Clinical, molecular & reference labs
From accessioning to sign-out, with every specimen accounted for
HDLIMS handles the full specimen lifecycle for reference, molecular and clinical research labs, from requisition and accessioning through multi-step molecular workflows to signed reports delivered to the ordering provider’s EHR.
The challenge
The challenges we hear most
Accessioning bottlenecks
Paper requisitions, missing patient identifiers and mislabeled tubes stall specimens at the front bench while the turnaround clock keeps running.
Molecular work outgrows the LIS
Extraction, library prep, sequencing runs and bioinformatics handoffs involve plates, pools and reruns that a traditional LIS was never built to track.
Interface work never ends
Every new client, EHR and reference partner means another HL7 interface to build, test and maintain, and every delay holds up onboarding.
Inspection readiness is manual
CAP checklists and ISO 15189 assessments expect documented QC, competency, reagent lot verification and corrective actions. Pulling that evidence from binders is slow and error-prone.
Capabilities
How HDLIMS supports Clinical & Diagnostics
Preconfigured workflows, terminology and reports for your industry, on the same unified platform.
Accessioning and requisitions
Electronic and scanned requisitions, two-identifier patient matching, specimen acceptance and rejection criteria, and label printing at the bench.
Specimen tracking and TAT
Follow every primary tube, aliquot and extract by location and status, with turnaround dashboards that flag specimens at risk of missing their target.
Molecular and NGS workflows
Plate and pool management for extraction, PCR, library prep and sequencing, with index tracking, run QC and handoff to bioinformatics pipelines.
HL7 and FHIR interfaces
Receive orders and return results to EHRs, LIS and billing systems over HL7 v2 and FHIR, with message logs and reprocessing.
QC and proficiency testing
Westgard rules, Levey-Jennings charts, reagent lot crossover checks and PT tracking, organized for CAP and ISO 15189 assessments.
Patient data protection
Role-based access, minimum-necessary views, logging of every PHI access and encryption, designed to support HIPAA safeguards.
Workflow
From requisition to signed report
- 1
Order
Orders arrive over HL7 or FHIR from the EHR, or are entered from a scanned requisition at accessioning.
- 2
Accession
Specimens are matched to two patient identifiers, checked against acceptance criteria and labeled.
- 3
Process
Aliquots move through extraction, amplification or sequencing, with plate maps and controls tracked at each step.
- 4
Review
Results are checked against QC rules, delta checks and reference ranges before technical review.
- 5
Report
The laboratory director or designee signs out, and the report goes to the ordering provider and EHR.
Regulations & standards
Designed to support your compliance program
HDLIMS provides the technical controls and records these frameworks call for. Compliance remains a property of how your lab configures and operates the system, and our validation package helps you demonstrate it.
Recommended modules
The modules Clinical & Diagnostics teams use most
FAQ
Clinical & Diagnostics: frequently asked questions
Is HDLIMS a LIS or a LIMS?
How does HDLIMS connect to EHRs and reference labs?
Does HDLIMS support HIPAA compliance?
Can HDLIMS track turnaround time by test and client?
See HDLIMS configured for Clinical & Diagnostics
Book a tailored demo with a lab informatics specialist. We map your sample types, methods and compliance requirements, then show you exactly how HDLIMS fits.