Department of Health and Human Services OMB No. 0915-0184
Health Resources and Services Administration Expiration Date: XX/XX/2023
CERTIFICATION
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
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 if applying for Pediatric Component: ☐
A lung 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 (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 Lung 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 Thoracic Surgery or currently certified in thoracic surgery by 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 Thoracic Surgery. Therefore, the surgeon is requesting conditional approval for 24 months to allow time to complete board certification, with the possibility of renewal for one additional 24-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 American Board of Thoracic Surgery certification or current certification in thoracic surgery by 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 lung 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 |
# of Lung /Heart-Lung Transplants |
# of Lung Procurements |
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Start |
End |
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Residency |
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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 formal cardiothoracic surgery residency pathway, as described in Section 5A: Cardiothoracic Surgery Residency Pathway below.
☐ The 12-month lung transplant fellowship pathway, as described in Section 5B: Twelve-month Lung Transplant Fellowship Pathway below.
☐ The lung transplant program clinical experience pathway, as described in Section 5C: Clinical Experience Pathway below.
☐ The alternative pathway for predominantly pediatric programs, as described in Section 5D: Alternative Pathway for Predominantly Pediatric Programs below.
Surgeons can meet the training requirements for primary lung transplant surgeon by completing a cardiothoracic surgery residency if all of the following conditions are met:
During the cardiothoracic surgery residency, the surgeon has performed at least 15 lung or heart/lung transplants as primary surgeon or first assistant under the direct supervision of a qualified lung transplant surgeon and in conjunction with a lung transplant physician at a lung transplant program. At least half of these transplants must be lung procedures.
This experience must be documented on the log provided.
The surgeon has performed at least 10 lung procurements as primary surgeon or first assistant under the supervision of a qualified lung transplant surgeon. These procurements must have been performed anytime during the surgeon’s cardiothoracic surgery residency and the two years immediately following cardiothoracic surgery residency completion.
This experience must be documented on the log provided.
The surgeon must maintain a current working knowledge of all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The surgeon has experience with acute lung failure.
☐ The surgeon has experience with chronic lung failure.
☐ The surgeon has experience with cardiopulmonary bypass.
☐ The surgeon has experience with donor selection.
☐ The surgeon has experience with recipient selection.
☐ The surgeon has experience with pre- and postoperative ventilator care.
☐ The surgeon has experience with postoperative immunosuppressive therapy.
☐ The surgeon has experience with histological interpretation and grading lung biopsies for rejection.
☐ The surgeon has experience with long-term outpatient follow-up.
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 verifying that the surgeon has met the above requirements and is qualified to direct a lung transplant program.
A letter of recommendation from the 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 individual that details the training and experience they have gained in lung transplantation.
Surgeons can meet the training requirements for primary lung transplant surgeon by completing a 12-month lung transplant fellowship if the following conditions are met:
The surgeon has performed at least 15 lung or heart/lung transplants under the direct supervision of a qualified lung transplant surgeon and in conjunction with a qualified lung transplant physician as primary surgeon or first assistant during the 12-month lung transplant fellowship. At least half of these transplants must be lung procedures.
This experience must be documented on the log provided.
The surgeon has performed at least 10 lung procurements as primary surgeon or first assistant under the supervision of a qualified lung transplant surgeon. 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 all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The surgeon has experience with acute lung failure.
☐ The surgeon has experience with chronic lung failure.
☐ The surgeon has experience with cardiopulmonary bypass.
☐ The surgeon has experience with donor selection.
☐ The surgeon has experience with recipient selection.
☐ The surgeon has experience with pre- and postoperative ventilator care.
☐ The surgeon has experience with postoperative immunosuppressive therapy.
☐ The surgeon has experience with histological interpretation and grading lung biopsies for rejection.
☐ The surgeon has experience with long-term outpatient follow-up.
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 verifying that the surgeon has met the above requirements and is qualified to direct a lung transplant program.
A letter of recommendation from the 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 individual that details the training and experience they have gained in lung transplantation.
