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Laboratory information systems

LIS additional features


Ugochukwu John Jonah, M.B.B.S.
Anil Parwani, M.D., Ph.D., M.B.A.

Last author update: 27 September 2023
Last staff update: 27 September 2023

Copyright: 2023, PathologyOutlines.com, Inc.

PubMed Search: Laboratory information system features

Ugochukwu John Jonah, M.B.B.S.
Anil Parwani, M.D., Ph.D., M.B.A.
Page views in 2023: 89
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Table of Contents
Definition / general | Essential features | Diagrams / tables | Result reporting | Notification management system | Data mining and cross sectional reports | Method validation | Quality management | Administrative and financial issues | Other operational issues | Board review style question #1 | Board review style answer #1
Cite this page: Jonah UJ, Parwani A. LIS additional features. PathologyOutlines.com website. https://www.pathologyoutlines.com/topic/informaticslisadditionalfeatures.html. Accessed December 11th, 2024.
Definition / general
  • A laboratory information system (LIS) is computer software that processes, stores and manages data from all stages of medical processes and tests (TechTarget: Laboratory Information System [Accessed 7 August 2023])
  • A great deal of LISs are utilized by physicians and laboratory technicians to coordinate a wide variety of inpatient and outpatient medical testing, including microbiology, chemistry, hematology, transfusion medicine, immunology, etc.
  • For a more comprehensive review and understanding, read through our previous Laboratory information systems (LIS) topic
Essential features
  • An ideal LIS should be able to improve the quality and cost efficiency of clinical laboratories and most importantly, improve the interface between healthcare providers and clinical laboratories (Arch Pathol Lab Med 2013;137:1129)
  • The goal of an LIS should be to properly package the information produced by clinical laboratories for optimal use by clinical healthcare providers
  • LIS should be able to replace humans in most activities that are predisposed to human error
  • To arrive at a comprehensive, fully functional, user friendly and clinically useful LIS, all stakeholders should be willing to incorporate any combinations of the following into the current LIS
    • Artificial intelligence
    • Expert systems
    • Advance database
    • Data mining
    • State of the art information technologies
Diagrams / tables

