General Assembly Raised Bill No. 5479
February Session, 2020 LCO No. 2420
Referred to Committee on PUBLIC HEALTH
Introduced by:
(PH)
AN ACT CONCERNING BLOOD SAFETY.
Be it enacted by the Senate and House of Representatives in General
Assembly convened:
1 Section 1. (NEW) (Effective October 1, 2020) (a) As used in this section:
2 (1) "Person" means an individual, business, corporation, limited
3 liability company, union, association, firm, partnership, committee, club
4 or other organization or group of persons; and
5 (2) "Immunohematology reference laboratory" means a laboratory
6 that provides an exchange of information and consultation on rare blood
7 group antibodies, grouping, component preparation and therapy and
8 blood compatibility testing and research.
9 (b) No person shall collect blood, blood products, plasma or blood
10 derivatives, including, but not limited to, platelets, unless such person
11 (1) is registered with the federal Food and Drug Administration
12 pursuant to section 510 of the federal Food, Drug and Cosmetic Act, 21
13 USC 360, as amended from time to time, provided such person is not
14 exempt from registration under 21 CFR 607.65, as amended from time
15 to time, (2) is licensed as a clinical laboratory pursuant to section 19a-30
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 Raised Bill No. 5479
16 of the general statutes, and (3) maintains a facility in the state (A) for the
17 collection of blood, blood products, plasma or blood derivatives, (B) for
18 the processing of blood, blood products, plasma or blood derivatives,
19 and (C) that includes an immunohematology reference laboratory.
20 (c) The Commissioner of Public Health may implement a licensure
21 program for persons who collect blood, blood products, plasma or blood
22 derivatives.
This act shall take effect as follows and shall amend the following
sections:
Section 1 October 1, 2020 New section
Statement of Purpose:
To ensure the safe collection of blood and blood products.
[Proposed deletions are enclosed in brackets. Proposed additions are indicated by underline, except
that when the entire text of a bill or resolution or a section of a bill or resolution is new, it is not
underlined.]
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