How Culture Media Can Deliver Value to Your Lab · 2020-03-24 · your risk profile from you old...
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1 How Culture Media Can Deliver Value to Your Lab March 16, 2020
Transcript of How Culture Media Can Deliver Value to Your Lab · 2020-03-24 · your risk profile from you old...
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How Culture Media Can Deliver Value to Your Lab March 16, 2020
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Nathan A Ledeboer Professor of Pathology and Vice Chair
Department of Pathology Medical College of Wisconsin
Medical Director, Microbiology and Molecular
Pathology Wisconsin Diagnostic Laboratories and
Froedtert Health
Medical Director, Client Services, Reference Services,
and Specimen Processing Wisconsin Diagnostic Laboratories
Milwaukee, WI
Nathan A. Ledeboer, PhD Clinical Speaker
Presenter
Presentation Notes
The technical portion will be delivered by Dr. NAL, PhD. He is…
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Technology and the Microbiology Lab
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Laboratory Section
Market Size
Year over Year Growth
Immunoassays $17.5 B ~6% Point of Care $15.4 B ~8%
Chemistry $7.7 B ~6% Molecular $7.2 B ~11%
Hematology $5.8 B ~2% Microbiology $3.4 B ~6%
Molecular is growing but so too is culture
5 Do not copy, not for distribution
AST Format Changes 2014 2020 2025
Dilution + + + Diffusion ++ ++ + E-strips + + + Automated Instrument +++++ +++++ ++++
Molecular + + +
ID Format Changes 2014 2020 2025
Manual + + + Biochemical ++++ ++ + Mass Spec +++ ++++ ++++ Molecular + + ++
Average percent of specimens using that particular technology scale: 0-15 +, 16-30 ++, 31-45 +++, 46-60 ++++, 61-75 +++++
Projected ID and AST Format Changes Through 2025
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Media in Susceptibility Testing
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Essential AGREEMENT and CATEGORICAL
AGREEMENT for Colistin* MICS
Matuschek et al. 2018. CMI. 24:865-870
*For Research Use Only. Not for diagnostic use
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TigeCycline and the Penems
Rechenchoski DZ et al. 2017. BJM. 509-514
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New Drugs and Media – One Extreme EXample
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Media and the Future
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Ideal results can be obtained when automation and media are paired
Partnering with your vendor and optimizing your media with your instrumentation is essential to automation success and can lead to gains in economic and clinical value • Redeploy skilled personnel for optimal productivity-
throughput capacity matches 2-3 FTE
When introducing a new dish into your automation system adjustments to the equipment are necessary to optimize functionality
Media is critical to automation
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How Automation can improve how we use media
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AI, Image Differential and Colonies
Presenter
Presentation Notes
HSV Color Space, where H (Hue) represents the Type of color, S (Saturation) represents the Intensity of the color and V (Value) represents the Brightness of the color. The “bubble” is the visual representation of the threshold volume in this three-dimensional space.
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Discrepant analysis of Manual Negative/Automation Positive Plates
Discrepant Category
MN/APa
Automation Positive 2nd
Manual Positive
Residual Matrix/Yeas
t Borderline Colors
Total number of plates
10,348 499 8,234 1,616
Colorex VRE 8996 432 7684 881
Remel VRE 1352 67 550 735
a Manual Negative/Automation Positive
Faron et al. 2016
Media Matters to All!
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• 486 vaginal/rectal swabs
• All swabs were initially incubated in LIM for 18-24h at 35-37 degrees C
• Compared WASPLab segregation software to CLS read and BD MAX
• Chromogenic Strepto B agar w/AI Enhanced Image Analysis:
• detected 6 additional positive cultures that were missed by technologist manual digital image culture reading
• was equivalent in sensitivity to molecular detection
Tim
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Total Positive
True Positive
False Positive
False Negative
True Negative
Sensitivity Specificity PPPV NPV
Tech Read 86 84 2 10 390 89.36% 99.49% 97.67% 97.50%
Software Read
221 90 131 4 261 95.74% 66.58% 40.72% 98.49%
BD MAX 94 90 4 4 388 95.74% 98.98% 95.74% 98.98%
AI Can improve the sensitivity of culture
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Transitioning Media Vendors
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What are the key steps to a successful lab conversion?
1. Prepare your laboratory
1. Recognize impact of and involve the lab techs in the upcoming change
2. Validation procedures & Techniques
3. Check ordering systems
2. Train your staff
1. Colonies/hemolysis presentation differences in media
2. Conduct broad Verification study
My Lab Has Decided to Switch Vendors, What do I do now?
Presenter
Presentation Notes
Does not require extra time to be left at room temperature or outside of cellophane bag to “dry”. Does not require extra time to be left at room temperature or outside of cellophane bag to “dry”. Media comes ready to use. It is less moist therefore does not require curing time at room temperature or outside of cellophane bag to “dry”. While awaiting use media should be kept in cellophane bag until ready. If need to store out of cellophane bag for large quantity usage/automation, recommend cellophane bag removed 4-5 hours prior to use and stored away from airflow in a space that has around 40% humidity. Visual representation of organisms may present differently on our media versus your current media. Variations in color Variations in colony formations
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What are the key steps to a successful lab conversion?
