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pdfORGAN PROCUREMENT AND TRANSPLANTATION NETWORK (OPTN)
BYLAWS
APPENDIX A
APPENDIX A TO BYLAWS
OPTN
Table of Contents
Section
Page
Application and Hearing Procedures for Members and
Designated Transplant Programs ............................................................................................................................. A1-1
1.01A-Nature of Membership/Designated Transplant Program Status
1.02 A-Duration of Membership
1.03A-Procedures upon Application for Membership
1.04A-Processing the Application
1.05A-Effect of Membership and Professional Standards Committee Action
1.06A-Time Periods for Processing
1.07A-Reapplication after Adverse Decision
Corrective Action and Enforcement of OPTN Requirements
OPO, Transplant Hospital, and Histocompatibility Laboratory Members............................................................... A2-1
2.01A-Member Responsibilities
2.02A-Executive Director
2.03A-Criteria for Initiation
2.04A-Requests
2.05A-Referral to Membership and Professional Standards Committee
2.06A-Membership and Professional Standards Committee Action
2.07A-Medical Peer Review
2.08A-Enforcement Period
2.09A-Restoration of Membership Privileges
2.10A-Notice
2.11A-Procedural Rights
2.12A-Time Period for Action
Interviews and Hearings .......................................................................................................................................... A3-1
3.01A-Definition of “Adverse”
3.02A-Hearings
3.03A-Appellate Review
Final Decision of the Board of Directors ................................................................................................................. A4-1
4.01A-Board of Directors Action
Effect of Board Actions ........................................................................................................................................... A5-1
5.01A-Terms of Probation
5.02A-Terms of Member Not in Good Standing
5.03A-Suspension and Expulsion
5.04A-Secretarial Approval for Certain Actions
5.05A-Restoration of Unrestricted Membership
5.06A-Restoration of Privileges after Violation of Mandatory Policies under Section 121.10(c) of the
OPTN Final Rule
Costs and Expenses ................................................................................................................................................. A6-1
6.01A-Chargeable Costs and Expenses
6.02A-Advanced Deposit for Reimbursable Costs and Expenses
6.03A-Default in Payment of Reimbursable Cost and Expenses
Time Periods for Action .......................................................................................................................................... A7-1
7.01A-Time Periods for Action
Figures ....................................................................................................................................................................... A-1
Figure A-1-Application and Hearing Procedures for Members and Designated Transplant Programs
Figures ..................................................................................................................................................................A-2a-1
Figure A-2a-OPTN Policy Enforcement Options(Potential Violation of Voluntary Policy/Referral to
MPSC (Subcommittee))
Figures ................................................................................................................................................................ A-2b -1
Figure A-2b-OPTN Policy Enforcement Options (Potential Violation of Mandatory Policy/Referral to
MPSC (Subcommittee))
APPENDIX A TO BYLAWS
OPTN
Application and Hearing Procedures
for Members and Designated Transplant Programs
1.01A - Nature of Membership/Designated Transplant Program Status
Any organ procurement organization, transplant hospital, 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 OPTN 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 OPTN Charter, Bylaws, and Policies may be
amended by the Board of Directors, with approval if and as necessary from the Secretary of the Department
of Health and Human Services (HHS), from time to time. See Figure A-1 for a general overview of the
application process for membership in the OPTN. OPTN designated transplant program status will not be
granted for types of clinical, vascularized organ transplantation for which the OPTN 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
OPTN 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 with any necessary approval from the Secretary of HHS) shall be cause
for corrective action as described in Section 2 of this Appendix A, which may impact OPTN membership
status, and a failure to qualify as an OPTN 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 an OPTN
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, and signed by the applicant.
OPTN Bylaws, Appendix A1-1
March 23, 2007
(3)
Content: The application form shall include:
(a)
Acknowledgment and Agreement: A statement that the applicant has received and
read the current Charter, 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 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.
NOTE: OPTN Bylaws, Appendix A, Section 1.03A (Procedures upon Application for Membership) shall be
effective pending distribution of appropriate notice and programming in UNetsm. (Approved at the
March 2007 Board of Directors Meeting)
(c)
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 the request
of the organization that operates the OPTN under contract with HHS (OPTN
Contractor), the applicant or member shall furnish a current certificate of insurance.
(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.
(e)
Release of Information to HHS: A statement whereby the Member authorizes the
release of any and all information to HHS (directly or through the OPTN Contractor)
regarding applications for membership or designation as a transplant program in the
OPTN, and activities for monitoring and enforcing OPTN membership criteria,
policies, and Federal regulations as described in these Bylaws.
1.04A - 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.
OPTN Bylaws, Appendix A1-2
March 23, 2007
(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, the OPTN Contractor 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 the OPTN
Contractor and its representatives, to, from, or by any third party, including other
Members concerning activities within the scope of the OPTN Contract relating but
not limited to:
(1)
applications for membership or designation as a transplant program;
(2)
proceedings regarding monitoring and enforcement of membership
requirements, change in membership or designated transplant program
status, termination of membership, or other policies of or regulations
concerning the OPTN;
(3)
hearings and appellate reviews;
(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)
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 the OPTN Contractor, anywhere at anytime, for the
purposes set forth in (a) above shall be privileged as components of OPTN
medical peer review to the fullest extent permitted bylaw. Such peer review
privilege shall extend to employees of the OPTN Contractor 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.
(c)
As used in this section, the term "OPTN Contractor and its representatives"
means the corporation currently operating the OPTN under contract with HHS,
its officers, its Board of Directors, and their appointed representatives or
employees, consultants to the OPTN Contractor, the Contractor'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 the OPTN Contractor or its
authorized representatives or who have requested such information from the
OPTN Contractor and its authorized representatives.
OPTN Bylaws, Appendix A1-3
March 23, 2007
(e)
(3)
The immunity and release from liability provided in this section shall not apply
to acts of willful misconduct by the OPTN Contractor 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 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 the complete 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.
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)
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
OPTN Bylaws, Appendix A1-4
March 23, 2007
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.
(b)
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.
1.05A - Effect of Membership and Professional Standards Committee Action
(a)
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.
In the event any such cases involve interim approval determinations by the MPSC, a decision to
defer the matter will continue the interim approval until the next regular meeting of the Board of
Directors 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.
(b)
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.
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 recommendations for acceptance 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
shall 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, including an appeal to the Secretary, in writing, within 30 days
of the recommendation for rejection of the application.
1.07A - Reapplication after Adverse Decision
An applicant who has been denied OPTN 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 or designated transplant program criteria in effect
at the time of reapplication. Any such reapplication shall be processed as an initial application and the
OPTN Bylaws, Appendix A1-5
March 23, 2007
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.
OPTN Bylaws, Appendix A1-6
March 23, 2007
Corrective Action and Enforcement of OPTN Requirements
OPO, Transplant Hospital, and Histocompatibility Laboratory Members
2.01A - Member Responsibilities
A voting or non-voting Member shall be obligated to comply with all applicable provisions of the National
Organ Transplant Act, as amended, 42 U.S.C. 273 et seq.; OPTN Final Rule, 42 CFR Part 121; these
Bylaws; and OPTN Policies, as in effect from time to time (hereafter referred to as "OPTN requirements").
The OPTN will conduct ongoing and periodic reviews and evaluations of each Member OPO and
Transplant Hospital for compliance with these Bylaws, the OPTN Final Rule and OPTN policies. All
OPTN Members are subject to review and evaluation for compliance with applicable OPTN requirements.
All such compliance monitoring is performed using processes and protocols developed by the OPTN
Contractor in accordance with the OPTN Contract. The OPTN also is responsible under the Final Rule to
conduct reviews at the request of the Secretary of HHS where the Secretary has reason to believe that an
OPTN Member Transplant Hospital or OPO is non-compliant with the Final Rule or poses a risk to the
health of patients or to public safety. Such reviews may result in recommendations for action entitling the
Member to procedural rights as provided in Sections 3.01A – 3.03A and/or recommendations for
appropriate action by the Secretary. The failure of an OPO, Transplant Hospital, or Histocompatibility
Laboratory Member to pay, within 30 days, any OPTN fee, charge, or other monetary obligation to the
OPTN Contractor shall be considered a violation of OPTN requirements. The failure of a
Medical/Scientific, Public Organization, Business, or Individual Member to comply with applicable OPTN
requirements shall result in rejection of any request to serve for a successive term as OPTN Member unless
the deficiencies are shown to be corrected to the satisfaction of the MPSC and Board of Directors. Any
person who becomes aware of an alleged violation of OPTN requirements shall inform the Chair of the
Board of Directors or the Executive Director. If the Chair of the Board shall be so informed, he/she shall
promptly inform the Executive Director.
2.02A - Executive Director
The Executive Director, or his/her designee, is hereby authorized and directed to monitor compliance by all
Members with the OPTN requirements and refer incidences of potential non-compliance to the MPSC.
2.03A - Criteria for Initiation
Whenever an OPO, Transplant Hospital, or Histocompatibility Laboratory Member has failed to conform to
the applicable OPTN requirements, corrective action to enforce OPTN requirements may be initiated by the
Executive Director, the MPSC, or the Board of Directors, in accordance with these Bylaws.
2.04A - Requests
All requests for corrective action to enforce OPTN requirements shall be submitted to the MPSC in writing
by the Executive Director or his/her designee, and shall be supported by reference to the specific activities
or conduct which constitute the grounds for the request. The Executive Director, or his/her designee, shall
promptly give notice of such request for corrective action to the Member by registered or certified mail,
return receipt requested.
2.05A - Referral to Membership and Professional Standards Committee
(1)
Upon being informed of or discovery of possible failure of an OPO, Transplant Hospital, or
Histocompatibility Laboratory Member to comply in all material respects with applicable OPTN
requirements, the Executive Director or his/her designee shall communicate with the Member
alleged to be in violation and the Regional Councillor requesting clarification and /or explanation
of the alleged violation.
