Solicitation V8.docx

COMBINED SYNOPSIS/SOLICITATION

1. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with the format in FAR subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

2. The solicitation number is 75A50524R00002 and the solicitation is issued as a request for proposal (RFP).

3. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2024-06, effective July 31, 2024. Inspection and acceptance shall be at designated locations to be identified at a time prior to contract award.

4. The acquisition is not being set-aside for small business interests. The applicable NAICS Code is 493110 General Warehousing and Storage. The Product Service Code is M1GD Operation of Other Warehouse Buildings.

5. Items, quantities, and units of measure (including options) are described in detail within the Solicitation, Section B – Supplies or Services and Prices.

6. The U.S. Department of Health and Human Services (HHS), Administration for Strategic Preparedness and Response (ASPR), HHS Coordination Operations and Response Element (H-CORE) Office has a requirement to procure logistics services for warehousing, warehousing operations and distribution operations, for Vendor Managed Inventory (VMI) that has a cloud-based warehouse management system with a modern stack, uses current code, and is housed in a United States Government (USG) approved environment. The Vendor (i.e., the Contractor selected for contract award) shall be responsible for ensuring that all computerized systems that create, modify, maintain, archive, retrieve, or transmit data that directly or indirectly may affect the quality of the cGMP products are 21 CFR Part 11 compliant and are validated as per Software Development Life Cycle (SDLC) concept.

7. Date(s) and place(s) of delivery and acceptance and FOB Destination requirements are described in detail in the Solicitation, Section C – Statement of Work.

8. The provision at FAR 52.212-1, Instructions to Offerors-Commercial Products and Commercial Services (Sep 2023), applies to this acquisition.

9. The provision at 52.212-2, Evaluation-Commercial Products and Commercial Services (Nov 2021), is applicable to the acquisition and the specific evaluation criteria are described in detail in the Solicitation, Section M – Proposal Evaluation.

10. Each Offeror shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services (May 2024), with its offer.

11. The clause at FAR 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (Nov 2023), applies to this acquisition.

12. The clause at FAR 52.212-5, Contract Terms and Conditions Required To Implement Statutes or Executive Orders-Commercial Products and Commercial Services (May 2024), applies to this acquisition.

13. Contract requirements, terms and conditions are specified in the Solicitation that follows.

14. Proposals are due no later than September 11, 2024 at 1:30 pm September 13, 2024 @ 12pm Eastern Standard Time (EST).

15. For information regarding the solicitation, offerors must contact Ketwana Wright at Ketwana.Wright@hhs.gov or Sidnie Miranda at Sidnie.Miranda@hhs.gov.

SECTION B – SUPPLIES OR SERVICES AND PRICES

B.1 CONTRACT TYPE

This acquisition will result in a single firm fixed price (FFP) and time and materials (T&M) hybrid contract.

B.2 SERVICES AND SUPPLIES

The required supplies shall be provided in accordance with the requirements specified in Section C. Statement of Work (SOW). The quality and quantities of supplies shall be delivered in accordance with the terms and conditions specified herein.

B.3 CONTRACT LINE ITEM NUMBER (CLIN) DESCRIPTION

BASE YEAR

Minimum 50,000 Pallets

Includes all services to perform product management, documentation, reporting and as necessary to store and maintain ancillary products including pre-packaged kits and materials in deployable status in accordance with Section C.4.1, Task 1.

Includes all services as necessary for the initial receipt and continuous management of the fixed number of pallets invoiced by 50,000 pallets at a fixed monthly price.

TBD

(T&M)

In accordance with the table Section C.4.2. Task 2.

NTE $3,875,000.00

NTE $3,400,000.00

TBD

Material may be Non-hazardous/ Hazardous/Sharps

TBD

HAZ:

NonHAZ:

TBD

Monthly Rate per Pallet - $_________

TBD

TBD

TBD

OPTION YEAR 1

1001 (FFP)

Minimum 25,000 Pallets

Includes all services to perform product management, documentation, reporting as necessary to store and maintain product kits and materials in deployable status in accordance with Section C.4.1, Task 1.

Includes all services as necessary for the initial receipt and continuous management of the fixed number of pallets invoiced by 25,000 pallets at a fixed monthly price.

TBD

(T&M)

In accordance with the table Section C.4.2. Task 2.

NTE

$3,875,000

Vendor shall ship VMI items under appropriate conditions for up to 100,000 packages in accordance with the table in Section 4.3.. Task 3.

Average package size is 1,820 cubic inches and between 10-15 pounds.

