RFP Vendor Managed Inventory -VMI Combined Synopsis Solicitation.pdf

NOTE: Due to the length of this combined synopsis/solicitation, a pdf copy to help provide easier readability is attached to this posting.

COMBINED SYNOPSIS SOLICITATION

i. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in

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 document will not be issued.

ii. The solicitation number is 75A50323R00002, which is being issued as a Request for Proposal (RFP). The

Government anticipates the award of a single Hybrid Firm Fixed Price (FFP) and Time and Materials (T&M) type contract for severable services.

iii. The solicitation document and incorporated provisions and clauses are those in effect through Federal

Acquisition Circular 2023-03, effective April 26, 2023.

iv. This acquisition is being posted as Full and Open and is not set aside for small businesses. NAICS 493190 (Other Warehousing and Storage). The size standard is $32.0 (millions of dollars).

v. The Division of Strategic National Stockpile (SNS), of the U.S. Department of Health and Human Services

(HHS) Administration for Strategic Preparedness and Response (ASPR), has a requirement for Vendor Managed Inventory (VMI) and distribution services of government furnished property (GFP) consisting of medical supplies, pharmaceuticals, and equipment. The Government intends to evaluate offers and award a contract without discussions. However, the Government may, at its sole discretion, elect to conduct discussions if determined to be in the best interest of the Government.

vi. See below for description of requirements.

vii. The period of performance is anticipated to be 60 months, inclusive of a base period of 12 months with four

(4) one-year option periods. See below for place(s) of delivery and acceptance and FOB point(s).

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

ix. The provision at FAR 52.212-2, Evaluation-Commercial Products and Commercial Services (NOV 2021), applies to this procurement. Addenda to the provision include evaluation factors and evaluation criteria.

x. Offerors shall include a completed copy of FAR 52.212-3, Offeror Representations and Certifications-

Commercial Products and Commercial Services (DEC 2022), with its offer. (Note, if offerors are registered within the System for Award Management (SAM) and certs and reps are up to date, make a statement to that effect in accordance with paragraph (b)(2) of this provision).

xi. The clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services (DEC

2022), applies to this acquisition.

xii. The clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders

Commercial Products and Commercial Services (MAR 2023), applies to this acquisition and FAR clauses applicable are 52.219-9, 52.219-16, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.225-5, 52.225-13, and 52.232-33. Other applicable clauses include Health & Human Services Acquisition Regulation (HHSAR) clauses. See below for details.

xiii. There are no special contract requirements or terms and conditions related to contract financing arrangements.

xiv. HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations System.

xv. Offers are due no later than June 16, 2023, 5:00 PM Eastern Standard Time (EST). Offerors must submit an electronic copy of the Technical Proposal and Price/Business Proposal via email to SNSsolicitations@cdc.gov with the subject line “SUBMISSION RFP 75A50323R00002,” and by email to Lawrence McCoy at gwg8@cdc.gov and Mattie Washington at qva7@cdc.gov. The offeror’s complete proposal (including all information required to be submitted as part of the offeror’s Volume I- Technical Proposal and Volume II-Price/Business Proposal) must be received by the date and time specified for receipt of offers. See Section L for additional details for the content of proposals.

Electronics submissions only will be accepted and shall be submitted via email to the email addresses specified above. Email submissions are limited to 10MB. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

o All questions regarding this RFP of contractual or technical nature must be submitted electronically by email with the subject line “QUESTIONS RFP 75A50323R00002” to Lawrence McCoy at gwg8@cdc.gov and Mattie Washington at qva7@cdc.gov no later than 1:00 p.m. Eastern Standard Time (EST) June 5, 2023. The Government’s responses to questions will be posted as an amendment to the combined synopsis/solicitation posting. Unless the Government otherwise determines that it is in its best interest to provide a response, questions received after the deadline will not be answered.

xvi. The point of contact for information regarding this combined synopsis/solicitation is:

Contracting Officer Lawrence McCoy Office of Resource Management (ORM) Administration for Strategic Preparedness and Response (ASPR) U.S. Department of Health and Human Services (HHS) Email: gwg8@cdc.gov mailto:gwg8@cdc.gov mailto:qva7@cdc.gov mailto:.

SNS VMI and Distribution

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

B.1 Base Year: June 30, 2023 - June 29, 2024

CLIN Description Quantity /Unit of Measure

(UOM)

Unit Price

Extended Price

1 Vendor Managed Inventory Services for Government Furnished Property in accordance with Section C of the Statement of Work (SOW)

Firm Fixed Price

Months

2 Inbound/Outbound services in accordance with Section C, Task 1A

Time and Materials

1 LOT $2,880,000.00

NTE

3 Freight & Transportation Fees based on outbound shipments by mode and zone in accordance with Section B.3 – Freight and Transportation Cost Schedule

