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Down’s Syndrome Screening Standard Operating Procedure
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Document Control
Title
Down’s, Patau’s & Edwards Syndrome Screening Standard
Operating Procedure
Author
Author’s job title Antenatal & Newborn Screening Coordinator
Directorate Women’s & Children’s
Department Team/Specialty Antenatal Clinic
Version Date
Issued Status Comment / Changes / Approval
0.1 June 2015
Draft Initial version for consultation
1.0 June 15 Final Approved by the maternity services Guideline Group on 17/06/2015 and published on Bob
1.1 April 18 Draft revision
Revision and minor amendments to comply with the FASP National Screening Standards.
2.0 Oct 18 Final Approved at the Maternity Specialist Governance Group.
Main Contact Antenatal & Newborn Screening Coordinator North Devon District Hospital Raleigh Park Barnstaple, EX31 4JB
Tel: Direct Dial – 01271 Tel: Internal – Email:
Lead Director
Document Class Standard Operating Procedure
Target Audience
Distribution List Senior Management
Distribution Method Trust’s internal website
Superseded Documents
Issue Date October 2018
Review Date October 2021
Review Cycle Three years
Consulted with the following stakeholders: (list all)
All users of this document
Ultra Sonographers
Midwives
Midwifery care assistance
Obstetricians
Management team
Contact responsible for implementation and monitoring compliance: Antenatal & Newborn Screening Coordinator
Education/ training will be provided by:
Approval and Review Process
Maternity Services Guideline Group
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Local Archive Reference G:\\Maternity Services Local Path Policies and procedures Filename Down’s, Patau’s & Edward’s Syndrome Screening Standard Operating Procedure V2.0
Policy categories for Trust’s internal website (Bob) Maternity Services
Tags for Trust’s internal website (Bob) Maternity, Screening,
Down’s Syndrome Screening Standard Operating Procedure
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CONTENTS
Document Control........................................................................................................................ 1
1. Introduction ....................................................................................................................... 4
2. Purpose.............................................................................................................................. 4
3. Scope ................................................................................................................................. 4
4. Location ............................................................................................................................. 5
5. Equipment ......................................................................................................................... 5
6. Procedure .......................................................................................................................... 5
7. References ........................................................................................................................ 9
8. Associated Documentation ............................................................................................. 9
9. Appendix 1 ...................................................................................................................... 10
10. Appendix 2 ...................................................................................................................... 11
11. Appendix 3 ...................................................................................................................... 12
12. Appendix 4 ...................................................................................................................... 13
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1. Introduction
1st trimester screening for Down’s, Patau’s & Edward’s Syndrome is to be offered to all women booked for Maternity Care with the Northern Devon Healthcare Trust who are equal to or under 14+1 week’s gestation. In the event that the pregnancy is more that 14+1 week’s gestation or the nuchal fold measurement is unable to be obtained 2nd trimester serum screening for Down’s syndrome should be offered up to 20 weeks gestation.
The patient information leaflet ‘Screening tests for you & your baby’ to be given to all women, before their first booking appointment with the Community Midwife.
The Community Midwife to counsel all women at the first midwifery appointment for Patau’s, Edward’s and Down’s syndrome Screening.
The woman may choose to have screening for:
o Down’s, Edward’s & Patau’s Syndrome
o Edward’s & Patau’s syndrome only
o Down’s syndrome Only
o None of the conditions, dating only
The offer, decline or acceptance of screening should be documented on Trakcare, in the woman’s handheld notes and on the ‘Maternal Booking Information form’ which is filed in the woman’s hospital notes.
2. Purpose
The Standard Operating Procedure (SOP) has been written to:
Offer all eligible pregnant women booked for maternity care the option of screening for Down’s, Patau’s and Edward’s syndrome.
Offer a clear pathway to all staff involved in the screening process.
