AB 2750: Tissue banks.
- Session Year: 2015-2016
- House: Assembly
- Latest Version Date: 2016-09-09
Existing federal law governs the processing, storage, and use of human tissue and human cell, tissue, or cellular- or tissue-based products (HCT/P), as specified, and imposes certain regulatory duties relating to HCT/P upon the federal Food and Drug Administration (FDA).
Existing state law requires the State Department of Public Health to license and regulate tissue banks, which process, store, or distribute human tissue for transplantation into human beings. Existing law generally requires every tissue bank operating in this state to have a current and valid tissue bank license issued or renewed by the department, but exempts certain activities from that requirement, including the storage of HCT/P by a licensed physician or podiatrist, as specified, if the products were obtained from a California-licensed tissue bank, stored in strict accordance with manufacturer instructions, and used solely for the express purpose of direct implantation into or application on the practitioners own patient, among other criteria.
This bill would create an additional exemption from the tissue bank licensing requirement for the storage of allograft tissue by a person if that person is a hospital or outpatient setting, the person maintains a log including specified information pertaining to the allograft tissue, and the allograft tissue meets specified requirements, including, among other things, that the allograft tissue was obtained from a California-licensed tissue bank, is individually boxed and labeled with a unique identification number and expiration date, and is intended for the express purpose of implantation into or application on a patient.
Existing federal law governs the processing, storage, and use of human tissue and human cell, tissue, or cellular- or tissue-based products (HCT/P), as specified, and imposes certain regulatory duties relating to HCT/P upon the federal Food and Drug Administration (FDA).
Existing state law requires the State Department of Public Health to license and regulate tissue banks, which process, store, or distribute human tissue for transplantation into human beings. Existing law generally requires every tissue bank operating in this state to have a current and valid tissue bank license issued or renewed by the department, but exempts certain activities from that requirement, including the storage of HCT/P by a licensed physician or podiatrist, as specified, if the products were obtained from a California-licensed tissue bank, stored in strict accordance with manufacturer instructions, and used solely for the express purpose of direct implantation into or application on the practitioners own patient, among other criteria.
This bill would create an additional exemption from the tissue bank licensing requirement for the storage of allograft tissue by a person if that person is a hospital or outpatient setting, the person maintains a log including specified information pertaining to the allograft tissue, and the allograft tissue meets specified requirements, including, among other things, that the allograft tissue was obtained from a California-licensed tissue bank, is individually boxed and labeled with a unique identification number and expiration date, and is intended for the express purpose of implantation into or application on a patient.
Existing federal law governs the processing, storage, and use of human tissue and human cell, tissue, or cellular- or tissue-based products (HCT/P), as specified, and imposes certain regulatory duties relating to HCT/P upon the federal Food and Drug Administration (FDA).
Existing state law requires the State Department of Public Health to license and regulate tissue banks, which process, store, or distribute human tissue for transplantation into human beings. Existing law generally requires every tissue bank operating in this state to have a current and valid tissue bank license issued or renewed by the department, but exempts certain activities from that requirement, including the storage of HCT/P by a licensed physician or podiatrist, as specified, if the products were obtained from a California-licensed tissue bank, stored in strict accordance with manufacturer instructions, and used solely for the express purpose of direct implantation into or application on the practitioners own patient, among other criteria.
This bill would create an additional exemption from the tissue bank licensing requirement for the storage of allograft tissue by a person if that person is a hospital or outpatient setting, the person maintains a log including specified information pertaining to the allograft tissue, and the allograft tissue meets specified requirements, including, among other things, that the allograft tissue was obtained from a California-licensed tissue bank, is individually boxed and labeled with a unique identification number and expiration date, and is intended for the express purpose of implantation into or application on a patient.
Existing federal law governs the processing, storage, and use of human tissue and human cell, tissue, or cellular- or tissue-based products (HCT/P), as specified, and imposes certain regulatory duties relating to HCT/P upon the federal Food and Drug Administration (FDA).
Existing state law requires the State Department of Public Health to license and regulate tissue banks, which process, store, or distribute human tissue for transplantation into human beings. Existing law generally requires every tissue bank operating in this state to have a current and valid tissue bank license issued or renewed by the department, but exempts certain activities from that requirement, including the storage of HCT/P by a licensed physician or podiatrist, as specified, if the products were obtained from a California-licensed tissue bank, stored in strict accordance with manufacturer instructions, and used solely for the express purpose of direct implantation into or application on the practitioners own patient, among other criteria.
This bill would create an additional exemption from the tissue bank licensing requirement for the storage of HCT/P allograft tissue by a person if that person is a hospital or outpatient setting setting, the person maintains a log including specified information pertaining to the allograft tissue, and the HCT/P allograft tissue meets specified requirements, including, among other things, that the HCT/P allograft tissue was obtained from a California-licensed tissue bank licensed by the state, bank, is stored in the original unopened enclosure for one finished unit of transplantable tissue and in strict accordance with the package insert and any other manufacturer instructions and guidelines, individually boxed and labeled with a unique identification number and expiration date, and is intended for the express purpose of implantation into or application on a patient.
Existing federal law governs the processing, storage, and use of human tissue and human cell, tissue, or cellular- or tissue-based products (HCT/P), as specified, and imposes certain regulatory duties relating to HCT/P upon the federal Food and Drug Administration (FDA).
Existing state law requires the State Department of Public Health to license and regulate tissue banks, which process, store, or distribute human tissue for transplantation into human beings. Existing law generally requires every tissue bank operating in this state to have a current and valid tissue bank license issued or renewed by the department, but exempts certain activities from that requirement, including the storage of HCT/P by a licensed physician or podiatrist, as specified, if the products were obtained from a California-licensed tissue bank, stored in strict accordance with manufacturer instructions, and used solely for the express purpose of direct implantation into or application on the practitioners own patient, among other criteria.
This bill would create an additional exemption from the tissue bank licensing requirement for the storage of HCT/P by a person if that person is a hospital or outpatient setting and the HCT/P meets specified requirements, including, among other things, that the HCT/P was obtained from a tissue bank licensed by the state, is stored in the original unopened enclosure for one finished unit of transplantable tissue and in strict accordance with the package insert and any other manufacturer instructions and guidelines, and is intended for the express purpose of implantation into or application on a patient.
(1)Existing law exempts a student, other than a nonimmigrant alien, as defined, from paying nonresident tuition at the California State University and the California Community Colleges if the student meets certain requirements. These requirements include either high school attendance in California for 3 or more years or the attainment of credits earned in California from a California high school equivalent to 3 or more years of full-time high school coursework and a total of 3 or more years of attendance in California elementary or secondary schools, or a combination of those schools.
This bill would delete the requirement of a total of 3 or more years of attendance in California elementary or secondary schools, or a combination of those schools, as referenced above. The bill would also add the requirement that a student be born after January 1, 1980.
The bill would request the Regents of the University of California to enact exemptions from requirements to pay nonresident tuition for its students that are equivalent to those applicable to students of the California Community Colleges and the California State University pursuant to this bill.
Because the bill would impose new duties on community college districts with respect to determining eligibility for exemptions from paying nonresident tuition, the bill would constitute a state-mandated local program.
(2)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that, if the Commission on State Mandates determines that the bill contains costs mandated by the state, reimbursement for those costs shall be made pursuant to these statutory provisions.
(1)Existing law exempts a student, other than a nonimmigrant alien, as defined, from paying nonresident tuition at the California State University and the California Community Colleges if the student meets certain requirements. These requirements include either high school attendance in California for 3 or more years or the attainment of credits earned in California from a California high school equivalent to 3 or more years of full-time high school coursework and a total of 3 or more years of attendance in California elementary or secondary schools, or a combination of those schools.
This bill would delete the requirement of a total of 3 or more years of attendance in California elementary or secondary schools, or a combination of those schools, as referenced above. The bill would also add the requirement that a student be born after January 1, 1980.
The bill would request the Regents of the University of California to enact exemptions from requirements to pay nonresident tuition for its students that are equivalent to those applicable to students of the California Community Colleges and the California State University pursuant to this bill.
Because the bill would impose new duties on community college districts with respect to determining eligibility for exemptions from paying nonresident tuition, the bill would constitute a state-mandated local program.
(2)The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that, if the Commission on State Mandates determines that the bill contains costs mandated by the state, reimbursement for those costs shall be made pursuant to these statutory provisions.
Existing law, the Donahoe Higher Education Act, sets forth the missions and functions of the 4 segments comprising the states postsecondary education system. These segments are the University of California, administered by the Regents of the University of California, the California State University, administered by the Trustees of the California State University, the California Community Colleges, administered by the Board of Governors of the California Community Colleges, and independent institutions of higher education. Provisions of the act apply to the University of California only to the extent that the regents act, by resolution, to make the provisions applicable.
This bill would make nonsubstantive changes in a provision of the act.
Existing law, the Donahoe Higher Education Act, sets forth the missions and functions of the 4 segments comprising the states postsecondary education system. These segments are the University of California, administered by the Regents of the University of California, the California State University, administered by the Trustees of the California State University, the California Community Colleges, administered by the Board of Governors of the California Community Colleges, and independent institutions of higher education. Provisions of the act apply to the University of California only to the extent that the regents act, by resolution, to make the provisions applicable.
This bill would make nonsubstantive changes in a provision of the act.
(a)Except as provided in subdivision (b), every tissue bank operating in California on or after July 1, 1992, shall have a current and valid tissue bank license issued or renewed by the department pursuant to Section 1639.2 or 1639.3.
(b)This chapter does not apply to any of the following:
(1)The collection, processing, storage, or distribution of human whole blood or its derivatives by blood banks licensed pursuant to Chapter 4 (commencing with Section 1600) or any person exempt from licensure under that chapter.
