New CLSI Standards Development
Process Changes
Quick Guide for CLSI Volunteers
Introduction
Consensus Standards: The Core of CLSI
Since our founding nearly 50 years ago, consensus standards have
been integral to our role as a champion for excellence in laboratory
testing around the world. Equally important is the standards’ role in
our continued success as a dynamic community and not-for-profit
membership organization.
It is through standards development that CLSI sees its mission realized in practice. The consensusbased documents created by our volunteers enable the laboratory community to effectively
achieve and exceed required levels of clinical laboratory testing quality.
In order to improve the timeliness, consistency, and efficiency of our standards and their
development, we have enacted a strategic restructuring of the standards development process
and committee structure that fortifies a clear path forward for all future document development.
While the new structure does represent a change for our community and volunteers, it also
represents a critical gain in our ability to serve and respond to the ever-evolving needs of our users.
These strategic improvements will strengthen our mission while optimizing and respecting the
time and skills so generously provided by our dedicated volunteers.
Use the following pages as your guide
to understanding and navigating the
more efficient and focused path to
standards development, as well as to
answer any important questions you
may have on the changes.
Part I
STRUCTURE
Understanding Structural
Changes in the Process and Roles
The new standards development structure builds upon existing
strengths while addressing core challenges and limitations of
the historical process. It clearly delineates process oversight from
technical expertise to streamline efficiency and unite volunteers
with a shared goal: to consistently develop timely documents
that meet user needs, in support of CLSI’s mission.
New 2016
Process Structure
CLSI Board of Directors
Consensus Council
Expert Panels for Each Specialty Area
Document Development Committees,
Subcommittees, and Working Groups
The Consensus Council:
Providing Process-Driven Oversight
The new structure will create a single, unified Consensus Council to uphold the consensus-driven
requirements of all documents published by CLSI. This consolidated body, composed of approximately
10 CLSI-selected volunteers, provides holistic, process-focused oversight of standards developed
across specialty areas.
The Consensus Council will prioritize these development projects, based on greatest need,
gaining discipline-specific technical and scientific input from the Expert Panels as needed.
KEY BENEFITS
Mastering the
Science of Priority
Unlocking Parallel
Efficiences
The Consensus Council will foster
In addition, the Consensus Council will ensure that each
collaboration between specialty areas
project adheres to the proper processes, procedures,
to properly prioritize projects across
and requirements. Technical quality will be upheld
disciplines and fast track documents
by the Document Development Committees with
with the greatest impact.
support from the Expert Panels as needed, balancing
responsibility and creating parallel efficiencies.
Expert Panels:
Upholding the Scientific Excellence of Our Standards
The Consensus Council will be supported by Expert Panels, which will provide discipline-specific
expertise as needed to ensure that the standards CLSI develops are of the highest technical and
scientific quality. Approximately 10 CLSI-selected volunteers will compose each Expert Panel for
our key specialty areas.
Expert Panels will also help fill the pipeline for timely document development by proposing
new standards to champion through the process.
KEY BENEFITS
Placing Responsibility
in the Right Hands
Expert Panels will ensure that
valued specialty expertise is
not diluted, but rather focused
where it is most needed.
Creating Document
Champions
Expert Panels will prepare new project proposals
for review. Each panel must make a compelling
case for its documents, encouraging higherquality proposals and elevating the quality of
documents in the pipeline.
4
The Birth of a Standard: Mapping the New Process
Our new process structure maintains the input of our diverse volunteers in the ideation and conception of new consensus-based
standards. At the same time, parallel efficiencies between process and technical oversight empower CLSI to better prioritize, drive,
and streamline document development and production.
CLSI Members
and General Public
Expert Panels
Consensus Council
Expert Panels
Consensus Council
CLSI Staff
Ideation
Selection
Recruitment
New project ideas can be proposed by
anyone, including individuals from our vast
member base, and from the specialty
leaders serving on Expert Panels.
The Consensus Council evaluates
document proposals across specialty areas
and focuses resources on those that meet
the greatest need.
Recruitment is a collaborative effort between the
Expert Panel, the Consensus Council, and CLSI Staff.
CLSI Delegates
Development Groups
Development Groups
Expert Panels
Consensus Council
Voting
Development
Kickoff
In one consolidated voting period, CLSI Delegates
and Development Groups are encouraged to vote
and comment on the document.
The project’s Development Groups, with
oversight from the Consensus Council, work to
draft the standard, looking to Expert Panels for
technical input as needed.
Once a Development Group is formed, the
project is presented to the Consensus
Council for final review and approval.
Development begins.
Development Groups
Consensus Council
Commenting
Resolution
Approval
Expert Panels and the General Public are
invited to provide meaningful comments
and feedback on the document for further
development and refinement.
