0

Organ Procurement and Transplantation Network

A4_LI_LDL_combined_appl

Organ Procurement and Transplantation Network Application

OMB: 0915-0184

Document [pdf]
Download: pdf | pdf
PART 3: Liver Transplant Program
Including Programs Performing Living Donor Liver Transplantation
This application is for (check all that apply):
Liver
Transplantation

Living Donor Liver
Transplantation

New Program/ Initial Application
Key Personnel Change

PART 3A: Personnel – Transplant Program Director(s)
1.

Identify the Transplant Program Surgical and/or Medical Director(s) of the Liver transplant program (include
C.V.). Briefly describe the leadership responsibilities for each individual, including their role in living donor
liver transplantation if applicable.

Check
list

Question
Reference
3A 1

Name

Version date pending

Required Supporting Documents
Current C.V.

Date of
Appointment

Liver - 1

Primary areas of responsibility

PART 3B, Sections 1 & 2: Personnel – Surgical – Primary Surgeon(s)
1.

Primary Liver and/or Living Donor Liver 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
3B 1,a
3,B, 1,d

3B 1e,h,i
3,B, 1,h
3,B, 1,h
3,B, 1,i
3,B, 1,i
3,B, 1,m

3B
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 (organized by date) of the transplant and procurement procedures
Transplant Experience: A letter from the program director verifying that the individual has met the
primary surgeon requirements and is qualified to direct a liver transplant program
Transplant Experience: A log (organized by date) of the transplant and procurement procedures
Living Donor Liver Experience: A log (organized by date) of major hepatic resection surgeries and
living donor hepatectomies performed within the past 5 years. Required only for programs
performing or seeking to perform living donor liver transplantation or for changes in the
primary living donor liver transplant surgeon(s).
Other Letters of Recommendation (Reference)
Letter of recommendation 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) This individual is being proposed as (check all that apply):
Primary Liver Transplant Surgeon
Primary Living Donor Liver Transplant Surgeon (must complete question c) below)
c)

Living Donor Liver applicants only:
Is this individual currently designated as the OPTN/UNOS primary liver transplant surgeon for the liver
transplant program at this center? _____ Yes
_____ No.
If Yes, supply the documents requested in lines 1, 2, 3, 8 and 10 of the checklist above and answer
questions j) and m) below. If No, complete questions d) through m) below. NOTE: If the individual is
being proposed simultaneously as the primary liver transplant surgeon and one of the two primary
living donor liver transplant surgeons, all questions in this section must be answered and all
required supporting documentation must be submitted.

d) 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.
e)

Version date pending

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

Liver - 2

f)

List below the hospitals, health care facilities, and medical group practices and percentage of
professional time this individual is on site at each:

Facility

Type

Location (City, State)

% Professional
Time Spent
On Site

g) 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

Liver - 3

Effective Date
(MM/DD/YY)

Certification Number

h) Formal Training: List the name of the institution(s) in which liver transplant training (fellowship) was received including Program Director(s)
names, applicable dates, and the number of transplant 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.
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

i)

# LI
Transplants
as Primary

# LI
Transplants
First Assisted

# of LI
Procurements
as Primary

# LI
Procurements
First Assisted

Transplant Experience (Post fellowship): List the name of the institution(s), Program Director name(s), applicable dates, and number of liver
transplants 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.
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

Program
Director

Institution

Liver - 4

Program
Director

# LI
Transplants
as Primary

# LI
Transplants
First Assisted

# of LI
Procurements
as Primary

# LI
Procurements
First Assisted

j)

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, Osteopathic Surgery or the foreign
equivalent
3. Two-year liver transplant fellowship
a. Primary surgeon or first assistant on at least 45 liver transplants
b. Primary surgeon or first assistant on at least 20 liver procurements of which at least 3
include the selection and management of the donor
c. Involved in all levels of pre-, peri-, and post-operative patient care within the last 2
years
4. Experience (Post Fellowship)
a. Primary surgeon or first assistant on 60 or more liver transplants over a minimum of 2
years and a maximum of 5 years
b. Primary surgeon or first assistant on at least 30 liver procurement procedures of which
3 include selection and management of the donor
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. Demonstrate that the individual has maintained current working knowledge in all
aspects liver transplantation and patient care within the last 2 years.
c. Petition the MPSC for approval
d. A preliminary interview before the Committee shall be required
6. Living Donor Liver Experience – Criteria for Full Approval
a. Primary surgeon or first assistant on 20 major hepatic resection surgeries, including at
least 7 living donor hepatectomies, within the past 5 years
7. Living Donor Liver Experience – Criteria for Conditional Approval
a. Primary surgeon or first assistant on 20 major hepatic resection surgeries within the past
5 years.