OPTN Bylaws, Appendix A2-1
June 26, 2007
At the same time, the Executive Director, or his/her designee, in consultation with other
designated staff shall make a preliminary determination of the seriousness and./or time-sensitivity
of the matter, referring the most serious and/or time sensitive for further consultation among the
Executive Director, Chairperson of the MPSC, and President. These matters of potential noncompliance with OPTN requirements shall be defined as Category I potential violations involving
action or inaction that poses substantial threat to patient health and/or public safety. In the event
of agreement by the MPSC Chairperson with the preliminary determination of a Category I
potential violation, the Secretary of HHS, or his/her designee, will be notified that the matter is
under investigation, and rapid review of the matter will proceed as follows:
(a)
(b)
(c)
(d)
(2)
Preliminary investigation of the matter conducted by OPTN Contractor staff, which may
include but is not limited to: data and document review, telephone interviews, and onsite reviews.
Referral to a subcommittee of the MPSC formed to consider policy compliance issues
(MPSC-PCSC), or, at the discretion of the MPSC Chairperson, to an Ad Hoc
Subcommittee. The subcommittee shall include at least five members, including two
members with expertise in the organ system or specific issue that is the subject of the
review.
Determination by the subcommittee to continue review of the matter as a Category I
potential violation, or to remove the matter from Category I review and refer it for
Category II or III (as defined in Section 2.06 of this Appendix A below) review.
In the event the matter continues as Category I, a determination by the subcommittee that
there exists a time sensitive threat to patient health or public safety shall require
immediate referral to the Executive Committee with notice of the subcommittee’s
determinations. At the same time, notice will be given to the Member with a stated time
period within which to respond. The Executive Committee shall then determine whether
it or the Board of Directors shall consider the matter and whether the procedural rights
provided to the Member in Sections 3.01A and 3.02A shall be conducted by the MPSC,
by the Board of Directors, or by the Executive Committee.
For matters other than Category I potential violations, Members shall be given a period of up to 21
days to respond. If a response, considered satisfactory to the Executive Director and Chairperson
of the MPSC, or their respective designees, has not been received within the time period granted,
the Executive Director will refer the alleged violation to the MPSC-PCSC or, at the discretion of
the Chairperson of the MPSC, to the full MPSC, for confidential medical peer review
investigation and consideration. At the same time, the Executive Director will notify the relevant
committee(s) of the alleged violation and referral to the MPSC or its subcommittee without
identifying the Member. Matters also may be referred initially to the relevant organ-specific
committee without identifying the Member to obtain input based upon the committee’s expertise
in the particular organ system. If the result of the committee deliberations is a recommendation
for further action by the MPSC, the committee Chairperson will refer the matter to the MPSCPCSC, or, at the discretion of the Chairperson of the MPSC, to the full MPSC, for additional
investigation. The Member will be notified of the committee’s determination, any
recommendation for a specific action, and that the matter has been referred to the MPSC/MPSCPCSC. In cases where the committee recommends an action that would entitle the Member to an
interview as discussed in Section 2.06A, Members will be notified of their right to an interview
before the MPSC/MPSC-PCSC at the time they are informed of the committee determinations and
recommendations.
The Secretary, or his/her designee, will be notified, in writing, within three days of meetings of the
MPSC-PCSC or MPSC in which alleged violations by Transplant Hospitals or OPOs are
considered. Additionally, upon determination with respect to a particular alleged violation that the
Secretary requires written documentation pertaining to the matter, the documentation shall be
provided to the Secretary or his/her designee, upon written request therefor to the OPTN
Contractor and in the form specified by the Secretary.
OPTN Bylaws, Appendix A2-2
June 26, 2007
The MPSC-PCSC will meet by conference call approximately once monthly, as needed, for the
purpose of considering any new and/or ongoing alleged policy violations. In each Category II or
III case the MPSC-PCSC, or full MPSC at the discretion of the Chairperson of the MPSC, will:
(a)
Determine that no further investigation is appropriate because no violation occurred, any
violation was the result of a good faith mistake or bona fide lack of knowledge of
relevant criteria/policies with assurances regarding future behavior satisfactory to the
MPSC-PCSC/MPSC, or non-compliant activity was present but has been corrected with
assurances regarding future behavior satisfactory to the MPSC-PCSC/MPSC, in which
case the affected Member will be notified of the sanctions imposed (if any) to ensure
ongoing compliance with membership requirements. These matters generally would be
considered as Category III.
(b)
Determine that a violation or activity warranting inquiry may have occurred and that
additional investigation is appropriate but that dialogue between the MPSC-PCSC and
the Member in accordance with principles of confidential medical peer review is
expected to bring the Member into compliance. Responses by the Member that may
contribute to such expectations of compliance include, for example, involvement and
commitment from institutional leadership in the matter or demonstration of improvement
in terms of compliance or an outcome under review. These matters generally would be
considered as Category III; or
(c)
Determine that a material breach of OPTN requirements, such as occurrence of a repeat
violation of OPTN policy or expectation of such an occurrence in the future based upon
the Member's failure to respond and/or develop or agree to a reasonable compliance
action plan, may have taken place. The MPSC-PCSC or MPSC will proceed with
additional investigation, as appropriate, in accordance with principles of confidential
medical peer review in order to bring the Member into compliance. These matters
generally would be considered as Category II.
2.06A - Membership and Professional Standards Committee Action
(a)
Category I, II, and III Potential Violations. Matters referred to the MPSC, MPSC-PCSC, or a
MPSC ad hoc subcommittee will be defined initially by decision of the MPSC Chairperson (with
advice from the Executive Director and President) as Category I potential violations according to
the process outlined in Section 2.05 above, or by the MPSC, MPSC-PCSC, or MPSC ad hoc
subcommittee as either Category II or Category III potential violations. For Category I potential
violations, the MPSC-PCSC or ad hoc subcommittee shall report its determination in writing to
the Executive Committee and full MPSC.
Category II potential violations generally are of the type described in Section 2.05(2)(c) above,
while Category III potential violations generally are of the type described in Section 2.05(2)(a-b)
above. Category II and III potential violations are further distinguished by the expectation that
Category II potential violations will proceed to formal Hearings and, perhaps, Appellate Reviews.
Upon determination of a Category II potential violation, the MPSC shall consider a timeline for
review and action to assist in timely resolution of the matter.
(b)
For Category II and III potential violations, the MPSC-PCSC shall report its action in writing to
the full MPSC. The MPSC shall report its action in writing to the Board of Directors.
Category I, II, and III potential violations are generally defined as follows. Individual cases may
vary depending upon the unique circumstances, and cases may move among the categories as
circumstances may change.
OPTN Bylaws, Appendix A2-3
June 26, 2007
•
•
•
Category I = potential violation of OPTN requirements posing substantial, time sensitive
threat to patient health or public safety,
Category II = material breach of OPTN requirements, and
Category III = dialogue with MPSC expected to correct any noncompliant behavior and
lead to ongoing future compliance.
Actions available for all categories of potential violations may include, without limitation (see
Figures A-2a and A2b for a general overview of these actions), the following. Sanctions listed
under numbers (1) and (2) below may be imposed directly by action of either the MPSC-PCSC or
MPSC. Sanctions listed under numbers (3) – (7) below must be recommended by the MPSC to
the Board of Directors and imposed by the Board, or may be imposed by the Executive Committee
or the Board without recommendation of the MSPC. Unless specifically noted, the sanctions
listed below may be taken in cases of : (i) noncompliance with policies or behavior posing risk to
patient health or public safety covered by Section 1138 of the Social Security Act, 42 U.S.C. §
1320-b8, by virtue of (a) recommendation by the OPTN to be mandatory and designation by the
Secretary of HHS for coverage, (b) determination by the Secretary of HHS to be mandatory under
the OPTN Final Rule, or (c) determination of risk to the health of patients or to the public safety,
which is confirmed by the Secretary of HHS, and (ii) noncompliance with all other OPTN
requirements. Policies and behavior posing risk to patient health or public safety described under
category (i) above are hereinafter referred to collectively as “policies covered by Section 1138 of
the Social Security Act,” or individually as “policy covered by Section 1138 of the Social Security
Act.”
The MPSC-PCSC or the MPSC may impose the following sanctions without referral to the Board
of Directors for approval:
(1)
Reject Request for Corrective Action. The MPSC-PCSC or the MPSC may reject
the request for corrective action, notice of which shall be provided to the Board of
Directors;
(2)
Notice of Uncontested Violation, Letter of Warning or Letter of Reprimand.
The MPSC-PCSC or the MPSC may issue a Notice of Uncontested Violation, Letter
of Warning or a Letter of Reprimand, any of which is not an adverse action under the
Bylaws but is meant to inform the Member of the need for the Member to ensure
continuing compliance with OPTN requirements. The Board of Directors and the
Secretary of HHS shall be notified of final decisions to issue a Notice of Uncontested
Violation, Letter of Warning or a Letter of Reprimand. These categories of nonadverse actions are appropriate under the following circumstances:
(a)
Notice of Uncontested Violation – There has been a violation of OPTN
requirements with no substantial evidence of mitigating factors based on
medical judgment, and there is believed to be no likelihood of recurrence.
The Member is not entitled to an interview.
(b)
Letter of Warning – There has been an apparent violation of OPTN
requirements under circumstances in which medical judgment is credibly
put forth as a partial mitigating factor and there is believed to be no
likelihood of recurrence. The Member is not entitled to an interview.
(c)
Letter of Reprimand – There has been an apparent violation of OPTN
requirements under circumstances where medical judgment is not a credible
mitigating factor and there is believed to be no likelihood of recurrence.
The Member shall be entitled to an interview under the procedures
described in Section 3.01A prior to any issuance of a Letter of Reprimand
by the MPSC/PCSC or the MPSC.
OPTN Bylaws, Appendix A2-4
June 26, 2007
The MPSC may make recommendations to the Board of Directors for the imposition of
the following adverse sanctions or the Board of Directors or the Executive Committee
may take such action without recommendation by the MSPC:
(3)
Probation.
a.
