Department of Health and Human Services OMB No. 0915-0184
Health Resources and Services Administration Expiration Date: XX/XX/2023
The undersigned, a duly authorized representative of the applicant, does hereby certify that the answers and attachments to this application are true, correct and complete, to the best of his or her knowledge after investigation. I understand that the intentional submission of false data to the OPTN may result in action by the Secretary of the Department of Health and Human Services, and/or civil or criminal penalties. By submitting this application to the OPTN, the applicant agrees: (i) to be bound by OPTN Obligations, including amendments thereto, if the applicant is granted membership and (ii) to be bound by the terms, thereof, including amendments thereto, in all matters relating to consideration of the application without regard to whether or not the applicant is granted membership.
If you have any questions, please call the UNOS Membership Team at 833-577-9469 or email [email protected].
OPTN Representative
____________________________ ____________________________ ____________________________
Printed Name Signature Email Address
Program Director
____________________________ ____________________________ ____________________________
Printed Name Signature Email Address
Program Director (if applicable)
____________________________ ____________________________ ____________________________
Printed Name Signature Email Address
Program Director (if applicable)
____________________________ ____________________________ ____________________________
Printed Name Signature Email Address
Program Director (if applicable)
____________________________ ____________________________ ____________________________
Printed Name Signature Email Address
Proposed Primary Surgeon
____________________________ ____________________________ ____________________________
Printed Name Signature Email Address
Proposed Primary Physician
____________________________ ____________________________ ____________________________
Printed Name Signature Email Address
Proposed Primary Pediatric Surgeon
____________________________ ____________________________ ____________________________
Printed Name Signature Email Address
Proposed Primary Pediatric Physician
____________________________ ____________________________ ____________________________
Printed Name Signature Email Address
Proposed Open Living Donor Nephrectomies Surgeon
____________________________ ____________________________ ____________________________
Printed Name Signature Email Address
Proposed Laparoscopic Living Donor Kidney Surgeon
____________________________ ____________________________ ____________________________
Printed Name Signature Email Address
Part 1: General Information
Name of Transplant Hospital: ___________________________________________________________
OPTN Member Code (4 Letters): ____________
Transplant Program Office Address
Street: _________________________________________ Ste:________ Phone #: __________________
City: _________________________ ST: _________ Zip: _____________ Fax #: ____________________
Name of Person Completing Form: _____________________________ Title: _____________________
Email Address of Person Completing Form: _________________________________________________
Date Form is submitted to OPTN Contractor: ____________________________
Check all that are applicable:
Pediatric Component
☐ Applying for Full Approval
☐ Applying for Conditional Approval
☐ Applying for Living Donor Component
A kidney transplant program must identify at least one designated staff member to act as the transplant program director. The director must be a physician or surgeon who is a member of the transplant hospital staff.
Name of Program Director(s) (list all): New Existing
________________________________________________________________ ☐ ☐
________________________________________________________________ ☐ ☐
________________________________________________________________ ☐ ☐
________________________________________________________________ ☐ ☐
Include the resume/CV of each individual listed.
A primary program administrator is the identified administrative lead for the transplant program.
Name of Primary Program Administrator:
Credentials:
Title at Hospital:
Phone Number:
Email:
A primary data coordinator is the identified data lead for the transplant program.
Name of Primary Data Coordinator:
Credentials:
Title at Hospital:
Phone Number:
Email:
Name of Proposed Primary Kidney Transplant Surgeon (as indicated in Certificate of Assessment):
__________________________________________ ___________________________________
Name NPI #
Check yes or no for each of the following. Provide documentation where applicable:
Yes No
☐ ☐ 2a. Does the surgeon have an M.D., D.O., or equivalent degree from another country, with a current license to practice medicine in the hospital’s state or jurisdiction?
Provide a copy of the surgeon’s resume/CV.
☐ ☐ 2b. Has the surgeon been accepted onto the hospital’s medical staff, and is practicing on site at this hospital?
Provide documentation from the hospital credentialing committee that it has verified the surgeon’s state license, board certification, training, and transplant continuing medical education, and that the surgeon is currently a member in good standing of the hospital’s medical staff.
Certification. Check one and provide corresponding documentation:
☐ 3a. The surgeon is currently certified by the American Board of Surgery, the American Board of Urology, the American Board of Osteopathic Surgery, or the Royal College of Physicians and Surgeons of Canada.
Provide a copy of the surgeon’s current board certification.
☐ 3b. The surgeon has just completed training and is pending certification by the American Board of Urology. Therefore, the program is requesting conditional approval for 16 months to allow the surgeon time to complete board certification, with the possibility of renewal for one additional 16-month period.
Provide documentation supporting that training has been completed and certification is pending, which must include the anticipated date of board certification and where the surgeon is in the process to be certified.
☐ 3c. The surgeon is without certification by the American Board of Surgery, the American Board of Urology, the American Board of Osteopathic Surgery, or the Royal College of Physicians and Surgeons of Canada or pending certification by the American Board of Urology.
If this option is selected:
The surgeon must be ineligible for American board certification. Provide an explanation why the individual is ineligible:
______________________________________________________________________________________________________________________________________________________
Provide a plan for continuing education that is comparable to American board maintenance of certification; and
Provide at least 2 two letters of recommendation from directors of designated transplant programs not employed by the applying hospital that address
why an exception is reasonable,
the individual’s overall qualifications to act as a primary kidney transplant surgeon,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
Summarize the surgeon’s training and experience in transplant:
Training and Experience |
Approved Fellowship Program? Y/N |
Date (MM/DD/YY) |
Transplant Hospital |
Program Director |
# Kidney Transplants as Primary |
# Kidney Transplants as 1st Assistant |
# of Kidney Procurements as Primary or 1st Assistant |
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End |
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Experience Post Fellowship |
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Which of the following pathways is the proposed primary surgeon applying (check one, and complete the corresponding pathway section below):
☐ The fellowship pathway, as described in Section 5A: Formal 2-year Transplant Fellowship Pathway below.
☐ The clinical experience pathway, as described in Section 5B: Clinical Experience Pathway below.
Surgeons can meet the training requirements for primary kidney transplant surgeon by completing a formal 2-year surgical transplant fellowship if the following conditions are met:
The surgeon performed at least 30 kidney transplants as the primary surgeon or first assistant during the 2-year fellowship period.
This experience must be documented on the log provided.
The surgeon performed at least 15 kidney procurements as primary surgeon or first assistant. At least 10 of these procurements must be from deceased donors. These procurements must have been performed anytime during the surgeon’s fellowship and the two years immediately following fellowship completion.
This experience must be documented on the log provided.
The surgeon has maintained a current working knowledge of kidney transplantation, defined as direct involvement in kidney transplant patient care in the last 2 years.
Check all that apply
☐ The surgeon has experience with managing patients with end stage renal disease.
☐ The surgeon has experience with the selection of appropriate recipients for transplantation.
☐ The surgeon has experience with donor selection.
☐ The surgeon has experience with histocompatibility and tissue typing.
☐ The surgeon has experience with performing the transplant operation.
☐ The surgeon has experience with immediate postoperative and continuing inpatient care.
☐ The surgeon has experience with the use of immunosuppressive therapy including side effects of the drugs and complications of immunosuppression.
☐ The surgeon has experience with differential diagnosis of renal dysfunction in the allograft recipient.
☐ The surgeon has experience with histological interpretation of allograft biopsies.