Version date pending

Liver - 5

Yes

k)

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
end stage liver disease
Recipient selection
Donor selection
Histocompatibility and tissue
typing
Transplant surgery
Post-operative and continuing
inpatient care
Use of immunosuppressive
therapy
Differential diagnosis of liver
allograft dysfunction
Histologic interpretation of
allograft biopsies
Interpretation of ancillary tests
for liver dysfunction
Long term outpatient care
Coverage of multiple transplant
centers (if applicable)
Living Donor Transplantation
(if applicable)
Additional Information

Version date pending

Liver - 6

l)

Describe the proposed primary surgeon's transplant training and experience in the areas listed below.
(Expand rows below as necessary).
Describe Experience/Training
Management of patients
with end stage liver disease
Recipient selection
Donor selection
Histocompatibility and
tissue typing
Transplant surgery
Post-operative and
continuing inpatient care
Use of immunosuppressive
therapy
Differential diagnosis of
liver allograft dysfunction
Histologic interpretation of
allograft biopsies
Interpretation of ancillary
tests for liver dysfunction
Long term outpatient care
Additional Information

m) Living donor liver applicants only:
Provide documentation (complete Table 3) that demonstrates that this individual has experience as the
primary surgeon or first assistant in 20 major hepatic resection surgeries, including at least 7 living donor
hepatectomies, within the past 5 years.
These cases must be documented. 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. A blank log for documenting these procedures has been provided at the end of this
application (Table 3). 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.
Please note: When documenting involvement in living donor hepatectomies, be sure to specify that the
procedure was performed on the donor if the corresponding CPT code is not provided (e.g., left lobectomy
– donor).

Version date pending

Liver - 7

2.

Primary Living Donor Liver Transplant Surgeon #2. Complete this section ONLY if applying for approval
to perform living donor liver transplantation or a change in key personnel for one of the primary living donor
liver transplant surgeons. Refer to the Bylaws for the necessary qualifications and more specific descriptions of
the required supporting documents listed below.
Check
list

Question
Reference
3,B, 2,a
3,B, 2,c

3,B, 2,d,g
& ,h
3,B, 2,g
3,B, 2,g
3,B, 2,h
3,B, 2,h
3,B, 2,l

3B
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 (organized by date) of the transplant and procurement procedures
Transplant Experience: A letter from the program director verifying that the individual has met the
primary surgeon requirements and is qualified to direct a liver transplant program
Transplant Experience: A log (organized by date) of the transplant and procurement procedures
Living Donor Liver Experience: A log (organized by date) of major hepatic resection surgeries and
living donor hepatectomies performed within the past 5 years. Required only for programs
performing or seeking to perform living donor liver transplantation or for changes in the
primary living donor liver transplant surgeon(s).
Other Letters of Recommendation (Reference)
Letter of recommendation 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 currently designated as the OPTN/UNOS primary liver transplant surgeon for the liver
transplant program at this center? _____ Yes
_____ No.
If Yes, supply the documents requested in lines 1, 2, 3, 8, and 10 of the checklist above and answer
questions i) and l) below. If No, complete questions c) through l) below.
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

Version date pending

Liver - 8

e)

List below the hospitals, health care facilities, and medical group practices and percentage of
professional time this individual is 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

Liver - 9

Effective Date
(MM/DD/YY)

Certification Number

g) Formal Training: List the name of the institution(s) in which liver transplant training (fellowship) was received including Program Director(s)
names, applicable dates, and the number of transplant 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.
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

