Pre-Solicitation Conference.pptx

Centralized Vaccine Distribution Pre-Solicitation Conference December 13, 2022

11:30 AM EST

Zoom Webinar

Disclaimers This webinar is being recorded.

Captioning service is available.

Agenda Introduction Centralized Vaccine Distribution Request for Proposals (RFP) Questions and Answers

Introduction

Centralized Vaccine Distribution Pre-Solicitation Conference

Purpose Provide a briefing about the Centralized Vaccine Distribution project and solicitation.

Answer received questions.

Goal to enhance prospective offeror understanding.

CDC Team Office of Acquisition Services Alan Sims, Branch Chief Pellumbeshe (Puli) Hoxhaj, Team Lead Christina McMichael, Contracting Officer National Center for Immunization and Respiratory Diseases (NCIRD) Dr. Jeanne Santoli, Branch Chief Cameron Noblit, Team Lead, Contract Officers Representative

Centralized Vaccine Distribution Pre-Solicitation Conference

Ground Rules This slide deck and answered Q&A will be posted on SAM.gov following the conference.

Questions may be submitted during the conference but will not be answered during this session. All subsequent answers will be posted on SAM.GOV during the solicitation Q&A period.

No changes to the draft solicitation will be made verbally today.

The draft solicitation was posted on SAM.GOV and the final official solicitation with any subsequent changes will be posted on SAM.GOV.

Agenda Introduction Centralized Vaccine Distribution

Centralized Vaccine Distribution

Centralized Vaccine Distribution Pre-Solicitation Conference

Mission The mission of the National Center for Immunization and Respiratory Diseases (NCIRD) is the prevention of disease, disability, and death through immunization and by control of respiratory and related diseases.

The mission of the Immunization Services Division (ISD) is to protect individuals and communities from vaccine-preventable diseases through provision of federal funds and contracts to purchase vaccine, the provision of technical and financial support of immunization programs, provider and public education, and evaluation and research.

CDC’s National Immunization Programs Within NCIRD are two established public health programs that work in concert to support routine immunization in the United States Vaccines for Children (VFC) Program Section 317 program

Each of these programs facilitates the vaccination of vulnerable populations and is administered as a collaboration between CDC and its 64 state/local/territorial immunization awardees

A fundamental aspect of these programs is that federally purchased vaccines are made available at no cost to enrolled providers for administration to eligible children, adolescents, and adults

Vaccines for Children (VFC) Program Section 1928 of the Social Security Act Enacted in 1993 (Omnibus Budget Reconciliation Act); implemented in 1994 Response to measles resurgence of 1989-1991 Part of Childhood Immunization Initiative Entitlement program Advisory Committee on Immunization Practices (ACIP) responsible for VFC formulary Entitlement is to the child Provides vaccines at no cost to families for eligible children, enabling them to receive vaccines in the context of primary care provided in their medical home Eligible children include represent approximately 50% of the US pediatric population and include:

Medicaid eligible Uninsured American Indian/Alaska Native Underinsured when served in an FQHC/RHC or deputized provider

Section 317 Program Public Health Service Act Enacted in 1962 as part of the Public Health Service Act Section 317 of the Public Health Service Act authorizes the federal purchase of vaccines to vaccinate children, adolescents, and adults Section 317 discretionary funding also supports immunization program operations at the local, state, and national levels.

Discretionary program Over its 50-year history, Section 317-purchased vaccine has been directed towards meeting the needs of priority populations Most recently this has included underinsured children not eligible for VFC, and uninsured adults.

Provides for vaccine to support outbreaks of vaccine preventable diseases

Centralized Vaccine Distribution Overview Initially launched in 2008 to provide in-kind support for CDC’s immunization awardees in implementing the VFC and Section 317 programs Involves the distribution of publicly funded vaccines for adults and children as directed by state, local, and territorial immunization programs funded by CDC Supports distribution of vaccines purchased by CDC’s immunization awardees (State/Local/CHIP funds) in additional to federally purchased vaccines Delivers approximately 69M – 83M doses of vaccine via approximately 600,000 shipments to nearly 38,000 providers each year Centralized vaccine distribution utilizes a single vaccine order management system (VTrckS) that is used by immunization awardees

Centralized Vaccine Distribution Requirements Receipt, storage and report on inventory Federal inventory Awardee-specific inventories Support security of vaccines and continuity of operations Pick/pack/ship refrigerated vaccines Pick/pack/ship frozen vaccines (at option of CDC) Pick/pack/ship ultracold vaccines (at option of CDC) Refrigerated shipment Ultra cold shipment Maintain VFC stockpiles Provide customer service Handle and process non-viable vaccine returns Comply with liability processes

Centralized Vaccine Distribution Pre-Solicitation Conference

Centralized Vaccine Distribution Requirements (2) Comply with federal security requirements—physical and IT-related Participate in transition-related activities at the beginning and end of the contract Prepare facilities and distribution of pandemic vaccines (at option of CDC) Provide required reports and data feeds Receive and transmit electronic messaging with VTrckS using electronic data interchange (EDI) Meet or exceed performance metrics for quality of service, EDI transmission, timeliness, and business relations.

