"Application for Clinical Laboratory Licensure, Registration and Approval" - Connecticut

Application for Clinical Laboratory Licensure, Registration and Approval is a legal document that was released by the Connecticut State Department of Public Health - a government authority operating within Connecticut.

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  • Released on January 26, 2010;
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CONNECTICUT DEPARTMENT OF PUBLIC HEALTH
BUREAU OF REGULATORY SERVICES, DIVISION OF HEALTH SYSTEMS REGULATION
410 CAPITOL AVE., MS#12HSR, P.O. BOX 340308, HARTFORD, CT 06134-0308, TEL: 860 509-7400
APPLICATION FOR CLINICAL LABORATORY
LICENSURE, REGISTRATION & APPROVAL
REV. 01-26-2010
Office Use Only: License / Registration No.:
; Date Received:
Fee Paid :
Price List:
1. NAME OF LABORATORY:
U
U
2. ADDRESS:
Street
City
State
Zip Code
3. TELEPHONE #:
FAX #:
CLIA #
E-mail ID of Director, Lab Manager, or Supervisor:
4. NAME OF DIRECTOR:
5. NAME OF LICENSEE / REGISTRANT:
Clinical Laboratory (CL).
6. Type of Laboratory:
Hospital
(Other specify):
Government / Municipal
7. OWNERSHIP:
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, address, directors and officers. Corporation or
other Ownership entity:
Name
Address
Directors / Officers:
Name
Title
8.
LABORATORY DIRECTOR QUALIFICATIONS:
For High Complexity Testing, the director is: (Check One):
Licensed Physician, Certified in Anatomic Pathology by the American Board of Pathology or
American Osteopathic Board of Pathology; or is a
Licensed Physician, Certified in Clinical Pathology; or is a
Licensed Physician & 1 Yr. Training or 2 Yrs. Directing / Supervising Experience; or earned a
Ph.D. and is Board Certified by: (specify board: ____________________________________).
An acceptable doctoral degree is a Doctor of Philosophy (Ph.D.) or Doctor of Science (D.Sc.)
Previously qualified as director of a high complexity laboratory.
Page 1 of 5
CONNECTICUT DEPARTMENT OF PUBLIC HEALTH
BUREAU OF REGULATORY SERVICES, DIVISION OF HEALTH SYSTEMS REGULATION
410 CAPITOL AVE., MS#12HSR, P.O. BOX 340308, HARTFORD, CT 06134-0308, TEL: 860 509-7400
APPLICATION FOR CLINICAL LABORATORY
LICENSURE, REGISTRATION & APPROVAL
REV. 01-26-2010
Office Use Only: License / Registration No.:
; Date Received:
Fee Paid :
Price List:
1. NAME OF LABORATORY:
U
U
2. ADDRESS:
Street
City
State
Zip Code
3. TELEPHONE #:
FAX #:
CLIA #
E-mail ID of Director, Lab Manager, or Supervisor:
4. NAME OF DIRECTOR:
5. NAME OF LICENSEE / REGISTRANT:
Clinical Laboratory (CL).
6. Type of Laboratory:
Hospital
(Other specify):
Government / Municipal
7. OWNERSHIP:
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, address, directors and officers. Corporation or
other Ownership entity:
Name
Address
Directors / Officers:
Name
Title
8.
LABORATORY DIRECTOR QUALIFICATIONS:
For High Complexity Testing, the director is: (Check One):
Licensed Physician, Certified in Anatomic Pathology by the American Board of Pathology or
American Osteopathic Board of Pathology; or is a
Licensed Physician, Certified in Clinical Pathology; or is a
Licensed Physician & 1 Yr. Training or 2 Yrs. Directing / Supervising Experience; or earned a
Ph.D. and is Board Certified by: (specify board: ____________________________________).
An acceptable doctoral degree is a Doctor of Philosophy (Ph.D.) or Doctor of Science (D.Sc.)
Previously qualified as director of a high complexity laboratory.
Page 1 of 5
9.
LABORATORY DIRECTOR QUALIFICATIONS:
For Moderate Complexity Testing, the director qualifies as above, or has earned a: (Check One):
Doctoral degree in medicine, dentistry, or in a chemical, physical, biological or clinical laboratory
science and has at least 1 year experience directing or supervising non-waived testing.
Master's degree in chemical, physical, biological or clinical laboratory science and has
at least 1 year experience supervising non-waived testing.
Bachelor's degree in a chemical, physical, or biological science, or medical technology and
at least 2 years of laboratory training or experience or both in non-waived testing and
at least 2 years of supervisory laboratory experience in non-waived testing.
10. Name of Clinical Consultant:
Clinical Consultant Qualifications: The clinical consultant is a:
(Check One)
Licensed Physician Certified in Anatomic or Clinical Pathology; or has earned a:
Ph.D. and is certified by: the
American Board of Medical Microbiology
(ABMM),
American Board of Clinical Chemistry
American Board of Medical Genetics
(ABCC),
(ABMG),
American Board of Bioanalysis
American Board of Forensic Toxicology
(ABB),
(ABFT),
American Board of Histocompatibility and Immunogenetics
or the
(ABHI),
American Board of Medical Laboratory Immunology
or is a
(ABMLI);
Physician licensed to practice medicine, osteopathy or podiatry in Connecticut.
11. DAYS AND HOURS OF OPERATION:
M.
Tues.
Wed.
Th.
Fri.
Sat.
Sun.
