Certificate of Waiver Laboratory Set-Up Assistance:
ProLab Consulting, LLC offers assistance in setting up new CLIA Certificate of Waiver (COW) laboratories. This service includes:
- preparation of CMS-116 (CLIA application) and other required forms as applicable;
- assistance in selecting waived tests appropriate for laboratory setting;
- education of staff on how to perform selected waived tests.
In addition, ProLab Consulting, LLC provides the laboratory with necessary policies / procedures and all forms needed to meet CLIA regulations for waived testing and maintain CLIA complianceProLab Consulting, LLC also assists the COW laboratory (either on-site or by phone) in the event of an inspection within the contract period.
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.
This service is offered as a one year contract.