"Application for Registration of a Plasmapheresis Center and/Or Blood Collection Facility" - Connecticut

Application for Registration of a Plasmapheresis Center and/Or Blood Collection Facility is a legal document that was released by the Connecticut State Department of Public Health - a government authority operating within Connecticut.

Form Details:

  • Released on August 19, 2005;
  • The latest edition currently provided by the Connecticut State Department of Public Health;
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Download "Application for Registration of a Plasmapheresis Center and/Or Blood Collection Facility" - Connecticut

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CONNECTICUT DEPARTMENT OF PUBLIC HEALTH
HEALTHCARE SYSTEM BRANCH, HEALTH SYSTEMS REGULATION
410 CAPITOL AVE., MS#12HSR, P.O. BOX 340308, HARTFORD, CT 06134-0308, TEL: 860 509-7400
APPLICATION FOR REGISTRATION OF A PLASMAPHERESIS CENTER
AND/OR BLOOD COLLECTION FACILITY
REV. 8/19/2005
Office Use Only: Blood Bank Registration No. BB- __________; Date Received: _______
CENTER, FACILITY or BLOOD BANK NAME:
1.
ADDRESS:
2.
Number & Street
City
State
Zip Code
TELEPHONE NUMBER:
FAX #:
E-Mail:
3.
NAME OF DIRECTOR:
CT License No.
4.
NAME OF REGISTRANT:
5.
"Registrant" means the person in whose name the registration is granted. The registrant shall be the owner, if the
center is owned by a single individual, or a responsible officer or representative when the center is owned by a
group, partnership, firm, corporation, or governmental agency.
FACILITY TYPE: (Check all that apply.)
6.
Plasmapheresis and / or Plateletpheresis.
Blood Collection Facility (Collection for administering blood / components to any human being).
Homologous
Autologous
Directed Donors
Therapeutic.
General Blood Bank Procedures:
ABO Group & RH Type
Antibody Detection (Transfusion);
Antibody Identification
Compatibility Testing
Other; infectious disease testing.
ACCREDITATION: The blood bank is accredited by the American Association of Blood Banks:
7.
Yes:
; No:
.
OWNERSHIP:
8.
Sole Proprietorship
Partnership
Other (Specify):
Corporation (profit)
Corporation (nonprofit)
If sole proprietorship, partnership or other, list name and address of owner below. If a
corporation, list name of corporation, directors and officers.
Corporation:
Name
Address
Directors / Officers:
Name
Title
Page 1of 3
CONNECTICUT DEPARTMENT OF PUBLIC HEALTH
HEALTHCARE SYSTEM BRANCH, HEALTH SYSTEMS REGULATION
410 CAPITOL AVE., MS#12HSR, P.O. BOX 340308, HARTFORD, CT 06134-0308, TEL: 860 509-7400
APPLICATION FOR REGISTRATION OF A PLASMAPHERESIS CENTER
AND/OR BLOOD COLLECTION FACILITY
REV. 8/19/2005
Office Use Only: Blood Bank Registration No. BB- __________; Date Received: _______
CENTER, FACILITY or BLOOD BANK NAME:
1.
ADDRESS:
2.
Number & Street
City
State
Zip Code
TELEPHONE NUMBER:
FAX #:
E-Mail:
3.
NAME OF DIRECTOR:
CT License No.
4.
NAME OF REGISTRANT:
5.
"Registrant" means the person in whose name the registration is granted. The registrant shall be the owner, if the
center is owned by a single individual, or a responsible officer or representative when the center is owned by a
group, partnership, firm, corporation, or governmental agency.
FACILITY TYPE: (Check all that apply.)
6.
Plasmapheresis and / or Plateletpheresis.
Blood Collection Facility (Collection for administering blood / components to any human being).
Homologous
Autologous
Directed Donors
Therapeutic.
General Blood Bank Procedures:
ABO Group & RH Type
Antibody Detection (Transfusion);
Antibody Identification
Compatibility Testing
Other; infectious disease testing.
ACCREDITATION: The blood bank is accredited by the American Association of Blood Banks:
7.
Yes:
; No:
.
OWNERSHIP:
8.
Sole Proprietorship
Partnership
Other (Specify):
Corporation (profit)
Corporation (nonprofit)
If sole proprietorship, partnership or other, list name and address of owner below. If a
corporation, list name of corporation, directors and officers.
Corporation:
Name
Address
Directors / Officers:
Name
Title
Page 1of 3
Mon.
Tues.
Wed.
Th.
Fri.
Sat.
Sun.
9. DAYS AND HOURS OF OPERATION:
Day Shift
Evening Shift
Night Shift
24 Hrs./Day, 7 Days/Wk.
10. HOURS OF SUPERVISOR(S):
Day Shift
Evening Shift
Night Shift
Coverage 24 Hrs./Day, 7 Days/Wk.
11. BLOOD BANK LABORATORY / CENTER DIRECTOR QUALIFICATIONS:
The director is a physician licensed to practice medicine in Connecticut who is:
board certified in clinical pathology, or
board certified in blood banking by the American Board of Pathology; or
received a minimum of one year of specialized training in blood banking, or
has equivalent experience and training acceptable to the department.
12. Blood Bank Laboratory General Supervisor (person who supervises daily quality control and patient testing).
Name
Degree / Certification
13. Number of Personnel Employed:
M.D.;
Ph.D. / D. Sc.;
M.S.;
BA / BS with MT Registration
BA / BS without MT Registration;
AA / AS;
Technical personnel without degrees.
14. The director is present and in active direction of the center at least one-half of its normal working hours each
Yes
No.
week (or a minimum of 15 working hours)?
15. Plasmapheresis is not performed except when a physician licensed to practice in Connecticut is on the premises?
Yes
No
NA
16. If this is a renewal application for an existing registration, application is made: (check all that apply)
prior to expiration of current registration
before any change in ownership or director;
prior to major expansion or alteration in quarters
prior to removal of the center to new quarters.
17. Reference Laboratories within Connecticut (Name, Address, CLIA Number).
18. Reference Laboratories outside Connecticut (Name, Address, CLIA Number).
Page 2of 3
Yes
No
NA
19. A list of all additional blood collection facilities in permanent locations is attached?
20.
The facility has written approval from the department for a program of mobile or permanently fixed collection
Yes
No
NA
stations?
We, the undersigned, individually and jointly certify that the information provided in this application
is to the best of our knowledge and belief accurate and correct.
If registration and laboratory approval is granted to this center / blood collection facility by the
Commissioner of Health, we agree to comply fully with all statutes and regulations by the State of
Connecticut and directives pursuant thereto that may be issued by the Commissioner of Health or
his/her representatives.
We fully understand that the Commissioner of Health may at any time revoke or suspend the registration
of this center / blood collection facility or certificate of approval, if in his/her opinion, the center / blood
collection facility has violated any statutes, regulations, or directives pursuant thereto, or if the continued
operation of the center / blood collection facility is deemed prejudicial to the public health.
In witness whereof, we have hereunto set our hands and seal this
________ day of _________________, 20 ____.
____________________________________
______________________________________
Name of Director (print)
Name of Registrant (print)
____________________________________
______________________________________
Signature of Director
Signature of Registrant
State of ____________________________
County of ____________________________
Personally appeared before me duly qualified to administer oaths and subscribed and made oath to the
truth of the foregoing affidavit.
_________________________________
Signature of Notary Public
_________________________________
__________________________
Notary Public (Print Name)
Date My Commission Expires
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