As information technology continues to open new pathways in clinical diagnostics and broaden how we measure and define success, lab directors must consider how IT can complement their investment in automation. In fact, automation and IT systems can no longer be regarded as separate laboratory solutions, but rather must be viewed as a single entity that exists to maximize input and output across the laboratory continuum. With automation serving to centralize testing and tube throughput and IT to aggregate and display testing data quickly and accurately, the benefits of the whole clearly become more important than the sum of its parts. That is why it is paramount to research the availability and capabilities of an IT system that can enhance an automation solution. When automation and IT functionality combine, the closed-system loop provides seamless, total process management at a magnitude far greater than can be achieved by an automation solution that lacks adequate IT support.

1. Clinical Laboratory has a great influence on clinical decisions and 60%-70% of the most important decisions on
admission, discharge, and medication are based on laboratory results.
Various reasons have been given to automate the processes in clinical laboratories and these include staff shortage
and the increase in workload from consolidation and requesting patterns.
As information technology continues to open new pathways in clinical diagnostics and broaden how we measure and
define success, lab directors must consider how IT can complement their investment in automation. In fact,
automation and IT systems can no longer be regarded as separate laboratory solutions, but rather must be viewed as a
single entity that exists to maximize input and output across the laboratory continuum. With automation serving to
centralize testing and tube throughput and IT to aggregate and display testing data quickly and accurately, the benefits
of the whole clearly become more important than the sum of its parts.
That is why it is paramount to research the availability and capabilities of an IT system that can enhance an
automation solution. When automation and IT functionality combine, the closed-system loop provides seamless, total
process management at a magnitude far greater than can be achieved by an automation solution that lacks adequate
IT support.
1. Sample identification: The tube containing each of the samples is labelled at the time of collection of blood or
other fluids for analysis. On reaching the lab where it is to be tested, the sample is recorded by computerized
procedure after which the samples are processed.
2. Bar coding: The bar coding technology for sample identification is available in several analytical systems.
A bar coded label is placed onto the sample containers and is read by the bar readers placed at key
positions in the analytical train. The information that is read by the reader is transferred to and
processed by the system software.
3. Sample preparation: The clotting of blood, centrifugation and transfer of serum causes delay in the specimen
preparation. To eliminate these problems the use of whole blood for analysis and automation of specimen
can be done.
4. Sample handling, transport and delivery: The containers (tubes) holding the samples are kept covered till the
time of analysis to avoid evaporation or spillage. For analysis, the sample is loaded on loading zone of the
analyzer.
5. Sample processing: Automation of the analysis of analytes requires the capability of removing the interfering
substances from blood for the analyte to be tested
6. Reagent handling and delivery: Reagents should be stored in 4°C refrigerator till the assay as per requirement,
and the instrument may also be pre-cooled.

2. 7. Chemical reaction: The samples undergo chemical reactions in the analyzers in the presence of the
appropriate reagents and optimum conditions set.
8. Measurement, signal processing and microprocessing: The measurements and output signals are
automatically processed and the results are made available in form of readings/ graphs as per the
requirements input initially.
In general the main purposes of Modular Clinical Laboratory Automation (using standalone automated clinical
analyzers – fig .1) are;
- Increase the number of tests in a given period of time
- Minimize the variations in results
- Minimize errors
- Use less sample and reagent for each test.
Fig.1
In most resent Clinical Laboratories there are so many automated clinical /analytical analyzers/systems, which are
separated in function, with different material resources, some needs special preparation of the measured samples,
some required special dedicated services and location, need well trained LAB - staff to operate, control & manage,
some require special environmental LAB condition, usually occupy a large space and affect the staff and material flow.

