Kiestra™ Solution: User's Manual

Kiestra™ Solution
User's Manual
L012255(07) 2023-06
444063, 444139, 444150, 444900, 444902, 444908, 444910, 446097, 446942, 446948, 446958, 446971,
446972, 446973, 447202, 447206, 496017, 496018, 496019, 496020, 496022
English
bd.com/e-labeling
BD Kiestra™ Solution User's Manual
Change History
Revision Date Change Summary

Added integrated BarcodA and InoqulA
workflows. Added printing and application of
05 2022-03 labels on plates at an integrated BarcodA. Added
inoculation on an integrated InoqulA. Added
blood culture workflows.
Updated the FA inoculation on an InoqulA Track,
Load balancing, Plate sorting in Stackers, Plate
sorting with a single ReadA, Error plates,
06 2022-07
Undeliverable plates, Connected workstations,
and Culture workup on a connected workstation
topics. Added a new Adding plates topic.
Added new Configuration in BarcodA topic.
Updated Fully automated (FA) inoculation on an
InoqulA Track, Error plates, Connected
workstations, Track transports the plates, and
07 2023-06
Culture workup on a connected workstation
topics. Updated and added new topics to support
the new integrated ErgonomicA workstation
workflows.
BD, the BD Logo, BACTEC, BD Kiestra Optis, InoqulA, Kiestra, and Synapsys are trademarks
of Becton, Dickinson and Company or its affiliates. All other trademarks are the property of
their respective owners. © 2023 BD. All rights reserved.
For U.S. patents that may apply, see bd.com/patents.
No part of this publication may be reproduced, transmitted, transcribed, stored in retrieval
systems, or translated into any language or computer language, in any form or by any means,
electronic, mechanical, magnetic, optical, chemical, manual, or otherwise, without the prior
written permission of BD Kiestra B.V., Marconilaan 6, 9207 JC Drachten, The Netherlands.
2
Table of Contents
1 Instructions for use guidance 5

1.1 Customer release notes 5
1.2 Conventions 5
1.3 Notes, cautions, and warnings 5
1.4 Depiction of patient information 6
2 Introduction 7
2.1 Intended use 7
2.2 Solution workflows 7
2.3 Integrated vs. connected modules 8
3 Specimen management 9
4 User management 11
5 Media and media protocol configuration 13
5.1 Configuration in DB Manager 13
5.2 Configuration in BarcodA 14
6 Inoculation 15
6.1 Manual inoculation at a connected workstation 16
6.2 Manual inoculation at an integrated ErgonomicA workstation 17
6.3 Manual inoculation at a satellite laboratory 18
6.4 Fully automated (FA) inoculation on a connected InoqulA+™ 19
6.5 Semi-automated (SA) inoculation on a connected InoqulA+™ 19
6.6 Fully automated (FA) inoculation on a connected InoqulA 19
6.7 Semi-automated (SA) inoculation on a connected InoqulA 20
6.8 Fully automated (FA) inoculation on an InoqulA Track 20
6.9 Semi-automated (SA) inoculation on an InoqulA Track 21
7 Plate transport 23
7.1 Adding plates 23
7.2 Imaging 23
7.3 Incubation in a ReadA 23
7.4 Incubation in an external incubator 23
7.5 Load balancing 24
7.6 Plate sorting in Stackers 25
7.7 Plate sorting in ErgonomicA Stackers 25
7.8 Plate sorting with a single ReadA 26
7.9 Error plates 27
7.10 Clear & Sync plates from a connected InoqulA+™ 28
7.11 Error plates from InoqulA 28
7.12 Undeliverable plates 28
7.13 Empty ReadA for cleaning 28
7.14 Connected workstations 29
7.15 Integrated ErgonomicA workstations 31
7.16 External incubation 32
7.17 Waste plates 32
3
7.18 Positive waste 32

7.19 Discarded plates / Custom Waste 32
8 Incubation and imaging 33
8.1 Incubation and imaging in a ReadA 33
8.2 Incubation and imaging in an external incubator 33
8.3 Evaluating cultures using BD Kiestra™ Imaging Apps 34
8.4 Viewing incubation progress 34
9 Culture Reading 37
10 Micro Workcard 39
11 Culture workup on a connected workstation 41
12 Culture workup on an integrated ErgonomicA workstation 45
13 Culture workup on IdentifA 49
14 Positive blood culture workflows 51
14.1 Using rules to automatically order tests and subcultures for positive BD BACTEC™ bottles 51
14.2 Manually ordering tests and subcultures for a positive BD BACTEC™ bottle 52
14.3 Processing positive BD BACTEC™ bottles on BD Kiestra™ InoqulA 52
14.4 Processing positive BD BACTEC™ bottles manually 53
14.5 Creating a Culture Reading worklist 54
14.6 Using 5 Day Rolling Final rules for reporting negative BD BACTEC™ bottles 55
14.7 Viewing BD BACTEC™ FX results 55
15 Configuring the main database 57
15.1 DB Manager 58
15.2 Configuring media 59
15.3 Configuring incubation types 60
15.4 Configuring analysis sets 61
15.5 Configuring programs 62
15.6 Program execution 63
15.7 Program templates 63
15.8 Creating programs 63
15.9 Edit incubation step 64
15.10 Edit imaging step: BD Kiestra™ Optis™ images 65
15.11 Edit destination step 66
15.12 Edit vortex step 67
15.13 Add or edit workflow conditions 67
15.14 Configuring the sample jar TLC 68
15.15 Configuring Stackers 68
15.16 Example programs 69
15.16.1 Internal incubation 70
15.16.2 External incubation 70
15.16.3 Destination step 71
15.16.4 Program structure considerations 72
15.17 Log files 72
16 Glossary 73
17 Contacts 77
18 Index 79
4
1 Instructions for use guidance
Before using the product, it is recommended that all users become thoroughly familiar with the
contents of the instructions for use.
These instructions for use are a reference tool for trained laboratory personnel who operate
and maintain the product on a regular basis. Every attempt has been made to include all
information which would be required during normal use and maintenance.
EU Only: Users shall report any serious incident related to the device to the Manufacturer and
National Competent Authority.
Outside EU: Contact your local BD representative for any incident or inquiry related to this
device.
Technical Service and Support: In the United States contact BD at 1.800.638.8663 or bd.com.
For regions outside of the United States, contact your local BD representative or bd.com.
Should a question arise that is not answered in these instructions, please contact BD.
See 17 Contacts.
1.1 Customer release notes

Customer release notes (in English) are available at bd.com/e-labeling.
1.2 Conventions
The following conventions are used in this guide:
Convention Example
Bold type is used for software options and to Select Save and select OK.
indicate a menu path. Select File > Save As.
For more information, refer to the Example
Italics type is used for names of documents.
Instrument User's Manual.
1.3 Notes, cautions, and warnings

Throughout the instructions for use, important information is presented in boxes offset from the
regular text that are labeled as a NOTE, CAUTION, or WARNING. These messages are
formatted as follows:
NOTE
Information worthy of special attention is presented as a NOTE.
5
CAUTION
Information on an activity which potentially could cause a product to malfunction
is presented as a CAUTION.
WARNING
INFORMATION ON AN ACTIVITY WHICH POTENTIALLY COULD CAUSE INJURY
TO THE USER IS PRESENTED AS A WARNING.
1.4 Depiction of patient information

Patient names, identification numbers, and medical information presented in the instructions
for use, including those within images of the graphical user interface (GUI), are provided as
examples only, and do not represent actual patients or clinical information.
6
2 Introduction
These instructions for use provide an overview of configurations and laboratory workflows for
BD Kiestra™ Solutions.
2.1 Intended use

The BD Kiestra™ Solution is a combination of BD products/modules which together may
enable inoculation, plate labeling, transportation, plate incubation, digital imaging, digital
reading, automated MALDI target preparation, and communication with BD BACTEC™ and
the LIS. The functionalities which are applicable on the solution depend on its configuration.
2.2 Solution workflows

The following sections describe workflows for solutions comprised of BD Kiestra™
InoqulA+™, BD Kiestra™ InoqulA, BD Kiestra™ InoqulA Track, BD Kiestra™ BarcodA Track,
BD Kiestra™ Track, BD Kiestra™ ReadA , BD Kiestra™ IdentifA, and BD Kiestra™
ErgonomicA modules; BD Kiestra™ Urine Culture Application and BD Kiestra™ Methicillin-
resistant Staphylococcus aureus (MRSA) Application; BD BACTEC™ FX and BD BACTEC™
FX40 instruments.
l 6 Inoculation
l 7 Plate transport
l 8 Incubation and imaging
l 9 Culture Reading
l 11 Culture workup on a connected workstation
l 13 Culture workup on IdentifA
l 14 Positive blood culture workflows
Solution configuration instructions are found in 15 Configuring the main database.
Detailed instructions for use are available for the following modules and applications:
l BD Synapsys™ Informatics Solution
l BD Kiestra™ InoqulA+™
l BD Kiestra™ InoqulA
l BD Kiestra™ Track
l BD Kiestra™ ReadA
l BD Kiestra™ IdentifA
l BD Kiestra™ ErgonomicA
l BD Kiestra™ Urine Culture Application (US)
l BD Kiestra™ Urine Culture Application (EU and Canada)
l BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application (US)
l BD Kiestra™ Methicillin-resistant Staphylococcus aureus (MRSA) Application (EU and
Canada)
7
l BD BACTEC™ FX
l BD BACTEC™ FX40
2.3 Integrated vs. connected modules

BD Kiestra™ Lab Automation modules may be used in a variety of configurations. The terms
"integrated" and "connected" are used to differentiate between configurations where a module
is or is not physically integrated with Track.
References to an integrated module (e.g., integrated ErgonomicA, InoqulA Track, BarcodA
Track, or integrated ReadA) denotes a configuration where the module is physically integrated
into a Track solution. Plates coming from or destined to an integrated module are automatically
transported by Track.
A connected module (e.g., standalone IdentifA, InoqulA, or ReadA) denotes a configuration
where the modules are not physically connected to each other with Track elements. While a
connected module is physically separated from Track, it always remains digitally connected to
the solution.
Plates coming from or destined to these modules must be transported manually between the
connected module and other connected modules or Track-based solutions. Plates that will be
manually transported from a Track to a connected module are delivered to a Stacker on the
Track configured for that purpose. Plates manually transported from a connected module to a
Track-based solution will be placed on a Destacker on the Track, for automated delivery to the
appropriate integrated module. The Stacker and Destacker locations on the Track are defined
in the software as Stacker skills.
8
3 Specimen management
Specimen information may be communicated to the solution in two different ways.
LIS specimen management
1. Specimen, patient, and test information is entered into the LIS.
2. Specimen information is communicated between the LIS and the solution by order
download or by host query.
l Order download - specimen information is pushed from the LIS to BD Synapsys™
Informatics as soon as the information is available in the LIS.

l Host query - specimen information is requested by BD Synapsys™ Informatics from
the LIS when the information is needed by BD Synapsys™ Informatics.
BD Synapsys™ Informatics Solution specimen management
If the laboratory does not use an LIS, or if a particular specimen is not logged in the LIS, then
specimen information can be entered in BD Synapsys™ Informatics Specimen Management
or in a batch using Specimen Creator. Alternatively, a specimen can be created by entering the
accession number in BD Synapsys™ Informatics Culture Inoculation, and then adding
demographics in Specimen Management. Refer to the BD Synapsys™ Informatics Solution
instructions for use for further details.
9
10
4 User management
Each Lab Technician has a user account with a personal username and password. Some
module software applications and features will require a user to log in. The same account can
be used for all modules of the solution. When a Lab Technician logs into
Microsoft® Windows®, the same user account can be automatically logged into
BD Synapsys™ Informatics depending on PC settings.
User accounts are managed using authentication software called Identity Management (IDM).
IDM can be configured to manage usernames and passwords locally in BD Synapsys™
Informatics, or to integrate with the laboratory's existing Information Technology (IT) systems.
See User authentication in the BD Synapsys™ Informatics Solution instructions for use.
11
12
5 Media and media protocol configuration
This section covers the following topics:
l 5.1 Configuration in DB Manager
l 5.2 Configuration in BarcodA
5.1 Configuration in DB Manager

