What Is a Laboratory Information System?
A plain-English guide to the LIS: what it is, what it does, how it differs from a LIMS, how it connects to the EHR, and what to look for when choosing LIS software.
A laboratory information system (LIS) is the software that runs a clinical laboratory. It manages the full life of a test, from the moment an order arrives, through specimen accessioning, testing, and quality control, to the point a result is reported back to the ordering clinician and stored in the patient record. If the analyzers are the muscle of a lab, the LIS is its nervous system.
In short
A laboratory information system is a software platform that captures, processes, stores, and reports the data a clinical or diagnostic laboratory generates. It is built around patients, orders, and results: every test is tied to a patient and an order, moves through a defined workflow, and ends as a reported, retrievable result.
What does an LIS do?
Most laboratory information systems share the same core capabilities, whatever the vendor.
Order entry & management
Receiving and managing test orders, whether entered directly, sent from an EHR, or submitted through a portal, and turning them into work the lab can act on.
Specimen accessioning & tracking
Assigning a unique accession ID to each specimen, labeling it, and tracking its status from receipt through processing so nothing is lost or misidentified.
Instrument interfacing
Connecting analyzers to the LIS so results flow back automatically, rather than being keyed in by hand.
Results management & validation
Capturing results, applying reference ranges and flags, and routing them for technologist or pathologist review before release.
Quality control
Running and recording QC, tracking instrument performance, and flagging out-of-range control results.
Reporting & result delivery
Producing the final report and delivering it to the ordering clinician, the EHR, or a patient portal.
Records, compliance & billing
Retaining test records to meet regulatory requirements and capturing the data used for billing and reimbursement.
Interfaces & data exchange
Moving orders and results between the lab and other systems using healthcare data standards such as HL7, FHIR, and LOINC.
What is the difference between an LIS and a LIMS?
LIS and LIMS are often used interchangeably, but they describe two different tools built for two different worlds. A laboratory information system (LIS) runs a clinical, patient-facing lab and is organized around patients, orders, and results. A laboratory information management system (LIMS) runs a research, quality-control, or industrial lab and is organized around samples, batches, and experimental workflows.
| Laboratory Information System (LIS) | Laboratory Information Management System (LIMS) | |
|---|---|---|
| Primary setting | Clinical and diagnostic labs (hospitals, reference labs, physician office labs) | Research, biotech, pharma, environmental, food, and QC labs |
| Organized around | Patients, orders, and results | Samples, batches, tests, and workflows |
| Core job | Report accurate patient results to clinicians and the medical record | Track samples and data through experiments and quality processes |
| Regulatory frame | CLIA, CAP, and patient-privacy rules (HIPAA) | GLP, GMP, ISO 17025, and industry-specific standards |
| Key integration | Electronic health record (EHR/EMR) | Instruments, ELN, and enterprise systems |
The practical takeaway: if the lab reports results on named patients for care decisions, it needs an LIS. If it manages samples and data for research, testing, or QC, it needs a LIMS. Many organizations run both, and connecting them, and connecting either to an EHR, is where integration work concentrates.
How an LIS connects to the rest of healthcare
An LIS is only as useful as the systems it can talk to. Connectivity rests on a few healthcare data standards.
The messaging standard
Health Level Seven (HL7) is the long-standing standard for exchanging clinical and laboratory data between health IT systems, and it is how most LIS-to-EHR order and result interfaces are built.
The modern API standard
HL7 FHIR (Fast Healthcare Interoperability Resources) is the modern, API-based standard increasingly used for real-time data exchange alongside or in place of older HL7 v2 messaging.
The coding standard
Logical Observation Identifiers Names and Codes (LOINC), maintained by the Regenstrief Institute, is the universal standard for identifying lab tests and observations, so a result means the same thing in every system that receives it.
Connectivity is no longer optional. In the US, the ONC Cures Act Final Rule advances interoperability and prohibits information blocking, requiring certified health IT to support standardized data sharing, including through FHIR-based APIs. A lab whose LIS cannot exchange data cleanly is increasingly out of step with both the rules and its referring providers.
