Newborn Screening Information for Providers:
Pulse Oximetry Screening in the Well-Baby Nursery
Minnesota state law (Statute 144.1251) outlines the following responsibilities for all licensed hospitals and birthing centers in Minnesota:
- Communicate newborn pulse oximetry screening information and parental options to parents prior to screening
- Screen all infants for Critical Congenital Heart Disease (CCHD) after 24 hours but before discharge unless parents have signed the Parental Refusal of Newborn Screening form (found on the Education Materials and Forms page)
- Report all pulse oximetry results to the Minnesota Department of Health Newborn Screening Program
Screening should be performed by qualified personnel who have been trained in both newborn pulse oximetry monitoring and Minnesota’s recommended screening algorithm.
The following resources may be used for training screeners:
- Pulse Oximetry Screening Protocol for Critical Congenital Heart Disease (CCHD) and Tips for Pulse Oximetry Screeners (available to order free-of-charge on the Education Materials and Forms page)
- Newborn Heart Screening video (approx. 10 minutes) – produced through a collaboration between MDH, the Newborn Foundation, and the University of Minnesota Amplatz Children’s Hospital
- Basics of Screening for Critical Congenital Heart Disease video (approx. 19 minutes) – produced by Wisconsin SHINE
- Pulse Oximetry Screening for Critical Congenital Heart Disease Online Learning Module (includes 7 video modules, approx. 2-10 minutes each) – produced by Wisconsin SHINE
- Heart Smart: CCHD Screening for Parents videos in English, Arabic, Chinese, French, Russian, and Spanish (approx. 6 minutes each)
- Recommendations for Implementing Pulse Oximetry Screening for Critical Congenital Heart Disease (CCHD) packet (PDF: 900KB/20 pages) – designed for Minnesota hospitals by the Minnesota Department of Health Newborn Screening Program
Providers are responsible for educating parents about pulse oximetry screening before screening takes place. Education materials to aid in the discussion about pulse oximetry screening are available free of charge and can be ordered on the Education Materials and Forms page. For more information on educating parents about newborn screening, including pulse oximetry screening, visit the Postnatal Education page.
Initial pulse oximetry screening is best performed between 24 and 48 hours of life for healthy term newborns. If early discharge is planned, screening should occur as close as possible to the time of discharge. Earlier screening may produce false positive results due to the newborn’s transition from fetal to neonatal circulation and the stabilization of systemic oxygen saturation levels. Screening after 48 hours may not afford the opportunity for early CCHD intervention before the closing of the ductus arteriosus.
Birth facilities are responsible for selecting and securing pulse oximetry equipment for screening newborns for CCHD. A variety of pulse oximeters are available for use with newborns. Birth facilities can contact the Newborn Screening Program with any questions regarding pulse oximeter options and their compatibility with MDH reporting systems. It is important to ensure that the selected equipment is compliant with national standards, including:
- Approval by the Food and Drug Administration (FDA) for use in newborns
- Validation in low-perfusion conditions and provides accurate readings with movement
- 2% root, mean-square accuracy
- Reporting of functional oxygen saturation
Hospitals should choose a probe recommended by the pulse oximeter manufacturer for use with the device. Both disposable and reusable probes with a disposable foam wrap are available and acceptable for screening.
To verify that your facility’s pulse oximeter meets FDA clearance for use in neonates, follow the instructions below:
- Go to the FDA website 510(k) Premarket Notification
- Enter known information for the pulse oximeter device and/or sensor
- Enter the name of the oximeter company in the Applicant Name field
- Supply the information you know - some fields may be left blank
- When a list of devices appear, click on the appropriate device for more information
- Additional information about the device will appear, then select Summary
- The Intended Use/Indications for Use section will state whether the device is cleared for neonatal use
Pulse Oximeter Vendors
Irvine CA 92618
15 Hampshire Street
Mansfield MS 02048
13700 1st Avenue N.
Plymouth, MN 55441
Recommended Screening Algorithm
- Perform pulse oximetry screening when the baby is quiet and alert
- Measure oxygen saturations on the right hand and either right or left foot – measurements can be done at the same time or in direct sequence
- Ensure good pulse waveform for at least one full minute
The Minnesota Newborn Screening Program recommends using a slightly modified protocol from the one endorsed by the US Secretary of Health and Human Services and the American Academy of Pediatrics. This updated approach is currently employed by several states and has been shown to increase the detection rate of CCHD. The recommended protocol for screening in Minnesota is reflected in all MDH education materials.Education Materials and Forms page.
All pulse oximetry screening results and follow-up arrangements should be conveyed to the newborn’s parents and primary care provider. Results should be communicated with parents both verbally and in writing once the final screen is complete.
If the infant receives a pass result, give the parent(s) the Pass Result: Pulse Oximetry Result Notification sheet and explain that pulse oximetry does not detect all cases of CCHD. Encourage parent(s) to contact their infant’s primary care provider should concerns arise.
Did Not Pass Result
If the infant receives a non-passing result, give the parent(s) the Did Not Pass Result: Pulse Oximetry Result Notification sheet and discuss what further evaluation and/or testing is needed and the timeframe for that testing.
Result notification sheets are are available to order free-of-charge on the Education Materials and Forms page.
Recommended Follow-up for Did Not Pass Results
The following steps are recommended for any newborn with a non-passing pulse oximetry result:
- Perform a comprehensive evaluation for causes of hypoxemia
- If a non-cardiac explanation for the hypoxemia is not identified, CCHD must be excluded on the basis of a diagnostic echocardiogram
- A diagnostic echocardiogram should not be replaced by other cardiac evaluations (e.g., chest radiograph, electrocardiogram)
- It is recommended that the diagnostic echocardiogram occur within four hours of the final pulse oximetry screen
- A CME-credit approved Sonographer Education training is available to assist cardiac sonographers in performing the initial neonatal echocardiogram as part of a comprehensive evaluation for hypoxemia
- Pediatric cardiology specialists are available to consult on any non-passing pulse oximetry screen result and can help discuss stabilization and transport needs and/or provide interpretation of echocardiogram findings
Reporting Results to MDH
Minnesota state law (Statute 144.1251) requires that all pulse oximetry screening results be reported to the Minnesota Department of Health. All results should be reported electronically using the mechanism established by MDH.
As of March 2014, MDH is in the process of establishing and purchasing an appropriate electronic reporting system for both pulse oximetry and hearing screening results. All birth facilities will be contacted by MDH once this system is in place and ready for use. Until then, MDH does not have the capacity to receive screening results, but all Minnesota birth facilities should continue screening to comply with Minnesota State Law.