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Sole Source Solicitation: Diagnostica Stago STA Compact Coagulation-Analyzer Specific Reagents - Justification and Approval #17-10220

General Information

Document Type:AWARD
Posted Date:Oct 11, 2017
Category: Research and Development
Set Aside:N/A

Contracting Office Address

Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States

Description

Contract Award Date:         DTD 092817

Contract Award Number:    CNT N6264517D5041

Contract Award Amount:     AMT $42,679.00

Contract Line Item Number: 

Contractor:     TO Diagnostica Stago, Inc., 5 Century Drive, Suite 1, Parsippany, New Jersey 07054-4607, United StatesJUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Activity. The Naval Medical Logistics Command (NMLC), Fort Detrick, MD is the contracting activity. The requiring activity is the Naval Medical Research Unit San Antonio (NAMRU-SA), located at 3650 Chambers Pass, Building 3610, JBSA Fort Sam Houston, TX 78234 2. Description of the Action Being Approved. The contract action being proposed is the award of an indefinite delivery, indefinite quantity (IDIQ) contract with Firm Fixed Price (FFP) task orders to provide NAMRU- SA with STA Compact Coagulation-analyzer specific reagents. The proposed source is Diagnostica Stago, 5 Century Drive, Parsippany NJ, 07054. Diagnostica Stago is the only manufacturer of the required products and there are no known distributors. 3. Description of Supplies/Services. These reagents must be compatible with the Diagnostica Stago STA Compact coagulation instruments currently in operation at NAMRU-SA. The reagents must be compatible with the positive barcode identification feature of the Diagnostica Stago STA Compact coagulation instruments. The use of the positive barcode identification provides the instrument and the user with the reagent name, lot number, expiration date, reagent volume, and on-board stability and allows for the continuous monitoring of these reagent characteristics, which is vital to ensuring that the results of the coagulation analysis will be comparable within an individual project, as well as across studies. The reagents must be calibrated and validated for the Diagnostica Stago STA Compact coagulation instruments from the manufacturer of the reagents. The proposed IDIQ contract will provide for the delivery of up to 50 STA Deficient XII assay (6 x 1mL vials), 50 STA Deficient XI assay (6 x 1mL vials), 50 STA Deficient IX assay (6 x 1mL vials), 50 STA Deficient VIII assay (6 x 1mL vials), 50 STA Deficient X assay (6 x 1mL vials), 50 STA Deficient VII assay (6 x 1mL vials), 50 STA Deficient V assay (6 x 1mL vials), and 50 STA Deficient II assay (6 x 1mL vials). The ordering period for this IDIQ contract is divided into a base and four option periods, each consisting of 12 months, for a total of 60 months (if all options are exercised). 4. Estimated Dollar Value. The estimated maximum value of each of the base and option ordering periods is up to $112,100.00. The total estimated contract value is $560,500.00. Funding will be provided on the firm fixed price delivery orders and are expected to be FY 2017 RDT&E funds in the base period. 5. Statutory Authority Permitting Other Than Full and Open Competition. 41 U.S.C. 1901, as implemented by FAR 13.501; only one responsible source and no other supplies or services will satisfy agency requirements. 6. Rationale Justifying Use of Cited Statutory Authority. Market research was conducted to ascertain what reagents are available in the commercial marketplace that will meet the requirements of the Government, as outlined in section 3. These reagents must be compatible with the Diagnostica Stago STA Compact coagulation instruments currently in operation at NAMRU-SA. Diagnostica Stago is the sole source located by market research that produces reagents that are compatible with the Diagnostica Stago STA Compact coagulation instruments. The reagents must be calibrated and validated for the Diagnostica Stago STA Compact coagulation instruments from the manufacturer of the reagents. Diagnostica Stago is the sole source located by market research that produces reagents that are pre calibrated for use with the Diagnostica Stago STA Compact coagulation instruments and have been validated by the manufacturer of the reagents. NAMRU-SA currently has two Diagnostica Stago STA Compact coagulation instruments that support ongoing research in the study of hemorrhage and hemorrhagic shock. The Diagnostica Stago STA Compact coagulation instruments are equipped with positive barcode identification for the identification of reagents. The use of the positive barcode identification provides the instrument and the user with the reagent name, lot number, expiration date, reagent volume, and on-board stability and allows for the continuous monitoring of these reagent characteristics, which is vital to ensuring that the results of the coagulation analysis will be comparable within an individual project, as well as across studies. Therefore, the reagents must be compatible with the positive barcode