BILL ANALYSIS Ó SENATE COMMITTEE ON APPROPRIATIONS Senator Ricardo Lara, Chair 2015 - 2016 Regular Session AB 2750 (Gomez) - Tissue banks ----------------------------------------------------------------- | | | | | | ----------------------------------------------------------------- |--------------------------------+--------------------------------| | | | |Version: June 13, 2016 |Policy Vote: HEALTH 7 - 0 | | | | |--------------------------------+--------------------------------| | | | |Urgency: No |Mandate: No | | | | |--------------------------------+--------------------------------| | | | |Hearing Date: June 27, 2016 |Consultant: Brendan McCarthy | | | | ----------------------------------------------------------------- This bill does not meet the criteria for referral to the Suspense File. Bill Summary: AB 2750 would provide an exemption from the requirement that tissue banks be licensed by the state for persons providing health care services, under specified conditions Fiscal Impact: Ongoing reduction in licensing workload and fee revenues, likely less than $100,000 per year (Tissue Bank License Fund). Currently, there are about 270 hospitals and ambulatory surgical centers that are licensed as tissue banks. Under the bill, some portion of those facilities could surrender their tissue bank license, to the extent that such entities have a tissue bank license only due to their storage of allograft tissue that meets the exemption requirement in the bill. The share of hospitals or ambulatory surgical centers that only have a tissue bank license due to their storage of such tissue is unknown. Because the exemption provided for in this bill is only for tissue that is designated for storage at ambient room temperature, there are likely to be a significant number of AB 2750 (Gomez) Page 1 of ? hospitals and ambulatory surgical centers that will still need to maintain their tissue bank license, in order to continue to store other tissues. For example, if 40% of such facilities surrendered their license, the reduction in licensing workload and fee revenue would be about $100,000 per year. Background: Under current law, entities acting as tissue banks must be licensed by the Department of Public Health and must meet specified regulatory requirements. Tissue banks collect, store, and provide musculoskeletal tissue, skin, and veins for transplantation. Current law exempts a number of activities from the licensing requirement, such as the collection and storage of human blood and its derivatives. Under current law, the Department is required to develop and adopt regulations governing tissue banks. However, the Department has not yet adopted regulations. In guidance provided to potential licensees, the Department has indicated that any facility that stores any tissue or does not return unused tissue to a licensed tissue bank within the same day as receiving the tissue must be licensed as a tissue bank. In many cases, a tissue bank will send tissue for transplantation for a specific patient to a hospital or ambulatory surgical center but the transplantation cannot occur on that day. In such cases, a hospital or surgery center may store the tissue overnight for transplantation the next day. According the Department, such a hospital or surgery center would need to be licensed as a tissue bank in that case. In fact, according to the Department, 191 hospitals and 77 ambulatory surgery centers are licensed as tissue banks, presumably due to this requirement. Proposed Law: AB 1822 would provide an exemption for persons providing health care services, under specified conditions from the requirement that tissue banks be licensed by the state. Specifically, the bill would exempt a hospital or ambulatory surgical center from licensure as a tissue bank if certain record keeping requirements are met, certain storage and handling requirements are met, and the allograft tissue is AB 2750 (Gomez) Page 2 of ? registered with the federal Food and Drug Administration and designated to be maintained at ambient room temperature. Related Legislation: AB 1822 (Bonta, 2014) was substantially similar to this bill. That bill was vetoed by Governor Brown. Staff Comments: Staff notes that it is not likely that the Department would reduce staff expenditures immediately under the bill, therefore the Department is likely to support current staff with other licensing fees for some period of time before staff are fully redirected to other licensing activities or positions are eliminated. -- END --