Time and Materials

1 LOT $26,600,798.00

NTE

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMS 1 through 3: $

Option Period I: June 30, 2024 - June 29, 2025

CLIN Description Quantity

/UOM

Unit Price

Extended Price

1001 Vendor Managed Inventory Services for Government Furnished Property (GFP) in accordance with Section C of the SOW

Firm Fixed Price

1002 Inbound/Outbound services in accordance with Section C, Task 1A

Time and Materials

1 LOT $3,030,400.00

NTE

1003 Freight & Transportation Fees based on outbound shipments by mode and zone in accordance with Section B.3 – Freight and Transportation Cost Schedule

Time and Materials

1 LOT $28,000,840.00

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMS 1001 through 1003: $_______________

Option Period II: June 30, 2025 - June 29, 2026

/UOM

Unit Price

Extended Price

2001 Vendor Managed Inventory Services for Government Furnished Property in accordance with Section C of the

SOW

Firm Fixed Price

2002 Inbound/Outbound services in accordance with Section

Time and Materials

1 LOT $3,187,200.00

NTE

2003 Freight & Transportation Fees based on outbound shipments by mode and zone in accordance with Section B.3 – Freight and Transportation Cost Schedule

Time and Materials

1 LOT $29,474,568.42

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMS 2001 through 2003: $_______________

Option Period III: June 30, 2026 - June 29, 2027

/UOM

Unit Price

Extended Price

3001 Vendor Managed Inventory Services for Government Furnished Property in accordance with Section C of the Statement of Work (SOW)

Firm Fixed Price

3002 Inbound/Outbound services in accordance with Section

Time and Materials

1 LOT $3,353,600.00

NTE

3003 Freight & Transportation, Fees based on outbound shipments by mode and zone in accordance with Section B.3 – Freight and Transportation Cost Schedule

Time and Materials

1 LOT $31,025,861.49

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMS 3001 through 3003: $_______________

Option Period IV: June 30, 2027 - June 29, 2028

TOTAL POTENTIAL AGGREGATE PRICE of LINE ITEMS 4001 through 4003: $_______________

TOTAL POTENTIAL AGGREGATE PRICE of ALL LINE ITEMS (1 through 4003): $

B.2 CONTRACT TYPE:

This is a Hybrid Firm Fixed Price (FFP) and Time and Materials (T&M) contract type.

NOTE: Below “*X” represents the first numbers of a set of CLINs (example: X003 represents CLINs 3, 1003, 2003, 3003, 4003).

B.3 Breakdown of estimated costs for CLINs X003 - Freight & Transportation Due to the Government Furnished Property (GFP) under this contract being medical supplies, pharmaceuticals, and maintenance equipment for responding to current and future public health emergencies, it is not possible for the Government to identify the locations of delivery in advance. Accordingly, for pricing purposes only, the Offeror shall provide a set of common assumptions for each performance period, including, but not limited to:

• the kinds and quantities of GFP being stored/managed;

• the kinds and quantities of GFP being accepted for inbound services

• the kinds and quantities of GFP being shipped for outbound services

• the number of outbound deliveries, identification of delivery locations, and method of delivery

• the organization of the GFP being shipped in and out (e.g., cases, pallets, freestanding pieces of equipment, etc.)

• the circumstances under which services are being provided (e.g., steady state vs. public health crisis or another emergency)

• standard escalation rate/factor for pricing the freight/transportation CLIN for the option periods

For purposes of evaluations, the contractor shall base its pricing upon the point of origin (that is, the contractor’s proposed facility locations in which GFP will be held) to the specified delivery locations via the specified shipping method.

During performance, the contractor shall bill the Government for services under the applicable CLIN. For services provided under the Freight & Transportation CLINs, the contractor may utilize government (e.g., USPS) or

CLIN Description Quantity

/UOM

Unit Price

Extended Price

4001 Vendor Managed Inventory Services for Government Furnished Property in accordance with Section C of the

SOW

Firm Fixed Price

4002 Inbound/Outbound services in accordance with Section

Time and Materials

1 LOT $3,529,600.00

NTE

4003 Freight & Transportation Fees based on outbound shipments by mode and zone in accordance with Section B.3 – Freight and Transportation Cost Schedule

Time and Materials

1 LOT $32,658,801.56

commercial (e.g., UPS, FedEx, etc.) shipping services, or the contractor may use its own internal transportation fleet.

When utilizing government or commercial shipping services, the contractor shall bill the Government at the rates applicable at the time of delivery/performance. The contractor may also use its own internal transportation fleet, provided that such pricing is the lowest applicable transportation charge.

SECTION C – BACKGROUND AND STATEMENT OF WORK

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.

The mission of the Strategic National Stockpile (SNS), of the U.S. Department of Health and Human Services (HHS) ASPR, is to ensure the availability and rapid deployment of life-saving pharmaceuticals, antidotes, other medical supplies, and equipment necessary to counter the effects of biological, chemical, radiological, natural disasters or other emerging infectious disease agents and pandemic events. When state, local, tribal, and territorial public health and healthcare systems request federal assistance to support their response efforts, SNS ensures that the right medicines and supplies get to those who need them most during a public health emergency or pandemic event. During a public health emergency, federal stockpiles of medical and testing supplies may need to be distributed and dispensed to people throughout the country.