identification feature of the Diagnostica Stago STA Compact coagulation instruments that are currently in operation by NAMRU-SA. Diagnostica Stago is the sole source located by market research that produces reagents that are compatible with the instruments positive barcode identification Market research looked to see Diagnostica Stago, Inc had more than one distributor for the required reagents. Market research did not locate any distributors for Diagnostica Stago, Inc regents except for the OEM manufacturer. Market research located one manufacturer of reagents that will meet the requirements of the Government. Market research determined that Diagnostica Stago, Inc. (the OEM manufacturer of the instruments) is the sole manufacturer of reagents that will meet the Governments requirements. 7. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable. To date, no other sources have written to express and interest in this requirement. NMLC will post a notice of intent (NOI) on FedBizOpps in accordance with FAR 5.202. Any sources capable of distributing the PromoCell brand stromal cells will receive consideration. 8. Determination of Fair and Reasonable Cost. The Contracting Officer will perform a cost analysis in order to determine that the anticipated cost to the Government of the services covered by this J&A will be fair and reasonable. 9. Actions to Remove Barriers to Future Competition. For the reasons set forth in Paragraph 6, NMLC has no plans at this time to compete future contracts for the type of services covered by this document. If other potential sources emerge, NMLC will assess whether competition for future requirements is feasible. If future requirements exist that do not involve the same research efforts, the government will solicit through full and open competition to remove barriers. 10. Contracting Point of Contact. The point of contact at Naval Medical Logistics Command is Jennifer M. Reed, Code 05, (301) 619-1200 or by e-mail at Jennifer.m.reed20.civ@mail.mil.|**|TO Diagnostica Stago, Inc., 5 Century Drive, Suite 1, Parsippany, New Jersey 07054-4607, United StatesJUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Activity. The Naval Medical Logistics Command (NMLC), Fort Detrick, MD is the contracting activity. The requiring activity is the Naval Medical Research Unit San Antonio (NAMRU-SA), located at 3650 Chambers Pass, Building 3610, JBSA Fort Sam Houston, TX 78234 2. Description of the Action Being Approved. The contract action being proposed is the award of an indefinite delivery, indefinite quantity (IDIQ) contract with Firm Fixed Price (FFP) task orders to provide NAMRU- SA with STA Compact Coagulation-analyzer specific reagents. The proposed source is Diagnostica Stago, 5 Century Drive, Parsippany NJ, 07054. Diagnostica Stago is the only manufacturer of the required products and there are no known distributors. 3. Description of Supplies/Services. These reagents must be compatible with the Diagnostica Stago STA Compact coagulation instruments currently in operation at NAMRU-SA. The reagents must be compatible with the positive barcode identification feature of the Diagnostica Stago STA Compact coagulation instruments. The use of the positive barcode identification provides the instrument and the user with the reagent name, lot number, expiration date, reagent volume, and on-board stability and allows for the continuous monitoring of these reagent characteristics, which is vital to ensuring that the results of the coagulation analysis will be comparable within an individual project, as well as across studies. The reagents must be calibrated and validated for the Diagnostica Stago STA Compact coagulation instruments from the manufacturer of the reagents. The proposed IDIQ contract will provide for the delivery of up to 50 STA Deficient XII assay (6 x 1mL vials), 50 STA Deficient XI assay (6 x 1mL vials), 50 STA Deficient IX assay (6 x 1mL vials), 50 STA Deficient VIII assay (6 x 1mL vials), 50 STA Deficient X assay (6 x 1mL vials), 50 STA Deficient VII assay (6 x 1mL vials), 50 STA Deficient V assay (6 x 1mL vials), and 50 STA Deficient II assay (6 x 1mL vials). The ordering period for this IDIQ contract is divided into a base and four option periods, each consisting of 12 months, for a total of 60 months (if all options are exercised). 4. Estimated Dollar Value. The estimated maximum value of each of the base and option ordering periods is up to $112,100.00. The total estimated contract value is $560,500.00. Funding will be provided on the firm fixed price delivery orders and are expected to be FY 2017 RDT&E funds in the base period. 5. Statutory Authority Permitting Other Than Full and Open Competition. 41 U.S.C. 1901, as implemented by FAR 13.501; only one responsible source and no other supplies or services will satisfy agency requirements. 