Institution

Program Director

# LI
Transplants
as Primary

# LI
Transplants
First Assisted

# of LI
Procurements
as Primary

# LI
Procurements
First Assisted

h) Transplant Experience (Post fellowship): List the name of the institution(s), Program Director(s) names, applicable dates, and number of liver
transplants 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.
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

Liver - 10

Program Director

# LI
Transplants
as Primary

# LI
Transplants
First Assisted

# of LI
Procurements
as Primary

# LI
Procurements
First Assisted

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, Osteopathic Surgery or the foreign
equivalent
3. Two-year liver transplant fellowship
a. Primary surgeon or first assistant on at least 45 liver transplants
b. Primary surgeon or first assistant on at least 20 liver procurements of which at least 3
include the selection and management of the donor
c. Involved in all levels of pre-, peri-, and post-operative patient care within the last 2
years
4. Experience (Post Fellowship)
a. Primary surgeon or first assistant on 60 or more liver transplants over a minimum of 2
years and a maximum of 5 years
b. Primary surgeon or first assistant on at least 30 liver procurement procedures of which
3 include selection and management of the donor
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. Demonstrate that the individual has maintained current working knowledge in all
aspects liver transplantation and patient care within the last 2 years.
c. Petition the MPSC for approval
d. A preliminary interview before the Committee shall be required
6. Living Donor Liver Experience – Criteria for Full Approval
a. Primary surgeon or first assistant on 20 major hepatic resection surgeries, including at
least 7 living donor hepatectomies, within the past 5 years
7. Living Donor Liver Experience – Criteria for Conditional Approval
a. Primary surgeon or first assistant on 20 major hepatic resection surgeries within the
past 5 years.

Version date pending

Liver - 11

Yes

j)

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
end stage liver disease
Recipient selection
Donor selection
Histocompatibility and tissue
typing
Transplant surgery
Post-operative and continuing
inpatient care
Use of immunosuppressive
therapy
Differential diagnosis of liver
allograft dysfunction
Histologic interpretation of
allograft biopsies
Interpretation of ancillary tests
for liver dysfunction
Long term outpatient care
Coverage of multiple transplant
centers (if applicable)
Living donor transplantation (if
applicable)
Additional Information

Version date pending

Liver - 12

k) Describe the proposed primary surgeon's transplant training and experience in the areas listed below.
(Expand rows below as necessary).
Describe Experience/Training
Management of patients
with end stage liver disease
Recipient selection
Donor selection
Histocompatibility and
tissue typing
Transplant surgery
Post-operative and
continuing inpatient care
Use of immunosuppressive
therapy
Differential diagnosis of
liver allograft dysfunction
Histologic interpretation of
allograft biopsies
Interpretation of ancillary
tests for liver dysfunction
Long term outpatient care
Additional Information

l)

Provide documentation (complete Table 3) that demonstrates that this individual has experience as the
primary surgeon or first assistant in 20 major hepatic resection surgeries, including at least 7 living donor
hepatectomies, within the past 5 years.
These cases must be documented. 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. A blank log for documenting these procedures (Table 3) has been provided at the end of
this application. 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.
Please note: When documenting involvement in living donor hepatectomies, be sure to specify that the
procedure was performed on the donor if the corresponding CPT code is not provided (e.g., left lobectomy
– donor).

Version date pending

Liver - 13

Additional Instructions for PART 3B, Section 3: Personnel – Surgical
Complete this section of the application to describe the involvement, training, and experience of other
surgeons associated with 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.

Version date pending

Liver - 14

PART 3B, Section 3: Personnel – Surgical
3.

Additional and Other Surgeons (Duplicate this section as needed). Provide the attachments listed below.
Check
list

Question
Reference
3,B, 3,a
3,B, 3,c

3,B,3,d,f,
&g

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

a) Name: _____________________________________________________________
b) This surgeon participates in (check all that apply):
Type

Active
Yes/No

Additional

Other

Liver Transplantation
Living Donor Liver Transplantation
c)

Date of appointment (MM/DD/YY) at this 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 on site: _______% = _____ hrs/week
e)

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

Liver - 15

Effective Date
(MM/DD/YY)

Certification
Number

f)

Training (Fellowship): List the name of the institution(s) in which liver transplant training (fellowship) was received including Program Director(s)
names, applicable dates, and the number of transplants the individual performed.

