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Reading and Follow-up Rules

Reader 1
Dry-Run February, Customer Run February
We have a total of three Readers, out of which 2 will also do follow-up work. Below you can find the responsibilities per Reader.

- Reader 1: Urines + Wound + Gyno + Nares + Body Fluid + Bone + Blood


- Reader 2: Stool + Follow-up work ErgonomicA 1
- Reader 3: Screening + Follow-up work ErgonomicA 2

User is on an connected workup bench, equipped with a bench top printer.

Expected workflow:
1. User is on an connected workup bench, equipped with a bench top printer.
2. User opens Reading screen in Synapsys
3. User selects a worklist.
a. Urines
b. Wound
c. Gyno
d. Nares
e. Body Fluid
f. Bone
g. Blood
4. Urines
a. Check if there is growth on any of the plates
i. When no growth is noticed on all plates and the incubation program is finished, then Reader can finalize
and discard sample. (negative urines should been auto reported, auto review screen can be checked
ii. When there is growth on the plate:
On the culture plate image, create a new isolate and mark colonies to be picked by clicking on the
image. It is recommended that the user zoom in when marking small colonies to ensure the picking is
accurate.   
1. At least 1 and up to 9 individual colonies can be selected to be picked by IdentifA. For best results,
mark 3 colonies if large or 9 colonies if small/medium to achieve a high enough turbidity (if
possible) to spot a single layer on the+ target plate.
2. Colonies that have already been picked by IdentifA will display as a black circle with a slash where
the colony markings were made.
3. As organism name fill in: (-) Gram - Bacteria. Order MALDI ID test (automated) and PHX (semi-
automated) + Purityplate (semi) test group for each isolate under the Test tab.
4. Click “Mark as Read” to save the test and isolate markings.
5. User repeats steps 1-4 on all plates that are ready for reading if ordering an automated test to be
processed on IdentifA.
5. Blood (all)
a. Check if there is growth on any of the plates
i. When there is no growth on the plate and the incubation program is finished, finish and discard sample.
1. Probably all positive because of positive bactec.
ii. When there is growth on the plate:
On the culture plate image, create a new isolate and mark colonies to be picked by clicking on the
image. It is recommended that the user zoom in when marking small colonies to ensure the picking is
accurate.   
1. At least 1 and up to 9 individual colonies can be selected to be picked by IdentifA. For best results,
mark 3 colonies if large or 9 colonies if small/medium to achieve a high enough turbidity ( if
possible) to spot a single layer on the target plate. 
2. Colonies that have already been picked by IdentifA will display as a black circle with a slash where
the colony markings were made.
3. As organism name fill in: (+) Gram + Bacteria. Order MALDI ID test (automated).
4. Click “Mark as Read” to save the test and isolate markings. 
5. User repeats steps 1-4 on all plates that are ready for reading if ordering an automated test to be
processed on IdentifA.
6. Wound
a. Check if there is growth on any of the plates
i. When there is no growth on the plate and the incubation program is finished, finish and discard sample .
ii. When there is growth on the plate:
On the culture plate image, create a new isolate and mark colonies to be picked by clicking on the
image. It is recommended that the user zooms in when marking small colonies to ensure the picking is
accurate.   
1. At least 1 and up to 9 individual colonies can be selected to be picked by IdentifA. For best results,
mark 3 colonies if large or 9 colonies if small/medium to achieve a high enough turbidity (if
possible) to spot a single layer on the target plate. 
2. Colonies that have already been picked by IdentifA will display as a black circle with a slash where
the colony markings were made.
3. As organism name fill in: (+) Gram + Bacteria. Order MALDI ID test (automated), Purityplate
(manual) + KB_GP (manual) test group, for each isolate under the Test tab.
4. Click “Mark as Read” to save the test and isolate markings.
5. User repeats steps 1-4 on all plates that are ready for reading if ordering an automated test to be
processed on IdentifA.
7. Gyno, Nares, Body Fluid and bone
a. Check if there is growth on any of the plates
i. When there is no growth on the plate and the incubation program is finished, finish and discard sample.
ii. When there is growth on the plate:
On the culture plate image, create a new isolate and mark colonies to be picked by clicking on the
image. It is recommended that the user zoom in when marking small colonies to ensure the picking is
accurate.   
1. At least 1 and up to 9 individual colonies can be selected to be picked by IdentifA. For bes t results,
mark 3 colonies if large or 9 colonies if small/medium to achieve a high enough turbidity (if
possible) to spot a single layer on the target plate. 
2. Colonies that have already been picked by IdentifA will display as a black circle with a slash where
the colony markings were made.
3. As organism name fill in: (+) Gram + Bacteria. Order MALDI ID test (automated)
4. Click “Mark as Read” to save the test and isolate markings.
5. User repeats steps 1-4 on all plates that are ready for reading if ordering an automated test to be
processed on IdentifA.
Expected Workflow Zone Reading:
1. User has a disk diffusion plate that is ready for reading in a pre-defined reading worklist in Synapsys.
2. Disk diffusion plate must have an organism identification populated for isolate to display disk diffusion
breakpoints.
3. User will read disk diffusion zones using the Zone Measurement Tool in Synapsys.
a. Zones are measured with the tool by placing the circular cursor over the perimeter of the disk and
dragging/expanding the circle to the area of growth inhibition

