text:
(a) A contract of admission shall state that, except in an emergency, a resident may not be involuntarily transferred or discharged from a long-term health care facility unless the resident and, if applicable, the resident’s representative, are given reasonable notice in writing and transfer or discharge planning as required by law. The written notice shall meet both of the following conditions:

(1) The notice shall state the reason for the transfer or discharge.

(2) The notice shall include the following statement: “At the time of admission, this facility is an enrolled provider with the following: ____ Medi-Cal ____ Medicare.

If we participate in Medi-Cal, you will not be discharged from the facility or transferred within the facility, solely as a result of changing your manner of purchasing the services from private payment or Medicare to Medi-Cal, except for a potential transfer within the facility from a private room to a semiprivate room.

If we participate in Medi-Cal, you may be eligible for the Long-Term Care Medi-Cal program to help pay for your stay in the facility. For more information, refer to the attached notice DHCS 7077, Notice Regarding Standards for Medi-Cal Eligibility, from the State Department of Health Care Services. Medi-Cal, Medicare, or a private payor may require that the resident pay a copayment, coinsurance, or a deductible, all of which the facility considers to be the resident’s share of cost.” (b) The facility shall promptly notify the Office of the State Long-Term Care Ombudsman in every case of involuntary discharge as specified in Section 1439.7.

(c) The provisions of this section are intended to be consistent with federal law and regulations.

history: (History: Amended by Stats. 2024, Ch. 339, Sec. 2. (SB 1354) Effective January 1, 2025.)


kind: section

code: HSC

text: Every contract of admission shall meet the requirements of Section 72520 of Title 22 of the California Administrative Code, which requires that the facility offer to hold a bed for the resident in the event the resident must be transferred to an acute care hospital for seven days or less. The facility shall also give the resident, or a representative for the resident, notice of the rights to a bedhold at the time of transfer. The resident or representative for the resident has 24 hours from receipt of notice to request the bedhold. The contract of admission shall state that the facility shall offer the next available appropriate bed to the resident in the event the facility fails to follow this required procedure. The facility shall inform the resident that Medi-Cal will pay for up to seven bedhold days.

history: (History: Added by Stats. 1987, Ch. 625, Sec. 1.)

division: 2. LICENSING PROVISIONS

path: 2. LICENSING PROVISIONS > 3.93. Admission Contracts for Long-Term Health Care Facilities


text: Facilities that wish to photograph a resident for other than staff identification or health care purposes shall obtain permission from the resident whether for one photograph or for multiple photographs for one particular purpose on a document separate from the admission contract as a whole. This document shall describe the specific use to be made of the photograph and indicate that the photograph will be used only for that purpose.

chapter: 3.93. Admission Contracts for Long-Term Health Care Facilities


text:
(a) All contracts of admission that contain an arbitration clause shall clearly indicate that agreement to arbitration is not a precondition for medical treatment or for admission to the facility.

(b) All arbitration clauses shall be included on a form separate from the rest of the admission contract. This attachment shall contain space for the signature of any applicant who agrees to arbitration of disputes.

(c) On the attachments, clauses referring to arbitration of medical malpractice claims, as provided for under Section 1295 of the Code of Civil Procedure, shall be clearly separated from other arbitration clauses, and separate signatures shall be required for each clause.

(d) In the event the contract contains an arbitration clause, the contract attachment pertaining to arbitration shall contain notice that under Section 1430, the patient may not waive his or her ability to sue for violation of the Patient’s Bill of Rights.


text: No contract of admission shall include a clause that purports to alter the statutory period for filing an action against a facility.


text: If a provision for the payment of attorney’s fees is included in the admission contract, it shall state that in disputes arising from the admission contract, the prevailing party shall be entitled to attorney’s fees.


text: This chapter applies to new admissions to skilled nursing and intermediate care facilities on and after January 1, 1988. This chapter shall not be construed to require the execution of new admission agreements for patients who were residing in those facilities prior to the enactment of this chapter. However, those patients shall be given notice of changes in admission contracts pursuant to this chapter.

history: (History: Amended by Stats. 1988, Ch. 160, Sec. 98.)


text: Long-term health care facilities must prominently and clearly display the following notice on all contracts of admission, and all advertisements used to solicit consumers to enter into contracts of admission: “For more information about our facility, you may call the State Ombudsman’s Office at (insert toll-free number).”

history: (History: Added November 8, 1988, by initiative Proposition 105. Operative January 1, 1990. Invalidated in 1991 by court decision.)

chapter: 3.95. Seniors Nursing Home Disclosure

path: 2. LICENSING PROVISIONS > 3.95. Seniors Nursing Home Disclosure


text: “Contract of admission,” as used in this chapter, includes all documents which a resident or his or her representative must sign at the time of, or as a condition of, admission to a long-term care health facility as defined in Health and Safety Code Section 1326.


text: The Department of Health Services (the Department) shall compile a list of approximately twenty five % (25%) of the long-term health care facilities with the most serious records of violations of laws or regulations by virtue of proven or admitted Class AA and Class A citations. Those facilities on this list shall include this statement on all contracts of admission, and all advertisements used to solicit consumers to enter into contracts of admission: “This facility’s record of citations is posted at the facility, and a copy may be obtained from the Department of Health Services.”


text: The Department shall issue regulations to implement this Chapter, including permitting one disclosure to satisfy the requirements of Section 1599.85 for all advertisements on the same page.


text: The remedies for violations of this Chapter are as provided in Government Code Section 12269.


text:
(a) Within 30 days of approval of a change of ownership by the State Department of Public Health, the skilled nursing facility shall send written notification to all current residents and patients and to the primary contacts listed in the admission agreement of each resident and patient. The notice shall disclose the name of the owner and licensee of the skilled nursing facility and the name and contact information of a single entity that is responsible for all aspects of patient care and the operation of the facility.

(b) The department shall accept a copy of the written notice and a copy of the list of individuals and mailing addresses to whom the facility sent the notification as satisfactory evidence that the facility provided the required written notification.

history: (History: Amended by Stats. 2010, Ch. 328, Sec. 125. (SB 1330) Effective January 1, 2011.)


text:
A person who seeks to be admitted to the same long-term health care facility for which there exists a prior executed contract of admission which was signed by that person, or his or her legal representative, responsible party, or agent, in accordance with this chapter shall not be required to execute a new contract of admission if the person, or his or her legal representative, responsible party, or agent, either prior to or upon readmission, signs a written statement prepared by the facility which lists the modifications to the contract of admission.

The written statement shall indicate the date upon which the person’s signature was obtained. The written statement shall be kept on file by the facility with the person’s previously signed contract of admission.

This section shall not apply to any person who has been declared legally incompetent subsequent to the time he or she signed the contract of admission. This section shall not apply to any person when the physician and surgeon of that person has determined that the person is unable to understand and sign the written statement because of his or her medical condition.

No written statement shall contain any provision that is prohibited from being included in a contract of admission.

A new contract of admission or a written statement which lists the modifications need not be signed by the person, or his or her legal representative, responsible party, or agent, in the case of a transfer during a bedhold period.

history: (History: Added by Stats. 1990, Ch. 353, Sec. 1.)


text:
A person who seeks to be admitted to the same skilled nursing facility or intermediate care facility to receive respite care services for which there already exists a prior executed abbreviated contract of admission which was signed by that person, or his or her legal representative or responsible party, in accordance with this chapter shall not be required to execute a new abbreviated contract of admission if the person, or his or her legal representative or responsible party, either prior to or upon admission, signs a written statement prepared by the facility which lists the modifications to the abbreviated contract of admission.

The written statement shall indicate the date upon which the person’s signature was obtained. The written statement shall be kept on file by the facility with the person’s previously signed abbreviated contract of admission.

This section shall not apply to any person who has been declared legally incompetent subsequent to the time he or she signed the abbreviated contract of admission. This section shall not apply to any person when the physician and surgeon of that person has determined that the person is unable to understand and sign the written statement because of his or her medical condition.

history: (History: Added by Stats. 1990, Ch. 1329, Sec. 6. Effective September 26, 1990.)


citation: HSC § 1600

text: Unless the context otherwise requires, the definitions in this article govern the construction of this chapter.

history: (History: Repealed and added by Stats. 1963, Ch. 1055.)

article: 1. Definitions

path: 2. LICENSING PROVISIONS > 4. Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics > 1. Definitions


text:
“Biologics” includes the following products which are offered for sale or distribution for the prevention or treatment of disease, except biologics which are registered pursuant to Chapter 1.5 (commencing with Section 9201), Part 1, Division 5 of the Food and Agricultural Code:

(a) Human whole blood.

(b) Human whole blood derivatives specified by regulations.

(c) Serum, vaccine, live vaccine, killed vaccine, tissue vaccine, autogenous vaccine, live virus, killed virus, live bacterial culture, killed bacterial culture, bacterin, hormone, tissue extract, gland extract, gland preparation, insulin, and similar products made from human or animal tissues or micro-organisms.