(2)The collection, processing, storage, or distribution of tissue for autopsy, biopsy, training, education, or for other medical or scientific research or investigation, when transplantation of the tissue is not intended or reasonably foreseeable.
(3)The collection of tissue by an individual physician and surgeon from his or her patient or the implantation of tissue by an individual physician and surgeon into his or her patient. This exemption shall not be interpreted to apply to any processing or storage of the tissue, except for the processing and storage of semen by an individual physician and surgeon when the semen was collected by that physician and surgeon from a semen donor or obtained by that physician and surgeon from a tissue bank licensed under this chapter.
(4)The collection, processing, storage, or distribution of fetal tissue or tissue derived from a human embryo or fetus.
(5)The collection, processing, storage, or distribution by an organ procurement organization (OPO), as defined in Section 486.302 of Title 42 of the Code of Federal Regulations, if the OPO, at the time of collection, processing, storage, and distribution of the tissue, has been designated by the Secretary of Health and Human Services as an OPO and meets the requirements of Sections 486.304 and 486.306 of Title 42 of the Code of Federal Regulations, as applicable.
(6)The storage of prepackaged, freeze-dried bone by a general acute care hospital.
(7)The storage of freeze-dried bone and dermis by any licensed dentist practicing in a lawful practice setting, if the freeze-dried bone and dermis have been obtained from a licensed tissue bank, are stored in strict accordance with a kits package insert and any other manufacturer instructions and guidelines, and are used for the express purpose of implantation into a patient.
(8)The storage of a human cell, tissue, or cellular- or tissue-based product (HCT/P), as defined by the federal Food and Drug Administration (FDA), that is either a medical device approved pursuant to Section 510 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 360 et seq.) or that is a biologic product approved under Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262) by a licensed physician or podiatrist acting within the scope and authority of his or her license and practicing in a lawful practice setting. The medical device or biologic product must have been obtained from a California-licensed tissue bank, been stored in strict accordance with the devices or products package insert and any other manufacturer instructions, and used solely for the express purpose of direct implantation into or application on the practitioners own patient. In order to be eligible for the exemption in this paragraph, the entity or organization where the physician or podiatrist who is eligible for the exemption is practicing shall notify the department, in writing, that the practitioner is licensed and meets the requirements of this paragraph. The notification shall include all of the following:
(A)A list of all practitioners to whom the notice applies.
(B)Acknowledgment that each listed practitioner uses the medical device or biologic product in the scope and authority of his or her license and practice for the purposes of direct patient care as described in this paragraph.
(C)A statement that each listed practitioner agrees to strictly abide by the directions for storage in the devices or products package insert and any other manufacturer instructions and guidelines.
(D)Acknowledgment by each practitioner that the medical device or biologic product shall not be resold or distributed.
(9)The collection, processing, storage, or distribution of any organ, as defined in paragraph (2) of subdivision (c) of Section 1635, within a single general acute care hospital, as defined in subdivision (a) of Section 1250, operating a Medicare-approved transplant program.
(10)The storage of allograft tissue by a person if all of the following apply:
(A)The person, as defined in Section 1635, is a hospital, or an outpatient setting regulated by the Medical Board of California pursuant to Chapter 1.3 (commencing with Section 1248), including an ambulatory surgical center.
(B)The person maintains a log that includes the date on which the allograft tissue was received, the expiration date of the allograft tissue, the date on which each allograft tissue is used for clinical purposes, and the disposition of any allograft tissue samples that remain unused at the time the allograft tissue expires.
(C)The allograft tissue meets all of the following:
(i)The allograft tissue was obtained from a tissue bank licensed by the state.
(ii)Each allograft tissue is individually boxed and labeled with a unique identification number and expiration date so that opening the shipping container will not disturb or otherwise alter any of the allograft tissue that is not being utilized.
(iii)The allograft tissue is intended for the express purpose of implantation into or application on a patient.
(iv)The allograft tissue is not intended for further distribution.
(v)The allograft tissue is registered with the FDA and designated to be maintained at ambient room temperature requiring no refrigeration.
(a)Except as provided in subdivision (b), every tissue bank operating in California on or after July 1, 1992, shall have a current and valid tissue bank license issued or renewed by the department pursuant to Section 1639.2 or 1639.3.
(b)This chapter does not apply to any of the following:
(1)The collection, processing, storage, or distribution of human whole blood or its derivatives by blood banks licensed pursuant to Chapter 4 (commencing with Section 1600) or any person exempt from licensure under that chapter.
(2)The collection, processing, storage, or distribution of tissue for autopsy, biopsy, training, education, or for other medical or scientific research or investigation, when transplantation of the tissue is not intended or reasonably foreseeable.
(3)The collection of tissue by an individual physician and surgeon from his or her patient or the implantation of tissue by an individual physician and surgeon into his or her patient. This exemption shall not be interpreted to apply to any processing or storage of the tissue, except for the processing and storage of semen by an individual physician and surgeon when the semen was collected by that physician and surgeon from a semen donor or obtained by that physician and surgeon from a tissue bank licensed under this chapter.
(4)The collection, processing, storage, or distribution of fetal tissue or tissue derived from a human embryo or fetus.
(5)The collection, processing, storage, or distribution by an organ procurement organization (OPO), as defined in Section 486.302 of Title 42 of the Code of Federal Regulations, if the OPO, at the time of collection, processing, storage, and distribution of the tissue, has been designated by the Secretary of Health and Human Services as an OPO and meets the requirements of Sections 486.304 and 486.306 of Title 42 of the Code of Federal Regulations, as applicable.
(6)The storage of prepackaged, freeze-dried bone by a general acute care hospital.
(7)The storage of freeze-dried bone and dermis by any licensed dentist practicing in a lawful practice setting, if the freeze-dried bone and dermis have been obtained from a licensed tissue bank, are stored in strict accordance with a kits package insert and any other manufacturer instructions and guidelines, and are used for the express purpose of implantation into a patient.
(8)The storage of a human cell, tissue, or cellular- or tissue-based product (HCT/P), as defined by the federal Food and Drug Administration (FDA), that is either a medical device approved pursuant to Section 510 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 360 et seq.) or that is a biologic product approved under Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262) by a licensed physician or podiatrist acting within the scope and authority of his or her license and practicing in a lawful practice setting. The medical device or biologic product must have been obtained from a California-licensed tissue bank, been stored in strict accordance with the devices or products package insert and any other manufacturer instructions, and used solely for the express purpose of direct implantation into or application on the practitioners own patient. In order to be eligible for the exemption in this paragraph, the entity or organization where the physician or podiatrist who is eligible for the exemption is practicing shall notify the department, in writing, that the practitioner is licensed and meets the requirements of this paragraph. The notification shall include all of the following:
(A)A list of all practitioners to whom the notice applies.
(B)Acknowledgment that each listed practitioner uses the medical device or biologic product in the scope and authority of his or her license and practice for the purposes of direct patient care as described in this paragraph.
(C)A statement that each listed practitioner agrees to strictly abide by the directions for storage in the devices or products package insert and any other manufacturer instructions and guidelines.
(D)Acknowledgment by each practitioner that the medical device or biologic product shall not be resold or distributed.
(9)The collection, processing, storage, or distribution of any organ, as defined in paragraph (2) of subdivision (c) of Section 1635, within a single general acute care hospital, as defined in subdivision (a) of Section 1250, operating a Medicare-approved transplant program.
(10)The storage of allograft tissue by a person if all of the following apply:
(A)The person, as defined in Section 1635, is a hospital, or an outpatient setting regulated by the Medical Board of California pursuant to Chapter 1.3 (commencing with Section 1248), including an ambulatory surgical center.
(B)The person maintains a log that includes the date on which the allograft tissue was received, the expiration date of the allograft tissue, the date on which each allograft tissue is used for clinical purposes, and the disposition of any allograft tissue samples that remain unused at the time the allograft tissue expires.
(C)The allograft tissue meets all of the following:
(i)The allograft tissue was obtained from a tissue bank licensed by the state.
(ii)Each allograft tissue is individually boxed and labeled with a unique identification number and expiration date so that opening the shipping container will not disturb or otherwise alter any of the allograft tissue that is not being utilized.
(iii)The allograft tissue is intended for the express purpose of implantation into or application on a patient.
(iv)The allograft tissue is not intended for further distribution.
(v)The allograft tissue is registered with the FDA and designated to be maintained at ambient room temperature requiring no refrigeration.
(a)Except as provided in subdivision (b), every tissue bank operating in California on or after July 1, 1992, shall have a current and valid tissue bank license issued or renewed by the department pursuant to Section 1639.2 or 1639.3.
(b)This chapter does not apply to any of the following:
(1)The collection, processing, storage, or distribution of human whole blood or its derivatives by blood banks licensed pursuant to Chapter 4 (commencing with Section 1600) or any person exempt from licensure under that chapter.
(2)The collection, processing, storage, or distribution of tissue for autopsy, biopsy, training, education, or for other medical or scientific research or investigation, when transplantation of the tissue is not intended or reasonably foreseeable.
(3)The collection of tissue by an individual physician and surgeon from his or her patient or the implantation of tissue by an individual physician and surgeon into his or her patient. This exemption shall not be interpreted to apply to any processing or storage of the tissue, except for the processing and storage of semen by an individual physician and surgeon when the semen was collected by that physician and surgeon from a semen donor or obtained by that physician and surgeon from a tissue bank licensed under this chapter.
(4)The collection, processing, storage, or distribution of fetal tissue or tissue derived from a human embryo or fetus.
