an appreciation of NHS and Department of Health policy recommendations for screening for Trisomy 21.

43


No. 1PS / GS(see

footnote)



FMF accredited sonographers who contribute to an NHS Trust combined screening service will receive6 monthly cycle reports from DQASS of their NT and CRL distributions in the same way as those sonographers who have undertaken the NHS model of training route. The theoretical modules include: -Condensed Education Modules for Trisomy 21 (CEMT21) – for all health professionals involved on the screening pathway (this constitutes 60 - 90 minutes of learning time) -NT training resource – a course for sonographers who wish to perform NT and CRL measurements as part of an NHS Trust combined screening programme for Trisomy 21 (this constitutes 60 – 90 minutes of learning time)

44

Reference List

(1) Royal College of Obstetricians and Gynaecologists. Standards for Maternity Care: Report of a working party. London: RCOG Press; 2008.

(2) NHS Fetal Anomaly Screening Programme. Screening for Down's Syndrome: UK NSC Policy Recommendations 2011-2014 Model of Best Practice . Department

of Health; 2011.

(3) NICE. NICE Antenatal Care: Routine care for the healthy pregnant woman. London; 2010. Report No.: 6.

(4) National Down's Syndrome Screening Programme for England. Antenatal screening - Working standards for Down's syndrome screening 2007. Exeter: NHS

FASP; 2007.

(5) Cuckle H, Aitken D, Goodburn S, Senior B, Spencer K, Standing S. Age standardisation when target setting and auditing performance of Down syndrome

screening programmes. Prenatal diagnosis 2004;24(11):851-6.

(6) NHS Fetal Anomaly Screening Programme. NHS Fetal Anomaly Screening Programme: Failsafe processes - Down's syndrome screening. v1.1, 1-8. 201. UK

National Screening Committee.

Ref Type: Online Source

(7) NHS Fetal Anomaly Screening Programme. Consent standards and guidance. Exeter: NHS Fetal Anomaly Screening Programme; 2011.

(8) Boyd T, Edwards J, Wright D, Nix B, Baker A, Williams P, et al. An audit of antenatal ultrasound scans from 22 hospitals in England and Wales during 2007:

Report on behalf of the NHS Fetal Anomaly Screening Programme. 1-56. 2009. Exeter, NHS Fetal Anomaly Screening Programme (NHS FASP).


(9) NHS Fetal Anomaly Screening Programme. National T21 screening standards and guidance for England. Exeter; 2012.

(10) UK National Screening Committee. Key performance indicators for screening. v1.7, 1-44. 2011.

45

Ref Type: Generic

(11) Parliament UK. Equality Act 2010. legislation gov uk 2010;8.

(12) General Medical Council (GMC). Consent: Patients and doctors making decisions together. GMC; 2008.

(13) NHS Fetal Anomaly Screening Programme. Essentials campaign. 2012.


(14) NICE, National Collaborating Centre for Women and Children's Health. Multiple pregnancy:the management of twin and triplet pregnancies in the

antenatal period. London: RCOG Press; 2011.

(15) Gjerris AC, Loft A, Pinborg A, Christiansen M, Tabor A. The effect of a GÇÿvanishing twinGÇÖon biochemical and ultrasound first trimester screening

markers for Down's syndrome in pregnancies conceived by assisted reproductive technology. Human Reproduction 2009;24(1):55-62.

(16) K Spencer, IStaboulidou, K H Nicolaides.

First trimester aneuploidy screening in the presence of a vanishing twin: implications for maternal serum markers. Prenat Diagn . 2010.

Ref Type: Journal (Full)

(17) NHS Fetal Anomaly Screening Programme. Condensed Education Module for T21. NHS Fetal Anomaly Screening Programme (NHS FASP) website .

2011.


(18) Royal College of Obstetricians and Gynaecologists. Amniocentesis and Chorionic Villus Sampling: Green Top Guideline Number 8. 8, 1-13. 2010.