The amendments to this section enacted at the 1973–74 Regular Session of the Legislature shall become operative on July 1, 1975.

history: (History: Amended by Stats. 1974, Ch. 776.)

chapter: 4. Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics

article: 1. Definitions


text: “Blood bank” means any place where human whole blood, and human whole blood derivatives specified by regulation, are collected, prepared, tested, processed, or stored, or from which human whole blood or human whole blood derivatives specified by regulation are distributed.

history: (History: Added by Stats. 1963, Ch. 1055.)

article: 1. Definitions


text: “Blood bank depository” means any place other than a blood bank where human whole blood and human whole blood derivatives specified by regulation are stored and held for transfusion. Such blood bank depositories shall be clinical laboratories, licensed in accordance with the provisions of Chapter 3 (commencing with Section 1200), Division 2 of the Business and Professions Code, or such other places where services essentially equivalent are maintained, as determined by the department.

article: 1. Definitions


text: “Distribution” includes sale and exchange.

article: 1. Definitions


text: “Production” includes collection, preparation, testing, processing, storage, and distribution of biologics under a license issued by the department.

article: 1. Definitions


text: “Department” means the State Department of Health Services.

history: (History: Amended by Stats. 1977, Ch. 1252.)

article: 1. Definitions


text: “Carrier donor” means any donor of human whole blood whose blood donation has been found, either by laboratory tests or by the tracing of a transfusion-associated hepatitis case where there was a single donor, to contain viral hepatitis, or any donor of human whole blood who has twice been determined by the department to be a possible carrier donor.

history: (History: Added by Stats. 1974, Ch. 985.)

article: 1. Definitions


text: “Possible carrier donor” means any donor of human whole blood whose blood donation was administered where multiple transfusions from multiple donors were administered to a recipient and such transfusions result in a case diagnosed by a physician as transfusion-associated hepatitis.

article: 1. Definitions


text: “Carrier of viral hepatitis” means a person under treatment by a physician who has contracted viral hepatitis which has been confirmed by voluntary laboratory tests or who exhibits symptoms which lead a physician to render a diagnostic opinion that the person has contracted viral hepatitis.

article: 1. Definitions


text: “Blood collection center” means a stationary auxiliary to a blood bank which is designed, equipped, and staffed to procure human whole blood or blood components which are to be transported to the blood bank for processing, storing, and distribution.

history: (History: Added by Stats. 1991, Ch. 800, Sec. 2.)

article: 1. Definitions


text: “Stationary” means a nonmobile room or building maintained at a fixed address.

history: (History: Added by Stats. 1991, Ch. 800, Sec. 3.)

article: 1. Definitions


text: “Mobile unit” means a transportable auxiliary to a blood bank designed, equipped, and staffed to procure human whole blood and to transport this blood to the bank for processing, storing, and distribution.

history: (History: Added by Stats. 1991, Ch. 800, Sec. 4.)

article: 1. Definitions


text: “Blood component” or “blood derivative” means any product produced from whole blood.

history: (History: Added by Stats. 1991, Ch. 800, Sec. 5.)

article: 1. Definitions


text:
(a) No person shall engage in the production of human whole blood or human whole blood derivatives unless the person is licensed under this chapter and the human whole blood or human whole blood derivative is collected, prepared, labeled, and stored in accordance with both of the following:

(1) The standards set forth in the 13th Edition of “Standards for Blood Banks and Transfusion Services,” as published by the American Association of Blood Banks and in effect on November 15, 1989, or any amendments thereto or later published editions or amendments thereto. These shall be the standards for all licensed blood banks and blood transfusion services in the state.

(2) Those provisions of Title 17 of the California Code of Regulations that are continued in effect by subdivision (c) or that are adopted pursuant to subdivision (b).

(b) The department may, by the adoption of regulations, establish and require compliance with requirements in addition to, or in lieu of, those in subdivision (a) as the department deems appropriate to reflect changing technology or to improve the safety of human whole blood or human whole blood derivatives. Any standards adopted pursuant to this subdivision shall be adopted after consultation with representatives of the American Association of Blood Banks.

(c) Until the time superseded by any regulation adopted pursuant to this section, all of the provisions of Group 1 (commencing with Section 950) of Subchapter 1 of Chapter 2 of Part 1 of Title 17 of the California Code of Regulations shall remain in effect with the exception of the following:

(1) Subdivisions (i) to (k), inclusive, of Section 997.

(2) Sections 999 and 1001.

(3) Subdivisions (a) to (c), inclusive, of Section 1002.

(4) Paragraphs (2) and (3) of subdivision (e) of Section 1002.

(5) Subdivisions (f) and (g) of Section 1002.

(6) Paragraphs (2) to (6), inclusive, of subdivision (h) of Section 1002.

(7) Subdivisions (i), (k), and ( l) of Section 1002.

(8) Subdivisions (a) to (c), inclusive, of Section 1004.

(9) Sections 1010, 1012, 1013, 1014, 1024, and 1024.1.

(10) Subdivisions (a), (b), and (e) of Section 1025.

(11) Paragraphs (1) to (3), inclusive, of subdivision (c) of Section 1025.

(d) (1) Any amendment to the 13th Edition of “Standards for Blood Banks and Transfusion Services,” any later editions, or any amendments thereto, published by the American Association of Blood Banks shall become effective in California 90 days after the effective date of this section, or 90 days after publication by the association, unless the department sends written notice, within such a 90-day period, to all persons licensed under this chapter to engage in the production of human whole blood or human whole blood derivatives, indicating which portions shall not become effective.

(2) The department may determine that no portion of any amendments or later editions shall become effective. The department shall determine that no portion of an amendment or later edition shall become effective pursuant to this section whenever the department has not received a copy of the amendment or later edition by the date it is published by the American Association of Blood Banks.

(e) This section does not apply to a clinical trial site storing or preparing for patient administration human whole blood and human whole blood derivatives intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs or devices if the investigation is conducted in accordance with the requirements of Section 505(i) of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Sec. 360j(g)) and the regulations adopted pursuant to the federal act.

history: (History: Amended by Stats. 2022, Ch. 955, Sec. 1. (SB 1500) Effective January 1, 2023.)

path: 2. LICENSING PROVISIONS > 4. Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics > 2. Human Whole Blood and Human Whole Blood Derivatives


text:
(a) No person shall import any human whole blood or human whole blood derivative produced outside the state unless that blood or blood product meets the standards set forth in the latest edition of the “Standards for Blood Banks and Transfusion Services,” as published by the American Association of Blood Banks, or any later published editions or amendments thereto.

(b) Any later editions of the “Standards for Blood Banks and Transfusion Services,” or amendments thereto, published by the American Association of Blood Banks, shall become effective for purposes at this section 90 days after the effective date of this section, or 90 days after publication by the association, whichever is later, unless the department sends written notice, within the 90-day period, to all persons who import human whole blood or human whole blood derivatives produced outside the state that have requested this notice, stating the portions of those later editions or amendments that shall not become effective.

(c) The department may determine that no portion of any later editions or amendments shall become effective for purposes of this section. The department shall determine that no portion of a later edition or amendment shall become effective for purposes of this section whenever the department has not received a copy of the later edition or amendment by the date it is published by the American Association of Blood Banks.

(d) The department shall administer and enforce this section in accordance with this chapter and in a manner that assures, to the greatest degree, consistency with Section 1602.5.

history: (History: Added by Stats. 1992, Ch. 760, Sec. 1. Effective January 1, 1993.)

article: 2. Human Whole Blood and Human Whole Blood Derivatives


text:
(a) Except as provided in this subdivision, no blood or blood components shall be used in vivo for humans in this state, unless the blood or blood components have been tested and found nonreactive for HIV or the blood or blood components are used for research or vaccination programs pursuant to an informed consent.

Additional exceptions to the requirement of this subdivision are as follows:

(1) Blood or blood components released for transfusion in emergency circumstances, as determined by the department.

(2) Blood or blood components used for autologous purposes.

(b) Blood banks and plasma centers shall make laboratory tests of all human whole blood and blood components received to detect the presence of viral hepatitis and HIV in the manner specified in Section 1603.3. If the blood bank or plasma center finds the presence of viral hepatitis, or an antigen thereof, in the blood or blood components tested, it shall report that finding, the date of the human whole blood or blood components donation, the name, address, and social security number of the person who donated the blood or blood components, and the name and address of the blood bank or plasma center that received the human whole blood or blood components from the person and any additional information required by the department, to the local health officer within 72 hours of the confirmation of the presence of viral hepatitis, or an antigen thereof, in the blood or blood components tested.

(c) A physician, hospital, or other health care provider shall report all AIDS cases, HIV infections, and viral hepatitis infections, including transfusion-associated cases or infections, to the local health officer with the information required, and within the timeframes established by the department, pursuant to Title 17 of the California Code of Regulations.

(d) Upon receipt of a report concerning any transfusion-associated hepatitis or transfusion-associated HIV or AIDS cases, the local health officer shall identify which blood bank or plasma center is the source of the infectious blood or blood components and shall report this fact to the blood bank or plasma center that issued the blood or blood components. The blood bank or plasma center shall undertake an investigation to determine the donor source of the infectious blood or blood components.

