DOH Blood Establishments Application Washington : Department of Health
Organisation : Department of Health
Facility Name : Blood Establishments Application
State : Washington
Country : USA
Website : https://doh.wa.gov/licenses-permits-and-certificates/facilities-z/blood-establishments
What is DOH Blood Establishments?
The 2016 Washington State Legislature enacted Substitute House Bill 2580 requiring the Department of Health to:
**Establish and administer a registration process for blood-collecting or blood-distributing establishments that collect or distribute blood for allogeneic transfusion in Washington State that are licensed by the U.S. Food and Drug Administration (FDA);
**Create and maintain an online public registry of all registered blood establishments that supply blood products for transfusion in Washington State; and
**Set fees for those blood establishments applying for or renewing a registration.
Related / Similar Facilities : DOH Birthing / Childbirth Centers Application Washington
Purpose of the Registry
The purpose of the registry is to ensure the safety and transparency of Washington’s blood supply. The department registry will allow hospitals, etc., that use blood for transfusion in Washington, to be able to see that blood establishments are in good standing with the FDA. The documents to be submitted by the blood establishment upon application and yearly thereafter, will include any enforcement actions taken by the FDA such as titled letters, consent decries, etc. This information is currently available on the FDA website, but is very hard to access.
How To Apply DOH Blood Establishments?
To Apply DOH Blood Establishments,follow the below link
Applications & Forms
1. Application (PDF) : https://doh.wa.gov/sites/default/files/legacy/Documents/Pubs//505130.pdf?uid=62cfeef50b918
2. Credential Status Change Form (PDF) : https://doh.wa.gov/sites/default/files/legacy/Documents/Pubs//505133.pdf?uid=62cfeef50be2a
In order to process your request:
1. Mail your application with initial documentation and your check or money order payable to:
Department of Health
P.O. Box 1099
Olympia, WA 98507-1099
2. If you are submitting an application with no payment or additional documents, mail them to:
Blood Establishment Credentialing
P.O. Box 47877
Olympia, WA 98504-7877
Contact us: 360-236-4700
Fee Schedule For DOH Blood Establishments
The Fee Schedule For DOH Blood Establishments are given below,
| Non-Refundable Fee Type | Fee Amount |
|---|---|
| Initial application fee | $13,000 |
| Annual renewal fee | $13,000 |
| Late renewal fee | $300 |
| Application fee – change of ownership | $13,000 |
Rules in Progress For DOH Blood Establishments
The rules of DOH Blood Establishments writing process is open to the public. These rules are created through a public process involving open public meetings and hearings. Each of these rules is in various stages of rule writing.
Current rules in progress for DOH Blood Establishments
On January 23, 2018, the Washington State Department of Health (department) filed a preproposal statement of inquiry (CR-101) with the Office of the Code Reviser. The statement notifies the public of the department’s intent to consider amendments to certain provisions of Chapter 246-339 WAC–Blood establishments. Those amendments relate to the department’s registration requirements for blood establishments that except hospitals from providing proof of a Food and Drug Administration license. The department may amend other rules in the chapter or make grammatical corrections as needed.
The department will conduct a rules workshop on February 12, 2018, 9 a.m.
Department of Health
Kent Regional Office
Lab Quality Assurance
20425 72nd Ave. S., Suite 310
Room 307
Kent, WA 98032 | Directions
This rule process is open to the public and we encourage your participation. Interested people may sign up for the Department of Health’s interested parties list (GovDelivery) to receive rules information and updates for blood establishment.
For more information or to learn how you can participate in the department’s rule process, please contact:
Susan Walker, MT, MA (HEd), Program Manager
HSQA/IIO-Laboratory Quality Assurance
20425 72nd Ave. S., Suite 310
Kent, WA 98032
More agency rule resources:
**Department of Health Rule Making
**State Board of Health rules
**Other Department rules in Washington Administrative Code Title 246