Clinical laboratory analyst at a hospital lab workstation loading a tray of sample tubes into an automated analyser, with the results screen blurred behind
    Healthcare / Laboratory Information System

    Laboratory information system development

    Clinical labs run on the handoffs: an order from the EHR, a specimen at the bench, a result back to the clinician, a charge to billing. Agnotic Technologies builds laboratory information systems that carry those handoffs over HL7 v2 and FHIR R4, with LOINC coding and CLIA report requirements designed in.

    HL7 v2
    ORM orders in, ORU results out
    FHIR R4
    DiagnosticReport and Observation
    LOINC
    Standard codes on every result

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    Industry Overview

    What is a laboratory information system?

    A laboratory information system (LIS) is the clinical lab's system of record: it receives orders from the EHR, routes specimens and analyzer results, applies LOINC codes, releases reports to clinicians and hands off charges to billing. Agnotic Technologies builds laboratory information systems for hospital, reference and physician office labs, with HL7 v2, FHIR R4 and CLIA reporting designed in.

    Industry Challenges

    What goes wrong between the EHR and the lab?

    Failure points we check first when a lab asks us to replace or extend its LIS.

    • Orders that do not match: an ORM message arrives with a test code the LIS does not map, and the specimen waits.

    • Results without codes: a result goes back as free text with no LOINC code, so the EHR cannot trend it.

    • Critical values by phone only: the alert is made but not recorded, so the lab cannot prove it happened.

    • Corrected results that overwrite: the first value disappears instead of being marked superseded.

    • Charges typed twice: the LIS and the billing system disagree on what was performed.

    Our Approach

    How do we keep orders and results in step?

    Interface rules we build into every LIS so the EHR, the bench and billing agree.

    Every test has a map

    Order codes, LOINC codes and billing codes maintained in one place, with unmapped orders routed to a queue instead of silently failing.

    Results are versioned

    Preliminary, final and corrected results keep their history, and the EHR receives the status with each ORU message.

    Alerts are recorded

    Critical value notifications capture who was told, when and by whom, as CLIA expects.

    Capabilities

    What we build into a LIS

    Modules delivered for clinical laboratory information systems, in the order the lab needs them.

    Order management

    Orders from the EHR, portal or paper, with specimen requirements and labels.

    Specimen tracking

    Collection, receipt, routing and storage with barcodes.

    Analyzer interfaces

    Bidirectional connections to chemistry, hematology and molecular analyzers.

    Result review and release

    Auto-verification rules, delta checks, critical value handling and sign-out.

    Reporting to clinicians

    ORU messages, FHIR DiagnosticReport, PDF reports and portal release.

    Billing handoff

    Performed tests mapped to charges and sent to the billing system or clearinghouse.

    How It Works

    How does an order become a result?

    The reference path we build for a laboratory information system. Each step has a message, a record and a status the EHR can see.

    Order received

    The EHR sends an HL7 v2 ORM (or a FHIR ServiceRequest). The LIS maps the order code, creates the accession and prints labels.

    1

    Specimen collected and received

    Collection time, container and receipt are recorded against the accession, as CLIA test records require.

    2

    Analyzer run

    The instrument receives the worklist and returns raw results with flags, linked to the accession and the operator.

    3

    Review and release

    Auto-verification or a technologist releases the result; critical values trigger a recorded notification.

    4

    Result delivered

    An HL7 v2 ORU message or a FHIR DiagnosticReport with Observation resources, each LOINC-coded, reaches the EHR and the portal.

    5

    Charge posted

    Performed tests are mapped to charges and handed to billing, with the accession as the reference.

    6
    Engineering Stack

    Technologies we use for LIS builds

    Standards at the edges so the EHR, analyzers and billing can change behind them.

    Standards

    HL7 v2 (ORM, ORU, ADT)FHIR R4LOINCSNOMED CT

    Interfaces

    Mirth ConnectMLLP listenersAnalyzer middleware

    Platform

    PostgreSQLNode.jsNext.js

    Infra

    AWSAzureOn-premise where the lab requires it
    Message map

    Which messages carry each lab handoff?

    The messages and resources a LIS exchanges, and what each one must carry. This is the map we agree with the EHR team before the first interface is built.

    LIS interfaces: HL7 v2 messages and FHIR resources for each handoff
    HandoffHL7 v2FHIR R4Must carry
    Patient registrationADT (A01, A04, A08)PatientIdentifiers, demographics, visit
    Order placedORM^O01 (OML in newer versions)ServiceRequestOrder code, priority, specimen requirements, ordering clinician
    Order statusORR, ORM with statusServiceRequest.statusReceived, in progress, cancelled
    Result releasedORU^R01DiagnosticReport with ObservationLOINC code, value, units, reference range, status, performing lab
    Corrected resultORU^R01 with corrected statusDiagnosticReport.status amendedSuperseded value kept, correction reason
    ChargeDFT^P03ChargeItemPerformed test, accession, date of service
    Measured Impact

    What decides the scope of a LIS build?

    There is no fixed price. These factors move effort most, and we size each on the scoping call.

    Interfaces
    EHRs and analyzers to connect

    Each EHR feed and each analyzer has its own message profile and testing cycle.

    Test menu
    Tests to map and code

    Every test needs order, LOINC and billing codes, reference ranges and release rules.

    Sites
    Locations and lab sections

    Multiple sites add routing, send-out and reporting rules.

    Migration
    Historical results

    Result history migrated so trends in the EHR stay intact.

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    Use Cases

    Who builds a laboratory information system with us?

    Lab types and first releases we scope most often.

    01

    Hospital laboratories

    An LIS integrated with the hospital EHR over HL7 v2 and FHIR.

