Amended IN Senate March 05, 2020 CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION Senate Bill No. 851Introduced by Senator AtkinsJanuary 13, 2020 An act to add Section 1603.35 to the Health and Safety Code, relating to blood donations. LEGISLATIVE COUNSEL'S DIGESTSB 851, as amended, Atkins. Blood donations. Existing law requires any person engaged in the production of human whole blood or human whole blood derivatives to be licensed by the State Department of Public Health. Existing law provides for the regulation of, among others, blood banks and plasma centers, as defined. Existing law requires, before donation of blood or blood components, a donor to be notified in writing that, among other things, their blood or blood components will be tested for evidence of antibodies to human immunodeficiency virus, and that donor blood or blood components found to have the antibodies will not be used for transfusion, which is commonly referred to as a deferral. Existing law authorizes a blood bank or plasma center to incorporate voluntary means of self-deferral for donors, as specified. A violation of these provisions is a crime.This bill would require a blood bank or plasma center to develop a protocol to provide information to a potential donor who is subject to a deferral deferral, including the reason for the deferral, including deferral and information relating to standards established pursuant to federal law. The bill would require the information provided under these protocols to be consistent with federal standards and medical standards of care. The bill would require the protocols to be provided to the department annually, and would require the department to review those protocols and compliance as part of the administration and enforcement of licensure.Because a violation of these provisions would be a crime, this bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES Bill TextThe people of the State of California do enact as follows:SECTION 1. Section 1603.35 is added to the Health and Safety Code, immediately following Section 1603.3, to read:1603.35. Each blood bank or plasma center shall provide information to a develop a protocol to ensure that information is provided to any potential donor who is subject to a deferral deferral, including the reason for the deferral, including deferral and information relating to standards established pursuant to federal law. The information shall be consistent with the current United States Food and Drug Administration requirements and guidelines and shall be provided in a manner consistent with applicable medical standards of care. The protocols shall be provided to the department annually. The department shall review the protocols and review compliance as part of the administration and enforcement of licensure.SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
Amended IN Senate March 05, 2020 CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION Senate Bill No. 851Introduced by Senator AtkinsJanuary 13, 2020 An act to add Section 1603.35 to the Health and Safety Code, relating to blood donations. LEGISLATIVE COUNSEL'S DIGESTSB 851, as amended, Atkins. Blood donations. Existing law requires any person engaged in the production of human whole blood or human whole blood derivatives to be licensed by the State Department of Public Health. Existing law provides for the regulation of, among others, blood banks and plasma centers, as defined. Existing law requires, before donation of blood or blood components, a donor to be notified in writing that, among other things, their blood or blood components will be tested for evidence of antibodies to human immunodeficiency virus, and that donor blood or blood components found to have the antibodies will not be used for transfusion, which is commonly referred to as a deferral. Existing law authorizes a blood bank or plasma center to incorporate voluntary means of self-deferral for donors, as specified. A violation of these provisions is a crime.This bill would require a blood bank or plasma center to develop a protocol to provide information to a potential donor who is subject to a deferral deferral, including the reason for the deferral, including deferral and information relating to standards established pursuant to federal law. The bill would require the information provided under these protocols to be consistent with federal standards and medical standards of care. The bill would require the protocols to be provided to the department annually, and would require the department to review those protocols and compliance as part of the administration and enforcement of licensure.Because a violation of these provisions would be a crime, this bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.Digest Key Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: YES
Amended IN Senate March 05, 2020
Amended IN Senate March 05, 2020
CALIFORNIA LEGISLATURE 20192020 REGULAR SESSION
Senate Bill
No. 851
Introduced by Senator AtkinsJanuary 13, 2020
Introduced by Senator Atkins
January 13, 2020
An act to add Section 1603.35 to the Health and Safety Code, relating to blood donations.
LEGISLATIVE COUNSEL'S DIGEST
## LEGISLATIVE COUNSEL'S DIGEST
SB 851, as amended, Atkins. Blood donations.
Existing law requires any person engaged in the production of human whole blood or human whole blood derivatives to be licensed by the State Department of Public Health. Existing law provides for the regulation of, among others, blood banks and plasma centers, as defined. Existing law requires, before donation of blood or blood components, a donor to be notified in writing that, among other things, their blood or blood components will be tested for evidence of antibodies to human immunodeficiency virus, and that donor blood or blood components found to have the antibodies will not be used for transfusion, which is commonly referred to as a deferral. Existing law authorizes a blood bank or plasma center to incorporate voluntary means of self-deferral for donors, as specified. A violation of these provisions is a crime.This bill would require a blood bank or plasma center to develop a protocol to provide information to a potential donor who is subject to a deferral deferral, including the reason for the deferral, including deferral and information relating to standards established pursuant to federal law. The bill would require the information provided under these protocols to be consistent with federal standards and medical standards of care. The bill would require the protocols to be provided to the department annually, and would require the department to review those protocols and compliance as part of the administration and enforcement of licensure.Because a violation of these provisions would be a crime, this bill would impose a state-mandated local program.The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.This bill would provide that no reimbursement is required by this act for a specified reason.
