SOLICITATION NOTICE
65 -- Heart Lung Bypass units
- 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
- N62645-15-R-1023
- 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-3134
- Award Date
- 9/22/2015
- Description
- JUSTIFICATION AND APPROVAL 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 2. Nature and/or description of the action. The proposed action is for two (2) ea. heart-lung bypass units [11-969] with associated modules and components for Naval Medical Center San Diego. The Government intends on awarding a Firm Fixed Price contract. The proposed source is Sorin Group USA Inc, 14401 W. 65th Way, Arvada, CO 80004, or an authorized Sorin distributer. 3. Description of Supplies or Services: Naval Medical Center San Diego has a requirement for two (2) ea. heart-lung bypass units [11-969] with associated modules and components. The systems shall be able to provide temporary external circulatory support for open heart surgery. The systems shall be able to oxygenate venous blood and pump it throughout the arterial system. The systems shall be consistent with the equipment utilized by currently trained contractor personnel (Apex Perfusion, Inc.) to ensure the safety of the patients during cardiac procedures. The system shall be modular in design, and individual components and modules shall be able to be added and removed from the system. The system shall have a mast system for the positioning of different accessories. The systems shall have an emergency uninterruptible power supply equipped with a manual crank. The uninterruptible power supply shall be capable of up to 90 minutes of bypass operating time depending on the workload. The system shall have two (2) ea. single roller pumps and two (2) ea. double roller pumps that are operable in continuous or pulse mode. At least one of the single roller pumps shall be mast mountable. The system shall include one (1) ea. centrifugal pump. The system shall have a locking wheel/knob mechanism for inclusion adjustment to prevent accidental adjustment. The system shall have an arterial line clamp. The system shall have at least two pressure sensors and at least four temperature sensors. The system shall be capable of monitoring venous saturation, hematocrit, and venous temperature. The system shall be able to stop the connected pump when an air bubble is detected within the tubing. The system shall have a level sensor capable of detecting when blood falls below acceptable levels in the unit. The system shall have both audible and visual alarms. The system shall have an electronic gas blender with four connectors for Air, O2, CO2, and total gas flow. The system shall have at least three timers which can be set independently. The unit shall have an attached LED lamp. The system shall have cable holding and organizing systems and clamps to allow for proper positioning of the system during procedures. The power requirement for the heart-lung bypass unit is 120VAC, 60Hz. The system shall also include a warming/cooling unit, patient, heart-lung bypass [17-206]. The warming/cooling unit shall have separate cold and warm water tanks to allow for fast changes between warm and cold cardioplegia. The warming/cooling unit shall have a separate water Form 02.4G.AB 1 Nov 2012 circuit for controlling the temperature of the patient and for controlling the temperature of the cardioplegia solution. The power requirement for the warming/cooling units is 120VAC, 60Hz. 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 system shall be compliant with the Food and Drug Administration (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. Upon delivery, the vendor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage. o other than full and open competition. The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1), FAR 13.501(a) sole source (including brand name) acquisitions. There are multiple distributors capable of providing the equipment that meets the minimum government requirements. 5. Demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited. Sorin Group USA, Inc. is the only manufacturer that can provide a heart-lung bypass unit that meets the requirements of Naval Medical Center San Diego (NMCSD). There are no other manufacturers that can provide heart-lung bypass units consistent with the equipment utilized by currently trained contractor personnel (Apex Perfusion, Inc.). Apex Perfusion, Inc. provides a Certified Clinical Perfusionist (CCP) for cardiac surgeries at NMC San Diego and works at multiple facilities, working with the same equipment platform for all heart-lung bypass procedures. It is a typical practice for CCPs to rotate among various facilities due to their specialized knowledge/experience and the relative low volume of open heart procedures performed at any one given facility. The workload for the CCP at NMCSD is approximately 7 - 8 per month. The CCP contract at NMCSD requires a minimum of three years' experience within the previous five year period. For that experience to be considered relevant, both technical competence and clinical proficiency with the equipment platform must be Form 02.4G.AB 1 Nov 2012 demonstrated with an average caseload of 75 - 100 cardiopulmonary bypass cases per year. It is not feasible for the existing CCP to become proficient on a platform other than Sorin. Given the life sustaining quality of this type of equipment, a change in the personnel contractor (Apex Perfusion, Inc.) could decrease patient safety and result in significant risk of patient death. If a heart-lung bypass unit from another manufacturer were acquired, Apex Perfusion, Inc. would not be capable of providing the same standard of patient care and safety. Additionally, the ubiquity of Sorin equipment decreases the likelihood of a CCP possessing the required experience on another platform. Sorin Group USA, Inc. is the only manufacturer that can meet the minimum requirements of the Government. There are multiple Sorin authorized distributers that could potentially meet the requirement. 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 a statement of the reasons a market survey was not conducted. Market research was conducted in March 2015. It included a search of the Internet using Google, Bing, GSA Advantage, and the ECRI Sourcebook. Manufacturers which can provide heart-lung bypass units include Sorin, Medtronic, Maquet, and Terumo. Medtronic, Maquet, and Terumo have similar heart-lung bypass units but these units are not consistent (i.e. different user interface, location of components and varying technology) with the units utilized by Apex Perfusion, Inc. Sorin Group USA, Inc. is the only manufacturer that can meet the requirements of the Government. There are multiple Sorin authorized distributers that could potentially meet the requirement. 9. Other facts supporting the use of other than full and open competition. None 10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition. Form 02.4G.AB 1 Nov 2012 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, NMLC has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMLC) 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. The Government (or Program Office) expects to obtain a technical data package that will support competition for future acquisitions of the same or similar items. 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 4200.83 series 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, NMLC Code 03 Form 02.4G.AB 1 Nov 2012 CONTRACTING 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. ______________________________________________________________________________ Code 00L
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