Form 11 A10_OPO_Inhouse

Part 5: Organ Procurement

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 hospital 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

Section A – Organ Procurement Organization (OPO) Arrangements - Contracted1) Provide name, mailing address, and primary phone numbers for the organ procurement organization (OPO).

Name	Address /phone

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

Section B- Application for Hospital Based Organ Procurement Organization (OPO)

1. Provide the full name and address of the OPO, and the CMS provider identification number.

a) OPO Name: _________________________________________________

Address: _________________________________________________

_________________________________________________

b) CMS Provider Number: ____________________

2. 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 hospitals this OPO will serve and the type of programs that it will serve for each transplant hospital (i.e. kidney, heart, heart/lung, lung, liver, pancreas, pancreas islet cell). (Expand rows as needed)

• Describe the regional transplant agreements

• Attach the written contracts/agreements with each organization.

Name & Address	Type of Program(s)	Regional Transplant Agreements

5. Outline the purposes and the goals of this organization as stipulated in the 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 this OPO insured for professional liability? Yes __________ No ___________.

• If “yes”, name the insurer and give the policy limits per person and per occurrence and the expiration date of your current insurance coverage.

• If “no” and it has 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 this institution from the fund.

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, that will provide donor infectious disease screening including acquired immune deficiency virus, consistent with OPTN standards.

10. Provide the name of OPTN approved histocompatibility laboratory(ies) with which the OPO will be affiliated.

• 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 the 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 current copy of each agreement.

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

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

Name	Background	% of time dedicated to data collection & submission

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

Name	Position

17. Plan for Public Education on Organ Donation. Provide a description of activities that the OPO will be involved with 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.

18. 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

________________________________________ ___________________

12/01/2010 version Organ Procurement-1