(5)The collection, processing, storage, or distribution by an organ procurement organization (OPO), as defined in Section 485.302 486.302 of Title 42 of the Code of Federal Regulations, if the OPO, at the time of collection, processing, storage, and distribution of the tissue, has been designated by the Secretary of Health and Human Services as an OPO, pursuant to Section 485.305 of Title 42 of the Code of Federal Regulations, OPO and meets the requirements of Sections 485.304 486.304 and 485.306 486.306 of Title 42 of the Code of Federal Regulations, as applicable.
(6)The storage of prepackaged, freeze-dried bone by a general acute care hospital.
(7)The storage of freeze-dried bone and dermis by any licensed dentist practicing in a lawful practice setting, if the freeze-dried bone and dermis has have been obtained from a licensed tissue bank, is are stored in strict accordance with a kits package insert and any other manufacturer instructions and guidelines, and is are used for the express purpose of implantation into a patient.
(8)The storage of a human cell, tissue, or cellular- or tissue-based product, product (HCT/P), as defined by the federal Food and Drug Administration, Administration (FDA), that is either a medical device approved pursuant to Section 510 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Secs. Sec. 360 and 360e) et seq.) or that is a biologic product approved under Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262) by a licensed physician or podiatrist acting within the scope and authority of his or her license and practicing in a lawful practice setting. The medical device or biologic product must have been obtained from a California licensed California-licensed tissue bank, been stored in strict accordance with the devices or products package insert and any other manufacturer instructions, and used solely for the express purpose of direct implantation into or application on the practitioners own patient. In order to be eligible for the exemption in this paragraph, the entity or organization where the physician or podiatrist who is eligible for the exemption is practicing shall notify the department, in writing, that the practitioner is licensed and meets the requirements of this paragraph. The notification shall include all of the following:
(A)A list of all practitioners to whom the notice applies.
(B)Acknowledgment that each listed practitioner uses the medical device or biologic product in the scope and authority of his or her license and practice for the purposes of direct patient care as described in this paragraph.
(C)A statement that each listed practitioner agrees to strictly abide by the directions for storage in the devices or products package insert and any other manufacturer instructions and guidelines.
(D)Acknowledgment by each practitioner that the medical device or biologic product shall not be resold or distributed.
(9)The collection, processing, storage, or distribution of any organ, as defined in paragraph (2) of subdivision (c) of Section 1635, within a single general acute care hospital, as defined in subdivision (a) of Section 1250, operating a Medicare-approved transplant program.
(10)The storage of allograft tissue by a person if all of the following apply:
(A)The person, as defined in Section 1635, is a hospital, or an outpatient setting regulated by the Medical Board of California pursuant to Chapter 1.3 (commencing with Section 1248), including an ambulatory surgical center.
(B)The person maintains a log that includes the date on which the allograft tissue was received, the expiration date of the allograft tissue, the date on which each allograft tissue is used for clinical purposes, and the disposition of any allograft tissue samples that remain unused at the time the allograft tissue expires.
(C)The allograft tissue meets all of the following:
(i)The allograft tissue was obtained from a tissue bank licensed by the state.
(ii)Each allograft tissue is individually boxed and labeled with a unique identification number and expiration date so that opening the shipping container will not disturb or otherwise alter any of the allograft tissue that is not being utilized.
(iii)The allograft tissue is intended for the express purpose of implantation into or application on a patient.
(iv)The allograft tissue is not intended for further distribution.
(v)The allograft tissue is registered with the FDA and designated to be maintained at ambient room temperature requiring no refrigeration.
SECTION 1.Section 1635.1 of the Health and Safety Code is amended to read:1635.1.(a)Except as provided in subdivision (b), every tissue bank operating in California on or after July 1, 1992, shall have a current and valid tissue bank license issued or renewed by the department pursuant to Section 1639.2 or 1639.3.
(b)This chapter does not apply to any of the following:
(1)The collection, processing, storage, or distribution of human whole blood or its derivatives by blood banks licensed pursuant to Chapter 4 (commencing with Section 1600) or any person exempt from licensure under that chapter.
(2)The collection, processing, storage, or distribution of tissue for autopsy, biopsy, training, education, or for other medical or scientific research or investigation, when transplantation of the tissue is not intended or reasonably foreseeable.
(3)The collection of tissue by an individual physician and surgeon from his or her patient or the implantation of tissue by an individual physician and surgeon into his or her patient. This exemption shall not be interpreted to apply to any processing or storage of the tissue, except for the processing and storage of semen by an individual physician and surgeon when the semen was collected by that physician and surgeon from a semen donor or obtained by that physician and surgeon from a tissue bank licensed under this chapter.
(4)The collection, processing, storage, or distribution of fetal tissue or tissue derived from a human embryo or fetus.
(5)The collection, processing, storage, or distribution by an organ procurement organization (OPO), as defined in Section 486.302 of Title 42 of the Code of Federal Regulations, if the OPO, at the time of collection, processing, storage, and distribution of the organ, has been designated by the Secretary of Health and Human Services as an OPO and meets the requirements of Sections 486.304 and 486.306 of Title 42 of the Code of Federal Regulations, as applicable.
(6)The storage of prepackaged, freeze-dried bone by a general acute care hospital.
(7)The storage of freeze-dried bone and dermis by any licensed dentist practicing in a lawful practice setting, if the freeze-dried bone and dermis have been obtained from a licensed tissue bank, are stored in strict accordance with a kits package insert and any other manufacturer instructions and guidelines, and are used for the express purpose of implantation into a patient.
(8)The storage of a human cell, tissue, or cellular- or tissue-based product (HCT/P), as defined by the federal Food and Drug Administration (FDA), that is either a medical device approved pursuant to Section 510 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 360 et seq.) or that is a biologic product approved under Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262) by a licensed physician or podiatrist acting within the scope and authority of his or her license and practicing in a lawful practice setting. The medical device or biologic product must have been obtained from a California-licensed tissue bank, been stored in strict accordance with the devices or products package insert and any other manufacturer instructions, and used solely for the express purpose of direct implantation into or application on the practitioners own patient. In order to be eligible for the exemption in this paragraph, the entity or organization where the physician or podiatrist who is eligible for the exemption is practicing shall notify the department, in writing, that the practitioner is licensed and meets the requirements of this paragraph. The notification shall include all of the following:
(A)A list of all practitioners to whom the notice applies.
(B)Acknowledgment that each listed practitioner uses the medical device or biologic product in the scope and authority of his or her license and practice for the purposes of direct patient care as described in this paragraph.
(C)A statement that each listed practitioner agrees to strictly abide by the directions for storage in the devices or products package insert and any other manufacturer instructions and guidelines.
(D)Acknowledgment by each practitioner that the medical device or biologic product shall not be resold or distributed.
(9)The storage of allograft tissue by a person if all of the following apply:
(A)The person, as defined in Section 1635, is a hospital, or an outpatient setting regulated by the Medical Board of California pursuant to Chapter 1.3 (commencing with Section 1248), including an ambulatory surgical center.
(B)The person maintains a log that includes the date on which the allograft tissue was received, the expiration date of the allograft tissue, the date on which each allograft tissue is used for clinical purposes, and the disposition of any allograft tissue samples that remain unused at the time the allograft tissue expires.
(C)The allograft tissue meets all of the following:
(i)The allograft tissue was obtained from a tissue bank licensed by the state.
(ii)Each allograft tissue is individually boxed and labeled with a unique identification number and expiration date so that opening the shipping container will not disturb or otherwise alter any of the allograft tissue that is not being utilized.
(iii)The allograft tissue is intended for the express purpose of implantation into or application on a patient.
(iv)The allograft tissue is not intended for further distribution.
(v)The allograft tissue is registered with the FDA and designated to be maintained at ambient room temperature requiring no refrigeration.
(a)Except as provided in subdivision (b), every tissue bank operating in California on or after July 1, 1992, shall have a current and valid tissue bank license issued or renewed by the department pursuant to Section 1639.2 or 1639.3.
(b)This chapter does not apply to any of the following:
(1)The collection, processing, storage, or distribution of human whole blood or its derivatives by blood banks licensed pursuant to Chapter 4 (commencing with Section 1600) or any person exempt from licensure under that chapter.
(2)The collection, processing, storage, or distribution of tissue for autopsy, biopsy, training, education, or for other medical or scientific research or investigation, when transplantation of the tissue is not intended or reasonably foreseeable.
(3)The collection of tissue by an individual physician and surgeon from his or her patient or the implantation of tissue by an individual physician and surgeon into his or her patient. This exemption shall not be interpreted to apply to any processing or storage of the tissue, except for the processing and storage of semen by an individual physician and surgeon when the semen was collected by that physician and surgeon from a semen donor or obtained by that physician and surgeon from a tissue bank licensed under this chapter.
(4)The collection, processing, storage, or distribution of fetal tissue or tissue derived from a human embryo or fetus.
(5)The collection, processing, storage, or distribution by an organ procurement organization (OPO), as defined in Section 486.302 of Title 42 of the Code of Federal Regulations, if the OPO, at the time of collection, processing, storage, and distribution of the organ, has been designated by the Secretary of Health and Human Services as an OPO and meets the requirements of Sections 486.304 and 486.306 of Title 42 of the Code of Federal Regulations, as applicable.
(6)The storage of prepackaged, freeze-dried bone by a general acute care hospital.
(7)The storage of freeze-dried bone and dermis by any licensed dentist practicing in a lawful practice setting, if the freeze-dried bone and dermis have been obtained from a licensed tissue bank, are stored in strict accordance with a kits package insert and any other manufacturer instructions and guidelines, and are used for the express purpose of implantation into a patient.
