The New York State Department of Health (NYSDOH) Newborn Screening (NBS) Program securely stores residual (unused during routine testing) dried blood spot specimens for up to 27 years. These dried blood spot specimens are available by request for use in approved public health research and assay development projects, for delayed diagnostic investigations and for forensic purposes.
Public Health Research or Assay Development
To obtain specimens for a specific research project, the Principal Investigator for the project must:
- Obtain approval from their Institutional Review Board (IRB) to perform the proposed research.
- Complete and submit the proper paperwork along with the aforementioned IRB approval to the Director of the Newborn Screening Program (contact information is to the right).
- If the project requires information to specifically identify specimens (e.g. name, date of birth, and hospital of birth), fill out the Newborn Screening Specimen Request Form for Identified Specimens. An appropriate signed consent form must also be submitted for each requested identifiable newborn specimen.
- If the project does not require information that can specifically identify a specimen (e.g. allowed non-identifying information might include maternal age, zip code, gender, identified disorder), fill out the Newborn Screening Specimen Request Form for De-identified Specimens.
The Program will forward the request to the NYSDOH IRB for consideration, and upon our IRB approval, will process the specimen request. It should be noted that unless complete specimen destruction is requested by the parents/legal guardians, the Program retains a portion of all specimens in the event that the specimen is needed for future clinical or legal purposes. If specimen quantity is limited, some specific requests may not be granted. Specimens will be delivered to the Principal Investigators as per agreed upon method, and will include a copy of the completed request form.
New York State licensed health care providers may also request dried blood specimens for additional clinical testing, following NYSDOH regulations governing clinical laboratory testing. Such requests are limited to physicians providing care directly to the patient in question; parents and non-direct care physicians may not request specimens for these purposes. To obtain a specimen(s) for this purpose, a written request must be submitted to the Director of the Newborn Screening Program, containing the following information to ensure accurate specimen identification and proper specimen usage:
- Infant’s name
- Infant’s date of birth
- Infant’s gender
- Mother’s name
- Any other names by which the baby might be identified
- Name of the hospital of birth
- Any other information necessary to ensure accurate specimen identification
- Reason for the request and the intended use of the specimen
- Address for mailing the specimen
- Consent document signed by the parents or the legal guardians
Occasionally, the Program is required to provide specimens for the purpose of establishing identity in official law enforcement investigations. These requisitions come in the form of a request from a medical examiner or by court subpoena. Requests for specimens for such purpose should follow the same protocol as above for obtaining a specimen for additional clinical testing. Additionally, a copy of the subpoena should be included. Approvals for release of specimens require review by DOH counsel.