State of California—Health and Human Services Agency |
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California Department of Public Health |
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OWNER’S ATTESTATION |
I attest that effective |
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, I am the laboratory owner, or a co-owner of: |
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(date) |
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clinical laboratory, located at |
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(name of laboratory) |
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CLIA ID number: |
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(street address) |
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State ID number (if known): |
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As the owner or co-owner, I understand I am legally responsible for the operation of the laboratory under both CLIA and State law. I understand that as an owner of this laboratory, I, along with the director, must ensure the accuracy and reliability of all testing performed and that the laboratory meets all applicable CLIA and state requirements.
I understand that I will be held jointly and severally responsible with the laboratory director(s) for the maintenance and conduct of the laboratory and all employees therein or for any violations of law by this clinical laboratory (Business and Professions Code (BPC) section 1265(b)). If deficient or unlawful practices are found that occurred while I was serving as laboratory owner or co-owner, which the laboratory fails or is unable to correct, and which results in the revocation of the laboratory’s CLIA certificate or state license or registration, I understand that pursuant to Title 42 of the United States Code (USC), section 263(a)(i) (3), 42 CFR 493.1840(a)(8), and BPC section 1324, I would be prohibited from owning, operating, or directing another clinical laboratory for a period of at least two years from the date of revocation. Such action may also be grounds for referral to the Medical Board of California or other licensing board for appropriate action.
I understand that any reasons listed in BPC section 1320, including any false statement or representation of fact in obtaining or retaining CLIA certification or state licensure or registration may be grounds for revocation of the laboratory’s CLIA certificate under 42 CFR 493.1840(a)(1), and state license or registration under BPC section 1320 and may subject me to criminal or civil sanctions.
I understand that I will be responsible, along with the laboratory director(s), to notify the Department of Public Health in writing of any changes in the laboratory ownership, directorship, name or location within thirty days of the change, and that failure to provide such notification will result in automatic revocation of the state license or registration (BPC section 1265(g)), and sanctions against the CLIA certificate (42 CFR 493.39(b), 493.45(b)(2), 493.51(a), 493.53(a), 493.57(a)(2), and 493.63(a)).
I understand that I will continue to be held responsible as a laboratory owner of this laboratory until the day that the California Department of Public Health receives a signed statement from me notifying the Department of my resignation or termination.
I affirm under penalty of perjury, that all information I have given in this document is true. This statement must be signed by the owner or a person legally authorized by the owner.
Owner or Authorize Representative’s signature |
Date |
Print or type name and title |
Owner's contact telephone number |
Owner’s address