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Full automation
Full Automation
Dr. Jayesh Warade
MBBS MD PGDHHCM DCRM PGDip (Endo)
Consultant Biochemistry and Molecular Biology
Quality Manager
Laboratory Services
Meenakshi Mission Hospital and Research Center, Madurai
Automation
It is automation of manual processes and
involves automated or robotic equipment.
Automation is the use of control
systems and information technologies to
reduce the need for human work in the
production of goods and services
Laboratory Automation
Laboratory automation is the use of
instrument and specimen processing
equipment to perform clinical assay
with only minimal involvement the
technologist
Types of automation
Total Laboratory automation (TLA)
System based automation
Operations in Laboratory
Divided into three phases
preanalytic,
analytic, and
postanalytic
The analytic phase is the most automated, and more
research and development efforts are focusing on
increasing automation of the preanalytic and
postanalytic processes.
Inidividual Steps in Process
Specimen acquistion
specimen identification
specimen delivery to laboratory
specimen preparation
specimen loading and aspiration
on analyzer specimen delivery
reagent handling and storage
reagent delivery
chemical reaction phase
measurement approches
signal processing, data handling and process control
Specimen Acquistion
Veebot
Specimen Identification
2D Bar Code
1D Bar Code
Wrist
Band
Bar Code Sticker
Specimen Delivery to Laboratory
Laboratory station
Carriers Pneumatic Tube
Specimen Delivery to Laboratory
Electric Track Vehicles
Specimen Preparation
presorting,
specimen volume
inspection,
centrifugation,
decapping,
aliquoting, and
destination sorting
into analyzer-
specific racks
The Tecan Genesis FE500 Ô workcell
Specimen Sorting
Analytical
Analytical
Contineous Flow Analayis
Discrete Analysis
Centrifugal Analyzer
Random Access Analyzer
Batch Analyzer
Modular Analyzer
Laboratory Infromation System
Computerized information management
system designed for laboratories
Manages lab data from sample log-in to
reporting
Interfaces with analytical instruments
Sorts and organizes data into various
report formats
Stores data for future reference and use
Full automation
Autoverification
Autoverification
What is Autoverification? (CAP)
“Autoverification is the process by which patient results
are generated from interfaced instruments and sent to
the LIS, where they are compared against laboratory-
defined acceptance parameters.
If the results fall within these defined parameters, the
results are automatically released to patient reporting
formats without any additional laboratory staff
intervention.
Any data that fall outside the defined parameters is
reviewed by laboratory staff prior to reporting.”
Why Autoverification?
↑ Consistency:
Autoverification removes technologist’s “subjectivity” and improves
consistencyof reporting (regardless of the number and skill set of the
technologists in the lab)
↑Quality:
Autoverification reduces errors/mistakes, and improves quality
↓TAT:
Autoverification reduces amount of labor required for validation of
results
About 60-80% of results could be automatically verified, while 20-40%
require further attention.
Holy Trinity of Lab Testing
1.Increase Patient Safety
2.Decrease TAT
3.Cost-Savings
Guideline is Available for
Autoverification?
CLSI AUTO 10-A; Volume 26 Number 4
Autoverification of Clinical Laboratory
Test Results Guideline
Integrated Automation
WorkSations
Workcell
Automated
Speciment Transport
Integrated Automation
Speciment Input Area
Bar code reading Sations
Transport System
High Level sorting or routing device
Automated Centrifuge
Level Detections and evalution of speciment adequacy
Decapping Station
Recapping station
Aliquoter
Interface to Automated Analyzer
Sorter
Take Out Station
Storage and retrival system
Integrated Automation
Middleware
Middleware is connectivity
software that provides a
mechanism for processes to
interact with other
processes running on
multiple networked
machines.
Middleware Application
Programming Interfaces
provide a more functional
set of capabilities than the
OS and network services
provide on their own.
Middleware
Sample tracking & routing of samples to different
instruments/work stations.
Differentiation of STAT & Routine samples to be handled efficiently
for fast TAT
Monitoring TAT for STAT & Routine samples
Auto-validation of results based on configurable set of criteria (QC &
Calibration pass, Delta check, Moving average, etc)
Monitoring QC performance of all configured instruments & alert to
user on ‘outliers’
Monitoring ‘instrument maintenance protocols’, error & event logs on
linked instruments
Inventory management on all instruments linked to the middleware
Instant access to patient test orders and results
Instrument reports (events, calibration, reagent status)
Systematic Approach to
Automation
Evaluation of needs (move current state to desired state)
Logistics and handling issues
Facilities and space consideration
Temperature considerations
Mapping workflow, timing workflow
Finding bottlenecks and time wasters
Identify possible solutions to meet needs
Evaluation of alternatives
Progress measures
Cost justification
WHY AUTOMATION?
