Implementation of a Laboratory Information Management System

at the Chemical Pathology & Haematology Laboratories,

Lady Ridgeway Hospital for Children – Colombo 08

Introduction
A Laboratory Information Management System (LIMS) is a software-based information management
system that can be used to manage laboratory data starting from acquisition of the samples at the
laboratory to reporting the results, quality management, inventory keeping, data mining, and workflow
automation.
The main features of a LIMS include flexible architecture which can be customized to cater the needs
of the laboratory with provision to designate workflow, data tracking, and use interfaces (user/
analyzer/ software) for data exchange, quality control (QC) data management and graphical
presentation. It can also be interconnected with the Hospital Health Information Management System
(HHIMS) allowing bidirectional data transfer for acquisition of patient demographic information from
HHIMS while transferring test results to the HHIMS.
Justification

At present the laboratory information management including QC data viewing and interpretation at
both Chemical Pathology and Haematology Laboratories – LRH are done manually. This mainly
includes manual registration of samples, QC data management and graphical interpretation, inventory
management, and report dispatch. Also the computers and the analyzers used in the laboratory are not
interconnected thus requiring repetitive data entering at each machine.

The quality control is the core essence of laboratory which ensures the accuracy and precision of the
results. A LIMS would become a great assistance in managing the QC data and their graphical
interpretation by allowing QC data viewing without operator bias and increasing the transparency of
the workflow.

Having a central data base with all information from analyzers on patient test results provide easy
reference to any test result during case discussions on investigations without interfering with the
workflow of analyzers to retrieve stored information.

Following are the deficiencies/ areas requiring improvement identified in the present system:

• Manual log entries of QC data

• Need for operator assistance to view QC information which may result in bias and less
transparent process
• Large space needed to store printed QC results and other documents
• Need for manual drawing of graphs for QC data interpretation
• Need for operator assistance in retrieving old test results stored in the analyzer which may
interrupt the workflow of the analyzer
• Duplication of data due to manual and analyzer data bases
• Time consuming clerical work at the expense of less man power
• Increased transcription errors
• Manual adding of age specific reference ranges on the result sheets
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 • Defects in the present system of report dispatch system for the clinics increasing risk of
report not reaching the patient on time
• Increased laboratory turnaround time
• Manual inventory management of reserved samples, reagents, and QC materials
• Time consuming manual data mining for audits and research
• Manual calculation of statistics

There are several major hospitals under the Ministry of Health, that have laboratories with well
functioning stand-alone LIMSs. National Cancer Institute – Maharagama, Colombo North Teaching
Hospital – Ragama, and Teaching Hospital – Karapitiya are few examples for government hospitals
with such laboratories. Considering above facts, installation of a LIMS at the Chemical Pathology and
Haematology Laboratories – LRH would provide many benefits to the laboratory for better efficiency.
For the efficient use of the LIMS all laboratory staff including doctors, medical laboratory
technologists, minor staff personnel will be trained with the help of the service provider following
establishment of the system.

Objectives for the Establishment of a LIMS at the Chemical Pathology & Haematology
Laboratories

• To prevent data duplication by creating a single record entry at the specimen reception
counter
• To minimize transcription errors by limiting manual data entry for a single specimen by using
barcodes to track the samples following initial registration
• To manage and store QC data
• To view QC data without operator assistance and increasing the transparency of the workflow
• To automatically generate charts for interpretation of QC results
• To conveniently view old test results without having to disturb the workflow of the analyzer
or inconvenience the operator
• To interconnect all laboratory instruments via compatible interfaces
• To reduce turn-around-time by restructuring the workflow
• To establish an efficient report dispatch system for the clinics
• To allow real-time data exchange between the laboratory and the test requesting parties
(wards/ OPD/ clinics) via HHIMS
• To use software based data mining for audits/ research
• To conduct scheduled instrument calibration maintenance
• To keep tabs on instrument maintenance procedures
• To improve traceability by creating a log for all actions performed through LIMS
• To securely store confidential clinical data for future reference
• To generate statistical reports for planning and monitoring purposes
• To comply with the international standards for the exchange, integration, sharing, and
retrieval of electronic health information (Health Level Seven, 21 CFR Part 11 of Food and
Drug Administration (US), ISO 15189 Medical Laboratories)

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Specifications for the Proposed LIMS
1. Compatibility, Interconnectivity, and System Requirement

• The LIMS should be able to function as a stand-alone system.

