0

Pancreas Islet Cell Transplant Program
Part 3: Facilities
This section must be completed when applying for a new program or reactivating an existing program.
1.

Does this hospital presently have an OPTN approved pancreas transplant program?
___ Yes
___ No. If No, Part 7 of this application will need to be completed.

2.

Year Islet Cell Transplant Program to Start (or started):______________

3.

Provide the following required documents:
Check
list

Required Supporting Documents

Documentation that verifies that the program has adequate clinical and laboratory facilities for
pancreatic islet transplantation as defined by the current regulations provided by the Food and
Drug Administration (FDA)
Copy of the center’s IND application form (2 pages) and a copy of the letter from the FDA
that verifies receipt of the application
Copy of written documentation provided by the FDA that confirms the active status of the IND
(if received by center at the time of OPTN application submission)
Letter of agreement or contract with the center’s OPO that specifically indicates it will provide
the pancreas for islet cell transplantation
4.

Islet Isolation – Pancreatic islets must be isolated in a facility with an FDA Investigational New Drug (IND)
application in effect, with documented collaboration between the program and such facility. Provide a description of
how this criterion is being met.

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Islet - 1

PART 4: Personnel
PART 4A: Personnel – Transplant Program Director(s)
1.

Identify the Transplant Program Surgical and/or Medical Director(s) of the islet cell transplant program (include
C.V.). Briefly describe the leadership responsibilities for each.
Check
list

Question
Reference
4A 1

Name

Required Supporting Documents
Current C.V.

Date of
Appointment

Primary areas of responsibility

PART 4B, Section 1: Personnel – Surgical – Primary Surgeon
1.

Primary Islet Cell Transplant Surgeon. Refer to the Bylaws for the necessary qualifications and more specific
descriptions of the required supporting documents listed below.
Check
list

Question
Reference
4B 1a
4B 1c
4B 1d,g,h
4B 1g
4B 1g
4B 1h
4B 1h
4B
5a

a)

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 transplant
experience/training.
Formal Training: A letter from the training director verifying that the fellow has met the requirements
Formal Training: A log (See Tables 1 & 2) of the transplant and procurement procedures.
Transplant Experience: A letter from the program director verifying that the individual has met the
requirements
Transplant Experience: A log (See Tables 1 & 2) of the transplant and procurement procedures.
Other Letters of Recommendation (Reference)
Letter(s) of recommendation from person(s) named as primary surgeon and program director attesting
to the individual’s overall qualifications to act as primary surgeon and addressing the individual’s
personal integrity, honesty, familiarity with and experience in adhering to OPTN requirements and
compliance protocols, and other matters as deemed appropriate.

Name: _____________________________________________________

b) Is this individual presently designated as the OPTN primary pancreas transplant surgeon for the pancreas
transplant program? ______ Yes ______ No.
• If Yes, supply the first 3 documents and the final document in the checklist above and answer question
“i”.
• If no, complete questions “c”-“k”.

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c)

Date of Appointment (MM/DD/YY): Facility: __________ To this position: ___________
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. Include an explanation that
describes the scope of privileges.

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

List other hospitals, health care facilities, and medical group practices and percentage of professional time
spent on site at each:

Facility

f)

Type

Board certification type(s) or equivalent. If board certification is pending, indicate the date the exam has
been scheduled. If individual has been recertified, please use that date.

Certification Type

Version date pending

Location (City, State)

% Professional
Time Spent On
Site

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Effective Date
(MM/DD/YY)

Certification Number

g) Formal Training: List the name of the institution(s) in which pancreas, kidney/pancreas and/or islet cell transplant training (fellowship) was received,
including the Program Director(s) names, applicable dates, and the number of transplant and procurement procedures performed. Refer to the Bylaws for the
necessary qualifications and descriptions of the required supporting documents listed below unless the individual meets the pathway for post-fellowship
experience as described in the requirements:
•
•

A letter from program director verifying that the fellow has met the requirements.
A log (See Tables 1 & 2) of the transplant and procurement procedures. The log should include a patient identifier/OPTN ID Number, transplant/procurement date and
the surgeon’s role in the procedure (i.e., primary or 1st assistant). These logs must be signed by the director of the training program.