(e) Local health officials shall contact all persons who have confirmed cases of AIDS, as determined by a person responsible for the care and treatment of the person with AIDS, to suggest appropriate treatment alternatives and for the purposes of epidemiological studies and followup.

(f) The department may adopt regulations governing the procedures in this section as it deems necessary to protect the public health and safety.

(g) “Plasma center,” as used in this chapter, means any place where the process of plasmapheresis is conducted, as defined in Section 1025 of Title 17 of the California Code of Regulations and includes a place where leukopheresis or platelet pheresis, or both, is conducted.

(h) “AIDS,” as used in this chapter, means acquired immune deficiency syndrome.

(i) “HIV,” as used in this chapter, means human immunodeficiency virus.

(j) “Blood components,” as used in this chapter, means preparations separated from single units of whole blood or prepared for hemapheresis and intended for use as final products for transfusions.

(k) A local health officer may disclose to a blood bank or plasma center, on a confidential basis, whether blood or blood components previously transfused may have been donated by a person infected with HIV, in order to implement the blood bank’s or plasma center’s program to notify a recipient of blood or blood components that might have transmitted HIV. The blood bank or plasma center may not disclose information that would identify a donor to which this subdivision applies and shall destroy information communicated to it as authorized by this subdivision immediately after reviewing its records as necessary to implement this program.

history: (History: Amended by Stats. 2003, Ch. 419, Sec. 1. Effective January 1, 2004.)


text:
(a) Each blood bank or plasma center shall require as identification either a photographic driver’s license or other photographic identification that is issued by the Department of Motor Vehicles, pursuant to Division 6 (commencing with Section 12500) of the Vehicle Code, from all donors of human whole blood or blood components who receive payment in return for the donation of that blood or blood components.

(b) For the purposes of this section, “payment” means the transfer by a blood bank or plasma center to any person of money or any other valuable consideration that can be converted to money by the recipient, except that payment shall not include any of the following:

(1) Cancellation or refund of the nonreplacement fees or related blood or blood components transfusion charges.

(2) Blood assurance benefits to a person as a result of a blood or blood components donation to a donor club or blood assurance program.

(3) Time away from employment granted by an employer to an employee in order to donate blood or blood components.

history: (History: Amended by Stats. 2003, Ch. 419, Sec. 2. Effective January 1, 2004.)


text:
(a) Before donation of blood or blood components, a donor shall be notified in writing of, and shall have signed a written statement confirming the notification of, all of the following:

(1) That the blood or blood components shall be tested for evidence of antibodies to HIV.

(2) That the donor shall be notified of the test results in accordance with the requirements described in subdivision (c).

(3) That the donor blood or blood component that is found to have the antibodies shall not be used for transfusion.

(4) That blood or blood components shall not be donated for transfusion purposes by a person if the person may have reason to believe that he or she has been exposed to HIV or AIDS.

(5) That the donor is required to complete a health screening questionnaire to assist in the determination as to whether he or she may have been exposed to HIV or AIDS.

(b) A blood bank or plasma center shall incorporate voluntary means of self-deferral for donors. The means of self-deferral may include, but are not limited to, a form with checkoff boxes specifying that the blood or blood components are for research or test purposes only and a telephone callback system for donors to use in order to inform the blood bank or plasma center that blood or blood components donated should not be used for transfusion. The blood bank or plasma center shall inform the donor, in a manner that is understandable to the donor, that the self-deferral process is available and should be used if the donor has reason to believe that he or she is infected with HIV.

(c) Blood or blood components from any donor initially found to have serologic evidence of antibodies to HIV shall be retested for confirmation. Only if a further test confirms the conclusion of the earlier test shall the donor be notified of a reactive result by the blood bank or plasma center.

The department shall develop permissive guidelines for blood banks and plasma centers on the method to be used to notify a donor of a test result.

(d) Each blood bank or plasma center operating in California shall prominently display at each of its collection sites a notice that provides the addresses and telephone numbers of sites, within the proximate area of the blood bank or plasma center, where anonymous HIV antibody testing provided pursuant to Chapter 3 (commencing with Section 120885) of Part 4 of Division 105 may be administered without charge.

(e) The department may promulgate any additional regulations it deems necessary to enhance the safety of donated blood and blood components. The department may also promulgate regulations it deems necessary to safeguard the consistency and accuracy of HIV test results by requiring any confirmatory testing the department deems appropriate for the particular types of HIV tests that have yielded “reactive,” “positive,” “indeterminate,” or other similarly labeled results.

(f) Notwithstanding any other provision of law, civil liability or criminal sanction shall not be imposed for disclosure of test results to a local health officer if the disclosure is necessary to locate and notify a blood or blood components donor of a reactive result if reasonable efforts by the blood bank or plasma center to locate the donor have failed. Upon completion of the local health officer’s efforts to locate and notify a blood or blood components donor of a reactive result, all records obtained from the blood bank or plasma center pursuant to this subdivision, or maintained pursuant to this subdivision, including, but not limited to, any individual identifying information or test results, shall be expunged by the local health officer.

history: (History: Amended by Stats. 2017, Ch. 537, Sec. 1. (SB 239) Effective January 1, 2018.)


text:
(a) Notwithstanding Chapter 7 (commencing with Section 120975) of Part 4 of Division 105, or any other provision of law, no public entity or any private blood bank or plasma center shall be liable for an inadvertent, accidental, or otherwise unintentional disclosure of the results of an HIV test.

As used in this section, “public entity” includes, but is not limited to, any publicly owned or operated blood bank or plasma center, local health officer, and the department.

(b) Neither the department nor any blood bank or plasma center, including a blood bank or plasma center owned or operated by a public entity, or local health officer shall be held liable for any damage resulting from the notification of test results, as set forth in paragraph (2) of subdivision (a) of, or in subdivision (c) of, Section 1603.3.

history: (History: Amended by Stats. 2003, Ch. 419, Sec. 4. Effective January 1, 2004.)


text:
(a) Notwithstanding any other provision of law, every person engaged in the production of blood shall, if the product is intended for transfusion, label each container of blood which the person produces with a label, upon which the following designations shall be printed in letters the size of which shall be no less prominent than the proper name of the product.

(1) If the person giving the blood received no payment for the blood, the designation shall be “volunteer donor.”

(2) If the person giving the blood received payment for the blood, the designation shall be “paid donor.”

(b) As used in this section:

(1) “Blood” means human whole blood or components of human blood, including plasma, which are prepared from human whole blood by physical, rather than chemical processes, but does not include blood derivatives manufactured or processed by industrial use.

(2) “Industrial use” means a use of blood in which the blood is modified by physical or chemical means to produce derivatives for therapeutic or pharmaceutic biologics, laboratory reagents, or in vitro diagnostics.

(3) “Payment” means the transfer by a blood bank, or any other party, to any person of money or any other valuable consideration which can be converted to money by the recipient, except that “payment” shall not include any of the following:

(i) Cancellation or refund of the nonreplacement fees or related blood transfusion charges.

(ii) Blood assurance benefits to a person as a result of a blood donation to a donor club or blood assurance program.

(iii) Time away from employment granted by an employer to an employee in order to donate blood.

(c) Any blood bank receiving blood from a blood bank outside of California shall comply with the labeling requirements of this chapter. Any blood bank receiving this blood may label the blood as “volunteer donor” blood only if the blood bank receives with the blood a certificate from the out-of-state blood bank which states either that the particular shipment of blood was acquired from volunteer donors not receiving payment or that all blood processed by the out-of-state blood bank is acquired from volunteer donors not receiving payment. If the blood bank receiving such blood receives no such certificate with the blood, the blood shall be labeled as “paid donor” blood.

(d) No warranty shall be implied from the fact that any blood is labeled in accordance with the requirements of this section.

history: (History: Amended by Stats. 1989, Ch. 513, Sec. 1.)


citation: HSC § 1604

text: The distribution or release for distribution by blood banks of human whole blood, or those human whole blood derivatives specified by regulation, shall be made only to blood bank depositories or to other licensed blood banks.


text:
(a) Notwithstanding any other provision of law, in order to provide umbilical cord blood banking storage services, a blood bank shall be licensed pursuant to this chapter. Any additional standards for blood banks to store umbilical cord blood may be implemented by the department through the adoption of regulations.

(b) (1) The department may adopt emergency regulations to implement and make specific subdivision (a) in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. For purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.

(2) (A) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law. Notwithstanding Sections 11346.1 and 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing.

(B) Emergency regulations adopted pursuant to this section shall become effective immediately upon filing by the Secretary of State, shall be subject to public hearing within 120 days of filing with the Secretary of State, and shall comply with Sections 11346.8 and 11346.9 of the Government Code, or shall be repealed by the department.

(3) The Office of Administrative Law shall provide for the printing and publication of emergency regulations adopted pursuant to this section in the California Code of Regulations.

