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Table 18.1 Choice of blood group for exchange transfusion
Laboratory ndings Blood needed for exchange transfusion
Mother and baby of same blood group Identical blood group as foetal cells, Rh-negative
Blood groups of infant and mother are dierent Blood group О
Suitable donor not available Use mother’s cells with repeated washings*
Dire emergency Use incompatible cellst†
*Remove plasma by repeated washings. The cells are guaranteed to be compatible with maternal antibody and the
lack of natural antibody in the newborn does not destroy the incompatible cells instantly. Eventually when the crisis
is over, they are removed by the developing antibody.
† The transfusion may have to be repeated. The transfused incompatible cells will be coated by any remaining free
antibody and will eventually be destroyed. But the process will remove bilirubin and coated red cells of the infant.
Medical Laboratory Technology: Volume 1
revIew QuestIons
1. What will be the transfusion reaction in a recipient who is Rh-negative when he receives:
a. Rh-negative blood-group compatible blood?
b. Rh-positive blood-group compatible blood?
2. What is the most common cause of haemolytic transfusion reaction?
3. What is HDFN? When does HDFN-Rh occur? How does the laboratory help in its
diagnosis?
4. When does the mother receive anti-D in order to prevent HDFN-Rh?
5. What causes HDFN-ABO? Why is HDFN-Rh more important than HDFN-ABO?
6. What is exchange transfusion? When is it done?
7. An accident victim is bleeding profusely and requires immediate blood transfusion.
What will be the safest blood group (with Rh-type)?
8. Why is it necessary to wash the cells thoroughly before adding Coombs’ reagent in the
AHG phase of compatibility testing?
9. A person is blood group A and Rh positive. If the blood bank has O-negative and
A-positive blood, which one of these will be your choice?
Note Consider both to be compatible with the recipient’s serum.
10. A person of blood group О has been found to carry C, D and e antigens (Rh-allelic
genes). Which of the following antibody can he not have in his serum: anti-Α, anti-B,
anti-c, anti-D and anti-Ε (choose one)?
11. During compatibility testing, you see haemolysis. Would you report this as a ‘positive
reaction’?
Laboratory Information Systems
Aim of LAborAtory informAtion And
LAborAtory informAtion mAnAgement SyStemS
z Use computerized physician order entry (CPOE) for more than 30% of laboratory orders.
z Implement ve clinical decision support interventions related to four or more clinical quality
measures, if applicable, at a relevant point in patient care. These can be based on lab results in
combination with other variables, such as demographics and medical lists.
z Provide more than 50% of patients with an electronic copy of their health information (including
diagnostic test results, problem lists, medication lists, medication allergies), upon request. More than
5% of all unique patients discharged from the inpatient or emergency departments of the eligible
hospital must view, download, or transmit their health information to a third party.
z Incorporate more than 55% of all clinical lab results that are in a positive/negative or numerical format
as structured data. EHRs must be able to transmit structured lab results to ambulatory providers.
z Submit electronic data on reportable (as required by state or local law) lab results to public health
agencies.
z Generate lists of patients by specic conditions to use for quality improvement, reduction of disparities,
research, or outreach. Lists can be based on lab results in combination with other variables, such as
demographics or medications.
z Use clinically relevant information to identify patients who should receive reminders for preventive/
follow-up care and send these patients the reminder, per patient preference. May use lab results,
among other variables.
z Use clinically relevant information from certied EHRs to identify patient-specic education
resources and provide those resources to the patient. May use lab results, among other variables.
A laboratory information system (LIS) is a software system that records, manages, and stores data
for clinical laboratories. An LIS has traditionally been adopted at sending laboratory test orders to lab
instruments, tracking those orders, and then recording the results, typically to a searchable database.
The standard LIS has supported the operations of public health institutions (like hospitals and clinics)
and their associated labs by managing and reporting critical data concerning “the status of infection,
immunology, and care and treatment status of patients.”
History of the LIS
Advances in computational technology in the early 1960s led some to experiment with time and data
management functions in the healthcare setting. Company Bolt Beranek Newman and the Massachusetts
General Hospital worked together to create a system that “included time-sharing and multi-user
techniques that would later be essential to the implementation of the modern LIS.” At around the same
time General Electric announced plans to program a hospital information system (HIS), though those
plans eventually fell through.
