CA LAB 1513 2007-2024 free printable template

State of California Health and Human Services Agency California Department of Public Health DISCLOSURE OF OWNERSHIP AND CONTROL INTEREST STATEMENT I. Identifying Information Name of entity D/B/A Address

How to fill out clia disclosure of ownership

How to fill out CLIA disclosure of ownership:

1. Obtain the CLIA disclosure of ownership form from the appropriate regulatory agency or website. The form may be available online or can be requested by mail.
2. Read the instructions carefully to understand what information is required and how it should be provided. Ensure that you have all the necessary documentation and details ready before starting to fill out the form.
3. Begin by providing your facility's name, address, and contact information at the top of the form. Make sure to include any affiliated organizations or parent companies, if applicable.
4. Identify the type of ownership for your facility. This could include options such as sole proprietorship, corporation, partnership, or government agency. Select the appropriate box or fill in the required information accordingly.
5. Provide detailed information about all individuals or entities with an ownership or control interest in the facility. Include their full name, social security number or employer identification number, and ownership percentage. If it is an organization, include the legal name and address as well.
6. If there are any changes in ownership during the reporting period, indicate the effective date and provide the same detailed information as mentioned above for the new owners or entities. It may be necessary to attach supporting documentation such as legal agreements or certificates of stock ownership.
7. Review the completed form for accuracy and completeness. Make sure that all the required fields are filled out correctly and that you have provided all necessary supporting documents.
8. Sign and date the form to certify that the information provided is true and accurate to the best of your knowledge.

Who needs CLIA disclosure of ownership:

1. Facilities that are subject to the Clinical Laboratory Improvement Amendments (CLIA) regulations need to submit the CLIA disclosure of ownership form. These facilities include clinical laboratories that perform diagnostic testing on human specimens.
2. Any facility that wishes to obtain or maintain CLIA certification or compliance must provide the necessary information regarding ownership and control. This helps regulatory agencies ensure transparency and accountability in laboratory operations.
3. The CLIA disclosure of ownership is required to be submitted when a facility initially applies for CLIA certification, undergoes a change in majority ownership, or as part of routine compliance reporting.
4. Whether it is a hospital-based laboratory, independent lab, physician office lab, or any other type of testing facility, compliance with CLIA regulations and submission of the disclosure of ownership form is mandatory.

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What is clia disclosure of ownership?

The CLIA Disclosure of Ownership is a requirement by the Clinical Laboratory Improvement Amendments (CLIA) program in the United States. It mandates that laboratory facility owners, as defined by CLIA, disclose certain information about their ownership structure to the Centers for Medicare and Medicaid Services (CMS). This disclosure ensures transparency and accountability in the ownership of clinical laboratories. The disclosed information may include the names and addresses of individuals or organizations with a direct or indirect ownership interest of 5% or more in the laboratory. It also includes the identification of individuals who have the power to direct or control the management or policies of the laboratory. The purpose of this disclosure is to prevent conflicts of interest and ensure the integrity and quality of laboratory testing. It allows CMS to evaluate the qualifications and appropriateness of individuals or entities that have a financial interest in laboratory operations. The CLIA Disclosure of Ownership information is submitted to the CMS through the appropriate forms and must be updated within 30 days of any changes in ownership. Failure to disclose ownership information accurately and timely can result in penalties or other enforcement actions by CMS.

Who is required to file clia disclosure of ownership?

The Clinical Laboratory Improvement Amendments (CLIA) requires all clinical laboratories that require a CLIA certificate to file a disclosure of ownership form. This applies to any individual or entity that possesses or has ownership or control interest of at least 5% or more in the laboratory. The disclosure of ownership form (CMS-116) must be submitted to the Centers for Medicare & Medicaid Services (CMS) regional office within 30 days of a change in ownership or when applying for initial accreditation or certification.

How to fill out clia disclosure of ownership?

