Sources Sought ASnD DBPAO 23 May 2024.pdf

Version – July 2015

SOURCES SOUGHT TECHNICAL DESCRIPTION FOR SERVICES

INTRODUCTION

The U.S. Army Contracting Command – APG, Edgewood Division, (SCRT), 4215 Brigade Street, APG, MD 21010, is issuing this sources sought synopsis as a means of conducting market research to identify parties having an interest in and the resources to support the requirement for Assembly/Manufacture, Storage, and Distribution of Defense Biological Product Assurance Office (DBPAO) Products.

The intention is to procure these services on a competitive basis

BASED ON THE RESPONSES TO THIS SOURCES SOUGHT NOTICE/MARKET

RESEARCH, THIS REQUIREMENT MAY BE SET-ASIDE FOR SMALL BUSINESSES

(IN FULL OR IN PART) OR PROCURED THROUGH FULL AND OPEN

COMPETITION. All Small Business Set-Aside categories will be considered. Telephone inquiries will not be accepted or acknowledged, and no feedback or evaluations will be provided to companies regarding their submissions.

PLACE OF PERFORMANCE

Location

% On-Site Government

% Off-Site Contractor

Contractor Site 0% 100%

DISCLAIMER

“THIS SOURCES SOUGHT IS FOR INFORMATIONAL PURPOSES ONLY. THIS

IS NOT A “REQUEST FOR PROPOSAL (RFP)” TO BE SUBMITTED. IT DOES

NOT CONSTITUTE A SOLICITATION AND SHALL NOT BE CONSTRUED AS A

COMMITMENT BY THE GOVERNMENT. RESPONSES IN ANY FORM ARE

NOT OFFERS AND THE GOVERNMENT IS UNDER NO OBLIGATION TO

AWARD A CONTRACT AS A RESULT OF THIS ANNOUNCEMENT. NO FUNDS

ARE AVAILABLE TO PAY FOR PREPARATION OF RESPONSES TO THIS

ANNOUNCEMENT. ANY INFORMATION SUBMITTED BY RESPONDENTS TO

THIS TECHNICAL DESCRIPTION IS STRICTLY VOLUNTARY. RESPONSES

WILL NOT BE RETURNED TO THE RESPONDER. NOT RESPONDING TO

THIS NOTICE DOES NOT PRECLUDE PARTICIPATION IN ANY FUTURE

REQUEST FOR QUOTE (RFQ) OR INVITATION FOR BID (IFB) OR RFP, IF

ANY ISSUED. IF A SOLICITATION IS RELEASED, IT WILL BE SYNOPSIZED

ON THE GOVERNMENT-WIDE POINT OF ENTRY (GPE). IT IS THE

RESPONSIBILITY OF POTENTIAL OFFERORS TO MONITOR THE GPE FOR

ADDITIONAL INFORMATION PERTAINING TO THIS REQUIREMENT.”

PROGRAM BACKGROUND

The Defense Biological Product Assurance Office (DBPAO), is designated as the principal resource of high quality, validated, and standardized biological detection assays and reagents that meet the requirements of the warfighter and the Joint Biological Defense Systems, and support the biological defense community by facilitating the transition of new technologies and coordinating their advanced development, efficient production, and timely distribution. In accordance with these assignments, the DBPAO is responsible for the development, production, conformance testing, inventory management, and security of DBPAO products.

DBPAO products include antibodies, polymerase chain reaction (PCR) assays, electrochemiluminescence (ECL) assays and positive controls, lateral flow immunoassays (LFI) that include handheld assays (HHA) and biological sampling kits (BSK), that are crucial to the mission of all current and future biological warfare agent detection systems.

REQUIRED CAPABILITIES

The Contractor shall provide assembly/manufacture, storage, and distribution services in support of the areas specified in Program Background (above).

If your organization has the potential capacity to perform these contract services, please provide the following information: 1) Organization name, address, email address, Web site address, telephone number, and size and type of ownership for the organization; and 2) Tailored capability statements addressing the particulars of this effort, with appropriate documentation supporting claims of organizational and staff capability. If significant subcontracting or teaming is anticipated in order to deliver technical capability, organizations should address the administrative and management structure of such arrangements.

The Government will evaluate market information to ascertain potential market capacity to: 1) provide services consistent, in scope and scale, with those described in this notice and otherwise anticipated; 2) secure and apply the full range of corporate financial, human capital, and technical resources required to successfully perform similar requirements; 3) implement a successful project management plan that includes: compliance with tight program schedules; cost containment; meeting and tracking performance; hiring and retention of key personnel and risk mitigation; and 4) provide services under a performance based service acquisition contract.

