View source for Laboratory Information Systems (LIS)

'''Laboratory Information Systems (LIS)''' have been developed and deployed to support all aspects of the contemporary clinical and specialty laboratory, helping technologists manage: the quality and integrity of test samples (Pre-Analytical Phase); all aspects of the testing and result review process (Analytical Phase); and the reporting of finalized results, interpretations, and diagnosis (Post-Analytical Phase).

LIS have also evolved beyond departmental workflow functions and today often include advanced features as: lab-specific electronic medical records; direct clinician access via secure web connections (“Lab Portals”); full-blown billing modules for laboratories performing commercial testing (“outreach”); sophisticated interface engines for routing orders and results to external systems; and on-board image archival systems (PACS) for pathology images. 

== Introduction ==

Clinical laboratories were among the first hospital departments to actively exploit computers and software for managing internal work processes and quality. Since the 1970’s, hospital and commercial laboratories have used homegrown and vendor-provided systems to manage requests for patient testing; direct and track patient specimens; interact with testing instrumentation for analysis and the reporting of test results; and provide a wide variety of clinical, administrative, and quality control reports.

The typical work flow in a clinical laboratory is:
*Pre-analytical:
**Tests requested by doctors --> Specimen collection by nurses or phlebotomists
*Analytical:
**Specimen received and tests ordered by Specimen Processing Service --> Tests performed by technologists --> Results reported by technologists
*Post-analytical:
**Results reviewed by doctors  

This flow chart depicts the work flow in a clinical laboratory and where LIS plays a role during this process: [http://upload.wikimedia.org/wikipedia/commons/9/95/Clinical_Laboratory_Work_Flow.jpg]

== LIS Sub-Systems ==

=== Clinical Laboratory Systems ===

Virtually all hospital-based or commercial clinical laboratories perform a wide range of standard blood, urine, and other substance testing falling into several broad areas including clinical chemistry, hematology, urinalysis, toxicology, immunology/serology, and other types of common clinical analysis. Most LIS handle these areas in a “General Laboratory” or “Core Laboratory” module which interacts with increasingly complex arrays of instruments, robotic sub-systems and “middleware”.

=== Microbiology ===

A specialized LIS module for Microbiology provides workflow and data management support for routine bacteriology, virology, mycology, parasitology and specialty infectious disease testing. Today, many work tasks in this area are automated including monitoring of blood cultures and instruments that can automatically identify isolated organisms and run pre-defined panels of antibiotics to determine the most effective treatment.

=== Anatomic Pathology Systems ===

Anatomic Pathology has long been considered separate discipline from the Clinical Laboratory and has spawned many “niche” LIS vendors (the term “APLIS” may be used to describe this sub-system). LIS support for Anatomic Pathology (and the related discipline of Cytology) includes the receiving of tissue or other samples (“accessioning”); histologic or other processing of the sample; visual or cytochemical analysis, interpretation, and review of the diagnostic/therapeutic findings; transcription or entry of findings; and a final release (“signout”) by an authorized pathologist or cytotechnologist.

APLIS have been the focus of extensive informatics research as genetic and molecular diagnostic methods proliferate and technologies for microscopic image management become more mature.

=== Billing/Accounts Receivable/RCM Systems ===

Billing systems are responsible for issuing invoices, submitting claims, and tracking receivables for laboratories. In order to prepare for potential new payment model and minimize cost after the Health Care Reform, business intelligence reporting has been a sought-after function in recent upgrades. Rules based and automated systems help the laboratories to submit claims with less denials, staff and time. Laboratories are seeking more ways to identify the major payers, demonstrate profitability, and achieve the goal of “getting paid for the service provided with the least number of people.”

=== Blood Bank Systems ===

Like APLIS (see above), Blood Bank LIS sub-systems are dominated largely by niche vendors. One reason for this is that LIS for managing blood manufacturing and transfusion are considered regulated medical devices by the U.S. FDA, subjecting developers to stringent “medical device” regulations for software development, testing, and distribution. Many CIS vendors, in fact, prefer to partner with niche Blood Bank vendors.

