A significant component of the HL7 ballot process involves reconciliation of negative ballots submitted, and, in the normative process, the recirculation ballot to make the consensus group aware of any negative ballots unresolved by reconciliation.
Under the American National Standards Institute (ANSI) rules, a standards developing organization (SDO), such as HL7, is required to notify the submitter of a negative ballot or comment of the disposition of their ballot or comment. The purpose of this notification process is to ensure the submitter is aware of the action taken by the SDO and, if such action is deemed acceptable and appropriate, consider withdrawal of their negative.
HL7 has occasionally encountered the circumstance of being unable to contact a negative ballot submitter with the notice of disposition of a negative ballot. Even though every effort is made to contact the submitter, an SDO cannot unilaterally change the submitter’s ballot from negative to affirmative regardless of the appropriateness of the action recommended during reconciliation. When a situation arises where there is no response from the submitter, the SDO is obligated to record the ballot as an unresolved negative.
ANSI rules stipulate that any normative ballot which meets the approval criteria but has unresolved negatives must be returned to the approving consensus group for consideration, resulting in a recirculation ballot. The intent of the recirculation ballot is to apprise the consensus group of those negatives unresolved by the reconciliation process. Members of the consensus group have the option to change their response to the ballot should they feel the unresolved negative is of sufficient severity or the recommended action does not adequately address the issue.
ANSI does not require unanimous approval from an SDO for the publication of an American National Standard. HL7 defines approval for normative ballots as 75% affirmative response of the combined affirmative and negative ballots cast. However, the process is greatly facilitated if reconciliation results in unanimous approval, which then serves to eliminate the need for a recirculation ballot.
Typically, the inability to contact the submitter of a negative ballot has been due to a change in employment, family situations or health. All of these circumstances are beyond the control of HL7. While there is little recourse when such situations arise involving individual members, the use of a proxy for the designated voting representatives of HL7 organizational and affiliate members seems a viable possibility.
HL7 asks that its organizational and affiliate members identify a key member as the point of contact regarding ballot issues. In the past, HL7 policy stipulated that the key member held virtual proxy for all designated voting representatives of their organization or affiliate. As a result of an ANSI audit, this policy was rescinded as ANSI considered this an “anonymous” proxy and, as such, unacceptable.
After much research and discussion, it was decided that a named proxy could be implemented at the organizational or affiliate member level. The recent update to the Governance and Operations Manual (GOM) and HL7 Essential Requirements (HL7 ER) institutes this process.
GOM §03.03.02 establishes the organizational key voting representative, formerly known as the key member. Likewise, GOM §03.09.01 establishes the affiliate key voting representative. The key voting representative for both organizational or affiliate members is tasked with maintaining a current file of signed proxy statements from each of their designated voting representatives. Although not required, it is suggested that the designated voting representatives name their key voting representative as proxy. In the case of the key voting representative themselves, the proxy may be any of their designated voting representatives; which may also be the choice of any of their designated voting representatives should they choose not to name the key voting representative.
A template has been created so that the key voting representatives can download the suggested proxy statement. The proxy statement is limited in scope and takes the form of a “springing” proxy; i.e., it only becomes effective under specific circumstances (springs into effect) somewhat analogous to a healthcare directive or “living will”. It is specific to the normative process of disposition of negative comments and recirculation ballots. You can download the template here: https://www.hl7.org/documentcenter/public/procedures/Proxy%20Assignment%20R2.docx.
As cited in the GOM, the proxy statement takes the form: “Having submitted a HL7 Normative Ballot, should I <name of designated voting representative> be unable to respond, for whatever reason, to the subsequent notice of disposition of negative comments or the recirculation of said Normative Ballot I designate <name of Key Voting Representative> to act as my agent and complete such action.” Once the key voting representative has collected the signed proxy statements from their designated voting representatives, it is suggested that the statements be scanned into a PDF file to facilitate transmission to HL7 headquarters should the need arise.
Note that the proxy statement is not ballot specific. The proxy is, therefore, reusable. For example, if the unresponsive designated voting representative is on a temporary hiatus due to family or health matters, their proxy is submitted for a specific ballot. Once back to work and participating in the normative ballot process, their proxy is still available should subsequent circumstances demand it. The key voting representative need only update their proxy files upon a change in designated voting representatives within their organization or affiliate.
HL7 ER §02.11.02 establishes the process whereby the key voting representative would, after a reasonable attempt to engage their unresponsive designated voting representative, submit their signed proxy statement to HL7 headquarters via email. Once submitted, the named proxy would respond to the disposition of negative comments or recirculation ballot, as appropriate. HL7 would retain the submitted proxy statement with the ballot material for ANSI audit purposes.
Although HL7 has no means to enforce the proxy process, it is hoped that our organizational and affiliate members will make every effort to implement it in the hopes of an improved normative ballot process.
In closing, it should be noted that HL7 individual members also have the option of designating a proxy, as long as the proxy is another individual member or designated voting representative, should they foresee the need.