CLIA Application Instructions

‍The CLIA application can be submitted via:‍‍

Email

Katherine.Ross@alaska.gov
CLIA-HSSLab@alaska.gov‍

CLIA Application Instructions

‍The CLIA application can be submitted via:‍‍

Email

Tim.Simpson@arkansas.gov
adh.hfs@arkansas.gov‍

CLIA Application Instructions

When submitting the CMS-116 Form, use Colorado’s version of the CMS-116 Form as it includes the Annual Test Volume Report (page 2-A) specific for Colorado.

‍The CLIA application can be submitted via:‍‍

Email

jeff.groff@state.co.us
cdphe.lab@state.co.us ‍

Fax

(303) 344-9965

CLIA Application Instructions

‍The CLIA application can be submitted via:‍‍

Mail

State of Delaware CLIA Program
Delaware Public Health Laboratory
30 Sunnyside Road
Smyrna, DE 19977

CLIA Application Instructions

‍The CLIA application can be submitted via:‍‍

Fax

(850) 410-1511

Mail

Bureau of Health Facility Regulation
2727 Mahan Drive – Mail Stop #32
Tallahassee, FL 32308

CLIA Application Instructions

When submitting the CMS-116 Form, also attach the following completed forms and fee:

Form 1513 – Disclosure of Ownership and Control Interest Statement
Instructions for Form 1513
OHCA 110.1 – Application for Clinical Lab Permit/License  (Include payment for the state licensing fee)
Instructions for OHCA 110.1

The CLIA application can be submitted via:

Email

paul.kuiken@doh.hawaii.gov
doh.ohcamco@doh.hawaii.gov

Fax

(808) 692-7447

Mail

Office of Health Care Assurance
Medicare Section
601 Kamokila Boulevard, ROOM 395
Kapolei, HI 96707

About the Clinical Lab Permit Application

This application has a separate fee and will be invoiced from the OHCA Office. Refer to the Hawaiian Administrative Rules (§11-103-6) for the fee amount.  
For non-physician labs performing only waived tests, include payment for the Hawaii Clinical Lab Permit Class I registration application fee when submitting the application. Acceptable forms of payment include corporate check, bank, or other financial institution check, or money order.

Make checks payable to:

State of Hawaii Office of Health Care Assurance Special Fund

Send payment and a copy of the invoice to:

Office of Health Care Assurance
Medicare Section
601 Kamokila Boulevard, ROOM 395
Kapolei, HI 96707

For Class I Permits, laboratories are required to have a Laboratory Consultant who possesses a Clinical Laboratory Director or Medical Technologist license in Hawaii if the Laboratory Director on the application does not have one of these licenses. Refer to Hawaii’s Department of Health website for information on licensure or the List of Possible Laboratory Consultants.

CLIA Application Instructions

When submitting the CMS-116 Form, use Illinois’ version of the CMS-116 Form as it includes additional details on personnel qualification requirements.

The CLIA application can be submitted via:

Fax

(217) 782-0382

Mail

IDPH CLIA Program
525 W. Jefferson St., Fourth Floor
Springfield, IL 62761

CLIA Application Instructions

The CLIA application can be submitted via:

Fax

(319) 335-4174

Mail

Iowa CLIA Laboratory Program
State Hygienic Laboratory
University of Iowa Research Park
2490 Crosspark Road
Coralville, IA 52241-4721

CLIA Application Instructions

The CLIA application can be submitted via:

Fax

(502) 564-6546

Mail

KENTUCKY CLIA PROGRAM
Office of Inspector General
Division of Healthcare
275 East Main Street, 5E-A
Frankfort, KY 40621-0001

CLIA Application Instructions

The CLIA application can be submitted via:

Email

dale.payne@maine.gov

Fax

(207) 287-9304

Mail

CLIA PROGRAM
Division of Licensing & Regulatory Services
41 Anthony Avenue, Station #11
Augusta, ME 04333-0011

Additional Requirements Prior to Conducting Tests

The Maine Department of Health and Human Services also requires waived testing sites to obtain a Health Screening Permit for authorization to perform health screening tests (including occult blood, colon cancer testing, lipid profile, and glucose screenings) in addition to the CLIA Certificate of Waiver. The Health Screening Permit is not required to perform COVID-19 tests that have been granted EUA by the FDA; only the CLIA Certificate of Waiver is required.

About the Health Screening Permit Application

To request a Health Screening Permit application, please email Dale Payne (dale.payne@maine.gov). Dale can also be reached at (207) 287-9339.