Adverse Action. The MPSC may recommend that the Board of Directors or the
Executive Committee place the Member on Probation, or the Executive
Committee or the Board of Directors may do so on its own accord. Such action
would be an adverse action under the Bylaws. This adverse action would first
entitle the Member to procedural rights as provided in Section 3.01A – 3.03A.
The Member is entitled to the procedural rights described in that Section in the
case of a recommendation of Probation by the MPSC. The Member is also
entitled to those same rights by a final decision of the Board of Directors or the
Executive Committee to place the Member on Probation and give notice of that
final action to the Secretary of HHS.
b.
General Requirements. The OPTN will give notice to all Members that a
Member has been placed on Probation. Probation may include one or more of
the following or other actions specified by the MPSC-PCSC, the MPSC, the
Executive Committee, or the Board of Directors:
c.
(1)
Required submission of a compliance action plan or plan of
correction developed to specifications defined by the MPSCPCSC, the MPSC, the Executive Committee, or the Board of
Directors. The Member must demonstrate to such specifying body
that it has adhered to the plan and that it has corrected any noncompliant activity within a period of time as specified.
(2)
Unscheduled on-site audit(s) performed by the OPTN Contractor
audit staff throughout the period of Probation. The Member shall
be responsible for reimbursing the reasonable costs and expenses
of the audit(s). Such costs and expenses shall include, but not be
limited to personal salaries and benefits, administrative overhead,
and travel and lodging expenses of OPTN Contractor staff.
(3)
Specified submission of reports, data, or other evidence to the
OPTN Contractor documenting correction of the non-compliant
activity throughout the period of Probation.
Additional Notice Requirements if the Member Placed on Probation is a
Transplant Center. Notice of this adverse action must be given by the Member
to all Patients directly associated with the cited transplant program. For purposes
of this requirement, “Patients” shall include the following individuals:
(1)
Patients undergoing the cited transplant program’s evaluation process;
(2)
Candidates on the waitlist of the cited transplant program;
(3)
Candidates added to the cited transplant program’s waiting list; and
(4)
Recipients being followed by the cited transplant program.
If the Member placed on Probation by the OPTN is a Transplant Center, then the Member
Transplant Center must notify its patients that the Member received this adverse action. This
notice to Patients must be given within 30 days of the Member receiving formal notification from
the OPTN that it has been placed on Probation. The notice must be sent by the Member
Transplant Center to each Patient as defined above during the time the Member is on Probation.
OPTN Bylaws, Appendix A2-5
June 26, 2007
The notice to Patients must be provided in writing, in each Patient’s spoken language, and as
specified by the Executive Committee or Board of Directors.
The Member shall comply with any additional notification requirements specified by the MPSCPCSC, MPSC, Executive Committee, or Board of Directors.
(4)
Member Not in Good Standing.
a.
Adverse Action. The MPSC may recommend that the Board of Directors or the
Executive Committee declare the Member a “Member Not in Good Standing,”
or the Executive Committee or the Board of Directors may do so on its own
accord. Such action would be an adverse action under the Bylaws. This adverse
action would first entitle the Member to procedural rights as provided in Section
3.01A – 3.03A. The Member is entitled to the procedural rights described in that
Section in the case of recommendation of declaring a Member a “Member Not
in Good Standing” by the MPSC. The Member is also entitled to those same
rights by a final decision of the Board of Directors or the Executive Committee
to declare the Member a “Member Not in Good Standing” and give notice of
that final action to the Secretary of HHS.
b.
General Requirements. The adverse action of Member Not in Good Standing
may include one or more of the following, plus any other action, as specified by
the Board of Directors or the Executive Committee:
c.
(1)
Suspension of voting privileges in OPTN affairs.
(2)
During the duration of the adverse action, suspension of the ability
for any personnel named in the OPTN Contractor Membership
database as associated with the Member to sit on any Committee,
hold office, and sit on the Board of Directors.
(3)
Formal notification, along with subsequent changes in such status,
to the entire OPTN Membership, including the Chief Executive
Officer of each OPTN Institutional Members
(4)
Formal notification, along with subsequent changes in such status,
to the Member’s Chief Executive Officer or Administrator and to
the state health commissioner or other appropriate state
representative with oversight of health care institutions doing
business in the Member’s state.
(5)
Notice within reasonable limits and means to the general public in the
area of the Member as specified by the Board of Directors or the
Executive Committee. Such notice may include, but is not limited to,
communication using the OPTN website.
(6)
The actions listed for a Member on Probation.
Additional Notice Requirements for Transplant Centers Declared a
Member Not in Good Standing. Notice of this adverse action must be given
by the Member to all Patients directly associated with the Member Transplant
Center, including Patients of all of the Member’s transplant programs. For
purposes of this requirement, “Patients” shall include the following individuals:
(1)
Patients undergoing the evaluation process at all of the Member’s
transplant programs;
OPTN Bylaws, Appendix A2-6
June 26, 2007
(2)
Candidates on the waitlist of all of the Member’s transplant programs;
(3)
Candidates added to all of the Member’s transplant programs’ waiting
lists; and
(4)
Recipients being followed by all of the Member’s transplant programs.
If the Member declared a Member Not in Good Standing by the OPTN is a Transplant Center,
then the Member must notify its Patients that the Member received this adverse action. This notice
to Patients must be given within 30 days of the Member receiving formal notification from the
OPTN that it has been declared a Member Not in Good Standing. The notice must be sent by the
Member to each Patient as defined above during the time the Member is a Member Not in Good
Standing of the OPTN.
The notice to Patients must be provided in writing, in each Patient’s spoken language, and as
specified by the Executive Committee or Board of Directors.
The Member shall comply with any additional notification requirements specified by the MPSCPCSC, MPSC, Executive Committee, or Board of Directors.
(5)
Suspension of Member Privileges.
a.
Adverse Action. In the case of noncompliance with policies covered by Section
1138 of the Social Security Act, the MPSC may recommend that the Board of
Directors or the Executive Committee request approval from the Secretary of
HHS to suspend the Member’s Privileges. The Board of Directors or the
Executive Committee may request such approval from the Secretary on its own
accord. This adverse action would first entitle the Member to procedural rights
as provided in Section 3.01A – 3.03A. The Member is entitled to the procedural
rights described in that Section in the case of a recommendation by the MSPC
that the Board of Directors or the Executive Committee request approval from
the Secretary to suspend the Member’s Privileges. The Member is also entitled
to those same rights by a final decision of the Board of Directors or the
Executive Committee to request such approval from the Secretary.
b.
General Requirements. Suspension of membership privileges may include
one or more of the following or other actions as specified by the MPSCPCSC, the MPSC, the Executive Committee, or the Board of Directors.
The actions requested to be taken shall be included in the request for
approval from the Secretary.
(1)
Suspension of voting privileges in OPTN affairs.
(2)
During the duration of the adverse action, suspension of the ability
for any personnel named in the OPTN Contractor Membership
database as associated with the Member to hold office and/or sit on
OPTN Board of Directors or Committees.
(3)
Suspension of the privilege to receive all organ offers or offers of
particular organ types for transplantation and related services.
(4)
Suspension of the privilege to list all patients or patients in need of
particular organ types on the OPTN Waiting List.
(5)
The actions listed for a Member on Probation and the actions listed
for a Member Not in Good Standing
OPTN Bylaws, Appendix A2-7
June 26, 2007
c.
Additional Notice Requirements if the OPTN Recommends Suspension of
Member Privileges for a Transplant Center. Notice of this adverse action
must be given by the Member to all Patients directly associated with the
Member Transplant Center, including Patients of all of the Member’s transplant
programs. For purposes of this requirement, “Patients” shall include the
following individuals:
(1)
Patients undergoing the evaluation process at all of the Member’s
transplant programs;
(2)
Candidates on the waitlist of all of the Member’s transplant programs;
(3)
Candidates added to all of the Member’s transplant programs’ waiting
lists; and
(4)
Recipients being followed by all of the Member’s transplant programs.
If the Member whose Privileges are suspended is a transplant center, then the Member must notify
its Patients that the Member received this adverse action. This notice to Patients must be given
within 30 days of the Member receiving formal notification from the OPTN that its Privileges
have been suspended. The notice must be sent by the Member to each Patient as defined above
during the time the Member’s Privileges are suspended.
The notice to Patients must be provided in writing, in each Patient’s spoken language, and as
specified by the Executive Committee or Board of Directors.
The Member shall comply with any additional notification requirements specified by the MPSCPCSC, MPSC, Executive Committee, or Board of Directors.
(6)
Termination of Membership or Designated Transplant Program Status.
a.
Adverse Action. The MPSC may recommend that the Board of Directors or the
Executive Committee request approval from the Secretary of HHS to terminate
membership or designated transplant program status for one or more of the
Member’s organ transplant programs. The Board of Directors or the Executive
Committee may request such approval from the Secretary on its own accord.
This adverse action would first entitle the Member to procedural rights as
provided in Section 3.01A – 3.03A. The Member is entitled to the procedural
rights described in that Section in the case of a recommendation of the MPSC
that the Board of Directors, or the Executive Committee, request approval from
the Secretary to terminate membership or designated transplant program status
for one or more of the Member’s organ transplant programs. The Member is
also entitled to those same procedural rights by a final decision of the Board of
Directors or the Executive Committee to request such approval from the
Secretary.
b.
General Requirements. Termination of Membership or Designated
Transplant Program Status may include one or more of the following or
other actions as specified by the MPSC-PCSC, the MPSC, the Executive
Committee, or the Board of Directors. The actions requested to be taken
shall be included in the request for approval from the Secretary.
(1)
Suspension of voting privileges in OPTN affairs.
(2)
During the duration of the adverse action, suspension of the ability
for any personnel named in the OPTN Contractor Membership
OPTN Bylaws, Appendix A2-8
June 26, 2007
database as associated with the Member to hold office and/or sit on
OPTN Board of Directors or Committees.
c.
(3)
Suspension of the privilege to receive all organ offers or offers of
particular organ types for transplantation and related services.
(4)
Suspension of the privilege to list all patients or patients in need of
particular organ types on the OPTN Waiting List.
