(602) 755-1892 [email protected]

Obtaining Your
CLIA Waiver

Obtaining a clear waiver is not difficult and only takes a few minutes if you have the right information. We have helped many dental and medical practices apply for and receive their CLIA waiver. Read below how simple this is and how to avoid the pitfalls so that you may be approved for this waiver on your first submission.  

Why do I need a CLIA waiver?

In April 2020 there was a survey and found that concerns about COVID-19 have been increasing and that dentist felt that testing in their office would be necessary saying:

  • “COVID rapid tests for offices would be great for security of staff and patients.”
  • “We will need to test everyone for COVID.”
  • “The secret to getting offices up and running is rapid testing of all patients before any and all dental procedures.”
  • “Every office will have pre-appointment testing for all patients and staff. No one that tests positive will be treated.”

The American Dental Association is a strong supporter of Covid-19 testing, and has come out with support for this as As well as a CLIA toolkit to help dentists obtain their CLIA waivers which are required to perform rapid tests in their offices.

ADA Executive Director Kathleen O’Loughlin, DMD, has stated, “All dentists need a fast point-of-care test that accurately predicts the presence or absence of COVID-19 in real-time. […] An accurate test for the presence of COVID-19 is the most predictable way for dentists, dental teams, and patients to be safely treated in traditional elective care.”

In addition, according to the ADA “[l]icensed dentists are eligible to administer COVID-19 diagnostic tests within their scope of practice, provided they obtain a Certificate of Waiver ….”

Applying for testing

So, the question is how do you get set up for testing in your office? Most dental practices have started by applying for their own Clinical Laboratory Improvement Amendments (CLIA) Application for Certification with Waiver. The application may be found at https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf.

You may also download our template that we have created to simplify some of the areas that you may not be familiar with. We have filled out several of the sections for you so all you need to do is fill in your company information and then send this in for approval.  Just look for the XXXXXX in the template and replace with your information.

 

The application may seem long, but you really only need to complete sections I–VI, IX, and X.

We have filled out the sections that describe the CLIA waived rapid tests to make this easier for you. All tests offered by US health diagnostics are “Waived Test to be Performed” as “Point of Care COVID-19 testing using a test kit that has received Emergency Use Authorization (EUA) from the FDA for use in patient care settings with a CLIA Certificate of Waiver.”

For “Estimated Annual Test Volume,” I entered the following: “Testing volume as appropriate and necessary to assist patients in my community, and my office personnel, during the COVID-19 pandemic. Estimated total annual test volume approximately [my patient count].”

The application usually costs between $150-$200 and is not payable until your office is certified.  Payments Are made directly to your state health department.

While we have seen approvals happen within four hours, this approval usually takes between one and three days from our experience.

Once you have your certificate of waiver in hand you will be able to conduct testing in your office for your staff and patients.

Do you have difficulties please don’t hesitate to reach out so that we can help you get this waiver quickly.

Download the CLIA Application for Certification CMS-116 Template

Fill Out of sections 1 and 10

Print out the completed CMS-116 Form and sign it in ink

Scan the signed CMS-116 Form and Send To Your Health Department Via Email

Once your application has been processed, you will receive your CLIA Number and can begin testing

** Please note, there may be additional forms and fees as required by your state and send to your State Agency. See details below.

State-Specific Instructions

For your convenience, We have gathered each state’s requirements and forms that will need to be submitted with the CMS-116 Form. Click on your state for submission instructions.

Please be aware that state regulations and requirements may change at any time. For changes to application requirements or submission instructions, please contact your CLIA State Agency.

Alabama

Alabama CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected] (for use during COVID-19 emergency only)

[email protected]

Fax (334) 206-5254

Mail ALABAMA DEPARTMENT OF PUBLIC HEALTH

Division of Health Care Facilities

CLIA Program

P.O. Box 303017

Montgomery, AL 36130-3017

Upcoming Changes to Alabama Requirements

Beginning October 2020, all waived testing sites in Alabama must possess an Independent Clinical Laboratory (ICL) license in addition to the CLIA Certificate of Waiver.

