65--Ultrasonic Unit

JUSTIFICATION FOR THE EXCEPTION TO FAIR OPPORTUNITY 1. IDENTIFICATION OF THE AGENCY AND THE CONTRACTING ACTIVITY: This is an exception to the fair opportunity process. The Naval Medical Logistics Command, acting on behalf of U.S. Naval Fleet, multiple hulls, intends to award a delivery order against Defense Logistics Agency (DLA) Troop Support Indefinite Delivery, Indefinite Quantity (IDIQ) contract SPM2D1-09-D8339. 2. NATURE/DESCRIPTION OF CONTRACT ACTION: The proposed acquisition is for four (4) M-Turbo Portable Ultrasound Systems, accessory transducers and mobile stands manufactured by Sonosite, Inc. 21919 30th Drive SE, Bothell, WA 98021. The Government intends on awarding a Firm Fixed Price delivery order. 3. DESCRIPTION OF REQUIRED SUPPLIES/SERVICES: The U.S. Navy Fleet, multiple hulls, has a need for four (4) Portable Ultrasound Systems. The item shall be a U.S. FDA market approved, portable ultrasound system capable of providing imaging of the abdomen, pelvis, chest, head, neck, eyes, heart, breast, extremities and intracranial; be capable of scanning from a cold start within 25 seconds; operate in 2-D real time, M-Mode; provide color Doppler, power Doppler and duplex color capability; include at a minimum, the following biopsy compatible transducers or probes capable of supporting Multi-Beam Imaging and technology for reducing speckle noise and enhancing resolution: Curved or sector array capable of under 5.0 MHz, Linear Array capable of 7.0 MHz (Threshold) or 10.0 MHz (Objective) or higher, Endo-Cavitary probe supporting Obstetrical and Gynecologic examinations, and a Phased array to support cardiac examinations; have an LCD display adjustable for light and brightness of at least 10 inches measured diagonally; have a digital scan converter shall have at least a 512 X 512 NTSC matrix with a display of at least 256 grayscale levels; perform zoom and freeze frame image capture manipulations; be capable of transmitting static and dynamic images with calculation and demographic data via USB or DICOM 3 ports; have at a minimum 8 GB of on-board memory to retain data from examinations, still frames and reports; have at a minimum a single caliper measurement for obstetrical and gynecological examinations with OB/GYN application specific calculations; have the ability to be upgradeable with application-specific calculations for Cardiac, Vascular and Intima-Media Thickness; be operable on 100-120 VAC, 60 Hz input and rechargeable battery; operable on battery power at minimum settings for at least two hours; with the exception of any accessory cart, stand or transducer, not weigh more than 10 pounds with battery; with the exception of any accessory cart, stand or transducer, not exceed two cubic feet; have applications training be included with teaching modules on CD-Rom or DVD; have documentation including user and OEM service manual(s) included on CD-Rom; include vendor installation, use and maintenance training at locations within CONUS; not require proprietary tools or equipment to repair or set-up the system; withstand a drop test of at least 3 feet; be impervious to damage secondary to contact from spills, gel or bodily fluids; have at a minimum a four year warranty that includes the use of a loaner system while repairs are being conducted. The mobile stand shall accommodate the portable ultrasound system; be height adjustable; have at least four transducer holders; shall incorporate a docking station that allows connection of the ultrasound system to an external monitor via a DVI connection; have locking casters. FY 13 O&MN SERP funds in the amount of $198,127.20 will be used to procure these Ultrasound Systems. 4. IDENTIFICATION OF THE JUSTIFICATION RATIONALE AND/OR DEMONSTRATION OF CONTRACTOR’S UNIQUE QUALIFICATIONS: The statutory authority exception to the fair opportunity process is implemented by 10 U.S.C 2304(c)(1) and FAR 16.505(b)(2)(ii), only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized. The Sonosite M-Turbo is the only product that provided the multi-discipline capabilities of ultrasound imaging for the abdomen, pelvis, chest, head, neck, eyes, heart, breast, extremities and intracranial area in one product that met the size, weight, shock and ingress requirements. This item will not only be used in the casualty receiving and operating areas of the ships, but will also be required to be rapidly transported to remote Battle Dressing Stations, and battle or accident sites where sailors may be trapped or crushing injuries may be present. The need for an extremely portable ultrasound unit is required to assess internal bleeding and vascular