HHS/ASPR/SNS has a need for a comprehensive storage and distribution contractor to oversee the material requirements, storage, deployment, and rotation of material that may be requested and allocated to areas of need.

C.2 Purpose/Objectives

The purpose of these requirements is to provide the Government with comprehensive contractor support that includes the provision of all necessary expertise, labor, materials, and space to conduct receiving safely and securely, store, rotate, audit, stage, package, manage, and ship stored material. The space occupied will consist of material ranging from pallets of varying heights in accordance with International Organization for Standardization (ISO) to cases, boxes, bottles, vials. The Government also requires storage of medical supplies and medical equipment. For planning purposes, the National Fire Protection Association (NFPA) classification for the stored products is Class IV; however, it is the responsibility of the contractor to verify this classification and meet the necessary requirements for each type of GFP stored. The Contractor shall meet the Quality Control criteria outlined in Section C.4, 1.4 Task 1D Quality Control. The Quality Control Subtask contains the Government’s requirements for the operation of the facility.

C.3 Scope of Work

The United States Government (USG) has a requirement for Vendor Managed Inventory (VMI) and distribution services for government furnished property (GFP) consisting of medical supplies, pharmaceuticals, equipment, and related items. The contractor shall provide all personnel, necessary licensing, support, and space to manage the inventory requirements for up to 320,000 pallet positions total for all sites. The USG estimates that 10,000 of those pallet positions will be pharmaceuticals broken out as follows: 8,200 pallets under ambient storage at 20°C to 25°C;

and 1,800 pallets for cold chain products at 2°C to 8°C (1,200 pallets), -20°C/-80C (400 pallets) and -80C (200 pallets). The contractor shall have a geographically diverse network of warehouse sites and capabilities to rapidly deliver products to anywhere in the United States and to select locations outside the continental United States

(OCONUS).

The Contractor shall provide all capabilities including, but not limited to, expertise, record management, labor, materials, equipment, and properly licensed and secure facilities. The Contractor shall meet applicable Federal, State, and Local regulatory requirements, including, but not limited to, the Occupational Safety and Health Administration (OSHA), National Institute for Occupational Safety and Health (NIOSH), and Department of Transportation (DOT) requirements related to the performance of the required services.

The Contractor shall maintain inventory records and provide the Government with reports that capture all activities pertaining to stored medical supplies, pharmaceuticals, and equipment. This reporting requirement includes making reports available monthly and as requested by the Government. If shipping is needed, the contractor shall provide shipping reports to the SNS representative prior to shipment. The shipping report shall include truck number, air tracking information, shipping destination, item nomenclature, serial/lot numbers, and any special handling notes in spreadsheet format. To the extent reasonably practicable, but at the sole discretion of the Government, the Government will endeavor to provide the contractor advance notice of any changes to the equipment packaging, such as serial numbers, kit components, ancillaries, and containerization.

C.4 Technical Requirements:

The Contractor shall perform all storage and distribution activities (including, but not limited to labor, materials, and space to conduct receiving safely and securely, store, rotate, audit, stage, package, maintain, and ship material stored) for up to 320,000 pallet positions of material. The Contractor shall provide all personnel, support, and facilities to fulfill the requirements at each site. The Contractor shall ensure that all Government products stored in the Contractor-provided facility remains viable based on the identified requirements. As directed by the Government, the contractor shall perform special handling for domestic and international shipments. “Special handling” refers to processes such as palletizing, weighing, wrapping heavy shipments, placarding hazmat materials in accordance with DOT regulations and working with cold-packed items. The Government anticipates, but does not guarantee, that approximately 95 percent of the product received by the Contractor will be on standard pallets and 5% small parcel. The Contractor shall provide after-hours operations as needed for emergency shipments or shipments that arrive later than the scheduled time as part of the firm-fixed-price.

1. Task 1: Vendor Managed Inventory

The Contractor shall provide VMI (logistical and supply chain support) for up to 310,000 pallets of GFP (medical supplies and equipment) and up to 10,000 pallets of pharmaceuticals, under the required storage conditions for each type of product. Normal hours of operation are Monday - Friday, 7 a.m. - 5 p.m. local time, and full mission capability is required during these hours. The Contractor shall provide weekend and after-hours operations as needed for emergency shipments or shipments that arrive later than the scheduled time as part of the firm-fixed-price. All contractor support shall be provided at contractor-provided facilities.

