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<ns0:ActionText>INTRODUCED</ns0:ActionText>
<ns0:ActionDate>2026-02-17</ns0:ActionDate>
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<ns0:SessionYear>2025</ns0:SessionYear>
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<ns0:AuthorText authorType="LEAD_AUTHOR">Introduced by Assembly Members Chen and Solache</ns0:AuthorText>
<ns0:AuthorText authorType="COAUTHOR_ORIGINATING">(Coauthor: Assembly Member Ellis)</ns0:AuthorText>
<ns0:AuthorText authorType="COAUTHOR_OPPOSITE">(Coauthor: Senator Blakespear)</ns0:AuthorText>
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<ns0:Legislator>
<ns0:Contribution>LEAD_AUTHOR</ns0:Contribution>
<ns0:House>ASSEMBLY</ns0:House>
<ns0:Name>Chen</ns0:Name>
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<ns0:Legislator>
<ns0:Contribution>LEAD_AUTHOR</ns0:Contribution>
<ns0:House>ASSEMBLY</ns0:House>
<ns0:Name>Solache</ns0:Name>
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<ns0:Legislator>
<ns0:Contribution>COAUTHOR</ns0:Contribution>
<ns0:House>ASSEMBLY</ns0:House>
<ns0:Name>Ellis</ns0:Name>
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<ns0:Legislator>
<ns0:Contribution>COAUTHOR</ns0:Contribution>
<ns0:House>SENATE</ns0:House>
<ns0:Name>Blakespear</ns0:Name>
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<ns0:Title> An act to amend Section 1246.7 of, and to add Section 1265.7 to, the Business and Professions Code, and to amend Sections 1603.2, 1605, and 1615 of, and to add Section 1606.7 to, the Health and Safety Code, relating to public health. </ns0:Title>
<ns0:RelatingClause>public health</ns0:RelatingClause>
<ns0:GeneralSubject>
<ns0:Subject>Blood banks and plasma centers.</ns0:Subject>
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<html:p>
(1)
<html:span class="EnSpace"/>
Existing law requires a person engaged in the production of human whole blood or human whole blood derivatives to be licensed by the state, and requires licensed blood banks and blood transfusion services to meet specified standards. Existing law authorizes the State Department of Public Health to establish and require compliance with additional requirements, as specified. A violation of these licensing provisions is a misdemeanor.
</html:p>
<html:p> Existing law requires a license to be automatically revoked when there is a change of address, ownership, or person in charge of biologics production. Existing law authorizes a new license to be secured for the new location, owner, or person in charge prior to the actual change, as specified. </html:p>
<html:p>This bill would delete the requirement to automatically
revoke a license if there is a change of the person in charge of biologics production. The bill would instead require a license to be revoked if a replacement person in charge of biologics production is not designated within 45 days, unless the period of time is extended by the department, as specified. If a person in charge of biologics production disassociates with the licensed facility, the bill would require the licensee to provide written notification to the department within 24 hours of the date of the disassociation. The bill would prohibit a licensee from operating without the supervision of a duly appointed person in charge of biologics production. The bill would authorize a licensee to designate an interim person in charge of biologics production for a period not to exceed 45 calendar days if certain conditions are met. </html:p>
<html:p>Existing law requires each blood bank or plasma center to require as identification either a photographic driver’s license or other
photographic identification that is issued by the Department of Motor Vehicles from all donors of human whole blood or blood components who receive payment in return for the donation of the blood or blood components. </html:p>
<html:p>The bill would instead require each blood bank or plasma center to require identification issued by the Department of Motor Vehicles, as described above, or identification issued by another state, federal agency, or tribal government from all donors of human whole blood or blood components who receive payment in return for the donation of the blood or blood components.</html:p>
<html:p>By creating new crimes, this bill would impose a state-mandated local program. </html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Existing law requires certain establishments that receive specified human whole blood and derivatives to be considered blood bank depositories and requires specified procedures on blood for
transfusion to be the sole responsibility of the blood bank depository.
</html:p>
<html:p>This bill would specify that source plasma donation centers, as defined, that are licensed pursuant to the above-described provisions are not blood bank depositories. The bill would exempt licensed source plasma donation centers performing only a total protein test, as specified, from clinical laboratory licensure requirements.</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Existing law authorizes a person to perform a total protein test using a digital refractometer in a licensed plasma collection center in this state, if the State Department of Public Health determines several conditions are met, including, among others, that the person meets specified training and education requirements, and performs the total protein test under supervision and using standard operating procedures, as specified.
