Pulse Oximetry Newborn Screening for Critical Congenital Heart Defects
In June 2011, the Indiana legislature added pulse oximetry to Indiana's newborn screen. According to IC 16-41-17-2, effective January 1, 2012, all birthing facilities in Indiana will be required to perform pulse oximetry newborn screening to detect critical congenital heart defects.
NOTE: EVERY baby born in Indiana, regardless of gestational age or NICU status, must be screened for CCHD. See below for more information.
Pulse Oximetry Newborn Screening Protocols
To view or print a copy of the Indiana's pulse oximetry newborn screening protocols, please click here.
Indiana's pulse oximetry newborn screening protocols are based on the recommended screening protocols that have been endorsed by the Secretary's Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC) and released nationally.
NOTE: EVERY baby born in Indiana, regardless of gestational age, must be screened for CCHD. Although the national protocols that were distributed by ISDH are for infants born at or after 35 weeks’ gestation, infants who are less than 35 weeks gestation, as well as infants in the NICU, should receive pulse oximetry screening or an echocardiogram prior to discharge in order to be compliant with Indiana’s newborn screening law.
Since no standard protocols for screening infants < 35 weeks currently exist, each birthing facility is responsible for developing its own protocols in order to ensure that these children (and all children at your facility) are screened for CCHD.
Frequently Asked Questions - Screening Protocols & Diagnostic Recommendations
To which group(s) of infants do the pulse oximetry screening protocols apply?
A workgroup convened with members of the Secretary’s Advisory Committee on Heritable Disorders in Newborns and Children (SACHDNC), the American Academy of Pediatrics (AAP), the American College of Cardiology Foundation (ACCF) and the American Heart Association (AHA) has “…endorsed screening babies in intermediate-care nurseries or other units in which discharge is common within the first week.”1
Pulse oximetry newborn screening protocols apply to healthy-appearing infants who were born at or after 35 weeks gestation. The protocols do not apply to babies who were prenatally diagnosed with a critical congenital heart defect or babies who were born before 35 weeks gestation. However, according to Indiana's newborn screening law, EVERY baby born in Indiana must be screened for CCHD. Each birthing facility is responsible for developing its own protocols to ensure that all children (regardless of gestational age or NICU status) receives screening for CCHD.
Does Indiana have a set of pulse oximetry screening protocols for the NICU population?
Currently, there are no national guidelines for the NICU population. Although the SACHDNC workgroup recognized the importance of providing pulse oximetry screening to children in the NICU, the workgroup stated that "developing a simple algorithm for the NICU setting is challenging because of the heterogeneity of underlying conditions (e.g., prematurity, meconium aspiration syndrome, sepsis)."1
In 2011, ISDH consulted with neonatologists at Riley Hospital for Children at Indiana University Health & St. Vincent Hospital in order to ask for their recommendations on screening infants who were not included in the national pulse oximetry screening protocols. These professionals recommended that, in order to be compliant with Indiana's newborn screening law, all children born prior to 35 weeks gestational age & all children in the NICU should receive either pulse oximetry screening or an echocardiogram prior to discharge.
What critical congenital heart defects are detected by pulse oximetry newborn screening?
The SACHDNC listed the following seven specific heart defects1:
- Hypoplastic left heart syndrome (HLHS)
- Pulmonary atresia
- Tetralogy of Fallot (TOF)
- Total anomalous pulmonary venous return (TAPVR)
- Transposition of the great arteries (TGA)
- Tricuspid atresia
- Truncus arteriosus
Are there secondary conditions that can be detected by pulse oximetry newborn screening?
Yes. Pulse oximetry monitoring is capable of detecting other conditions that include hypoxia and which may be associated with cardiac findings, including persistent pulmonary hypertension.1
When should pulse oximetry newborn screening be performed?
The SACHDNC workgroup recommended that pulse oximetry screening be performed no earlier than 24 hours of age. Earlier screening can lead to an increased rate of false positive results due to the transition from fetal to neonatal circulation & the stabilization of systemic oxygen saturation levels.
The SACHDNC workgroup also stated that pulse oximetry screening should be completed by the 2nd day of life, as later screening can miss an opportunity for intervention for defects that are impacted by the closing of the ductus arteriosus.1
Should the hand & foot oximetry readings be done at the same time, or consecutively?