NTE

$3,400,000

TBD

Material may be Non-hazardous/ Hazardous/Sharps

TBD

HAZ:

NonHAZ

TBD

TBD

SECTION C - STATEMENT OF WORK (SOW)

C.1 BACKGROUND

The Administration for Strategic Preparedness and Response (ASPR) leads the nation in preventing, preparing for, responding to, and recovering from the adverse health effects of emergencies and disasters by supporting our communities’ ability to withstand adversity, strengthening our health and response systems, and enhancing national health security.

HHS Coordination Operations Response Element (H-CORE) is responsible for maintaining and deploying the vaccines, ancillary kits, testing supplies and personal protective equipment (PPE) needed during a public health response. During a public health emergency, federal supplies of ancillary kits, testing supplies and PPE may need to be distributed and dispensed to vaccine administration sites throughout the country. Currently, distribution and dispensing/administration of, ancillary kits, testing supplies and PPE from H-CORE relies on the public health system (state and local health departments) along with partnerships to store and distribute the ancillary goods.

C.2 OBJECTIVE

The goal of this contract is to provide VMI services, storage, distribution, and destruction, for United States Government (USG) procured ancillary kits and products.

C.3 SCOPE OF WORK

Due to the continued efforts to provide a ready response to COVID-19, H-CORE has a requirement for Vendor Managed Inventory (VMI) and distribution services of Government furnished product (GFP) consisting of ancillary kits and materials for the successful administration of the COVID-19 vaccine. The Vendor shall provide VMI (logistical and supply chain support) for up to 119,000 pallet positions of GFP during the base year. The Vendor shall be responsible for providing all VMI, distribution and disposal services (such as, but not limited to, expertise, record & inventory management, labor, material, equipment, inspection, order picking, repackaging/palletizing, transportation assets, and properly licensed and secure facilities).

The Vendor shall maintain the capability organically, or by subcontract, for medical waste disposal services for; material that is still in manufacturers packaging or kits but has been damaged, is expired, or is no longer required to support an ASPR response.

The Vendor shall maintain the capability to process material requests and distribute pallets of kits or materials to locations as directed by the USG. The vendor is required to have interoperable data feeds with H-CORE’s system of record and accountability for all inventory.

The Vendor must be willing to enter into supporting contracts with other federal entities and commercial manufacturers to meet unique mission requirements.

C.4 TECHNICAL REQUIREMENTS

The Government is seeking to utilize the services of medical supply distributors to store and distribute ancillary kits and or supplies for the successful administration of the COVID-19 vaccine in the event of a pandemic or similar event during an infectious disease emergency across the United States. The Vendor must have in place and maintain all medical licensing and facilities required to store and deliver medical supplies in accordance with manufacturer specification and all applicable regulations as administered by the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Drug Enforcement Agency (DEA), and other Federal, State, or local laws and regulations that may apply.

C.4.1. Task 1: Vendor Managed Inventory (VMI) Services

1. The vendor shall have capacity to coordinate receipt of up to 119,000 pallets of USG product into its warehouses at time of award. At a minimum, the vendor shall have location(s) capable of warehousing the quantities referenced above under proper conditions and with the proper licensing for the storage and handling of the GFP medical countermeasures. The Government anticipates there could be many suitable locations and would like solutions presented based on the vendor’s expertise considering population centers, historical distribution patterns for these types of products, and other relevant factors. The vendor shall possess and populate upon receipt of GFP, an inventory system capable of providing up to date information on all Government owned inventory including quantity by lot, location, and expiration date, if applicable. Vendor shall conform to industry FIFO (first in first out) practices.

2. For planning purposes, and notwithstanding initial load-in and surge requirements, the number of trucks delivering and/or removing products from the facility may average 25 per day. There may be domestic, international, and shipments to US Territories. The Government anticipates that approximately 95 percent of the product received by the vendor will be on standard pallets weighing no more than 2,500 pounds per pallet.

3. The USG anticipates the initial load-in consisting of 3,000,000 number of kits on 77,000 number of pallets in addition to 42,000 number of pallets of un-kitted product.

4. 50,000 pallet spaces shall be billed at a fixed price monthly and may be a mixture of kits and un-kitted supplies.

5. Additional pallets up to the projected 119,000 shall be billed individually with the monthly invoice calculated by peak quantity of pallets above 50,000.

6. Any additional pallets stored utilizing the surge of 69,000 pallets (see Task 6) shall be added to the calculation of pallets above 50,000 for peak quantity monthly.

7. Normal operating hours for H-CORE and Vendors are, at a minimum, Monday-Friday 8 a.m. - 5 p.m. Eastern Standard time, and full mission capability is required during these hours. For all deliveries to the Vendor, appointments will be scheduled in advance.

8. Vendor receiving hours must be at a minimum, between 7 a.m. – 2 p.m. local time. Offerors shall provide their proposed receiving hours. Vendor shall keep a log of unscheduled deliveries and provide to the HHS Representative upon request.

