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Organ Procurement and Transplantation Network

A10_LDK_TX_program_appl_initial only

Organ Procurement and Transplantation Network Application

OMB: 0915-0184

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Department of Health and Human Services
Health Resources and Services Administration

OMB No. PENDING
Expiration Date: PENDING

APPLICATION FOR APPROVAL OF
LIVING DONOR KIDNEY TRANSPLANTATION
IN AN EXISTING MEMBER TRANSPLANT CENTER THAT IS APPROVED FOR
KIDNEY TRANSPLANTATION.
ORGAN PROCUREMENT AND TRANSPLANTATION
NETWORK (OPTN)
700 North 4th Street
Richmond, VA 23219
Main Phone: 804-782-4800

Name of Hospital:
Hospital Address:
City, State, Zip Code:

Contact Person and Title:
Phone: (

)

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 45 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 center, 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
(OPTN) rules and requirements, 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.
Date:

Signature: _____________________________________
Print Name: ____________________________________

Center Code:
Version date pending

Print Title: ______________________________________

Version date pending

Application Instructions
1.

A duly authorized representative of the transplant center must review the answers and attachments to the
change forms, perform sufficient investigation to determine accuracy and completeness, and sign and date
the Certification on the cover page of the form. Failure to furnish accurate and complete information in
connection with the form and subsequent site visits and requests for supplemental information, constitutes
grounds for denial or suspension of OPTN membership. (Authorized representatives include hospital
CEO/President, OPTN Representative, and Program Directors. Individuals whose credentials are being
submitted should not sign the application)

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.

Do not submit two-sided pages.

Attach additional pages as necessary and reference the question and page number on each attachment.
Expand table rows as needed to fully answer questions.

Answer all questions in full. "See C.V." and “see logs” are not acceptable answers.

CV's should be included for all primary and new personnel listed. Abbreviated CV’s that do not include
publications and presentations are preferred.

Each set (original and copy) should be loose bound with tabs. Originals and copy should be organized in the
following sequence:
a) Application form (including signed certification page) and staffing survey (Parts 1-5).
b) Documentation of Medicare/Medicaid certification of this program (as applicable).
c) Letters from Hospital Credentialing Committee.
d) Letters of Commitment.
e) Letters of Reference.
f)
Nephrectomy – Experience and Training (Table 1 within document).
g) Nephrectomy log for the donor surgeon (Table 2 within document).
Title each log with surgeons name, date range, and hospital where the experience occurred.
Please use a separate log for each institution.
h) CV’s (individual CV’s must be stapled together in the original and hardcopy).

Supporting documentation such as letters of support, letters of commitment, and logs must be included as
requested to document compliance with OPTN requirements. Documentation may be blinded in such a
way as to protect patient confidentiality. Check lists are provided throughout the application to help
applicants compile the documentation that is required. Each item in the checklist is cross referenced to the
application questions.

The Membership and Professional Standards Committee (MPSC) may not accept for review applications
that are not appropriately completed and that are missing the supporting documents for the proposed
primary individual(s). Applications determined to be incomplete may be returned to the institution.

10.

The Criteria for Institutional Membership are found in the Bylaws which can be accessed on the OPTN
website at www.optn.org.

Version date pending

Living Donor Kidney Instructions - 1

11.

Return the original and one (1) complete paper copy of all application materials. Also provide a copy of the application
that has been scanned to a CD in PDF format. Label the CD with the Hospital name, contact name, date, and include
an electronic table of contents.

12.

Completed packets should be shipped as listed below:
Member Services
UNOS
700 North 4th Street
Richmond, VA 23219
Main Phone: 804-782-4800

Version date pending

Living Donor Kidney Instructions - 2

Kidney Transplant Program that Performs Living Donor Transplants
Part 1 - General
Application for __ Open ___Laparoscopic (Check all that apply)
1.

Answer the questions below that describe this program/proposed program.

a) Year Program to Start(ed):
Yes

b) Does/will this program perform living donor kidney
transplants in patients under age 18?
c) Is this center a stand-alone pediatric hospital? (If yes, answer
#2 below)
d) If no, is there a stand-alone pediatric facility affiliated with
this hospital? If yes, specify facility:

e) Is this program certified by Medicare?
If yes, provide the CMS provider number:________
Certification date:_________
Attach evidence of Medicare certification.