(8)The storage of a human cell, tissue, or cellular- or tissue-based product (HCT/P), as defined by the federal Food and Drug Administration (FDA), that is either a medical device approved pursuant to Section 510 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 360 et seq.) or that is a biologic product approved under Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262) by a licensed physician or podiatrist acting within the scope and authority of his or her license and practicing in a lawful practice setting. The medical device or biologic product must have been obtained from a California-licensed tissue bank, been stored in strict accordance with the devices or products package insert and any other manufacturer instructions, and used solely for the express purpose of direct implantation into or application on the practitioners own patient. In order to be eligible for the exemption in this paragraph, the entity or organization where the physician or podiatrist who is eligible for the exemption is practicing shall notify the department, in writing, that the practitioner is licensed and meets the requirements of this paragraph. The notification shall include all of the following:
(A)A list of all practitioners to whom the notice applies.
(B)Acknowledgment that each listed practitioner uses the medical device or biologic product in the scope and authority of his or her license and practice for the purposes of direct patient care as described in this paragraph.
(C)A statement that each listed practitioner agrees to strictly abide by the directions for storage in the devices or products package insert and any other manufacturer instructions and guidelines.
(D)Acknowledgment by each practitioner that the medical device or biologic product shall not be resold or distributed.
(9)The storage of an HCT/P allograft tissue by a person if both all of the following apply:
(A)The person, as defined in Section 1635, is a hospital, or an outpatient setting regulated by the Medical Board of California pursuant to Chapter 1.3 (commencing with Section 1248), including an ambulatory surgical center.
(B)The person maintains a log that includes the date on which the allograft tissue was received, the expiration date of the allograft tissue, the date on which each allograft tissue is used for clinical purposes, and the disposition of any allograft tissue samples that remain unused at the time the allograft tissue expires.
(B)
(C)The HCT/P allograft tissue meets all of the following:
(i)The HCT/P allograft tissue was obtained from a tissue bank licensed by the state.
(ii) The HCT/P is stored in the original unopened enclosure for one finished unit of transplantable tissue and is stored in strict accordance with the package insert and any other manufacturer instructions and guidelines.
(ii)Each allograft tissue is individually boxed and labeled with a unique identification number and expiration date so that opening the shipping container will not disturb or otherwise alter any of the allograft tissue that is not being utilized.
(iii)The HCT/P allograft tissue is intended for the express purpose of implantation into or application on a patient.
(iv)The HCT/P allograft tissue is not intended for further distribution.
(v)The HCT/P allograft tissue is regulated by registered with the FDA pursuant to Part 1270 and Part 1271 of Title 21 of the Code of Federal Regulations. and designated to be maintained at ambient room temperature requiring no refrigeration.
(a)Except as provided in subdivision (b), every tissue bank operating in California on or after July 1, 1992, shall have a current and valid tissue bank license issued or renewed by the department pursuant to Section 1639.2 or 1639.3.
(b)This chapter does not apply to any of the following:
(1)The collection, processing, storage, or distribution of human whole blood or its derivatives by blood banks licensed pursuant to Chapter 4 (commencing with Section 1600) or any person exempt from licensure under that chapter.
(2)The collection, processing, storage, or distribution of tissue for autopsy, biopsy, training, education, or for other medical or scientific research or investigation, when transplantation of the tissue is not intended or reasonably foreseeable.
(3)The collection of tissue by an individual physician and surgeon from his or her patient or the implantation of tissue by an individual physician and surgeon into his or her patient. This exemption shall not be interpreted to apply to any processing or storage of the tissue, except for the processing and storage of semen by an individual physician and surgeon when the semen was collected by that physician and surgeon from a semen donor or obtained by that physician and surgeon from a tissue bank licensed under this chapter.
(4)The collection, processing, storage, or distribution of fetal tissue or tissue derived from a human embryo or fetus.
(5)The collection, processing, storage, or distribution by an organ procurement organization (OPO), as defined in Section 485.302 486.302 of Title 42 of the Code of Federal Regulations, if the OPO, at the time of collection, processing, storage, and distribution of the organ, has been designated by the Secretary of Health and Human Services as an OPO, pursuant to Section 485.305 of Title 42 of the Code of Federal Regulations, OPO and meets the requirements of Sections 485.304 486.304 and 485.306 486.306 of Title 42 of the Code of Federal Regulations, as applicable.
(6)The storage of prepackaged, freeze-dried bone by a general acute care hospital.
(7)The storage of freeze-dried bone and dermis by any licensed dentist practicing in a lawful practice setting, if the freeze-dried bone and dermis has have been obtained from a licensed tissue bank, is are stored in strict accordance with a kits package insert and any other manufacturer instructions and guidelines, and is are used for the express purpose of implantation into a patient.
(8)The storage of a human cell, tissue, or cellular- or tissue-based product, product (HCT/P), as defined by the federal Food and Drug Administration, Administration (FDA), that is either a medical device approved pursuant to Section 510 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Secs. Sec. 360 and 360e) et seq.) or that is a biologic product approved under Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262) by a licensed physician or podiatrist acting within the scope and authority of his or her license and practicing in a lawful practice setting. The medical device or biologic product must have been obtained from a California licensed California-licensed tissue bank, been stored in strict accordance with the devices or products package insert and any other manufacturer instructions, and used solely for the express purpose of direct implantation into or application on the practitioners own patient. In order to be eligible for the exemption in this paragraph, the entity or organization where the physician or podiatrist who is eligible for the exemption is practicing shall notify the department, in writing, that the practitioner is licensed and meets the requirements of this paragraph. The notification shall include all of the following:
(A)A list of all practitioners to whom the notice applies.
(B)Acknowledgment that each listed practitioner uses the medical device or biologic product in the scope and authority of his or her license and practice for the purposes of direct patient care as described in this paragraph.
(C)A statement that each listed practitioner agrees to strictly abide by the directions for storage in the devices or products package insert and any other manufacturer instructions and guidelines.
(D)Acknowledgment by each practitioner that the medical device or biologic product shall not be resold or distributed.
(9)The storage of an HCT/P by a person if both of the following apply:
(A)The person, as defined in Section 1635, is a hospital, or an outpatient setting regulated by the Medical Board of California pursuant to Chapter 1.3 (commencing with Section 1248), including an ambulatory surgical center.
(B)The HCT/P meets all of the following:
(i)The HCT/P was obtained from a tissue bank licensed by the state.
(ii) The HCT/P is stored in the original unopened enclosure for one finished unit of transplantable tissue and is stored in strict accordance with the package insert and any other manufacturer instructions and guidelines.
(iii)The HCT/P is intended for the express purpose of implantation into or application on a patient.
(iv)The HCT/P is not intended for further distribution.
(v)The HCT/P is regulated by the FDA pursuant to Part 1270 and Part 1271 of Title 21 of the Code of Federal Regulations.
SECTION 1.Section 68130.5 of the Education Code is amended to read:68130.5.Notwithstanding any other law:
(a)A student, other than a nonimmigrant alien within the meaning of paragraph (15) of subsection (a) of Section 1101 of Title 8 of the United States Code, who meets all of the following requirements shall be exempt from paying nonresident tuition at the California State University and the California Community Colleges:
(1)Satisfaction of either of the following:
(A)High school attendance in California for three or more years.
(B)Attainment of credits earned in California from a California high school equivalent to three or more years of full-time high school coursework.
(2)Graduation from a California high school or attainment of the equivalent thereof.
(3)Registration as an entering student at, or current enrollment at, an accredited institution of higher education in California not earlier than the fall semester or quarter of the 200102 academic year.
(4)Was born after January 1, 1980.
(5)In the case of a person without lawful immigration status, the filing of an affidavit with the institution of higher education stating that the student has filed an application to legalize his or her immigration status, or will file an application as soon as he or she is eligible to do so.
(b)A student exempt from nonresident tuition under this section may be reported by a community college district as a full-time equivalent student for apportionment purposes.
(c)The Board of Governors of the California Community Colleges and the Trustees of the California State University shall prescribe rules and regulations for the implementation of this section.
(d)Student information obtained in the implementation of this section is confidential.
SEC. 2.The Regents of the University of California are requested to enact exemptions from requirements to pay nonresident tuition for its students that are equivalent to those applicable to students of the California Community Colleges and the California State University pursuant to Section 68130.5 of the Education Code, as amended pursuant to this act.
SEC. 3.If the Commission on State Mandates determines that this act contains costs mandated by the state, reimbursement to local agencies and school districts for those costs shall be made pursuant to Part 7 (commencing with Section 17500) of Division 4 of Title 2 of the Government Code.
Notwithstanding any other law:
(a)A student, other than a nonimmigrant alien within the meaning of paragraph (15) of subsection (a) of Section 1101 of Title 8 of the United States Code, who meets all of the following requirements shall be exempt from paying nonresident tuition at the California State University and the California Community Colleges:
(1)Satisfaction of either of the following:
(A)High school attendance in California for three or more years.
(B)Attainment of credits earned in California from a California high school equivalent to three or more years of full-time high school coursework and a total of three or more years of attendance in California elementary schools, California secondary schools, or a combination of those schools. coursework.
(2)Graduation from a California high school or attainment of the equivalent thereof.
(3)Registration as an entering student at, or current enrollment at, an accredited institution of higher education in California not earlier than the fall semester or quarter of the 200102 academic year.
(4)Was born after January 1, 1980.
(4)
(5)In the case of a person without lawful immigration status, the filing of an affidavit with the institution of higher education stating that the student has filed an application to legalize his or her immigration status, or will file an application as soon as he or she is eligible to do so.
(b)A student exempt from nonresident tuition under this section may be reported by a community college district as a full-time equivalent student for apportionment purposes.
(c)The Board of Governors of the California Community Colleges and the Trustees of the California State University shall prescribe rules and regulations for the implementation of this section.