3. Scope
This Standard Operating Procedure (SOP) relates to the following staff groups who may be involved in the assessment and delivery of Down’s, Patau’s and Edwards Syndrome Screening:
Registered Midwives
Maternity Care Assistants
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4. Location
This Standard Operating Procedure can be implemented in all clinical areas where competent staff, are available to undertake this role.
Staff undertaking this procedure must be able to demonstrate continued competence as per the organisation’s policy on assessing and maintaining competence.
5. Equipment
1st Trimester combined Down’s syndrome screening
1st Trimester Screening Diary.
Royal Devon & Exeter 1st trimester Screening laboratory request form.
5x barcode stickers.
Clotted blood sample bottle (Ochre).
2nd Trimester Down’s syndrome screening.
2nd Trimester Down’s syndrome screening diary.
The Newcastle Upon Tyne Hospitals’ Maternal Serum Screening laboratory request form.
Clotted blood sample bottle (Ochre)
6. Procedure
1st Trimester Down’s syndrome Screening (11+2 - 14+1 weeks’ gestation)
Before ultrasound scan weigh woman and document weight in hospital notes.
Allocate 5 x barcode stickers to each woman for sonographer to scan into the Viewpoint IT system.
After Ultrasound Scan, check scan report for NT measurement and barcode number.
Obtain 4mls of clotted blood (Ochre)
Label blood sample bottle.
Place patient identification sticker on laboratory request form and in the 1st Trimester Down’s Syndrome Screening Diary under the date the blood sample was taken.
Document on the laboratory form, next to woman’s details if screening for Down’s syndrome only or Patau’s & Edward’s syndrome only and inform the Antenatal and Newborn Screening Co-ordinator/deputy that this is required.
Bar code stickers;
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1x blood bottle.
1x laboratory request form.
1x 1st Trimester combined Screening Diary, next to patient identification sticker.
1x handheld notes.
1x Hospital notes.
Inform women that low chance results, 1:151 & above, will be posted within 2 weeks. Any high chance results, 1:150 & below, the woman will be contacted by the Antenatal Screening Coordinator/ Antenatal Clinic Midwife and offered an appointment for counselling.
2nd Trimester Down’s syndrome screening (14+2 - 20 weeks’ gestation)
Performed after 14+2 weeks’ gestation if Nuchal Translucency measurement cannot be obtained on Ultrasound or the woman’s gestation is over 14+1 and 1st trimester combined screening cannot be completed. For singleton and di-chorionic, di-amniotic twin pregnancies only.
Obtain 4mls of clotted blood (Ochre).
Label blood sample bottle.
Complete the Newcastle Upon Tyne Hospitals’ Maternal Serum Screening laboratory request form.
Place patient identification sticker in the 2nd Trimester Down’s Syndrome Screening Diary, under the day’s date.
Document clearly in woman’s notes reason for 2nd trimester Down’s syndrome screening and blood sample taken.
Inform women that low Chance results, 1:151 & above, will be posted within 2 weeks. Any high chance results’ 1:150 & below, the woman will be contacted by the Antenatal Screening Coordinator/ Antenatal Clinic Midwife and offered an appointment for counselling.
If the woman’s pregnancy is under 14+2 weeks’ gestation and requires 2nd trimester Down’s syndrome screening, place a patient identification sticker in the 2nd Trimester Down’s Syndrome Screening Diary, under the day’s date. Document ‘form’s given’ next to it.
Complete the Newcastle Upon Tyne Hospitals’ Maternal Serum Screening laboratory request form and give to the woman with a letter (Appendix 1). Explain that to complete the Down’s syndrome screening a blood sample will need to be taken by the community midwife between 14+2 and 20 weeks’ of pregnancy.
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Document clearly in notes reason for 2nd trimester Down’s syndrome screening and forms given.
The Community Midwife completes the slip at the bottom of the letter (Appendix 1) once blood has been taken or screening declined and sends it to the Antenatal and Newborn Screening Coordinator to document blood taken in the 2nd Trimester Down’s Syndrome Screening Diary.