☐ The surgeon has experience with interpretation of ancillary tests for renal dysfunction.
☐ The surgeon has experience with long term outpatient care.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
Provide the following letters with the application:
A letter from the director of the training program and chair of the department or hospital credentialing committee verifying that the surgeon has met the above requirements and is qualified to direct a kidney transplant program.
A letter of recommendation from the fellowship training program’s primary surgeon and transplant program director outlining
the individual’s overall qualifications to act as primary transplant surgeon,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary physician, primary surgeon, director, or others affiliated with any transplant program previously served by the surgeon, at its discretion.
A letter from the surgeon that details the training and experience the surgeon has gained in kidney transplantation.
Surgeons can meet the requirements for primary kidney transplant surgeon through clinical experience gained post-fellowship if the following conditions are met:
The surgeon has performed 45 or more kidney transplants over a 2 to 5-year period as primary surgeon, co-surgeon, or first assistant at a designated kidney transplant program. Of these 45 kidney transplants, 23 or more must have been performed as primary surgeon or co-surgeon. Each year of the surgeon’s experience must be substantive and relevant and include pre-operative assessment of kidney transplant candidates, performance of transplants as primary surgeon or first assistant, and post-operative care of kidney recipients.
This experience must be documented on the log provided.
The surgeon has performed at least 15 kidney procurements as primary surgeon, co-surgeon, or first assistant. Of these 15 kidney procurements, at least 8 must have been performed as primary surgeon or co-surgeon. At least 10 of these procurements must be from deceased donors.
This experience must be documented on the log provided.
The surgeon has maintained a current working knowledge of kidney transplantation, defined as direct involvement in kidney transplant patient care in the last 2 years.
Check all that apply
☐ The surgeon has experience with managing patients with end stage renal disease.
☐ The surgeon has experience with the selection of appropriate recipients for transplantation.
☐ The surgeon has experience with donor selection.
☐ The surgeon has experience with histocompatibility and tissue typing.
☐ The surgeon has experience with performing the transplant operation.
☐ The surgeon has experience with immediate postoperative and continuing inpatient care.
☐ The surgeon has experience with the use of immunosuppressive therapy including side effects of the drugs and complications of immunosuppression.
☐ The surgeon has experience with differential diagnosis of renal dysfunction in the allograft recipient.
☐ The surgeon has experience with histological interpretation of allograft biopsies.
☐ The surgeon has experience with interpretation of ancillary tests for renal dysfunction.
☐ The surgeon has experience with long term outpatient care.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
Provide the following letters along with the application:
A letter from the director of the transplant program and chair of the department or hospital credentialing committee verifying that the surgeon has met the above qualifications and is qualified to direct a kidney transplant program
A letter of recommendation from the primary surgeon and transplant program director at the transplant program last served by the surgeon outlining
the individual’s overall qualifications to act as primary transplant surgeon,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary physician, primary surgeon, director, or others affiliated with any transplant program previously served by the surgeon, at its discretion.
A letter from the surgeon that details the training and experience the surgeon has gained in kidney transplantation.
A designated kidney transplant program must have a primary physician who meets all the following requirements:
Name of Proposed Primary Kidney Transplant Physician (as indicated in Certificate of Assessment):
__________________________________________ ___________________________________
Name NPI #
Check yes or no for each of the following. Provide documentation where applicable:
Yes No
☐ ☐ 2a. Does the physician have an M.D., D.O., or equivalent degree from another country, with a current license to practice medicine in the hospital’s state or jurisdiction?
Provide a copy of the physician’s resume/CV.
☐ ☐ 2b. Has the physician been accepted onto the hospital’s medical staff, and is practicing on site at this hospital?
Provide documentation from the hospital credentialing committee that it has verified the physician’s state license, board certification, training, and transplant continuing medical education, and that the physician is currently a member in good standing of the hospital’s medical staff.
Certification. Check one and provide corresponding documentation:
☐ 3a. The physician is currently certified in nephrology by the American Board of Internal Medicine, the American Board of Pediatrics, or the Royal College of Physicians and Surgeons of Canada.
Provide a copy of the physician’s current board certification.
☐ 3b. The physician is without certification in nephrology by the American Board of Internal Medicine, the American Board of Pediatrics, or the Royal College of Physicians and Surgeons of Canada.
The physician must be ineligible for American board certification. Provide an explanation why the individual is ineligible: ______________________________________________________________________________________________________________________________________________________
Provide a plan for continuing education that is comparable to American board maintenance of certification
Provide at least 2 two letters of recommendation from directors of designated transplant programs not employed by the applying hospital that address
why an exception is reasonable,
the individual’s overall qualifications to act as a primary kidney transplant physician,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
Summarize the physician’s training and experience in transplant:
Tr Training and Experience |
Approved Fellowship Program? Y/N |
Date (MM/DD/YY) |
Transplant Hospital |
Program Director |
#Kidney Patients Followed |
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Experience Post Fellowship |
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Which of the following pathways is the proposed primary physician applying (check one, and complete the corresponding pathway section below):
☐ The transplant nephrology fellowship pathway, as described in Section 5A: Transplant Nephrology Fellowship Pathway below.
☐ The clinical experience pathway, as described in Section 5B: Clinical Experience Pathway below.
☐ The 3 year pediatric nephrology fellowship pathway, as described in Section 5C: Three-year Pediatric Nephrology Fellowship Pathway below.
☐ The 12-month pediatric transplant nephrology fellowship pathway, as described in Section 5D: Twelve-month Pediatric Transplant Nephrology Fellowship Pathway below.
☐ The combined pediatric nephrology training and experience pathway, as described in Section 5E. Combined Pediatric Nephrology Training and Experience Pathway below.
☐ The conditional approval pathway, as described in Section 5F: Conditional Approval for Primary Transplant Physician below, if the primary kidney transplant physician changes at an approved kidney transplant program.
Physicians can meet the training requirements for a primary kidney transplant physician during a separate transplant nephrology fellowship if the following conditions are met:
The physician completed at least 12 consecutive months of specialized training in transplantation under the direct supervision of a qualified kidney transplant physician and along with a kidney transplant surgeon at a kidney transplant program that performs 50 or more transplants each year. The training must have included at least 6 months of clinical inpatient transplant service. The remaining time must have consisted of transplant-related experience, such as experience in a tissue typing laboratory, on another solid organ transplant service, or conducting basic or clinical transplant research.
During the fellowship period, the physician was directly involved in the primary care of 30 or more newly transplanted kidney recipients and continued the outpatient follow-up of these recipients for a minimum of 3 months from the time of transplant. If the physician’s fellowship was longer than 12 months, the physician also must have been directly involved in the outpatient follow-up of at least 30 kidney recipients for an additional period of 3 consecutive months.
This experience must be documented on the log provided.
During the fellowship period, the physician was directly involved in the evaluation of at least 25 potential kidney recipients, including participation in selection committee meetings.
This experience must be documented on the log provided.
During the fellowship period the physician was directly involved in the evaluation of at least 10 potential living kidney donors, including participation in selection committee meetings.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of kidney transplantation, defined as direct involvement in kidney transplant care in the last 2 years.
Check all that apply
☐ The physician has experience with managing patients with end stage renal disease?
☐ The physician has experience with the selection of appropriate recipients for transplantation.
☐ The physician has experience with donor selection.
☐ The physician has experience with histocompatibility and tissue typing.
