What constitutes a clinical laboratory?
A clinical laboratory is a facility for the examination of materials taken from the human body, to help diagnose, prevent, or treat a human disease or condition. CLIA ’88 requires all entities that perform even one test, including a waived test on “…materials derived from the human body…” to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA ’88 to be a laboratory. For the full CLIA ’88 definition of a clinical laboratory, see 57 FR 7139, Section 493.2 Definitions. • What constitutes an “adequate quality assurance system?” An adequate quality assurance system consists of planned and systematic activities to ensure that a laboratory will meet certain requirements for quality. CDC is currently developing recommendations for quality assurance systems for rapid HIV tests. These recommendations should be available soon. They are being developed in a manner to ensure that both quality and broader access to testing will be possible.
A clinical laboratory is a facility for the examination of materials taken from the human body, to help diagnose, prevent, or treat a human disease or condition. CLIA requires all entities that perform even one test, including waived tests on … “materials derived from the human body” to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory. For CLIA’s definition of a clinical laboratory, see 493.257 FR 7139, Section 493.2 Definitions.
A clinical laboratory is a facility for the examination of materials taken from the human body, to help diagnose, prevent, or treat a human disease or condition. CLIA requires all entities that perform even one test, including waived tests on … “materials derived from the human body” to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory. For CLIAs definition of a clinical laboratory, see 493.257 FR 7139, Section 493.2 Definitions.
A clinical laboratory is a facility for the examination of materials taken from the human body, to help diagnose, prevent, or treat a human disease or condition. CLIA requires all entities that perform even one test, including waived tests on … “materials derived from the human body …” to meet certain Federal requirements. If an entity performs tests for these purposes, it is considered under CLIA to be a laboratory. For CLIA’s definition of a clinical laboratory, see 493.257 FR 7139, Section 493.2 Definitions.
