The Regional and National Courier & Logistics Network Best Practices in Specimen Collection, Packaging, and Transport Robin Hooker Director, Healthcare Marketing Daniel Weaver Regional Logistics Manager - Americas
The Regional and National Courier & Logistics Network Best Practices in Specimen Collection, Packaging, and Transport
Robin Hooker Director, Healthcare Marketing
Daniel Weaver Regional Logistics Manager - Americas
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Complexity
Disruptive forces are driving changes
The business need to improve
efficiency
The clinical need to maintain
specimen integrity
Specimen Logistics
Agenda
! Intros
! Covance Background
! Specimen Logistics Pain
Points and Strategies
Confidential
Covance contributed to the development of the top 50 prescription medicines on the market today
Over $200B in sales
Confidential
Maximize your development flexibility through our experience
Global Experience by Therapeutic Area
4,458 protocols
92 countries
141,522 sites
1,374,767 patients
COVANCE EXPERIENCE
*Data source: 2011-2015 Covance CLS internal metrics
Maximize your development flexibility through our experience
ONCOLOGY 1266 Studies
CNS 820 Studies
IMMUNE SYSTEM 882 Studies
ENDOCRINE/METABOLIC 692 Studies
DERMATOLOGY 601 Studies
INFECTIOUS DISEASES 525 Studies
GASTROINTESTINAL 532 Studies
RESPIRATORY 387 Studies
HEMATOLOGY 399 Studies
PATHOLOGICAL 233 Studies
CARDIOVASCULAR 299 Studies
OPHTHALMOLOGY 124 Studies
MUSCULOSKELETAL 358 Studies
GENITAL / URINARY 261 Studies
Confidential
>99.8% Globally
*Data based on internal metrics, 2015 Logistics Service Level
Europe (Geneva) 99.9% Asia Pac
(Singapore) 99.8%
Americas (Indianapolis) 99.8%
Covance Global Logistic Metrics (Courier performance level in 2015)
Customers can count on our ability to deliver: Over 2 million shipments to and from 85 countries each year.
Confidential
Contingency Planning: Data you can depend on
9 CONFIDENTIAL
Earthquakes Japan Earthquake / Tsunami
>99% within stability
Severe storms Hurricane Katrina Superstorm Sandy
COVANCE CLS HELPS YOU MANAGE THE EXCEPTIONS
Volcanic ash clouds Icelandic Ash Cloud 2010
>99% within stability
>92% within stability
Confidential
The Superstorm Sandy Challenge:
Logistics Partnerships >25 Dedicated Personnel Site Support
Proactive Planning
Visit schedule management Shipment diversions to safe storage locations
Storm Alert
Pickup prioritization for Covance packages Dry ice replenishment Movement to holding locations
During the Crisis
Resumption of visits Delivery of stored samples to ref labs Continuous monitoring during recovery
Regional Recovery
>99.2% of kits received at Covance CLS within stability. No lost shipments to referral labs.
>$7Million Shipments
safeguarded
Turn Around Time Packaging
Lean Strategies
Visibility
Parcel & Couriers Contingency Planning
Specimen Stability
Lab Site Selection
Specimen Logistics
Got Clinician Issues?
Specimen Collection Errors
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• Where possible pre-label boxes and complete the documents as much as possible.
• Use default weights
• Make packaging brand identifiable— It should stand out.
• Example: If the Lab Operates on Saturday, use Saturday service for all kits (keeps simple for clinicians), parcel carrier can create special solutions for this.
Rule #1 –Make it easy on sites
Specimen Logistics Kitting 101
Specimen Collection Issues
Poor Kit Quality
(Packing)
Mislabeling
Lack of follow-up with clinician
errors
Collection container used for transport
Clinicians tend to be transient
Specimen tubes left in
office
Improper sealing and
packing Poor Kit Quality
(Containers)
It’s still here, I left it in the centrifuge
Are the results in yet?
Are my results in yet?
We are missing a vial?