1.1 Task 1A: Inbound/Outbound Services (CLIN 2, 1002, 2002, 3002 and 4002)

A. Inbound Services

The contractor shall coordinate receipt of product (GFP shipped directly from USG or from manufacturers/vendors) into designated warehouse sites across the United States (reference section C.5 for facility location requirements). The GFP includes medical supplies, including, but not limited to, gloves, gowns, coveralls, goggles, face shields, masks, N-95s, boot covers, test kits, swabs, media, ancillary vaccine kits, needles, medical equipment, and pharmaceuticals. At a minimum, contractor shall have locations (sites) that are geographically dispersed and be able to service all the United States and capable of warehousing the required quantities of GFP (see Section C.5 for specific facilities requirements). Contractor shall possess an inventory system capable of providing up-to-date information on all Government owned inventory and capture this information at time of receipt to include:

(1) Manufacturer and Model Number / Part Number

(2) SKU Description

(3) Unit of Measure

(4) Quantity transported

(5) Quantity on hand by facility

(6) Warehouse locations/storage points

(7) Lot number

(8) Expiration date

(9) Product recalls

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

(11) Bill of Lading

(12) Packing Slip

The Contractor shall have the capability to receive a minimum of 80 pallets of GFP per week (Monday- Friday). There will be domestic and international shipments and shipments from U.S. Territories. The Government anticipates that the product received by Contractor will be on standard pallets with dimensions of 48” L x 40” W with a maximum height of 60” per International Organization for Standardization (ISO) and weighing no more than 2,500 pounds per pallet. The Contractor is not required to accept any unpalletized containers.

The Contractor shall inventory and validate receiving documentation of the product by annotating the incoming documentation with the name of the person receiving the product, the date, and time of receipt.

Any discrepancies between the incoming (packing list) documentation and the actual product shall be annotated on the inbound documentation. The contractor shall ensure that quantities received are accurate and lot numbers match. Upon inspection of the inbound shipment, any damage, shelf-life issues, discrepancies in quantities, or other notable irregularities shall be reported to the Contracting Officer’s Representative (COR) within 48 hours of delivery. The product shall be sequestered and suspended by the contractor, pending further instruction from the COR.

The contractor shall acknowledge receipt and forward copies of all inbound documentation to the COR within 48 hours after receipt of product.

The contractor shall notify the COR within 48 hours of any product moves from one contractor-managed location to another contractor-managed location within its network.

B. Outbound Services

The contractor shall prepare each shipment in conformance with the selected carrier’s requirements and in a manner that ensures protection of the goods. The contractor shall use the transportation/delivery method that results in the lowest applicable transportation charge or the cost most advantageous to the Government. The contractor shall track all shipments via a vendor-produced tracking number, café system tracking, or transportation shipper tracking. When requested by the SNS, the contractor shall provide transportation tracking information for all points from the shipping origin to the shipping point of destination.

The Contractor shall:

(1) Maintain a readiness level to receive and respond to a notice to distribute from ASPR 24/7/365, to include the readiness level necessary to distribute product as directed.

(2) Have an emergency email established that will notify a designated contact person who is on call

24/7/365 of a notice to distribute product as directed within specified timeframes.

(3) Be able to coordinate with the receiving location, load, and begin transporting product to ASPR designated locations CONUS within 12 hours of receipt of a distribution direction from ASPR.

(4) Identify, pick, package, and process paperwork for the GFP identified for distribution.

(5) Make final delivery of product to the local site(s) within the continental United States (CONUS) within 4 business days from the date of shipment. Delivery requirements for OCONUS distributions will be specified at the time of need. For OCONUS distributions, the Contractor shall use commercially reasonable efforts to have products delivered within the required timeframe.

(6) Ship all items under appropriate conditions (i.e., temperature, weight limitations, etc.).

Confirmation of delivery shall be provided to ASPR by email within 24 hours of delivery in a format specified by the COR.

(7) Distribute from all combined locations up to 1,520 pallets or 7,500 parcels to multiple locations per day. In addition, the Contractor shall distribute from all combined locations up to 7,500 cases (parcel) to 7,500 locations daily.

(8) Ship product in accordance with Task 2.

1.2 Task 1B: Product Rotation (CLIN 1, 1001, 2001, 3001 and 4001)

The contractor shall rotate the GFP inventory to mitigate stock loss caused by expiration or obsolescence. Expiration date of the GFP will be listed on the packages. SNS will make arrangement to dispose of the GFP when the product expires.

1.3 Task 1C: Product Warehousing & Management Services (CLIN 1, 1001, 2001, 3001 and 4001)

The contractor shall provide services for up to 320,000 pallet positions for GFP medical supplies.

This entails 310,000 pallets of GFP to be stored in controlled room temperature (CRT) ambient conditions defined as temperature range of 68°F to 77°F (20°C to 25°C), and 10,000 pallets of pharmaceuticals broken out as follows: 8,200 under ambient storage at 20°C to 25°C and 1,800 pallets for cold chain products 2°C to 8°C (1,200 pallets), -20°C (400 pallets), and -80C (200 pallets).

The Contractor shall ensure that all products are managed, including receiving, storing, packaging, and transporting, in compliance with all applicable regulations administered by the Department of Health and Human Services (HHS), Food and Drug Administration (FDA), Department of Transportation (DOT), OSHA, and all Federal, State, or local laws and regulations applicable to the performance of the services under this contract. Materials management shall also be in accordance with the FDA’s current Good Manufacturing Practices (cGMPs), 21 CFR Part 210 and 21 CFR Part 211.

The GFP will consist of pallets of varying heights; however, most pallets will be 48” long (L) by 40” wide

(W) in accordance with the International Organization for Standardization (ISO) standards.

