(1) The department will issue a renewal registration for a Washington state registered blood establishment when the owner or authorized representative of the blood establishment:
(a) Submits a completed application provided by the department at least five working days prior to the expiration of the current registration, which is signed by the owner or authorized representative that includes the following:
(i) The name, current and valid email address, mailing address, and telephone number of the blood establishment.
(ii) Proof of the blood establishment's current FDA licensure unless the applicant is a hospital that meets the criteria in RCW
70.335.020(1).
(iii) A list of all of the blood establishment's clients in Washington state as required by chapter
70.335 RCW, including current and valid email addresses for all clients of a blood establishment.
(iv) A copy of any of the following disciplinary actions issued upon, or active against, the blood establishment's FDA license in the two years prior to the submission of a renewal application to the department:
(A) Titled letters, fines, or license suspensions or revocations issued by the FDA.
(B) Judicial consent decrees.
(v) Any other information as required by the department.
(b) Submits the designated fee(s) with the application for renewal registration pursuant to WAC
246-339-990.
(c) Meets all of the requirements set forth under chapter
70.335 RCW and this chapter.
(2) The renewal registration will expire one year from the date of issuance.
[Statutory Authority: RCW
43.70.040 and chapter
70.335 RCW. WSR 17-14-026, § 246-339-035, filed 6/23/17, effective 7/24/17.]