New media and media protocols must be defined in DB Manager. Information is transmitted
from DB Manager to BD Synapsys™ Informatics manually or during nightly synchronization.
See File synchronization in the BD Synapsys™ Informatics Solution instructions for use. After
media and media protocol information is transmitted to BD Synapsys™ Informatics, it can be
used to configure culture protocols in BD Synapsys™ Informatics.
The following parameters are defined in DB Manager:
l Media - for plates and broth tubes: code, name, description, media type, selectivity, plate
diameter, and plate height
l Incubation types - temperature, atmosphere, ReadA incubation, external incubation
l Analysis sets - processing requirements for specific media, e.g., container type, media,
specimen volume, spreading pattern, and incubation program
NOTE
Analysis sets in DB Manager are called media protocols and are assigned an order type
in BD Synapsys™ Informatics.
l Incubation programs - incubation duration and imaging time points (reading schedules).
Users may select from predefined program templates that are optimized for BD Synapsys™
Informatics.
l Sample Jar TLCs - Specimen groups that require a vortex step on InoqulA+™ must be
assigned to an analysis set with a vortex step in its incubation program.
Media protocols to be used with BD Kiestra™ Imaging Apps require additional configuration in
DB Manager to differentiate system images from user images.
l System images are read automatically by the BD Kiestra™ Imaging Apps and are visible in
BD Synapsys™ Informatics. However, when system images are processed by the imaging
apps, the culture is not automatically set to Ready for Reading.
l User images are set to Ready for Reading.
NOTE
The BD Kiestra™ Imaging Apps require additional configuration in order to set up media
protocols for use with the BD Kiestra™ Imaging Apps. Contact BD for assistance.
13
5.2 Configuration in BarcodA

BarcodA Track provides plated media for InoqulA, connected workstations, and integrated
ErgonomicA workstations. By default, requests from an InoqulA are routed to the BarcodA with
the same suffix, e.g., InoqulA2 will request media from BarcodA2. If a media type is not
present or configured, the request may be routed to a different BarcodA. It is recommended to
configure BarcodA with media for the expected sample types on InoqulA.
Plate requests from a connected workstation or integrated workstation will always be routed to
the BarcodA with the highest suffix; this is a dedicated BarcodA for those workstations. If
media is not present or configured, then a label will be printed at the workstation.
It is recommended to configure the dedicated BarcodA so that it is capable of handling the
most common media requests. Keep in mind the position of the BarcodA with respect to the
workstation; a farther distance between BarcodA and the workstation might result in longer
wait time when requesting media.
14
6 Inoculation
Specimens ready for inoculation must be scanned at a BD Synapsys™ Informatics
workstation, at an integrated or connected InoqulA, or at a connected InoqulA+™. A test
assigned to a specimen typically requires inoculation onto a plate, broth tube, and/or slide. If
tests are added to a specimen that has already been inoculated, then the specimen container
must be scanned again to inoculate additional containers.
Specimen inoculation methods are described below:
Barcode Labels
Inoculation
Printing Application
Inoculation
Broth Broth Spreading
Method Broth
tubes tubes
tubes and Plates Plates Plates
and and
slides
slides slides
Manual
At
inoculation
At workstation
at a Manual Manual Manual Manual Manual
workstation or BarcodA
connected
Track
workstation
Manual
At
inoculation
At workstation
at an Manual Manual Manual Manual Manual
workstation or BarcodA
integrated
Track
workstation
Manual
inoculation At At
Manual Manual Manual Manual Manual
at a satellite workstation workstation
lab
Fully
automated
InoqulA BarcodA
inoculation Manual Automatic Automatic Automatic Automatic
printer printer
on
InoqulA+™
Semi-
automated
InoqulA BarcodA
inoculation Manual Automatic Manual Manual Automatic
printer printer
on
InoqulA+™
Fully InoqulA
Manual
automated printer
(broth
inoculation (broth BarcodA tubes) Automatic Automatic Automatic Automatic
on a tubes) printer
connected Automatic
SPM
InoqulA (slides)
(slides)
15
Barcode Labels
Inoculation
Printing Application
Inoculation
Broth Broth Spreading
Method Broth
tubes tubes
tubes and Plates Plates Plates
and and
slides
slides slides
Semi-
automated
inoculation InoqulA BarcodA
Manual Automatic Manual Manual Automatic
on a printer printer
connected
InoqulA
Fully InoqulA
Manual
automated printer
(broth
inoculation (broth BarcodA tubes) Automatic Automatic Automatic Automatic
on an tubes) Track
InoqulA Automatic
SPM
Track (slides)
(slides)
Semi-
automated
inoculation InoqulA BarcodA
Manual Automatic Manual Manual Automatic
on an printer Track
InoqulA
Track
6.1 Manual inoculation at a connected workstation

1. Scan the specimen container or enter the barcode number in BD Synapsys™ Informatics
Culture Inoculation.
2. Request the media. Select whether to print the plate barcode labels on the workstation
printer or on the BarcodA Track. The barcode labels for broth tubes and slides will only be
printed on the workstation printer.
NOTE
If the BarcodA destacker runs out of plates during manual inoculation, a
label is printed on the workstation printer. "The system requires plates" is
displayed in the BarcodA System Alerts view.
3. Retrieve the plates from the Track Stacker.

4. Manually apply labels to the required plates, broth tubes, and slides.
5. Inoculate the specimen onto the required plates, broth tubes, and slides.
6. Place inoculated plates into the Track Destacker.
16
6 - Inoculation
7. Process inoculated broth tubes and slides manually.
NOTE
The plates associated with the culture protocol are marked as inoculated
after the container ID is scanned by a BD Kiestra™ barcode scanner. Broth
tubes and slides are marked as inoculated when the Inoculated column in
the My Requested Work list is checked on the Culture Inoculation page.
Workflow tips
l Keep the BarcodA Track stocked with the required media. Request plates from the BarcodA
Track rather than printing plate labels on the workstation.
l Store required media in a refrigerator near the workstation. If the refrigerator is not nearby,
then a cart can be used to store the media near the workstation.
6.2 Manual inoculation at an integrated ErgonomicA workstation

1. Scan the specimen container or enter the barcode number in BD Synapsys™ Informatics
Culture Inoculation.
2. Request the media. Select whether to print the plate barcode labels on the workstation
printer or on the BarcodA Track. The barcode labels for broth tubes and slides will only be
printed on the workstation printer.
NOTE
If the BarcodA destacker runs out of plates during manual inoculation, a
label is printed on the workstation printer. "The system requires plates" is
displayed in the BarcodA System Alerts view.
3. Plates are delivered to the workstation using the ErgonomicA Stacker. The requested
number of plates will be pushed out in stacks. After plates are pushed out, retrieve the
stack.
WARNING
DO NOT RETRIEVE PLATED MEDIA DIRECTLY FROM THE
STACKER. WAIT UNTIL THE STACK HAS BEEN PUSHED OUT.
6. Place inoculated plates into the ErgonomicA Destacker or the Track Destacker.
17
7. Process inoculated broth tubes and slides manually.
NOTE
The plates associated with the culture protocol are marked as inoculated
after the container ID is scanned by a BD Kiestra™ barcode scanner. Broth
tubes and slides are marked as inoculated when the Inoculated column in
the My Requested Work list is checked on the Culture Inoculation page.
Workflow tips
l When one or more BarcodA Track modules are configured, all workstation plate requests
will be processed by the BarcodA with the highest reference number (suffix). Configure this
BarcodA with the proper media types to support the activities on the workstations and keep
it well stocked. If a media type is not available in this BarcodA, even if it is present in another
BarcodA, a label will be printed on the workstation printer.
l Store required media in a refrigerator near the workstation. If the refrigerator is not nearby,
then a cart can be used to store the media near the workstation.
6.3 Manual inoculation at a satellite laboratory

Satellite Lab Inoculation is an optional feature that allows a remote laboratory to mark
containers as Incubating after they are inoculated, but prior to entry into the BD Kiestra™
Solution. The time required to transport the containers to the main laboratory is included in the
incubation time. Refer to the BD Synapsys™ Informatics Solution instructions for use for
information about enabling this feature.
1. Scan the specimen container or enter the barcode number in BD Synapsys™ Informatics.
2. Request the media. The barcode labels for plates, broth tubes, and slides will be printed on
the workstation printer.
5. Select Start Incubation for the desired test in My Requested Work to confirm and start the
incubation counter. The incubation counter will be started for all requested media
associated with the culture. If media have not been requested, they will not be marked as
inoculated and the incubation counter does not start.
6. As soon as possible, place the media into the mobile incubator with the proper incubation
environment.
7. Transport the mobile incubator to the main laboratory.
8. Place inoculated plates into the Track Destacker or the ErgonomicA Destacker.
9. Incubate broth tubes and process slides according to laboratory procedures.
Workflow tips
The incubation counter runs continuously after Start Incubation is selected. Users are advised
to:
l Place inoculated plates onto Track as soon as possible after arrival at the main laboratory.
l Limit the time that plates are outside of the required incubation environment.
18
6 - Inoculation
6.4 Fully automated (FA) inoculation on a connected InoqulA+™

Liquid specimens can be inoculated in FA mode on InoqulA+™. Specimen containers and
broth tubes are loaded in racks onto the FA module. Each container is shaken and decapped.
A sample of the specimen may be pipetted into a broth tube, onto a slide, or onto a number of
plates. Specimen containers and broth tubes are recapped. A bead is placed onto each plate,
and the lids are replaced. Plates are transported to the semi-automated (SA) module for
automatic spreading. When spreading is complete, beads are deposited into disposal
containers. Plates are transported to stackers on the BarcodA module. The stacked plates
must be manually transported to their destinations.
The printer located on the SA module prints barcode labels for broth tubes and slides. The
labels must be manually applied to broth tubes and slides before they are loaded onto the
FA module.
See the BD Kiestra™ InoqulA+™ instructions for use for workflow details.
InoqulA+™ is only supported in a ReadA Standalone solution without a connected InoqulA.
6.5 Semi-automated (SA) inoculation on a connected InoqulA+™

Both liquid and non-liquid specimens can be inoculated in SA mode on InoqulA+™. Specimen
containers are scanned to create a batch. Barcodes are applied to plates, a bead is placed
onto each plate, and the lids are replaced. Plates are transported to the manual inoculation
position. As each specimen is verified, the associated plates are opened and slides are
dispensed, if necessary. Barcode labels for slides and broth tubes are printed and manually
applied. Plates, slides, and broth tubes are manually inoculated, and then plates are shifted
into position for automatic spreading. When spreading is complete, beads are deposited into
disposal containers. Plates are transported to stackers on the BarcodA module. The stacked
plates must be manually transported to their destinations.
See the BD Kiestra™ InoqulA+™ instructions for use for workflow details.
InoqulA+™ is only supported in a ReadA Standalone solution without a connected InoqulA.
6.6 Fully automated (FA) inoculation on a connected InoqulA

