Instrument Validation Assistance

ProLab Consulting, 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 ProLab Consulting, 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.

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

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

This service is offered as a one-time service per instrument installed or moved.