State of California—Health and Human Services Agency California Department of Public Health
DIRECTOR’S ATTESTATION
I attest that effective , I am the laboratory director, or a co-director of:
(date)
clinical laboratory, located at
(name of laboratory)
(street address)
CLIA number: State ID number (if known):
As the director or co-director, I assume all directorship responsibilities for CLIA and State of California
purposes. I understand that as a director of this laboratory, I am responsible for the accuracy and
reliability of all testing performed by the laboratory and for ensuring that the laboratory meets all
applicable CLIA and state requirements as stipulated in both federal and California laws (Code of Federal
Regulations [CFR], Title 42, Sections 493.1407, 493.1445; California Business and Professions
Code [BPC], Section 1209).
I understand that I will be held jointly and severally responsible with the laboratory owner(s) for any
violations of law by this clinical laboratory (BPC Section 1265(b)). If deficient or unlawful practices are
found that occurred while I was serving as laboratory director or co-director, 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 false statement or representation of material fact in obtaining or retaining
CLIA certification or state licensure or registration may be grounds fo
r revocation of the laboratory’s
CLIA certificate under 42 CFR 493.1840(a)(1), and state license or registration under BPC Section
1320(f).
I understand that I will be responsible, along with the laboratory owner(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 director 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.
Director’s signature Date
CLIA Director: Yes No
Print or type director’s name and title
Director’s address (as recorded on personal professional license)
California Board license number:
Director’s direct contact telephone number
Or
California Director license number:
LAB 183 (7/07)