Date
From – To
MM/DD/YY
_______ to
_______

Institution

Program
Director

# Transplants as Primary
PA

KP

IS

# Transplants First Assisted
PA

KP

IS

# of
Procurements
PA

KP

_______ to
_______

h) Transplant Experience (Post fellowship):
List the name of the institution(s), applicable dates, and number of pancreas, kidney/pancreas and/or islet cell transplant and procurement procedures
performed by the individual at each institution. Refer to the Bylaws for the necessary qualifications and descriptions of the required supporting documents
listed below.
•
•

Letter(s) of reference from the program director(s) listed below.
A log (See Tables 1 & 2) of the transplant and procurement procedures. The log should include a patient identifier/OPTN ID Number, transplant/procurement date and the
surgeon’s role in the procedure (i.e., primary or 1st assistant).
The transplant log(s) should be signed by the program director, division chief, or department chair from the program where the experience was gained.

Date
From – To
MM/DD/YY

Version date pending

Institution

Islet - 4

Program
Director

# Transplants as Primary
PA

KP

IS

# Transplants First Assisted
PA

KP

IS

# of
Procurements
PA

KP

i)

Summarize how the surgeon's experience fulfills the membership criteria.
(Check all that apply)
Membership Criteria
1. On site
2. Certified by the American Board of Surgery, Urology or the equivalent
3. Two Year Transplant Fellowship
a. Primary surgeon or 1st assistant on at least 15 pancreas transplants
b. Primary surgeon or 1st assistant on at least 10 pancreas procurement procedures
c. Involved in all levels of pre-, peri-, and post-operative patient care within the last 2 years
d. Training program approved by the Education Committee of the American Society of
Transplant Surgeons or UNOS
4. Experience (Post Fellowship)
a. Primary surgeon or 1st assistant on 20 or more pancreas transplants over a minimum of 2
years and a maximum of 5 years
b. Primary surgeon or 1st assistant on 10 or more pancreas procurement procedures
c. Involved in all levels of pre-, peri-, and post-operative patient care within the last 2 years
5. Pediatric Pathway
a. Program serves predominantly Pediatric Patients
b. Individual has maintained current working knowledge in all aspects of pancreas
transplantation and patient care within the last 2 years
c. Center has petitioned the Membership and Professional Standards Committee for approval
under this pathway
d. A preliminary interview before the Membership and Professional Standards Committee
shall be required

j)

Yes

Describe in detail the proposed primary surgeon's level of involvement in this transplant program, and if
applicable, describe the surgeon's plan for coverage of transplant programs located in multiple transplant
centers. (Expand rows below as necessary).
Describe Level of Involvement
Management of Patients
with Diabetes Mellitus
Recipient Selection
Donor Selection
Histocompatibility and
Tissue Typing
Transplant Surgery
Immediate Post-Operative
and Continuing Inpatient
Care
Post-Operative
Immunosuppressive
Therapy
Differential Diagnosis of
Pancreatic Dysfunction in
the Allograft Recipient
Histologic Interpretation of
Allograft Biopsies
Interpretation of Ancillary
Tests for Pancreatic
Dysfunction
Long-Term Outpatient
Follow-up

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Describe Level of Involvement
Coverage of Multiple
Transplant Centers (if
applicable)
Additional Information:

k) Describe the proposed primary surgeon's transplant training and experience in the areas listed below. (Expand
rows below as necessary).
Describe Training/Experience
Management of Patients
with Diabetes Mellitus
Recipient Selection
Donor Selection
Histocompatibility and
Tissue Typing
Transplant Surgery
Immediate Post-Operative
and Continuing Inpatient
Care
Post-Operative
Immunosuppressive
Therapy
Differential Diagnosis of
Pancreatic Dysfunction in
the Allograft Recipient
Histologic Interpretation of
Allograft Biopsies
Interpretation of Ancillary
Tests for Pancreatic
Dysfunction
Long-Term Outpatient
Follow-up
Additional Information:

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Additional Instructions for PART 4B, Section 2: Personnel – Surgical
Complete this section of the application to describe the involvement, training, and experience of any other
surgeons participating in the program. Surgeons must be designated as Additional or Other as described
below.
The Bylaws provide the following definition of Additional Transplant Surgeon:
Additional Transplant Surgeons must be credentialed by the institution to provide transplant services and be
able to independently manage the care of transplant patients including performing the transplant operation
and procurement procedures.
Surgeons that also support this program but who do not meet the definition of “primary” or additional,” should
complete this section as well. The type should be indicated as “other.”
Duplicate pages as needed.

