Solicitation 12.16.docx

SOLICITATION, OFFER AND AWARDPAGES

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-23-R-72522

12/16/2022

6. REQUISITION/PURCHASE NO.

Centers for Disease Control and Prevention (CDC) Office of Acquisition Services (OAS) 2900 Woodcock Blvd, MS TCU-4 Atlanta, GA 30341-4004

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

(Hour)

CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Christina McMichael

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-2697

C. E-MAIL ADDRESS

Wpn6@cdc.gov

11. TABLE OF CONTENTS

(x)PAGE(S)

SEC.

SEC.

PAGE(S)

DESCRIPTION

(x)

DESCRIPTION

XK

REPRESENTATIONS, CERTIFICATIONS, AND

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within calendar days (60 calendar days unless a differentCALENDAR DAYS

(Type or Print)

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

18. OFFER DATE

AWARD (To be completed by Government)

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

Centers for Disease Control and Prevention (CDC) Office of Acquisition Services (OAS) 2900 Woodcock Blvd, MS TCU-4 Atlanta, GA 30341-4004

Centers for Disease Control and Prevention (FMO) PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.7

75D30123R72522

Section B - Supplies or Services and Prices

Base Period Items:

· Routine

· Flu

· Priority

· Depot Transfer

· Stockpile Storage & Rotation

· Frozen Option

This is a severable firm fixed price commercial line item.

Period of Performance: August 1, 2023 – July 31, 2024

This is a non-severable Cost Plus Fixed Fee completion form line item.

Period of Performance: August 1, 2023 – July 31, 2024

· Refrigerated

· Frozen

· Ramp down

· Transition Activities

This is a severable Cost Plus Fixed Fee completion form line item.

Period of Performance: August 1, 2023 – July 31, 2024

· Refrigerated

· Frozen

This is a severable firm fixed price line item.

Period of Performance: August 1, 2023 – July 31, 2024

Option Period 1 Items:

OPTION

Routine Distribution:

· Routine

· Flu

· Priority

· Depot Transfer

· Stockpile Storage & Rotation

· Frozen Option

This is a severable firm fixed price commercial line item.

Period of Performance: August 1, 2024 – July 31, 2025

OPTION

Pandemic Facilities

This is a non-severable Cost Plus Fixed Fee completion form line item.

Period of Performance: August 1, 2024 – July 31, 2025

OPTION

Pandemic Domestic Distribution:

· Refrigerated

· Frozen

· Ramp down

· Transition Activities

This is a severable Cost Plus Fixed Fee completion form line item.

Period of Performance: August 1, 2024 – July 31, 2025

OPTION

Pandemic International Donations

· Refrigerated

· Frozen

This is a severable firm fixed price line item.

Period of Performance: August 1, 2024 – July 31, 2025

Option Period 2 Items:

OPTION

Routine Distribution:

· Routine

· Flu

· Priority

· Depot Transfer

· Stockpile Storage & Rotation

· Frozen Option

This is a severable firm fixed price commercial line item.

Period of Performance: August 1, 2025 – July 31, 2026

OPTION

Pandemic Facilities

This is a non-severable Cost Plus Fixed Fee completion form line item.

Period of Performance: August 1, 2025 – July 31, 2026

OPTION

Pandemic Domestic Distribution:

· Refrigerated

· Frozen

· Ramp down

· Transition Activities

This is a severable Cost Plus Fixed Fee completion form line item.

Period of Performance: August 1, 2025 – July 31, 2026

OPTION

Pandemic International Donations

· Refrigerated

· Frozen

This is a severable firm fixed price line item.

Period of Performance: August 1, 2025 – July 31, 2026

Option Period 3 Items:

OPTION

Routine Distribution:

· Routine

· Flu

· Priority

· Depot Transfer

· Stockpile Storage & Rotation

· Frozen Option

This is a severable firm fixed price commercial line item.

Period of Performance: August 1, 2026 – July 31, 2027

OPTION

Pandemic Facilities

This is a non-severable Cost Plus Fixed Fee completion form line item.

Period of Performance: August 1, 2026 – July 31, 2027

OPTION

Pandemic Domestic Distribution:

· Refrigerated

· Frozen

· Ramp down

· Transition Activities

This is a severable Cost Plus Fixed Fee completion form line item.

Period of Performance: August 1, 2026 – July 31, 2027

OPTION

Pandemic International Donations

· Refrigerated

· Frozen

This is a severable firm fixed price line item.

Period of Performance: August 1, 2026 – July 31, 2027

Option Period 4 Items:

OPTION

Routine Distribution:

· Routine

· Flu

· Priority

· Depot Transfer

· Stockpile Storage & Rotation

· Frozen Option

This is a severable firm fixed price commercial line item.

