Free 49621.PDF - Indiana


File Size: 118.5 kB
Pages: 3
Date: June 19, 2000
File Format: PDF
State: Indiana
Category: Government
Author: RICK APPLEGATE
Word Count: 803 Words, 5,587 Characters
Page Size: Letter (8 1/2" x 11")
URL

http://www.state.in.us/icpr/webfile/formsdiv/49621.pdf

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APPLICATION FOR LICENSE TO OPERATE A BLOOD CENTER Pursuant to IC 16-41-12
State Form 49621 (R / 3-00)

Indiana State Department of Health Division of Acute Care DIVISION OF ACUTE CARE USE ONLY
Date received

Forward application and all requested information to: Indiana State Department of Health Acute Care / Blood Center Program, Room 4A 2 N. Meridian Street Indianapolis, IN 46204 All questions on this application must be answered completely and requested copies and / or attachments submitted. Incomplete applications will be returned without being processed. This application and the license, which may be issued thereupon, are not transferrable between Blood Centers, Medical Directors, or Responsible Heads. PLEASE PRINT OR TYPE I. TYPE OF APPLICATION: (check appropriate item) Initial (New Center) Renewal of Existing License License Expiration Date Change of Ownership Anticipated Date of Sale / Transfer / Lease (if applicable) Submit a dated and signed copy of the bill of sale, lease or other document of transfer Other II. IDENTIFYING INFORMATION
A. Legal name of center B. d/b/a Name of center Date approved Date denied

Address (number and street, city, state, ZIP code)

County

Township

Telephone number

Fax number

Include a list of all locations operated by the Blood Center. (You may attach list)
If Mobile Units are operated by the Blood Center, indicate the number in operation as of the date of this application

C. Type of control / ownership

Incorporated Not-for-Profit
Is this facility chain affiliated?

Proprietary __________________ Government Other
If yes, list name

Yes

No

Address (number and street, city, state, ZIP code)

Attach a list of owners / Board of Directors / trustees identifying those individuals who are responsible for overseeing the Blood Center operations.
D. Type of operation (check all applicable)

Blood Bank Blood Center Hospital Donor Center Donor Testing Recipients Testing

Transfusion Service Blood Storage Facility Component Preparation Product Distribution Therapeutic Pheresis Therapeutic Bleeding
Establishment license number Registration number

Is this Blood Center licensed / registered by the Federal Government?

Yes

No

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Product license numbers:

Date of last FDA inspection If yes, name of organization(s):

Is this Blood Center a member of a national professional / accreditation organization?

Yes

No

E. Personnel Name of Medical Director Degree(s)

Specialty

Name of Responsible Head

Title

Qualifications

Name of Consultant Physician

Degree(s)

Specialty Name of Technical Supervisor (Laboratory Testing) Specialty

Degree(s)

Technical Personnel: Laboratory Technologist Laboratory Technician Medical Doctors Registered Nurses LPN Other (specify)
F. Blood Components collected:

Number of Full-Time

Number of Part-Time

License / Registry (if any)

Whole Blood Cryoprecipitate Platelets Recovered Plasma Stem Cells

Fresh or Frozen Plasma Packed Red Cells Autologous Blood Directed donations Cord Blood

Units for research and / or pharmaceutical products Other: (specify)
Number and type of units collected previous year: Number of units of whole blood drawn:

From: (month, year) ___________/_____
Number of units of Plasmapheresis:

To: (month, year) ____________/_____
Number of Leukopheresis units:

Single: ___________________
Number of Plateletphersis units:

Double: ___________________
Number of Cryoprecipitate units prepared:

Other (specify)

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G. Donor Selection and Collection:

Attach a copy of the donor history card, Informed Consent Form, labels, record sheets, and other forms used in the blood center.
Who interviews donors? Where and what kind of training have the interviewers had?

Who collects blood from donors? Where and what kind of training have they had for blood collection?

Is a licensed physician present during donor selection and collection?

If licensed physician is not present, is one available for consultation?

Yes

No

Yes

No

When a physician is not present, who is in charge of direct supervision of donor selection and collection? (name, title)

H. Laboratory Testing

Attach copies of the following procedures if performed on-site. If not performed on-site, give name, address, and licensure / certification numbers of reference laboratory used.
ABO grouping and sub-grouping

Rh typing

Testing for Hepatitis viruses

HIV-I antibody and antigen testing (screening and confirmation)

HTLV-I testing (screening and confirmation)

Name of Proficiency Testing (PT) Program enrolled in?

List PT testing modules you are enrolled for

Attach copies of the last PT event testing results / scores. Copies of the proficiency testing program results are required to be submitted to the Indiana Department of Health following receipt of each event's result (three times annually).
I. Test Reporting and Donor Counseling

Attach copies of procedures / policies for assuring that all reactive tests for hepatitis / HIV are repeated and those found repeatedly positive are destroyed. Include procedure, example of letters, etc. for notification of donors when confirmatory testing is inconclusive or indicates the presence of antibodies to the human immunodeficiency virus.
J. Blood Shortage Emergency

Attach a copy of blood centers written criteria for declaration of a blood shortage emergency.
K. Suppliers

Include a list of all blood centers, pharmaceutical companies, etc. which supplies blood and / or blood derivatives to or through your blood center.
Signature of Authorized Representative Type name

Title

Date (month, day, year)

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