Liquid specimens can be inoculated in FA mode on InoqulA. Specimen containers and broth
tubes are loaded in racks onto the FA module. Each container is shaken and decapped. A
sample of the specimen may be pipetted into a broth tube, onto a slide, or onto a number of
plates. The plates are labeled on a BarcodA Track. Specimen containers and broth tubes are
recapped. A bead is placed onto each plate, and the lids are replaced. Plates are transported
to the SA module for automatic spreading. When spreading is complete, beads are deposited
into disposal containers. Plates are transported to stackers on the BarcodA module. The
stacked plates must be manually transported to their destinations.
The printer located on the SA module prints barcode labels for broth tubes. The labels must be
manually applied to broth tubes before they are loaded onto the FA module.
Slides are automatically labeled and inoculated in the Slide Processing Module (SPM). After
dried slides are removed from the SPM, the user must process the slides according to the
laboratory standard operating procedures.
See the BD Kiestra™ InoqulA instructions for use for workflow details.
19
6.7 Semi-automated (SA) inoculation on a connected InoqulA

Both liquid and non-liquid specimens can be inoculated in SA mode on InoqulA. Specimen
onto each plate, the lids are replaced, and plates are transported to the manual inoculation
position. As each specimen is verified, the associated plates are opened. Barcode labels for
slides and broth tubes are printed and manually applied. Plates, slides, and broth tubes are
manually inoculated, and then plates are shifted into position for automatic spreading. When
spreading is complete, beads are deposited into disposal containers. Plates are transported to
stackers on the BarcodA module. The stacked plates must be manually transported to their
destinations.
6.8 Fully automated (FA) inoculation on an InoqulA Track

Liquid specimens can be inoculated in FA mode on InoqulA. Specimen containers and broth
tubes are loaded in racks onto the FA module. Each container is shaken and decapped. A
sample of the specimen may be pipetted into a broth tube, onto a slide, or onto a number of
plates. Specimen containers and broth tubes are recapped. The required plates are requested
from a BarcodA Track. The plates are delivered in the order as requested. When a plate enters
the InoqulA, the plate is scanned, a bead is placed onto the plate, and the lid is replaced.
Plates are transported to the SA module for automatic spreading. When spreading is
complete, the beads are deposited into disposal containers, and the plates are transported to
their incubation destination.
The printer located on the SA module prints barcode labels for broth tubes. The labels must be
manually applied to broth tubes before they are loaded onto the FA module.
Slides are automatically labeled and inoculated in the SPM. After dried slides are removed
from the SPM, the user must process the slides according to the laboratory standard operating
procedures.
NOTE
By default, an InoqulA will request media from a BarcodA with the same suffix. It is
recommended to configure the required media accordingly.
By default, all plate requests coming from an InoqulA will be processed on the BarcodA
with a higher priority than plate requests coming from a connected or integrated
workstation.
20
6 - Inoculation
6.9 Semi-automated (SA) inoculation on an InoqulA Track

Both liquid and non-liquid specimens can be inoculated in SA mode on InoqulA. Specimen
onto each plate, the lids are replaced, and plates are transported to the manual inoculation
position. As each specimen is verified, the associated plates are opened. Barcode labels for
slides and broth tubes are printed and manually applied. Plates, slides, and broth tubes are
manually inoculated, and then plates are shifted into position for automatic spreading. When
spreading is complete, the beads are deposited into disposal containers, and the plates are
transported to their incubation destination.
21
22
7 Plate transport
Plates are transported to or from integrated modules, such as ReadA or InoqulA, and to
Stackers or from Destackers by Track. Track monitors each plate’s program and proper
destination.
l Plates may be placed on Track manually by putting a stack of plates into the Track
Destacker or ErgonomicA Destacker.
l Plates can be placed into the Track Destacker or ErgonomicA Destacker at any time.
l Plates exit Track through Stackers.
NOTE
At the end of the workday, ensure that all plates in the Track or ErgonomicA
Destackers are transported to their proper destinations, that no plates are
left in the Stackers, and that any errors on the integrated modules are
resolved.
7.1 Adding plates

The Track Destacker or ErgonomicA Destacker allows plates to be added to Track. By default,
these plates will circulate around Track until the designated destination is available. A
configurable default of 15 plates from a Destacker can be transported on Track at a time.
7.2 Imaging
Plates that require imaging will be transported to a ReadA, independent of their incubation
destination.
7.3 Incubation in a ReadA

Plates that require incubation in a ReadA will be transported to the specific ReadA with the
required incubation environment (temperature, O2, CO2).
If a plate is inoculated at a connected workstation or a connected InoqulA, then it must be
placed on the Track Destacker for transport to the ReadA.
If a plate is inoculated at an integrated InoqulA, then it will be automatically transported to the
ReadA by Track.
If a plate is manually inoculated at an ErgonomicA workstation, then it will be automatically
transported to the ReadA by Track once placed into the ErgonomicA Destacker.
The incubation clock begins as soon as the plate enters the ReadA incubator.
7.4 Incubation in an external incubator

Plates that require incubation in an external incubator will be transported to an External
Incubation Stacker.
If a plate is inoculated at a connected workstation or an integrated ErgonomicA workstation,
then it must be placed on Track to be sent to the External Incubation Stacker.
23
The incubation clock begins as soon as the plate is stacked on the External Incubation
Stacker. Plates must be retrieved from the External Incubation Stacker and manually placed
into an external incubator with the required incubation environment.
If a plate is inoculated on a standalone InoqulA, then the plate will be sent to an output stacker.
The plate must be retrieved from the output stacker and manually placed into an external
incubator with the required incubation environment.
7.5 Load balancing

If multiple plates are sent to the same destinations, Track will balance the load by transporting
the plates to multiple destinations with the same conditions; for example, when multiple ReadA
modules have the same incubation environment or multiple Stackers are assigned the same
skill.
Workflow tips
l Configure multiple ReadA modules to image externally incubated plates in order to reduce
the number of plates sent to the Undeliverable Stacker.
l Create program steps to store externally incubated plates in the ReadA for a limited amount
of time, so the plates are available for follow-up. This will also reduce the amount of traffic
on Track.
l Request clean media in sets of five samples at a time to prevent overpopulating Track. This
applies to a connected workstation or an integrated ErgonomicA workstation.
24
7 - Plate transport
7.6 Plate sorting in Stackers

Plates leave Track by way of Stackers that have been assigned one or more skills. A skill
refers to a destination or condition assigned to a Stacker. A solution has four Stackers for each
ReadA. See 15.15 Configuring Stackers for more information.
The following skills may be assigned to a Stacker:
l Error
l Undeliverable
l Cleaning
l Connected Workstation (clean plates)
l Connected Workstation (incubated plates)
l IdentifA
l Waste
l Discard / Custom Waste
l Positive Waste
NOTE
The External Incubation skill cannot be combined with any other skill
assigned to a Stacker.
NOTE
Be aware of the potential risk of cross-contamination between plates if
multiple skills are assigned to the same Stacker, especially when combining
incubated plates with clean plates.
Closely monitor the plate cart and remove plates on a regular basis. This will
avoid the cart or a compartment on the cart becoming full, and avoid creating
errors or damaging plates when the push action occurs on the Stacker.
Make sure the undeliverable plates re-enter Track as soon as possible by
placing them on the Destacker.
7.7 Plate sorting in ErgonomicA Stackers

Plates requested to an integrated ErgonomicA workstation leave Track by way of an
ErgonomicA Stacker.
Plates are stored in one of two ErgonomicA Stackers:
l Incubated plates will be stored in the “incubated” stacker and pushed out as a maximum
stack of 15 plates, or one at a time as they are received.
l Clean plates will be stored in the “clean” stacker and pushed out per the number of plates
requested, e.g., if five plates were requested as a group, five plates will be pushed out at
once, to a maximum height of 15 plates.
The ErgonomicA Stackers are configured this way by default to avoid cross-contamination and
cannot be changed.
25
ErgonomicA Left configuration:

l left stacker: clean plates
l right stacker: incubated plates
ErgonomicA Right configuration:
l left stacker: incubated plates
l right stacker: clean plates
7.8 Plate sorting with a single ReadA

In a solution with a single ReadA and four Stackers, the number of skill or destination
assignments is limited.
The following skill or destination assignments are recommended:
l Error / Undeliverable / Cleaning
l External Incubation
l Connected Workstation / IdentifA / Disk Diffusion
l Waste / Positive Waste
Error plates must be scanned at a BD Synapsys™ Informatics workstation to investigate and
clear errors. See 7.9 Error plates.
Undeliverable plates could not be delivered to their destination and must be placed back into
the Track Destacker as soon as possible. See 7.12 Undeliverable plates.
There is a single Stacker for all external incubators. These plates must be sorted manually.
There is a single Stacker for all workstations. In a solution with a single ReadA, the number of
workstations is limited as well. It is recommended to use one workstation for all workup. If more
than one workstation is used, then plates in the Connected Workstation Stacker must be
sorted manually.
Since there is a single Waste / Positive Waste Stacker, it is not possible to sort positive or
custom waste.
NOTE
A Waste / Positive Waste Stacker must be assigned; otherwise positive waste plates will
be sent to the Error Stacker.
26
7 - Plate transport
7.9 Error plates
NOTE
Be aware of the potential risk of cross-contamination between plates mixed in the Error or
Undeliverable Stackers.
Closely monitor the plate cart and remove plates on a regular basis. This will avoid the
cart or a compartment on the cart becoming full, and avoid creating errors or damaging
plates when the push action occurs on the Stacker.
Make sure the plates re-enter Track as soon as possible by placing them on the
Destacker.
Plates that cannot be processed are transported to the Error Stacker. The solution monitors
plates in an error state and will always transport such plates to the Error Stacker. Plates in the
Error Stacker must be scanned at a BD Synapsys™ Informatics workstation in order to
investigate and resolve the error. After resolution, these plates can be returned to the Track
Destacker.
NOTE
If there is an error with a request, or a plate cannot be delivered to a workstation prior to
inoculation, the plate will be sent to the Error Stacker. The following message is
displayed: "In sequence container <Barcode> with <TestIdentifier> could not be delivered
at <destination workstation>."
The user will need to resolve the error in BD Synapsys™ Informatics, and then inoculate
the plate prior to returning it to the Track Destacker.
Error due to unreadable, damaged, or missing label
NOTE
It is recommended to create a worklist in BD Synapsys™ Informatics using criteria to
easily identify and troubleshoot error plates.
Retrieve the plates from the Error Stacker and identify all of the error plates using the error
worklist. By process of elimination, the plates with unreadable, damaged, or missing labels will
remain.
If you can confirm the error plates’ identification, use the workstation printer to replace the
barcode. Perform the required actions on the plate to remove the error condition. When
reintroduced to Track, the plate should continue with the next program step.
If a plate is present in the Error Stacker but not present in the error worklist, try to identify the
plate based on the plate characteristics (lawn pattern, media type, etc.). In this case, it is likely
that the plate is not in the error worklist because the solution cannot obtain the barcode from
the source. Determine where the plate may have originated and reproduce the steps to identify
the plate or sample. If the plate came from an InoqulA or BarcodA, it will likely be present in the
error list.
27
7.10 Clear & Sync plates from a connected InoqulA+™

When a Clear & Sync is performed on InoqulA+™ SA or when a plate is marked as defective,
plates may be sent to the InoqulA+™ Error Stacker. When these plates are then put on Track,
they are transported to the Waste Stacker.
7.11 Error plates from InoqulA

When an error occurs on a connected InoqulA, the plates are sent to the connected BarcodA
Error Stacker. When these plates are then put on Track, they are transported to the Waste
Stacker.
When an error occurs on an InoqulA Track, the plates are immediately transported to the Track
Waste Stacker.
7.12 Undeliverable plates