SPECIAL REQUIREMENTS:

Personnel and Facility Security Clearances. A DD Form 254 Contract Security Classification Specification shall apply to this requirement and the prime contractor shall have a Secret Facility Clearance and Secret level personnel clearance at contract award.

Berry Amendment

IT (e.g. Clinger-Cohen Act)

Service Contract Act

Government Furnished Property plan.

ELIGIBILITY

The applicable NAICS code for this requirement is 339999 with a Small Business Size Standard of 550 employees. The Product Service Code is 9390. Businesses of all sizes are encouraged to respond; however, each respondent must clearly identify their business size in their capabilities statement.

ADDITIONAL INFORMATION AND SUBMISSION DETAILS (CAPABILITIES

STATEMENT)

Interested parties are requested to submit a capabilities statement of no more than ten

(10) pages in length in Times New Roman font of not less than 10 pitch. The deadline for response to this request is no later than 5 pm, Eastern Standard Time (EST), 30 May 2024. All responses under this Sources Sought Notice must be e-mailed to Jemel Hogan at jemel.m.hogan.civ@army.mil and Emily McGill at emily.c.mcgill.civ@army.mil.

This documentation must address at a minimum the following items:

1.) What type of work has your company performed in the past in support of the same or similar requirement?

a. Does your company have the capability to assemble/manufacture the following end items that incorporate the Government-provided lateral flow immunoassay (LFI) strips: Hand Held Assays (HHAs), HHA Panels, Biological Sampling Kits (BSKs), Joint Biological Point Detection System (JBPDS) carrier box, and the Joint Portal Shield (JPS) system carrier box?

b. Does your company have the capability to meet the manufacturing area requirements listed below?

Dedicated manufacturing areas that are physically controlled with access limited to contractor personnel identified as manufacturing and quality assurance teams who will perform assembly/manufacturing.

A standalone 800 square feet minimum, temperature range for 20°C– 25°C (66°F–77°C), and humidity controlled/clean room (HCR) with HEPA filtration (Class 100,000) to minimize particulate exposure during the assembly of end items.

A wireless monitoring system to ensure the required temperature and humidity of the HCR are maintained.

Segregated areas for incoming assembly supplies to hold materials through the quality inspection process.

Floor space for acceptance of incoming materials sufficient for potential maximum operations.

Assembly tables and chairs to complete the assembly of end items.

Cameras to monitor assembly area to ensure products are handled in accordance with Government specifications.

c. Does your company have the capability to meet the storage requirements listed below?

A minimum of two dedicated coolers, with capability to maintain 2°-8° C temperature range, for storage of assay strips to maintain separation between agents.

A minimum total storage capacity of 18,000 cubic feet that will accommodate a minimum single cooler size of 350 cubic feet for bulk box product storage.

24-hour emergency power backup system(s) with o temperature and humidity monitoring to maintain storage at 2°-8°C and at less than 40% relative humidity o capability to provide uninterrupted power to maintain required manufacturing and storage conditions during power outages o automated monitoring system with recorder and alarm features and capability to notify personnel of possible power failue and loss of environmental control

d. Does your company have the capability to meet the distribution requirements listed below?

Packaging IAW 49 CFR Part 173 (2023) Shippers – General

Requirements for Shipments and Packaging, and IAW best manufacturing practice to ensure protection of products from damages, environmental conditions, and reasonable transpostation delays.

Capability to ship within CONUS and to OCONUS locations IAW import/export regulations while ensuring product quality, performance, and shelf life are maintained with the use of validated thermal (cold chain) management protocols.

Registration with the U.S. Department of State for shipment of military products to OCONUS locations.

Registration under the International Traffic in Arms Regulations (ITAR) IAW ITAR 22 CFR Parts 120-130.

Capability to use commercial tracking software to ensure products arrive at each particular destination intact and on time.

Capability to use documented quality control procedures to assure products are packaged and shipped to prevent damages or deterioration.

Capability to provide customer notification with shipping information, including tracking number, within 24 hours of shipment.

e. Does your company have the capability to perform inventory management?

Capability to use proven commercial or military best inventory management practices to store DBPAO products under the appropriate storage conditions as required by product labels or other Government provided storage conditions (e.g., 2°-8° Celsius) to maximize product performance integrity and shelf life.

Capablity to provide and maintain an inventory management system to manage the movement of goods to, from, and throught the warehouse.

Capability to implement first-in, first-out stock rotation plan.

f. Does your company have the capability to meet the requirements for disposal of DBPAO products?

