Pre GoLive Site Visit

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Vaccine Management Business Improvement
Project(VMBIP)

• Pre Go-Live Site Visit

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In todays discussion we would like to

• Provide a brief overview of the Vaccine
  Management Business Improvement Project (VMBIP)
  
• Discuss roles and responsibilities under
  centralized distribution
  
• Discuss the data transmission process between CDC
  and McKesson
  
• Discuss funds management under centralized
  distribution
  

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We would like to share a quick overview of the
Vaccine Management Business Improvement Project
(VMBIP)

• VMBIP comprehensive review of how public vaccine
  is managed
  
• The first top-to-bottom study conducted since
  inception of VFC in 1994 many existing
  processes established over a decade ago
  
• Several factors drove need for the assessment
• Implementation of a national pediatric stockpile
  
  
• Presidents Management Agenda and HHS goals to
  drive efficiency and reduce costs
  
• Operational changes for distributing Direct
  Assistance funds to states
  
• Ongoing need to improve vaccine management
  activities
  
• Initial recommendations expected to significantly
  improve operations
  
• Enhance capabilities to respond to public health
  crises
  
• Improve operational efficiency
• Immunization program managers have helped shape
  the recommendations

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VMBIP is revolutionizing public-sector vaccine
management while delivering significant financial
benefits
Vaccine Management Enterprise System (VTrckS)
Distribution

• Centralized distribution of vaccine from 2 -3
  locations
  
• Eliminates need for multiple state and local
  depots
  
• Reduces storage risks and distribution costs

• Web-based provider ordering and automated
  approvals
  
• Improved operational efficiency
• Improved Internal Controls
• Resilient, recoverable, standardized system

Provider Ordering
Distribution
Internal Efficiencies
Internal Efficiencies

• Funding flows through single account instead of
  64 grants
  
• Improved inventory management results in enhanced
  visibility and significant savings
  
• Reduced administrative processes
• Process Improvements and CQI

Stockpile
Stockpile

• Migration of a portion of Pediatric Stockpile
  offsite
  
• Reduces storage cost and ensures vaccine
  availability

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Centralized Distribution Recap

• First grantee transitions 2/5/07
• 37 grantees transitioned by 12/17/07
• Pause for CQI implementation 12/17/07 2/25/08
• 3 additional CQI teams formed mid-February
• Sacramento Distribution Center opened 2/25/08
• Rollout resumed 2/25/08
• Rollout to be completed by 6/30/08

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How are we addressing challenges?

• Using alternate data sources to monitor
  performance and communicate results to grantees
  
• Regularly scheduled CDC and McKesson meetings to
  formulate and implement solutions
  
• Major enhancements at McKesson
• Pause in rollout schedule
• Continuous Quality Improvement (CQI)
• The team shared preliminary results of the
  analysis with CA, CDC, and McKesson
  
• Will use data to make other programmatic
  enhancements
  
• Grantee survey of issues needing further
  attention
  
• VMBIP Reports

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The CQI teams have been reviewing existing
processes and developing recommendations for
improvement
CQI Initiatives
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Grantee Transition Schedule for 2007-2008
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Please ensure that those who need to receive
information on VMBIP are included in the NCIRD
Immunization Grantee mailbox

• VMBIP information and updates are currently
  distributed to grantees through the NCIRD
  Immunization Grantee Mailbox.
  
• There may be key VMBIP personnel at the grantee
  level who are not receiving these messages.
  
• Please provide CDC with a list of email addresses
  that you would like added to the distribution
  list for VMBIP messages.
  
• This list should include only those persons who
  are not currently receiving messages through the
  NCIRD Immunization Grantee Mailbox and who should
  be included on messages related to VMBIP.
• Please forward your list of email addresses to
  your POB Project Officer

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There have been many changes and additions to
activities under centralized distribution

• The next section of information describes changes
  or additional activities for grantees once they
  transition to centralized distribution
  
• This information came from the Project Point of
  Contact (PPOC) document which is a users guide
  to communications and activities between the
  PPOC, McKesson, and CDC
• The information on the following slides has been
  paraphrased from this PPOC document

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There may be times after transition that provider
orders are held at the CDC
What should a grantee do?
Why Orders are held at the CDC?