Development Groups work to refine the
document, resolving all comments and
feedback that arose during the voting
and commenting period.
The revised document is presented to the
Consensus Council, who confirms that
the consensus process was followed,
and approves it for publication.
CLSI Members
and General Public
Expert Panels
Publication
6
Part 2
PURPOSE
Meaningful Change:
The Purpose Behind the Structure
Among other purposes, the restructured standards development
process enhances CLSI’s mission, time to market, quality, resource
allocation, and use of specialty expertise. While a departure from
the historical process, the new structure will empower CLSI to better
fulfill its driving purpose.
To Support and Sustain Our Mission
The Consensus Council now gains a holistic view of document development and can
prioritize precious resources to those standards most needed by the stakeholders.
This gives CLSI the flexibility to develop standards in any number of technical areas
based on customer demand and in line with our driving mission: to develop clinical
and laboratory practices and promote their use worldwide.
To Improve Timeliness and Efficiency
In addition, the new structure allows CLSI to produce more high-quality standards
faster, speeding our time to publication and more quickly getting our standards
in the hands of users, and into practice. The needs of our users evolve every day—
and so must our standards in order for them to remain timely and relevant.
To Elevate the Quality of Our Standards
Our new structure gives process-driven oversight of all CLSI-developed documents to
a unified Consensus Council. This allows us to align standards with one another to
ensure consistency and higher-quality standards across each of our specialty areas.
With the new structure, we will raise a new level of excellence together.
To Optimize Volunteer and Staff Resources
This new structure optimizes the use of precious volunteer and staff resources.
Volunteers can use convenient online tools to collaborate on documents between
meetings, making in-person sessions more focused and meaningful. In turn, CLSI
staff can direct its time to closely managing the process alongside volunteers.
To Align Participation With Specialties and Strengths
The new structure creates purposeful roles for both process and technical experts.
By flattening consensus document creation, more experts are empowered to contribute
and volunteers can focus their contributions and efforts where they will make the
greatest impact—in areas well aligned with their individual specialties and strengths.
8
Part 3
ROLES
Building Consensus for Change
There is room for all of CLSI’s dedicated volunteers in the new
structure. From project managers to technical experts, each respective
role makes a unique and essential contribution to the creation of CLSI’s
consensus-based standards. It is our goal to sustain and elevate the
impact of each valued contribution, while unlocking new efficiencies
in standards creation. This section explains the focused roles and
responsibilities now available for volunteers in our new process.
What Does the New Structure Look Like?
The evolved structure clearly delineates process oversight from technical expertise
to streamline efficiency and unite volunteers in a shared goal: to consistently develop
consensus-based timely documents that meet user needs.
Roles and Responsibilities
The Consensus Council: Consolidation of Consensus Committees
All formerly segmented Consensus Committees will be streamlined into a single, unified
Consensus Council. This consolidated body, composed of selected volunteers, provides holistic
process oversight of all documents developed through the CLSI consensus process.
Responsibilities:
Determine priority and resource allocation
across documents in all specialty areas.
Approve project proposals before the Call
for Volunteers, and render final approval for
development, including committee rosters.
Interface with document development groups,
overseeing due process throughout document
development (not related to technical quality).
Look to Expert Panels for input and
validation on technical accuracy and
quality of documents in each topical
specialty.
Provide final consensus approvals of
documents developed for publication.
Expert Panels: Upholding Technical Excellence
Technical experts may be selected for Expert Panels, where they can focus on driving scientific
excellence in their specialty. The Expert Panels provide technical input to ensure documents are
of the highest scientific quality and accuracy. They also create proposals for new projects to fill
the development pipeline.
Responsibilities:
Interface with document development
groups to help ensure the technical quality
and accuracy of documents in a given
specialty area.
Create a robust pipeline of meaningful,
specialty-related document ideas.
Prepare and present document proposals
to the Consensus Council, championing
projects that will drive quality.
Assist in selecting chairholders and
rosters for document development
groups.
10
Document Development Committees, Subcommittees, and Working Groups:
Speeding Time to Knowledge
The new structure flattens operational processes to drive efficiency and streamline document
review cycles. These modifications help CLSI achieve consensus in a shorter timeframe, so
committees can get their valuable documents in the hands of the users that need them, faster.
Responsibilities:
Report document status updates to the
Consensus Council, and interface with
your specialty area’s Expert Panel on
technical questions.
Vote (if on a Document Development Committee)
and comment on draft documents during the
review period, and resolve comments in line with
the consensus process.
Work hands-on in the drafting of CLSI
documents in your specialty area.
Utilize convenient online tools to collaborate
with fellow committee members throughout
the document development process.
How Is the New Structure More Effective?