6. Rationale Justifying Use of Cited Statutory Authority. Market research was conducted to ascertain what reagents are available in the commercial marketplace that will meet the requirements of the Government, as outlined in section 3. These reagents must be compatible with the Diagnostica Stago STA Compact coagulation instruments currently in operation at NAMRU-SA. Diagnostica Stago is the sole source located by market research that produces reagents that are compatible with the Diagnostica Stago STA Compact coagulation instruments. The reagents must be calibrated and validated for the Diagnostica Stago STA Compact coagulation instruments from the manufacturer of the reagents. Diagnostica Stago is the sole source located by market research that produces reagents that are pre calibrated for use with the Diagnostica Stago STA Compact coagulation instruments and have been validated by the manufacturer of the reagents. NAMRU-SA currently has two Diagnostica Stago STA Compact coagulation instruments that support ongoing research in the study of hemorrhage and hemorrhagic shock. The Diagnostica Stago STA Compact coagulation instruments are equipped with positive barcode identification for the identification of reagents. The use of the positive barcode identification provides the instrument and the user with the reagent name, lot number, expiration date, reagent volume, and on-board stability and allows for the continuous monitoring of these reagent characteristics, which is vital to ensuring that the results of the coagulation analysis will be comparable within an individual project, as well as across studies. Therefore, the reagents must be compatible with the positive barcode identification feature of the Diagnostica Stago STA Compact coagulation instruments that are currently in operation by NAMRU-SA. Diagnostica Stago is the sole source located by market research that produces reagents that are compatible with the instruments positive barcode identification Market research looked to see Diagnostica Stago, Inc had more than one distributor for the required reagents. Market research did not locate any distributors for Diagnostica Stago, Inc regents except for the OEM manufacturer. Market research located one manufacturer of reagents that will meet the requirements of the Government. Market research determined that Diagnostica Stago, Inc. (the OEM manufacturer of the instruments) is the sole manufacturer of reagents that will meet the Governments requirements. 7. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable. To date, no other sources have written to express and interest in this requirement. NMLC will post a notice of intent (NOI) on FedBizOpps in accordance with FAR 5.202. Any sources capable of distributing the PromoCell brand stromal cells will receive consideration. 8. Determination of Fair and Reasonable Cost. The Contracting Officer will perform a cost analysis in order to determine that the anticipated cost to the Government of the services covered by this J&A will be fair and reasonable. 9. Actions to Remove Barriers to Future Competition. For the reasons set forth in Paragraph 6, NMLC has no plans at this time to compete future contracts for the type of services covered by this document. If other potential sources emerge, NMLC will assess whether competition for future requirements is feasible. If future requirements exist that do not involve the same research efforts, the government will solicit through full and open competition to remove barriers. 10. Contracting Point of Contact. The point of contact at Naval Medical Logistics Command is Jennifer M. Reed, Code 05, (301) 619-1200 or by e-mail at Jennifer.m.reed20.civ@mail.mil.|**|TO Diagnostica Stago, Inc., 5 Century Drive, Suite 1, Parsippany, New Jersey 07054-4607, United StatesJUSTIFICATION AND APPROVAL FOR USE OF OTHER THAN FULL AND OPEN COMPETITION 1. Contracting Activity. The Naval Medical Logistics Command (NMLC), Fort Detrick, MD is the contracting activity. The requiring activity is the Naval Medical Research Unit San Antonio (NAMRU-SA), located at 3650 Chambers Pass, Building 3610, JBSA Fort Sam Houston, TX 78234 2. Description of the Action Being Approved. The contract action being proposed is the award of an indefinite delivery, indefinite quantity (IDIQ) contract with Firm Fixed Price (FFP) task orders to provide NAMRU- SA with STA Compact Coagulation-analyzer specific reagents. The proposed source is Diagnostica Stago, 5 Century Drive, Parsippany NJ, 07054. Diagnostica Stago is the only manufacturer of the required products and there are no known distributors. 3. Description of Supplies/Services. These reagents must be compatible with the Diagnostica Stago STA Compact coagulation instruments currently in operation at NAMRU-SA. The reagents must be compatible with the positive barcode identification feature of the Diagnostica Stago STA Compact coagulation instruments. The use of the positive barcode identification provides the instrument and the user with the reagent name, lot number, expiration date, reagent volume, and on-board stability and allows for the continuous monitoring of these reagent characteristics, which is vital to ensuring that the results of the coagulation analysis will be comparable within an individual project, as well as across studies. The reagents must be calibrated and validated for the Diagnostica Stago STA Compact coagulation instruments from the manufacturer of the reagents. The proposed IDIQ contract will provide for the delivery of up to 50 STA Deficient XII assay (6 x 1mL vials), 50 STA Deficient XI assay (6 x 1mL vials), 50 STA Deficient IX assay (6 x 1mL vials), 50 STA Deficient VIII assay (6 x 1mL vials), 50 STA Deficient X assay (6 x 1mL vials), 50 STA Deficient VII assay (6 x 1mL vials), 50 STA Deficient V assay (6 x 1mL vials), and 50 STA Deficient II assay (6 x 1mL vials). The ordering period for this IDIQ contract is divided into a base and four option periods, each consisting of 12 months, for a total of 60 months (if all options are exercised). 