​​​Clinical Laboratory Application Information

Required Documents

1. Driver’s License or state-issued identification card (issued within the 50 United States or the District of Columbia) of the provider, or person signing the application who has the authority to legally bind the applicant or provider. The signature must be that of the provider, unless the provider is a corporation. If the provider is a corporation and the application is going to be signed by a person other than the provider, please submit a copy of the section of the corporation’s bylaws that identifies the signing person’s authority to legally bind the corporation.  
2. Federal Employer Identification Number (FEIN) or Individual Taxpayer Identification Number (ITIN) verification, if a social security number is not used, by submitting a current Internal Revenue Service (IRS) generated document. The only acceptable documents include an IRS-generated Letter 147-C, IRS-generated Form 941 (Employer’s Quarterly Federal Tax Return), IRS-generated Form 8109-C (Deposit Coupon), or IRS-generated Form SS-4 (only the official Confirmation Notification of FEIN/ITIN assignment). Note: The legal name of the applicant or provider on the application must exactly match the name on the IRS-generated document; and the applicant/provider must be an owner or officer of the entity listed on the IRS document. For further information, please check with the IRS or call them at (800) 829-4933.
3. Clinical Laboratory Improvement Amendment (CLIA) Certificate (all pages), appropriate for the level of testing performed. For further information, visit the Centers for Medicare and Medicaid Services. 
• Note: The name and business address of the applicant or provider on the application, the CLIA Certificate, and the State Clinical Laboratory License/Registration must exactly match. If you are providing services at a hospital and using the hospital’s CLIA, include written confirmation from the hospital that you are allowed to use the hospital’s CLIA.
4. California Clinical Laboratory License/Registration, or verification of exemption from licensure/registration. Call the Laboratory Field Services office at (510) 620-3800 to determine what specific forms you are required to submit, and then download these forms.  Note: The name and business address of the applicant or provider on the application, the CLIA Certificate, and the State Clinical Laboratory License/Registration (or exemption) must exactly match.
5. Local Business License, Tax Certificate, and Permit for any city and/or county where business activities are conducted. Note: The name and business address of the applicant or provider on the application must exactly match the business name and business address on all local licenses and permits. If a business license/permit is not required, please submit a written statement from your local city/county indicating that your business does not require any license or permit. For further information, please contact your city business license office and/or visit the California State Association of Counties click on the "California’s Counties" link, and select "County Web Sites."  
6. Recorded/stamped Fictitious Business Name Statement (FBNS), issued by the county where the principal place of business is located, if using a fictitious business name AND the business name is different from the legal name on your application. For example, in the case of a corporation, any name other than the corporation name on record with the Secretary of State requires a FBNS. Note: The business name and business address of the applicant or provider on the application, all local business licenses/permits, and the FBNS must exactly match. To determine the applicable county agency where fictitious business names are filed, please visit the California State Association of Counties click on the "California’s Counties" link, and select "County Web Sites."
7. Seller’s Permit issued by the California State Board of Equalization, if applicable. Note: The business name and business address of the applicant or provider on the application must match the business name and business address on the seller’s permit. For further information, visit the Board of Equalization or cal them at (916) 445-6362.
8. Fully executed Partnership Agreement, if your business is a partnership. Processing delays may be avoided by indicating whether the entity is a General Partnership or Limited Partnership and also submitting the following:
• a) For a General Partnership, a list of all partners with percentage of ownership or control interest for each; or
• b) For a Limited Partnership, information identifying the General Partner, and a list of all partners with percentage of ownership or control interest for each.
• To verify or change the name and/or status of your partnership or for further information, please visit the Secretary of State California Business Portal  and click on the "California Business Search" link or other appropriate link.  
9. If your business is a corporation, processing delays may be avoided by attaching a copy of the filed Articles of Incorporation from the Secretary of State, and a list of directors’ and officers’ names and titles, with percent of ownership and control interest for each. To verify or change the name and/or status of your corporation or for further information, please visit the Secretary of State California Business and click on the "California Business Search" link or other appropriate link.
10. Certificate of Commercial Liability Insurance (business, general, or comprehensive liability, or office premis​es insurance) in an amount of not less than $100,000 per claim and a minimum annual aggregate of $300,000. Acceptable verification is either evidence of being self-insured, or a certificate of insurance or declaration sheet issued by the insurance company that contains the name of the insurance company, the name and business address of the insured, effective dates, and limits of coverage. Note: The name and business address, including suite number if applicable, of the applicant or provider on the application must exactly match the insured’s name and address on the certificate of insurance or declaration sheet.
11. Certificate of Professional Liability Insurance in an amount of not less than $100,000 per claim and a minimum annual aggregate of $300,000. Acceptable verification is a certificate of insurance or declaration sheet issued by the insurance company that contains the name of the insurance company, the name of the insured, effective dates, and limits of coverage. Note: The provider’s name, as it appears on the California Clinical Laboratory License, must also show on the verification of the professional liability insurance.
12. Certificate of Workers’ Compensation Insurance is required by California law, if your business has one or more employees. Acceptable verification is either evidence of being self-insured, or a certificate of insurance or declaration sheet issued by the insurance company that contains the name of the insurance company, the name and business address of the insured, and effective dates. If no Workers’ Compensation insurance is required, an explanation must be provided. Note: The name and business address of the applicant or provider must exactly match the insured’s name and address on the certificate of insurance.
13. Signed Lease Agreement, if business premises are not owned by the applicant or provider. Note: The name and business address of the applicant or provider must exactly match the lessee’s name and address on the lease agreement.
14. Successor Liability with Joint and Several Liability Agreement (DHCS 6217), if applicable.