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Section 493.1105 of the CIA requires a clinical laboratory to have written authorization for all diagnostic tests. Oral requests for additional laboratory tests are permitted only if the testing laboratory
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42 cfr4931241 - standard is needed by healthcare organizations and laboratories that perform clinical laboratory testing on human specimens, such as hospitals, clinics, and diagnostic laboratories. It ensures that these facilities meet certain quality standards and comply with the regulations set forth by the Centers for Medicare and Medicaid Services (CMS). Compliance with this standard is necessary for laboratories to participate in federal healthcare programs and provide reliable and accurate testing services.

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42 CFR 493.1241 refers to specific federal regulations that establish standards for laboratory tests and procedures related to patient care and testing in clinical laboratories.
Clinical laboratories that perform testing on human specimens and seek certification under the Clinical Laboratory Improvement Amendments (CLIA) are required to comply with 42 CFR 493.1241 standards.
To fill out the 42 CFR 493.1241 form, laboratories must provide accurate and detailed information about their operations, compliance with standards, and the types of tests performed, following the guidelines provided by the CMS.
The purpose of 42 CFR 493.1241 is to ensure that clinical laboratories meet specific quality standards to ensure the accuracy and reliability of laboratory testing, which is critical for patient care.
Information that must be reported includes laboratory identification details, ownership information, types of services provided, and evidence of compliance with CLIA standards.
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