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GENERAL SECTION
This section must be completed when applying for a new program or reactivating an existing
program. The tables allow for expansion of cells and increasing the number of rows as needed to
provide a complete response.

GENERAL: PART 1, SECTION A - INSTITUTIONAL
Check the type(s) of organ transplant programs for which your transplant center is applying for membership:

Application
(Check)

Program Type

Application
(Check)

Kidney
Living Donor Kidney
Liver
Living Donor Liver
Pancreas

Program Type
Pancreas Islet Cell
Heart
Lung
Heart/lung

Complete the portions of this application that apply to each program checked above.
1.

The Bylaws require that an applicant has in force medical liability insurance with at least $1,000,000 limits
of coverage per occurrence. Coverage must be provided by an insurer that is either
• Licensed; or
• approved by the insurance regulatory agency of the state in which the applicant's principal office is
located.
In lieu of commercial insurance coverage, evidence of equivalent coverage through a funded self-insurance
arrangement shall suffice.
a)

Is your institution insured for professional liability with at least $1,000,000 limits of coverage per
occurrence? Yes ______ No ______

b) 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.
Fund Administrator

c)

Amount of Self
Insurance Fund

Describe Coverage

Will you require transplant surgeons and transplant physicians on your medical staff to carry
professional liability insurance or to participate in a funded self-insurance program beyond what is
described in “a” or “b” above? If yes, describe the amount of coverage or funded self-insurance that
you will require.
Check
response

Required

Amount of coverage/Self Insurance Required

No
Yes

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GENERAL: PART 1, SECTION B –
DONATION AFTER CARDIAC DEATH (DCD) PROTOCOLS
Donation after Cardiac Death (DCD). In accordance with the Bylaws, transplant hospitals must develop, and
once developed must comply with, protocols to facilitate the recovery of organs from DCD donors. Transplant
Hospital DCD recovery protocols must address the required model elements set forth in the 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 implemented in accordance with OPTN Bylaws and that the DCD organ recovery
protocol addresses the required model elements.
Chief Executive Officer

Date

________________________________________

___________________

________________________________________
Print name

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PROGRAM SPECIFIC: PART 2, SECTION A – PROGRAM DESCRIPTION
Duplicate this section for each organ application that is being submitted
Application
(Check)

Program Type

Application
(Check)

Program Type

Kidney
Pancreas Islet Cell
Living Donor Kidney
Heart
Liver
Lung
Living Donor Liver
Heart/lung
Pancreas
** Living Donor Kidney Transplant Program application process will begin in late 2007.
**

1.

Answer the questions below that describe this program (proposed program)

a) Year Program to Start (started):
Yes

No

Not
Applicable

b) Does/will this program perform transplants in patients under
age 18?
c) Is this center a stand-alone pediatric hospital?
d) If no, is there a stand-alone pediatric facility affiliated with
this hospital? If yes, specify facility: _________________
e) Will this program perform living donor transplants?
(Applicable for kidney, liver, pancreas, and lung programs)
f) Is this program certified by Medicare?
If yes, provide the CMS provider number:________
Certification date:_________
Attach evidence of Medicare certification.
g) Medicare approved programs: If this is an application for a
change in key personnel, have you notified CMS of this
change?

2.

Is a Certificate of Need (CON) required by your state prior to initiation of this transplant program?
Yes ____
No ____
If the response is “Yes” answer the questions below.

CON Required

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Date Application made

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Application
approval date

Anticipated
approval date

PROGRAM SPECIFIC: PART 2, SECTION B – FACILITIES
Transplant programs require extensive facilities and commitment of resources. Consequently, institutions must
allocate sufficient operating and recovery room resources, intensive care resources, and surgical beds to the
transplant program. Describe below how this hospital satisfies these requirements.
1.

Floor and Clinic Space
Floor & Clinic Space
a) Operating rooms
b) Recovery room
c) ICU
d) Surgical Intensive Care (SICU)
e) Step-Down Unit/Floor & Clinic:
f) Total number of days/hours available for outpatient
transplant clinic
Additional Information:

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Response

PROGRAM SPECIFIC: PART 2, SECTION C – HUMAN RESOURCES
1.