(d)Student information obtained in the implementation of this section is confidential.
SEC. 2.The Regents of the University of California are requested to enact exemptions from requirements to pay nonresident tuition for its students that are equivalent to those applicable to students of the California Community Colleges and the California State University pursuant to Section 68130.5 of the Education Code, as amended pursuant to this act.
SEC. 3.If the Commission on State Mandates determines that this act contains costs mandated by the state, reimbursement to local agencies and school districts for those costs shall be made pursuant to Part 7 (commencing with Section 17500) of Division 4 of Title 2 of the Government Code.
SECTION 1.Section 66000 of the Education Code is amended to read:66000.This part shall be known, and may be cited, as the Donahoe Higher Education Act.
This part shall be known known, and may be cited cited, as the Donahoe Higher Education Act.
|
Date
|
Status
|
|---|---|
| May 12, 2016 | Read third time. Passed. Ordered to the Senate. (Ayes 78. Noes 0.) |
| Sep 9, 2016 | Chaptered by Secretary of State - Chapter 273, Statutes of 2016. |
| Sep 9, 2016 | Approved by the Governor. |
| Aug 24, 2016 | Enrolled and presented to the Governor at 11:45 a.m. |
| Aug 18, 2016 | Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 79. Noes 0. Page 5871.). |
| Aug 18, 2016 | Senate amendments concurred in. To Engrossing and Enrolling. |
| Aug 11, 2016 | Read third time. Passed. Ordered to the Assembly. (Ayes 37. Noes 0. Page 4879.). |
| Aug 11, 2016 | Read third time. Passed. Ordered to the Assembly. |
| Aug 11, 2016 | In Assembly. Concurrence in Senate amendments pending. May be considered on or after August 14 pursuant to Assembly Rule 77. |
| Aug 3, 2016 | Ordered to special consent calendar. |
| Jun 28, 2016 | Read second time. Ordered to third reading. |
| Jun 27, 2016 | From committee: Do pass. (Ayes 6. Noes 0.) (June 27). |
| Jun 13, 2016 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on APPR. |
| Jun 8, 2016 | From committee: Do pass and re-refer to Com. on APPR. (Ayes 7. Noes 0.) (June 8). Re-referred to Com. on APPR. |
| May 23, 2016 | From committee chair, with author's amendments: Amend, and re-refer to committee. Read second time, amended, and re-referred to Com. on HEALTH. |
| May 19, 2016 | Referred to Com. on HEALTH. |
| Feb 19, 2016 | Introduced. To print. |
| May 12, 2016 | Read third time. Passed. Ordered to the Senate. (Ayes 78. Noes 0. Page 4789.) |
| May 12, 2016 | Read third time. Passed. Ordered to the Senate. |
| May 12, 2016 | In Senate. Read first time. To Com. on RLS. for assignment. |
| May 5, 2016 | Read second time. Ordered to Consent Calendar. |
| May 4, 2016 | From committee: Do pass. To Consent Calendar. (Ayes 20. Noes 0.) (May 4). |
| Apr 20, 2016 | From committee: Do pass and re-refer to Com. on APPR. with recommendation: To Consent Calendar. (Ayes 16. Noes 0.) (April 19). Re-referred to Com. on APPR. |
| Apr 14, 2016 | From committee: Be re-referred to Com. on HEALTH. Re-referred. (Ayes 11. Noes 0.) (April 14). Re-referred to Com. on HEALTH. |
| Apr 11, 2016 | Re-referred to Com. on RLS. pursuant to Assembly Rule 96. |
| Apr 11, 2016 | Re-referred to Com. on HIGHER ED. |
| Apr 7, 2016 | From committee chair, with author's amendments: Amend, and re-refer to Com. on HIGHER ED. Read second time and amended. |
| Mar 28, 2016 | Re-referred to Com. on HIGHER ED. |
| Mar 17, 2016 | Referred to Com. on HIGHER ED. |
| Mar 17, 2016 | From committee chair, with author's amendments: Amend, and re-refer to Com. on HIGHER ED. Read second time and amended. |
| Feb 22, 2016 | Read first time. |
| Feb 21, 2016 | From printer. May be heard in committee March 22. |
|
Date
|
Description
|
Location
|
Votes
|
|
|---|---|---|---|---|
| Aug 18, 2016 | AB 2750 GOMEZ Concurrence in Senate Amendments | Assembly Floor |
Passed |
|
| Aug 11, 2016 | Special Consent AB2750 Gomez | Senate Floor |
Passed |
|
| Jun 27, 2016 | Do pass | Senate Standing Committee on Appropriations |
Passed |
|
| Jun 8, 2016 | Do pass, but first be re-referred to the Committee on [Appropriations] | Senate Standing Committee on Health |
Passed |
|
| May 12, 2016 | AB 2750 GOMEZ Consent Calendar Second Day Regular Session | Assembly Floor |
Passed |
|
| May 4, 2016 | Do pass. To Consent Calendar. | Assembly Standing Committee on Appropriations |
Passed |
|
| Apr 19, 2016 | Do pass and be re-referred to the Committee on [Appropriations] with recommendation: To Consent Calendar | Assembly Standing Committee on Health |
Passed |
|
| Apr 14, 2016 | Be re-referred to the Committee on [Health] | Assembly Standing Committee on Rules |
Passed |
This list shows positions taken on this bill by organizations on the date displayed, which is linked to the original source.
Positions by individuals are not included.
|
Organization
|
Position
|
Date
|
|---|---|---|
| Medex | * Indeterminate | Jun 8, 2016 |
| Mimedx | ** Support | Aug 18, 2016 |
CONCURRENCE IN SENATE AMENDMENTS
CSA1 Bill Id:AB 2750
Author:(Gomez)
As Amended Ver:June 13, 2016
Majority vote
ASSEMBLY: | 78-0 | (May 12, 2016) | SENATE: | 37-0 | (August 11, 2016) |
Original Committee Reference: HEALTH
SUMMARY: Creates an additional exemption from tissue bank licensing requirements.
The Senate amendments exempt the storage of allograft issue by a person from tissue bank licensure requirements if all of the following apply:
- The person is a hospital or an outpatient setting regulated by the Medical Board of California, including an ambulatory surgical center;
- The person maintains a log that includes the date on which the allograft tissue was received, the expiration date of the allograft tissue, the date on which each allograft tissue is used for clinical purposes, and the disposition of any allograft tissue samples that remain unused at the time the allograft tissue expires; and,
- The allograft tissue meets all of the following:
- Was obtained from a tissue bank licensed by the state;
- Is individually boxed and labeled with a unique identification number and expiration date so that opening the shipping container will not disturb or otherwise alter any of the allograft tissue that is not being utilized;
- Is intended for the express purpose of implantation into or application on a patient;
- Is not intended for further distribution; and,
- Is registered with the Food and Drug Administration and designated to be maintained at ambient room temperature requiring no refrigeration.
FISCAL EFFECT: According to the Senate Appropriations Committee, 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 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.
COMMENTS: According to the author, due to the burdens of licensure, many hospitals and ambulatory surgical centers located in California are simply opting not to obtain a tissue bank license from the state. Rather, they make daily deliveries of the specified tissue grafts at the beginning of the calendar day, and then use a courier to return any unused tissue grafts at the end of the day. The author states that courier fees have been known to cost one California licensed tissue supplier over $150,000 in one year. These fees are generally included in the overall cost of providing tissue grafts in California, further increasing the cost of health care.
BACKGROUND: Allograft is a graft of tissue obtained from a donor of the same species as, but with a different genetic make-up from the recipient, used as a tissue transplant between two humans. Also called homograft. Tissues commonly used for allografts include cornea, cartilage, bone, artery, and cadaver skin stored in a skin-tissue bank.
Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097 FN: 0003651
Office of Senate Floor Analyses (916) 651-1520 Fax: (916) 327-4478 | AB |
THIRD READING
Bill No: AB 2750
:
SENATE HEALTH COMMITTEE: 7-0, 6/8/16
AYES: Hernandez, Nguyen, Mitchell, Monning, Nielsen, Pan, Roth
NO VOTE RECORDED: Hall, Wolk
SENATE APPROPRIATIONS COMMITTEE: 6-0, 6/27/16
AYES: Bates, Beall, Hill, McGuire, Mendoza, Nielsen
NO VOTE RECORDED: Lara
ASSEMBLY FLOOR: 78-0, 5/12/16 (Consent) - See last page for vote
DIGEST: This bill exempts from tissue bank licensure the storage of allograft tissue by a person, as defined, if specified criteria are met.
Existing law:
- Requires every tissue bank operating in California to have a current and valid tissue bank license issued or renewed by the Department of Public Health (DPH) with the following exceptions:
- Licensed blood banks;
- Entities collecting, processing, storing or distributing tissue for autopsy, biopsy, training, education, or for other medical or scientific research or investigation where transplantation of the tissue is not intended;
- A licensed physician and surgeon collecting tissue from his or her patient, or the implantation of tissue into his or her patient. This exemption does not apply to any processing or storage of the tissue, except for the processing and storage of semen collected from a semen donor or obtained from a licensed tissue bank;
- The collection, processing, storage, or distribution of fetal tissue or tissue derived from a human embryo or fetus;
- The collection, processing, storage, or distribution by an organ procurement organization;
- The storage of prepackaged, freeze-dried bone by a general acute care hospital;
- The storage of freeze-dried bone and dermis by a licensed dentist, provided that it has been obtained from a licensed tissue bank and stored in accordance to the manufacturer’s instructions and is used for the express purpose of implantation into a patient; and,
- The storage of a human cell, tissue, or cellular- or tissue-based product that is either a medical device approved by the federal Food and Drug Administration (FDA), or that is a biologic product approved under the federal Public Health Service Act by a licensed physician or podiatrist. The medical device or biologic product must have been obtained from a licensed tissue bank, been stored in accordance with the device’s or product’s package insert and any other manufacturer instruction, and be used solely for the use of direct implantation into or application on the practitioner’s own patient.