The Contractor shall maintain accurate records of inbound and outbound shipments that are auditable and reconcilable by the Contractor and the Government. The Contractor shall maintain an inventory record and location system for the GFP throughout the term of the contract, including option years. All documentation related to the inventory quantities of product shall be retained by the Contractor and made available to the USG upon request throughout the term of the contract, including option years.

If GFP is damaged while under possession of the Contractor, the Contractor is responsible for all disposal and replacement costs. The Contractor shall provide loss prevention and insurance on stored product equal to the replacement cost and payable to the United States Federal Government. The Contractor shall report damaged GFP to the COR within 24 hours of discovery in order for the Government to provide instruction regarding disposition and replacement of the damaged GFP.

1.4 Task 1D: Quality Control (CLIN 1, 1001, 2001, 3001 and 4001)

The Contractor shall adhere to all applicable cGMP requirements and Government-directed quality assurance requirements. The contractor shall ensure the appropriate operation of its facilities, including receiving, preparing, holding, and shipping GFP, including, but not limited to, finished pharmaceuticals, medical devices, Investigational New Drug (IND) products, and other related GFP. Applying cGMP standards, the contractor shall have a Quality Assurance Surveillance Plan (QASP) and program to manage the range of complex pharmaceutical products to maintain quality characteristics such as product integrity and reliability. The contractor shall ensure that packing, shipping and storage methods, techniques, and special processes are in accordance with cGMP standards. The contractor shall incorporate new and innovative conceptual approaches, technologies, and methods for enhancing the assessment of quality performance and identifying areas for improvement.

a. Contractor Quality Qualification - The Government will assess the contractor’s Quality Systems within

60 calendar days after award, and on an annual basis, to make a determination about the site’s continued acceptability and the contractor’s compliance with GFP storage and handling requirements. The assessment agenda will include, but is not limited to, a review of the following areas covering the receiving, holding, and shipping preparation of product:

1. Standard operation procedures (SOPs)

2. Inventory management

3. Software and equipment validations

4. Deviation system

5. Corrective Action and Preventative Action system

6. Quality Assurance

7. Change Control

8. Training management system

9. Facility maintenance

10. Equipment maintenance and calibration

11. Environmental monitoring

12. Facility sanitation program

13. Document control system

14. Vendor management program

15. Organization and personnel qualifications and responsibilities

16. Regulatory inspection history if applicable (e.g., FDA 482, 483, warning letter, etc.)

b. Document Control Program - The contractor shall maintain a formal document control program to manage the approval, distribution, archival, and change control of all cGMP-relevant documents. This program shall minimally include SOPs, manuals and protocols, software and equipment validation documents, and training records covering the receiving, holding, and shipping of GFP, and it shall be made available to the Government upon request.

c. Standard Operating Procedures - The contractor shall maintain SOPs applicable to receiving, holding, preparing, and shipping of GFP in accordance with cGMP and regulations applicable to the performance of the required services. All contractor employees performing under the contract shall be trained on all approved SOPs applicable to assigned tasks prior to performing the tasks. Current, approved, and controlled SOPs shall be readily available to contractor employees at the facility. At the Government’s request, the contractor shall make SOPs available to the Government for review.

d. Facility Temperature/Humidity Monitoring System - The contractor shall maintain written procedures describing the equipment installation, operation, performance, maintenance (including scheduled storage temperature alarm testing), and Out-Of-Specification (OOS) reporting (including emergency contact information with back-up personnel) of all temperature-controlled storage areas/units. The contractor shall monitor relative humidity in all storage areas (excluding reach-in units) and utilize the required number of probes to accurately record the relative humidity.

The contractor shall report the Mean Kinetic Temperature (MKT) calculation in accordance with the current edition of the United States Pharmacopeia (USP). If an electronic monitoring system is used, the system shall comply with all applicable Federal, state, and local regulations and Government performance requirements cited throughout this SOW for warehousing (i.e., receiving, holding, preparing, and shipping).

1. The COR shall approve each Cold Storage Unit (CSU) temperature monitored area, have a preapproved number of primary temperature probes and back-up temperature probes in accordance with industry standards. They shall be positioned in the coldest and hottest spots of the unit based on the latest temperature mapping. Controlled Room Temperature (CRT) areas shall have primary and back-up temperature probes to accurately record the environmental conditions.

2. Each Reach-in Unit (Cooler/Freezer) temperature monitored area shall have a minimum of two primary temperature probes and two back-up temperature probes positioned in the coldest and hottest spots of the unit based on the latest temperature mapping.

e. Monthly Temperature Reports – By the fifth business day of each month, the contractor shall provide the

Government with a report of the previous month’s temperature data for all storage units, including units that have been validated but contain no product and units holding GFP. At a minimum, the report shall include:

1. Facility code name

2. Unit number identification

3. Storage temperature range

4. Graphical representation of the monthly readings from each storage area

5. Relative humidity for each storage area (excluding reach-in units)

6. Deviations and corrective/preventive actions

7. Detailed temperature readings and explanation for all reportable excursions

8. Explanation for all temperature excursions

9. MKT for the month and previous rolling 12 months

10. Continuous data from the beginning of the month to the end of the month

i. Monthly temperature reports shall be generated from the primary validated temperature monitoring system for each storage area holding GFP, including units that have been validated but contain no product.

