What the Harmony requisition is for
Harmony is a cell-free DNA screen for fetal trisomy 21, 18 and 13, with optional fetal sex, monosomy X and sex chromosome aneuploidy add-ons. The PDF has three parts: the requisition, the patient informed consent information, and the MOH Criteria for Eligibility form that supports funding. It is a screening test. A high-risk result needs confirmation by diagnostic testing such as amniocentesis. LifeLabs offers publicly funded Panorama on its own requisition.
Who completes it
The prescriber completes the requisition, signs the attestation that the patient was informed and consented, and completes Category I of the eligibility form. Category II must be completed and signed by a genetics or maternal fetal medicine specialist. The patient doesn’t complete a section, though the consent page is written for them to read.
How to fill in the requisition and eligibility form
Patient, prescriber and blood draw
Give the patient’s details and weight, your clinic and contact numbers, the collection date and centre, and whether this is a redraw.
Clinical information
Complete either the gestational age at a dated ultrasound or the LMP or IVF transfer date. Give the number of fetuses, whether it’s an IVF pregnancy, and for donor eggs the donor’s age at retrieval. The patient must be at least 10 weeks at collection.
Clinician signature
Sign and date the attestation that the patient was fully informed of the test’s capabilities and limits and consented, with your licence number.
Eligibility form: Category I
Category I covers trisomy 21, 18 or 13 only, after pre-test counselling. Tick one criterion: a positive multiple marker screen, age 40 or over at delivery, twins with fetal heart activity in both, nuchal translucency of 3.5 mm or more, or a previous pregnancy or child with one of these trisomies. Sign with your CSN number.
Eligibility form: Category II
The specialist ticks a congenital anomaly on ultrasound, a calculated risk above a positive screen with the risk factors, or NIPT for sex chromosome determination. A patient under 40 needs at least one other risk factor.
Common reasons it’s sent back
- No eligibility form attached, so the test isn’t funded.
- Category II completed by a referring clinician who isn’t a genetics or MFM specialist.
- Collection before 10 weeks.
- Neither gestational age method completed.
- Sex chromosome options ordered for twins.
- Missing attestation signature or licence number.
Submitting and who pays
The patient has blood drawn at a Dynacare collection centre with the requisition and eligibility form. The Ministry funds the test when the patient meets a listed criterion. Fetal sex and the sex chromosome options can be added up to 30 days after the first report.