Laboratory Information System Development for Clinical and Specialty Labs
Laboratory information system development creates the software that runs a lab: order entry, specimen accessioning and tracking, instrument interfaces, result validation, quality control, reporting, and billing. Custom Healthcare Solutions builds LIS software for clinical, reference, specialty, molecular, and toxicology labs whose testing menus and workflows packaged systems don't fit. Every system is designed for accuracy, traceability, and CLIA-ready record keeping, with EHR and instrument connectivity included. A typical first release launches in 16 to 28 weeks. Tell us about your test menu and volumes.
When Labs Need a Custom LIS
Many labs run established LIS products successfully. A custom laboratory information system makes sense when testing menus, workflows, or business models don't fit those products: molecular and genetic testing with complex reporting, toxicology with confirmatory workflows, new lab startups wanting modern architecture, or labs serving many client providers with different ordering systems. An LIS is one of the more specialized custom healthcare software solutions we build. Our custom healthcare software services show how LIS work connects with integration and analytics for labs across your organization.
Molecular and Genetic Testing
Molecular labs need sample batching, multi-step workflows, bioinformatics pipeline integration, and interpretive reports that general LIS products struggle to support without extensive customization and manual steps by technologists for each run.
Toxicology and Confirmatory Workflows
Toxicology labs manage screening and confirmation testing, cutoffs, medication reconciliation, and specialized reports. Custom LIS workflows apply these rules consistently and significantly reduce manual review steps for scientists and reviewers each day.
Lab Startups and Growth Labs
New labs can build on modern cloud architecture from the start, designed for their test menu, client model, and growth plans, rather than adapting legacy systems built decades ago for other labs.
Labs Serving Many Client Providers
Reference and outreach labs receive orders from many practices using different EHRs. A custom LIS can efficiently manage client accounts, ordering methods, report routing, and billing rules per client and contract.
Laboratory Information System Features
LIS features follow the specimen from order to final report. Each step needs accuracy and traceability, because errors can affect diagnosis and treatment. We build features around your test menu and workflows, with barcode-driven tracking, instrument automation, and validation rules that keep technologists focused on exceptions. Every action is logged, supporting quality management, inspections, and investigations whenever questions arise later about a specimen or result. Here are the core components.
Order Entry and Accessioning
Orders arrive electronically from EHRs or through a provider portal, with requisition validation, insurance capture, and barcode labeling. Accessioning confirms specimen type, quantity, and collection details on receipt at the bench.
Specimen Tracking and Chain of Custody
Every specimen is tracked by barcode through receiving, processing, storage, testing, and disposal. Chain-of-custody records support forensic, toxicology, and occupational testing where documentation requirements are always stricter than routine clinical work.
Instrument Interfaces and Automation
Analyzers send results directly to the LIS through instrument interfaces, eliminating manual transcription. Worklists are sent to instruments automatically, and instrument flags are captured promptly with each result for technologist review. Connecting the LIS to EHRs and other systems is covered by our lab system integration work.
Result Validation and Reporting
Autoverification rules release normal results automatically, while abnormal, critical, or flagged results route to technologists. Reports are delivered to EHRs, portals, or fax, with critical value notification documented for every call and timestamp.
Quality, Compliance, and Laboratory Regulations
Clinical labs operate under CLIA regulations, and many also hold CAP or other accreditation, each with requirements for quality control, personnel, proficiency testing, and record retention. A laboratory information system should make compliance easier by capturing required records automatically and making them easy to retrieve during inspections. Your laboratory director and quality team should confirm requirements for your test complexity and accreditation. Our healthcare compliance and security page covers PHI safeguards.
Quality Control Management
QC results are captured from instruments, evaluated against rules such as Westgard rules, and documented with corrective actions. Patient results can be held automatically when QC fails until resolved.
Audit Trails and Record Retention
Every order, result, edit, and release is logged with user and timestamp. Records are retained according to CLIA, accreditation, and state requirements, and retrievable quickly during inspections or audits by inspectors.
Personnel and Competency Records
Technologist qualifications, training, and competency assessments can be tracked alongside the tests each person performs, so labs can consistently demonstrate personnel requirements are met for each test during inspections at all times.
Billing and Medical Necessity Checks
Orders are checked automatically for required diagnosis codes and payer coverage rules, such as Medicare medical necessity policies, before testing. Lab billing integrates with clearinghouses for claims and remittances each day, using the same approach as our medical billing software.
Implementation and Timeline
LIS projects require careful validation, because results directly affect patient care. We start with your test menu, instruments, ordering clients, and reporting requirements, then build and validate in stages before go-live. A typical first release covering core workflows and initial instruments launches in 16 to 28 weeks, depending on menu size and integrations. Our laboratory information system pricing page explains costs, and interfaces are configured with Mirth Support where needed.
Test Menu and Workflow Discovery
We document your tests, specimen types, instruments, reference ranges, reporting formats, and client ordering methods. You receive a scope, interface plan, validation approach, and fixed estimate before development begins for approval.
Instrument and EHR Interfaces
Instrument interfaces and EHR order and result interfaces are configured and tested with real instruments and client systems. Engine-level interface work is carefully handled by specialists at Mirth Support where needed.
System Validation
The LIS is validated against your test menu with documented test cases covering calculations, reference ranges, autoverification rules, reporting, and interfaces. Your laboratory director reviews and approves validation before patient testing begins on the system.
Go-Live and Parallel Testing
Patient testing transitions in stages, sometimes with parallel reporting from old and new systems. Support continues after go-live with monitoring, fixes, new tests, and instrument additions as your menu grows over time.
Related Lab Resources
Connecting existing lab systems and supporting referral-based labs.
Frequently Asked Questions About LIS Development
What is a laboratory information system?
A laboratory information system, or LIS, manages laboratory operations from test ordering to result reporting. It handles accessioning, specimen tracking, instrument interfaces, quality control, result validation, reporting to providers, record retention, and often billing, helping labs deliver accurate results efficiently while supporting CLIA and accreditation requirements.
When should a lab build a custom LIS?
When packaged LIS products don't fit your test menu, workflows, or business model, such as molecular testing with complex reports, toxicology confirmation workflows, labs serving many clients with different EHRs, or new labs wanting modern cloud architecture. Many labs extend existing systems instead of replacing them entirely.
How do instruments connect to an LIS?
Analyzers typically connect through instrument interfaces using standard protocols such as ASTM or HL7, sometimes through middleware. Worklists are sent to instruments, and results return automatically with flags. Each instrument model has its own interface specifications, so interfaces are configured and tested individually.
Does a custom LIS need to be validated?
Yes. Before patient testing, the system should be validated against your test menu, covering calculations, reference ranges, autoverification rules, reports, and interfaces, with documented test cases approved by the laboratory director. Changes after go-live also require appropriate validation under your quality system.
How long does LIS development take?
A first release covering core workflows, initial instruments, and EHR connectivity typically takes 16 to 28 weeks, including validation. Large test menus, many instruments, molecular reporting, and multiple client interfaces extend timelines. Labs usually add tests and instruments in later releases after go-live.
An LIS Built Around Your Test Menu
Tell us about your test menu and volumes, or visit the Custom Healthcare Solutions homepage.