Surgeons can meet the requirements for primary lung transplant surgeon through clinical experience gained post-fellowship if the following conditions are met:
The surgeon has performed 15 or more lung or heart/lung transplants over a 2 to 5-year period as primary surgeon or first assistant at a designated lung transplant program. At least half of these transplants must be lung procedures, and at least 10 must be performed as the primary surgeon. The surgeon must also have been actively involved with cardiothoracic surgery.
This experience must be documented on the log provided.
The surgeon has performed at least 10 lung procurements.
This experience must be documented on the log provided.
The surgeon has maintained a current working knowledge of all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The surgeon has experience with acute lung failure.
☐ The surgeon has experience with chronic lung failure.
☐ The surgeon has experience with cardiopulmonary bypass.
☐ The surgeon has experience with donor selection.
☐ The surgeon has experience with recipient selection.
☐ The surgeon has experience with pre- and postoperative ventilator care.
☐ The surgeon has experience with postoperative immunosuppressive therapy.
☐ The surgeon has experience with histological interpretation and grading lung biopsies for rejection.
☐ The surgeon has experience with long-term outpatient follow-up.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
Provide the following letters with the application:
A letter from the director of program where the surgeon gained their experience verifying that the surgeon has met the above requirements and is qualified to direct a lung transplant program.
A letter of recommendation from the primary surgeon and transplant program director of the program last served by 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 individual that details the training and experience they have gained in lung transplantation.
If a surgeon does not meet the requirements for primary lung transplant surgeon through either the training or clinical experience pathways, hospitals that serve predominantly pediatric patients may petition the MPSC in writing to consider the surgeon for primary transplant surgeon if the program can demonstrate that the following conditions are met:
Provide an explanation why the proposed surgeon needs to utilize this pathway:
_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
The surgeon’s lung transplant training or experience must be equivalent to the formal cardiothoracic surgery residency pathway, as described in Section 5A: Cardiothoracic Surgery Residency Pathway, the 12-month lung transplant fellowship pathway, as described in Section 5B: Twelve-month Lung Transplant Fellowship Pathway, or the lung transplant program clinical experience pathway, as described in Section 5C: Clinical Experience Pathway above.
This experience must be documented on the log provided.
The surgeon has maintained a current working knowledge of all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The surgeon has experience with acute lung failure.
☐ The surgeon has experience with chronic lung failure.
☐ The surgeon has experience with cardiopulmonary bypass.
☐ The surgeon has experience with donor selection.
☐ The surgeon has experience with recipient selection.
☐ The surgeon has experience with pre- and postoperative ventilator care.
☐ The surgeon has experience with postoperative immunosuppressive therapy.
☐ The surgeon has experience with histological interpretation and grading lung biopsies for rejection.
☐ The surgeon has experience with long-term outpatient follow-up.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
Provide the following letters with the application:
A letter of recommendation from the primary surgeon and transplant program director of the fellowship training program or 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.
If this pathway is selected, the OPTN contractor will contact the program to schedule an informal discussion with the MPSC.
Name of Proposed Primary Lung 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 adult or pediatric pulmonary medicine by the American Board of Internal Medicine, the American Board of Pediatrics, of 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 or has not achieved eligibility in adult or pediatric pulmonary medicine by the American Board of Internal Medicine, the American Board of Pediatrics, of 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 lung 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 |
Date (MM/DD/YY) |
Transplant Hospital |
Program Director |
# Lung Patients Followed |
# Heart/Lung Patients Followed |
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Start |
End |
Pre |
Peri |
Post |
Pre |
Peri |
Post |
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Experience Post Fellowship |
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Fellowship Training |
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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 12-month transplant pulmonary fellowship pathway, as described in Section 5A: Twelve-month Transplant Pulmonary Fellowship Pathway below.
☐ The clinical experience pathway, as described in Section 5B: Clinical Experience Pathway below.
☐ The alternative pathway for predominantly pediatric programs, as described in Section 5C: Alternative Pathway for Predominantly Pediatric Programs below.
