microbiology automation a new frontieruserfiles/pdfs/clma micro automation 2015.pdfmicrobiology...

Microbiology Automation

A New Frontier

Terri Riddle, MBA, MLS(ASCP)

MicroScan Global Marketing

Global Process Consultant

Beckman Coulter, Inc.

Disclosures

I am an employee of Beckman Coulter, Inc.,

a distributor of Copan WASP/WASPLab.

Agenda

� What is microbiology automation?

� Digital microbiology work flow

� Impact of automation and financial justification

� Questions

Learning Objectives

� Learn about the key features, benefits, and impact of

microbiology automation systems

� Describe how work flow will change with digital microbiology

� Understand strategies to financially justify micro automation

Continued

decrease in

reimbursement

Retirements

and staffing

challenges

Outsourcing

and

consolidation of

micro testing

Increased

demand

for

automation

Challenges of

antimicrobial

resistance

Customer Challenges and Needs

Today’s Microbiology Processes

OtherBlood

Culture Gram StainEnrichment Molecular Other

Read Cultures

ID/AST

Spot Tests

Blue = largely automated

Red = partly automated

Grey = largely manual

No Growths Normal Flora Pathogen

With Future Automation Solutions

OtherBlood

Culture Gram StainEnrichment Molecular Other

Read Cultures

ID/AST

Spot Tests

Blue = largely automated

Red = partly automated

Grey = largely manual

No Growths Normal Flora Pathogen

The First Challenge for Micro Automation

� Different containers

� Different sizes and caps

� Different sample viscosities

� Different processing protocols

� Variability in bar code placement

Micro Automation Requires Liquid Specimens

Photo © 2012 Copan Diagnostics, Inc. All rights reserved.

Flocked Swabs – Quality and Flexibility

� Up to 48 hours organism viability* for aerobes, anaerobes & fastidious organisms

� Gram stains, traditional culture, PCR and rapid antigen assays

� Automation ready*Product tested and validated full in compliance with CLSI M40-A: Quality Control

Microbiological Transport Systems, including Neisseria gonorrhea survival at 24 hrs

Liquid Sputum Specimens?

� SL Solution - A mucolytic reagent that transforms sputum into liquid format

� Allows easier and more consistent planting and streaking.

� Does not affect morphology or growth of pathogens

� Room temperature stability


� Pre-analytical specimen processor

� Full micro automation

� Conveyor track

� Robotic incubation

� Digital imaging

� Reading and work up benches

Components of Micro Automation Systems

Evolution of Specimen Processors

ISOPLATER 180

This photo is the exclusive right of Vista Technology, Inc

� Operator manually inoculates and labels plates

� Plates are loaded onto the system

� ISOPLATER® streaks plates in a circular pattern using a series of patented “S” shaped loops to achieve colony isolation


Previ Isola

This photo is the exclusive right of bioMerieux, Inc

� Operator loads specimens that have been manually mixed and decapped

� Instrument automatically inoculates liquid specimens using disposable pipette tips

� Disposable combs streak for isolation using a circular pattern

� Plates are automatically labeled

Previ™ Isola is a registered product of bioMerieux, Inc.


InocuLAB

This photo is the exclusive right of Dynacon Inc

� One of first systems to automate the decapping and recapping of specimens

� Manual mixing still required

� Calibrated metal loops used for sampling and streaking

� Automatic plate labeling

� Note: InocuLAB is no longer sold

InocuLAB™ is a registered product of Dynacon Inc., Ontario, CA


BD Innova

� Based on the InocuLAB platform, but with added features

� Innova™ automatically processes urine, ESwab, and fecal Carey Blair samples

� Can sample with either a disposable pipette or a reusable metal loop

� 5 specimens drawers can be accessed independently

This photo is the exclusive right of Becton Dickinson Inc

Innova™ is a registered product of Becton Dickinson Inc.

Next Generation Specimen Processors

� Automates all the core aspects of specimen processing

� Identifies and tracks specimens with bidirectional LIS interface

� Fully automates mixing, inoculation and streaking

� Inoculates plates and broths

� Applies discs – both direct specimens and Kirby Bauer

� Prepares and labels Gram slides

� Can automate up to 95% of culture specimens

� Engineered for stand alone specimen processing or as part of a complete micro automation line

This photo is the exclusive right of BD Kiestra B.V.