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Medical Laboratory Technology: Volume I
Aside from the Massachusetts General Hospital experiment, the idea of a software system capable of
managing time and data management functions wasn’t heavily explored until the late 1960s, primarily
because of the lack of proper technology and of communication between providers and end-users. The
development of the Massachusetts General Hospital utility multi-programming system (MUMPS) in the
mid-1960s certainly helped as it suddenly allowed for a multi-user interface and a hierarchical system
for persistent storage of data. Yet due to its advanced nature, fragmented use across multiple entities, and
inherent diculty in extracting and analyzing data from the database, development of healthcare and
laboratory systems on MUMPS was sporadic at best. By the 1980s, however, the advent of structured
query language (SQL), relational database management systems (RDBMSs), and health level 7 (HL7)
allowed software developers to expand the functionality and interoperability of the LIS, including the
application of business analytics and business intelligence techniques to clinical data.
In the early 2010s, web-based and database-centric internet applications of laboratory informatics
software changed the way researchers and technicians interacted with data, with web-driven data
formatting technologies like extensible markup language (XML) making LIS and electronic medical
record (EMR) interoperability a much-needed reality. SaaS and cloud computing technologies have
since further changed how the LIS is implemented, while at the same time raising new questions about
security and stability.
The modern LIS has evolved to take on new functionalities not previously seen, including congurable
clinical decision support rules, system integration, laboratory outreach tools, and support for point-ofcare testing (POCT) data. LIS modules have also begun to show up in EMR and EHR products, giving
some laboratories the option to have an enterprise-wide solution that can cover multiple aspects of the
lab. Additionally, the distinction between an LIS and a laboratory information management system
(LIMS) has blurred somewhat, with some vendors choosing to use the ‘LIMS’ acronym to market their
clinical laboratory data management system.
Common LIS Functions
Functions that an LIS has historically performed include, but are not limited to :
z Patient management, including admission date, admitting physician, ordering department, specimen
type, etc.
z Patient data tracking
z Decision support, including comparisons of lab orders with their respective ICD-9 codes
z Standard test ordering and specimen tracking
z Test ordering for point-of-care, molecular, and genetic testing
z Quality assurance
z Workload and management reporting
z Analytical reporting
z Workow management
z Billing
z Third-party software integration
Clinical vs. Anatomic Pathology LIS
The laboratory information system has been primarily segmented into two broad categories (though
other variations exist): The clinical pathology and anatomic pathology LIS.
In clinical pathology, the chemical, hormonal, and biochemical components of body uids are
analyzed and interpreted to determine if a disease is present, while anatomic pathology tends to focus
on the analysis and interpretation of a wide variety of tissue structures, from small slivers via biopsy
to complete organs from a surgery or autopsy. These dierences may appear to be small, but the
dierentiation in laboratory workow of these two medical specialties has led to the creation of dierent
functionalities within LISs. Specimen collection, receipt, and tracking; work distribution; and report
Laboratory Information Systems
iii
generation may vary—sometimes signicantly—between the two types of labs, requiring targeted
functionality in the LIS. Other dierences include :
z Specic dictionary-driven tests are found in clinical pathology environments but not so much in
anatomic pathology environments.
z Ordered anatomic pathology tests typically require more information than clinical pathology tests.
z A single anatomic pathology order may be comprised of several tissues from several organs; clinical
pathology orders usually do not.
z Anatomic pathology specimen collection may be a very procedural, multi-step processes, while
clinical pathology specimen collection is routinely more simple.
Differences between an LIS and a LIMS
There is often confusion regarding the dierence between an LIS and a LIMS. While the two laboratory
informatics components are related, their purposes diverged early in their existences. Up until recently,
the LIS and LIMS have exhibited a few key dierences:
1. An LIS has been designed primarily for processing and reporting data related to individual
patients in a clinical setting. A LIMS has traditionally been designed to process and report data
related to batches of samples from drug trials, water treatment facilities, and other entities that
handle complex batches of data.
2. An LIS must satisfy the reporting and auditing needs of hospital accreditation agencies, HIPAA,
and other clinical medical practitioners. A LIMS, however, needs to satisfy good manufacturing
practice (GMP) and meet the reporting and audit needs of the US Food and Drug Administration
and research scientists in many dierent industries.
