An infant is sick and the physician would like to rule out metabolic disease. Should I do a newborn screen?

What is the fee for newborn screening?

An infant has a family history of one of the diseases screened for. Is NBS sufficient testing to rule out these disorders?

What measures does NSO take to ensure that patient information is secure?

What happens to the newborn screening sample after testing is complete? 

Can stored newborn screening samples be used for research?

How long does NSO store the NBS cards?


An infant is sick and the physician would like to rule out metabolic disease. Should I do a NBS?

No. Newborn screening is a screen, and cannot substitute for diagnostic testing.


What is the fee for newborn screening?

Currently, newborn screening is free for all babies born in Ontario including those who are not residents and do not have OHIP.


An infant has a family history of one of the disorders screened for. Is NBS sufficient testing to rule out these disorders?

No. NBS is a ­screen only, and cannot replace diagnostic testing. If there is a significant family history of a condition (for example, an affected sibling), diagnostic testing should be performed to rule out that condition in an infant.


What measures does NSO take to ensure that patient information is secure?

NSO has implemented multiple safeguards to ensure the security and accuracy of the personal health information collected as part of the newborn screening process.

All personal health information is stored within the baby’s record in our electronic information management system that is specifically designed for Newborn Screening Programs. Protected by network firewalls and login/password access, the system is accessible only to NSO staff and it allows privileges to be set for users based on their role in the program, thereby limiting access to information on a “need to know” basis. The system also provides tools for ensuring accuracy, identifying errors, auditing, and specimen tracking, designed to meet privacy requirements and laboratory standards.

The program is located at the Children’s Hospital of Eastern Ontario and is therefore supported by the robust IT infrastructure in place and well defined policies and procedures around access control and appropriate use of information. Our facilities and storage areas are secure, requiring key and swipecard access.


What happens to the newborn screening sample when testing is complete?

At the present time in Ontario, blood spots are stored for 19 years, as they have traditionally been regarded as part of a child’s medical record. The primary purpose of the spot is for screening infants for the conditions noted here. However, other secondary uses are possible, including:
a)   Quality control and quality assurance within the NBS laboratory (i.e. ensuring that the laboratory and its testing are functioning properly);
b)   Retesting of the sample to assist in making a diagnosis and at the request of health care providers involved in the care of the baby;
c)   Usage after a legal warrant or court order (e.g. by the Coroner’s office for the investigation of a sudden infant death);
d)   Release of a portion of a sample to a third party with the written consent of the individual or their surrogate decision maker (usually a parent);
e)   Fully deidentified samples may be used for research approved by a research ethics board, and in compliance with the provisions in the Personal Health Information Privacy Act (PHIPA).  Identified samples can only be used for research with the written consent of the individual or their surrogate decision maker.


Can stored newborn screening samples be used for research?

There are currently only two ways that your infant’s samples can be used for research:

1.   Research that needs the infant’s sample linked to the infant’s identity. This could only happen after obtaining written consent from the child (if they were old enough to give consent) or from their surrogate decision maker (a parent or guardian).  The study would have to be approved by a research ethics board.
·     The parent/guardian and/or child would be fully informed of the purpose of the research as well as the pros and cons of participating in the research. 
·     The parent/guardian and/or child would have the ability to choose to participate or decline to participate in such a research study. 
·     If the parent/guardian and/or child declined – the child’s sample would NOT be used in the research.
·     A research ethics board is a group of people representing the fields of medicine, science, ethics and the general public.  A lay person sits on this board to ensure that the research being done is in the best interest of society.  The remainder of the committee make sure the research is scientifically sound and does not violate ethical principles.

2.   Research that requires the infant’s sample may be allowed without obtaining the parent/guardian and/or child's consent ONLY IF:
·     The infant’s sample is de-identified. This means that the portion of the child’s sample used for such a study can NOT be traced back to the child in any way (e.g. all identifying information is removed from the sample: name, date of birth, health card number, address, postal code, mother’s name, birth hospital, etc.).  This means no one, including the researcher, the government or insurance companies, will be able to link the research results to the infant or their family.
AND
·     The study has been approved by a research ethics board.  


How long does NSO store the NBS cards?

At the present time, NBS cards are considered a part of the child’s medical record and are kept until the child is 19 years old. The demographic information and testing results on each baby are stored permanently in our database.