3. Why do we need Total Automated LAB?
Having a fully automated lab means replacing human-driven lab processes with robots or other devices and using
computers to monitor experiments and integrate the data. This upgrade would not only enhance productivity, but also
increase reproducibility and accuracy. But do we really need this?.
In Total Clinical Laboratory Automation (TCLA), the main target is to integrate all the clinical laboratory processes in
one consolidated lab system /process (fig.2)
Fig.2
Modern laboratory automation [3] resembles a traditional assembly line, termed total clinical laboratory automation
(TCLA).
TCLA consists of a specimen sorter that can sort specimens by analytical needs and transport specimens requiring
serum or plasma testing to an automated centrifugation station for processing.
Following sample separation the serum or plasma is then transported for sampling to various chemistry and immuno
assay analyzers.
The sorter can also identify whole blood specimens and convey them to automated instruments for complete blood
counts and other hematology testing.
Remaining specimens are automatically sent to racks that are specific for each analytical platform. These specimens
can then be manually transported and inserted into the instrument of choice.
Regardless the mentioned reasons the automation is an emerging trend in modern clinical laboratories with a positive
impact on service level to patients and on staff safety. In fact, it allows process standardization which, in turn,
decreases the frequency of outliers and errors. In addition, it induces faster processing times, thus improving the
service level. On the other side, automation decreases the staff exposition to accidents strongly improving staff
safety.

4. Clinical laboratories have rapidly evolved since the 1990s, mainly driven by technological advances that focus
on automation. The level of automation depends on the needs and resources of laboratories, and the reasons for
introducing automation vary on the basis of the application. Nowadays there is a consensus in the bioanalytical
industry that automation in bioanalytical laboratories improves sample throughput and data integrity, shortens
method development time and sample data turnaround time (TAT).
Laboratory services are an essential component of quality healthcare delivery and require adequate space and
equipment so that the quality of work and the safety of staff, patients, customers and visitors are not compromised.
Clinical laboratories are potentially dangerous places because of biological hazards.
Persons facing risk include laboratory staff, customers and visitors entering the laboratory environment.
Introducing automation leads to a reduction of manipulation of biological sample by the staff, in particular sample
transport, subsampling, analytical operations and waste management. Furthermore the automatic storage space
maintains the integrity of samples and is adequately secured against unauthorized access. In addition to reducing
occupational hazards, automation reduces tedious labour, employee turnover, allows reallocation of staff for
growth and expansion and, in general, improves productivity.
The rapid development in technologies has allowed the automating of many clinical laboratory processes;
- Specimen Separation,
- Transportation,
- Sorting,
- Accessioning,
- Storage,
- Inspection and
- Measurements.
I. the studies [1], shows that the introduction of clinical laboratory automation led to a slight
increase in equipment costs which is highly compensated by a remarkable decrease in staff costs.
Consequently, total costs decreased by approximately 12.55%. The analysis of the turnaround time (TAT)
shows an improvement of non-emergency exams while emergency exams are still validated within the
maximum time.
II. some studies [2], shows that the Total clinical laboratory Automation (fig. 3) leads to more
organized work flow and better used of the available space.

5. Fig. 3
III. (fig. 4) , the TCLA helps in [2] :
Fig. 4
In respect to patient ;
 Improvement in patient safety by decrease in number of errors,
 provide better analytical quality & More reliable results
 Improvement in perceived quality ; Less tubes & less blood needed
Quality
Patient
Economics
Organization
HOSPITAL

6.  Improvement in outcomes ;
 Great flexibility in the analytical phase( reflex test, reruns, add new tests and more expert rules
implemented)
 Better management of stat samples
 Improvement in TAT (predictable and adjustable): quicker treatments, discharge patients
In respect to ORGANIZATION / HOSPITAL;
 STAFF
 Reduced chance of Injuries  minimal manual intervention
 Improvement in utilization of human resources. Less manual and repetitive tasks and frustrating
processes
 Higher staff motivation. New education and research capabilities
 Provides valuable walk-away time. Allows new developments of specific areas (high value added
tasks)
 Better environment, better working conditions
 More uniform training
 HOSPITAL
 Improvement in TAT (predictable and adjustable): discharge patients, reorganize day hospitals
activities
 Saving space for other purposes
 Simplicity for the administration and supply department
 Integrates of all the steps of the analytical process in a single technologic platform with full
traceability of the process.
 Increase productivity by speeding up production process  rise the lab throughput with easy
adaptation to peak workloads
 Allows to add new activities/disciplines with minimal changes
 Help in building and control of an unique quality management system
 Decrease & control the amount of waste (solid and liquid)
 Provide better conditions for education and research capabilities
 ECONOMICS / COST
 Reduction in “direct” costs for material resources
 Reduction in “indirect” costs for material resources (tubes, waste)
 Reduction in human resources
 Reduction in surface for the same activity
 Reduction in TIME
Again as per [3], currently, approximately 80% of the testing and only about 50% of the manual labor
performed in a clinical laboratory is impacted by automation, leaving many opportunities for novel
automation technologies in sample collection, centrifugation, accessioning, sample inspection,
transportation, and more.
Reasons behind unsuccessful of some TCLA projects [5].
a. Incomplete understanding of current environment...processes, costs, customer expectations
b. Loss in flexibility due to fixed processes and limited throughput
c. Unrealistic expectations of system in respect to cost reduction, throughput, return on investment