</html:p>
<html:p>This bill would also require the
department to determine that the licensed plasma collection center’s supervising physician and surgeon or licensed clinical laboratory director has sufficient proficiency and knowledge with the use and supervision of digital refractometers in performing total protein tests. The bill would authorize a licensed plasma collection center’s supervising physician and surgeon to delegate to other licensed health care professionals the performance of health services duties, including donor screenings, predonation health screenings, and donor suitability assessments. </html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>This bill would provide that no reimbursement is required by this act for a specified reason.</html:p>
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<ns0:Preamble>The people of the State of California do enact as follows:</ns0:Preamble>
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<ns0:Num>SECTION 1.</ns0:Num>
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Section 1246.7 of the
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is amended to read:
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<ns0:Num>1246.7.</ns0:Num>
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<html:p>
(a)
<html:span class="EnSpace"/>
Notwithstanding any other law, a person may perform a total protein test using a digital refractometer in a licensed plasma collection center in this state, if the department, as part of its routine, fee-supported inspection of the licensed plasma collection center, including its review of personnel reports for licensed and unlicensed personnel and job descriptions of all center positions for a licensed plasma collection center, determines that all of the following conditions are met:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
(A)
<html:span class="EnSpace"/>
The person has earned a high school diploma or equivalent, as determined by the federal Centers for Medicare and Medicaid Services (CMS) pursuant to the federal Clinical Laboratory Improvement Amendments of 1988 (CLIA) (42 U.S.C. Sec. 263a).
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
The person has training sufficient to demonstrate that the individual has the skills and abilities described in paragraph (2) of subdivision (a) of Section 1269.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
(A)
<html:span class="EnSpace"/>
In addition to the education and training requirements specified in paragraph (1), the person has received five hours of training in the proper procedures to be employed when performing a total protein test using a digital refractometer, including evaluation of specimen acceptability and criteria for rejection of inadequate specimens, and the procedures for recording the test results pursuant to paragraph (9).
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
Their training in the proper procedure to be employed when performing a total protein test using a digital refractometer has been certified by a moderate complexity laboratory technical consultant as specified in
Section 1036.2 of Title 17 of the California Code of Regulations, by a physician and surgeon licensed in this state, or by a licensed clinical laboratory director who is in charge of the licensed plasma collection center.
</html:p>
<html:p>
(C)
<html:span class="EnSpace"/>
The instructor documents, and the plasma collection center maintains the documentation of, the individual’s successful completion of training in the performance of the total protein test using a digital refractometer. This documentation shall be made available to the department upon request.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
The person performs the total protein test using a digital refractometer under the supervision of one of the following individuals:
</html:p>
<html:p>
(A)
<html:span class="EnSpace"/>
A moderate complexity laboratory technical consultant as specified in Section 1036.2 of Title 17 of the California Code of Regulations.
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
A registered nurse licensed pursuant to Chapter 6 of Division 2.
</html:p>
<html:p>
(C)
<html:span class="EnSpace"/>
A physician or surgeon licensed pursuant to Chapter 5 of Division 2.
</html:p>
<html:p>
(D)
<html:span class="EnSpace"/>
A clinical laboratory director licensed pursuant to this chapter.
</html:p>
<html:p>
(E)
<html:span class="EnSpace"/>
A clinical laboratory scientist licensed pursuant to this chapter.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
The supervisor is physically onsite in the licensed plasma collection center and available for consultation during the entire time that the person is processing specimens and performing the test.
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
The licensed plasma collection center’s supervising physician and
surgeon or licensed clinical laboratory director has sufficient proficiency and knowledge with the use and supervision of digital refractometers in performing total protein tests pursuant to this section. If the plasma collection center only performs services related to plasma collection pursuant to this section, the department shall not impose additional unrelated experiential requirements for supervisors of plasma donation centers, including, but not limited to, those required for the supervision of blood banks.
</html:p>
<html:p>
(6)
<html:span class="EnSpace"/>
The licensed plasma collection center’s supervising physician and surgeon or licensed clinical laboratory director provides a
written job description for each employee who performs a total protein test using a digital refractometer that specifies the responsibilities and supervision requirements as specified in this section.
</html:p>
<html:p>
(7)
<html:span class="EnSpace"/>
The person performs the total protein test using a digital refractometer in accordance with both of the following:
</html:p>
<html:p>
(A)
<html:span class="EnSpace"/>
Standardized operating procedures required by the licensed plasma collection center’s license.
