(1) As used in this section, the term:(a) “Blood establishment” means any person, entity, or organization, operating within the state, which examines an individual for the purpose of blood donation or which collects, processes, stores, tests, or distributes blood or blood components collected from the human body for the purpose of transfusion, for any other medical purpose, or for the production of any biological product. A person, entity, or organization that uses a mobile unit to conduct such activities within the state is also a blood establishment.
(b) “Volunteer donor” means a person who does not receive remuneration, other than an incentive, for a blood donation intended for transfusion, and the product container of the donation from the person qualifies for labeling with the statement “volunteer donor” under 21 C.F.R. s. 606.121.
(2) Any blood establishment operating in the state may not conduct any activity defined in paragraph (1)(a) unless that blood establishment is operated in a manner consistent with the provisions of 21 C.F.R. parts 211 and 600-640.
(3) Any blood establishment determined to be operating in the state in a manner not consistent with the provisions of 21 C.F.R. parts 211 and 600-640 and in a manner that constitutes a danger to the health or well-being of donors or recipients as evidenced by the federal Food and Drug Administration’s inspection reports and the revocation of the blood establishment’s license or registration is in violation of this chapter and must immediately cease all operations in the state.
(4) The operation of a blood establishment in a manner not consistent with the provisions of 21 C.F.R. parts 211 and 600-640 and in a manner that constitutes a danger to the health or well-being of blood donors or recipients as evidenced by the federal Food and Drug Administration’s inspection process is declared a nuisance and inimical to the public health, welfare, and safety. The Agency for Health Care Administration or any state attorney may bring an action for an injunction to restrain such operations or enjoin the future operation of the blood establishment.
(5) A local government may not restrict the access to or use of any public facility or infrastructure for the collection of blood or blood components from volunteer donors based on whether the blood establishment is operating as a for-profit organization or not-for-profit organization.
(6) In determining the service fee of blood or blood components received from volunteer donors and sold to hospitals or other health care providers, a blood establishment may not base the service fee of the blood or blood component solely on whether the purchasing entity is a for-profit organization or not-for-profit organization.
(7) A blood establishment that collects blood or blood components from volunteer donors must disclose on the Internet the information required under this subsection to educate and inform donors and the public about the blood establishment’s activities. A hospital that collects blood or blood components to be used only by that hospital’s licensed facilities or by a health care provider that is a part of the hospital’s business entity is exempt from the disclosure requirements in this subsection. The information required to be disclosed under this subsection may be cumulative for all blood establishments within a business entity. A blood establishment must disclose on its website all of the following information:(a) A description of the steps involved in collecting, processing, and distributing volunteer donations.
(b) By March 1 of each year, the number of units of blood components which were:1. Produced by the blood establishment during the preceding calendar year;
2. Obtained from other sources during the preceding calendar year;
3. Distributed during the preceding calendar year to health care providers located outside this state. However, if the blood establishment collects donations in a county outside this state, distributions to health care providers in that county shall be excluded. Such information shall be reported in the aggregate for health care providers located within the United States and its territories or outside the United States and its territories; and
4. Distributed during the preceding calendar year to entities that are not health care providers. Such information shall be reported in the aggregate for purchasers located within the United States and its territories or outside the United States and its territories.
(c) The blood establishment’s conflict-of-interest policy, policy concerning related-party transactions, whistleblower policy, and policy for determining executive compensation. If a change occurs to any of these documents, the revised document must be available on the blood establishment’s website by the following March 1.
(d) Except for a hospital that collects blood or blood components from volunteer donors:1. The most recent 3 years of the Return of Organization Exempt from Income Tax, Internal Revenue Service Form 990, if the business entity for the blood establishment is eligible to file such return. The Form 990 must be available on the blood establishment’s website within 60 calendar days after it is filed with the Internal Revenue Service; or
2. If the business entity for the blood establishment is not eligible to file the Form 990 return, a balance sheet, income statement, and statement of changes in cash flow, along with the expression of an opinion thereon by an independent certified public accountant who audited or reviewed such financial statements. Such documents must be available on the blood establishment’s website within 120 days after the end of the blood establishment’s fiscal year and must remain on the blood establishment’s website for at least 36 months.
(8) A blood establishment is liable for a civil penalty for failing to make the disclosures required under subsection (7). The Department of Legal Affairs may assess the civil penalty against the blood establishment for each day that it fails to make such required disclosures, but the penalty may not exceed $10,000 per year. If multiple blood establishments operated by a single business entity fail to meet such disclosure requirements, the civil penalty may be assessed against only one of the business entity’s blood establishments. The Department of Legal Affairs may terminate an action if the blood establishment agrees to pay a stipulated civil penalty. A civil penalty so collected accrues to the state and shall be deposited as received into the General Revenue Fund unallocated. The Department of Legal Affairs may terminate the action and waive the civil penalty upon a showing of good cause by the blood establishment as to why the required disclosures were not made.