7. d. Unplanned and poorly developed ‘workarounds’ required to interface automation with manual
processes
e. Unclear expectations of system functionality
f. Overbuilt and unnecessarily complicated system design
g. Inadequate technical support
h. Credible and realistic impact analysis never conducted
i. Hidden costs...labor, supplies, maintenance
j. Failure to op mize current processes prior to automa on → never automates a poor process!
Systematic Planning Approach to TCLA.
2.1. Determining & Evaluation the laboratory’s needs
This includes the expected / actual (for existing sites) laboratory’s specimen volume, specimen count
by hour of day and day of week, percentage are centrifuged, percentages are aliquotted, percentage
of specimens are shared between two or more lab sections and percentage of specimens are
refrigerated or frozen
2.2. Logistics and handling considerations
The following questions need to be answered;
 How and where do specimens arrive? Courier vehicles, tube system, dumb waiter, window,
phlebotomists, patient walk-ins, nurse delivery? Are these near each other or in separate areas?
 Patient registration - is it required, is it before or after processing, where is it located, who does it
- lab personnel or hospital personnel?
 Patient identification: is there a wrist band bar code system linked to the LAB INFORMATION
SYSTEM (LIS)?
 How do phlebotomists verify patient ID?
 Do nurses or patient care assistants (i.e., employees not under lab control) draw or collect
specimens?
 For tests ordered on the floors, do LIS labels print on the floors or in the lab?
 Where are tubes centrifuged? Specimen Processing or Chemistry?
 Pour-offs and aliquotting – what is the workload?
 Sorting - how much sorting of specimens occurs - in Specimen Processing and in lab sections?
 Transport - delivery by Specimen Processing or pick-up by labs? What are the distances covered?
 How, where, and for how long are archived specimens stored?
 Centralized or decentralized?
 Manual system or using bar codes?
 What is the percentage of repeat testing?
 What is the percentage of additional testing requested to be added to archived specimens?
2.3. Facilities, space and environmental
The Basic rules cover the followings;
 Arrange the facilities in a manner that follows the flow of the specimens.
 Position highest volume testing (Chemistry, Hematology, etc.) closest to Specimen Receiving
and lowest volume testing furthest away.
 Avoid having all lab traffic go through a key area such as Specimen Receiving.
 Position client service and exception handling activities in or close to Specimen Receiving.
2.4. Environmental space considerations; TO
, RH%, air pressure and flow, HVCA, water supplies,
drainages, waste, electrical power supplies , communications & IT requirements, any other services.