Specimen Collection Issues Risk Mitigation and Q/A Processes
Poor Kit Quality
(Packing)
Mislabeling
Lack of follow-up with clinician
errors
Collection container used for transport
Clinicians tend to be transient
Specimen tubes left in
office
Improper sealing and
packing Poor Kit Quality
(Containers)
! Develop feedback system for kit quality ! Develop Closed-Loop follow-up for clinician errors ! Leverage common-error feedback forms ! Engineer errors out of the process
! Deskill processes ! Use graphical how-to ! Audible click seals ! Tertiary zip-lock and absorbents ! Over-boxing
Specimen Logistics Pain Points
• Solution - Use appropriate rigid outer box. Clinician Training/Follow-up, Extra Absorbent Liners and Zip Lock Bags – shipping vials VS. flimsy cups.
Leaking Specimen Packaging
• Solution – Additional internal zip lock bag to hold specimen, biohazard bag & absorbent pad, inside the lab pack to prevent external leaking and bio hazard incident response
• Positive Closures, Parafilm seals for tops
Leaking patient specimens / carrier
discarded specimens
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What matters most.
Guaranteed early delivery
Full supply chain visibility
Efficient workflow
Absolute specimen integrity
Optimal patient/clinician
drug discovery process
Specimen Logistics – Classification Exempt vs Biological Substances Category B, and Cat A
Category A – An infectious substance in a form capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. Category B - An infectious substance that is not in a form generally capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. This includes Category B infectious substances transported for diagnostic or investigational purposes. Exempt Human Specimen – Patient specimens for which there are minimal likelihood that pathogens are present are not subject to other provisions of the regulations except minimal packaging and marking requirements.
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Streamline Pick-Ups Generate Inbound Visibility
• Visibility through portal technology
• Online Pick-up Scheduling
• Reduce errors and improve clinician experience through online pick-up request vs. phone calls
• Real-time visibility gives lab and clinicians greater control.
Inbound workflow planning requires visibility.
Labs should be tied into parcel tracking systems.
Helps labs provide more accurate workflow forecasting, customer service, and critical timeline deadline planning.
"We are on 1980's technology" -Major Lab Operations VP
Inbound Visibility
Legacy
Your Professional Group 123 Main St. Sandy Springs, GA 30328 (404) 828-1001
Any Lab 123 Grade Lane Suite 123 Louisville, KY 40123 (678) 555-1212
Current Your Professional Group 123 Main St. Sandy Springs, GA 30328 (404) 828-1001
Any Lab 123 Grade Lane Suite 123 Louisville, KY 40123 (678) 555-1212
Advanced
Laboratory Pick-Up Request & Shipping Portal
Lab Portal App
Clinician time saver
Electronic signal when shipping label is
prepped is visible to lab
Supports improved clinician experience , Workflow Planning, Specimen Viability
Laboratory Pick-Up Request & Shipping Portal
Specimen Logistics – Temperature Excursions
• Temperature requirements are important considerations to cost and contingencies
• Ambient, Frozen (dry ice, LN2), Refrigerated conditions for specimen viability.
– Refrigerated 2-8º c very difficult to maintain.
– LN2 expensive to maintain
• Use insulators such as phase change gel packs to mitigate concerns of extreme heat and cold variations
– Very useful for tissue blocks
Carrier Temperature Profiles A wealth of information for effective / efficient packaging
Next Day Air Ground
25C
-14C
2C
Got Contingency?
• Service disruptions / delays • Contingency planning or package intervention
when shipment disruptions occur Challenge
• Parcel Monitoring/Intervention Service or courier “white glove” service for proactive or reactive package intervention
Solution
! Real time tracking ! Customized Operating
Plans ! Expediting ! Consequential insurance
! Proactive Monitoring ! Contingency plans ! Data Loggers ! Ability to intercept ! Quality Agreement ! Control Towers
! Track and Trace ! Temp Indicators ! Monitor during business
hours
Best
Better
Good
Logistics Risk Management
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Proprietary and Confidential: This presentation may not be used or disclosed to any person other than employees of
customer, unless expressly authorized by UPS. | © 2014 United Parcel Service of America, Inc. UPS, the UPS
brandmark, the color brown and photos are trademarks of United Parcel Service of America, Inc. All rights reserved.