(5)
The actions listed for a Member on Probation, the actions listed for
a Member Not in Good Standing, and/or the actions listed for
Suspension of Member Privileges.
Additional Notice Requirements for Transplant Centers if the OPTN
Recommends Termination of Membership or Designated Transplant
Program Status. Notice of this adverse action must be given by the Member to
all Patients directly associated with the Member Transplant Center, including
Patients of all of the Member’s transplant programs. For purposes of this
requirement, “Patients” shall include the following individuals:
(1)
Patients undergoing the evaluation process at all of the Member’s
transplant programs;
(2)
Candidates on the waitlist of all of the Member’s transplant programs;
(3)
Candidates added to all of the Member’s transplant programs’ waiting
lists; and
(4)
Recipients being followed by all of the Member’s transplant programs.
If the Member whose Membership is terminated or whose organ transplant program’s Designated
Transplant Program Status is terminated must notify its Patients that the Member received this
adverse action. This notice to Patients must be given within 30 days of the Member receiving
formal notification from the OPTN that its Membership or Designated Transplant Program Status
has been terminated.
The notice to Patients must be provided in writing, in each Patient’s spoken language, and as
specified by the Executive Committee or Board of Directors.
The Member shall comply with any additional notification requirements specified by the MPSCPCSC, MPSC, Executive Committee, or Board of Directors.
(7)
Action Specified in OPTN Final Rule.
a.
Adverse Action. In the case of noncompliance with policies covered by Section
1138 of the Social Security Act, the MPSC may recommend that the Board of
Directors or the Executive Committee recommend to the Secretary of HHS any
action specifically identified in Section 121.10(c) of the OPTN Final Rule. The
Board of Directors or the Executive Committee may make such a
recommendation to the Secretary on its own accord. This adverse action would
first entitle the Member to procedural rights as provided in Section 3.01A –
3.03A. The Member is entitled to the procedural rights described in that Section
in the case of a recommendation by the MPSC that the Board of Directors or the
Executive Committee recommend that the Secretary take any action specifically
identified in Section 121.120(c) of the OPTN Final Rule. The Member is also
entitled to those same rights by a final decision of the Board of Directors or the
Executive Committee to make such a recommendation to the Secretary of HHS.
OPTN Bylaws, Appendix A2-9
June 26, 2007
b.
Additional Notice Requirements if the OPTN Recommends an Action
Specified in OPTN Final Rule against a Transplant Center. Notice of this
adverse action must be given by the Member to all Patients directly associated
with the Member Transplant Center, including Patients of all of the Member’s
transplant programs. For purposes of this requirement, “Patients” shall include
the following individuals:
(1)
Patients undergoing the evaluation process at all of the Member’s
transplant programs;
(2)
Candidates on the waitlist of all of the Member’s transplant programs;
(3)
Candidates added to all of the Member’s transplant programs’ waiting
lists; and
(4)
Recipients being followed by all of the Member’s transplant programs.
If the Member against which the adverse action is taken is a transplant center, then the Member
must notify its Patients that the Member received this adverse action. This notice to Patients must
be given within 30 days of the Member receiving formal notification from the OPTN that the
adverse action has been taken.
The notice to Patients must be provided in writing, in each Patient’s spoken language, and as
specified by the Executive Committee or Board of Directors.
The Member shall comply with any additional notification requirements specified by the MPSCPCSC, MPSC, Executive Committee, or Board of Directors.
2.07A- - Medical Peer Review
Deliberations and actions of the MPSC, the Executive Committee, and the Board of Directors while
investigating and considering applications for membership and designation as a transplant program, as well
as incidences of potential non-compliance with the OPTN requirements shall be accorded confidentiality as
an essential element of OPTN medical peer review. The Project Officer for the OPTN Contract and the
Director of the Division of Transplantation within the Health Resources and Services Administration, HHS,
or their designee(s) serve as ex-officio, non-voting members of these bodies and, as such, are parties with
full access to these deliberations and actions. Records of and documents associated with MPSC, and the
Executive Committee, and the Board deliberations and actions shall, to the extent permitted by law, be
confidential and protected by the peer review privilege. Peer review privilege shall not be asserted,
however, to withhold any document from the Secretary, or his/her designee, upon submission of a request
therefor by the Secretary or his/her designee to the OPTN Contractor.
2.08A - Enforcement Period
The failure by an OPO, Transplant Hospital, or Histocompatibility Laboratory Member to comply in all
material respects with the OPTN requirements may ultimately result in a recommendation to the Secretary
of HHS for expulsion from membership or action as specifically identified in Section 121.10(c) of the
OPTN Final Rule, 42 CFR § 121.10(c), including, for example, termination of a Transplant Hospital or
OPO Member’s reimbursement under Medicare and Medicaid. The nature of the violation will determine
the time period allowed to bring the Member into compliance prior to a recommendation to the Secretary of
HHS for such action (hereafter referred to as the "enforcement period"). By way of example, and not by
way of limitation, the following demonstrate examples of policy violations and potential enforcement
periods and actions that may apply:
(1)
Failure to comply with OPTN allocation policy designated as a Category I potential violation, with
finding of urgent, time sensitive threat to patient health and/or public safety:
OPTN Bylaws, Appendix A2-10
June 26, 2007
(a)
(2)
(3)
(4)
Recommend to Member that it voluntarily inactivate the applicable program, with
recommendation to Secretary of HHS to suspend the Member's ability to list patients on
the waiting list, eligibility to receive organ offers for transplant or related services, and
other privileges of membership if Member does not take action voluntarily (during this
period the Member's patients will be offered the opportunity for transfer to another
Member's waiting list pursuant to OPTN requirements); simultaneous declaration that the
Member is Not in Good Standing
Failure to comply with OPTN allocation policy designated as a Category II potential violation:
(a)
Letter from MPSC-PCSC requesting full compliance within 30 days.
(b)
Placement on probation or declaration that the Member is Not in Good Standing if the
violation continues beyond 45 days.
(c)
Recommendation to the Secretary of HHS for expulsion from membership or action
specifically identified under Section 121.10(c) of the OPTN Final Rule only if the
violation involves a policy covered by Section 1138 of the Social Security Act and is not
corrected within 45 days after the Member has been placed on probation or declared a
Member Not in Good Standing.
Failure to submit data within time periods as may be specified in the OPTN policies:
(a)
Letter from the MPSC or MPSC-PCSC, allowing a 60-day period to correct deficiencies
and bring all data current;
(b)
If the violation is not corrected within 75 days after the issuance of a warning letter, the
Member will be placed on probation or declared a Member Not in Good Standing.
(c)
Only if the violation involves a policy covered by Section 1138 of the Social Security Act
and is not corrected within 30 days after the Member has been placed on probation or
declared a Member Not in Good Standing, a request for approval from the Secretary of
HHS to suspend the Member's ability to list patients on the waiting list, eligibility to
receive organ offers for transplant or related services, and other privileges of membership
for 60 days. During this period the Member's patients will be offered the opportunity for
transfer to another Member's waiting list;
(d)
Recommendation to the Secretary of HHS for expulsion from membership or action
specifically identified under Section 121.10(c) of the OPTN Final Rule only if the
violation involves a policy covered by Section 1138 of the Social Security Act and the
Member fails to demonstrate full compliance by end of the 60-day suspension period.
Failure to pay OPTN registration fees:
(a)
Letter from the MPSC or MPSC-PCSC allowing 10 to 90 days, at the discretion of the
Committee, to correct the specified deficiencies.
(b)
If the violation is not corrected within the specified time period, the Member will be
placed on probation or declared a Member Not in Good Standing.
(c)
Only if the violation involves a policy covered by Section 1138 of the Social Security Act
and is not corrected within 30 days after the Member has been placed on probation or
declared a Member Not in Good Standing, a request for approval from the Secretary of
HHS to suspend the Member's ability to list patients on the waiting list, eligibility to
receive organ offers for transplant or related services, and other privileges of membership
OPTN Bylaws, Appendix A2-11
June 26, 2007
for 60 days. During this period the Member's patients will be offered the opportunity for
transfer to another Member's waiting list.
(d)
Recommendation to the Secretary of HHS for expulsion from membership or action
specifically identified under Section 121.10(c) of the OPTN Final Rule only if the
violation involves a policy covered by Section 1138 of the Social Security Act and the
Member fails to demonstrate full compliance by end of the 60-day suspension period.
2.09A - Restoration of Membership Privileges
An OPO, Transplant Hospital, or Histocompatibility Laboratory Member that is declared a Member Not in
Good Standing or placed on probation shall be entitled to full restoration of membership privileges at any
time prior to recommendation for expulsion, if the Member demonstrates to the Board of Directors full
compliance with OPTN requirements, including completion of actions prescribed as a result of the
imposition of sanctions. An OPO, Transplant Hospital, or Histocompatibility Laboratory Member that is
placed on suspension shall, with prior approval from the Board and Secretary of HHS, be entitled to full
restoration of membership privileges at any time prior to recommendation for expulsion, if the Member
demonstrates to the Board of Directors full compliance with OPTN requirements, including completion of
actions prescribed as a result of the imposition of sanctions. After expulsion, the Member must submit a
new complete application for OPTN membership.
2.10A - Notice
All OPTN Members and OPOs and Histocompatibility Laboratories with whom the Member has affiliation
known to the OPTN Contractor shall be notified by the Executive Director when an OPO, Transplant
Hospital, or Histocompatability Laboratory Member has been finally placed on probation, declared Not in
Good Standing, suspended or expelled, as well as when there is a subsequent change in such status.
2.11A - Procedural Rights
Procedural rights, including “interviews and hearings,” are further described in Section 3.01A – 3.03A of
the Bylaws. If the Member does not deliver a written request for an interview to the chairperson of the
MPSC or the Executive Director either in person or by certified or registered mail within 14 days following
his receipt of such notice, the Member waives it rights to an interview and the MPSC may proceed to
implement its proposed action.
2.12A - Time Period for Action
To the extent practicable, the MPSC-PCSC or full MPSC shall initiate investigation of a request for
corrective action within 45 days of receipt by the OPTN Contractor of the request.