Capablity to dispose of end items and other DBPAO products as directed by the Government and IAW local, state, and federal statutes and regulations.

Capability to prepare expired products for disposal by o palletizing, shrink wrapping, labeling for desctruction o auditing, updating inventory report to reflect product movement from active inventory to destruction inventory o inventory of pallet o marking of pallet for destruction

Capability to conduct destruction efforts of expired products on a semiannual basis.

Capability to destroy non-hazardous wastes (i.e., cardboard boxes, aluminum foil, alumnium pouches) by witnessed burn at a solid waste incinerator IAW Guidelines for the Thermal Processing of Solid Wastes, Solid Wastes Accepted, 40 CFR Part 240.200.

Capability to expose expired products to a suitable chemical solution to ensure denaturing of biologics prior to transfer to a licensed medical waste disposal or incinerated IAW federal, state, and local guidelines/restrictions.

g. Does your company have the capability to implement a Shelf Life Evaluation Program?

Capability to develop shelf life evaluation protocol to o inspect and test shelf life of DBPAO products for a period of three years from receipt of Government furnished materials within the contract period of performance o test assembled end items and measure packaging integrity o inspect packaging for leaks or moisture breach o inspect labels for fading or conditions affecting legibility and dessicant discoloration Capability to develop a Shelf Life and Product Stability Plan that follows the ANSI/ASQ Z1.4-2008 standard that includes o Exterior hermetically sealed packaging leak test (MIL-STD-3010

Test Method 5009) o Ensure labeling is legible and intact so barcode is readable by automated reader o Identification of products for destructive testing by inspecting dessicant upon opening for proper color indication of sealed conditions.

h. Does your company have the capability to meet the Quality Control/Quality Assurance?

Have and maintain a Quality Management System that is equivalent to

ISO 9001:2015 and aligned with MIL-STD-1916 where appropriate, to ensure DBPAO products are assembled/manufacture, stored, and distributed IAW Government requirements.

Have and maintain a Quality Assurance Plan that o Defines the quality standards that will be employed in the assembly/manufacture, storage, and distribution of DBPAO products o Includes a sampling plan that is based on ANSI/ASQ Z1.4-2008 o Includes Standard Operating Procedures for assembly/manufacture, storage, and distribution of DBPAO products, temperature/humidity monitoring, equipment calibrations, security of manufacturing/storage areas, records management, warehousing and material handling, dangerous goods shipment, international shipment, shipping and receiving, special packaging, chemical safety plan, biological security plan, biological safety plan.

i. Does your company have the capability to implement supply chain management best practices to ensure minimum disruption of the supply chain?

2.) Can or has your company managed a task of this nature? If so, please provide details.

3.) Can or has your company managed a team of subcontractors before? If so, provide details.

4.) What specific technical skills does your company possess which ensure capability to perform the tasks?

5.) Please note that under a Small-Business Set-Aside, in accordance with FAR 52.219-14, the small business prime must perform at least 50% of the work themselves in terms of the cost of performance. Provide an explanation of your company’s ability to meet this requirement, referencing activities that will be performed to the greatest extent possible, for the base period as well as the option periods.

6.) Provide a statement including current small/large business status and company profile to include number of employees, annual revenue history, office locations, DUNs number, etc.

7.) Respondents to this notice also must indicate whether they qualify as a Small, Small Disadvantaged, Women-Owned, HUBZone, or Service Disabled Veteran- Owned Small Business Concern.

8.) Include in your response your ability to meet the requirements in the Facility and Safeguarding requirements.

The estimated period of performance consists of base year plus 4 options with performance commencing in September 2024. Specifics regarding the number of option periods will be provided in the solicitation.

The contract type is anticipated to be Firm Fixed Price.

The proposed contract is anticipated to include tasking that would be accomplished by labor categories that are subject to the Service Contract Act or a collective bargaining agreement.

Upon evaluation of the capability statements, if it is determined that this requirement will be an unrestricted competition, the Government intends to evaluate the Small-Business responses and conduct further market research to identify a subcontracting goal.

Your response to this Sources Sought, including any capabilities statement, shall be electronically submitted, in either Microsoft Word or Portable Document Format (PDF), to Jemel Hogan at jemel.m.hogan.civ@army.mil and Emily McGill at emily.c.mcgill.civ@army.mil

All data received in response to this Sources Sought that is marked or designated as corporate or proprietary will be fully protected from any release outside the Government.

No phone calls will be accepted.

All questions must be submitted to the Contract Specialist identified above. The Government is not committed nor obligated to pay for the information provided, and no basis for claims against the Government shall arise as a result of a response to this Sources Sought.