New Lab Setup

Xmacode, LLC offers assistance in setting up new laboratories. This service includes:

  • preparation of CMS-116 (CLIA application) and other required forms, as applicable
  • evaluation of laboratory director and other personnel qualifications
  • enrollment in an appropriate proficiency testing program
  • assistance with instrument validation / performance specifications
  • support / education of applicable CLIA requirements

In addition, Xmacode, LLC provides the laboratory with a complete policy / procedure manual (including quality assurance policies / procedures) and all forms needed to maintain CLIA compliance. Xmacode, LLC also provides assistance with the initial CLIA inspection, either on-site or by phone, depending on the laboratory’s needs.

This service is provided through an initial on-site consultation with the laboratory director (and laboratory representative, if applicable). Subsequent contact with the laboratory director and / or laboratory representative may be electronic, via phone, or face-to-face, according to the laboratory’s needs.

Any documents developed may be delivered to the laboratory electronically or in the form of a hard copy (additional printing fee may apply).