US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
Subpart K: quality system for nonwaived testing, general laboratory and preanalytic systems (sections 493.1200 to 493.1249) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1242: Establish and follow written procedures for patient preparation, specimen collection, labelling, storage and preservation, transport, processing, acceptability and rejection, and referral; record the date and time of receipt; refer specimens only to CLIA-certified laboratories; and give clients written submission instructions

What does 1242 require?

The laboratory must establish and follow written policies and procedures, as applicable, for patient preparation, specimen collection, specimen labelling (including patient name or unique identifier and, where appropriate, specimen source), storage and preservation, transportation conditions, processing, acceptability and rejection criteria, and specimen referral. It must document the date and time each specimen is received, must refer specimens only to a CLIA-certified laboratory or one CMS accepts as meeting equivalent requirements, and, where it accepts referred specimens, must make written instructions covering those matters available to its clients.

Maintained by Gerard Blokdyk

What else in your programme already covers this

This control maps to 1 controls across 1 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

  • 7.2.4.1 7.2.4.1 Primary sample collection and handling: general

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Subpart K: quality system for nonwaived testing, general laboratory and preanalytic systems (sections 493.1200 to 493.1249) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

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