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PART 4B, Section 2: Personnel – Surgical
2.

List Additional/Other Surgeons (duplicate this section as needed). Provide the attachments listed below:
Check
list

Question
Reference
4B 2a
4B 2b

4B 2c,e,f

a)

Required Supporting Documents
Current C.V.
A 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.
A letter from the Surgeon detailing his/her commitment to the program and level
of involvement in substantive patient care.

Name: _____________________________________________________________
For Pancreas Islet Cell transplantation this individual is classified as (Check only one)
___
Additional Surgeon
___
Other Surgeon

b) Date of appointment (MM/DD/YY) at this Facility: ____________

To this Program: _________

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. Include an explanation that
describes the scope of privileges.

c)

Percentage of professional time spent on site: _______% = _____ hrs/week

d) Board certification type(s) or equivalent. If board certification is pending, indicate the date the exam has been
scheduled. If individual has been recertified, please use that date.

Certification Type

Version date pending

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Effective Date
(MM/DD/YY)

Certification Number

e) Training (Fellowship): List the name of the institution(s) in which pancreas, kidney/pancreas and/or islet cell transplant training (fellowship) was received
including Program Director(s) names, applicable dates, and the number of transplant and procurement procedures the individual performed.
Date
From – To
MM/DD/YY

f)

Institution

Program
Director

# Transplants as
Primary
PA

KP

# Transplants
First Assisted
IS

PA

KP

# Procurements
IS

PA

KP

Transplant Experience (Post fellowship): List the name of the institution(s), Program Director(s), applicable dates, and number of pancreas, kidney/pancreas
and/or islet cell transplant and procurement procedures performed by the individual at each institution.
Date
From – To
MM/DD/YY

Version date pending

Institution

Islet - 9

Program
Director

# Transplants as
Primary
PA

KP

# Transplants
First Assisted
IS

PA

KP

# Procurements
IS

PA

KP

g) Describe the surgeon's level of involvement in this pancreas islet transplant program in the areas listed below.
(Expand rows as necessary)
Describe Level of Involvement
Management of Patients
with Diabetes Mellitus
Recipient Selection
Donor Selection
Histocompatibility and
Tissue Typing
Transplant Surgery
Immediate Post-Operative
and Continuing Inpatient
Care
Post-Operative
Immunosuppressive
Therapy
Differential Diagnosis of
Pancreatic Dysfunction in
the Allograft Recipient
Histologic Interpretation of
Allograft Biopsies
Interpretation of Ancillary
Tests for Pancreatic
Dysfunction
Long-Term Outpatient
Follow-up
Additional Information:

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h) Describe the surgeon's pancreas islet transplant training and experience in the areas listed below. (Expand rows as
necessary)

Describe Training/Experience
Management of Patients
with Diabetes Mellitus
Recipient Selection
Donor Selection
Histocompatibility and
Tissue Typing
Transplant Surgery
Immediate Post-Operative
and Continuing Inpatient
Care
Post-Operative
Immunosuppressive
Therapy
Differential Diagnosis of
Pancreatic Dysfunction in
the Allograft Recipient
Histologic Interpretation of
Allograft Biopsies
Interpretation of Ancillary
Tests for Pancreatic
Dysfunction
Long-Term Outpatient
Follow-up
Additional Information:

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PART 4C, Section 1: Personnel – Medical – Primary Physician
1.

Primary Islet Cell Transplant Physician. Refer to the Bylaws for necessary qualifications. Provide the
attachments listed below.
Check
list

Question
Reference
4C 1a
4C 1c
4C
1d,g,h
4C 1g
4C 1g
4C 1g
4C 1h
4C 1h
4C

5a

Required Supporting Documents
Current C.V.
Letter from the Credentialing Committee of the applicant hospital stating that the physician meets
all requirements to be in good standing. Please provide an explanation of any status other than
active/full.
Letter from the Physician detailing his/her commitment to the program; level of involvement with
substantive patient care; and summarizing their previous transplant experience.
Formal Training: A letter from training director verifying that the fellow has met the requirements
Formal Training: A letter from supervising qualified pancreas transplant physician verifying that the
fellow has met the requirements
Formal Training: A log (See Table 3) of the transplant recipients followed.
Transplant Experience: A letter from qualified transplant physician and/or pancreas transplant
surgeon directly involved with the individual verifying that the individual has met the requirements
Transplant Experience: A log (See Table 3) of the transplant recipients followed.
Other Letters of Recommendation (Reference)
Letter(s) of recommendation from person(s) named as primary physician and program director
attesting to the individual’s overall qualifications to act as primary physician and addressing the
individual’s personal integrity, honesty, familiarity with and experience in adhering to OPTN
requirements and compliance protocols, and other matters as deemed appropriate

a) Name:______________________________________________________________
b) Is this individual presently designated as the OPTN primary pancreas transplant physician for the pancreas
transplant program? ______ Yes ______ No.
• If Yes, supply the first 3 documents and the final document requested above and answer question “j”.
• If no, complete questions “c” – “l”.
c)

