利用者:Akaniji/臨床検査規格協会

沿革[編集]

1967年秋、15団体の代表者31名の臨床医と研究者が集まり、「我々が患者のためにしていることを改善する（improving what we are doing for patients）」方法を議論し、標準化のための正式な規格手順を開発するための会合を開いた。1977年には、CLSIは有志による調和標準化団体として、米国規格協会（英：American National Standards Institute、ANSI）によって公認された。またほぼ同時期に、CLSIは国立臨床検査室参照システム（英：National Reference System for the Clinical Laboratory、以下「NRSCL」）の拠点となった^[1]。

In the fall of 1967, 31 clinicians and laboratory scientists representing 15 organizations met to discuss ways of "improving what we are doing for patients" and to develop a formal consensus process for standardization. In 1977, CLSI was accredited by the American National Standards Institute (ANSI) as a voluntary consensus standards organization. At about the same time, CLSI became the home of the National Reference System for the Clinical Laboratory (NRSCL), a collection of broadly understood reference systems intended to improve the comparability of test results, consistent with the needs of medical practice.

CLSIは、世界中の標準化団体と協議を行っており、各団体によってまちまちな規格の調和（統一）を図っている。

CLSI actively promotes global harmonization of standards through its own initiatives and through direct communication links and cooperative programs with many standards-developing organizations around the world.

また、策定した規格や指針を有効活用してもらうべく開始されたCLSI公式講習会は、遠隔通信会議や動画、PCソフトといった形で提供している。

CLSI's formal education program began with workshops designed to increase the effectiveness of their standards and guidelines, and continues today with teleconferences, videos, and software programs.

1967年に創始したCLSIは、いまや2000社以上の加盟団体と2000人以上のボランティアを擁する国際団体に発展し、臨床検査の品質向上に努めている。

Since its start in 1967, CLSI has evolved into a global association of over 2,000 member organizations and more than 2,000 volunteers – all working together to advance quality in heath care testing.

部会[編集]

Clinical and Laboratory Standards Institute (CLSI) documents are developed by experts working on subcommittees or working groups under the direction and supervision of an area committee. Development of CLSI standards is a dynamic process. Each CLSI area committee is committed to producing consensus documents related to a specific discipline, as described in its mission statement.

調和手順 The consensus process[編集]

CLSIの本業は、臨床検査のための国際的に適用できる任意の合意文書の発展である。これが会員とボランティアが活発にCLSIを支持・参加する理由である。CLSIは、公認の合意手順によって合意文書を開発する。CLSIの自発的な合意は、具体的に影響を受けて、権限のあって、利害関係のある派閥による相当な協定である。それは満場一致を必ずしも意味するわけではなく、合意文書の発展の参加者がすべての関連した異議を考慮して、分解して、結果として生じる合意に応じる気があったことを意味する。

Clinical and Laboratory Standards Institute's (CLSI) core business is the development of globally applicable voluntary consensus documents for health care testing. It is why members and volunteers actively support and participate in CLSI. CLSI develops consensus documents through an accredited consensus process. CLSI's voluntary consensus is the substantial agreement by materially affected, competent, and interested parties. It does not always connote unanimous agreement, but does mean that the participants in the development of a consensus document have considered and resolved all relevant objections and are willing to accept the resulting agreement.

会員[編集]

Membership in the Clinical and Laboratory Standards Institute (CLSI) connects organizations with a large and diverse network of organizations and their representatives concerned with quality in the medical testing and health care fields. The CLSI consensus process brings together multiple constituencies to address and mutually resolve issues. This process is open to any interested organization that has the opportunity to be involved; balanced, to ensure that manufacturers, practitioners, and government meet on an equal basis; and fair. Participation enables development of consensus documents by openly presenting organization's needs and perspectives on issues and having this input considered deliberately and fairly within the consensus process. By having an active voice, participants can work to ensure that goals of the standards and guidelines directly affecting them are practical and achievable.

ボランティア Volunteers[編集]

CLSI relies on over 2,000 volunteers to create laboratory standards and guidelines and to improve health care worldwide through CLSI's global health program. People who are interested in creating laboratory standards and guidelines can volunteer to serve as subcommittee members or observers for new projects by responding to a Call for Nominations. Volunteers are also needed for global health programs to help establish laboratory quality systems in resource-limited countries.

規格・指針[編集]

Clinical and Laboratory Standards Institute (CLSI) documents are published as a standard, guideline, or committee report.

Standards are 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.
Guidelines are 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.
Reports are documents that have not been subjected to consensus review and are released by the Board of Directors.

Global Health Partnerships[編集]

CLSI is well into its third year of providing direct assistance in Sub-Saharan Africa to combat HIV/AIDS and other infectious diseases. With grants from the US-based PEPFAR (President's Emergency Plan for AIDS Relief) program administered by a Cooperative Agreement from the Centers for Disease Control and Prevention (CDC) and the National Institute of Allergy and Infectious Diseases (NIAID), CLSI has been directly engaged in essential laboratory services improvement. During the past few years, CLSI volunteers and staff have provided technical assistance Tanzania. CLSI is in preliminary planning efforts for providing assistance to these countries:

国際標準化機構（ISO）[編集]

The Clinical and Laboratory Standards Institute (CLSI) participates in the development of international standards as the Secretariat of ISO/TC 212, clinical laboratory testing and in vitro diagnostic test systems, a responsibility that was delegated to CLSI by the American National Standards Institute (ANSI), which is an ISO member body. CLSI also serves as the administrator for the US Technical Advisory Committee (TAG) for ISO/TC 212.

脚注[編集]

^ NRSCLはよく知られた参照システムの集積所であり、医療が必要とする臨床検査結果の合致性の向上を目的とする。