, I am the laboratory owner, or a co-owner of:
:
State of California—Health and Human Services Agency California Department of Public Health
OWNER’S ATTESTATION
I attest that effective
(date)
clinical laboratory, located at
(name of laboratory)
(street address)
State ID number (if known):CLIA ID number
As the owner or co-owner, I understand I am legally responsible for the operation of the laboratory under
both CLIA
and
S
tate
law. I
understand
that as
an
owner
of this
laboratory,
I, along with the director, must
ensure the accuracy
and
reliability of all
testing per
formed
and
that the laboratory
meets a
ll applicable
CLI
A 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 deficie nt or unlawful
practice s are fo und that oc curred wh ile I was serving as laboratory owner or co-owner, which th e
laborator y fails or is unabl e to correct, and which results in the revocatio n of th e laboratory’s CLIA
certificate or state license or registration, I understan d that pursuant to Title 42 of th e United States Code
(USC ), section 263(a)(i) (3), 42 CFR 493.1840(a)(8), and BPC secti on 1324, I would be prohibite d from
owning, op erating, or directi ng anot her clinic a l laboratory for a period of at le ast two years fr om the dat e of
revocati on. Such acti on may also be grounds for referra l 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
fals
e statement or representation
of fact in obtaining or r
etaining CLIA certific
ation or state licens
ure 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 n
otify the Department of
Public Health in writing of any changes in the laboratory owners
hip, dir
ectorship, name or loc
ation within
thirty days of the change, and that failure to provide such not
ification 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 c
ontinue to be held r
es
ponsible 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
Prin
t or
ty
pe nam
e and
title
Owner
's contac
t
telephone
number
Owner
’s address
LAB 182 (12/17)
click to sign
signature
click to edit
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