☐ The physician has experience with immediate postoperative patient care.
☐ The physician has experience with the use of immunosuppressive therapy including side effects of the drugs and complications of immunosuppression.
☐ The physician has experience with differential diagnosis of renal dysfunction in the allograft recipient.
☐ The physician has experience with histological interpretation of allograft biopsies.
☐ The physician has experience with interpretation of ancillary tests for renal dysfunction.
☐ The physician has experience with long term outpatient care.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 kidney procurements, including at least 1 deceased donor and 1 living donor. The physician must have observed the evaluation, donation process, and management of these donors.
This experience must be documented on the log provided.
The physician has observed at least 3 kidney transplants.
This experience must be documented on the log provided.
Provide the following letters with the application:
A letter from the director of the training program and the supervising qualified kidney transplant physician verifying that the physician has met the above requirements and is qualified to direct a kidney transplant program.
A letter of recommendation from the fellowship training program’s primary physician and transplant program director outlining
the individual’s overall qualifications to act as primary transplant physician,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary physician, primary surgeon, director, or others affiliated with any transplant program previously served by the physician, at its discretion.
A letter from the physician that details the training and experience the physician has gained in kidney transplantation.
The training requirements outlined above are in addition to other clinical requirements for general nephrology training.
A physician can meet the requirements for a primary kidney transplant physician through acquired clinical experience if the following conditions are met:
The physician has been directly involved in the primary care of 45 or more newly transplanted kidney recipients and continued the outpatient follow-up of these recipients for a minimum of 3 months from the time of transplant. This patient care must have been provided over a 2 to 5-year period on an active kidney transplant service as the primary kidney transplant physician or under the direct supervision of a qualified transplant physician and in conjunction with a kidney transplant surgeon at a designated kidney transplant program.
This experience must be documented on the log provided.
The physician was directly involved in the evaluation of at least 25 potential kidney recipients, including participation in selection committee meetings.
This experience must be documented on the log provided.
The physician was directly involved in the evaluation of at least 10 potential living kidney donors, including participation in selection committee meetings.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of kidney transplantation, defined as direct involvement in kidney transplant care in the last 2 years.
Check all that apply
☐ The physician has experience with managing patients with end stage renal disease.
☐ Does the physician have experience with the selection of appropriate recipients for transplantation.
☐ The physician has experience with donor selection.
☐ The physician has experience with histocompatibility and tissue typing.
☐ The physician has experience with immediate postoperative patient care.
☐ The physician has experience with the use of immunosuppressive therapy including side effects of the drugs and complications of immunosuppression.
☐ The physician has experience with differential diagnosis of renal dysfunction in the allograft recipient.
☐ The physician has experience with histological interpretation of allograft biopsies.
☐ The physician has experience with interpretation of ancillary tests for renal dysfunction.
☐ The physician has experience with long term outpatient care.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 kidney procurements, including at least 1 deceased donor and 1 living donor. The physician must have observed the evaluation, donation process, and management of these donors.
This experience must be documented on the log provided.
The physician has observed at least 3 kidney transplants.
This experience must be documented on the log provided.
Provide the following letters with the application:
A letter from the qualified transplant physician or the kidney transplant surgeon who has been directly involved with the proposed physician documenting the physician’s experience and competence.
A letter of recommendation from the primary physician and transplant program director at the transplant program last served by the physician outlining
the individual’s overall qualifications to act as primary transplant physician,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary physician, primary surgeon, director, or others affiliated with any transplant program previously served by the physician, at its discretion.
A letter from the physician that details the training and experience the physician has gained in kidney transplantation.
5C. Three-year Pediatric Nephrology Fellowship Pathway
A physician can meet the requirements for primary kidney transplant physician by completion of 3 years of pediatric nephrology fellowship training as required by the American Board of Pediatrics in a program accredited by the Residency Review Committee for Pediatrics (RRC-Ped) of the ACGME. The training must contain at least 6 months of clinical care for transplant patients, and the following conditions must be met:
During the 3-year training period the physician was directly involved in the primary care of 10 or more newly transplanted kidney recipients for at least 6 months from the time of transplant and followed 30 transplanted kidney recipients for at least 6 months, under the direct supervision of a qualified kidney transplant physician and in conjunction with a qualified kidney transplant surgeon. The pediatric nephrology program director may elect to have a portion of the transplant experience completed at another kidney transplant program in order to meet these requirements.
This experience must be documented on the log provided.
The experience caring for pediatric patients occurred with a qualified kidney transplant physician and surgeon at a kidney transplant program that performs an average of at least 10 pediatric kidney transplants a year.
During the fellowship period the physician was directly involved in the evaluation of at least 25 potential kidney recipients, including participation in selection committee meetings.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of kidney transplantation, defined as direct involvement in kidney transplant patient care over the last 2 years.
Check all that apply
☐ The physician has experience managing pediatric patients with end-stage renal disease.
☐ The physician has experience with the selection of appropriate pediatric recipients for transplantation.
☐ The physician has experience with donor selection.
☐ The physician has experience with histocompatibility and tissue typing.
☐ The physician has experience with immediate post-operative care including those issues of management unique to the pediatric recipient.
☐ The physician has experience with fluid and electrolyte management.
☐ The physician has experience with the use of immunosuppressive therapy in the pediatric recipient including side-effects of drugs and complications of immunosuppression, the effects of transplantation and immunosuppressive agents on growth and development.
☐ The physician has experience with differential diagnosis of renal dysfunction in the allograft recipient.
☐ The physician has experience with the manifestation of rejection in the pediatric patient.
☐ The physician has experience with histological interpretation of allograft biopsies?
☐ The physician has experience with interpretation of ancillary tests for renal dysfunction.
☐ The physician has experience with long-term outpatient care of pediatric allograft recipients including management of hypertension, nutritional support, and drug dosage, including antibiotics, in the pediatric patient.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 kidney procurements, including at least 1 deceased donor and 1 living donor. The physician must have observed the evaluation, donation process and management of these donors.
This experience must be documented on the log provided.
The physician has observed at least 3 kidney transplants involving a pediatric recipient.
This experience must be documented on the log provided.
Provide the following letters with the application:
A letter from the director and the supervising qualified transplant physician and surgeon of the fellowship training program verifying that the physician has met the above requirements and is qualified to direct a kidney transplant program.
A letter of recommendation from the fellowship training program’s primary physician and transplant program director outlining
the individual’s overall qualifications to act as primary transplant physician,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary physician, primary surgeon, director, or others affiliated with any transplant program previously served by the physician, at its discretion.
A letter from the physician that details the training and experience the physician has gained in kidney transplantation.
5D. Twelve-month Pediatric Transplant Nephrology Fellowship Pathway
The requirements for the primary kidney transplant physician can be met during a separate pediatric transplant nephrology fellowship if the following conditions are met:
The physician is currently board certified in pediatric nephrology by the American Board of Pediatrics, the Royal College of Physicians and Surgeons of Canada, or is approved by the American Board of Pediatrics to take the certifying exam.
Provide a copy of the physician’s current board certification.
During the fellowship the physician was directly involved in the primary care of 10 or more newly transplanted kidney recipients for at least 6 months from the time of transplant and followed 30 transplanted kidney recipients for at least 6 months, under the direct supervision of a qualified kidney transplant physician and in conjunction with a qualified kidney transplant surgeon. The pediatric nephrology program director may elect to have a portion of the transplant experience completed at another kidney transplant program in order to meet these requirements.
