UNIVERSITI TEKNOLOGI MARA

A Review of Laboratory Information Management System (LIMS)

SYS704 : Term Paper

PREPARED BY:

MIMI NURAKMAL BINTI MUSTAPA

2013425632

LECTURER:

DR. EMMA NURAIHAN MIOR IBRAHIM

Contents

Abstract............................................................................................................................................1

1. Introduction..............................................................................................................................1

2. Research Background...............................................................................................................4

3. Problems Background..............................................................................................................6

4. Research Implications..............................................................................................................8

5. Recommendations..................................................................................................................10

6. Conclusion..............................................................................................................................12

Reference.......................................................................................................................................13

ii

Abstract

Given the dynamic nature of their operations, today’s public health laboratories need to be

nimble and agile. They need to cope with ever‐changing requirements brought about by changing

technology, increased government regulation, growing competition, expanding public health

reporting responsibilities, and greater expectations from both medical professional and the

clients. The traditional way of simply test and producing report were no longer give so much

impact in providing a better healthcare to the public. As much as the technology is growing,

diseases are also spreading rapidly and new mutate diseases can emerge in any day now. With

these reasons, public health laboratories must be able to receive a lot of test orders and manage

all the orders efficiently. From here, an extensive amount of data will be collected and without

proper information system, the data could be left unattended and underutilized whereas this data

could be analyzed further to provide useful disease reports to the physicians. Despite having a

sophisticated analyzer machine system that could only produce test result, laboratories

information system offers more laboratories management capability. An increasing awareness

among society of public health issues especially on communicable diseases give stronger reason

for an effective laboratory information system to be implemented in public health laboratories.

An interoperability ability in laboratory information system to channel reports via various

channels could help the stakeholders get the information in the first hand. This can cater the

reporting burden that government holds to disseminate harmful diseases information to public

through reliable infrastructures thus helps to provide better healthcare.

1. Introduction

Delivering the highest-quality care in a timely and efficient manner has always been paramount

for Ministry of Health of Malaysia. Not surprisingly, the premier healthcare provider has

leveraged the use of information technology (IT) for years with the implementation of Hospital

Information System (HIS) at several general hospitals. Depending on the size of the hospital,

there are three types of HIS been deployed and they are categorizing as Basic Hospital

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Information System (BHIS), Intermediate Hospital Information System (IHIS) and Total

Hospital Information System (THIS). The implementation of HIS in general hospital depicted

the on-going commitments by the Malaysia government in transforming the nation into a

knowledge based society driven by the new economy through ICT as well as realizing one of the

Seven Flagship Application under the Multimedia Super Corridor (MSC) initiatives (Hassan

2012).

To keep in pace with the MSC initiatives, National Public Health Laboratory (NPHL) of

Malaysia intends to transform their services through Information and Communication

Technology (ICT). With the mission to provide latest analytical and diagnostic services, cost

effective, timely and friendly, a reliable Laboratory Management Information System (LIMS)

can drive the success factor. Currently, beside NPHL, there are 4 others Public Health

Laboratories (PHL) which resides in Ipoh, Johor Bahru, Kota Bahru and Kota Kinabalu. These

PHL are interconnected to NPHL as the main reference laboratories.

Although each general hospital has its own laboratory or called Pathology Department, their test

environment and objective is slightly different from NPHL. Pathology Department produces

result by each patient in their own hospital whereas NPHL concern is more on the diseases itself.

This will give NPHL information on disease trends and thorough research of the characters of

the viruses can be conduct further. Pathology Department at the hospital outcome is the test

result and their objective can be accomplish in shorter period of time compare to NPHL which is

responsible to perform surveillance and disease monitoring for time to time.

The aim of this paper is to review the process of creating, building and implementing a LIS or

LIMS from others point of experience. There a many ways to build a system and each system is

unique with the own purposes and functions. The next section of this paper will give a brief

description of LIS and LISM and what are the differences between these two systems. Also will

be looking are their problems, issues and challenges of creating, building or implementing the

LIS or LIMS. Another section will discuss some of the benefits and future prospect of having

LIMS. Summary of this paper and future works will be identified at the end section of this paper.