8. 2.5. Mapping workflow, timing workflow; this includes
 Material flows (specimens)
 Process flows
 Data flow diagram  done at different layers of detail
 Workload map  can be used in simulation studies
Fig. 5 shows an example of workload map
Fig.5
2.6. Finding bottlenecks and time wasters
The Purpose is to count and time everything in relation to the workflow map, on the other hand is to
Identifies bottlenecks, idling time, and time wasters.
2.7. Identify possible solutions to meet needs
 Use quality and turn-around time measures, workflow, and timing studies to find bottlenecks
and potential areas for re-engineering.
 Re-engineering of processes should precede introduction of automation.
 Not all solutions need to involve automation
 Several seemingly small, low-cost re-engineering projects sometimes have more impact on
laboratory performance than an expensive automation project.
 “Automating a poor process still leaves one with a poor process.”
For Re-Engineer Processes;
 Use continuous quality improvement (CQI) tools such as Lean and Six Sigma to foster process
improvements
 Standardize processing procedures to “best practice” solutions with fewest “hand-offs.”
 Reduce or eliminate non-value added handling and sorting.
 Eliminate “running around” to find shared specimens.
 Redesign workstations so that individuals process orders from start to finish.
 Maximize the number of specimens at test run start times.
2.8. Evaluation of alternatives
 Define and rank objectives (needs to be filled).
 Identify alternative solutions, some of which may not involve automated equipment.

9.  Match the key features of alternative solutions to the most important needs of your lab that
are solved by those solutions.
 Emphasis in any solution that is selected should be on process control and process
improvement.
 A solution with several small steps sometimes is better than a major implementation of
automation.
2.9. Progress measures
The potential progress measures can be done during implementation of the system to improve the
outcomes; these measures cover the followings;
 Average turn-around time
 The 95th
% turn-around time
 Stat turn-around time
 Lost specimens
 Mislabeled specimens
 Billed units
 Rate of hiring of technical employees
2.10. Cost justification
Need to perform case study in respect to the cost and Does TCLA will have a reasonable return on
investment.
Space planning considerations of TCLP
3.1. Degree of Automation, is the key driver of space planning
The instrumentation required performing the test menu in the laboratory, and the degree of automation, is
the key driver of space. In the automated lab, a very large volume of tests can be performed on one or more
analyzer run by one staff member ― test volume and staffing are not generally used to determine the
amount of space required for Laboratory operations in automated areas. The degree of automation has a
significant impact on both the space and configuration of the laboratory. One new automated instrument
often consolidates several manual workstations or individual instruments. Automation is taking tremendous
strides ― every year; more tests are available on automated analyzers, reducing the number of staff needed
in technical areas and giving laboratories the capability to perform esoteric tests that they could not provide
in the past. TCLP areas should provide a more efficient workflow for technical staff.
3.2. Space required
The required space depends totally on the system that shall be purchased. The system itself depends on the
load capacity of samples that need to be processed & tested. The location and layout of the laboratory and
shape of the room is critical for many related factors (material and staff flow, required environmental
condition, needed services, input and output data management, maximizing the return on investment and
others). Most of the manufactures are proposing a linear platforms layout design/plan (fig. 6) for the total
automated clinical laboratory.

10. Fig. 6
In such linear plan:
 Specimen arrivals should take place at the proximal end of the laboratory where accessioning
can occur immediately after unpacking, and the automated sorter should be readily accessible
at the end of the accessioning line.
 Each analytical automation line should run in parallel so that bench scientists can service
several analytical areas with as few steps as possible.
 Completed specimens should be automatically stored at the distal end of the laboratory
conveyor belt so that they may participate in reflex, repeat, or add-on testing without human
intervention. Automated specimen refrigerators (4°C) and freezers (either -20°C or -80°C) are
available that are capable of performing these tasks.
 Laboratories that anticipate making their medical waste available for research may install
automated aliquoting and labeling systems, as well as biorepository-sized automated storage
systems.
 Delivery and storage of analytical reagents is ideally accomplished in a bank of
refrigerators/freezers with doors on both sides of the laboratory installed parallel to the
analytical systems they serve. Stocking occurs from the back of each unit and retrieval of
reagents from the front.
 Finally, medical and reagent packaging waste should exit the laboratory at the distal end,
accessible to automated pickup carts and vehicles.
It is important to point, that the future expansion of the TCLA should be considered at early stage of
the design and space planning.
3.3. Flexibility/adaptability of the lab automation system
The laboratory diagnostics field is constantly evolving, making it difficult to anticipate future testing needs.
Not only can laboratories expect testing volume to rise, but testing menus also will change as new assays are
developed. Therefore, laboratories must ensure they select an automation solution that can be configured to
meet current testing needs and also be easily reconfigured to handle future demands. For example, a
medium-sized laboratory today may only require (and have space) to run chemistry and immunoassay tests
through two systems connected to an automation track. But what happens when that same lab needs to add
another immunoassay system and expand its automated line to include a hematology analyzer? If the
automation platform is not flexible enough to adapt to these needs or enable the lab to keep up with growing
testing demand, then not only is the ability of the lab to increase testing capacity impacted, but result

