FMF Regulations for Certification in the 11-13+6 weeks scan
The Fetal Medicine Foundation (FMF) has set up a process for certification in the 11-13+6 weeks scan to ensure that those performing this ultrasound examination have been adequately trained to do so and that high standards of performance are maintained by continuous education and audit.
Once the certificate of training in the 11-13+6 weeks scan has been obtained, the doctor/sonographer will be entitled to receive the FMF software for the calculation of risk of Down syndrome by a combination of maternal age, nuchal translucency (NT) measurement and first-trimester maternal serum free ß-hCG and PAPP-A. The accredited individual will be included in the FMF list of ‘Accredited Sonographers’ and the hospital/clinic of the doctor/sonographer will be included in the FMF list of ‘Registered Centres’.
The only condition for ongoing certification and use of the software is provision of NT data and images by the Centre and / or sonographer for the purposes of audit.
The Certification Process
The requirements for certification in the 11-13+6 weeks scan are:
- Attendance of a FMF-recognised theoretical course
- Practical training in performing the 11-13+6 weeks scan
- Submission of a logbook of 10 images demonstrating the measurement of NT
The Theoretical Course
This course is intended for all medical personnel involved in antenatal care and is not confined to those performing the 11-13+6 weeks scan. The course content is supported by a book which will be distributed at the time of the course. The complete text of this book can also be viewed by clicking here.
The course will cover the following topics:
- FMF guidelines on the measurement of NT
- Principles of screening
- NT and chromosomal defects
- Amniocentesis and chorionic villus sampling
- Increased NT with normal karyotype
- Pathophysiology of NT
- Diagnosis of fetal abnormalities at the 11-13+6 weeks scan
- Determination of chorionicity and diagnosis and management of multiple pregnancy at the 11-13+6 weeks scan
The FMF runs regular courses in London and supports a number of other recognised Training Centres throughout the world to run similar courses. Further details can be found in the training courses section of the FMF website.
At the end of the course there is a multiple choice questionnaire which aims to test that the doctor/sonographer has understood the concepts of the course.
Practical Training
It is important that the doctor/sonographer fully understands the methodology and implications of performing the 11-13+6 weeks scan. Hands-on practical training may be available at the time of the theoretical course, otherwise the doctor/sonographer will be asked to attend a Training Centre for practical instruction.
The Training Centres are obstetric departments / fetal medicine units whose personnel have extensive experience in performing the 11-13+6 weeks scan and who have consistently obtained good results from the FMF audit of their NT measurements. Each has agreed to act as a Training Centre on behalf of the FMF and will provide the doctor/sonographer with the opportunity to see how the 11-13+6 weeks scan is conducted, as well as how pre- and post-test counselling of the patient is carried out.
The Logbook
This consists of ten thermal images, placed loosely in an envelope, and submitted to the FMF. Each image is assessed on the following criteria:
- Image size (only the fetal head, neck and upper thorax on screen)
- Head position (neutral, not flexed or extended)
- True sagittal section obtained (rather than oblique)
- Calliper position (on the borders of the translucency)
- Area of measurement (at the widest point of the translucency thickness)
- Thin nuchal membrane (thickness of the nuchal membrane)
It is expected that each of the above criteria are met in at least 8 of the 10 images before the logbook can be passed. If this standard is not met in 3-5 images, the sonographer will be asked to submit another 5 images demonstrating a definite improvement before the logbook can be passed. If this standard is not met in more than 5 images, another 10 images will be required.
If you have not yet registered with the FMF please download the FMF registration form by clicking here (Word document format). Please use the Word document version if at all possible as you can type your details directly into this form and this will assist us in reading your information unambiguously. If you cannot use this Word version click here for a copy in PDF format. Complete the form and send it to the specified address together with any other information you are sending to us. It is vital that this form should be completed accurately to enable us to identify you in the future.
Certification
After attendance of the theoretical course and practical training and successful completion of the logbook, the doctor/sonographer will be sent the Certificate of Competence in the 11-13+6 weeks scan.
