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Hematology

Information Technology

In the modern Hematology laboratory, Information Technology (IT) is the central nervous system of operations. The flow of data is just as critical as the flow of specimens. The laboratory scientist relies on complex software systems to order tests, interface analyzers, validate results, and report data to the patient’s medical record. Mastery of Laboratory Information Systems (LIS) and their connectivity to the Hospital Information System (HIS) is essential for efficiency, error reduction, and regulatory compliance

System Architecture: HIS vs. LIS

It is important to distinguish between the broader hospital system and the specific laboratory system, and how they communicate

  • Hospital Information System (HIS) / Electronic Medical Record (EMR)
    • Examples: Epic, Cerner (Oracle Health), Meditech
    • Function: This is the master database for the patient. It handles Admit/Discharge/Transfer (ADT) data, billing, physician order entry (CPOE), and the final display of results to the clinician
  • Laboratory Information System (LIS)
    • Examples: Sunquest, Beaker (Epic’s lab module), SoftLab
    • Function: This is the specialized software used inside the lab. It manages specimen accessioning, instrument interfacing, QC storage, result verification, and workload recording
  • The Interface (HL7): The HIS and LIS speak different languages. They communicate via an interface using a standard protocol called Health Level 7 (HL7)
    • Unidirectional Interface: Data flows one way (e.g., Physician orders in HIS \(\rightarrow\) LIS)
    • Bidirectional Interface: Data flows both ways (HIS sends orders \(\rightarrow\) LIS; LIS sends results \(\rightarrow\) HIS). This is the standard for modern operations

Instrument Interfacing & Middleware

Hematology analyzers do not usually plug directly into the LIS. They often pass through an intermediate software layer known as Middleware (e.g., Sysmex WAM, Abbott AlinIQ, Remisol)

  • Function of Middleware
    • Data Filtration: The analyzer generates hundreds of data points (scattergrams, research parameters). The LIS doesn’t need all of that; it just needs the reportable CBC. Middleware filters the data
    • Autoverification Rules: Middleware houses the logic for autoverification. It evaluates the results against a complex set of “If/Then” rules (e.g., “If PLT < 50,000 AND no flags, perform automated rerun”)
    • Centralized Management: Middleware allows a single laboratory scientist to monitor multiple analyzers from one computer screen
  • Barcode Technology: The cornerstone of interfacing. The LIS generates a barcode label with a unique Accession Number. When the analyzer scans this barcode, it queries the LIS/Middleware (“What tests do I run on this tube?”). This “Host Query” prevents manual programming errors

Autoverification

Autoverification is the automated release of results by the LIS/Middleware without human intervention. This is the single most effective tool for improving Turnaround Time (TAT) in Hematology

  • The Logic: The computer reviews the data. If the results fall within defined normal ranges, have no instrument error flags, and pass Delta Checks, the computer verifies the result and sends it to the chart instantly
  • The Scientist’s Role: The laboratory scientist only reviews the “exceptions” - results that fail the rules (e.g., critical values, blasts, significant changes). This allows the laboratory scientist to focus their expertise on the abnormal patients while the normal workload flows automatically
  • Validation: Autoverification rules must be validated annually (per CLIA/CAP). The lab must feed “test patients” with known values to prove the software stops the abnormal results and releases the normal ones

Data Integrity & Delta Checks

The LIS serves as a powerful Quality Control tool by monitoring patient data over time

  • Delta Checks: The LIS compares the current result to the previous result for the same patient. If the difference exceeds a predefined limit (the “Delta Limit”), the result is flagged and held for review
    • Example: A patient had a Hgb of 14.0 g/dL yesterday. Today, the Hgb is 7.0 g/dL. This huge drop triggers a Delta Check
    • Investigation: Is the patient bleeding? Or was the sample diluted with IV fluid? Or was the wrong tube labeled (WBIT)? The Delta Check alerts the laboratory scientist to investigate potential mislabeling errors
  • Limit Checks
    • Reference Range (Normal): Comparison against the healthy population
    • Critical Limits: Comparison against life-threatening values (e.g., Plt < 20k)
    • Linearity Limits: Comparison against the analyzer’s reportable range. If the WBC is 300,000 (above linearity), the LIS flags it so the laboratory scientist knows to dilute the sample

Security & HIPAA Compliance

The LIS contains Protected Health Information (PHI). IT security is a legal requirement under HIPAA

  • Access Control: Users are assigned specific security levels based on their role. A phlebotomist may have “View Only” access, while a laboratory scientist has “Verify/Edit” access
  • Audit Trails: The LIS records every single keystroke. If a result is changed, the system logs who changed it, when it was changed, and what the previous value was. This prevents data falsification
  • Cybersecurity: Laboratories are prime targets for ransomware attacks. Operational continuity plans (Downtime Procedures) must be in place. When the LIS goes down (Planned or Unplanned), the lab switches to manual requisitions and paper reporting logs

Reflex Testing Logic

The LIS can be programmed to automatically order follow-up tests based on an initial result, improving efficiency and clinical utility

  • Example: If a urinalysis is positive for Leukocyte Esterase, the LIS automatically orders a Urine Culture (Reflex to Culture)
  • Hematology Example: If the automated differential shows “Blasts detected,” the LIS adds a “Manual Differential” order to the queue so the laboratory scientist knows to pull the slide
  • Billing Implication: The LIS must ensure that reflex tests are billed correctly. The physician’s original order must authorize “Reflex testing if indicated.”