☐ The conditional approval pathway, as described in Section 5D: Conditional Approval for Primary Transplant Physician below, if the primary lung transplant physician changes at an approved lung transplant program.
Physicians can meet the training requirements for primary lung transplant physician during a 12-month transplant pulmonary fellowship if all of the following conditions are met:
The physician was directly involved in the primary and follow-up care of at least 15 newly transplanted lung or heart/lung recipients. This training will have been under the direct supervision of a qualified lung transplant physician and in conjunction with a lung transplant surgeon. At least half of these patients must be single or double-lung transplant recipients. This experience must be documented on the log provided.
The physician has maintained a current working knowledge of all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The physician has experience with acute lung failure.
☐ The physician has experience with chronic lung failure.
☐ The physician has experience with cardiopulmonary bypass.
☐ The physician has experience with donor selection.
☐ The physician has experience with recipient selection.
☐ The physician has experience with pre- and postoperative ventilator care.
☐ The physician has experience with postoperative immunosuppressive therapy.
☐ The physician has experience with histological interpretation and grading lung biopsies for rejection.
☐ The physician has experience with long-term outpatient follow-up.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 lung or heart/lung procurements. 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 lung 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 verifying that the physician has met the above requirements and is qualified to direct a lung transplant program.
A letter of recommendation from the 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 individual that details the training and experience they have gained in lung transplantation.
A physician can meet the requirements for primary lung transplant physician through acquired clinical experience if the following conditions are met.
The physician has been directly involved in the primary care of 15 or more newly transplanted lung or heart/lung recipients and continued to follow these recipients for a minimum of 3 months from the time of transplant. At least half of these transplant must be lung transplants. This patient care must have been provided over a 2 to 5-year period at a designated lung transplant program. This care must have been provided as the lung transplant physician or directly supervised by a qualified lung transplant physician along with a lung transplant surgeon.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The physician has experience with acute lung failure.
☐ The physician has experience with chronic lung failure.
☐ The physician has experience with cardiopulmonary bypass.
☐ The physician has experience with donor selection.
☐ The physician has experience with recipient selection.
☐ The physician has experience with pre- and postoperative ventilator care.
☐ The physician has experience with postoperative immunosuppressive therapy.
☐ The physician has experience with histological interpretation and grading lung biopsies for rejection.
☐ The physician has experience with long-term outpatient follow-up.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 lung or heart/lung procurements. 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 lung transplants.
This experience must be documented on the log provided.
Provide the following letters with the application:
A letter from the lung transplant physician or surgeon of the training program who has been directly involved with the physician verifying that the physician has met the above requirements and is qualified to direct a lung transplant program.
A letter of recommendation from the program’s primary physician and transplant program director at the program last served 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 individual that details the training and experience they have gained in lung transplantation.
If a physician does not meet the requirements for primary physician through any of the transplant fellowship or clinical experience pathways as described above, hospitals that serve predominantly pediatric patients may petition the MPSC in writing to consider the physician for primary transplant physician if the program can demonstrate that the following conditions are met:
Provide an explanation why the proposed physician needs to utilize this pathway:
_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
That the physician’s lung transplant training or experience is equivalent to the fellowship or clinical experience pathways as described in the 12-month transplant pulmonary fellowship pathway, as described in Section 5A: Twelve-month Transplant Pulmonary Fellowship Pathway or the clinical experience pathway, as described in Section 5B: Clinical Experience Pathway above.
The physician has maintained a current working knowledge of all aspects of lung transplantation, defined as direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The physician has experience with acute lung failure.
☐ The physician has experience with chronic lung failure.
☐ The physician has experience with cardiopulmonary bypass.
☐ The physician has experience with donor selection.
☐ The physician has experience with recipient selection.
☐ The physician has experience with pre- and postoperative ventilator care.
☐ The physician has experience with postoperative immunosuppressive therapy.
☐ The physician has experience with histological interpretation and grading lung biopsies for rejection.
