CONTRACT ESTABLISHMENT AGREEMENT FORM

gapingthingsUrban and Civil

Nov 15, 2013 (3 years and 8 months ago)

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CONTRACT ESTABLISHMENT AGREEMENT FORM


Facility Name:
………………………………………………………….

Address: …………………………………………………………………………………………………………..

Phone: ……………………………………. Fax: …………………………………….


This agreement is to document facilities which

(facility)

……………………
…………
……contracts

with in the
processing, production, handling, testing, transport, or storage of HCT/Ps


Establishment Name:

Fertility & Cryogenics Services LLC

Address:


8635 Lemont Rd.



Downers Grove, IL 60516


Phone: (630) 427 0300


Fax: (630) 427 0302



This
facility:


Is not required to hold a CLIA license







Holds a current CLIA license

CLIA Number:

14D1078862








Issuing Agency: CMS








Director: Hisham Greiss, MD, PhD, HCLD



This facility is not registered with the FDA as a
HCT/P establishment

This facility is currently registered with the FDA as a HCT/P establishment

Registration

Number:

FDA establishment registration functions include:




Recover

Screen


Test * Package


Store L
abel Distribute


I agree

Fertility & Cryogenic Services
will maintain FDA registrat
ion for HCT/Ps as required. In

a
ddition
, Fertility

& Cryogenic Services
will remain compliant with all regulations governing the

manufacture of HCT/Ps.


*If
“test” is marked above as per FDA regulations, we use only FDA approved screening tests for donor
testing. Tests are conducted and interpreted as per manufacture recommendations. On page 2 of this
agreement I have listed the tests performed for Fertility

& Cryogenics services to be used for donor
eligibility determination (attach additional test documentation pages as needed):

I agree to notify Fertility & Cryogenics services within 5 business days of any change in our status.

FCS
Responsible Person Signa
ture: ____
_______________________
Date:_________________


Test
:

Hepatitis B Surface Ag




Format
: ELISA


Trade

name: GS HBs Ag EIA 3.2



Sample
: Serum

Manufacturer: Bio
-
Rad




Use
: Donor screening FDA
Lic.
# 1109



Test: Hepatitis B Core Ab
. Total




Format: ELISA


Trade name: O
RTHO

HBc

ELISA test system

Sample: Serum

Manufacturer: Ortho
-
Clinical Diagnostics

Use: Donor screening FDA
Lic.
# 1236


Test: Hepatitis C Ab





Format: ELISA


Trade name:
ORTHO
HCV Version

3.0


Sample: Serum

Manufacturer: Ort
ho
-
Clinical Diagnostics

Use: Donor screening FDA
Lic.# 1236



Test: HIV
I/II

+O






Format: ELISA


Trade name:
GS HIV1/HIV2 Plus O EIA


Sample: Serum

Manufacturer: Bio
-
Rad




Use: Donor screening
FDA
Lic.
# 1109



Test:
HTLV I/II






Format
: E
IA


Trade name:
Abbott HTLV
-
I
/HTLV
-
II EIA


Sample: Serum

Manufacturer:
Abbott




Use: Donor screening
FDA
Lic.
# 43



Test:
Cytomegalovirus (CMV) Screen


Format:


In
-
vitro qual
.

solid phase red cell adherence

Trade name:
Gamma Capture CMV Total

Sample: Serum

Manufacturer:
Immucor Inc.



Use: Donor screening FDA
Lic.# 0886



Test:
RPR Screen





Format
: Card Antigen Screen


Trade name:

ADI
-
RPR




Sample: Serum

Manufacturer:
Arlington Scientific Inc


Use:
Recommended by FDA for Donor Screening



Test:
Anti T
reponema EIA Screen



Format: EIA


Trade name:
Trep
-
Sure




Sample: Serum

Manufacturer
: Phoenix Bio
-
Tech Corp


Use:
Confirmatory for Syphilis

cleared

by FDA



Test:
HIV
-
1
-

NAT






Format: Nucleic Acid Amplification


Trade name: cobas Ampliscreen

HIV
-
1 test V
.
1.5

Sample: Plasma (Lavender Top)

Manufacturer: Roche Diagnostics



Use: Donor screening FDA
Lic.
# 1636


Test: HCV
-

NAT







Format: Nucleic Acid Amplification


Trade name:
cobas AmpliS
creen H
C
V
-
1 test V
. 2.0

Sample: Plasma (Lavender To
p)

Manufacturer: Roche Diagnostics



Use: Donor screening FDA
Lic.
# 1636


Test: HBV
-

NAT






Format: Nucleic Acid Amplification


Trade name:
cobas AmpliS
creen HBV

test


Sample: Plasma (Lavender Top)

Manufacturer: Roche Diagnostics



Use: Donor screen
ing FDA
Lic.
# 1636


Test: WNV







Format: Nucleic Acid Amplification


Trade name: cobas TaqScreen West Nile Virus


Sample: Plasma (Lavender Top)

Manufacturer: Roche Diagnostics



Use: Donor screening FDA
Lic.
# 1636


Test: CT/NG
-

NAT






Format:
Nucleic Acid Amplification


Trade name:
cobas AmpliS
creen CT/NG

test


Sample: Cervical swab/Urine

Manufacturer: Roche Diagnostics



Use: Donor screening FDA
Lic.
# 1636


Test:
Anti
-
T cruzi assay






Format: ELISA


Trade name: ORTHO T. cruzi

Elisa test system


Sample: Serum

Manufacturer: Ortho
-
Clinical Diagnostics


Use:
Cleared for d
onor screening
by
FDA





Instructions:


1.

Fill the upper portion of the contract with your facility’s
information

2.

Fax to Fertility & Cryogenics Services at
(630) 427 0302

3.

A signed copy shall be mailed to you

4.

Keep for

your records

5.

Print the CLIA certificate, and FDA registration form from the
website and include in your records

6.

If you have any questions, please call (630) 427 030
0