From:
AM
To:
PM
12. HOURS OF SUPERVISOR(S):
Day Shift
Evening Shift
Night Shift
Coverage 24 Hrs./Day, 7 Days/Wk.
13. Supervisor:
Title / Degree:
(
Person who, in the absence of the director, assumes the duties and responsibilities of the laboratory director.)
14. If this is a renewal application for an existing license/registration, application is made: (check all that apply)
prior to expiration of current license/registration
before any change in ownership or director;
prior to major expansion or alteration in quarters
prior to relocating the laboratory to new quarters.
Connecticut License #: CL-
Registration #: HP-
or PH#:
GUIDELINES FOR COUNTING TESTS
For chemistry profiles, each individual test is counted separately.
For complete blood counts, each measured individual analyte is counted separately.
Differential leukocyte counts are counted as one test.
Do not count calculations, i.e. A/G ratio, MCH, MCHC, HCT, and T7.
Do not count quality control, quality assurance and proficiency test results.
Urinalysis by dipstick and/or tablet reagent is counted as one test. Urine microscopic is counted as one test.
Microbiology susceptibility: count one test per group of antibiotics used to determine sensitivity for one organism.
Microbiology cultures are counted as one test per specimen regardless of the extent of identification, number of
organisms isolated and number of tests/procedures required for identification.
Testing for allergens should be counted as one test per individual allergen.
For cytology, each slide (not case) is counted as one test for both Pap smears and non-gynecologic cytology.
For histopathology, each block (not slide) is counted as one test
For histocompatibility, each HLA typing (including disease associated antigens), HLA antibody screen, and HLA
crossmatch is counted as one test.
Page 2 of 5
15. LIST OF TESTS PERFORMED ON-SITE & ANNUAL TEST VOLUME REPORT. Laboratory
Name:
Laboratory Address:
Date:
For each test performed in your laboratory, list the test performed, instrument or method used, the
estimated annual test volume, and (if applicable).the proficiency testing program (CAP, AAB, EXCEL,
MLE, API, AAP, etc), that you are enrolled in. Continue on next page if necessary.
State Use
State Use
Test
Instrument
Proficiency
Annual
0B
1B
Method or Test Kit
Test Program Test Volume
Complexity
Specialty
Make additional copies of this page if necessary. Complexity column is for State use only.
Page 3 of 5
16. Laboratory Specialties:
Check the laboratory specialties and subspecialties performed in your laboratory.
Specialties / Subspecialties
Specialties / Subspecialties
Specialties / Subspecialties
Histocompatibility
Chemistry
Immunohematology
Routine
ABO Group & Rh Type
Microbiology
Bacteriology
Urinalysis
Antibody Detection
(transfusion)
Mycobacteriology
Endocrinology
Antibody Detection
(non-transfusion)
Mycology
Toxicology & TDM
Antibody Identification
Parasitology
Other - Chemistry
Compatibility Testing
Virology
Hematology
Other – Immunohem.
Other - Micro
Pathology
Diagnostic Immunology
Radiobioassay
Histopathology
Syphilis Serology
Clinical Cytogenetics
Oral Pathology
General Immunology
Cytology
17. Annual volume of tests referred to out-of-state laboratories:
Reference Laboratories outside Connecticut:
(Provide Name, Address & CLIA Number or attach a list).
18. Laboratory Report of Significant Findings: Form OL-15C. To order forms call (860) 519-7994.
Tests of public health significance are reported within 48 hours to the local director of health of the town in
which the affected person normally resides, or, in the absence of such information, of the town from which
the specimen originated, and to the CT Dept. of Public Health on form OL-15C.
Yes
No
N/A
See: Public Health Code, Section 19a-36-A3(b); and Updated List of Reportable Diseases at:
www.state.ct.us/dph
19. A Current Itemized Price List for laboratory tests is included with this application
Yes
No
20. Contractual relationships, written or oral, with any physician(s) are included with this application.
Yes
No
N/A
Page 4 of 5
21.
Licensee or Registrant: Enter the name of the individual designated by the owner(s) or corporation to
be the agent for service of process and the agent’s address. "Licensee” means the person in whose
name licensure of a laboratory is sought and granted; this shall be the owner if an individual, the owners
if a partnership of two, or a responsible officer of any other group, firm or corporation owning the
laboratory. (19a-36-D20). “Registrant" means any person, firm or corporation, or the duly authorized
agent thereof, operating or maintaining a laboratory in which there is made any examination, determination
or test specified in section 19a-36-A26. (19a-36-A25).
*For registered hospital laboratories, if the director of the laboratory requests to also be the registrant, the
director must attach a letter from the hospital verifying that he or she is the duly authorized agent for the
hospital laboratory.
Name:
Address:
22.
A list of all additional blood collection facilities in permanent locations is attached?
Yes
No
NA
23. For clinical laboratory licensure, a non-refundable fee of $200.00, made payable to: Treasurer, State of
Connecticut is included with this application.
Yes
No
NA (Not applicable to
Municipality/State or Federal laboratories).
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 licensure or registration is granted to this laboratory 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 license /
registration of this laboratory if in his / her opinion, the laboratory has violated any statutes, regulations,
or directives pursuant thereto, or if the continued operation of the laboratory is not in the best interest of
the health and safety of the citizens of the state of Connecticut.
In witness whereof, we have hereunto set our hands and seal this
day
of
,
20
Name of Licensee / Registrant (print)
Name of Director (print)
____________________________________
_______________________________________
Signature of Director
Signature of Licensee / 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 Name (Print)
Date My Commission Expires.
Page 5 of 5