(4) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, and subject to subparagraph (B) of paragraph (2), the emergency regulations adopted pursuant to this subdivision shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department.

history: (History: Amended by Stats. 2007, Ch. 130, Sec. 160. Effective January 1, 2008.)


citation: HSC § 1605

text: Establishments which receive human whole blood and human whole blood derivatives specified by regulation and are not subject to license in accordance with this chapter shall be considered as blood bank depositories. Laboratory tests and other procedures with respect to the preparation of blood for transfusion shall be the sole responsibility of the blood bank depository.

history: (History: Repealed and added by Stats. 1963, Ch. 1055.)


citation: HSC § 1606

text: The procurement, processing, distribution, or use of whole blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing the same, or any of them, into the human body shall be construed to be, and is declared to be, for all purposes whatsoever, the rendition of a service by each and every person, firm, or corporation participating therein, and shall not be construed to be, and is declared not to be, a sale of such whole blood, plasma, blood products, or blood derivatives, for any purpose or purposes whatsoever.


citation: HSC § 1607

text:
(a) Notwithstanding any other law, licensed clinical laboratory bioanalysts, licensed clinical laboratory technologists, registered clinical laboratory technologist trainees, licensed vocational nurses, registered nurses, and blood donor phlebotomists, as defined by the American Association of Blood Banks, may perform skin puncture and venipuncture for the purposes of collecting human blood if both of the following are satisfied:

(1) The acts are performed in a blood bank licensed pursuant to this chapter and personnel training and standards meet accreditation requirements of the American Association of Blood Banks.

(2) The acts are performed under the direct and responsible supervision of a licensed physician and surgeon. The licensing and registration referred to in this section shall be licensing and registration pursuant to the Business and Professions Code.

(b) (1) Notwithstanding paragraph (2) of subdivision (a), blood may be collected at a blood bank when a physician or surgeon is not physically present on the premises if both of the following conditions are met:

(A) The medical director and their medical advisory committee, if one exists, approves of blood collection without a physician or surgeon present on the premises.

(B) The employee placed in charge, in the absence of a physician or surgeon, is a registered nurse.

(2) The registered nurse placed in charge pursuant to subparagraph (B) of paragraph (1) may be physically present on the premises or may be available via telehealth, as defined in Section 2290.5 of the Business and Professions Code, so long as the method of telehealth used is synchronous.

(3) (A) A blood bank shall annually report to the department any adverse donor events requiring emergency medical intervention that occur pursuant to this subdivision, including the date, location, type of adverse event, onsite response, and whether a registered nurse was physically present on the premises.

(B) At the request of the department, a blood bank shall provide written procedures for managing adverse donor reactions.

(4) This subdivision shall become inoperative on January 1, 2028.

(c) In accordance with the American Association of Blood Banks standards, the medical director of the blood bank shall be responsible for all medical and technical policies and procedures that relate to the safety of staff members, donors, and patients, including, but not limited to, ensuring that the blood bank has a qualified and competent staff to perform all tasks involved in the collection, storage, processing, and distribution of blood and blood components. The employer blood bank shall be responsible for determining the appropriate mix of qualified, competent employees that meets the accreditation requirements of the American Association of Blood Banks and is consistent with the services rendered.

(d) Personnel who are explicitly authorized by the blood bank and who meet the education, training, and competency standards of the blood bank, may obtain a predonation medical history and perform predonation screening. When unlicensed personnel perform these duties, the review of work required by federal regulations relating to good manufacturing practices, as set forth in Part 211 and Part 606 of Title 21 of the Code of Federal Regulations, shall be performed by those staff members who are licensed health care personnel.

(e) The collection of blood from autologous patients and other individuals who do not meet the American Association of Blood Banks criteria for regular volunteer donation shall be conducted by licensed health care personnel.

(f) This chapter does not prohibit the collection of blood at a state institution, a blood bank licensed pursuant to this chapter, or other establishment, under conditions established and acceptable to the department, by the personnel of the collecting entity.

(g) A staff position for a blood donor phlebotomist created as a consequence of this section shall not be the only cause for the displacement of any licensed personnel employed in a licensed blood bank. As used in this section, the term “displacement” shall mean a reduction in hours of nonovertime work, the loss of wages, or the loss of employment.

(h) This section does not limit the rights of employees or employee organizations to bargain in good faith on matters of wages, hours, or other terms and conditions of employment, including the negotiation of workplace standards within the scope of collective bargaining as authorized by state and federal law.

(i) For purposes of this section, “American Association of Blood Banks” means the American Association of Blood Banks or its successor organization.

history: (History: Amended by Stats. 2022, Ch. 726, Sec. 1. (SB 1475) Effective January 1, 2023.)


text:
(a) Notwithstanding any other provision of law, a person who has attained the age of 17 may consent to the donation of his or her blood and to the penetration of tissue which is necessary to accomplish such donation, and a blood bank may accept such donation.

(b) Notwithstanding any other provision of law, a person who has attained the age of 15 may consent to the donation of his or her blood and to the penetration of tissue which is necessary to accomplish such donation, and a blood bank may accept such donation, if he or she has the written consent of his or her parents or a guardian, and the written authorization of a physician and surgeon.

(c) As used in this section “donation of blood” means a giving of blood in which the donor of the blood receives no payment therefor.

history: (History: Amended by Stats. 1981, Ch. 23.)


citation: HSC § 1608

text: This chapter does not repeal or in any manner affect any provision of the Business and Professions Code relating to the practice of medicine.


citation: HSC § 1609

text:
No person shall engage in the production of biologics other than human whole blood and human whole blood derivatives unless:

(a) In a laboratory licensed by the Public Health Service, United States Department of Health, Education and Welfare.

(b) In a laboratory licensed by the Animal Inspection and Quarantine Branch, Agricultural Research Service, United States Department of Agriculture.

(c) In a clinical trial site storing or preparing for patient administration biologics, other than human whole blood and human whole blood derivatives, intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs or devices if the investigation is conducted in accordance with the requirements of Section 505(i) of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Sec. 360j(g)) and the regulations adopted pursuant to the federal act.

(d) Under the provisions of this chapter.

history: (History: Amended by Stats. 2022, Ch. 955, Sec. 2. (SB 1500) Effective January 1, 2023.)

path: 2. LICENSING PROVISIONS > 4. Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics > 3. Biologics Other Than Human Whole Blood and Human Whole Blood Derivatives


citation: HSC § 1610

text: The department shall make rules and regulations governing the production of all biologics produced in establishments under subdivision (c) of Section 1609.

article: 3. Biologics Other Than Human Whole Blood and Human Whole Blood Derivatives


citation: HSC § 1611

text: The department may make rules and regulations governing the transportation or distribution of cultures of micro-organisms which may produce disease in man or animals.


citation: HSC § 1613

text:
Applications for licenses issued under this chapter shall be made upon forms issued by the department. The applications shall contain at least the following:

(a) The name and address of the person owning the place, establishment, or institution in which biologics production is planned.

(b) The name and address of the person to be in charge of biologics production.

(c) The types of biologics to be produced.

(d) A full description of the building, its location, facilities, equipment, and apparatus to be used in biologics production.

(e) The name and address of each blood collection center operated by the applicant and whether the applicant operates any mobile units.

(f) Any additional information as the department may require.

history: (History: Amended by Stats. 1991, Ch. 800, Sec. 12.)

article: 4. Licenses

path: 2. LICENSING PROVISIONS > 4. Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics > 4. Licenses


citation: HSC § 1614

text:
If the department does not within 60 days after the filing of the application issue a license, it shall state the grounds and reasons for its refusal in writing, serving a copy upon the applicant.

The notice may be served by registered mail addressed to the applicant at his last known address.

history: (History: Amended by Stats. 1991, Ch. 800, Sec. 13.)

article: 4. Licenses


citation: HSC § 1615

text:
(a) A license shall be automatically revoked when there is a change of address, ownership, or person in charge of biologics production. However, a new license may be secured for the new location, owner, or person in charge prior to the actual change if the contemplated change is in compliance with all the provisions of this chapter and regulations pertaining thereto.

(b) Proceedings for denial of license shall be conducted in accordance with Section 100171.

history: (History: Amended by Stats. 1997, Ch. 220, Sec. 18. Effective August 4, 1997.)

article: 4. Licenses


citation: HSC § 1616

text:
(a) Each application for a license or license renewal under this chapter shall be accompanied by a fee determined by the director by regulations and in an amount sufficient to cover the cost of administering this chapter but not to exceed those costs, as specified pursuant to Section 1616.5.

(b) The state department shall receive and account for all moneys received pursuant to this chapter and shall deposit them with the Treasurer for deposit in the Clinical Laboratory Improvement Fund established pursuant to Section 1302 of the Business and Professions Code. All funds received pursuant to this chapter shall, upon appropriation, be expended to administer this chapter.