Due to the processing time and to avoid interruptions in your pharmacy’s ability to conduct waived testing, consider submitting the ICL application in advance of October 2020 such as at the same time as the CLIA application.

About the ICL Application

This application has a separate fee and requires additional documentation including:

      • Organizational documents
        • I.e. Articles of Incorporation, LLC Agreement, Partnership Agreement, or Statement of Sole Proprietorship under which the facility will operate).
        • A copy of the registration to conduct business in Alabama if the entity was established in a state other than Alabama.
      • A copy of the Certificate of Existence
      • A copy of the Medical Director’s license

If you have questions regarding the ICL application, please call (334) 206-5175.

Submit ICL applications via mail addressed to:

State of Alabama

Department of Public Health

Division of Provider Services

P.O. Box 303017

Montgomery, AL 36130-3017

 


Alaska

Alaska CLIA Application Instructions

The CLIA application can be submitted via:

Alaska CLIA Program

Alaska State Public Health Laboratory 5455 Dr. Martin Luther King Jr. Ave.

Anchorage, Alaska 99507

(907) 334-2112

FAX: (907) 334-2161

Email: [email protected]

Website: http://dhss.alaska.gov/dph/Labs/Pages/clia/default.aspx

Or Email [email protected]

 


Arizona

Arizona CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

[email protected]

Fax (602) 364-0759

 


Arkansas

Arkansas CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

[email protected]

 


California

California CLIA Application Instructions

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

LAB 155 – Application for Clinical Laboratory Registration (Include payment for the application fee)

LAB 183 – Director Attestation

Note: Only submit completed forms with physical signatures. Copies 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 and additional forms can be submitted via:

Mail California Department of Public Health

CALIFORNIA DEPARTMENT OF PUBLIC HEALTH

Division of Laboratory Science Laboratory Field Services

320 W 4TH ST STE 890

LOS ANGELES CA 90013-2398 (213) 620-6160

FAX: (213) 620-6565

Email: [email protected]

 

About the Clinical Laboratory Registration Application

This application has a separate non-refundable fee. Refer to the fee schedule as the fee amount is subject to change with each fiscal year.

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:

California Department of Public Health

 


Colorado

Colorado 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 [email protected]

[email protected]

Fax (303) 344-9965

 


Connecticut

Connecticut CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

Fax (860) 706-5805

Additional Requirements Prior to Conducting Tests That Have Been Granted EUA

If utilizing validated manufacturer assays granted Emergency Use Authorization (EUA) by the FDA to perform point-of-care testing during a public health emergency, an approval must be obtained prior to use. The following must be submitted for each test kit in order to obtain approval:

FDA-EUA Approval Form

A sample test report

Based on the test kit used, the FDA requires that the fact sheet is provided to the patient and/or the provider. The fact sheet for the test kits along with EUA information can be found under the In Vitro Diagnostic Products section through the FDA website. When searching for the fact sheets:

  • Make sure the manufacturer of the test kit your pharmacy is using matches the Entity column and the name of the test kit matches the Diagnostic column
  • Make sure the Authorized Setting(s) column for the test kit indicates a W for patient care settings operating under a CLIA Certificate of Waiver.
  • Access the fact sheet by selecting the “+” button to the left of the table which will expand the row and reveal the Authorization Labeling documents. There will be a separate file for the healthcare provider fact sheet, patient fact sheet, and manufacturer’s instructions for use.

 


Delaware

Delaware 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

 


District of Columbia

District of Columbia CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

Fax (202) 442-9431

Mail DC DEPARTMENT OF HEALTH

Health Regulations and Licensing Administration

Health Facilities Division

Laboratory Services

899 North Capitol Street, NE 2nd floor

Washington, DC 20002


Florida

Florida 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

 


Georgia

Georgia CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

Fax (404) 463-4398

Mail GEORGIA DEPARTMENT OF COMMUNITY HEALTH

Healthcare Facility Regulation Division

Diagnostic Services Unit

2 Peachtree Street, N.W.

Suite 31-447

Atlanta, GA 30303-3142

 


Hawaii

Hawaii 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 [email protected]

[email protected]

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.

