Planning for Laboratory Automation

June 21, 2024

Aurel Tamburri, MHM, CRSP, D.OHS, MLS

Rachel Gamble, DrPH, CBSP, RBP

www.merrick.com
TEAM OVERVIEW

Aurel Tamburri, MHM, MLS, DOHS, CRSP

Senior Scientist
Years of Experience: 25+
[email protected]

Rachel Gamble, DrPH, CBSP, RBP

Associate Director of Biosafety & Biosecurity
Years of Experience: 18
[email protected]
Laboratory Automation: Step by Step

3
 Where do I start? What about
the facility?

What is automation?

Where are everyone’s What are the

gloves and safety benefits?
What are my glasses?
options?

How much
is the cost?

Summary
What about
safety?

4
What is Automation?
• Transition of manual processes to ones that are
automated by equipment
• Re-engineering of manual processes

But Why?!?
• Improved the quality of laboratory performance
• Better operation
• Fewer human errors
• Increased safety for workers
 • Expect the use and sophistication
of automated systems to increase.

• Automation and process re-

engineering are the prime ways to
address staff shortages.
What is
Automation? • Industry will drive automated
solutions – mega ‘factory’ labs.
 • Ability to maintain a close
connection between the search for
efficiency through automation and
consolidation of services.

• Breaking down traditional silos

What is using laboratory metrics to
optimize workflow and the
Automation? assurance of effectiveness both
within the lens of quality, cost, and
utilization.
Courtesy of CDC/ Public Register
 Incomplete
understanding of Constrained
current financial or spatial
environment resources

Unrealistic
Loss in flexibility expectations of
due system

Automation
Unclear
Pitfalls Unplanned and
poorly developed
expectations of
system
“workarounds” functionality

Overbuilt and
unnecessarily Inadequate
complicated technical support
system design
 Credible and
realistic impact
analysis never Hidden costs
conducted

Vendors
Failure to overstating the
Automation optimize current benefits and
processes elevating
Pitfalls expectations

Pandemic is over
Where do I start?
 Before You Put the Cart Before the Horse….

• Needs Assessment
• Cost-Benefit Analysis
• Workflow Analysis
• Scalability and Flexibility
Before You Requirements
Buy-In • Technology Compatibility
• Vendor Research
• Stakeholder Consultation
• Regulatory Compliance
• Training and Support
 Identifying 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 the

introduction of automation.
Identify
Solutions Automation is not always the solution. Check-in with
other labs.

Examine performance-based re-engineering

projects; these may have more impact on laboratory
performance than an expensive automation project.

Automating a poor process is not the answer.

 • Use continuous quality improvement
(CQI) tools to foster process
improvements.
• Standardize processing procedures to
‘best practice’ solutions with the fewest
hand-offs.
• Reduce or eliminate non-value added
Re-Engineering handling and sorting.
Needs • Eliminate checking many locations 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.
 Determining the Laboratory’s Needs
• Automated systems must match the specific work volumes and needs of
each laboratory.

• In a fully automated laboratory, the layout of the laboratory and the shape
of the spaces are critical for maximizing the return on investment.

Laboratory
Needs
 Determining the Laboratory’s Needs

• What is the laboratory’s specimen

volume?

• Chart specimen count by hour of day

and day of week.

Laboratory • What percentage are centrifuged?

Needs • What percentage are aliquoted?

• What percentage of specimens are

shared between two lab sections?

• What percentage of specimens are

refrigerated or frozen?
 Workflow Analysis

Technology Assessment

Integration Planning

Systematic Training and Change Management

Approach to
Quality Assurance
Automation
Continuous Improvement

Supply Chain Issues

Workflow Mapping Pre-Automation

• Material flows (specimens)

• Process flows

• Data flow diagram - done at

different layers of detail

• Workload map - can be used in

simulation studies
 Purpose is to count and time everything in relation to the workflow
map.

Specimen arrival v. accession time. Note the date & time of each step,
the number of tubes in each batch, and the dwell time for each batch.
Timing
Analysis should be done at different times of the day.

Identify bottlenecks, idling time, and re-work (multiple handling).

 • Pour-offs and aliquoting – what is
the workload?

• Sorting - how much sorting of

specimens occurs - in Specimen
Handling Processing and in lab sections?
Considerations • 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?
 • Sample management- centralized or decentralized?

• Using a manual system, paper requisitions, or QR codes?

• What is the percentage of repeat testing? Reflex algorithms?