☐ The physician has experience with long-term outpatient follow-up.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
Provide letter(s) of recommendation from the primary physician and transplant program director of the fellowship training program or 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.
If this pathway is selected, the OPTN contractor will contact the program to schedule an informal discussion with the MPSC.
If the primary lung transplant physician changes at an approved lung transplant program, a physician can serve as the primary lung transplant physician for a maximum of 12 months if the following conditions are met:
The physician has 12 months of experience on an active lung transplant service as the primary lung transplant physician or under the direct supervision of a qualified lung transplant physician and in conjunction with a lung transplant surgeon at a designated lung transplant program. These 12 months of experience must be acquired within a 2-year period.
The physician has been involved in the primary care of 8 or more newly transplanted lung or heart/lung transplant recipients as the lung transplant physician or under the direct supervision of a qualified lung transplant physician and in conjunction with a lung transplant surgeon. At least half of these patients must be lung transplant recipients.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The physician has experience with acute lung failure.
☐ The physician has experience with chronic lung failure.
☐ The physician has experience with cardiopulmonary bypass.
☐ The physician has experience with donor selection.
☐ The physician has experience with recipient selection.
☐ The physician has experience with pre- and postoperative ventilator care.
☐ The physician has experience with postoperative immunosuppressive therapy.
☐ The physician has experience with histological interpretation and grading lung biopsies for rejection.
☐ The physician has experience with long-term outpatient follow-up.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 lung or heart/lung procurements. 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 lung transplants.
This experience must be documented on the log provided.
Provide documentation that supports that the program has established and documented a consulting relationship with counterparts at another lung transplant program.
Provide the following letters with the application:
A letter from the supervising lung transplant physician or surgeon at the training program verifying that the physician has met the above requirements and is qualified to direct a lung transplant program.
A letter of recommendation from the 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 lung transplantation.
A designated lung 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 lung transplant program must identify a qualified primary pediatric lung transplant surgeon and a qualified primary pediatric lung transplant physician, as described below.
Name of Proposed Primary Pediatric Lung 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 Thoracic Surgery or currently certified in thoracic surgery by 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 Thoracic Surgery. Therefore, the surgeon is requesting conditional approval for 24 months to allow time to complete board certification, with the possibility of renewal for one additional 24-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 American Board of Thoracic Surgery certification or current certification in thoracic surgery by 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 lung 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 |
# of Lung /Heart-Lung Transplants |
# of Lung Procurements |
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Start |
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 formal cardiothoracic surgery residency pathway, as described in Section 5A: Cardiothoracic Surgery Residency Pathway below.
☐ The 12-month lung transplant fellowship pathway, as described in Section 5B: Twelve-month Lung Transplant Fellowship Pathway below.
☐ The lung transplant program clinical experience pathway, as described in Section 5C: Clinical Experience Pathway below.
☐ The alternative pathway for predominantly pediatric programs, as described in Section 5D: Alternative Pathway for Predominantly Pediatric Programs below.
Surgeons can meet the training requirements for primary lung transplant surgeon by completing a cardiothoracic surgery residency if all of the following conditions are met:
During the cardiothoracic surgery residency, the surgeon has performed at least 15 lung or heart/lung transplants as primary surgeon or first assistant under the direct supervision of a qualified lung transplant surgeon and in conjunction with a lung transplant physician at a lung transplant program. At least half of these transplants must be lung procedures.
This experience must be documented on the log provided.
The surgeon has performed at least 10 lung procurements as primary surgeon or first assistant under the supervision of a qualified lung transplant surgeon. These procurements must have been performed anytime during the surgeon’s cardiothoracic surgery residency and the two years immediately following cardiothoracic surgery residency completion.
This experience must be documented on the log provided.
The surgeon must maintain a current working knowledge of all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years. Check all that apply
☐ The surgeon has experience with acute lung failure.
☐ The surgeon has experience with chronic lung failure.
☐ The surgeon has experience with cardiopulmonary bypass.
☐ The surgeon has experience with donor selection.
