# Presentation: 326919

## Pre Go-Live Site Visit

**Vaccine Management Business Improvement Project****(VMBIP)**

## In today’s discussion we would like to...

**In today’s 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

## 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 
President’s 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

- 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
- President’s 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

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

## VMBIP is revolutionizing public-sector vaccine management while delivering significant financial benefits

**Distribution**

**Provider Ordering**

**Stockpile**

**Vaccine Management Enterprise System (VTrckS)**

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

**Distribution**

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

**Stockpile**

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

**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

**VMBIP is revolutionizing public-sector vaccine management while delivering significant financial benefits**

## Centralized Distribution Recap

**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

## How are we addressing challenges?

**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

## The CQI teams have been reviewing existing processes and developing recommendations for improvement

**CQI Initiatives**

| Initiative | Scope |
| --- | --- |
| Information and Product Shipment Integrity | Identify and correct root causes for discrepancies between lot number/expiration date on packing materials, shipment information and actual product |
| Cold Chain Monitoring and Standardization | Identify and correct root causes of potential failures in the  cold chain process – focusing primarily on product in-transit |
| Data, Systems and Reporting Issues | Identify potential gaps in IT systems and reporting between grantees, CDC and McKesson |

## Grantee Transition Schedule for 2007-2008

| "Go-live Date" | Grantee | Project Officer |
| --- | --- | --- |
| 2/5/07 | Maryland | Jack Nemecek |
| 2/5/07 | Washington | Anne Lutz |
| 2/13/07 | Chicago | Victoria Wright |
| 2/19/07 | WASHINGTON'S BIRTHDAY |  |
| 3/19/07 | California | Jack Nemecek |
| 3/2-3/16 | PILOT RUN-TIME |  |
| 3/19/07 | Tennessee | Harry McKnight |
| 3/23-3/30 | PILOT RUN-TIME |  |
| 4/2/07 | Rhode Island | Gayle Daniels |
| 4/9-4/20 | PILOT RUN-TIME |  |
| 4/23/07 | Nebraska | Mimi Larzelere |
| 4/23/07 | Oklahoma | Anne Lutz |
| 4/30/07 | Hawaii | Gabe Anaya |
| 4/30/07 | Arizona | Mimi Larzelere |
| 5/7/07 | Virginia | Victoria Wright |
| 5/14/07 | Indiana | Gayle Daniels |
| 5/14/07 | Philadelphia | Jack Nemecek |
| 5/21/07 | Pennsylvania | Jack Nemecek |
| 5/29/07 | New York City | Lewis Anderson |
| 6/4/07 | District of Columbia | Gayle Daniels |
| 6/4/07 | Delaware | Mimi Larzelere |
| 6/11/07 | Kansas | Jack Nemecek |
| 6/11/07 | Connecticut | Mimi Larzelere |
| 6/18/07 | Missouri | Jack Nemecek |

| "Go-live Date" | Grantee | Project Officer |
| --- | --- | --- |
| 6/25/07 | Nevada | Mimi Larzelere |
| 7/2/07 | Maine | Gayle Daniels |
| 7/9 -7/16 | BYE WEEKS |  |
| 7/23/07 | Idaho | Lewis Anderson |
| 7/23/07 | Kentucky | Harry McKnight |
| 7/30/07 | Wyoming | Lewis Anderson |
| 8/6/07 | Colorado | Anne Lutz |
| 8/6/07 | Oregon | Victoria Wright |
| 8/13/07 | North Dakota | Victoria Wright |
| 8/13/07 | New Jersey | Jack Nemecek |
| 8/20/07 | West Virginia | Victoria Wright |
| 8/27/07 | Utah | Anne Lutz |
| 8/27/07 | Montana | Victoria Wright |
| 9/4/07 | Texas | Harry McKnight |
| 9/10/07 | BYE WEEK |  |
| 9/17/07 | Minnesota | Anne Lutz |
| 9/24/07 | BYE WEEK |  |
| Oct-Nov | FLU VACCINE DISTRIBUTION |  |
| 12/10/07 | New Mexico | Lewis Anderson |
| 12/17/07 | New York | Lewis Anderson |
| 12/17/07 | North Carolina | Mimi Larzelere |
| Dec-Feb | CQI IMPLEMENTATION |  |
| 2/25/08 | Ohio | Gayle Daniels |
| 3/3/2008 | Iowa | Mimi Larzelere |
| 3/3/08 | San Antonio | Harry McKnight |