• No funding in the grantee NIPVAC account
• VACMAN Error
• NIPVAC Error

• Contact your POB project officer if you receive a
  message stating Held at CDC or Pending CDC
  approval
  
• Regularly check status in VACMAN
• Please note that the same message may occur if
  the grantee does not correctly download and
  deposit update files to the RCV folder

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and possibly at McKesson
Why Orders are held at McKesson?
What should a grantee do?

• Vaccine temporarily out of stock
• Restricted days and hours of operation at the
  provider site
  
• Grantee exceeds allocation in shortage situation
• Federal holiday
• Grantee requests non-shipment to all providers
  for a specific period of time
  
• Grantee requests temporary non-shipment to
  specific zip codes due to extreme acts of nature
  
• 3-5 day shipping metric

• It is your responsibility to ensure providers
  open day/hours and addresses are correct in
  VACMAN
  
• In the event that the providers office is closed
  for an extended period of time, do not place an
  order until the provider returns and can accept
  delivery
• McKesson should not be asked to hold orders
• Call McKesson Specialty Customer Service

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How should provider order delivery and returns be
handled?
Provider Order Delivery and Returns Guidelines
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What is the process for vaccine handling,
compromised vaccine and/or temperature monitor
issues?

• Providers must open vaccine packages, check the
  temperature monitor reading, inspect the vaccine
  and store at appropriate temperatures immediately
  after the package is delivered
• If temperature monitor is tripped, customer
  service must be notified within two hours of
  provider signing for vaccine
  
• Immediately contact McKesson Specialty Customer
  Care in the event a provider informs you that a
  vaccine shipment has been compromised

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Can Urgent (Priority) Orders be placed once
transitioned to centralized distribution?
Process for Urgent (Priority) Orders

• Orders are placed ahead of routine orders
• McKesson will work with you to arrange for
  receipt of shipment on a Friday or Saturday

• Check the Urgent Order box in VACMAN
• Failure to do so makes it difficult to track,
  bill and ship order

• After order is transmitted, call or email
  customer care to ensure the order is being
  treated as urgent, including requests for
  Thursday shipment for Friday delivery

• This is vaccine that is needed immediately
• Put order in VACMAN and email screen shots of the
  order to your POB Project Officer

• Example situations include flooding, disease
  outbreaks, severe weather
  
• Failure to place an order in a timely manner is
  not an acceptable example of an emergency
  

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What happens in the case of backorders?
Vaccine out at the manufacturer
Vaccine out at McKesson

• CDC will send an email to all grantees notifying
  you that the item is not available
  
• The corresponding NDC will be removed from VACMAN
  so orders for this product cannot be placed
  
• If you have questions about satisfying your
  providers needs for vaccine in the event of
  backorders, please contact your POB Project
  Officer

• The corresponding NDC will remain in VACMAN, but
  please do not place additional orders for that
  specific product in VACMAN until it is restocked
  at McKesson
• Affected orders will appear on the auto-generated
  backorder report.
  

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How can a grantee put additional materials in
provider shipments?

• In the event you would like to include materials
  in vaccine shipments, send an electronic version
  of the document(s) to CDC at vaccinedistributionc_at_
  cdc.gov (.pdf format is preferred)
• CDC may limit the number and size of such
  materials
  
• After receipt of CDC approval, you must print and
  ship a supply of materials to McKesson
  
• Vaccine Information Statements (VIS) are not
  approved materials to include in vaccine shipments

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What should a grantee do with a providers
expired or wasted vaccine?

• McKesson will accept the return of all nonviable
  vaccine from providers and shall arrange for the
  return of nonviable vaccine at no cost to the
  provider
• For vaccine that expires prior to transition
• Should be processed for excise tax credit by the
  grantee
  
• All product that is shipped by grantee prior to
  transition, but expires or is wasted after
  transition can be returned to McKesson for excise
  tax credit processing
• All product that is shipped by McKesson after
  transition can be returned to McKesson for excise
  tax credit processing
  

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What should a grantee do with a providers
expired or wasted vaccine?

