Request for Information - Site G.pdf

GENERAL SERVICES ADMINISTRATION (GSA)

ASSISTED ACQUISITION SERVICES (AAS)

REQUEST FOR INFORMATION (RFI)

I. INTRODUCTION

General Services Administration (GSA) Assisted Acquisition Services (AAS) is releasing this

Request for Information (RFI) on behalf of a United States (U.S.) Government Agency (the

Agency) that is considering a requirement for managed services for medical supplies and pharmaceuticals at a single, contractor-provided site. The purpose of this RFI is to assist the

Government in conducting market research focused on identifying respondents. This information will be used for market research only. The Government is not obligated to release a future solicitation.

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.

II. BACKGROUND

The purpose of this RFI is to understand the options for managed services at a contractor-provided site in the designated area and the capabilities of the open market to provide services that support the Agency’s requirements. The RFI responses will assist GSA AAS and the Agency with tailoring the requirement as well as selection of the most appropriate procurement source. The

Government requests information that includes the respondent’s corporate capabilities related to providing pharmaceutical supply chain logistics and management. This information is intended to assist the Government in determining if the potential final RFP will be set-aside for Small

Business. More information about the requirements will be provided with any potential future solicitation. Feedback to this RFI may impact the Government’s choice of an acquisition vehicle and any potential future government requirements.

This RFI is being issued on behalf of the Agency considering a requirement for a contractor-provided site and managed services including the shipping preparation, receiving, secure storage, and inventory management of medical supplies and pharmaceuticals at a single, contractor-provided site. The designated geographical area for the site is encompassed in the Mid-Atlantic region. A map of the specific designated geographical area for the site will be disclosed to respondents that agree, in writing, to keep that area confidential. Respondents desiring that information should complete and return the attached Corporate Non-Disclosure Agreement

(NDA) via e-mail to the AAS Contracting Officer, at elizabeth.steiner@gsa.gov and the AAS

Contract Specialist, at natalia.belinsky@gsa.gov. Note: It is not mandatory to submit the mailto:brendan.miller@gsa.gov mailto:jane.facchina@gsa.gov

Corporate NDA in order to respond to this RFI. However, only respondents that submit the signed

Corporate NDA will receive the map of the designated geographical area.

GSA AAS is issuing this notice as an RFI for market research and to obtain industry feedback about the structure of a potential RFP as described below. The Government is considering the release of a solicitation for contractor support on the Open Market using FAR Part 12, Commercial Acquisition. This support entails the logistical management of Government-owned pharmaceuticals, medical supplies, and medical equipment at a contractor-provided site. The

Government anticipates that potential RFP will be for a total period of ten years, structured with a five-year base and five one-year option periods, on a firm-fixed-price (FFP) basis for the mandatory managed services. Monthly FFP Managed Service contract line-item number (CLIN) may commence after the contractor provides the use of a site that satisfies all requirements for ambient product at a minimum, and upon the commencement of the contractor receiving products for storage and management. The monthly Managed Service CLIN price shall include all management and operational costs. The Government anticipates a separate FFP CLIN which will allow conditioning the facility up to the standards set forth in the RFP.

III. ANTICIPATED MANAGED SERVICE REQUIREMENTS

The contractor shall provide all necessary expertise, labor, materials, equipment, and use of space to receive, stage, kit and prepare for shipment pallets and other containers holding these items safely and securely. The Government’s anticipated managed service requirements include, but are not limited to, the following which are subject to change prior to any potential procurement action.

a. The contractor shall provide a fully staffed and continuously operational facility during core hours of operation. Core hours of operation are Monday to Friday, 7 a.m. to 5 p.m. local time. At a minimum for palletized shipments, the everyday staff size shall be able to pick, pull, prepare for shipment, and load or receive 100 pallets per hour. Additionally, the everyday staff size must be able to pick, pull, and prepare for shipment in support of the automated small partial shipments system completing 300 shipments per hour. Except for initial transition-in of the product, the Government will manage the transportation of medical materials and other stock to and from the facility. The contractor will only be required to receive, stage, sort, manage, inventory, weigh, package, certify and load onsite inventory.