OPTN Bylaws, Appendix A2-12
June 26, 2007
Interviews and Hearings
3.01A - Definition of "Adverse"
(1)
(2)
(3)
Recommendations or Actions: Subject to Section 3.01a (4) below, the following
recommendations or actions shall, if deemed adverse pursuant to Section 3.01a (2) below, entitle
the applicant or Member affected thereby to a hearing:
(a)
Rejection of initial membership or rejection of designation as a transplant program;
(b)
Probation;
(c)
Initial declaration of Member Not in Good Standing and subsequent determinations
not to restore the Member to unrestricted membership status;
(d)
Suspension of membership privileges either directly or after a period of probation;
(e)
Termination of membership, either directly or after a period of probation or
suspension.
(f)
Any other action specified in Section 121.10(c) of the OPTN Final Rule, 42 CFR §
121.10(c), including, by way of example and not limitation, removal of designation
as a transplant program.
When Deemed Adverse: A recommendation or action listed in section 3.01a (1) above shall be
deemed adverse only when it has been:
(a)
Recommended by the MPSC or, in the case of: (i) rejection of initial membership, (ii)
rejection of designation as a transplant program, or (iii) findings with respect to Category
I potential violations, recommended by a Subcommittee of the MPSC; or
(b)
Taken by the Board of Directors or the Executive Committee contrary to a favorable
recommendation by the MPSC or subcommittee of the MPSC under circumstances where
no right to a hearing existed; or
(c)
Taken by the Board of Directors or the Executive Committee on its own initiative without
benefit of a prior recommendation by the MPSC.
Interviews: Except in the case of Category I potential violations, when the MPSC or MPSCPCSC is considering making an adverse recommendation concerning an applicant or a Member or
issuing a letter of reprimand, or when an organ-specific committee refers a matter to the
MPSC/MPSC-PCSC with a recommendation that the MPSC consider such an action under
Section 2.05A above, the applicant or Member shall be entitled to an interview before the MPSC
or the MPSC-PCSC. The interview shall not constitute a hearing, shall be preliminary in nature,
and shall not be conducted according to the procedural rules provided with respect to hearings.
The applicant or Member shall be informed of the general nature of the circumstances and may
present information relevant thereto. A summary record of such interview shall promptly be made
by the MPSC and a copy promptly provided to the applicant or Member who was granted the
interview. Notwithstanding the foregoing, upon determination by the Board of Directors based on
available evidence that an alleged violation of OPTN requirements poses a substantial and
imminent threat to the quality of patient care, the Board may take appropriate action even if the
Member has not had the opportunity for an interview and/or other procedural rights described
below.
Members shall not be entitled to an interview in the case of Category I potential violations.
OPTN Bylaws, Appendix A3-1
December 14, 2006
(4)
Right to a Hearing:
(a)
An applicant or Member shall have the right to one hearing proceeding, and subsequent
appellate review unless the Board of Directors conducts the hearing, with respect to any
application for membership, application for designation as a transplant program, and
request for corrective action to enforce membership requirements in which an adverse
recommendation or action is taken. The hearing may be requested upon the first to occur
of the adverse recommendations or actions listed in section 3.01A(1) above or, if waived
at such time by the applicant's or member's failure to request a hearing within the time
and in the manner specified in section 3.02A below, upon any subsequent adverse
recommendation or action arising out of the same application for membership,
application for designation as a transplant program, or request for corrective action to
enforce membership requirements.
(b)
Category I Potential Violations. In the case of a determination of time sensitive threat
to patient health or public safety in connection with Category I potential violations, the
hearing and any subsequent appellate review will commence together with or follow
rather than precede the Executive Committee’s or the Board’s decision regarding and
action upon the MPSC subcommittee’s recommendation, as set forth below:
(i)
The MPSC subcommittee recommendation will be referred immediately to the
Executive Committee. At the same time, notice will be given to the Member by
registered or certified mail, return receipt requested, as well as facsimile
transmission. Where the finding continues to be a Category I potential violation
with time sensitive threat to patient health or public safety, the MPSC
subcommittee action shall include a recommendation for designation of the
Member to be Member Not in Good Standing and that the offending transplant
program or institution voluntarily inactivate, and, failing acceptance of this
recommendation to voluntarily inactivate with immediate action to so inactivate
(including notice to and assistance for patients pursuant to OPTN requirements),
the MPSC subcommittee shall further recommend approval from the Secretary
to suspend member privileges, terminate membership or designated transplant
program status, and/or take action specified in the OPTN Final Rule.
(ii)
Following receipt of the MPSC subcommittee recommendation, the Executive
Committee shall determine whether it or the Board of Directors shall consider
the matter and the Executive Committee or the Board, as the case may be, shall
consider the same and affirm, modify, or reverse the recommendation or action
in the matter. A concise statement of the result and the reasons therefore, and all
documentation considered, shall be transmitted to the Executive Director.
(iii)
The Executive Director, or his/her designee, shall promptly send a copy of the
result to the Member by registered or certified mail, return receipt requested (as
well as facsimile transmission), and to the Secretary of HHS within three
business days or such longer period as may be necessitated for good cause, as
determined by the Secretary, if the decision continues to be adverse to the
Member. A copy of the result also shall be forwarded to the MPSC or to the
Board of Directors, as determined by the Executive Committee, in the event the
Member exercises its rights to a hearing under Section 3.02A of the Bylaws.
The Member may request that a copy of the supporting documentation be
furnished at the Member’s expense.
(iv)
Notice of a decision by the Executive Committee or Board that the Member has
been placed on probation or declared Not in Good Standing shall be circulated
to all Members. The membership shall be notified of decisions by the Executive
Committee or Board to recommend to the Secretary of HHS suspension of
OPTN Bylaws, Appendix A3-2
December 14, 2006
membership privileges or termination of membership only upon approval of
such recommendation by the Secretary.
(v)
In the event the Member exercises its right to a hearing, the process described in
Section 3.02A will be initiated or continued, as applicable, consistent with the
timing of delivery and receipt of notices. The hearing will be before the MPSC,
the Board or the Executive Committee as determined by the Executive
Committee.
Notwithstanding the foregoing, upon determination by the Board of Directors based on
available evidence that an alleged violation of OPTN requirements poses a substantial
and imminent threat to the quality of patient care, the Board may take other appropriate
action using other appropriate process even if the steps noted above for a Category I
proceeding have not been completed or the Member otherwise has not had the
opportunity for a hearing and/or subsequent appellate review.
(5)
Right of Appeal to the Secretary. An applicant for membership or designation as a transplant
program shall have the right to appeal decisions of the MPSC, MPSC subcommittees, or the Board
of Directors regarding these applications to the Secretary of HHS in accordance with the OPTN
Final Rule, 42 CFR Part 121. In the event an applicant exercises this right of appeal prior to
exhaustion of the applicant’s other procedural rights as described in these Bylaws, the applicant
shall notify the OPTN Contractor of this exercise by registered or certified mail, return receipt
requested. Upon receiving such notification, the OPTN Contractor shall notify the Secretary of
the status of the matter with respect to these procedures within three business days or such longer
period as may be necessitated for good cause, as determined by the Secretary. Pending a decision
on the appeal, the process defined by these procedures shall continue unless the Secretary directs
otherwise. In the event the appeal is denied, the process shall be further continued or reinitiated,
as applicable. Any other decision on the appeal by the Secretary shall be submitted to the MPSC
or Board of Directors as appropriate for action consistent with the Secretary’s decision.
3.02A – Hearings
(1)
Parties: The parties to a hearing shall be the applicant or Member against whom an adverse
recommendation or action has been taken and the MPSC, the Executive Committee, or the Board
of Directors, i.e., the body whose adverse recommendation or action is at issue.
(2)
Notice of Adverse Recommendation or Action: An applicant or Member against whom an
adverse recommendation or action has been taken shall promptly be given notice of such action by
registered or certified mail, return receipt requested. Such notice shall:
(a)
Briefly advise the applicant or Member of the nature of the adverse recommendation
or action and the grounds therefor; and
(b)
Advise the applicant or Member of the right to a hearing pursuant to the provisions
of these Bylaws; and
(c)
Specify the number of days following the date of receipt of notice within which a
request for a hearing must be submitted; and
(d)
State that the failure to request a hearing within the specified time period shall
constitute a waiver of rights to a hearing and to any appellate review of the matter;
and
(e)
State that all materials about the applicant or Member that were generated by or
submitted to the MPSC, the Executive Committee, or the Board, as the case may be,
prior to that body's adverse recommendation or action, shall be made available to the
applicant or Member, upon request, for inspection and copying; and
OPTN Bylaws, Appendix A3-3
December 14, 2006
(f)
(3)
Request for Hearing:
(a)
(b)
(4)
State that upon the OPTN Contractor’s receipt of the hearing request, the applicant
or Member will be notified of the date, time and place of the hearing.
Except in the case of Category I potential violations, an applicant or Member shall have
14 days following his receipt of a notice to file a written request for a hearing. If the
applicant or Member wishes to be represented at the hearing by an attorney, the request
for hearing shall include a statement to that effect and identify by name and business
address the attorney who will represent the applicant or Member. Such requests shall be
delivered to the chair of the MPSC or the Executive Director either in person or by
certified or registered mail.
Category I Potential Violations. In the case of Category I potential violations, an
applicant or Member shall have seven days following his receipt of a notice to file a
written request for a hearing. If the applicant or Member wishes to be represented at the
hearing by an attorney, the request for hearing shall include a statement to that effect and
identify by name and business address the attorney who will represent the applicant or
Member. Such requests shall be delivered to the chair of the MPSC or the Executive
Director either in person or by certified or registered mail.
Waiver by Failure to Request a Hearing: An applicant or Member who fails to request a hearing
within the time and in the manner specified waives any right to such a hearing or any appellate
review to which he might otherwise have been entitled. Such waiver in connection with:
(a)
An adverse action by the Board of Directors or the Executive committee, shall
constitute acceptance of that action, which shall thereupon become effective as the
final decision by the Board;
(b)
An adverse recommendation by the MPSC or the Executive committee shall
constitute acceptance of that recommendation, which shall thereupon become and
remain effective pending the final decision of the Board of Directors.
