NEWBORN BLOOD SAMPLES - S.B. 807 (S-1): FLOOR ANALYSIS
Senate Bill 807 (Substitute S-1 as reported)
Sponsor: Senator John J.H. Schwarz, M.D.
Committee: Health Policy
CONTENT
The bill would amend the Public Health Code to provide for the retention and disposal of blood specimens taken from a newborn infant for the newborn screening tests required under the Code; allow the blood specimens to be used for medical research under certain conditions; allow the health professional in charge of a birth, or the hospital, to offer to a newborn's parents a blood sample from the newborn, for future identification purposes; and require the Department of Community Health (DCH) to rewrite its pamphlet explaining the newborn screening requirements.
Currently, the health professional in charge of the care of a newborn infant, or the health professional in charge of the birth, must administer to the infant tests for various conditions as prescribed in the Code. The bill provides that the DCH, by April 1, 2000, would have to develop a schedule for the retention and disposal of the blood specimens used for the screening tests after the tests were completed. The schedule would have to meet at least all of the following conditions:
-- Be consistent with nationally recognized standards for laboratory accreditation and Federal law.
-- Require that the disposal be conducted in compliance with the Code's requirements regarding the disposal of medical wastes.
-- Require that the disposal be conducted in the presence of a witness (who could be an individual involved in the disposal or any other individual).
-- Require that a written record of the disposal be made and kept, and signed by the witness.
The DCH would have to allow the blood specimens to be used for medical research during the retention period established under the schedule, as long as the medical research was conducted in a manner that preserved the anonymity of the test subjects, and was consistent to protect human subjects from research risks, pursuant to the Code of Federal Regulations.
MCL 333.5431 - Legislative Analyst: G. Towne
FISCAL IMPACT
It would appear that additional costs resulting from this bill, if any, would be nominal. Costs to the Department of Community Health would be limited as the required pamphlet would not have to be rewritten until the existing supply of pamphlets had been distributed. Standards already exist for the disposal of biohazardous material and any additional record-keeping would be spread across the 130,000 to 135,000 births each year.
Date Completed: 10-22-99 - Fiscal Analyst: J. WalkerFloor\sb807 - Bill Analysis @ http://www.state.mi.us/sfa
This analysis was prepared by nonpartisan Senate staff for use by the Senate in its deliberations and does not constitute an official statement of legislative intent.