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CLINICAL LAB SCIENEC

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ESSENTIALS OF CLINICAL LABORATORY SCIENCE

The federal government’s first attempt to improve the situation centered on

the Clinical Laboratory Improvement Act of 1967 (CLIA 67). Those who were

qualified under previous regulations were “grandfathered” on a permanent basis.

But then ways were sought to credential laboratory workers who were supposedly

already deemed qualified to work in a medical laboratory through a hodgepodge

of on-the-job training, various obscure registries, and sometimes on a

self-regulating basis. Problems continued to erupt, and the Health Care Financing

Administration (HCFA) developed the final regulations called CLIA 88. This

act attempted to deal with the competence and credentials of medical laboratory

workers but it has done nothing if not worsened the scene. HCFA, under CLIA

88, now states that all personnel performing high complexity testing must have

had a minimum of 2 years of college by 1997. Critics of this provision, on both

sides, argue that it places an undue burden on those who were previously qualified,

while other interest groups say that at least a baccalaureate degree is necessary

to be a supervisor. HCFA claims that personnel standards are so intertwined

with complexity models and other sections of the law that modifying one aspect

could lead to other complex adjustments and would give various interest groups,

including private registering agencies, more grounds for appeal.

Those who were deemed qualified and worked before March 14, 1967, were

permanently “grandfathered” in the first version of CLIA. But the final rule of

CLIA 88 states that those with only a 1-year program of training must not perform

high-complexity testing without supervision. And to keep their jobs, they

must have completed an associate’s degree by 1997. This requirement has sometimes

been conveniently overlooked by individuals, institutions, and governing

bodies. Debate still rages from those who say the personnel requirements are too

strict. And there are those who say that the educational requirements have been

gutted by all of the interest groups. Some of these groups have much to gain by

maintaining their status quo. These groups often resist efforts requiring that their

members expend more educational effort but may insist that their constituents

maintain the same level of employment as their peers who have 4-year college

degrees and should earn the same salary with essentially on-the-job training and

no advanced formal education.

These final regulations have done nothing to enhance the profession from the

personal viewpoint of most medical laboratory workers. It has also not served as

a means of added protection to the consumer. The medical laboratory profession

would do well to adopt the stance of the various nurses’ and pharmacist’s associations.

In an informal show of unity by the various licensing boards and professional

associations, nurses and pharmacists have greatly advanced the stature

of their respective professions. State licensure even includes specialty boards for

various nurse practice acts; for example, for a certified nurse anesthetist (CRNA),

the nurse with this specialty education is licensed separately from those practicing

basic nursing care. The nursing and pharmaceutical professions also appear

to have achieved somewhat consistent standards from state to state, with standardized

tests that are the same, regardless of the state issuing the license. And

for medical technology workers, CLIA 88 was a classic example of a movement

that started out with extremely lofty goals and then was gradually weakened by

the attempts of special interest groups or by ignoring the provisions by many.

Copyright 2010 Cengage Learning. All Rights Reserved. May not be copied, scanned, or duplicated, in whole or in part. Due to electronic rights, some third party content may be suppressed from the eBook and/or eChapter(s).

Editorial review has deemed that any suppressed content does not materially affect the overall learning experience. Cengage Learning reserves the right to remove additional content at any time if subsequent rights restrictions require it.

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