The document discusses the evolution and current requirements of Laboratory Information Management Systems (LIMS), highlighting the transition from traditional methods to modern web-based solutions. It outlines the features necessary for a clinical LIMS to effectively manage patient information, regulatory compliance, and data integrity while addressing challenges like training, costs, and implementation risks. Furthermore, it emphasizes the importance of selecting the right system tailored to the unique needs of a laboratory to ensure efficient data management and improved workflow.

1. Laboratory Information System :
Today’s Needs
Dr Rajesh V Bendre
Chief Pathologist , MD(Path), DNB(Path), DPB

2. History of Laboratory Data Management
Prior to 1980
- Paper, pen, and
slide rule
calculations
- Large bound
books for data &
sample tracking
- Chart paper
instrument
printouts
- Pre-printed
stationary
- Manually
typed reports
w/carbon copies
1980 to 1990
- Expensive hand-
held calculators
- Sophisticated
software
programs for data
crunching &
sample tracking
that were difficult
to us, First
rudimentary
commercial
LIMS available
- Large bound
books still
common
- Basic word
processing for
reports
1990 to 1999
- Personal computers
and software
databases made
programming and
documentation easier
- LIMS move from
minicomputers to PCs
- Different software
systems spoke different
languages creating
communication issues
- Direct instrument
uploads developed
- Analytical reports
evolve from ground
mail to overnight
deliveries to facsimiles
to e-mail PDFs to
electronic files
21st Century –
•Laboratory data systems
reach beyond simple lab
sample tracking to web-
based exchange of data
•Field sample bar-coding &
location ID via GPS possible
• Data uses facilitated and
expanded:
– Exposure assessment
data management
– Industry-wide
reports by job
functions
– Comparisons to
historical data

3. Laboratory Information System :Today’s Needs
Today, laboratory medicine creates demand for a system that
combines features of both a LIMS and an LIS.
A true Clinical LIMS meets these requirements by -convergence of
functionality between a traditional LIS, which manages patient care, and a
LIMS, which manages dynamic work flows across a lab, including
everything from sample tracking to results reporting.
Clinical laboratories require an end-to-end system that manages all
information related to patients, from point-of-care testing and diagnostics
to treatment.
Regulatory Requirement- New clause 5.10 (ISO 15189:2012)- a
section in relation to Laboratory Information Management which has been
taken from Annex B - this was previously informative.

4. LIMS
What is LIMS?-
Computerized information management system designed for
laboratories is a concept and combination of three words:
 Management: It means to manage information in a organize
manner to make information useful. Manages lab data from
sample log-in to Interfaces with analytical instruments to
reporting.
 Information: Information refers to collected, organized and
meaningful data. Sorts and organizes data into various report
formats, Stores data for future reference and use
 System: A system means co-related components which works
together for a same goal.

5. Effective
communication
Effective
communication
Effective
reporting
systems
Effective
reporting
systems
ConfidentialConfidential
Data
protection
Data
protection
Checking
processes
Checking
processes
Logs,
worksheets
Logs,
worksheets
Standardized
request forms
Standardized
request forms
Unique
identifiers
samples,
patients
Unique
identifiers
samples,
patients
LIMS
Important
Elements
LIMS Requirements

7. Integrate
with other
sites
Integrate
with other
sites
Financial
management
Financial
management
Access
control
Access
control
Track,
analyze
trends
Track,
analyze
trends
Track
reports
Track
reports
Detailed,
legible
reports
Detailed,
legible
reports
Data
retrieval
options
Data
retrieval
options
QCQC
Error
reduction
Error
reduction
Advantages

8. Advantages of
computerized systems
 Error reduction —A well planned computer system, with check systems for errors,
will help to alert the user of inconsistencies, and reduce the number of errors.
 Quality control management— It becomes easy to keep good quality control
records, perform analysis on QC data, and generate statistics automatically.
 Provision of options for data searching —A variety of parameters can be used
for data retrieval, e.g. it is usually possible to access data by name, by laboratory
or patient number, and sometimes by test result or analysis performed.
 Access to patient information —Most computer systems allow access to all
recent laboratory data for a patient. This is very useful in the process of checking
the most recent results against previous data to look for changes, which is a good
practice, and helps to detect errors.
 Generate reports —It is easy to generate detailed, legible reports quickly. A LIMS
will provide standardized (or customized) reports.

