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California Law (Last Updated: March 4, 2014) |
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Health and Safety Code - HSC |
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Division 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) |
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Part 5. HEREDITARY DISEASES/CONGENITAL DEFECTS |
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Chapter 2. Genetic Disease Services |
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ARTICLE 5. Standards of Service for Providers of Blood Clotting Products for Home Use Act |
Section 125286.20.
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Unless the context otherwise requires, the following definitions shall apply for purposes of this article:
(a) "Assay" means the amount of a particular constituent of a mixture or of the biological or pharmacological potency of a drug.
(b) "Ancillary infusion equipment and supplies" means the equipment and supplies required to infuse a blood clotting product into a human vein, including, but not limited to, syringes, needles, sterile gauze, field pads, gloves, alcohol swabs, numbing creams, tourniquets, medical tape, sharps or equivalent biohazard waste containers, and cold compression packs.
(c) "Bleeding disorder" means a medical condition characterized by a deficiency or absence of one or more essential blood clotting proteins in the human blood, often called "factors," including all forms of hemophilia and other bleeding disorders that, without treatment, result in uncontrollable bleeding or abnormal blood clotting.
(d) "Blood clotting product" means an intravenously administered medicine manufactured from human plasma or recombinant biotechnology techniques, approved for distribution by the federal Food and Drug Administration, that is used for the treatment and prevention of symptoms associated with bleeding disorders. Blood clotting products include, but are not limited to, factor VII, factor VIIa, factor VIII, and factor IX products, von Willebrand factor products, bypass products for patients with inhibitors, and activated prothrombin complex concentrates.
(e) "Emergency" means care as defined in Section 1317.1.
(f) "Hemophilia" means a human bleeding disorder caused by a hereditary deficiency of the factors I, II, V, VIII, IX, XI, XII, or XIII blood clotting protein in human blood.
(g) "Hemophilia treatment center" means a facility for the treatment of bleeding disorders, including, but not limited to, hemophilia, that receives funding specifically for the treatment of patients with bleeding disorders from federal government sources, including, but not limited to, the federal Centers for Disease Control and Prevention and the federal Health Resources and Services Administration (HRSA) of the United States Department of Health and Human Services.
(h) "Home use" means infusion or other use of a blood clotting product in a place other than a state-recognized hemophilia treatment center or other clinical setting. Places where home use occurs include, without limitation, a home or other nonclinical setting.
(i) "Patient" means a person needing a blood clotting product for home use.
(j) (1) "Provider of blood clotting products for home use" means all the following pharmacies, except as described in Section 125286.35, that dispense blood clotting factors for home use:
(A) Hospital pharmacies.
(B) Health system pharmacies.
(C) Pharmacies affiliated with hemophilia treatment centers.
(D) Specialty home care pharmacies.
(E) Retail pharmacies.
(2) The providers described in this subdivision shall include a health care service plan and all its affiliated providers if the health care service plan exclusively contracts with a single medical group in a specified geographic area to provide professional services to its enrollees.