APPENDIX A TO BYLAWS
UNITED NETWORK FOR ORGAN SHARING
Application and Hearing Procedures
For Members and Designated Transplant Programs
1.01A
Nature of Membership/Designated Transplant Program Status
Any transplant hospital, organ procurement organization or independent histocompatibility laboratory, or
organization, institution, or individual with an interest in the fields of organ donation or transplantation that
demonstrates compliance with all applicable UNOS membership criteria shall be entitled to become a
Member upon completion of the prescribed application process and satisfaction of applicable requirements.
Additionally, in the case of Transplant Hospital Members that request status as a designated transplant
program for one or more organs, the Member shall be entitled to attain such status upon completion of the
prescribed application process and satisfaction of applicable requirements. Membership shall be extended
only to institutions, agencies, laboratories, entities, and individuals who consistently meet the membership
qualifications, and requirements established from time to time by the Board of Directors. The rights,
privileges, and responsibilities of Members as set forth in the UNOS Articles of Incorporation, Bylaws and
Policies may be amended by the Board of Directors from time to time. See Figure A-1 for a general
overview of the application process for membership in the OPTN. UNOS designated transplant program
status will not be granted for types of clinical, vascularized organ transplantation for which UNOS has not
yet established criteria. In order to initiate or conduct clinical, vascularized organ transplantation for which
there are no established criteria, including but not limited to multi-visceral organ transplants, an institution
must be a UNOS member transplant center approved for transplantation of at least one other organ; in the
case of abdominal multi-visceral transplants, the approved organ must be liver.
1.02A
Duration of Membership
The term of an OPO, Transplant Hospital, or Histocompatibility Laboratory Member shall be for an
indefinite period, provided that a failure to conform to membership requirements (as established from time
to time by the Board of Directors) shall be cause for corrective action as described in Section 2 of this
Appendix A, which may impact UNOS membership status, and a failure to qualify as a UNOS Member
shall be cause for removal pursuant to Articles 1.10 and 1.11 of the Bylaws. The term of
Medical/Scientific Members; Public Organization Members; Business Members; or Individual Members
shall be two years, provided that a failure to qualify as a Member shall be cause for removal pursuant to
Articles 1.10 and 1.11 of the Bylaws. Any of these Members may serve for successive terms upon
application and approval for such term. A Medical/Scientific Member; Public Organization Member;
Business Member; or Individual Member may resign at any time by written notice to the Executive
Director.
1.03A
Procedures upon Application for Membership
(1)
General Procedure: The Membership and Professional Standards Committee shall investigate
and consider under confidential medical peer review each application for membership and
designation as a transplant program and shall adopt and transmit recommendations thereon to the
Board of Directors.
(2)
Application Form : Each application for membership and designation as a transplant program
shall be in writing, submitted on the prescribed form approved by the Membership and
Professional Standards Committee, signed by the applicant.
(3)
Content: The application form shall include:
(a)
Acknowledgment and Agreement: A statement that the applicant has received and read
the current Articles of Incorporation, Bylaws, and Policies and that the applicant agrees:
(i) to be bound by the terms thereof, as amended, if the applicant is granted membership
and/or designated transplant program status and (ii) to be bound by the terms thereof in
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all matters relating to consideration of the application without regard to whether or not
the applicant is granted membership or designated transplant program status;
(b)
Qualifications: Detailed information and supporting documentation, as may be specified
by the Membership and Professional Standards Committee (MPSC) from time to time
and described in the application form, concerning the applicant’s qualifications, including
information in satisfaction of the basic qualifications specified in Article 1 of the Bylaws
and the Criteria for Membership (Appendix B) regarding applicable membership
requirements. This shall include, by way of example and without in any way limiting
information that may be required in the application, submission of a:
(1)
Plan for Continuing Policy Compliance that reports results from an assessment
by the named primary physician and/or surgeon for transplant programs
designated to perform organ transplants regarding involvement of any of the
program’s physicians or surgeons in prior transgressions of UNOS requirements
and plans to ensure that the improper conduct is not continued.
(c)
(d)
Administrative Remedies: A statement whereby the Member agrees that, when an
adverse ruling is made with respect to membership or designated transplant program
status, the Member will exhaust the administrative remedies afforded by these Bylaws
and applicable Federal regulations before resorting to formal legal action; and
(e)
1.04A
Information on Liability Insurance Coverage: For OPO, Transplant Hospital, and
Histocompatibility Laboratory Members, information as to whether the applicant has
currently in force liability insurance with at least $1,000,000 limits of coverage per
occurrence. Coverage must be provided by an insurer that is either licensed or approved
by the insurance regulatory agency of the state in which the applicant’s principal office is
located. In lieu of insurance coverage, evidence of equivalent coverage through a funded
self-insurance arrangement shall suffice. At UNOS’ request the applicant or member
shall furnish a current certificate of insurance;
Release of Information to HHS: A statement whereby the Member authorizes the
release of any and all information to HHS regarding applications for membership or
designation as a transplant program in UNOS, and activities for monitoring and enforcing
UNOS membership criteria, policies, and Federal regulations as described in these
Bylaws.