</html:p>
<html:p>
(B)
<html:span class="EnSpace"/>
Standardized procedures approved by the licensed plasma collection center’s supervising physician and surgeon or licensed
clinical laboratory director for administration of the total protein test by the persons authorized to perform the total protein test pursuant to this section. These standardized procedures shall be made available to the department upon request.
</html:p>
<html:p>
(8)
<html:span class="EnSpace"/>
The person does not draw the blood sample required for the test using a procedure that requires a registration, certification, or license under state law unless they are properly registered, certified, or licensed to perform the procedure.
</html:p>
<html:p>
(9)
<html:span class="EnSpace"/>
The person’s competency in performing total protein tests using a digital refractometer is evaluated before testing on donors, and every six months thereafter, by the CLIA lab director or technical consultant by direct observation. A licensed plasma collection center shall maintain documentation of the competency evaluation, which shall be made available to the department upon request.
</html:p>
<html:p>
(10)
<html:span class="EnSpace"/>
The person accurately records the results of the predonation total protein test in a federal FDA 510k-approved
blood establishment computer system (BECS).
</html:p>
<html:p>
(11)
<html:span class="EnSpace"/>
For each protein refractometer test system in use at the licensed plasma collection center, the center shall perform control procedures using the number and frequency specified by the manufacturer that meet the requirements of Section 493.1256 of Title 42 of the Code of Federal Regulations and this chapter.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
The digital refractometer used to perform a total protein test pursuant to this section shall meet all of the following criteria:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Is used within 30 feet of the donor for whom the
test is being conducted.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Is used in accordance with the donor test management system, the quality control program, and the comprehensive quality assurance program established and maintained by the laboratory pursuant to paragraph (2) of subdivision (d) of Section 1220, if applicable to the licensed plasma collection center under federal law.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Performs total protein tests classified as waived or of moderate complexity under CLIA.
</html:p>
<html:p>
(4)
<html:span class="EnSpace"/>
Performs total protein tests using a digital refractometer on biological specimens that require manual blood collection, centrifugation to separate the blood cells from the plasma, pipetting the plasma from the cells, and application of the plasma into the refractometer.
</html:p>
<html:p>
(5)
<html:span class="EnSpace"/>
Provides total protein test results without
calculation or discretionary intervention by the testing personnel.
</html:p>
<html:p>
(6)
<html:span class="EnSpace"/>
Performs total protein tests without the necessity for testing personnel to perform calibration or maintenance, except basic cleaning, resetting, and daily standardization pursuant to the manufacturer’s instructions.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
To assess the competency and performance of persons authorized to perform the total protein test pursuant to this section, a licensed plasma collection center utilizing this section shall make available to the department any information required by statute or regulation to be collected or maintained by the licensed plasma collection center, and the results of any testing required by statute or regulation to be performed by the licensed plasma collection center, related to assessing the competency and performance of persons using a digital refractometer, as determined by the department.
Information obtained pursuant to this subdivision shall be confidential and is not a public record. The department may contract for collection and review of the information required by this subdivision. The contract shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code and shall be exempt from review or approval by any division of the Department of General Services.
</html:p>
<html:p>
(d)
<html:span class="EnSpace"/>
Records of digital refractometer test results collected pursuant to paragraph (9) of subdivision (a) shall be maintained for three years and made available to the department upon request.
</html:p>
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<ns0:Num>SEC. 2.</ns0:Num>
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Section 1265.7 is added to the
<ns0:DocName>Business and Professions Code</ns0:DocName>
, to read:
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<ns0:Num>1265.7.</ns0:Num>
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<html:p>
(a)
<html:span class="EnSpace"/>
Notwithstanding any other law, a source plasma donation center licensed pursuant to Chapter 4 (commencing with Section 1600) of Division 2 of the Health and Safety Code performing only a total protein test pursuant to Section 1246.7, using only a digital total protein refractometer classified as a moderate complexity test and performing no other test of a moderate or high complexity classification under the federal Clinical Laboratory Improvement Amendments of 1988 (42 U.S.C. Sec. 263a), is exempt from licensure as a clinical laboratory pursuant to this chapter.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
For purposes of this section, “source plasma donation center” means a facility, other than a licensed blood bank, where source plasma is collected by plasmapheresis.
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<ns0:Num>SEC. 3.</ns0:Num>
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Section 1603.2 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
is amended to read:
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<ns0:Num>1603.2.</ns0:Num>
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<html:p>
(a)
<html:span class="EnSpace"/>
Each blood bank or plasma center shall require as identification from all donors of human whole blood or blood components who receive payment in return for the donation of the blood or blood components either of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Identification issued by another state, federal agency, or tribal government.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
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:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Cancellation or refund of the nonreplacement fees or related blood or blood
components transfusion charges.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Blood assurance benefits to a person as a result of a blood or blood components donation to a donor club or blood assurance program.