• The LIMS service provider should provide an interface for the integration with the
Hospital Health Information Management System (HHIMS) which is established at the
Lady Ridgeway Hospital.

• The LIMS service provider should provide analyzer interfaces that allow bidirectional
data transfer between the analyzers and the LIMS with minimal manual intervention.
The interfaces should be compatible with the available biochemistry and haematology
analyzers without compromising their through put rates. The LIMS should be able to
send the work lists to the analyzers through interfaces and capture the results reported.
2. Sample Registration

• LIMS should be able to retrieve patient demographic data from the HHIMS using the
Patient Health Number (PHN)/ BHT number when entered at the specimen reception.

• Provision to register stand-alone samples which may not include patient information in
the HHIMS (e.g. patients referred from other hospitals)

• Provision to register manually conducted test (e.g. Blood picture, ESR)

• Provision to add requesting doctor

• Provision to print barcodes for sample tracking following registration

• LIMS should be able to identify the correct analyser to which sample should be sent
when the tests are entered and register the sample for the particular analyser at
registration counter and indicate the operator to place the sample in the designated
dispatch box to be sent to correct analyser.

• Provision for inclusion of a scanned copy of the request form baring the barcode to be
sent along with the sample/ result (to be included in the system in the future)
3. User Management

• Provision to create/disable or modify users accounts with different levels of

accessibility with a unique user ID and password for each system user.

• Provision to classify/restrict the users into different accessible levels and create user
access rights for each level.

• Provision to reset the system login password of any user account.

4. Laboratory Management (Functions)

• Provision to setup type of sample, ‘Pick lists’ (Prefixed Templates)

• Provision to setup age and gender specific reference ranges

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 • Provision to add/modify units

• Provision to setup individual tests (e.g. serum electrolytes, serum creatinine, FBC)

• Provision to setup parameters for a test (e.g. Na, K and Cl set as parameters under the
serum electrolyte test; Hb, PCV, MCV, MCHC, WBC, etc. as parameters under FBC )

• Provision to enter results of manually performed test (e.g. ESR, blood picture, bone
marrow, Urinary PBG) and create the report

• Provision to store microscope photographs of blood pictures etc. along with the report.

• Provision to create calculated parameters in the special test setup (e.g. estimated GFR,
fractional excretion of electrolytes in urine)

• Provision to give several parameters a cumulative validation

• Provision to group parameters under a special test (e.g. OGTT: 1st hour value, 2nd hour
value)

• Provision to set up profiles where several tests are grouped under one profile (e.g. Liver
profile: AST, ALT, Total bilirubin, Direct bilirubin, GGT, ect.)

• Provision for automatic configuration of age and gender specific reference range to be
printed on the reports
5. Quality Control

• Provision to collect the IQC results and calculate mean, standard deviation, etc. and
provide a graphical interpretation in Levey Jennings charts of the collected data in a
range of dates.

• Provision for creation of Cusum charts and ‘V’ mask interpretation

• Provision to create decision limit Cusum charts

• Provision to maintain an archive of IQC and EQC results and reports

• Provision to graphically represent EQC results

• Provision for automatic IQC flagging and sending alerts to the MLT/ Doctor/
Pathologist
6. Laboratory Transactions, Workflow, and Electronic Data Transfer

• The LIMS should be provided with a single screen status view (Lab Workflow Screen)
where all details of a particular sample can be seen including sample reception, orders
received, sample run, result received, result authenticated, and report generated.