11. turnaround times may be compromised. Therefore, it is important to consider implementing an automation
solution that easily supports connection of additional instruments and has the ability to quickly extend track
length as needed.
3.4. Design issues can influence the planning
A variety of programmatic and design issues can influence the planning. While programmatic issues
theoretically come before design, the issues are intertwined. The following categories of planning and design
considerations, all of which are relevant to creating a successful facility solution (mentioned in non-sequential
manner [4]);
 The operational concept: the programming space begins with understanding the staffing model,
which includes everything from hours of operation and the work-shift strategy to safety protocols
and cleaning procedures. Then comes the development of a logistical plan for sample management
along the entire chain of custody control, including receiving, sample login, distribution, testing,
reporting, freezer or cold-room storage, waste removal and management of consumables.
Equipment-related optimization issues like capacity modeling, throughput analysis and backup
strategy round out this operational strategy.
 Organization of flows: in this stage the team then tackles work cell development with sample
flows and efficient use of equipment and space and evaluates layout opportunities as well as
personnel, equipment, sample and waste flows. Flow analysis is used to confirm contamination
control, sample integrity and protocols anticipated. The team should looks for opportunities to
prevent contamination, process overlaps and bottleneck conditions. It also evaluates furnishings
and equipment arrangement (e.g., sample prep and instrument layout) to help optimize work
patterns and shared equipment opportunities. The team considers lab, office and support space
adjacencies, which are critical for connectivity and supervision, as well as interaction space for
coordination between testing groups.
 Modular planning for flexibility: An open-lab concept allows the greatest flexibility of space for
future change with functional separations only where required. Within this space, utility
distribution is planned to allow for open floor plates and flexible connections. The team should
establish a planning grid that allows for adaptability in the technology platform, lab automation,
and assay and equipment upgrades. Sample preparation, incubation, amplification/detection and
recording stations — which are important to optimize movement between operations — are
located within the grid. Additionally, serviceability of equipment and calibration requirements
(utilization logs) are confirmed. Finally, structural loading and vibration criteria, essential for
sensitive equipment and robotics, are reviewed.
 Development of a safety and containment strategy: The team determines the biosafety level or
potency of compounds and provides safeguards for personnel (e.g., personal protective
equipment) and product (e.g., containment device or room), gowning and degowning concepts
and isolation requirements. It also conducts safety or hazard and operability reviews and confirms
intended standard operating procedures.
 Cross-contamination control: This involves functional separation of special testing needs; space
pressure cascade and relationships between adjacent areas; and special procedure/special design
requirements, including those for cleanrooms designed to ISO standards, cleanable surfaces,
particulate-free finishes, environmental monitoring and, potentially, high-efficiency particulate
air filtration. An air-handling zoning and cleanliness strategy will need to be put in place, whether
using directional air flows or special spatial monitoring, when required.
 Regulatory impacts: Besides typical building codes and standards, these may include Centers for
Disease Control and Prevention and World Health Organization guides; Clinical and Laboratory
Standards Institute regulations; American Society of Heating, Refrigerating and Air-Conditioning

