Request for Information Site L 47QFCA21N0009.docx

General Services Administration (GSA) Federal Systems Integration and Management Center (FEDSIM) Request for Information (RFI) Disclaimer: This RFI does NOT constitute a Request for Proposal (RFP) and is not to be construed as a commitment, implied or otherwise, by the Government that a procurement action will be issued. Response to this notice is not a request to be added to a bidders list or to receive a copy of a solicitation. No entitlement to payment of direct or indirect costs or charges by the Government will arise as a result of the submission of the requested information. No reimbursement will be made for any costs associated with providing information in response to this announcement and any follow up information requests. Responses to this RFI may be considered in the future determination of an appropriate acquisition strategy for the program. The Government may not respond to any specific questions or comments submitted in response to this RFI or information provided as a result of this request. Any information submitted by respondents as a result of this notice is strictly voluntary.

To Be Released on the Open Market:

This RFI is being issued by FEDSIM on behalf of a U.S. Government Agency (the Agency) that is considering a requirement for managed services including the secure storage, management, and distribution of medical supplies and pharmaceuticals, “Site L.” The Site L’s geographic location will be disclosed to prospective offerors that agree, in writing, to keep confidential that location, the Agency’s identity, and other sensitive information. Prospective offerors desiring that information should complete and return the attached Non-Disclosure Agreement (NDA) via e-mail to the FEDSIM Contracting Officer, Nydia Roman-Albertorio at nydia.roman-albertorio@gsa.gov and the Contract Specialists, Jane Hardesty at jane.facchina@gsa.gov and Natalia Belinsky at natalia.belinsky@gsa.gov as soon as possible. Note, it is not mandatory to submit the NDA in order to respond to this RFI – submission of the NDA and receipt of the site and Agency information is at the prospective offeror’s option, but only those that do so will receive the sensitive information.

BACKGROUND

FEDSIM plans to solicit for contractor support on the Open Market using FAR Part 12, Commercial Acquisition, for the logistical management of Government owned pharmaceuticals, medical supplies, medical equipment, medical surgical, and/or Investigational New Drugs product at a site located within the United States and its territories. The contractor will provide all necessary expertise, labor, materials, equipment, and use of space to safely and securely receive, store, weigh, stage, kit and prepare for shipment pallets and other containers holding product (as described in the Scope section below, with greater detail to be provided in any resulting solicitation).

SCOPE

1. Site: Shall be located within the prescribed driving distance of an international airport capable of large aircraft (exceeds 41,000 lbs.) takeoff and landing. Site shall be located no more than five miles from a limited access highway, as defined by Federal Highway Administration guidelines. The site will be used to manage Schedule II, III, IV, and V controlled products (refer to Title 21 Code of Federal Regulations (CFR), Part 1308) as well as medical equipment and related medical items. There will be a requirement to validate, monitor, and perform maintenance on multiple refrigeration systems with temperatures range of -25 to 8 degrees Celsius where bulk and individual Cold Chain products will be stored. The warehouse temperature range for Controlled Room Temperature (CRT)/ambient will be between 20 – 25 degrees Celsius.

The facility shall be fully conditioned and have the necessary security in place prior to gaining Government approval. Government approval is required within approximately 180 calendar days of award and prior to any receipt of product for storage and emergency preparedness. A timely transition within 120 days is preferred. Conditioning time may vary for each location and will be coordinated by the contractor based upon location specific requirements and corresponding licensures. Each site will require the Contractor to manage approximately 35,000 pallets of medical products / equipment with at least 16” of space between backs of pallets with pallet stops above the main floor level. Approximately fifteen percent of the ambient floor positions will accommodate 83” high pallets and containers with and without wheels, with the remaining positions accommodating 60” high pallets. This inventory is managed with a combination of Tri-wall containers, cases, and rolling containers suitable for medical and pharmaceutical products. Inventory control will be required onsite and certain inventoried products will be subject to validated weight checks using calibrated instruments. The space occupied will consist of pallets of varying heights in accordance with the International Organization for Standardization (ISO). A typical pallet is 48”x 40” at the base, however, sometimes non-typical pallets are received, and the racking positions must accommodate those pallets.