Date of Appointment (MM/DD/YY): Facility: __________ To this position: ___________
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. Include an explanation that
describes the scope of privileges.

d) Percentage of professional time on site: _______% = _____ hrs/week
e)

List below other hospitals, health care facilities, and medical group practices and percentage of
professional time spent on site at each facility:

Facility

Version date pending

Type

Islet - 12

Location (City, State)

% Professional
Time Spent On
Site

f)

Board certification type (s) or equivalent. If board certification is pending, indicate the date the exam has
been scheduled. If individual has been recertified, please use that date.

Certification Type

Version date pending

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Effective Date
(MM/DD/YY)

Certification Number

g) Training (Fellowship): List the program(s) in which pancreas, kidney/pancreas, and/or islet cell transplant training was received, including name of institution(s),
Program Director(s) names, applicable dates, and the number of transplant patients for whom the physician provided substantive patient care (pre-, peri- and postoperatively from the time of transplant).
Refer to the Bylaws for the necessary qualifications and descriptions of the required supporting documents listed below unless the individual meets the pathway for post
fellowship experience as described in the requirements.
•
•

Letters from the Director of fellowship training program and the supervising qualified pancreas transplant physician verifying that the fellow has met the requirements.
A recipient log (See Table 3) that includes the date of transplant, the patient’s medical record and/or OPTN ID number. This log must be signed by the director of the training
program and/or primary transplant physician at that transplant program.

Date
From To
mm/dd/yy

Institution

Program Director

# Pancreas Patients
Followed
Pre
Peri
Post

# Kidney/Pancreas
Patients Followed
Pre
Peri
Post

# Islet Patients
Followed
Pre
Peri
Post

h) Experience (Post fellowship only): List the name of the institution(s), Program Director(s), applicable dates, and number of pancreas, kidney/pancreas, and/or islet cell
transplants performed at the institution for whom the Transplant Physician accepted primary responsibility for substantive patient care (pre-, peri-, and post-operatively
from the time of transplant). Refer to the Bylaws for the necessary qualifications and descriptions of the required supporting documents listed below.
•
•

Supporting letter(s) from the qualified transplant physician and/or the pancreas transplant surgeon who has been directly involved with the individual
A recipient log (See Table 3) that includes the date of transplant, the patient’s name and/or OPTN ID number. This log should be signed by the program director, division chief, or
department chair from the program where the experience was gained.

Date
From To
mm/dd/yy

Version date pending

Institution

Islet - 14

Program Director

# Pancreas Patients
Followed
Pre
Peri
Post

# Kidney/Pancreas
Patients Followed
Pre
Peri
Post

# Islet Patients
Followed
Pre
Peri
Post

i)

Training/Experience. Describe how the physician fulfills the requirements for participation as an observer in three
organ procurements and three pancreas transplants, as well as observing the evaluation of the donor and donor
process, and management of at least 3 multiple organ donors that include the pancreas.
•

•

Provide a log (See Table 4) of these cases that includes the date of procurement, medical record ID number and/or OPTN ID
number, and the location of the donor.
If these requirements have not been met, submit a plan explaining how the individual will fulfill them.

