NCCLS...
Serving the World’s Medical Science Community Through Voluntary Consensus
NCCLS is an international, interdisciplinary, nonprofit,
standards-developing, and educational organization that
promotes the development and use of voluntary
consensus standards and guidelines within the healthcare
community. It is recognized worldwide for the
application of its unique consensus process in the
development of standards and guidelines for patient
testing and related healthcare issues. NCCLS is based on
the principle that consensus is an effective and cost-
effective way to improve patient testing and healthcare
services.
In addition to developing and promoting the use of
voluntary consensus standards and guidelines, NCCLS
provides an open and unbiased forum to address critical
issues affecting the quality of patient testing and health
care.
PUBLICATIONS
An NCCLS document is published as a standard,
guideline, or committee report.
Standard A document developed through the consensus
process that clearly identifies specific, essential
requirements for materials, methods, or practices for use
in an unmodified form. A standard may, in addition,
contain discretionary elements, which are clearly
identified.
Guideline A document developed through the
consensus process describing criteria for a general
operating practice, procedure, or material for voluntary
use. A guideline may be used as written or modified by
the user to fit specific needs.
Report A document that has not been subjected to
consensus review and is released by the Board of
Directors.
CONSENSUS PROCESS
The NCCLS voluntary consensus process is a protocol
establishing formal criteria for:
• the authorization of a project
• the development and open review of documents
• the revision of documents in response to comments
by users
• the acceptance of a document as a consensus
standard or guideline.
Most NCCLS documents are subject to two levels of
consensus—“proposed” and “approved.” Depending on
the need for field evaluation or data collection, documents
may also be made available for review at an intermediate
(i.e., “tentative”) consensus level.
Proposed An NCCLS consensus document undergoes the
first stage of review by the healthcare community as a
proposed standard or guideline. The document should
receive a wide and thorough technical review, including an
overall review of its scope, approach, and utility, and a line-
by-line review of its technical and editorial content.
Tentative A tentative standard or guideline is made
available for review and comment only when a
recommended method has a well-defined need for a field
evaluation or when a recommended protocol requires that
specific data be collected. It should be reviewed to ensure its
utility.
Approved An approved standard or guideline has achieved
consensus within the healthcare community. It should be
reviewed to assess the utility of the final document, to
ensure attainment of consensus (i.e., that comments on
earlier versions have been satisfactorily addressed), and to
identify the need for additional consensus documents.
NCCLS standards and guidelines represent a consensus
opinion on good practices and reflect the substantial
agreement by materially affected, competent, and interested
parties obtained by following NCCLS’s established
consensus procedures. Provisions in NCCLS standards and
guidelines may be more or less stringent than applicable
regulations. Consequently, conformance to this voluntary
consensus document does not relieve the user of
responsibility for compliance with applicable regulations.
COMMENTS
The comments of users are essential to the consensus
process. Anyone may submit a comment, and all comments
are addressed, according to the consensus process, by the
NCCLS committee that wrote the document. All comments,
including those that result in a change to the document when
published at the next consensus level and those that do not
result in a change, are responded to by the committee in an
appendix to the document. Readers are strongly encouraged
to comment in any form and at any time on any NCCLS
document. Address comments to the NCCLS Executive
Offices, 940 West Valley Road, Suite 1400, Wayne, PA
19087, USA.
VOLUNTEER PARTICIPATION
Healthcare professionals in all specialties are urged to
volunteer for participation in NCCLS projects. Please
contact the NCCLS Executive Offices for additional
information on committee participation.
