Instrumentation Validation

Xmacode, LLC offers assistance with instrument validation (termed “performance specifications” in CLIA) whenever a new instrument is placed into use, or an existing instrument is moved from one location to another. This service requires the laboratory staff to perform the testing (per CLIA regulations), but Xmacode, LLC offers educational support and an interpretation of the data collected by the laboratory.

Performance specifications generally include:

  1. accuracy
  2. Precision
  3. reportable range
  4. reference ranges

Xmacode, LLC provides the laboratory with all the documentation needed to show instrument validation was performed in accordance with CLIA regulations.

Xmacode, LLC will inform the laboratory director and staff of their responsibilities and how Xmacode, LLC can assist. If subsequent information is needed, Xmacode, LLC may provide that electronically, or face-to-face, depending on the needs of the laboratory.