Consulting Solutions

We provide comprehensive solutions for a variety of clinical laboratory needs. This include but are not limited to:

  • New lab start up, including selection of CLIA qualified personnel
  • Pre-inspection readiness
  • Ongoing regulatory and compliance monitoring
  • Post inspection follow-up

Lab Set-up

Module Positions

Our Lab set-up package includes:

  • CLIA licenses applications and selection of qualified personnel
  • Creating a test menu
  • Writing procedure manuals and policies
  • Validation studies
  • A Quality Assurance (QA) program
  • Developing IQCP plans as needed
  • Enrollment in a proficiency testing program if required
  • Providing logs for patients, QCs, temperature and inventory recordings

Being present on your first laboratory inspection to provide support and help answer questions.

CLIA Qualified Testing Personnel Selection and Training

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Depending on the complexity of testing on your test menu, your laboratory may be required to comply with specific personnel qualifications. We can assist your laboratory with hiring the right candidates that meet the testing requirements on your test menu. We will also ensure that your staff is well trained on all phases of testing, and with our seasoned track record of performing numerous training and competencies you can be rest assured that your team will receive training that is above industry standards. If you have foreign educated personnel and want to add them as testing personnel, we got you covered! We have years of experience working with foreign credential evaluation agencies that are approved by CLIA and other regulatory agencies, and we will handle all the required paperwork to get their credentials evaluated.