Conn. Agencies Regs. § 19a-36-A48 - Registration of a plasmapheresis center and/or blood collection facility

Current through March 4, 2022

(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.

Notes

Conn. Agencies Regs. § 19a-36-A48
Effective October 25, 1989

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