Code of Massachusetts Regulations
105 CMR - DEPARTMENT OF PUBLIC HEALTH
Title 105 CMR 270.000 - Blood Screening Of Newborns For Treatable Diseases And Disorders
Section 270.012 - Storage and Use of Residual Specimens and Data

Universal Citation: 105 MA Code of Regs 105.270

Current through Register 1531, September 27, 2024

(A) Residual specimens and data shall be retained, stored, used, and destroyed by the Newborn Screening Program only in accordance with the Massachusetts Department of Public Health Policy on the Retention, Storage and Use of Newborn Screening Data and Residual Specimens.

(B) Except as provided in 105 CMR 270.012(C), the Newborn Blood Screening Program shall retain and use residual specimens for a minimum of 15 years and a maximum of 16 years for the purposes of:

(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;

(3) Individual or family forensic purposes;

(4) Uses authorized by law;

(5) Research studies approved by the Department or UMMS Institutional Review Board provided that a residual specimen is not provided to a researcher without the written consent of the parent or guardian for specimens collected on or after March 16, 2015. The IRB retains discretion to require consent for use of any stored residual specimen for any particular research study.

(C) Upon written request from all parents or legal guardians of a child, the Newborn Blood Screening Program shall destroy a stored residual specimen within a reasonable period of time not to exceed one year from the receipt of the written request.

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