The new structure will empower CLSI and our volunteers to make great strides
in efficiency, focus, and impact.
Focused Oversight,
Parallel Efficiencies
The new structure segments process and
technical oversight to achieve greater
focus and unlock parallel efficiencies. The
Consensus Council is responsible for the
prioritization and process oversight of all
documents while Expert Panels serve as
technical advisors of documents within
specific specialty areas.
Flattened
Structure
By flattening the document development
structure, CLSI has empowered our volunteers
to channel direct input and influence over
the documents that impact their daily work.
Now, more than ever, our volunteers can work
shoulder to shoulder with other industry
leaders to advance clinical laboratory testing
practices around the world.
Tools for Remote
Collaboration
CLSI has made collaboration during the
document creation process easier than
ever. With online collaboration tools,
our volunteers can engage and submit
feedback on an ongoing basis, seamlessly
participating in document creation from
wherever they are.
Streamlined Document
Review
A single, consolidated voting round
ensures that development bodies have all
comments and feedback from government,
industry, and health care professionals via
a streamlined process. As a result, CLSI can
get more documents into the hands of
users in a timelier manner.
11
Part 4
FAQS
Frequently Asked Questions
You can use this section as a quick reference to find key information
and explanations on process updates, see how your volunteer role
may change, and see a summary of benefits of our new structure.
1
I’m on a Consensus Committee; how am I affected?
You may be selected to participate on an Expert Panel for your specialty area. If you
are selected, you will prepare project proposals, review draft documents, and provide
comments on those draft documents. You may be asked to chair and/or participate
on a Document Development Committee or Working Group. If you are not selected
for the Expert Panel, you are encouraged to participate on a Document Development
Committee, where you can help shape standards first-hand.
2
I’m on a Document Development Committee or Working Group;
how am I affected?
Meetings and conference calls will be scheduled in advance, for the duration of the
project. The timeline for development is expected to be shorter. The project status will be
reviewed on a regular basis by the Consensus Council in order to help it stay on schedule.
You can also tap the knowledge of the Expert Panel members in your specialty area as
needed, to gain their expert scientific and technical input when questions arise.
3
I’m on a Subcommittee; how am I affected?
Subcommittees will continue to work as they do today. The calls and meetings will be
scheduled in advance, and the project status will be reviewed by the Consensus Council
to help document development stay on schedule.
4
What is the purpose of the Consensus Council?
The Consensus Council reviews and approves project proposals, prioritizes projects,
oversees project status and expenditures, and gives the final consensus approvals for
publication. The Consensus Council serves as CLSI’s consensus body, and therefore
reviews the consensus process, not the technical content of documents.
5
What is the purpose of the Expert Panels?
The Expert Panels each support the technical quality of documents developed in
their specialty area. They write project proposals, and review and comment on
documents in their technical areas. They also assist the Consensus Council with
selecting chairholders and rosters for Document Development Committees.
13
6
When will this new structure be in effect?
All of the changes take effect on January 1, 2016.
7
How much time does it take to develop a document?
Our new process targets total development time to span no more than
12 to 18 months.
For details on how the evolved process flows, refer to the diagram on pages 5–6.
8
What is the new structure? How are volunteers selected?
The Consensus Council will be selected from a Call for Volunteers, and is planned to
include 8 to 10 volunteers from each of the three CLSI constituencies. The Expert Panels
are selected from Calls for Volunteers, and are planned to include 8 to 10 volunteers
with expertise in the technical areas. In the beginning, we will have 9 Expert Panels.
The Expert Panels do not need to include experts from every constituency. Document
Development Committees, Working Groups, and Subcommittees do not change.
For further details on the structure, refer to the diagram on page 3.
9
Why are these changes being made?
These changes are being implemented to decrease document development time,
increase efficiency, and optimize volunteer experience and time.
10
Who is eligible to vote on documents?
During the document drafting process, the Document Development Committees,
Working Groups, and Subcommittees review, vote on, and may comment on
the proposed draft, along with the CLSI Delegates. The associated Expert Panel
members may review and comment on the draft. Any person may request a copy
of the Proposed Draft for review and comment. At the Final Draft voting stage, the
Consensus Council votes to confirm the consensus process was followed, and then
approves the document for final publication.
14
11
I submitted a project proposal; how does my project get approved
and prioritized?
The project proposal is reviewed first by the associated Expert Panel, and then
reviewed and approved by the Consensus Council. The Consensus Council determines
how the proposal fits within several criteria established by the Board of Directors.
After approval, the Consensus Council determines the priority of the project to
finalize its timing for development.
12
Where can I find more information?
Please visit www.clsi.org/NewStandard to find more details and resources
regarding the CLSI standards development process changes.
15