WHY AUTOMATION?
Reduce human error
Safety
decrease laboratory costs
improve turnaround time
increase productivity
Run more tests
Test in fewer sites
Operate with fewer instruments.
Retain lower operating costs.
Employ relatively less skilled labor.
Use more automation in a paperless environment
Specimen Volumes and Workload
What is laboratory’s specimen volume?
Chart specimen count by hour of day and day
of week
What percentage are centrifuged?
What percentage are aliquotted?
What percentage of specimens are shared
between two lab sections?
What percentage of specimens are
refrigerated or frozen?
Handling Considerations
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 LIS?
How do phlebotomists verify patient ID?
Handling Considerations
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?
Handling Considerations
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?
Facilities and Space
If there is the opportunity to design a new facility, great.
Whether yes or no, here are several worthwhile ideas:
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.
Workflow Mapping
Material flows (specimens)
Process flows
Data flow diagram-done at different layers
of detail
Workload map-can be used in simulation
studies
Workflow Mapping
Workflow Mapping
Workflow Mapping
Steps For Tracking
Registration
Consultation
Time of prescription by
physician
Billing time
Time of collection
Time of transport to
collection
Receiving at reception and
barcode
Transportation to
segregation
Segregation and transfer to
department
Department reception
Transfer to centrifuge
Centrifuge
Transfer to instrument
Waiting and processing
Updating
Approval
Non-Track Automation Possibilities
Wristband bar code systems for
phlebotomy
Document management systems
Autoverification, middleware, and QC
software
PC or LIS-based specimen storage and
retrieval
Timing Studies
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 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.”
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.
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.
Progress Measures
Median turn-around time
95th percentile turn-around time
Stat turn-around time
Lost specimens
Mislabeled specimens
Billed units per FTE
Rate of hiring of technical employees
Objectives To be Included...
To compare and contrast the TAT pre-
and post-LAS
To compare and contrast laboratory errors
pre- and post-LAS
To gauge the level of staff satisfaction and
their feedback post-LAS
To document the advantages and
limitations of the LAS and the continuous
improvement process for the first 6
months.
Cost Justification
Automation Projects Not Successful
Reasons Why Automation Projects
are Not Successful
Incomplete understanding of current environment...processes, costs,
customer expectations
Loss in flexibility due to fixed processes and limited throughput
Unrealistic expectations of system...cost reduction, throughput, return
on investment
Unplanned and poorly developed ‘workarounds’ required to interface
automation with manual processes
Unclear expectations of system functionality
Overbuilt and unnecessarily complicated system design
Inadequate technical support
Credible and realistic impact analysis never conducted
Hidden costs...labor, supplies, maintenance
Failure to optimize current processes prior to automation→never
automate a poor process!
Future Concept Lab Automation
Full automation
Future Concept Lab Automation
Future Concept Lab Automation
Future Concept Lab Automation
Automation and Robo Scientist
Future Concept Lab Automation
Microbiology Laboratory
Culture & Phenotypic Drug Sensitivity
(Minimum TAT 24 hrs)
Molecular Testing Laboratory
PCR & Genetic Drug Sensitivity
(Minimum TAT 45 min)
Future Concept Lab Automation
World Largest Taxi Company
Future Concept Lab Automation
Future Concept Lab Automation
Future Concept Lab Automation
Future Concept Lab Automation
Future Concept Lab Automation
Biorepository-sized automated storage
systems, inexpensive radiofrequency
identification (RFID), Drone - based
sample dispatching, development of
new positions such as
"Robotechnologist", Multilayer
Perception Neural Network
Future Concept Lab Automation
Drone - based sample dispatching
Future Concept Lab Automation
Radiofrequency identification (RFID)
Future Concept Lab Automation
Robotic Pipette
Future Concept Lab Automation
Multilayer Perception Neural Network
Future Concept Lab Automation
Robotechnologist
Automation Lessons and Take Home
Messages
Automation Lessons and Take Home
Messages
Know your laboratory’s business!
