This section sets forth formal appeal mechanisms for the impartial handling of complaints regarding substantive procedural actions or inactions related to AAMI standards and TIRs. Procedural appeals cannot be based on simple error or omission but require substantive error, action, or inaction in the development process.
To appeal an action or inaction, an appellant shall demonstrate that his or her due process rights were compromised and shall have a direct and material interest that is or may be adversely affected.
8.2 Actions and inactions subject to appeal
The following actions may be appealed:
approval or denial of a new work proposal;
approval or disapproval of a document as a final or reaffirmed standard or TIR;
authorization or refusal to submit a document to ANSI for approval as an American National Standard;
withdrawal of a published AAMI standard or TIR;
establishment of a new consensus body or initiation of new work on a standard or TIR;
termination of a consensus body or cessation of work on a standard or TIR;
refusal or termination of membership on a consensus body;
termination of membership on SB or CSS;
dismissal of a consensus body, SB or CSS chair;
other substantive uncorrected committee actions that deny due process rights;
substantive procedural inactions, not covered above, that violate the due process rights of the adversely affected party.
The fee for an appeal with the Standards Board is $1,500 (U.S.) payable by the appellant. The fee for a subsequent appeal with the Board of Directors is an additional $1,500 (U.S.).
Fees are payable by the appellant within seven calendar days of notification of the decision by the appeal body (the Standards Board or the AAMI Board of Directors) to hear an appeal.
An appellant may request that AAMI reduce, waive, or refund these fees and shall provide a rationale for this request (e.g., demonstrable financial hardship). The decision to reduce, waive or refund any appeal fee will be made by the AAMI Standards Program HOD after review of the request and rationale.
8.3 Appeal procedure
8.3.1 Appeal to the AAMI Standards Board
184.108.40.206 Filing of an appeal
An appeal of a covered action shall be filed within 15 calendar days of notification of the action. There is no deadline for appealing a procedural inaction.
The appeal shall state the nature of the objection, including the details of the denial of due process rights, the real or potential adverse effects upon the appellant, the actions or inactions at issue, and the specific remedial action that would satisfy the appellant’s concerns. Previous efforts to resolve the objection and the outcome shall be reported. Upon the filing of a properly executed appeal, the responsible consensus body and Standards Board are notified, and the original action is suspended until the appeal can be resolved or considered.AAMI’s appeals process shall conclude before final submittal of evidence of consensus is made to ANSI in support of the approval of a standard as an American National Standard.
220.127.116.11 Initial staff review of the appeal (informal resolution phase)
Within 30 calendar days of the filing of an appeal, AAMI staff shall make a preliminary determination as to whether a substantive error or omission occurred that violated the appellant’s due process rights. If staff determines that a procedural error or omission appears to have occurred but is correctable by further consideration or action of the consensus body, staff will consult with the Standards Board and chairs of the consensus body to determine what action can be taken to cure any real or potential adverse effect.
If, in staff's estimation, a remedy cannot be agreed upon by the parties or if staff cannot establish that a procedural omission or error occurred, the appeal shall be submitted to the Standards Board with all relevant documentation.
8.3.2 Standards Board consideration of the appeal
The Standards Board will be asked to review the appeal to determine if significant evidence exists of a substantive procedural error or omission that violated the due process rights of the appellant and that created potential or actual harm to the appellant. A decision by the Standards Board to hear an appeal requires approval by a majority of the Standards Board by ballot or at a meeting. When the Standards Board reaches a decision, the appellant and the responsible committee are notified in writing within 60 calendar days of the filing of the appeal.
If the Standard Board decides not to hear the appeal, the appellant may submit his or her appeal to the AAMI Board of Directors as detailed below.
If the Standards Board agrees to hear the appeal, a hearing will be scheduled in accordance with the following provisions.
18.104.22.168 Standards Board hearing
The Standards Board shall set a time to hear the appeal via a face-to-face meeting, web meeting, or conference call within six months of the date on which the appeal was filed (or on a date mutually agreeable to all parties). The appellant and the responsible committee shall be invited to be represented at the hearing with at least 30 calendar days' notice. Any committee member or other materially interested party may attend the public portion of the appeal hearing, provided advance notice of attendance is given. Upon hearing all arguments, the Standards Board will decide the matter in closed session. A two-thirds vote of eligible Standards Board members is required to modify an original action or position.
8.3.3 Notification of Standards Board decision
Standards Board decisions on appeals are rendered only in writing. The appellant and the responsible committee shall receive written notification of the Standards Board decision and reason(s) thereof within 15 calendar days of the decision.
8.4 Appeal to the AAMI Board of Directors
22.214.171.124 Filing of an appeal to the Board of Directors
An appeal to the AAMI Board of Directors shall be filed in writing within 15 calendar days of notification of the results of an appeal to the Standards Board and must explain why the Standards Board decision should be modified.
A decision by the Board of Directors to hear an appeal requires approval by a majority of the Board of Director by ballot or at an electronic or in-person meeting. The complete Standards Board case file shall be made available to the Board of Directors for consideration in reaching a decision on whether to hear the appeal. When the Board of Directors reaches a decision, the appellant and the responsible committee shall be notified in writing.
126.96.36.199 Board of Directors hearing
If the Board of Directors agrees to hear an appeal, the appellant and the responsible committee are invited, with at least 15 calendar days’ notice, to be represented at the hearing. The hearing may be held in person or via a web meeting or conference call. The chairs of the Standards Board participate in the Board's deliberations without vote. Any consensus body member or other interested party may attend the public portion of the appeal hearing with advance notice to the Standards Program HOD. Upon hearing all arguments, the Board of Directors will decide the matter in closed session. To reverse a Standards Board decision, a majority vote of all eligible voting members of the Board of Directors is required.
188.8.131.52 Notification of Board decision
Board decisions on appeals are rendered only in writing. The appellant, the responsible committee, and the Standards Board shall receive written notification of the Board of Directors' decision within 30 calendar days of the appeal hearing.
8.5 Appeal of ANSI decisions on American National Standards
Persons who maintain negative votes on and/or unresolved objections to proposed American National Standards also may have rights of appeal under ANSI's procedures.