Period of Performance: August 1, 2027 – July 31, 2028

OPTION

Pandemic Facilities

This is a non-severable Cost Plus Fixed Fee completion form line item.

Period of Performance: August 1, 2027 – July 31, 2028

OPTION

Pandemic Domestic Distribution:

· Refrigerated

· Frozen

· Ramp down

· Transition Activities

This is a severable Cost Plus Fixed Fee completion form line item.

Period of Performance: August 1, 2027 – July 31, 2028

OPTION

Pandemic International Donations

· Refrigerated

· Frozen

This is a severable firm fixed price line item.

Period of Performance: August 1, 2027 – July 31, 2028

COST PLUS FIXED FEE

Note: The final quantities for the table above will be added before award.

Total contract value for the base period: $____________ Total contract value for the option period one: $____________ Total contract value for the option period two: $____________ Total contract value for the option period three: $____________ Total contract value for the option period four: $____________ Total contract value is: $____________

Payment is based on actual doses distributed at the unit price within each CLIN. The total cost of the period is based on actual doses distributed. All remaining funds, in excess of actual doses distributed, will be de-obligated at the end of each 12-month base or option period.

1. The Government may unilaterally exercise any tier in CLIN 0001, 1001, 2001, 3001, and 4001 in accordance with 52.217-7 for any quantity of doses to be distributed within the quantity range of the selected tier.

1. Option for increased quantity: The Government may unilaterally increase the quantity of doses in CLIN 0001, 1001, 2001, 3001, and 4001 to be distributed at the unit price specified, within the tier that was originally exercised. The Contracting Officer may exercise the option to increase the quantity by written notice to the Contractor within 7 days of the required delivery of the additional doses to be distributed.

1. If actual doses shipped are less than or greater than the quantity of the exercised tier in CLIN 0001, 1001, 2001, 3001, and 4001, the pricing will be reconciled retroactively based on the tier, that aligns with the actual doses shipped.

EXAMPLE: If Tier 2 is exercised and funding is added to support the distribution of 70M doses, but only 50M doses are distributed, the unit price will be adjusted to match the price in Tier 1.

B.1 Price Breakdown – All offerors will fill out the table below.

Routine Distribution (PWS Section 3 Refrigerated) - CLIN 0001, CLIN 1001, CLIN 2001, CLIN 3001, CLIN 4001

Tier I: < 62,000,000 (excludes Depot to Depot Transfers)

Tier II: 62,000,001 – 77,000,000 (excludes Depot to Depot Transfers)

Tier III: 77,000,001 – 92,000,000 (excludes Depot to Depot Transfers)

Tier IV: > 92,000,001 (excludes Depot to Depot Transfers)

Depot to Depot Transfer

Process Frozen (-50ºC to -15ºC) Vaccines Option (PWS Section 4.)

Store Vaccine Ultra-Cold (-90ºC to -60ºC) and Ship at Ultra-Cold Option (PWS Section 5)

Store Vaccine Ultra-Cold (-90ºC to -60ºC) and Ship at (2ºC to 8ºC) Option (PWS Section 6)

Stockpile Storage and Rotation

Transition Activities

Pandemic Domestic Distribution for Moderate Throughput <10M doses/week (PWS Section 15.20) – CLIN 0003, CLIN 1003, CLIN 2003, CLIN 3003, CLIN 4003

Refrigerated Distribution (PWS Section 3 & 15)

Process Frozen (-50ºC to -15ºC) Vaccines Option (PWS Section 4 & 15)

Store Vaccine Ultra-Cold (-90ºC to -60ºC) and Ship at Ultra-Cold Option (PWS Section 5 & 15)

Store Vaccine Ultra-Cold (-90ºC to -60ºC) and Ship at (2ºC to 8ºC) Option (PWS Section 6 & 15)

Pandemic Domestic Distribution for High Throughput >10M to 30M doses/week (PWS Section 15.20) – CLIN 0003, CLIN 1003, CLIN 2003, CLIN 3003, CLIN 4003

Refrigerated Distribution (PWS Section 3 & 15)

Process Frozen (-50ºC to -15ºC) Vaccines Option (PWS Section 4 & 15)

Store Vaccine Ultra-Cold (-90ºC to -60ºC) and Ship at Ultra-Cold Option (PWS Section 5 & 15)

Store Vaccine Ultra-Cold (-90ºC to -60ºC) and Ship at (2ºC to 8ºC) Option (PWS Section 6 & 15)

Pandemic Transition Activities

Pandemic International Donations - CLIN 0004, CLIN 1004, CLIN 2004, CLIN 3004, CLIN 4004

Refrigerated or Frozen Donations

Section C – Description and Specifications Performance Work Statement (PWS) Abbreviations and Definitions

· ACIP – Advisory Committee on Immunization Practices

· AIS – Automated Information Systems

· Allocation - A limit on the total doses of a shortage vaccine available to a Awardee, as determined by CDC.