LIS for Blood Banks (BBLIS) can be divided into two types; systems to support the donation, processing, testing, and distribution of blood and blood products (Donor Center Systems) and systems used by hospital transfusion services to match and distribute blood to patients. 

UPDATE:  In addition to scrutiny by the FDA, developers and users of blood bank systems have also had to respond to major changes in the blood labeling and barcode standards from a Codabar-based format to a new, international ISBT-128 format. ISBT-128 codes more information, creates the first international labeling standard for blood, and prevents the duplication of unit numbers from different donation centers.

=== [[Genetic and Molecular Diagnostics Support Systems]] ===

The recent explosion of PCR-based methods has expanded molecular and gene-based diagnostic testing into the routine laboratory, forcing vendors and users to either adapt existing LIS functions to new modes of testing or to develop completely new sub-systems. To date, two commercial LIS vendors offer a genetic testing module, and several niche suppliers have emerged to fill this gap. 

The data management aspects of genomic/proteomic laboratory testing is one of the most active areas of pathology pnformatics research, and will have a significant impact on future CIS and EMR design and use as genetic data becomes a core part of a patient’s medical record.

=== Laboratory Automation Systems ===

Laboratory Automation Systems(LAS) were developed to handle and process the large amount of clinical specimen in the clinical laboratory. Robotics, specimen carriers/containers, instruments, and information systems are installed and configured according the laboratory workflow to streamline the analytical process. The system is able to receive the specimen from the floor, recognize and enter the specimen through barcoding, transport the specimen to designated analyzers to perform testing, and archive the specimen for storage. Communication of the various components in the system is controlled by the central unit of LAS.   

=== Other LIS Applications ===

LIS are also found outside of typical hospital or commercial lab environments, and will be briefly mentioned here. Generally, the term “LIS” is use for hospital and commercial medical laboratory systems, but the term can be extended to the support of dedicated public health, environmental testing, clinical trials (human or animal), and specialty labs (nutrition, forensic, etc.). The term “Laboratory Information Management System (LIMS) is frequently applied to LIS outside of the realm of the clinical laboratories discussed above.

== LIS Information Exchange ==
*Data exchange between different systems within the hospital
Traditionally, LIS has two aspects of data input: 1) test ordering and 2) result entry. Test ordering can be done through computerized physician order entry or directly entered by specimen processing service department into LIS. Test results are generated by automated analyzer or manual testing by the medical technologists. Then the results are either fed into LIS by the analyzers or entered by the medical technologists. 

The increasing adoption of information technology around the hospital expands the source of data input and output of LIS. The interfacing between systems enables the LIS to get data input from EHR, computerized physician order entry(CPOE), and pharmacy system, etc. It also feeds data into financial system and EHR. 

Within the hospital, LIS interacts and exchanges data with the automated analyzers, EMR, CPOE, decision support system and financial systems. A typical LIS connection is shown in [http://commons.wikimedia.org/wiki/File:WithinHospital.jpg] 

*Data exchange between different hospitals/organization
Test results can travel further to other hospitals and organizations. With established networks, the test results can be passed real-time to affiliated hospitals, reference laboratories, and outpatient clinics. Moreover, public health and clinical research organizations are also benefited by the multi-directional and coordinated communication from the links to LIS. [http://commons.wikimedia.org/wiki/File:BetweenOrganizations.jpg]


Data standards are used in health care to ensure unambiguous data capture, interpretation, and exchange within and across the heterogeneous applications. LIS has many interfaces to communicate with other systems either within or between hospitals. Inter-system interfaces are typically Health Level 7(HL7), instrument interfaces are mostly standards developed by American Society for Testing and Materials(ASTM), and financial data is often transported using Electronic Data Interchange(EDI) X12 which is governed by standards released by Accredited Standards Committee(ASC). Currently there are also many other custom or proprietary interfaces.

