Month-by-Month: The Basics
A breakdown of the CLSI voting process: how it works, what's involved, and how you can participate

Introduction:  An Idea

It begins, of course, with an idea. 

Your idea. 

The idea of a group of veterinary microbiologists from Europe, Japan, Australia, and the United States, that fish disease can and should be combated using the same type of antimicrobial susceptibility testing as is performed on humans. 

The idea of a Canadian phlebotomy student who, having seen enough tears and pain and mistakes, wonders whether there’s a special blood collection guideline for young patients, and if not, why?  
 
The idea an old friend and colleague mentioned offhandedly at the President’s Reception of last year’s Leadership Conference, but, in the meantime, has bloomed, in his mind, his computer, at the end of his pen, into a goal.  A project.  A design.

A proposal.

Anyone may submit a project proposal to Clinical and Laboratory Standards Institute (CLSI):  CLSI members, volunteers, delegates, and people who have never before been involved in CLSI activities.  There are no criteria for experience or credentials, and anyone who perceives a need for a standard or guideline in the patient-testing field is encouraged to submit a project proposal form to the CLSI offices.

The Authorization Process

From the time of the proposal’s submission, two simultaneous activities take place over the space of roughly five months:  1) the Authorization Process and 2) the development of a Business Plan.  This preconsensus phase of a document’s development is executed primarily by the CLSI staff, for review by the Chairholders Council.

1) In the Authorization Process, the potential project is assessed for:
a. consistency with the mission and goals of CLSI;
b. demand on the part of CLSI’s constituency; and
c. (on an optional basis) merit and potential value.

2) The Business Plan is developed to incorporate:
a. available market data;
b. a proposed roster for the authoring subcommittee, with concern for expediting the consensus process for approved documents, including volunteers committed to the project;
c. a sales plan;
d. budgetary concerns; and
e. a timeline, including committee meeting dates.
Following approval by the Chairholders Council, the consensus process begins.

The Consensus Process

Months 1-9:
1) The projects coordinator or staff liaison convenes initial meetings of the subcommittee charged specifically with authoring the new document, and oversees the allocation of assignments to its various members. 
2) At this point, the initial stage of the consensus process takes place within the subcommittee, with the assignments of various group members exchanged and reviewed internally through a series of meetings—most often conference calls.
3) With subcommittees sometimes numbering into the hundreds—housing members of varying opinions and specific areas of expertise—this is the stage at which the consensus process is at its most acute and, often, delicate. 

Month 9:
Subcommittee vote
At this point, a vote is taken in which two-thirds of the subcommittee must approve the draft as it stands, in order for it to move on to the next stage.  In order to uphold the integrity of the consensus process, discord between subcommittee members on any issue means a return to the drawing board until agreement can be reached.  Subcommittee members are given a maximum of 20 days to place their votes.

Month 10:
Area Committee vote
Another 20-day vote requiring two-thirds majority, this time by the area committee under which the document is being developed. (CLSI has a total of ten area committees.) The area committee, though not as directly involved in the document’s development as the subcommittee, is equipped with the technical knowledge that enables it to base judgments upon scientific grounds; the area committee serves as the consensus body in its field

Month 11:
Publication of proposed-level document
Upon approval by the area committee, a proposed-level document is published and distributed.

Months 11-13:
90-day proposed-level consensus period
1)  The document is distributed for use and review by the public as a proposed-level document; it is during this time that valuable feedback from users and reviewers will be gathered for the subcommittee’s use at the next level.  (A description of the proposed-level review process, as well as a call for comments, appear in a box on the front cover of the proposed-level document.)  
2)  All delegates have an opportunity to comment and vote on the document—simple majority approval by delegates is required for the document to move past this stage. 
3)  All Board members receive the document for the opportunity to comment on its technical content, scope, utility, etc.

Months 14-18:
Subcommittee revision
At the end of the 90-day consensus review process, the project manager pulls together all comments and reconvenes the subcommittee, which then works together to address all comments received during the proposed-level period, revising the document based either upon the comments received, or any new information that has become available since the publication of the proposed-level document and is necessary for inclusion in the approved-level document.

Month 19:
Second subcommittee vote
The subcommittee has completed updating the document and has responded to the comments.  Once all proposed-level comments have been addressed, the document becomes an approved draft.  The subcommittee now votes on the approved edition, again, with a minimum of two-thirds majority required.

Month 20:
Second area committee vote
The area committee vote that follows the second subcommittee vote is the final vote to have technical bearing on the development of the consensus document.  If the approved edition passes subcommittee vote, the area committee votes on the document as an approved-level consensus document.  The area committee judges the document by two major criteria:  1) technical accuracy, and 2) that all comments from the proposed-level review period have been addressed by the subcommittee.  Once the area committee has voted as the consensus body, the document is complete.

Month 21:
Board Vote
The final review of the CLSI Board of Directors, which follows the area committee vote, is a function of the Board’s fiduciary responsibility, as related to its publication, and therefore seldom involves technical comment on the document.  Rather, the Board operates in the interest of ensuring that the organization will carry the document in its portfolio, allocate funds for it, and ensure its maintenance.  

Month 22:
Publication and distribution
When the document has passed all levels of voting, it is published in both print and electronic formats and is available for distribution as an approved-level document. Within three to five years following publication, the document must be reviewed by the area committee to determine if the information is current and useful.  If there are no changes to the document, it will be reaffirmed by the area committee. If the document needs to be revised, CLSI will solicit nominations for a new subcommittee to be formed for the revision of the document.

Conclusion:  Balance, Consensus

Says CLSI Vice-President, Standards John Zlockie, MS, MBA, "To be a responsive organization, we’ve set up a schedule to complete a document from authorization to approved-level consensus status in 22 months. 

"There are going to be some documents for which this schedule seems too long, and some for which it’s going to seem too short.  But this schedule was developed as a schedule that strikes the best balance, for the sake of open, balanced consensus.”

Questions about the CLSI consensus process can be directed to the CLSI offices at +610.688.0100, or customerservice@clsi.org. 

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