· CDC - Centers for Disease Control and Prevention, U.S. Department of Health and Human Services

· Cold chain - Maintenance of a vaccine at appropriate temperatures throughout its storage, issue, and shipment cycles such that it remains viable until its expiration date

· Contracting Officer - CDC designated person who is responsible for the award and administration of the contract including the monitoring of contract performance, investigating and resolving complaints, reviewing requests for change, and implementing approved changes

· Contracting Officer’s Technical Representative (COR) – The person designated by the Contracting Officer to perform specified contract-related activities

· Depot – A physical storage and shipping location

· DHHS – U.S. Department of Health and Human Services

· Distribution – The receipt, storage, inventory management, picking, packing, shipment, and delivery of vaccines

· DSCSA – Drug Supply Chain Security Act

· Emergency situations – Situations surrounding an outbreak of disease or immediate need for vaccine order fulfillment or situations where a shortage of vaccine has occurred based on production or other problems that require the use of the government vaccine stockpiles and/or rationing of existing vaccine supplies

· EDI – Electronic Data Interchange – Structured transmission of data between organizations by electronic means

· FEFO – First Expired, First Out Process by which the units of operating inventory closest to expiration are the first doses shipped to providers

· Federal Excise Tax (FET) – Tax paid on each antigen within a vaccine

· Federal Excise Tax Credit (FETC) – Credit for tax paid by the manufacturer on unadministered vaccine

· Federal contract vaccine – Vaccine available on CDC contracts with vaccine manufacturers. The contracts are negotiated annually, and the prices may be updated an additional two times per year between negotiations. Current prices can be found at http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.htm

· FIP – Federal Information Processing

· FIPS 199 - Federal Information Processing Standard, standards for security categorization of federal information and information systems

· FIRMR – Federal Information Resources Management Regulation

· FISMA - Federal Information Security Management Act

· FOIA – Freedom of Information Act

· Awardee – Designation for State, City or Territory Immunization Projects (e.g., Pennsylvania, Philadelphia, Marshall Islands) that are serviced through the National Center for Immunization and Respiratory Diseases. See Attachment J.1, for a listing of the Awardees.

· Awardee Points Of Contact (APOC) - The designated points of contact at each Awardee who will coordinate delivery activities with the Contractor. The APOCs are not authorized to make any changes to the terms and conditions of this contract.

· Awardee Specific Inventory - Inventory that is electronically tracked for each Awardee, but not necessarily physically segregated for each Awardee.

· IT – Information Technology

· Initial inventory - The initial vaccine inventory provided to the Contractor by the Contracting Officer

· NCIRD – National Center for Immunization and Respiratory Diseases

· NDC – National Drug Code – Unique 10-digit product identifier for vaccines

· NIST – National Institute of Standards and Technology

· Nonviable vaccine - Vaccine that is out-of-date or whose cold chain has been compromised

· OMB – Office of Management and Budget

· Operating inventory – Vaccine inventory ready for shipment to providers

· Priority orders – Provider orders requiring immediate fulfillment by the Contractor. Priority orders shall be placed ahead of other routine orders and a faster shipment method may be selected (i.e., overnight) and may be shipped on non-shipping days with prior notification.

· Provider order – All vaccines ordered by one provider within one day

· Providers - Public and private health care individuals and organizations that administer vaccinations

· Provider identification number (PIN) - Number assigned to a provider

· Replacement – Vaccine order replaced with new inventory

· Replenishment Orders – A bulk order placed to replenish vaccine inventory

· Return to Vendor (RTV) – A process by which the expired doses are returned to the vaccine manufacturer for excise tax credit.

· Section 317 – A discretionary federal grant program which provides vaccines to underinsured children and adolescents not served by the Vaccines for Children (VFC) program

· Shipping days – Days in which the Contractor is regularly able to ship vaccine

· Small Business – As stated in FAR Part 19 – Small Business Programs

· Stockpile Reserve – Vaccine doses required by legislation to be held in storage (other than a Contractor’s operating inventory) and not used for routine distribution. The legislation requires six months of national demand to be held in federal inventory.

· Third Party Destruction (TPD) – Expired doses pulled from the inventory and shipped to the designated destruction company, that is contracted by a manufacturer to count the physical doses, provide a report, and dispose of the vaccine.

· United States Asian Pacific Islands (USAPI) – Referrers to the six Pacific Island Awardees: American Samoa, Federated States of Micronesia, Guam, Marshall Islands, N. Mariana Islands and Palau

· Vaccine - The use of this term in this contract specifically refers to publicly funded vaccines and biologics (e.g., MMR, HIB, DTaP, Immune globulins, diluents, etc.)