Images hosted on other servers:
Useful flags for test results

Useful flags for test results

Result reporting
  • LIS should be capable of incorporating hyperlinks to test results (Arch Pathol Lab Med 2013;137:1129)
    • These hyperlinks should lead to pages containing additional textual information regarding the test; such information may include any of the following
      • Analytic parameters
      • Half life of toxins
      • Drugs
      • Information on analytes
      • Calculators
      • Clinical guidelines
      • Suggested follow up
      • Literature references
    • The information above will equip healthcare providers with the relevant data to interpret the results for clinical use
  • An ideal LIS should be able to link pretest and posttest diagnostic data
    • Such linkage will enable the LIS to display positive and negative likelihood ratios for selected diagnoses based on either the hospital information systems (HIS) or user input
    • When a diagnosis is eventually selected, the LIS should display the following with appropriate references
      • Sensitivity
      • Specificity
      • Accuracy
      • Positive predictive value
      • Negative predictive value
      • Receiver - operator curves
  • LIS should readily display possible significant interferences as well as causes of abnormal test results, such as
    • Diseases
    • Herbal supplements
    • Medications (Arch Intern Med 2003;163:893)
    • Relevant information extracted from the HIS by the LIS should be flagged for possible review
  • LIS should be equipped with a discharge alert system aimed at preventing inadvertent hospital discharges before addressing unidentified or unaddressed abnormal clinically significant laboratory results (J Patient Saf 2012;8:69)
  • LIS should be equipped with an expert system that allows the appending of interpretative comments on test results (Clin Microbiol Rev 2011;24:515, Clin Chem 1997;43:134, Stud Health Technol Inform 2004;107:89)
    • Such systems should take note of pertinent clinical information of patients available in the HIS
    • Should also possess a knowledge database that can be updated with local information, such as disease prevalence
    • The table above shows useful flags that can be associated with test results (Arch Pathol Lab Med 2013;137:1129)
Notification management system
  • LIS notification system should be governed by
    • Institutional policy for certain results (e.g., critical results)
    • User selected notification for routine reports using mechanisms, such as printout, fax, email, HIS alert
    • Appropriate mechanism and timing for user notification should be selected using a rule based system (Arch Pathol Lab Med 2013;137:1129)
  • Notification system for significant results in the LIS should be sophisticated
    • There should be multiple tiers of urgency for significant results notifications
    • One example of the above is the Massachusetts Coalition for the Prevention of Medical Errors, which established 3 levels of notification: red, orange and yellow (Jt Comm J Qual Patient Saf 2005;31:68)
      • Red results imply an immediate danger of mortality or morbidity if immediate action is not taken
        • Such results correspond to the Joint Commission's and College of American Pathologists's (CAP) definition of critical test results
        • Consequently, the laboratory in such cases is mandated to directly notify a healthcare provider with the ability to intervene in patient care
        • In addition, such notifications must be carried out within a given maximum timeframe determined by institutional policy (e.g., within 15 - 60 minutes)
        • Such notifications also require acknowledgment of the receipt of the information by the healthcare provider or read back process
        • Typical example of the above is when the patient's potassium level is 7 mEq/L (7 mmol/L)
      • Orange results are highly significant results that must be acknowledged but are not immediately life threatening
        • Such results are not usually life threatening and may wait several hours (e.g., 6 - 8 hours) before notification
        • Examples of orange results include highly elevated creatinine, amylase, lipase and aminotransferase levels
        • Provider in these circumstances should be notified by a high priority HIS alert
        • Recipient is also required to acknowledge receipt of the information and possibly document steps taken following afterward
        • There should be a cascading process of surrogate notification if the appropriate provider is unavailable
      • Yellow level results may be associated with significant morbidity or mortality if diagnosis and treatment are delayed but are usually not immediately life threatening
        • Yellow results require notification within 3 days
        • Notifications can be made using passive methods, such as a HIS alert or chart note
        • There should also be mandatory acknowledgment and tracking of the result
        • Examples of yellow results include a high thyroid stimulating hormone (TSH), high lead level, a new diagnosis of cancer or human immunodeficiency virus infection
  • Notification of significant results should be done using artificial intelligence and expert decision making support systems to enable better identification of true positive signals (e.g., life threatening results) and minimize false positive signals (e.g., expected results)
    • Expert system should also employ the various inputs previously described for order entry and autovalidation systems
    • Dynamic rules should be employed to determine the criticality of results
  • LIS should be capable of notifying appropriate third parties using a rule based system
    • These third parties include infection control and public health departments
    • Notifications should depend on the laboratory result findings
  • In addition, LIS should allow for rapid communication of changes or corrections made to the laboratory results
