Technical Consulting & Lab Startup

Banner
Banner
Banner

Whether you are starting up a new laboratory or seeking guidance on expanding your test menu, our team of experts is here to assist you throughout the entire process. We provide comprehensive support for laboratory licensure, address technical inquiries, and prepare your laboratory for accreditation and inspections.

Our commitment is to help you establish and maintain a compliance-driven laboratory, from the initial application to inspections and ongoing management.

 

Are you ready to start your own clinical laboratory or need help with your existing one?

Continuous Support

We are with you every step of the way.

We have a proven track record of establishing and supporting successful licensed laboratories to operate within regulatory guidelines.

Technical Consulting Services

Laboratory licensure process

  • CLIA1 application and submission
  • COLA2 accreditation enrollment
  • Applicable state licensing
  • Proficiency testing enrollment

Lab Staffing and Personnel

  • Evaluation of personnel requirements and qualifications
  • Verification of Lab Director and staffing credentials
  • Assistance with staffing technical lab positions

Site preparation and workflow design

  • Instrument and equipment site preparation
  • Evaluation of pre-analytical, analytical and post-analytical lab testing phases

Education and laboratory compliance training during initial set up

  • Training on laboratory standard operating procedures
  • Training on CLIA/COLA compliance standards

Implementation of written lab compliance manuals per regulatory guidelines

  • Laboratory administrative policies and procedures
  • Pre-analytical processes and protocol
  • Quality Control protocol, acceptability limits and documentation
  • Quality Assurance implementation
  • Written job descriptions and competency assessment forms
  • Proficiency testing and split sample protocol
  • Maintenance and daily monitors

Ongoing technical consulting support

  • Inspection preparation and support
    Periodic compliance audits
  • Technical consulting resource via phone and email

References

1. Clinical Laboratory Improvement Amendments (CLIA)

2. Commission on Office Laboratory Accreditation (COLA)

*Licensure, COLA and PT fees must be paid directly to applicable agency. Client is responsible for employing qualified personnel.

Your Privacy Choices CCPA Opt-Out
Loading...
Loading...
Loading...
Loading...
Loading...
Loading...
Loading...
Loading...