• To ensure nonviable vaccine is returned to
  McKesson and the provider is not charged for
  return postage, please follow the process below
  
• Have your provider notify you that they have
  expired/wasted vaccine
  
• Have your provider complete and send you a copy
  of the grantee-specific wastage form (CDC does
  not provide a standard form)
  
• Ensure that your provider includes a copy of the
  wastage form in the box with the vaccine
  
• Call or send an email to McKesson Specialty
  Customer Care to notify McKesson that nonviable
  vaccine is available for pickup
  
• McKesson will arrange for nonviable vaccine to be
  picked up
  

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Do providers need to return their boxes?

• It is recommended that providers return the empty
  shipment boxes
  
• UPS will pick up the boxes to return to McKesson,
  even when packages are shipped to the providers
  via another carrier
  
• A return label should be included in every
  vaccine shipment instruct providers to reverse
  the flaps to find the return label
  
• In the rare event your providers box does not
  have a return label, the provider may call
  McKesson Specialty Customer Care at 877-822-7746
  
• This is the only time it is appropriate for the
  provider, instead of the PPOC, to have direct
  contact with McKesson Specialty Customer Care
  

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What should a grantee do during acts of nature
(e.g., flood, hurricane, snow, ice storm,
tornado, wildfire, etc.)?

• In order to pause shipments temporarily to
  providers in affected areas, contact McKesson
  Specialty Customer Care as soon as possible via
  email and telephone
• Please follow up with an email and/or telephone
  call to your POB Project Officer if the event has
  funding implications
  
• If a shipment is en route and cannot be
  suspended, or the provider(s) is (are) not
  available to receive the shipment, please contact
  McKesson Specialty Customer Care and request that
  McKesson recall the shipment(s)
• Please follow up with McKesson to secure a second
  delivery attempt once affected areas are clear
  
• Inform McKesson Specialty Customer Care of zip
  codes that specific carriers will not reach

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What is the process for bulk orders purchased
with state/317-FA funds?

• McKesson receives and ships the following
  vaccines to providers, in addition to the
  standard federally contracted vaccine inventory
  
• Non-federal vaccines and biologicals, which
  include those vaccine presentations (i.e., NDCs)
  that are not available on the CDC federal
  contract
• Federal vaccines purchased with state/local
  dollars using the federal contract
  
• Vaccine presentations that are available on the
  CDC federal contract, but are purchased with
  state/local dollars using a non-federal contract
  
• To ensure proper management of this inventory,
  McKesson needs to receive information from
  grantees detailing incoming purchases.
  
• This information will come from a required Excel
  spreadsheet that you will complete and submit,
  per the following instructions (on the next
  slide).
• Do not include direct ship vaccines, rabies, or
  smallpox vaccine on this spreadsheet
  
• This excel spreadsheet is required every time an
  order is placed for state and 317-FA funded bulk
  orders, including bulk orders placed through CDC
  federal vaccine contracts as well as bulk orders
  placed outside CDC federal vaccine contracts

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Sample state and 317 FA-funded bulk order
spreadsheet
Example
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In order to ensure proper inventory, grantees are
asked to provide information about state funded
bulk orders
McKesson Specialty 4853 Crumpler Road Memphis, T
N 38141 Phone [phone] Fax [phone]
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Shipping Contact Tommy McRae
McKesson Specialty 3775 Seaport Blvd West Sacram
ento, CA 95691 Phone [phone] Fax (916)
373-5294
Shipping Contact Randy Mohring
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Scanned copies of the packing slip from grantee
purchased vaccine will be emailed after the
packages have been received
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Out-of-the-ordinary, previously unanticipated,
large provider orders for adult vaccines
exceeding 3,000 doses/month

• Before you place the orders in VACMAN, as far in
  advance as possible send an email to your POB
  Project Officer and to vaccinedistributionc_at_cdc.go
  v with the following information
• Brand
• Presentation (NDC)
• Number of doses
• This communication will give CDC enough time to
  ensure adequate inventory at McKesson

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Below are other important processes under
centralized distribution
New Processes and Guidelines
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With centralized distribution, there are many
systems working together to get the provider
order to McKesson and back