    • These changes should be communicated to the providers and promptly updated on the interface of the HIS systems
  • LIS should enable end users to inquire about laboratory testing, receipt of specimens and availability of results
    • Links to appropriate online information should be available in the LIS
    • Laboratory staff should also be readily contacted via the LIS should more information be needed
    • LIS search engines should be fitted with state of the art technologies allowing for synonyms, misspellings and advanced Boolean combination of search terms (Am J Clin Pathol 2006;126:208)
    • Users' activity should be made available to laboratory managers to enable them to improve the process
Data mining and cross sectional reports
  • Data mining here refers to the ability to perform queries into the laboratory and clinical databases (Arch Pathol Lab Med 2013;137:1129)
    • Such inquiries help to maximize the efficiency and quality of laboratory operations
    • Provides means of identifying clinical issues affecting a specified population
    • Data mining enables epidemiologic and public health studies
    • Also allows case finding for the purpose of clinical and research purposes
    • An ideal LIS should possess advanced data warehouse and mining capabilities
  • LIS should have search functions for combinations of laboratory and clinical information; such search functions should make use of Boolean logic and include things like diagnoses, medications and treating specialty
    • LIS should produce reports with user customizable fields like patient demographics, specimen accession data and location
    • Reports generated by the LIS should be exportable to spreadsheet programs for further analysis
  • LIS should be capable of producing laboratory testing turnaround time reports that can be further split into the following categories
    • Order to collection
    • Collection to receipt in the laboratory
    • Receipt in the laboratory to testing
    • Testing to reporting
  • LIS should also be able to group test results based on the following
    • Accession areas
    • Individual tests
    • Test groups
    • Hours or shifts
    • Employee
    • Patient location
    • Clinics
    • Providers, etc.
  • LIS should be capable of reporting online surveillance data to public health agencies
    • Such reporting should be done using the agencies required format as well as appropriate standards
  • LIS should be able to track nosocomial infections and antibiograms
    • Should also be capable of reporting the frequency distribution of microbial susceptibility to antimicrobial agents
    • Should properly interface with pharmacy records and possess the ability to monitor antimicrobial utilization versus susceptibility
  • LIS should contain laboratory utilization reports that can be grouped by the following parameters
    • Providers
    • Provider groups
    • Specialties
    • Clinics
    • Wards
    • Patient types
    • Diagnoses and diagnostic groups
    • ICD-9 / 10 codes, etc.
    • Test types
    • Test volumes
    • Test costs per case
  • LIS should provide appropriate real time feedback on utilization data to providers, especially at the time of the patient discharge
  • LIS should employ data mining capabilities and clinical data extracted from the HIS to determine patient outcome analysis
    • Example of useful clinical data that could be correlated with laboratory testing results in this regard includes mortality, morbidity, length of stay in the hospital and cost of care
    • Further analysis of the parameters above can be done by stratifying patients based on diagnostic groups
Method validation
  • Method validation is used to assess the stability of assay systems and compliance with regulatory and accrediting agencies (Arch Pathol Lab Med 2013;137:1129)
    • Usually precedes the implementation of new assays in the clinical laboratory
    • Can also be done periodically usually in a summarized mode
  • LIS module for method validation should possess the ability to guide and record the following studies using appropriate statistics and graphic displays
  • LIS should alert laboratory staff on the need to perform validation procedures, such as biannual linearity checks and instrument correlations, whenever necessary
Quality management
  • LIS should be able to assist institutions to achieve the following goals
  • LIS quality management system (QMS) should allow for enhanced quality throughout all the aspects of clinical laboratories operation
    • Thus, the LIS should make provisions for quality control (QC) in the laboratory
    • Quality control is the periodic assaying of samples with known reactivity or analyte concentrations to estimate assay accuracy and precision
    • LIS QC should aim at improving the accuracy and reliability of laboratory results by maximizing error detection and minimizing false rejections of test runs (Clin Chim Acta 2004;346:3)
  • LIS quality management module should support the following accreditation requirements
  • LIS quality control protocols and alerting mechanisms should be based on the concept of total acceptable error derived from biological variation and regulatory requirements (Clin Chem 2022;48:395, Scand J Clin Lab Invest 1993;53:8, Clin Chem 2011;57:1334)
  • LIS users should be able to customize the QC protocol based on
    • Built in databases of biological variability
    • Measured imprecision of the various tests at relevant clinical decision points
    • Specific analyzer used to perform the test
  • LIS quality control files for each assay system should contain
    • Information about a particular quality control material, such as test components, lot number, expiration date
    • Manufacturer
    • Laboratory assigned control values for each relevant testing system
    • Serial quality control test results associated with each control material and each analyzer
  • Each patient test result should be linked to the relevant quality control results in an easily retrievable record
