LABORATORIES EXPERIENCING CHANGE OF NAME,
CHANGE OF OWNERSHIP, OR CHANGE IN OPERATIONS
To allow accreditation of a laboratory to transfer more smoothly
from one owner to another while ensuring compliance with the
relevant accreditation standards, and/or document any major
changes regarding laboratory operations, the Intersocietal Accreditation
Commission has provided answers to your questions, as well as
two sample forms, below.
All questions regarding agreement or ownership changes should be directed
to the ICAVL
Sample forms and instructions are provided as links at the bottom of this page.
Frequently
Asked Questions:
Affidavit Approving Change of Name or Change of Ownership
Do I need to use a form provided by IAC, or can I use my own?
As long as all of the required information is included, you may use your own form to notify IAC
of changes.
What is required for a laboratory to transfer ownership of accreditation?
A notice form must be sent to IAC with the review fee (currently $200). IAC will then review
the form and determine whether the laboratory must apply for accreditation as a new facility, or
if the laboratory’s existing accreditation remains valid. Accreditation cannot be transferred
without IAC’s written approval.
Who owns the accreditation?
The entity named in the accreditation agreement maintains ownership of accreditation until the
affidavit form is approved by IAC.
Who can sign the notice regarding transfer of ownership?
Only the president or legal counsel of the laboratory initially granted accreditation may sign it.
His/Her notarized signature is required.
Why must I attest to the standards of the new owner?
In order for a laboratory to transfer accreditation to another owner, it must ensure that the entity
receiving the transferred accreditation had both a medical director and a technical director and
that it complied with all IAC Standards at the time of the transfer. If the laboratory is uncertain
as to whether or not the new owner meets these requirements, it cannot transfer its accreditation.
If my laboratory is just changing its name does it need to submit one of these forms?
Yes, a laboratory needs to submit a notice when a name change occurs, even if the laboratory is
not changing ownership.
What if my laboratory adds another site during the accreditation process?
Any time an accredited laboratory adds a site (including a mobile service site) it must submit a
notice and the additional fee (currently $750 per added site for laboratories meeting the multiple
site exemption criteria and an additional $500 fee for laboratories applying for a mobile
component). IAC will then review the affidavit. If there is a significant change in the
laboratory’s operations, IAC may require the laboratory to submit additional evidence of
compliance with IAC’s Standards, policies, and procedures.
Frequently
Asked Questions:
Affidavit Approving Change of Operations
What
if my laboratory has had no change in ownership, but is making
a major change to its operations (i.e. corporate name, Medical
or Technical Director, permanent site location, mobile service)?
The laboratory needs to submit the second sample form, Affidavit
Approving Change In Operations, or other formal legal
documentation, to document these changes in operations. This
form is only provided as a sample; a different form would be
accepted by IAC as long as all of the necessary representations
are included from the sample form provided.
What
if my laboratory adds another site during the accreditation
process?
Any time an accredited laboratory adds a site,
it must complete the multiple site application, submit cases
and the additional fee of $750 per added site for the laboratories
meeting the multiple site criteria.
Download Sample Forms
Affidavit
Approving Change Of Ownership
>> DOWNLOAD THE FORM <<
Affidavit
Approving Change In Operations
>> DOWNLOAD THE FORM <<
Affidavit Instructions
All questions regarding agreement or ownership changes should be directed
to the ICAVL
|