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 the correct classification prior to submitting their proposal. Additionally, the contractor shall use single pallet racking storage to accommodate timely response and to reduce product damage. The Site will be required to have both standardized and non-standardized pallet racked spaces. Non-standardized racking will accommodate medical products such as tents and generators. The Site shall have extra-large aisles and forklift truck travel route access large enough to transport non-standardized pallets and products to the main shipping and receiving docks. This area will have 5,000 square feet of open floor space with electrical outlets, potable water and floor drainage for maintenance. Aisles and forklift / truck lanes will not count toward warehouse open floor space. Along with loading docks, this site will have a drive up/in ramp.

2. Logistics: The contractor will provide staff for normal hours of operation, which are Monday through Friday, 7AM to 5PM local time. The contractor will also provide materials handling equipment necessary for storage and retrieval of the pallets, containers and equipment in accordance with current Good Manufacturing Practices (cGMP), along with calibrated and certified scales. Also, the Contractor shall be responsible to adhere to all other applicable cGMP requirements and Government quality assurance requirements to ensure the appropriate operation of a Government-contracted storage facility as it pertains to receiving, holding and shipping preparation of finished owned pharmaceuticals, medical supplies, medical equipment, medical surgical, and/or Investigational New Drugs products. The Government will manage transport of medical materials and other assets to and from the facility; at a minimum, the contractor will be required to stage, sort, inventory, weigh, load, document, and report pertinent transportation information on-site. Also, the contractor will be required to pack and document all HAZMAT and controlled substance shipments using both distributor and export registrations. The contractor shall be required to provide emergency surge support of the managed services on short notice, the SLA requires support at the rate of up to 200 pallets per hour. Skilled management of inventory is critical to emergency preparedness; flexibility and scalability is desired as inventory is evaluated and replenished over the duration of the contract. The Government will manage transportation of supplies to the contractor-provided space for storage and will transport those materials away from the contractor-provide space due to stock expiration or for scheduled rotation. More information will be provided at the time of a potential solicitation.

PURPOSE

FEDSIM is issuing this notice as an RFI for market research and to obtain industry comments about the structure of potential Request For Proposal as described below.

The Government anticipates that any potential RFP will be for a total period of ten years, structured with a five-year base and five one-year optional periods on a firm fixed price (FFP) basis for the mandatory managed services. Monthly FFP Managed Service Charges will commence after the contractor provides for the use of a facility that satisfies all requirements, the site is accepted, and the contractor begins receiving the products for storage and management. The monthly Managed Service Charges shall include all management, operational, and facility costs. The conditioning costs shall be proposed as a separate FFP line item. The contractor will be required to obtain its own financing for any necessary facility modifications, although the Government is willing to consider progress payments for transition-in milestones to lessen the financial burden of preparing the facility for long-term use.

To determine if the potential RFP will be set-aside for Small Business, please follow the instruction below by providing the size standard(s) of your firm as stated in the System for Award Management (SAM).

REQUEST FOR INFORMATION

The Government requests information that includes the vendor’s corporate experiences related to providing pharmaceutical supply chain logistics and management. More information about the requirements will be provided in any resulting solicitation.

All prospective offerors are requested to respond to attached Sections 1, 2, and 3, herein.

Section 1 - Market Research Data Submission Section 2 - Corporate Capabilities Section 3 - Medical Warehouse Management Corporate Experience

The Corporate Non-Disclosure Agreement for Managed Services is not a requirement as part of the RFI submission but IS a requirement to receive the Site location for consideration. Responses should be concise and meet the following limitations: an editable Word document with a maximum of 10 pages, using one-inch margins and font size greater than or equal to Times New Roman 12. There is no font size restriction for graphics if any are provided. Cells in the Corporate Experience table in Sections 1 and 3 may be stretched as needed to fit required information, subject to the overall page limitation.