It is recognized that in the case of pediatric living donor transplantation, the living organ donation may occur at a
center that is distinct from the approved transplant center. If this program performs pediatric transplants, please list
any other hospitals where the donation may occur.
Hospital Name

Location

Part 2A - Personnel - Director(s)
1. Identify the Transplant Program Surgical and/or Medical Director(s) role in living donor kidney transplantation
(include C.V.). Briefly describe the leadership responsibilities for each individual.
Check
list

Required Supporting Documents
Current C.V.

Name

Version date pending

Date of
Appointment as
Director

Living Donor Kidney - 1

Primary Areas of Responsibility

Part 2B - Personnel –Existing Kidney Transplant Program
1. Identify the Primary Surgeon and Primary Physician for the kidney transplant program:
Role
Primary Kidney Transplant Surgeon:
Primary Kidney Transplant Physician:

Part 2C

Name

Personnel – Primary Renal Donor Surgeon – Open Nephrectomy
(The laparoscopic and open donor nephrectomy expertise may reside within the same or different individuals.)
Refer to the Bylaws for the necessary qualifications and provide the following documents:
Check
list

Question
Reference
2,C,1
2,C,1,d

2,C,1, c; e;
f;& h
2,C,1 e& i
2,C,1,f
2,C,1,g

Required Supporting Documents
Current C.V.
Letter from the Credentialing Committee of the applicant hospital stating that the
surgeon meets all requirements to be in good standing. Please provide an
explanation of any status other than active/full.
Letter from the Surgeon detailing his/her commitment to the program and
describing their previous experience/training.
ASTS Certificate in Kidney (as applicable)
Experience/Training Log (Table 1)
Log of nephrectomies (Table 2)

Name: _____________________________________________________
a)

This surgeon participates in ____ Open Nephrectomies ____ Laparoscopic Nephrectomies (Check all that apply)

b) Date of Appointment (MM/DD/YY): Facility: _____ To this position: ______
c)

Percentage of professional time spent at this facility: _______% = _____ hrs/week

d) Does individual have FULL privileges at this hospital?
_____ Yes
Provide copy of hospital credentialing letter.
_____ No
If the individual does not have full privileges, explain why and provide the date the individual will be
considered for full privileges. Also include an explanation that describes the scope of privileges.
e)

Experience/ Training
i) Qualifying by ASTS Fellowship with a certificate in Kidney
Yes
Did this individual complete an accredited ASTS Fellowship with a
certificate in Kidney?
If “Yes,” complete the questions below and provide a copy of the Certificate.
Institution:
Fellowship Program Director:
Date of training: mm/dd/yy format):
Start ________
End: ___________

Version date pending

Living Donor Kidney - 2

ii) Qualifying by Experience/Training:
Yes

Has this individual performed 10 or more open nephrectomies
(to include living donor nephrectomy, deceased donor
nephrectomy, removal of polycystic or diseased kidneys) as the
primary surgeon or first assistant, within the prior 5-year period?

f) Complete TABLE 1 (at the end of this document) summarizing this individuals training and experience. Include the
number of open nephrectomy (and laparoscopic if applicable) cases in which the individual participated as the
primary surgeon or first assistant.
g) Nephrectomy Log: Provide documentation that demonstrates that this individual has experience as the primary
surgeon or first assistant in at least 10 open nephrectomies (to include living donor nephrectomy, deceased donor
nephrectomy, and removal of polycystic or diseased kidneys) within the prior 5-year period. A blank log for
documenting open and laparoscopic living donor nephrectomies has been provided as TABLE 2 in this
application.
Documentation should include the date of the surgery, medical records identification and/or UNOS identification
number, the role of the surgeon in the operative procedure, and the type of procedure. A current Procedural
Terminology (CPT) code for the procedure is optional but recommended.
h) Describe the proposed primary donor surgeon's level of involvement in the program for which the application is
being made. If applicable, describe the surgeon's plan for coverage of transplant programs located in multiple
transplant centers.

i) Are there other individuals in the program who routinely perform open donor nephrectomies for the living donor
program?
___ Yes __ No. If yes, complete Part 2E of this application.

