California Newborn Screening Program
Ensuring Testing of All Infants
The Newborn Screening (NBS) Program has several mechanisms in place to ensure testing of all babies born in California. State NBS Regulations specify reporting requirements for both licensed perinatal health facilities and county registrars to ensure testing. All newborns must be tested; the only legal ground for refusal is a conflict with beliefs and practices. The following procedures and forms are utilized to ensure testing.
The Newborn and Prenatal Screening laboratories enter demographic data and test results on terminals linked to a Genetic Disease Screening Program central computer in Richmond. A computer-generated printed report of all test results, referred to as a "result mailer", is mailed to the hospital where the specimen was collected. Another copy is mailed to the physician of record as reported on the specimen collection form.
Perinatal facilities must review each newborn's medical record within 14 days from the date of discharge to determine that the NBS results are filed in it, or that a parent's or legal guardian's signed refusal is present. If it has been determined that a newborn was not tested, the facility must notify the infant's physician and the NBS Program. If a specimen was collected (as indicated by the presence of the goldenrod copy of the specimen collection form) but there is no NBS Results Mailer in the chart, the facility must complete a Missing Result Form (see below) and submit it to the State within five days. Most often the State has a record of the baby having been tested and a duplicate result mailer is forwarded to the hospital. Occasionally, a baby is not tested or the specimen is lost between the hospital and lab, and these are followed up. It is the responsibility of the pediatrician who provides comprehensive care for the child to ensure that a newborn screening test has been done and that the results have been reviewed and noted in the patient's chart. Pediatric care providers who do not have a copy of the NBS Result Mailer can request a duplicate from the State or regional Area Service Center.
Our Consent for Release of Information form, which also serves as our request for Newborn Screening results, can be found at Consent for Release (PDF) . Make sure to fill out the form completely, as the more information we have, the easier it will be to process the request. Per HIPAA regulations, we will need a parent/guardian signature to provide results, unless your practice is listed as the physician of record on the original test request form. If the family is unavailable to sign our form, but has already signed a 'Consent to Treat' or 'Consent to Release of Information' with your ofiice, you may send a copy of that release along with the completed newborn screening form and the request will be processed. Feel free to make copies of our blank release form for future use. Completed forms can be faxed to the Newborn Screening Program at 510-412-1559 or mailed to the address above. Results are sent by mail in as timely a manner as possible, but any interesting cases will be reported immediately. Please contact us at 510-412-1541 if you have any questions.
It is essential that the NBS-NO and NBS-OH forms be mailed promptly to the California NBS Program. The State follows up on each of these forms to make sure the baby has been tested. Unless there is a record of parent refusal on file, the State refers all untested babies under one year of age to the Area Service Center NBS Coordinators for assistance in obtaining the test. If there is a delay in sending the forms to the State, there is a delay in getting the babies tested, which in turn could delay treatment if a baby has one of the disorders for which the newborn screening panel tests.
Information for County Birth Registrars