Date
From – To
MM/DD/YY

Institution

Program Director

# LI
Transplants
as Primary

# LI
Transplants
First
Assisted

# of LI
Procurements
as Primary

# of LI
Procurements
First Assisted

g) Transplant Experience (Post fellowship): List the name of the institution(s), Program Director name(s), applicable dates, and number of liver
transplants performed by the individual at each institution.

Date
From – To
MM/DD/YY

Version date pending

Institution

Liver - 16

Program Director

# LI
Transplants
as Primary

# LI
Transplants
First
Assisted

# of LI
Procurements
as Primary

# of LI
Procurements
First Assisted

h) Describe the surgeon's level of involvement in this liver transplant program in the areas listed below. (Expand
rows as necessary)
Describe Level of Involvement
Management of patients with
end stage liver disease
Recipient selection
Donor selection
Histocompatibility and tissue
typing
Transplant surgery
Post-operative and continuing
inpatient care
Use of immunosuppressive
therapy
Differential diagnosis of liver
allograft dysfunction
Histologic interpretation of
allograft biopsies
Interpretation of ancillary tests
for liver dysfunction
Long term outpatient care
Living donor transplantation (if
applicable)
Additional Information

Version date pending

Liver - 17

i)

Describe the surgeon's liver transplant training and experience in the areas listed below. (Expand rows as
necessary)
Describe Experience /Training
Management of patients with
end stage liver disease
Recipient selection
Donor selection
Histocompatibility and tissue
typing
Transplant surgery
Post-operative and continuing
inpatient care
Use of immunosuppressive
therapy
Differential diagnosis of liver
allograft dysfunction
Histologic interpretation of
allograft biopsies
Interpretation of ancillary tests
for liver dysfunction
Long term outpatient care
Additional Information

Version date pending

Liver - 18

PART 3C, Section 1: Personnel – Medical – Primary Physician
1.

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

Question
Reference
3,C, 1,a
3,C, 1,c
3,C,
1,d,g,h
3,C, 1,g
3,C, 1,g
3,C, 1,h
3,C, 1,h
3C

5a

a)

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 the training director verifying that the fellow has met the
requirements
Formal Training: A log (organized by date) of the transplant patients followed.
Transplant Experience: A letter from the program director verifying that the individual has met
the primary physician requirements and is qualified to direct a liver transplant program.
Transplant Experience: A log (organized by date) of the transplant patients followed.
Other Letters of Recommendation (Reference)
Letter of recommendation 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

Name:______________________________________________________________

b) Does this individual participate in the care of living liver donors? _____ Yes
c)

_____ No

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

Version date pending

Liver - 19

e)

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

Facility

f)

Type

Location (city, state)

% Professional
Time Spent On
Site

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

Liver - 20

Effective Date
(MM/DD/YY)

Certification Number

g) Training (Fellowship): List the program(s) in which liver 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).
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 physician verifying that the fellow has met the requirements.
Recipient log (see Table 4) 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

# LIVER
Patients Followed:
Pre
Peri
Post

h) Experience (Post fellowship only): List the name of the institution(s), Program Director name(s), applicable dates, and number of liver 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 liver transplant physician and/or liver transplant surgeon with whom the proposed primary physician has previously worked.
Recipient log (see Table 4) that includes the date of transplant and 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

Liver - 21

Program Director

# LIVER
Patients Followed:
Pre
Peri
Post

i)

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

Provide a log (Complete Table 5) 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 LI
Procurements
Observed

