PIEZOELECTRIC EXTRACORPOREAL LITHOTRIPTER

Solicitation N62645-13-R-0020 posted on 29 MAY 2013 with a response date of 01 JULY 2013 has closed and has resulted in a contract award. No set-asides were used. United Medical Systems (DE), Inc. has been awarded a firm fixed price contract (N62645-13-P-2032) on 03 SEP 2013 to provide one (1) ea. Richard Wolf Piezolith 3000 Lithotripter to the Naval Medical Center, Portsmouth VA. The total contract value is $398,000.00. The Naval Medical Logistics Command, Fort Detrick, MD 21702 is the contracting activity. 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 (NMLC), Fort Detrick, MD, on behalf of the Navy to meet Naval Medical Center (NMC) Portsmouth requirements. 2. Nature and/or description of the action. The proposed action is for a piezoelectric lithotripsy system for NMC Portsmouth. The Government intends on awarding a Firm Fixed Price contract. 3. Description of Supplies or Services: The Naval Medical Center Portsmouth has a requirement for a piezoelectric extracorporeal lithotripter. The system shall be capable of extracorporeal shock wave lithotripsy (ESWL). The system shall be capable of operating during urological procedures, specifically kidney stone localization, positioning and therapy. The system shall include a piezoelectric shock wave therapy source. The system shall be capable of at least a 45 degree rotational focal adjustment for the therapy source. The system shall be capable of adapting the focal size depending on the composition and density of the kidney stone. The system shall be capable of producing pulse frequencies of at least 0-4 Hz. The system shall include both radiographic/fluoroscopic (RF) and ultrasonic imaging modalities. The system shall be capable of simultaneous ultrasound and radiographic imaging. The system shall include a mobile radiographic/fluoroscopic unit, specifically a mobile C-arm. The mobile RF unit shall be capable of at least - 30 degrees lateral rotation range. The mobile RF unit shall be capable of pulsed fluoroscopy. The mobile RF unit shall include a monitor for real-time image viewing. The system shall include an ultrasound scanning system. The ultrasound shall be mobile on a wheeled cart. The ultrasound shall be capable of tissue harmonic and pulsed wave spectral Doppler imaging. The ultrasound system shall be capable of 2D and 3D imaging. The ultrasound unit shall be capable of simultaneous 2D and pulsed wave Doppler imaging modes. The ultrasound shall have at least 2 probe ports. The ultrasound probe shall be in line with the therapy shock wave source. The system shall include a treatment table. The table shall have a radiolucent surface. The table shall have a patient area of at least 85" x 27". The table shall be capable of longitudinal, transverse and vertical adjustment. The table shall be capable of at least 10 degrees Trendelenburg adjustment. The table shall have wheels with wheel locks. The facility power requirement is 120V, 60Hz. The vendor shall provide radiation safety and operator training. The requirement includes de-installation of the existing lithotripsy system. The vendor shall provide at least two (2) operating manuals, and at least two (2) user manuals. 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 Form 02.4G.AB / TDP 12-304-13 Page 2 of 4 1 NOV 2012 requirements. Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system 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. 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. 4. Identification of the statutory exceptions permitting other than full and open competition. The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1), FAR 6.302-1(c), brand name only. 5. Demonstration that the proposed contractor's unique qualifications or the nature of the acquisition requires use of the authority cited. Only one manufacturer, Richard Wolf Medical Instruments, can provide a lithotripsy system that meets the minimum requirements of the government. The Richard Wolf Piezolith 3000 is the only piezoelectric lithotripter currently available. Piezoelectric is a specific class of devices for extracorporeal lithotripsy; other device classes include electromagnetic and electrohydraulic. Piezoelectric lithotripsy is the only device class that does not require the services of an anesthesiologist and the use of anesthetic agents. This allows the procedure to be completed on an outpatient basis. The technology involved in piezoelectric lithotripsy minimizes tissue damage due to the small focal size of the piezoelectric elements. The focal size (2-8 mm) of the piezoelectric elements allows for minimal energy density, which allows for a more focused energy transmission while avoiding unnecessary exposure to surrounding tissue. The other device classes utilize focal sizes between 3-8 times greater, which leads to a higher energy density causing increased tissue damage, which leads to the requirement for additional anesthetics. The Piezolith 3000 is the only piezoelectric lithotripsy system currently available. The Piezolith 3000 is the only lithotripsy system that meets 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. Form 02.4G.AB / TDP 12-304-13 Page 3 of 4 1 NOV 2012 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 by technical experts in November 2012. This research consisted of reviews of previous procurements for these types of systems and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Yahoo, MSN, and GSA Advantage. Besides Richard Wolf, three other manufacturers were identified that provide extracorporeal lithotripsy systems, but none meet the minimum requirements of the government. Dornier used to provide the HM3 lithotripter, which utilized electrohydraulic technology, but they no longer manufacture that system. Dornier currently provides the SII and Delta lithotripsy systems, but these systems are not piezoelectric systems, do not include focal size adjustment, and thus, do not meet the minimum requirements of the government. All of Dornier's systems are electromagnetic lithotripsy systems. Siemens provides the Lithoskop and Modularis, but both of these systems utilize electromagnetic technology and also do not include a focal size adjustment capability and do not meet the minimum requirements of the government. Storz-Medical provides the Modulith SLX-F2 system, but it is a electromagnetic system and is not capable of piezoelectric lithotripsy. The Modulith SLX-F2 does not meet the minimum requirements of the government. EDAP TMS had previously provided a piezoelectric system (LT01), but they have stopped manufacturing that system and now provide the Sonolith i-sys, which uses an alternative "electroconductive" shock wave source mechanism, and does not include piezoelectric capability. The Sonolith i-sys also is not capable of adjusting focal size. The Sonolith i-sys does not meet the minimum requirements of the government. Richard Wolf Medical Systems is the only manufacturer that is able to provide a system that meets the minimum requirements of the government. Additionally, the requirement was solicited under solicitation number N6264513R0002 for 30 days and no offers were received. Richard Wolf is the only manufacturer that can provide a system that meets the minimum requirements of the government. 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. One source has expressed a written interest in the acquisition. However, this particular source is not able to meet the minimum requirements of the government. This requirement will be posted Form 02.4G.AB / TDP 12-304-13 Page 4 of 4 1 NOV 2012 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