CLIA Application Instructions

When submitting the CMS-116 Form, also attach the following completed forms and documentation:

List of Laboratory Test Performed On-Site
Common Form: Initial Licensure/Suitability Notice of Intent to Acquire (Include payment for the state license application fee)
Clinical Laboratory Disclosure of Ownership Interest Statement
Clinical Laboratory License Information Form
Articles of Incorporation or Partnership approved by the Massachusetts Secretary of State
Criminal Offender Record Information (CORI) Acknowledgement Form
Instructions for the CORI Form
Suitability Disclosure Form (if prompted by Common Form)
Note: Only submit completed forms with physical signatures as a copy will not be accepted. Leave fields for CLIA Number blank if applying for initial CLIA certificate and CLIA Number not yet provided.

The CLIA application can be submitted via:

Mail

Clinical Laboratory Program
Department of Public Health
67 Forest Street
Marlborough, MA 01752

About the Licensure Common Form

The Massachusetts State Department of Public Health requires testing sites to also possess a Clinical Laboratory License in addition to the CLIA Certificate of Waiver for performing CLIA-waived tests.  There is a separate application fee. Refer to the Licensure Fee Schedule for the limited clinical laboratory license type fee amount. Include payment for the registration application fee when submitting the application.
Payment must be in the form of a check or money order payable to: Commonwealth of Massachusetts.

CLIA Application Instructions

The CLIA application can be submitted via:

Email

health.clia@state.mn.us

Mail

Minnesota Department of Health
CLIA Program
3333 West Division Street, Suite 212
St. Cloud, MN 56301-4557

CLIA Application Instructions

The CLIA application can be submitted via:

Email

CLIA@health.mo.gov

Fax

(573) 751-6158

Mail

DHSS – Bureau of Diagnostic Services
CLIA Program
P.O. Box 570
Jefferson City, MO 65102

CLIA Application Instructions

When submitting the CMS-116 Form, also attach the following completed forms:

CLIA Ownership Information Form
List of Tests Performed
Note: Only submit completed forms with physical signatures as a copy will not be accepted. Leave fields for CLIA Number blank if applying for initial CLIA certificate and CLIA Number not yet provided.

The CLIA application can be submitted via:

Mail

DHHS Public Health – Licensure Unit/CLIA
P.O. Box 94986
301 Centennial Mall South
Lincoln, NE 68509-4986

CLIA Application Instructions

When submitting the CMS-116 Form, also submit the following completed forms, fee, and documentation:

Application for Residential or Health Care License (Laboratories and Collecting Stations) (Include payment for the application fee)

• Floor plan of the facility
• NH Secretary of State Authority to do business in the State of NH
• “Certificate of Authority,” if a corporation
• “Certificate of Formation,” if a limited liability company
• “Certificate of Trade Name,” if a sole proprietorship
• Written disclosure from the owner(s) and the lab director containing:
• A list of any felony convictions; and an explanation of the circumstances surrounding any felony convictions
• Obtain local health, building, zoning and fire officers signed approval

Note: Leave fields for CLIA Number blank if applying for initial CLIA certificate and CLIA Number not yet provided.

The CLIA application can be submitted via:

Email

CLIA@dhhs.nh.gov

Fax

(603) 271-8716

About the Application for Residential or Health Care License

The State of New Hampshire requires testing sites to obtain laboratory licensure in addition to the CLIA Certificate of Waiver.

• If applying as a collection station, the lab director must meet qualifications according to He-P 817.
• If applying as a laboratory, the lab director must meet qualifications according to He-P 808.

There is a separate fee for this application. Refer to the application for the fee amount.

Include payment for the registration application fee when submitting the application. Payment must be in the form of a check or money order made payable to:

STATE OF NEW HAMPSHIRE, TREASURER

To expedite the submission process, email the initial application and send the original copies in the mail:

Email

Marilee.Curran@dhhs.nh.gov
DHHS.HFA-Certification@dhhs.nh.gov

Mail

Health Facilities Administration
129 Pleasant Street
Concord, NH 03301

Option to Obtain a Waiver of Licensing

During the COVID-19 state of emergency, the State of New Hampshire is offering to waive the Laboratory and Collection Station licensing requirements. Pursuant to Emergency Order #47, licensed Pharmacists may initiate, order, administer, and analyze COVID-19 test kits, provided:

• The pharmacist has received the adequate education and training to initiate, order, administer, and analyze COVID-19 test kits;
• The COVID-19 tests are administered at a pharmacy that holds the appropriate clinical laboratory improvement amendments (CLIA) certificate and a New Hampshire laboratory license issued by the Health Facilities Administration of the New Hampshire Department of Health and Human Services (DHHS). Alternatively, tests may be administered at a pharmacy with a DHHS waiver, pursuant to DHHS’ authority to waive licensure requirements when it deems appropriate health and safety standards are met; and
• The pharmacy creates and implements policies and procedures to address the collection, storage, transport, and analysis of samples collected as a result of administering and analyzing COVID-19 test kits. Such policies and procedures shall be in line with the manufacturer’s instructions and supplemented as needed.

