Regulations
Regulations for Certification and Audit in the 11-14 Week Scan
The Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) in conjunction with the Fetal Medicine Foundation (FMF) in the United Kingdom, has set up a process for certification in the 11-14 Week Scan to ensure that all those performing this ultrasound examination process 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 11-14 week scan has been obtained candidates will be entitled to receive the FMF software for the calculation of risk using maternal age and Nuchal Translucency (NT) measurement.
The only condition for the use of this software and ongoing certification is that candidates provide their measurements for the purpose of audit at the request of RANZCOG.
The Certification Process 
The Theoretical Course 
The Logbook 
The Practical Assessment 
Ongoing Certification and Audit 
Guidelines for Measuring Nuchal Translucency 
The Certification Process
The requirements for Certification in the 11-14 week scan are:
Attendance of a FMF/RANZCOG recognised theoretical course and completion of an multiple-choice questionnaire
Submission of a logbook of 25 images demonstrating the candidate's measurement of NT translucency
Completion of a practical assessment in the performance of the 11-14 week scan
The Theoretical Course
All practitioners involved in antenatal care and first trimester ultrasound are invited to attend one of the FMF / RANZCOG courses on the 11-14 week scan. The course will cover the following topics:
FMF / RANZCOG guidelines on the measurement of NT
NT and chromosomal defects
Increased NT with normal karyotype
Pathophysiology of increased NT
Amniocentesis and chronic villus sampling
Diagnosis of fetal abnormalities at the 11-14 week scan
Determination of chorionicity, diagnosis and management of multiple pregnancy at the 11-14 week scan
Principles of Screening
Biochemistry
The course content is supported by a monograph 11-14 Week Scan - The Diagnosis of Fetal Abnormalities edited by Professor Kypros H Nicolaides and published by The Fetal Medicine Foundation London 2004. A CD of this book will be distributed to delegates registered for the Theoretical Course.
The FMF runs regular courses in London and supports a number of other recognised Training Centres throughout the World to run similar courses. Courses held in Australia follow the same format as the ones run in the UK .
Delegates attending the Theoretical Course who are participating in a Practice Improvement projects / MOSSIP Programs etc: with their professional organisations will complete a multiple-choice questionnaire before the commencement of the course and also at the completion. This is designed to ensure that candidates have understood the concepts of the course and the source book can be used for reference. On receipt of two completed questionnaires, candidates will be sent a certificate to acknowledge the successful completion of the theoretical component. Practitioners are then eligible to progress to the practical component.
The Logbook
The aim of the logbook is to demonstrate an understanding of the FMF / RANZCOG guidelines for the measurement of the NT. See below or http://www.nuchaltrans.edu.au/guidelines.shtml
Twenty five (25) thermal / photo images pasted chronologically into a small exercise book, (one image per double page) are required to demonstrate the candidate's evolving experience in performing the 11-14 Week Scan. These images are to be collected on an ultrasound machine whose specifications include:
Zoom facility
Cineloop function
Focal zone adjustment
Is able to measure in 0.1 mm increments
The candidate's images should demonstrate their skill at:
obtaining sagittal section of fetus
determining appropriate image magnification
positioning the callipers on the borders of the translucency
placing the callipers on the area of maximal translucency thickness
Once completed, the logbook should be sent to:
Nuchal Translucency Program Officer
RANZCOG
254- 260 Albert Street
East Melbourne VIC 3002
The Practical Assessment
Once the logbook has been satisfactorily assessed, candidates will be asked to attend a Training Centre for the practical assessment. Practitioners performing the practical assessment have extensive experience in performing the 11-14 week scan and have consistently obtained good results, and have been working in the area for longer than three years. These practitioners can be located in both the public and private sectors, supported by staff that are also very proficient in performing the Nuchal Translucency scan.
Each has agreed to act as a Training Assessor on behalf of the NT Program and will provide candidates with the opportunity to see how the 11-14 week scan is conducted, as well as how pre and post test counselling of the patient is carried out. The designated trainer will carry out an informal assessment of the candidate's ability to perform the 11-14 week scan in at least one patient.
Having successfully completed the practical assessment, a form recommending certification of the candidate will be completed by the examiner. The candidate is responsible for sending the form to the Nuchal Translucency Program at RANZCOG. On receipt, a Certificate of Competence in the 11-14 week scan will be issued. Candidates will be asked to complete an “Intent to Practice” form on receipt of the Certificate of Competence.
Ongoing Certification and Audit
In order for your Certification in the 11-14 Week Scan to remain valid, it is expected that the candidate will continue to perform this scan on a regular basis and must submit their measurements of NT to the NT Program for audit.
The FMF software has an audit function, which allows the candidates to audit their own results on a regular basis. At six-monthly intervals, a printout of the audit report should be submitted to the NT Program. In addition, on an annual basis, each candidate should submit their audit data file from the software, along with five images so that a more detailed analysis can be made available to the Centre and its operators.
All the information that is provided by way of the automated audit function is anonymous and no data is used for research without explicit consent.
Candidates not actively using the FMF software, but who wish to remain accredited need to submit five images annually for audit. Each request for continuing certification will be assessed on an individual basis.
Guidelines for Measuring Nuchal Translucency
The fetal crown-rump length should be between 45 and 84mm.
A good sagittal section of the fetus must be obtained, with the fetus horizontal on the screen.
The fetus should be in a neutral position , with the head in line with the spine, not hyper-extended or flexed.
The fetus should be magnified so that the head to upper thorax occupy the whole of the image.
The widest part of translucency must be measured.
Measurements should be taken with the inner border of the horizontal line of the calipers placed ON the line that defines the nuchal translucency thickness - the crossbar of the caliper should be such that it hardly visible as it merges with the white line of the border, not in the nuchal fluid.
Turning down the gain can reduce any fuzziness to the line. Otherwise the calipers should be placed on the sharpest region of the border, not on the fuzzy edge. Do not use harmonics or post- zoom magnification – both accentuate the fuzziness.
Care must be taken to distinguish between fetal skin and amnion .
During the scan more than one measurement must be taken and the maximum one that meets all the above criteria should be recorded in the database. It is good practice to retain at least one image for your patient records.
© RANZCOG
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