ILLINOIS DEPARTMENT OF PUBLIC HEALTH

DIVISION OF LABORATORIES

2121 WEST TAYLOR STREET

CHICAGO, ILLINOIS  60612

INITIAL LICENSE APPLICATION FOR BLOOD BANKS

1.

APPLICATION DATE:

/

/

Month

Date

Year

2.

FACILITY IDENTIFICATION

A.

Name of Laboratory

B.

Address (Number and Street)

C.

Address (City, State, Zip Code)

D.

Telephone Number:

/

E.

County:

Area Code

F.

Hours of Operation:

M

to

:    T

to

:    W

to

:

Th

to

:   F

to

:   Sa

to

:  Su

to

.

3.

OWNERSHIP

A.

Check the appropriate box below:

Individual

Partnership*

Corporation**

Trust

County

Township

City

Other

Specify

B.

List owner(s), title, and address below.  Use an additional sheet if necessary.

*Partnership – Provide names of all partners and percent of interest.

**Corporation – Provide corporate name, names of officers and all stockholders owning 5 percent or more of stock, with an indication of percent of stock owned.  If no stockholder owns more than 5 percent, so indicate below.

EXACT NAME(S) OF OWNER(S) – IF A COPORATION PROVIDE EXACT CORPORATE NAME)

%

INTEREST

ADDRESS

C.

IF THE OWNER LISTED IN 3B IS A

CORPORATION, INDICATE NAMES OF OFFICERS AND ALL STOCKHOLDERS OWNING 5% OR MORE OF STOCK

TITLE

OF

OFFICERS

ADDRESS

4.

PERSONNEL – MEDICAL DIRECTOR(S)

A.

The director(s) must BE PRESENT in the blood bank EACH WEEK of operation, except for defined absences. Provide the name of each blood bank director and indicate his/her weekly regularly scheduled hours in the blood bank. A personnel form is required for each director. Use an additional sheet if necessary.

LAST NAME

FIRST NAME

HOURS e.g. 8AM – 11AM

M

T

W

Th

F

Sa

S

B.

For each medical director, list each laboratory or blood bank (hospital, independent, or industrial) which he/she is associated with as director. Use an additional sheet if necessary.

LAST NAME OF DIRECTOR

NAME OF FACILITY

ADDRESS OF FACILITY

5.

PERSONNEL – SUPERVISOR(S)

List the name of each blood bank supervisor and indicate his/her scheduled hours in this blood bank. Use an additional sheet if necessary. A personnel form must be submitted for each supervisor.

LAST NAME

FIRST NAME

HOURS  e.g. 8AM – 11AM

M

T

W

Th

F

Sa

S

6.

PERSONNEL OTHER THAN DIRECTORS OR SUPERVISORS

List the names of all technical personnel employed by this blood bank other than directors or supervisors. Use an additional sheet if necessary. A personnel form must be submitted for each individual. Use the codes below to indicate how each employee is functioning.

T = technologist   TE = technician   C = consultant   P = phlebotomist   PC = patient care

LAST NAME

FIRST NAME

INITIAL

FUNCTIONING AS:

T

TE

C

P

PC

7.

PROGRAM AND SERVICES

Complete the attachment entitled "Program and Services". In accordance with Section 3-103 of the Illinois Blood Bank Act, the Department will issue a license to the applicant to operate a blood bank to provide the services and programs described in the application if the Department is satisfied that the applicant has complied with the provisions of the Illinois Blood Bank Act and rules and regulations pertaining thereto.

In accordance with Section 3-105 of the Illinois Blood Bank Act, you are required to notify the Department of any changes in the program or services within 30 days after the changes take place.

8.

INFORMATION ITEM

A.

PROFICIENCY TESTING INFORMATION

Regulations require the demonstration of proficiency in the performance of tests performed by the blood bank by means of participating in State-operated or State-approved proficiency testing programs.  The Department recognizes the following as State-approved proficiency testing programs.

1.

College of American Pathologists

5202 Old Orchard Road

Skokie, IL  60077-1034

Phone: (312) 966-5700

2.

American Association of Bioanalysts

205 West Levee

Brownsville, Texas  78520

Phone: (800) 544-3081

B.