- Defines “tissue” as a human cell, group of cells, 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, but does not include an organ when recovered for transplantation or research purposes.
- Defines “person” as an individual, corporation, business trust, estate trust, partnership, association, state or local government, or subdivision or agency thereof, or any other legal entity.
- Requires the DPH to adopt rules and regulations, on or before July 1, 2004, governing tissue banks engaged in the collection of human musculoskeletal tissue, skin, and veins for transplantation in humans; requires the regulations to be substantially based upon criteria used by tissue bank trade associations; and requires the regulations to include minimum standards for storing and using tissue. Requires DPH, on or before July 1, 2003, to report to the appropriate policy and fiscal committees of the Legislature regarding the status of the proposed regulations.
This bill exempts from tissue bank licensure the storage of allograft tissue by a person, as defined in 3) of existing law above, if all of the following apply:
- The person is a hospital or an outpatient setting regulated by the Medical Board of California, including an ambulatory surgical center;
- The person maintains a log that includes the date on which the allograft tissue was received, the expiration date of the allograft tissue, the date on which each allograft tissue is used for clinical purposes, and the disposition of any allograft tissue samples that remain unused at the time the allograft tissue expires; and,
- The allograft tissue meets all of the following:
- Was obtained from a tissue bank licensed by the state;
- Is individually boxed and labeled with a unique identification number and expiration date so that opening the shipping container will not disturb or otherwise alter any of the allograft tissue that is not being utilized;
- Is intended for the express purpose of implantation into or application on a patient;
- Is not intended for further distribution; and,
- Is registered with the FDA and designated to be maintained at ambient room temperature requiring no refrigeration.
Background
The Center for Biologics Evaluation and Research (CBER) within the FDA regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Food, Drug, and Cosmetic Act. Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient are regulated as human cell, tissue, and cellular- and tissue-based product. Examples of such tissue are bone, skin, corneas, ligaments, tendons, heart valves, oocytes, and semen. CBER does not regulate the transplantation of vascularized human organs, such as the kidney, liver, heart, lung, or pancreas. Federal regulations require tissue banks to screen and test donors, to prepare and follow written procedures for the prevention of the spread of communicable disease, and to maintain records. In California, tissue banks are licensed by DPH for an annual license fee of $975.
Comments
- Author’s statement. According to the author, due to the burdens of licensure, many hospitals and ambulatory surgical centers located in California are simply opting not to obtain a tissue bank license from the state. Rather, they make daily deliveries of the specified tissue grafts at the beginning of the calendar day, and then use a courier to return any unused tissue grafts at the end of the day. Courier fees have been known to cost one California licensed tissue supplier over $150,000 in one year. These fees are generally included in the overall cost of providing tissue grafts in California, further increasing the cost of health care. AB 2750 is intended to help mitigate courier costs by enabling hospitals and ambulatory surgery centers to store certain tissue products under certain protocols, without having a tissue bank license.
- DPH regulations. Current law requires DPH to develop regulations regarding tissue banks engaged in the collection of human tissue, skin, and veins for transplantation into humans. According to DPH, regulations were drafted in 1998 but were not successfully promulgated because a subcommittee of the Clinical Laboratory Technology Advisory Committee (CLTAC) stated that it would take several years to develop a regulatory package of this complexity. CLTAC stated that technical and administrative changes were advancing at such a rate that the regulations would be out of date before being promulgated. Instead, it was recommended that, by reference, the American Association of Tissue Bank (AATB) standards and the annual updates be adopted into law.
To date, regulations have yet to be promulgated. DPH instead has developed a frequently asked questions (FAQ) document to provide guidance to entities as to whether or not they need to apply for a tissue bank license. The FAQ states that entities will need to apply for a tissue bank license if they perform any or all of four functions: collection, processing, storage, or distribution of human tissue for purposes of transplantation. The FAQ further states that a facility needs a tissue bank license whenever the facility stores any material without using it or does not return unused tissue on the same calendar day.
AB 1822 (Bonta, of 2014), which was substantially similar to this bill, was vetoed by Governor Brown. Subsequently, DPH issued a document, “Important Notice Regarding Storage of Allograft Tissue,” in which it announced that the FAQ was updated to state that a facility does not need a tissue bank license if it orders a frozen or cryopreserved allograft for a specific patient and holds it in the unopened, validated, temperature-controlled shipping container for no longer than the validation expiration date and time specified by the shipper before implanting, returning, or discarding the tissue. The updated FAQ does not allow for the temporary storage of room temperature allografts that do not require refrigeration. The FAQ also states that DPH’s Tissue Bank Program of Laboratory Field Services is in the process of formulating regulations to interpret and clarify tissue bank statutes. However, no expected date for when the regulations would be promulgated is provided.
Related/Prior Legislation
AB 1822 (Bonta, 2014) was substantially similar to this bill. AB 1822 was vetoed by Governor Brown who stated, in part, "While I support eliminating overly burdensome regulation, I'm not convinced that the bill strikes the right balance between safety and economy. I will direct DPH to continue working with interested parties to develop an approach that balances appropriate oversight with cost savings for suppliers."
AB 995 (Block, Chapter 497, Statutes of 2009) provided an exemption from tissue bank licensure for medical devices approved pursuant to Section 510 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 360, 360e) or that is a biologic product approved under Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262) by a licensed physician or podiatrist acting within the scope and authority of his or her license and practicing in a lawful practice setting.
AB 1060 (Laird, Chapter 427, Statutes of 2008) established an exemption from existing tissue bank licensure requirements for licensed dentists who store freeze-dried bone and dermis, under specified conditions.
SB 1135 (Polanco, Chapter 929, Statutes of 2002) required DPH, on or before July 1, 2004, to adopt rules and regulations governing tissue banks, and requires the rules and regulations to be substantially the same as the standards set forth in the most recent publication of the AATB Standards for Tissue Banking. Required DPH, on or before July 1, 2003, to report to the appropriate policy and fiscal committees of the Legislature regarding the status of the proposed regulations.
AB 2209 (Speier, Chapter 801, Statutes of 1991) required tissue banks to be licensed by the Department of Health Services (now DPH) with certain exceptions.
FISCAL EFFECT: Appropriation: Fiscal Com.: Local:
According to the Senate Appropriations Committee, 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 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.
MiMedx
OPPOSITION: (Verified 6/28/16)
None received
ARGUMENTS IN SUPPORT: MiMedx states that Governor Brown, when vetoing AB 1822, directed DPH to work with tissue providers on new guidance to strike a balance between appropriate oversight and cost savings for suppliers. MiMedx states that DPH’s FAQ still requires that each tissue sample be shipped individually, which is wasteful and unnecessary, especially when one considers that many of the products are approved to be stored at ambient temperatures for extended periods of time. MiMedx argues that this bill mitigates the need for additional oversight and reduces costs, and, as a result, will make more tissue readily available to hospitals and ambulatory surgery centers, and ultimately patients.
ASSEMBLY FLOOR: 78-0, 5/12/16
AYES: Achadjian, Alejo, Travis Allen, Arambula, Atkins, Baker, Bigelow, Bloom, Bonilla, Bonta, Brough, Brown, Calderon, Campos, Chang, Chau, Chávez, Chiu, Chu, Cooley, Cooper, Dababneh, Dahle, Daly, Dodd, Eggman, Frazier, Beth Gaines, Gallagher, Cristina Garcia, Eduardo Garcia, Gatto, Gipson, Gomez, Gonzalez, Gordon, Gray, Grove, Hadley, Harper, Roger Hernández, Holden, Irwin, Jones, Kim, Lackey, Levine, Linder, Lopez, Low, Maienschein, Mathis, Mayes, McCarty, Medina, Melendez, Mullin, Nazarian, Obernolte, O'Donnell, Olsen, Patterson, Quirk, Ridley-Thomas, Rodriguez, Salas, Santiago, Steinorth, Mark Stone, Thurmond, Ting, Wagner, Waldron, Weber, Wilk, Williams, Wood, Rendon
NO VOTE RECORDED: Burke, Jones-Sawyer
6/30/16 9:04:15
**** END ****
SENATE COMMITTEE ON HEALTH
Senator Ed Hernandez, O.D., Chair
BILL NO: AB 2750
AUTHOR: | Gomez | ||
VERSION: | May 23, 2016 | ||
HEARING DATE: | June 8, 2016 | ||
CONSULTANT: | Reyes Diaz | ||
SUBJECT: Tissue banks
SUMMARY:
Exempts from tissue bank licensure the storage of allograft tissue by a person, as defined, if specified criteria are met.
Existing law:
- Requires every tissue bank operating in California to have a current and valid tissue bank license issued or renewed by DPH with the following exceptions:
- Licensed blood banks;
- Entities collecting, processing, storing or distributing tissue for autopsy, biopsy, training, education, or for other medical or scientific research or investigation where transplantation of the tissue is not intended;
- A licensed physician and surgeon collecting tissue from his or her patient, or the implantation of tissue into his or her patient. This exemption does not apply to any processing or storage of the tissue, except for the processing and storage of semen collected from a semen donor or obtained from a licensed tissue bank;
- The collection, processing, storage, or distribution of fetal tissue or tissue derived from a human embryo or fetus;
- The collection, processing, storage, or distribution by an organ procurement organization;
- The storage of prepackaged, freeze-dried bone by a general acute care hospital;
- The storage of freeze-dried bone and dermis by a licensed dentist, provided that it has been obtained from a licensed tissue bank and stored in accordance to the manufacturer’s instructions and is used for the express purpose of implantation into a patient; and,
- The storage of a human cell, tissue, or cellular- or tissue-based product that is either a medical device approved by the federal Food and Drug Administration (FDA), or that is a biologic product approved under the federal Public Health Service Act by a licensed physician or podiatrist. The medical device or biologic product must have been obtained from a licensed tissue bank, been stored in accordance with the device’s or product’s package insert and any other manufacturer instruction, and be used solely for the use of direct implantation into or application on the practitioner’s own patient.