Processing the Application
(1)
Applicant’s Burden: The applicant shall have the burden of producing adequate information for
a proper evaluation of the applicant’s qualifications.
(2)
Statement of Release and Immunity From Liability: The following are express conditions
applicable to any applicant during the period membership is sought and to any Member during the
term of membership. By applying for membership, an applicant expressly accepts these
conditions during the processing and consideration of the application, regardless of whether or not
the applicant is granted membership or designation as a transplant program.
(a)
To the fullest extent permitted by law, the applicant or Member extends absolute
immunity to, and releases from liability, UNOS and its representatives and any third
party with respect to any and all civil liability which might arise from any acts,
communications reports, recommendations, or disclosures involving an applicant or
Member, performed, made, requested or received by UNOS and its representatives, to,
from, or by any third party, including other Members concerning activities relating but
not limited to:
(1)
applications for membership or designation as a transplant program;
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(2)
proceedings regarding monitoring and enforcement of membership
requirements, change in membership or designated transplant program status or
termination of membership, or other policies of or regulations applicable to
UNOS;
(3)
hearings and appellate reviews; and
(4)
other committee activities relating to the membership status or status as a
designated transplant program of either an applicant or a Member and
concerning statements, investigations, materials provided, or inquiries, oral or
written, relating to an applicant’s or Member’s qualifications, as well as the
inspection of all records and documents that may be material to such questions.
(b)
(c)
As used in this section, the term “UNOS and its representatives” means the Corporation,
its officers, its Board of Directors, and their appointed representatives or employees,
consultants to UNOS, the Corporation’s attorney and his or her partners, assistants or
designees, and all Members, organizations or other persons who have any responsibility
for obtaining or evaluating the applicant’s or Member’s qualifications and/or acting upon
his or her application or membership or designated transplant program status and any
authorized representative of any of the foregoing;
(d)
As used in this section, the term “third parties” means all individuals or government
agencies, organizations, associations, partnerships and corporations, from whom
information has been requested by UNOS or its authorized representatives or who have
requested such information from UNOS and its authorized representatives; and
(e)
(3)
Any act, communication, report, recommendation or disclosure, with respect to any such
applicant or Member made in good faith and at the request of an authorized
representative of UNOS, anywhere at anytime, for the purposes set forth in (a) above
shall be privileged as components of medical peer review to the fullest extent permitted
bylaw. Such peer review privilege shall extend to employees of UNOS and its authorized
representatives, and to any third parties who either supply or are supplied information and
to any of the foregoing authorized to receive, release or act upon the same;
The immunity and release from liability provided in this section shall not apply to acts of
willful misconduct by UNOS and its representatives.
Verification of Information: The applicant shall deliver a completed application (including the
supporting documentation and such other information that may be relevant to consideration of the
applicant’s qualifications) to the Chairman of the Membership and Professional Standards
Committee or Executive Director or the designated representative of either of them, who shall in
timely fashion seek to collect or verify the qualification evidence submitted. The Chairman or the
Executive Director or the designated representative of either of them shall promptly notify the
applicant of any problems in obtaining the information required and it shall then be the applicant’s
obligation to obtain the required information.
Designated staff representatives will conduct a preliminary review of all applications (including the
required support documentation and such other information that may be relevant to consideration of
the applicant's qualifications) for the purpose of assessing completeness before presenting it to the
Membership and Professional Standards Committee (MPSC) for review. This review will be
conducted for all application types. Applications that are not appropriately completed and that are
missing the key supporting information and/or documents will not be forwarded to the MPSC for
review. Key information and/or documents for applying for changes in key personnel include,
without limitation, physician or surgeon Curriculum Vitae, letter of commitment, letter(s) of
reference, transplant log, and Board certification, as well as surgeon transplant operative notes,
where applicable, and procurement notes and/or log. Key information and/or documents for
applications for Membership or designated transplant program status include, without limitation,
OPO or Histocompatibility Laboratory contract/letter, where applicable, in addition to the
information/documentation associated with key personnel listed above. Applications not completed
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in the appropriate manner will be deemed “incomplete.” The Chair or the Executive Director or the
designated representative of the MPSC will notify the applicant of the incomplete status as well as
their available options.