To request temporary approval to conduct COVID-19 testing in accordance to Emergency Order #47, please submit your request in writing to DHHS.hfaregcorrespondence@nh.gov. For all pharmacies with a current laboratory license, please provide the following information when submitting your request for temporary waiver of collection site licensure:

• Name of Licensee;
• Name of Contact Person;
• Email address and phone number of Contact Person;
• Address of pharmacy;
• Proposal for collection, storage, transport, and analysis of samples collected (including the name of the EUA test)

For ALL OTHER pharmacies, please provide the following information when submitting your request for temporary waiver of laboratory and collection site licensure:

• Name of Pharmacy;
• Name of Contact Person;
• Email address and phone number of Contact Person;
• Address of pharmacy;
• Proof of CLIA certificate;
• Proposal for collection, storage, transport, and analysis of samples collected (including the name of the EUA test).

CLIA Application Instructions

The CLIA application can be submitted via:

Email

CLIA.DHI@state.nm.us

CLIA Application Instructions

The CLIA application can be submitted via:

Email

DHSR.CLIA@dhhs.nc.gov

Fax

(919) 855-4620

Mail

NORTH CAROLINA DEPARTMENT OF HEALTH AND HUMAN SERVICES
Division of Health Service Regulation/CLIA Certification
2713 Mail Service Center
Raleigh, NC 27699-2713

CLIA Application Instructions

The CLIA application can be submitted via:

Email

CLIA@odh.ohio.gov

Fax

(614) 564-2478

Mail

Ohio Department of Health
Office of Health Assurance and Licensing, CLIA Program
246 North High Street
Columbus, OH 43215

CLIA Application Instructions

When submitting the CMS-116 Form, also attach the following completed form:

Waived Tests Performed

The CLIA application can be submitted via:

Email

LC.INFO@state.or.us

Fax

(503) 693-5602

Mail

Oregon State Public Health Laboratory (OSPHL)
Laboratory Compliance Section
7202 NE Evergreen Parkway, Suite 100
Hillsboro, OR 97124

Note: Do not send hard copies following a fax or email of a lab form. Double forms can cause duplication and extra work. You can verify receipt of your forms by calling (503) 693-4125 or by emailing LC.INFO@state.or.us.

CLIA Application Instructions

The CLIA application can be submitted via:

Email

DOH.OFR@health.ri.gov

Fax

(401) 222-2721

Mail

RI DEPARTMENT OF HEALTH
Division of Facilities Regulation
3 Capitol Hill, Room 306
Providence, RI 02908

CLIA Application Instructions

The CLIA application can be submitted via:

Email

SDCLIA@state.sd.us

Fax

(605) 773-6667

Mail

SOUTH DAKOTA DEPARTMENT OF HEALTH
Office of Health Care Facilities Licensure & Certification
615 E 4th Street
Pierre, SD 57501-1700

CLIA Application Instructions

When submitting the CMS-116 Form, also attach the following completed forms:

Listing of Tests Performed in the Facility
Disclosure of Ownership

Submit the CLIA application and additional forms via Email to the respective zone office:

Zone 1 – Central (CLIAzone1@hhsc.state.tx.us)