• What is the percentage of additional testing requested to be added to

archived specimens?

Handling
Considerations
Evaluation of Alternatives

Define and rank objectives (needs to be filled).

Identify alternative solutions, some of which may not involve

automated equipment.

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.

There are several options available, from stand-alone integrated

systems to pre- and post-analytical modules that can be used with
analytical units, modular systems to total laboratory automation.
What are my options?
 • Robotic Process Automation: Use of robots for repetitive tasks
such as sample handling, sorting, and pipetting.

• Automated Sample Processing: Systems for centrifuging,

aliquoting, and sorting samples.
Automation • Integrated Platforms: Combining multiple automation solutions
Options into a single, cohesive system to handle various laboratory
processes.

• Automated Storage and Retrieval Systems: Efficiently manage and

access archived samples.
 • Workflow Automation: Software to automate scheduling, task
assignment, and result reporting.

• High-Throughput Screening (HTS): Technologies for rapidly

conducting a large number of tests.
Automation • Digital Pathology: Automation of slide scanning and image
Options analysis for pathology.

• Artificial Intelligence (AI) and Machine Learning: Enhancing data

analysis, predictive maintenance, and decision-making
processes.
 • Barcode and QR Code Systems: For efficient
sample tracking and management.

• Automated Microscopy: Systems for high-

resolution imaging and analysis.

Automation • Lab Robotics: Advanced robots for complex tasks

such as liquid handling, colony picking, and plate
Options handling.

• Remote Monitoring and Control: Systems for

managing lab processes remotely.
 • Lab Automation Workstations: Modular robotic systems that can
perform multiple tasks, including sample preparation, nucleic
acid extraction, and PCR setup.

• Liquid Handling Robots: Perform tasks such as dispensing,

mixing, and transferring liquids, often used in high-throughput
screening and assay development.
Automation
Options
What about the
facility?
 • Automation of Routine Tasks

• AI and Machine Learning

• Integrated Systems

• Real-Time Monitoring and Control

Self-Driving • Data Management
Laboratories
• Adaptability and Scalability

• Enhanced Safety and Reliability

• Predictive Maintenance
When designing new space or renovating existing facilities:

• Organize facilities to align with the flow of specimens.

• Place high-volume testing areas (e.g., chemistry,

hematology) nearest to Specimen Receiving and low-
volume testing areas farther away.

• Minimize traffic congestion by avoiding routing all lab activity

through critical areas like Specimen Receiving.

• Locate client service and exception handling activities within

or near Specimen Receiving.

• Consider future design considerations to control costs while

strategically positioning for future needs.
Workflow Analysis/Process Mapping RECEIVING PROCESSES
Bacteriology- Secondary Molecular based testing

20th Floor
Molecular Suite Sample
TB Mycology Parasitology Research
(need clarification) Triage
1200x900 1200x900 1200x900 1200x900

EBV
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MRSA, VRE, Antrhax, Legionella Environmental

wit h p 671
cobas p 612
Mycoplasma, TB, PCP Research
Molecular Surveillance, C. diff

Work
Other Bacterial PCR
Si e m e ns Im m ul i te 2 0 0 0

Stations/

19th Floor
Head Tech Reference ID
108

108
kg

kg
Virus Isolation

Office
108

108
kg

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3'-0"

108

108
kg

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Sample Triage
108
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108
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Lab Enteric
Co n trol Un i t

Entry
Respiratory &
108

108
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wit h p 671
cobas p 612

Dock

18th Floor
RECEIVING PROCESSES
Fridge Fridge
Front End Processing Research
Fridge Fridge Fridge Fridge
2-8°C 2-8°C 2-8°C 2-8°C 2-8°C 2-8°C
Research- Molecular based testing
108

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kg

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HVT Sample/
108

108
kg

kg
Co n trol Un i t

20th Floor
108

108
kg

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Si e m e ns Im m ul i te 2 0 0 0

Storage
108

Sample
kg

TB Molecular Suite Mycology Research Parasitology

108
kg

Triage
108

108
kg

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1200x900 1200x900 1500x750

Rack Washer
108

108
kg

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Storage
EC2 Fume Hood
Manual Molecular (suite 1,2,3) / DNA Services

Carts/
Environmental
Cappilary Electrophoreisis Sequncing
Research
Aliquotting
EBA 2 1

Genome Sequncing
He ttic h

Storage
Optical Mapping

19th Floor
Fridge Fridge
2-8°C 2-8°C
Reference ID
Virus Isolation

Problem
Send Outs
Bench Sample
Triage

Enteric
Respiratory &
Fume Hood Copier Legionella

FIle
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5'-3"

Copier

18th Floor
Fume Hood
Front End Processing Research

Scanning
Equipment Layout
 • Plan for routine maintenance of automated systems and
infrastructure.

• Ensure easy access for repairs and upgrades.

Maintenance
& Upkeep
Maintenance and Upkeep: Planning!!!

•Collaboration is crucial!!!

•Open lines of communication

 • Incorporate robotic workstations
with adequate bench space and
connectivity for automated
equipment.

• Plan for overhead service carriers or

tracks for robotics movement,
ensuring safety and accessibility.

• Design infrastructure to support the

electrical, plumbing, and HVAC
Automation needs of automated equipment and
Integration & robotics.

Infrastructure • Provide sufficient power outlets,

data connections, and backup
power sources.

• Consider specialized infrastructure,

such as vibration-resistant flooring
for sensitive instruments.
Lab Layout and Space Allocation

Design the layout to accommodate

Design automated equipment, robotics, and
workflow efficiency.

Allocate space for sample preparation,

Allocate analysis, storage, and robotics operation.

Consider the need for separate

Consider cleanrooms or controlled environments,
depending on the type of research.
Data Management & IT
Infrastructure
• Establish a robust IT
infrastructure for data
storage, transfer, and
analysis.

• Implement cybersecurity
measures to protect
sensitive research data.

• Ensure network connectivity

for remote monitoring and
control.
Instrumentation
& Equipment
• Design spaces to
accommodate analytical
instruments, storage, and
maintenance areas.

• Plan for equipment access,

maintenance, and calibration.

• Consider centralized
instrument management
systems for scheduling and
data collection.
 • Design the facility to be modular and adaptable to changing research
needs.

• Allow for the integration of new technologies and the reconfiguration of

lab spaces.

Flexibility &
Scalability
Collaboration
Spaces
• Include areas for
collaboration, meetings,
and data analysis to
encourage interdisciplinary
teamwork.

• Consider shared spaces

for researchers from
different labs or
organizations.
 • Incorporate sustainable
building materials and energy-
efficient systems.

Environmental • Plan for waste management

Sustainability and recycling solutions.

• Consider green building

certifications, if applicable.
What are the benefits?
Robotics – Initial Design – COVID-19

Risk Assessment

LIFE SCIENCES
FEDERAL

ACADEMIC

PUBLIC HEALTH
What is the strategy ?
BIOPHARMA & BIOTECH

HEALTHCARE

INTERNATIONAL

COMMERCIAL
 Continuous
High- Testing
throughput
PCR assays

Benefits
COVID-19 Efficiency
Testing and
Quality
Ramp-Up

Public
Health
Flexibility and Scalability
Flexibility and Scalability

• Modular Design

• Interoperable Systems

• Flexible Software

• Remote Monitoring and Control

• Scalable Infrastructure

• Regular Upgrades

• Vendor Partnerships
How much is the cost?
 • Installation and Setup

• Training

• Maintenance and Service

Contracts
Cost
Considerations • Consumables and Supplies

• Software Licenses

• Facility Requirements

• Return on Investment (ROI)

 • Scalability

• Regulatory Compliance
Cost
Considerations • Energy Consumption

• Lifecycle Costs

• Vendor Partnerships
What about safety?
 Many positive impacts of
automation
Automation
Safety

Automation can be worker-

focused
Automation Enables Elimination of the Hazard

• Avoid the reliance on manual instruments/tools (e.g., pipettes).

• Minimize musculoskeletal injury by enabling task variation.

• Reduce repetitive tasks – considering the high volume of testing!

• Let the equipment do the work!

Automation Enables Elimination of the Hazard

• Create safety enclosures around

equipment.

• Remove hazards using local exhaust

ventilation directly over equipment ports.

• Waste collection within the system.

 • Design work with
workers in mind

Ergonomics o Efficiency

o Comfort

o Safety
 Choose equipment
Ergonomics Ensure automation does not
interfere with

• Low noise • Room temperature

• Locate carefully away from • Overall comfort
quieter areas
• Other equipment
 • Accessibility and size of knobs, buttons.

• Visual displays w/ options for brightness and contrast control.

• Keyboard & mouse are suitably positioned.

Ergonomic
Considerations
Summary
What did I learn?
Automation Lessons and Take-Home Messages
Questions?