(c) Each license issued under this chapter shall expire 12 months from the date of its issuance. Application for renewal of license accompanied by the fee shall be filed with the department not less than 10 days prior to the expiration each year. Failure to make a timely renewal shall result in expiration of the license.

history: (History: Amended by Stats. 1994, Ch. 492, Sec. 5. Effective January 1, 1995.)

article: 5. Revenue

path: 2. LICENSING PROVISIONS > 4. Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics > 5. Revenue


text:
(a) The fee required pursuant to Section 1616 for the calendar year commencing January 1, 1992, and for each fiscal year thereafter unless adjusted pursuant to subdivision (b), shall not exceed the following:

One thousand five hundred dollars ($1,500) for a blood bank and no more than one blood collection center operated at the same location as the blood bank. In addition and irrespective of the location of the blood collection center, a fee of five hundred dollars ($500) for each additional blood collection center operated by the blood bank up to a maximum of one thousand five hundred dollars ($1,500) for three or more blood collection centers.

(b) The maximum application and renewal fees for blood bank licenses pursuant to subdivision (a) shall be adjusted annually in the manner specified in Section 100450. The adjustments shall be rounded off to the nearest whole dollar.

(c) This chapter shall not be interpreted to exempt the state, a district, city, county, or city and county, from payment of fees or from meeting the requirements established pursuant to this chapter or regulations adopted thereunder.

history: (History: Amended by Stats. 1996, Ch. 1023, Sec. 169. Effective September 29, 1996.)

article: 5. Revenue


citation: HSC § 1617

text:
(a) The department shall administer this chapter.

(b) In order to carry out this chapter, any duly authorized representative of the department may do any of the following:

(1) Enter or inspect on an announced or unannounced basis any building, premise, equipment, materials, records, or information at any reasonable time to secure compliance with, or prevent a violation of, this chapter or the regulations adopted pursuant thereto.

(2) Inspect, photograph, or copy any records, reports, test results, test specimens, or other information related to the requirements of this chapter or the regulations adopted pursuant thereto.

(3) Secure any sample, photograph, or other evidence from any building or premise for the purpose of enforcing this chapter or the regulations adopted pursuant thereto.

history: (History: Amended by Stats. 1991, Ch. 800, Sec. 16.)

article: 6. Enforcement

path: 2. LICENSING PROVISIONS > 4. Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics > 6. Enforcement


citation: HSC § 1618

text:
(a) Licenses shall be suspended or revoked by the department for the violation of any provision of this chapter, or of any rule or regulation made by the department under authority conferred by this chapter. The proceedings shall be conducted in accordance with Section 100171.

(b) Licenses may be denied for any reason applicable to revocation and suspension of licenses.

(c) District and city attorneys shall prosecute violations of this chapter upon evidence of violations within their respective jurisdictions submitted by the department.

history: (History: Amended by Stats. 1997, Ch. 220, Sec. 19. Effective August 4, 1997.)

article: 6. Enforcement


citation: HSC § 1619

text:
Nothing in this chapter shall be considered to be in conflict with Part 5 (commencing with Section 109875) of Division 104 of this code and all provisions of that division shall apply to biologics within the meaning of this chapter, except that this chapter shall not apply to products of:

(a) A laboratory licensed by the Public Health Service, United States Department of Health, Education and Welfare.

(b) A laboratory licensed by the Animal Inspection and Quarantine Branch, Agricultural Research Service, United States Department of Agriculture.

history: (History: Amended by Stats. 1996, Ch. 1023, Sec. 170. Effective September 29, 1996.)

article: 6. Enforcement


citation: HSC § 1620

text: The violation of any provision of this chapter is a misdemeanor punishable by a fine of not less than one hundred dollars ($100) nor more than one thousand dollars ($1,000), or by imprisonment for not more than 30 days, or by both.

history: (History: Amended by Stats. 1983, Ch. 1092, Sec. 148. Effective September 27, 1983. Operative January 1, 1984, by Sec. 427 of Ch. 1092.)

article: 6. Enforcement


citation: HSC § 1625

text:
As used in this article:

(a) “Blood” means human whole blood or components of human blood, including plasma, which are prepared from human whole blood by physical, rather than chemical processes, but does not include blood derivatives manufactured or processed for industrial use.

(b) “Cytapheresis” means the separation and collection of blood cells by hemapheresis.

(c) “Hemapheresis” means the removal of whole blood from a donor, separation of the blood into components, retention of the desired components, and return of the recombined remaining elements to the donor.

(d) “Industrial use” means a use of blood in which the blood is modified by physical or chemical means to produce derivatives for therapeutic or pharmaceutic biologics, laboratory reagents, or in vitro diagnostics.

(e) “Paid donor” means a person who donates blood and who receives payment in return for the donation of such blood.

(f) “Payment” means the transfer by a blood bank to any person of money or any other valuable consideration which can be converted to money by the recipient, except that payment shall not include any of the following:

(1) Cancellation or refund of the nonreplacement fees or related blood transfusion charges.

(2) Blood assurance benefits to a person as a result of a blood donation to a donor club or blood assurance program.

(3) Time away from employment, with or without pay, granted by an employer to an employee in order to donate blood.

(g) “Person” means any individual, blood bank, hospital, firm, corporation, or any other entity.

(h) “Transfusion” means a use of blood in which the blood is administered to a human being for treatment of sickness or injury.

history: (History: Amended by Stats. 1986, Ch. 1007, Sec. 2.)

article: 7. Blood Donations

path: 2. LICENSING PROVISIONS > 4. Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics > 7. Blood Donations


text:
In addition to the requirements of Section 1602.1, subdivisions (a) to (c), inclusive, of Section 1002 of Title 17 of the California Administrative Code, and any other requirements identified by the State Department of Health Services, hemapheresis donors shall provide a medical history questionnaire completed by a trained interviewer who questions and verifies the accuracy of responses before every donation.

The department may require testing or examinations to reflect changing technology and to increase the safety of blood products.

history: (History: Added by Stats. 1986, Ch. 1007, Sec. 3.)

article: 7. Blood Donations


citation: HSC § 1626

text:
(a) Except as provided in subdivisions (b) and (c), it shall be unlawful, in any transfusion of blood, to use any blood that was obtained from a paid donor.

(b) Subdivision (a) shall not be applicable to any transfusion of blood that was obtained from a paid donor if the physician and surgeon performing the transfusion has determined, taking into consideration the condition of the patient who is the recipient of the transfusion, that other blood of a type compatible with the blood type of the patient cannot reasonably be obtained for the transfusion.

(c) Subdivision (a) shall not apply to blood platelets secured from paid donors through the hemapheresis process if all of the following requirements are satisfied:

(1) The blood platelets are ordered by a doctor holding a valid California physician’s and surgeon’s certificate.

(2) The blood platelets are secured from a single donor and are sufficient to constitute a complete platelet transfusion.

(3) The donor’s identification number is recorded on the platelet label and is kept in the records of the entity providing the blood platelets for a minimum of five years.

(4) The donor has been examined by a doctor holding a valid California physician’s and surgeon’s certificate, and a repeat donor is reexamined at least annually.

(5) The transfusion is performed in a general acute care hospital.

(6) The blood platelets are processed according to standards issued by the American Association of Blood Banks, pursuant to Section 1602.1.

(7) The donor and blood are tested in accordance with regulations issued by the State Department of Health Services.

(8) The entity providing the blood platelets is licensed by the State Department of Health Services.

(9) The information that the donor of the blood platelets was compensated is printed on the label in accordance with Section 1603.5.

(10) In all instances, a potential donor shall provide a blood sample, which shall be tested with the standard panel of blood tests required by the State Department of Health Services for all blood donations. The results of the testing shall be obtained, evaluated, and determined to be acceptable prior to allowing the potential donor to provide his or her first donation of platelets. In addition, all donors shall be required to schedule an appointment for platelet donation.

(11) Any entity that is not collecting blood platelets from paid donors on August 1, 2000, shall obtain written permission from the director prior to compensating any donor for blood platelets.

(d) Subdivision (c) shall become inoperative on January 1, 2003.

history: (History: Amended by Stats. 2012, Ch. 728, Sec. 83. (SB 71) Effective January 1, 2013.)

article: 7. Blood Donations


citation: HSC § 1627

text:
(a) (1) The University of California is requested to develop a plan to establish and administer the Umbilical Cord Blood Collection Program for the purpose of collecting units of umbilical cord blood for public use in transplantation and providing nonclinical units for research pertaining to biology and new clinical utilization of stem cells derived from the blood and tissue of the placenta and umbilical cord. The program shall conclude no later than January 1, 2027.

(2) For purposes of this article, “public use” means both of the following:

(A) The collection of umbilical cord blood units from genetically diverse donors that will be owned by the University of California. This inventory shall be accessible by the National Registry and by qualified California-based and other United States and international registries and transplant centers to increase the likelihood of providing suitably matched donor cord blood units to patients or research participants who are in need of a transplant.

(B) Cord blood units with a lower number of cells than deemed necessary for clinical transplantation and units that meet clinical requirements, but for other reasons are unsuitable, unlikely to be transplanted, or otherwise unnecessary for clinical use, may be made available for research.

(b) (1) In order to implement the collection goals of this program, the University of California may, commensurate with available funds appropriated to the University of California for this program, contract with one or more selected applicant entities that have demonstrated the competence to collect and ship cord blood units in compliance with federal guidelines and regulations.

