Quality & compliance
Accurate results and protected patient information, from the moment a swab is collected to the moment results reach the care team.
The rules behind every result
Federal quality standards for laboratory testing. Our lab is certified for high-complexity testing.
Privacy and security rules that protect patient health information, including genetic results.
Limits how health insurers and employers can use genetic information.
Evidence-based guidelines our reports reference for each drug-gene pair.
Laws and guideline bodies are named for reference. They do not certify or endorse AchieveDx.
Our laboratory in brief
Quality checks at every stage
AchieveDx performs PGx testing in its own CLIA-certified, high-complexity laboratory. Each specimen moves through the same controlled process.
- Intake
Identity check
Every specimen must be labeled with the patient's name and date of birth. Unlabeled specimens are not accepted.
- Before testing
DNA adequacy check
The lab confirms each sample has enough DNA. If it falls short, the facility is notified and a new sample is collected.
- Testing
Controlled genotyping
Testing follows documented procedures with quality control, under CLIA requirements for high-complexity labs.
- Reporting
Pharmacist review
Results are interpreted against CPIC guidelines and FDA labeling, with a pharmacist-written summary.
Genetic information gets extra care
As a clinical laboratory, AchieveDx is a HIPAA covered entity. Genetic results are protected health information, and they are handled that way at every step.
Read our notice of privacy practicesMinimum necessary
Staff and partners see only the information they need for their role.
Business associate agreements
Partners who handle PHI on our behalf sign agreements to protect it.
Genetic privacy
Results are never used for insurance underwriting. Federal and California law limit how genetic data can be used.
Patient rights
Patients can request their results, ask for corrections and learn how their information is used.
How we protect data
Administrative, technical and physical safeguards protect patient information wherever it's stored or sent.
- Encryption of sensitive information in transit
- Firewalls and network security controls
- Access controls and authentication requirements
- Role-based access limited to legitimate need
- Confidentiality requirements and training for staff and contractors
- Secure result delivery by portal, encrypted email or secure fax
Testing done the right way
Our process is built to keep every test appropriate, documented and transparent for patients.
Ordered by the treating clinician
Tests run only on a signed order from the provider who will use the results.
Medical necessity documented
Each order records the medication decision the result will inform.
Coverage verified first
Eligibility is checked before testing, and patients approve any cost in advance.