9. The Vendor shall provide after-hours operations as needed for emergency shipments or shipments that arrive later than the scheduled time on an as needed basis and is not anticipated to exceed more than two occurrences per month. All vendor support shall be provided at the vendor-provided facilities.

10. The Vendor shall maintain an existing customer service toll-free number and email address will be required to address inquiries from shipping locations and administration sites re: ancillary kits about shipping status and product damage.

11. The Vendor shall inventory and validate receiving documentation for GFP. Any discrepancies between the incoming (packing list) documentation and the actual product shall be annotated on the inbound documentation. At a minimum, the vendor shall ensure that quantities received are accurate and lot numbers match. Upon inspection of the inbound shipment, any damage, shelf-life issues, or missing quantities shall be reported to the HHS Representative immediately and material suspended by the vendor pending resolution of the problem. Ship all items under appropriate conditions (i.e., temperature, weight limitations, etc.). Confirmation of delivery shall be provided to H-CORE by email in a format mutually agreed upon on each business day by 10:00 am EST.

12. Vendor shall acknowledge receipt and forward copies of all inbound documentation to the H-CORE representative within 24 hours after receipt of material.

13. The Vendor may receive pallets with mixed lots. Lot and expiration date tracking is required by the USG, the Vendor shall maintain accountability by lot number and expiration date in accordance with their SOP and may require pallets to be broken down and stored accordingly.

14. Receiving requirements:

a. 40”w X 48”d X 48”- 60”h pallets (standard commercial size)

b. Only one packing list per truck.

c. Packing list needs to be taped to the last pallet loaded onto the trailer.

d. Single SKU pallets

e. Each pallet should be labeled with the lot #(s) (marker on shrink wrap, paper attached, etc.)

f. Delivery appointments are required.

15. The Vendor shall provide up to 119,000 pallet spaces in an ambient warehouse for storage with the ability to maintain temperature ranges from 59-89 degrees Fahrenheit for all GFP if required by manufacturer specifications. The vendor shall adhere to all manufacturer specifications for the storage of GFP. Products and kits that do not require temperature controls may be stored in non- temperature-controlled warehouse, such as gloves and gowns.

16. At the warehouse location(s), vendor shall have adequate space for storage, staging, receiving, and shipping product. The facility must have dock doors to adequately support receiving and shipping simultaneously.

17. The Vendor shall ensure that accurate records and accountability of both inbound and outbound shipment records are auditable and reconcilable to the Government. All documentation that is related to the inventory quantities of product shall be retained by the vendor and made available to the USG upon request.

18. Below is an example of, but not the only, products that will be serviced under this VMI contract.

a. Ancillary kits

b. Un-kitted ancillary supplies

c. Other related vaccine administration supplies and medical countermeasures

d. PPE

e. Pharmaceuticals

19. Under Free on Board (FOB) Destination procedures, any loss of material or damages of product while in storage at the Vendor facilities are the responsibility of the Vendor. The Vendor shall always handle, maintain, transport, deliver and/or otherwise manage, and distribute the GFP in its possession in accordance with the applicable handling and storage requirements (as set forth in the special handling and storage requirements of the Product Information sheet provided by the manufacturers for any GFP). In the event the Vendor has not handled, maintained, stored, transported, and/or otherwise managed GFP in accordance with this paragraph, the Vendor shall notify H-CORE within 24 hours of knowledge of such incident and provide a GFP Handling Issue Report and shall destroy such GFP in accordance with all applicable laws, ordinances, regulations, and rules at no cost to the Government within three (3) business days of becoming aware of such incident. Within 72 hours after providing such notice of loss or damage to the H-CORE official, the Vendor shall reimburse H-CORE for the lost or damaged GFP at the USG’s acquisition cost.

1. Deliver GFP within 96 hours of notification to Continental US destinations and 120 hours to destinations located in US Territories. Vendor shall work with H-CORE to plan any international delivery requirements to ensure safe, effective, and expeditious delivery.

2. Maintain a readiness level to receive and respond to a notice to distribute from H-CORE 24/7/365 and distribute product as directed.

3. Have an emergency email established that will notify customer service 24/7/365 of a notice to distribute product as directed within specified timeframes. Customer service will coordinate with the distribution center to bring staff on site to prepare for distribution.

4. Within 24 hours of receipt of appropriate authorizations during normal hours of operation, the vendor must be able to load and begin transporting product to desired locations throughout the United States.

5. Be capable of making final delivery of product to the local site within the continental United States within four (4) business days of receipt of authorization.

