SOLICITATION NOTICE
65 -- Centrifugal blood cell processors
- Notice Date
- 10/28/2015
- Notice Type
- Justification and Approval (J&A)
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, Naval Medical Logistics Command, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
- ZIP Code
- 21702-9203
- Solicitation Number
- N6264515RCES068
- Archive Date
- 11/15/2015
- Point of Contact
- Deborah L. Hagan, Phone: 3016199357
- E-Mail Address
-
deborah.l.hagan.civ@mail.mil
(deborah.l.hagan.civ@mail.mil)
- Small Business Set-Aside
- N/A
- Award Number
- N62645-15-P-3102
- Award Date
- 9/17/2015
- Description
- JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION 1. Identification of the agency and the contracting activity. This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD to meet the requirements of U.S. Naval Hospital Sigonella, Italy. 2. Nature and/or description of the action. The requirement is for four (4) ea. glycerolization/deglycerolization centrifugal blood cell processors. The Government intends on awarding a Firm Fixed Price contract. The proposed source is Haemonetics Corporation, 400 Wood Road, Braintree, MA 02184. The Haemonetics Corporation is the sole manufacturer and distributor of their products. 3. Description of the supplies/services required. The requirement is for four (4) ea. glycerolization/deglycerolization centrifugal blood cell processors for U.S. Naval Hospital Sigonella, Italy. The systems shall be automated, closed systems. The systems shall be capable of thawing frozen blood, providing a minimum blood shelf life of 10 days, and of glycerolizing and deglycerolizing blood. The Armed Forces Blood Program (AFBP) must have a biologics license from the Food and Drug Administration (FDA) to use the processors in the AFBP's operations. The power requirement is 220 VAC, 50 Hz. Vendor shall be an Original Equipment Manufacturer (OEM) authorized maintenance contractor for the proposed equipment/systems such that OEM warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The systems shall be compliant with the FDA requirements to market and deliver medical products for use in the United States of America; even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements. 4. Identification of the statutory exceptions permitting other than full and open competition. than full and open competition for this acquisition is 10 USC 2304(c)(1) and FAR 13.501(a), sole source (including brand name) acquisitions. Form 02.4G.AB/N6264515RCP3504 1 Nov 2012 5. Demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited. The AFBP has an FDA biologics license to use the Haemonetics Automatic Cell Processor, Model 215 in its blood program operations. The AFBP is licensed by the FDA, contingent on the AFBP's adherence to the processes detailed in the approved instruction, TM 8-227-11/NAVMED P-5123/AFI 44-118, dated 1 September 2007. The approved process allows donated blood to be glycerolized and frozen for long-term shelf life, and then thawed and deglycerolized with at least 10 days of shelf life prior to transfusion. The AFBP does not have an FDA biologics license to use any other glycerolization/deglycerolization centrifugal blood cell processor. The Haemonetics Automatic Cell Processor (ACP) Model 215 is the only product available that can meet the minimum requirements of the government. The ACP 215 is the only instrument capable of thawing frozen blood, providing a minimum blood shelf life of 10 days, and of glycerolizing and deglycerolizing blood. Haemonetics Corporation is the sole manufacturer and distributor of ACP, Model 215 glycerolization/deglycerolization centrifugal blood cell processors. There are no other manufacturers or distributors of the Haemonetics ACP, Model 215. The AFBP must inform the FDA of any equipment or process changes than those specifically detailed in the current FDA biologic license and obtain approval before implementing any such changes. At present, no other vendor or product is capable of meeting the minimum requirements of the government 6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable. Market research was performed, the results of which are in paragraph 8. This requirement will be posted to NECO and/or FedBizOpps in accordance with FAR 5.202. The government will evaluate any responses received. 7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable. The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made. In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor's commercial price list and will be determined fair and reasonable. 8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted. Market research was conducted in July 2015. The market research conducted included research conducted by the internet, and review of product literature. The internet search was done using Google, Bing, GSA Advantage, and the ECRI Sourcebook. Haemonetics Corporation is the only vendor which can provide a glycerolization/deglycerolization centrifugal blood cell processor which meets the minimum requirements. Hettich Lab, Thermo Scientific and Helmer Scientific also manufacture blood cell washer systems, but these products are not capable of Form 02.4G.AB/N6264515RCP3504 1 Nov 2012 glycerolization/deglycerolization and thus do not meet the minimum requirements. Terumo BCT manufactures a blood cell processor system capable of glycerolization/deglycerolization, but its thawed blood products do not meet the requirement of having a minimum shelf life of 10 days and thus it does not meet the minimum requirements. Only the Haemonetics ACP, Model 215 is FDA approved to thaw frozen blood through glycerolization/deglycerolization and provide a minimum shelf life of 10 days. No product other than the Haemonetics ACP, Model 215 is currently capable of meeting the minimum requirements. If another make and model blood cell processor were procured that met the minimum requirement, the AFBP would need to modify its FDA biologics license to use this different processor. The time required to complete FDA biologic licensing process would delay fulfilling the current requirement for at least/approximately 24 months. Therefore, the Haemonetics ACP, Model 215 provided by Haemonetics Corporation is the only system that can meet the Government's requirements. 9. Other facts supporting the use of other than full and open competition. Previous acquisition: Contract N62645-13-P-2034 dated 26 June 2014 for a total amount of $114,864.00. This procurement was conducted in accordance with FAR 13.106-1(b)(1) Soliciting from a single source. 10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition. To date, no other sources have written to express an interest. This requirement will be posted on FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration. 11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required. Future requirements will be synopsized in accordance with FAR 5.203. For the reasons set forth in Paragraph 5, Naval Medical Logistics Command has no plans at this time to compete future contracts for the types of supplies/services covered by this document. If another potential source emerges, Naval Medical Logistics Command will assess whether competition for future requirements is feasible. However, there is constant attention to the market to insure that shall technology change, the source selection is reconsidered. U.S. Navy Subject Matter Experts are required to take into consideration the impact on the installed base of equipment when source selection occurs. All necessary components of integrated logistics support are taken into consideration. 12. Point of Contact The point of contact at the Naval Medical Logistics Command, Fort Detrick, Frederick, MD, regarding the contents of the Justification and Appro. Form 02.4G.AB/N6264515RCP3504 1 Nov 2012 TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED BY FAR 13.501 I CERTIFY THAT THE FACTS AND REPRESENTATIONS UNDER MY COGNIZANCE WHICH ARE INCLUDED IN THIS JUSTIFICATION AND APPROVAL AND WHICH FORM A BASIS FOR THIS JUSTIFICATION ARE COMPLETE AND ACCURATE. Technical Cognizance ____________________________________ _________ OFFICER CERTIFICATION I certify that this justification is accurate and complete to the best of my knowledge. ___________________________________________________________________________ REVIEW AND CONCURRENCE I have reviewed the facts set forth in the above Justification and Approval and found to be legally sufficient, based on these facts, to the best of my knowledge and belief. _________________________________________________________________________ Form 02.4G.AB/N6264515RCP3504 1 Nov 2012
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N6264515RCES068/listing.html)
- Place of Performance
- Address: Sigonella, Italy, United States
- Record
- SN03932059-W 20151030/151028234159-e4ceea410ea8f635690e40c3fe5f3007 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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