Vaccine Tracking System (VTrckS)

Centralized Vaccine Distribution Pre-Solicitation Conference

VTrckS VTrckS is built on the SAP ERP platform, an application broadly used for supply chain management.

First implemented in 2010, VTrckS replaced three customized software applications that had been developed in-house at CDC.

VTrckS is an enterprise vaccine order management system used by CDC, state programs and enrolled providers; it integrates the entire publicly-funded vaccine supply chain, from purchasing vaccine to distribution to providers.

Sends and receives electronic messaging with HHS’s UFMS, vaccine manufacturers who contract with CDC, and CDC’s centralized vaccine distributor

Centralized Vaccine Distribution Pre-Solicitation Conference

VTrckS High Level Architecture

Electronic Data Interchange (EDI) with CDC

Agenda Introduction Centralized Vaccine Distribution

Request for Proposals (RFP)

Centralized Vaccine Distribution Pre-Solicitation Conference

Agenda Solicitation Details Type of Contract CLIN Structure Performance Based Matrix Site Visit Basis for Award Decision Evaluation Factors Contract Award

Solicitation Details RFP will be posted in December to SAM.gov.

Full and open competition using FAR Subpart 15.3.

NAICS code is 493120, Refrigerated Warehousing and Storage.

The small business size standard is $32.0 Million.

Place of performance will be the contractor’s site(s).

Government intends to make an award of the contract on or about summer of 2023.

Type of Contract Definitive Contract.

CLINs are firm fixed price or cost plus fixed fee.

The base period of performance begins on August 1, 2023 and concludes on July 31, 2024.

All following periods are broken down into twelve month increments.

This total contract period of performance is for five years.

CLIN Structure CLIN 0001 Series – Routine Distribution:

Commercial, Severable, Firm Fixed Price Routine Distribution encompasses the following activities:

Routine distribution Flu distribution Priority distribution Depot transfers Stockpile storage and rotation Frozen options

CLIN Structure – CLIN 0001 Series

CLIN Structure – CLIN 0001 Series (continued)

CLIN Structure CLIN 0002 Series – Pandemic Facilities:

Non-Severable, Cost plus Fixed Fee Completion Form

CLIN Structure CLIN 0003 Series – Pandemic Domestic Distribution:

Severable, Cost Plus Fixed Fee Completion Form Pandemic Domestic Distribution encompasses the following activities for CLINs 0003, 1003, 2003, 3003, & 4003 Refrigerated distribution Frozen distribution Ramp down Transition Activities

CLIN Structure – CLIN 0003 Series

CLIN Structure CLIN 0004 Series:

Severable, Firm Fixed Price Pandemic International Donations encompasses the following activities:

Refrigerated distribution Frozen distribution

CLIN Structure – CLIN 0004 Series

CLIN Structure Routine Distribution:

Payment is based on the actual doses distributed at the unit price within each CLIN.

The total cost of the period is based on the actual doses distributed.

All remaining funds, in excess of the actual doses distributed, will be deobligated at the end of each 12 month base or option period.

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

Centralized Vaccine Distribution Pre-Solicitation Conference

CLIN Structure Pandemic Distribution:

Payment is based on the actual doses distributed at the unit price within each CLIN.

The pandemic distribution is a cost plus fixed fee competition form CLIN.

Performance Based Matrix

The Offeror shall propose their Minimum Performance Standards for meeting the Desired Outcomes listed in the Metrics in the Performance Work Statement, Section 21 “Performance Based Matrix” and Section 15.16 “Pandemic Performance Based Matrix”. The proposed standards must meet or exceed CDC Minimum Standards that are listed.

Performance Based Matrix For both the Routine Distribution and the Pandemic Distribution the following categories apply:

Quality of service EDI transmission Timeliness Business relations

Centralized Vaccine Distribution Pre-Solicitation Conference

Site Visit

The Government reserves the right to visit any and all existing facilities proposed and to visually inspect all proposed equipment and spaces.

If the site visit does not demonstrate the Offeror’s capacity and operational plan as described in the proposal, this will be considered a deficiency in the Facilities technical evaluation criteria.

If the proposed site is not yet operational and the site visit is scheduled for a site used for similar operations, the Offeror shall illustrate the clear compare and contrast between the facility being toured and the facility to be used if the contract is awarded.

Centralized Vaccine Distribution Pre-Solicitation Conference

Basis for Award Decision This is a best value acquisition using a tradeoff process.

The Government will not make an award at a significantly higher overall price to the Government to achieve only slightly superior technical performance.

When proposals are technically equal, price will then become the significant factor.

Past performance will be evaluated on a pass or fail basis.