(2) It is the intent of the Legislature that, if the University of California contracts with another entity pursuant to this subdivision, the following shall apply:

(A) The University of California may use a competitive process to identify the best proposals submitted by applicant entities to administer the collection and research objectives of the program, to the extent that the University of California chooses not to undertake these activities itself.

(B) In order to qualify for selection under this section to receive, process, cryopreserve, or bank cord blood units, the entity shall, at a minimum, have obtained an investigational new drug (IND) exemption from the FDA or a biologic license from the FDA, as appropriate, to manufacture clinical grade cord blood stem cell units for clinical indications.

(C) In order to qualify to receive appropriate cord blood units and placental tissue to advance the research goals of this program, an entity shall, at a minimum, be a laboratory recognized as having performed peer-reviewed research on stem and progenitor cells, including those derived from placental or umbilical cord blood and postnatal tissue.

(3) A medical provider or research facility shall comply with, and shall be subject to, existing penalties for violations of all applicable state and federal laws with respect to the protection of any medical information, as defined in Section 56.05 of the Civil Code, and any personally identifiable information contained in the umbilical cord blood inventory.

(c) The University of California is encouraged to make every effort to avoid duplication or conflicts with existing and ongoing programs and to leverage existing resources.

(d) (1) All information collected pursuant to the program shall be confidential, and shall be used solely for the purposes of the program, including research. Access to confidential information shall be limited to authorized persons who are bound by appropriate institutional policies or who otherwise agree, in writing, to maintain the confidentiality of that information.

(2) Any person who, in violation of applicable institutional policies or a written agreement to maintain confidentiality, discloses any information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section, may be denied further access to any confidential information maintained by the University of California, and shall be subject to a civil penalty not exceeding one thousand dollars ($1,000). The penalty provided for in this section shall not be construed to limit or otherwise restrict any remedy, provisional or otherwise, provided by law for the benefit of the University of California or any other person covered by this section.

(3) Notwithstanding the restrictions of this section, an individual to whom the confidential information pertains shall have access to their own personal information.

(e) It is the intent of the Legislature that the plan and implementation of the program provide for both of the following:

(1) Limit fees for access to cord blood units to the reasonable and actual costs of storage, handling, and providing units, as well as for related services such as donor matching and testing of cord blood and other programs and services typically provided by cord blood banks and public use programs.

(2) The submittal of the plan developed pursuant to subdivision (a) to the health and fiscal committees of the Legislature.

(f) It is additionally the intent of the Legislature that the plan and implementation of the program attempt to provide for all of the following:

(1) Development of a strategy to increase voluntary participation by hospitals in the collection and storage of umbilical cord blood and identify funding sources to offset the financial impact on hospitals.

(2) Consideration of a medical contingency response program to prepare for and respond effectively to biological, chemical, or radiological attacks, accidents, and other public health emergencies where victims potentially benefit from treatment.

(3) Exploration of the feasibility of operating the program as a self-funding program, including the potential for charging users a reimbursement fee.

history: (History: Amended by Stats. 2022, Ch. 604, Sec. 1. (SB 883) Effective January 1, 2023. Repealed as of January 1, 2027, pursuant to Section 1630.)

article: 8. Umbilical Cord Blood Program

path: 2. LICENSING PROVISIONS > 4. Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics > 8. Umbilical Cord Blood Program


citation: HSC § 1628

text:
(a) The University of California may accept public and private funds for the purpose of implementing this article.

(b) The Umbilical Cord Blood Collection Program Fund is hereby created in the State Treasury. Any fees collected pursuant to Section 103625 shall be deposited into the fund. Moneys in the fund shall be available, upon appropriation by the Legislature, for purposes of this article.

(c) The fund may include additional federal, state, and private funds made available for purposes of the program, including, but not limited to, the fees collected for the fund pursuant to Section 103625, and, notwithstanding Section 16305.7 of the Government Code, any interest earned on moneys in the fund.

(d) (1) Funds shall be appropriated for the purposes of this article to the extent the plan the University of California is requested to develop pursuant to subdivision (a) of Section 1627 and the implementation of the plan are consistent with the goals and intent of this article.

(2) In the event that funds are not appropriated for the program as described in this article, it is the intent of the Legislature that the University of California shall not implement the program.

history: (History: Amended by Stats. 2010, Ch. 529, Sec. 3. (AB 52) Effective September 29, 2010. Repealed as of January 1, 2027, pursuant to Section 1630.)

article: 8. Umbilical Cord Blood Program


citation: HSC § 1629

text: In implementing the program, the department shall make every effort to avoid duplication or conflicts with existing and ongoing programs and to leverage existing resources.

history: (History: Added by Stats. 2007, Ch. 516, Sec. 2. Effective January 1, 2008. Repealed as of January 1, 2027, pursuant to Section 1630.)

article: 8. Umbilical Cord Blood Program


text:
(a) On or before January 1, 2026, if it elects to administer the Umbilical Cord Blood Collection Program, the University of California shall provide a report to the Assembly and Senate Committees on Health that addresses, at a minimum, all of the following:

(1) The number of cord blood units collected and registered under the program, disaggregated by race and ethnicity.

(2) The number of registered units transplanted as a result of the program, disaggregated by race and ethnicity.

(3) The number of California residents receiving a transplant as a result of the program.

(4) The number of units made available for research and a summary of key research findings as a result of the program.

(5) Annual budget information on the program, including revenues, spending, and beginning- and end-of-year balances.

(6) Budget information for each participating cord blood bank, including collection and storage costs and available revenues to cover those costs.

(7) Fees charged by participating cord blood banks for collecting, storing, handling, and providing units, and a summary of how these fees were determined.

(8) Nationwide data on cord blood units collected, registered, and transplanted, disaggregated by race and ethnicity.

(9) A summary of available cell sources for a hematopoietic stem cell transplant and research on the ability of underrepresented groups to find a suitable match for a transplant.

(10) Any other outcomes or data regarding the impact of the program.

(b) The requirement for submitting a report imposed under subdivision (a) is inoperative on December 31, 2026, pursuant to Section 10231.5 of the Government Code.

history: (History: Amended by Stats. 2022, Ch. 604, Sec. 2. (SB 883) Effective January 1, 2023. Repealed as of January 1, 2027, pursuant to Section 1630.)

article: 8. Umbilical Cord Blood Program


citation: HSC § 1630

text: This article shall remain in effect only until January 1, 2027, and as of that date is repealed.

history: (History: Repealed and added by Stats. 2022, Ch. 604, Sec. 4. (SB 883) Effective January 1, 2023. Repealed as of January 1, 2027, by its own provisions. Note: Repeal affects Article 8, commencing with Section 1627.)

article: 8. Umbilical Cord Blood Program


citation: HSC § 1635

text:
(a) “Department” means the State Department of Public Health.

(b) “Donor” means an individual, living or deceased, from whom tissue is removed.

(c) “Gamete bank” means a tissue bank that collects, processes, stores, or distributes sperm, oocytes, or embryos, including a facility that provides professional reproductive services, other than those facilities exempt from tissue bank licensure.

(d) “Person” means an individual, corporation, business trust, estate trust, partnership, association, state or local government, or subdivision or agency thereof, or any other legal entity.

(e) (1) “Tissue” means 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, oocytes, embryos, blood, other fluids, and any other portion of a human body, but shall not include an organ when recovered for transplantation or research purposes.

(2) For purposes of paragraph (1), “organ” means a human kidney, liver, heart, lung, pancreas, intestine (including the esophagus, stomach, small or large intestine, or any portion of the gastrointestinal tract), or vascularized composite allograft, and associated blood vessels recovered from an organ donor during the recovery of the organ.

(f) “Tissue bank” means a place, establishment, or institution that collects, processes, stores, or distributes tissue for transplantation into human beings.

(g) “Transplantation” means the act or process of transferring tissue, including by ingestion, from a donor to the body of the donor or another human being.

history: (History: Amended by Stats. 2019, Ch. 539, Sec. 1. (AB 785) Effective January 1, 2020.)

chapter: 4.1. Tissue Banks

path: 2. LICENSING PROVISIONS > 4.1. Tissue Banks > 1. Definitions, Licensure, and Exceptions


text:
(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 their patient or the implantation of tissue by an individual physician and surgeon into their 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 kit’s 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 their 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 device’s or product’s package insert and any other manufacturer instructions, and used solely for the express purpose of direct implantation into or application on the practitioner’s 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 their 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 device’s or product’s 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.

(11) The storage or preparation for patient administration of tissue performed at a clinical trial site that is intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs or devices if the investigation is conducted in accordance with the requirements of Section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Sec. 360j(g)) and the regulations adopted pursuant to the federal act.

