Pregnancy & Newborn Screening Developments Family Origin Questionnaire (FOQ) Implementation in Scotland

Background The use of the Family Origin Questionnaire (FOQ) in low prevalence areas in England is well established for selecting women at high risk of haemoglobinopathies for screening. In addition using these specific ‘family origin’ categories has the advantage of: Providing comprehensive ethnicity data on both the woman & the baby’s father which is collected at the time of booking for antenatal care Allowing the laboratory to make informed decisions regarding the need for further screening for a potential ‘at risk’ pregnancy and is particularly useful for identification of high risk groups for alpha thalassaemia screening Reducing the numbers of partners who require screening Helps the identification of antenatal samples as the form is easily identifiable for laboratories who use paper format for data collection

Background The use of the FOQ has been endorsed by NICE and recommended for use to support all sickle cell and thalassaemia screening in their antenatal screening guidelines ‘Preconception counselling (supportive listening, advice giving and information) and carrier testing should be available to all women who are identified as being at higher risk of haemoglobinopathies, using the Family Origin Questionnaire’ (NICE Antenatal Screening Guidelines 2008:133) Antenatal care: routine care of the healthy pregnant woman 3

Family Origin Questionnaire FOQ Categories may be used in paper format or electronically Use is endorsed by NICE Information from both the woman and the baby’s father are required 4

of using a FOQ (1) Health Professionals: As an integral part of the booking appointment the FOQ helps to obtain accurate family origin information on both the woman and the baby’s father Assists with consistent data collection for annual returns Provides a significant cost savings with less follow up of inconclusive results required Reduces the screening associated anxiety of the women who may have inconclusive results that are not clinically significant 5

of using a FOQ (2) Laboratory Staff: Assists in identifying samples from women and their partners who are both at increased risk of alpha thalassaemia zero (possible alpha thalassaemia major offspring) Assists with the interpretation of screening results Supports issuing more accurate reports particularly in relation to ‘father testing’ Assists with consistent data collection about family origins for annual returns Provides a significant cost savings with less father testing Helps with the identification of antenatal samples as the form is easily identifiable 6

of using a FOQ (3) Women and their partners: Assists women and baby’s father in providng more accurate family origin information at antenatal booking Reduces the number of fathers who require screening following some inconclusive results Supports informed choice for screening Reduces the anxiety associated with waiting for some inconclusive screening results where these are not clinically significant 7

Evaluation of the FOQ ETHNOS Report 2006 The FOQ was piloted in seven low prevalence Trusts in England: The overwhelming majority of stakeholders were very positive about using the FOQ The FOQ was invaluable for midwives and laboratory staff – increased confidence in asking questions about family origins and highlighted high risk groups easily Despite concerns about increased workload, midwives were positive about the FOQ finding it clear, simple, easy to use, quick to complete and easy to integrate within the booking process Consultant Haematologists and biomedical scientists thought that FOQ made screening more reliable, quicker, more streamlined and less anxiety-inducing for parents than their previous screening methods 8

Key Aspects of Implementation Training for all staff involved in the use of the FOQ, to ensure that relevant Health care and Allied Professionals are aware of the rationale and process for use of the FOQ prior to implementation. This will include: Laboratory reception staff/phlebotomists Biomedical Scientists Midwives (community & hospital based) IT responsible for laboratory and maternity services Primary care (where relevant) Access implementation guidelines from National Services Division/National Programme Centre Support is available for Education & training from the Project Lead at NHS Education for Scotland 9

Practical Issues for Midwives Provide written information about screening as soon as possible following confirmation of pregnancy (8 – 10 weeks) Offer all women screening for thalassaemia irrespective of family origin Offer women screening for sickle cell based on FOQ answers Obtain and document consent to take blood sample Inform women of how and when they will receive their screening results Provide written information following a carrier result 10

Practical Issues for Laboratories Information on the FOQ should be used in conjunction with the screening algorithm There should be FOQ information accompanying every antenatal screening booking blood received in the lab Information on family origins should help the lab with diagnosis of high risk patients for alpha zero thalassaemia and make recommendations for associated partner screening straightforward The initial time factor for processing the FOQ form is balanced against more accurate reporting of results which saves time and resources associated with partner testing Important to establish robust links with maternity services 11

Indentifying Groups at Highest Risk of Alpha Thalassaemia Zero People whose origins can be traced to: South East Asia China (including Hong Kong), Taiwan, Sinapore Thailand, Indonesia, Burma Cambodia, Vietnam, Laos, Philippines, Malaysia Southern & other European Cyprus, Greece, Turkey Sardinia Unknown/uncertain family origins 12

Using the FOQ Midwives need to include information on family origins for all women to accompany the FBC and haemoglobinopathy screen sample Complete all demographic information. If using triplicate forms remember there are 3 layers of the form! (especially if using printed labels) The FOQ should be completed for every woman Need to probe family origins for the woman and the baby’s father as far back as possible (at least 2 generations) Midwives to complete and sign the FOQ form 13

Completion of FOQ: Points to consider If woman declines, explore the reasons for this and document on FOQ There are boxes for ‘Don’t Know’ and ‘Declined to Answer’ Midwife completing the FOQ signs the form (not the woman) Estimated date of delivery is important to assess gestation and link with the newborn screening programme Send a copy to the lab with the request form. A second copy should be added to the woman’s maternity record. (A third copy can be added to the hospital records if applicable) Laboratory to check screening declined box for all FOQs completed Remember that ‘Partner’ & ‘Baby’s Father’ may not be the same person

Common errors when completing the FOQ Not all relevant boxes on the FOQ are ticked Writing too faint on duplicate copies of the FOQ form No patient labels attached to duplicate copies of the FOQ form Blood samples do not arrive in the laboratory at the same time as the FOQ form Failure to send the FOQ form with the FBC request form The FOQ has been filled in and signed by the woman Allied services unaware of the FOQ form Primary Care (GP, Practice Nurse) Phlebotomy services Laboratory reception staff

(1) Ethnicity = self defined, changeable, may include ancestry or nationality, may become a social norm or part of an individuals’ values and group identity Ancestry = area of the world where your ancestors come from (also may be defined as Family Origins) Nationality = country of birth 16

(2) The importance of informed consent for screening The midwives themselves must complete and sign the FOQ Probe for at least two generations of family origin on each side of the family Accurately record women who do not know their family origins Avoid the common mistakes that can be made when completing the FOQ form 17

(3) Primary Care will have a valuable role in: Early testing of antenatal women Completing the Family Origin Questionnaire Father testing Communication of results Even if the woman has been previously screened – still provide the FOQ information and blood sample – the lab will decide whether or not the sample should be processed The Family Origin Questionnaire should be used for every woman & the baby’s father when taking the maternal history 18

Resources NSD National Guidance Checklist for implementation PowerPoint Presentation Resource Portfolio (training materials) Laboratory Handbook Screening Algorithm www.pnsd.scot.nhs.uk www.sct.screening.nhs.uk 19

When You Are Ready! STA START! 20