US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)
Subpart J: facility administration for nonwaived testing (sections 493.1100 to 493.1105) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493) 1101: Keep the laboratory constructed, arranged and maintained with adequate space, ventilation and utilities, contamination minimised, uni-directional workflow for open molecular amplification, sufficient equipment and supplies, compliance with federal, State and local laboratory laws, observed safety procedures, and records and slides stored to preserve them

What does 1101 require?

The laboratory must be built, arranged and maintained to provide the space, ventilation and utilities needed for every phase of testing, to minimise contamination of patient specimens, equipment, instruments, reagents, materials and supplies, and, for molecular amplification procedures not contained in closed systems, to give a uni-directional workflow with separate areas for specimen preparation, amplification and product detection and, where applicable, reagent preparation. It must have appropriate and sufficient equipment, instruments, reagents, materials and supplies for the type and volume of testing, comply with applicable federal, State and local laboratory requirements, establish and observe accessible safety procedures protecting against physical, chemical, biochemical, electrical and biohazardous hazards, and maintain and store records and, as applicable, slides, blocks and tissues under conditions that preserve them.

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.

  • 6.3.1 6.3.1 Facilities and environmental conditions: 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 J: facility administration for nonwaived testing (sections 493.1100 to 493.1105) – US Clinical Laboratory Improvement Amendments (CLIA) Regulations (42 CFR Part 493)

Query this from an agent

The graph holds this control, the 1 it maps to, and the evidence behind each claim, over MCP and REST.