This experience must be documented on the log provided.
During the four years that include the physician’s three-year pediatric nephrology fellowship and twelve-month pediatric transplant nephrology fellowship, the physician was directly involved in the evaluation of at least 25 potential kidney recipients, including participation in selection committee meetings.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of kidney transplantation, defined as direct involvement in kidney transplant patient care over the last 2 years.
Check all that apply
☐ The physician has experience managing pediatric patients with end-stage renal disease.
☐ The physician has experience with the selection of appropriate pediatric recipients for transplantation.
☐ The physician has experience with donor selection.
☐ The physician has experience with histocompatibility and tissue typing.
☐ The physician has experience with immediate post-operative care including those issues of management unique to the pediatric recipient.
☐ The physician has experience with fluid and electrolyte management.
☐ The physician has experience with the use of immunosuppressive therapy in the pediatric recipient including side-effects of drugs and complications of immunosuppression, the effects of transplantation and immunosuppressive agents on growth and development.
☐ The physician has experience with differential diagnosis of renal dysfunction in the allograft recipient.
☐ The physician has experience with the manifestation of rejection in the pediatric patient.
☐ The physician has experience with histological interpretation of allograft biopsies?
☐ The physician has experience with interpretation of ancillary tests for renal dysfunction.
☐ The physician has experience with long-term outpatient care of pediatric allograft recipients including management of hypertension, nutritional support, and drug dosage, including antibiotics, in the pediatric patient.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 kidney procurements, including at least 1 deceased donor and 1 living donor. The physician must have observed the evaluation, donation process, and management of these donors.
This experience must be documented on the log provided.
The physician has observed at least 3 kidney transplants involving a pediatric recipient.
This experience must be documented on the log provided.
Provide the following letters with the application:
A letter from the director and the supervising qualified transplant physician and surgeon of the fellowship training program verifying that the physician has met the above requirements and is qualified to become the primary transplant physician of a designated kidney transplant program.
A letter of recommendation from the fellowship training program’s primary physician and transplant program director outlining
the individual’s overall qualifications to act as primary transplant physician,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary physician, primary surgeon, director, or others affiliated with any transplant program previously served by the physician, at its discretion.
A letter from the physician that details the training and experience the physician has gained in kidney transplantation.
5E. Combined Pediatric Nephrology Training and Experience Pathway
A physician can meet the requirements for primary kidney transplant physician if the following conditions are met:
The physician is currently board certified in pediatric nephrology by the American Board of Pediatrics, the Royal College of Physicians and Surgeons of Canada, or is approved by the American Board of Pediatrics to take the certifying exam.
Provide a copy of the physician’s current board certification.
The physician gained a minimum of 2 years of experience during or after fellowship, or accumulated during both periods, at a kidney transplant program.
This experience must be documented on the log provided.
During the 2 or more years of accumulated experience, the physician was directly involved in the primary care of 10 or more newly transplanted kidney recipients for at least 6 months from the time of transplant and followed 30 transplanted kidney recipients for at least 6 months, under the direct supervision of a qualified kidney transplant physician, along with a qualified kidney transplant surgeon.
This experience must be documented on the log provided.
The physician was directly involved in the evaluation of at least 25 potential kidney recipients, including participation in selection committee meetings.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of kidney transplantation, defined as direct involvement in kidney transplant patient care over the last 2 years.
Check all that apply
☐ The physician has experience managing pediatric patients with end-stage renal disease.
☐ The physician has experience with the selection of appropriate pediatric recipients for transplantation.
☐ The physician has experience with donor selection.
☐ The physician has experience with histocompatibility and tissue typing.
☐ The physician has experience with immediate post-operative care including those issues of management unique to the pediatric recipient.
☐ The physician has experience with fluid and electrolyte management.
☐ The physician has experience with the use of immunosuppressive therapy in the pediatric recipient including side-effects of drugs and complications of immunosuppression, the effects of transplantation and immunosuppressive agents on growth and development.
☐ The physician has experience with differential diagnosis of renal dysfunction in the allograft recipient.
☐ The physician has experience with the manifestation of rejection in the pediatric patient.
☐ The physician has experience with histological interpretation of allograft biopsies?
☐ The physician has experience with interpretation of ancillary tests for renal dysfunction.
☐ The physician has experience with long-term outpatient care of pediatric allograft recipients including management of hypertension, nutritional support, and drug dosage, including antibiotics, in the pediatric patient.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 kidney procurements, including at least 1 deceased donor and 1 living donor. The physician must have observed the evaluation, donation process, and management of these donors.
This experience must be documented on the log provided.
The physician has observed at least 3 kidney transplants involving a pediatric recipient.
This experience must be documented on the log provided.
Provide the following letters with the application:
A letter from the supervising qualified transplant physician and surgeon who were directly involved with the physician documenting the physician’s experience and competence.
A letter of recommendation from the fellowship training program’s primary physician and transplant program director outlining
the individual’s overall qualifications to act as primary transplant physician,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary physician, primary surgeon, director, or others affiliated with any transplant program previously served by the physician, at its discretion.
A letter from the physician that details the training and experience the physician has gained in kidney transplantation.
5F. Conditional Approval for Primary Transplant Physician
If the primary kidney transplant physician changes at an approved Kidney transplant program, a physician can serve as the primary kidney transplant physician for a maximum of 12 months if the following conditions are met:
The physician has been involved in the primary care of 23 or more newly transplanted kidney recipients, and has continued the outpatient follow-up of these patients for at least 3 months from the time of their transplant.
This experience must be documented on the log provided.
The physician was directly involved in the evaluation of at least 25 potential kidney recipients, including participation in selection committee meetings.
This experience must be documented on the log provided.
The physician was directly involved in the evaluation of at least 10 potential living kidney donors, including participation in selection committee meetings.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of kidney transplantation, defined as direct involvement in kidney transplant care in the last 2 years.
Check all that apply
☐ The physician has experience with managing patients with end stage renal disease.
☐ The physician has experience with the selection of appropriate recipients for transplantation.
☐ The physician has experience with donor selection.
☐ The physician has experience with histocompatibility and tissue typing.
☐ The physician has experience with immediate postoperative patient care.
☐ The physician has experience with the use of immunosuppressive therapy including side effects of the drugs and complications of immunosuppression.
☐ The physician has experience with differential diagnosis of renal dysfunction in the allograft recipient.
☐ The physician has experience with histological interpretation of allograft biopsies.
☐ The physician has experience with interpretation of ancillary tests for renal dysfunction.
☐ The physician has experience with long term outpatient care.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has 12 months experience on an active kidney transplant service as the primary kidney transplant physician or under the direct supervision of a qualified kidney transplant physician and in conjunction with a kidney transplant surgeon at a designated kidney transplant program. These 12 months of experience must be acquired within a 2-year period.
The physician has observed at least 3 kidney procurements, including at least 1 deceased donor and 1 living donor. The physician must have observed the evaluation, donation process, and management of these donors.
This experience must be documented on the log provided.
The physician has observed at least 3 kidney transplants.
This experience must be documented on the log provided.
Provide documentation that the program has established and documented a consulting relationship with counterparts at another kidney transplant program.