    02

    Reference laboratories

    Orders and results from many client EHRs, with routing and send-out.

    03

    Physician office labs

    A small LIS with analyzer connections and portal reporting.

    04

    Molecular and genomics labs

    Complex reports delivered as structured results plus PDF.

    05

    Point-of-care programs

    Device results captured and sent to the record with the right codes.

    06

    Lab startups

    A fixed-scope first release before the first client EHR is connected.

    Integrations

    Which systems does a LIS exchange data with?

    The systems around a clinical lab, and the standards used to reach them.

    EHR

    Epic, Oracle Health (Cerner), athenahealth

    Instruments

    Chemistry, hematology and molecular analyzers

    Integration

    Interface engines (Mirth Connect)

    Revenue

    Billing systems and clearinghouses (X12)

    Patient access

    Patient portals

    Reporting

    Public health reporting
    Self-assessment

    Go-live checklist for a LIS interface

    What we confirm with the lab and the EHR team before an interface carries real orders and results.

    Codes and mapping

    Codes and mapping

    Messages

    Messages

    Reports and records

    Reports and records

    Compliance-First Development Services Backed by Global Standards

    We build secure, scalable products designed for privacy, interoperability, and regulatory readiness from day one across every sector we serve.

    HIPAA logo

    Health Insurance Portability and Accountability Act

    Protect PHI with privacy-first architecture, encrypted storage and transmission, and strict access controls.

    FHIR logo

    Fast Healthcare Interoperability Resources

    Enabling standardized health data exchange through standards-based API mappings.

    HL7 logo

    Health Level Seven International

    Supporting enterprise-grade interoperability for clinical messaging and record workflows.

    Our Edge

    Why Global Leaders Choose Us

    We combine deep technical expertise with industry-specific knowledge to deliver solutions that aren't just functional, but transformational.

    Enterprise-Grade Security

    We implement rigorous security protocols and compliance standards (HIPAA, GDPR, SOC2) across all industrial solutions to protect sensitive data.

    High-Performance Scaling

    Our architectures are built to handle massive data loads and user bases, keeping performance steady whether you're serving ten or ten million.

    Accelerated Time-to-Market

    Using our suite of internal tools and proven frameworks, we reduce development cycles and get your product to market 40% faster.

    Embedded AI Integration

    Beyond simple wrappers, we build deep-learning integrations and predictive analytics directly into the core of your industry-specific workflows.

    Engagement Model

    How does an LIS engagement work?

    Timing depends on interfaces and test menu size. We agree a fixed first release on the scoping call.

    01

    Scoping call

    We agree the lab type, the EHRs and analyzers involved and the first test menu.

    02

    Interface mapping

    Order, result and charge messages mapped with the EHR team using real examples.

    03

    Fixed-scope first release

    One EHR feed, one analyzer and one lab section in production, with weekly demos.

    04

    Interfaces and sections

    More analyzers, client EHRs and lab sections added in order of volume.

    05

    Support and monitoring

    Interface monitoring, message replay and change control for every later release.

    Facts and sources

    Rules and standards behind a LIS

    Facts we design around, each linked to its primary source.

    • CLIA regulations at 42 CFR 493.1291 require each test report to show patient identification, the name and address of the laboratory that performed the test, the report date, the test performed, the specimen source where appropriate, and the result with its units or interpretation.

      Source: 42 CFR 493.1291 (eCFR)
    • 42 CFR 493.1291(g) requires the laboratory to immediately alert the individual or entity that requested the test when a result indicates an imminently life-threatening condition or a panic (critical) value.

      Source: 42 CFR 493.1291(g) (eCFR)
    • 42 CFR 493.1283 requires a laboratory record system that includes positive identification of each specimen, the date and time of specimen receipt, and the records and dates of all specimen testing, including the identity of the personnel who performed each test.

      Source: 42 CFR 493.1283 (eCFR)
    • The HL7 FHIR R4 DiagnosticReport resource carries the findings and interpretation of diagnostic tests, references Observation resources for the individual results, and links back to the originating order through basedOn.

      Source: HL7 FHIR R4, DiagnosticReport
    • The HL7 FHIR R4 Observation resource represents measurements and simple assertions made about a patient, device or other subject, and is the resource individual laboratory results are exchanged as.

      Source: HL7 FHIR R4, Observation

    Voice of success

    We don't just build products; we forge lasting partnerships. See how we've helped industry leaders transform their vision into technical reality.

    Benchmark

    “I can clearly see how Agnotic has a unique way of handling end-to-end development. They are always active on quick chat and provide support quickly.”

    Aaron Phelan

    Aaron Phelan

    Founder, Benchmark

    Latimer

    “Agnotic combines deep technical expertise with strong domain knowledge. They understand the business context, anticipate challenges, and make collaboration smooth and effective.”

    John Pasmore

    John Pasmore

    Founder, Latimer

    My Lauren

    “Agnotic is the best technical team we evaluated. Their engineering excellence made our work dramatically easier and allowed us to stay focused on what matters most for maternal care outcomes. They took full ownership of the technical execution, and we are always happy to continue working together.”

    Kim Smith

    Kim Smith

    Founder, My Lauren

    Related pages

    Where should you start?

    Detailed pages for the standards and services around a laboratory information system.

    Cross-Industry Reach

    The Same Engineering Patterns, Across Other Industries

    The technical patterns behind this platform translate naturally into adjacent verticals.

    Frequently Asked Questions

    It depends on the number of EHR and analyzer interfaces and the size of the test menu. We agree a fixed-scope first release on the scoping call and give you its timeline before work starts.