 


Idaho

Idaho CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

Fax (208) 334-4067

Mail LABORATORY IMPROVEMENT SECTION

Idaho Bureau of Laboratories

2220 Penitentiary Road

Boise, ID 83712-8299

 


Illinois

Illinois 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

 


Indiana

Indiana CLIA Application Instructions

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

Enclosure A – Disclosure of Ownership

Enclosure I – Test Methodology and Annual Test Volume Log

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 [email protected]

[email protected]

Fax (317) 233-7157

Mail Indiana State Department of Health

Attn: CLIA Program

2 North Meridian St, Rm 4A

Indianapolis, IN 46204

 


Iowa

Iowa 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

 


Kansas

Kansas CLIA Application Instructions

For Section 6 of the application, include the manufacturer and method for each waived analyte.

The CLIA application can be submitted via:

Email [email protected]

Fax (785) 559-5207

 


Kentucky

Kentucky 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

 


Louisiana

Louisiana CLIA Application Instructions

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

Listing of Tests Performed in the Facility

 

The CLIA application can be submitted via:

Email [email protected]

Fax (225) 342-9349

Mail CLIA Laboratory Program

P.O. Box 3767

Baton Rouge, LA 70821

 


Maine

Maine CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

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 ([email protected]). Dale can also be reached at (207) 287-9339.

 


Maryland

Maryland CLIA Application Instructions

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

State Compliance Application

Copy of highest degree of education (i.e. Doctorate of Pharmacy)

Copy of practicing license (i.e. pharmacy license)

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 MARYLAND DEPARTMENT OF HEALTH & MENTAL HYGIENE

Office of Health Care Quality – Laboratory Licensing Programs

7120 Samuel Morse Drive

Second Floor

Columbia, MD 21046-3422

About the State Compliance Application

The Maryland Department of Health requires laboratories to obtain state licensure along with a CLIA Certificate of Waiver in order to conduct waived tests. By submitting the State Compliance Application, your pharmacy will be able to receive the state laboratory license allowing pharmacists to perform CLIA-waived tests that are also listed in the Letters of Exception.

There is no separate fee for this application.

 


Massachusetts

Massachusetts CLIA Application Instructions

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

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

 


Michigan

Michigan CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

 


Minnesota

Minnesota CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

Mail Minnesota Department of Health

CLIA Program

3333 West Division Street, Suite 212

St. Cloud, MN 56301-4557

 


Mississippi

Mississippi CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

[email protected]

Fax (601) 364-5053

Mail Mississippi State Department of Health

Licensure and Certification/CLIA

P.O. Box 1700

Jackson, MS 39215-1700

 


Missouri

Missouri CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

Fax (573) 751-6158

Mail DHSS – Bureau of Diagnostic Services

CLIA Program

P.O. Box 570

Jefferson City, MO 65102

 


Montana

Montana CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

Fax (406) 444-3456

Mail Certification Bureau-CLIA Program

2nd floor DPHHS-QAD

P.O. Box 202953

Helena, MT 59620-2953

 


Nebraska

Nebraska 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

 


Nevada

Nevada CLIA Application Instructions

When submitting the CMS-116 Form, also be prepared to upload the following completed form and documentation:

Form 1513 – Disclosure of Ownership and Control Interest Statement

Instructions for Form 1513

Laboratory Director Proof of Identity *Options for proof of identity

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:

Online Portal https://nvdpbh.aithent.com/login.aspx

 

About the State of Nevada Exempt Laboratory Licensure

In Nevada, pharmacists qualify as lab directors for testing sites that are only performing glucose tests. Otherwise, the lab director needs to be a medical physician for the testing site to perform other CLIA-waived tests. To perform any CLIA-waived tests (including glucose tests), a State of Nevada Exempt Laboratory License is needed.

There is a separate fee for licensure. Refer to the Exempt Laboratory Online Initial Application Checklist for payment amount.

