Initial Laboratory Set-Up Assistance
ProLab Consulting, 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, ProLab Consulting, LLC provides the laboratory with a complete policy / procedure manual (including quality assurance policies / procedures) and all forms needed to maintain CLIA compliance. ProLab Consulting, 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).
This service is offered as a one year contract.