| "Go-live Date" | Grantee | Project Officer |
| --- | --- | --- |
| 3/10/08 | Mississippi | Harry McKnight |
| 3/17/08 | NIC BREAK |  |
| 3/23/08 | New Hampshire | Gayle Daniels |
| 3/31/08 | Louisiana | Harry McKnight |
| 3/31/08 | South Dakota | Victoria Wright |
| 4/7/08 | Florida | Mimi Larzelere |
| 4/14/08 | BYE WEEK |  |
| 4/21/08 | Alabama | Gayle Daniels |
| 4/28/08 | Georgia | Anne Lutz |
| 5/5/08 | US Virgin Islands | Gabe Anaya |
| 5/5/08 | Puerto Rico | Gabe Anaya |
| 5/12/08 | Michigan | Anne Lutz |
| 5/12/08 | South Carolina | Harry McKnight |
| 5/19/08 | Illinois | Victoria Wright |
| 5/26/08 | MEMORIAL DAY |  |
| 6/9/08 | Wisconsin | Lewis Anderson |
| 6/16/08 | Arkansas | Lewis Anderson |
| 6/16/08 | Vermont | Gayle Daniels |
| 6/23/08 | Massachusetts | Anne Lutz |
| 6/30/08 | Alaska | Lewis Anderson |
| 6/30/08 | Samoa | Gabe Anaya |
| 6/30/08 | Micronesia | Gabe Anaya |
| 6/30/08 | Guam | Gabe Anaya |
| 6/30/08 | Marshall Islands | Gabe Anaya |
| 6/30/08 | North Mariana | Gabe Anaya |
| 6/30/08 | Palau | Gabe Anaya |

**Grantee Transition Schedule for 2007-2008**

## Please ensure that those who need to receive information on VMBIP are included in the NCIRD Immunization Grantee mailbox

**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_

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

**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 user’s guide to communications and activities between the PPOC, McKesson, and CDC
- The information on the following slides has been paraphrased from this PPOC document

## There may be times after transition that provider orders are held at the CDC...

**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

## ...and possibly at McKesson

**...****and possibly at McKesson**

**Why Orders are held at McKesson?**

- 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

**What should a grantee do?**

- It is your responsibility to ensure providers’ open day/hours and addresses are correct in VACMAN
- In the event that the provider’s 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

## How should provider order delivery and returns be handled?

**How should provider order delivery and returns be handled?**

| Reason | Guideline |
| --- | --- |
| A delivery or a provider order is delayed or thwarted due to incorrect hours, days, or address | McKesson will notify you (by phone or email) of the reason for the delay within two workings days after failed delivery
The order will be returned to McKesson if it cannot be delivered
If returned, McKesson will automatically ship a replacement to the provider; therefore do not place a replacement order in VACMAN
Implement on-going system to ensure provider addresses and hours of operation are up-to-date |
| The provider refuses to accept the vaccine shipment | The carrier documents the date, time and intended recipient of the package
Returns the vaccine shipment to McKesson |
| The provider receives more vaccines than was ordered | Please arrange to have the vaccine transferred
The provider should contact you to transfer vaccine from one provider to another
Viable vaccine cannot be returned to McKesson Specialty
Inform McKesson customer service of the overage |

**Provider Order Delivery and Returns Guidelines**

## What is the process for vaccine handling, compromised vaccine and/or temperature monitor issues?

**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

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

**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

## What happens in the case of backorders?

**What happens in the case of backorders?**

**Vaccine out at the manufacturer**

- 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

**Vaccine out at McKesson**

- 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.

