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How to Obtain a CLIA Certificate of Waiver

Start Point-of-Care Testing

Test For COVID-19 At Your Pharmacy

As more opportunities arise for pharmacies to provide point-of-care testing, it’s increasingly important to be prepared to provide these tests. A CLIA Certificate of Waiver allows your pharmacy to perform point-of-care tests that have a waived degree of complexity as assigned by the U.S. Food and Drug Administration according to 42 CFR 493.15(c). This now includes testing for SARS-CoV-2, the virus that causes COVID-19.

This page will guide you through completing a CLIA application and provide state-specific submission instructions.

The Application Process

1

Open the CLIA Application for Certification CMS-116 Form

2

Fill out Sections 1-6, 9, and 10

Section 1: General Information

  • If you are a first-time applicant for your location, check “Initial Application” and leave the CLIA Identification Number field blank.
  • Fill in your pharmacy’s information providing the physical address of the testing site as the Facility Address.
  • Choose the address the fee coupon and/or certificate should be mailed to.
  • Indicate the name of the lab director in the Name of Director field. For pharmacies, this is typically the pharmacist that will be responsible for ensuring compliance to regulations and proper testing procedures.
  • For a lab director who is a pharmacist, indicate “PharmD” or “BSPharm” in the Credentials field.

Section 2: Type of Certificate Requested

  • Check “Certificate of Waiver.”

Section 3: Type of Laboratory

  • Check option 20, “Pharmacy.”

Section 4: Hours of Laboratory Testing

  • List the times your pharmacy will perform laboratory testing in HH:MM format. This is typically your pharmacy’s usual hours of operation.

Section 5: Multiple Sites

  • If your pharmacy has multiple locations, a separate application will need to be filled out for each location that testing will occur unless your location is not-for-profit, a hospital with several labs, or using a mobile testing site.
  • Check “No” and move on to Section 6 if you are applying for an individual location or if your pharmacy does not meet at least one of the regulatory exceptions.

Section 6: Waived Testing

List the test(s) your pharmacy will perform being as specific as possible. Include the lab test name and, if available, the manufacturer’s name for the test kit. The following databases or files may be helpful:
FDA’s database of waived test systems
FDA’s database of waived analytes
FDA’s database of test kits and their complexity categorization
FDA’s database of IVD OTC lab tests
CMS’ list of tests mapped to CPT codes

Note: For COVID-19 testing, naming a specific test may be difficult due to the rapid changes in options and requirements. Some departments may accept use of “FDA authorized COVID-19 related testing” in this section while others may require you to amend the application once you have the exact test name. 

  • Indicate an estimated volume of waived tests that will be performed in a year.

Section 9: Type of Control

  • Most pharmacies are for-profits and should check option 04, “Proprietary.” Otherwise, check the type of ownership most appropriate for your pharmacy.

Section 10: Director Affiliation with Other Laboratories

If the listed lab director oversees other testing sites, indicate the Name of Laboratory of those other sites along with their respective CLIA Number. CLIA Number may be left blank and later amended for sites that have not yet received one, i.e., an application for that site is or will be in process.

3

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

4

Scan the signed CMS-116 Form into your computer to save a copy

5

Complete additional forms and fees as required by your state and send to your State Agency contact

6

Once your application has been processed, CMS will send your test site’s CLIA Number

State-Specific Instructions

For your convenience, PioneerRx has 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 Patricia.Watson@adph.state.al.us (for use during COVID-19 emergency only)

CLIAAlabama@adph.state.al.us

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: 

Email Katherine.Ross@alaska.gov 

CLIA-HSSLab@alaska.gov

 


Arizona

Arizona CLIA Application Instructions

The CLIA application can be submitted via: 

Email Marcie.Bentley@azdhs.gov 

Denise.Barbeau@azdhs.gov 

Fax (602) 364-0759

 


Arkansas

Arkansas CLIA Application Instructions

The CLIA application can be submitted via: 

Email tim.simpson@arkansas.gov 

adh.hfs@arkansas.gov

 


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
         Laboratory Field Services
         850 Marina Bay Pkwy, Bldg. P-1st Floor
         Richmond, CA 94804-6403

 

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 jeff.groff@state.co.us 

cdphe.lab@state.co.us 

Fax (303) 344-9965

 


Connecticut

Connecticut CLIA Application Instructions

The CLIA application can be submitted via: 

Email DPH.FLISLab@ct.gov 

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 DCHealth.CLIA@dc.gov  

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 hfrd.diagnostic@dch.ga.gov 

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 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.  

 


Idaho

Idaho CLIA Application Instructions

The CLIA application can be submitted via: 

Email LabImprovement@dhw.idaho.gov  

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 lswitzer@isdh.in.gov

klara@isdh.in.gov 

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 kdhe.clia2@ks.gov 

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 alexa.little@la.gov  

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 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.

 


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 BCHS-CLIA@michigan.gov 

 


Minnesota

Minnesota 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

 


Mississippi

Mississippi CLIA Application Instructions

The CLIA application can be submitted via: 

Email Nancy.Cheatham@msdh.ms.gov

CLIA.MSDH@msdh.ms.gov  

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 CLIA@health.mo.gov 

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 mtssad@mt.gov  

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

 


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 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:

  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 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:

  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 CLIA.DHI@state.nm.us

 


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 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

 


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 CLIAlab@nd.gov   

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 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

 


Oklahoma

Oklahoma CLIA Application Instructions

The CLIA application can be submitted via: 

Email medicalfacilities@health.ok.gov  

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 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.   

 


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 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

 


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 SC_CLIA@dhec.sc.gov    

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 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

 


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 (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) 

 


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 labimprovement@utah.gov     

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 CLIA@dhhs.nh.gov    

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 DHHROLSCLIA@wv.gov      

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 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

 


Wyoming

Wyoming CLIA Application Instructions

The CLIA application can be submitted via: 

Email DHSDQACLIA@dhs.wisconsin.gov       

Fax (608) 283-7462

Mail Healthcare Licensing and Surveys
           Hathaway Building, Suite 510
           2300 Capitol Avenue
           Cheyenne, WY 82002