Storage and Use of Residual Specimens

(A) The Newborn Blood Screening Program is the custodian of Residual Specimens. Residual Specimens shall be retained, stored, used, and destroyed by the Newborn Blood Screening Program only in accordance with 105 CMR 270.000. Residual Specimens shall be retained in a secure environment under the direction of the Newborn Blood Screening Program. The Program shall ensure that no specimen shall be retrieved or shared for any purpose other than authorized uses specified in 105 CMR 270.000. 105 CMR - 1284.2 270.012: continued (B) The Newborn Blood Screening Program shall retain and use Residual Specimens for a minimum of 15 years and a maximum of 16 years, except upon written request for destruction from all parents or legal guardians of a child, the Newborn Blood Screening Program shall destroy a stored Residual Specimen as soon as practicable, but no later than one year from the receipt of a written request. After 16 years from the date of birth of a child, the newborn screening specimen shall be destroyed. (C) Residual Specimens shall be used and shared for only the following purposes, subject to specimen availability as determined by the Newborn Blood Screening Program: (1) Laboratory Quality Assurance, including laboratory quality control, laboratory validation, participation in proficiency testing, and the practice of continuous quality improvements; (2) Individual or family clinical benefit with individual or parent/guardian authorization in writing; (3) Individual or family forensic purposes with individual or parent/guardian authorization in writing; (4) Uses authorized by law including, but not limited to, an investigation of a child death by a state or local child fatality review team pursuant to M.G.L. c. 38, § 2A, at the request of the local district attorney, or by the Office of the Chief Medical Examiner pursuant to M.G.L. c. 38, § 4, at the request of the Chief Medical Examiner, or his or her designee, in order to establish the cause and manner of death and identity of the deceased; (5) In response to a court order. Upon receipt of a court order, the Newborn Blood Screening Program shall notify the Department and the specimen subject's parent or legal guardian in writing as soon as possible in order to provide an opportunity to object to the order in court; or (6) Research studies approved by the Department pursuant to M.G.L. c. 111, § 24A and an Institutional Review Board, provided that a Residual Specimen is not provided to a researcher without the written consent of the parent or guardian.