6. Ship all items under appropriate conditions (i.e., temperature, weight limitations, etc.). The vendor shall provide confirmation of delivery to H-CORE by 10:00 am EST each business day via the daily report.

7. Invoice monthly based on distribution completed between first day and last day of the month..

8. Provide transportation tracking information from their facility to agreed destinations when requested by the USG (ASPR) and lot, track, and trace is required for all product shipping.

Table 1 Proposed Cost 40”w x 48”d x 48”–60”h x ~800lbs: One Time Only (OTO) Bulk Distribution to freight forward sites

*LTL- “less-than-truckload **FTL- “full truckload”

C.4.3. Task 3: Freight & Transportation (Small Parcel) The Vendor shall, at the direction of H-CORE, distribute products to all points of care as directed by the USG. The Vendor shall deliver GFP within 72 hours of notification to continental US; 96 hours to US Territories. Shipment of parcels will require lot, track, and trace for shipping.

Table 2: Distribution Fee Schedule Distribution Fee Schedule

C.4.4. Task 4: Pick, Pack, and Prepare

1. Following receipt and confirmation of items listed above, the Vendor shall pick and prepare specified quantities of GFP identified by H-CORE for shipment to any such delivery location(s) located within the US and Territories using the process outlined in Task 3 Freight & Transportation. For each shipment, the Vendor shall provide the following information to the H-CORE Designee within 48 hours after delivery:

a. Delivery/order number

b. National Drug Code (NDC)/Product number

c. Product Name

d. Quantity Shipped

e. Number of Containers/Pallets

f. Date Shipped

g. Estimated Arrival date/time

h. Carrier Name

i. Tracking Number(s)

j. Proof of Delivery

2. Outside packing label for each shipping container pallet, case or box must contain the following minimum data elements:

a. Shipper’s address

b. Ship to address

c. Mark for data or Transportation Control Number (TCN)

d. Delivery/Order Number

e. Number of Boxes/Cases Shipped; 1 of 4, 2 of 4, 3 of 4, 4 of 4, etc.

f. Shipping Label Fixed to outer box(es) may contain additional wording as determined by the designated H-CORE Representative, such as “PANDEMIC COVID-19 PROGRAM.”

g. FDA Discretion Notification Sticker as required.

3. At a minimum the inside packing slip must contain the following information:

a. Customer name

b. Ship to address

c. NDC

d. Product Name

e. Unit of Issue

f. Quantity Shipped

g. Delivery/Order number

h. Transportation Control Number or Customer Requisition Number

C.4.5. Task 5: Product Disposal

1. The vendor shall maintain the capability organically, or by subcontract, for medical waste disposal services for; material that is still in manufacturers packaging or kits but has been damaged, is expired, or is no longer required to support an ASPR response.

2. The material disposal process begins with a representative from H-CORE initiating the directive for waste disposal by product/lot/quantity.

3. Vendor shall dispose of GFP upon direction from the USG.

4. Pricing is to be on a fixed per pound (lbs.) cost basis and shall be billed at that rate multiplied by poundage disposed of required and include to all freight costs from Contractor warehouse to disposal facility. Pricing is to include both a rate for hazardous and non-hazardous materials. Contractor shall provide a per pound price for HAZMAT and Non-HAMAT.

5. The Vendor shall be responsible for complying with all applicable federal regulations such as the Code of Federal Regulation (CFR) Title 21 Food & Drugs, Title 29 Hazardous Materials, Title 40 Protection of the Environment, Title 49 Department of Transportation; U.S. Environmental Protection Agency (EPA), Occupational Safety and Health Administration (OSHA), Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), Department of Natural Resources (DNR), and the Center for Disease Control and Prevention (CDC). The Contractor shall also consult applicable state/local regulations and the regional office of the federal regulatory agency that has jurisdiction over their operation to assure compliance.

6. The Vendor shall maintain record of disposal for each occurrence that provides quantity, lot, disposal vendor, disposal method and certification that materials were disposed of in accordance with federal, state and local regulations

C.4.6. Task 6: Surge VMI Vendor shall provide services described in Task 1 above for up to an additional 69,000 pallets. Any additional pallets stored utilizing the surge of 69,000 pallets shall be added to the calculation of pallets above 50,000 for peak quantity monthly.

C.4.8. Task 8: Transition Over the course of the base year and if the 12-month option is exercised, the Vendor shall take possession of all GFP (up to 119,000 pallets weighing a total of approximately 30M Lbs.) from current vendor location (30k OH, 87k GA) and transport all materials to proposed new locations. Vendor shall provide a transition plan and proposed transition costs with the price proposal.

C.5 DELIVERABLES

All Deliverables shall be electronic files sent via email to the COR and other H-CORE designated representatives.

