Built on Compliance.
Trusted by Healthcare.
Every Routely delivery is governed by rigorous compliance standards. From HIPAA training to cold-chain documentation, we hold ourselves to the highest bar in medical logistics.
HIPAA Compliance
Federal LawRoutely operates as a HIPAA Business Associate for all healthcare clients. We execute Business Associate Agreements (BAAs) prior to handling any Protected Health Information (PHI).
All drivers undergo mandatory HIPAA training and are certified before their first delivery. Training is refreshed annually and upon any regulatory update.
Our digital systems are designed with minimum necessary access principles. Driver-facing apps display only the information required to complete each delivery.
We maintain written policies for PHI breach notification, incident response, and workforce sanctions in full compliance with the HIPAA Privacy and Security Rules.
Chain of Custody
SOPsEvery delivery is documented from pickup to drop-off with timestamped digital records. Drivers collect electronic signatures and photographic proof of delivery.
Specimen containers are labeled, logged, and tracked using barcode scanning at pickup and delivery. Any discrepancy triggers an immediate alert to operations.
Our chain-of-custody documentation is available to clients in real time through the Routely portal and retained for a minimum of seven years.
For legal documents and sensitive materials, enhanced custody protocols include tamper-evident packaging verification and dual-confirmation delivery procedures.
Driver Certification
OngoingAll Routely drivers pass a comprehensive background check including criminal history, driving record review, and identity verification before onboarding.
Drivers complete a multi-module training program covering HIPAA basics, specimen handling, cold-chain protocols, professional conduct, and emergency procedures.
Annual re-certification is mandatory. Drivers who fall below performance or compliance thresholds are suspended pending review and re-training.
Our driver onboarding process meets or exceeds standards set by the Florida Department of Health for medical courier personnel.
Temperature Control
Cold ChainRoutely maintains a fleet of temperature-controlled transport containers for specimens, pharmaceuticals, and biologics requiring cold-chain management.
We support ambient (15–25°C), refrigerated (2–8°C), and frozen (≤ -20°C) transport depending on the material's requirements as specified by the client.
Temperature is continuously monitored during transport using calibrated data loggers. Excursions trigger immediate notification to the client and dispatch supervisor.
Cold-chain validation documentation is included with every temperature-sensitive delivery, providing clients with full audit-ready records.
CAP/CLIA Ready
Lab StandardsRoutely's specimen handling procedures align with the requirements of CAP (College of American Pathologists) and CLIA (Clinical Laboratory Improvement Amendments) regulations.
Specimens are transported in accordance with laboratory-specified requirements including container type, orientation, temperature, and time-to-processing constraints.
Our drivers are trained to identify compromised or improperly labeled specimens and to escalate immediately rather than deliver a potentially invalid sample.
We work directly with laboratory directors and quality managers to customize our procedures to each lab's specific accreditation requirements.
BAA Agreements
AvailableRoutely executes Business Associate Agreements with all covered entity clients as required under 45 CFR §164.502(e) of the HIPAA Privacy Rule.
Our standard BAA covers all HIPAA-required provisions including permissible uses and disclosures of PHI, safeguard requirements, subcontractor obligations, and breach notification.
Clients may request our standard BAA template or submit their own. Our compliance team reviews and executes BAAs within 3 business days.
We maintain executed BAAs in a secure compliance management system and can provide copies to clients upon request or in response to audit inquiries.
Request our compliance documentation.
Need our BAA template, training certifications, or policy documentation for your compliance team? We'll send it within one business day.
Email Compliance Teamcompliance@routelypro.com