SB 368 — AN ACT CONCERNING SOURCE PLASMA DONATION CENTERS.

Substitute Senate GeneralBill Assembly File No.

300368 FebruaryPublic Session,Act 2024 Substitute Senate Bill No.

36824-7 Senate,AN AprilACT 8,CONCERNING 2024SOURCE ThePLASMA CommitteeDONATION onCENTERS. Public Health reported through SEN.

ANWAR of the 3rd Dist., Chairperson of the Committee on the part of the Senate, that the substitute bill ought to pass.

AN ACT CONCERNING SOURCE PLASMA DONATION CENTERS.

Such regulations shall (1)[include allowa requirement that a registered nurse or advanced practice registered nurse licensed under chapter 378 be onsite during the hours of operation of a blood collection facility or source plasma donation centerscenter] toprovide designatethat physicians,a licensedresponsible pursuantphysician, as defined in 21 CFR 630.3, as amended from time to chaptertime, 370,may serve as directorsthe director of sSB368a /blood Filecollection facility or source plasma donation Substitute Senate Bill No.

300368 1center. sSB368 File No.

300On suchfacilities,and(2)forsourceplasmadonationcenters,havethesameor requirementsbefore asOctober set1, forth2023, inthe federalCommissioner lawsof andPublic regulationsHealth governingshall sourceimplement plasmapolicies donation center staff supervision, training and duties,procedures andnecessary shallto notadminister includethe aprovisions requirementof thatthis asection registeredwhile nursein orthe advancedprocess practiceof registeredadopting nursesuch licensedpolicies underand chapterprocedures 378as beregulations, onsiteprovided during the hoursdepartment ofposts operationsuch ofpolicies aand bloodprocedures collectionon facilitythe oreRegulations sourceSystem plasmaprior donationto center.adopting them.

On or before October 1, 2023,2024, the [Commissioner of Public Health] commissioner shall implementupdate policies and procedures necessary to administer the provisionsdepartment's of this section while in the process of adopting such policies and procedures asto regulations,include provided the department posts such policies and procedures onconsistent with the eRegulationsprovisions Systemof priorthis tosubsection. adopting them.

On or before October 1, 2024, the commissioner shall update the department's policies and procedures to include policies and procedures consistent with the provisions of subdivisions (1) and (2) of this subsection.

(NEW) (Effective from passage) Notwithstanding any provision of chapter 368v or 378 of the general statutes, a person performing apheresis on a healthy donor for the purpose of collecting blood or blood components for transfusion need not be licensed pursuant to chapter 378 of the general statutes, provided such person performs such procedure in accordance with federal and state regulations.

For the purposes of this section, (1) "apheresis" means a process by which blood is drawn from a donor and separated into its components, one or more of which is retained, with the remainder returned by transfusion to the donor, and (2) "donor" means a person who (A) donates blood or blood components for therapeutic use or further manufacturing use, or (B) presents as a potential candidate for such donation.

ThisApproved actMay shall9, take2024 effectPublic asAct followsNo. and shall amend the following sections:

Section24-7 12 fromof passage2 19a-565(b) sSB368 / File No.

300 2 sSB368 File No.

300 Sec.

2 from passage New section PH Joint Favorable Subst.

sSB368 / File No.

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300 The following Fiscal Impact Statement and Bill Analysis are prepared for the benefit of the members of the General Assembly, solely for purposes of information, summarization and explanation and do not represent the intent of the General Assembly or either chamber thereof for any purpose.

In general, fiscal impacts are based upon a variety of informational sources, including the analyst’s professional knowledge.

Whenever applicable, agency data is consulted as part of the analysis, however final products do not necessarily reflect an assessment from any specific department.

OFA Fiscal Note State Impact:

None Municipal Impact:

None Explanation The bill makes various changes to statutes concerning source plasma donation centers and blood collection facilities that are not anticipated to result in a fiscal impact to the state or municipalities.

The Out Years State Impact:

None Municipal Impact:

None sSB368 / File No.

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300 OLR Bill Analysis sSB 368 AN ACT CONCERNING SOURCE PLASMA DONATION CENTERS.

SUMMARY Existing law requires the Department of Public Health (DPH) to adopt regulations to implement new licensure categories for source plasma donation centers and blood collection facilities established by PA 23-31.

This bill eliminates current law’s requirement that the regulations require a registered nurse or advanced practice registered nurse to be on-site during these facilities’ operating hours.

It also requires the regulations to (1) allow source plasma donation centers to designate licensed physicians as directors of these centers and (2) have the same requirements in federal law and regulation on source plasma donation center staff supervision, training, and duties.

Under the bill, the commissioner must update DPH policies and procedures by October 1, 2024, to include the bill’s requirements.

By law, these policies and procedures are valid until final regulations are adopted.

(DPH issued initial policies and procedures for these centers and facilities to implement PA 23-31’s requirements in October 2023, and proposed regulations for public comment in January 2024.) Additionally, the bill exempts someone who performs apheresis on a healthy donor to collect blood or its components for transfusion from needing a nursing license.

A person may do this regardless of existing health care institution and nursing laws, so long as they follow federal and state regulations.

Under the bill, “apheresis” is a process that removes blood from a sSB368 / File No.

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300 personandseparatesitscomponents(e.g.,whitebloodcells,plasma,red blood cells, and platelets), of which some is kept and the rest is returned to the donor by transfusion.