(Contractor format) One electronic copy –H-CORE

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

· Location Received

· Received From

· Received Date

Additional fields as negotiated.

(Contractor format) One electronic copy – H-CORE

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

· Location

Inventory Report (Contractor format) One electronic copy – H-CORE

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

(Contractor format) One electronic copy – H-CORE

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

(Contractor format)

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

· Shipper Name

· Shipper Address

· Consignee Name

· Consignee Address

· Date Shipped

(Contractor format) One electronic copy – H-CORE

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

· Destruction vendor

· Disposal Date

· Destruction Method

· Order Number

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity Shipped

· Quantity Delivered

· Customer Name

· Customer Address

· Date Shipped

· Date Delivered

· Delivery Status

· Tracking Number(s)

(Contractor format) One electronic Copy – H-CORE

Minimum data fields:

· Product Name

· Item #/NDC

· Lot #

· Expiration Date

· Quantity

C.6 SECURITY CRITERIA

The vendor’s facility shall meet the following security criteria.

1. Exterior camera coverage

a. Cameras to be day and night capable, DVR must store a minimum of 30 days motion activated images.

b. Provide 360-degree coverage of the exterior building.

c. Exterior personnel entrances

d. Dock area

2. Interior camera coverage

a. Each personnel door

b. All roll-up doors (can be grouped)

c. Load and unload areas.

3. Intrusion Detection System

a. Reports to Underwriter Laboratories (UL)-certified Central Alarm Station (Contract for monitoring required)

b. All doors and roof hatches with alarms and monitors.

c. Motion detectors covering dock doors and external doors.

4. Access Control System

a. Card access for all exterior doors, interior doors to warehouse areas, and gates.

b. Access control shall be a stand-alone system with storage capacity for entrance/egress logs to be a minimum of 6 months.

c. Access cards shall be provided to permanent, on-site, vendor personnel. Temporary employees, USG personnel and visitors shall be required to check-in with the Security Guard for access to the building.

d. Security Guards shall be provided a daily list of approved personnel and must confirm each individual’s name and badge before allowing entry to the building.

5. Vendor shall be responsible for quarterly maintenance and repair or replacement of security equipment for the duration of the contract (option periods included).

C.7 SITE CRITERIA

The vendor’s site shall conform to the following criteria:

1. The site shall have access to multiple routes to the highway system and airport.

2. Have property terrain that is flat and level.

3. Not be located over watersheds, wetlands, and/or floodplains.

4. Any hazardous material capable of creating an explosive, biological, or hazardous event within a quarter mile radius (as measured from the nearest property line of the facility in question to the nearest property line of the proposed facility) shall be identified. The Government shall assess risk and provide waivers to this requirement on a case-by- case basis. Current exceptions include hazardous material dedicated to airport operations and gasoline stations.

5. Be of an architectural make-up that does not cause undue attention to it within the context of an industrial park.

6. Be positioned in an industrial park in such a way that it is readily identifiable from the industrial park’s main thoroughfare so it can be found during an emergency response.

7. Not be in an area with high crime rates at the time of award (that is above the national average) or showing evidence of gang or other criminal activity as identified by police in the jurisdiction within which the vendor facility is located. Such information shall be made available to the Government if requested.

C.8 GROUNDS CRITERIA

The vendor’s facility grounds shall conform to the following criteria:

1. Provide visitor and employee parking areas and follow all local codes regarding parking standards.

2. Provide enough parking space for staging trucks during an actual event.

3. Landscaping and vegetation shall not impede access/egress of trucks from the site and shall not obscure line of vision around the perimeter and fencing of the facility.

4. Landscaping and vegetation shall comply with local jurisdiction requirements.

5. Be able to support a minimum height of six feet (unless preempted by local code and ordinance) fencing of the entire perimeter.

6. Be standalone facilities. However, a multi-tenant facility may be considered if the vendor can demonstrate to the satisfaction of the Government that the space for this contract is separated and secured from other tenants, including external points of egress.

7. Internal roof access is preferred for guards to gain access.

8. Have a minimum of a 50’ setback from access site boundaries.

9. Have limited glass frontages and skylights. If present, the vendor shall demonstrate how glass frontages and skylights shall be physically secured.

10. Comply with all applicable local zoning requirements.

11. Provide the Government adequate space to store raw materials and finished goods for up to 119,000 pallets to be stored and all other site requirements.

12. Provide the following redundant systems:

a. Back-up generator power to maintain all necessary life safety features as required by code.

b. Uninterruptible power supply (UPS) for all data capture and security systems.

c. Data back-up of electronic data capture.

d. Network backup is accomplished with redundant wired circuits from two different providers, four circuits in total.

13. Ensure that all outside communications services are provided with conduit diversity and that multiple providers are available for redundancy.