The oximetry readings for the infant's right hand & right foot may be done in parallel (at the same time) OR consecutively (one after the other). The results of the pulse oximetry screen will not be different.
What constitutes a "pass" or "did not pass" result?
A "did not pass result" should be given to any screen where:
- The oxygen saturation measurement is < 90%,
- Oxygen saturation measurements are < 95% in both extremities on three consecutive measurements separated by one hour, OR
- There is a > 3% absolute difference in oxygen saturation between the right hand & foot on three consecutive measurements separated by one hour.
NOTE: The SACHDNC workgroup stated that any infant who has an oxygen saturation measurement of < 90% should be immediately referred for an echocardiogram & clinical assessment. Pulse oximetry screening should NOT be repeated for these infants.1
A "pass" result should be given to any screen where the pulse oximetry readings are ≥ 95% in the hand or foot AND where there is ≤ 3% difference between the hand & foot measurements.
What are the diagnostic recommendations for children who do not pass the pulse oximetry newborn screen?
Any infant who does not pass the pulse oximetry newborn screen should receive:
A comprehensive clinical evaluation to rule out infectious & pulmonary pathology that can cause hypoxemia, A diagnostic echocardiogram to confirm/exclude a critical congenital heart defect (if no other cause of hypoxemia is identified), Referral to Pediatric Cardiology
The diagnostic echocardiogram should be done by a sonographer trained to perform pediatric echocardiograms & interpreted by a board-certified Pediatric Cardiologist. Echocardiograms should be performed immediately for symptomatic infants. For asymptomatic infants, the echocardiogram should be done prior to discharge; if a pediatric echocardiogram cannot be performed at your facility, the infant should be transferred to a facility that can perform pediatric echocardiograms.
The SACHDNC workgroup emphasized the need for high-quality echocardiograms that are interpreted by a pediatric cardiologist due to the challenge of diagnosing some of the critical congenital heart defects. Echocardiogram should NOT be replaced with alternate evaluations (e.g., chest x-ray, hyperoxia test).1
Can parents/legal guardians refuse pulse oximetry screening for a child?
According to Indiana's newborn screening law, the only legal reason that parents/legal guardians can refuse newborn screening (including pulse oximetry screening) is if they object based on their religious beliefs and if the objection is documented in writing.
If your facility uses its own form for refusal of newborn screening (instead of the state Religious Waiver form), the form should clearly state that parents/legal guardians are refusing newborn screening (including heelstick, hearing screening, and/or pulse oximetry screening) based on their religious beliefs. ISDH will no longer accept generic "refusal of newborn care" forms as documentation of religious refusal of newborn screening.
Birthing facilities can download a copy of the current state Religious Waiver form from the ISDH Newborn Screening Professionals' website at http://www.in.gov/isdh/20381.htm.
Frequently Asked Questions - Training, Equipment, & Reporting
Will birthing facilities need to maintain a "logbook" for pulse oximetry newborn screening?
Yes. Birthing facilities will need to create & maintain their own logbooks for pulse oximetry newborn screening, just as they do for heelstick & hearing screening. For more information about what report(s) is/are required by the ISDH Newborn Screening Program, see below.
Will the heelstick card be updated to include pulse oximetry data?
In fall 2012, ISDH will begin a project with Oz Systems in order to obtain pulse oximetry screening results & additional newborn screening information via electronic transmission from each facility's screening equipment. Facilities that do not have internet access or are otherwise unable to electronically transmit data will need to submit pulse oximetry screening data on every infant through an updated heelstick card. The new heelstick card will be distributed to birthing facilities in late 2012 or early 2013. More information will be provided as soon as it is available.
What report(s) are required by ISDH?
Birthing facilities are required to complete & submit a Pulse Oximetry Monthly Summary Report (MSR). Children who are reported on the Pulse Oximetry MSR include:
- Children who do not pass pulse oximetry newborn screening
- Children who did not receive pulse oximetry newborn screening due to various exception codes (e.g., NICU, Religious Waiver, child is deceased)
Summary data is also collected. The Pulse Oximetry MSR is submitted through the Indiana Newborn Screening Tracking & Education Program (INSTEP) web-based application or via a paper MSR form for facilities that have not yet been trained to use INSTEP.
How will birthing facility staff receive training for pulse oximetry screening & MSR reporting?