If plates are assigned a destination that is not available at the time, the plates will be
transported to the Undeliverable Stacker. This happens for example when a ReadA is off-line
for cleaning. These plates must be manually returned to Track via the Destacker, and will
attempt to be delivered again when the assigned destination becomes available.
NOTE
Be aware of the potential risk of cross-contamination between plates mixed in the Error or
Undeliverable Stackers.
Closely monitor the plate cart and remove plates on a regular basis. This will avoid the
cart or a compartment on the cart becoming full, and avoid creating errors or damaging
plates when the push action occurs on the Stacker.
Make sure the plates re-enter Track as soon as possible by placing them on the
Destacker.
l If a plate that is requested by InoqulA goes to the Undeliverable Stacker, all plates that are
requested after this plate will remain on Track until the first plate is put back on Track via the
Destacker.
l If a plate that is requested by a workstation from a BarcodA is sent to the Undeliverable
Stacker, this will impact the remaining requested plates for that workstation. All plates that
are requested after this plate will remain on Track until the first plate is put back on Track via
the Destacker.
7.13 Empty ReadA for cleaning

There are two options for unloading a ReadA module for cleaning:
1. Remove plates manually through the back door.
l The removed plates must be deregistered using the ReadA software.
28
7 - Plate transport
2. Send plates to the Cleaning Stacker.

l This is not an option for a solution with only one ReadA and four Stackers on Track.
l For a solution with only one ReadA, select Clean in the ReadA. After plates are
transported to Stackers, check plates in the Error Stacker at a BD Synapsys™
Informatics workstation. Resolve any errors, and then start the cleaning protocol on the
ReadA.
Plates should be stored in another ReadA with the appropriate incubation environment during
cleaning. If another ReadA is not available, the plates can be put on a cart or into an external
incubator during cleaning.
NOTE
The incubation timer is paused while plates are on the cart or in an external incubator.
After cleaning the ReadA, these plates must be manually returned to Track via the Destacker.
7.14 Connected workstations

Plates that need to be processed at a connected workstation are transported to a Connected
Workstation Stacker. Up to 15 plates will be stacked on the Connected Workstation Stacker
and then pushed onto a plate cart positioned in front of the Stacker element. Plates in a
Connected Workstation Stacker must be manually transported to the appropriate
workstations.
WARNING
DO NOT REMOVE PLATES DIRECTLY FROM THE STACKER. WAIT UNTIL THE
STACK HAS BEEN PUSHED ONTO THE PLATE CART.
Each workstation can be assigned to a specific Stacker, or multiple workstations can be

assigned to a single Stacker.
Single connected workstation assigned to multiple Stackers
BD recommends that each connected workstation be assigned to two separate Connected
Workstation Stackers: (1) incubated plates and (2) clean plates. If the incubated plates and
clean plates must be combined onto one Connected Workstation Stacker:
l Track will prohibit incubated plates and clean plates from being stacked on top of each other
in the Stacker.
o The same type of plates (e.g., clean plates) will be stacked together; and then, if a
different type of plate is received (e.g., incubated plates), the Stacker will push out the
initial type of plates to make room for the new type of plates. This can result in smaller
stacks being pushed out onto the plate cart.
29
NOTE
Closely monitor the plate cart and remove plates on a regular basis. This
will avoid the cart or a compartment on the cart becoming full, and avoid
creating errors or damaging plates when the push action occurs on the
Stacker.
l It is advised to turn off the Subculture Plates Included option in BD Synapsys™

Informatics Culture Workup. This will prioritize the incubated plates to the Stacker. After
those plates have been retrieved from the Stacker, request the clean plates.
Multiple workstations assigned to single Stacker
BD recommends that each connected workstation has its own assigned Connected
Workstation Stackers, however, if multiple workstations must be assigned to one Stacker:
l The plates will need to be sorted manually by lab technicians. Coordinate plate requests
between lab technicians to prevent confusion.
l Assign the Reading skill for multiple workbenches to one Stacker. Plates need to be sorted
per workstation after they are pushed out.
l Avoid combining workup for two workbenches because this will have a negative impact on
the user experience.
o It is advised to turn off the Subculture Plates Included option in BD Synapsys™
Informatics Culture Workup. This will prioritize the incubated plates to the Stacker. After
those plates have been removed from the Stacker, request the clean plates.
Push single plate
1. Select the Status tab on the Track GUI.
2. Select the desired Stacker element and select the desired Stacker.
3. Toggle Pushout single plate to ON.
This option is recommended for Stackers that will receive incubated plates for workup.
NOTE
Changing the max stack height to 1 will impact the capacity of the plate cart. Changing
this setting when the plate cart is not empty may result in stacks tipping over during
pushout.
Workflow tips
l Work on only two or three samples at any given time (depending on how many plates are
needed per sample), and no more than 5 samples at a time. This will reduce the traffic on
Track.
l Limit clean plate requests to a maximum of 15 plates at the same time. The clean plates are
delivered in requested order and requesting more than 15 at a time will delay the delivery of
plates. Retrieve the plates when the Stacker has pushed the stack out onto the plate cart.
30
7 - Plate transport
7.15 Integrated ErgonomicA workstations

Plates requested to an integrated ErgonomicA workstation for workup are transported to the
ErgonomicA Stacker.
l Clean plates from BarcodA will be delivered to the designated "clean" Stacker per each
individual group request from BD Synapsys™ Informatics to a maximum height of 15 plates.
l Incubated plates from ReadA or an external incubator, or inoculated plates from InoqulA,
will be delivered to the "incubated" Stacker which can be configured to push out a maximum
stack of 15 plates, or one at a time.
WARNING
DO NOT REMOVE PLATES DIRECTLY FROM THE STACKER. WAIT UNTIL THE
STACK HAS BEEN PUSHED ONTO THE PUSHOUT LANE.
NOTE
A Stacker push can be manually forced using the Track GUI if you cannot wait for the
automatic push.
Push single plate

1. Select the Status tab on the Track GUI.
2. Select the desired Stacker element and select the desired Stacker.
3. Toggle Pushout single plate to ON.
This option is recommended for Stackers that will receive incubated plates for workup.
NOTE
Changing the max stack height to 1 will impact the capacity of the pushout lane on the
ErgonomicA Stacker. Changing this setting when the pushout lane is not empty may
result in stacks tipping over during pushout.
Workflow tips
l Work on only two or three samples at any given time (depending on the number of plates
needed per sample), and no more than 5 samples at a time. This will reduce the traffic on
Track.
l Each integrated workstation will request plates from the dedicated BarcodA. It is
recommended to configure multiple BarcodA Destackers with the proper media types to
support the activities on the workstations and keep them well stocked. If a media type is not
available in this BarcodA, even if it is present in another BarcodA, a label will be printed on
the ErgonomicA workstation printer.
31
7.16 External incubation

If plates need to be incubated in an external incubator, Track transports the plates to an
External Incubation Stacker. Each incubation environment can be assigned to a specific
Stacker or multiple incubation environments can be assigned to a single Stacker.
Plates in an External Incubation Stacker must be manually transported to the appropriate
incubator. If multiple incubation environments are assigned to a Stacker, then the plates must
be sorted manually.
7.17 Waste plates

Plates that are intended for final discard are transported to the Waste Stacker. These plates
must be manually discarded. If there is only one Waste Stacker, then custom waste must be
manually sorted.
7.18 Positive waste

Waste plates with isolate markings are transported to the Positive Waste Stacker. These
plates must be manually discarded.
NOTE
A Positive Waste Stacker must be assigned; otherwise positive waste plates will be sent
to the Error Stacker.
7.19 Discarded plates / Custom Waste

A currently viewed plate in BD Synapsys™ Informatics can be sent to a Discard / Custom
Waste Stacker. Up to four custom discard types can be defined in BD Synapsys™ Informatics.
The four discard types can be assigned to Stackers that have been assigned a Custom Waste
skill in DB Manager.
Discard plates will be transported to the associated Discard / Custom Waste Stacker. Even if
such a plate is sent to waste by its incubation program, the plate will still go to the Discard /
Custom Waste Stacker.
32
8 Incubation and imaging
Each plate is assigned an incubation program that determines incubation duration, incubation
environment, and imaging time points. Incubation programs are defined in DB Manager,
assigned to an analysis set, and then synchronized to BD Synapsys™ Informatics as a media
protocol.
Incubation environments are linked to ReadA incubators and Stackers. Plates are incubated in
a ReadA or transported to an External Incubation Stacker that matches the required incubation
environment.
l Plates sent to a ReadA will be imaged according to the incubation program schedule.
l The incubation and imaging schedule for externally incubated plates must be managed
according to laboratory procedures. The solution monitors these schedules, but does not
give instructions to the user. If an externally incubated plate is two hours late for imaging,
then the status is set to Ready for Reading in BD Synapsys™ Informatics. This situation
must be investigated by the user.
Workflow tip
l Avoid removal of an entire batch of plates from an external incubator if only a portion of the
plates are scheduled for imaging. It is recommended to organize and batch plates by time of
inoculation and specimen source.
l Increase the incubation step margin in the program to increase the range of time that the
external plates can be imaged. See 15.9 Edit incubation step.
8.1 Incubation and imaging in a ReadA

l An inoculated plate is placed into the Track Destacker.
l Track transports the plate to a ReadA with the required incubation environment, and the
incubation timer starts.
l According to the incubation program schedule, ReadA moves the plate to the camera
position and takes images.
l If additional incubation is required, the plate is returned to the ReadA incubator.
l If the user discards the plate in BD Synapsys™ Informatics, or if the plate is in a ReadA
seven days past the last imaging time point, the plate is transported to a Waste Stacker.
8.2 Incubation and imaging in an external incubator

A plate inoculated at a connected workstation is placed into the Track Destacker. Track
transports the plate to an External Incubation Stacker and the incubation timer starts.
A plate inoculated on a connected InoqulA or InoqulA+™ does not need to be placed on Track.
The incubation timer starts when the plate reaches the BarcodA output stacker.
1. Regularly check plates in the External Incubation Stackers.
2. If there are more incubation environments than the number of External Incubation
Stackers, then sort the plates by incubation environment.
3. Place the plates into external incubators.
33
4. Manually track the incubation and imaging schedules.

5. At the scheduled imaging time points, remove plates from the external incubators and
place them into a Track Destacker. Track transports each plate to a ReadA, which moves
the plate to the camera position and takes images.
NOTE
The incubation program configures a margin period prior to the imaging time point.
Externally incubated plates will be imaged if placed on Track within this period. Plates that
are placed on Track too early will not be imaged. Plates placed on Track after the imaging
time point will always be imaged.
l If additional incubation is required, the plate is transported to a Track External Incubation

Stacker.
l If the user discards the plate in BD Synapsys™ Informatics, or if seven days have elapsed
since the last imaging time point, the plate is transported to a Track Waste Stacker.
8.3 Evaluating cultures using BD Kiestra™ Imaging Apps

The BD Kiestra™ Imaging Apps evaluate plates for the presence of bacterial growth. A plate
must be imaged three times at predefined timepoints to provide a time series for the algorithm
to evaluate.
Image timepoints
1. An initial image is obtained to evaluate the appearance of the plate prior to the presence of
observable bacterial growth. This image is processed by the algorithm, and will not be
Ready for Reading for the user.
2. An intermediate image is obtained halfway through the incubation cycle. This image can be
used to evaluate early growth of bacterial colonies.
3. A final image is taken at the normal evaluation time (end of incubation). The algorithm can
determine what has grown on the plate between the first and the final image.
System images
Initial images and intermediate images are marked as system images as configured in
DB Manager. These images are not typically viewed by the user, will not be set to Ready for
Reading, and therefore will not appear in Culture Reading worklists. Marking these images as
system images helps to prevent a user from mistaking a culture with non-significant growth as
final.
In some cases, the technologist may deem it necessary to evaluate an intermediate image.
Although system images do not appear in reading worklists, it is possible to view system
images by searching for the culture and viewing the plate image in Culture Reading.
8.4 Viewing incubation progress

