Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A48 - Registration of a plasmapheresis center and/or blood collection facility

Current through July 10, 2024
(a) The owner or duly designated registrant
			 shall apply to the department for registration of the center or renewal thereof
			 on forms provided for that purpose by the department. No procedures shall be
			 performed therein until the registrant has been notified by the department that
			 registration is in effect. No such procedures shall be performed after
			 registration has expired or has been suspended or revoked as provided herein
			 until such registration is renewed or reinstated.
(b) In applying for registration, the
			 applicant shall set forth the name and location of the center, a complete
			 statement of its ownership, the name and qualifications of the director, the
			 procedures for which registration is sought and such other information as to
			 quarters, facilities, personnel and proposed operations as the department may
			 require. In the application for registration or renewal thereof, the registrant
			 and director shall agree to abide by all general statutes, regulations and
			 administrative directives pursuant thereto.
(c) Prior to registration, the owner shall
			 cause the quarters, facilities and records of the center to be made available
			 for inspection upon request of a representative of the department and shall
			 cooperate with such representative by furnishing information in any pertinent
			 investigation or inspection. The commissioner or his designee shall inspect
			 each center at least once every twelve months unless the commissioner elects to
			 accept an inspection report from the American Association of Blood Banks in
			 lieu of one annual departmental inspection during any two year period. For the
			 purpose of this subsection, representatives of the department shall have the
			 right of entry into the premises of the center at any time during the hours of
			 operation.
(d) The duration of each
			 registration shall be set at the discretion of the department but no longer
			 than two years from its effective date. The terms of registration or renewal
			 thereof may restrict the scope of operations or establish a time limit for the
			 owner to carry out recommendations based upon inspection or investigation. In
			 all cases, application for renewal of registration shall be made as follows:
			 (1) within thirty calendar days prior to the expiration of the registration
			 then current; (2) before any change in ownership or change in director is made;
			 (3) prior to any major expansion or alteration in quarters in an existing
			 location; and (4) prior to removal of the center to new quarters. Registration
			 or renewal thereof shall not be effective until the registrant is so
			 notified.
(e) A Connecticut
			 registration number will be assigned to the center by the department upon
			 initial registration.
(f) A mobile
			 or temporary blood collection facility shall not require registration provided
			 that the person or organization conducting said facility is otherwise
			 registered in this state in accordance with these regulations.
(g) Additional blood collection facilities
			 shall not require separate registration provided that the person or
			 organization conducting such facilities is otherwise registered in accordance
			 with these regulations and has filed with the department a list of all
			 permanent locations.