A colleague who works in a Los Angeles area hospital reports that California State Law requires an institution to have a valid California Tissue License if "mother's milk" is stored on the premises, even if the milk is for a mother's own baby's use. The "mother's milk" must be labeled and handled in such a way to assure that it is delivered to the correct infant. It is also her understanding that if the "mother's milk" is given to the mother's own baby, the baby's mother can be exempt from donor testing, much like autologous donors can be exempt from donor testing, if their blood is collected and transfused within the same institution. For other donors, California State regulation HEALTH AND SAFETY CODE SECTION 1644.5(e) requires that human donors of breast milk must test non-reactive for agents of viral hepatitis (HBV and HCV), human T lymphotrophic virus-1 (HTLV-1), HIV, or syphilis, since milk from sero-reactive donors would be impermissible to be deposited into a milk bank for human ingestion in California. The inquiring colleague's hospital blood bank has a Tissue License for the storage and dispensing of various tissues, but the hospital blood bank does not handle human milk. The human milk is stored in the newborn nursery and Labor and Delivery. Consequently, the hospital is requiring that the nursery and Labor and Delivery areas obtain their own Tissue License jointly, but separate from the hospital blood bank's Tissue License, and to develop their own policies and procedures for "handling" the mother's milk. She wonders how other facilities are addressing this issue. Is this unique to California? What has been the experience of others?

Editor's Note: The information in the pdf file from the San Diego County Breastfeeding Coalition is germane to this dicussion.

ADDENDA Jan. 25, 2006

1. Editor's note: The initial question for this discussion focused on the requirement for a hospital in California to have a Tissue Licence in order to 'store' breast milk that has been collected from a mother for her own baby's feeding. However, pasteurized human milk products are commercially available in California. Therefore, it seems appropriate for this discussion to also address the question: 'Does a hospital in California need to have a Tissue Bank License in order to store and dispense pasteurized human milk products? If so, must the product be stored and dispensed from the area of the hospital that stores and dispenses other human tissues, or can any area of the hospital (specifically the nursery and labor and delivery) store and dispense this product without interaction with the hospital's main tissue storage area?'

In response to this additional question, Ron Harkey and Jan Otey (of California Department of Health / Laboratory Field Services (also see directory HERE) have given permission for the following response to be shared with the e-Network Forum.

"Yes, the hospital must have a tissue bank license for the storage of pasteurized human milk that has been collected and processed by another licensed tissue bank. If the hospital already has a license for the storage of a mother’s milk for her own child, the pasteurized human milk could be stored under that license. The licensed bank would be required to follow the instructions that accompany the pasteurized product and to include these in their procedure manual. If there is not a licensed milk bank within the hospital, the pasteurized milk could be stored under an existing tissue bank license if the director agrees to assume responsibility and oversight for its storage and distribution. If the director does not agree, a separate unit with its own director and license would be required for the pasteurized milk. Department of Health / Laboratory Field Services does not specify where tissue should be stored as long as manufacturer’s instructions are followed as well as the hospital’s own written policies and procedures to ensure appropriate tissue handling and patient and public safety."

ADDENDA Mar. 12, 2006

2. Editor's Note: The Editor wonders if the proposal Senate Bill No. 1785, introduced by Senator Figueroa February 24, 2006 might be worth considering.

ADDENDA Apr. 11, 2006

3. Ms. Andrea Hoberman, Program and Public Policy Manager of the Perinatal Advisory Council (PAC/LAC; attribution used with permission), reports that her organization is a co-sponsor of SB 1785, along with the California Hospital Association, and is happy to offer their expertise on this topic. Over the past few months, PAC/LAC has held informational forums with perinatal health care professionals to clarify the current tissue bank licensing laws and to discuss possible legislative change to exempt storage of human milk collected from a mother exclusively for her own child from the licensing requirements. Their most recent gathering on April 5, 2006 was geared towards empowering nurses to advocate individually, and on behalf of their health care facilities, to gather support for SB 1785. PAC/LAC has developed a number of advocacy tools, including sample letters, phone scripts, and postcards for this purpose that they would be happy to share with interested parties. Attached for download are the Health and Safety code sections documenting the current law, the most recently amended text of SB 1785, and a fact sheet on this issue. Ms. Hoberman can be contaced by email at ahoberman@paclac.org for additional information or materials.

ADDENDA May 12, 2006

4. Editor's Note: SB 1785 (Figueroa) Human Milk (also see fact sheet and Breast Feeding Task Force of Greater Los Angeles- California Legislative Alert) reportedly has passed out of the California Senate Health Committee and is on to the California Senate Floor.

ADDENDA May 13, 2006

5. Editor's Note: The attached News Release from Senator Figueroa confirms that SB 1785 has passed the first Senate Committee.

ADDENDA Oct. 1, 2006

6. Editor's Note: Senate Bill 246 was approved by the Governor Sept. 26, 2006 and was filed with Secretary of State September 26, 2006. This is an act to add Section 1648 to the Health and Safety Code, relating to human milk (full text).

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Ira A. Shulman, MD
CBBS e-Network Forum Editor & Moderator