From these data extraction, a desirable concept of LIMS can be understand to suit NPHL needs

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Laboratory Information System (LIS) vs Laboratory Information Management System

(LIMS)

An international company called Abbot Company who has build an award winning laboratory

software called STARLiMS define Laboratory Information System (LIS) as a series of computer

programs that process, store and manage data from all stages of medical processes and tests. By

putting a ‘management’ word, LIS could also referred as Laboratory Information Management

System (LIMS). What is the difference between these two? Laboratory Information Systems

(LIS), exclusively serving clinical laboratories, and Laboratory Information Management

Systems (LIMS), serving analytical, manufacturing, and R&D laboratories across many

industries. LIMS software is required to be inherently more flexible as LIMS managed a wide

variety of business requirements. Physicians and lab technicians use LIS to supervise many

varieties of inpatient and outpatient medical testing, including hematology, chemistry,

immunology and microbiology. Basic LIS commonly have features that manage patient check in,

order entry, specimen processing, result entry and patient demographics.

According to Grasiani, Koch et al. (2014), a LIS tracks and stores every detail about a patient

from the minute they arrive until they leave and keeps the information stored in its database for

future reference. Cosper, A (2012) in his article wrote that the two programs differ in regulatory

requirements and workflow structure. LIS software is for hospital and typically used by

physician after making a diagnosis whilst LIMS is used in research and manufacturing labs for

pharmaceutical, chemical and food processing companies. LIMS are designed to report results

for batches of samples to the responsible parties. LIS are designed to report test results for

individual patients back to the physicians caring for them. LIMS is not a competing system to

LIS since LIMS is based more on test development than patient care. Nonetheless, traditionally,

LIMS should be able to manage samples, including receiving and tracking samples, schedule the

sample into the lab’s workflow, processing the sample, data storage related to analysis and

captured level of approval and compilation of sample data for reporting. Therefore, for the case

of NPHL, it is suitable to develop a LIMS as the design and functions purpose suit the NPHL

mission.

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2. Research Background

The review method for this paper consists of using various electronic database resources to

search relevant works on LIS. These include: IEEE Xplore, Emerald Insight, Elsevier, Science

Direct, ACM Digital Library and Google Scholar. Among the keywords that have been use

include “Laboratory Information System”, “Laboratory Information Management System”,

“Laboratory”, “Implementing LIS”, “Requirement engineering”, “Agile” and “Methodology”. At

the first stage, there are many research papers related to LIS, but only five papers were selected

on the experience of building or creating a LIS or LIMS from the very beginning. Other papers

were referring for their problems, challenges and future aspect.

Clément, Fillon et al. (2010) introduce a web-based application of LIS for the gathering and

display of data generated through medium to large-scale single nucleotide polymorphism (SNP)

identification by re-sequencing called TreeSNPs. It was built on an open-source platform with

the objective to organize, centralize, and share genomic and genetic data among the different

research units of the project. Another open-source application of LIMS was introduced by Melo,

Faria-Campos et al. (2010) called Sistema Integrado de Gerência de Laboratórios (SIGLa)

because the researchers has found that the available LIMS are not easy to be implemented in

various laboratories as it was developed to suit one kind of laboratory only. By having SIGLa,

the researchers intend to introduce new approach of LIMS that can cater various types of

laboratories. A workflow management system has been incorporated into the system so that new

laboratory can define their activities, rules and procedures.

Another LIMS called Emergency Response Management System (ERMS) was introduced by

Sandlin, Johnson et al. (2009) and has its own customizable ability to support chemical terrorism

emergency response laboratory activities. This LIMS collect data from laboratory instruments to

identify the chemical agent of interest and report these data to public health responders and

decision makers. From here, public health system will use the result to facilitate the treatment of

patients who were already exposed and protect others who might be exposed to the harmful

diseases. Vu and Nguyen (2010) designed a LIS called BK-LIS for health facilities in Vietnam

which can automatically acquire and manage data from the medical laboratory equipment. By

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having BK-LIS, clinical doctors or medical staff in hospital will be able to review patient

information for diagnosis and treatment. A more in depth screening system called Screensaver

was developed by Tolopko, Sullivan et al. (2010) high throughput screening facilities. This

LIMS is based upon the Java Server Faces and Facelets web development technologies, allowing

its web pages to be defined in terms of reusable templates and high-level components. It gives a

consistent user interface to the user and easily interpreted and modification for developer. The

characteristics of each LIS and LIMS mentioned above are summarized in Table 1.

Table 1Summary of LIS/LIMS and its characteristics

LIS/LIMS Application

FunctionSoftware platform Researchers

1.

