Help! Has anyone in California heard of this? We received this email from
the CA department of health services. Any other states requiring this? We
are checking to see if the blood bank would cover the NICU too.


Janet Hoover, LM, IBCLC
Santa Cruz, CA

A healthcare facility that stores human milk, even for administration to the
donor's own child, is required by California law to be a licensed tissue
bank.  I am send this information to be distributed to your members because
many, if not most, have been under the impression that milk stored for a
donor's own use does not require a tissue bank license.


The tissue bank law is found in Chapter 4.1 of the California Health and
Safety Code (Sections 1635 though 1643.2).  The following definitions apply;
italics have been added for emphasis.

1635 (c) "Tissue" is any human cell, group of cells, tissue or organ
including the cornea, sclera, or vitreous humor and other segments of, or
the whole eye, bones, skin, arteries, sperm, blood, other fluids, and any
other portion of a human body. 

1635 (d) "Tissue bank" is any place, establishment, or institution that
collects, processes, stores, or distributes tissue for transplantation into
human beings.

1635 (e) Transplantation is the act or process of transferring tissue,
including by ingestion, from a donor to the body of the donor or another
human being. 

By definition any institution that stores milk from a mother for her own
child would require a tissue bank license since the milk is processed
(labeled) and stored using the hospital's equipment and personnel.  Certain
precautions must be taken by the hospital to assure that the milk is safely
stored at temperature that will prevent contamination and assure that it is
safely given to the correct child.   In regard to human milk all activities
listed below would require a tissue bank license.  


The storage of human milk by a hospital for a mother's own child.  The
hospital is assuming full responsibility for the safe storage of the milk. 
Storage of human milk by a hospital that has been received from a commercial
milk bank. 
The collection of milk from donors to be processed for homologous
distribution (STD testing requirements would apply). 
 

For application for a tissue bank license, please contact one of the
following individuals in the Department of Health Services (see e-mails
above):


Clint Venable: (510) 620-3829

Jan Otey: (510) 620-3816

Tom Tempske: (510) 620-3817

Jon

Jon Rosenberg, M.D.

Division of Communicable Disease Control

Infectious Diseases Branch

Infection Control and Healthcare Epidemiology

CA Department of Health Services

850 Marina Bay Parkway

Bldg. P, 2nd Floor

Richmond, CA 94804-6403

Voice: (510) 620-3427 (not 3428)

Fax: (510) 620-3425

mailto:[log in to unmask]

visit our web site at http://www.dhs.ca.gov/ps/dcdc/dcdcindex.htm  

 

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