· VFC – Vaccines for Children program – a federally funded program administered through NCIRD that provides vaccines at no cost to children birth through 18 years of age who might not otherwise be vaccinated because of inability to pay.

· Viable vaccine - Vaccine with current shelf life date and proper cold chain maintenance

· VTrckS – CDC’s overall system for vaccine ordering and management Background and Purpose The Vaccines for Children (VFC) program is an entitlement program that was created by the Omnibus Budget Reconciliation Act (OBRA) of 1993 as Section 1928 of the Social Security Act and was enacted on August 10, 1993. On October 1, 1994, the U.S. Department of Health and Human Services (DHHS) implemented the VFC program. The program provides federally purchased vaccine to all children, at no cost to the child or parent/guardian, aged birth through 18 years if they meet the following criteria:

Are enrolled in Medicaid; or Have no health insurance; or Have health insurance that does not provide for immunizations and are seen at a Federally Qualified Health Center (FQHC) or Rural Health Center (RHC); or Are American Indian; or Are Alaska Native.

The VFC program covers vaccines recommended by the Advisory Committee on Immunization Practices (ACIP) and approved by the Centers for Disease Control and Prevention (CDC). Vaccines currently approved for inclusion in the VFC program and purchased through the federal contracts can be found at: http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html on the pediatric and influenza vaccine price lists.

CDC also has federal contracts for the purchase of adult vaccines that will be distributed under this contract. Funding for adult vaccines is provided by the Section 317 vaccine program, which also provides operational funding for state, local, and territorial immunization programs. Vaccine funding via the Section 317 Program is substantially less than what is available for the VFC program, and the program utilizes discretionary funding rather than mandatory funding. Based on the COVID-19 epidemic and lessons that have been learned from the ongoing response, discussions are ongoing about potential options for expanding CDC’s purchase of vaccines for adult populations. The current list of vaccines purchased through the federal adult vaccine contracts can be found at: http://www.cdc.gov/vaccines/programs/vfc/awardees/vaccine-management/price-list/index.html on the adult vaccine price list.

Following licensure, new vaccines are regularly added to the federal contracts based on ACIP recommendations. In addition to VFC and Section 317 funds, state, and local funds are used to purchase vaccines for children, adolescents, and adults not served by the federal programs.

The Awardee immunization programs also handles vaccines and immunoglobulins that are not recommended for routine use and are not available on CDC’s vaccine contracts. These non-federal vaccines are estimated to represent less than one percent of total volume. Examples of vaccines not currently on the federal contracts but purchased independently by some Awardees may include:

· DT vaccine

· Hepatitis B Immune Globulin (HBIG)

· Other Immune Globulins

· Rabies vaccine

In addition, the VFC program has a legislative requirement to maintain stockpiles of federal contract pediatric vaccines. These reserves are primarily held in manufacturer managed sites, but partial stockpiles for a range over the last five years of 1.3M to 2.5M doses of vaccines are held at centralized distribution facilities.

Historically, frozen vaccines such as Varicella and Zoster, have been direct shipped from the manufacturer to providers. While that remains the current approach at this time, the contract will include an option to have the Contractor store and ship frozen vaccines to providers and CDC is exploring the feasibility of incorporating the distribution of frozen vaccines into this centralized distribution mechanism.

Program Scope Historical data in this section is provided for information only and may not be predictive of future distribution, based on legislative or programmatic changes that may occur.

Inventory

The on-hand refrigerated inventory across all centralized distribution facilities consists of the following:

· Operating inventory (non-Flu): Total monthly operating inventory (not including flu doses) over the past 5 years has ranged from as low as 8M to as high as 20M doses per month, depending on the time of year.

· Operating inventory (Flu): Total monthly operating inventory for Flu vaccine has ranged over the last 5 years between 1M to 13.5M doses per month, depending on the time of year.

· Stockpile inventory: Over the past five years, the stockpile reserves held at the centralized distributor have ranged between 1.3M and 2.5M doses per month.

· Contractor should be prepared for inventory increase of up to 30% above these historical levels.

The centralized distribution model includes both vaccines purchased through the CDC federal contracts and vaccines purchased through Awardee non-federal contracts for all 62 Awardees. Vaccines that can be purchased through the CDC federal contracts are held in a single physical inventory, while non-federal vaccines and immunoglobulins are held in Awardee-specific storage locations that are physically and virtually segregated from other Awardee-specific and the federal single physical inventory. All publicly funded vaccines purchased by CDC and Awardees, including influenza vaccines, are included in the scope of this contract

Orders

Type of Ordering- All Awardees Annual Total Ordered Doses (Range over last 5 years) Annual Number of Orders (Range over last 5 years) Average Order Size (Range over last 5 years)

Data pulled for 5 calendar years: 2017,2018, 2019, 2020, 2021

Repackaged vaccines: For a limited subset of vaccines, repackaging is needed in order to distribute orders in less than package size. Overall, repackaged orders represent an average of 35K to 134K doses per year over the last five years.

