QUALITY MOVEMENTS

This section includes the significant developments in the history of medical technology in the
United States during and after World War 2
1950s
In the 1950s, medical technologists in the United States sought professional recognition for their
educational credentials from the government through licensure statutes. Furthermore, a
standard curriculum was also formalized in 1950 in preparation for a Bachelor of Science
Degree in Medical Technology.
1967
The "Clinical Laboratories Improvement Act of 1967" (CLIA '67) was included in Section 5 of
Public Law 90-174, which was enacted by the United States on December 5, 1967. CLIA '67
established rules for the licensing of clinical laboratories and the transport of samples into and
out of them across state lines. However, this law received amendments in 1988 when a new set
of proposed regulations were put forth by the Health Care Financing Administration. The
proposal aimed to replace formal credentialing requirements and detailed personnel standards
in existing regulations with more emphasis on the responsibilities and duties of personnel. It
also sought to make room for new technologies, increase reliance on outcome measures of
performance, and eliminate out-dated, redundant, and obsolete requirements. These
amendments eventually led to the proposal becoming law on October 31, 1988 under Public
Law 100-578 as the Clinical Laboratory Improvement Amendments of 1988.
In December of 1967, the US Centers for Disease Control (CDC) distributed a news release
announcing the intention of representatives from scientific and professional groups and
government agencies to form a national committee on clinical laboratory standards. A group of
31 individuals met at the urging of the College of American Pathologists (CAP). The members
established the Provisional National Committee for Clinical Laboratory Standards (NCCLS) after
deciding that a committee was necessary. The inaugural president of NCCLS was Dr. Russell
Eilers, who served as the chairman of the standards committee for CAP and was elected interim
secretary. NCCLS published its first standard, Preparation of Manuals for Installation, Operation,
and Repair of Laboratory Instruments, in 1969. And in its first ten years, twenty laboratory
standards were written. In 2005 NCCLS changed its name to Clinical and Laboratory Standards
Institute (CLSI). In general, CLSI provides standards and guidelines for medical professionals
through its unique consensus process.
1977
The American National Standards Institute (ANSI), originally established as the American
Engineering Standards Committee (AESC) in 1918, is a private non-profit organization that
oversees the development of voluntary consensus standards for products, services, processes,
systems, and personnel in the United States. In 1977 CLSI was accredited by the American
National Standards Institute (ANSI) as a voluntary consensus standards organization. Around
this time, the National Reference System for the Clinical Laboratory (NRSCL), a set of
standardized reference systems designed to improve the uniformity of laboratory test findings,
was also housed by CLSI.