(12) The storage or distribution of pasteurized donor human milk that was obtained from a tissue bank, licensed pursuant to this chapter, by a general acute care hospital. A general acute care hospital that is exempt from licensure as a tissue bank pursuant to this paragraph shall comply with the requirements of subdivision (b) of Section 1648.

history: (History: Amended by Stats. 2024, Ch. 975, Sec. 2. (AB 3059) Effective January 1, 2025.)

article: 1. Definitions, Licensure, and Exceptions


text: The Legislature hereby declares its intent that the collection, processing, storage, or distribution of tissue for the purpose of transplantation, as regulated by this chapter, shall be deemed a service by those persons engaged in these activities. Therefore, the collection, processing, storage, or distribution of tissue for the purpose of transplantation, as regulated by this chapter, shall not be subject to the requirements of Division 2 (commencing with Section 2101) of the Commercial Code.

history: (History: Added by Stats. 1991, Ch. 801, Sec. 2.)


citation: HSC § 1639

text:
(a) The department may adopt rules and regulations governing the administration and enforcement of this chapter.

(b) Regulations adopted by the department may include minimum standards for the following:

(1) Safe preservation, transportation, storage, and handling of tissue acquired or used for transplantation.

(2) Testing of donors to determine compatibility when appropriate.

(3) Testing or assessment of donors to prevent the spread of disease through transplantation.

(4) Equipment.

(5) Methods.

(6) Personnel qualifications.

(7) Any other area concerning the operation or maintenance of a tissue bank, not inconsistent with this chapter, as may be necessary to carry out this chapter.

(c) The department shall report to the Legislature by January 1, 2004, on the status of the regulations developed pursuant to this section.

history: (History: Amended by Stats. 2003, Ch. 464, Sec. 1. Effective January 1, 2004.)

article: 2. Regulation of Tissue Banks

path: 2. LICENSING PROVISIONS > 4.1. Tissue Banks > 2. Regulation of Tissue Banks


text:
(a) Notwithstanding Section 1639, the state department shall adopt, on or before July 1, 2004, rules and regulations governing licensed tissue banks engaged in the collection of human musculoskeletal tissue, skin, and veins for transplantation in humans. The regulations shall be substantially based upon the criteria used by tissue bank trade associations in their respective accreditation processes including, but not limited to, those of the Eye Bank Association of America and the American Association of Tissue Banks, and the scientific and technical data submitted by individual tissue banks.

(b) Regulations adopted by the state department, pursuant to subdivision (a), shall include minimum standards for all of the following:

(1) Safe preservation, transportation, storage, and handling of tissue acquired or used for transplantation.

(2) Testing of donors to determine compatibility when appropriate.

(3) Testing or assessment of donors to prevent the spread of disease through transplantation.

(4) Equipment.

(5) Methods.

(6) Personnel qualifications.

(7) Any other area concerning the operation or maintenance of a tissue bank, not inconsistent with this chapter, as may be necessary to carry out this chapter.

(c) On or before July 1, 2003, the department shall report to the appropriate policy and fiscal committees of the Legislature regarding the status of the proposed regulations.

history: (History: Added by Stats. 2002, Ch. 929, Sec. 1. Effective January 1, 2003.)

article: 2. Regulation of Tissue Banks


text:
Any person desiring a license issued pursuant to Section 1639.3 shall file with the state department a verified application on forms prescribed by the state department containing all of the following:

(a) The name of the applicant for licensure.

(b) The street address of the tissue bank. If more than one street address is occupied by the tissue bank, all occupied street addresses shall be listed.

(c) Whether the applicant is an individual, partnership, unincorporated association, or corporation.

(d) Whether the applicant does business under a fictitious name, and, if so, the fictitious name and the name of the locality wherein any fictitious name permit is filed.

(e) If the applicant is a partnership, the names of all the members of the partnership, or unincorporated association, whether general or limited.

(f) If the applicant is a corporation, the name of the officers, directors, shareholders holding a 5 percent or more interest in the corporation, and any person, partnership, or corporation who or which has the responsibility to manage or conduct the day-to-day operation of the tissue bank.

(g) The type of tissue collected, processed, stored, or distributed by the tissue bank.

(h) The names, titles, and qualifications of the persons responsible for the collection, processing, storage, or distribution of tissue by the tissue bank.

(i) Any process utilized by the tissue bank to ensure safe preservation, transportation, storage, and handling, of tissue acquired or used by the tissue bank.

(j) Any process utilized by the tissue bank to determine if, when appropriate, donors have been tested to determine compatibility.

(k) Any process utilized by the tissue bank to determine if donors have been tested or assessed for the transmission of disease through transplantation.

article: 2. Regulation of Tissue Banks


text:
(a) Each license issued pursuant to subdivision (a) of Section 1639.3 before July 1, 1992, shall expire July 1, 1993. Every other license issued pursuant to subdivision (a) of Section 1639.3 shall expire 12 months from the date of issuance.

(b) An application for renewal of a license issued pursuant to subdivision (a) of Section 1639.3 shall be filed with the state department not less than 30 days prior to its expiration date and shall be accompanied by the annual renewal fee required in Section 1639.5. Failure to make timely application or payment for renewal shall result by operation of law in expiration of the license on its expiration date.

(c) Upon application and payment of the required fee, a renewal license issued under subdivision (a) of Section 1639.3 shall be renewed for one- or two-year periods, at the option of the licensee, as long as the licensee has been found to be in substantial compliance with this chapter and the rules and regulations adopted under this chapter during the preceding license period.

(d) Any license issued pursuant to this chapter shall be forfeited by operation of law prior to its expiration date when one of the following occurs:

(1) The tissue bank is sold or otherwise transferred.

(2) The license is surrendered to the state department.

article: 2. Regulation of Tissue Banks


text:
(a) Upon the filing of the verified application for licensure required by Section 1639.1, payment of the application fee in the amount required in Section 1639.5, and full compliance with this chapter and the rules and regulations adopted by the state department, the state department shall issue a license to operate a tissue bank to the applicant.

(b) If the state department finds that the applicant is not in compliance with this chapter or the rules or regulations adopted under this chapter, or if it finds that the applicant has acted in a manner which would justify the revocation or suspension of a tissue bank license as described in Section 1643, the license shall be denied.

(c) The state department may, prior to a determination under subdivision (a) that the applicant is in full compliance, but after the filing of a complete and verified application and payment of the application fee, issue a provisional license to operate a tissue bank to the applicant. The provisional license shall remain in effect until a license is either granted under subdivision (a) or denied under subdivision (b).

If this period is longer than a year from the date of filing the application for licensure, the applicant shall pay an additional annual fee of nine hundred fifty dollars ($950) in order for the provisional license to remain in effect for an additional one-year period. Failure to pay the additional annual fee shall result, by operation of law, in automatic expiration of the provisional license one year from the date of its original issuance. If the provisional license does so expire, the applicant may not continue to operate a tissue bank pending the department’s determination of whether a license shall be granted or denied.

article: 2. Regulation of Tissue Banks


text: Immediately upon the denial of any application for a license, the state department shall notify the applicant in writing. Within 20 days after the state department mails the notice, the applicant may present a written petition for a hearing to the state department. Upon receipt by the state department of the petition in proper form, the petition shall be set for hearing. The proceedings shall be conducted in accordance with Section 100171.

history: (History: Amended by Stats. 1997, Ch. 220, Sec. 20. Effective August 4, 1997.)

article: 2. Regulation of Tissue Banks


text:
(a) The application and annual renewal fee for a tissue bank license shall be nine hundred fifty dollars ($950). Upon application for renewal of a license issued pursuant to subdivision (a) of Section 1639.3, the amount of the annual renewal fee required shall be determined by the period of time for which renewal is sought, which shall be either a one- or two-year period. The amount due shall be the amount prorated to the length of time the renewal is sought, based on the annual nine hundred fifty dollar ($950) fee.

(b) Notwithstanding subdivision (a), no license fee shall be required for any tissue bank operated by the state or any state agency, or by a district, city, county, or city and county, or any subdivision or agency thereof, or by a “mothers’ milk bank,” as defined in subdivision (b) of Section 14132.34 of the Welfare and Institutions Code, that has applied for tissue bank licensure prior to January 1, 1995.

history: (History: Amended by Stats. 1994, Ch. 639, Sec. 1. Effective January 1, 1995.)

article: 2. Regulation of Tissue Banks


text:
(a) In order to carry out the purpose of this chapter, any duly authorized representative of the department may do any of the following:

(1) Enter or inspect on an announced or unannounced basis any building, premise, equipment, materials, records, or information at any reasonable time to secure compliance with, or prevent a violation of, this chapter or the rules or regulations adopted by the state department.

(2) Inspect, photograph, or copy any records, reports, test results, test specimens, or other information related to the requirements of this chapter or the rules or regulations adopted by the state department.

(3) Secure any sample, photograph, or other evidence from any building or premise for the purpose of enforcing this chapter or the rules or regulations adopted by the state department.