Low chance results.
The laboratories notify the Antenatal & Newborn Screening Coordinator of low risk results by email for 1st trimester screening: [email protected] and by fax sent to Maternity Reception for 2nd trimester screening.
1st trimester result letters are generated using the Viewpoint IT application. Print 3 copies of the results:
1x sent to woman
1x sent to GP
1x filed in hospital notes.
Document Chance and date results sent to woman next to woman’s details in the 1st Trimester Screening Diary.
2nd trimester result letters are generated using a proforma letter (Appendix 2). The risk and woman’s details documented in the letter by Antenatal Screening Coordinator/Antenatal Clinic Midwife. 3 copies of the letter produced:
1x sent to woman.
1x sent to GP
1x filed in hospital notes.
Document risk and date results sent to woman next to woman’s details in the 2nd
Trimester Screening Diary.
Send copy of faxed results to the Biochemistry Laboratory, North Devon District Hospital.
File results in woman’s notes once received by mail from The Newcastle Upon Tyne Hospital Laboratory.
Outcome of pregnancy form to be completed once baby delivered and sent to: The Newcastle Upon Tyne Hospital Laboratory.
High Chance Results.
The laboratories notify the Antenatal Screening Coordinator of high chance screening results initially by telephone and also by email: [email protected] for 1st trimester results and by fax for 2nd trimester.
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Any woman receiving a high chance Down’s syndrome screening result through the private sector would follow the pathway set out below, via self, GP or provider referral.
Once results received the Antenatal Screening Coordinator/Antenatal Clinic Midwife to contact woman via the phone to inform of results and offer an appointment within 3 working days for counselling.
Antenatal Result & Choices (ARC) contact details given to woman: http://www.arc-uk.org/
If woman is not contactable via the phone proforma letter (Appendix 3) generated, inviting woman to an appointment for counselling within 3 working days. Letter to be sent 1st class post with results letter.
Community Midwife informed of result.
High risk audit form completed (Appendix 4).
Chance to be reframed as a percentage, for discussion with woman.
Options discussed with woman at appointment:
1. Do nothing, continue with pregnancy
2. Opt for prenatal diagnosis via CVS or Amniocentesis, dependant on gestation:
CVS, up to 14 weeks’ gestation.
Amniocentesis from 15 weeks’ gestation.
3. Await fetal anomaly ultrasound scan at 18 - 20+6 weeks’ gestation. Woman to be made aware that ultrasound cannot diagnose Down’s syndrome.
4. Woman to be advised to contact ARC for discussion and advice, also regarding screening test available within the private sector: http://www.arc-uk.org/
Information to be given to woman:
http://www.arc-uk.org/
http://www.downs-syndrome.org.uk/for-families-and-carers/
http://www.soft.org.uk/
FASP patient information leaflets for CVS and and/or Amniocentesis;
http://fetalanomaly.screening.nhs.uk/leafletsforparents
Discussion to be documented clearly in woman’s handheld and hospital notes.
If prenatal diagnosis requested, referral faxed to tertiary centre:
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Fetal Medicine Unit St Michael’s Hospital Southwell Street Bristol BS2 8EG Telephone: 0117 342 5470 Fax: 0117 342 5180
http://www.uhbristol.nhs.uk/patients-and-visitors/your-hospitals/st-michaels- hospital/what-we-do/fetal-medicine-unit/information-for-patients/
Fetal Medicine unit: telephone and make aware of referral being sent.
Referral to be filed in woman’s hospital notes.