4. Estimated Dollar Value. The estimated maximum value of each of the base and option ordering periods is up to $112,100.00. The total estimated contract value is $560,500.00. Funding will be provided on the firm fixed price delivery orders and are expected to be FY 2017 RDT&E funds in the base period. 5. Statutory Authority Permitting Other Than Full and Open Competition. 41 U.S.C. 1901, as implemented by FAR 13.501; only one responsible source and no other supplies or services will satisfy agency requirements. 6. Rationale Justifying Use of Cited Statutory Authority. Market research was conducted to ascertain what reagents are available in the commercial marketplace that will meet the requirements of the Government, as outlined in section 3. These reagents must be compatible with the Diagnostica Stago STA Compact coagulation instruments currently in operation at NAMRU-SA. Diagnostica Stago is the sole source located by market research that produces reagents that are compatible with the Diagnostica Stago STA Compact coagulation instruments. The reagents must be calibrated and validated for the Diagnostica Stago STA Compact coagulation instruments from the manufacturer of the reagents. Diagnostica Stago is the sole source located by market research that produces reagents that are pre calibrated for use with the Diagnostica Stago STA Compact coagulation instruments and have been validated by the manufacturer of the reagents. NAMRU-SA currently has two Diagnostica Stago STA Compact coagulation instruments that support ongoing research in the study of hemorrhage and hemorrhagic shock. The Diagnostica Stago STA Compact coagulation instruments are equipped with positive barcode identification for the identification of reagents. The use of the positive barcode identification provides the instrument and the user with the reagent name, lot number, expiration date, reagent volume, and on-board stability and allows for the continuous monitoring of these reagent characteristics, which is vital to ensuring that the results of the coagulation analysis will be comparable within an individual project, as well as across studies. Therefore, the reagents must be compatible with the positive barcode identification feature of the Diagnostica Stago STA Compact coagulation instruments that are currently in operation by NAMRU-SA. Diagnostica Stago is the sole source located by market research that produces reagents that are compatible with the instruments positive barcode identification Market research looked to see Diagnostica Stago, Inc had more than one distributor for the required reagents. Market research did not locate any distributors for Diagnostica Stago, Inc regents except for the OEM manufacturer. Market research located one manufacturer of reagents that will meet the requirements of the Government. Market research determined that Diagnostica Stago, Inc. (the OEM manufacturer of the instruments) is the sole manufacturer of reagents that will meet the Governments requirements. 7. Description of Efforts Made to Solicit Offers from as Many Offerors as Practicable. To date, no other sources have written to express and interest in this requirement. NMLC will post a notice of intent (NOI) on FedBizOpps in accordance with FAR 5.202. Any sources capable of distributing the PromoCell brand stromal cells will receive consideration. 8. Determination of Fair and Reasonable Cost. The Contracting Officer will perform a cost analysis in order to determine that the anticipated cost to the Government of the services covered by this J&A will be fair and reasonable. 9. Actions to Remove Barriers to Future Competition. For the reasons set forth in Paragraph 6, NMLC has no plans at this time to compete future contracts for the type of services covered by this document. If other potential sources emerge, NMLC will assess whether competition for future requirements is feasible. If future requirements exist that do not involve the same research efforts, the government will solicit through full and open competition to remove barriers. 10. Contracting Point of Contact. The point of contact at Naval Medical Logistics Command is Jennifer M. Reed, Code 05, (301) 619-1200 or by e-mail at Jennifer.m.reed20.civ@mail.mil.

Original Point of Contact

POC Jennifer M. Reed, Phone: 3016191200, Thomas L. Hood, Phone: 3016198894

Place of Performance

Link: FBO.gov Permalink
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