Provide documentation that the transplant program will submit activity reports to the OPTN Contractor every 2 months describing the transplant activity, transplant outcomes, physician recruitment efforts, and other operating conditions as required by the MPSC to demonstrate the ongoing quality and efficient patient care at the program. The activity reports must also demonstrate that the physician is making sufficient progress to meet the required involvement in the primary care of 45 or more kidney transplant recipients, or that the program is making sufficient progress in recruiting a physician who meets all requirements for primary kidney transplant physician and who will be on site and approved by the MPSC to assume the role of primary physician by the end of the 12 month conditional approval period.
Provide the following letters with the application:
A letter from the supervising qualified transplant physician and surgeon who were directly involved with the physician documenting the physician’s experience and competence.
A letter of recommendation from the primary physician and director at the transplant program last served by the physician outlining
the individual’s overall qualifications to act as primary transplant physician,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary physician, primary surgeon, director, or others affiliated with any transplant program previously served by the physician, at its discretion.
A letter from the physician that details the training and experience the physician has gained in kidney transplantation.
A designated kidney transplant program that registers candidates less than 18 years old must have an approved pediatric component. To be approved for a pediatric component, the designated kidney transplant program must identify a qualified primary pediatric kidney transplant surgeon and a qualified primary pediatric kidney transplant physician.
Name of Proposed Primary Pediatric Kidney Transplant Surgeon (as indicated in Certificate of Assessment):
__________________________________________ ___________________________________
Name NPI #
Check yes or no for each of the following. Provide documentation where applicable:
Yes No
☐ ☐ 2a. Does the surgeon have an M.D., D.O., or equivalent degree from another country, with a current license to practice medicine in the hospital’s state or jurisdiction?
Provide a copy of the surgeon’s resume/CV.
☐ ☐ 2b. Has the surgeon been accepted onto the hospital’s medical staff, and is practicing on site at this hospital?
Provide documentation from the hospital credentialing committee that it has verified the surgeon’s state license, board certification, training, and transplant continuing medical education, and that the surgeon is currently a member in good standing of the hospital’s medical staff.
Certification. Check one and provide corresponding documentation:
☐ 3a. The surgeon is currently certified by the American Board of Surgery, the American Board of Urology, the American Board of Osteopathic Surgery, or the Royal College of Physicians and Surgeons of Canada.
Provide a copy of the surgeon’s current board certification.
☐ 3b. The surgeon has just completed training and is pending certification by the American Board of Urology. Therefore, the program is requesting conditional approval for 16 months to allow the surgeon time to complete board certification, with the possibility of renewal for one additional 16-month period.
Provide documentation supporting that training has been completed and certification is pending, which must include the anticipated date of board certification and where the surgeon is in the process to be certified.
☐ 3c. The surgeon is without certification by the American Board of Surgery, the American Board of Urology, the American Board of Osteopathic Surgery, or the Royal College of Physicians and Surgeons of Canada.
If this option is selected:
The surgeon must be ineligible for American board certification. Provide an explanation why the individual is ineligible:
______________________________________________________________________________________________________________________________________________________
Provide a plan for continuing education that is comparable to American board maintenance of certification; and
Provide at least 2 two letters of recommendation from directors of designated transplant programs not employed by the applying hospital that address
why an exception is reasonable,
the individual’s overall qualifications to act as a primary kidney transplant surgeon,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
Summarize the surgeon’s training and experience in transplant:
Training and Experience |
Approved Fellowship Program? Y/N |
Date (MM/DD/YY) |
Transplant Hospital |
Program Director |
# Kidney Transplants as Primary |
# Kidney Transplants as 1st Assistant |
# of Kidney Procurements as Primary or 1st Assistant |
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Which of the following pathways is the proposed primary surgeon applying (check one, and complete the corresponding pathway section below):
☐ The fellowship pathway, as described in Section 5A: Formal 2-year Transplant Fellowship Pathway below.
☐ The clinical experience pathway, as described in Section 5B: Clinical Experience Pathway below.
Surgeons can meet the training requirements for primary kidney transplant surgeon by completing a formal 2-year surgical transplant fellowship if the following conditions are met:
The surgeon performed at least 30 kidney transplants as the primary surgeon or first assistant during the 2-year fellowship period.
This experience must be documented on the log provided.
The surgeon performed at least 15 kidney procurements as primary surgeon or first assistant. At least 10 of these procurements must be from deceased donors. These procurements must have been performed anytime during the surgeon’s fellowship and the two years immediately following fellowship completion.
This experience must be documented on the log provided.
The surgeon has maintained a current working knowledge of kidney transplantation, defined as direct involvement in kidney transplant patient care in the last 2 years.
Check all that apply
☐ The surgeon has experience with managing patients with end stage renal disease.
☐ The surgeon has experience with the selection of appropriate recipients for transplantation.
☐ The surgeon has experience with donor selection.
☐ The surgeon has experience with histocompatibility and tissue typing.
☐ The surgeon has experience with performing the transplant operation.
☐ The surgeon has experience with immediate postoperative and continuing inpatient care.
☐ The surgeon has experience with the use of immunosuppressive therapy including side effects of the drugs and complications of immunosuppression.
☐ The surgeon has experience with differential diagnosis of renal dysfunction in the allograft recipient.
☐ The surgeon has experience with histological interpretation of allograft biopsies.
☐ The surgeon has experience with interpretation of ancillary tests for renal dysfunction.
☐ The surgeon has experience with long term outpatient care.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
Provide the following letters with the application:
A letter from the director of the training program and chair of the department or hospital credentialing committee verifying that the surgeon has met the above requirements and is qualified to direct a kidney transplant program.
A letter of recommendation from the fellowship training program’s primary surgeon and transplant program director outlining
the individual’s overall qualifications to act as primary transplant surgeon,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary physician, primary surgeon, director, or others affiliated with any transplant program previously served by the surgeon, at its discretion.
A letter from the surgeon that details the training and experience the surgeon has gained in kidney transplantation.
Surgeons can meet the requirements for primary kidney transplant surgeon through clinical experience gained post-fellowship if the following conditions are met:
The surgeon has performed 45 or more kidney transplants over a 2 to 5-year period as primary surgeon, co-surgeon, or first assistant at a designated kidney transplant program. Of these 45 kidney transplants, 23 or more must have been performed as primary surgeon or co-surgeon. Each year of the surgeon’s experience must be substantive and relevant and include pre-operative assessment of kidney transplant candidates, performance of transplants as primary surgeon or first assistant, and post-operative care of kidney recipients.
This experience must be documented on the log provided.
The surgeon has performed at least 15 kidney procurements as primary surgeon, co-surgeon, or first assistant. Of these 15 kidney procurements, at least 8 must have been performed as primary surgeon or co-surgeon. At least 10 of these procurements must be from deceased donors.
This experience must be documented on the log provided.
The surgeon has maintained a current working knowledge of kidney transplantation, defined as direct involvement in kidney transplant patient care in the last 2 years.
Check all that apply
☐ Does the surgeon have experience with managing patients with end stage renal disease?
☐ Does the surgeon have experience with the selection of appropriate recipients for transplantation?
☐ Does the surgeon have experience with donor selection?
☐ Does the surgeon have experience with histocompatibility and tissue typing?
☐ Does the surgeon have experience with performing the transplant operation?
☐ Does the surgeon have experience with immediate postoperative and continuing inpatient care?
☐ Does the surgeon have experience with the use of immunosuppressive therapy including side effects of the drugs and complications of immunosuppression?
☐ Does the surgeon have experience with differential diagnosis of renal dysfunction in the allograft recipient?