Version date pending

Living Donor Kidney - 3

Part 2D

Personnel – Primary Renal Donor Surgeon - Laparoscopic Nephrectomy
(The laparoscopic and open nephrectomy expertise may reside within the same or different individuals.)
Refer to the Bylaws for the necessary qualifications and provide the following documents:
Check
list

Question
Reference
2,D,1
2,D,1,d

2,D,1, c; e;
f; & h
2,D,1,g

Name: _____________________________________________________
a)

This surgeon participates in ____ Open Nephrectomies ____ Laparoscopic Nephrectomies (Check all that apply)

b) Date of Appointment (MM/DD/YY): Facility: __________ To this position: ___________
c)

Percentage of professional time spent at this facility: _______% = _____ hrs/week

Experience/Training:
Yes

Does this individual have experience as the primary surgeon or
first assistant in 15 laparoscopic nephrectomies (including
deceased donor nephrectomy, removal of polycystic or diseased
kidneys, etc.), within the prior 5-year period.

Complete TABLE 1 (within this document) summarizing this individuals training and experience. Include the
number of laparoscopic nephrectomies (and open nephrectomy if applicable) cases in which the individual participated
as the primary surgeon or first assistant.

Version date pending

Living Donor Kidney - 4

g) Nephrectomy Log: Provide documentation that demonstrates that this individual has experience as the primary
surgeon or first assistant in performing at least 15 laparoscopic nephrectomies within the prior 5-year period. A
blank log for documenting open and laparoscopic living donor nephrectomies has been provided as TABLE 2 in
this application (duplicate as necessary).
Documentation should include the date of the surgery, medical records identification and/or UNOS identification
number, the role of the surgeon in the operative procedure, and the type of procedure. A current Procedural
Terminology (CPT) code for the procedure is optional but recommended. It is recognized that in the case of
pediatric kidney donor transplantation, the live organ donation may occur at a center that is distinct from the
approved transplant center.
h) Describe the proposed primary donor surgeon's level of involvement in the program for which the application is
being made. If applicable, describe the surgeon's plan for coverage of transplant programs located in multiple
transplant centers.

Conversion Coverage Plan: If the open and laparoscopic expertise resides within different individuals, then the
program must document how both individuals will be available to the surgical team. Describe how the center will
handle surgical decisions and coverage for the laparoscopic to open conversion.

Are there other individuals in the program who also perform laparoscopic nephrectomies for the living donor
program?
___ Yes __ No. If yes, complete Part 2E of this application:

Version date pending

Living Donor Kidney - 5

Part 2E

Personnel – Renal Donor Surgeons
Open and Laparoscopic Donor Nephrectomy Surgeons: Complete this section for each surgeon, other than
the designated primary(ies), who will be performing live donor nephrectomies at this center. Provide the
following documents:
Check
list

Question
Reference
2,E,1
2,E,1,d

2,E,1,c;e; &
f

Name: _____________________________________________________
a)

This surgeon participates in ____ Open Nephrectomies ____ Laparoscopic Nephrectomies (Check all that apply)

b) Date of Appointment (MM/DD/YY): Facility: _____
c)

To this position: ______

Percentage of professional time spent at this facility: _______% = _____ hrs/week

d) Does individual have FULL privileges at this hospital?
_____ Yes
Provide copy of hospital credentialing letter.
_____ No
If the individual does not have full privileges, explain why and provide the date the
individual will be considered for full privileges. Also, include an explanation that describes the
scope of privileges.

e) Complete TABLE 1 (at the end of this document) summarizing this individuals training and experience. Include the
number of open nephrectomy and laparoscopic cases in which the individual participated as the primary surgeon or
first assistant.

Describe the donor surgeon's level of involvement in the program for which the application is being made.

Version date pending

Living Donor Kidney - 6

Part 2F- Other Staff and Resources
1.

How does the center assess that the short and long term risks for the potential live donor are acceptable to the medical staff at
the transplant center and the donor? Response needs to address the following: evaluation, consent, surgical risk, and long-term
donor considerations for being made uninephric.

Mental Health and Social Support Services: Identify the designated members of the transplant team who have primary
responsibility for coordinating the psychosocial needs of living donors. Describe their role in this process (expand rows as
needed).