Existing law requires any person engaged in the production of human whole blood or human whole blood derivatives to be licensed by the State Department of Public Health. Existing law provides for the regulation of, among others, blood banks and plasma centers, as defined. Existing law requires, before donation of blood or blood components, a donor to be notified in writing that, among other things, their blood or blood components will be tested for evidence of antibodies to human immunodeficiency virus, and that donor blood or blood components found to have the antibodies will not be used for transfusion, which is commonly referred to as a deferral. Existing law authorizes a blood bank or plasma center to incorporate voluntary means of self-deferral for donors, as specified. A violation of these provisions is a crime.
This bill would require a blood bank or plasma center to develop a protocol to provide information to a potential donor who is subject to a deferral deferral, including the reason for the deferral, including deferral and information relating to standards established pursuant to federal law. The bill would require the information provided under these protocols to be consistent with federal standards and medical standards of care. The bill would require the protocols to be provided to the department annually, and would require the department to review those protocols and compliance as part of the administration and enforcement of licensure.
Because a violation of these provisions would be a crime, this bill would impose a state-mandated local program.
The California Constitution requires the state to reimburse local agencies and school districts for certain costs mandated by the state. Statutory provisions establish procedures for making that reimbursement.
This bill would provide that no reimbursement is required by this act for a specified reason.
## Digest Key
## Bill Text
The people of the State of California do enact as follows:SECTION 1. Section 1603.35 is added to the Health and Safety Code, immediately following Section 1603.3, to read:1603.35. Each blood bank or plasma center shall provide information to a develop a protocol to ensure that information is provided to any potential donor who is subject to a deferral deferral, including the reason for the deferral, including deferral and information relating to standards established pursuant to federal law. The information shall be consistent with the current United States Food and Drug Administration requirements and guidelines and shall be provided in a manner consistent with applicable medical standards of care. The protocols shall be provided to the department annually. The department shall review the protocols and review compliance as part of the administration and enforcement of licensure.SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
The people of the State of California do enact as follows:
## The people of the State of California do enact as follows:
SECTION 1. Section 1603.35 is added to the Health and Safety Code, immediately following Section 1603.3, to read:1603.35. Each blood bank or plasma center shall provide information to a develop a protocol to ensure that information is provided to any potential donor who is subject to a deferral deferral, including the reason for the deferral, including deferral and information relating to standards established pursuant to federal law. The information shall be consistent with the current United States Food and Drug Administration requirements and guidelines and shall be provided in a manner consistent with applicable medical standards of care. The protocols shall be provided to the department annually. The department shall review the protocols and review compliance as part of the administration and enforcement of licensure.
SECTION 1. Section 1603.35 is added to the Health and Safety Code, immediately following Section 1603.3, to read:
### SECTION 1.
1603.35. Each blood bank or plasma center shall provide information to a develop a protocol to ensure that information is provided to any potential donor who is subject to a deferral deferral, including the reason for the deferral, including deferral and information relating to standards established pursuant to federal law. The information shall be consistent with the current United States Food and Drug Administration requirements and guidelines and shall be provided in a manner consistent with applicable medical standards of care. The protocols shall be provided to the department annually. The department shall review the protocols and review compliance as part of the administration and enforcement of licensure.
1603.35. Each blood bank or plasma center shall provide information to a develop a protocol to ensure that information is provided to any potential donor who is subject to a deferral deferral, including the reason for the deferral, including deferral and information relating to standards established pursuant to federal law. The information shall be consistent with the current United States Food and Drug Administration requirements and guidelines and shall be provided in a manner consistent with applicable medical standards of care. The protocols shall be provided to the department annually. The department shall review the protocols and review compliance as part of the administration and enforcement of licensure.
1603.35. Each blood bank or plasma center shall provide information to a develop a protocol to ensure that information is provided to any potential donor who is subject to a deferral deferral, including the reason for the deferral, including deferral and information relating to standards established pursuant to federal law. The information shall be consistent with the current United States Food and Drug Administration requirements and guidelines and shall be provided in a manner consistent with applicable medical standards of care. The protocols shall be provided to the department annually. The department shall review the protocols and review compliance as part of the administration and enforcement of licensure.
1603.35. Each blood bank or plasma center shall provide information to a develop a protocol to ensure that information is provided to any potential donor who is subject to a deferral deferral, including the reason for the deferral, including deferral and information relating to standards established pursuant to federal law. The information shall be consistent with the current United States Food and Drug Administration requirements and guidelines and shall be provided in a manner consistent with applicable medical standards of care. The protocols shall be provided to the department annually. The department shall review the protocols and review compliance as part of the administration and enforcement of licensure.
SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
SEC. 2. No reimbursement is required by this act pursuant to Section 6 of Article XIIIB of the California Constitution because the only costs that may be incurred by a local agency or school district will be incurred because this act creates a new crime or infraction, eliminates a crime or infraction, or changes the penalty for a crime or infraction, within the meaning of Section 17556 of the Government Code, or changes the definition of a crime within the meaning of Section 6 of Article XIIIB of the California Constitution.
### SEC. 2.