BD Kiestra InoqulA

InoqulA® is a registered product of BD Kiestra B.V. Friesland, Netherlands

� Consists of 2 modules – fully automated and semi-automated

� Pipette tips deliver inoculum

� Unique streaking method using rolling balls

� Customer defined streak patterns

� Streaks up to 5 plates simultaneously


Copan WASP: Walk Away Specimen Processor

� Fully automated and “streak only” modes

� Random loading of pallets

� Reusable metal loops - 1 µL, 10 µL, 30 µL, plus dual biplate loop

� Customer defined streak patterns

� Camera system and image analysis ensure planting

� Unique spinner to automate processing of fecal specimens


� Pre-analytical specimen processor

� Full micro automation

� Conveyor track

� Robotic incubation

� Digital imaging

� Reading and work up benches

Components of Micro Automation Systems

Complete Microbiology Automation Systems

This photo is the exclusive right of BD Kiestra B.V.This photo is the exclusive right of BD Kiestra B.V.

Components of Microbiology Automation

Conveyor Tracks

� Transport plates

� From the specimen processor to the incubators

� From incubators to work up canisters or to work stations

� Bar code readers along track ensure placement in the proper incubator

� Configuration of line depends on work flow preference and space availability



Robotic Incubators

� High capacity storage (854-1708 plates) in a small footprint

� Automated plate management using side bar code label

� Optimal environmental conditions support rapid growth

� Individual plate shelves have good thermal conductivity, allowing plate to quickly come up to appropriate temperature

� No disruption of temperature or CO2

from manually opening doors

� Robotic inversion of plates is possible


Impact of Consistent Optimal Environment

Micro Activity

Conventional

Reading Time

WASPLab

Reading Time*

Culture set up at 0 hours Not performed Baseline image

1st read 18-24 hours 14-16 hours

2nd read Appx 48 hours 30 hours

3rd read Appx 72 hours 52 hours

4th read Appx 96 hours 78 hours

* Based on active WASPLab installations; may vary

based on system validation and customer preference

A consistent optimal environment, combined with strategic staffing and reading practices, can contribute

to a significant decrease in turnaround times.


Digital Imaging

� Digital camera captures images of plate

� Various lighting scenarios can be used

� Images can be taken at specified intervals

� Image quality ranges from 5 – 27 megapixels depending on the system

� Enlarge image to show colony detail

� Evaluate colonial morphology

� Unique WASPLab Time0 image will allow differential analysis

� Chromogenic markers1

� Growth vs. No Growth1

Photos © 2012 Copan Diagnostics, Inc. All rights reserved.

1 Under development; not yet available for sale in US

July 2013 Riddle/ MM Global Marketing

Compare growth over time Enlarge for detail

Select the optimal lighting scenario

Digital Imaging


Reading and Picking Stations

� Work flow will change with digital microbiology

� Majority of culture analyses will be performed using a computer monitor

� Plates requiring work up or further investigation are automatically moved out of the robotic incubator for manual picking

Screening

Functions

Reading

Functions

Picking

Functions

� Rapidly sort negative

from positive cultures

� WASPLab

automatically organizes

plates based on

amount of growth

� Detect suspect

colonies on

chromogenic agar

� Screen 800-1200

plates per hour*

� Detailed analysis of

positive cultures to

define appropriate

work up

� Create electronic

work up tickets

� Report results

� Read 100 plates

per hour*

� Only time the plates

are manually touched

� Perform tasks defined

on work up ticket

� Provides a valuable

quality check on

reader’s interpretation

� Pick 80 plates per

hour*

* Performance reported by established WASPLab installations

WASPLab Workflow

Screening Functions

� Quickly scan images to sort negative cultures from the positive cultures that require more detailed analysis

� Typically used for urine cultures, chromogenic agar screening, and other simple culture types

� Screen multiple images which are sorted by biomass

� Work flow benefits

� Move positive cultures to reading phase quickly

� Efficient resulting of negative cultures

Reading Functions

� Analyze cultures to define appropriate work up

� Observe growth over time and under various lighting scenarios

� Enlarge image for better visualization of growth

� Identify colonies that require further analysis and create electronic work tickets

� Result culture finding in the LIS

Picking Functions

� Perform tasks defined on work up tickets

� Easily document completion of task to remove it from the work list

Conventional vs. Digital Work Flow

Process Conventional Micro (Typical Lean work flow)

Digital Micro

Reading

Functions

- Benches typically divided

by type of culture: urine, wound, etc.

- Each bench tech reads,

results, and picks every culture

- Work functions divided

between READERS and PICKERS

- Readers – Perform digital

analysis and resulting

Picking

Functions

N/A - Pickers – Designated techs

perform all “hands on” tasks

What Does the Future Hold?