1. Know what to expect with new media
1. Evaluation & Validation
2. Media differences
3. Proper handling and storage
4. Adjustments for automation
My Lab Has Decided to Switch Vendors, What do I do now?
Presenter
Presentation Notes
Does not require extra time to be left at room temperature or outside of cellophane bag to “dry”. Does not require extra time to be left at room temperature or outside of cellophane bag to “dry”. Media comes ready to use. It is less moist therefore does not require curing time at room temperature or outside of cellophane bag to “dry”. While awaiting use media should be kept in cellophane bag until ready. If need to store out of cellophane bag for large quantity usage/automation, recommend cellophane bag removed 4-5 hours prior to use and stored away from airflow in a space that has around 40% humidity. Visual representation of organisms may present differently on our media versus your current media. Variations in color Variations in colony formations
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• Plate formulation can have a significant impact on the hemolysis that you expect
• Users may see less dramatic effect, but that does not interfere with results or workflow
• Consequently, the ability to do follow up testing on discrete colonies could be improved
Hemolysis
Evaluation Expectations
Presenter
Presentation Notes
An accurate 5% RBC concentration results in greater growth and colony size
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Streptococcus pyogenes ATCC 19614 Thermo Scientific: flat gray, looks like water droplet
BD: small, round, whitish clear
Streptococcus pneumoniae ATCC 49619 Thermo Scientific: watery, alpha BD: growth of S. pneumo.
Shared with permission from Poudre Valley Hospital, BD to Remel media comparison tests
Evaluation Expectations
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Escherichia coli ATCC 25922 Remel: round, demarcated edges, isolated colonies
BD: Spready, fried egg appearance
E. coli lactose fermenter patient Remel: Heavy growth BD: Scant or “light” growth
Shared with permission from Poudre Valley Hospital, BD to Remel media comparison tests
Evaluation Expectations
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While validation is not always needed, think IQCP. You’ll need to reflect on your risk profile from you old vendor to your new vendor to ensure you’re prepared for any inspections.
Media validation
Presenter
Presentation Notes
You may also want to check with your accrediting body on the requirements to be prepared for any inspections.
The world leader in serving science
Brittney Bunn, PhD. 16 March 20
How Cultural Media Can Deliver Value To Your Lab
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Technical support specialist
Dr. Brittney M. Bunn obtained her Ph. D. in chemistry from Case Western Reserve University. She currently serves as a Service Support supervisor for Thermo Fisher Scientific and has held other roles in the Technical Service department during her tenure of four years.
Dr. Brittney M. Bunn, PhD.
Presenter
Presentation Notes
The technical portion will be delivered by Dr. Brittney Bunn of Thermo Fisher. Brittney has been with Thermo Fisher for 4 years now and is currently the supervisor of service support in Oakwood Village, OH. Brittney will walk you through the conversion process provide some helpful insights into making the transition an easy an simple procedure.
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Simple Conversion Steps to Remel Media
1. 2.
3. 4.
Onboarding Inventory
Worksheet
Cross Reference
List
Validate (If required)
Conversion Completed
Preparation Implementation
Provide your Thermo Fisher Account Manager with a list of your annual media usage.
Equivalent part numbers and descriptions and will submit your usage information to our planning department.
Free of Charge Validation Media Pack will be shipped containing the media you have selected.
Technical support will provide assistance and confirm successful validation. Your regular shipment date will be confirmed.
Presenter
Presentation Notes
Converting to Remel media is actually a very simple process. In this slide I will walk you through the steps of a successful media conversion, which can be broken down into two main categories - preparation and implementation. Preparation includes 2 steps. Step 1. is to provide your Thermo Fisher account manager with a list of your annual media usage. In Step 2. we will use that information to determine equivalent part numbers within Thermo Fisher Scientific’s portfolio and submit your usage information to our planning department so that we can ensure that we meet your needs. We will share the cross reference information with a contact in your laboratory so that you can easily reference this information to place future orders. Once we’ve partnered to complete the preparation steps, we’ll move to implementation, which starts with step 3 of the overall conversion process: Step 3 is validation. A free of charge validation media pack can be shipped to your laboratory upon request. Some users may require this and some may not; we encourage you to contact the regulatory department within your institution to determine if this is something that you need. Lastly, Step 4 is to contact our technical support team to confirm your successful validation, if one was necessary, and to confirm your regular shipment date.
The world leader in serving science
Ordering
Presenter
Presentation Notes
Now that we have discussed the process of a successful conversion to Remel media, let’s talk about how to order the products that enable us to make the world healthier, cleaner, and safer.