London, RCOG Press London. Green Top Guidelines.

Ref Type: Pamphlet

(19) Chudleigh T, Loughna P, Evans T. A practical solution to combining dating and screening for Down's syndrome. Journal of Ultrasound: Royal Society

of Medicine Press; 2011.

46

(20) NHS National Down's Syndrome Screening Programme for England. The Down's syndrome sreening Quality Assurance Support Service (DQASS):

DQASS Working Structure. Kettering, Northants: NHS National Programme Centre; 2012.

(21) Maddocks F, Butler A. NHS nuchal translucency training and support structure for combined screening for Trisomy 21: Manual for Sonographers. 1-

24. 2012. Exeter, NHS Fetal Anomaly Screening Programme (NHS FASP).


(22) Budgen Paul. The development of a safety case for the laboratory serum screening process. Northants: UK National Screening Committee Down's

Syndrome Screening Programme; 2006.

(23) Nursing and Midwifery Council (NMC).

The code: Standards of conduct, performance and ethics for nurses and midwives . 1. 2008. Nursing and Midwifery Council.

Ref Type: Pamphlet

(24) Nursing and Midwifery Council (NMC). Midwives rules and standards. Nursing and Midwifery Council (NMC); 2004.

(25) Clinical Pathology Accreditation (CPA). Clinical Pathology Accreditation: Delivering Confidence in Healthcare. 1-12. 2012. Middlesex, United

Kingdom Accreditation Service (UKASS).

Ref Type: Pamphlet

(26) United Kingdom National External Quality Assessment Service. United Kingdom National External Quality Assessment Service . 2012.


(27) Data Protection Act. 1998.

Ref Type: Statute

(28) Association for Clinical Cytogenetics (ACC) Professional Standards Committee. Professional guidelines for clinical cytogenetics: Prenatal diagnosis

best practice guidelines. Association of Clinical Cytogenetics (ACC); 2009. Report No.: Version 1.

47

(29) MHS Fetal Anomaly Screening Programme. Nuchal Translucency (NT) Training Resource. 2011. Seedata.


(30) NHS Fetal Anomaly Screening Programme.

Nuchal translucency greater than or equal to 3.5mm. 2006. NHS FASP.


(31) Kirwan DM, NHS Fetal Anomaly Screening Programme. 18+0 to 20+6 Weeks Fetal Anomaly Scan: National Standards and Guidance for England. 1st

edition. 2010. Exeter, NHS Fetal Anomaly Screening Programme.

Ref Type: Serial (Book, Monograph)

(32) Department of Health (DH). The handbook to The NHS Constitution for England. Department of Health: COI; 2009.

Endnotes

i The eligible population refers to the total number of women booked for antenatal care before 20 weeks of pregnancy, regardless of the intended place of delivery ii There have been concerns that this might change maternal blood levels of the biochemical markers used in the combined test, perhaps secondary to placental disruption. However current data suggest that the biochemical marker levels are not significantly different in women with this history. iii If one of a MC/DA twin pregnancy is found to have miscarried at the time of the Combined Screening Test, such cases should be referred to a tertiary level fetal medicine centre. If Down’s syndrome screening is wanted in the meantime, then whether biochemistry is used in addition to ultrasound and age will depend on whether a second fetus is seen. iv The biochemical markers appear no different to those in a singleton pregnancy when there is an empty second sac, thus maternal serum analytes (PAPP-A and free beta HCG) with NT can be used to calculate the risk. If a dead fetus (sometimes called ‘vanished’ twin) is present in the second sac it is possible that there could be a contribution to the maternal biochemical markers for many weeks and in this event just maternal age and NT is recommended. v The Quadruple Screening Test cannot be offered to women with triplet or higher order pregnancies viThe throughput requirement figure of 10000 samples was derived to substantiate a 95% confidence interval for a SPR no more than 0.5% (expected SPR to be around 3%). The managed network came as a consequence, with statements about the need for there to be an overall network director to ensure equivalence at component sites

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