Features Under Development1

� Automated Growth vs. No Growth resulting

� Kirby Bauer halo recognition and interpretation

� Early positive growth notification for critical cultures

� Automated picking, to include

� Inoculation of Prompts and turbidities

� MALDI target spotting

� Subcultures from plated cultures

� Integration of Gram slide images

� Integration of front end processor onto central lab automation line

� Integration of instruments onto micro automation line

1 Under development; not yet available for sale in US

Impact of Microbiology Automation on Productivity

% Improvement in Productivity

With Microbiology Automation

0%

50%

100%

150%

200%

250%

300%

Lab 1 Lab 2 Lab 3

Labs 1 and 2 – Automation in Clinical Microbiology,

J. Clin. Microbiol. June 2013, vol. 5 no. 6 1658-1665

Lab 3 – Copan Italia (unpublished data), 2013

Demonstrated increases in productivity, by as much as 2.5-fold to 4-fold, have been reported by laboratories adopting microbiology automation.1

1 Automation in the Clinical Microbiology Laboratory, Clin Lab Med 33 (2013)

Impact of WASP on Productivity:

Specimen Processing

Source: Nexus work flow evaluation –

University of Kentucky Healthcare, February 2015

� Full WASP integration resulted in a 74% decrease

in manual labor related to

specimen processing� This calculates as a

decrease of 98 manual

labor hours per month

Average Hands On Time

Pre-WASP With WASP

82 sec 21 sec

Impact of WASPLab on Productivity:

Estimated Staffing Impact for Analytical Activities

Current Staffing by Reading Bench

Hours per Day

Urine 18-26 hrs

Respiratory 8 hrs

Wound/MDR/ear/eye 18-26 hrs

Genital 12 hrs

TOTAL 56-72 hrs/day

With WASPLab - Typical Busy Day

Hours per Day

Screening (only urine,MRSA, VRE, and SA) 1.8 hrs

Reading (positive screens

and all other cultures) 29.8 hrs

Picking 8.3 hrs

TOTAL 39.9 hrs/day

Assumptions:

� Based on productivity metrics more

conservative than those seen in existing

WASPLab microbiology laboratories

� Screening – 600 plates per hour

� Reading – 80 plates per hour

� Picking – 60 plates per hour

Strategies for Financial Justification

� Improve productivity to address:

� Increasing volumes

� Staffing challenges

� Lab consolidation

� Improve turnaround time

� Faster growth of cultures in controlled environment

� Supports 24/7 reading and resulting

� “Read when ready” philosophy

� Support antimicrobial stewardship and improved patient outcomes

Courtesy of Sandra Mills, Chief Microbiology Technologist, UK Healthcare

2013 data is annualized.

The Case for Antimicrobial Stewardship

Courtesy of Sandra Mills, Chief Microbiology Technologist, UK Healthcare

QA study comparing length of incubation at initial culture read to MIC TAT

Average MIC TAT

Incubation period 12-18 hrs

Average MIC TAT

Incubation period <12 or >18 hrs

<2 days 3.5 days

Improve TAT with “Read When Ready” Analysis

Maximize Impact of Micro Automation

On Patient Care

� 24/7 reading to minimize TAT of clinically significant results

� Use of MALDI-TOF for rapid identification

� Molecular platform to detect known resistance mechanisms

� Accurate MIC platform to detect newly emerging resistance

� Active antimicrobial stewardship program

Benefits of Microbiology Automation

� Automate routine tasks, e.g. sorting plates

� Eliminate manual transport of plates to and from

incubators, to and from reading benches, etc.

� Streamline analysis and resulting of cultures

� Better visualization of growth with digital imaging

� Simplified supervisory review to ensure accuracy

� Enhanced opportunities for teaching and consultation

� Faster growth in the controlled incubator environment

allows earlier culture reading

� “Read when ready” images support 24/7 reporting

� Software can streamline documentation

Increase

Productivity

Improve Quality

Decrease

Turnaround Time

Questions?

© 2013 Beckman Coulter, Inc.

Move Your Lab Forward with

Beckman Coulter

Contact with Disclaimer

Terri Riddle, MBA, MLS(ASCP)

MicroScan Global Marketing

Global Process Consultant

Beckman Coulter, Inc.

[email protected]

1. MicroScan is a trademark of Beckman Coulter, Inc. All other trademarks are properties of their respective owners.

2. Product availability may vary from country to country and is subject to varying regulatory requirements.

3. Beckman Coulter, Inc. is an authorized distributor of the Copan WASP System and the BrukerMALDI Biotyper System. Copan and Bruker are Strategic Alliance Partners of Beckman Coulter, Inc.

microbiology automation a new frontieruserfiles/pdfs/clma micro automation 2015.pdfmicrobiology...

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