Name

Role in Providing Support to Living Donors

Does the program have the ability to perform a psychosocial assessment of the donor to
• make an informed decision?
• affirm voluntary nature of proceeding with the evaluation and donation?

Yes ____
Yes ____

No ____
No ____

Describe how the program meets the requirement for having an Independent Donor Advocate (IDA) who is not involved with
the potential recipient evaluation and is independent of the decision to transplant the potential recipient.

Version date pending

Living Donor Kidney - 7

Part 3 - Protocols:
1.

Kidney transplant programs that perform living donor kidney transplants must demonstrate that they have the following
listed below. Submission of protocols is not required as a part of this application.
Written protocols must address at a minimum the areas listed below:

Included in
Protocol?
Yes

Protocols addressing all phases of living donation process:
• Evaluation
• Pre-operative
• Operative
• Post-operative care
• Submission of follow up forms.
IDA – descriptions of duties and responsibilities:
Include the following elements:
• promotes the best interests of the potential living donor;
• advocates the rights of the potential living donor; and
• assists the potential donor in obtaining and understanding information regarding
the consent process; evaluation process; surgical procedure; and benefit and need
for follow-up.
Medical Evaluation by a physician and/or surgeon experienced in living donation to assess
and minimize risks to the potential donor post-donation, which shall include a screen for
any evidence of occult renal and infectious disease and medical co-morbidities, which
may cause renal disease.
Psychosocial Evaluation of the potential living donor by a psychiatrist, psychologist, or
social worker with experience in transplantation to
• determine decision making capacity,
• screen for any pre-existing psychiatric illness, and
• evaluate any potential coercion.
Screening for evidence of transmissible diseases such as cancers and infections; and
Anatomic assessment of the suitability of the organ for transplant purposes.
Informed Consent for Donor Evaluation Process and Donor Nephrectomy:
• discussion of the potential risks of the procedure including the medical,
psychological, and financial risks associated with being a living donor;
• assurance that all communication between the potential donor and the transplant
center will remain confidential;
• discussion of the potential donor’s right to opt out at any time during the donation
process;
• discussion that the medical evaluation or donation may impact the potential donor’s
ability to obtain health, life, and disability insurance; and

Version date pending

Living Donor Kidney - 8

Written protocols must address at a minimum the areas listed below:

Included in
Protocol?
Yes

• disclosure by the transplant center that it is required, at a minimum, to submit Living
Donor Follow-up forms addressing the health information of each living donor at 6
months, one-year, and two-year post donation. The protocol must include a plan to
collect the information about each donor.

How will the center assess its compliance with each protocol listed above?

Version date pending

Living Donor Kidney - 9

PART 4: Certification of Investigation
The Bylaws state that “Each primary surgeon or primary physician, listed on the application as a part of the plan for who
shares coverage responsibility, shall submit an assessment, subject to medical peer review confidentiality requirements and
which follows guidelines provided in the application and is satisfactory to the MPSC, of all physicians and surgeons
participating in the program regarding their involvement in prior transgressions of UNOS requirements and plans to ensure
that the improper conduct is not continued.” (Emphasis Added)
a)

This hospital has conducted its own peer review of all surgeons and physicians listed below to ensure compliance
with applicable OPTN/UNOS Bylaws.

Names of Surgeons*

Names of Physicians*

b) If prior transgressions were identified has the hospital developed a plan to ensure that the improper conduct is not
continued?
____ Yes
___ No
___ Not Applicable

c) What steps will be/were taken to correct the prior improper conduct or to ensure the improper conduct is not repeated
in this program? Provide a copy of the plan.

I certify that this review was performed for each named surgeon and physician according to the hospital’s peer
review procedures.
Signature of Primary Surgeon:

Date:

Print name:
Signature of Primary Physician:

Date:

Print name:
* Additional rows may be added as necessary.