TreeSNPs Gathering and display of data generated through medium- tolarge-scale for single nucleotide polymorphism (SNP) identification

Open source- Ruby on Rails- PostgreSQL

Clément, Fillon et al. (2010)

2.

Sistema Integrado de Gerenciamentode Laboratórios (SIGLa)

Incorporated workflow management system to adapt it activities and processes to various types of laboratory.

Independent- JSP & J2EE- MySQL

Melo, Faria-Campos et al. (2010)

3.

Emergency Response Management System (ERMS)

To support chemical terrorismemergency response laboratory activities at the Centers for Disease Control and Prevention (CDC)

Microsoft- MS Access

2003- SQL Server

2000

Sandlin, Johnson et al. (2009)

4.

BK-LIS Automatically acquired and managed data from the medical laboratory equipment’s and transform it into readable electronic medical records.

Microsoft- VB.Net- SQL Server

2000

Vu and Nguyen (2010)

5.

Screensaver Supports the storage and comparison of screening data sets, as well as the management of information about genome-scale RNAi screening, libraries and laboratory work requests.

Open source- Java- PostgreSQL

Tolopko, Sullivan et al. (2010)

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LIS modules

LIS can be defined broadly, and some specific functionality listed might be provided by software

modules not strictly considered as LIS. For this paper, various LIS models has been study to get

the idea of what specific module should be in the priority of developing LIS for NPHL. The

common modules identified from various LIS examples are as describe in Table 2.

Table 2LIS modules

Module Function

1.

Patient Management

Flexible patient query tools; centralized management of demographic details, including family genealogy; patient merge tool; patient alerts and flags that can be displayed at test ordering or accessioning.

2.

Specimen Registration

Responsible to register the specimen received and categorize it according to the test unit. More efficient specimen registration will involve bar code system for easier labelling, tagging and tracking.

3.

Test Order Customer-configurable, template-driven booking screens for test request and specimens; test order frequency alerts; reflex tests; delta checking and configurable reference range criteria (e.g., age, gender, clinical study, diagnosis, etc.).

4.

Test Unit Specific unit to do the test such as Microbiology, Serology, Virology, Mycology, Cytology etc. The number of units depends on the size of the laboratory.

5.

Result Result of the test will be generating through this module. Clients can either view this result through the system or simply print it for record management.

6.

Billing Comprehensive invoicing and billing for management of all types of private and commercial billing. Automatic generation of claims and individual patient invoices. For public health laboratory, this module is not applicable as the entire test is funded by government.

7.

Reporting Report formatting that is entirely configurable by the lab. Support for HL7 web-based reports. Integrated remote access for clinicians providing fully secure access to reports.

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8.

Quality Control Allow the users to control gauge and sample quality, data entry standards, and workflow.

9.

Audit Trail This module ensures the security handling of each specimen. Every step taken by the staff will be recorded to prevent data loss, theft, and any illegal access to the data.

3. Problems Background

As a central public health laboratory in Malaysia, National Public Health Laboratory (NPHL)

receives a lot of specimens to undergo for test each day. These specimens could come from

various facilities including health clinics, hospitals, district offices, institutes or general

practitioners from both private and public sector. All of them are called clients as they request

NPHL to do the test. Each time NPHL receives a specimen, it will first be inspected whether the

specimen is in good condition without any leakage at the sample reception counter. The

turnaround time (TAT) will started to count as NPHL receive the specimens. With current

conventional system, clients will have to wait for NPHL to issue final result and send by mail to

respective clients addresses. Not to mention that this process added more clerical work on

laboratory’s staff and it is not cost efficient. This mail result will take longer TAT if the

specimens were sent by batch. By that time, other people might have the possibility to be expose

to harmful diseases as public health authorities can’t get information on the diseases in the first

hand with reasonable time to warn other people.

Having four other PHL running at different region, it is cumbersome task for NPHL to compile

reports which were sent by each PHL. With no electronic centralized database, many reports

could not be produce in time and it became harder for the physicians or clinicians to analyze

manual reporting data. Furthermore, there is no information sharing between all the public

laboratories. If a single patient demographic was being registered at one PHL, the next time

around the same patient demographic had to be re-registered if their specimen is being tested at

other PHL. This situation did not create a unique data for single patient demographic and no

history of the patient’s specimen can be captured.