Cost Savings
• Transportation mode optimization
• Some Carriers offer integrated Ground and Air Networks
• Accepting specimens in ground networks for local delivery saves money
• Single Driver for all services
• Leverage Parcel/Courier Model Analysis
• Courier Model Value Analysis vs Parcel Model—under compressed reimbursements many firms are re-evaluating
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Transport, Turn Around Time and Cost Downside/Upside of Couriers and Parcel
+ —
Cost
Geography
Infrastructure
Multiple Couriers
Customization
Flexibility
Turnaround Time
Courier
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Transport, Turn Around Time and Cost Downside/Upside of Couriers and Parcel
+ —
Customization
24/7/365
Flexibility
Turnaround Time
Cost
Reliability
Geography
Parcel
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Transport, Turn Around Time and Cost Downside/Upside of Couriers and Parcel
+ —
Cost
Multiple Parties
Infrastructure
Logistics Management
Customization
24/7/365
Flexibility
Turnaround Time
Hybrid
Transport, Turn Around Time and Cost Downside/Upside of Couriers and Parcel
Couriers
Cost Geography
Infrastructure
Customizable Flexibility
Geography TAT
Hybrid
Cost Multiple Parties
Customizable Flexibility
Geography TAT
Parcel
Customizable Flexibility
Days/Hours
Cost Geography
Infrastructure Reliability
Specimen Logistics
Monitoring Work with your courier. Dedicate resources to ensure sample stability – Measure success
Fixatives If shipping UN3373 small quantities of class 3, 8 or 9 may be shipped without further declaration. If sending Exempt Human, one must declare the fixative if it is considered to be a dangerous good
Efficient Accessioning
Engineer collection kits to standardize inbound processing, and identify samples
Receiving integrity
scanning to ensure receipt, follow up on delays, predefine contingencies
Visibility Use available tools such as UPS’s Quantum View Compliance Know the regulations because you or someone in your
company will be talking to the DOT and FAA at some point
Specimen Logistics Pain Points
• Solution – Compare Carriers and Couriers for earliest delivery time possible
• Tip: Ask about Special Operating Plans for earliest possible delivery
Specimen delivery time
• Solution - Engage carrier for packaging consultation and temperature monitoring capabilities
Specimen Stability
• Solution - Engage carrier and/or courier for in-transit monitoring and intervention solutions
Risk Mitigation
Parcel Firms can offer Specialized Solutions to Enhance TAT
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Special Operating Plans to Enhance TAT ! Dedicated Sort Position
! LIFO Air Container Position in Aircraft
! Expedited Shuttle Run from Air Ramp to Lab
Additional Pain Points
• Solution – Integrated scanning and bar-coding and tie tracking number to reference field patient requisition form number & container ID
Chain of custody tracking
• Solution – Milk run courier pickups and consolidation of specimens for a consolidated international inbound shipment
Growing international business markets
• Solution –Deskill decision making Next Day Air Saturday Return Service label for no client decision making, single RS label and automatic Saturday upgrade
Multiple return shipping labels for
client
A collaborative, solutions-based approach is needed
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Share business goals
Engage experts
Collaborative analysis
Innovative solutions
Expert implementation
• TAT • Early
Delivery
• Efficiency • Couriers • Parcel • Air/Ground
• Stability • Viability • Temp
Control
• Cat A • Cat B • Exempt
Confidential
Regulatory Compliant Service Level Monitoring 24 X 7 monitoring Pre-Study Consultation Unique Courier Relationships Customs Clearance Special Sort 24 X 7 delivery New Country / Region Financial Benefit Kit Receipt Billing Process Process Excellence
24x7 Monitoring • Dedicated UPS Clinical Trials Support hotline for pickup
requests • EDI tracking feeds sent each morning • Dedicated UPS Healthcare Support team for exception
management Special Sort/Unique Courier Relationships/24x7 Delivery • UPS Express Critical partnership • 5:00 AM delivery • Customized load configuration • Temp-controlled vehicles • Delivery every day that Worldport operates which includes
Sundays and Holidays • 2nd Day Air sort contingency • Risk Mitigation: Proactive Response / Dry Ice
Replenishment • 99.5% Next Day Air on time delivery Financial benefit • Customized contractual pricing streamlines billing process • Economic alternative to specialty courier • Reduces the transportation cost of running a trial
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It’s a patient,
not a package.®
Questions?
Thank You
Daniel Weaver Regional Logistics Manager - Americas
Robin Hooker Director, Healthcare Marketing