This Government Contract opportunity from Department Of Defense was posted on April 6, 2016. The submission period has ended. Browse the details below for market research, or find similar active opportunities.

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Meso Scale Diagnostic; Biological Agent Detecting Kits

Awarded

W91ZLK-16-T-0077Federal

Submission Closed04/06/2016, 12:00:00 AM UTC

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

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NAICS: 325413

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Supply of ALBAcyte Blood Bank ReagentsThis subcontract involves the manufacture and supply of specialized ALBAcyte blood bank reagents for prime contractors supporting the Department of Veterans Affairs North Texas Health Care System. The scope of work includes the delivery of A1, A2, B, IgG Sensitized, Antibody ID Panels, and C3 Coated RBCs. To ensure product efficacy, the contractor must utilize shipping containers that maintain reagent integrity and adhere to a defined Quality Plan and FDA approval standards. Deliveries are to be made FOB Destination to the Transfusion Medicine Unit located in Dallas, Texas. The contract is categorized under NAICS code 325413 and is managed through the Department of Veterans Affairs Network Contract Office 17.

257-NETWORK Contract Office 17 (36C257)

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6550--Blood Bank Reagents

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The Department of Veterans Affairs VA North Texas Health Care System is issuing a Sources Sought Notice to identify qualified vendors capable of providing blood bank reagents for the Transfusion Medicine Unit in Dallas, Texas. These reagents, including ALBAcyte A1, A2, B, IgG Sensitized, Antibody ID Panels, and C3 Coated Red Blood Cells, are essential for manual blood typing and serum antibody detection used in cross-matching blood for transfusions. The anticipated acquisition strategy includes a base year starting May 1, 2027, with four subsequent one-year option periods extending through April 30, 2032. To be considered, vendors must be FDA approved, provide documentation of such approval, and maintain a defined quality plan with adequate supply availability. All shipments must be FOB Destination, and the contractor is responsible for providing appropriate shipping containers. Interested vendors must submit an electronic capability statement in PDF or Word format, including the place of manufacture for all listed reagents, to the designated contract specialist by November 5, 2026, at 9:00 AM CST. This notice is for market research purposes only to determine the appropriate acquisition strategy, such as a small business set-aside, and does not constitute a formal solicitation.

257-NETWORK Contract Office 17 (36C257)

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6505--DRESSING, DRAWTEX 4IN X 4IN (VA-27-00014447)

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National Cmop Office (36C770)

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262-NETWORK Contract Office 22 (36C262)

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National Institutes Of Health Olao

POSTED

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Solicitation # 36C24527Q0042

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245-NETWORK Contract Office 5 (36C245)

POSTED

8 days ago

DEADLINE

in 6 days

AI Contract Overview

The Army Contracting Command - Aberdeen Proving Ground is awarding a firm-fixed-price contract to Meso Scale Diagnostics, LLC for custom biological kits used to detect twelve specific target agents, including various bacteria, viruses, and toxins. These kits are designed for use with the MSD PR21800 instrument and utilize proprietary ElectroChemiLuminescent technology to provide the necessary sensitivity and throughput for the Environmental BioMonitoring Laboratory. This procurement is being conducted as other than full and open competition because Meso Scale Defense is the sole manufacturer and the only responsible source capable of fulfilling the requirement. The use of an alternative platform would result in significant national security risks and an estimated cost of 3.5 million dollars and six years of duplicated testing and data analysis. Previous attempts to increase competition through public notices have yielded no other interested contractors.

General Info

Agency

Department Of Defense → W6QK Acc-Apg Director

Contract Value

$432,116

NAICS

325413 - In-Vitro Diagnostic Substance Manufacturing

Place of Performance

6001 Combat Drive, ABERDEEN PROVING GROUND, MD, 21005-3013, USA

Set-Aside

NONE

Awardee

MESO SCALE DIAGNOSTICS LLC

Award Issued Date

04/06/2016, 12:00:00 AM UTC

Documents

A02_-_Abbreviated_Justification_and_Approval_Document_for_FedBizOpps.docx

AI Contract Breakdown

Uniform Contract Format

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Timeline

PhaseAwarded

PostedMar 25

special-notice

AwardedApr 6

Contract was awarded

Submission Closed

04/06/2016, 12:00:00 AM UTC

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Organization & Contact Information