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4. Research Implications

The pressures on a laboratory to improve performance in terms of sample turnaround and the

quality of the data being reported are becoming more intense and a well implemented LIS can

assist in these areas. The introduction of a LIS into a laboratory provides great implications to all

aspects of the business, not just to the laboratory itself but also to the clients of the laboratory

whether they are internal or external clients. Kim Futrell (2013) stated in her paper that

implementing LIS has the advantages on reduced clerical work, better evaluation of workload,

faster communication, improvement of information given to the clinicians in terms of adapted

reference values, better interpretation, comments, improved retrieval operations and faster billing

process. Supporting these advantages were paper written by Blaya, Fraser et al. (2010) that says

there are two major benefits that LIS can provide; one is decreasing times for communications of

results which also means turnaround time and secondly is improving the productivity of the

laboratory. Vu and Nguyen (2010) in other words said that having LIS can reduce unnecessary

delays due to paper-based result or report and this will also reduce errors due to manual entry of

data.

Our healthcare system has developed in disjointed silos of care, and this has created an

inefficient system that causes poor utilization of lab tests. By using the LIS and the data within,

labs can make a positive impact at the point of order for diagnostic testing. This will ensure that

the most appropriate and cost-effective tests are selected and eliminate redundant tests.

Laboratorians and pathologists can be instrumental in the collaborative efforts needed to track

and monitor test utilization patterns and be involved in committees to develop and implement

best-ordering guidelines and evidence based testing algorithms or cascades that lead to optimum

patient outcomes and benefits the entire organization (Futrell 2013).

Having an electronic database also allow data to be retrieved with just a click of a button and

data can be archive rather than rummaging through a bunch of files. These and other benefits

such as improving business efficiency, improving data quality has been highlighted by Tagger

(2011).

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Challenges

The past 30 years have seen the development of laboratory information system from simple

system designed just to generate results to even complex system capable of tracking the entire

laboratory workflow throughout all phases of the total testing process, including pre-analytical,

analytical and post analytical (Futrell 2013).

As it will be a web-based application, LIS will not have an exception from harmful attack from

the cyberspace. Sepulveda and Young (2013) suggest that information system must be secured

from unauthorized from both internal and external access without hindering the functionality of

the legitimate users as they are working on highly confidentiality data of patients. This security

features should be provided along three directions: data entry validation, system access control,

and memory protection.

As healthcare continues to transform and facilities decide where and how their laboratory fits in,

laboratory professionals and pathologists need to be in tune and involved in these decisions. In a

large healthcare facility, the administration may not see the lab as a big priority because it is not

a large cost; however, it can be a huge factor in improving patient outcomes as diagnostic

information becomes ever more important in the future of healthcare (Kim Futrell 2013).

With the explosion in the use of smart phones and tablets that provide anytime, anywhere access

to a broad variety of business and personal information, expectation from clients and clinicians

have increasing with regard to timely access to clinical laboratory data. Therefore, LIS should be

design to suit in various platforms of technology to ensure its high availability of accessibility.

Other biggest challenge for implementing a LIS is likely due to human factors. Lack of a

proficiency in user requirements specification will lead to failure to meet the user’s initial

expectations. As user requirement might change accordingly, it takes very skillful personnel not

just to understand the business needs and problems arise, but also to identified and put it in

standard documentations (Tagger 2011).

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5. Recommendations

Investment and funding are important for implementing a LIMS in a laboratory that is why a

proposal must justify the cost and demonstrates the value of it in a laboratory in order to gain

approval for such major project. In order to justify a LIMS investment, a detailed review of

processes and practices both within and outside the laboratory is required. There are many

attributes that need to be taken into consideration while successful implementation of LIMS such

as financial fitness, technological viability, company culture, schedule and timing, business

understanding and competitive quality etc. (Prasad and Bodhe 2012). For some organization who

face IT budget constraints, an embedded in-house programmers should be in place to provide

software development support to the laboratory. This approach could also reduce LIMS

development cost and furthermore ensure easier customization of the software to meet dynamic

changes of workflow process in the laboratory (Melo, Faria-Campos et al. 2010). Having an in-

house technical expertise and well-train staff that know the structure of the LIMS also ensure

modification of the system can be done internally. Some LIMS has not been a success story due

to lack of proper customization, improper installation, non-availability of well-trained technician,

hasty installation and inefficient feedback mechanism (Prasad and Bodhe 2012).

