ProLab Consulting, LLC
(205) 515-3487
rblack@prolabconsulting.com
  • About CLIA
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  • Services
    • COW Laboratory Set-Up Assistance
    • Certificate of Waiver Assistance
    • Lab Set-Up Assistance
    • Lab Assessment Services
    • On-going CLIA Assistance
    • Procedure Manual Assistance
    • Proficiency Testing Assistance
    • Personnel Review
    • Quality Assurance Assistance
    • Instrument Quality Control and Calibration Monitoring
    • Instrument Validation Assistance
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Lab Set-Up Assistance

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.

Consulting Options

Onsite Consulting
Call Program Cost Analysis
Call Program Data Analysis
Call Program Lab Set-Up
Call Program Continued Consulting

What Are Your Needs?

Starting A New Laboratory?
Upcoming Inspection?
Failed Inspection?

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