California Tissue Bank Law and Human Milk Storage
Nancy E. Wight MD, IBCLC, FABM, FAAP
In early November 2005, Dr. Jon Rosenberg (Infectious Diseases Branch, CA DHS) sent a message to California infection control professionals indicating that any healthcare facility that stores human milk, even for administration to the mother's own child, is required by California law to be a licensed tissue bank. The tissue bank law is found in Chapter 4.1 of the California Health and Safety Code (Sections 1635-1643.2). According to this law, any human milk for a mother's own infant, stored (definition is overnight or change of date) would require a tissue bank license.
The law in question and its regulations are not new. The DHS Tissue Bank Licensing Program has been licensing homologous milk banks since the beginning of the program in 1992. Recently a number of new commercial for-profit milk banks have caused them to look at existing facilities more closely. Any hospital that accepts and stores milk from one of these facilities must also be a milk bank. They did not realize, but soon found out, that storage of milk for a mother's own child by the hospital was quite common, and that in a few instances record keeping, labeling, and storage requirements for this activity were somewhat lax. The Tissue Bank Program is in the process of licensing all hospitals, but they did clarify that a consent form would not be needed or appropriate for mother's own milk.
Paul B. Kimsey, PhD, Assistant Deputy Director of the Division of Laboratory Science has stated that the tissue bank program in LFS (Laboratory Field Services) "is committed to assuring
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that babies in hospitals continue to receive their mother's own milk or any other medically recommended human milk that may be provided by a licensed milk bank." He requested we contact him (Dr. Kimsey) at 510-412-5846 or Ron Harkey, Section Chief for the Tissue Bank Program at 510-620-3808 for questions or problems.
I think we all are in agreement that a mother's own milk can be literally lifesaving for her preterm infant and results in improved short and long-term outcomes for all infants. We also agree that there must be quality control policies/procedures and guidelines as to how to store and use mother's own milk safely for her own infant. Most of us believe we do a good job, using recognized national (www.hmbana.org) and California (www.cpqcc.org) guidelines. Where we disagree is the appropriateness of classifying the storage and use of a mother's own milk as a "tissue bank". As physicians, lactation consultants, nurses and hospitals, we are concerned that the gains we have made in the use of mother's milk for preterm and ill infants in California's NICUs will be lost due to burdensome regulations that discourage hospitals from collecting, storing and providing the mother's own milk to feed her own infant.
The CA Hospital Association has taken the lead in emergency corrective legislation (SB 1785, Senator Figueroa) so that the Tissue Bank licensing law does not act as a disincentive to breastfeeding in California hospitals. Co-sponsoring organizations are being sought. If you have questions or comments, please contact Sheree Kruckenberg at the CHA (skruckenberg@calhospital.org).
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