Code of Maine Rules
10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES
144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL
Chapter 283 - NEWBORN BLOODSPOT SCREENING RULE
Section 144-283-12 - RESIDUAL FILTER PAPER SPECIMEN STORAGE AND USE

Universal Citation: 10 ME Code Rules ยง 144-283-12

Current through 2024-38, September 18, 2024

A. The primary use of residual filter paper specimens is for the processing of newborn screening tests as allowed by this rule. Residual filter paper specimens are used to support essential program functions such as program evaluation, quality assurance, result verification, test refinement, and quality improvement initiatives. Specifically, residual filter paper specimens are used to document that specimens were properly collected, transported, received and analyzed for the benefit of the newborn.

B. After testing is completed, the contracted laboratory will store residual filter paper specimens indefinitely. The contracted laboratory storage must be in accordance with Clinical and Laboratory Standards Institute Guidelines (CLSI) (https://clsi.org/). Storage conditions must be appropriate, secure and stable, and storage must allow specimens to be retrieved, if necessary.

C. Residual filter paper specimens may be used for further testing as recommended by the healthcare provider if these tests are available through the contracted laboratory or through other laboratories. The healthcare provider must obtain a signed (Department) Authorization to Release Information from the parent/guardian or the individual if they are a legal adult. The healthcare provider must also complete and sign the Request for Retrieval of Residual Filter Paper Specimens for Additional Testing Form provided by the Department at the request of the healthcare provider. The costs associated with additional testing that is not required by this rule is the responsibility of the parent or legal guardian.

D. The information collected in this program is maintained by the Department. Information is used to identify infants at risk of developing intellectual and developmental disabilities or serious illness and to develop programs to prevent and detect such disorders.

E. Information obtained during the testing process becomes the property of the Department and may be used in compliance with confidentiality laws, for program evaluation or research by the Department or Department-approved scientific researchers to improve the health of mothers and children.

F. Newborn blood specimens obtained during the testing process become the property of the Department and may be used in compliance with confidentiality laws, for program evaluation or research by the Department or Department-approved scientific researchers to improve the health of mothers and children, unless the person or his/her legal authorized representative:

1. Specifically prohibits such use in writing on a form provided by the Department; or

2. Requests destruction of the residual filter paper specimen under Section 13.

G. The Department, with input from the JAC, may release de-identified residual filter paper specimens or samples to external agencies for research projects, if the research project has received approval through the Department's process for research requests.

1. Prior to release of any residual filter paper specimens or samples, the Department must de-identify specimens or samples by assigning a unique numeric identifier to prevent the specimen or sample from being linked to the original specimen or sample, unless the Department has written record of parental consent to release identifiable information; and

2. Prior to release of any residual filter paper specimens or samples, the external agency receiving the specimens or samples will sign an appropriate Confidentiality and Use Agreement which will specify that the released specimen or sample and any information obtained with, or derived from, it may only be used for the specifically approved study.

3. Any remaining residual filter specimens or samples in the custody of researchers must be destroyed by the research program upon completion of the study.

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