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| 2 | 2 | | SENATE DOCKET, NO. 1509 FILED ON: 1/19/2023 |
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| 3 | 3 | | SENATE . . . . . . . . . . . . . . No. 1426 |
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| 4 | 4 | | The Commonwealth of Massachusetts |
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| 5 | 5 | | _________________ |
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| 6 | 6 | | PRESENTED BY: |
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| 7 | 7 | | Michael O. Moore |
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| 8 | 8 | | _________________ |
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| 9 | 9 | | To the Honorable Senate and House of Representatives of the Commonwealth of Massachusetts in General |
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| 10 | 10 | | Court assembled: |
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| 11 | 11 | | The undersigned legislators and/or citizens respectfully petition for the adoption of the accompanying bill: |
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| 12 | 12 | | An Act relative to source plasma donation centers. |
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| 13 | 13 | | _______________ |
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| 14 | 14 | | PETITION OF: |
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| 15 | 15 | | NAME:DISTRICT/ADDRESS :Michael O. MooreSecond Worcester 1 of 3 |
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| 16 | 16 | | SENATE DOCKET, NO. 1509 FILED ON: 1/19/2023 |
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| 17 | 17 | | SENATE . . . . . . . . . . . . . . No. 1426 |
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| 18 | 18 | | By Mr. Moore, a petition (accompanied by bill, Senate, No. 1426) of Michael O. Moore for |
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| 19 | 19 | | legislation relative to source plasma donation centers. Public Health. |
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| 20 | 20 | | [SIMILAR MATTER FILED IN PREVIOUS SESSION |
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| 21 | 21 | | SEE SENATE, NO. 1493 OF 2021-2022.] |
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| 22 | 22 | | The Commonwealth of Massachusetts |
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| 23 | 23 | | _______________ |
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| 24 | 24 | | In the One Hundred and Ninety-Third General Court |
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| 25 | 25 | | (2023-2024) |
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| 26 | 26 | | _______________ |
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| 27 | 27 | | An Act relative to source plasma donation centers. |
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| 28 | 28 | | Be it enacted by the Senate and House of Representatives in General Court assembled, and by the authority |
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| 29 | 29 | | of the same, as follows: |
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| 30 | 30 | | 1 SECTION 1. The General Laws, as appearing in the 2020 Official Edition, are hereby |
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| 31 | 31 | | 2amended by inserting after chapter 111O the following chapter:- |
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| 32 | 32 | | 3 Chapter 111P. |
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| 33 | 33 | | 4 Section 1. Definitions. As used in this chapter, the following words shall have the |
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| 34 | 34 | | 5following meanings unless the context or subject matter clearly requires otherwise:- |
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| 35 | 35 | | 6 “Department”, the department of public health. |
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| 36 | 36 | | 7 “Source plasma donation center”, a facility where source plasma is collected by |
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| 37 | 37 | | 8plasmapheresis. 2 of 3 |
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| 38 | 38 | | 9 “Source plasma”, the fluid portion of human blood collected by plasmapheresis and |
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| 39 | 39 | | 10intended as source material for further manufacturing use. The definition excludes single donor |
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| 40 | 40 | | 11plasma products intended for intravenous use. |
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| 41 | 41 | | 12 “Plasmapheresis”, a procedure in which, during a single visit to the facility, blood is |
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| 42 | 42 | | 13removed from an individual, the source plasma separated from the formed elements, and at least |
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| 43 | 43 | | 14the red blood cells are returned to the donor. |
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| 44 | 44 | | 15 Section 2. A source plasma donation center may collect source plasma through |
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| 45 | 45 | | 16plasmapheresis and may employ a person to perform total protein tests pursuant to regulations of |
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| 46 | 46 | | 17the department. |
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| 47 | 47 | | 18 Section 3. (a) The department shall establish requirements for registration of source |
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| 48 | 48 | | 19plasma donation centers in the commonwealth that are consistent with federal requirements, |
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| 49 | 49 | | 20including 42 CFR 493, 21 CFR Subchapter F. The department shall approve and issue |
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| 50 | 50 | | 21certificates of registration and shall maintain a list of registered source plasma donation centers. |
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| 51 | 51 | | 22 (b) The regulations may include, but shall not be limited to, laws governing staff |
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| 52 | 52 | | 23supervision, training, and duties, including but not limited to, requirements for performing total |
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| 53 | 53 | | 24protein tests using digital refractometers in a source plasma donation center. |
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| 54 | 54 | | 25 (c) The department shall collect and establish registration fees, investigate complaints, |
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| 55 | 55 | | 26and take appropriate disciplinary action for violations of the regulations to protect the public |
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| 56 | 56 | | 27health, safety, and welfare. |
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| 57 | 57 | | 28 Section 4. Blood or blood products obtained from a paid donor shall not be used for |
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| 58 | 58 | | 29transfusion; provided, however, that blood or blood products obtained from a paid donor may be 3 of 3 |
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| 59 | 59 | | 30used for transfusion if the physician and surgeon performing the transfusion has determined, |
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| 60 | 60 | | 31taking into consideration the condition of the patient who is the recipient of the transfusion, that |
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| 61 | 61 | | 32other blood of a type compatible with the blood type of the patient cannot reasonably be obtained |
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| 62 | 62 | | 33for transfusion. |
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