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Department of Health and Human Services
Health Resources and Services Administration

OMB No. pending

Expiration Date: pending

APPLICATION FOR APPROVAL FOR INSTITUTIONAL MEMBERSHIP
AS AN INDEPENDENT ORGAN PROCUREMENT ORGANIZATION
(IOPO)
IN THE ORGAN PROCUREMENT AND TRANSPLANTATION
NETWORK (OPTN)
UNOS
700 North 4th Street
Richmond, VA 23219
Main Phone: 804-782-4800

Name of OPO:

________________________________________________________________

Address:

________________________________________________________________

City, State, and Zip Code: _________________________________________________________________
Contact Person:

_______________________________________________________________

Phone Number:

(______)____________________

PUBLIC BURDEN STATEMENT: An agency may not conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB control number. The OMB control number for this
project is 0915-0184. Public reporting burden for the applicant for this collection of information is estimated to average 40
hours per response, including the time for reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the collection of information. Send comments regarding this
burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to
HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 10-33, Rockville, Maryland 20857.
CERTIFICATION
The undersigned, a duly authorized representative of the applicant, does hereby certify that the answers and attachments to
this application are true, correct and complete, to the best of his or her knowledge after investigation. By submitting this
application to the OPTN, the applicant agrees: (i) to be bound by the Organ Procurement and Transplantation Network's
rules and regulations, including amendments thereto, if the applicant is granted membership and (ii) to be bound by the
terms, thereof, including amendments thereto, in all matters relating to consideration of the application without regard to
whether or not the applicant is granted membership.
Signature:

_____________________________________________

Date: ___________________________

Print Name:

______________________________________________

Title:

Center Code: _____________

Version date pending

________________________

Independent Organ Procurement Organization
Organ Procurement Organizations: An organization 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 an
organization that meets all requirements for such designation other than OPTN membership (OPO) is eligible for
membership in the OPTN.
OPOs shall abide by applicable provisions of the National Organ Transplant Act, as amended, 42 U.S.C. 273 et seq.; the
requirements set forth in the OPTN Final Rule, 42 CFR Part 121; the Bylaws; and OPTN policies.
OPOs shall also submit to reviews (including on-site reviews) and requests for information as may be necessary to
determine compliance with the OPTN Final Rule, 42 CFR Part 121; the Bylaws; and OPTN policies. Failure to conform
with such requirements shall be cause for corrective action described in Appendix A of the Bylaws.
Instructions
1.

An independent organ procurement organization (IOPO) must complete this application for institutional membership.
“Independent" is defined as the demonstration of distinct governing body that is separate and not under the direct or
indirect control of the governing body of any of the transplant hospitals or of the governing body of a commonly
controlled group of OPO’s or Hospitals. The Criteria for Institutional Membership are found in the Bylaws which can
be accessed on the OPTN website at www.optn.org.

2.

An IOPO is eligible for a voting institutional membership.

3.

By submitting this application to the OPTN, the applicant acknowledges that its duly authorized representatives have
received and read the current Charter and Bylaws of OPTN and the applicant agrees: (i) to be bound by the terms
thereof, including amendments thereto, if the applicant is granted membership and (ii) to be bound by the terms
thereof, including amendments thereto, in all matters relating to consideration of the application without regard to
whether or not the applicant is granted membership.

4.

A duly authorized representative of the applicant must review the answers and attachments to the Application, perform
sufficient investigation to determine accuracy and completeness, and sign and date the Certification on the cover page
of the Application. Failure to furnish accurate and complete information in connection with the Application and
subsequent site visits and requests for supplemental information constitute grounds for denial or suspension of OPTN
membership.

5.

Application responses must be typed and complete. Do not omit pages that were not used. Electronic versions
(WORD) of this application are available upon request.

6.

Attach additional pages as necessary and reference the question and page number on each attachment. Table rows
should be expanded as needed to fully respond to questions.

7.

The original application should be loose bound with tabs and returned to the address listed below.
Also provide a copy of the application that has been scanned to a CD in PDF format. Label the CD with the OPO
name, contact name, date, and include an electronic table of contents.
Member Services
UNOS
700 North 4th Street
Richmond, VA 23219
Main Phone: 804-782-4800

Instructions-1

OPO-1

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
1) 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
2) that this organization that meets all requirements for such designation other than OPTN membership (OPO)
and is eligible for membership in the OPTN.

4.

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

OPO-1

5.

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

6.

Attach 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.

Attach a copy of the organization’s most recent annual report.

9.

Is your IOPO 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.

10.

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.

OPO-1

11.

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 any agreements.

12.

Describe your 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.

13.

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

14.

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.

OPO-2

15.

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

16.

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

17.

Background

% of time dedicated to data
collection & submission

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

Name

Position

OPO-3

18.

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

19.

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

________________________________________

___________________

OPO-4