LESSON 10: LABORATORY 10.1.

2 The purpose of a LIMS

MANAGEMENT INFORMATION SYSTEM
The ultimate motive of a LIMS is to enhance
efficiency in lab operations through reducing
Overview of Laboratory Information
manual responsibilities. As an example, a
Management System
LIMS automatically records information that
10.1.1 Overview of LIMS might in any other case need to be typed in
or written down, thereby saving time, and
A laboratory information management reducing mistakes.
system (LIMS) is a software designed to
make labs more efficient and effective, What information your LIMS automatically
especially those that process massive captures, the way it enters the system, and
amounts of samples for research and where and how it is saved relies upon on
development (R&D), manufacturing, and which LIMS supplier you select. Some LIMS
medical research. might be better at supporting certain kinds
of labs function more successfully, but not
Any kind of lab can gain from a LIMS or a be as suitable for others (Reisenwitz, 2017).
laboratory management system (LMS).
However, they are more commonly found in
manufacturing and quality assurance. A few
examples include:
Functional Requirements and Features of
LIMS
 Labs dealing with R&D for oil and
fuel companies Reisenwitz (2017) elaborates on the
 industrial chemical creation and functionality of a LIMS as follows:
testing
 Water treatment plant testing Sample management
 food safety As samples move from person to person
 Environmental facilities and place to place, it is easy for them to get
lost or mixed up. Accurate, detailed records
are essential to making sure everything gets
The form of lab you run will decide which
done and done right. For example, a good
type of software you ought to go with.
record should tell you whether a sample
LIMSs are also used in the medical and
pharmaceutical industries. And, in meets project criteria, but they can be a
pain to create and maintain.
conjunction with laboratory information
systems (LIS), LIMS is also a form of When you create a sample, most LIMSs will
medical lab software program. record and store information such as:
Almost each top pharma lab presently
makes use of a LIMS, consistent with  Who or what the sample was taken
Gartner’s 2016 life Sciences Hype Cycle from?
(full content available to Gartner clients).  Which researchers/providers are
They are beneficial for biobanks and working with it?
genomics testing centers together with labs  Where it's been, and where it needs
that study drugs and develop formulations to go next?
(Reisenwitz, 2017).  How to store it?
 When it needs to move?

1
Ideally, the LIMS will automate as much of EMR/EHR
this as possible. Some use RFID to create Electronic health records (EHR) is its own
and update audit logs and chain of custody type of software, but some LIMSs have
to automatically track where the sample is in EHR functionality built-in, including patient
every stage of the process. Barcode also check-in and billing. If you don't have a
works for this purpose. software package offering these features,
choosing a LIMS with this kind of
Workflow management
functionality can be a huge asset when
You should use a LIMS to automate
managing your clinical lab.
workflow for the same reason you should
use it to automate records keeping, but Mobile
instead of saving work, this function saves Gartner's Hype Cycle says that mobile LIMS
you time. When you codify existing methods offerings are limited right now. But as
and procedures in a LIMS, you delegate smartphones become more acceptable in
decision-making to the software. For the lab, consider whether it will be useful to
example, it can automatically assign work to you in the future to have a mobile-friendly
scientists and suggest instruments based LIMS.
on preset rules. And instead of looking up
ERP
what you need to do with a sample and
ERP software helps manage inventory, and
where it needs to go next, a good LIMS will
it can be very helpful to have a LIMS that
automatically provide this information.
performs this function. Being able to view
Reporting what you have on hand at a glance, getting
It's good to be able to quickly pull reports alerts when supplies are running low, auto-
that can answer questions such as which calculation of storage and freezer capacity,
instruments get used the most, how long and location management can be extremely
your sample backlog is, and how long it useful in a clinical lab.
takes your lab, on average, to process a
sample. This kind of data is extremely Core Components of LIMS
useful for data analysis auditing and audit
trail. LIMS software suites usually involve
multiple components in order to provide a
Some LIMS will be more granular in their variety of functions for different levels of the
reporting than others. For example, one laboratory. IEEE GlobalSpec (2015)
LIMS might be able to tell you what your specifies that components may include:
average sample processing time is, but
another might tell you your average time  Electronic lab notebooks
broken out by type of sample. It's helpful to  Sample management programs
know what kind of reporting and level of  Process execution software
reporting you need before you begin  Records management software
comparing vendors.  Applications to interface with
analytical instruments or data
Keep in mind, just because a LIMS can run
systems
a report doesn't mean it's easy. Some
 Workflow tools
reports require custom coding to set up and
 Client tracking applications
run. And some systems can export to
 Best practice and compliance
Adobe PDF and Microsoft Word, but not
databases
Google Drive.

