College of American Pathologists - Pre-Analytical Automation Systems · • Pre-analytical...

Pre-Analytical Automation Systems

Robin A. Felder, Ph.D.Director, Medical Automation Research Center

Professor of PathologyThe University of Virginia

© College of American Pathologists 2004. Materials are used with the permission of Robin Felder, PhD.

Improving healthcare quality and efficiency through the development of advanced

technologies

Medical Automation Research Center

http://marc.med.virginia.edu

The Hospital/Laboratory Partnership

• Improving physician efficiency and efficacy by providing rapid definitive diagnostic data– Electronic medical records, minimally invasive

Point-of-Care diagnostics, efficient sample collection, labeling, and transportation

• Improving overall hospital efficiency– Resource tracking, schedule optimization,

inventory control, skill level assessment and training, process control

• Allowing patients to self diagnose– Internet health portals, home diagnostics

• Creating a partnership between the lab and the physician

Course Objectives

• Describe pre-analytical and analytical molecular diagnostic automation

• Show actual performance data on some of these systems

Small Laboratory Issues

• Smaller laboratories have had few options to improve their competitiveness against larger reference laboratories

• Improve competitiveness– Better service (faster turnaround time,

improved consults, better patient education, fewer errors)

– Reduced costs (eliminate send out costs, reduce labor, reduce tube diversity, reduce inefficient arrival patterns)

Tube Diversity

Specimen Arrival RatesArrival Pattern

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1 4 7 10 13 16 19 22

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Arrival Pattern

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60% Centrifugation30 % 1 Aliquot

70 % Centrifugation20 % 1 Aliquot

60% Centrifugation50% 1 Aliquot

60 % Centrifugation40 % 1 Aliquot

Arrival Pattern

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60% Centrifugation5 % 1 Aliquot

72 % Centrifugation31 % 1 Aliquot

40 % Centrifugation23 % 1 Aliquot

Source: Donna Crook, Tecan, Research Triangle Park, NC, USA

Selection of Automation Based on Test Volume and Versatility

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ples

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illio

ns)

Relative Cost

Total LaboratoryAutomation

Workstation

Workcell

Clinical Laboratory Automation

Total LaboratoryAutomation (TLA)

Workcell

Modular LaboratoryAutomation (MLA)

Workstation

Benefits of Pre-Analytical Automation

• Pre-analytical workstations installed worldwide are exceeding customer expectations

• Optimized preparation of high quality samples

• Exceptional use of laboratory space• Significant increases in laboratory

productivity• Predictable return on investment

Standardized AutomationPreanalytical Module

Picture: Courtesy of A&T Corp.

Open LA21 Project

Picture: Courtesy of A&T Corp.

A&T Open LA21 Modular

• Maximizing Analyzer Throughput– Single tube but “high speed” transportation– Buffering Module avoids traffic jam– Efficient distribution of sample – the number of samples

loaded in sampling point will be monitored and controlled

Sample Load/Sample Load/Unload M.Unload M. Buffering M.Buffering M. ImmunoImmuno--a. M.a. M. Chemistry M.Chemistry M.

Conveyor with FeederConveyor with Feeder Universal Connection M.Universal Connection M.

Picture: Courtesy of A&T Corp.

Load/Unload M.Load/Unload M.Buffering M.Buffering M. ImmunoImmuno--a. M.a. M. Chemistry M.Chemistry M.

Conveyor Module with FeederConveyor Module with Feeder Universal Connect. M.Universal Connect. M.

Open LA21

• Random Access for Routine, Emergency and Repeat Testing– All the samples will be dispatched from Buffering Module to the

Analyzer with “random access”– STAT Sample will be fed to Sampling Point with priority– The sample will be kept in Buffering Module for Retesting

Picture: Courtesy of A&T Corp.