Mental Health and Social Services: Describe the support that will be provided to the transplant program in the
areas below. The description should include the name of the individuals, their on site availability, their role on
the transplant team, and description of their responsibility for coordinating the needs of transplant candidates,
recipients, living donors (as applicable) and families.
Area
Mental Health

Description of Support/ Scope of Duties

Social Support Services

2.

Clinical Nursing: Describe the nursing support that will be provided to the transplant program(s)
Area
What will be the patient nurse ratio on the transplant unit?

Response
ICU ____
Non-ICU: ___

Will the transplant nurse specialist be active in the care of
patients on the transplant unit?
What transplant specific orientation will be provided to a
nurse before she/he is given responsibility for care of
transplant patients?

3.

Clinical Transplant Coordinator(s): Identify one or more staff members who will be responsible for coordinating
clinical aspects of patient care (including the Candidate Phase, Transplant/Inpatient Phase, and Recipient/Outpatient
Phase). Indicate their transplant experience and relevant certifications.
Transplant
Experience
In years

Name

Professional
Certifications

Describe below the Role and Responsibilities of the Clinical Transplant Coordinator(s).
Role and Responsibilities
Designated member of the transplant team.
The coordinator is a registered nurse or other licensed clinician.
Specific responsibilities during Candidate Phase:
Assures necessary studies are conducted to determine a patient’s
candidacy.
Participates in both patient and family education.
Assists in the evaluation and selection of potential living donors.
Monitors medical patients’ status throughout work-up and while on the
deceased donor organ transplant waiting list.
Specific responsibilities during Transplant/Inpatient Phase:
Assumes lead in directing all patient and family transplant education
and understanding of the process.
Maintains communication with patients’ referring physicians.
Acts as a transplant resource for all staff nurses and contributes to their
education regarding transplantation
Works as liaison between patient families and other health care staff
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Yes

No

Role and Responsibilities
Prepares patients for discharge and outpatient follow-up.
Specific responsibilities during Recipient/Outpatient Phase:
Monitors and follows all diagnostic studies.
Evaluates patient health status on a regular basis.
Communicates all patient issues and concerns to appropriate transplant
physicians.
Coordinates comprehensive care with other team members (i.e.
financial coordinator, social worker, dietician, etc).
Describe any other clinical transplant responsibilities:

Yes

No

Involved with the organ procurement process? If Yes, explain scope of involvement.

4.

Financial Coordinator: All transplant centers should identify one or more staff members who are responsible for
coordinating and assisting the patient with all financial aspects specific to transplant care.
Indicate the number of Transplant Financial Coordinators that support this program __________ (FTE)
Indicate below which responsibilities are fulfilled by the financial coordinator(s).
Role and Responsibilities
Designated member of the transplant team
Primarily Responsible for coordinating financial services related to
transplant care
Obtains detailed patient insurance benefit information for all aspects of the
transplant process, including, but not limited to, outpatient prescription
drugs, organ acquisition, follow-up clinic visits, and travel and housing if
necessary.
Discusses benefits and other transplant financial issues with patients and/or
family members during initial evaluation.
Advises patients on insurance and billing issues and options. Serves as a
resource for patients and their family members on financial matters.
Obtains all necessary payor authorizations. Verifies transplant coverage
and other medical benefits and acquiring necessary referrals and
authorizations.
Monitors and updates information regarding insurance data, physicians,
authorizations, and preferred providers. Assisting patients with questions
concerning insurance and other financial issues.
Identifies and effectively communicates financial information to transplant
team members, patients and their families with emphasis on identifying any
potential patient out-of-pocket liability.
Works with patients, their families and team members when possible to
help address insurance coverage gaps via alternative funding options.
Facilitates resolution of patient billing issues.

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Yes

No

5.

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

5.

% of Time
dedicated to this
TX Program

Background

Clinical Transplant Pharmacist: All transplant programs should identify one or more pharmacists who are
responsible for providing pharmaceutical care to solid organ transplant recipients.
Number of Transplant Pharmacists that support this program: __ (FTE).
Indicate below which responsibilities are fulfilled by the Transplant Pharmacist(s).