To fill out the CLIA (Clinical Laboratory Improvement Amendments) Disclosure of Ownership form, follow these steps: 1. Obtain the CLIA Disclosure of Ownership form from the Centers for Medicare & Medicaid Services (CMS) website or request it from the CLIA program. 2. Read the instructions and form carefully before filling it out. Ensure you understand the information being requested and the ownership disclosure requirements. 3. Begin filling out the form by providing the laboratory's name, address, CLIA number, and the laboratory director's name. 4. Section I: Disclosure of Ownership: a. Identify the type of ownership: Check the appropriate box indicating whether the laboratory is a corporation, partnership, individual, or other entity. b. Provide the legal business name of the laboratory and the name of any parent organization (if applicable). c. List the name, address, and Social Security Number (SSN) or Tax Identification Number (TIN) of each owner with a 5% or more direct or indirect interest in the laboratory. d. Indicate the percentage ownership interest of each owner listed. 5. Section II: Disclosure of Convictions: a. List any convictions (felony or misdemeanor) in the past ten years for each owner included in Section I. b. Provide details of the convictions, including the date, court, location, and nature of the offense. 6. Section III: Disclosure of Payments: a. If any listed owners have received any payments (consulting fees, compensation, etc.) from the laboratory within the past twelve months, provide the information for each payment. b. Include the payment date, amount, description of services rendered, and the name of the recipient. 7. Section IV: Signatures: a. Obtain the required signatures from the laboratory director or authorized officer. b. Ensure the date is included. 8. Review the filled-out form for accuracy, ensuring all required information has been provided. 9. Submit the completed form to the appropriate CLIA program personnel as instructed on the form or follow the submission guidelines outlined by CLIA. Remember, it is crucial to comply with all the regulations and guidelines associated with the CLIA program. If you have any doubts or questions, it is advisable to seek guidance from the CLIA program or a legal professional.

What is the purpose of clia disclosure of ownership?

The purpose of the CLIA (Clinical Laboratory Improvement Amendments) disclosure of ownership is to provide transparency and ensure accountability in clinical laboratory testing. This requirement ensures that the ownership and control of clinical laboratories are disclosed to the Centers for Medicare & Medicaid Services (CMS), allowing them to monitor and regulate these facilities effectively. By disclosing ownership information, CLIA aims to prevent conflicts of interest, unethical practices, and potential fraud in laboratory services. It also enables regulators and accreditation bodies to evaluate the qualifications, expertise, and financial arrangements of laboratory owners to ensure compliance with quality standards and patient safety. Disclosure of ownership helps to maintain public trust and confidence in laboratory testing by ensuring that the operation of clinical laboratories is performed by qualified and responsible individuals or organizations.

What information must be reported on clia disclosure of ownership?

The Clinical Laboratory Improvement Amendments (CLIA) program requires laboratories to disclose ownership information. The specific information that must be reported on CLIA disclosure of ownership forms may vary, but generally, it includes: 1. Name and address: The name and address of the laboratory, including contact information. 2. Legal entity: The legal entity under which the laboratory operates, such as a corporation, partnership, or sole proprietorship. 3. Ownership type: The type of ownership, whether it is a publicly traded company, privately held company, government entity, etc. 4. Ownership level: The level or percentage of ownership held by each individual or entity. This may include both direct and indirect ownership. 5. Names of owners: The names of all individuals or entities that have any ownership interest in the laboratory. 6. Relationship to other laboratories: If the laboratory has any relationship or affiliation with other laboratories, such as shared ownership, this must be disclosed as well. 7. Compliance with CLIA requirements: Confirmation that the laboratory meets CLIA requirements and will comply with ongoing regulations. It is important to refer to the specific CLIA guidelines and follow the instructions provided on the disclosure of ownership form to ensure accurate reporting.

What is the penalty for the late filing of clia disclosure of ownership?

The Clinical Laboratory Improvement Amendments (CLIA) do not specify a specific penalty for the late filing of the CLIA Disclosure of Ownership. However, failure to comply with CLIA requirements can lead to enforcement actions and penalties by the Centers for Medicare and Medicaid Services (CMS), which oversees CLIA regulations. Penalties for non-compliance with CLIA regulations can include civil monetary penalties, suspension or revocation of CLIA certification, exclusion from participation in Medicare and Medicaid programs, and criminal penalties for intentional violations. The specific penalties imposed may depend on the severity of the violation and any previous compliance history of the laboratory.

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