• VACMAN
• NIPVAC
• Secure Data Network (SDN) - FTP site
• McKesson SAP
• Daily Shipping Log
• Daily Backorder Report
• McKesson TecSys

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Key messages to communicate to providers

• Different boxes
• Chemical monitors
• Acronym on written materials PPOC
• FedEx and UPS shipping only UPS pick-up (never
  call carrier directly)
  
• Expectation setting 2-3 week delivery time
  instruct providers to submit orders to PPOC to
  allow for lead time
  
• Expect vaccine deliveries on Monday and Friday
• Providers may call McKesson customer service
  directly only for EMPTY box return coordination

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Key messages to communicate to providers

• McKesson does not ship direct-ship vaccines
• Have providers verify open days, hours, and
  address information each time they submit an
  order to PPOC
  
• Call customer service within 2 hours of receipt
  for any order exception or temperature monitor
  issue
  
• Have providers call PPOC on Day 1 of partial or
  split shipment
  
• Flu will be shipped separately from other
  vaccines
  
• Hib may be shipped incrementally throughout the
  month
  
• Expired vaccines after transition get returned to
  McKesson
  
• 72-hour shipper
• Cancel signature release on file?

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There are several online resources to help
grantee pre and post transition

• VMBIP website (main) http//www.cdc.gov/vaccines/
  programs/vmbip/default.htm
  
• VMBIP documents web page http//www.cdc.gov/vacci
  nes/programs/vmbip/documents.htm
  
• All-grantee messages
• Link to weekly e-newsletter
• VACMAN 4.x guidance web page http//www.cdc.gov/v
  accines/programs/vacman/vacman4-x.htmvmbipdocs

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Spend plans should reflect actual bulk orders
prior to transition and expected provider orders
after transition
Spend Plans at Transition

• Pre-transition, bulk orders by grantees are
  assigned to a funding source by the grantee and
  the funds are debited from the appropriate
  manufacturer budget based on that assignment
• Post-transition, bulk orders by CDC are assigned
  to a funding source by CDC based on the expected
  provider orders from the transitioned grantees
  spend plans
• In order to ensure funds are apportioned
  correctly, grantees spend plans at transition
  must reflect actual bulk orders prior to
  transition and expected provider orders after
  transition so that VFC allocations and available
  funds (317 and State) are not exceeded for the
  fiscal year
• CDC has extrapolated historical
  provider distribution data that will be offered
  to grantees who do not have access to good data
  of their own.  This data can be used as a
  starting point for the grantees' VOFA projections
  but should be adjusted by the grantee based on
  their project-specific knowledge and available
  information

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The Grantee Replenishment model will require
upfront planning and regular monitoring
throughout the year
Throughout the month
Before the beginning of the fiscal year

• RAM will create a Replenishment Order Schedule
  for each grantee also known as the grantee
  commitment. This schedule will be created using
  the grantees spend plan
• RAM and POB Project Officer will then work with
  the grantee to determine the frequency and the
  timing the grantee anticipates placing their
  replenishment order this should include the
  month and the week of each order

• VSAB will create the monthly Replenishment
  Reports at the beginning of each month
  
• In the end state, this report will be created
  automatically
  
• Once grantees receive their replenishment report,
  they should place their replenishment order
  
• In VACMAN 4.1.3.1 during transition
• In VTrckS in the end state
• If ordering less frequently than monthly, the
  grantee will wait until that specified time to
  order

• POB Project Officer and RAM will monitor the
  grantee replenishment reports, looking for
  grantees who do not follow through on their
  commitments
• If a grantee does not follow through with its
  commitment, communications will begin

A Replenishment Report is sent to every grantee
at the beginning of each month for the previous
months provider orders This report will let the
grantee know how the orders were broken down by
funding source, including their state portion (if
applicable). This portion is what needs to be rep
lenished back to the CDC
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Grantees choose the debit card model and/or the
credit card (arrears) model for state funded
replenishment orders

• Grantees will not own any of this vaccine,
  regardless of which model they choose
  

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This Document

• This document can be found on the CDC website
  at
  
• http//www.cdc.gov/vaccines/programs/vmbip/downloa
  ds/pgl-sv-coreinfo.ppt