(5)
Notice of Hearing: Upon receipt of a timely request for a hearing, notification of the time, place,
and date of the hearing shall be sent to the applicant or Member by certified mail at least 7 days
prior to the hearing.
(6)
Statement of Issues: The notice of hearing described in Section 3.02A(5) above shall contain a
concise statement of the issues raised by the adverse recommendation or action which is the
subject of the hearing.
(7)
Appointment of Hearing Committees:
(a)
By MPSC: A hearing occasioned by an adverse MPSC recommendation shall be
conducted by a hearing committee appointed by the chair of the MPSC and
composed of three (3) members of the MPSC or in the discretion of the chair, shall
be composed of those MPSC members who are in attendance at a regular or special
MPSC meeting and are not disqualified under section 3.02A(8) below.
(b)
By Board of Directors: A hearing occasioned by an adverse action of the Board of
Directors may be conducted by a hearing committee appointed by the chair of the
Board of Directors and composed of three (3) directors. One of the appointees shall
be designated as chair. Alternatively, in the discretion of the chair of the Board, the
hearing shall be conducted by those Board Members who are in attendance at a
regular or special meeting of the Board, provided that such Members are not
OPTN Bylaws, Appendix A3-4
December 14, 2006
disqualified under Section 3.02A(8) below and constitute at least a quorum of the
full Board.
(c)
(8)
By MPSC-PCSC or Ad Hoc MPSC Subcommittee/Executive Committee or
Board in the Case of Category I Potential Violations: A hearing occasioned by an
adverse recommendation from a subcommittee of the MPSC or Executive
Committee or Board in the case of Category I potential violations shall be conducted
by a hearing committee appointed by the chair and composed of at least three (3)
members of the MPSC or, in the discretion of the chair, shall be composed of those
members who are in attendance at a regular or special meeting and are not
disqualified under section 3.02A(8) below, provided that such members constitute at
least a quorum of the full committee or Board.
Service on Hearing Committee: A MPSC or Board of Directors member shall be disqualified
from serving on a hearing committee if he/she has been personally and directly involved in
compiling evidence for the OPTN Contractor on the matter at issue.
(9)
Appearance and Representation: Appearance by the applicant or Member who requested the
hearing shall be required. An applicant or Member who fails without good cause to appear and
proceed at such hearing shall be deemed to have waived his rights to such a hearing or any
appellate review to which it might otherwise have been entitled. The applicant or Member may be
represented by an attorney at any hearing or at any appellate review proceeding. The MPSC,
MPSC subcommittee, Executive committee, or the Board of Directors shall be allowed
representation by an attorney.
(10)
Presiding Officer: The chair of the hearing committee shall be the presiding officer. The
presiding officer shall regulate the course of the hearing to assure that all participants in the
hearing have a reasonable opportunity to present relevant oral and documentary evidence and to
conduct such cross-examination as may be required for a full and true disclosure of the facts.
He/she shall determine the order of procedure during the hearing and shall make all rulings on
interpretation or construction of the OPTN Charter and Bylaws and other relevant documents and
OPTN requirements on procedure; and on the admissibility of evidence. He/she shall provide for
the exclusion of irrelevant, immaterial, or unduly repetitious evidence.
(11)
Rights of Parties: During a hearing, each of the parties shall have the right, subject to the
presiding officer's rulings, to:
(a)
Call and examine witnesses;
(b)
Introduce exhibits;
(c)
Cross-examine any witness on any matter relevant to the issue;
(d)
Impeach any witness;
(e)
Rebut any evidence.
If the applicant or Member who requested the hearing does not testify in its own behalf,
representatives of the application who are present may be called and examined as if under crossexamination.
(12)
Procedure and Evidence: The hearing need not be conducted strictly according to rules of law
relating to the examination of witnesses or presentation of evidence. Any relevant matter upon
which responsible persons customarily rely in the conduct of serious affairs shall be admitted,
regardless of the admissibility of such evidence in a court of law. Each party shall, prior to or
during the hearing, be entitled to submit memoranda concerning any issue, and such memoranda
shall become part of the hearing record. The presiding officer may, but shall not be required to,
OPTN Bylaws, Appendix A3-5
December 14, 2006
order that oral evidence be taken only on oath or affirmation administered by any person
designated by him/her and entitled to notarize documents in the state where the hearing is held.
(13)
Official Notice: In reaching a decision, the hearing committee may take official notice, either
before or after submission of the matter for decision, of any generally accepted technical or
scientific matter relating to the issues under consideration and of any facts that may be judicially
noticed by the courts of the state where the hearing is held. Parties present at the hearing shall be
informed of the matters to be thus noticed and those matters shall be noted in the hearing record.
Any party shall be given opportunity, on timely request, to request that a matter be officially
noticed and to refute the officially noticed matters by evidence or by written or oral presentation of
authority, the manner of such refutation to be determined by the hearing committee. The
committee shall also be entitled to consider all other information that can be considered, pursuant
to these Bylaws, in connection with applications for membership, applications for designation as a
transplant program, or requests for corrective action.
(14)
Burden of Proof: The body whose adverse recommendation or action occasioned the hearing
shall have the initial obligation to present evidence in support thereof, including an explanation of
the action or recommendation and why it was taken. The applicant or Member who requested the
hearing shall then have the burden of proving and persuading, by clear and convincing evidence,
that the adverse recommendation or action lacks any substantial factual basis or that such basis or
the conclusions drawn therefrom are arbitrary, unreasonable, or capricious.
(15)
Record of Hearing: A record of the hearing shall be kept that is of sufficient accuracy to permit
an informed and valid judgment to be made by any group that may later be called upon to review
the record and render an appellate recommendation or decision in the matter. The hearing
committee and the applicant or Member shall, by mutual agreement, select the method to be used
for making the record such as court reporter, electronic recording unit, detailed transcription, or
minutes of the proceedings. In the absence of mutual agreement, a court reporter shall be in
attendance and shall prepare a written transcript. All exhibits admitted into evidence at the hearing
and all memoranda submitted to the hearing committee before, during, or after the hearing, shall
be incorporated in the record.
(16)
Postponement: Request for postponement of a hearing shall be granted by the hearing committee
only upon a showing of good cause and only if the request therefor is made as soon as is
reasonably practicable.
(17)
Presence of Hearing Committee Members and Vote: A majority of the hearing committee must
be present throughout the hearing and deliberations. If a committee member is absent from any
part of the proceedings, he/she shall not be permitted to participate in the committee's
deliberations or the decision.
(18)
Recesses and Adjournment: The hearing committee may recess the hearing and reconvene the
same without additional notice for the convenience of the participants or for the purpose of
obtaining new or additional evidence or consultation. Upon conclusion of the presentation of oral
and written evidence, the hearing shall be closed. The hearing committee shall thereupon, at a
time convenient to itself, conduct its deliberations outside the presence of the parties. Upon
conclusion of its deliberations, the hearing shall be declared finally adjourned.
(19)
Hearing Committee Report: Following preparation of the hearing record, the hearing committee
shall make a written report of its findings and recommendations in the matter and shall forward the
same, together with the hearing record and all other documentation considered by it, to the body
whose adverse recommendation or action occasioned the hearing. At the same time, a copy of the
hearing committee report shall be forwarded to the applicant or Member. All findings and
recommendations by the hearing committee shall be supported by reference to the hearing record.
The presiding officer may extend the time for making the hearing committee's written report in
his/her discretion by giving written notice to the participants.
OPTN Bylaws, Appendix A3-6
December 14, 2006
(20)
Action on Hearing Committee Report: Following receipt of the report of the hearing committee,
the MPSC, MPSC subcommittee, the Executive Committee, or the Board of Directors, as the case
may be, shall consider the same and affirm, modify, or reverse its recommendation or action in the
matter. It shall transmit a concise statement of the result and the reasons therefor, together with
the hearing record, the report of the hearing committee, and all other documentation considered, to
the Executive Director.
(21)
Notice: The Executive Director, or his/her designee, shall promptly send a copy of the result to the
applicant or Member by registered or certified mail, return receipt requested. A copy of the result
also shall be forwarded to the MPSC, Executive Committee, and/or to the Board of Directors in
the event the applicant or Member exercises its rights to appellate review under Section 3.03A of
the Bylaws. The applicant or Member may request that a copy of the hearing record and related
documentation be furnished at the applicant's or Member's expense.
(22)
Effect of Favorable Result:
(23)
(a)
Adopted by the Board of Directors or Executive Committee: If the Board of
Directors' or Executive Committee’s action is favorable to the applicant or Member,
such action shall become the final decision of the Board and the matter shall be
considered finally closed.
(b)
Adopted by the MPSC: If the MPSC's action is favorable to the applicant or
Member, the Executive Director shall promptly forward it, together with all
supporting documentation, to the Board of Directors for its final action. The Board
shall take action thereon by adopting or rejecting the MPSC's action in whole or in
part, or by referring the matter back to the MPSC for further consideration. Any
such referral back shall state the reasons therefor, set a limit within which a
subsequent recommendation to the Board must be made, and may include a directive
that an additional hearing be conducted to clarify issues that are in doubt. After
receipt of such subsequent recommendation and any new evidence in the matter, the
Board shall take final action. The Executive Director shall promptly send the
applicant or Member notice by registered or certified mail, return receipt requested,
informing him/her of each action taken. Favorable action shall become the final
decision of the Board of Directors, and the matter shall be considered finally closed.
In the case of favorable action with respect to a Category I potential violation that
has resulted in notice to the Secretary of HHS and/or public, the Board of Directors
shall remove the designation of Member Not in Good Standing or probation, as
applicable, with appropriate notice thereof, and recommend restoration of
unrestricted membership privileges to the Secretary of HHS. If the Board's action is
adverse, the special notice shall inform the applicant or Member of his right to
request an appellate review by the Board of Directors as provided in Section 3.03A
below, unless the Board itself has conducted the hearing.