All providers that receive public vaccine purchased by CDC are included in the scope of this contract. A small number of providers will not be accessible through standard commercial carriers, as noted below.

· Vaccines distributed to the six USAPI awardees (American Samoa, Federated States of Micronesia, Guam, Marshall Islands, N. Mariana Islands and Palau) will be dropped off at a central depot or airport as instructed by the APOC in each of the islands. See Exhibit C below for addition details on USAPI awardees.

Frozen vaccines (option) Currently, frozen vaccine shipments are made directly by the manufacturer, although the contract includes an option for frozen distribution. Over the past three years frozen vaccine orders have consisted of approximately 4 to 6 million doses per year.

Type of Ordering- All Awardees Annual Total Ordered Doses (Range over last 5 years) Annual Number of Orders (Range over last 5 years) Average Order Size (Range over last 5 years)

Data pulled for 5 calendar years: 2017,2018, 2019, 2020, 2021

Provider sites The number of providers receiving routine vaccine through this program are approximately 41,000, though the provider panel continues to expand to accommodate additional providers.

Returns Over the past five years, nonviable vaccine returned from providers have totaled between 3 and 6.5M doses annually.

(Range over last 5 years)

doses 92,000 to 118,000 Provider Returns 1 to 20,000a doses

Doses Returned 301 to 534c Return POs 2 to 1,300,000 doses

a. Includes returns from individual providers as well as consolidated returns from Awardees

b. High end of range reflects a backlog of doses that were processed during the period when the return range was pulled.

c. Multiple return POs are typically combined into a single return shipment to a manufacturer

Customer Service

Historical data in this section is provided for information only and may not be predictive of future distribution, based on legislative or programmatic changes that may occur.

Specific requirements for each of the elements of the work are identified in the following sections.

PWS - Scope of Work

1. Receive/store/report on inventory

1.1. Maintain at least 2 depots for vaccine storage and distribution. Additional depots may be considered; however, a limited number of depots is required rather than a larger, distributed network to streamline inventory, mitigate vaccine wastage/expiry, and support management of vaccine supply shortages and constraints.

1.2. Receipt of product and notifications to CDC and awardees occurs within timeframes specified in metrics; at a minimum, receiving should be supported during normal business days/hours

1.3. Receipt process and documentation are compliant with DSCSA (including special procedures for vaccines purchased outside of CDC’s contracts)

1.4. Vaccine cold chain process/parameters are met and documented at all times and consistent with manufacturer package inserts.

1.5. Detailed temperature monitoring reports from all vaccine storage units are sent to CDC on a monthly basis for review

1.6. System and processes are used to monitor that the product received into inventory is consistent with CDC requirements (e.g., dating, transit temperatures, package condition)

1.7. Fixed alignment of awardees to each depot is used to support depot inventory management by CDC

1.8. Inventory management follows FEFO principles

1.9. Capability to transfer vaccine from one depot to another at the direction of CDC within timeframes specified in metrics

1.10. Within each depot, separate awardee inventories are maintained for non-federal items; a single inventory is maintained for all federal items

1.11. System and processes in place to physically and virtually quarantine viable vaccines

1.12. Participate in routine reconciliation processes with CDC to ensure inventory information in the Contractor IT system remains synchronized with VTrckS, including conducting research to understand and resolve open orders, inventory discrepancies, failed inventory movements, growth/shrinkage, etc. in collaboration with CDC.

1.13. Comply with all reporting requirements related to vaccine receiving and inventory, as noted in Section 20, Reports and Data Feeds.

2. Security of vaccine/continuity of operation

2. Security of vaccine/continuity of operations

2.1. For continuity of operations purposes, a minimum of two depots located in 2 different geographically distinct locations must be used. Contractor must have/maintain all necessary licenses and comply with state/federal regulations necessary to distribute to CDC’s 62 awardees from all depots

2.2. In the event where only one depot was left operational, the remaining depot(s) must have sufficient space and capacity to ensure full operational continuity for vaccine storage and order fulfillment should a depot be temporarily compromised

2.3. Maintain insurance coverage for all vaccines held in the CDC depots (viable and non-viable) at commercial replacement value

2.4. Ensure facilities and vaccine storage units are protected from theft and unauthorized access and are continuously monitored

2.5. Employ a complete physical inventory count at least annually to achieve independent reconciliation by an outside party of all viable vaccines

2.6. CDC will conduct a minimum of two announced physical site inspections per depot each year, as well as additional unannounced physical site inspections performed at the Government’s discretion.

3. Pick/pack/ship for refrigerated (Pick/pack/ship for refrigerated (2ºC to 8ºC) vaccines

3.1.

