Description of screening programme. Screening for Down’s, ▇▇▇▇▇▇▇’ and Patau’s syndromes is part of the NHS Fetal Anomaly Screening Programme (FASP). In line with NICE guidance (Clinical guideline 62 Antenatal care June 2010 ▇▇▇▇://▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇▇.▇▇▇.▇▇/antenatal-care-cg62 all pregnant women should be offered an early ultrasound scan to determine gestational age. The NHS Screening programme’s recommended screening tests are gestation dependent, and are as follows: • between 10+0 and 14+1 weeks of pregnancy the combined test, which consists of a nuchal translucency scan and a blood test that measures two specific maternal biochemical markers for use in screening for Down’s, ▇▇▇▇▇▇▇’ and Patau’s syndromes. • between 14+2 to 20+0 weeks the quadruple test which measures four maternal biochemical markers for use in screening for Down’s syndrome only To complete the ultrasound component of this screening strategy, the scan appointment should allocate time to incorporate pre-scan counselling, the ultrasound examination, post- scan counselling and reporting. The time allocation for appointments to meet these requirements is a minimum of twenty (20) minutes. The results of either test give an individual risk assessment to the woman on the possibility that her baby/ies will have Down’s, ▇▇▇▇▇▇▇’ or Patau’s syndromes. If the risk of having a term pregnancy affected with any of these syndromes is 1 in 150 or higher, the pregnancy is regarded as higher risk and the woman will be offered a prenatal diagnostic (PND) test. In delivering a national screening programme and to ensure national consistency the local Provider is expected to fulfill the following, in conjunction with guidance from the National Screening Programme where appropriate and as detailed in the standards and policies available on ▇▇▇▇▇://▇▇▇.▇▇▇.▇▇/government/publications/fetal-anomaly-screening- programme-standards • work to nationally agreed common standards and policies • be required to implement and support national IT developments • use materials provided by the national screening programme, e.g. leaflets, training media and protocols for their use • be required to respond to national action/lessons such as change of software, equipment supplier, techniques • work with NHS England in reporting, investigating and resolving screening incidents • provide data and reports against programme standards, key performance indicators (KPIs), and quality indicators as required by the national screening programme on behalf of the NHS Screening Programmes • take part in quality assurance processes and implement changes recommended by QA including urgent suspension of services if required • implement and monitor failsafe procedures and continuously ensure quality • work with bordering Providers to ensure that handover of results or patients is smooth and robust • participate in evaluation of the screening programme • ensure all health care professionals access appropriate training to maintain continuous professional development and competency • ensure appropriate governance structures are in place
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Description of screening programme. Screening for Down’s, ▇▇▇▇▇▇▇’ and Patau’s syndromes is part of the NHS Fetal Anomaly Screening Programme (FASP). In line with NICE guidance (Clinical guideline 62 Antenatal care June 2010 ▇▇▇▇://▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇▇.▇▇▇.▇▇/antenatal-care-cg62 /guidance/CG62 all pregnant women should be offered an early ultrasound scan to determine gestational age. The NHS Screening screening programme’s recommended screening tests are gestation dependent, and are as follows: • between 10+0 and 14+1 weeks of pregnancy the combined test, which consists of a nuchal translucency scan and a blood test that measures two specific maternal biochemical markers for use in screening for Down’s, ▇▇▇▇▇▇▇’ and Patau’s syndromes. • between 14+2 to 20+0 weeks the quadruple test which measures four maternal biochemical markers for use in screening for Down’s syndrome only To complete the ultrasound component of this screening strategy, the scan appointment should allocate time to incorporate pre-scan counselling, the ultrasound examination, post- scan counselling and reporting. The time allocation for appointments to meet these requirements is a minimum of twenty (20) minutes. The results of either test give an individual risk assessment to the woman on the possibility that her baby/ies will have Down’s, ▇▇▇▇▇▇▇’ or Patau’s syndromes. If the risk of having a term pregnancy affected with any of these syndromes is 1 in 150 or higher, the pregnancy is regarded as higher risk and the woman will be offered a prenatal diagnostic (PND) test. In January 2016 the UK NSC recommended an evaluative roll out of NIPT to assess what impact it would have on the existing NHS Fetal Anomaly Screening Programme. If the screening test shows that the chance of having a baby with Down’s, ▇▇▇▇▇▇▇’ and Patau’s syndromes is higher than 1 in 150, this is called a higher-risk result. Currently, women who have a higher risk result have the option of having an invasive diagnostic test (amniocentesis or CVS). The proposed change is for Non-Invasive Prenatal Testing to be offered to women who are deemed at higher risk following the current primary screen. NIPT is not diagnostic and an invasive diagnostic test is still required to receive a definitive diagnosis. Through 2017-18 the FASP programme will undertake a scoping exercise to plan how NIPT might be integrated into the current screening pathway as an additional option for women with a higher risk result. This will require education and training of all staff contributing to the screening pathway and development of local pathways and policies in readiness for an evaluative roll out in 2018-19. In delivering a national screening programme and to ensure national consistency the local Provider is expected to fulfill the following, in conjunction with guidance from the National Screening Programme where appropriate and as detailed in the standards and policies available on ▇▇▇▇▇://▇▇▇.▇▇▇.▇▇/government/publications/fetal-anomaly-screening- programme-standards • work to nationally agreed common standards and policies • be required to implement and support national IT developments • use materials provided by the national screening programme, e.g. leaflets, training media and protocols for their use • be required to respond to national action/lessons such as change of software, equipment supplier, techniques • work with NHS England in reporting, investigating and resolving screening safety incidents • provide data and reports against programme standards, key performance indicators (KPIs), and quality indicators as required by the national screening programme on behalf of the NHS Screening Programmes • take part in quality assurance processes and implement changes recommended by QA including urgent suspension of services if required • implement and monitor failsafe procedures and continuously ensure quality • work with bordering Providers to ensure that handover of results or patients is smooth and robust • participate in evaluation of the screening programme • ensure all health care professionals access appropriate training to maintain continuous professional development and competency • ensure appropriate governance structures are in place
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