# of LI
Transplants
Observed

# of LI Donors/
Donor Process

# of Multi-Organ
Donors Observed
Mgmt.

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

Membership Criteria
1. On site
2. M.D., D.O. or equivalent degree from another country
3. Certified in Gastroenterology by the American Board of Internal Medicine, American Board of
Pediatrics or the foreign equivalent
4. Direct involvement in liver transplant patient care within the last 2 years.
5. Gastroenterology Fellowship
a. Participated in 12 month Gastroenterology fellowship
b. Fellowship training program accredited by the ACGME RRC-IM
c. Involved in primary care of 30 or more liver transplant recipients for a minimum of 3 months
from the time of their transplant
d. Observed 3 organ procurement procedures and 3 liver transplants
e. Observed the evaluation of the donor and donor process and management of at least 3 multiple
organ donors that include the liver
6. Transplant Hepatology Fellowship
a. Participated in 12 month transplant hepatology fellowship
b. Involved in primary care of 30 or more liver transplant recipients for a minimum of 3 months
from the time of their transplant
c. Observed 3 organ procurement procedures and 3 liver transplants
d. Observed the evaluation of the donor and donor process and management of at least 3 multiple
organ donors that include the liver
7. Experience in Liver transplantation (Post Fellowship)
a. 2-5 years experience on an active liver transplant service
b. Involvement in the primary care of 50 or more liver transplant recipients for a minimum of 3
months from the time of their transplant over a 2-5 year period
c. Observed 3 organ procurement procedures and 3 liver transplants
d. Observed the evaluation of the donor and donor process and management of at least 3 multiple
organ donors that include the liver
Version date pending

Liver - 22

Yes

Membership Criteria
8. Pediatric Gastroenterology Fellowship (3 years)
a. Fellowship training program accredited by the ACGME RRC-Ped
b. Transplant program at which training takes place performs an average of at least 10 liver
transplants on pediatric patients per year.
c. Involved in the primary care of 10 or more pediatric liver transplant recipients
d. Followed 20 liver transplant recipients for a minimum of 3 months from the time of their
transplant
e. Direct involvement in the pre-, peri-, and post-operative care of 10 or more pediatric liver
recipients
f. Observed 3 organ procurement procedures and 3 liver transplants
g. Observed the evaluation of the donor and the donor process and management of at least 3
multiple organ donors that include the liver
9. Transplant Medicine Fellowship – for Board-Certified or Eligible Pediatric Gastroenterologists
a. Transplant program at which training takes place performs an average of at least 10 liver
transplants on pediatric patients per year.
b. Involved in the primary care of 10 or more pediatric liver transplant recipients
c. Followed 20 liver transplant recipients for a minimum of 3 months from the time of their
transplant
d. Direct involvement in the pre-, peri-, and post-operative care of 10 or more pediatric liver
recipients
e. Observed 3 organ procurement procedures and 3 liver transplants
f. Observed the evaluation of the donor and the donor process and management of at least 3
multiple organ donors that include the liver
10. Combined Training/Experience – for Board-Certified or Eligible Pediatric Gastroenterologists
a. Two or more years of experience accumulated during fellowship, after fellowship or during both
periods at a UNOS-approved liver transplant center
b. Involved in the primary care of 10 or more liver transplants on pediatric patients
c. Followed 20 liver transplant recipients for a minimum of 6 months from the time of their
transplant
d. Directly involved in the pre-, peri- and post-operative care of 10 or more liver transplants in
pediatric patients.
e. Observed 3 organ procurement procedures and 3 liver transplants
f. Observed the evaluation of the donor and the donor process and management of at least 3
multiple organ donors that include the liver
11. Pediatric Pathway
a. Program serves predominantly pediatric patients
b. Demonstrate that the individual has maintained current working knowledge in all aspects of
liver transplantation and patient care within the last 2 years.
c. Petition the MPSC for approval
d. A preliminary interview before the Committee shall be required
12. 12-month Conditional Pathway - Only available to Existing Programs
a. Board Certified Gastroenterologist/Hepatologist
b. Involved in the primary care of 15 or more liver transplant recipients and has followed these
patients for a minimum of 3 months from the time of their transplant
c. Minimum of 12 months on an active liver transplant service acquired over a maximum of 2
years for individuals qualifying by virtue of acquired clinical experience.
d. Consulting relationship with counterparts at another UNOS-approved liver transplant center
established (include letter of support)

Version date pending

Liver - 23

Yes

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).

