Compliance & Ethics Program

At Molecular Testing Labs, we are committed to establishing compliance and ethics as key elements of our values and our culture. We expect all employees, contractors and agents of the lab to conduct themselves with the utmost integrity. Because of the work we do, state and federal laws and regulations require constant attention. We strive for excellence in our Compliance and Ethics Program which is comprised of the following seven pillars:

  • Standards and Procedures

  • Oversight
  • Education and Training
  • Monitoring and Auditing
  • Reporting
  • Enforcement and Discipline
  • Response and Prevention

HIPAA and Privacy

Molecular Testing Labs™ is in full compliance with the Health Insurance Portability and Accountability Act. Molecular reinforces the following:

  • Molecular is a CMS Designated “Covered Entity” sworn to uphold all HIPAA Considerations.
  • All employees, contractors and agents of the lab must complete annual compliance training.

  • All providers must be registered with Molecular.

  • Physician oversight and approval is mandatory on all diagnostic tests.

  • Use of encryption is required on applicable communications.
  • Laboratory Information System access is protected per HIPAA Guidelines.

Molecular Testing Labs is Clinical Laboratory Improvement Act (CLIA) certified and College of American Pathologists (CAP) accredited, and all testing is run in compliance with FDA requirements. Many of our assays are quite novel, leveraging technologies to make it easier for patients to be active participants in their care. Because of the novelty, we do not submit all of our assays to the FDA. However, this does not mean that we don’t take our validations and compliance very seriously.

Molecular is regulated under CLIA as qualified to perform high complexity clinical testing, the FDA does not require that they be approved. That oversight is regulated by CLIA and CAP. Our CAP certification goes beyond the requirements of CLIA and holds us to an even higher standard.

With appropriate oversight (e.g. CAP, CLIA, trained medical director, etc.), there is no need for direct FDA intervention. More than 85% of all laboratory testing in the US is performed on platforms and equipment that has not been FDA cleared.

Report a Concern

As a part of Molecular’s Compliance Program, we provide a reporting hotline. The purpose of this service is to ensure that anyone wishing to submit a report has the ability to do so. Reports may be submitted anonymously.

The following toll-free numbers and other methods of reporting are available 24 hours a day, 7 days a week.