integrity to determine transportability or the need for emergency amputation. This requires a unit that is not only light, but extremely compact, have extended battery operation and withstand a shipboard environment that may be influenced by heavy seas and combat action. The Sonosite M-Turbo is the only system meeting all requirements of the essential characteristics. Sonosite, Inc is the sole manufacturer of the M Turbo Ultrasound System. It is currently used across DoD for the U.S. Navy, U.S. Army, U.S. Air Force and U.S. Marine Corps for forward deployed Level 2 & 3 medical capability. It is imperative that interoperability of this equipment be maintained between the services in forward deployed units supporting combat operations in a variety of theaters. Interoperability supports the sharing of compatible transducers, repair parts, maintenance support and software upgrades to enable the highest possible level of emergency care and operational readiness. This is a Life Saving/Life Support piece of equipment used to externally examine for vascular function and damage, intracranial abnormalities, obstetrical evaluation, internal bleeding, cardiac anomalies, muscular-skeletal deformities, etc. The system and associated transducers need to be at the ready at all times with the ability to rapidly be brought back on line in the event of a malfunction. As the predominant portable ultrasound unit for Level 2 & 3 medical units, the equipment and transducers would be interchangeable across all forward deployed theaters. Procurement of any other device would require the development of entirely new supply/support packages that would be applicable to only the platforms for this solicitation. If forward deployed and in dire need of a specific transducer or a functioning system, the platform could not rely on a locally deployed unit which would increase the likelihood of loss of life or limb. 5. DETERMINATION OF BEST VALUE: DLA has already determined the prices of equipment on the IDIQ as fair and reasonable. The Contracting Officer shall make a determination of best value for the Government before a delivery order is executed. 6. DESCRIPTION OF MARKET RESEARCH: Market research was conducted in the December 2012, based off of an extensive product comparison conducted in 2010 by the DoD Defense Medical Materiel Program Office (DMMPO), a 2011 review of the latest ECRI product comparisons, an updated review of the latest 2012 ECRI comparisons, review of existing DLA Troop Support contracts and review of manufacturer websites. A DMMPO comparison of 14 products from: B-K Medical, Dymax, Esaote, Direct Medical System, G.E. Healthcare, Medison, Mindray, Shantou Institute, Shimadzu, Siemens Medical, Sonosite, Terason, Toshiba and Zonare indicated that the Sonosite M Turbo was the only product to satisfy the essential characteristics required by DoD for level 2 & 3 medical units in forward deployed theaters and U.S. Navy combat ships. The 2012 ECRI comparisons revealed a new model from GE Healthcare not previously reviewed, but was included in this new market research. The 2012 ECRI comparisons indicated 35 FDA market approved models from 11 different vendors. While a number of vendors manufacture various lines of portable ultrasound systems, the majority of system capabilities are limited to specific specialties rather than a system that comprises capability across a multitude of specialties. Other vendors, who manufacture a system with wider capabilities, could not keep the system in a compact size with the minimum 10 inch LCD screen, meet the minimum 10 pound weight restriction or meet the drop test and ingress protection requirements for use on U.S. Navy combat ships. While a number of vendors manufacture various lines of portable ultrasound systems, the majority of system capabilities are limited to specific specialties rather than a system that comprises capability across a multitude of specialties. Other vendors, who manufacture a system with wider capabilities, could not keep the system in a compact size with the minimum 10 inch LCD screen, meet the minimum 10 pound weight restriction or meet the drop test and ingress protection requirements for use on U.S. Navy combat ships. The Sonosite M-Turbo is the only product that fulfilled all the requirements of paragraph 3. 7. ANY OTHER SUPPORTING FACTS: Previous awards for this item: - SPM2D1-09-D-8339-0016, 05 Feb 2010, $56,482.50. - SPM2D1-09-D-8339-N029, 22 Aug 2011, $247,659.00. - SPM2D1-09-D-8339-N031, 25 Jan 2012, $49,531.80. 8. ACTIONS TAKEN TO REMOVE BARRIERS TO COMPETITION: Future procurements will be done in accordance with FAR 16.505.