14. Conduit diversity is a building with an additional wire line conduit entry point.

15. Ensure that all communications, water, fire, natural gas, power, and sewer service connections are each located within five feet of the building.

16. Facilities constructed after the year 2000 shall have been constructed utilizing International Building Code (IBC) seismic design parameters.

17. All designs, construction, renovation, and modifications shall comply with the latest available version of the IBC and National Fire Protection Association (NFPA) standards. The latest available version of the IBC and NFPA are defined as the latest version as of the date of the RFP.

C.9 REPORTING REQUIREMENTS AND SITE VISITS

The Vendor shall provide daily reports to the USG in a mutually agreed upon format.

Teleconferences. The Vendor, upon request, shall participate in teleconferences with the USG to discuss progress and performance. The status of the contract and current circumstances will dictate the frequency of meetings. The purpose of these meetings will be oriented on the coordination efforts necessary to ensure continuity of effort and uninterrupted flow of materials.

The USG reserves the right to conduct site visits, collect samples, and conduct a joint physical inventory of up to 10% of products held and stored by the Vendor. The USG may ask to place a representative on site during peak operations. Five business day notification is required to schedule Vendor Distribution Center site visits to allow for proper coordination of both the USG and Vendor.

The Vendor shall provide primary and secondary points of contact who will be available 24/7.

C.10 ONSITE GOVERNMENT PERSONNEL

When USG personnel are on-site for the inspection and acceptance of GFP at the Vendor facilities, USG personnel shall comply at all times with all facility security, access, safety, and other policies provided in writing to the USG personnel. USG personnel shall conduct their work at Vendor facilities in such a manner as to avoid endangering the safety or interfering with the job responsibilities of Vendor employees, representatives, suppliers, or other personnel.

C.11 VENDOR QUALIFICATIONS

The Vendor shall adhere to all applicable current good manufacturing practice (cGMP) requirements and Government quality assurance requirements to ensure the contracted for VMI service satisfies such standards for receiving, storing, and distributing GFP (i.e., ancillary kits and materials for the successful administration of the COVID-19 vaccine). .

The Vendor shall be responsible for maintaining comprehensive Quality System programs, which shall comply with all applicable federal, state, and local regulations, and the Government performance requirements cited throughout this existing contract for the warehousing (receiving, holding, and shipping preparation) of product.

Vendor shall utilize a VMI process that has a cloud-based warehouse management system with a modern stack, uses current code, is housed in a USG approved Environment. The Vendor shall be responsible for ensuring that all computerized systems that create, modify, maintain, archive, retrieve, or transmit data that directly or indirectly may affect the quality of the cGMP products are 21CFR Part11 compliant and are validated as per Software Development Life Cycle (SDLC) concept.

After the first six (6) months of performance, the USG may annually assess the Vendor’s facility and Quality Systems and the site’s on-going acceptability and compliance to ensure proper and safe storage and handling of the Government-owned product. The assessment agenda will include, but not be limited to, a review of the following areas covering the receiving, holding, and shipping preparation of product:

1. Standard Operating Procedures (SOPs)

2. Deviation system

3. Corrective Action and Preventive Action system

4. Quality Assurance

5. Training management system

6. Facility maintenance

7. Equipment maintenance and calibration

8. Facility Sanitation program

9. Document control program

10. Organization and personnel qualifications and responsibilities

11. Regulatory inspection history (FDA form 482, FDA form 483, warning letter, etc.)

Upon completion of a Government quality assessment site visit, the Vendor shall receive a written formal assessment report. Upon the Vendor’s receipt of the Government’s written formal assessment report, the Vendor shall have 30 calendar days to respond in writing to the Government’s required and/or suggested improvement recommendations with proposed corrective actions and target dates for completion. ASPR, based on the requirements of this agreement, shall determine when the Vendors completed/proposed corrective actions are sufficient to allow Government owned product(s) to remain stored at the vendors’ facility. The Government may conduct “for cause” audits to address product quality or safety concerns within ten (10) business days of notification to the Vendor.

a. Document Control Program - The Vendor shall be responsible for maintaining a formal document control program to manage the approval, distribution, archival, and change control of all documents. This program shall minimally include SOPs, manuals and protocols, and training records covering the receiving, holding, and shipping preparation of product, and shall be made available to the Government.

b. Standard Operating Procedures (SOP) - The Vendor’s performance responsibilities and activities shall be described and controlled in their SOPs covering the receiving, holding, and shipping preparation of product. All Vendor employees shall be trained on all approved SOPs applicable to assigned tasks prior to performing the tasks in areas that may affect Government-owned products or equipment. Current, approved, and controlled SOPs shall be readily available to Vendor employees at the managed service facility.