Version date pending

Living Donor Kidney - 10

Part 5 - OPTN Staffing Report

KIDNEY TRANSPLANT PROGRAM – LIVING DONOR STAFF

Member Code:

Name of Hospital:

Main Program Phone Number:

Main Program Fax Number:

Toll Free Phone numbers for Patients:

Hospital #
Program #:

Hospital URL: http://www

Identify the Medical and/or Surgical Director(s) of this transplant program:
Name

Address

Phone

Fax

Phone

Fax

The donor surgeons who participate in this transplant program are:
Name

Version date pending

Address

Living Donor Kidney - 11

Identify the Hospital Administrative Director/Manager who will provide oversight to this transplant program. Use an * to indicate which individual will serve as the primary
Transplant Administrator if more than one.
Name

Address

Phone

Fax

Phone

Fax

List the clinical transplant coordinators who participate in the care of the living donor:
Name

Address

List the data coordinators for this transplant program below. Use an * to indicate which individual will serve as the primary data coordinator.
Name

Version date pending

Address

Living Donor Kidney - 12

Phone

Fax

List the Independent Donor Advocate(s) (IDA) who participate in the care of the living donor:
Name

Address

Phone

Fax

Identify the Social Worker(s) and other Mental Health Professionals who will be prominently involved in the care of the living donor:
Name

Version date pending

Address

Living Donor Kidney - 13

Phone

Fax

TABLE 1 – Open and Laparoscopic Nephrectomies
SUMMARY OF EXPERIENCE AND TRAINING FOR DR. ________________________________
List each institution on a separate row.
This summary must document (at a minimum) that the individual:
1) performed no fewer than 10 open nephrectomies (to include living donor nephrectomy, deceased donor nephrectomy, and removal of polycystic or diseased kidneys)
as primary surgeon or first assistant within the prior 5-year period; and/or
2) acted as primary surgeon or first assistant in performing no fewer than 15 laparoscopic nephrectomies within the prior 5-year period.
Periods of training and post-fellowship experience must be listed on separate rows.

Date
From
To
mm/dd/yy

Institution

Program Director

The numbers entered above should be validated by the attached log.
Insert additional rows as needed.
Version date pending

Living Donor Kidney - 14

#
Open
Nephrectomies
as
Primary

#
Open
Nephrectomies
as 1st
Assistant

#
Laparoscopic
Nephrectomies
as
Primary

#
Laparoscopic
Nephrectomies
as 1st
Assistant

TABLE 2
Nephrectomy Log (Sample)
(Header should include the following information. Cases should be listed by type, then date order)
Application Type:

____ Open

___ Laparoscopic (Check all that apply)

Name of Proposed Primary Donor Surgeon:
Name of transplant center where he/she was
working when the nephrectomies were
performed:

This log must document (at a minimum) that the individual:
1) performed at least 10 open nephrectomies (to include living donor nephrectomy, deceased donor nephrectomy, and
removal of polycystic or diseased kidneys) as primary surgeon or first assistant within the prior 5-year period; and/or
2) acted as primary surgeon or first assistant in performing at least 15 laparoscopic nephrectomies within the prior 5-year
period.
Applicable CPT codes are listed on the next page.
#

Date of
Nephrectomy

Donor ID
Number

Nephrectomy site
(hospital)

Procedure
(Check Type)
Open

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Insert additional rows as needed.

Version date pending

Living Donor Kidney - 15

Laparoscopic

CPT Code
(Optional)

Applicable CPT Codes

Open Donor Nephrectomy:
50220
Remove kidney, open
50225
Removal kidney open, complex
50230
Removal kidney open, radical
50234
Removal of kidney &total ureter and bladder cuff, through same incision
50236
Removal of kidney & ureter through separate incision
50300
Removal of donor kidney (Cadaver donor, unilateral or bilateral)
50320
Removal of donor kidney (open)
50340
Removal of recipient kidney
Laparoscopic Nephrectomy:
50545
Laparo radical nephrectomy (includes removal of Gerota's fascia and surrounding fatty tissue,
removal of regional lymph nodes, and adrenalectomy)
50546
Laparoscopic nephrectomy including partial ureterectomy
50547
Laparo removal donor kidney (including cold preservation), from living donor
50549
Laparoscope proc, renal

Version date pending

Living Donor Kidney - 16

File Type	application/pdf
File Title	Microsoft Word - A10_LDK_TX_program_appl_initial only.doc
Author	aungiesh
File Modified	2007-11-11
File Created	2007-11-11