3. An LIS is usually most competitive in patient-centric settings (dealing with ‘subjects’ and
‘specimens’) and clinical labs, whereas a LIMS is most competitive in group-centric settings
(dealing with ‘batches’ and ‘samples’) that often deal with mostly anonymous research-specic
laboratory data.
However, these distinctions began to fade somewhat in the early 2010s as some LIMS vendors
began to adopt the case-centric information management normally reserved for an LIS, blurring the
lines between the two components further. Thermo Scientic’s Clinical LIMS was an example of this
merger of the LIS with LIMS, with Dave Champagne, informatics vice president and general manager,
stating: “Routine molecular diagnostics requires a convergence of the up-to-now separate systems
that have managed work in the lab (the LIMS) and the clinic (the LIS). The industry is asking for,
and the science is requiring, a single lab-centric solution that delivers patient-centric results.” Abbott
Informatics Corporation’s STARLIMS product was another example of this LIS/LIMS merger. With the
distinction between the two entities becoming less clear, discussions within the laboratory informatics
community began to include the question of whether or not the two entities should be considered the
same. As of 2017, vendors continue to recognize the historical dierences between the two products
while also continuing to acknowledge that some developed LIMS are taking on more of the clinical
aspects usually reserved for an LIS.
Currently Used Lab Reporter Softwares/Information Systems
LabMate/LIMS Overview
The Labmate.net ERP LIMS software is a laboratory information management system (from Busysoft
Systems, India) and is an enterprise resource planning (ERP) solution for the management of medical
diagnostic laboratories and centers.
The LabMate/LIMS has been implemented in all types of medical diagnostic laboratories, namely:
1. Reference laboratory
2. Private laboratory
3. Clinical research laboratory
4. Clinical trial and research laboratory
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Medical Laboratory Technology: Volume I
5. Hospital laboratory
6. Clinician laboratories
It covers all types of laboratory diagnostic centers’ workload such as:
z Clinical Pathology
Clinical microbiology: Bacteriology, mycobacteriology, virology, mycology, parasitology,
immunology, serology.
Clinical chemistry laboratories: Analysis of blood components, enzymology, toxicology, and
endocrinology.
Haematology: Analysis of blood cells
Genetic health assessment and diagnostic center
Genetics: Cytogenetics
Reproductive biology: Semen analysis
z Anatomic pathology: Histopathology, cytopathology, etc.
LabMate ERP LIMS Introduction
What is ERP?
ERP is the acronym of Enterprise Resource Planning. ERP utilizes ERP software applications to
improve the performance of organizations’ resource planning, management control, and operational
control. ERP software is multi-module application software that integrates activities across functional
departments, from product planning, purchasing, inventory control, sales, and product distribution, to
order tracking. ERP software may include application modules for the nance, accounting, and human
resources aspects of a business.
Why ERP in LIMS?
Traditionally, LIMS systems concentrate on actions related to sample and laboratory test production,
feeding of lab reports and delivering of reports. In today’s competitive environment laboratories have to
perform well to maintain prot margins to survive. As management, you have to focus on four Ps of any
business activity, namely Product, Price, Promotion, and Place. In the laboratory management context,
management has to concentrate on:
z Good laboratory practice or GLP, specically refers to a quality system of management controls
for research laboratories and organizations to try to ensure the uniformity, consistency, reliability,
reproducibility, quality, and integrity of all kinds of tests.
This is all done to ensure good customer services, timely delivery of zero error reports without fail to
all types of clients, namely patients, consultants, referring doctors, companies.
