Starting July 1, 2012, Virginia law requires hospitals with obstetric services to offer to provide to the parent of each infant born at the hospital a blood sample collected from the infant.
§ 32.1-134.02. Infants; blood sample provided to parents.
Every hospital providing maternity care shall offer to obtain a sample of blood from an infant born at the hospital and provide that sample to the mother of the infant.
The hospital gives this blood sample to the mother after it is collected for future use if needed to obtain a DNA analysis to help identify a child in the event of an emergency such us an accident, natural or manmade disaster, or abduction. The parent is responsible for storage of the sample. Once the hospital collects the sample and provides it to the parent, only the parent will have access to the sample; the hospital has no further responsibility for the sample, its storage, analysis.
VHHA has prepared this information to assist you in developing your organization’s policies and procedures for implementation of the Child ID Program in your hospital or health system. The following materials are included in the package:
Suggested consent form (PDF)
The materials in this packet are suggested approaches to implementation and patient communication. Your organization may use or revise them as determined appropriate by administrators; obstetric service and newborn nursery physician, nursing and other staff; legal counsel; risk managers; and financial/reimbursement personnel.
At this time Florida is the only other state that operates a similar program. In preparing this information packet, we have consulted with Florida hospitals on their procedures and with experts both within and outside Virginia on the technical issues related to collection and storage of blood samples for DNA analysis. However, we expect that, as the program is implemented by Virginia hospitals, questions will arise, and we will learn how to improve the program.
More detail on the Child ID Program follows. We recommend that you develop your own organization’s policies and procedures after consultation with appropriate personnel, including your obstetric and newborn nursery service physician, nursing and other staff; legal counsel; risk managers; and financial/reimbursement personnel.
The new law requires that hospitals providing obstetric/maternity care offer to obtain and give to the mother a sample of the newborn’s blood. The hospital is required to offer to collect the sample, but the mother may decline the collection offer.
Information for parents on the Child ID Program is included in this packet to help you explain the program and procedures to parents.
To demonstrate that the hospital complied with the law requiring that it offer to obtain the blood sample, hospitals should document that they made the offer and document the parent’s acceptance or refusal of the offer.
Once the sample is collected, it is given directly to the mother, who then assumes responsibility for any storage or further use of the sample. Once it is given to the mother, the hospital has no further access to or responsibility for the sample, including its storage, analysis or use.
A suggested consent form is included in this package to obtain parental consent for collection of the sample and to clarify the respective responsibilities of the parent and the hospital for the collection, storage and use of the sample.
The sample may be collected in the delivery room from the newborn’s cord blood. It also may be collected later in the nursery from the same prick used to collect blood for state-mandated newborn screening for metabolic and other disorders, but the Child ID Program blood spot will be collected on a separate stain card and provided to the mother.
The Child ID Program stain card clearly shows where blood is to be spotted and provides space to label the card with the newborn’s name and date of birth. Once the sample is collected, the stain card should be inserted in a foil storage envelope with desiccant to keep the sample dry and protect the viability of the sample for DNA analysis as needed at a later date.
The experts VHHA consulted agree that stain cards containing untreated paper are adequate to preserve the sample under dry room-temperature storage conditions for the purposes of the Child ID Program. Stain cards using treated (FTA) papers can be used to better preserve blood samples for DNA analysis under extreme storage conditions, and they reportedly kill potential pathogens in the blood, but we are advised that the less expensive untreated paper will preserve the sample for many years under normal storage conditions. See below for sources for the card, desiccant and foil envelope:
4300 Shoreline Drive, Spring Park, MN 55384
Order Form: http://www.fitzcoinc.com/images/Fitzco%20Order%20form.pdf
To order from Fitzco:
By phone: Dial (952)224-2700 or toll free (800)367-8760 to speak with a customer service representative.
By fax: Send a purchase order or fax form to (952)224-2717.
By e-mail: Attach a purchase order and send a quick summary e-mail to firstname.lastname@example.org
By mail: Send a purchase order to: Fitzco, 4300 Shoreline Drive, Spring Park, MN 55384
For hospitals wishing to use their own GPO contracts, GE Healthcare, offers similar products. The 903 Protein Saver Card contains untreated paper and the FTA Micro Card contains treated paper as described above. For more information, consult your materials management department or go to the GE Healthcare website at www.gelifesciences.com.
Each hospital may wish to confer with its own financial/reimbursement staff and advisers to determine how to manage the cost of and billing for the blood spot collection materials and services.
The Virginia Department of Medical Assistance Services advises VHHA that Child ID Program blood spot collection is covered for Medicaid enrollees; include charges in Revenue Code 0399 (other blood handling).
Other coverage and reimbursement for Child ID Program blood spot collection is likely to vary by carrier and related contract provisions. VHHA is seeking and will provide to members any additional information we have on this issue as it is available.
The Child ID Program blood spot will be collected on a stain card containing treated or untreated paper and placed in a foil storage envelope with desiccant.
The blood sample may be collected in the nursery at the same time that blood is collected for newborn screening. Generally, technical blood collection procedures will be the same as for newborn screening blood collection except that the Child ID Program sample is given to the mother. The sample also may be collected at delivery using cord blood.
