How to choose a laboratory information system

What is a laboratory information system (LIS)?

A laboratory information system (LIS) is software that runs a clinical lab’s testing workflow: receiving orders, accessioning specimens, capturing instrument results, reviewing and releasing them, and delivering reports to ordering providers. It is the system of record for every specimen and result the lab produces.

A good LIS does more than store results. It decides how fast specimens move, how often staff retype data, how easily clients order, and how confidently the lab passes an inspection. Choosing one is a ten-year operational decision, so it pays to evaluate it like one.

LIS vs. LIMS: which one does your lab need?

An LIS is built around patients, orders, and clinical reporting for diagnostic testing. A LIMS is built around samples and batches in research, manufacturing, or environmental testing.

If your lab reports patient results to physicians, practices, or health systems, you need an LIS. Some vendors use the two terms interchangeably, so judge a product by what it does: patient demographics, provider orders, clinical reports, and EHR interfaces point to an LIS.

What LIS middleware does, and when you need it

LIS middleware sits between your instruments and your LIS. It translates each analyzer’s protocol, routes orders to instruments and results back, and can apply rules before results reach the LIS.

Middleware earns its place when you run many instruments, still use older analyzers that only offer a serial port, add instruments often, or want the freedom to change LIS without reconnecting every analyzer. Modern middleware can run in the cloud, with a small local agent at the lab carrying instrument traffic securely, which removes the on-site middleware server.

Core capabilities every clinical LIS should have

• Electronic orders. HL7 order interfaces with client EHRs and an online ordering portal, so requisitions arrive complete and legible.
• Barcode accessioning and specimen tracking. Labels at intake and a clear status for every specimen, from receipt to result.
• Work queues and batching. Work organized by department, instrument, and priority, with visibility into what is late.
• Bidirectional instrument interfaces. Orders sent to analyzers and results captured automatically, with no manual transcription.
• Quality control and result review. Flags for abnormal and critical values, QC visibility, and controlled verification and release.
• Configurable reporting and delivery. Reports styled for your lab and delivered by HL7, portal, fax, or email, per provider.
• Billing interface. Charges passed to billing with the right codes, so revenue is not lost to manual reconciliation.
• Security and audit trails. Role-based access, encryption, and a complete history of who did what and when, to support HIPAA and inspections.

Requirements by specialty

A general-purpose LIS often struggles with the details that matter most in specialized testing. Check these against every product you evaluate.

Toxicology

• Screen-to-confirmation workflows with drug-level cutoffs
• Chain of custody support
• Pain management and medication monitoring panels
• Interfaces to LC-MS/MS and immunoassay analyzers

Molecular and PCR

• Plate mapping and run or batch management
• Controls tracked per run
• Respiratory, infectious disease, and other multi-target panel reporting

Clinical chemistry

• High-volume result handling with reference ranges and flags
• Delta checks against prior results
• Panels such as metabolic, lipid, and thyroid testing

Histology and anatomic pathology

• Cases with parts, blocks, and slides tracked from grossing to staining
• Synoptic reporting, diagnosis coding, and electronic sign-out
• Connections to digital pathology scanners and viewers

Pharmacogenomics

• Genotype-to-phenotype translation with star allele definitions you can manage
• Drug-gene guidance aligned with published guidelines such as CPIC
• Prescriber-friendly reports and EHR delivery

Interfaces to plan for before you sign

Interfaces are where LIS projects slip. List every connection before the first demo and ask each vendor who builds, tests, and supports each one.

• Instruments: ASTM / CLSI LIS2-A2, HL7, RS-232 serial, TCP/IP, and flat-file output.
• Client EHRs and practice systems: HL7 orders in, results out.
• Reference and send-out labs: orders out, results back into your own reports.
• Billing: charges with CPT and ICD-10 codes.
• Code standards: LOINC for tests, CPT and ICD-10 for billing and diagnosis.

Cloud-hosted vs. self-hosted LIS

A cloud-hosted LIS removes servers, patching, and backups from your team’s workload and is usually faster to deploy. Self-hosting gives your organization direct control over infrastructure and where data lives.

Ask hosted vendors how they handle backups, disaster recovery, updates, and HIPAA safeguards, and whether they sign a business associate agreement. Ask how instruments on your floor reach a cloud system. A secure local relay agent is a common and reliable answer.

What LIS implementation looks like

1. Discovery. Map current workflows, test menu, instruments, connected systems, users, and reports.
2. Configuration. Build tests, panels, reference ranges, work queues, permissions, and report templates.
3. Interfaces. Connect instruments, EHRs, billing, and partners, and test each one end to end.
4. Data migration. Decide what history moves from the old system and how it will be checked.
5. Validation. Confirm that results travel accurately from instrument to final report, and document it the way your accreditation, such as CLIA or CAP, expects.
6. Training and go-live. Train each role, run in parallel where needed, and go live with the vendor’s team on hand.

Questions to ask every LIS vendor

1. Who builds and supports interfaces, your own team or a third party?
2. Can you connect our older serial-only instruments?
3. Can we keep our instruments connected if we change LIS later?
4. How do clients order and get results online?
5. Which parts of the system can our own staff configure without you?
6. How are updates, backups, and disaster recovery handled?
7. Will you sign a business associate agreement?
8. What does implementation include, and what costs extra?
9. Who do we call when something breaks, and do they know our setup?
10. Can we talk to a lab like ours that uses your system?

Where Lab Dynamo fits

Lab Dynamo builds the complete lab software stack and supports it with one in-house team: SparkLIS for toxicology, chemistry, and molecular labs; PathArray for histology and anatomic pathology; SparkPGx for pharmacogenomics reporting; SparkRelay middleware that connects instruments to nearly any LIS; HL7, ASTM, RS-232, and flat-file interfaces; and client ordering and results portals.

If you are comparing systems, schedule a demo and bring your test menu, instrument list, and connected systems. We will walk through how your lab would run, step by step.