Role and Responsibilities

Yes

Designated member of the transplant team
Primary responsibility for providing comprehensive pharmaceutical
care to transplant recipients
The transplant pharmacist is a licensed pharmacist with experience in
transplant pharmacotherapy, who performs or oversees a team of other
healthcare personnel and support staff in performing the functions
listed below.
Specific responsibilities during Peri-operative Phase:
Evaluates, identifies and resolves medication related problems for
transplant recipients.
Educates transplant recipients and their family members on transplant
medications and adherence to medication regimen.
Acts as liaison (advocate) between patient and patients’ families and
other health care team members regarding medication issues.
Prepares and actively participates with discharge planning for all
transplant recipients.
Provides drug information for all members of the transplant team.
Specific responsibilities during Post Transplant Phase:
Evaluates transplant recipient medication regimens routinely.
Communicates all transplant recipient medication issues and concerns
to appropriate members of the transplant team.
Assists with designing, implementing, and monitoring of
comprehensive care plans with other transplant team members (i.e.
physicians, transplant coordinators, financial coordinator, social
worker, dietician, etc.).
Describe Additional responsibilities:

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No

% Time
Transplant
related

6.

Anesthesiology Commitment: All transplant centers must show evidence of collaborative involvement with
experts in the field of anesthesiology.
a)

Does this facility/program have a Director of Transplant Anesthesiology and/or an Anesthesiology Service
Chief for the organ covered in this application?
__ Yes
__ No
• If yes, provide this individual’s CV.
Describe the Director’s experience in transplantation:
Description
Does the director provide clinical care for transplant
recipients?
If yes, for which of the following organs?
[Options: Kidney, liver, small bowel, pancreas, heart,
lung]
Does the director provide: (check all that apply)

___ Intraoperative
___ Postoperative care

Approximately how many transplants of the applied for
organ type has the director participated in?

Options:
y <10 ___
y10-20 ___
y 20-30 ___
y>30 ___
Yes

Does the Department of Anesthesiology or the hospital
medical staff have a credentialing process for
transplant anesthesiologists?

No

Explanation
If yes, (check all that apply):
___ Proctored by experienced
group member
___ visit other facility
___ other: (describe) ___

Has the Director attended transplant-related CME
meetings in the last 2 years?
Was the Director’s transplant experience for the organ
covered in this application obtained at this facility?
(Please describe transplant experience within the CV)

b) Which of the following best describes the anesthesiology care?
___ Care for transplant procedures will be provided exclusively by members of a transplant anesthesiology
team
___ Care for transplant procedures will be provided by members of a transplant anesthesiology team and
other non-team members
___ Care for transplant procedures will be distributed among anesthesiology department members

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c)

How many anesthesiologists, including the Director, will participate in transplant care?
#
Anesthesiologists
2-4
4-6
6-8
8-10
10-15
>15

Yes

d)

Is there a written protocol for the conduct of anesthesia?

e)

In what way do the Anesthesiologists participate in transplant patient care?
Phase of Patient Care
See patients preoperatively?
Participate on the Selection Committee?
Consultation preoperatively with subspecialists (e.g.
cardiologists, pulmonologists) as needed for specific
cases?
Participate in M&M Conferences?

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__ Yes __ No

Yes

No

If Requested

7.

Other Medical Discipline Involvement: Describe briefly the support available to the transplant effort in the
disciplines listed below. Each description should answer the following:
• When are these services provided? (pre-, peri-, post-operative)
• Where are these services provided? (on site, off site or both)
• Is support primary provided by one individual or a team? What is their experience in transplant?
• Are specialty representatives participating with the transplant team in quality assessments post transplant?

Specialty Area

Description

Given Role:
Consultant or
Transplant
Staff Member

Time % devoted to
this organ type
Other Organ Types
(list other organs)

Radiology
Infectious Disease
Pulmonary Medicine
Pathology
Immunology
Physical Therapy
Rehabilitation Medicine
Dietary & Nutritional Support
Laboratory Services: Does the transplant program have immediate access to the following services?
− Microbiology
− Clinical Chemistry
− Immunological Monitoring
− Blood Bank

Others Areas as Appropriate:
Hepatology
Pediatrics
Nephrology (with dialysis
capability)
Pulmonary medicine (with
respiratory therapy support)

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8.