Date
From To
mm/dd/yy

j)

Institution

# of PA
Procurements
Observed

# of PA
Transplants
Observed

# of PA Donors/
Donor Process

# of Multi-Organ
Donors Observed
Mgmt.

Summarize how the Transplant Physician's experience fulfills the membership criteria for membership.
(Check all that apply)

Membership Criteria
1. On site
2. M.D., D.O. or equivalent degree
3. Certified by the American Board of Internal Medicine, Pediatrics or the equivalent in:
a. Nephrology
b. Endocrinology
c. Diabetology
4. Achieved eligibility in:
a. Nephrology
b. Endocrinology
c. Diabetology
5. Direct involvement in pancreas transplant patient care within the last 2 years
6. One year of specialized training in pancreas transplantation during fellowship
a. Involved in primary care of 8 or more pancreas transplant recipients for a minimum of 3
months from the time of their transplant
b. Observed 3 procurement procedures and 3 pancreas transplants
c. Observed the evaluation of the donor and donor process, and management of at least 3
multiple organ donors which include the pancreas
d. Fellowship training program accredited by the RRC-IM
7. 12-month Transplant Medicine Fellowship
a. Involved in primary care of 8 or more pancreas transplant recipients for a minimum of 3
months from the time of their transplant
b. Observed 3 procurement procedures and 3 pancreas transplants
c. Observed the evaluation of the donor and donor process, and management of at least 3
multiple organ donors which include the pancreas
d. Didactic curriculum approved by the RRC-IM
8. Experience in pancreas transplantation
a. 2-5 years experience on an active pancreas transplant service
b. Involved in primary care of 15 or more pancreas transplant recipients for a minimum of 3
months from the time of their transplant
c. Observed 3 procurement procedures and 3 pancreas transplants
d. Observed the evaluation of the donor and donor process, and management of at least 3
multiple organ donors which include the pancreas
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Islet - 15

Yes

Membership Criteria

Yes

9. Pediatric Pathway
a. Program serves predominantly pediatric patients
b. Individual has maintained current working knowledge in all aspects of pancreas
transplantation and patient care within the last 2 years.
c. Center has petitioned the Membership and Professional Standards Committee for
approval under this pathway
d. A preliminary interview before the Committee shall be required
10. Conditional Pathway – Only available to Existing Programs
a. Qualifying by virtue of training
i. Involved in the primary care of 5 or more pancreas transplant recipients for a
minimum of 3 months from the time of their transplant
b. Qualifying by virtue of acquired clinical experience
i. Involved in the primary care of eight or more pancreas transplant recipients for a
minimum of 3 months from the time of their transplant
ii. Has acquired experience equal to 12 months on an active pancreas transplant service
over a maximum of 2 years
c. Consulting relationship established with counterparts at another UNOS member
transplant center approved for pancreas transplantation (include letter of support)

k) Describe in detail the proposed primary transplant physician's involvement in the management of patients in this
program and, if applicable, their plan for coverage of multiple transplant centers. (Expand rows as necessary).

Areas of Involvement in This Program
Management of Patients with End Stage
Pancreas Disease
Candidate Evaluation Process
Donor Selection
Recipient Selection
Histocompatibility and Tissue Typing
Immediate Post-Operative Patient Care
Post-Operative Immunosuppressive Therapy
Differential Diagnosis of Pancreas Dysfunction
in the Allograft Recipient
Histologic Interpretation of Allograft Biopsies
Interpretation of Ancillary Tests for Pancreas
Dysfunction
Long-term Outpatient Follow-up
Coverage of Multiple Transplant Centers
Additional Information

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Islet - 16

Description

l)

Describe the proposed primary physician's transplant training and experience in the areas listed below.
(Expand rows as necessary)
Training and Experience

Description of Individual’s current working
knowledge in the these areas

Management of Patients with End Stage
Pancreas Disease
Candidate Evaluation Process
Donor Selection
Recipient Selection
Histocompatibility and Tissue Typing
Immediate Post-Operative Patient Care
Post-Operative Immunosuppressive Therapy
Differential Diagnosis of Pancreas Dysfunction
in the Allograft Recipient
Histologic Interpretation of Allograft Biopsies
Interpretation of Ancillary Tests for Pancreas
Dysfunction
Long-term Outpatient Follow-up
Additional Information

Version date pending

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Additional Instructions for PART 4C, Section 2: Personnel – Physicians
Complete this section of the application to describe the involvement, training, and experience of other physicians
associated with the program. Physicians must be designated as Additional or Other as described below.
The Bylaws provide the following definition of Additional Transplant Physician:
Additional Transplant Physicians must be credentialed by the institution to provide transplant services and be
able to independently manage the care of transplant patients.
Physicians that also support this program but who do not meet the definition of “primary” or “additional,” should
complete this section of the application. The type should be indicated as “other.”
Duplicate pages as needed

Version date pending

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PART 4C, Section 2: Personnel – Physicians
2.