Responses to this RFI are due no later than 11:00 AM Eastern Time, June 28, 2021, via e-mail to the FEDSIM Contracting Officer, at Nydia.Roman-Albertorio@gsa.gov and the Contract Specialists, at Jane.Facchina@gsa.gov and Natalia.Belinsky@gsa.gov.

Section 1: Market Research Data Submission

All respondents are requested to provide the following Company Data, Corporate Capabilities, and Corporate Experiences. This information could help to determine if the potential final RFP will be set-aside for Small Business.

Company Data:

Name of Company

Name of Business Unit Responding to the RFI (as applicable)

DUNS Number

CAGE Code

Corporate Address

Total Number of Full Time Employees

Website URL

Type of Small Business, if Applicable (e.g. Woman-Owned, Service Disabled Veteran Owned, 8(a), HUBZone)

One Point of Contact Name (Enter Name, phone number and email address)

Please identify which, if any, of the below formal accreditations or certifications are held by your firm (Do not include any self-certifications):

Section 2: Corporate Capabilities Please provide, to the extent of your capabilities, the following information:

1. Describe your corporate capabilities handling pharmaceutical and medical supplies in accordance with cGMP. Please describe experience with special handling of supplies, including but not limited to vaccines, hazmat products, and controlled substances.

2. Describe your company/business unit’s experience with cold-chain management as described in the Agency’s requirements.

3. If you have an inventory management system, please describe it.

4. Describe your company/business unit’s experiences and methods for handling surge (emergency response) requirements while maintaining day-to-day operations.

5. Does your company currently have existing and available suitable space(s) suitable to meeting the size specifications outlined above? □Yes □No

6. In the event new space would need to be acquired, providing information on the availability in this market of a facility needed to meet the size required in the RFI, and current market price per square foot for facilities this size.

7. What would be required to convert the possible warehouse to a cGMP compliant facility and the amount of time required for this conditioning? Please describe any concerns around this transition-in timeline.

Optional:

The Government appreciates additional information for this market research. If applicable, please share any relevant details pertaining to the following areas:

1. Describe your company/business unit’s experience with Enterprise Resources Planning (ERP) management systems and/or technology with specific tools as recommended. Expand on your company’s experience with electronic data interchange (EDI) methodologies and technologies utilized in your business.

2. What information is critical to a bid/no-bid decision for this scope of managed services?

3. State if your company/business unit would intend to partner or team in order to fulfill the scope and needs of this requirement.

4. Due to the magnitude of the federal response to the COVID-19 pandemic, the Government has established auxiliary support at multiple locations. The Agency continues to seek cost-effective solutions to manage the supply and demand of inventory. Describe if your company/business/unit would be able to provide a more cost-effective solution with modified requirements for ambient storage, such as 25,000 or 50,000 pallets.

Section 3: Medical Warehouse Management Corporate Experience FEDSIM and the Agency are principally concerned with the prospective offerors’ corporate experience with services that are similar in size and/or scope to the Agency’s requirements mentioned in this RFI. Please provide up to three examples of corporate experience, stating which company or business unit is performing or previously performed the work. Note, internal, commercial, and state or local experience as well as U.S. Government contract work experiences are of interest.

Corporate Experience

Contractor / Business Unit Performing the Work

Dollar Value of Warehouse and Supply Chain Logistics Services (Total and Annual)

Scope (e.g., Primary Tasks)

List the types of products stored in the warehouse facility.

Client Organization

Client Organization Name

Client Organization Locations

Client Points of Contact

Corporate Experience Information

Project Name/Title

Contract Identification (Number, Title)

Contract Type (FFP, LH, CPAF, CPFF, etc.)

Period During Which Service Was/Is Provided

Specific Responsibilities of Prime Contractor

Specific Responsibilities of any Subcontractors

Percentage of overall work directly provided/performed by the Prime Contractor