  • System should schedule automated running of quality control and also alert appropriate staff to perform QC tasks
  • LIS system should guide the user in QC rule selection; this should take into consideration the total acceptable error and analytic performance (precision and bias) of the testing system (Clin Chim Acta 2004;346:3)
  • LIS should be able to customize active QC rules and reports based on
    • Tests
    • Test groups
    • Analyzer types
    • Laboratory location
    • Work shifts
  • LIS should be able to present QC results using sophisticated user definable displays including Levey-Jennings plots and interactive display of violations of user selected rules, such as Westgard rules
  • QC reports should be easy to interpret
    • Easy interpretation of reports allow staff to quickly make critical decisions about test acceptability
    • Users should be able to access corrective guidelines for QC violations as well as troubleshoot QC related issues
  • LIS users should be able to customize
    • Date intervals
    • Time scales and aggregate
    • Split or compare multiple QC levels
    • QC lot numbers
    • Test groups
    • Reagent cartridge
    • Reagent lot number
    • Analyzers
    • Laboratory sections
    • Multiple laboratories
  • LIS should reliably interface with third party vendors for automated upload of QC data and real time download of peer performance data
  • LIS should allow for real time documentation of corrective actions arising from QC failure
  • LIS should allow for the removal of erroneous results and outliers from QC calculations based on appropriate statistical parameters and user input
  • LIS should be capable of allowing a user guided assurance of quality on certain test runs by
    • Allowing the system to automatically interrupt analysis or perform autoverification in case of QC failure
    • Guiding staff into proper investigations and decision choices in case of QC failure
  • LIS should be able to batch hold QC results so that users do not have to regularly switch screens to verify QC
  • LIS should contain peer comparison statistics involving the following
    • Range
    • Mean
    • Median
    • Standard deviations
    • Coefficient of variation ratio
    • Youden charts
    • Time based plots
    • Histograms
  • LIS should be able to import the parameters above from external interlaboratory programs
  • LIS should allow for alternative means of quality control including moving averages of normal values of all results or by user defined criteria
    • If all results are used, a median value should be presented
    • Display of histogram results by test and various patient characteristics will provide valuable reports for quality monitoring
    • These displays can be done with definable flags highlighting deviations from the historical frequency distributions
  • LIS should provide user definable QC summary reports for review by supervisory and appropriate management staff
  • LIS should have functionalities to interface with
    • Instrument performance data
    • Temperature monitoring systems
    • Water quality parameters
    • Environmental measurements
    • Other data pertinent to good laboratory practice
    • Accreditation requiring periodic documentation
  • LIS should manage proficiency testing (PT) programs, such as
    • Inventory control of PT materials
    • Documentation of PT results
    • Investigation of PT failures
    • Online review and certification of PT results by appropriate management staff
    • In addition, interfacing with external PT program providers should allow seamless transmission of PT data
  • LIS should be able to manage accreditation requirements online, such as
    • Preparation of appropriate documents, e.g.,
      • Incorporation of checklists and questionnaires from accrediting agencies in a database allowing for tracking and documenting answers to checklist questions and inspection findings
      • Containing links to relevant policies, procedures and other electronic documents as evidence of compliance
    • LIS should be able to capture and manipulate data required for accreditation agencies, such as CAP or ISO 15189
  • LIS should possess a user friendly incident, error and process improvement tracking mechanism
    • Tracking system should come with sophisticated database, querying and reporting functionalities (Clin Chim Acta 2009;404:28)
    • LIS should also allow users to initiate reporting of errors and incidents in real time with an option of anonymity
Administrative and financial issues
  • LIS should be capable of incorporating advanced administrative and financial functionalities as detailed below (Arch Pathol Lab Med 2013;137:1129)
  • LIS should be able to generate and transmit the necessary forms and notifications for reimbursement of tests
    • This should be done using the appropriate test codes selected, such as
      • Current Procedural Terminology (CPT)
      • Systemized Nomenclature of Medicine (SNOMED)
      • ICD-9 or ICD-10
  • LIS should be capable of intelligent generation of online and printed regulatory forms associated with laboratory testing, billing, compliance and accreditation
    • Health Insurance Portability and Accountability Act of 1996 (HIPAA) standard transaction formats
      • Medicare Waiver / Advance Beneficiary Notice forms
      • These forms can be used at the point of care as well as in administrative locations
  • LIS should be able to track costs of laboratory operation, such as consumables, labor, amortization and other fixed costs
  • LIS should carry out the following analysis
    • Pricing
    • Profitability
    • Make or buy decision tools
    • Outreach client management capabilities
  • LIS workload statistics should be based on system variables, such as
    • Time logged in
    • Number of tests verified
    • Instrument raw test counts
    • User inputs