z Maintain ISO standards and accreditations
z Keep non-conformance (NC) in check and keep its record
z Keep audit trail
z Keep a record of corrective actions and preventive actions (CAPA)
z The lowest level of inventory without expiry
z The lowest level of accounts receivables and payables
z Proper training to employees for competency
z Proper instrument planning, load management, and maintenance
z Instrument calibration, standardization, and QC
z Maintain turnover and prots for the principles by processing samples from various market
segments as per the production capacity
z Reduce cost per test by proper production planning
Laboratory Information Systems
LabMate Functions, Feature, Modules
Basic functions and process flow
z Front desk operations
z Test ordering
z Patient management
z Sample collection
z Sample transportation
z Sample receiving
z Sample segregation and distribution
z Sample tracking management
z Workload list management
z Laboratory analyzer interface
z Report entry and printing function
z Report release management
z Patient report delivery
z Sample storage and discard management with tracking
Patient record management and services
z Patient home sample collection management
z Patient reminder management
z Patient appointment management
z Estimate management
z Patient discount management
z Patient refunds
z Patient document management system
z Patient forms management system
z Medical aid/insurance management
z Patient additional information management
z Patient report attachment
z Automatic processes
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Smart processing functions
z Slide image capture and printing
z Slide control function
z Bar code printing
z Patient envelope printing
z Results graphs printing
z Bar code labeler
Management control and functional tools
z Total quality management (TQM) systems
z Audit trail
z Process time management (turnaround time, TAT)
z Non-conformance (NC) management
z Statistics
z Document management system
z Asset management system
z Quality control (QC)
vi
z Patient satisfaction survey
z Environment data recording
z Biomedical waste management
Medical Laboratory Technology: Volume I
The systems in use now also take care of the following:
z Analyzer interface
z Inventory control and purchase management
z Account receivables, payables, and accounting
z Payroll, HR and employee training management
z Marketing and communications
LAbmAte™—PAthoLogy LAbS, X-rAy, ULtrASoUnd And
diAgnoStic mAnAgement SoftwAre
Introduction
The LabMate software is for pathology labs, X-ray, ultrasound and medical diagnostic centers
management. The pathology labs, X-ray, ultrasound and medical diagnostic centers are the most
important part of today’s healthcare industry. These centers process large number of lab specimen
samples, X-rays, ultrasounds, CT scans, MR investigations for the patients sent by several independent
physicians, hospitals and referring laboratories. The centers have to perform the investigations and give
the reports to the patients and other physicians in time. The record of patients and their investigation
reports also have to be kept in proper fashion for MIS reports, future reference and billing.
The critical issue faced by these centers is to seek a cutting edge solution to automate its result
reporting system along with management of patient records and billing of various related parties. In
the current competitive marketplace nicely presented reports along with zero errors would provide
competitive advantage to the lab or diagnostic center. Assessment and quality control of the results is
another area of importance. Diagnostic centers use dierent types of reagents and other chemicals to
conduct tests during various time periods. The chemical quality and expiry along with the human errors
can cause havoc with the results.
The LabMate software helps in solving these problems. LabMate program helps in performing
several diagnostic center management functions. Some of the functions, which can be done by this
program, are:
z A centralized patient booking and issuing of a booking slip
z Issuing of receipt, bill to the patient
z Recording of lab results
z Printing of patient reports
z Maintenance of daily collection, balances
z Other management reports such as doctor-wise collection, company-wise collection. Keeping
patient history
z Diagnosis-wise trends
z View results of a period with statistical and graphical presentation for quality control.
LabMate does not help in conducting the lab tests in any way.
Who can use it?
The program helps in management of most of the types of laboratory and diagnostic center units. It can
be used for clinical, diagnostic center, hospital and nursing-home labs.
LabMate helps in making dierent kinds of lab reporting. Major areas of lab reporting—pathology
(biochemistry, hematology, urine, stool, semen analysis, etc.), histopathology, microbiology, immuno-
Laboratory Information Systems
vii
logy, X-ray, ultrasound, ECG, EEG, echo, CT scan, etc. have been already included in the system. The
user can also add on, modify the required investigation in the system through a user-friendly menudriven operation.
Main functions of LabMate
LabMate is divided into three basic steps:
z Patient booking
z Result reporting
z Lab management information reporting
First two functions are the major functions for preparing patient reports. The third function gives
critical controlling reports.
Patient booking
The patient booking consists of:
z Adding the patient details
z Marking the tests for the patient
z Issuing a booking slip, a receipt and a bill
The patient name, age, sex, referring doctor, address is the main information recorded in this step.
This record is used in reporting the results of the patient. After booking the patient details, the tests are
marked by double clicking a test in a list of tests. The list of tests contains the charges against each test.
Total charges to be taken from the patient are added automatically and can be seen on the screen.
After booking, a booking slip is printed out and is given to the patient. This slip becomes reference
document for the patient to go to various departments for sample collection and also can be used as
reference document at the time of delivery of the report. The patient can also be issued a bill and a receipt
after booking.
Result reporting
After carrying out the lab tests, the results can be reported using the booking made against the patients.
The result-reporting module is the most important part of the LabMate system. It helps in reporting and
printing the lab results. The patients can be chosen in any manner as convenient for reporting.