Staffing Resources – Planning:
Using the Chart below show the expected transplant volume and staffing levels (FTE’s) for year 1 through year
3 of the program. In the case of a program that is reactivating, show the projected information 3 years out from
the anticipated reactivation date.

Position

Year 1
YEAR

Workload Volume
Projected Transplant Volumes
Projected # of candidates waitlisted
Personnel Projections
Surgeons – Primary/additional
Surgeons – other
Surgeons – transplant fellow
Physician – Primary/additional
Physician – Other (organ Specific)
Physician – Fellow (organ specific)
Nurse Practitioner(s)
Transplant Pathologists
Transplant Coordinators
Dietary/Nutritional Counselors
Financial Counselors
Social Workers
Transplant
Program
Administrative
Management
Practice Managers
Administrative Assistants
Data Coordinators
Transplant Pharmacists
Transplant Psychiatrist/Psychologist

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Year 2

Year 3

9.

Program Coverage Plan: In accordance with the Bylaws, the program director, in conjunction with the
primary transplant surgeon and transplant physician must submit to UNOS in writing a Program Coverage Plan,
which documents how 100% medical and surgical coverage is provided by individuals credentialed by the
institution to provide transplant service for the program. A transplant program served by a single surgeon or
physician shall inform its patients of this fact and potential unavailability of one or both of these individuals, as
applicable, during the year. The Program coverage Plan must address the following requirements:

Yes

No

Is this a single surgeon program?
Is this a single physician program?
If the answer to either one of the above questions is “Yes,” explain the protocol for
notifying patients.

Does this transplant program have transplant surgeon(s) and physician(s) available
365 days a year, 24 hours a day, 7 days a week to provide program coverage?
If the answer to the above question is “No” an explanation must be provided that justifies why the
current level of coverage should be acceptable to the MPSC.
Transplant programs shall provide patients with a written summary of the Program
Coverage Plan, at the time of listing and when there are any substantial changes in
program or personnel. Has this program developed a plan for notification?
Is a surgeon/physician available and able to be on the hospital premises within onehour ground transportation time to address urgent patient issues?
Is a transplant surgeon readily available in a timely manner to facilitate organ
acceptance, procurement, and implantation?
Unless exempted by the MPSC for specific causal reasons, the primary transplant
surgeon/primary transplant physician cannot be designated as the primary
surgeon/primary transplant physician at more than one transplant center unless
there are additional transplant surgeons/transplant physicians at each of those
facilities. Is this program requesting an exemption?
If yes, provide explanation below.
Additional information:

10.

Administration:
a)

Describe administrative relationships of the transplant program with the hospital (include an organizational
chart).

b) Describe the institutional commitment to this program and the hospital resources that are committed to this
program for the next two years.
c)

Describe the role of the transplant administrator and their areas of oversight.

d) Does/Will the transplant program routinely do an internal review of its performance? If yes, indicate the type,
frequency of meetings, and participants.

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e)

f)

Is there a plan for hospital administration to receive periodic performance reports for the transplant program?
If yes, indicate frequency and the data that will be reported.
•

Describe the steps taken to identify and correct problems that may affect the program’s success.

•

Provide a list of quality metrics that you use/will use for tracking this transplant program (include
name of responsible staff member)).

Who is responsible for ensuring that the hospital is in compliance with OPTN requirements and policies?
Name: __________________________________________________

11.

Data Collection and Submission: In accordance with the OPTN Policies members must submit data on candidates,
recipients, and donors. Describe the methods that will to be used to collect, verify, and submit data on a timely
basis.

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PROGRAM SPECIFIC: PART 2, SECTION D –
PROTOCOLS/METHODS/PROCEDURES
1.

Patient/Candidate Management
a)

Are there written policies and procedures for transplantation and patient management? __ Yes

___ No

How often will these reviewed and who participates in the review?

b) Describe below how candidates/recipients will move through the pre/peri/post-transplantation process (from
identification and referral, selection committee review process, patient notification, post surgery/post transplant care
and plan/policy for transitioning patients back to referring doctors post-transplant) as applicable. The description
should include
• resources involved with each step (address expected average volume of patients moving through the system
at any given time); and
• the process for continuous review of patients currently listed for transplant.

c)

What outreach programs exist?

d) How are patient calls and questions handled? How are out patient emergencies handled?