List Additional/Other Physicians (Duplicate this section as needed). Refer to the Bylaws for the necessary
qualifications and descriptions of the required supporting documents listed below.
Check
list

Question
Reference

Required Supporting Documents

4C 2a

Current C.V.

4C 2b

A letter from the Credentialing Committee of the applicant hospital stating that the
physician meets all requirements to be in good standing. Please provide an
explanation of any status other than active/full.
A letter from the Physician detailing his/her commitment to the program and level
of involvement in substantive patient care.

4C 2c,e,f

a)

Name: _____________________________________________________
For Pancreas Islet Cell transplantation this individual is classified as (Check only one)
___
Additional Surgeon
___
Other Surgeon

b) Date of Appointment (MM/DD/YY): Facility: __________ To this position: ___________
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. Include an explanation that
describes the scope of privileges.
c)

Percentage of professional time spent on site: _______% = _____ hrs/week

d) Board certification type(s) or equivalent. If board certification is pending, indicate the date the exam has been
scheduled. If individual has been recertified, please use that date.

Certification Type

Version date pending

Islet - 19

Effective Date
(MM/DD/YY)

Certification Number

e)

Training (Fellowship): List the program(s) in which pancreas, kidney/pancreas, and/or islet cell transplant training was received, including name of
institution(s), Program Director(s) names, applicable dates, and the number of transplant patients for which the physician provided substantive patient care (pre-,
peri- and post-operatively from the time of transplant).
Date
From To
mm/dd/yy

f)

Institution

Program Director

# Pancreas
Patients Followed
Pre
Peri
Post

# Kidney/Pancreas
Patients Followed
Pre
Peri
Post

# Islet
Patients Followed
Pre
Peri
Post

Transplant Experience (Post fellowship only): List the name of the institution(s), Program Director(s), applicable dates, and number of pancreas, kidney/pancreas,
and/or islet cell transplants performed at the institution for whom the Transplant Physician accepted primary responsibility for substantive patient care (pre-, peri-, and
post-operatively from the time of transplant).
Date
From To
mm/dd/yy

Version date pending

Institution

Islet - 20

Program Director

# Pancreas
Patients Followed
Pre
Peri
Post

# Kidney/Pancreas
Patients Followed
Pre
Peri
Post

# Islet
Patients Followed
Pre
Peri
Post

g) Describe in detail the transplant physician’s involvement in this islet cell transplant program. (Expand rows as
necessary)
Areas of Involvement in this program

Description

Management of Patients with End Stage
Pancreas Disease
Candidate Evaluation Process
Donor Selection
Recipient Selection
Histocompatibility and Tissue Typing
Immediate Post-Operative Patient Care
Post-Operative Immunosuppressive Therapy
Differential Diagnosis of Pancreas Dysfunction
in the Allograft Recipient
Histologic Interpretation of Allograft Biopsies
Interpretation of Ancillary Tests for Pancreas
Dysfunction
Long-term Outpatient Follow-up
Additional Information

h) Describe the physician’s transplant training and experience in the role of transplant patient management in the
areas listed below. (Expand rows as necessary).
Training and Experience

Description

Management of Patients with End Stage
Pancreas Disease
Candidate Evaluation Process
Donor Selection
Recipient Selection
Histocompatibility and Tissue Typing
Immediate Post-Operative Patient Care
Post-Operative Immunosuppressive Therapy
Differential Diagnosis of Pancreas Dysfunction
in the Allograft Recipient
Histologic Interpretation of Allograft Biopsies
Interpretation of Ancillary Tests for Pancreas
Dysfunction
Long-term Outpatient Follow-up
Additional Information
Version date pending

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Version date pending

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PART 5: 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:
* Expand rows as needed.
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Part 6: Supporting Personnel
1.

Provide documentation that verifies that the program has a collaborative relationship with a physician qualified to cannulate
the portal system under direction of the transplant surgeon.
Name of designated physician: __________________________________________________
Provide the following supporting documentation:
Check
list

Required Supporting Documents
Current C.V.

A letter from the Credentialing Committee of the applicant hospital that states that
the physician is qualified to perform this procedure and has privileges to practice in
this hospital. Please provide an explanation of any status other than active/full.
A letter from the physician detailing his/her level of commitment to the program.

2.