7. References
FASP 2015
8. Associated Documentation
Northern Devon Healthcare NHS Trust Policies for: Antenatal & Newborn Screening Guideline 2017
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9. Appendix 1
Kay Maytum Antenatal & Newborn Screening Coordinator
Department of Obstetrics & Gynaecology Date: ……………. North Devon District Hospital
Raleigh Park Barnstaple
N Devon EX31 4JB
Tel: Tel: 01271 322600
Email: [email protected] www.northdevonhealth.nhs.uk
Dear………………….. You attended the Antenatal Clinic for 1st Trimester Down’s Syndrome Screening. Unfortunately, this was not successful. You are currently …………..weeks’ pregnant. If you wish to have 2nd Trimester Down’s Syndrome Screening, you must have your blood taken between 14 weeks and 2 days and 20 weeks of pregnancy. Please make an appointment with your Community Midwife, taking this form with you. Kind regards, The Antenatal Screening Team. ……………………………………………………………………………………………………. Dear Midwife, Please complete and send to the Antenatal & Newborn Screening Coordinator at the above address. Name: D.O.B: Hospital Number: The blood sample for the 2nd Trimester Down’s Syndrome Screening was taken on…………………. 2nd trimester Down’s Syndrome Screening has been declined:………………….. Signed:………………………………… Date:…………………….
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10. Appendix 2
INSERT NAME INSERT HOSPITAL NUMBER Maternal serum screening for Down’s Syndrome. Dear INSERT NAME, We are pleased to inform you that the blood sample, taken on INSERT DATE, shows you are at low risk for Down’s Syndrome. Your risk was estimated at 1in INSERT RISK and no further investigation for Down’s Syndrome is required. If you have any questions, please ring the Antenatal clinic on 01271 322600. Yours Sincerely Kay Maytum Antenatal & Newborn Screening Coordinator
Kay Maytum Antenatal & Newborn Screening Coordinator
Department of Obstetrics & Gynaecology North Devon District Hospital
Raleigh Park Barnstaple
N Devon EX31 4JB
Tel: Tel: 01271 322600
Email: [email protected] www.northdevonhealth.nhs.uk
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11. Appendix 3
Kay Maytum
Antenatal & Newborn Screening Coordinator Department of Obstetrics & Gynaecology
North Devon District Hospital Raleigh Park
Barnstaple N Devon EX31 4JB
Tel: Tel: 01271 322600
Email: [email protected] www.northdevonhealth.nhs.uk
PATIENT’S NAME
HOSPITAL NUMBER
Screening for Down’s Syndrome Dear INSERT PATIENT’S NAME The result of your screening for Down’s Syndrome is: INSERT RISK We have arranged an appointment to discuss your result in Antenatal Clinic, Ladywell Unit, on: INSERT DATE & TIME If you have any questions, please contact the Antenatal & Newborn Screening Coordinator on: 01271 314037 or the Antenatal Clinic on: 01271 322600. Further information can be found at www.arc-uk.org , alternatively call Antenatal Results & Choices on 08450772290. Yours Sincerely Antenatal & Newborn screening Coordinator.
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12. Appendix 4
HIGH RISK RESULTS (SCREENING OR FETAL ANOMALY)
E.D.D.
DATE:
Form Completed by …………………… Named Cons: Community Midwife: GP & Surgery:
HIGH RISK SCREENING RESULTS; (circle) Date:……………………….
Quadruple 1 –
Quadruple AFP
Combined N.T. 1 -
Amnio / CVS / Declined / Awaiting 20/40 scan (circle)
Date: Amnio CVS
NDDH Exeter Bristol (Circle)
Reason for Amnio/CVS
H/R screening result: Abnormality on scan:
Maternal request: Other:
Abnormality on Scan Date: Referral to: (circle) SSA NDDH Bristol FMU Bristol Cardiology Exeter
Gestation: Reason for referral
OUTCOME:
DATE: FISH/CVS/AMNIO Comments:
Follow up Appointment made: Bristol Yes / No Date: SSA NDDH Yes/ No Date: G.P. / Community Midwifery Team informed: Yes / No Date: S. W. C. A. R Notification completed: Yes / No/ NA Date: Paediatric Referral Made: Yes / No/ NA Date:
Patient identification sticker &
Telephone number.
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13.