To apply for the Exempt Laboratory License:

  1. Go to the Nevada Division of Public and Behavioral Health online licensing system
  2. Select the Health Care Quality & Compliance (HCQC) as the Business Unit
  3. Select OK
  4. In the section labeled “NEW APPLICANTS APPLY HERE” (bottom left column), select the link to apply for a new medical laboratory license or change of ownership
  5. Register for an online account by entering in facility information, mailing address, and login account information Note: Be sure to save the password in a secure location in case you forget it as the password is not easily retrievable by the state agency.
  6. Upload the completed CMS-116 Form, Form 1513, and the lab director’s proof of identity when prompted

 

The Following Forms are required by the State of Nevada:

 


New Hampshire

New Hampshire 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 [email protected]

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 [email protected]

[email protected]

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:

  1. The pharmacist has received the adequate education and training to initiate, order, administer, and analyze COVID-19 test kits;
  2. 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
  3. 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 [email protected].

For all pharmacies with a current laboratory license, please provide the following information when submitting your request for temporary waiver of collection site licensure:

  1. Name of Licensee;
  2. Name of Contact Person;
  3. Email address and phone number of Contact Person;
  4. Address of pharmacy;
  5. 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:

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

 


New Jersey

New Jersey CLIA Application Instructions

The CLIA application can be submitted via Mail:

By FedEx/UPS Melanie Rinaldi

Manager, NJ CLIA Program

NJDOH/PHEL

3 Schwarzkopf Drive

Ewing, NJ 08628

By USPS Melanie Rinaldi

Manager, NJ CLIA Program

NJDOH/PHEL

P.O. Box 361

Trenton, NJ 08625-0361

 


New Mexico

New Mexico CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

 


New York

New York CLIA Application Instructions

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

Initial Limited Service Laboratory Registration Application (Include payment for the application fee)

Copy of the lab director’s current New York State Professional License

Note: Only submit completed forms with physical signatures (signature stamps 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:

Regular Mail Clinical Laboratory Evaluation Program

Wadsworth Center

New York State Department of Health

Empire State Plaza

P.O. Box 509

Albany, NY 12201-0509

Express Mail Clinical Laboratory Evaluation Program

Wadsworth Center

New York State Department of Health

Empire State Plaza

P1 South – Loading Dock J

Albany, NY 12237

About the Limited Service Laboratory Registration Application

The New York State Department of Health requires testing sites to also possess a Limited Service Laboratory Registration in addition to the CLIA Certificate of Waiver for performing CLIA-waived tests.

Instructions for this application are included in the same file as the application.

There is a separate non-refundable application fee. Refer to the application file 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. The check or check stub should indicate the laboratory’s name. Make check or money order payable to:

New York State Department of Health

 


North Carolina

North Carolina CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

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

 


North Dakota

North Dakota CLIA Application Instructions

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

Laboratory Tests Performed

 

The CLIA application can be submitted via:

Email [email protected]

Fax (701) 328-1890

Mail North Dakota Department of Health

Division of Health Facilities

600 E Boulevard Avenue Dept 301

Bismarck, ND 58505-0200

Additional Requirements Prior to Conducting Tests

In North Dakota, the PIC must also notify the State Board of Pharmacy prior to performing CLIA-waived tests in accordance with North Dakota Administrative Code (§61-04-10).

 


Ohio

Ohio CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

Fax (614) 564-2478

Mail Ohio Department of Health

Office of Health Assurance and Licensing, CLIA Program

246 North High Street

Columbus, OH 43215

 


Oklahoma

Oklahoma CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

Mail OKLAHOMA STATE DEPARTMENT OF HEALTH

Medical Facilities

CLIA

1000 NE 10th Street

Oklahoma City, OK 73117-1299

 


Oregon

Oregon 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 [email protected]

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 [email protected].

 


Pennsylvania

Pennsylvania CLIA Application Instructions

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

Clinical Laboratory Permit Application for In-State Laboratories (Include payment for the application fee)

  • Copies of the lab director’s credentials
    • Curriculum vitae
    • Any board certifications
    • Medical license

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:

Regular Mail Bureau of Laboratories

P.O. Box 500

Exton, PA 19341

Overnight Delivery Bureau of Laboratories

110 Pickering Way

Exton, PA 19341

About the Clinical Laboratory Permit Application

The Pennsylvania Department of Health requires testing sites to obtain a clinical laboratory permit in which the lab director must be a physician. Refer to Understanding Clinical Laboratory Regulations in Pennsylvania document for more information.