3.1. Fulfill provider orders for providers in each of CDC’s 62 immunization awardee jurisdictions, which include all 50 US states, several large urban areas, PR, VI and six territories.

3.2. Fulfill provider orders within timeframes specified in metrics (including routine; flu; priority shipments) and in accordance with provider receiving hours

3.3. Ensure provider order shipments maintain cold chain parameters and include high and low temperature indicators to document temperature excursions

3.4. Ensure provider order shipments are filled in a manner than is accurate and complete and consolidates all orders for one provider received on one day as a single shipment, excluding priority and influenza vaccine orders if not practical.

3.5. Ensure vaccine cold chain process/parameters (including vaccine pack-out for shipments) are met and consistent with manufacturer guidance.

3.6. Support next day delivery of vaccine requests made by awardees at direction of CDC (This will include priority shipments and potentially weekend deliveries)

3.7. Implement a repackaging process to support shipment of less than a package size of certain vaccines specified by CDC when ordered in less than package quantities

3.8. Implement a process to include flyers with provider shipments for a particular awardee’s orders when requested by the awardee and approved by CDC or for other orders when requested by CDC

3.9. Provider orders will include packing list documentation that includes NDC/lot/quantity and VTrckS order number; information about vaccine fund type; shipment date; provider information; items on backorder

3.10. Provider orders that transmitted with a provider email address will be preceded by an advance shipment email that includes carrier/tracking information

3.11. All Contractor depots must have/maintain all necessary licenses and must comply with state/federal regulations necessary to distribute to CDC’s 62 awardees

3.12. Support order holds requested by awardees and/or CDC and carry out proactive outreach to all awardees related to shipping associated with national holidays

3.13. Minimize backorders by shipping doses from alternative depots when approved by CDC. When backorders do occur, they should be managed by delayed order fulfillment (product substitution is not an option), information on the packing list and outreach to awardees.

3.14. Shipments must bear labeling that complies with all applicable Federal/State regulations

3.15. Develop a plan to mitigate vaccine loss during shipment

3.16. Comply with all reporting requirements related to vaccine orders and shipments, as noted in Section 20, Reports and Data Feeds.

4. Process Frozen Process Frozen (-50ºC to -15ºC) Vaccines at option of CDC

4.1.

4.1. Fulfill provider orders for providers in each of CDC’s 62 immunization awardee jurisdictions, which include all 50 US states, several large urban areas, PR, VI and six territories.

4.2. Fulfill provider orders within timeframes specified in metrics (including routine; priority shipments) and in accordance with provider receiving hours

4.3. Ensure provider order shipments maintain cold chain parameters and include high and low temperature indicators to document temperature excursions

4.3.1. Frozen products may include diluent that cannot be frozen

4.4. Ensure vaccine cold chain process/parameters (including vaccine pack-out for shipments) are met and consistent with manufacturer guidance. At present time, some vaccines (e.g., Varicella) can be packed out at controlled room temperature, and others (e.g., Moderna COVID-19) must be packed out in a -20ºC environment.

4.5. Ensure provider order shipments are filled in a manner than is accurate and complete and consolidates all orders for one provider received on one day as a single shipment, excluding priority vaccine orders if not practical.

4.6. Ensure vaccine cold chain process/parameters (including vaccine pack-out for shipments) are met and consistent with manufacturer guidance.

4.7. Support next day delivery of vaccine requests made by awardees at direction of CDC (This will include priority shipments and potentially weekend deliveries)

4.8. Implement a repackaging process to support shipment of less than a package size of certain vaccines specified by CDC when ordered in less than package quantities

4.9. Implement a process to include flyers with provider shipments for a particular awardee’s orders when requested by the awardee and approved by CDC or for other orders when requested by CDC

4.10. Provider orders will include packing list documentation that includes NDC/lot/quantity and VTrckS order number; information about vaccine fund type; shipment date; provider information; items on backorder

4.11. Provider orders that transmitted with a provider email address will be preceded by an advance shipment email that includes carrier/tracking information

4.12. All Contractor depots must have/maintain all necessary licenses and must comply with state/federal regulations necessary to distribute to CDC’s 62 awardees

4.13. Support order holds requested by awardees and/or CDC and carry out proactive outreach to all awardees related to shipping associated with national holidays

4.14. Minimize backorders by shipping doses from alternative depots when approved by CDC. When backorders do occur, they should be managed by delayed order fulfillment (product substitution is not an option), information on the packing list and outreach to awardees.

4.15. Shipments must bear labeling that complies with all applicable Federal/State regulations

4.16. Develop a plan to mitigate vaccine loss during shipment

4.17. Comply with all reporting requirements related to vaccine orders and shipments, as noted in Section 20, Reports and Data Feeds.