2.

e)

What provisions are made for patient assistance/funding for temporary housing, medications, etc.

f)

Who participates in transplant team meetings (by role, not name)? Are rounds conducted with a multi-disciplinary
team?

Outpatient Care
Response
Who directs/will direct the outpatient transplant clinic?
Which physicians and surgeons (will) participate regularly in
the transplant clinic? Include frequency of clinics.
Who will care/cares for transplant patients after initial
discharge?
How often will/are transplant patients seen for long-term
follow-up?

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3.

Patient Selection Criteria - Transplant programs must establish procedures for selecting transplant candidates and
distributing organs in a fair and equitable manner.
Response
Is there standard protocol in place for patient evaluation?
Is there formal exclusion criteria for acceptance?
Who gives final approval for adding patients to the waiting list?

___ Single Individual
___ Committee. If Committee, list members and
frequency of meetings (by role).

4. Immunosuppression
Yes

No

Is there a standard immunosuppression protocol?
Do individual team members use separate protocols?
Who manages immunosuppression?
Initial hospitalization:
First 3 months out-patient:
Long-term (After 3 months post-op):

Describe the interactions of team members in providing immunosuppression management.

5.

Articulate plans for any transplant-related services provided outside the hospital. This includes, but is not limited to
plans to assure immediate access to services and to assure patient safety during transports to off-site facilities.
• Provide a letter of support or agreement from each off-site provider.

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PROGRAM SPECIFIC, PART 2, SECTION E –
BUSINESS/IMPLEMENTATION PLAN
The availability of a Business/Implementation Plan is identified as a critical element in developing a
successful transplant program. OPTN requests for the CEO at each transplant center certify that such a
Business/Implementation Plan exists in support of the application.
This Certification is required in the following situations:
• When applying for institutional membership;
• Establishing a new transplant program; or
• Reactivating a transplant program
The following basic factors are integral and should be addressed in any adopted Plan:
Institutional Level
• Hospital Overview (ownership, management, history, etc.)
• Market Assessment (local/regional need for transplant service line; why did the hospital
decide to start a transplant program/this specific transplant program?)
• Financial Assessment (financial impact/costs/reimbursement sources)
• Commitment (money, physical plant, employee resources, etc.)
• Capability Assessment (chart to demonstrate that the institution is aware of everything that
needs to be in place for a successful program)
• Organizational Chart (transplant program fits where in the hospital structure? report
structure/oversight responsibility)
Program Level
• Who are our customers? (Internal and external – demonstrate that the program understands all
of the people/organizations they must work with)
• First Year Plan/Timeline
• Infrastructure/Operations
ƒ Staffing Model (Initial, retention and succession planning)
ƒ Resource Assessment (Physical resources, IT, Collaboration with other organizations, etc.)
• Marketing (Professional and community value recognition)
• Risk Assessment (Financial risks, staffing succession plan, exit strategy)
• Organizational chart (program report and staff interaction)
• Quality Assurance and Process Improvement Plan

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 Business Plan/Implementation Plan has
been developed, adopted and will be consulted regarding the institutional commitments being
made and acknowledged in this transplant program application.
Chief Executive Officer

Date

________________________________________

___________________

________________________________________
Print name

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PROGRAM SPECIFIC: PART 2, SECTION F–
ORGAN PROCUREMENT ARRANGEMENTS

1.

Who takes donor call? How do you handle organ referrals internally?

2.

Are there exiting Alternative Local Units (ALU) or variances that will be impacted by this proposed program?
If yes, has the hospital agreed to participate?
If no, explain.

Respond to Question 3 below if you are applying for a new transplant program in an existing member transplant
center. New transplant center applicants must complete PART 5, Question 1, and either Section A or B of the
application packet.
3.

Attach a letter of agreement or contract with your OPO that specifically indicates it will provide the organs for which
you are applying.

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