New Jersey Department of Health

Clinical Laboratory Improvement Services

PO Box 361

Trenton, NJ 08625-0361	Application for

Clinical laboratory license

(clia waived tests only)
Calendar Year

Initial ($200 Fee)

Renewal ($200 Fee)
For State Use Only
Date Received	Received By	Check/E-Pmt. Rec’d	Approved By

LABORATORY INFORMATION

Name of Laboratory

NJ CLIS ID Number (7 digit number)

Laboratory Address (Street Address/PO Box)

CLIA Number

(City, State, Zip Code)

Facility Type (Select one)

Physician Office Laboratory

School

City

County

Home Health Agency

Pharmacy Associated Clinic

Health Screening (incl. Mobile)

Other: ____________
Mailing Address [where License(s) should be mailed]

(City, State, Zip Code)

Laboratory Telephone Number

Laboratory Fax Number

Name of Contact Person

Contact Telephone No.

Contact Email Address

Normal Hours of Laboratory Operation (indicate specific hours EACH day):
Monday:

Tuesday:

Wednesday:

Thursday:

Friday:

Saturday:

Sunday:

LABORATORY director INFORMATION
Name of Laboratory Director

State Medical License Number

Laboratory Director’s Degree

Telephone No.

Email Address

Laboratory Director’s Time on Premises
Monday:

Tuesday:

Wednesday:

Thursday:

Friday:

Saturday:

Sunday:

primary general supervisor INFORMATION
Name of Primary General Supervisor

Primary General Supervisor’s Degree

Telephone No.

Email Address

Primary General Supervisor’s Time on Premises
Monday:

Tuesday:

Wednesday:

Thursday:

Friday:

Saturday:

Sunday:

ownership INFORMATION
Name of Owner/Authorized Agent

EIN Federal Tax ID

Address (Street Address/PO Box, City, State, Zip Code)

Telephone Number

Type of Entity (Select one)

Individual Partnership Corporation Non-Profit	Government Entity (Select one)

State County Municipal
LIST OF CLIA WAIVED TESTS AND NJ STATE WAIVED TESTS PERFORMED
Select [ ] or Add CLIA-Waived (including NJ State-Waived) Instrument or Test Kit	Name of Instrument

or Kit Manufacturer	Number of Tests Performed Annually
Adenovirus
Chemistry Panel
ESR (Non-Automated)
Fecal Occult Blood
Hemoglobin
Hemoglobin AIC
Lipid Panel
MMP-9
Prothrombin Time (PT) and/or INR
Rapid Flu
Rapid Group A Strep
Rapid HCV
Rapid HIV
Rapid Mono
Rapid RSV
Tear Osmolarity
Urine Dipstick (Non-Automated)
Urine Drug Screening Test Cup
Urine Pregnancy
Urine Reagent Strip (Automated)
Whole Blood Glucose
Whole Blood Lead
ADDITIONAL TESTS
Total Annual Test Volume:

PROFICIENCY TESTING PROVIDER(S)
Name of Proficiency Testing Provider(s)

ATTESTATION
I, the undersigned, certify that all the information given on this application and on the accompanying attachments is true, correct, and complete as of this date and that notification, by certified mail, of any change(s) will be made with 14 days of such change(s). I further certify that testing will not be performed until all applicable State and Federal certificates, licenses, and required approvals have been obtained in accordance with N.J.S.A. 45:9-42.26 et seq., N.J.A.C. 8:44-2.1 et seq., and 42 CFR 493.1 et seq.

I attest that I have I have not been indicted for or convicted of a felony crime and that the owner(s) and laboratory director are not presently suspended or had a CLIA certificate revoked and are not subject to pending administrative sanctions under any Federal, State or local laws. (Attach complete documentation regarding conviction, suspension, revocation or administrative actions.
Name of Laboratory Director (Print)

Signature of Laboratory Director

Date

Name of Owner (Print)

Signature of Owner

Date

Application for Clinical laboratory license - (clia waived tests only)

(Continued)

CL-4

SEP 16

CL-4

ewhite

2016-08-24

NJDOH