For the last several years, CLIA has chosen 2% of laboratories holding a certificate of waiver (COW) to inspect. The purpose of this inspection is largely educational. However, during the course of these inspections, inspectors evaluate the laboratory against manufacturers’ instructions, look for any non-waived tests the laboratory may be performing, and search the testing area(s) for expired reagents.
ProLab Consulting LLC offers a service to assist the COW laboratory in ensuring they meet CLIA Certificate of Waiver requirements. We educate the lab on how to perform waived testing in accordance with the manufacturer’s requirements and assist laboratories with waived test selection. Additionally, we provide any documentation the lab needs, and assist the COW laboratory during an inspection (either on-site or by phone) within the contract period.
An initial face-to-face consultation will be performed to assess the lab’s CLIA compliance. A “Report of Laboratory Assessment” will be presented to the laboratory in a subsequent on-site visit to discuss potential CLIA violations and suggest ways to correct the problems identified. A consultant will then return approximately 6 months later for an additional assessment. Subsequent contact with the laboratory may be electronic, via phone, or face-to-face, depending on the laboratory’s need.
This service is offered as a one year contract.