## How can a grantee put additional materials in provider shipments?

**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@cdc.gov](mailto:vaccinedistributionc@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

## What should a grantee do with a provider’s expired or wasted vaccine?

**What should a grantee do with a provider’s 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

## What should a grantee do with a provider’s expired or wasted vaccine?

**What should a grantee do with a provider’s 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

## Do providers need to return their boxes?

**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 provider’s 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

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

**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

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

**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**

## Sample state and 317 FA-funded bulk order spreadsheet

**Sample state and 317 FA-funded bulk order spreadsheet**

**Example**

## In order to ensure proper inventory, grantees are asked to provide information about state funded bulk orders

**In order to ensure proper inventory, grantees are asked to provide information about state funded bulk orders**

- McKesson Specialty
- 4853 Crumpler Road
- Memphis, TN  38141
- Phone: (901) 367-6982
- Fax: (901) 366-3825
- Shipping Contact: Tommy McRae

- McKesson Specialty
- 3775 Seaport Blvd
- West Sacramento, CA  95691
- Phone: (916) 373-5280
- Fax: (916) 373-5294
- Shipping Contact: Randy Mohring

## Scanned copies of the packing slip from grantee purchased vaccine will be emailed after the packages have been received

**Scanned copies of the packing slip from grantee purchased vaccine will be emailed after the packages have been received**

## Out-of-the-ordinary, previously unanticipated, large provider orders for adult vaccines exceeding 3,000 doses/month

**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@cdc.gov](mailto:vaccinedistributionc@cdc.gov)__ with the following information:_
- Brand
- Presentation (NDC)
- Number of doses
- This communication will give CDC enough time to ensure adequate inventory at McKesson

## Below are other important processes under centralized distribution

**Below are other important processes under centralized distribution**

| Process | Guidelines |
| --- | --- |
| Non-Federal Vaccine Inventory | You must monitor grantee specific non-federal vaccine inventory to ensure accuracy, use before expiration, and when to reorder |
| Provider Order Cancellation | If you notice an error in a provider order in VACMAN, please correct it before you transmit
Cancelling an order is a time-consuming, manual process for both the CDC and McKesson
If you find you still need to cancel an order, contact McKesson Customer Care immediately (via telephone and email)
McKesson will then contact CDC/VSAB for authorization |
| Influenza | McKesson established an influenza-only vaccine distribution line to help prioritize these orders
As a result, influenza may arrive in separate boxes
Please notify your providers that this may occur |
| CDC Vaccine Allocations | In the event of a national shortage, doses will be allocated by VSAB to each grantee
It is your responsibility to monitor the doses allocated and not go beyond this allocation
You may use VACMAN reports or other tools to help monitor your allocation |

**New Processes and Guidelines**

## With centralized distribution, there are many systems working together to get the provider order to McKesson and back

**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

## Slide 29

## Slide 30

## Slide 31

## Slide 32

## Key messages to communicate to providers

**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

## Key messages to communicate to providers

**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”?

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

**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/vaccines/programs/vmbip/documents.htm
- All-grantee messages
- Link to weekly e-newsletter
- VACMAN 4.x guidance web page: http://www.cdc.gov/vaccines/programs/vacman/vacman4-x.htm#vmbipdocs

## Spend plans should reflect actual bulk orders prior to  transition and expected provider orders after transition

**Spend plans should reflect actual bulk orders prior to  transition and expected provider orders after 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

**Spend Plans at Transition**

## The Grantee Replenishment model will require upfront planning and regular monitoring throughout the year

**The Grantee Replenishment model will require upfront planning and regular monitoring throughout the year**

- RA&M will create a Replenishment Order Schedule for each grantee – also known as the “grantee commitment.”  This schedule will be created using the grantee’s spend plan
- RA&M 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 RA&M 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

**Throughout the month**

**Before the beginning of the fiscal year**

- * A Replenishment Report is sent to every grantee at the beginning of each month for the previous month’s 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 replenished back to the CDC

## Grantees choose the debit card model and/or the credit card (arrears) model for state funded replenishment orders

**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**

## This Document

- This document can be found on the CDC website at:
- _[http://www.cdc.gov/vaccines/programs/vmbip/downloads/pgl-sv-coreinfo.ppt](http://www.cdc.gov/vaccines/programs/vmbip/downloads/pgl-sv-coreinfo.ppt)_