Effect of Adverse Result: If the result of the MPSC or of the Board of Directors or the Executive
Committee continues to be adverse to the applicant or Member, the notice sent to him by
registered or certified mail, return receipt requested, shall inform him of any applicable right to
request an appellate review by the Board of Directors as provided in section 3.03A below.
3.03A - Appellate Review
(1)
Request for Appellate Review:
(a)
Except in the case of Category I potential violations, in which the Board of Directors has
not been the forum for the Member’s exercise of hearing rights, an applicant or Member
shall have 14 days following his receipt of notice that a hearing resulted in adverse action
OPTN Bylaws, Appendix A3-7
December 14, 2006
to file a written request for appellate review. Such request shall be delivered to the
Executive Director either in person or by certified or registered mail and may include a
request for a copy of the report and record of the hearing committee and all other
material, favorable or unfavorable, if not previously forwarded, that was considered in
making the adverse action or result. The applicant or Member may be represented during
the appellate review by an attorney. If the applicant or Member wishes to be so
represented, the request for appellate review shall include a statement to that effect and
identify by name and business address the attorney who will represent the applicant or
Member. Notwithstanding the foregoing, upon determination by the Board of Directors
based on available evidence that an alleged violation of OPTN requirements poses a
substantial and imminent threat to the quality of patient care, the Board may take
appropriate action even if the Member has not had the opportunity for an appellate
review.
(b)
Category I Potential Violations. In the case of Category I potential violations in which
the Board of Directors has not been the forum for the Member’s exercise of hearing
rights, a Member shall have seven days following his receipt of notice that a hearing
resulted in adverse action to file a written request for appellate review. Such request shall
be delivered to the Executive Director either in person or by certified or registered mail
and may include a request for a copy of the report and record of the hearing committee
and all other material, favorable or unfavorable, if not previously forwarded, that was
considered in making the adverse action or result. If the Board of Directors is the forum
for the exercise of the Member’s procedural rights, there is no right to Appellate Review
and the decision of the Board is final. The Member may be represented during the
appellate review by an attorney. If the Member wishes to be so represented, the request
for appellate review shall include a statement to that effect and identify by name and
business address the attorney who will represent the Member. Notwithstanding the
foregoing, upon determination by the Board of Directors based on available evidence that
an alleged violation of OPTN requirements poses a substantial and imminent threat to the
quality of patient care, the Board may take appropriate action even if the steps for a
Category I proceeding have not been completed or the Member otherwise has not had the
opportunity for an appellate review.
(2)
Waiver by Failure to Request Appellate Review: An applicant or Member who fails to request
an appellate review within the time and manner specified in section 3.03A(1) above waives any
right to such review.
(3)
Notice of Time and Place for Appellate Review:
(a)
Upon receipt of a timely request for appellate review, the Executive Director shall deliver
such request to the Board of Directors. As soon as practicable, the Board shall schedule
and arrange for an appellate review which, except in the case of Category I potential
violations, shall be not less than 30 days from the date of receipt of the appellate review
request. At least 25 days prior to the appellate review, the Executive Director shall send
the applicant or Member notice of the time, place, and date of the review by registered or
certified mail, return receipt requested. The time for the appellate review may be
extended by the appellate review body for good cause and if the request therefor is made
as soon as is reasonably practicable.
(b)
Category I Potential Violations. In the case of Category I potential violations, the
Board shall schedule and arrange for an appellate review not less than seven nor more
than 30 days from the date of receipt of the appellate review request. At least five days
prior to the appellate review, the Executive Director shall send the applicant or Member
notice of the time, place, and date of the review by facsimile or electronic transmission.
The time for the appellate review may be extended by the appellate review body for good
cause and if the request therefor is made as soon as is reasonably practicable.
OPTN Bylaws, Appendix A3-8
December 14, 2006
(4)
Appellate Review Body: The appellate review shall be conducted by the Board as a whole.
(5)
Nature of Proceedings: The proceedings by the review body shall be in the nature of an appellate
review based upon the record of the hearing before the hearing committee, that committee's report,
and all subsequent results and actions thereon. The appellate review body shall also consider any
written or oral statements submitted by the applicant or Member, and its representative(s), if any,
and any written or oral statements by the MPSC or the Board of Directors and any of their
members, individually.
(6)
Written Statements: The applicant or Member seeking the review may submit a written
statement detailing the findings of fact, conclusions, and procedural matters with which it
disagrees, and the reasons for such disagreement. This written statement may cover any matters
raised at any step in the hearing process, and legal counsel may assist in its preparation. The
statement shall be submitted to the appellate review body through the Executive Director or
his/her designee at least 15 days prior to the scheduled date of the appellate review, except if such
time limit is waived or modified by the appellate review body. A written statement in reply may
be submitted by the MPSC or by the Board of Directors, and if submitted, the Executive Director,
or his/her designee, shall provide a copy thereof to the applicant or Member at least 5 days prior to
the scheduled date of the appellate review or such shorter time as determined by the appellate
review body.
(7)
Presiding Officer: The chair of the appellate review body shall be the presiding officer. He/she
shall determine the order of procedure during the review, make all required rulings, and maintain
decorum.
(8)
Oral Statement: The appellate review body, in its sole discretion, may allow the parties or their
representatives to personally appear and make oral statements in favor of their positions. Any
party or representative so appearing shall be required to answer questions put to him/her by any
member of the appellate review body.
(9)
Consideration of New or Additional Matters: An applicant or Member may introduce at the
appellate review matters or evidence related to steps taken after the conclusion of the original
hearing to bring the applicant or Member into full compliance with membership qualifications or
requirements. Other new or additional matters or evidence not raised or presented during the
original hearing or in the hearing report and not otherwise reflected in the record shall be
introduced at the appellate review only in the discretion of the appellate review body, following an
explanation by the party requesting the consideration of such matter or evidence as to why it was
not presented earlier. In the discretion of the appellate review body, new or additional matters or
evidence permitted to be introduced at the appellate review may, but need not, be referred back to
the hearing committee in accordance with section 3.03A(13) below.
(10)
Powers: The appellate review body shall have all the powers granted to the hearing committee,
and such additional powers as are reasonably appropriate to the discharge of its responsibilities.
(11)
Presence of Members and Vote: A majority of the appellate review body must be present
throughout the review and deliberations. If a member of the review body is absent from any part
of the proceedings, he/she shall not be permitted to participate in the deliberations or the decision.
(12)
Recesses and Adjournment: The appellate review body may recess the review proceedings and
reconvene the same without additional notice for the convenience of the participants or for the
purpose of obtaining new or additional evidence or consultation. Upon the conclusion of oral
statements, if allowed, the appellate review shall be closed. The appellate review body shall
thereupon, at a time convenient to itself, conduct its deliberations outside the presence of the
parties. Upon the conclusions of those deliberations, the appellate review shall be declared finally
adjourned.
OPTN Bylaws, Appendix A3-9
December 14, 2006
(13)
Action Taken: The appellate review body may recommend affirmation, modification, or reversal
the adverse result or action taken by the MPSC, by the Executive Committee or by a committee of
the Board or, in its discretion, may refer the matter back to the hearing committee for further
review and recommendation to be returned to it in accordance with its instructions. After receipt
of such recommendations after referral, the appellate review body shall make its decision as
provided in this section. In the case of favorable action, which reverses an adverse result with
respect to a Category I potential violation that has resulted in notice to the Secretary of HHS
and/or public, the Board of Directors shall remove the designation of Member Not in Good
Standing or probation, as applicable, with appropriate notice thereof, and recommend restoration
of unrestricted membership privileges to the Secretary of HHS.
(14)
Conclusion: The appellate review shall not be deemed to be concluded until all of the procedural
steps provided herein have been completed or waived.
OPTN Bylaws, Appendix A3-10
December 14, 2006
Final Decision of the Board of Directors
4.01A - Board of Directors Action
After the MPSC forwards a recommendation to the Board of Directors for which an applicant or Member
waives the hearing and appellate review rights or after the conclusion of hearing and appellate review
proceedings, the Board shall render its final decision in the matter (which, in the case of an appellate
review proceeding, shall be the decision of the Appellate Review Body) in writing and shall send notice
thereof to the applicant or Member by certified or registered mail, and to the Secretary of HHS within three
business days or such longer period as may be necessitated for good cause, as determined by the Secretary,
if the decision continues to be adverse to the applicant or Member. A majority vote by a quorum is
required for the Board to take any action permitted by these Bylaws.
If the Board should decide that amore serious sanction than the sanction recommended by the MPSC or
Executive Committee is appropriate, the Board shall return the matter to the MPSC or Executive
Committee, as the case may be, for its consideration of the imposition of the more serious sanction. If the
MPSC or Executive Committee agrees with the Board, the more serious sanction shall be the final decision
of the Board. If the MPSC or Executive Committee does not agree that the more serious sanction is
appropriate, its initial recommendation to the Board shall be the final decision of the Board.
Notice of a final decision by the Board of Directors or Executive Committee that the Member has been
placed on probation or declared Not in Good Standing shall be circulated to all Members. The membership
shall be notified of final decisions by the Board or Executive Committee to recommend to the Secretary of
HHS suspension of membership privileges or termination of membership only upon approval of such
recommendations by the Secretary.
OPTN Bylaws, Appendix A4-1
December 14, 2006
Effect of Board Actions
5.01A - Terms of Probation
A Board action placing a Member on probation shall be effective when taken or at such other time as the
Board may direct, and may remain in effect during the period in which hearing and appellate review
proceedings are pending. Notice of a Board action placing a Member on probation will not be circulated to
all Members until such time as the applicable hearing and appellate review proceedings are waived or
concluded.