Describe Level of Involvement
Management of patients with end stage
liver disease
Care of acute liver failure
Recipient selection
Donor selection
Histocompatibility and tissue typing
Post-operative and continuing inpatient
care
Use of immunosuppressive therapy
Differential diagnosis of liver allograft
dysfunction
Histologic interpretation of allograft
biopsies
Interpretation of ancillary tests for liver
dysfunction
Long term outpatient care
Care of the living liver donor (if
applicable)
Coverage of multiple transplant centers
(if applicable)
Care of living donors (as applicable)
Additional Information

Version date pending

Liver - 24

l)

Describe the proposed primary physician's transplant training and experience in the areas listed below. For
individuals certified in pediatric gastroenterology, please address these areas as they pertain to the pediatric
liver candidate/recipient. (Expand rows as necessary)
Describe Training/Experience
Management of patients with end stage
liver disease
Care of acute liver failure
Recipient selection
Donor selection
Histocompatibility and tissue typing
Post-operative and continuing inpatient
care
Use of immunosuppressive therapy
Differential diagnosis of liver allograft
dysfunction
Histologic interpretation of allograft
biopsies
Interpretation of ancillary tests for liver
dysfunction
Long term outpatient care
Fluid and electrolyte management (Peds
GI only)
Effects of transplantation and
immunosuppressive agents on growth and
development (Peds GI only)
Manifestation of rejection in the pediatric
patient (Peds GI only)
Additional Information

Version date pending

Liver - 25

Additional Instructions for PART 3C, Section 2: Personnel –Physician(s)
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 as well. The type should be indicated as “Other”.
Duplicate pages as needed

Version date pending

Liver - 26

PART 3C, Section 2: Personnel –Physician(s)
2.

Additional and 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

3,C, 2a

Current C.V.

3,C, 2,c

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.

3,C,2,d,f,
&g
a)

Name: _____________________________________________________

b) This physician participates in (check all that apply):
Type

Active
Yes/No

Additional

Other

Liver Transplantation
Care of Living Liver Donors

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 on site: _______% = _____ hrs/week
e)

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

Liver - 27

Effective Date
(MM/DD/YY)

Certification Number

f)

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

Institution

Program
Director

# LIVER
Pts. Followed:
Pre
Peri
Post

g) Transplant Experience (Post fellowship only): List the name of institution(s), Program Director(s) names, applicable dates, and the number of liver
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

Liver - 28

Program
Director

# LIVER
Pts. Followed:
Pre
Peri
Post

h) Describe in detail the transplant physician’s involvement in this liver transplant program. (Expand rows as
necessary)
Describe Level of Involvement
Management of patients with end stage liver
disease
Care of acute liver failure
Recipient selection
Donor selection
Histocompatibility and tissue typing
Post-operative and continuing inpatient care
Use of immunosuppressive therapy
Differential diagnosis of liver allograft
dysfunction
Histologic interpretation of allograft biopsies
Interpretation of ancillary tests for liver
dysfunction
Long term outpatient care
Care of the living liver donor (if applicable)
Additional Information

Version date pending

Liver - 29

i)

Describe the physician’s transplant training and experience in the role of transplant patient management in
the areas listed below. For individuals certified in pediatric gastroenterology, please address these areas as
they pertain to the pediatric liver candidate/recipient. (Expand rows as necessary).
Describe Training/Experience
Management of patients with end stage liver
disease
Care of acute liver failure
Recipient selection
Donor selection
Histocompatibility and tissue typing
Post-operative and continuing inpatient care
Use of immunosuppressive therapy
Differential diagnosis of liver allograft
dysfunction
Histologic interpretation of allograft biopsies
Interpretation of ancillary tests for liver
dysfunction
Long term outpatient care
Fluid and electrolyte management (Peds GI
only)
Effects of transplantation and
immunosuppressive agents on growth and
development (Peds GI only)
Manifestation of rejection in the pediatric
patient (Peds GI only)
Care of the living liver donor (if applicable)
Additional Information

Version date pending

Liver - 30

PART 4: Living Donor Liver Transplantation
Complete this section ONLY if applying for initial approval of living donor liver transplantation.
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 4A: Other Staff and Resources
1.