This application has a separate 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:

Pennsylvania Department of Health

 


Rhode Island

Rhode Island CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

Fax (401) 222-2721

Mail RI DEPARTMENT OF HEALTH

Division of Facilities Regulation

3 Capitol Hill, Room 306

Providence, RI 02908

 


South Carolina

South Carolina CLIA Application Instructions

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

Disclosure of Ownership and Control of Interest Statement

List of Tests Performed in the Facility

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 [email protected]

Fax (803) 545-4563

Mail SOUTH CAROLINA DEPARTMENT OF HEALTH & ENVIRONMENTAL CONTROL

Bureau of Certification/Health Regulation

2600 Bull Street

Columbia, SC 29201

 


South Dakota

South Dakota CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

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

 


Tennessee

Tennessee CLIA Application Instructions

The CLIA application can be submitted via:

Fax (615) 532-2700

Mail Office of Health Care Facilities, CLIA Certification

665 Mainstream Drive, 2nd Floor

Nashville, TN 37243

(For overnight delivery or courier mail use zip code 37228)

Additional Requirements Prior to Conducting Tests

The Tennessee Department of Health also requires waived testing sites to submit a Waived Testing Notification form. This form cannot be completed until after the CLIA Certificate of Waiver has been received.

About the Waived Testing Notification Form

The Waived Testing Notification form will require the following:

  • CLIA Number
  • A copy of the CLIA Certificate of Waiver
  • A copy of the supervising physician’s current Tennessee medical license
  • A physical signature on the form

Save a copy of the completed form and submit the original completed form via:

Fax (615) 532-2700

Mail Office of Health Care Facilities, Medical Laboratory Board

665 Mainstream Drive, 2nd Floor

Nashville, TN 37243

 


Texas

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 ([email protected])

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 ([email protected])

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 ([email protected])

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 ([email protected])

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

Zone 5 – Tyler ([email protected])

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 ([email protected])

 


Utah

Utah CLIA Application Instructions

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

Ownership & Control of Interest Statement Disclosure Statement

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 [email protected]

Fax (801) 536-0149

Mail Unified State Laboratories: Public Health

Bureau of Laboratory Improvement

4431 South 2700 West

Taylorsville, UT 84129

 


Vermont

Vermont CLIA Application Instructions

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

The CLIA application can be submitted via:

Email [email protected]

Fax (6003) 271-8716

Mail HEALTH FACILITIES ADMINISTRATION

Department of Health & Human Services

129 Pleasant Street

Concord, NH 03301

 


Virginia

Virginia CLIA Application Instructions

Note: Only submit completed forms with physical signatures.

The CLIA application can be submitted via:

Mail Acute Care Division – CLIA

Office of Licensure and Certification

9960 Mayland Drive, Suite 401

Henrico, Virginia 23233

 


Washington

Washington 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:

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

 


West Virginia

West Virginia CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

Fax (304) 746-0658

Mail WEST VIRGINIA DEPARTMENT OF HEALTH

Office of Laboratory Services

ATTN: CLIA Section

167 11th Avenue

South Charleston, WV 25303-1137

 


Wisconsin

Wisconsin CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

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

 


Wyoming

Wyoming CLIA Application Instructions

The CLIA application can be submitted via:

Email [email protected]

Fax (608) 283-7462

Mail Healthcare Licensing and Surveys

Hathaway Building, Suite 510

2300 Capitol Avenue

Cheyenne, WY 82002

 


Frequently Asked Questions

It's a CLIA waiver required?

At this time the ADA is recommending each dental practice to receive their own CLIA waiver so that they can perform rapid tests in their office.

How long does this take?

Why are we have seen approvals within four hours, this typically takes between one and seven days depending on your state.

Does this cost?

The cost on this waiver typically runs between $150 and $200 which is paid directly to your state health department.  Some states are waiving this fee and providing the CLIA waiver at no cost.