Building data platform such as LIMS will require laboratory expertise in terms of the business

process of the laboratory itself. Thus a deep understanding of the nature of the laboratory itself

belongs to the pathologist. Software developer personnel would only interpret their

understanding into computer programs and codes, the workflow process still have to be

determined by the laboratory personnel. Hence, it is ideally to involve pathologist in LIMS

design and implementation to ensure the system work base on their activities, rules and

procedures. Living the software developer work on their understanding would lead to unwanted

functions being created and worst makes the system not meet the user requirements.

Interoperability among health facilities is well-known issues to be emphasized during LIMS

implementation. Hospital Information System (HIS) is well-known solutions for its huge

contribution for data management in hospital. In order to be competitive, LIMS need to have the

capability to deal with wide variety of HIS products in the market that vary tremendously for

their ability to send electronic lab orders (Futrell 2013). This interoperability would eliminate

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redundant work in terms of data entry as all patients demographic can come from single point of

entry which is the HIS. As more meaningful use, LIMS must keep in pace with the expanding

standards and other regulatory measures being use in the healthcare such as International

Statistical Classification of Diseases and Related Health Problems 10th Revision (ICD-10), the

ability of LIMS to support interoperability among multiple hospital, independent and physician

office laboratories is becoming increasingly important (Gregory, Katieb et al. 2014). Getting

data in the right form to the right system are the key examples for LIMS to not just connect but

to collaborate and going beyond the four walls of the lab hence help position the public health

laboratory for greater success. Sugijarto, Safie et al. (2013) in his paper analyze the model to

integrate LIMS with HIS. Although this study refer to LIMS within the HIS itself, further

research to use LIMS model from other laboratory can be done in the future. The LIMS and the

HIS will need to work in cycle to monitor population health dynamics, and these software

capabilities must be able to continually advance and become more sophisticated to support more

standardized, data-driven, best practice models.

Another aspect that can be considered for LIMS in this flexible future is to host the system in the

cloud. This will allow the labs free from old-fashioned, huge installations work and network

requirements. This gives the LIMS users almost instant and untethered software access which

enables management of the lab from any workstation or laptop at any time and location

(Gregory, Katieb et al. 2014). Not only has cloud computing scaled computing to the data center,

but it has also introduced software, systems, and programming models that significantly reduce

the complexity of accessing and using these resources (Grossman 2009).

With the growing number of test orders received every year, it is an essential features for LIMS

in the future to have an alert system for an emergency response especially during getting

approval from authorities. Functions like generated e-mail notifications or Short Message

Service (SMS) from the system allowed remote notifications contribute to quick turnaround time

to review the quality of results and reporting data. As the functions and demands of the

laboratory change, the functions of the LIMS may also change to include additional features such

as auditing, customer relationship management (CRM), quality assurance, and instrument

calibration in the future.

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6. Conclusion

The future of clinical laboratory software lies in its ability to adapt to the ever-changing

laboratory environment. LIS has a huge way forward to more mature quality solutions that

enable pathologist and laboratorians to be a fundamental part of the care team with a clear focus

on patient healthcare that promotes wellness and prevention while simultaneously reducing

government spending on public health care. A general LIS will not be the best solution for all the

requirements of the laboratory. A well- designed laboratory information systems have much

potential to improve patient care and public health monitoring even in resource-poor settings.

Some of the challenges described, such as lack of trained personnel, limited transportation, and

large coverage areas, are obstacles that a well-designed information system can overcome.

However, creating well-designed information systems is a difficult task necessitating appropriate

resources, expertise and time to be successful. Therefore, implementation of LIS or LIMS

requires a thorough study of the laboratory processes and understanding the operational

feasibility of experiments (Prasad and Bodhe 2012). Based on the study above, it can be said that

designing and developing an open-source web-based application of LIS for NPHL in Malaysia is

feasible. As suggested by Prasad and Bodhe (2012), the best approach to develop a LIS is by

adopting open web-based standards as it is easily customized and offer much more than sample

management and reporting functions. This standard allows LIS to connect to wider business

process by sharing scientific data through worldwide organization. For it is not a one-time

software development cycle, agile methods can be apply to suit the constantly change

requirements from the users and staff involved (Hui, Lei et al. 2012). NPHL also collaborate

with the public health laboratory internationally; World Health Organization (WHO) and other

related agencies. Therefore a comprehensive information system has to be establishing at NPHL

to set a standard benchmark of information sharing to combat communicable disease not just for

the country but also to the global epidemic.

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References

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