LIS and compliance
Because an LIS holds patient test data, it sits inside real regulatory requirements. In the United States, clinical laboratories are regulated under the Clinical Laboratory Improvement Amendments (CLIA), which set requirements for test records, result reporting, and record retention. Under CLIA, for example, labs must retain test requisitions, quality control, and patient test records for at least two years, and pathology reports for at least ten years, obligations a laboratory information system is built to help labs meet. Many labs also hold CAP accreditation and must protect patient data under HIPAA.
A capable LIS supports these obligations by retaining defensible records, controlling access, and producing the audit trails that inspections require.
How to choose LIS software
There is no single best LIS; the right system depends on the lab's discipline mix, volume, and the systems it must connect to.
Fit for your testing
Does it support your disciplines (chemistry, hematology, microbiology, molecular, anatomic and digital pathology) and your volume?
Interoperability
Does it exchange data cleanly over HL7 and FHIR, code results in LOINC, and interface with your analyzers and your EHR?
Compliance and security
Does it support CLIA and CAP record-keeping, access controls, and HIPAA-grade data protection?
Deployment and cost
Cloud or on-premises, and what is the true total cost including interfaces, implementation, and support?
Integration support
Who builds and maintains the interfaces to your EHR and instruments, and how quickly? This is where many LIS projects succeed or stall.
DS2 connects your lab to the systems it already runs
DS2 does not sell a laboratory information system. What DS2 does is connect labs to the systems they already have. Our integration team builds bidirectional interfaces between your LIS or LIMS and the DS2 platform, your instruments, and your referring providers' EHRs, using HL7, FHIR, or custom APIs, so orders and results move automatically instead of being re-keyed.
With more than 1,000 laboratory integrations performed, DS2 has likely already connected the platforms your lab depends on.
Laboratory information system questions
What is a laboratory information system (LIS)?
A laboratory information system is the software that manages a clinical lab's work: receiving test orders, tracking specimens, capturing and validating results, delivering reports to clinicians and the EHR, and retaining records. It is organized around patients, orders, and results.
What is the difference between an LIS and a LIMS?
An LIS runs a clinical, patient-facing lab and is organized around patients, orders, and results. A LIMS runs a research, QC, or industrial lab and is organized around samples, batches, and workflows. If a lab reports results on named patients for care, it needs an LIS; if it manages samples and data for research or testing, it needs a LIMS.
What does LIS stand for in healthcare?
LIS stands for laboratory information system. It is the core software platform a clinical or diagnostic laboratory uses to manage orders, specimens, results, quality control, and reporting.
How does an LIS connect to an EHR?
Through healthcare data standards. Most LIS-to-EHR interfaces use HL7 messaging (and increasingly FHIR APIs) to send orders and return results, with results coded in LOINC so they are interpreted consistently. Building and maintaining those interfaces is a specialized integration task.
Is an LIS regulated?
The laboratory using it is. US clinical labs are regulated under CLIA, which sets requirements for records, result reporting, and retention, and many are CAP-accredited and must protect data under HIPAA. A capable LIS is built to help labs meet those obligations.
What should I look for in LIS software?
Fit for your disciplines and volume, strong interoperability (HL7, FHIR, LOINC, EHR and instrument interfaces), CLIA and CAP compliance support, a deployment model and total cost that fit your lab, and a clear answer on who builds and maintains the integrations.
References
- 1.HL7 International. Health Level Seven (HL7) standards for exchanging clinical and health data between systems.
- 2.U.S. National Library of Medicine (NLM). LOINC: a universal standard for identifying laboratory observations, produced by the Regenstrief Institute.
- 3.ASTP/ONC (HealthIT.gov). ONC's Cures Act Final Rule: interoperability and information blocking.
- 4.eCFR, 42 CFR 493.1105 (CLIA): laboratory record and report retention requirements.
Ready to Streamline Your Diagnostic Workflow? Let's Talk.
No commitment required. Our team responds within 24 hours.