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PART 5: ORGAN PROCUREMENT ARRANGEMENTS
1.

Do you work with an organ procurement organization (OPO) which either
(1) is itself a member of the OPTN (or is currently applying for membership), or
(2) is controlled by another clinical transplant center that is an OPTN member (or currently applying for
membership), to serve your organ procurement needs?
Yes ____
No ____
•
•

If yes, answer the questions in Section A below.
If no, proceed to Section B

PART 5, SECTION A
1)

Provide name, mailing address, and primary phone numbers for the OPO.
Name

2)

Address /phone

Attach a copy of the current contract or letter of agreement with the OPO.

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PART 5, SECTION B- APPLICATION FOR HOSPITAL BASED OPO
1.

2.

Indicate full name of organization and CMS provider identification number below.
a)

IOPO Name:
Address:

_________________________________________________
_________________________________________________
_________________________________________________

b)

CMS Provider Number: ____________________

Identify the CEO, Executive Director, Medical Director(s). Provide names, addresses, and CVs.
Name

Mailing Address, Phone number, and email
address

CEO:

Executive Director:

Medical Director(s)

3.

Provide documentation that demonstrates that this organization has been designated as an organ procurement
organization by the Secretary of the Department of Health and Human Services (HHS) under Section 1138(b) of the
Social Security Act; or that this organization that meets all requirements for such designation other than OPTN
membership (OPO) and is eligible for membership in the OPTN.

4.

If applicable, list below the names and addresses of clinical transplant centers you serve and/or will serve and the type
of programs (i.e. kidney, heart, heart/lung, lung, liver, pancreas, pancreas islet cell) that you serve and/or will serve for
each transplant center.
• Describe the regional transplant agreements
• Attach the written contracts/agreements with each organization.

Name & Address

Type of Program

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5.

Outline purposes and goals of your organization as stipulated in your charter and bylaws. Attach copies of charter
and bylaws.

6.

Attach a list of names and positions of the Board of Directors and/or Advisory Board.

7.

Attach a copy of non-profit status notification from federal and state offices.

8.

Is your OPO insured for professional liability? Yes __________ No ___________.
• If “yes”, name your insurer and give the policy limits per person and per occurrence and the expiration date
of your current insurance coverage.
• If “no” and you have a funded self-insurance program, give the name of the fund administrator and the
amount of the self-insurance fund, and describe the coverage available to your institution from the fund.

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9.

Name below, and provide a copy of an agreement that documents arrangements with a CLIA certified
laboratory (or certified laboratories), in the appropriate specialty or subspecialty or service, to provide
donor infectious disease screening including acquired immune deficiency virus, consistent with OPTN
standards.

10.

Provide the name of histocompatibility laboratory(ies) with which you are affiliated that meets the OPTN
standards for accreditation as a tissue-typing laboratory.
• Attach copies of the agreements.

11.

Describe the defined service area in terms of geographic region (counties served), population base and
hospital allocation catchment area.
• Indicate to what extent your defined service area is exclusive and for any non-exclusive service areas
served, what other OPO's are involved.
• Include a map diagramming the area.

12.

Attach a list of donor hospitals served and provide a copy of each agreement.

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13.

Communication of Information for Organ Distribution: The OPO is responsible for equitable organ
allocation within its service area according to OPTN policies and must be able to communicate in a timely
manner appropriate information necessary to facilitate equitable organ distribution as well as perform other
functions necessary to discharge this responsibility.
• Describe how this OPO will fulfill this requirement including the arrangements for recovery and
distribution of renal and non-renal organs and tissues, and the arrangement for recovery and
distribution of tissue (eye, bone, skin, etc).
• Attach agreements with tissue and eye banks within area.

14.

Describe current and anticipated procedures for complying with the data submission requirements of OPTN
membership.

15.

List the personnel who are/or will be responsible for data collection and submission. Indicate their
background in this area and the percentage of their time that is dedicated to data collection and submission.

Name

16.

Background

% of time dedicated to data
collection & submission

List all personnel (by position) employed by this OPO. (Expand table rows as necessary).
Name

Position

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17.

Plan for Public Education on Organ Donation. Provide a description of activities with which the OPO will
be/is involved regarding public education about organ donation, including how donor families, transplant
patients, and transplant recipients participate.
• Attach a copy of the plan for addressing multi-cultural issues related to organ donation

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17.

Donation after Cardiac Death (DCD). OPOs must develop, and once developed must comply with,
protocols to facilitate the recovery of organs from DCD donors. OPO DCD recovery protocols must
address the required model elements set forth in the OPTN Bylaws.

Certification Statement
The undersigned, as the duly authorized Chief Executive Officer, hereby certifies after investigation that to
the best of his or her knowledge a Donation after Cardiac Death (DCD) organ recovery protocol has been
developed, adopted and will be implemented in accordance with OPTN Bylaws and that the DCD organ
recovery protocol addresses the required model elements.
Chief Executive Officer

Date

________________________________________

___________________

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