☐ The surgeon has experience with recipient selection?
☐ The surgeon has experience with pre- and postoperative ventilator care.
☐ The surgeon has experience with postoperative immunosuppressive therapy.
☐ The surgeon has experience with histological interpretation and grading lung biopsies for rejection.
☐ The surgeon has experience with long-term outpatient follow-up.
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 verifying that the surgeon has met the above requirements and is qualified to direct a lung transplant program.
A letter of recommendation from the 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 individual that details the training and experience they have gained in lung transplantation.
Surgeons can meet the training requirements for primary lung transplant surgeon by completing a 12-month lung transplant fellowship if the following conditions are met:
The surgeon has performed at least 15 lung or heart/lung transplants under the direct supervision of a qualified lung transplant surgeon and in conjunction with a qualified lung transplant physician as primary surgeon or first assistant during the 12-month lung transplant fellowship. At least half of these transplants must be lung procedures.
This experience must be documented on the log provided.
The surgeon has performed at least 10 lung procurements as primary surgeon or first assistant under the supervision of a qualified lung transplant surgeon. 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 all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The surgeon has experience with acute lung failure.
☐ The surgeon has experience with chronic lung failure.
☐ The surgeon has experience with cardiopulmonary bypass.
☐ The surgeon has experience with donor selection.
☐ The surgeon has experience with recipient selection.
☐ The surgeon has experience with pre- and postoperative ventilator care.
☐ The surgeon has experience with postoperative immunosuppressive therapy.
☐ The surgeon has experience with histological interpretation and grading lung biopsies for rejection.
☐ The surgeon has experience with long-term outpatient follow-up.
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 verifying that the surgeon has met the above requirements and is qualified to direct a lung transplant program.
A letter of recommendation from the 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 individual that details the training and experience they have gained in lung transplantation.
Surgeons can meet the requirements for primary lung transplant surgeon through clinical experience gained post-fellowship if the following conditions are met:
The surgeon has performed 15 or more lung or heart/lung transplants over a 2 to 5-year period as primary surgeon or first assistant at a designated lung transplant program. At least half of these transplants must be lung procedures, and at least 10 must be performed as the primary surgeon. The surgeon must also have been actively involved with cardiothoracic surgery.
This experience must be documented on the log provided.
The surgeon has performed at least 10 lung procurements.
This experience must be documented on the log provided.
The surgeon has maintained a current working knowledge of all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The surgeon has experience with acute lung failure.
☐ The surgeon has experience with chronic lung failure.
☐ The surgeon has experience with cardiopulmonary bypass.
☐ The surgeon has experience with donor selection.
☐ The surgeon has experience with recipient selection.
☐ The surgeon has experience with pre- and postoperative ventilator care.
☐ The surgeon has experience with postoperative immunosuppressive therapy.
☐ The surgeon has experience with histological interpretation and grading lung biopsies for rejection.
☐ The surgeon has experience with long-term outpatient follow-up.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
Provide the following letters with the application:
A letter from the director of program where the surgeon gained their experience verifying that the surgeon has met the above requirements and is qualified to direct a lung transplant program.
A letter of recommendation from the primary surgeon and transplant program director of the program last served by 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 individual that details the training and experience they have gained in lung transplantation.
If a surgeon does not meet the requirements for primary lung transplant surgeon through either the training or clinical experience pathways, hospitals that serve predominantly pediatric patients may petition the MPSC in writing to consider the surgeon for primary transplant surgeon if the program can demonstrate that the following conditions are met:
Provide an explanation why the proposed surgeon needs to utilize this pathway:
_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
The surgeon’s lung transplant training or experience must be equivalent to the formal cardiothoracic surgery residency pathway, as described in Section 5A: Cardiothoracic Surgery Residency Pathway, the 12-month lung transplant fellowship pathway, as described in Section 5B: Twelve-month Lung Transplant Fellowship Pathway, or the lung transplant program clinical experience pathway, as described in Section 5C: Clinical Experience Pathway above.