(b) The state department may require licensed tissue banks to demonstrate satisfactory performance in a proficiency testing program approved by the state department in laboratory procedures which the tissue bank performs.

article: 2. Regulation of Tissue Banks


text: Any person, when submitting an application for a license, including the renewal thereof, pursuant to this chapter, shall also submit, with the application, a copy of the applicant’s standard informed consent form required pursuant to Section 7158.3.

history: (History: Added by Stats. 2003, Ch. 464, Sec. 2. Effective January 1, 2004.)

article: 2. Regulation of Tissue Banks


text:
(a) There is hereby established in the State Treasury the Tissue Bank License Fund. Notwithstanding any other provision of law, if, at the end of any fiscal year, the unencumbered balance in any account in the Tissue Bank License Fund exceeds 110 percent of the amount appropriated from the account for the following fiscal year, the state department shall reduce the application and annual renewal fees which are deposited into the account. The amount of the reduction shall be sufficient to reduce the unencumbered balance in the account at the end of the following fiscal year to less than 110 percent of the amount appropriated in that fiscal year. The adjustment of fees pursuant to this section shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.

(b) The state department shall receive and account for all money received pursuant to this chapter and shall deposit it with the Treasurer who shall keep the money in the Tissue Bank License Fund.

(c) Moneys deposited to the credit of the Tissue Bank License Fund which are appropriated in the Budget Act or any other appropriation act for support of or expenditure by the state department shall be used by the state department to administer this chapter.

(d) Upon the request of the State Director of Health Services, the Director of Finance may make a loan to the Tissue Bank License Fund from funds appropriated from the General Fund for that purpose. The amount of any such loan shall be approved by the Director of Finance and be repaid under those terms and conditions as prescribed by the Director of Finance, but shall, in any event, be repaid not later than June 30, 1995.

article: 2. Regulation of Tissue Banks


text:
The department shall submit a report to the Legislature no later than January 1, 2003, including, but not limited to, examining and evaluating all of the following:

(a) Administrative expenditures of tissue banks.

(b) Current use of informed consent by tissue banks in tissue donation and recovery, including recommendations for improving and expanding informed consent policy.

(c) Full disclosure requirements by tissue banks to the donor or the person authorized to make a donation on behalf of a decedent of all potential uses of donated and recovered tissues.

(d) A system in which individuals with medically necessary conditions for which donated tissues are part of the prescribed treatment are given priority in receiving donated tissues, and the feasibility of state subsidies to implement the system.

(e) The current process for tissue recovery and distribution, including recommendations for improvement, where necessary.

history: (History: Added by Stats. 2000, Ch. 829, Sec. 1. Effective January 1, 2001.)

article: 2. Regulation of Tissue Banks


citation: HSC § 1641

text: Any person who violates this chapter or who willfully and repeatedly violates any rule or regulation adopted under this chapter, is guilty of a misdemeanor and upon conviction thereof shall be punished by a fine not to exceed one thousand dollars ($1,000) or by imprisonment in a county jail for a period not to exceed 180 days, or by both fine and imprisonment.

article: 2. Regulation of Tissue Banks


text: The state department may bring an action to enjoin the violation or threatened violation of Section 1635.1 in the superior court in and for the county in which the violation occurred or is about to occur. Any proceeding under this section shall conform to the requirements of Chapter 3 (commencing with Section 525) of Title 7 of Part 2 of the Code of Civil Procedure, except that the state department shall not be required to allege facts necessary to show or tending to show lack of adequate remedy at law or irreparable damage or loss. With respect to any action brought pursuant to this section alleging actual violation of Section 1635.1, the court shall, if it finds the allegations to be true, issue its order enjoining the continuance of the violation.

article: 2. Regulation of Tissue Banks


citation: HSC § 1643

text:
The state department may suspend or revoke any license issued under this chapter for any of the following reasons:

(a) Violation by the licensee of this chapter or any rule or regulation adopted under this chapter.

(b) Aiding, abetting, or permitting the violation of any provision of this chapter, the rules or regulations adopted under this chapter or the Medical Practice Act (Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code).

(c) Proof that the licensee has made false statements in any material regard on the application for a tissue bank license.

(d) Conduct inimical to the public health, morals, welfare, or safety of the people of the State of California in the maintenance or operation of the premises or services for which a license is issued.

(e) Conduct prohibited under Section 367f of the Penal Code and under Section 274e of Title 42 of the United States Code.

(f) The conviction of a licensee or the person in charge of the tissue bank of any crime which is substantially related to the qualifications or duties of the licensee or the person in charge of the tissue bank or which is substantially related to the functions of the tissue bank. For purposes of this section, a conviction means a plea or verdict of guilty or a conviction following a plea of nolo contendere. An action to revoke or suspend the license may be taken when the time for appeal has elapsed or the judgment of conviction has been affirmed on appeal or when an order granting probation is made suspending the imposition of sentence, notwithstanding a subsequent order pursuant to Section 1203.4 of the Penal Code permitting withdrawal of a plea of guilty and entry of a plea of not guilty, or setting aside the verdict of guilty, or dismissing the accusation, information or indictment. The director shall take into account all competent evidence of rehabilitation furnished by the licensee or person in charge of the tissue bank.

article: 3. Suspension or Revocation of License

path: 2. LICENSING PROVISIONS > 4.1. Tissue Banks > 3. Suspension or Revocation of License


text: Proceedings for the suspension or revocation of licenses under this chapter shall be conducted in accordance with Section 100171.

history: (History: Amended by Stats. 1997, Ch. 220, Sec. 21. Effective August 4, 1997.)

article: 3. Suspension or Revocation of License


text: The state department may temporarily suspend any license issued under this chapter prior to any hearing, when it has determined that the action is necessary to protect the public welfare. The state department shall notify the licensee of the temporary suspension and the effective date thereof and at the same time shall serve the licensee with an accusation. Upon receipt of a notice of defense by the licensee, the matter shall, within 15 days, be set for hearing. The hearing shall be held as soon as possible but not later than 30 days after receipt of such notice. The temporary suspension shall remain in effect until such time as the hearing is completed and the state department has made a final determination on the merits. However, the temporary suspension shall be deemed vacated if the state department fails to make a final determination on the merits within 60 days after the original hearing has been completed.

article: 3. Suspension or Revocation of License


citation: HSC § 1644

text:
(a) For purposes of this chapter, “donor,” “person,” “tissue,” “transplantation,” and “department” shall have the meaning as defined for those terms in Section 1635.

(b) For purposes of this chapter, “HIV” shall mean human immunodeficiency virus.

(c) “Identifying information” means the full name of the donor, the donor’s date of birth, and the permanent address or other contact information, or both, given at the time of donation, or, if different, the current address or other contact information, or both, of the donor retained by the gamete bank.

(d) “Medical information” means information regarding a present illness of the donor, past illness of the donor, and social, genetic, and family history of the donor.

history: (History: Amended by Stats. 2019, Ch. 539, Sec. 2. (AB 785) Effective January 1, 2020.)

path: 2. LICENSING PROVISIONS > 4.2. Donations of Organs, Tissues,or Body Fluids


text:
(a) A gamete bank licensed in this state shall collect and retain from a gamete donor the donor’s identifying information and medical information at the time of the donation. A gamete bank licensed in this state that receives gametes from a donor collected by another gamete bank shall collect and retain the name, address, telephone number, and email address of the gamete bank from which the gametes were received.

(b) A gamete bank licensed in this state shall disclose the information collected under subdivision (a) as provided in Section 1644.3.

(c) This section does not apply to gametes collected from a donor whose identity is known to the recipient of the gametes at the time of the donation.

(d) This section shall apply only to gametes collected on or after January 1, 2020.

history: (History: Amended by Stats. 2019, Ch. 539, Sec. 3. (AB 785) Effective January 1, 2020.)

chapter: 4.2. Donations of Organs, Tissues,or Body Fluids


text:
(a) A gamete bank licensed in this state that collects gametes from a donor shall do all of the following:

(1) Provide the donor with information in a record about the donor’s choice regarding identity disclosure.

(2) Obtain a declaration from the donor regarding identity disclosure.

(3) Maintain identifying information and medical information about each gamete donor. The gamete bank shall maintain records of gamete screening and testing and comply with reporting requirements, in accordance with federal law and applicable law of this state other than this chapter.

(b) A gamete bank licensed in this state shall give a donor the choice to sign a declaration, attested by a notary or witnessed, that does either of the following:

(1) States that the donor agrees to disclose the donor’s identity to a child conceived by assisted reproduction with the donor’s gametes, on request, once the child attains 18 years of age.

(2) States that the donor does not agree presently to disclose the donor’s identity to the child.

(c) A gamete bank licensed in this state shall permit a donor who has signed a declaration that the donor does not agree to disclose the donor’s identity under paragraph (2) of subdivision (b) to withdraw the declaration at any time by signing a declaration that the donor agrees to disclose the donor’s identity under paragraph (1) of subdivision (b).

(d) A gamete bank licensed in this state is not required to collect gametes from a donor who does not agree to disclose the donor’s identity under paragraph (2) of subdivision (b).

(e) This section does not apply to gametes collected from a donor whose identity is known to the recipient of the gametes at the time of the donation.

(f) This section shall apply only to gametes collected on or after January 1, 2020.

history: (History: Amended by Stats. 2019, Ch. 539, Sec. 4. (AB 785) Effective January 1, 2020.)