the regional and national courier & logistics network · the regional and national courier...

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

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



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

13

•  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

18

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.

20

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

28

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

29

Transport, Turn Around Time and Cost Downside/Upside of Couriers and Parcel

+ —

Cost

Geography

Infrastructure

Multiple Couriers

Customization

Flexibility

Turnaround Time

Courier

30


+ —

Customization

24/7/365

Flexibility

Turnaround Time

Cost

Reliability

Geography

Parcel

31


+ —

Cost

Multiple Parties

Infrastructure

Logistics Management

Customization

24/7/365

Flexibility

Turnaround Time

Hybrid


Couriers

Cost Geography

Infrastructure

Customizable Flexibility

Geography TAT

Hybrid

Cost Multiple Parties


Geography TAT

Parcel


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

36

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

38

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

It’s a patient,

not a package.®

Questions?

Thank You

Daniel Weaver Regional Logistics Manager - Americas

Robin Hooker Director, Healthcare Marketing

the regional and national courier & logistics network · the regional and national courier...

Documents