This experience must be documented on the log provided.
The surgeon has maintained a current working knowledge of all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The surgeon has experience with acute lung failure.
☐ The surgeon has experience with chronic lung failure.
☐ The surgeon has experience with cardiopulmonary bypass.
☐ The surgeon has experience with donor selection.
☐ The surgeon has experience with recipient selection.
☐ The surgeon has experience with pre- and postoperative ventilator care.
☐ The surgeon has experience with postoperative immunosuppressive therapy.
☐ The surgeon has experience with histological interpretation and grading lung biopsies for rejection.
☐ The surgeon has experience with long-term outpatient follow-up.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
Provide the following letters with the application:
A letter of recommendation from the primary surgeon and transplant program director of the fellowship training program or 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.
If this pathway is selected, the OPTN contractor will contact the program to schedule an informal discussion with the MPSC.
Name of Proposed Primary Pediatric Lung 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 adult or pediatric pulmonary medicine by the American Board of Internal Medicine, the American Board of Pediatrics, of 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 or has not achieved eligibility in adult or pediatric pulmonary medicine by the American Board of Internal Medicine, the American Board of Pediatrics, of 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 lung 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:
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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 12-month transplant pulmonary fellowship pathway, as described in Section 5A: Twelve-month Transplant Pulmonary Fellowship Pathway below.
☐ The clinical experience pathway, as described in Section 5B: Clinical Experience Pathway below.
☐ The alternative pathway for predominantly pediatric programs, as described in Section 5C: Alternative Pathway for Predominantly Pediatric Programs below.
☐ The conditional approval pathway, as described in Section 5D: Conditional Approval for Primary Transplant Physician below, if the primary lung transplant physician changes at an approved lung transplant program.
Physicians can meet the training requirements for primary lung transplant physician during a 12-month transplant pulmonary fellowship if all of the following conditions are met:
The physician was directly involved in the primary and follow-up care of at least 15 newly transplanted lung or heart/lung recipients. This training will have been under the direct supervision of a qualified lung transplant physician and in conjunction with a lung transplant surgeon. At least half of these patients must be single or double-lung transplant recipients. This experience must be documented on the log provided.
The physician has maintained a current working knowledge of all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The physician has experience with acute lung failure.
☐ The physician has experience with chronic lung failure.
☐ The physician has experience with cardiopulmonary bypass.
☐ The physician has experience with donor selection.
☐ The physician has experience with recipient selection.
☐ The physician has experience with pre- and postoperative ventilator care.
☐ The physician has experience with postoperative immunosuppressive therapy.
☐ The physician has experience with histological interpretation and grading lung biopsies for rejection.
☐ The physician has experience with long-term outpatient follow-up.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 lung or heart/lung procurements. 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 lung 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 verifying that the physician has met the above requirements and is qualified to direct a lung transplant program.
A letter of recommendation from the 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 individual that details the training and experience they have gained in lung transplantation.
A physician can meet the requirements for primary lung transplant physician through acquired clinical experience if the following conditions are met.
The physician has been directly involved in the primary care of 15 or more newly transplanted lung or heart/lung recipients and continued to follow these recipients for a minimum of 3 months from the time of transplant. At least half of these transplant must be lung transplants. This patient care must have been provided over a 2 to 5-year period at a designated lung transplant program. This care must have been provided as the lung transplant physician or directly supervised by a qualified lung transplant physician along with a lung transplant surgeon.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The physician has experience with acute lung failure.
☐ The physician has experience with chronic lung failure.
☐ The physician has experience with cardiopulmonary bypass.
☐ The physician has experience with donor selection.
☐ The physician has experience with recipient selection.
☐ The physician has experience with pre- and postoperative ventilator care.
☐ The physician has experience with postoperative immunosuppressive therapy.
☐ The physician has experience with histological interpretation and grading lung biopsies for rejection.
☐ The physician has experience with long-term outpatient follow-up.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 lung or heart/lung procurements. 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 lung transplants.
This experience must be documented on the log provided.
