Initial application procedure. To register with the department a blood establishment must:

(1) Submit a completed application on forms provided by the department that are signed by the owner or authorized representative that includes all of the following:

(a) The name, current and valid email address, mailing address, and telephone number of the blood establishment.

(b) 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).

(c) 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.

(d) 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 submission of the initial application to the department:

(i) Titled letters, fines, license suspensions, or revocations issued by the FDA.

(ii) Judicial consent decrees.

(e) Any other information required by the department.

(2) Submit the designated fee(s) with the application as required by WAC 246-339-990.