AgencyDepartment Of Defense → W6QK Acc-Apg Director

Contacts1 person available

OfficeABER PROV GRD, MD, 21005, USA

Organization / AgencyDepartment Of Defense → W6QK Acc-Apg Director

Office AddressABER PROV GRD, MD, 21005, USA

Contacts

Samantha Lee ShultzContracting Officer

contact@example.gov

+1 (555) 000-0000

Full Description

Abbreviated Justification and Approval Document FOR OTHER THAN FULL AND OPEN COMPETITION Of Requirements Not Exceeding $550,000 (IAW FAR 6.304) ABERDEEN INSTALLATION CONTRACTING DIVISION 1. Contracting Activity: Army Contracting Command - Aberdeen Proving Ground (ACC-APG) Tenant Division located at Bldg. 6001 Combat Drive, Aberdeen Proving Ground (APG), MD 21005-3013 2. Description of Action: Requirement: 1 Repeat Pricing: X Firm-Fixed Price 0 Time & Materials 0 Cost Funds: 0 OMA X Other Funds: Name of Proposed Contractor: Meso Scale Diagnostics, LLC (AKA; Meso Scale Defense) Street Address: 1601 Research Boulevard City, State, Zip: Rockville, MD 20850-3173 Phone: Cage Code: +1 (555) 000-0000 1ZHK4 3. Description of Supplies: The United States Research, Development and Engineering Command (RDECOM) Edgewood Chemical Biological Center (ECBC); Environmental BioMonitoring Laboratory (EBML) has a requirement for Meso Scale Defense (MSD) custom biological kits for twelve (12) target agents: Bacillus anthracis, Francisella tularensis, Yersinia pestis, Vaccinia virus, Brucella sp., Coxiella burnetti, Staphylococcal enterotoxin B, Ebola virus, Botulinum A/B toxin, Ricin, Abrin, Venezuelan Equine Encephalitis (VEE), Shiga-like toxin 1 and Shiga-like toxin 2. The items contained in this purchase request are assays that when analyzed on specialized equipment, are used for the detection of biological agents. The kits contain assay plates in a 96 well format. Each well contains 9 "spots": one or two contain antibody against a specific agent (capture antibody), one serves as a negative control, and one as a positive control. Liquid reagents included in the kit are: 1. Detector antibody, positive control antibody, positive control antigen, and antibody diluent which are combined to form a "working stock". 2. Read buffer which is used to activate the chemical reaction that occurs as a result of the working stock interaction with the plate and the sample being tested. 4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5 and Class Deviation - 2015-O00004 due to only one responsible source available and capable of fulfilling the requirements. Justification in accordance with FAR 6.302-1(a)(1) citation: 10 U.S.C. 2304(c)(1) and FAR 6.302-1(a)(2), "when the supplies or services required by the agency are available from only one responsible source, or, for DoD, NASA, and the Coast Guard, form only one or a limited number of responsible sources, and no other type of supplies or services will satisfy agency requirements, full and open competition need not be provided for." 5. Reason for Authority Cited: Meso Scale Defense is a division of Meso Scale Diagnostics, LLC. Meso Scale Defense is the manufacturer of the MSD custom biological kits for target agents (bacteria, viruses and toxins). They do not have any authorized distributors, resellers or authorized partners. RDECOMs ECBC EML requires these kits to detect biological warfare agents using ElectroChemiLuminescent (ECL) technology. These products are unique and are only available from one source, which is Meso Scale Defense. MSD ECL test kits are specifically designed to be used in conjunction with the MSD PR21800 instrument, which ECBC's laboratory currently owns. The required test kits are customized products which are designed, approved and validated by both the MSD Laboratory and EBML. The MSD test kits have been rigorously tested using standards set by ISO17025 and the Joint Program Executive Office Quality Program (JPEOQP) under which the EBML operates. The required test kits utilize MSD's propriety multiplexed ECL technology and fulfills the sensitivity, specificity, and throughput capacity needed for our clients. There are no other suppliers that provide products that incorporate the technology to allow the processing of samples as rapidly and accurately as the MSD platform. MSD owns a number of patents covering the manufacturing of instruments and test kits. MSD has exclusive, permanent and irrevocable license to the fundamental patent portfolio for the ECL technology. 6. Additional Information: (i) Not obtaining this requirement for MSD test kits will result in the failure to provide a high-level client with validated laboratory capabilities. This client has built a new testing facility that ECBC has outfitted with analytical equipment and reagents. This classified mission provides an important national security function, and a delay in providing these services will have a detrimental effect on national security. (ii) If MSD does not receive the award, EBML would be forced to find alternate sources for ECL testing of biological agents. The procurement of a different platform would require that this same level of testing be duplicated, costing approximately $1.5 million dollars and three years to complete. Generating comparable statistical data would take an additional $2 million dollars and no less than three (3) years of testing and data analysis. These figures are an approximation based on the amount of labor hours and materials that went into research for the development of these assays, the validation and demonstration of capability of the assays, and the incorporation of the technology into the client's concept of operations. Additionally, the statistical confidence of the assays is based on the number of samples (unknowns and quality assurance samples) which is of paramount importance to the clients. This would also mean a decrease in confidence of EBML and a decrease in client work for the Government. 7. Actions to Increase Competition: Notice of Intents to negotiate solely with Meso Scale Diagnostics, LLC. have been posted to FEDBIZOPs in 2012, 2013 and 2014 without response from interested contractors. If the need to change ECL platforms arises, new sources will be evaluated other than Meso Scale Defense in an effort to increase competition in the future. This will be accomplished by performing a market survey in advance of designing new protocols and equipment recommendations, by identifying several equipment choices that could be used for process development, and then competing for best value equipment. 8. Market Research: MSD is the only source for these test kits and there are no other suppliers. Due to the proprietary nature of the kits, there are no other comparable commercially available or customizable kits on the market. Market research is being conducted continuously by EBML biologists and scientist at Department of Homeland Security (DHS). Monthly research and development telecons take place to discuss new and upcoming technologies. Currently The MAGPIX platform (Luminex Corp.) is the only comparable platform to the PR21800 in use. However, the assays for this instrument are not as sensitive as the kits we intend to purchase and does not meet the needs set forth by the client. Also, it has been determined just recently the assay kits that were available through DHS are not available at this time. 9. Procurement History: Previous Contract or Purchase Order Number: Contract: W91ZLK-15-P-0500 Contractor: Meso Scale Defense Contract: W91ZLK-14-P-0399 Contractor: Meso Scale Defense Contract: W91ZLK-14-P-0061 Contractor: Meso Scale Defense Contract: W91ZLK-13-P-0505 Contractor: Meso Scale Defense Contract: W91ZLK-13-P-0208 Contractor: Meso Scale Defense Contract: W91ZLK-12-C-0015 Contractor: Meso Scale Defense Previously competed? No