Provide the following letters with the application:
A letter from the lung transplant physician or surgeon of the training program who has been directly involved with the physician verifying that the physician has met the above requirements and is qualified to direct a lung transplant program.
A letter of recommendation from the program’s primary physician and transplant program director at the program last served 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 individual that details the training and experience they have gained in lung transplantation.
If a physician does not meet the requirements for primary physician through any of the transplant fellowship or clinical experience pathways as described above, hospitals that serve predominantly pediatric patients may petition the MPSC in writing to consider the physician for primary transplant physician if the program can demonstrate that the following conditions are met:
Provide an explanation why the proposed physician needs to utilize this pathway:
_____________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________
That the physician’s lung transplant training or experience is equivalent to the fellowship or clinical experience pathways as described in the 12-month transplant pulmonary fellowship pathway, as described in Section 5A: Twelve-month Transplant Pulmonary Fellowship Pathway or the clinical experience pathway, as described in Section 5B: Clinical Experience Pathway above.
The physician has maintained a current working knowledge of all aspects of lung transplantation, defined as direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The physician has experience with acute lung failure.
☐ The physician has experience with chronic lung failure.
☐ The physician has experience with cardiopulmonary bypass.
☐ The physician has experience with donor selection.
☐ The physician has experience with recipient selection.
☐ The physician has experience with pre- and postoperative ventilator care.
☐ The physician has experience with postoperative immunosuppressive therapy.
☐ The physician has experience with histological interpretation and grading lung biopsies for rejection.
☐ The physician has experience with long-term outpatient follow-up.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
Provide letter(s) of recommendation from the primary physician and transplant program director of the fellowship training program or 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.
If this pathway is selected, the OPTN contractor will contact the program to schedule an informal discussion with the MPSC.
If the primary lung transplant physician changes at an approved lung transplant program, a physician can serve as the primary lung transplant physician for a maximum of 12 months if the following conditions are met:
The physician has 12 months of experience on an active lung transplant service as the primary lung transplant physician or under the direct supervision of a qualified lung transplant physician and in conjunction with a lung transplant surgeon at a designated lung transplant program. These 12 months of experience must be acquired within a 2-year period.
The physician has been involved in the primary care of 8 or more newly transplanted lung or heart/lung transplant recipients as the lung transplant physician or under the direct supervision of a qualified lung transplant physician and in conjunction with a lung transplant surgeon. At least half of these patients must be lung transplant recipients.
This experience must be documented on the log provided.
The physician has maintained a current working knowledge of all aspects of lung transplantation, defined as a direct involvement in lung transplant patient care within the last 2 years.
Check all that apply
☐ The physician has experience with acute lung failure.
☐ The physician has experience with chronic lung failure.
☐ The physician has experience with cardiopulmonary bypass.
☐ The physician has experience with donor selection.
☐ The physician has experience with recipient selection.
☐ The physician has experience with pre- and postoperative ventilator care.
☐ The physician has experience with postoperative immunosuppressive therapy.
☐ The physician has experience with histological interpretation and grading lung biopsies for rejection.
☐ The physician has experience with long-term outpatient follow-up.
If a box is not checked, please provide an explanation:
_______________________________________________________________________
The physician has observed at least 3 lung or heart/lung procurements. 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 lung transplants.
This experience must be documented on the log provided.
Provide documentation that supports that the program has established and documented a consulting relationship with counterparts at another lung transplant program.
Provide the following letters with the application:
A letter from the supervising lung transplant physician or surgeon at the training program verifying that the physician has met the above requirements and is qualified to direct a lung transplant program.
A letter of recommendation from the training program’s primary physician 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 physician, at its discretion.
A letter from the physician that details the training and experience the physician has gained in lung transplantation.
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].
Lung-
| File Type | application/vnd.openxmlformats-officedocument.wordprocessingml.document |
| File Title | Membership |
| Author | Roger Vacovsky |
| File Modified | 0000-00-00 |
| File Created | 2021-06-03 |