It is not important to book patients at the time of their arrival. The same can be done at any time
before reporting. With this, maintenance of register is necessary and the booking slips, receipts; bills
cannot be issued to the patient. The number of tests, which can be reported at one time for a patient, are
unlimited (subject to change). This capability combined with ease of reporting is one of the strengths of
the LabMate program.
Lab management and information reporting
The center in-charge requires daily information such as:
z Total workload
z Number of patients arrived
z Tests already done
z Tests not done yet
z Total collection, reports done, printed
z Reports not done, not printed
The LabMate program provides these reports for better lab management. These reports can be
produced for a day or for a particular period. For the labs, which have business connections with
referencing doctors, labs, nursing homes, and other such institutions, information on the business
provided by them can be printed on periodic basis. In case of labs, which are working under panel of
some companies, similar kind of, reports can be produced for billing these companies.
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Medical Laboratory Technology: Volume I
Features
To achieve maximum benets from the system, LabMate has following features:
z No preformatted report forms are required.
z The test parameters such as method, normal values, measurement units are changeable as and when
required.
z Any new test addition can also be done at any time. The limit is virtually unlimited.
z Can report any number of tests for one patient.
z Results are reported for only those tests, which have been selected for the patient.
For example if ESR is to be reported for the patient, then only ESR results will be printed in the report
and not the entire hematology.
Hardware and software requirements
LabMate program is used with computers having the Windows based operating systems. For minimum
performance following conguration is required.
Configuration Minimum requirement Best performance
Processor Pentium class CPU P III 650 MHz or more
Memory 32 MB RAM 64 MB RAM
Floppy drive 1.44 1.44
Hard disk 1.2 GB or more 10 GB or more
Monitor Minimum resolution (800 × 600) Minimum resolution (800 × 600)
Keyboard Standard Standard
OS Windows 95/98/2000/NT Windows 95/98/2000/NT
CD ROM Any CD ROM Any CD ROM
Printer DISKETTE/INKJET/LASER DISKETTE/INKJET/LASER
Phlebotomy/
Venipuncture
Procedure
PRINCIPLE: This policy establishes criteria for the correct collection of blood specimens by
venipuncture.
POLICY: By establishing a procedure for the correct collection of blood by venipuncture many preanalytical errors and patient management complications can be avoided. Patient safety is the ultimate
goal above all other considerations. Cost, eciency, etc. are secondary to ensuring that in no way will
the patient be harmed by the phlebotomy procedure. This includes all aspects of the procedure including
ordering, drawing, labelling, handling and transporting the specimen. The quality of the patient results
is directly dependent upon the quality of the specimen. By providing the highest standard of safety and
quality of care customer service satisfaction can be achieved.
Procedure
NOTE: Because it is often impossible to know what isolates or specimens might be infectious, all patient
and laboratory specimens are treated as infectious and handled according to ‘universal precautions’.
Needles and holders are not to be reused. They are to be properly discarded immediately after the
phlebotomy procedure. All needles and syringes must be taken out of the original package in the
patient’s presence. Never preassemble the vacutainer apparatus with a needle prior to use.
Supplies for Venipuncture
Blood Collecting Trays: Blood collecting trays should be lightweight and easy to handle with enough
space and compartments for the various supplies.
Gloves: Disposable, latex, vinyl, polyethylene, or nitrile gloves provide barrier protection.
Needles and Holders: Needles and holders should be compatible with the tubes selected for use.
Needles and winged blood collection sets are individually colour-coded according to their respective
gauze sizes. A large gauze number indicates a small needle, while a small gauze number indicates a large
needle. Needles must always be sterile. In order to prevent potential worker exposure, the needle safety
feature should be activated immediately after specimen collection and discarded without disassembly
into a sharps container.
For the safety of patients, a patient should never be re-stuck with a needle. Once a needle has been
used for a single venipuncture, it should not be used again. (For example, if a venipuncture results in a
miss, do not use that same needle to re-stick the patient. A new sterile needle must be used each time).
Sterile Syringes: Sterile syringes must remain sterile. If removed from their container and not used
immediately they are no longer considered sterile and are not to be used.
Venous Blood Collection Tubes: Venous blood collection tubes are sterile and manufactured to
withdraw a predetermined volume of blood.