An image timeline for each plate can be viewed in the BD Synapsys™ Informatics Culture
Reading summary view and Culture Reading detail view. The image timeline shows incubation
start time, planned image intervals, image time points, growth indicator time, and discard time.
34
8 - Incubation and imaging
In the BD Synapsys™ Informatics Culture Reading detail view, the following actions can be
performed:
l Request immediate imaging of a plate.
l Request imaging of a plate at the end of the original program. The incubation time will be
extended if necessary.
l Request that a plate be imaged with the lid on for future imaging time points.
l Request that a plate be transported to a workstation or a Track Stacker.
l Discard a plate and send it to a Track Waste Stacker.
Workflow tips
l ReadA incubators should remain powered on at all times except during cleaning.
l If a ReadA is in an error condition, then scheduled images will not be taken during that time.
Users should regularly monitor the ReadA status on the BD Synapsys™ Informatics
dashboard and immediately respond to error conditions.
l Before putting plates for external incubation into Destackers, sort the plates based on the
required incubation environment. This will avoid the need to manually sort plates again after
they are transported to the External Incubation Stackers.
35
36
9 Culture Reading
Technologists can evaluate broth media or plate images for growth, record initial status, mark
colonies, measure AST inhibition zones, enter results, and order additional tests in
BD Synapsys™ Informatics.
When cultures are ready for evaluation, they are set to Ready for Reading. For cultures being
processed on the solution, Ready for Reading means that scheduled images have been taken
or that an image was requested. For cultures that are not being processed on the solution,
Ready for Reading means that the container has been incubated for the specified period of
time.
A technologist can choose from multiple workflows to access cultures that are Ready for
Reading, depending on the desired outcome. A culture can be viewed with or without the use
of a worklist in order to report results, mark the culture as read, or order tests.
37
38
10 Micro Workcard
The BD Synapsys™ Informatics Micro Workcard consolidates patient, specimen, order, and
result data from multiple instrument and LIS sources, providing patient history and clinical
context to make diagnostic decisions. It is intended to compliment workflow pages such as
Culture Reading where that detail might not be available in designs optimized for specific tasks
or high volume workflow operations.
Micro Workcard allows technologists to view:
l Detailed patient, specimen, and test information for the current specimen and culture.
Based on LIS capabilities, this information may include relevant test results from other
instruments and laboratory departments.
l Patient history of prior specimens and cultures
l Lists and history of reports sent to the LIS for the current culture
Technologists can review, enter, and report results; and add isolates and tests in Micro
Workcard.
To avoid the need to refer to external systems during culture reading in BD Synapsys™
Informatics, and the risk of patient data mismatch between systems, Micro Workcard is
designed to remain in bi-directional synchronization with the Culture Reading pages. As the
user selects a patient culture in Culture Reading, the same patient culture is recalled in Micro
Workcard. If the user selects a different patient culture, either manually or automatically from
the worklist workflow, Micro Workcard recalls the newly selected patient culture. Likewise, if
the user selects a different patient record in Micro Workcard, the Culture Reading page
updates to display the new patient information.
NOTE
Data remains synchronized between the pages. However, data entered or modified in
Culture Reading only appears in Micro Workcard after the user saves changes or marks a
specimen as read.
39
40
11 Culture workup on a connected workstation
Workup can be requested in the Culture Workup page in BD Synapsys™ Informatics. A plate
that needs workup is requested from ReadA through a BD Synapsys™ Informatics
workstation, and labels for the clean workup plates are printed on the workstation printer or on
a BarcodA Track. The workup plates from ReadA and the clean plates from BarcodA are sent
to a Track Stacker, and then manually transported to the workstation for scanning to view the
assigned workup. After workup has been completed, all plates are returned to Track using the
Track Destacker.
To perform workup from a workup worklist:
1. Select Cultures > Workup Worklists from the BD Synapsys™ Informatics primary
navigation menu.
NOTE
Worklists can be defined in BD Synapsys™ Informatics to support the
laboratory workflow.
2. Select the name or icon of the desired worklist to begin the workup workflow.
3. Select the number of incubated plates to request, select whether to receive all required
subculture plates, and select Go.
NOTE
If Subculture Plates Included is selected when requesting plates, both
clean and incubated plates will be requested at the same time.
4. Plates are transported to the Track Stacker assigned to the connected workstation. Track
does not allow incubated and clean plates to be mixed and will push out a stack if needed.
NOTES
Clean plates will be sent once the incubated workup plates are scanned on
Track. This is true for plates incubating in ReadA or in an external
incubator.
If the clean plate type is not available in the dedicated BarcodA upon Track
detecting the incubated workup plate, the request to BarcodA will be
rejected. The user will then need to scan the incubated workup plate into
BD Synapsys™ Informatics Culture Workup and select to either re-request
the clean plate type from BarcodA, or to print the label at the workstation
printer.
41
5. Retrieve the plates from the Track Stacker and carry them to the workstation.
WARNING
IF SUBCULTURE PLATES INCLUDED WAS SELECTED WHEN
REQUESTING PLATES, THE REQUESTED CLEAN PLATES FROM
BARCODA AND THE INCUBATED WORKUP PLATE FROM THE
READA OR EXTERNAL INCUBATOR MAY NOT BE DELIVERED IN
THE REQUESTED ORDER ON THE TRACK STACKERS. THE USER
MUST VERIFY THAT THE CLEAN PLATES FROM BARCODA MATCH
WITH THE WORKUP PLATE FROM THE READA OR EXTERNAL
INCUBATOR PRIOR TO PERFORMING THE WORKUP ACTIONS.
NOTE
If Subculture Plates Included was deselected when requesting plates,
incubated workup plates will be sent to the Track Stacker in the order in
which they are requested.
6. Scan a plate to confirm the assigned workup.
NOTES
If Subculture Plates Included was deselected when requesting workup
plates, the user may select where to print the barcode labels for the plates
needed for workup – either on a BarcodA Track or workstation printer.
Barcode labels printed on BarcodA Track will automatically be applied to
the plates needed for workup, and these plates may be retrieved from the
Track Stacker. Barcode labels printed at the workstation will need to be
manually applied to clean plates retrieved from an external source.
7. Perform the workup.

8. Select the Perform Workup indicator to mark that the workup has been performed.
9. Place the plates into the Track Destacker. Plates will be sent to ReadA to continue the
incubation program.
Alternatively, there are two options to request a specific plate for workup:
l From the Culture Workup worklists page, select the View Worklist icon for any worklist to
view a line list of the items in the worklist. Select a specific container ID from the list.
l From the Culture Workup page, enter the source container ID or scan the plate.
42
11 - Culture workup on a connected workstation
NOTES
Plates requested from a BarcodA are always processed by the same dedicated BarcodA.
Plates cannot be requested from a different BarcodA when there are two BarcodA
modules in the configuration.
Externally incubated plates marked for processing must be requested for workup in
BD Synapsys™ Informatics before placing the plates on Track.
Refer to the BD Synapsys™ Informatics Solution instructions for use for further details.
43
44
12 - Culture workup on an integrated ErgonomicA workstation
12 Culture workup on an integrated ErgonomicA

workstation
Workup can be requested in the Culture Workup page in BD Synapsys™ Informatics. A plate
that needs workup is requested from ReadA through a BD Synapsys™ Informatics
workstation, and labels for the clean workup plates are printed on the ErgonomicA workstation
printer or on a BarcodATrack. The workup plates from ReadA and the clean plates from
BarcodA are sent to an ErgonomicA Stacker and then retrieved from the ErgonomicA Stacker
pushout lane for scanning to view the assigned workup. After workup has been completed, all
plates are returned to Track using the ErgonomicA Destacker.
To perform workup from a workup worklist:
1. Select Cultures > Workup Worklists from the BD Synapsys™ Informatics primary
navigation menu.
NOTE
Worklists can be defined in BD Synapsys™ Informatics to support the
laboratory workflow.
2. Select the name or icon of the desired worklist to begin the workup workflow.
3. Select the number of incubated plates to request, select whether to receive all required
subculture plates, and select Go.
NOTE
If Subculture Plates Included is selected when requesting plates, both
clean and incubated plates will be requested at the same time.
4. Plates are transported to the ErgonomicA Stacker.
NOTES
Clean plates will be sent once the incubated workup plates are scanned on
Track. This is true for plates incubating in ReadA or in an external
incubator. The plates should arrive at about the same time at the
ErgonomicA Stackers.
If the clean plate type is not available in the designated BarcodA upon
Track detecting the incubated workup plate, the request to BarcodA will be
rejected. The user will then need to scan the incubated workup plate into
BD Synapsys™ Informatics Culture Workup and select to either re-request
the clean plate type from BarcodA, or to print the label at the workstation
printer.
45
5. Retrieve the plates from the ErgonomicA pushout lanes.
WARNING
IF SUBCULTURE PLATES INCLUDED WAS SELECTED WHEN
REQUESTING PLATES, THE REQUESTED CLEAN PLATES FROM
BARCODA AND THE INCUBATED WORKUP PLATE FROM THE
READA OR EXTERNAL INCUBATOR MAY NOT BE DELIVERED IN
THE REQUESTED ORDER ON THE ERGONOMICA STACKERS. THE
USER MUST VERIFY THAT THE CLEAN PLATES FROM BARCODA
MATCH WITH THE WORKUP PLATE FROM THE READA OR
EXTERNAL INCUBATOR PRIOR TO PERFORMING THE WORKUP
ACTIONS.
NOTE
If Subculture Plates Included was deselected when requesting plates,
incubated workup plates will be sent to the Track Stacker in the order in
which they are requested.
6. Scan a plate to confirm the assigned workup.
NOTES
If Subculture Plates Included was deselected when requesting workup
plates, the user may select where to print the barcode labels for the plates
needed for workup – either on a BarcodA Track or ErgonomicA workstation
printer.
Barcode labels printed on BarcodA Track will automatically be applied to
the plates needed for workup, and these plates may be retrieved from the
ErgonomicA pushout lanes on the ErgonomicA Stacker. Barcode labels
printed at the ErgonomicA workstation will need to be manually applied to
clean plates retrieved from an external source.
7. Perform the workup.

8. Select the Perform Workup indicator to mark that the workup has been performed.
9. Place the plates into the ErgonomicA Destacker. Plates will be sent to ReadA to continue
the incubation program.
Alternatively, there are two options to request a specific plate for workup:
l From the Culture Workup worklists page, select the View Worklist icon for any worklist to
view a line list of the items in the worklist. Select a specific container ID from the list.
l From the Culture Workup page, enter the source container ID or scan the plate.
46
12 - Culture workup on an integrated ErgonomicA workstation
NOTES
Plates requested from a BarcodA are always processed by the same dedicated BarcodA.
Plates cannot be requested from a different BarcodA when there are two BarcodA
modules in the configuration.
Externally incubated plates marked for processing must be requested for workup in
BD Synapsys™ Informatics before placing the plates on Track.
Refer to the BD Synapsys™ Informatics Solution instructions for use for further details.
47
48
13 Culture workup on IdentifA
MALDI test preparation workup can be automated using the BD Kiestra™ IdentifA by ordering
automated tests in BD Synapsys™ Informatics Culture Reading. When an automated test is
ordered, the plate is sent to the IdentifA Stacker, and manually transported to the IdentifA
Destacker. After the plate is processed on IdentifA, it is manually transported to the Track
Destacker.
NOTE
The IdentifA skill will be assigned to a ReadA Stacker by BD Technical Service.
To perform workup using a standalone IdentifA:

1. In BD Synapsys™ Informatics Culture Reading, colonies are marked and automated tests
are ordered for workup on IdentifA. See the BD Synapsys™ Informatics Solution
instructions for use for more information.
2. If the IdentifA module is started, plates with IdentifA tests ordered will be sent to the Track
IdentifA Stacker.
3. The plates must be manually transported from the Track IdentifA Stacker to the IdentifA
Destacker. See the BD Kiestra™ IdentifA instructions for use for more information.
4. After the plates have been processed on IdentifA, they will be sent to the Stacker on
IdentifA. The plates must be manually transported to the Track Destacker.
5. Externally incubated plates must be placed on Track for processing. External plates with
IdentifA tests ordered will be sent to the Track IdentifA Stacker.
49
50
14 - Positive blood culture workflows
14 Positive blood culture workflows

The following sections describe workflows for solutions comprised of BD BACTEC™ FX
instrument, BD Synapsys™ Informatics, and BD Kiestra™ solution. The BD BACTEC™ FX
instrument is used to process blood culture bottles. BD Synapsys™ Informatics is connected
to the BD BACTEC™ FX instrument and the BD Kiestra™ solution, allowing for integrated
blood culture workflows. These workflows are performed on positive blood culture bottles
initially processed in the BD BACTEC™ FX instrument.
Refer to the Blood culture section of the BD Synapsys™ Informatics instructions for use for
additional information about blood culture workflows.
14.1 Using rules to automatically order tests and subcultures for

positive BD BACTEC™ bottles
The BD Synapsys™ Informatics Rules system can be used to automatically order tests and
subcultures when a positive BD BACTEC™ bottle is encountered. For general instructions on
creating rules, refer to Adding a new rule in the BD Synapsys™ Informatics Solution
instructions for use.
To create a rule that automatically orders a reflex test, use the following criteria:
Trigger Event
BACTEC Consumable Order Updated
Criteria
Field Current/Original/Has Changed Operator Value
BACTEC bottle
Order
Current Equals protocols (select
Definition
all applicable)
Growth Result Has Changed Equals Yes
Growth Result Current Equals Positive
Action
Order Reflex Test
Action Parameters
Reflex Test to Order Create Isolate?*
Select a media protocol No
Select Add Action to add additional reflex tests.