☐ Does the surgeon have experience with histological interpretation of allograft biopsies?
☐ Does the surgeon have experience with interpretation of ancillary tests for renal dysfunction?
☐ Does the surgeon have experience with long term outpatient care?
If a box is not checked, please provide an explanation:
_______________________________________________________________________
Provide the following letters along with the application:
A letter from the director of the transplant program and chair of the department or hospital credentialing committee verifying that the surgeon has met the above qualifications and is qualified to direct a kidney transplant program
A letter of recommendation from the fellowship training program’s primary surgeon and transplant program director outlining
the individual’s overall qualifications to act as primary transplant surgeon,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary physician, primary surgeon, director, or others affiliated with any transplant program previously served by the surgeon, at its discretion.
A letter from the surgeon that details the training and experience the surgeon has gained in kidney transplantation.
Pediatric-Specific Requirements
The surgeon has performed at least 10 kidney transplants, as the primary surgeon or first assistant, in recipients less than 18 years old at the time of transplant. At least 3 of these kidney transplants must have been in recipients less than 6 years old or weighing less than 25 kilograms at the time of transplant. These transplants must have been performed during or after fellowship, or across both periods.
This experience must be documented on the log provided.
The surgeon has maintained a current working knowledge of pediatric kidney transplantation, defined as direct involvement in pediatric kidney transplant patient care within the last 2 years.
Check all that apply
☐ The surgeon has experience with managing pediatric patients with end stage renal disease.
☐ The surgeon has experience with the selection of appropriate pediatric recipients for transplantation.
☐ The surgeon has experience with donor selection.
☐ The surgeon has experience with HLA typing.
☐ The surgeon has experience with performing the transplant operation.
☐ The surgeon has experience with immediate postoperative and continuing inpatient care.
☐ The surgeon has experience with the use of immunosuppressive therapy including side effects of the drugs and complications of immunosuppression.
☐ The surgeon has experience with differential diagnosis of renal dysfunction in the allograft recipient.
☐ The surgeon has experience with histological interpretation of allograft biopsies.
☐ The surgeon has experience with interpretation of ancillary tests for renal dysfunction.
☐ The surgeon has experience with long term outpatient care.
If a box is not checked, please provide an explanation:
____________________________________________________________________
Name of Proposed Primary Pediatric Kidney Transplant Physician (as indicated in Certificate of Assessment):
__________________________________________ ___________________________________
Name NPI #
Check yes or no for each of the following. Provide documentation where applicable:
Yes No
☐ ☐ 2a. Does the physician have an M.D., D.O., or equivalent degree from another country, with a current license to practice medicine in the hospital’s state or jurisdiction?
Provide a copy of the physician’s resume/CV.
☐ ☐ 2b. Has the physician been accepted onto the hospital’s medical staff, and is practicing on site at this hospital?
Provide documentation from the hospital credentialing committee that it has verified the physician’s state license, board certification, training, and transplant continuing medical education, and that the physician is currently a member in good standing of the hospital’s medical staff.
Certification. Check one and provide corresponding documentation:
☐ 3a. The physician is currently certified in nephrology by the American Board of Internal Medicine, the American Board of Pediatrics, or the Royal College of Physicians and Surgeons of Canada.
Provide a copy of the physician’s current board certification.
☐ 3b. The physician is without certification in nephrology by the American Board of Internal Medicine, the American Board of Pediatrics, or the Royal College of Physicians and Surgeons of Canada.
The physician must be ineligible for American board certification. Provide an explanation why the individual is ineligible: ______________________________________________________________________________________________________________________________________________________
Provide a plan for continuing education that is comparable to American board maintenance of certification
Provide at least 2 two letters of recommendation from directors of designated transplant programs not employed by the applying hospital that address
why an exception is reasonable,
the individual’s overall qualifications to act as a primary kidney transplant physician,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
Summarize the physician’s training and experience in transplant:
Tr Training and Experience |
Approved Fellowship Program? Y/N |
Date (MM/DD/YY) |
Transplant Hospital |
Program Director |
#Kidney Patients Followed |
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Which of the following pathways is the proposed primary pediatric physician applying (check one, and complete the corresponding pathway section below):
☐ The 3-year pediatric nephrology fellowship pathway, as described in Section 5A: Three-year Pediatric Nephrology Fellowship Pathway below.
☐ The 12-month pediatric transplant nephrology fellowship pathway, as described in Section 5B: Twelve-month Pediatric Transplant Nephrology Fellowship Pathway below.
☐ The combined pediatric nephrology training and experience pathway, as described in Section 5C: Combined Pediatric Nephrology Training and Experience Pathway below.
5A. Three-year Pediatric Nephrology Fellowship Pathway
A physician can meet the requirements for primary kidney transplant physician by completion of 3 years of pediatric nephrology fellowship training as required by the American Board of Pediatrics in a program accredited by the Residency Review Committee for Pediatrics (RRC-Ped) of the ACGME. The training must contain at least 6 months of clinical care for transplant patients, and the following conditions must be met:
During the 3-year training period the physician was directly involved in the primary care of 10 or more newly transplanted kidney recipients for at least 6 months from the time of transplant and followed 30 transplanted kidney recipients for at least 6 months, under the direct supervision of a qualified kidney transplant physician and in conjunction with a qualified kidney transplant surgeon. The pediatric nephrology program director may elect to have a portion of the transplant experience completed at another kidney transplant program in order to meet these requirements.
This experience must be documented on the log provided.
The experience caring for pediatric patients occurred with a qualified kidney transplant physician and surgeon at a kidney transplant program that performs an average of at least 10 pediatric kidney transplants a year.
During the fellowship period the physician was directly involved in the evaluation of at least 25 potential kidney recipients, including participation in selection committee meetings.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of kidney transplantation, defined as direct involvement in kidney transplant patient care over the last 2 years.
Check all that apply
☐ The physician has experience managing pediatric patients with end-stage renal disease.
☐ The physician has experience with the selection of appropriate pediatric recipients for transplantation.
☐ The physician has experience with donor selection.
☐ The physician has experience with histocompatibility and tissue typing.
☐ The physician has experience with immediate post-operative care including those issues of management unique to the pediatric recipient.
☐ The physician has experience with fluid and electrolyte management.
☐ The physician has experience with the use of immunosuppressive therapy in the pediatric recipient including side-effects of drugs and complications of immunosuppression, the effects of transplantation and immunosuppressive agents on growth and development.
☐ The physician has experience with differential diagnosis of renal dysfunction in the allograft recipient.
☐ The physician has experience with the manifestation of rejection in the pediatric patient.
☐ The physician has experience with histological interpretation of allograft biopsies?
☐ The physician has experience with interpretation of ancillary tests for renal dysfunction.
☐ The physician has experience with long-term outpatient care of pediatric allograft recipients including management of hypertension, nutritional support, and drug dosage, including antibiotics, in the pediatric patient.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 kidney procurements, including at least 1 deceased donor and 1 living donor. The physician must have observed the evaluation, donation process and management of these donors.
This experience must be documented on the log provided.
The physician has observed at least 3 kidney transplants involving a pediatric recipient.
This experience must be documented on the log provided.
Provide the following letters with the application:
A letter from the director and the supervising qualified transplant physician and surgeon of the fellowship training program verifying that the physician has met the above requirements and is qualified to direct a kidney transplant program.