5. Store Store Vaccine Ultra-Cold (-90ºC to -60ºC) and Ship at Ultra-Cold at option of CDC

5.1.

5.1. Fulfill provider orders for providers in each of CDC’s 62 immunization awardee jurisdictions, which include all 50 US states, several large urban areas, PR, VI and six territories.

5.2. Fulfill provider orders within timeframes specified in metrics (including routine; priority shipments) and in accordance with provider receiving hours

5.3. Ensure provider order shipments maintain cold chain parameters and include high and low temperature indicators to document temperature excursions

5.3.1. Ultra-Cold products may include diluent that cannot be frozen

5.4. Ensure vaccine cold chain process/parameters (including vaccine pack-out for shipments) are met and consistent with manufacturer guidance.

5.5. Ensure provider order shipments are filled in a manner than is accurate and complete and consolidates all orders for one provider received on one day as a single shipment, excluding priority vaccine orders if not practical.

5.6. Support next day delivery of vaccine requests made by awardees at direction of CDC (This will include priority shipments and potentially weekend deliveries)

5.7. Implement a repackaging process to support shipment of less than a package size of certain vaccines specified by CDC when ordered in less than package quantities

5.8. Implement a process to include flyers with provider shipments for a particular awardee’s orders when requested by the awardee and approved by CDC or for other orders when requested by CDC

5.9. Provider orders will include packing list documentation that includes NDC/lot/quantity and VTrckS order number; information about vaccine fund type; shipment date; provider information; items on backorder

5.10. Provider orders that transmitted with a provider email address will be preceded by an advance shipment email that includes carrier/tracking information

5.11. All Contractor depots must have/maintain all necessary licenses and must comply with state/federal regulations necessary to distribute to CDC’s 62 awardees

5.12. Support order holds requested by awardees and/or CDC and carry out proactive outreach to all awardees related to shipping associated with national holidays

5.13. Minimize backorders by shipping doses from alternative depots when approved by CDC. When backorders do occur, they should be managed by delayed order fulfillment (product substitution is not an option), information on the packing list and outreach to awardees.

5.14. Shipments must bear labeling that complies with all applicable Federal/State regulations

5.15. Develop a plan to mitigate vaccine loss during shipment

5.16. Comply with all reporting requirements related to vaccine orders and shipments, as noted in Section 20, Reports and Data Feeds.

6. Store Store Vaccine Ultra-Cold (-90ºC to -60ºC) and Ship at (2ºC to 8ºC) at option of CDC

6.1.

6.1. Fulfill provider orders for providers in each of CDC’s 62 immunization awardee jurisdictions, which include all 50 US states, several large urban areas, PR, VI and six territories.

6.2. Fulfill provider orders within timeframes specified in metrics (including routine; priority shipments) and in accordance with provider receiving hours

6.3. Ensure provider order shipments maintain cold chain parameters and include high and low temperature indicators to document temperature excursions

6.3.1. Ultra-Cold products may include diluent that cannot be frozen

6.4. Ensure vaccine cold chain process/parameters (including vaccine pack-out for shipments) are met and consistent with manufacturer guidance.

6.5. Ensure provider order shipments are filled in a manner than is accurate and complete and consolidates all orders for one provider received on one day as a single shipment, excluding priority vaccine orders if not practical.

6.6. Support next day delivery of vaccine requests made by awardees at direction of CDC (This will include priority shipments and potentially weekend deliveries)

6.7. Implement a repackaging process to support shipment of less than a package size of certain vaccines specified by CDC when ordered in less than package quantities

6.8. Implement a process to include flyers with provider shipments for a particular awardee’s orders when requested by the awardee and approved by CDC or for other orders when requested by CDC

6.9. Provider orders will include packing list documentation that includes NDC/lot/quantity and VTrckS order number; information about vaccine fund type; shipment date; provider information; items on backorder

6.10. Provider orders that transmitted with a provider email address will be preceded by an advance shipment email that includes carrier/tracking information

6.11. All Contractor depots must have/maintain all necessary licenses and must comply with state/federal regulations necessary to distribute to CDC’s 62 awardees

6.12. Support order holds requested by awardees and/or CDC and carry out proactive outreach to all awardees related to shipping associated with national holidays

6.13. Minimize backorders by shipping doses from alternative depots when approved by CDC. When backorders do occur, they should be managed by delayed order fulfillment (product substitution is not an option), information on the packing list and outreach to awardees.

6.14. Shipments must bear labeling that complies with all applicable Federal/State regulations

6.15. Develop a plan to mitigate vaccine loss during shipment

6.16. Comply with all reporting requirements related to vaccine orders and shipments, as noted in Section 20, Reports and Data Feeds.