== LIS Vendor Marketplace ==

Commercial vendor-supplied LIS products can be categorized into three broad groups based on their relationship to wider [[EMR|Clinical Information System (CIS)]] or their focus on a single department or sub-specialty (or niche). 

1. “Embedded” or integrated LIS support laboratory functions within a larger CIS offering that often include patient management, clinical orders (beyond laboratory), and electronic medical record (EMR) modules, to name a few.


2. “Stand-alone” or “Best-of-Breed” LIS exist solely to support the clinical laboratory including some or all sub-disciplines including Clinical Laboratory, Anatomic Pathology, Transfusion Medicine (Blood Bank), and other sections (see below). These are often considered “best-of-breed” in contrast to those bundled or sold with large CIS or EMRs.


3. “Niche LIS” systems focus exclusively on sub-disciplines or specialty testing areas such as Anatomic Pathology, Blood Bank (Donor collection and Transfusion Service), Transplant Medicine, Molecular and Genetic testing, etc.


A single vendor might produce and sell solutions fitting into any of the three categories. For example, a CIS vendor might also sell a “Best of Breed” LIS that competes with suppliers in the second and third categories with varying level of success.


Every November, College of American Pathologists(CAP) published a LIS product guide which lists current LIS in the market. CAP sends out a survey to LIS vendors asking about the company information, LIS features, and costs, etc. In the most recent survey, November 2011[http://www.cap.org/apps/docs/cap_today/1111/1111_LaboratoryInformationSystems.pdf], there were 29 LIS listed in the guide. 
*Among the available results: 
**LabDAQ LIS from Antek HealthWare held the most total number of contracts at 2593. 
**Only 8 out of 29 LIS didn't support the use of SNOMED CT.
**Installation costs ranged from $3,500 to $20,000,000.
**Number of instrument interfaces ranged from 60 to 1,300.

===Representative Vendors===

====CIS Vendors with LIS offerings====
Cerner, (PathNet, CoPath) GE (Triple-G), MediTech, McKesson (Horizon)
	
====Best of Breed LIS Vendors====
SunQuest (Flexilab), Soft Computer Corporation (SoftLab, SoftBank, SoftAP), Orchard (Harvest)

====Niche Vendors====
MediWare (HemoCare), Tamtron (PowerPath)

== Emerging Topics in Laboratory Informatics ==

* Clinical Image Management in Laboratory Medicine
* Clinical Laboratory Automation, Robotics, and Decision Support Systems
* Coding and Interoperability Initiatives and Standards
* Electronic Public Health Reporting and Surveillance of Laboratory Data
* Genetic and Proteomic Data Management Challenges
* Barcoding and RFID in Specimen and Biological Material Tracking[http://www.clinfowiki.org/wiki/index.php/Barcoding_in_transfusion_medicine] 
* Medical Device Status for Blood Bank Information Systems
* LEAN, Six-Sigma, and Process and Quality Management Techniques

== LIS Web Resources: ==

College of American Pathologists (CAP) Website; ''An annual survey of LIS Market and articles and columns on Lab Informatics''
http://www.cap.org/apps/cap.portal


American Association of Blood Banks (AABB); ''Articles and columns on BBLIS'', regulation, and ISBT
http://www.aabb.org/content


Advancing Practice, Instruction and Innovation through Informatics (APIII); ''The Premier association and academic resource for Pathology Informatics''
http://apiii.upmc.edu/


Lab Soft News:
An Idea Factory for Pathology Informatics and the Clinical Laboratory; ''An innovative and provocative blog from a pioneer in the LIS industry, Dr. Bruce Friedman''
http://labsoftnews.typepad.com/


--[[User:Jmccormack|Jmccormack]] 20:20, 1 December 2007 (CST)
[[Category:BMI-512-F-07]]

Submitted by Laura Yaju Yang
[[Category:BMI512-SUMMER-12]]