4. Each zone measured will populate into the Results table under Diameter.
5. The user will then select the interpretation based on the breakpoints that are displayed according to the specified
standard guidelines.

6. User then clicks OK and Save.


7. In Micro Workcard, the breakpoint interpretations will be displayed under the respective isolate.
Reading and Follow-up Rules
Reader 2
Dry-Run February, Customer Run February
We have a total of three Readers, out of which 2 will also do follow-up work. Below you can find the responsibilities per Reader.

- Reader 1: Urines + Wound + Gyno + Nares + Body Fluid + Bone + Blood


- Reader 2: Stool + Follow-up work ErgonomicA 1
- Reader 3: Screening + Follow-up work ErgonomicA 2

User is on an connected workup bench, equipped with a bench top printer.

Expected workflow Reading:


1. User is on an connected workup bench, equipped with a bench top printer.
2. User opens Reading screen in Synapsys
3. User selects a worklist.
a. Stool
4. Stool
a. Check if there is growth on any of the plates
i. When no growth is noticed on all plates and the incubation program is finished, then Reader can finalize
and discard sample.
ii. When there is growth on the plate:
On the culture plate image, create a new isolate and mark colonies to be picked by clicking on the
image. It is recommended that the user zoom in when marking small colonies to ensure the picking is
accurate.   
1. At least 1 and up to 9 individual colonies can be selected to be picked by IdentifA. For best results,
mark 3 colonies if large or 9 colonies if small/medium to achieve a high enough turbidity (if
possible) to spot a single layer on the target plate. 
2. Colonies that have already been picked by IdentifA will display as a black circle with a slash where
the colony markings were made.
3. As organism name fill in: (-) Gram - Bacteria. Order MALDI ID test (automated), PHX (manual) +
Purityplate (manual) test group, for each isolate under the Test tab.
4. Click “Mark as Read” to save the test and isolate markings.
5. User repeats steps 1-4 on all plates that are ready for reading if ordering an automated test to be
processed on IdentifA.
Expected workflow Follow up work:
1. User is on an integrated workup bench, equipped with a bench top printer.
2. User opens workup screen in Synapsys
3. Take cuvette arrays requiring further workup to Synapsys workstation and open Cuvette Array Workup under the ID/AST
tab.
4. Scan cuvette array barcode into Workup screen → Map of Cuvette array position with associated isolate and workup
information will appear and necessary labels will print out, or labele d media will arrive at workstation depending on system
configuration.
a. Barcode labels will only print out and plates will automatically be sent to a workstation upon scanning the cuvette
array if the toggle to “Request Plates and Print Labels” is enabled in the cuvette array workup screen. If the toggle
is not enabled, the user must manually request plates and print labels for each cuvette position.
Example of Cuvette Array Workup Screen with Toggle Enabled
3. Perform required workup for each cuvette position as directed and indicated. Click on “All Workup Performed”
when complete.
a. The user can choose to use an expired cuvette suspension for workups. See troubleshooting section for
further information.
4. Click Save & Close when all cuvette array workups have been performed.
Image 12: Cuvette Array Workup Screen with Pending Workup