7. Stockpiles

7. Stockpiles

7.1. A portion of CDC stockpiles for selected vaccines may be stored in the contractor’s depots; this inventory should be managed as part of the overall FEFO process

7.2. Implement a process for preventing these vaccines from being used for provider order fulfilment unless expressly directed by CDC

7.3. Comply with all reporting requirements related to vaccine stockpiles, as noted in Section 20, Reports and Data Feeds.

8. Customer Service

8. Customer Service

8.1. Develop a process to handle questions via phone call and email from CDC immunization awardees and vaccine providers in accordance with the metrics. Respond to awardees and providers on a wide variety of topics. Examples of topics may include cancellation requests, shipment status, vaccine returns, etc. CDC will provide directions on the types of provider calls that need to be referred to Awardees.

8.2. Service hours should, at a minimum, cover routine business hours within the continental US

8.3. Provide active and/or proactive communications with awardee staff related to time-sensitive issues. Examples of issues may include bulk product receiving without or with an incorrect PO, delayed shipment due to failed delivery attempts, weather holds or outreach regarding upcoming holiday shipping schedules.

8.4. Comply with all reporting requirements related to customer service, as noted in Reports, Section 20, Reports and Data Feeds

9. Non-viable vaccines

9. Non-viable vaccines

9.1. Maintain physical and systematic segregation from viable vaccines

9.2. Based on provider return transactions transmitted by CDC, arrange for the small parcel shipment of non-viable vaccines from the provider to the distribution depot(s) at no cost to the provider

9.3. Receive non-viable vaccines sent by providers/awardees and sort/store vaccine to prepare for vaccine returns to manufacturer that will be coordinated by CDC

9.4. Manage discrepancies between provider return transactions sent to contractor via EDI and contents of return packages received by providing regular feedback to APOCs requesting corrections to provider return transactions

9.5. Process and ship federal vaccine returns to manufacturer taken from federal non-viable vaccine inventory at direction of CDC at least quarterly

9.5.1. Where the vaccine manufacturer’s physical dose count does not match the return vaccines received from the Contractor, the Contractor will make updates to the inventory records in their IT system and transmit these updates to CDC.

9.6. Process and ship non-federal vaccine returns to manufacturer taken from awardee-specific non-viable vaccine inventory at direction of awardee

9.6.1. Where the vaccine manufacturer’s physical dose count does not match the return vaccines received from the Contractor, the Contractor will make updates to the inventory records in their IT system and transmit these updates to CDC.

9.7. Comply with all reporting requirements related to non-viable vaccines and returns, as noted in Reports, Section 20, Reports and Data Feeds.

10. Standard Operating Procedures Throughout the life of the contract, proposed changes to the SOPs shall be provided to the COR for review and comment.

11. Liability for routine vaccines Liability for routine vaccines (Applies for Frozen and Pandemic Options if exercised)

Liability for Vaccine Inventory at the Contractor’s Site

11.1. The Contractor shall insure all inventory in its possession at commercial replacement value against all situations that may result in loss of vaccine. Certificates of insurance or evidence of sufficient self-insurance shall be made available to the CO and COR annually.

11.2. The Contractor shall notify the COR of any defect or discrepancy from CDC bulk orders when receiving into operating inventory. The COR will then advise as to CDC action to be taken. If notification is not properly made, the Contractor will be liable for any vaccine inspection/ acceptance error that cannot be remedied by the Government under the Government’s contract with the vaccine manufacture. This includes payment for acceptance of any vaccine over and about the amount that was ordered and/or accepted of any vaccine that is not in conformance with contract standards of quality or quantity and that cannot be returned at no cost to the Government under the terms of its supply contract. Such liability will be effective only after the Government has exhausted all recourse available under the contracts against which vaccine was ordered and improperly inspected and/or accepted by the distribution as an agent of the Government under this contract.

11.3. The Contractor shall be fully responsible for all CDC & awardee purchased vaccine inventories from the point that they take possession of the vaccine from the manufacture until receipt at the provider’s office. The Contractor is liable for all loss of vaccine while the vaccine is stored in an authorized distribution center. In house loss of vaccine may include instances where the vaccine is not viable or deemed to be viable, but with a shortened shelf life or an inability to handle further excursions. This determination of vaccine viability will be determined by the vaccine manufacture, and CDC will make additional determination about the use of vaccine that has a shortened shelf life or inability to handle further excursions. Restitution will be payable to the U.S. Treasury at the price per dose listed on the CDC Vaccine Price List attributed to the date the loss occurred.

11.4. All Contractor liable inhouse vaccine loss shall submitted to CDC on a monthly basis. In the event that the loss of vaccine is greater than 500 doses for one particular product, per month, it would then be up to the discretion of the Government as to whether this would be a cost reimbursement or a dose for dose replacement. Documentation of replacements shall be provided to the Contracting Officer and the COR (and APOC, as appropriate).