(4)
Membership and Professional Standards Committee (MPSC): The Membership and
Professional Standards Committee shall review complete the application, the supporting
documentation, and such other information available to it that may be relevant to consideration of
the applicant’s qualifications. The Chairman or the Executive Director shall prepare for the Board
of Directors on the prescribed form a written report and recommendations as to whether
membership and/or designated transplant program status is recommended. The reason for each
recommendation shall be stated and supported by references to the completed application and all
other documentation considered by the Committee, all of which shall be included with the report.
Any minority views shall also be reduced to writing, supported by reasons and references, and
included with the majority report.
For processing of applications for approval of new transplant centers or new transplant
programs, the applicant center may request accelerated review, providing documentation of
the reason for the request. The MPSC or an Ad Hoc Subcommittee of at least four committee
members appointed by the Chairperson of the MPSC at his/her discretion is authorized to
make determinations regarding applications for membership or designation as a transplant
program. Such determinations shall be advisory to the Board of Directors, which is the body
responsible for final decisions with respect to membership and transplant designation
applications, and shall be effective on an interim basis pending final decisions by the Board or
action as may be directed through due process.
(a)
(b)
1.05A
Recommendations for Approval. Upon issuing a recommendation for approval,
the applicant is approved on an interim basis. This approval is effective until review
by the full MPSC (if not already accomplished) and final determination by the Board
of Directors. Such interim approval shall (subject to final action by the full Board)
grant the applicant status as a Member or designated transplant program, as
applicable; shall not extend beyond the date of the Board meeting following the
meeting of the full MPSC, subsequent to the subcommittee’s grant of interim
approval or at which the interim approval is granted by the full Committee (as
applicable) except as otherwise specified in Section 1.05A below; and shall expire if
the Board does not approve the interim action.
Recommendations for Rejection. Upon issuing a recommendation for rejection,
the application is rejected on an interim basis. This rejection is effective until review
by the full MPSC (if not already accomplished) and final determination by the Board
of Directors. Such interim rejection shall (subject to final action by the full Board)
result in denial of membership or designated transplant program status pending due
process, including any rights of appeal to the Secretary, and a different decision.
Effect of Membership and Professional Standards Committee Action
(a)
(b)
Favorable Recommendation: When the recommendation of the MPSC is favorable to the
applicant, the MPSC Chairman shall promptly forward its report and recommendation, together
with all supporting documentation, to the Board of Directors. The Board of Directors shall then
review the application and act on it at its next regular meeting at which a quorum is present after
receipt of the application unless it is not able to do so due to, for example, receipt of the
application from the MPSC ten (10) working days or less before a regular meeting, in which case
it shall defer review and action until the following regular meeting at which a quorum is present.
A majority vote of the Board members present at any meeting at which a quorum is present is
required to elect a Member.
Adverse Recommendation: When the recommendation of the MPSC (or Ad Hoc Subcommittee
of the MPSC) is adverse to the applicant, the MPSC Chairman shall immediately notify the
applicant and the applicant shall be entitled to the procedural rights as provided in section 3.01 A
and following entitled “Interviews and Hearings.” The applicant shall exercise its procedural
rights prior to submission of the adverse recommendation to the Board of Directors.
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March 23, 2007
1.06A
Time Periods for Processing
Applications for membership and designated transplant program status shall be considered in a timely and
good faith manner by all individuals and groups required by these Bylaws to act thereon and, except for
good cause, shall be processed within the time periods specified in this section. The MPSC (or Ad Hoc
Subcommittee of the MPSC) shall act on an application with a recommendation for acceptance and grant of
interim approval or a recommendation for rejection resulting in disallowance of membership or designated
transplant program status on an interim basis pending due process within 90 days after receiving it. The
Board of Directors shall then review and act on the application at its next regular meeting at which a
quorum is present after receipt of the application unless it is unable to do so, in which case it may, in its
discretion, defer review and action until the following regular meeting at which a quorum is present.
Recommendations for rejection resulting in interim rejection of membership or designated transplant
program status pending due process shall entitle the applicant to procedural rights as specified in Article
3.01(4) of this Appendix A to the Bylaws.
1.07A
Reapplication After Adverse Membership Decision
An applicant who has been denied UNOS membership or designated transplant program status shall be
reconsidered for membership or designation for transplantation for the particular organ upon reapplication.
The reapplication will be evaluated based on membership criteria in effect at the time of reapplication.
Any such reapplication shall be processed as an initial application and the applicant shall submit such
additional information as the MPSC or the Board of Directors may require to demonstrate that the basis for
the earlier adverse action no longer exists.
UNOS Appendix A-Section 1-5
March 23, 2007
