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Alternate site testing. The regulatory perspective

A C Belanger1

  • 1Laboratory Accreditation Services, Joint Commission on Accreditation of Healthcare Organizations, Oakbrook Terrace, IL 60181, USA.

Archives of Pathology & Laboratory Medicine
|October 1, 1995
PubMed
Summary
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Regulations for non-traditional laboratory testing mandate consistent standards, focusing on staff competency and result reliability. State-level rules vary regarding personnel and testing circumstances.

Area of Science:

  • Clinical Laboratory Science
  • Regulatory Affairs

Background:

  • Laboratory testing is expanding beyond traditional settings.
  • Existing regulations primarily stem from the Clinical Laboratory Improvement Amendments of 1988.
  • Ensuring quality in non-traditional testing environments is a growing concern.

Purpose of the Study:

  • To provide an overview of regulatory requirements for laboratory testing outside traditional settings.
  • To highlight the harmonization and variation in federal, state, and accrediting body regulations.
  • To identify key areas of regulatory focus for non-traditional laboratory testing.

Main Methods:

  • Review of federal, state, and accrediting body regulations.
  • Analysis of the Clinical Laboratory Improvement Amendments of 1988 as a regulatory framework.

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  • Comparative assessment of regulatory approaches across different jurisdictions.

    • Main Results:

    • A consistent regulatory standard applies regardless of testing location.
    • Significant variation exists at the state level concerning personnel qualifications and testing scope.
    • Key regulatory focuses include staff training, supervision, and result validation.

    Conclusions:

    • All laboratory testing, irrespective of location, must adhere to uniform quality standards.
    • State regulations present the most diversity in defining testing personnel and permissible tests.
    • Effective regulation hinges on ensuring staff competency, proper oversight, and reliable test outcomes.