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 may be downloaded at the bottom of this page.

Affidavit Instructions

Laboratories are often subject to name changes, mergers, or other operational changes that can affect a laboratory’s accreditation or result in an agreement to transfer ownership of accreditation. The Intersocietal Accreditation Commission (“IAC”) asks laboratories to notify it of these types of changes so that IAC can ensure that the laboratory remains in compliance with the relevant accreditation standards despite the change. Below are the instructions for preparing an affidavit. Sample forms are also available from IAC.

Each affidavit regarding a change in ownership must include:
1. The name and address of the accredited laboratory;
2. The name and address of the new owner;
3. The Employer Identification Number of the new owner;
4. The type of change (such as merger, dissolution, etc.);
5. The effective date of the change;
6. The name of the current medical director;
7. The name of the current technical director;
8. The following statements:
• A. “I represent and warrant that I have authority to execute this affidavit on behalf of the accredited laboratory.”
• B. “Ownership of the accredited laboratory has changed. To the best of my knowledge and belief, I represent and warrant that at the time of this change in ownership, the new owner:
• i. had a medical director;
• ii. had a technical director; and
• iii. was in compliance with all IAC Standards, policies, and procedures.”
• C. “The accredited laboratory requests that IAC approve this change and modify the laboratory’s accreditation status accordingly. I acknowledge and agree that a modification of accreditation status may require the submission of additional information and/or fees, and is not final unless reviewed and approved in writing by IAC.”
• D. “Under penalty of perjury, I certify that this information is accurate, true, and complete.”
9. And, a notarized signature.

Each affidavit regarding a change other than a change in ownership must include:
1. The name and address of the accredited laboratory;
2. A description of the change (such as the corporate name, new mobile site, new medical director, etc.);
3. The effective date of the change;
4. The name of the current medical director;
5. The name of the current technical director; and
6. The following statements:
• A. “The accredited laboratory requests that IAC approve this change and modify the laboratory’s accreditation status accordingly. I acknowledge and agree that a modification of accreditation status may require the submission of additional information and/or fees, and is not final unless reviewed and approved in writing by IAC.”
• B. “Under penalty of perjury, I certify that this information is accurate, true, and complete.”
7. A notarized signature is optional.

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 <<

All questions regarding agreement or ownership changes should be directed to the ICAVL