SECTION 3-106 OF THE ILLINOIS BLOOD BANK ACT

"A license to conduct a blood bank shall be issued to the owner for the premises stated in the application. The owner shall be responsible for the provision at all times of laboratory direction by a Medical Director who meets the provisions of this Act and the rules and regulations pertaining thereto:  for notifying the Department prior to any change in the medical directorship; and for forwarding necessary documentation to the Department to establish that the Medical Director is qualified to direct that blood bank. The owner shall be responsible to the Department for the maintenance and conduct thereof or for any violations of the provisions of this Act obtained for each location.  A license shall be valid only in the possession of the persons to whom it is issued and shall not be a subject of sale, assignment or transfer, voluntary or involuntary nor shall a license be valid for any premises other than those for which the license is issued. However, a new license may be secured for the new name, location or owner prior to the actual change provided the contemplated change Appendix A License Application for Blood Banks is in compliance with the provisions of this Act and regulations pertaining thereto. The fee for the issuance of such new license shall be $100."

9.

AFFIDAVIT

State of

County of

The undersigned owner or authorized officer and blood bank medical director(s) of the facility described herein, being duly sworn on oath, depose(s) and say(s) that the statements contained in the foregoing application are true and correct to the best of ___________ knowledge and belief; that no owner has been convicted of a felony or of any crime involving moral turpitude under the laws of any state or of the United States arising out of or in connection with the operation or a blood bank; and that __________ has (have) read and understand(s) this application and affidavit.

NAME

TITLE

Signature:

Type Name:

Signature:

Type Name:

Signature:

Type Name:

Signature:

Type Name:

Signature:

Type Name:

Subscribed and sworn to

before me this ____ day

of _____, 19_____.

Notary Public In and For Said State

NOTE:

This completed application along with the required license fee are to be returned to:

Fiscal and Management Services

Illinois Department of Public Health

Attn:    Validation Unit

535 W. Jefferson Street

Springfield, IL 62761

BLOOD BANK

PROGRAM SERVICES

BLOOD BANK NAME

DATE

A.

Enter the annual volume on the lines to the left of each procedure performed.

B.

Where requested, please provide the name of major pieces of equipment and the name of the manufacturer of equipment used in providing tests and services.

0210 Syphilis Serology

86592

VDRL, RPR, RST, ART

0220 Other Serology

86287

Hepatitis B antigen (HB_sAg)

86289

Hepatitis B antibody (anit-HBc)

86290

HIV antibody (anti-HIV)

86291

CMV antibody (anti-CMV)

86999

Unlisted immunology procedure (Briefly describe)

LIST MAJOR EQUIPMENT USED IN 0210 AND 0220 ABOVE

0310 Chemistry

84449

Alanine aminotransferase (ALT)

84460

Transaminase, glutamic pyruvic (SGPT)

84999

Unlisted chemistry procedures (Briefly describe)

LIST MAJOR EQUIPMENT USED IN 0310 ABOVE

0400 Hematology

85014

Hematocrit

85018

Hemoglobin

85999

Unlisted hematology (Briefly describe)

LIST MAJOR EQUIPMENT USED IN 0400

0510 Blood Grouping

86080

Blood Typing, ABO

86082

Blood Typing, ABO and Rho(D)

86090

M+N typing

86095

Blood typing, RBC antigens other than ABO or Rho(D)

86105

Rh genotyping

0520 Antibody Identification

86008

Antibody, titer

86016

Antibodies, RBC, saline high protein

0530 Compatibility testing

86068

Blood crossmatch, complete (typing antibody screen-recipient and donor)

86075

Blood crossmatch, minor only

0540 Immunohematology, other

86031

Antihuman globulin test, direct (Coombs)

86032

Antihuman globulin test, (indirect Coombs)

86201

Cryoprecipitate, prep.

86265

Frozen blood, prep.

86346

Leukocyte poor blood, prep.

86389

Plasmapheresis

86392

Platelet concentrate

86427

Red blood, cells, packed

86500

Unlisted immunochematology procedure (Briefly describe)

LIST MAJOR EQUIPMENT USED IN 0510, 0530, AND 0540

DIRECT PATIENT SERVICES (please list below)

ILLINOIS DEPARTMENT OF PUBLIC HEALTH

DIVISION OF LABORATORIES

2121 WEST TAYLOR STREET

CHICAGO, ILLINOIS  60612

RENEWAL LICENSE APPLICATION FOR BLOOD BANKS

1.

DATE OF APPLICATION

/

/

Month

Day

Year

2.

NAME/ADDRESS/HOURS OF OPERATION

A.

If either the name or address on the mailing label above is incorrect, indicate corrections and effective date(s) below

Month

Day

Year

New Name

Effective Date

/

/

New Address (Number and Street)

Effective Date

New address (City, State, Zip Code)

B.

Hours of Operation:

M

to

:    T

to

:    W

to

:

Th

to

:   F

to