ASCP (American Society for Clinical Pathology) Phlebotomy Technician Certification Practice Exam

Question: 1 / 400

Which federal law requires laboratories conducting moderately complex or highly complex testing to have written policies for specimen collection?

HIPAA

CLIA

The correct answer is the law that governs laboratory testing quality and procedure standards, specifically for facilities performing moderate to high complexity testing: CLIA, which stands for the Clinical Laboratory Improvement Amendments. CLIA regulations ensure that laboratories meet specific quality standards to ensure the reliability of laboratory results.

Under CLIA, laboratories are required to develop and adhere to written policies and procedures to standardize the process of specimen collection, as well as ensure the accuracy and reliability of testing. These policies typically cover aspects such as specimen handling, storage, and transport, thereby promoting consistent practices and reducing the risk of errors that could affect patient care.

Other mentioned laws do not directly address the requirements for laboratory policies related to specimen collection. For example, HIPAA focuses primarily on the privacy and security of patient information rather than laboratory operations. OSHA is concerned with workplace safety and does not specifically regulate laboratory testing procedures and policies. ICD-10 refers to the International Classification of Diseases, Tenth Revision, which is related to coding and billing processes rather than laboratory practices.

Thus, CLIA is the applicable federal law for requiring written policies in moderately and highly complex testing laboratories.

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