See Order reflex test action in the BD Synapsys™ Informatics Solution instructions for use for
additional information about this functionality. A user can define a rule to automatically order
the same media protocols and tests for all positive BD BACTEC™ bottles. Alternatively, a user
can define different rules to automatically order different media protocols and tests for different
bottle types by selecting different Order Definition values (e.g., anaerobic protocols vs. aerobic
protocols), and different reflex tests to order.
51
14.2 Manually ordering tests and subcultures for a positive

BD BACTEC™ bottle
Individual tests or Test Groups can be manually ordered in Culture Reading and Micro
Workcard in BD Synapsys™ Informatics.
Ordering individual tests
To order individual tests in Culture Reading or Micro Workcard, see Ordering tests in Culture
Reading, and Micro Workcard in the BD Synapsys™ Informatics Solution instructions for use.
Ordering Test Groups
To order Test Groups in Culture Reading, a Test Group order definition containing the
appropriate media and test protocols must first be created and enabled in Media, Tests, and
Protocols. Refer to Definitions of order type test group in the BD Synapsys™ Informatics
Solution instructions for use.
Complete the New Definition fields as follows:
Definition Type
Order Type
Test Group
Basic Definition
Definition Name LIS Code Display Name Enabled
Free text Free text Free text Ensure this is selected
Detailed Definition
Tests
Select all media protocols and tests to include in the Test Group.
A user can define a Test Group to include the same media protocols and tests for all positive
BD BACTEC™ bottles. Alternatively, a user can define different Test Groups to include
different media protocols and tests for different bottle types (e.g., different Test Groups for
aerobic vs. anaerobic bottles).
To order the Test Group in Culture Reading or Micro Workcard, recall the appropriate culture,
follow the steps to order a test, and select the Test Group that was created.
14.3 Processing positive BD BACTEC™ bottles on BD Kiestra™

InoqulA
The user can choose to process positive blood cultures in FA or SA mode.
Processing positive blood cultures in FA mode
1. Remove the positive bottle from the BD BACTEC™ FX instrument.
2. If a reflex rule is enabled, proceed to next step. If not, order tests per 14.2 Manually
ordering tests and subcultures for a positive BD BACTEC™ bottle.
52
3. Remove the sequence number label from the bottle, and place the label onto a
BD Vacutainer® tube that meets the requirements for BD Kiestra™ InoqulA processing.
a. If the sequence number label needs to be reprinted, this can be done in Culture
Inoculation in BD Synapsys™ Informatics. Scan the accession number, and click
under each bottle.
4. Use a syringe needle to aliquot 3 mL from the BD BACTEC™ bottle into the labeled
BD Vacutainer® tube.
5. Place the tube into a configured rack on BD Kiestra™ InoqulA.
6. Ensure that the BarcodA module is loaded with the appropriate media.
7. If using BD Kiestra™ InoqulA to prepare a gram stain, ensure that the FA module slide rack
is filled.
8. Process the tube on BD Kiestra™ InoqulA.
Processing positive blood cultures in SA mode
3. Navigate to the Batch Prepare page in the InoqulA GUI.
4. Scan the bottle sequence number.
a. If the sequence number label needs to be reprinted, this can be done in Culture
Inoculation in BD Synapsys™ Informatics. Scan the accession number, and select
under each bottle.
5. Select Add Samples to Batch.
6. When the plates arrive at the SA module, scan the first bottle sequence number in the
batch.
The lids of the subculture plates are removed. If a slide was ordered, the slide is released
onto the slide heater, and a slide label is printed.
7. Using a vented needle, inoculate the plates at the LED position indicator.
8. If a slide was ordered, label and inoculate the slide.
NOTE
Direct AST disk diffusion plates can also be ordered and processed on
InoqulA by creating or editing an AST Zone test in Media, Tests, and
Protocols in BD Synapsys™ Informatics. Refer to Definitions of order type
AST zone in the BD Synapsys™ Informatics Solution instructions for use.
Ensure that the AST Direct Diffusion checkbox is selected.
14.4 Processing positive BD BACTEC™ bottles manually

To process positive blood cultures manually, use the BD Synapsys™ Informatics workstation
to print labels and perform workup in Culture Workup. Refer to Performing follow-up work in
the BD Synapsys™ Informatics Solution instructions for use for detailed information.
53

3. Navigate to Cultures > Workup.
4. Scan the bottle sequence number, print the labels, and perform the workup.
5. Select Perform Workup next to the appropriate tests to mark work as complete, or select
All Work Performed to mark all work as complete.
14.5 Creating a Culture Reading worklist

When subcultures of positive BD BACTEC™ bottles are ready for evaluation, they are set to a
status of Ready for Reading in BD Synapsys™ Informatics. An efficient way to access positive
blood cultures that are Ready for Reading is via a Culture Reading worklist. See Creating a
worklist in the BD Synapsys™ Informatics Solution instructions for use for general steps for
creating worklists. Users can customize worklists by adding additional criteria in the Worklist
Criteria section when creating the worklist.
Example using Child Order Definition as the criteria to include specific types of
bottles
Field Operator Value

Select the appropriate child order
Child Order Definition Equals definition(s) (e.g., BACTEC PEDS
Plus; BACTEC PEDS Plus/F)
Example using Order Definition as the criteria

Order Definition Equals Default Blood Culture Protocol
Example using Specimen Type as the criteria

Specimen Type Equals Blood
Example using Child Order Definition to view a Reading worklist that includes
subculture plates

Select the appropriate order
Child Order Definition definition(s) for the subculture plates
Equals
Name (e.g., M38_BloodSub_BAP; M38_
BloodSub_CDC)
54
14.6 Using 5 Day Rolling Final rules for reporting negative

BD BACTEC™ bottles
The 5 Day Rolling Final rule can be enabled in BD Synapsys™ Informatics to automatically
report negative bottles and send a final report to the LIS. Refer to Rules management in the
BD Synapsys™ Informatics Solution instructions for use for information about rules.
Navigate to > Rules to locate the following default rules under the BACTEC Consumable
Order Updated trigger event:
l 5 Day Rolling Final (Test): Enable this rule to send a test (bottle)-level report to the LIS.
l 5 Day Rolling Final (Culture): Enable this rule to send a culture-level report to the LIS.
14.7 Viewing BD BACTEC™ FX results

The growth status of a BD BACTEC™ bottle can be viewed in BD Synapsys™ Informatics in
the following locations:
l Micro Workcard
l Culture Reading
l BD BACTEC™ FX Instrument Status tile on the homepage dashboard
The growth status is indicated as one of the following:
l indicates no growth (negative)
l indicates growth (positive)
l indicates unspecified
l indicates a result that has been manually changed to no growth (negative)
l indicates a result that has been manually changed to growth (positive)
The growth status is Unspecified when the bottle is initially placed into the instrument. The
growth status will change to Positive if the instrument detects growth. The status will change to
Negative if no growth is detected when the incubation cycle is complete.
If the growth status is changed to Positive on the instrument, the status can be returned to
Unspecified by removing the bottle and subsequently returning it to the instrument as an
ongoing bottle.
55
56
15 Configuring the main database
The initial configuration is performed by BD associates during the installation of the solution.
Configuration changes can only be performed by trained key users in the DB Manager
application.
CAUTION
For proper operation, the data in the BDK database must match the data in the
BD Synapsys™ Informatics database.
Normally, data is synchronized automatically every night. Data can also be
synchronized with BD Synapsys™ Informatics using a synchronization step. See
File synchronization in the BD Synapsys™ Informatics Solution instructions for
use.
If synchronization steps are omitted, proper operation of the solution cannot be
guaranteed.
The following table lists the tabs in DB Manager where changes can be made by key users.
Tabs not listed in the table should not be used.
DB Manager tab Comments

Add, edit, or delete media. Media identified in DB Manager is
Media added to the BD Synapsys™ Informatics database during
synchronization.
Incubation Types Add, edit, or delete incubation types.
Add, edit, or delete analysis sets. Information in analysis sets is
added to the BD Synapsys™ Informatics database during
synchronization.
Analysis Set In BD Synapsys™ Informatics, analysis sets are used to define
media protocols, AST Zone, or Other protocols. Changes made to
settings in analysis sets or programs may affect settings in the
corresponding media protocol.
Add, edit, or delete programs. Only BD Kiestra™ Optis™ images
should be used. Images associated with BD Kiestra™ Imaging
Programs
Apps can be set to system images which do not trigger Ready for
Reading, but are visible in BD Synapsys™ Informatics.
Workstations Assign skills and external incubation types to Track Stackers.
57
15.1 DB Manager
The DB Manager application is used to configure the main database according to the user's
laboratory standards.
Starting DB Manager
1. Select DB Manager at the workstation.
2. Enter username and password, then select OK.
The main menu is displayed in the left panel of the main screen.
Entering general information

1. From the main menu, select Name.
2. Enter general information about your laboratory.
58
15 - Configuring the main database
15.2 Configuring media

1. From the main menu, select Media. The Media tab displays a list of all plated media and
broth tubes.
2. Select Add, or select a medium from the list and select Edit.
3. Enter the media code.

4. Enter or change the name.
5. Enter or change the description.
6. Select the medium from the drop-down menu.
7. Select Selective if appropriate.
8. Select Dish Tap to use the dish tap.
9. Enter or change the plate parameters.
10. Select OK. A new medium is defined and a medium ID is automatically assigned.
11. Synchronize with BD Synapsys™ Informatics using the manual refresh option. After
synchronization, the media code will display as the media name in BD Synapsys™
Informatics.
Delete media
1. Select a medium from the list.
2. Select Delete.
Deleted media can no longer be selected. Previous use remains visible in overviews.
Media production order tab
The media production order defines the order from right to left in which plates are presented to
the technician for manual inoculation. When multiple plates for multiple specimens have been
requested, the plates will be grouped by specimen, and not by medium type.
To change the order, select a medium type and then select Move Up or Move Down.
59
15.3 Configuring incubation types

1. From the main menu, select Incubation Types.
2. Select Add, or select an incubation type from the list and select Edit.
3. Enter or change the temperature in degrees Celsius.