c. Training Program - The Vendor shall be responsible for implementing a training program that defines the training requirements covering the receiving, holding, and shipping preparation of product. The Vendor -provided training shall be in the operations that the Vendor performs. All training shall be documented, and records properly maintained.

d. Deviation and Corrective Action Tracking - The Vendor shall maintain deviation and Corrective Action/Preventive Action (CAPA) systems and document nonconformances to approved procedures including root cause analysis and actions taken. All deviations that can potentially impact product(s) safety, identity, strength, quality, or purity shall be evaluated and fully documented by the H-CORE in accordance with their standard procedures. H-CORE is responsible for product impact evaluation and contacting appropriate manufacturers, when required. The completed deviation report including product disposition, when applicable, may then be provided to the Vendor by the Government.

e. Incident Notification and Reporting - The Vendor shall be responsible for reporting to the Government, as applicable, the following:

1. Any event that results in product being unavailable for deployment. A detailed incident report shall be provided to the Government at no later than two workdays after the incident. More critical deviations or incidents may require an immediate interim written report upon request by the Government. If the incident results in a deviation, the deviation report shall be submitted within 30 calendar days from the date of the incident. All associated CAPA reports shall be forwarded to the Government and Facility Manager upon completion. The vendor shall provide additional supporting information as requested by the Government.

2. For situational awareness, if any Government personnel are present on-Site during an incident, the Vendor shall include them when making notification to the Government and H-CORE designated representative.

f. Facility Design and Maintenance/Sanitation Program - The Vendor shall be responsible for providing a maintenance program that shall document that all storage facilities are maintained in a good state of repair and cleanliness and that all facility documents associated with the maintenance program are retained in appropriate files. The Vendor shall institute appropriate measures concerning cleaning, maintenance, pest control, and the quality system governing these procedures to ensure that the storage specifications for Government-owned products are met.

g. 21 CFR Part 11 Compliance and Validation of Computerized System - The Vendor shall be responsible for ensuring that all computerized systems that create, modify, maintain, archive, retrieve, or transmit data that directly or indirectly may affect the quality of the cGMP products are 21 CFR Part 11 compliant and are validated as per Software Development Life Cycle (SDLC) concept. A periodic performance review process shall also be in place to ensure that all such systems remain in the validated state throughout their lifecycle. The inventory tracking system must interface with the HHS ordering posture. The Vendor shall provide the Government a written statement confirming these processes upon request and be able to demonstrate the capability of their inventory system to align with the HHS system.

h. Vendor or Subvendor Qualification - The Vendor shall be responsible for ensuring that all sub vendors (i.e., subcontractors) utilized by the Vendor to perform functions that may have an impact on Government-owned products have the training and skills to perform under the existing contract. All subvendors shall be regularly evaluated by the primary vendor to ensure performance and quality compliance. Records identifying acceptable subvendor, their evaluation, and evaluation criteria used shall be documented and available for review by the Government upon its request.

i. Redundant Systems - The Vendor shall be responsible for providing and maintaining the following redundant systems:

1. Uninterrupted Power Source (UPS) for all data capture

2. Data back-up of electronic data capture

j. Change Control - The Vendor shall be responsible to document changes to SOP’s and all validated systems utilized to monitor and hold Government-owned products. The Vendor shall notify the Government, in advance of implementation, for assessment and approval of any planned system changes that may impact Government-owned products. Notification of any unplanned change, such as a system repair, that is not a “like for like” change, that may affect the qualification of the system impacting Government-owned product processing shall be provided to the Government within two (2) workdays.

k. Facility Inspection Notifications - The Vendor shall be responsible for immediately notifying the Government of any notice of inspection and unscheduled inspections or actions by regulatory agencies, other enforcement agencies (e.g., FDA, DEA, OOSHA), and third-party vendors that may involve and/or impact Government-owned products. If no advance notice is given, the Government should be notified immediately upon the arrival of the inspector(s). The Government shall be permitted to delegate at least two persons to observe the inspection.

l. Inventory and Maintenance Management System -

1. Inventory management system should be able to provide status and location confirmation for all material. Inventory systems shall be maintained in accordance with National Institute for Standards and Technology (NIST) security standard NIST SP 800-171. In addition.