Refer to Section 6.1.3 in BD Synapsys™ Informatics User’s Manual for more detailed instructions on the cuvette array workflow.
• Cuvette suspension expiration = 2 hours for Gram Negative/Gram Positive Organisms
• Cuvette suspension expiration = 1 hour for Streptococcus
o If follow-up tests are required, the user has 2 hours (or 1 hour for Strep) from start of processing to use the
cuvette suspension.
o If cuvette suspension does expire, the user can choose to set up the follow-up test manually, use the
expired suspension, or delete the test. This is done in the cuvette array workup screen.
• Cuvette suspension processing errors
o If suspension processing fails on IdentifA, the user will see a “processing error” when scanning cuvette
array in Synapsys. The suspension in the cuvette array cannot be used for AST tests. The user will need to re -
process or manually set up the test.
o In the case of a “turbidity too low” error, the suspension in the cuvette array cannot be used for AST tests.
The user will need to re-process or manually set up the test.
Expected workflow Follow up work:
1. User selects Phoenix AST worklist.
2. Worklist contains pending workup requests.
The worklist can contain, depending on the configuration a mix of internal and external incubated plates and plates which
are on a workbench, IdentifA etc. *Plates which are locked because they have been requested by another user or are at the
IdentifA cannot be requested.
3. User needs to check “Subculture Plates Included” for requesting workups to workbench:
a.

4. User will select a batch (5, 10, 15, all plates) and click “Go”.
a. Alternative: Also the user can request specific parent plates from the worklist. (1-N these are individually
requested).
b. The parent plates will be delivered to the users workbench “dirty” stacker in the same order and at approximately
the same time (within 1 minute) as the child plates on the “clean” stacker coming from the BarcodA.
i. External parent plates: These parent plates need to be taken from their external incubation environment
by the user and placed on Track at which moment the BarcodA will produce its associated child plate to
send to the “clean” stacker in parallel.
ii. Stacking and pushout criteria
1. Parent plates will stack on top of each other in the “dirty” stacker until they reach their max height
or user requests stacker push on Track UI.
2. Child plates will stack together per parent plate they are linked to and push out.
5. Open Reading screen in parallel with Workup screen to see plate image of isolates with associated tests. See specific use
cases for the different tests.
6. User performs necessary workups and subcultures on ordered isolates.
7. Check off each test as completed or all together in workup screen. (Subculture media placed back on track will
automatically check off “workup completed” for that specific test)
8. Place completed media back onto the de-stacker along with the associated subculture plates and click on the destacker
button.
9. User can then move on to next batch of workups to request to stackers.

Expected workflow First Inoculation:

1. User is on an integrated workbench and has a batch of 1 to N specimens to be processed simultaneously for primary manual
Inoculation. *Recommendation to limit request to 5 at a time to limit interruption of InoqulA processing
2. User opens Synapsys, navigates to the inoculation tab
3. User can scan or enter manually the accession number for each sample individually.
4. User turn off “Auto-Request Media”, using the toggle switch.
a. If this option is turned off the user will request the plated media per specimen and the labels during the
inoculation using with “Request all” option in the inoculation tab
Alternative 1: the user will request the plated media one by one per specimen that is on the screen at the mom ent.
Each of those individual media requests will be pushed out one at a time.
Alternative 2: the user will not request the media from the BarcodA, even though the integrated BarcodA has the
media configured and available, but print the label on the table printer.
5. Pre-labelled plates are produced in the same order as the specimens have been scanned or entered by the user into culture
inoculation on Synapsys, following the culture protocol.
6. The BarcodA will label the plated media and send them to the clean stacker of the integrated workbench, using Track
7. Plates arrive on the integrated clean stacker on his bench. Plates can be stacked in the following ways:
a. There is a push out per specimen.
b. If plates are requested individually, then each individual plate is pushed out one at a time.
8. All labels for slides and tubes (broths or inclined agar) expected for the primary inoculation are printed on the bench top
printer in same order how the specimens have been scanned or entered. Upon print the state of the broth and slides are
updated to “inoculated”
9. User starts the inoculation.
10. User scans or enters the accession number of the first specimen, and checks that all necessary media are present.
11. User proceeds with the inoculation at their workbench.
12. Plates are then placed back on the Track using the destacker function of the Integrated ErgonomicA. At that moment, the
state of the plate is updated to “Inoculated”.
13. Alternative Workflow: User needs to defect a media and request replacement
a. User can reprint labels for a plate, broth or slide on the benchtop printer.
b. User can defect media in the inoculation screen and a replacement labeled plate with a new container ID will be sent
from the BarcodA to the user’s workstation.
14. Incubation
After the inoculation the user places the plates in the destacker and the system will destack the plates once the button at
the destacker is pressed.
a. When the internal plates are entering the ReadA and scanned the plates should get the state Incubating and start
incubation time.
b. When external plates are stacked on the stacker which has been configured for that external incubation environment
the state changes to Incubating and the incubation time starts. When this option is selected all external plates need to go
on the track.

15. User places the inoculated broths and slides, respectively in the right incubators, or proceed t o slide staining
16. User collects the next batch of specimen and starts the processing
Reading and Follow-up Rules
Reader 3
Dry-Run February, Customer Run February
We have a total of three Readers, out of which 2 will also do follow-up work. Below you can find the responsibilities per Reader.

- Reader 1: Urines + Wound + Gyno + Nares + Body Fluid + Bone + Blood


- Reader 2: Stool + Follow-up work ErgonomicA 1
- Reader 3: Screening + Follow-up work ErgonomicA 2

User is on an connected workup bench, equipped with a bench top printer.

Expected workflow Reading:


1. User is on an connected workup bench, equipped with a bench top printer.
2. User opens Reading screen in Synapsys
3. User selects a worklist.
a. Screening
4. Screening MRSA + screening ESBL + screening VRE
a. Check if there is growth on any of the plates
i. When no growth is noticed on all plates and the incubation program is finished, then Reader can finalize
and discard sample. For MRSA the negatives are reported in a batch worklist, click on release and all
specimens are reported as negative and will be discarded.
ii. When there is growth on the plate:
On the culture plate image, create a new isolate and mark colonies to be picked by clicking on the
image. It is recommended that the user zoom in when marking small colonies to ensure the picking is
accurate.   
1. At least 1 and up to 9 individual colonies can be selected to be picked by IdentifA. For best results,
mark 3 colonies if large or 9 colonies if small/medium to achieve a high enough turbidity (if
possible) to spot a single layer on the target plate. 
2. Colonies that have already been picked by IdentifA will display as a black circle with a slash where
the colony markings were made.
6. As organism name fill in: (+) Gram + Bacteria. Order MALDI ID test (automated) and Purityplate
(manual) + KB_GP (manual) test group, for each isolate under the Test tab.
3. Click “Mark as Read” to save the test and isolate markings. 
4. User repeats steps 1-4 on all plates that are ready for reading if ordering an automated test to be
processed on IdentifA.
Expected Workflow Zone Reading:
1. User has a disk diffusion plate that is ready for reading in a pre-defined reading worklist in Synapsys.
2. Disk diffusion plate must have an organism identification populated for isolate to display disk diffusion
breakpoints.
3. User will read disk diffusion zones using the Zone Measurement Tool in Synapsys.
a. Zones are measured with the tool by placing the circular cursor over the perimeter of the disk and
dragging/expanding the circle to the area of growth inhibition

4. Each zone measured will populate into the Results table under Diameter.
5. The user will then select the interpretation based on the breakpoints that are displayed according to the specified
standard guidelines.