4. Enter or change the atmosphere.
5. Enter a description. The field is automatically populated when temperature and
atmosphere are entered, but the description may be edited.
6. If the incubation type is external, select External Incubation.
7. Select OK.
To delete an incubation type:
1. Select an incubation type from the list.
2. Select Delete.
NOTE
A warning will display if you attempt to delete an incubation type that is
linked to a program. First edit the program to include a different incubation
step, then delete the incubation type.
60
15.4 Configuring analysis sets

1. From the main menu, select Analysis Set.
NOTE
Additional analysis sets, or changes made to analysis sets are
automatically synchronized with BD Synapsys™ Informatics.
See File synchronization in the BD Synapsys™ Informatics Solution
instructions for use.
2. Select Add or select an analysis set from the list and select Edit.
3. When adding a new analysis set, enter the code. This code populates as the LIS code for
the media protocol in BD Synapsys™ Informatics. The code should be unique, and should
contain the media type, incubation type, and incubation time for easy recognition; e.g.,
BAP_35C_CO2_2D. A maximum of 20 characters is allowed.
When editing an analysis set, the code cannot be changed. The code field will be grayed
out.
4. Enter or change the description. The description provides additional detailed information
about the analysis set.
5. Select a container type from the drop-down menu. Container type options are pre-defined
during the database installation and may vary depending on your database. If container
type Slide is selected, the Re-aspiration Volume field becomes active. Use this field to
select the required volume to re-aspirate after inoculation of a slide.
6. Select the analysis type. Analysis type options are pre-defined during the database
installation and may vary depending on your database. If analysis type Sensitivity is
selected, the Tablet Template field becomes active. Use this field to identify the tablet
template to be used.
When editing an analysis set, the analysis type cannot be changed. The analysis type field
will be grayed out.
7. The tablet template field is deprecated.
61
8. Select a spreading pattern. Spreading patterns are pre-defined during the database
installation.
9. Select the number of plate compartments ('1' for single compartment plate or '2' for
bi-plate).
10. Select the media.
11. Select the inoculum volume. The default value is 10 µL.
12. Select a program from the drop-down list or select Edit Program to create or edit
programs.
13. Select OK.
14. Synchronize with BD Synapsys™ Informatics using the manual refresh option. After
synchronization, the Analysis Set description will display as the Media Protocol name in
BD Synapsys™ Informatics.
To delete an analysis set:
1. Select an analysis set from the list.
2. Select Delete.
15.5 Configuring programs

A program is a scheme of process steps and workflow conditions. Contact BD for assistance to
standardize and properly configure programs.
Process steps are pre-defined and are displayed on the left side of the window.
l Incubation steps are outlined in red.
l Imaging steps are outlined in blue.
l Destination (skill or workstation) steps are outlined in green.
l Vortex steps are displayed in light-blue.
Workflow conditions are also pre-defined and are displayed on the right side of the program
window.
62
15.6 Program execution

The first program step is executed when it is scanned for the first time after inoculation. When
the first program step is completed, the workflow conditions to the right of the process step are
evaluated starting from left to right.
l When a condition is evaluated as false, then the workflow condition to the right is evaluated.
l When a condition is evaluated as true, then there are two options:
o One of the next process steps is initiated.
o The process step that was completed is repeated.

The links between workflow conditions and process steps are represented by black lines.
When a process step or workflow condition is selected, the outgoing links turn red.
NOTE
After program changes, the analysis set must be synchronized with BD Synapsys™
Informatics.
15.7 Program templates

The solution has program templates that have been optimized to work with BD Synapsys™
Informatics. Users are encouraged to modify pre-defined templates to suit their needs.
1. From the program editor window, select Templates.
2. Select Load to load an existing program template.
3. Select Save to save the selected program as a program template.
15.8 Creating programs

If no pre-defined templates meet the users' needs, then new programs can be created.
1. From the main menu, select Programs.
2. From the program window, select Add.
3. Enter a program name.
4. Select Add > Add Process.
5. Select the process steps to include in the program.

6. Select OK.
63
Edit a program
1. From the main menu, select Programs.
2. Select a program from the list and select Edit to open the Program editor window.
3. Edit program steps and/or workflow conditions by double-clicking the icons.
4. Make the desired changes to the program.
Delete a program
1. Select a program from the list.
2. Select Delete.
15.9 Edit incubation step
1. Enter a description.
2. Select an incubation type from the drop-down menu.
3. Enter the incubation time. Use the arrows to increase or decrease the values.
4. Enter the margin. This is the time allowed to elapse between the end of plate incubation
and the image. The recommended value is one hour.
5. Enter the margin alert. The recommended value is 30 minutes.
6. Select OK.
NOTE
ReadA can be configured to ignore the margin. When the margin is ignored,
ReadA will take an image of the plate as soon as possible after the
incubation time has expired.
The incubation time, margin time, and the alert time settings are used to determine the plate
status. This is done according to the following algorithm:
l The amount of time (T) expired since the start of the inoculation is calculated.
l If T is less than {incubation time – margin time – alert time}, then the plate status is set to
Incubating.
l If T is between {incubation time – 2 * margin time} and {incubation time – margin time}, then
the plate status is set to Almost ready.
l If T is between {incubation time – margin time} and {incubation time}, then the plate status is
set to Output allowed.
64
l If T is between {incubation time} and {incubation time + alert time}, then the plate status is
set to Ready.
l If T is between {incubation time + alert time} and {incubation time + margin time}, then the
plate status is set to Almost too long.
l If T is more than {incubation time + margin time}, then the plate status is set to Too long.
The plate status is used in algorithms that calculate the priority of imaging plates.
15.10 Edit imaging step: BD Kiestra™ Optis™ images

When the imaging step is edited, the following screen displays:
l When the software locates an image linked to the imaging step, this image is displayed.
l When no BD Kiestra™ Optis™ images are linked to the imaging step, the text No Optis
available is displayed. In this case, collect one or more images before proceeding.
1. Make sure the program contains at least an incubation step followed by an imaging
step with classic settings.
2. Save the program.
3. Select the program in an analysis set, and select the Save Optis checkbox.
4. Create a test specimen, link one or more plates to the test specimen, and request one
or more images. This will result in BD Kiestra™ Optis™ images being taken. The plates
should represent the images you want to routinely evaluate in BD Synapsys™
Informatics.
5. Return to the Program Editor, load the program, and open the imaging step. The plate
images will be displayed.
When at least one image of a plate is displayed, use these images to verify that the currently
loaded image profile renders a useful image.
If the image does not meet the user's needs, then pre-defined image profiles may be selected.
1. To start, select Edit. A new screen opens showing the same image.
2. Select Show Presets. The image will be displayed using all pre-defined image profiles.
3. Select a preset from the Preset Catalog by selecting the image, and then selecting OK.
This profile will be used to display the image.
65
If none of the preset image profiles results in a suitable image, then a customized image profile
can be created.
1. Select Edit to open a screen in which the image profile settings can be modified.
2. Adjust the values listed to the left of the image to alter the image profile.
3. Use the Previous and Next arrows to switch to other images using the same program.
Verify the images of all plates rendered with the selected image profile settings.
4. Select OK.
Optionally, select Add to create multiple renderings of a BD Kiestra™ Optis™ image using
different image profiles. The order of the renderings can be changed using the small left- and
right arrows in the top of the screen after selecting a rendered image.
Images can be set to system images. System images in programs created for use with the
BD Kiestra™ Imaging Apps are read automatically by the apps and are visible in
BD Synapsys™ Informatics, but they do not automatically set the culture to Ready for Reading
unless specifically programmed by the user (e.g., by creating a rule).
NOTE
The BD Kiestra™ Imaging Apps require additional configuration in order to set up media
protocols for use with the BD Kiestra™ Imaging Apps. Contact BD for assistance.
1. Right-click the Image step in the program and select System Image. The imaging step will
indicate that the image has been set to System Image.
NOTE
The order in which images are displayed routinely in BD Synapsys™ Informatics will
match the order in which images are displayed when the image profiles are evaluated.
15.11 Edit destination step
1. Enter a description that indicates the destination.

2. Select Send to skill.
66
3. Select the appropriate skill or destination from the drop-down menu.

4. Select OK.
15.12 Edit vortex step
1. Enter a description of the vortex (shake) step.

2. Select the arrow keys to set the duration of specimen shaking to the desired number of
seconds.
3. Select the arrow keys to set the speed value to 2.
4. Select OK.
After defining all program steps, the program editor window will look similar to the following
example.
The program consists of a number of process steps with empty workflow conditions.
15.13 Add or edit workflow conditions

Add workflow condition
1. Select the process step.
2. Select Add > Add workflow.
3. Select the appropriate workflow condition or Ctrl-click to select multiple conditions at
once.
4. Select OK. The selected workflow conditions will be displayed to the right of the process
step.
67
Edit workflow condition

1. Select the workflow condition icon you wish to edit. The Edit workflow window displays.
2. Change the description.
3. Select a template from the drop-down menu.
4. Select OK.
5. Select on the edited workflow condition and drag it to the process step it needs to be linked
to when the condition is true.
6. Repeat the steps to edit all workflow conditions.
Delete process steps and workflow conditions
1. From the Program editor window, select the process step or workflow condition to be
deleted.
2. Select the red X in the menu bar.
15.14 Configuring the sample jar TLC

The sample jar TLC is a mechanism that can be used to link an analysis set that contains a
shaking step to a specimen group. The processing of a sample jar from the selected specimen
group will then start with this shaking step. Refer to the BD Synapsys™ Informatics Solution
instructions for use for further details on creating a specimen group.
Link a sample jar TLC to a specimen
1. From the main menu, select TLC.
2. In the TLC window, select the Sample Jar TLC tab.
3. Double-click the appropriate specimen jar.
4. Select the appropriate specimen group.
5. Select the analysis set that contains the shaking step.
Delete a sample jar TLC
1. From the main menu, select TLC.
2. In the TLC window, select the Sample Jar TLC tab.
3. Select a sample jar TLC from the list.
4. Select Delete.
15.15 Configuring Stackers

Plates are sorted on Stackers according to the Stacker configuration set in DB Manager. Skills
can be assigned to each Stacker, and external incubation types can be assigned to create an
External Incubation Stacker. See 7.6 Plate sorting in Stackers for a list of skills that can be
assigned to Stackers.
68
NOTES
Incubation type cannot be combined with skills on the same Stacker.
The Error and Undeliverable skills, and workstations are configured during installation,
and cannot be configured in DB Manager. To make changes, please contact BD.
To configure a Stacker:
1. On the Track workstation, navigate to a ReadA workstation and open the DB Manager
application.
2. In the left menu, select Workstations.
3. In the left pane, select the + to the left of Track to display the Track modules.
4. In the left pane, select a Stacker to configure:
l For Track Stackers, the first number is the location of the Stacker on the Track, starting
to the right of the Main Base. The second number is the column number on that
particular Stacker.
l ErgonomicA Stackers are denoted first by the ErgonomicA, and second by the Stacker
number.
NOTE
The ErgonomicA Stackers are pre-configured to avoid cross-contamination
and cannot be changed.
5. In the right pane, the Skills tab lists the skills that can be assigned, and the Incubation
Types tab lists the incubation types that can be assigned to create an External Incubation
Stacker.
6. Select the skills or incubation types to assign to the selected Stacker.
15.16 Example programs