2. At a minimum, the Vendor shall maintain an inventory record and provide a monthly inventory status report of all material received, shipped, and moved. These reports will include notations of any material damaged, lost, or theft. These reports shall be sent to assigned ASPR/DASPR Project Officer and H-CORE Representative by close of business the last day of the month. At a minimum, this report shall contain the following:

a. Store Keeping Unit (SKU) Information

1. Manufacturer and Model Number / Part Number

2. SKU Description

3. Unit of Measure

4. Unit Cost (If provided)

5. Quantity transported

6. Quantity on hand by facility

7. Warehouse location/multiple warehouse/storage points

8. Lot number

9. Expiration date

10. Condition Code (used to account for product recall, materiel complaints, etc.)

11. Note Codes (materiel subject to damage by freezing, hazardous material, etc.)

b. Transactions

1. (Manufacturer and Model Number / Part Number

2. SKU Description

3. Unit of Measure

4. Unit Cost (If provided)

5. Quantity transported

6. Quantity on hand by facility

7. Warehouse location/multiple warehouse/storage points

8. Lot number

9. Expiration date

10. Condition Code (used to account for product recall, materiel complaints, etc.)

11. Note Codes (materiel subject to damage by freezing, hazardous material, etc.)

C.12 Warehouse Management System (WMS) The Vendor shall provide a warehouse management system that is cloud-based and able to be used in warehouses to store GFP. WMS must provide inventory management control – by manufacturer, lot number, expiration date of the products, warehouse location address segmentation required, ability to dynamically route parcel, LTL, FTL shipments from the warehouse that is closest to the final destination point, delivery coordination, onsite storage capabilities, and other logistics management of equipment and supplies needed.

HHS may decide to develop a Database Migration Service (DMS) connection that will connect to the WMS and will have the following features:

1. API and other input from feed provided by states, cities, medical centers, and other aggregators of caseload data. This data will be used by the system to predict demand.

2. Machine learning platform to take input data and produce regular predictions for demand by region and state.

3. Interface for State DOHs and others authorized to request tests from the system to display predicted demand signal and accept/modify request.

4. Interface for HHS managers to link system to real time inventory feeds.

5. Interface for third-party logistics providers chosen by HHS to provide delivery and other services.

6. The DMS will be cloud-based and hosted at a cloud provider chosen by HHS.

The DMS is not a requirement for an offeror’s proposal but within the proposal, the offeror shall acknowledge it will consent to working with ASPR and a DMS provider for this added capability in the event it is required.

WMS Minimum Requirements

1. Provide a secure cloud-based Warehouse Management System (WMS) existing and expandable System at the proposed warehouse location(s). HHS/ASPR will have access to the dashboard through an encrypted password protected portal. The IT Proposal must contain content on fire wall hardening to protect against a security breach. A Strict Non-Disclosure must be signed by all contract award winners and under no circumstance is any data, shipping addresses, final delivery names and any other details about the entire operation to be shared with anyone outside of the contract award winner. More specifically, no information shall be shared with anyone outside of the US Federal Government and the contract award winner/s unless authorized by the US Federal Government.

2. Furthermore, the WMS shall provide information reporting on product receiving, current inventory quantities by pallet, lot numbers, cartons, units, manufacturers, expiration dates of OTC or other products that is placed in inventory, planned-pending shipments, shipping schedules, overall property/product management reporting with all above information by warehouse addresses, product flow in and out, and the cloud based WMS that will provide visibility for all warehouse locations. The US Government will have access to the WMS data in accordance with required deliverables.

3. The WMS shall provide all the above functions in the Daily Inventory Report.

4. Inventory data shall be made available within 24 hours of receipt.

5. Inventory information, to include barcode data, shall be made available in the WMS within two (2) business days of receipt.

6. Provide order picking, packing, and palletization - if required – please note that all GFP will arrive mostly palletized. Provide and maintain shipping equipment at the stated operational facilities to fulfill orders placed by US Federal Government.

7. Provide a detailed shipping manifest (per parcel, pallet) identifying each POC\group to which GFP is being sent.

8. Provide shipping reporting in the WMS within 8 hours of departure from warehouse to include lot numbers, serial numbers, quantity, pallet/carton count, destination and receiving site, with confirmation that the site has authorized the release of this delivery. Proof of Delivery required for all shipments uploaded to the WMS dashboard is required within five (5) business days. Any exceptions must be communicated.

C.13 Closeout 60 calendar days prior to contract completion, the CO, COR or other designated HHS Representative will provide guidance for remaining products in vendor facilities. ASPR will provide direction to the vendor regarding final distribution of all USG products received from the Government and any products not yet moved.

Upon expiration or termination (including partial termination) of this contract, the USG will direct final distribution of any products or kits on this contract and remaining in storage at the vendor’s facility by any one or combination of the following methods:

1. The USG may elect to direct the vendor to ship to a consignee or consignees designated by the USG, all products remaining in storage at the vendor’s facilities.

2. The USG may offer products still in their original packaging for sale to the vendor.

3. The USG may request distribution or provide disposal instructions of unshipped Kit products.

4. As the contract period of performance approaches the end,…