9. Advantages of computerized systems
 Ability to track reports/ Audit trail —A computer system makes it much easier to
track reports; to know when work was finished, who performed the work, when the
data was reviewed, and when the report was sent.
 Ability to track and analyze trends / MIS—The computer and its data bases
provide very strong search capabilities, and with careful design it will be possible to
retrieve and use large amounts of data effectively to track and analyze trends of
various kinds.
 Improved capability for maintaining patient confidentiality —It is often easier to
maintain confidentiality of laboratory data when using a computer than when
dealing with a hand-written report form by establishing computer user codes that
control access to the data.
 Financial management —Some systems will allow for financial management, for
example, patient billing.
 Integration with sites outside the laboratory —A LIMS can be set up so that
data comes into the laboratory system directly from a patient or client registration
point. Data can be transmitted to many sites or interfaces as needed and Results
made accessible to the health care provider or public health official. Computers can
handle data entry into a national laboratory data base.

10. Back-up
requirements
Back-up
requirements
Costs:
purchase
and
maintenance
Costs:
purchase
and
maintenance
Adapting
to a new
system
Adapting
to a new
system
Training:
time
and money
Training:
time
and money
Disadvantages

11. Disadvantages of computerized systems
 Training —Personnel training is required, and because of the complexity of LIMS,
this training can be time consuming and expensive.
 Time to adapt to a new system —When starting up a computer system it may
seem inconvenient and unwieldy to laboratory staff. Personnel accustomed to
manual systems may be challenged by such tasks as correcting errors and
uncertain of how to proceed when encountering situations where a field must be
filled in.
 Cost —Purchase and maintenance are the most expensive parts of a computerized
system, and the costs can be prohibitive in some settings. Additionally, some
settings will not have good maintenance that is locally available. Also remember that
technology changes rapidly, and the life of a computer may not be more than a few
years. This might require repurchase of computer equipment periodically in order to
remain current and compatible with other systems.
 Physical restrictions —Adequate space and dedicated electrical requirements are
necessary, as well as placement of the computer away from heat, humidity, dust.
 Need for back-up system —All computer information must be carefully backed up.
Loss of data due to a damaged disk or system crash cannot be tolerated, and
backup systems will be critical.

12. Choosing a system
Client Responsibilities
Requirement Specifications- In reality, every lab is unique has their own
- types of tests, types of samples, set of instruments, analytical methods
and specifications. Evaluate lab’s existing LIMS capabilities.
In order to get a workable LIMS system, a lot of time has to be spent
implementing the Master data, also called template data, into the LIMS
System validation/maintenance
Interfacing capabilities
Regulatory compliance/accreditation status- as per-
CLIA, ISO 15189, NABL 112 (clinical / Technical requirements),
HIPAA (patient confidentiality),
21 CFR Part 11, HL 7 (Recording, Reporting and communication for
test reports)
Confidentiality/data integrity protection
Determine lab’s willingness & ability to meet current & future client needs

13. Choosing a system
SOFTWARE SPECIFICATIONS-
As managers we must be updated with
software developments-
Recognize the different generations of
Programming Languages
Understand the difference & major
developments in Application software and
System software.
Know the strengths and weaknesses of
tailored software vs. off-the-shelf
software.
Recognize characteristics that are
important in evaluating Packaged
software application for business use.
HARDWARE SPECIFICATIONS-
As compatible with software
Computers operate on a number of layers,
starting from the user interface and moving
inwards from software to the hardware.