How does the center assess that the short and long term risks for the potential living 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.

2.

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?
Yes ____
• affirm voluntary nature of proceeding with the evaluation and donation?
Yes ____

3.

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

Liver - 31

Part 4B: Living Donor Liver Transplantation – Protocols
1.

Liver transplant programs that perform living donor liver transplants must demonstrate that they have the protocols
listed below. Submission of actual protocol 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 liver 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
Radiographic assessment to ensure adequate anatomy and volume of the
donor and of the remnant liver.
Informed Consent for Donor Evaluation Process and Donor Hepatectomy:
• 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
• 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-years post donation.
The protocol must include a plan to collect the information about each
donor.

Version date pending

Liver - 32

No

2.

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

Version date pending

Liver - 33

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:
*additional rows may be added as necessary

Version date pending

Liver - 34

Part 6: OPTN Staffing Report
LIVER 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. Check “L” and/or “D” to specify each individual’s involvement with living donor liver transplantation, deceased
donor liver transplantation, or both as applicable. Add extra rows or use additional pages as necessary.
Identify the Transplant Program Medical and/or Surgical Director(s):
Name

L D Address

Phone

Fax

Email

Phone

Fax

Email

The surgeons who participate in this transplant program are:
Name

Version date pending

L D Address

Liver - 35

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

L D 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

L D Address

Phone

Fax

Email

Phone

Fax

Email

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

Version date pending

L D Address

Liver - 36

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

L D 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

L D Address

Phone

Fax

Email

Fax

Email

Identify the Social Worker(s) and other Mental Health Professionals who will be prominently involved with this program:
Name

Version date pending

L D Address

Liver - 37

Phone

The Independent Donor Advocate(s) (IDA) who participate in the care of living donors are (for Living Donor Liver transplantation only):
Name

Address

Phone

Fax

Email

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

L D Address

Phone

Fax

Email

Phone

Fax

Email

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

Version date pending

L D Address

Liver - 38

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

Liver - 39

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

Liver - 40

Date: ___________________

TABLE 3
Surgeon – Sample Log for Living Donor Hepatectomies and other Hepatic Resection Surgeries
(For Living Donor Liver Applicants Only)
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
Log should demonstrate that this individual has experience as the primary surgeon or first assistant in 20 major hepatic
resection surgeries, including at least 7 living donor hepatectomies, within the past 5 years.
These cases must be documented. 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 living donor transplantation, the living organ donation may occur at a center
that is distinct from the approved transplant center.
Please note: When documenting involvement in living donor hepatectomies, be sure to specify that the procedure was
performed on the donor if the corresponding CPT code is not provided (e.g., left lobectomy – donor).
List cases listed in date order
#

Date of
Surgery

Medical Records/
UNOS ID #

Surgeon Role
Primary/ 1st
Assistant

1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
Extend lines on log as needed
Version date pending

Liver - 41

Type of surgical procedure

CPT Code
(optional)

Applicable CPT codes for living donor hepatectomies/major hepatic resections:
Live Donor
47140 Live Donor Hepatectomy (segments II, III - left lateral segment)
47141 Live Donor Hepatectomy (segments II, III, IV -- left lobe)
47142 Live Donor Hepatectomy (segments V, VI, VII, VIII -- right lobe)
Major Hepatic Resections
47120 Hepatectomy (partial lobectomy)
47122 Trisegmentectomy
47125 Total left lobectomy
47130 Total right lobectomy
47399 Unlisted liver procedure

Version date pending

Liver - 42

TABLE 4 – 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: ____________________________________________
Version date pending

Liver - 43

Date: ___________________

Extend lines on log as needed

Version date pending

Liver - 44

TABLE 5 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 #

Location of Donor
(Hospital)

1
2
3
4
5

Version date pending

Liver - 45

Specify Organ specific
or Multi-organ?


File Typeapplication/pdf
File TitleMicrosoft Word - A4_LI_LDL_combined_appl.doc
Authoraungiesh
File Modified2007-11-11
File Created2007-11-11

© 2024 OMB.report | Privacy Policy