On-site skilled management will be critical. Some products are received in bulk and others will need to be palletized. Quality control procedures will be required onsite.

b. The contractor will also be prepared to provide emergent surge support 24 hours a day, seven days a week within two hours of notification at a rate of 200 pallets per hour.

c. The contractor’s inventory management system is required to transmit data and flat files with inventory details on a real time basis.

d. The contractor will also provide materials handling equipment necessary for storage and retrieval of the pallets, containers, calibrated and certified scales, and all other equipment necessary in accordance with Current Good Manufacturing Practice (cGMP).

e. The contractor shall manage a minimum of 48,000 pallets, consisting of approximately

43,000 pallets Controlled Room Temperature (CRT, (ambient)) and 5,000 pallets of refrigerated/frozen (Cold Storage) and Ultra-Low Temperature (ULT).

f. The contractor shall 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.

IV. ANTICIPATED SITE REQUIREMENTS

The Government’s anticipated requirements for the contractor-provided site include, but are not limited to, the following which are subject to change prior to any potential procurement action:

a. The site shall be located within the designated geographical area (to be provided after a signed Corporate NDA is received). The site shall be located no more than five miles from access to a major highway and shall not utilize limited access and/or restricted roads for 53’ tractor trailers as primary routes, as defined by Federal Highway Administration guidelines.

b. The site shall not be within two miles of an active landfill or one that was utilized for waste materials (e.g., municipal, household, commercial, metabolic, construction, demolition, hazardous, etc.) or waste management (collection, disposal, transport, treatment, offloading, containment, etc.) during the past ten years from the date of solicitation.

c. The site shall not be located over wetlands and/or in a Federal Emergency Management

Agency (FEMA) High Risk or coastal high risk designated floodplain. Additionally, if the site is located in a FEMA Category D (Undetermined Risk), the Government may require the contractor to have a third-party, independent engineering firm conduct an analysis and submit it to the Government for final suitability determination. The Government’s determination will be final.

d. If the site is located within an expanded watershed area, engineered drainage must be designed and illustrated to prevent the facility from being flooded under normal weather conditions (meets the 100-year floodplain). The designated parking, loading docks, or building must be more than 600 feet from the designated floodplain drainage area and within a ten feet difference in elevation from the designated floodplain drainage area. The lowest point of elevation of the site should be 10 feet above the water embankment area.

e. The Government will take into consideration the surroundings of the facility, general location, crime, environmental concerns, etc.

f. The building and parking must have at a minimum a single perimeter fence with two sliding powered gates with controlled electronic access that shall be secured except when access is required.

g. The building shall be sufficiently conditioned in order to gain Government approval and receive product for storage and emergency preparedness within 180 calendar days of award.

Additional time for walk-in cold storage may be considered, but transition timelines may be prioritized in source selection.

h. The building shall have four walk-in cold storage units (two coolers and two freezers) along with two ULT freezers where each freezer has two ULT chambers. There will be a requirement to map, validate, monitor, and perform maintenance on multiple refrigeration systems where product will be received, shipped, and stored. The temperature range will be between 20° Celsius (C) to -80°C (CRT/Ambient: 20°C to 25°C, Cold Storage: 2°C to -

30°C, and ULT -80°C).

i. At a minimum, the building shall have been constructed or will be rehabilitated to the

International Building Code (IBC) version 2018 or later. If local Authority Having

Jurisdiction (AHJ) has adopted a later IBC version or more stringent building or design codes, then the building must meet those building codes. For planning purposes, the National

Fire Protection Association (NFPA) classification for the stored products is Class IV;

however, final determination will be the local AHJ.

j. The building’s racking system shall consist of 50,000 to 60,000 pallet positions. At a minimum, 15 percent or 7,500 of the overall racking systems shall accommodate 83” high pallets with the remaining positions accommodating 60” high pallets not to exceed 2,500 pounds. Note, the Government anticipates approximately 95 percent of the product received by the contractor will be on standard pallets weighing no more than 2,500 pounds. The racking system 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 contractor shall use single pallet position storage with at least 16” of space between the backs of pallets with pallet stops to accommodate fire protection, timely response, and to eliminate product damage. No product will be stored outside of a racked position or directly on the floor unless it is in a rolling or specialized approved container. All pallet positions will utilize a pallet rack wire decking bottom positioned 4” off the floor unless roller containers will be stored at that position. For operational efficiency, rack position height will not exceed six positions. Specialized rolling containers and storage pallets will be required for ULT products, therefore, ULT storage will not count toward the overall pallet positions.