Counties served: Andrews, Armstrong, Bailey, Bastrop, Baylor, Bell, Blanco, Borden, Brewster, Briscoe, Burnet, Caldwell, Callahan, Carson, Castro, Childress, Cochran, Coke, Coleman, Collingsworth, Concho, Cottle, Crane, Crosby, Culberson, Dallam, Dawson, Deaf Smith, Dickens, Donley, Ector, El Paso, Fayette, Fisher, Floyd, Foard, Gaines, Garza, Gillespie, Glasscock, Gray, Hale, Hall, Hansford, Hardeman, Hartley, Haskell, Hays, Hemphill, Hockley, Howard, Hudspeth, Hutchinson, Irion, Jeff Davis, Jones, Kent, King, Knox, Lamb, Lampasas, Lee, Lipscomb, Llano, Loving, Lubbock, Lynn, Martin, Mason, McCulloch, McLennan, Menard, Midland, Milam, Mitchell, Moore, Motley, Nolan, Ochiltree, Oldham, Parmer, Pecos, Potter, Presidio, Randall, Reagan, Reeves, Roberts, Runnels, San Saba, Schleicher, Scurry, Shackelford, Sherman, Sterling, Stonewall, Swisher, Taylor, Terrell, Terry, Throckmorton, Tom Green, Travis, Upton, Ward, Wheeler, Wilbarger, Williamson, Winkler, Yoakum.

Zone 2 – Arlington (CLIAzone2@hhsc.state.tx.us)

Counties served: Archer, Bosque, Brown, Clay, Collin, Comanche, Cooke, Coryell, Dallas, Denton, Eastland, Erath, Grayson, Hamilton, Hill, Hood, Jack, Johnson, Mills, Montague, Palo Pinto, Parker, Somervell, Stephens, Tarrant, Wichita, Wise, Young.

Zone 3 – San Antonio (CLIAzone3@hhsc.state.tx.us)

Counties served: Aransas, Atascosa, Bandera, Bee, Bexar, Brooks, Calhoun, Cameron, Comal, Crockett, DeWitt, Dimmit, Duval, Edwards, Frio, Goliad, Gonzales, Guadalupe, Hidalgo, Jackson, Jim Hogg, Jim Wells, Karnes, Kendall, Kenedy, Kerr, Kimble, Kinney, Kleberg, La Salle, Lavaca, Live Oak, Maverick, McMullen, Medina, Nueces, Real, Refugio, San Patricio, Starr, Sutton, Uvalde, Val Verde, Victoria, Webb, Willacy, Wilson, Zapata, Zavala.

Zone 4 – Houston (CLIAzone4@hhsc.state.tx.us)

Counties served: Austin, Brazoria, Chambers, Colorado, Fort Bend, Galveston, Harris, Matagorda, Montgomery, Waller, Wharton.

Zone 5 – Tyler (CLIAzone5@hhsc.state.tx.us)

Counties served: Anderson, Angelina, Bowie, Brazos, Burleson, Camp, Cass, Cherokee, Delta, Ellis, Falls, Fannin, Franklin, Freestone, Gregg, Grimes, Hardin, Harrison, Henderson, Hopkins, Houston, Hunt, Jasper, Jefferson, Kaufman, Lamar, Leon, Liberty, Limestone, Madison, Marion, Morris, Nacogdoches, Navarro, Newton, Orange, Panola, Polk, Rains, Red River, Robertson, Rockwall, Rusk, Sabine, San Augustine, San Jacinto, Shelby, Smith, Titus, Trinity, Tyler, Upshur, Van Zandt, Walker, Washington, Wood.

Zone 6 – State-Wide (CLIAzone6@hhsc.state.tx.us)

CLIA Application Instructions

Note: Laboratories in Vermont should contact the New Hampshire State Agency.

The CLIA application can be submitted via:

Email

CLIA@dhhs.nh.gov

Fax

(603) 271-8716

Mail

HEALTH FACILITIES ADMINISTRATION
Department of Health & Human Services
129 Pleasant Street
Concord, NH 03301

CLIA Application Instructions

The State of Washington is a CLIA-exempt state and does not require a CMS-116 Form. This exemption expires on July 31, 2021.

In order to obtain a Certificate of Waiver, submit the following completed form and fee:

Certificate of Waiver MTS/CLIA License Application (Include payment for the application fee)
‍Note: Only submit completed forms with physical signatures.

The CLIA application can be submitted via:

DHHROLSCLIA@wv.gov

Mail

Department of Health
Revenue Section
P.O. Box 1099
Olympia, WA 98507-1099

About the Certificate of Waiver MTS/CLIA License Application

This application has a fee. Refer to the application for the fee amount.

Include payment for the application fee when submitting the application. Payment must be in the form of a check or money order made payable to:

Department of Health.

CLIA Application Instructions

The CLIA application can be submitted via:

Email

DHSDQACLIA@dhs.wisconsin.gov

Fax

(608) 283-7462

Mail

WISCONSIN DEPARTMENT OF HEALTH SERVICES
Division of Quality Assurance
Clinical Laboratory Section
1 West Wilson Street
P.O. Box 2969
Madison, WI 53701-2969