Pre-analytical Workstations

Front End ProcessorPyxis

Power ProcessorBeckman Coulter

Brea, CA

MODULAR Preanalytics,Roche Diagnostics, Indianapolis, IN

GENESIS FE500Abbott/Tecan, North Chicago, IL/Durham, NC

PathfinderAi-Scientific,ScarboroughAustralia

Bayer

• Single point connections for power, modem, network,water, and waste

• LabCell information system–ADVIA CentraLink®

–Process Control–Auto verification

ADVIA® LabCell®Bayer Healthcare (Tarrytown, NY)

noIn developmentyes600/module11.5x75-

16.2x100BayerADVIA, Lab Cell

yes

yes

no

yes

no

Recapping

ULyes200 – 425(300 if

aliquotting)

13x75-16x100

Lab-InterlinkFront-end Processor

5yes60013x75-16x100

RocheMODULAR

ULno30013x75-16x100

Ai-ScientificPathfinder

6yes30013x75-16x100

Beckman CoulterPower Processor

ULyes288 – 332,(8 -10 min spins)

13x75-16x100

Abbott/TecanFE 500

AliquotsCentrifugationThroughputPrimary/max

output/hr

Tube requirementsPre-analytical

Processors

UL = unlimited

Time to 1st Tube

20 secondsno centrifugation

15 seconds, no centrifugation

NA6 secondsPathfinder

11 min,1 sec

10 min, 55 sec

10 min,30 secCent (10 min,24 sec)

6 secFront End Processor

17 min, 40 sec

17 min, 32 sec

15 min,Cent (8 min)

52 secondsFE 500

Time to 1st

Tube, Cent + 2 Aliquots

Time to 1st

Tube, Cent + 1 Aliquot

Time to 1st

Tube w CentTime to 1st

Tube woCentrifugation

Tecan GENESIS FE500

Case Study 1: Clinical Trial FE500

• 4000 specimens over a period of 3 months

• Input rate from 40 to 300 tubes per hour

• Aliquots from 1 to 5• We measured

– throughput– error rate reduction– centrifuge efficiency– Labor savings

AliquotingStation

GENESIS FE 500 Layout

Specimen Input

Specimen OutputCentrifugation

Positive Specimen ID

Tube Loading

Installation

Site Preparation

System Fine TuningAnd Training

Delivering, Installation,Testing, Intelligent RoutingProgramming

Day 1

Day 2

Day 12

FE 500 Throughput40

100

200

72

180

360

104

260

520

68

170

340

96

240

480

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24 Minutes 36 Minutes 1 Hour

Average Time to Complete Primary and Secondary Tubes

Tube

s Lo

aded

and

Unl

oade

d

80% 1 aliquot, 20%

direct sort

Tubes loaded

80% 2 aliquots, 20%

direct sort

70% 1 aliquot, 30%

direct sort

70% 2 aliquots, 30%

direct sort

Error Reduction

99.3243,126Biohazard exposure events

80.01,8009,011Labeling errors

80.06143,072Pour-off errors

80.02,03810,192Sorting and routine errors

% ReductionPost FE500***Pre FE500Error / event classification

Number of Errors / Events per Month**

* Study performed at Milton S. Hershey Medical Center, Pennsylvania State University.** Estimated for one month’s period of data collection.*** Errors recorded in this category were from manually-handled samples for STAT testing plus those samples processed for microbiology and virology testing.

Centrifuge Efficiency

3.43 ± 3.21.9

7.51 ± 2.04.2

10.9 ± 2.46.1

180 ± 0100

Subject 2 (n=3)% of Ref.

1.6 ± 1.31.0

6.4 ± 2.84.0

6.4 ± 2.44.0

159 ± 6.6100

Subject 1 (n=3)% of Ref.

GENESIS FE500**(10 min cent)

GENESIS FE 500**(8 min cent)

Control run (manually centrifuged)*

Reference sample* (whole blood)

Data is expressed as mean ± SD of total platelets (x 103) / uL of whole blood. * NOTE: We performed a control run on each specimen according to NCCLS guidelines (e.g., 1500 x g for 10 minutes).

Fiscal Impact of the FE500

• Manual Processing Steps per month –75K

• 12 FTEs• Manual Processing

steps per month 25K• 8FTEs (- 33%)

Manual Processing

Automated Processing

SUMMARY

• Pre-analytical automation provides a cost effective improvement in specimen processing

• Throughput of pre-analytical automation workstations matches the needs of most medium sized laboratories

• Errors are significantly reduced by pre-analytical automation

Case Study 2: CoagAutolink

Automation Reduces Steps

INSPECT BALANCE LOAD ALIGN LOAD

TRANSPORT

Pre-analytical Processing Time

0 50 100 150

Minutes

Workcell Pre-labeled

Workcell

STAT Manual

Routine Manual

Source: Graves S, Felder RA. Robotic automation of coagulation analysis. Clinica Chemica Acta 278(2):269-279, 1998.

