| 1 | A bill to be entitled |
| 2 | An act relating to blood establishments; providing |
| 3 | legislative findings and intent; amending s. 381.06014, |
| 4 | F.S.; revising the definition of the term "blood |
| 5 | establishment"; requiring a blood establishment to report |
| 6 | certain financial information to the Agency for Health |
| 7 | Care Administration; requiring a blood establishment to |
| 8 | identify suppliers, sources, costs, destinations, and |
| 9 | pricing structure of its inventory of blood products; |
| 10 | providing for a fee; authorizing the agency to adopt |
| 11 | rules; providing an effective date. |
| 12 |
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| 13 | Be It Enacted by the Legislature of the State of Florida: |
| 14 |
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| 15 | Section 1. Legislative findings and intent.-The |
| 16 | Legislature finds that blood establishments in the state have |
| 17 | historically not been subject to financial disclosure or to |
| 18 | public disclosure of their basic operations despite the fact |
| 19 | that they are responsible for providing blood products on a vast |
| 20 | scale for use in transfusions and other vital and necessary |
| 21 | services to the citizens of the state. The Legislature intends |
| 22 | that blood establishments in the state be subject to financial |
| 23 | reporting requirements and transparency concerning the supply, |
| 24 | sources, cost, pricing, and destinations of blood products. |
| 25 | Section 2. Section 381.06014, Florida Statutes, is amended |
| 26 | to read: |
| 27 | 381.06014 Blood establishments.- |
| 28 | (1) As used in this section, the term "blood |
| 29 | establishment" means any person, entity, or organization, |
| 30 | operating within the state, which examines an individual for the |
| 31 | purpose of blood donation or which collects, processes, stores, |
| 32 | tests, or distributes blood or blood components collected from |
| 33 | the human body for the purpose of transfusion, for any other |
| 34 | medical purpose, or for the production of any biological |
| 35 | product. The term does not include a hospital licensed under |
| 36 | chapter 395. |
| 37 | (2) Any blood establishment operating in the state may not |
| 38 | conduct any activity defined in subsection (1) unless that blood |
| 39 | establishment is operated in a manner consistent with the |
| 40 | provisions of Title 21 parts 211 and 600-640, Code of Federal |
| 41 | Regulations. In addition, any blood establishment operating in |
| 42 | the state shall file an annual report with the Agency for Health |
| 43 | Care Administration disclosing the following information: |
| 44 | (a) The blood establishment's audited financial |
| 45 | statements, prepared according to generally accepted accounting |
| 46 | principles, disclosing all assets, liabilities, operating and |
| 47 | nonoperating revenues, operating and nonoperating expenses, net |
| 48 | income, cash flow, and accountants' notes. |
| 49 | (b) The quantity of blood products, by type, that are |
| 50 | within the blood establishment's inventory at the beginning and |
| 51 | at the end of the reporting period. |
| 52 | (c) The source of blood products collected during the |
| 53 | reporting period. This component of the report shall indicate |
| 54 | the extent to which blood was collected by the blood |
| 55 | establishment from individual donors within the state and the |
| 56 | extent to which blood was obtained by the blood establishment |
| 57 | from blood service providers within or outside of the state. The |
| 58 | identity of any individual donor shall not be disclosed. The |
| 59 | name, business address, and quantity of blood product received |
| 60 | from any other blood establishment within or outside of the |
| 61 | state shall be disclosed. |
| 62 | (d) The blood establishment's general administrative and |
| 63 | overhead costs, including salaries, associated with collecting, |
| 64 | processing, testing, storing, and distributing blood products, |
| 65 | itemized separately and with specificity. |
| 66 | (e) The destination of all blood products disseminated by |
| 67 | the blood establishment during the reporting period, indicating |
| 68 | the quantity, type of blood product, and name and business |
| 69 | address of the recipient. The sale or delivery of blood products |
| 70 | outside of the state and outside of the United States must be |
| 71 | separately designated in this report. |
| 72 | (f) The blood establishment net pricing, which is the list |
| 73 | price minus all applicable discounts, rebates, and any other |
| 74 | contractual or policy deductions, for the blood establishment's |
| 75 | 25 largest providers or recipients of the following blood |
| 76 | products: leukocyte-reduced red blood cells, non-leukocyte- |
| 77 | reduced red blood cells, leukocyte-reduced platelet pheresis, |
| 78 | leukocyte-reduced platelets, fresh frozen plasma, and |
| 79 | cryoprecipitate. |
| 80 | (3) Any blood establishment determined to be operating in |
| 81 | the state in a manner not consistent with the provisions of |
| 82 | Title 21 parts 211 and 600-640, Code of Federal Regulations, and |
| 83 | in a manner that constitutes a danger to the health or well- |
| 84 | being of donors or recipients as evidenced by the federal Food |
| 85 | and Drug Administration's inspection reports and the revocation |
| 86 | of the blood establishment's license or registration shall be in |
| 87 | violation of this chapter and shall immediately cease all |
| 88 | operations in the state. |
| 89 | (4) The operation of a blood establishment in a manner not |
| 90 | consistent with the provisions of Title 21 parts 211 and 600- |
| 91 | 640, Code of Federal Regulations, and in a manner that |
| 92 | constitutes a danger to the health or well-being of blood donors |
| 93 | or recipients as evidenced by the federal Food and Drug |
| 94 | Administration's inspection process is declared a nuisance and |
| 95 | inimical to the public health, welfare, and safety. The Agency |
| 96 | for Health Care Administration or any state attorney may bring |
| 97 | an action for an injunction to restrain such operations or |
| 98 | enjoin the future operation of the blood establishment. |
| 99 | (5) The Agency for Health Care Administration shall assess |
| 100 | each blood establishment an annual fee of $10,000 for the cost |
| 101 | of collecting and maintaining the information required by |
| 102 | subsection (2). |
| 103 | (6) The Agency for Health Care Administration may adopt |
| 104 | rules to implement the provisions of this section. |
| 105 | Section 3. This act shall take effect upon becoming a law. |