12. Engineers standards; and National Fire Protection Association standards for flammables and life
safety, among others.
 Special systems and security considerations: This will involve controlled access, equipment
monitoring and alarms, data storage and multiple electronic reporting systems (especially those
governing uninterruptible power supply, validation, redundancy and protection of personal
information) as well as a data backup strategy that is balanced against operational costs.
Some Laboratory procedures that still need to be considered in TCLA
a. Automated Specimen Separation
Sample separation should be done at the point of sample collection and incorporate automated labeling.
b. Specimen Transportation
Selection of methods of transportation is an important issue
Currently available methods are;
- Human and robotic courier services  have inflexible pickup times and delays
- Pneumatic tube systems  have potential for specimen damage and limited carrying capacity.
- Electric track vehicles reduce the damage risks of tube systems and the lack of flexibility from
the courier service, but they take up large amounts of space.
- Mobile robots for deliver it can payload and continue service without having to interrupt a
laboratory technologist but this technology is still under testing for implementation.
- Drones may provide both extra-laboratories as well as inter-laboratory delivery. A drone’s
ability to rapidly move small numbers of specimens from a clinic to a laboratory can avoid
automobile traffic delays.
c. Pre-Analytical Automation
Once specimens arrive in the laboratory there are new pre-accession processors that can start with a
bucket of randomly oriented specimens and finish with racked and processed specimens for downstream
analytical processing. An automated specimen inspector that can examines critical specimen quality
issues such as proper labeling, sufficient volume, and correct vial additive should be available.
d. Sample Labeling
Mistakes in sample labeling can lead to sample misplacement and mislabeling, resulting in a loss of
samples and inaccurate results. The progression from manual labeling to 2- and 3-D barcodes has dealt
with many labeling problems and significantly cut down on sample misplacement and mislabeling.
However, the development affordable radio-frequency identification (RFID) is poised to allow positive
passive specimen tracking as samples are moved from patient bedside to analysis. While barcodes often
require manual scans, RFID completely eliminates human involvement.
As per [6] adding or upgrading a laboratory automation system obviously impacts how laboratory staff performs their
jobs, and it may also provide opportunities for technologists to enhance their knowledge base and skill sets. As
existing responsibilities are reconfigured due to automated work flows, lab directors must reevaluate where to
reposition team members to maximize their value to the laboratory, promote continued professional development,
and ensure that the laboratory remains compliant.
To help prepare for this post implementation shift in staff responsibilities, laboratory directors must pinpoint several
key tasks within the laboratory that require more consistent staff involvement, particularly those that center around
patient safety and efficacy. With automation reducing the need for manual intervention in specimen handling, it can
free up staff to take on these other, often more critical roles.

13. Not only does automation help lab managers fill in these responsibility gaps, but it also can lead to greater job
satisfaction among technologists, who often find themselves able to more fully use their formal training and education
within the new scope of their jobs. When they no longer need to perform important, yet mundane, manual tasks such
as specimen handling, technologists in newly automated laboratories often transition to roles overseeing
establishment of clinical test performance parameters, directing quality control and quality assurance programs, or, in
some cases, transferring their skills to another laboratory diagnostics discipline, such as the growing and exciting field
of molecular diagnostics.
Some researchers for example in [7] claim, that TCLA & automation can provides an alternative approach to minimize
the errors occur in Lab. For this purpose they suggest;
- To simplify the automation technologies,
- To provide continuous process monitoring for the use of technology
- To prevents Equipment from functioning incorrectly (alerting the user as soon as or before an error has
occurred)
- And above of all to focus on staff training.
1. Claudia Archetti, Alessandro Montanelli, Dario Finazzi, Luigi Caimi, Emirena Garrafa, Clinical laboratory
automation: a case study , Journal of Public Health Research 2017; volume 6:881.
2. Antonio Buño Soto, laboratory Automation Benefits in 3D, Siemens Academy 2016.
3. Robin Felder Advances in Clinical Laboratory Automation, Clinical Laboratory News, DEC.1.2014 AACC
Organization.
4. Jim Gazvoda , Jeff Raasch, Hospitals Putting Their Labs in One Place, hospital & healthcare networks 11Aug
2017
5. Charles D. Hawker, Clinical Laboratory Automation - presentation, University of Utah, department of
Pathology2011
6. Dave Hickey, Laboratory Automation: Important Considerations, Laboratory Automation Magazine 28 March
2012.
7. Robin A. Felder, The Impact of Automation on Medical Laboratories and Hospitals; Predictions for the Future,
The 3rd Cherry Blossom Symposium April 2002, A&T