A letter of recommendation from the fellowship training program’s primary physician and transplant program director outlining
the individual’s overall qualifications to act as primary transplant physician,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary physician, primary surgeon, director, or others affiliated with any transplant program previously served by the physician, at its discretion.
A letter from the physician that details the training and experience the physician has gained in kidney transplantation.
5B. Twelve-month Pediatric Transplant Nephrology Fellowship Pathway
The requirements for the primary kidney transplant physician can be met during a separate pediatric transplant nephrology fellowship if the following conditions are met:
The physician is currently board certified in pediatric nephrology by the American Board of Pediatrics, the Royal College of Physicians and Surgeons of Canada, or is approved by the American Board of Pediatrics to take the certifying exam.
Provide a copy of the physician’s current board certification.
During the fellowship the physician was directly involved in the primary care of 10 or more newly transplanted kidney recipients for at least 6 months from the time of transplant and followed 30 transplanted kidney recipients for at least 6 months, under the direct supervision of a qualified kidney transplant physician and in conjunction with a qualified kidney transplant surgeon. The pediatric nephrology program director may elect to have a portion of the transplant experience completed at another kidney transplant program in order to meet these requirements.
This experience must be documented on the log provided.
During the four years that include the physician’s three-year pediatric nephrology fellowship and twelve-month pediatric transplant nephrology fellowship, the physician was directly involved in the evaluation of at least 25 potential kidney recipients, including participation in selection committee meetings.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of kidney transplantation, defined as direct involvement in kidney transplant patient care over the last 2 years.
Check all that apply
☐ The physician has experience managing pediatric patients with end-stage renal disease.
☐ The physician has experience with the selection of appropriate pediatric recipients for transplantation.
☐ The physician has experience with donor selection.
☐ The physician has experience with histocompatibility and tissue typing.
☐ The physician has experience with immediate post-operative care including those issues of management unique to the pediatric recipient.
☐ The physician has experience with fluid and electrolyte management.
☐ The physician has experience with the use of immunosuppressive therapy in the pediatric recipient including side-effects of drugs and complications of immunosuppression, the effects of transplantation and immunosuppressive agents on growth and development.
☐ The physician has experience with differential diagnosis of renal dysfunction in the allograft recipient.
☐ The physician has experience with the manifestation of rejection in the pediatric patient.
☐ The physician has experience with histological interpretation of allograft biopsies?
☐ The physician has experience with interpretation of ancillary tests for renal dysfunction.
☐ The physician has experience with long-term outpatient care of pediatric allograft recipients including management of hypertension, nutritional support, and drug dosage, including antibiotics, in the pediatric patient.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 kidney procurements, including at least 1 deceased donor and 1 living donor. The physician must have observed the evaluation, donation process, and management of these donors.
This experience must be documented on the log provided.
The physician has observed at least 3 kidney transplants involving a pediatric recipient.
This experience must be documented on the log provided.
Provide the following letters with the application:
A letter from the director and the supervising qualified transplant physician and surgeon of the fellowship training program verifying that the physician has met the above requirements and is qualified to become the primary transplant physician of a designated kidney transplant program.
A letter of recommendation from the fellowship training program’s primary physician and transplant program director outlining
the individual’s overall qualifications to act as primary transplant physician,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary physician, primary surgeon, director, or others affiliated with any transplant program previously served by the physician, at its discretion.
A letter from the physician that details the training and experience the physician has gained in kidney transplantation.
5C. Combined Pediatric Nephrology Training and Experience Pathway
A physician can meet the requirements for primary kidney transplant physician if the following conditions are met:
The physician is currently board certified in pediatric nephrology by the American Board of Pediatrics, the Royal College of Physicians and Surgeons of Canada, or is approved by the American Board of Pediatrics to take the certifying exam.
Provide a copy of the physician’s current board certification.
The physician gained a minimum of 2 years of experience during or after fellowship, or accumulated during both periods, at a kidney transplant program.
This experience must be documented on the log provided.
During the 2 or more years of accumulated experience, the physician was directly involved in the primary care of 10 or more newly transplanted kidney recipients for at least 6 months from the time of transplant and followed 30 transplanted kidney recipients for at least 6 months, under the direct supervision of a qualified kidney transplant physician, along with a qualified kidney transplant surgeon.
This experience must be documented on the log provided.
The physician was directly involved in the evaluation of at least 25 potential kidney recipients, including participation in selection committee meetings.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of kidney transplantation, defined as direct involvement in kidney transplant patient care over the last 2 years.
Check all that apply
☐ The physician has experience managing pediatric patients with end-stage renal disease.
☐ The physician has experience with the selection of appropriate pediatric recipients for transplantation.
☐ The physician has experience with donor selection.
☐ The physician has experience with histocompatibility and tissue typing.
☐ The physician has experience with immediate post-operative care including those issues of management unique to the pediatric recipient.
☐ The physician has experience with fluid and electrolyte management.
☐ The physician has experience with the use of immunosuppressive therapy in the pediatric recipient including side-effects of drugs and complications of immunosuppression, the effects of transplantation and immunosuppressive agents on growth and development.
☐ The physician has experience with differential diagnosis of renal dysfunction in the allograft recipient.
☐ The physician has experience with the manifestation of rejection in the pediatric patient.
☐ The physician has experience with histological interpretation of allograft biopsies?
☐ The physician has experience with interpretation of ancillary tests for renal dysfunction.
☐ The physician has experience with long-term outpatient care of pediatric allograft recipients including management of hypertension, nutritional support, and drug dosage, including antibiotics, in the pediatric patient.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 kidney procurements, including at least 1 deceased donor and 1 living donor. The physician must have observed the evaluation, donation process, and management of these donors.
This experience must be documented on the log provided.
The physician has observed at least 3 kidney transplants involving a pediatric recipient.
This experience must be documented on the log provided.
Provide the following letters with the application:
A letter from the supervising qualified transplant physician and surgeon who were directly involved with the physician documenting the physician’s experience and competence.
A letter of recommendation from the fellowship training program’s primary physician and transplant program director outlining
the individual’s overall qualifications to act as primary transplant physician,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations and compliance protocols, and
any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary physician, primary surgeon, director, or others affiliated with any transplant program previously served by the physician, at its discretion.
A letter from the physician that details the training and experience the physician has gained in kidney transplantation.
Part 7C: Conditional Approval for a Pediatric Component
A designated kidney transplant program can obtain conditional approval for a pediatric component if either of the following conditions is met:
Check one, and complete the corresponding portions of the application. Provide supporting documentation where applicable:
☐ Option A. The program has a qualified primary pediatric kidney physician who meets all of the requirements described in application Part 5C: Primary Pediatric Kidney Transplant Physician Requirements and a surgeon who meets all of the following requirements:
The surgeon meets all of the requirements described in Part 3: Primary Kidney Transplant Surgeon Requirements, including completion of at least one of the following training or experience pathways:
The formal 2-year transplant fellowship pathway as described in application Part 3, Section 5A: Formal 2-year Transplant Fellowship Pathway
The kidney transplant program clinical experience pathway, as described in application Part 3, Section 5B: Clinical Experience Pathway
Provide documentation that the surgeon has performed at least 5 kidney transplants, as the primary surgeon or first assistant, in recipients less than 18 years old at the time of transplant. At least 1 of these kidney transplants must have been in recipients less than 6 years old or weighing less than 25 kilograms at the time of transplant. These transplants must have been performed during or after fellowship, or across both periods.