</html:p>
<html:p>
(3)
<html:span class="EnSpace"/>
Time away from employment granted by an employer to an employee in order to donate blood or blood components.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may notify collection centers of the acceptable forms of donor identification by means of a provider bulletin or notice, policy letter, or other similar instructions without taking regulatory action.
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<ns0:Num>SEC. 4.</ns0:Num>
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Section 1605 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
is amended to read:
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<ns0:Num>1605.</ns0:Num>
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<html:p>
(a)
<html:span class="EnSpace"/>
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.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
Source plasma donation centers licensed pursuant to this chapter are not blood bank depositories.
</html:p>
<html:p>
(2)
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For purposes of this section, “source plasma donation center” means a facility, other than a licensed blood bank, where source plasma is collected by plasmapheresis.
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<ns0:Num>SEC. 5.</ns0:Num>
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Section 1606.7 is added to the
<ns0:DocName>Health and Safety Code</ns0:DocName>
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<ns0:Num>1606.7.</ns0:Num>
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<html:p>
(a)
<html:span class="EnSpace"/>
Notwithstanding any other law, a licensed plasma collection center’s supervising physician and surgeon may establish protocols for authorizing other licensed health care professionals acting within their scope of practice to perform donor screenings, predonation health screenings, and donor suitability assessments.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
Notwithstanding any other law, a licensed plasma collection center’s supervising physician and surgeon may delegate to other licensed health care professionals the performance of health services duties that are both of the following:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
Within the scope of practice of the licensed health care professional, as defined under that person’s respective licensing
act.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Performed under the supervision and protocols established by the supervising physician and surgeon, consistent with facility policies and applicable federal requirements.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
This section does not expand the scope of practice of any licensed health care professional or limit the authority of the State Department of Public Health to regulate source plasma collection facilities.
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<ns0:Num>SEC. 6.</ns0:Num>
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Section 1615 of the
<ns0:DocName>Health and Safety Code</ns0:DocName>
is amended to read:
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<ns0:Num>1615.</ns0:Num>
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<ns0:Content>
<html:p>
(a)
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A license shall be automatically revoked when there is a change of address of, or ownership of, biologics production. However, a new license may be secured for the new location or owner prior to the actual change if the contemplated change is in compliance with all the provisions of this chapter and regulations pertaining thereto.
</html:p>
<html:p>
(b)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
If a person in charge of biologics production disassociates with the licensed facility, the licensee shall provide written notification to the department within 24 hours of the date of the disassociation.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
The licensee shall have 45 days to submit an amendment to the application designating a new person in charge of biologics production pursuant to the provisions of this chapter.
</html:p>
<html:p>
(c)
<html:span class="EnSpace"/>
(1)
<html:span class="EnSpace"/>
A licensee shall not operate without the supervision of a duly appointed person in charge of biologics production.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
If a new person in charge of biologics production is required, a qualified backup person in charge of biologics production, who has been approved for another center, including a center affiliated with the same or a different licensee, shall assume immediate oversight of operations. This oversight shall continue pending submission of the amendment designating the new person in charge of biologics production to, and approval by, the department.
</html:p>
<html:p>
(d)
<html:span class="EnSpace"/>
If a person in charge of biologics production disassociates themselves with a licensed facility, a licensee may designate an interim person in charge of biologics production for a period not to exceed 45 calendar days if both of the following conditions are met:
</html:p>
<html:p>
(1)
<html:span class="EnSpace"/>
The interim designee otherwise satisfies the qualifications to be the person in charge of biologics production.
</html:p>
<html:p>
(2)
<html:span class="EnSpace"/>
Written notice is provided to the department of the interim designee’s relevant information, qualifications, and anticipated duration of service.
</html:p>
<html:p>
(e)
<html:span class="EnSpace"/>
If a replacement person in charge of biologics production is not designated within 45 days, the license shall be revoked. The department may provide an additional 45-day extension for good cause.
</html:p>
<html:p>
(f)
<html:span class="EnSpace"/>
Proceedings for denial of license shall be conducted in accordance with Section 100171.
</html:p>
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<ns0:Num>SEC. 7.</ns0:Num>
<ns0:Content>
<html:p>
No reimbursement is required by this act pursuant to Section 6 of Article XIII
<html:span class="ThinSpace"/>
B 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 XIII
<html:span class="ThinSpace"/>
B of the California Constitution.
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