ii. The contractor shall provide additional supporting information in the monthly reports as requested by the Government.

f. Deviation/Non-conformances and Corrective Action Tracking - The contractor shall maintain deviation and Corrective Action/Preventive Action (CAPA) systems and document non-conformances to approved procedures, including root cause analysis and actions taken. These systems shall track and trend all deviations, system non-conformances, and CAPAs. The Government reserves the right to evaluate all deviations identified by the contractor that, in the opinion of the Government, can potentially impact product safety, identity, strength, quality, or purity. The Government shall provide product disposition instructions to the contractor, when applicable.

g. Deviation/Non-conformances and Corrective Action Tracking - The contractor shall maintain deviation and Corrective Action/Preventive Action (CAPA) systems and document non-conformances to approved procedures, including root cause analysis and actions taken. These systems shall track and trend all deviations, system non-conformances, and CAPAs. The Government reserves the right to evaluate all deviations identified by the contractor that, in the opinion of the Government, can potentially impact product safety, identity, strength, quality, or purity. The Government shall provide product disposition instructions to the contractor, when applicable.

h. Incident Notification and Reporting – The contractor shall report the following to the Government:

1. Any CRT excursion outside of 68-77°F (20-25°C) for a continuous 24-hour period. Additional notification if CRT excursion falls outside of 59-86°F (15-30°C) for a continuous 24-hour period.

2. Any refrigeration or freezer temperature excursion outside the established range for greater than 0 minutes or preapproved alarm delays.

3. Any temperature monitoring system software and/or equipment failure upon discovery.

4. Any temperature data loss or gaps upon discovery.

5. Any event that may result in product loss, damage, or the potential to impact product quality requires notification to the Government upon discovery.

6. A detailed incident report shall be provided to the Government no later than two business days after 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 contractor shall submit a deviation report within 30 calendar days from the date of the incident. All associated CAPA reports shall be forwarded to the Government upon completion. The contractor shall provide additional supporting information as requested by the Government.

7. If authorized ASPR/SNS personnel are present on site during an incident, the contractor shall include them when making notification to the COR and SNS Quality POC(s).

i. Facility Design and Maintenance/Sanitation Program - The contractor shall implement a maintenance program to ensure that all storage facilities are maintained in a good state of repair and cleanliness and ensure that all facility documents associated with the maintenance program are accurate, complete, and retained in appropriate files. The contractor shall institute appropriate measures concerning cleaning, refrigeration, maintenance, pest control, and the quality system governing those procedures to ensure that the storage specifications for GFP are met.

The contractor shall implement a system to track equipment and software systems required for cGMP compliance including, but not limited to, temperature monitoring; Heating, Ventilation, and Air Conditioning (HVAC); cold storage; and primary and back-up power. This tracking system shall log and schedule all preventive maintenance, validations, and calibrations. Any corrective, scheduled, and non-scheduled maintenance shall be documented, and the contractor shall include the documentation in the records for each piece of equipment.

j. Comprehensive Validation Program - The contractor shall validate all CRT; refrigerated and frozen storage areas; temperature monitoring systems; and any electronic document control, inventory management, change control, training management, CAPA, and deviation systems. Temperature mapping of the CRT area is required.

The contractor shall establish a re-calibration/re-validation program to ensure proper performance of the automatic, mechanical, electronic equipment, or other types of equipment, including computerized systems. All validation documentation shall be available to the Government for review upon request. Equipment used during the qualification shall have a current National Institute for Standards and Technology (NIST) traceable calibration status.

For initial validation, temperature mapping of temperature-controlled areas is required. The backup temperature probes shall be placed in close proximity to the primary temperature monitoring probe(s). The primary and secondary temperature monitoring systems shall be compared to each other. The temperature mapping shall include, at a minimum, 72 hours of temperature data to determine hot and cold spot probe locations.

The contractor shall perform re-qualification and mapping and/or re-mapping of the refrigerated and frozen storage area when significant repairs/changes are made that could affect the temperature within the area, previous validation, or product quality; when storage capacity of the unit reaches 50 percent, 75 percent, and 100 percent; and five years after the previous validation, whichever comes first. For reach-in units, the storage capacity and five-year validation requirements will not apply. The primary and secondary temperature monitoring systems shall be compared to each other.

The contractor shall ensure that all equipment and system validations/re-validations are performed in a timely and accurate manner. The Government reserves the right to review protocols prior to execution for adequacy.

The contractor shall provide a complete report to the Government, including raw data, after each protocol is executed. This report shall contain a synopsis of the purpose of the validation, the tests performed, the acceptance criteria for each test, departures from a protocol, and the results of the validation including a “Pass” or “Fail” declaration. The Government will review the report for each completed validation to determine its adequacy. The contractor shall correct any errors and/or omissions within 30 calendar days of identification.