- Defines “tissue” as a human cell, group of cells, 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.
- Defines “person” as an individual, corporation, business trust, estate trust, partnership, association, state or local government, or subdivision or agency thereof, or any other legal entity.
- Requires the Department of Public Health (DPH) to adopt rules and regulations, on or before July 1, 2004, governing tissue banks engaged in the collection of human musculoskeletal tissue, skin, and veins for transplantation in humans; requires the regulations to be substantially based upon criteria used by tissue bank trade associations; and requires the regulations to include minimum standards for storing and using tissue. Requires DPH, on or before July 1, 2003, to report to the appropriate policy and fiscal committees of the Legislature regarding the status of the proposed regulations.
This bill:
- Exempts from tissue bank licensure the storage of allograft tissue by a person, as defined in 3) of existing law above, if all of the following apply:
- The person is a hospital or an outpatient setting regulated by the Medical Board of California, including an ambulatory surgical center;
- The person maintains a log that includes the date on which the allograft tissue was received, the expiration date of the allograft tissue, the date on which each allograft tissue is used for clinical purposes, and the disposition of any allograft tissue samples that remain unused at the time the allograft tissue expires; and,
- The allograft tissue meets all of the following:
- Was obtained from a tissue bank licensed by the state;
- Is individually boxed and labeled with a unique identification number and expiration date so that opening the shipping container will not disturb or otherwise alter any of the allograft tissue that is not being utilized;
- Is intended for the express purpose of implantation into or application on a patient;
- Is not intended for further distribution; and,
- Is registered with the FDA and designated to be maintained at ambient room temperature requiring no refrigeration.
FISCAL EFFECT:
According to the Assembly Appropriations Committee, this bill will potentially result in a decrease of about 40% in workload and a commensurate $260,000 reduction in annual fee revenue to DPH’s tissue bank licensing program. Remaining fee revenues and the fund balance in the Tissue Bank Licensing Fund appear to be adequate to support the remaining workload.
PRIOR VOTES:
Assembly Floor: | 78 - 0 |
Assembly Appropriations Committee: | 20 - 0 |
Assembly Health Committee: | 16 - 0 |
COMMENTS:
- Author’s statement. According to the author, due to the burdens of licensure, many hospitals and ambulatory surgical centers located in California are simply opting not to obtain a tissue bank license from the state. Rather, they make daily deliveries of the specified tissue grafts at the beginning of the calendar day, and then use a courier to return any unused tissue grafts at the end of the day. Courier fees have been known to cost one California licensed tissue supplier over $150,000 in one year. These fees are generally included in the overall cost of providing tissue grafts in California, further increasing the cost of health care. AB 2750 is intended to help mitigate courier costs by enabling hospitals and ambulatory surgery centers to store certain tissue products under certain protocols, without having a tissue bank license.
- Background. The Center for Biologics Evaluation and Research (CBER) within the FDA regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Food, Drug, and Cosmetic Act. Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient are regulated as human cell, tissue, and cellular- and tissue-based product. Examples of such tissue are bone, skin, corneas, ligaments, tendons, heart valves, oocytes, and semen. CBER does not regulate the transplantation of vascularized human organs, such as the kidney, liver, heart, lung, or pancreas. Federal regulations require tissue banks to screen and test donors, to prepare and follow written procedures for the prevention of the spread of communicable disease, and to maintain records. In California, tissue banks are licensed by DPH for an annual license fee of $975.
- DPH regulations. Current law requires DPH to develop regulations regarding tissue banks engaged in the collection of human tissue, skin, and veins for transplantation into humans. However, according to DPH, regulations were drafted after the passage of SB 1135 (Polanco, Chapter 929, Statutes of 2002), which required DPH to adopt tissue bank rules and regulations by July 1, 2004, but were not successfully promulgated because a subcommittee of the Clinical Laboratory Technology Advisory Committee (CLTAC) stated that it would take several years to develop a regulatory package of this complexity. CLTAC stated that technical and administrative changes were advancing at such a rate that the regulations would be out of date before being promulgated. Instead, it was recommended that, by reference, the American Association of Tissue Bank (AATB) standards and the annual updates be adopted into law.
To date, regulations have yet to be promulgated. DPH instead has developed a frequently asked questions (FAQ) document to provide guidance to entities as to whether or not they need to apply for a tissue bank license. The FAQ states that entities will need to apply for a tissue bank license if they perform any or all of four functions: collection, processing, storage, or distribution of human tissue for purposes of transplantation. The FAQ further states that a facility needs a tissue bank license whenever the facility stores any material without using it or does not return unused tissue on the same calendar day.
AB 1822 (Bonta, of 2014), which was substantially similar to this bill, was vetoed by Governor Brown. Subsequently, DPH issued a document, “Important Notice Regarding Storage of Allograft Tissue,” in which it announced that the FAQ was updated to state that a facility does not need a tissue bank license if it orders a frozen or cryopreserved allograft for a specific patient and holds it in the unopened, validated, temperature-controlled shipping container for no longer than the validation expiration date and time specified by the shipper before implanting, returning, or discarding the tissue. The updated FAQ does not allow for the temporary storage of room temperature allografts that do not require refrigeration. The FAQ also states that DPH’s Tissue Bank Program of Laboratory Field Services is in the process of formulating regulations to interpret and clarify tissue bank statutes. However, no expected date for when the regulations would be promulgated is provided.
- Prior legislation. AB 1822 (Bonta, of 2014), was substantially similar to this bill. AB 1822 was vetoed by the Governor who stated, in part, "While I support eliminating overly burdensome regulation, I'm not convinced that the bill strikes the right balance between safety and economy. I will direct DPH to continue working with interested parties to develop an approach that balances appropriate oversight with cost savings for suppliers."
AB 995 (Block, Chapter 497, Statutes of 2009), provided an exemption from tissue bank licensure for medical devices approved pursuant to Section 510 or 515 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 360, 360e) or that is a biologic product approved under Section 351 of the federal Public Health Service Act (42 U.S.C. Sec. 262) by a licensed physician or podiatrist acting within the scope and authority of his or her license and practicing in a lawful practice setting.
AB 1060 (Laird, Chapter 427, Statutes of 2008), established an exemption from existing tissue bank licensure requirements for licensed dentists who store freeze-dried bone and dermis, under specified conditions.
SB 1135 (Polanco, Chapter 929, Statutes of 2002), required DPH, on or before July 1, 2004, to adopt rules and regulations governing tissue banks, and requires the rules and regulations to be substantially the same as the standards set forth in the most recent publication of the AATB Standards for Tissue Banking. Required DPH, on or before July 1, 2003, to report to the appropriate policy and fiscal committees of the Legislature regarding the status of the proposed regulations.
AB 2209 (Speier, Chapter 801, Statutes of 1991), required tissue banks to be licensed by the Department of Health Services (now DPH) with certain exceptions.
- Support. MiMedx states that the Governor, when vetoing AB 1822, directed DPH to work with tissue providers on new guidance to strike a balance between appropriate oversight and cost savings for suppliers. MiMedx states that DPH’s FAQ still requires that each tissue sample be shipped individually, which is wasteful and unnecessary, especially when one considers that many of the products are approved to be stored at ambient temperatures for extended periods of time. MiMedx argues that this bill mitigates the need for additional oversight and reduces costs, and, as a result, will make more tissue readily available to hospitals and ambulatory surgery centers, and ultimately patients.
SUPPORT AND OPPOSITION:
Support: MiMedx Group (sponsor)
Oppose: None received
-- END --
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 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 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 --
Date of Hearing: May 4, 2016
ASSEMBLY COMMITTEE ON APPROPRIATIONS
Lorena Gonzalez, Chair
ABPCA Bill Id:AB 2750
Author:(Gomez) – As Amended Ver:April 7, 2016
Policy Committee: | Rules | Vote: | 11 - 0 |
Health | 16 - 0 | ||
|
|
Urgency: No State Mandated Local Program: No Reimbursable: No
SUMMARY:
This bill exempts specified health care providers storing human cell, tissue, or cellular- or tissue-based product (tissue) that is regulated by the federal Food and Drug Administration (FDA) from state licensure as a tissue bank if all of the following apply:
- The tissue has been obtained from a licensed tissue bank.
- The tissue is stored in accordance with specified guidelines.
- The tissue is used for the express purpose of implantation into or application on a patient, and is not intended for further distribution.
FISCAL EFFECT:
A potential decrease of about 40% in workload, and a commensurate $260,000 reduction in annual fee revenue to the California Department of Public Health (CDPH) Tissue Bank licensing program. Remaining fee revenues and the fund balance in the Tissue Bank Licensing Fund appear to be adequate to support remaining workload. A tissue bank license fee costs $975 annually.
COMMENTS:
- Purpose. According to the author, due to the burdens of licensure, many hospitals and ambulatory surgical centers located in California opt not to obtain a tissue bank license from the state, and instead make daily deliveries of the specified tissue grafts at the beginning of the calendar day, using couriers to return any unused tissue grafts at the end of the day. The author states this is inefficient and costly. This bill is sponsored by the MiMedx, a private company that processes, markets, and distributes human amniotic tissue. The sponsor believes it is unnecessary for providers to be licensed as tissue banks with the state when they are only storing tissue for use in their own patients in accordance with FDA regulations and oversight.