(simulated)

Times from Central Receiving to Aspiration

Manual

Auto

Case Study 3: Beckman Coulter

• Step I– Power

Processor– 16X100 mm– Manual barcode

scan• Step II

– Power Processor II

– Many size tubes– Automated bar

code scanning

Dadoun R., Case Study: Automation’s Impact on productivity and turnaround timeMLO, May 2002, 36-38.

0

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STEPS STAT TOT Routine TOT

BeforeStep IStep II

Mobile Robots for Medical Deliveries

• Hospital wide delivery using the Helpmate (Pyxis, Inc., Danbury, CT)

• Intra-laboratory delivery using the RoboCart (CCRI, Lake Arrowhead, CA)

PIC & PLACE

• Automated pick up and delivery for medical specimens

• Does not interrupt busy technologists

• Provides high capacity transportation

• Provides greater efficiency than human based delivery methods

• Point of origin to point of need connectivity

Mobile Robots and Delivery Efficiency

Delivery Time Costs

050,000

100,000150,000200,000250,000300,000350,000400,000450,000

Cost

s, $

USA

2 Robots 3 Robots 6 Robots Courier

Alternatives

COSTS, Robot vs Courier

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Alternatives

Delivery Time, Robot vs Courier

30% more efficient$250,000annual savings

Tecan Freedom EVO

• Modular design to serve genomics, proteomics, and diagnostics

• Modular hardware for detection, separation and storage

• Meets European EU In-Vitro Diagnostics Directive 98/79/EC and FDA’s 21 CFR Part 11 regulations

Gen-Probe Tigris DTS

• Automates all steps related to molecular diagnostic testing (nucleic acid amplification)– Sample processing– Amplification– Detection– Data analysis

Molecular Diagnostics

• Fastest growing diagnostic test sector• Presents new pre-analytical challenges

– Sample Identification and privacy– Cross contamination– Sample size

• Analytical techniques

Pre-analytical DNA Processors

• Automated DNA extraction at a rate of 40-96 specimens/day

• Whole blood, buffycoat, packed cells, lysates for compromised samples, buccals, cultured cells

• Cost per test is about $4/specimen

• DNA is suitable for most reactions

Gentra Autopure LS

Gentra Versapure 1000

Single Function MDx Automation• Completely automated

DNA/RNA extraction / purification

Magtration Extractor Precision System Science Tokyo, Japan.

Magnetic bead based extraction

Multiple Function MDx Automation

• Performs multiple parts of MDx reaction scheme

• Can be programmed for user flexibility

• Thermal cyclers, pipetting automation, and signal detection instruments placed on board

• Ideal for clinical molecular biology method development

TECAN Genesis RSP 150

Making DNA testing a routine part of medicine and industryD N A D E T E C T I O N T E C H N O L O G Y

Relies on bioelectronics—using organic molecules to form electronic circuits.

Allows the simple, rapid, and cost-effective detection of up to 36 DNA or RNA targets simultaneously: SNP, Mutation, Bacterial, Viral, Transgene, and Gene Expression

Simplified DNA Detection

• Electronic biochip reader• Custom and catalog biochip cartridges • Software and protocols • Designed for use in a commercial lab

setting

Molecular Diagnostics Summary

Ideal Small Laboratory Initial Molecular Diagnostic Devices

• Nucleic acid extractor• Polymorphism detection system

Post Analytical Automation

• Usually a function available on a pre-analytical processor

• Sorting, labeling, capping, organizing

• Automated reflex, repeat, add-on

AutomatedLowTemperatureStorage andRetrieval System

Compact Secure Storage

Summary and Conclusion

Goals• Provide examples of

modular automation systems that make sense in smaller laboratories

• Show actual performance data on some of these modular systems

Conclusions• Modular automation is

possibly the best first step in clinical laboratory automation

• Substantial process improvement, error reduction, and cost savings are being realized

• Modular automation is evolving to keep pace with the changing clinical diagnostics market