After final acceptance by the Government, an acceptance document shall be sent to the contractor, filed with the completed validation, and retained on site with the contractor qualification report.

k. 21 CFR Part 11 Compliance and Validation of Computerized System - The contractor shall ensure all computerized systems that create, modify, maintain, archive, retrieve, or transmit data that may directly or indirectly affect the quality of the cGMP products are 21 CFR Part 11 compliant and validated per Software Development Life Cycle (SDLC) concept. Upon request by the Government, the contractor shall provide the Government a written statement certifying that a periodic performance review process is in place to ensure all such systems remain in the validated state throughout their lifecycle.

l. Contractor and Subcontractor Qualifications - The contractor shall ensure all contractor and subcontractors utilized by the contractor in the performance of this requirement have the training and skills required to perform under the contract. All subcontractors shall be regularly evaluated by the prime contractor to ensure performance and quality compliance. Records related to subcontractor performance (including, but not limited to, subcontractor performance assessments or evaluations) shall be made available for review by the Government upon request.

m. Redundant Systems – The contractor shall implement and maintain the following redundant systems:

1. Back-up generator power to maintain and monitor temperature-controlled environments.

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

3. Back-up temperature monitoring system. Each temperature monitored area shall have a minimum of two back-up temperature probes positioned in the coldest and hottest spot of the unit based on the most recent temperature mapping.

4. Data back-up of electronic data capture.

n. Change Control - The contractor shall document changes to all validated systems utilized to monitor and hold GFP. The contractor shall notify the Government, in advance of implementation, of any system changes that may impact GFP for Government assessment and approval.

o. Facility Inspection Notifications - The contractor shall immediately notify the Government of any notice of inspection and of unscheduled inspections or actions by regulatory agencies, other enforcement agencies (e.g., FDA, OSHA), and third-party vendors that may involve and/or impact GFP. For unscheduled inspections or actions, the contractor shall notify the Government immediately upon the arrival of the inspector(s). The Government may designate at least two persons to observe the inspection. The contractor shall immediately provide the Government with any FDA 483 observations, FDA Establishment Inspection Reports (EIRs), and/or other inspection reports upon receipt.

p. Licensing – Prior to the Government’s acceptance of the proposed facility, the contractor (or at least one member of the Joint Venture, if applicable) shall possess current Federal, state, and local jurisdiction licenses for holding and distributing pharmaceuticals as required by the state and local jurisdictions where the facility is located and maintain all required licenses for the life contract. In the event that the local jurisdiction does not require licensing for holding and distributing pharmaceuticals, the contractor (or at least one member of the Joint Venture, if applicable) shall satisfy the applicable legal requirements and provide evidence of compliance to the Government upon request. At a minimum, the contractor shall have registered for the storage and distribution of pharmaceuticals with the FDA.

1.5 Task 1G: Quality Management System (CLIN 1, 1001, 2001, 3001 and 4001)

A. The Contractor shall maintain an internal audit program to assess all elements of its quality management system. Records of internal audit schedules and evidence of audit completion shall be made available to the Government upon request. Internal audits shall include, but are not limited to:

(1) Previous Audit Findings

(2) Standard Operation Procedures

(3) Software and equipment validations

(4) Deviation system

(5) Corrective Action and Preventive Action System

(6) Quality Assurance

(7) Change Control

(8) Training management system

(9) Facility maintenance

(10) Equipment maintenance and calibration

(11) Environmental monitoring

(12) Facility sanitation program

(13) Document control system

(14) Vendor management program

(15) Organization and personnel qualifications and responsibilities

B. The contractor shall conduct weekly cycle counts to ensure 100% of the inventory locations are counted over the course of the calendar year. All locations shall be counted, to include any empty locations. The contractor shall provide the count reports of the inventory to the COR by the end of each month.

(1) The method of location counting may be determined by the Contractor. For example:

i. Sequential aisle from the first to last, left side to right, top to bottom.

ii. Random selection by system selection that only selects the size sample that has not already been counted.

(2) A monthly report of cycle count results shall include:

i. Number of counts since the previous report.

C. The contractor shall conduct 100 percent annual Physical Inventory (PI) of GFP.

(1) The method of locations counting may be determined by the Contractor. For example:

(i) Sequential aisle from the first to last, left side to right, top to bottom.

(2) The contractor may select how the 100 percent annual physical inventory is conducted.

(3) A full report of the PI results shall include:

i. Percentage of YTD completion

ii. Number of discrepancies, not to include scanning errors that are rescanned.

iii. Results of discrepancy research.

iv. Action taken to correct discrepancies and prevent recurrence.

v. An attached document, preferably in Excel, that lists the items and quantities counted compared to the Contractor’s system with user ID and date/time.

vi. Locator

vii. Part Number

viii. Item Description

ix. Quantity

x. Lot Number

xi. Expiration date

xii. Unit of measure

D. Contractor shall document and retain approvals for all changes to building, security, and inventory systems.

Contractor shall document measures to maintain inventory controls and preservation of GFP.

