SECTION 1. The General Laws, as appearing in the 2020 Official Edition, are hereby amended by inserting after chapter 111O the following chapter:-

Chapter 111P.

Section 1. Definitions. As used in this chapter, the following words shall have the following meanings unless the context or subject matter clearly requires otherwise:-

“Department”, the department of public health.

“Source plasma donation center”, a facility where source plasma is collected by plasmapheresis.

“Source plasma”, the fluid portion of human blood collected by plasmapheresis and intended as source material for further manufacturing use. The definition excludes single donor plasma products intended for intravenous use.

“Plasmapheresis”, a procedure in which, during a single visit to the facility, blood is removed from an individual, the source plasma separated from the formed elements, and at least the red blood cells are returned to the donor.

Section 2. A source plasma donation center may collect source plasma through plasmapheresis and may employ a person to perform total protein tests pursuant to regulations of the department.

Section 3. (a) The department shall establish requirements for registration of source plasma donation centers in the commonwealth that are consistent with federal requirements, including 42 CFR 493, 21 CFR Subchapter F. The department shall approve and issue certificates of registration and shall maintain a list of registered source plasma donation centers.

(b) The regulations may include, but shall not be limited to, laws governing staff supervision, training, and duties, including but not limited to, requirements for performing total protein tests using digital refractometers in a source plasma donation center.

(c) The department shall collect and establish registration fees, investigate complaints, and take appropriate disciplinary action for violations of the regulations to protect the public health, safety, and welfare.

Section 4. Blood or blood products obtained from a paid donor shall not be used for transfusion; provided, however, that blood or blood products obtained from a paid donor may be used for transfusion if the physician and surgeon performing the transfusion has determined, taking into consideration the condition of the patient who is the recipient of the transfusion, that other blood of a type compatible with the blood type of the patient cannot reasonably be obtained for transfusion.