5.02A - Terms of Member Not in Good Standing
A Board action declaring a Member a Member Not in Good Standing, except as provided in the next
sentence, shall be effective when final Board action is taken pursuant to Section 4.01A above after the
Member has waived its right to a hearing and appellate review with respect to such Board action or
applicable hearing and appellate review proceedings have been concluded. Notwithstanding the foregoing,
a Board or Executive Committee action declaring a Member Not in Good Standing may be made effective
pursuant to the process for considering Category I potential violations described in this Appendix A of the
Bylaws or at any time if the Board shall find based on available evidence that the alleged violation of
membership requirements poses a substantial and imminent threat to the quality of patient care.
5.03A - Suspension and Expulsion
A Board action recommending suspension of membership privileges or expelling a Member, except as
provided in the next sentence, shall not become effective until final Board action is taken pursuant to
Section 4.01A above after the Member has waived its right to a hearing and appellate review with respect
to such Board action or applicable hearing and appellate review proceedings have been concluded and
acceptance of the Board’s recommendation by the Secretary of HHS. Notwithstanding the foregoing, a
Board or Executive Committee action recommending suspension of a Member may be made effective
pursuant to the process for considering Category I potential violations described in this Appendix A of the
Bylaws or at any time, subject to acceptance by the Secretary of HHS, if the Board shall find based on
available evidence that the alleged violation of membership requirements poses a substantial and imminent
threat to the quality of patient care.
5.04A - Secretarial Approval for Certain Actions
A Board decision recommending suspension of member privileges, termination of OPTN membership,
termination of status as designated transplant program, termination of participation in Medicare/Medicaid,
or termination of reimbursement under Medicare/Medicaid for violation of mandatory policies except as
provided in the next sentence, shall not become effective until (i) final Board action is taken pursuant to
Section 4.01A above; (ii) the Member has waived its right to a hearing and appellate review with respect to
such Board action or applicable hearing and appellate review proceedings have been concluded; (iii) the
Secretary of HHS has accepted the Board’s recommendation; and (iv) the Secretary of HHS has authorized
the implementation of such action. Notwithstanding the foregoing, a Board or Executive Committee
decision recommending such action for violation of mandatory policies may be made effective pursuant to
the process for considering Category I potential violations described in this Appendix A of the Bylaws or
at any time, subject to acceptance and authorization of implementation by the Secretary of HHS, if the
Board shall find, based on available evidence, that the alleged violation of mandatory policies poses a
substantial and imminent threat to the quality of patient care.
OPTN Bylaws, Appendix A5-1
December 14, 2006
5.05A - Restoration of Unrestricted Membership
Upon presentation of evidence to the satisfaction of the MPSC that a probationary Member, Member
declared Not in Good Standing, or suspended Member has fully complied with OPTN requirements,
including completion of actions prescribed as a result of the imposition of sanctions, the MPSC shall
recommend that the Board of Directors restore unrestricted membership privileges, in the case of a Member
placed on probation or declared Not in Good Standing, or recommend restoration of unrestricted
membership privileges to the Secretary of HHS, in the case of suspension of the Member’s membership
privileges.
5.06A - Restoration Of Privileges After Violation of Mandatory Policies Under Section 121.10(c) Of the
OPTN Final Rule
Upon presentation of evidence to the satisfaction of the MPSC that a Member penalized for violation of a
mandatory policy under Section 121.10(c) of the OPTN Final Rule, 42 CFR § 121.10(c), has fully
complied with OPTN requirements, including completion of actions prescribed as a result of the imposition
of sanctions, the MPSC shall recommend that the Board of Directors recommend to the Secretary of HHS
that the penalty be removed.
OPTN Bylaws, Appendix A5-2
December 14, 2006
Costs and Expenses
6.01A –Reimbursement of OPTN Contractor Costs and Expenses
Reasonable costs and expenses of (i) conducting other than routine on-site audits, reviewing and
monitoring corrective action plans and conducting due process proceedings (“compliance costs and
expenses”) resulting from enforcement of OPTN requirements under Section 2.01A and (ii) following and
conducting evaluations of transplant programs with low survival rates under Appendix B, Section II,
including on-site visits and review and monitoring of plans for quality improvement (“program evaluation
costs and expenses”) shall be reimbursed by the applicant or Member. Such costs and expenses shall
include, but shall not be limited to, travel and lodging expenses of volunteers and OPTN Contractor
representatives; compensation of OPTN Contractor representatives, and costs of preparation of reports. A
binding decision as to the nature and amount of costs and expenses charged to be reimbursed by the
applicant or Member shall be made by the Treasurer, or his/her designees, after consultation with the
Executive Director.
Reasonable costs and expenses of conducting interviews, hearings and appellate reviews under Section
3.01A and following shall be reimbursed by the applicant or Member. Such costs and expenses shall
include, but shall not be limited to, travel and lodging expenses of the applicant or Member and of
volunteers and OPTN Contractor representatives; compensation of OPTN Contractor representatives; court
reporter fees and the cost of preparation of the necessary number of copies of the hearing record; and the
costs of preparing for and attending, and of obtaining and compiling evidence and exhibits. A binding
decision as to the nature and amount of costs and expenses to be reimbursed shall be made by the Presiding
Officer after consultation with the Executive Director.
“OPTN Contractor representatives” shall include staff and outside counsel, consultants and expert
witnesses. Reasonable costs and expenses may be estimated and billed, wholly or partially, to the applicant
or Member in advance or may be billed, wholly or partially, to the applicant or Member as the matter
progresses. If actual costs and expenses otherwise reimbursable by the applicant or Member for the entire
matter before the MPSC are less than $500.00, or if the applicant or Member is not determined to be in
violation of OPTN requirements, no reimbursement shall be due from the application or Member and any
amounts previously reimbursed or deposited shall be returned. If the applicant or Member has multiple
matters before the MPSC within any twelve-month period, the dollar amount in the preceding sentence
shall apply to all such matters in the aggregate.
6.02A - Advanced Deposit for Reimbursable Costs and Expenses
As a condition to allowing a compliance or program evaluation site visit, an interview, a hearing or an
appellate review to proceed, the Presiding Officer may require that the applicant or Member make and
maintain a deposit with the Executive Director in an amount equal to the currently projected compliance
costs and expenses, program evaluation costs and expenses or costs and expenses of the interview, hearing
or appellate review, as the case may be. The failure to make the required deposit within 10 days after the
Presiding Officer requests an advance deposit shall be considered a waiver of the applicant or Member's
interview, hearing or appellate review rights. Following such a waiver, the MPSC and the Board of
Directors may go forward with the imposition of sanctions.
6.03A - Default in Payment of Reimbursable Cost and Expenses
Any applicant or Member who fails to pay reimbursable costs and expenses assessed pursuant to Section
6.01A within 30 days after having received notice by certified or registered mail, at the applicant or
Member's address as shown on the records of the OPTN Contractor, shall be referred to the Secretary for
termination of either OPTN membership or further consideration of the application, as appropriate.
OPTN Bylaws, Appendix A6-1
December 14, 2006
Time Periods for Action
7.01 A - Time Periods for Action
To the extent practicable, the following time periods shall apply in scheduling and taking actions with
respect to interviews, hearings, and appellate reviews:
(1)
Interviews: Interviews will be scheduled within 60 days of the decision of the MPSC-PCSC or
full MPSC that entitles the Member to the interview.
(2)
Initial Determination of Category I Potential Violations: Determination of Category I
potential violation by decision of MPSC Chairperson (with advice from Executive Director and
President) will occur within 72 hours of OPTN Contractor receipt of notice of issue, followed by
OPTN Contractor staff preliminary investigation within 14 days of determination.
(3)
Initial Consideration of Category I Potential Violation. Initial consideration of Category I
potential violations by the MPSC-PCSC or ad hoc subcommittee of the MPSC, followed by the
action of the Executive Committee or the Board regarding the subcommittee’s recommendations
and the Executive Committee’s determination of the forum for exercise of the Member’s
procedural rights, will occur within 14 days of referral of the matter to the MPSC subcommittee.
(4)
Hearings: In the case of Category II and III potential violations, hearings will be scheduled
less than 7 days nor more than 60 days from the date of the OPTN Contractor’s receipt of
request for hearing. In the case of Category I potential violations, hearings will be scheduled
less than 7 days nor more than 30 days from the date of the OPTN Contractor’s receipt of
request for hearing.
(5)
Hearing Committee Report: In the case of Category II and III potential violations, the Hearing
Committee report will be issued within 30 days after preparation of the hearing record. In the case
of Category I potential violations, the Hearing Committee report will be issued within seven days
after preparation of the hearing record.
(6)
Action on Hearing Committee Report: In the case of Category II and III potential violations, the
MPSC or Board of Directors, as applicable, will consider and act on the report of the Hearing
Committee within 30 days following receipt of the report. In the case of Category I potential
violations, the MPSC, Executive Committee or the Board will consider and act on the report of the
Hearing Committee within two days following receipt of the report.
(7)
Appellate Review: In the case of Category II and III potential violations, appellate reviews will be
scheduled not less than 30 days nor more than 90 days from the date of the OPTN Contractor’s
receipt of the request for appellate review.
(a)
not
the
not
the
Action Taken: In the event the Appellate Review Body refers a matter back to the
Hearing Committee, the Appellate Review Body will make its decision with respect to
the matter within 14 days after receipt of any recommendations from the Hearing
Committee.
In the case of Category I potential violations, appellate reviews will be scheduled not less than
seven days nor more than 30 days from the date of the OPTN Contractor’s receipt of the request
for appellate review. If the Board of Directors conducts the hearing, there is no right to Appellate
Review and the decision of the Board is final.
(b)
(8)
Action Taken: In the event the Appellate Review Body refers a matter back to the
Hearing Committee, the Appellate Review Body will make its decision with respect to
the matter within 14 days after receipt of any recommendations from the Hearing
Committee.
Board of Directors Action: The Board of Directors will render its decision within 90 days after
the conclusion of applicable hearing and appellate review proceedings.
OPTN Bylaws, Appendix A7-1
December 14, 2006
| File Type | application/pdf |
| File Title | Microsoft Word - OPTN Bylaws-Appendix A-June 2007 |
| Author | gingrast |
| File Modified | 2007-08-24 |
| File Created | 2007-08-24 |