Accreditation of Genetic Testing Labs
April 10, 1997
TO: STATE AGENCIES ADMINISTERING CHILD SUPPORT ENFORCEMENT PLANS APPROVED UNDER TITLE IV-D OF THE SOCIAL SECURITY ACT AND OTHER INTERESTED INDIVIDUALS
SUBJECT: Accreditation of Genetic Testing Labs
PURPOSE: The purpose of this IM is to share information about national organizations that accredit laboratories doing genetic testing for paternity.
BACKGROUND: The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (P.L.104-193) mandates that states have and use procedures by which genetic test results can be admitted as evidence of paternity without the need for additional foundation testimony or other proof of accuracy. For states to take advantage of this expedited procedure in contested cases, the test must be of a type generally acknowledged as reliable by an approved accreditation body, and be performed by an accredited laboratory. P.L. 104-193 requires the Secretary of HHS to designate the accreditation bodies.
To fulfill this requirement, two nationally organized accreditation bodies have been identified: the American Association of Blood Banks and the American Society for Histocompatibility and Immunogenetics.
INQUIRIES TO: ACF Regional Administrators
David Gray Ross
Office of Child Support
Current program performance standards require State Child Support Enforcement Agencies to contract with genetic testing laboratories to perform paternity tests to resolve disputed paternity of children born to unmarried parents. The laboratories must perform at reasonable cost tests that are legally and medically acceptable to identifying or excluding an alleged father.
Several reforms related to paternity determination are mandated in the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (P.L. 104-193), which reinforce the national movement of the last decade to expedite contested paternity cases quickly and fairly. One of the new requirements pertains to the introduction into evidence of genetic test results. P.L. 104-193 says that states must have and use procedures under which they can introduce as evidence of paternity the results of any genetic test that is of a type generally acknowledged as reliable by accreditation bodies and is performed by an accredited laboratory. When both conditions are satisfied, the test results can be introduced as evidence of paternity without the need for foundation testimony or other proof of authenticity or accuracy, unless some objection is made. Existing law requires states to have and use procedures under which objections must be made within a specific time period; the new law gives states the flexibility to base the timeframe for objections on the scheduled hearing date or the date the test result was received.
The requirement that states choose accredited laboratories for paternity testing in order to expedite contested cases reflects the widespread acceptance in scientific and legal circles of the validity of particular genetic tests for paternity, as well as for existing standards, such as chain-of-custody, for safeguarding test results. A customary means of assuring the reliability and validity of genetic tests for paternity is for testing laboratories to voluntarily seek accreditation under the standards and requirements set by recognized accrediting bodies. In genetic testing for parentage, there are two accrediting bodies, the American Association of Blood Banks (AABB) and the American Society for Histocompatibity and Immunogenetics (ASHI). Information about accreditation of labs for parentage testing is available from the American Association of Blood Banks, 8101 Glenbrook Rd., Bethesda, Maryland 20814. Phone (301) 907-6895. Similar information is available from the American Society for Histocompatibility and Immunogenetics, 8310 Nieman Rd., Lenexa, Kansas 66214. Phone (913) 541-0009.