California Law (Last Updated: March 4, 2014) |
Health and Safety Code - HSC |
Division 2. LICENSING PROVISIONS |
Chapter 4. Human Whole Blood, Human Whole Blood Derivatives, and Other Biologics |
ARTICLE 2. Human Whole Blood and Human Whole Blood Derivatives |
Section 1603.3.
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(a) Prior to a donation of blood or blood components, each 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. The blood bank or plasma center shall also inform the donor that it is a felony pursuant to Section 1621.5 to donate blood if the donor knows that he or she has a diagnosis of AIDS or knows that he or she has tested reactive to 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, no civil liability or criminal sanction shall be imposed for disclosure of test results to a local health officer when 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.