Birthing facility staff should work with their nursing managers & administrators to coordinate & provide training to teach new staff how to perform pulse oximetry measurements. If your facility does not already offer some form of pulse oximetry training to new staff, contact the hospital to which infants born at your facility are commonly referred for cardiology follow-up (e.g., echocardiograms) & ask if the hospital would be willing to provide training to your staff. Alternatively, contact the vendor from which your facility has purchased pulse oximeters to ask if the vendor is able & willing to provide pulse oximetry training.
Make sure that pulse oximetry training for your facility's staff includes an explanation of the differences between adult & pediatric oximeter probes, an explanation of the importance of adequate circulation, & the effects of hypothermia & phototherapy on pulse oximetry screening.
The ISDH Newborn Screening Program is currently offering training classes (through June 2012) for facilities whose Pulse Oximetry MSR contacts do not already utilize the INSTEP web-based application. Your facility's Pulse Oximetry MSR contacts should have already received notification of available INSTEP MSR classes.
Is there assistance available for birthing facilities that need to purchase pulse oximeters?
Each birthing facility is responsible for obtaining & maintaining equipment for pulse oximetry newborn screening. It is understood that some birthing facilities will have additional expenditures related to purchasing pulse oximeters and pulse oximeter probes in order to be compliant with pulse oximetry newborn screening.
Are there recommendations for which type/brand of pulse oximeter & probe facilities should use?
Currently, there are no FDA guidelines or standards related to pulse oximeters. Per the FDA, information on devices that are cleared for use in neonates (including labeling, intended use statements, & clearance letters) is available on the FDA's website. Facilities might also consider contacting the vendor or manufacturer of your facility's pulse oximeters & probes to obtain more information about whether the equipment is FDA-cleared for use in neonates.
A tutorial to guide your facility through the process of determining whether a device or sensor has been FDA-cleared for use in neonates is available here. This tutorial was provided by Children's National Medical Center.
The SACHDNC workgroup recommended that facilities perform pulse oximetry newborn screening with motion-tolerant pulse oximeters that report functional oxygen saturation. Pulse oximeters in use should have been validated in low-perfusion conditions, have been cleared by the FDA for use in newborns, and have a 2% root-mean-square accuracy. Pulse oximeters are often labeled with a "generation of technology" by the manufacturer (e.g., "next generation"). However, facilities should know that generation designation is NOT standardized and may not be related to validity or reliability.
Pulse oximeters can be used with either disposable or reusable probes. Currently, there are no specifications related to which type of probe should be used for pulse oximetry newborn screening; however, birthing facilities should ONLY use the probes that have been validated & approved for their specific pulse oximeters. NOTE: Pulse oximetry newborn screening should ONLY be performed using pediatric probes. Do NOT use an adult oximetry probe for this screen!
The FDA is currently developing a document to provide standardized guidance on which types of pulse oximeters and probes should be used for pulse oximetry newborn screening. When the FDA document is finalized and published, all birthing facilities should ensure that they are using a pulse oximeter that meets FDA recommendations.1
Frequently Asked Questions - Billing & Educational Materials
How should birthing facilities bill for pulse oximetry newborn screening?
Currently, there are no clear guidelines for pulse oximetry newborn screening billing. According to the SACHDNC workgroup, “…the currently available Current Procedural Terminology (CPT) codes for pulse oximetry are only appropriate when accompanied by a diagnostic code for a pulmonary disease associated with hypoxia.”1
The SACHDNC workgroup recommended that the AAP, AHA, ACCF and American Medical Association (AMA) collaborate to develop appropriate CPT codes for pulse oximetry newborn screening. An additional recommendation included working with public & private payers to assure appropriate reimbursement.
Indiana’s newborn screening fee of $85 only covers the cost of performing the screening tests included in the heelstick portion of NBS. Hospitals can bill separately for performing pulse oximetry newborn screening (& hearing screening). ISDH strongly recommends that birthing facilities and physicians work with their billing departments to ensure that there are protocols in place for billing costs related to pulse oximetry newborn screening.
Are educational materials available for families of children who did not pass pulse oximetry screening?
The ISDH Newborn Screening Program has developed a parent fact sheet for pulse oximetry newborn screening.
1Kemper AR, et al. Strategies for Implementing Screening for Critical Congenital Heart Disease. Preprint for publication in Pediatrics (peer-reviewed and accepted; not copyedited or formatted). DOI (10.1542/peds.2011-1317). 2011.