This experience must be documented on the log provided.
The surgeon maintained a current working knowledge of pediatric kidney transplantation, defined as direct involvement in pediatric kidney transplant patient care in the last 2 years. This includes (check all that apply)
☐ the management of pediatric patients with end stage renal disease
☐ the selection of appropriate pediatric recipients for transplantation
☐ donor selection
☐ histocompatibility and HLA typing
☐ performing the pediatric transplant operation
☐ immediate postoperative and continuing inpatient care
☐ the use of immunosuppressive therapy including side effects of the drugs and complications of immunosuppression
☐ differential diagnosis of renal dysfunction in the allograft recipient
☐ histological interpretation of allograft biopsies
☐ interpretation of ancillary tests for renal dysfunction
☐ long term outpatient care
☐ Option B. The program has a qualified primary pediatric kidney surgeon who meets all of the requirements described in application Part 5B: Primary Pediatric Kidney Transplant Surgeon Requirements and a physician who meets all of the following requirements:
The physician is currently board certified in pediatric nephrology by the American Board of Pediatrics or the foreign equivalent, or is approved by the American Board of Pediatrics to take the certifying exam.
Provide a copy of the physician’s current board certification.
The physician gained a minimum of 2 years of experience during or after fellowship, or accumulated during both periods, at a kidney transplant program.
During the 2 or more years of accumulated experience, the physician was directly involved in the primary care of 5 or more newly transplanted kidney recipients and followed 15 newly transplanted kidney recipients for at least 6 months from the time of transplant, under the direct supervision of a qualified kidney transplant physician, along with a qualified kidney transplant surgeon.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of pediatric kidney transplantation, defined as direct involvement in kidney transplant patient care during the past 2 years.
This includes (check all that apply)
☐ the management of pediatric patients with end-stage renal disease
☐ the selection of appropriate pediatric recipients for transplantation
☐ donor selection
☐ histocompatibility and HLA typing
☐ immediate post-operative care including those issues of management unique to the pediatric recipient
☐ fluid and electrolyte management
☐ the use of immunosuppressive therapy in the pediatric recipients including side-effects of drugs and complications of immunosuppression
☐ the effects of transplantation and immunosuppressive agents on growth and development
☐ differential diagnosis of renal dysfunction in the allograft recipient
☐ manifestation of rejection in the pediatric patient
☐ histological interpretation of allograft biopsies
☐ interpretation of ancillary tests for renal dysfunction
☐ long-term outpatient care of pediatric allograft recipients including management of hypertension, nutritional support, and drug dosage, including antibiotics, in the pediatric patient
The physician has observed at least 3 organ procurements and at least 3 pediatric kidney transplants. The physician should also have observed the evaluation, the donation process, and management of at least 3 multiple organ donors who donated a kidney.
This experience must be documented on the log provided.
Provide the following letters with the application:
A letter from the supervising qualified transplant physician and surgeon who were directly involved with the physician documenting the physician’s experience and competence.
A letter of recommendation from the fellowship training program’s primary physician and transplant program director outlining
the individual’s overall qualifications to act as a primary transplant physician,
the individual’s personal integrity and honesty,
the individual’s familiarity with and experience in adhering to OPTN obligations,
and any other matters judged appropriate.
The MPSC may request additional recommendation letters from the primary pediatric surgeon, Director, or others affiliated with any transplant program previously served by the physician, at its discretion.
A letter from the physician that details the training and experience the physician has gained in kidney transplantation.
A designated kidney transplant program’s conditional approval for a pediatric component is valid for a maximum of 24 months.
A kidney recovery hospital is a designated kidney transplant program that performs the surgery to recover kidneys from living donors for transplantation.
Kidney recovery hospitals must meet all the requirements of a designated kidney transplant program and must also have the following:
For questions 1 through 4, check to attest that the program has adequate resources in place for living donor kidney recovery:
Protocols and Resources for Evaluations
☐ The kidney recovery hospital has protocols and resources in place for performing living donor evaluations.
Surgical Resources
☐ The kidney recovery hospital has surgical resources on site for open or laparoscopic living donor kidney recoveries.
☐ The kidney recovery hospital has the clinical resources available to assess the medical condition of and specific risks to the living donor.
☐ The kidney recovery hospital has the clinical resources to perform a psychosocial evaluation of the living donor.
The kidney recovery hospital must have an independent living donor advocate (ILDA) who is not involved with the evaluation or treatment decisions of the potential recipient, and is a knowledgeable advocate for the living donor. The ILDA must be independent of the decision to transplant the potential recipient and follow the protocols that outline the duties and responsibilities of the ILDA according to OPTN Policy 14.2: Independent Living Donor Advocate (ILDA) Requirements.
Name of Independent Living Donor Advocate (ILDA):
_______________________________________________________________________
A kidney donor surgeon who performs open living donor nephrectomies must be on site.
Name of Proposed Open Living Donor Nephrectomies Surgeon:
__________________________________________ ___________________________________
Name NPI #
An open living donor nephrectomies must meet one of the following criteria.
Check one and provide corresponding documentation
☐ Completion of a formal 2-year surgical transplant fellowship in kidney at a fellowship program approved by the American Society of Transplant Surgeons, the Royal College of Physicians and Surgeons of Canada, or other recognized fellowship training program accepted by the OPTN Contractor as described in Bylaw Section E.4.A: Transplant Surgeon Fellowship Training Programs.
Provide this surgeon’s resume/CV with the application.
☐ Completion of at least 10 open nephrectomies, including deceased donor nephrectomies or the removal of diseased kidneys, as primary surgeon, co-surgeon, or first assistant. At least 5 of these open nephrectomies must have been performed as the primary surgeon or co-surgeon.
This experience must be documented on the log provided.
A surgeon who performs laparoscopic living donor kidney recoveries must be on site and must meet the following criteria:
Name of Proposed Primary Laparoscopic Living Donor Kidney Surgeon:
__________________________________________ ___________________________________
Name NPI #
☐ The surgeon must have completed at least 15 laparoscopic nephrectomies in the last 5 years as primary surgeon, co-surgeon, or first assistant.
This experience must be documented on the log provided.
☐ Seven of these nephrectomies must have been performed as primary surgeon or co-surgeon, and this role should be documented by a letter from the fellowship program director, program director, division chief, or department chair from the program where the surgeon gained this experience.
Provide the letter with the application.
PUBLIC BURDEN STATEMENT
The private, non-profit Organ Procurement and Transplantation Network (OPTN) collects this information in order to perform the following OPTN functions: to assess whether applicants meet OPTN Bylaw requirements for membership in the OPTN; and to monitor compliance of member organizations with OPTN Obligations. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection is 0915-0184 and it is valid until XX/XX/2023. This information collection is required to obtain or retain a benefit per 42 CFR §121.11(b)(2). All data collected will be subject to Privacy Act protection (Privacy Act System of Records #09-15-0055). Data collected by the private non-profit OPTN also are well protected by a number of the Contractor’s security features. The Contractor’s security system meets or exceeds the requirements as prescribed by OMB Circular A-130, Appendix III, Security of Federal Automated Information Systems, and the Departments Automated Information Systems Security Program Handbook. The public reporting burden for this collection of information is estimated to average 3 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N136B, Rockville, Maryland, 20857 or [email protected].
Kidney-
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Membership |
| Author | Roger Vacovsky |
| File Modified | 0000-00-00 |
| File Created | 2021-06-03 |