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Ordering process – Direct from the Thermo Fisher Scientific
How to place your order
csemail @
thermofisher.com
1-800-255-6730 Option 1
What to include in your order When you’ll receive your order
Submit Product Information
Orders received by 2:00 P.M. (Central
Standard Time) Monday through
Thursday
NEXT DAY DELIVERY
Thermo Fisher Part Number
Thermo Fisher Product Description
Thermo Fisher Pack Size
R01202 Blood Agar, 5% Sheep Blood
100/PK
R01302 Chocolate Agar
100/PK
1. 2. 3.
PHONE
Presenter
Presentation Notes
Some of you may order directly through Thermo Fisher, meaning that you do not utilize our channel partners like HMD and Cardinal. When ordering direct, we aim to make the process as efficient and convenient as possible. You can place your order in one of two ways– either by emailing us at (INSERT APPROPRIATE EMAIL ADDRESS) or calling 1-800-255-6730 Option 1 to speak with one of our customer service representatives. To make sure that your order processes seamlessly, we ask that you please include part numbers, product descriptions, and pack sizes. If your order is placed before 2:00 PM central standard time, you can anticipate to receive your materials the next day. We understand how important your work is, and we want to support your laboratory so that it has the supplies that it needs, when it needs it.
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What is the ordering process now that we‘ve converted?
No changes to your current ordering process!
Cardinal Health and Fisher Healthcare customers order processes will remain the same
ORDER CHANGES
Orders are dropped -shipped overnight to ensure our customers receive their orders as soon as possible
Presenter
Presentation Notes
If you were already ordering our products directly or through our channel partners, there will be no change to your current ordering process. If you have any questions or concerns regarding placing an order, please call customer service at 1-800-255-6730 Option 1 and one of our customer service representatives will be happy to assist. Please keep in mind that order cut-off time for channel partners is 2:00pm EST. And, for media being drop shipped, the potential for delivery time variance is possible given the changes regional differences.
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Managing Deliveries
Presenter
Presentation Notes
At this time I’ve given you lots of information about converting to our media and what to expect during the ordering process. But what should you do once your delivery arrives?
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Receiving your new media
Orientation
Keep in mind REMEL plated media are shipped media side up. You will have to rotate the plates 180 degrees to a right side up position before using
Documentation REMEL has provided a section on the packing list for the customer to record this inspection when the media is unpacked
Packing List The packing list provides the information required for quality control documentation
Inspection Laboratory personnel are responsible for inspecting media upon receipt and documenting the inspection
Presenter
Presentation Notes
When you receive your new media please perform a thorough inspection and be sure to document your findings. The packing slip that comes with your order will provide information required for quality control documentation. Remel has also provided a section directly on the packing list to record the results of your inspection for straightforward record-keeping. Keep in mind REMEL plated media are shipped media side up. You will have to rotate the plates 180 degrees to a right side up position before using
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Media Handling & Storage Guide
• Most media have 10-12 week shelf life from date of manufacture
• Prepared Media shipments are validated at ambient temperature so avoid drying by leaving out for extended periods of time
• Different manufacturing processes determine the moisture levels and result in wetter or dryer media
Maintaining Optimal Media Performance
Proper handling of your new media will ensure optimal performance
Presenter
Presentation Notes
As most of you are aware, proper media handling is vital to ensuring optimal performance. Our prepared media shipments are validated at ambient temperature but should be expedited to the laboratory upon receipt to ensure proper refrigeration. We recommend that you store the media in the original packaging with the media-filled side of the plate at the top. Dehydration of media can be minimized by avoiding direct air flow and incubating with the right amount of humidity. Incubating at a humidity of 70% or higher will not only help fight against media dehydration, but will ensure maximum growth and recovery of microorganisms as well. Please keep in mind, most media have a 10-12 week shelf life from the date of manufacture. For more tips and tricks regarding media best practices- refer to the Handling and Storage of Prepared Plate media document, which will be included in your welcome kit, or call our technical service team at 1-800-255-6730 Option 2.
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Technical Support
Presenter
Presentation Notes
When you choose Thermo Scientific products for your microbiology needs, consider it the start of a life-long partnership. Whether you need assistance with protocols, product transitions or troubleshooting, our best-in-class team of experts is ready to help you.
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Technical Support
• Dedicated member resources readily available to assist with protocols, product transitions, troubleshooting and IQCP resources
• You can reach us via: • Email: [email protected] • Phone: 1-800-255-6730 Option 2
• Best-in-class, multi-language support with unparalleled global reach
Our technical support team offers world class expertise at your demand
Microbiologists serving Microbiologists
Presenter
Presentation Notes
Our technical support team includes dedicated HPG member resources that can assist with topics ranging from troubleshooting to IQCP resources. Our team can be reached via email or phone, with the information displayed on your screen. And with that, I’d like to ask Dr. Ledeboer to join me for a question and answer period, Dr. Ledeboer? (Cut to questions)
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Questions