Evaluation Factors The evaluation criteria will be used to evaluate the Offeror’s understanding of the requirements of this contract and the soundness, practicality, and feasibility of the contractor’s technical approach for the requirements in the PWS.

Evaluation Factors Similar Large Scale Distribution Experience:

List and describe experience with similar large scale distribution projects.

Experience will be evaluated to determine the nature, complexity, and scope of the experience and how it relates to the solicitation requirements.

Include information about similar or related contracts, experience with subcontracts, consultants, or grants.

Evaluation Factors Technical Approach and Understanding of the Requirements for Distributor Information and Messaging Specifications:

Demonstrate understanding of the PWS and potential problems that may be encountered.

Describe the proposed technical approach to Distributor Information and Messaging Specifications to comply with each of the requirements specified in the PWS.

The proposal must be consistent with the stated purpose and scope.

The proposal must ensure the achievement of timely and acceptable performance.

Discuss the plan and solutions for identifying and overcoming difficulties involved with performing the work requirements.

Evaluation Factors Technical Approach and Understanding of the Requirements for Storage and Distribution:

Demonstrate understanding of the PWS and potential problems that may be encountered.

Describe the proposed technical approach to comply with each of the requirements specified in the PWS.

The proposal must be consistent with the stated purpose and scope.

The proposal must ensure the achievement of timely and acceptable performance.

Discuss the plan and solutions for identifying and overcoming difficulties involved with performing the work requirements.

Evaluation Factors Management and Transition Plan:

Provide list of key personnel.

Provide a copy of the subcontract, as applicable.

Describe management and structure to ensure that the tasks and requirements in the PWS are achieved.

Describe corporate experience in acquiring, training, and managing qualified staff.

Evaluation Factors Management and Transition Plan:

Describe how Offeror will ensure knowledge of and compliance with federal and state laws and regulations that govern vaccine storage, handling and distribution including compliance with current and future the Drug Supply Chain Security Act (DSCSA) requirements.

System and tools for customer service to respond to calls and questions from CDC immunization awardees and vaccine providers. Direct calls from providers are limited to questions about shipment viability only.

Evaluation Factors Management and Transition Plan:

Describe plan for maintaining communication and collaboration between the offeror and Government regarding:

Customer service Inventory IT interface and system updates Unique or urgent situations

Evaluation Factors Management and Transition Plan:

Incoming Contractor will prepare for the startup of vaccine distribution activities, including:

Set up of facilities IT system set up and testing Finalization of distribution Standard Operating Procedures (SOPs) Physical receipt of product (viable and non-viable), if applicable

Evaluation Factors Management and Transition Plan:

Outline how to organize and participate in the transition of materials and responsibilities to or from another contractor for the commencement of the contract, if applicable.

Outgoing Contractor shall ensure an approach to ramp down/transition activities and transfer product (viable and non-viable) to another contractor at the end of the contract.

Evaluation Factors Facilities:

Describe in detail the facility(ies) Complete addresses Storage space Parking space Layout of the complete process of picking, packing, and shipping the vaccine Address maintenance on emergency power generation equipment and refrigeration equipment.

Describe security of facilities

Evaluation Factors Facilities:

Describe the systems to be used and how the process will be implemented for:

Refrigerated product Frozen product Ultracold product Influenza vaccines Pandemic vaccines

Evaluation Factors Facilities:

If proposed facilities are not currently operational:

Provide the complete address of a site used for a similar operation that demonstrates the offeror’s capacity and operational plan Provide a clear compare and contrast between the alternate facility described and the facilities to be used if awarded a contract Describe a detailed plan to identify and ready facilities Milestones Timelines Letters of intention to lease facilities from a leasing company

Evaluation Factors Facilities:

Every contractor facility used for the storage, handling, packing, and shipping of Government purchased vaccine shall be licensed for the distribution of pharmaceuticals in accordance with federal and state law.

Include proof of all applicable licenses or certifications that allow for distribution of vaccines in all 50 state and US territories or the complete plan to achieve this within 45 days of award.

Contract Award Definitive Contract.

Government intends to make an award of the contract in the summer 2023.

Centralized Vaccine Distribution Pre-Solicitation Conference

Agenda Introduction Centralized Vaccine Distribution

Questions and Answers

Centralized Vaccine Distribution Pre-Solicitation Conference

Questions and Answers Due to the large number of questions submitted, the Q&As will be uploaded to SAM.gov after the conference.

Questions may be submitted during the conference but will not be answered during this conference.

Answers to these questions will be uploaded to SAM.GOV.

Closing Upcoming Tentative Key Dates:

The solicitation will be posted on SAM.GOV in December.

The solicitation will include the question due date and proposal due date.

All materials submitted electronically to Christina McMichael, Contracting Officer, at wpn6@cdc.gov.

image5.jpeg image6.png image7.jpeg image8.png image9.png image10.png image11.png image12.png image13.png image1.png image2.png image3.jpeg image4.jpeg