Give program information to the parent. Obtain parental consent to collect the sample.
Wear gloves at all times when handling the stain card to prevent contamination of the stain card with your DNA.
Wearing gloves, place the newborn’s name and date of birth on the stain card and on the outside of the foil pouch. A hospital patient label can be used for this purpose.
Fill the circle outlined on the stain card with blood sample using concentric circular motion. Don’t puddle, rub or smear the sample.
Allow the blood to dry. This can be done by setting the card up in a triangular shape.
Put the card, along with the desiccant, into the foil pouch and seal. (Desiccant should be stored in an airtight container prior to use.)
Give the card to the mother.
Once the stain card is sealed in the foil pouch, it is protected from contamination as long as the pouch remains sealed. The pouch should not be opened unless and until DNA analysis is to be performed.
What is the Child ID Program?
The Child ID Program gives you the option at the time of your child’s birth of having the hospital collect and give you a sample of your newborn's blood. In the event of a future emergency involving your child such as an accident, abduction, or natural or manmade disaster, the blood collected can be used to perform a DNA analysis for use in identifying your child. As with a child’s fingerprints, just having the blood sample does not keep your child safe, but when you store your child’s blood sample you will have an additional piece of information you can give to authorities in an emergency.
Is collection of the sample required?
No. The hospital is required to offer to collect your infant’s blood sample and provide it to you, but the hospital will not collect the sample unless you say you want it. The hospital will ask you for your consent before collecting this blood sample for child identification.
How is the sample taken?
A drop of blood is spotted onto a specially designed blood stain card, placed in a protective envelope with a drying agent, sealed, and given directly to you for storage and safekeeping. The sample can be collected at delivery using your baby’s cord blood or later when your baby’s blood is collected in the hospital nursery for the separate newborn screening that is required by law to identify diseases and disorders.
How is this Child ID Program blood sample collection different from the collection of blood for required newborn screening?
State law requires that every newborn infant be screened for certain diseases and disorders. This newborn screening process, which allows for diagnosis and early treatment of these disorders in order to prevent mental retardation and permanent disability or death, begins when the hospital collects several spots of the newborn infant’s blood on a special card and sends the card to a state-approved laboratory for analysis to identify any disorders. This differs from the Child ID Program blood collection, which is done on a separate card and is given directly to you, the parent, for storage and safekeeping.
What should I do with the Child ID Program sample?
Only you, the parent, will have access to this sample. Once the hospital collects the sample and provides it to you, the hospital has no further responsibility for the sample, including its storage, analysis or use. We recommend that you place the sample in a safe, dry place at normal room temperature. Once sealed, this pouch should not be opened unless and until there is a need for DNA testing to identify your child because exposure to air and light can cause the DNA in the bloodstain to break down or can expose the sample to contamination.
How long does the sample last?
If the pouch remains sealed and is kept in a dry place at normal room temperature, the sample should be useful for DNA analysis for many years.
What is DNA?
DNA stands for deoxyribonucleic acid. It is often referred to as the building block of life. DNA contains the genetic information that makes each human unique. With the exception of identical twins, everyone's DNA is different. DNA does not change over the course of an individual’s life.
Is an inked footprint taken of my child at birth a good method of identification?
An inked footprint could be useful in identifying an infant who was abducted shortly after birth and then quickly recovered. In most cases, a newborn’s feet are full of creases and wrinkles, but as a baby grows, these creases and wrinkles will decrease and the footprint ridges will become more prominent. Because of these changes, the footprints taken at birth might not be useful in identifying an older child. Having a blood sample could be a valuable tool for identification.
DNA can be obtained from saliva, so why use blood?
DNA test results can be obtained from saliva. However, for purposes of long-term storage, blood is the best option. The normal bacteria found in the mouth can cause the DNA in the saliva to break down over time. By storing a blood sample, you significantly increase the possibility that the sample will be useable for DNA testing.
Who else has access to this blood sample?
No one has access to the sample but you. Only one blood sample will be taken, and this sample will be given to you after collection. The hospital does not keep or have access to the blood sample after it is collected for the purposes of the Child ID Program.
Must DNA testing be done at the time the blood sample is taken from my child?
No, it is not necessary to perform DNA testing at this time. This blood sample is only a method of keeping a sample containing your child's DNA available in the case of an emergency requiring identification of your child. Your child's DNA will not change over the course of his or her lifetime. DNA testing methods, however, do change. The type of test performed today might be outdated in the future. By storing the blood stain card without analyzing it, the best technology in place at the time of need can be used.
Information Available in Spanish
Prince William Hospital has translated into Spanish the “Child ID Program – Information for Parents” document that VHHA provided to members in its implementation information in April. The hospital also has translated into Spanish its consent form for collection of the blood sample. The hospital has generously agreed to make these translations available to other hospitals for their use. Any hospital using the translations should assure that their content is consistent with the hospital’s own policies and procedures. Thanks to Prince William Hospital for this effort.
Collection of Samples in Babies Who Receive Transfusions
The Virginia Department of Health is researching the impact of infant blood transfusions on the usefulness of the collected blood spot for DNA analysis and will provide VHHA with guidance on managing these cases. VHHA will provide this information to hospitals as soon as it is available.