• All the tests and patient information that are being received from the HHIMS will be
reflected on the Lab Workflow Screen

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 • Provision to receive samples by reading a barcode (when the HHIMS is able to print
barcodes at the ward/ phlebotomy setting)

• Provision to generate an automatic message to be sent to the wards via HHIMS as the
sample is received at the reception

• Provision to receive the results through interface of the machine or through manual
entry

• Provision for the Medical Laboratory Technologists (MLTs) to add a comment if the
sample is unsatisfactory (e.g. inadequate sample, inappropriate container as in serum
electrolytes sent in an EDTA tube or FBC sent in a plain tube) and an automatic
massage generation to be sent to the wards/ OPD/ clinic via HHIMS immediately

• Provision for the MLTs to add their electronic signature and comments in the test result
sheet (e.g. haemolysed/ lipaemic sample/ clotted sample)

• Provision to automatically flag abnormal results

• Provision for the doctors to analytically validate the result and add their electronic
signature and comments where necessary

• Provision for the doctors to create reports for blood pictures and bone marrow reports.

• Provision to add test authorisation levels (simple tests like SE, FBC report issuing can
be authorized by MLTs; Osmolality, Blood picture can be authorized by doctors; amino
acid profile, bone marrow reports can only be authorized by the Pathologist)

• Provision to repeat the test upon authentication when necessary, the system should
display two results wherein only one of them can be selected for authentication

• Provision to send the pdf copy of the result to the wards/ OPD/ clinic via HHIMS

• Provision to send a message to wards in the case of critical values reported in the results

• Provision to print part of the result or complete result

• Provision to reprint the results as single result or using a time frame for older result.

• Provision to display an alert symbol on the Lab Workflow Screen if the turn-around-
time for any test is increased above the average/ designated time limit.

• Provision to send authorized reports or real-time status of the test of all investigations
requested by clinics and OPD to a remote computer based at the report distribution
station allowing the report distributor easily search for the report and distribute to the
patients.
7. Inventory Management

• Provision to maintain preserved sample inventory

• Provision to maintain calibrator/ standard material, reagent inventory and indicate when
they are closer to expiry date/ stocks reduce
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 • Provision to maintain QC material inventory

• Analyzer health monitoring

8. Management System Information (MIS) Reports of LIMS

• Provision to give daily summary/ night summary according to the test/ time/ ward/ etc.

• Provision to alert the MLT/ Doctor when an analytically unacceptable report is

generated as in a sample with very high analyte concentration needing dilution.

• Creation of a daily log on all analytically unacceptable results generated at the end of
each session (morning and night) including information of values of the dilutions if
done.

• Provision to track the sample collected time, received time, result entered time and print
out time and give a complete turn-around-time report of the laboratory

• Provision to give a daily summary on failed tests (sample not aspirated etc.), repeated
tests etc.
9. Data Security of Confidential Health Information

• Provision to physically locate(on premises) the database at the Pathology Laboratory

• Provision for automatic backup to be used for restoration of original data during a data
loss

• All frontend modification to the database should leave a log including the date/time of
access, user name, information accessed and log should available to read by authorised
personal.

• Provision for automatic auditing of the database to overview the actions of the database
admin users. The audit results will be available only to the Pathologist and the head
medical laboratory technologist of the chemical pathology lab and any other personnel
appointed by the Pathologist.

• Provision to feed all test reports to the main HHIMS as pdf documents
10. After Sales Services

• The LIMS provider should conduct training sessions free of charge for the laboratory
staff on using the LIMS along with user manual.

• The LIMS service provider should take the laboratory requirements into consideration
and comply with modifying the software with free of charge, up to six months from the
installation (go Live date) as certain features may show less compatible with the
laboratory work flow once LIMS is put into use.

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 11. Other Requirements

• Server computer complying with the system requirements of the service provider of
LIMS and system requirement to serve during peak hours including minimum 10%
buffering

• User Computers: for the work stations (registration, reporting, validation)

• Operating system licenses (Server / Desktop computers)

• Database software license

• Barcode printer

• Barcode reader

• Network facility for the laboratory

• Online UPSs for each computer / server

…………………………………………………………………………………………………

- End Of Document -

Prepared by;

Dr. Udara D. Senarathne

Registrar in Chemical Pathology
Department of Chemical Pathology, LRH

Under the supervision of;

Dr. Eresha Jasinge Dr. Nipunika Senadheera Dr. Chandima Thevarapperuma

Consultant Chemical Pathologist Consultant Haematologist Consultant Haematologist
Dept. of Chemical Pathology Department of Haematology Department of Haematology
LRH LRH LRH

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