- Background. A tissue bank is defined as an establishment that collects, processes, stores, or distributes tissue (cells, groups of cells, segments of eyes and other body parts, sperm, blood, and other fluids) for transplantation into humans. Current law requires CDPH to adopt regulations on or before January 1, 2004, governing tissue banks, and requires the regulations to be based on criteria used by tissue bank trade associations in their accreditation processes. Finally, it requires every tissue bank to have a valid license. CDPH has not issued regulations as required by existing law. CDPH maintains that any facility collecting, processing, storing, or distributing human tissue for purposes of transplantation needs to be licensed as a tissue bank, as specified in the law. Eight exemptions have been added over the years; this bill would add a ninth exemption.
- Related Legislation. AB 1822 (Bonta) of 2014 was substantially similar to this bill. AB 1822 was vetoed by the Governor who stated, in part, "While I support eliminating overly burdensome regulation, I'm not convinced that the bill strikes the right balance between safety and economy. I will direct the Department of Public Health to continue working with interested parties to develop an approach that balances appropriate oversight with cost savings for suppliers." CDPH has developed an Frequently Asked Questions document to clarify the application of current law, but it has not addressed the problem that this bill seeks to address.
This bill does not address the veto message, as it is substantially similar to AB 1822, but neither has CDPH developed a different approach that balances oversight and cost savings, as indicated in the veto message.
Analysis Prepared by: Lisa Murawski / APPR. / (916) 319-2081
Date of Hearing: April 19, 2016
ASSEMBLY COMMITTEE ON HEALTH
Jim Wood, Chair
ABPCA Bill Id:AB 2750
Author:Gomez – As Amended Ver:April 7, 2016
SUBJECT: Tissue banks.
SUMMARY: Creates an additional exemption from tissue bank licensing requirements for the storage of human cell, tissue or cellular- or tissue-based product (HCT/P). Specifically, this bill:
- Allows a person licensed to provide health care services, acting within the scope of his or her license and practicing in a lawful practice to store HCT/P if all of the following apply:
- The person, as defined, is a hospital, or an outpatient setting regulated by the Medical Board of California, including an ambulatory surgical center; and,
- The HCT/P being stored meets all of the following requirements:
- Was obtained from a tissue bank licensed by the state;
- Is stored in the original unopened enclosure for one finished unit of transplantable tissue and is stored in strict accordance with the package insert and any other manufacturer instruction and guidelines;
- Is intended for the express purpose of implantation into or application on a patient;
- Is not intended for further distribution; and,
- Is regulated by the federal Food and Drug Administration (FDA), as specified.
- The person, as defined, is a hospital, or an outpatient setting regulated by the Medical Board of California, including an ambulatory surgical center; and,
EXISTING LAW:
- Requires the Department of Public Health (DPH) to adopt rules and regulations, on or before July 1, 2004, governing tissue banks engaged in the collection of human musculoskeletal tissue, skin, and veins for transplantation in humans, requires the regulations to be substantially based upon criteria used by tissue bank trade associations, and requires the regulations to include minimum standards for storing and using tissue.
- Requires every tissue bank operating in California to have a current and valid tissue bank license issued or renewed by DPH with the following exceptions:
- Licensed blood banks;
- Entities collecting, processing, storing or distributing tissue for autopsy, biopsy, training, education, or for other medical or scientific research or investigation where transplantation of the tissue is not intended;
- A licensed physician and surgeon collecting tissue from his or her patient, or the implantation of tissue into his or her patient. This exemption does not apply to any processing or storage of the tissue, except for the processing and storage of semen collected from a semen donor or obtained from a licensed tissue bank;
- The collection, processing, storage, or distribution of fetal tissue or tissue derived from a human embryo or fetus;
- The collection, processing, storage or distribution by an organ procurement organization;
- The storage of prepackaged, freeze-dried bone by a general acute care hospital;
- The storage of freeze-dried bone and dermis by a licensed dentist, provided that it has been obtained from a licensed tissue bank and stored in accordance to the manufacturers' instructions and is used for the express purpose of implantation into a patient.
- The storage of a HCT/P that is either a medical device approved by the FDA, or that is a biologic product approved under the federal Public Health Service Act by a licensed physician or podiatrist. The medical device or biologic product must have been obtained from a licensed tissue bank, been stored in accordance with the device's or product's package insert and any other manufacturer instruction and be used solely for the use of direct implantation into or application on the practitioner's own patient.
- Licensed blood banks;
- Establishes the Medical Board of California to regulate the practice of medicine and approve accrediting agencies that accredit outpatient settings in California.
FISCAL EFFECT: This bill has not been analyzed by a fiscal committee.
COMMENTS:
- PURPOSE OF THIS BILL. According to the author, DPH guidance requires that an entity that simply stores tissue without implantation or without returning the unused tissue on the same calendar day of receipt to be licensed as a tissue bank. The author states that this does not take into account advancements in technology or other FDA and American Association of Tissue Bank (AATB) standards. The author states this bill addresses this by providing an exemption when products are obtained from a licensed tissue bank, are stored in accordance with FDA regulations and guidance, and intended for implantation, not for distribution. The author concludes this will reduce costs and make more tissue readily available to hospitals and ambulatory surgery centers, and ultimately patients.
- BACKGROUND. The Center for Biologics Evaluation and Research (CBER) within the FDA regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. Human cells or tissue intended for implantation, transplantation, infusion, or transfer into a human recipient are regulated as HCT/P. Examples of such tissues are bone, skin, corneas, ligaments, tendons, heart valves, oocytes, and semen. CBER does not regulate the transplantation of vascularized human organs such as the kidney, liver, heart, lung, or pancreas. Federal regulations require tissue banks to screen and test donors, to prepare and follow written procedures for the prevention of the spread of communicable disease and to maintain records.
Current law requires DPH to develop regulations regarding tissue banks engaged in the collection of human tissue, skin, and veins for transplantation into humans. However, according to DPH these regulations were drafted but not successfully promulgated because a subcommittee of the Clinical Laboratory Technology Advisory Committee (Committee) stated that it would take several years to develop a regulatory package of this complexity because technical and administrative changes were advancing at such a fast rate that the regulations would be out-of-date before promulgation. Instead the Committee recommended that DPH adopt into law the AATB standards and the annual updates. AB 995 (Block) of 2009, attempted to do this, but was later amended to deal with a different subject matter. To date, regulations have yet to be promulgated.
- SUPPORT. MiMedx supports this bill stating, while not defined in regulations, DPH guidance requires that an entity that simply stores tissue without implantation or without returning the unused tissue on the same calendar day of receipt be licensed as a tissue bank. MiMedx notes, due to the burdens of licensure, many hospitals and ambulatory surgery centers located in California are simply opting not to obtain a tissue bank license from the state, rather they enter into agreements with tissue bank suppliers to deliver tissues via costly courier services at the beginning of the calendar day and then obtain a courier to return any unused tissue at the end of the day. MiMedx concludes such courier fees have been known to cost one California licensed tissue supplier more than $150,000 in one year and these fees are generally included in the overall cost of providing tissue, further increasing the cost of health care in California.
- PREVIOUS LEGISLATION.
- AB 1822 (Bonta) of 2014 was substantially similar to this bill. AB 1822 was vetoed by the Governor who stated, in part, "While I support eliminating overly burdensome regulation, I'm not convinced that the bill strikes the right balance between safety and economy. I will direct the Department of Public Health to continue working with interested parties to develop an approach that balances appropriate oversight with cost savings for suppliers."
- AB 1060 (Laird), Chapter 427, Statutes of 2008, establishes an exemption from existing tissue bank licensure requirements for licensed dentists who store freeze-dried bone and dermis, under specified conditions.
- SB 1135 (Polanco and Murray), Chapter 929, Statutes of 2002, requires DPH (then Department of Health Services), on or before July 1, 2003, to adopt rules and regulations governing tissue banks, and requires the rules and regulations to be substantially the same as the standards set forth in the most recent publication of the AATB Standards for Tissue Banking.
- AB 1822 (Bonta) of 2014 was substantially similar to this bill. AB 1822 was vetoed by the Governor who stated, in part, "While I support eliminating overly burdensome regulation, I'm not convinced that the bill strikes the right balance between safety and economy. I will direct the Department of Public Health to continue working with interested parties to develop an approach that balances appropriate oversight with cost savings for suppliers."
- POLICY COMMENTS.
- Underground regulations. To date, the Legislature has granted eight separate exemptions to tissue bank licensing requirements. DPH is required to develop regulations but as yet has not done so, failing to fulfill its regulatory obligation. According to health care practitioners and facilities, the lack of regulations creates uncertainty and a greater potential for committing a violation. DPH has attempted to address their concern by publishing a Frequently Asked Questions (FAQ) document. However, to the extent that the FAQs provide regulatory guidance, it could be construed as underground regulations and should be subject to the provisions of the Administrative Procedures Act, including public review and comment.
- Veto. This bill is similar to AB 1822 which was vetoed by the Governor. The Committee may wish to ask the author how he will address the Governor's veto message.
REGISTERED SUPPORT / OPPOSITION:
Support
MiMedx
Opposition
None on file.
Analysis Prepared by: Lara Flynn / HEALTH / (916) 319-2097
Discussed in Hearing
47SEC
Assembly Floor
2MIN
Senate Standing Committee on Appropriations
4MIN
Senate Standing Committee on Health
Bill Author
Bill Co-Author(s):