Please also note:
- All the sonographers performing scans and using the FMF software must hold the FMF Certificate of Competence in the 11-13+6 weeks scan
- NT data and images must be sent to the FMF for ongoing audit after the first 6 months of use and periodically thereafter.
Once the Sybase Anywhere license fee has been paid, the centre will receive the FMF risk calculation software and entered onto the FMF list of Registered Centres.
If you are applying for certification in the 11-13+6 weeks scan and have not yet registered with the FMF please download the FMF registration form by clicking here (Word document format). Please use the Word document version if at all possible as you can type your details directly into this form and this will assist us in reading your information unambiguously. If you cannot use this Word version click here for a copy in PDF format. Complete the form and send it to the specified address together with any other information you are sending to us. It is vital that this form should be completed accurately to enable us to identify you in the future.
FMF First Trimester Screening Software
The new version of the First Trimester Screening software (ver. 2.2 released 7th August 2008) no longer requires the Sybase license fee. You can simply register your centre for the new software by completing the FTS registration form, please click here. Once you have concluded your application we will send you the installation instructions via email.
NT Quality Review and Ongoing Certification
Each registered centre must be audited by the FMF six-months after the
NT screening programme is launched.
The audit involves:
- Assessment of the distribution of measurements of each sonographer
- Examination of the quality of five random images from each sonographer
An audit is considered to be satisfactory if 40-60% of NT measurements are above the median and the images are of a high quality. Sonographers or centres passing their audit will be re-audited and re-licensed on an annual basis thereafter. The NT distribution cannot be assessed if fewer than 30 scans have been performed, but in this situation an individual can still pass their audit if their images are satisfactory.
Accredited Sonographers List
All sonographers passing their FMF audit will be included on the Accredited Sonographers list. Individuals performing less than 30 NT scans per year and those that are not actively involved in an NT screening service can remain accredited, as long as they submit five satisfactory NT images annually.
Registered Centres List
Centres scanning more than 50 patients per year and where more than 75% of the scans are performed by sonographers who have passed their audit and are on the Accredited Sonographers list will be included on the FMF Registered Centres list (click here). Those performing less than 50 scans a year can continue to have the programme license if the images that they submit are of acceptable quality, but they will not be included on the FMF Registered Centres list.
Management of the Under-performing Sonographers
If the NT distribution falls outside the satisfactory range:
- Advice will be given on how to improve NT technique, based on the review of images
- The name of the sonographer will be removed from the Accredited Sonographer list
- A new audit will be carried out in three to six months
- The sonographer will only be reinstated on the Accredited Sonographer list once the audit is considered satisfactory
- The programme license will be extended on the first occasion that it is due for renewal after the audit is noted to be sub-standard, but it will not be renewed the following year if there has been no improvement to achieve an acceptable standard
Centres excluded from the Registered Centres list will only be reinstated once efforts are made to ensure that everyone is accredited. The centre license will not be renewed the following year if they fail to do so. In centres with more than one sonographer where an individual sonographer fails to achieve the required standard, it will be the responsibility of the other sonographers to retrain and supervise the underperforming sonographer until a satisfactory level is achieved.
Re-licensing Arrangements
Once the programme license has been revoked, it is suggested that selected sonographers within that centre undergo a period of retraining and re-certification. Once this has been done, they may re-apply for the programme license, but it must be clearly noted that only they, and not unaccredited colleagues, may use the risk calculation software and that the above stringent audit policy will apply to all subsequent audits.
Internal Audit
In addition to the FMF audit, all centres are encouraged to perform their own internal quality assurance on a monthly basis by:
- “Spot-checking” three images from each sonographer, selected entirely at random
- Examining the NT distribution of each individual sonographer using the automated audit module incorporated within the FMF risk calculation software.
The FMF is willing to provide additional support to facilitate this process and advise if the results are suboptimal.
Contact Details
Submission of logbooks and any questions or comments about the 11-13+6 weeks scan, should be addressed to:
NT Certification
The Fetal Medicine Foundation
137 Harley Street
London W1G 6BG, UK
Tel +44 (0)20 7034 3070
Fax +44 (0)20 7034 3071
Email: certification@fetalmedicine.com