  • LIS should be able to produce periodic reports of laboratory productivity and management efficiency using aggregate numbers (such as the following) for top down analysis
    • Number of total and billable tests and interpretations (and who performed the interpretations)
    • Number of full time employee equivalents (FTEE) (FTEEs are classified as technical, nontechnical and scientists / pathologists)
    • Hours worked
    • Laboratory costs (broken down by section, variable versus fixed, etc.)
    • Number of patients (outpatient visits, discharges, bed days, etc.)
  • LIS should be able to carry out individual cost and productivity analysis per test and per laboratory work group for bottom up financial and productivity analyses
  • LIS should be able to help with user definable financial and productivity calculations, such as
    • Costs per billable test
    • Costs per FTEE
    • Paid hours per FTEE
    • Number of tests
    • Costs per patient (different categories)
    • Comparison with benchmarks
    • Ability to customize granularity (e.g., whole laboratory, laboratory section, accession group, individual test)
  • LIS should be equipped with inventory and materials management, such as functionalities for automated ordering from selected suppliers and real time tracking of budget
  • LIS should possess a document management system (DMS) with readily accessible procedure manuals from testing information menus
    • DMS should also contain mechanisms for periodic notification, review and certification by appropriate parties
    • DMS should equally allow scanning and proper linking of pertinent documents, such as reagent and QC package inserts, test requisitions and reports from outside laboratories
  • LIS personnel management capabilities should contain
    • Interfacing with human resource databases
    • Labor costing accounting
    • Tracking of credentials
    • Competency
    • Continuing education training
    • Performance appraisals
  • LIS should provide an interface to online continuing education and role based competency training modules
Other operational issues
  • LIS should have the capacity to record large datasets and interface with legacy systems (in real time or through import functions) to capture historical laboratory data
    • Goal of these is to store lifelong results of patients
  • LIS should be capable of
    • Handling large genomic data sets
    • Providing meaningful reports
    • Providing just in time education to clinical providers (Hum Genet 2011;130:33)
  • LIS should capture industry appropriate standards for coding, billing, document generation and interface formats, such as
    • CDC
    • HL7 CDA1/2
    • XML
    • ASC X12
    • LOINC
    • SNOMED-CT
    • ICD-9
    • ICD-10
  • LIS should also be able to map dictionaries for interconversion between the different standards
  • LIS user interface and navigation should be intuitive and user friendly
  • LIS should be able to minimize the number of keystrokes required for all activities and use automatic return where necessary
  • LIS should have uniformity for similar tasks within the software (e.g., using enter for all programs rather than clicking OK for some and double clicking for others)
  • LIS should print and export all screens and reports in appropriate document text, spreadsheet or graphic formats
  • LIS should possess a fully functional text editor in text entry fields with rich text and common word processing functionalities
  • LIS should be able to appropriately capture and retain data with rapid retrieval in the event of system failure
  • LIS auditing capabilities should track changes in all data made by the user; such changes include results, QC, patient information, etc.
  • LIS interface with single or multiple HIS systems should be flexible in data formats and fully functional; in addition, it should also contain appropriate routines for testing the functionality of the interfaces before use to meet end user expectations
  • LIS interface with HIS should allow real time updating of the LIS with pertinent information like patient location and provider
    • In addition, laboratory data should be rapidly available in all interfaced HIS systems
    • Of particular interest should be the interface between the LIS and the following pharmacy software
      • Drug and test selection
      • Detection and prevention of drug reactions
      • Drug - laboratory interactions
      • Monitoring of drug levels (Arch Intern Med 2003;163:893)
  • LIS should integrate the following to enhance communication among laboratorians and laboratory users
    • Instant messaging
    • Forums
    • Online meetings
    • Social networking capabilities
  • LIS should be able to perform multiple functions simultaneously with imperceptible impact on its speed
  • In laboratory areas where manual activities are carried out, the LIS should be able to
    • Minimize the number of keystrokes used
    • Minimize the waste of time and energy
    • Retain LIS overall performance regardless of workload (Arch Pathol Lab Med 2013;137:1129)
Board review style question #1
Which of the following fully encapsulates the ultimate objective of laboratory information systems?

  1. Improve the interface between healthcare providers and clinical laboratories
  2. Improve the quality and cost efficiency of clinical laboratories
  3. Incorporate advanced administrative and financial functionalities into the hospital information system and overall function of clinical laboratories
  4. Replace humans in most activities that are predisposed to human error
Board review style answer #1
A. Improve the interface between healthcare providers and clinical laboratories. The goal of LIS is to properly package the information produced by clinical laboratories for optimal use by clinical healthcare providers. Answers B - D are incorrect because although these are functions of the LIS, they do not encapsulate the overall goal and purpose of the LIS (Arch Pathol Lab Med 2013;137:1129).

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