14. Choosing a system
 Web based LIMS is a 100% web
based application requiring no
installation of software on the client
side.
 All functions of the laboratory
information system can be
accessed through an internet
browser. This reduces the
maintenance cost of LIMS since all
data and functions are stored on the
server.
 The performance of the LIMS
depends on the server, which can
be upgraded as per business
requirements.
• Web enabled LIMS is based on a
client server architecture where some
or all functionalities of LIMS are
available through a web interface.
• The use of web enabled laboratory
information system is limited to PCs
that have the client software installed.
These systems require maintenance
and updating of the client software for
efficient functioning.
• The performance of a web enabled
system depends on both components
of architecture, such as the client and
server.
A LIMS with flexibility, adaptability, ease of evolution and support, and system
speed will most benefit the laboratory

15. Sample results of Software-XYZ
Evaluation (5 is the highest score.)
Considerations in Purchasing Software
Sample- Software Evaluation Form / Checklist

16. LIMS Challenges- Costing
 Assessing cost- is dependant on the time spent on implementation.
Implementation time inturn depends on the number of instruments, tests,
laboratories, etc, that shall be implemented.
Initial costs = C+I, where:
C = Cost for purchase of system,
including supplier’s implementation
time
I = Internal training time, and
implementation and validation
time cost for the system itself and
for all items to be implemented in
LIMS. Any changes after the
implementation phase will be
included in the system maintenance
Annual costs = M+L+Tn–To, where:
M = Maintenance cost per year for changes,
validation, error handling, backups, helpdesk
L = License for the LIMS system, typically
calculated as % of initial cost per year. Depends on
number of concurrent users.
Tn = Cost of time spent using new LIMS,
To = Cost of time spent using old paper-based
system. Tn and To can be calculated from an
average batch type (or per time if a continuous
process is used), and multiplied by the number of
batches (or time units) per year.
The price of LIMS actually is a lot higher than the stated prices for purchase,
implementation and annual license costs. The monetary return of interest can be
calculated, and may or may not be positive.
However, the real benefit of LIMS is a long term value added quality to the
laboratory processes and the product (report).

17. LIMS Challenges - Implementation
“Implementing An Information Management System In
A Laboratory Is Like Changing The Tyres On A Car
Traveling 100 mph”
“Implementing An Information Management System In
A Laboratory Is Like A Major Organ Transplant
Operation having inherent risks for intra- and post-
operational failures”

18. LIMS Risk Components
• 60% of IT Projects Are Cancelled Prior To Implementation
Due To Functional, Time and Budget Constraints
RISKS IDENTIFIED-
• No Formal Process In Place to Select and Implement LIMS
• Customization And Integration Requirements
Underestimated
• Unrealistic Schedule And Budget Estimates
• Risk Management Plan Not Well Established

19. • Business Case Preparation
• Collect and Organize User Requirements
• Segment and Prioritize
o Priority 1 – Critical To Work Process
o Priority 2 – Improves Work Process
o Priority 3 – Nice To Have
• Development of Functional Specification
• Evaluation of Vendor Responses (GAP Analysis)
• Configuration/Customization/Integration
• Validation And Testing
• Planning and Maintenance
Guidelines for a Successful LIMS Implementation

20. Key Messages
A good information management system will:
ensure all data—the final product of the laboratory—is well
managed
ensure confidentiality and privacy of patient information
incorporate all the laboratory business processes as a part of
the system
assure the accessibility, accuracy, timeliness, and security of
data
Streamline sample tracking & sample workflow in the clinical
laboratory.

21. References-
WHO/CDC/CLSI Laboratory Quality Management System – Training
Toolkit
Nakagawa AS. LIMS i m p l e m e n t a t i o n and management.
Cambridge: Royal Society of Chemistry, 1994.
Mahaffey RR. LIMS applied information technology for the laboratory.
NY: Van Nostrand Reinhold, 1990.
Considerations in selecting a laboratory information management
system (LIMS) Christine Paszko and Carol Pugsley sept 2000
Importance of Management Information System in Electronic-
Information Era. C.L.P.Gupta, Shalini Sharma and Sudhakar Tripathi.
S-JPSET 2010: ISSN : 2229-7111, Vol. 1, Issue 2.