Describe the program’s access to the personnel listed below. Include the individual’s name, and if they are on site or not.
(Adequate access is defined by an agreement of affiliation with counterparts at another institution who employ
individuals with the expertise described below). Provide a letter of commitment/support from each individual listed.
a)

Board-certified endocrinologist
Name: __________________________________________________
Percentage of time on site: ___________________________________
Provide the following supporting documentation:
Check
list

Required Supporting Documents
Current C.V.

A letter from the Credentialing Committee of the applicant hospital that indicates
if the physician has privileges to practice in this hospital. Please provide an
explanation of any status other than active/full.
A letter from the physician detailing his/her level of commitment to the program and
involvement with substantive patient care.

b) A physician, administrator, or technician with experience in compliance with FDA regulations.
Name: __________________________________________________
Percentage of time on site: ___________________________________
Provide the following supporting documentation:
Check
list

Required Supporting Documents
Current C.V.

A letter from the physician detailing his/her level of commitment and experience.

Version date pending

Islet - 24

c) A laboratory-based researcher with experience in pancreatic islet isolation and transplantation.
Name: __________________________________________________
Percentage of time on site: ___________________________________
Provide the following supporting documentation:
Check
list

Required Supporting Documents
Current C.V.

A letter from the physician detailing his/her level of commitment and experience.

Version date pending

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Part 7: Programs not Located at an Approved Pancreas Transplant Center
A program that meets all requirements for a pancreatic islet transplant program set forth in the Bylaws, including, without limitation,
requirements applicable generally for membership and without regard to organ specificity, with the sole exception that the program is
not located at a medical center approved under the Bylaws to perform whole pancreas transplantation, may nevertheless qualify as a
pancreatic islet transplant program.
A preliminary interview with the Membership and Professional Standards Committee is required for programs seeking
approval under this pathway.
Please provide the following additional documentation to demonstrate that this program can qualify for approval under this pathway.
1.

Provide documentation of an affiliation relationship with an OPTN approved pancreas transplant program, including on
site admitting privileges at this applicant hospital for the primary whole pancreas transplant surgeon and physician.
a)

Name of Affiliated Center: ____________________________________________________

b) Name of designated surgeon: __________________________________________________
Percentage of time on site: _______________
Provide the following supporting documentation for this surgeon:
Check
list

Required Supporting Documents
Current C.V.

A letter from the Credentialing Committee of the applicant hospital that states that
the surgeon has on site admitting privileges. Please provide an explanation of any
status other than active/full.
A letter from the surgeon detailing his/her level of commitment to the program and
involvement with substantive patient care.

c)

Name of designated physician: _________________________________________________
Percentage of time on site: ______________
Provide the following supporting documentation:
Check
list

Required Supporting Documents
Current C.V.

A letter from the Credentialing Committee of the applicant hospital that states that
the physician has on site admitting privileges. Please provide an explanation of any
status other than active/full.
A letter from the physician detailing his/her level of commitment to the program and
involvement with substantive patient care.

Version date pending

Islet - 26

2.

Provide documentation that demonstrates the availability of qualified personnel to address pre-, peri-, and post-operative
care issues regardless of the treatment option ultimately selected.

3.

Provide a copy of the written protocols that demonstrate the program’s commitment and ability to counsel patients
regarding all their options for appropriate medical treatment for diabetes.

Version date pending

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Part 8: OPTN Staffing Report
PANCREAS ISLET TRANSPLANT PROGRAM
Member Code:

Name of Hospital:

Main Program Phone Number

Main Program Fax Number:

Toll Free Phone numbers for Patients:

Hospital #:

Hospital URL: http://www
Program #:

Answer the questions below for this transplant program. Since this information will be used to update UNETsm and the Membership Directory, make sure to include the best (most
accurate) telephone number and address for each person. Use additional pages as necessary.
Identify the Transplant Program Medical and/or Surgical Director(s):
Name

Address

Phone

Fax

Email

Phone

Fax

Email

The surgeons who participate in this transplant program are:
Name

Version date pending

Address

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Version date pending

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The physicians (internists) who participate in this transplant program are:
Name

Address

Phone

Fax

Email

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

Address

Phone

Fax

Email

Phone

Fax

Email

Identify the Financial Counselor(s) who will be prominently involved with this program:
Name

Version date pending

Address

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The clinical transplant coordinators who participate in this transplant program are:
Name

Address

Phone

Fax

Email

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

Address

Phone

Fax

Email

Phone

Fax

Email

Identify the Social Worker(s) who will be prominently involved with this program:
Name