2
  Enterprise resource planning (ERP) Laboratory means a facility where the
software laboratory use of hazardous chemicals
occurs. It is a workplace where relatively
Figure 10.1 below displays a view of the small quantities of hazardous chemicals are
primary components and interfaces of a used on a non-production basis.
Laboratory Information Management
Laboratory use of hazardous chemicals
System.
means handling or use of such chemicals in
Figure 10.1: Components of an LIMS which all of the following conditions are met:

 Chemical manipulations are carried

out on a laboratory scale (i.e., work
with substances in which the
containers used for reactions,
transfers, and other handling of
substances is designed to be easily
handled by one person);
 Multiple chemical procedures or
chemicals are used;
 The procedures involved are not part
of a production process, nor do they
in any way simulate a production
process; and
 "Protective laboratory practices and
equipment" are available and in
common use to minimize the
potential for worker exposure to
Source:https://www.globalspec.com/ hazardous chemicals.
learnmore/  Any hazardous chemical use which
industrial_engineering_software/ does not meet this definition is
engineering_scientific_software/ regulated under other standards.
laboratory_information_management_syste This includes other hazardous
ms_lims chemical use within a laboratory. For
instance:
o Chemicals used in building
maintenance of a laboratory
are not covered under the
Laboratory standard.
Laboratory Standards o The production of a chemical
for commercial sale, even in
The Occupational Safety and Health
small quantities, is not
Administration (OSHA) released an
covered by the Laboratory
"Occupational Exposure to Hazardous
standard.
Chemicals in Laboratories standard (29
o Quality control testing of a
CFR 1910.1450)" in 2011 to facilitate
product is not covered under
laboratory safety. Some important
the Laboratory standard.
provisions are excerpted from the standard
below:

3
If the Laboratory standard applies, Registration, billing, contract management,
employers must develop a Chemical accounts receivables
Hygiene Plan (CHP). A CHP is the
10.5.1 Patient Registration
laboratory's program which addresses all
aspects of the Laboratory
standard.

 The employer is
required to develop
and carry out the
provisions of a
written CHP.
 A CHP must
address virtually
every aspect of the
procurement,
storage, handling,
and disposal of
chemicals in use in a
facility.
When you arrive at the hospital, the
Primary elements of a CHP include the Admission Clerk will take some basic
following: information and then will guide you to a
registration window
 Minimizing exposure to chemicals by
establishing standard operating Figure 10.2: Patient Registration Form
procedures, requirements for
personal protective equipment,
engineering controls (e.g., chemical Source:Bizbox.ph
fume hoods, air handlers, etc.) and 10.5.2 Billing
waste disposal procedures. The process of generating SOAs or Billing
 For some chemicals, the work Statements of Inpatients, Outpatients, and
environment must be monitored for Emergencies are the same. In this example,
levels that require action or medical we used Inpatients.
attention.
 Procedures to obtain free medical Figure 10.3: Billing
care for work-related exposures
must be stated. The means to
administer the plan must be
specified.
 Responsible persons must be
designated for procurement and
handling of Material Safety Data
Sheets, organizing training sessions,
monitoring employee work practices,
and annual revision of the CHP

4
  Managerial reports display
laboratory billing status for payer
groups including projected return
values for each payer group
 Ability to change the Insurance
Organization of a Patient per visit.
 Ability to select which Tests of a
Patient's Visit are covered by the
Insurance Organization and which
are privately-with automatic
modification of the prices
accordingly.
 Supervision-financial data
Source:Bizbox.ph management of the Senders.
 Reminder for amounts due from past
visits
10.5.3 Contract Management  Immediate access to the Billing Card
Most Laboratory Information Management of each Patient.
Systems allow the laboratory professional to  Consistency with the International
manage the billing and payment aspects of Laws.
their activities and create statistical and
billing reports at par with the laboratory and 10.5.4 Accounts Receivables
management needs. They provide Because of the integration of the LIMS, the
parameters for a flexible price schedule and personnel in charge of managing Accounts
enable heightened attention on customer receivables can easily extract information
needs. LIMS automate billing processing, which was already available from the
hasten collections, and offer marketing tools invoicing and contract management
which minimizes the time spent on standard procedures. Additionally, the LIMS can:
flow and allows billing and accounting
personnel to focus on improving collection  Generate specific or complete
of problematic accounts (Informed, 2017). Accounts Receivable reports
In addition, common features of LIMS for  Monitor balances for reconciliation
invoicing and contract management include: and audit purposes
 Export data to other accounting
 Customer customizable invoices systems
including balance and charges  Ability to change the Insurance
history analysis, history balance, Organization of a Patient per visit.
detailed services, participation when  Customize reports according to
in insurance coverage, discounts specifications
etc.
 Different electronic formats for
invoices allow interfacing to
customer electronic systems
 Customizable information
completion reports for customers

5
Figure 10.4: Accounts Receivable 10.6 Work list and Workflow

LIMS assist laboratories in setting

priorities of current workloads, based on
Source: https://adniasolutions.com/wp-
analyst and instrument availability. This
content/uploads/2017/03/Accounts-
function allows user to track a sample, a
Receivable-Dashboard-Template-v1.02.jpg
batch of samples, or a "lot" of batches
through its lifecycle. Queueing can also be
done by sample or by workflow, a block of
repetitive procedures in a certain process.
The queueing and work list feature provide
an insight into when an event occurred, how
long it was, and who was involved.