k. The building shall have one side dedicated for 21 ambient operational dock doors (18 operational, one drive-up ramp, one door for small partial shipments, and one for trash). That same side of the building shall have four operational cold storage dock doors with the dock being a minimum of 4,000 square feet (sq ft). No cross docking will be permitted. For ambient only, there shall be a minimum of 1,100 sq ft (22’W x 50’L) of unimpeded staging area (open floor space) per operational dock door.

l. The building shall have 5,000 sq ft of open floor space with electric outlets, potable water, and floor drainage.

m. The building will have extra-large aisles and fork truck travel route access large enough to transport specialized products to the main shipping and receiving docks.

n. The building shall be outfitted for full small parcel automation storage and shipments. This will include but is not limited to flow racking, powered conveyors, scanning, ship sortation, ship labeling, weight, dimension, allocations, replacement, cycle counting location, reporting, etc. Also, it will include at least three pack out stations capable of shipping 40-60 shipments each per hour.

V. QUESTIONNAIRES

All respondents are requested to respond to attached Questionnaires A, B, and C, herein.

A - Corporate Overview

B - Corporate Capabilities

C - Market Assessment Questions

It is not mandatory to submit the Corporate NDA with your RFI response. However, a signed

Corporate NDA is required for the disclosure of the map of the designated geographical area.

Complete the questionnaire as outlined below:

a. Responses shall be submitted electronically by email only to Elizabeth Steiner, AAS

Contracting Officer, elizabeth.steiner@gsa.gov and Natalia Belinsky, AAS Contract

Specialist, natalia.belinsky@gsa.gov. Use the attached questionnaires to provide the requested information (i.e., no substitutions, additions, or deletions).

b. All responses shall maintain one-inch margins, use 12-point Times New Roman font, and be single spaced.

c. Responses should be concise and shall not exceed 10 pages for all three questionnaires combined.

d. All information submitted shall be UNCLASSIFIED.

e. Responses shall be submitted no later than 11 a.m. Eastern Time on December 11, 2024 according to the instructions in item V.a. above.

f. Send questions to the AAS Contracting Officer and Contract Specialist, as mentioned in item

V.a. above.

A: Corporate Overview

Name of Company

Name of Business Unit Responding to the

RFI (as applicable)

UEI Number

CAGE Code

Corporate Address

Total Number of Full Time Employees

Website URL

Company registered under NAICS

493120

□ YES □ NO

Small Business □ YES □ NO

Type of Small Business, if Applicable

(e.g. Woman-Owned, Service Disabled

Veteran Owned, 8(a), HUBZone)

One Point of Contact (POC)

(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):

Hazmat Level I Certification □ YES □ NO

DEA Certification (Level II, III, IV, and

V)

□ YES □ NO

State Business Pharmaceutical Licenses.

If so, please list each applicable state.

□ YES □ NO

cGMP Certification □ YES □ NO

Other Certifications, please specify:

□ YES □ NO

B: Corporate Capabilities

Please provide, to the extent of your capabilities, the following information:

1. Describe your company’s/business unit’s experiences and methods for handling surge

(emergency response) requirements while maintaining day-to-day operations in a cGMP compliant facility.

a. If your company has participated in emergency response, please define the emergency response time requirements during a surge exercise and provide examples of situations supported.

2. Identify any tools or technology (e.g., Enterprise Resource Planning Systems, Inventory

Management Systems) your company/business unit utilizes to reliably provide accurate inventory data in real time?

3. Provide a list of pharmaceutical grade facilities currently or recently managed by your organization including dates. Please indicate location, size, overall quantity and volume of the commodities handled at each facility.

4. Describe your experience managing subcontractors.

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

C: Market Assessment Questions

1. Based on your expertise, do you have any recommendations for the Government in the development of this requirement?

2. What is the biggest obstacle you anticipate in bidding to a requirement with the specifications described in Sections I through V?

If your company has provided a signed Corporate NDA and has received the map of the designated geographical area, please answer the following questions:

3. Has your company identified an existing and available suitable site(s) in the designated geographical area? ▢ Yes ▢ No

4. What are the challenges/biggest obstacles, if any, you anticipate in the designated geographical area.

5. What transportation issues would you anticipate as problematic in the designated geographical area (e.g., heavy traffic/bottlenecks, planned construction, special event traffic, road closures, etc)?