Version date pending

Address

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Identify the Pharmacist (s) who will be prominently involved with this program:
Name

Address

Phone

Fax

Email

Phone

Fax

Email

Fax

Email

Fax

Email

Identify the Director of Anesthesiology who will be prominently involved with this program:
Name

Address

Identify the Designated FDA Regulations Expert(s) who will be prominently involved with this program
Name

Address

Phone

Identify the Designated Laboratory based Researcher who will be prominently involved with this program:
Name

Version date pending

Address

Phone

Islet - 32

PART 9A: Reporting:

Islet Cell Transplants Performed by Center

Center Code _________

Once approved the program must submit data to UNOS through use of standardized forms. Data requirements include submission of information on all deceased and
living donors, potential transplant recipients, and actual transplant recipients. Pending development of standardized data forms for pancreatic islet transplantation, the
program must provide patient logs to UNOS every six months and on an annual basis, reporting transplants performed, by patient name, social security number, date of
birth, and donor identification number, as well as whether patient is alive or dead, and whether the pancreas was allocated for islet or whole organ transplantation. The
logs shall be cumulative.

Islet Cell Transplants Performed by Center (to date) – sort by Patient ID, then by transplant date.
#

Date of
Transplant

Pt. Name

SSN

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20

Version date pending

Islet - 33

Date of
Birth

Donor ID
Number(s)

Pt. Status
Alive/deceased

Pancreas allocated
for Islet or whole organ

Part 9B

Report – Pancreas Allocation
Center Code: ______________

For each donor pancreas allocated to the program for islet transplantation, the program must report to UNOS
whether the islets were used for clinical islet transplantation and, if not, why and their ultimate disposition, together
with such other information as requested on the Pancreatic Islet Donor Form.

(List in date order)

#

Date Pancreas
allocated

Islets used
for clinical
Islet TX

If no, Explain

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20

Version date pending

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Disposition

TABLE 1 – Primary Surgeon - Transplant Log (Sample)
Organ
Name of Proposed Primary Surgeon:
Name of hospital where transplants were
performed:
Date range of surgeon’s appointment/training:
MM/DD/YY TO MM/DD/YY
List cases listed in date order
#
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30

Date of Transplant

PT ID

Primary Surgeon

1st Assistant

Director’s Signature: ____________________________________________
Extend lines on log as needed

Version date pending

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Date: ___________________

TABLE 2

Primary Surgeon - Procurement Log (Sample)

Organ
Name of Proposed Primary Surgeon:
Name of hospital where surgeons was employed
when procurements were performed:
Date range of surgeon’s appointment/training:
MM/DD/YY TO MM/DD/YY
List cases listed in date order
#

Date of
Procurement

Donor ID
Number

Location of
Donor (hospital)

Comments
(LRD/CAD/Multi-organ)

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
*extend lines on log as needed
Director’s Signature: ____________________________________________

Version date pending

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Date: ___________________

TABLE 3 – Primary Physician Log (1) (Sample)
List only those patients followed for 3 months from the time of transplant (including pre-, peri-, and postoperative management)
Organ
Name of Proposed Primary Physician:
Name of hospital where transplants were
performed:
Date range of surgeon’s appointment/training:
MM/DD/YY TO MM/DD/YY
List cases listed in date order
#

Date of Transplant

PT ID

Comments

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
Director’s Signature: ____________________________________________
Extend lines on log as needed
Version date pending

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Date: ___________________

TABLE 4 Primary Physician Log (2) (Sample)
(Header should include the following information. Cases should be listed in date order)

Organ
Name of Proposed Primary Physician:
Name of hospital where transplants were
performed:
Date range of surgeon’s appointment/training:
MM/DD/YY TO MM/DD/YY
In the tables below document how the physician fulfills the requirements for participation as an observer in organ procurements
and transplants, as well as observing the selection and management of at least 3 multiple organ donors that include the organ for
which application is being submitted. List cases in date order.
Procurements Observed
#

Date of
Procurement

Medical Record/
OPTN ID #

Location of Donor (Hospital)

1
2
3
4
5
Transplants Observed
#

Date of
Transplant

Medical Record/
OPTN ID #

Location (Hospital)

1
2
3
4
5
Donor Selection and Management
#

Date of
Procurement

Medical Record/
OPTN ID #

1
2
3
4
5

Version date pending

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Location of Donor
(Hospital)

Specify Organ specific
or Multi-organ?