6
 In addition, other features in the effortlessly find and retrieve information
Laboratory Information Management about a tube, a specimen, or equipment
System also enable personnel and workload within the laboratory using a barcode
management, allowing users to plan scanner.
workload schedules and assignments, and
employee information and training.
Ultimately, the work list and workflow
functions operate to facilitate more efficient
laboratory processes. -

10.7 Quality Control

Diagnostic tests executed inside the
clinical laboratory may yield two kinds of
results, a patient result, or a quality control
(QC) result. The result can be quantitative
(in numbers) or qualitative (positive or
negative) or semi-quantitative (limited to a
few different values). Quality control results
are used to verify whether or not the
instrument is working within prescribed
parameters, confirming that patient test Figure 10.5: Barcode ID
results are reliable (Bio-Rad Laboratories,
2008).
LIMS have functions that enable
users to set standards about the relevant
range of patient test results, or extract test
result information for the purpose of quality
assurance. Outliers and deviations can be
flagged, and appropriate warning signals
can notify users of issues which might
involve the quality of the samples or the
equipment currently in use.
10.8 Barcode-generation, printing and
reading
LIMS modules are commonly linked
to a barcoding label generator, enabling a
fast and easy method to identify tubes, Source:Bizbox.ph
samples, documents, among many others.
10.9 In-built bi-directional interfaces with
Simply print it on labels stickers to place on
equipment
whatever item needs identification. A
barcode editor also allows multiple labels to Figure 10.6: A Bi-Directional Interface
be printed at a label printer. The barcode
series can usually be customized to suit
your organization or classification needs.
With this kind of technology, you can

7
 Lesson Intended Learning Outcomes
(LILO):

 Simulate retrieval and confirmation

or laboratory requests
 Record receipt of specimen and
assign the task to a medical
laboratory technician
 Review the results, check the patient
history and submit the report.

Requirements:
Source:http://www.medtechnet.com/
public_pdf/mtc16.pdf Complete the following using the
student portal.
A bi-directional interface (Figure 10.6)
involves true two-way communication
1. Using the LIS retrieve the laboratory
between the analyzer (equipment) and
request for the following patients and
information system interface. The LIMS
complete the information in the table
interface downloads specimen ID and test
below:
orders, while the analyzer uploads
specimen ID and test results.
More recently, bi-directional interface
capability has been implemented into
various microbiology, immunoassay,
coagulation, and hematology instruments.
A bi-directional interface application saves
the technologist the time to program test 2. Assign the following tasks to the
orders into the analyzer and eliminates following Med Lab Technician:
errors in manual entry. This can result in a
considerable enhancement in analyzer
productivity. Newer random-access testing,
bi-directionally interfaced analyzers also
incorporate bar code specimen label
scanning which provides automatic positive
specimen ID capability. This can further
eliminate manual entry of specimen IDs
and/or coding of specimens by tray/cup 3. Review the results. Check the
position (Selmyer and Cloutier, 1996). Patient history before submitting the
results.
HANDS-ON EXERCISES Laboratory
Information Management System (LIMS)

8
 identify tubes, samples, documents,
among many others. Simply print it
on labels stickers to place on
whatever item needs identification.
 A bi-directional interface application
saves the technologist the time to
KEY POINTS TO REMEMBER program test orders into the analyzer
and eliminates errors in manual
 A laboratory information entry. This can result in a
management system (LIMS) is considerable enhancement in
software designed to make labs analyzer productivity.
more efficient and effective.
 The ultimate motive of a LIMS is to
enhance efficiency in lab operations
through reducing manual
responsibilities.
 The core components of LIMS are
electronic la notebooks, sample
management programs, process
execution software, records
management software, applications
interface, workflow tools, client
tracking, best practice and
compliance databases and ERP
software.
 The Occupational Safety and Health
Administration (OSHA) released an
Occupational Exposure to
Hazardous Chemicals in
Laboratories standard (29 CFR
1910.1450) in 2011 to facilitate
laboratory safety.
 LIMS covers registration, billing,
contact management and accounts
receivable.
 LIMS assist laboratories in setting
priorities of current workloads, based
on analyst and instrument
availability.
 LIMS have functions that enable
users to set standards about the
relevant range of patient test results,
or extract test result information for
the purpose of quality assurance.
 LIMS modules are commonly linked
to a barcoding label generator,
enabling a fast and easy method to