1.6 Task 1H: Inventory and Maintenance Management System (CLIN 1, 1001, 2001, 3001 and 4001)

A. The contractor shall provide an inventory and maintenance management system that is transparent and directly accessible by the Government. The Government prefers a “real time” on-line electronic data interchange (EDI) that captures all transactions pertaining to the GFP and/or provides a digital dashboard to ASPR personnel that provides real-time readiness status.

B. The inventory management system shall provide status and location confirmation for all GFP. Inventory systems shall be maintained in accordance with NIST security standard NIST SP 800-171.

C. At a minimum, the Contractor shall maintain an inventory record and provide a monthly inventory status report of all GFP received, shipped, and moved. These reports shall include notations of any material damage, loss, or theft. These reports shall be sent to assigned ASPR/SNS Project Officer and COR by close of business the last day of each month. At a minimum, this report shall contain the following:

Store Keeping Unit (SKU) Information:

(1) Manufacturer and Model Number / Part Number

(2) SKU Description

(3) Unit of Measure

(4) Unit Cost

(5) Quantity transported

(6) Quantity on hand by facility

(7) Warehouse locations/storage points

(8) Lot number

(9) Expiration date

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

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

(12) National Drug Code (NDC)

(13) Disposal list

Transactions:

(1) Receipts/partial and complete

(2) Report of item discrepancies

(3) Inventory transfers and value of inventory in transit

(4) Inventory count sheets (for physical inventories)

(5) Inventory valuation (and method such as latest acquisition cost)

(6) Deployment capacity (calculates number of units that can be rotated based on historical demand and SKU

Shelf-Life/Expiration Date)

(7) Transportation time for the inventory transfers

2. Task 2: Freight & Transportation (CLIN 3, 1003, 2003 3003 and 4003)

2.1 Freight & Transportation

The contractor shall, at the direction of the HHS/ASPR, distribute products to all points of care as directed and bill in accordance Section B.3. All shipments shall be made using traceable means. The contractor shall provide transportation tracking information from its facility to the point of need.

A. For each shipment, Contractor shall provide the following information to the COR within 48 hours after shipment:

(1) Delivery/order number/Bill of Lading

(2) MFR/Product #

(3) Product Name

(4) Qty Shipped

(5) Number of Containers/Pallets

(6) Date Shipped

(7) Estimated delivery date/time

(8) Carrier Name

(9) Tracking Number(s)

(10) Proof of Delivery, provided within 48 hours after delivery

(11) Packing Slip

B. The contractor shall include an outside packing label for each shipping container (defined as a pallet or a full manufacturer case) that must contain the following minimum data elements:

(1) Shipper’s address

(2) Ship to address

(3) Any mark for data/wording directed by the COR (e.g., “PANDEMIC COVID PROGRAM”)

(4) Delivery/Order Number

(5) Number of Boxes/Cases Shipped (e.g., 1 of 4, 2 of 4, 3 of 4, 4 of 4, etc.)

(6) Special handling instructions

C. The contractor shall include an inside packing slip containing the following information:

(1) Customer name

(2) Ship to address

(3) MFR Part Number

(4) Product Name

(5) Unit of Issue

(6) Qty Shipped

(7) Delivery/Order number

(8) Customer PO number

D. Under FOB Destination procedures, any damages as well as any loss of GFP that occurs while under possession of the Contractor, including while in storage and in-transit to a delivery location, is the responsibility of the Contractor. The Contractor shall notify the Contracting Officer and COR within 24 hours after loss or damage of GFP is known to Contractor. Contractor shall initiate action to replace all damaged or missing GFP to the Government within 72 hours after the loss or damaged GFP is identified.

Risk of loss is limited to the insurable or replacement value of the products. If GFP is damaged while under possession of Contractor, Contractor is responsible for all disposal and replacement costs. If GFP is damaged upon delivery, the USG will coordinate a return or request the product to be delivered to a designated location at time of issue.

E. For delivery location(s) located outside the continental United States (OCONUS), Contractor shall notify

ASPR/SNS of the time frame for expected delivery, including information regarding whether the delivery schedule will be subject to any additional time required to clear Customs or other applicable import or export procedures. Shipments to a delivery location(s) in a U.S. Territory will be subject to the applicable OCONUS Outbound Fee set forth in the Freight and Transportation Cost Schedule. Contractor shall notify ASPR/SNS of any governmental support needed to facilitate deliveries to delivery location(s) in U.S. Territories. Delivery locations(s) in the U.S. Territories may require the use of a customs broker and/or the payment of import fees, taxes, or duties in order to deliver GFP. The Contractor shall bill the Government for any such import fees, taxes, duties, or similar charges incurred for such deliveries to location(s) in U.S. Territories under the CLIN(s) 3, 1003, 2003, 3003 and 4003.

F. The contractor shall notify COR or project manager within a reasonable time of any delays that may impact scheduled delivery times, but no later than 24 hours from the time the delay is known.

C.5 Facility Requirements:

A. Physical Infrastructure. The Contractor shall provide GFP management facilities and logistics footprint across the Continental United States (CONUS) in accordance with the following minimum criteria:

1. The contractor shall provide a minimum of eight (8) facilities capable of holding up to a combined 320,000 pallet positions for all locations.