OUR DEDICATION TO
COMPLIANCE & ETHICS

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 are constantly evolving and therefore require constant attention to ensure that all those that transact business on behalf of the Company adhere to them. We strive for excellence in our Compliance & Ethics Program, which is comprised of the following seven elements: 

Surveillance

We are a high-complexity CAP and CLIA-certified diagnostic laboratory and are in full compliance with the Health Insurance Portability and Accountability Act (HIPAA). Our lab is able to analyze various collection methods for community and individual-based testing of sexually transmitted infections, infectious disease, and other communicable diseases. As a CLIA-certified lab, we report all reactives to local health jurisdictions.

Prevention

Our self-collect testing kits remove barriers through testing in the privacy of the individual’s space. By lowering the barriers to testing, infections are identified that might otherwise have gone undetected and untreated. Creating easier access for surveillance allows public health departments the ability to work to prevent outbreaks that devastate communities. As a CLIA-certified lab, we report all reactives to local health jurisdictions.

Elimination

In 2021, Molecular reported out 114,829 HIV results from patient-collected samples. Based on HRSA data from 2020, that would account for over 4.5% of the total HIV testing in America. Each month, Molecular runs over 250,000 assays on patient-collected samples. This includes testing for over 43,000 unique PrEP patients.

We are actively working to help not only eliminate barriers to testing access, but eliminate the spread of preventable diseases.

Compliance

We are committed to establishing ethical standards and conducting ourselves with the utmost integrity and discretion.

Unity

We are stronger when we work collaboratively and treat employees equitably regardless of their position in the company.

Innovation

We use science, technology, creativity, and persistence to solve problems.

Integrity

We speak and act from a position of honesty to honor confidentiality and build trust.

Partnership

We are your scientific team providing accessible and innovative laboratory solutions.

Agility

We challenge the status quo with open minds, focus and speed.

Code of Ethics/Conduct

Our Code of Conduct defines our values and principles, and is designed to be used as a resource to help MTL employees make the right decisions. All MTL employees, contractors, and agents of the lab are required to be familiar with and to abide by our Code of Conduct.

Download our Code of Conduct

HIPAA and Privacy

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

• Molecular Testing Labs 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 Testing Labs.
• Provider oversight and approval is mandatory on all diagnostic tests.
• Use of modern encryption protocols is required for data in transit and while durably stored.
• Laboratory information system access is protected per HIPAA guidelines.
• For more information and to review our Notice of Privacy Practices, please visit https://moleculartestinglabs.com/notice-of-privacy-practices.

First Tier, Downstream or Related Entity (FDR)

Molecular Testing Labs requires first tier, downstream, and related entities (FDRs) to complete general compliance and fraud, waste, and abuse training. FDRs may conduct their own internal training or utilize MTL’s provided training below. Annual attestation is required.

FDR Training
Attestation Form

Molecular Testing Labs validates Assays with the feasibility of collection in mind.

Molecular Testing Labs is a CAP accredited and CLIA licensed lab. We apply the maximum level of control to obtain the most consistent and highest quality results.

Report a Concern

As a part of Molecular Testing Labs’ Compliance & Ethics 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.

• English: (855) 400-6002
• Spanish: (800) 216-1288
• Website: https://www.lighthouse-services.com/moleculartestinglabs

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