6. User then clicks OK and Save.


7. In Micro Workcard, the breakpoint interpretations will be displayed under the respective isolate.
Expected workflow Follow up work:
10. User selects Manual AST DD worklist.
11. Worklist contains pending workup requests.
The worklist can contain, depending on the configuration a mix of internal and external incubated plates and plates which
are on a workbench, IdentifA etc. *Plates which are locked because they have been requested by another user or are at the
IdentifA cannot be requested.
12. User needs to uncheck “Subculture Plates Included” for requesting workups to workbench:

a.
13. User will select a batch (5, 10, 15, all plates) and click “Go”.
a. Alternative: Also the user can request specific parent plates from the worklist. (1-N these are individually
requested).
i. Only parent plates will be delivered to the “dirty” stacker upon request.
1. These will push out after reaching max height or when requested on Track UI.
ii. Scan each delivered parent plate into the workup page.
iii. Request new “clean” media in workup list to be delivered to stacker. Will be delivered in order of
request.
1. Requested together: Pushed out in small batches of all child plates linked to a parent plate.
2. Requested Individually: Each child plate pushed out individually
14. Open Reading screen in parallel with Workup screen to see plate image of isolates with associated tests. See specific use
cases for the different tests.
15. User performs necessary workups and subcultures on ordered isolates.
16. Check off each test as completed or all together in workup screen. (Subculture media placed back on track will
automatically check off “workup completed” for that specific test)
17. Place completed media back onto the TMT-WCA de-stacker along with the associated subculture plates.
18. User can then move on to next batch of workups to request to stackers.

Expected workflow First Inoculation:

1. User is on an integrated workbench and has a batch of 1 to N specimens to be processed simultaneously for primary manual
Inoculation. *Recommendation to limit request to 5 at a time to limit interruption of InoqulA processing
2. User opens Synapsys, navigates to the inoculation tab
3. User can scan or enter manually the accession number for each sample individually.
4. User turn on “Auto-Request Media”, using the toggle switch.
a. If this option is turned on the BarcodA will automatically label the requested plated media and send them to Track.
Additionally, labels for tubes and slides will be printed out upon scanning at the workstation using the workbench
printer. Labels for plates, broths and sides are printed in the order of processing samples.
5. Pre-labelled plates are produced in the same order as the specimens have been scanned or entered by the user into culture
inoculation on Synapsys, following the culture protocol.
6. The BarcodA will label the plated media and send them to the clean stacker of the integrated workbench, using Track
7. Plates arrive on the integrated clean stacker on his bench. Plates can be stacked in the following ways:
a. There is a push out per specimen.
b. If plates are requested individually, then each individual plate is pushed out one at a time.
8. All labels for slides and tubes (broths or inclined agar) expected for the primary inoculation are printed on the bench top
printer in same order how the specimens have been scanned or entered. Upon print the state of the broth and slides are
updated to “inoculated”
9. User starts the inoculation.
10. User scans or enters the accession number of the first specimen, and checks that all necessary media are present.
11. User proceeds with the inoculation at their workbench.
12. Plates are then placed back on the Track using the destacker function of the Integrated ErgonomicA. At that moment, the
state of the plate is updated to “Inoculated”.
13. Alternative Workflow: User needs to defect a media and request replacement
a. User can reprint labels for a plate, broth or slide on the benchtop printer.
b. User can defect media in the inoculation screen and a replacement labeled plate with a new container ID will be sent
from the BarcodA to the user’s workstation.
14. Incubation
After the inoculation the user places the plates in the destacker and the system will destack the plates once the button at
the destacker is pressed.
b. When the internal plates are entering the ReadA and scanned the plates should get the state Incubating and start
incubation time.
c. When external plates are stacked on the stacker which has been configured for that external incubation environment
the state changes to Incubating and the incubation time starts. When this option is selected all external plates need to go
on the track.

15. User places the inoculated broths and slides, respectively in the right incubators, or proceed to slide staining
16. User collects the next batch of specimen and starts the processing

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