Map workflow to find bottlenecks
Determine your primary and secondary objectives
Use your workflow map and objectives to authenticate
vendor proposals
Focus on process improvement
Re-engineering processes may have just as much impact
on operations as automation
Maximize use of information technology
Consider alternatives
Justify all costs
Take your time
Email: jdyajdo@gmail.com
9028219916
7402619916
http://clinlabworld.blogspot.in/
Full automation

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Full automation

  • 2. Full Automation Dr. Jayesh Warade MBBS MD PGDHHCM DCRM PGDip (Endo) Consultant Biochemistry and Molecular Biology Quality Manager Laboratory Services Meenakshi Mission Hospital and Research Center, Madurai
  • 3. Automation It is automation of manual processes and involves automated or robotic equipment. Automation is the use of control systems and information technologies to reduce the need for human work in the production of goods and services
  • 4. Laboratory Automation Laboratory automation is the use of instrument and specimen processing equipment to perform clinical assay with only minimal involvement the technologist
  • 5. Types of automation Total Laboratory automation (TLA) System based automation
  • 6. Operations in Laboratory Divided into three phases preanalytic, analytic, and postanalytic The analytic phase is the most automated, and more research and development efforts are focusing on increasing automation of the preanalytic and postanalytic processes.
  • 7. Inidividual Steps in Process Specimen acquistion specimen identification specimen delivery to laboratory specimen preparation specimen loading and aspiration on analyzer specimen delivery reagent handling and storage reagent delivery chemical reaction phase measurement approches signal processing, data handling and process control
  • 9. Specimen Identification 2D Bar Code 1D Bar Code Wrist Band Bar Code Sticker
  • 10. Specimen Delivery to Laboratory Laboratory station Carriers Pneumatic Tube
  • 11. Specimen Delivery to Laboratory Electric Track Vehicles
  • 12. Specimen Preparation presorting, specimen volume inspection, centrifugation, decapping, aliquoting, and destination sorting into analyzer- specific racks The Tecan Genesis FE500 Ô workcell
  • 15. Analytical Contineous Flow Analayis Discrete Analysis Centrifugal Analyzer Random Access Analyzer Batch Analyzer Modular Analyzer
  • 16. Laboratory Infromation System Computerized information management system designed for laboratories Manages lab data from sample log-in to reporting Interfaces with analytical instruments Sorts and organizes data into various report formats Stores data for future reference and use
  • 19. Autoverification What is Autoverification? (CAP) “Autoverification is the process by which patient results are generated from interfaced instruments and sent to the LIS, where they are compared against laboratory- defined acceptance parameters. If the results fall within these defined parameters, the results are automatically released to patient reporting formats without any additional laboratory staff intervention. Any data that fall outside the defined parameters is reviewed by laboratory staff prior to reporting.”
  • 20. Why Autoverification? ↑ Consistency: Autoverification removes technologist’s “subjectivity” and improves consistencyof reporting (regardless of the number and skill set of the technologists in the lab) ↑Quality: Autoverification reduces errors/mistakes, and improves quality ↓TAT: Autoverification reduces amount of labor required for validation of results About 60-80% of results could be automatically verified, while 20-40% require further attention. Holy Trinity of Lab Testing 1.Increase Patient Safety 2.Decrease TAT 3.Cost-Savings
  • 21. Guideline is Available for Autoverification? CLSI AUTO 10-A; Volume 26 Number 4 Autoverification of Clinical Laboratory Test Results Guideline
  • 23. Integrated Automation Speciment Input Area Bar code reading Sations Transport System High Level sorting or routing device Automated Centrifuge Level Detections and evalution of speciment adequacy Decapping Station Recapping station Aliquoter Interface to Automated Analyzer Sorter Take Out Station Storage and retrival system
  • 25. Middleware Middleware is connectivity software that provides a mechanism for processes to interact with other processes running on multiple networked machines. Middleware Application Programming Interfaces provide a more functional set of capabilities than the OS and network services provide on their own.
  • 26. Middleware Sample tracking & routing of samples to different instruments/work stations. Differentiation of STAT & Routine samples to be handled efficiently for fast TAT Monitoring TAT for STAT & Routine samples Auto-validation of results based on configurable set of criteria (QC & Calibration pass, Delta check, Moving average, etc) Monitoring QC performance of all configured instruments & alert to user on ‘outliers’ Monitoring ‘instrument maintenance protocols’, error & event logs on linked instruments Inventory management on all instruments linked to the middleware Instant access to patient test orders and results Instrument reports (events, calibration, reagent status)
  • 27. Systematic Approach to Automation Evaluation of needs (move current state to desired state) Logistics and handling issues Facilities and space consideration Temperature considerations Mapping workflow, timing workflow Finding bottlenecks and time wasters Identify possible solutions to meet needs Evaluation of alternatives Progress measures Cost justification
  • 29. WHY AUTOMATION? Reduce human error Safety decrease laboratory costs improve turnaround time increase productivity Run more tests Test in fewer sites Operate with fewer instruments. Retain lower operating costs. Employ relatively less skilled labor. Use more automation in a paperless environment
  • 30. Specimen Volumes and Workload What is laboratory’s specimen volume? Chart specimen count by hour of day and day of week What percentage are centrifuged? What percentage are aliquotted? What percentage of specimens are shared between two lab sections? What percentage of specimens are refrigerated or frozen?
  • 31. Handling Considerations 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 LIS? How do phlebotomists verify patient ID?
  • 32. Handling Considerations 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?
  • 33. Handling Considerations 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?
  • 34. Facilities and Space If there is the opportunity to design a new facility, great. Whether yes or no, here are several worthwhile ideas: 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.
  • 35. Workflow Mapping Material flows (specimens) Process flows Data flow diagram-done at different layers of detail Workload map-can be used in simulation studies
  • 39. Steps For Tracking Registration Consultation Time of prescription by physician Billing time Time of collection Time of transport to collection Receiving at reception and barcode Transportation to segregation Segregation and transfer to department Department reception Transfer to centrifuge Centrifuge Transfer to instrument Waiting and processing Updating Approval
  • 40. Non-Track Automation Possibilities Wristband bar code systems for phlebotomy Document management systems Autoverification, middleware, and QC software PC or LIS-based specimen storage and retrieval
  • 42. 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 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.”
  • 43. 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.
  • 44. 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.
  • 45. Progress Measures Median turn-around time 95th percentile turn-around time Stat turn-around time Lost specimens Mislabeled specimens Billed units per FTE Rate of hiring of technical employees
  • 46. Objectives To be Included... To compare and contrast the TAT pre- and post-LAS To compare and contrast laboratory errors pre- and post-LAS To gauge the level of staff satisfaction and their feedback post-LAS To document the advantages and limitations of the LAS and the continuous improvement process for the first 6 months.
  • 49. Reasons Why Automation Projects are Not Successful Incomplete understanding of current environment...processes, costs, customer expectations Loss in flexibility due to fixed processes and limited throughput Unrealistic expectations of system...cost reduction, throughput, return on investment Unplanned and poorly developed ‘workarounds’ required to interface automation with manual processes Unclear expectations of system functionality Overbuilt and unnecessarily complicated system design Inadequate technical support Credible and realistic impact analysis never conducted Hidden costs...labor, supplies, maintenance Failure to optimize current processes prior to automation→never automate a poor process!
  • 50. Future Concept Lab Automation
  • 52. Future Concept Lab Automation
  • 53. Future Concept Lab Automation
  • 54. Future Concept Lab Automation Automation and Robo Scientist
  • 55. Future Concept Lab Automation Microbiology Laboratory Culture & Phenotypic Drug Sensitivity (Minimum TAT 24 hrs) Molecular Testing Laboratory PCR & Genetic Drug Sensitivity (Minimum TAT 45 min)
  • 56. Future Concept Lab Automation World Largest Taxi Company
  • 57. Future Concept Lab Automation
  • 58. Future Concept Lab Automation
  • 59. Future Concept Lab Automation
  • 60. Future Concept Lab Automation
  • 61. Future Concept Lab Automation Biorepository-sized automated storage systems, inexpensive radiofrequency identification (RFID), Drone - based sample dispatching, development of new positions such as "Robotechnologist", Multilayer Perception Neural Network
  • 62. Future Concept Lab Automation Drone - based sample dispatching
  • 63. Future Concept Lab Automation Radiofrequency identification (RFID)
  • 64. Future Concept Lab Automation Robotic Pipette
  • 65. Future Concept Lab Automation Multilayer Perception Neural Network
  • 66. Future Concept Lab Automation Robotechnologist
  • 67. Automation Lessons and Take Home Messages
  • 68. Automation Lessons and Take Home Messages Know your laboratory’s business! Map workflow to find bottlenecks Determine your primary and secondary objectives Use your workflow map and objectives to authenticate vendor proposals Focus on process improvement Re-engineering processes may have just as much impact on operations as automation Maximize use of information technology Consider alternatives Justify all costs Take your time