I sent this out early this morning, but somehow it didn't go through.
 
November 17. 2005
 
Colleagues:
 
Earlier this month, Dr. Jon Rosenberg sent a message to CACC [California APIC (Assoc. for Professionals in Infection Control) Coordinating Council] members 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):
1635. (a) "Donor" is an individual, living or deceased, from whom tissue is removed.
            (b) "Person" is an individual, corporation, business trust, estate trust, partnership, association, state or local government, or subdivision or agency thereof, or any other legal entity.
            (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.
            (d) "Tissue bank" is any place, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings.
            (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.
            (f) "State department" is the State Department of Health Services.  
 
(Underlining added by me)
 
According to this law, human milk for a mother's own infant, stored (definition is overnight or change of date) would require a tissue bank license.  Although most of us consider the definition of milk bank to be a facility that processes human milk, we are all milk banks/tissue banks by the above definition.  Blood banks are exempt because they have their own more extensive regulations.  Sperm banks are not exempt, only individual physicians who directly implant the sperm.
 
I have gone to the California Health and Safety Code (All 1600 sections pertain to Tissue Banks - primarily 1635-1635.2) (http://www.leginfo.ca.gov/cgi-bin/waisgate?WAISdocID=19999916188+1+0+0&WAISaction=retrieve) and related codes, emailed and spoken with Jon Rosenberg MD, Division of Communicable Disease Control, CA DHS, and Tuesday 11/15/05 participated in a conference call with Ron Harkey, Chief of the DHS Tissue Bank Licensing Program, and Jan Otey and Clint Venable of that program.  
 
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 some instances record keeping, labeling, and storage requirements for this activity were somewhat lax.  Historically, the tissue banking licensing program has been a slowly evolving program to which new activities are continuously added as the program becomes aware of their existence.  
 
Mr. Harkey did clarify that a consent form would not be needed or appropriate for mother's own milk.  Mr. Venable clarified that a separate tissue bank license (with a separate fee) would be appropriate for those hospitals who already have a tissue bank license for other tissues (skin, eye, kidneys) as the policies/ procedures and medical direction would be quite different and should there be any problems with the other tissue bank, any program on the same license would need to be shut down.
 
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.
 
It appears that a mother's own milk for her infant does fall within the current law as a "tissue bank".  Until we amend the law (if that is what we wish to do), Mr. Harkey and his colleagues must operate by that law, now that they are aware of current NICU milk storage and usage.  I believe they truly want to ensure safe milk for our infants and see the wide variation in handling and storage a danger to our patients.  I am confident that they will work with us to make the process as painless as possible, as we discuss our options further.
 
Nancy
Nancy E. Wight MD, IBCLC, FABM, FAAP
Neonatologist
Children's Hospital of San Diego and
Sharp Mary Birch Hospital for Women
Medical Director, Sharp HealthCare Lactation Services
Breastfeeding Coordinator, AAP District IX, Chapter 3
Immediate Past President, Academy of Breastfeeding Medicine
 
Resources:
 
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]
 
DHS Tissue Bank Licensing Program
Mr. Ronald Harkey  [log in to unmask]
Chief, DHS Tissue Bank Licensing Program
850 Marina Parkway
Richmond, CA  94804
 
Clint Venable  [log in to unmask]  510-620-3829
Jan Otey  [log in to unmask]  510-620-3816
Tom Tempske [log in to unmask]  510-620-3817
 

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