The example programs described in the following paragraphs are available as templates, and
should be used as a basis for programs that suit user needs:
1. Start with one of the example program templates.
2. Add additional steps as necessary.
3. Modify the imaging steps to suit user needs.
Do not change the structure of the template program. Do not modify the conditions of the
template program.
69
15.16.1 Internal incubation
The internal incubation example program is used for normal incubation of plates in a ReadA.
An image is taken after one and two days of incubation.
Plate path for the internal incubation example program
1. The plate is stored in a ReadA for incubation for 24 h at 35 °C in an O2 atmosphere.
2. After 23 h of incubation (24 h - 60 minutes margin) the plate is marked as ready for
imaging. The actual time of imaging depends on the other tasks to be performed by the
ReadA, and the plate prioritization settings.
3. During the imaging step, four Optis images are taken.
4. The plate is returned to the incubator for an additional 24 h incubation.
5. A second imaging step is performed after 47 h (48 h - 60 minutes margin) incubation.
6. After the second imaging step, an incubate loop step is initiated. The plate is incubated for
6 hours, with a margin of 350 minutes (5 hours and 50 minutes). The conditions of this step
are evaluated every 10 minutes.
7. When the Dish too old condition is true, the plate is sent to the Waste Stacker. A plate is
considered too old after seven days. This value cannot be modified.
15.16.2 External incubation
The external incubation example program is used for incubation of plates in an external
incubator.
70
Plate path for the external incubation example program

1. The plate is transported to the External Incubation Stacker that is assigned to the
appropriate incubation type for this program.
2. The technician takes the plate from the External Incubation Stacker and incubates the
plate in an external incubator.
3. After the incubation period (minus the margin) the technician places the plate into a Track
Destacker.
4. The plate is scanned. If the incubation has not yet finished, Track displays a warning and
the plate is routed to the External Incubation Stacker.
5. If the incubation is finished, the plate is transported to the camera compartment of the
appropriate ReadA.
6. During the imaging step, one SHQI image is taken.
7. The plate is returned to the External Incubation Stacker, and then manually returned to the
external incubator.
8. Every time the plate is manually placed on Track, the conditions of the incubate loop step
are evaluated.
9. When the Dish too old condition is true, the plate is sent to the Waste Stacker. A plate is
considered too old after seven days. This value cannot be modified.
NOTE
It is possible to separate externally incubated plates after the first
incubation period from the second incubation period by creating two
incubation environments in DB Manager; for example anaerobic day 1 and
anaerobic day 2. In the configured program, the incubation environments
must be linked to the corresponding incubation steps. On Track, the
different incubation environments must be linked to an individual Stacker.
15.16.3 Destination step
A program may start with a destination step to enable the user to perform a manual action on
the plate before the plate is incubated, for example adding antibiotic disks to the plate. A
destination step can also be added directly after an image step.
71
Plate path for the destination step

1. The plate is inoculated and the barcode is scanned immediately after inoculation. This
initiates the program.
2. The plate is transported to the Stacker identified as Stacker1, and retrieved by the
technician. In a solution with an integrated ErgonomicA, plate is retrieved from the
inoculated/incubated Stacker.
3. The technician performs the required actions, and places the plate into the Track
Destacker or the ErgonomicA Destacker.
4. The plate is scanned, and transported to a ReadA for 18 hours incubation.
15.16.4 Program structure considerations

l An incubation step followed by an image step can be repeated multiple times.
l The minimal incubation time is one hour and depends on the maximum throughput of the
ReadA.
l Each loop step should use the template created for that specific condition.
l Use of the SQL query option is not allowed.
15.17 Log files

Log files are maintained in BD Synapsys™ Informatics. See Logs and activity tracking in the
BD Synapsys™ Informatics Solution instructions for use.
72
16 Glossary
B
BD Kiestra™ ErgonomicA
BD Kiestra™ ergonomically designed and height-adjustable workbench module intended to be
used in clinical laboratories.
BD Kiestra™ InoqulA/BD Kiestra™ InoqulA Track

BD Kiestra™ in vitro diagnostic module used to automate specimen processing according to
user-defined procedures and protocols. The BD Kiestra™ InoqulA Track can be physically
connected to the BD Kiestra™ Track.
BD Kiestra™ ReadA
BD Kiestra™ in-vitro diagnostic module used to incubate plates and create images of plates,
and is intended to be used in clinical laboratories.
BD Kiestra™ Track
BD Kiestra™ module that provides transportation of plated media between various modules
within BD Kiestra™ Laboratory Automation Solutions, and is intended to be used in clinical
laboratories.
BD Synapsys™ Informatics Solution

Laboratory software solution providing data and workflow management functionality across
locations where clinical diagnostic activities take place
BDK
BD Kiestra™ database
C
Connected modules
Modules are not physically connected, but are digitally connected so that the identity of plates
is known to a Track solution.
Container
A receptacle for holding culture or testing material, for example, an agar plate, broth tube, or
slide
Culture protocol
The collection of tests performed on a specimen, based on a physician order downloaded from
the LIS
73
D
Digital Reading Workstation
Workstation designed for reading images of plates. Includes PC, two monitors, label printer,
keyboard, mouse, and barcode scanner.
F
Fully automated (FA) processing
Inoculation and inoculum spreading onto plates is automated.
G
GUI
Graphical User Interface. A type of software display screen that allows users to interact with
electronic devices through icons and visual indicators.
I
IDM
Identity Management user authentication software
Incubation program
The incubation and imaging steps for a particular medium
Instructions for use

Refers to product instructions in printable form (e.g., user's manual PDF) or digital (e.g., online
help).
Integrated modules
Modules are physically connected to a Track solution, allowing plates to automatically move
from one module to another.
L
LIS
Laboratory Information System. Software that tracks patient and associated test order and
result data for clinical laboratories. Depending on its configuration, the LIS can query and be
queried, and data can be downloaded from it and uploaded to it.
M
Media protocol
A medium and its associated incubation and imaging program
74
16 - Glossary
Mobile incubator
An incubator for temporary storage of inoculated plates during transport from a satellite lab to
the main lab
P
PLC
Programmable Logic Controller
S
Sample
A specimen that has been prepared for diagnostic testing
Semi-automated (SA) processing

Inoculation is performed manually and inoculum spreading onto plates is automated.
Skill
A destination or condition assigned to a Stacker
Specimen
Biological material obtained from a patient for the purposes of a diagnostic test
SPM
Slide Processing Module
T
TLA
Total Lab Automation
TLC
Test Laboratory Code
U
UPS
Uninterruptible Power Supply
USB
Universal Serial Bus
W
WCA
Work Cell Automation
75
Workstation
Combination of a workbench or ErgonomicA and a Digital Reading Workstation
76
17 Contacts
Becton, Dickinson and Company Monte Pelvoux 111 • 9th Floor
7 Loveton Circle Col. Lomas de Chapultepec
Sparks, Maryland 21152 USA 11000 Mexico D.F.
Voice: 1-800-638-8663 Voice: 52 5 237 1200 • Fax: 52 5 237 1287
Mail: Technical.Services@bd.com
bd.com 11 Rue Aristide Bergès BP4
38800 Le Pont de Claix France
BD Kiestra B.V. Voice: 33 476 68 36 36 • Fax: 33 476 68 34 95
Marconilaan 6
9207 JC Drachten, The Netherlands Rua Alexandre Dumas 1976
Voice: +31 (0)512 540 623 04717-004 Sao Paulo, S.P. Brazil
Mail: Lab_Automation_phone_support@bd.com Voice: (55) 11 5459833 • Fax: (55) 11 2478644
BD Switzerland Sàrl 30 Tuas Avenue 2

Route de Crassier 17 Singapore 639461
Business Park Terre-Bonne Voice: (65) 8610633 • Fax: (65) 8601590
Bâtiment A4
1262 Eysins
Switzerland
Becton Dickinson Distribution Center NV

Laagstraat 57
9140 Temse, Belgium
Becton Dickinson AG
Binningerstrasse 94
4123 Allschwil
Switzerland
Australian and New Zealand Sponsors:

Becton Dickinson Pty Ltd.
66 Waterloo Road
Macquarie Park NSW 2113
Australia
Customer Service: 1800 656 100
Technical Service: 1800 804 094
Becton Dickinson Limited

14B George Bourke Drive
Mt. Wellington Auckland 1060
New Zealand
Customer Service: 0800 572 468
Technical Service: 0800 445 392
2100 Derry Road West

Suite 100
Mississauga, ON
Canada L5N 0B3
Voice: 866-979-9408 • Fax: 800-565-0897
Akasaka DS Building
5-26 Akasaka 8-chome
Minato-ku, Tokyo 107-0052
Japan
Voice: (81) 3 54138181 • Fax: (81) 3 54138144
77
78
18 - Index
18 Index
B
Blood culture 51
C
Contacts 77
Conventions 5
Culture Reading 37
Culture workup
connected workstation 41
IdentifA 49
integrated ErgonomicA workstation 45
D
DB Manager 57-58
analysis sets 61
configure programs 62
create programs 63
example programs 69
incubation types 60
media 59
Depiction of patient information 6
I
Imaging Apps 34
Incubation and imaging 33
external incubator 33
ReadA 33
Inoculation 15
79
M
Media configuration 13
Micro Workcard 39
P
Plate transport 23
S
Specimen management 9
U
User management 11
80

Kiestra™ Solution: User's Manual

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Kiestra™ Solution: User's Manual

Uploaded by

Copyright:

Available Formats

Kiestra™ Solution

Revision Date Change Summary

1 Instructions for use guidance 5

7.18 Positive waste 32

1.1 Customer release notes

1.3 Notes, cautions, and warnings

1.4 Depiction of patient information

2.1 Intended use

2.2 Solution workflows

2.3 Integrated vs. connected modules

Informatics as soon as the information is available in the LIS.

5.1 Configuration in DB Manager

5.2 Configuration in BarcodA

6.1 Manual inoculation at a connected workstation

3. Retrieve the plates from the Track Stacker.

7. Process inoculated broth tubes and slides manually.

6.2 Manual inoculation at an integrated ErgonomicA workstation

7. Process inoculated broth tubes and slides manually.

6.3 Manual inoculation at a satellite laboratory

6.4 Fully automated (FA) inoculation on a connected InoqulA+™

6.5 Semi-automated (SA) inoculation on a connected InoqulA+™

6.6 Fully automated (FA) inoculation on a connected InoqulA

6.7 Semi-automated (SA) inoculation on a connected InoqulA

6.8 Fully automated (FA) inoculation on an InoqulA Track

6.9 Semi-automated (SA) inoculation on an InoqulA Track

7.1 Adding plates

7.3 Incubation in a ReadA

7.4 Incubation in an external incubator

7.5 Load balancing

7.6 Plate sorting in Stackers

7.7 Plate sorting in ErgonomicA Stackers

ErgonomicA Left configuration:

7.8 Plate sorting with a single ReadA

7.9 Error plates

Error due to unreadable, damaged, or missing label

7.10 Clear & Sync plates from a connected InoqulA+™

7.11 Error plates from InoqulA

7.12 Undeliverable plates

7.13 Empty ReadA for cleaning

2. Send plates to the Cleaning Stacker.

7.14 Connected workstations

Each workstation can be assigned to a specific Stacker, or multiple workstations can be

l It is advised to turn off the Subculture Plates Included option in BD Synapsys™

7.15 Integrated ErgonomicA workstations

Push single plate

7.16 External incubation

7.17 Waste plates

7.18 Positive waste

7.19 Discarded plates / Custom Waste

8.1 Incubation and imaging in a ReadA

8.2 Incubation and imaging in an external incubator

4. Manually track the incubation and imaging schedules.

l If additional incubation is required, the plate is transported to a Track External Incubation

8.3 Evaluating cultures using BD Kiestra™ Imaging Apps

8.4 Viewing incubation progress

6. Scan a plate to confirm the assigned workup.

7. Perform the workup.

12 Culture workup on an integrated ErgonomicA

4. Plates are transported to the ErgonomicA Stacker.

5. Retrieve the plates from the ErgonomicA pushout lanes.

6. Scan a plate to confirm the assigned workup.

7. Perform the workup.

To perform workup using a standalone IdentifA: