SOLICITATION NOTICE
B -- Prototype hydromagnetic spinal implant analysis
- Notice Date
- 5/27/2011
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 622110
— General Medical and Surgical Hospitals
- Contracting Office
- N00259 NAVAL MEDICAL CENTER SAN DIEGO MATERIAL MANAGEMENT 34800 Bob Wilson Drive San Diego, CA
- ZIP Code
- 00000
- Solicitation Number
- N0025911T0290
- Response Due
- 6/10/2011
- Archive Date
- 7/10/2011
- Point of Contact
- Rey de Vera 619-532-5564
- Small Business Set-Aside
- N/A
- Description
- This is a combined solicitation/synopsis for commercial items, prepared in accordance with the format in FAR subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes only solicitation, quotations are being requested and a written solicitation will not be issued. The solicitation number, N00259-11-T-0290 is issued as a request for quotation (RFQ). The North American Industry Classification System (NAICS) Code for this acquisition is 622110. All interested bidders shall submit quotations electronically by email to reynaldo.devera@med.navy.mil or by facsimile at 619-532-5596, attention Reynaldo de Vera E-mail submissions are limited to 2MB. The submitter should confirm receipt of facsimile and email submissions. Quotations are due on or before 10 June 2011, 8:00AM Pacific Standard Time to be considered responsive. CLIN 0001 Perform prototype hydromagnetic spinal implant analysis for research Qty 368 Hr $________ for the Orthopedic department at Naval Medical Center San Diego in accordance with the Statement of Work. (Period of Performance 01 July 2011 to 30 June 2012) CLIN 0002 MTS Equipment Use Fee Qty 86 Hr $________ (Period of Performance: 01July 2011 “ 30 June 2012) CLIN 0003 Radiology, CT, and Flouroscopy charges Qty 1 Ea $________ (Period of Performance: 01July 2011 “ 30 June 2012) CLIN 0004 Cadaveric spines, shipping, handling, and disposal Qty 20 Ea $________ (Period of Performance: 01July 2011 “ 30 June 2012) CLIN 0005 Hardware and Miscellaneous Supplies Qty 1 Ea $________ (Period of Performance: 01July 2011 “ 30 June 2012) CLIN 0006 Project Management and Required Overheads Qty 1 Ea $________ (Period of Performance: 01July 2011 “ 30 June 2012) Contractor must be registered to the Central Contractor Registration (CCR) prior to award. The website address for CCR registration is www.ccr.gov Contractor MUST complete FAR 52.212-3, Offeror Representations and Certifications “ Commercial Items, when submitting a proposal. The website address is http://www.acquisition.gov. DELIVERY ADDRESS: Naval Medical Center San Diego, 34800 Bob Wilson Drive, San Diego, CA. 92134 The solicitation document and incorporated provisions and clauses are those in effect through FAC 2005-50 and DFARS Change Notice 20110304. This acquisition incorporates the following FAR clauses: 52.204-7 Central Contractor Registration (APR 2008) 52.212-1 Instruction to Offerors-Commercial Item (JUN 2008) 52.212-3 Offeror Representations and Certification--Commercial Items (JAN 2011) 52.212-4 Contract Terms and Conditions--Commercial Items (JUN 2010) 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items (JAN 2011) 52.219-28 Post Award Small Business Program Representative (APR 2009) 52.222-3 Convict Labor (JUN 2003) 52.222-19 Child Labor -- Cooperation with Authorities and Remedies (JUL 2010) 52.222-21 Prohibition Of Segregated Facilities (FEB 1999) 52.222-26 Equal Opportunity (MAR 2007) 52.222.36 Affirmative Action for Workers with Disabilities (OCT 2010 52.222-48 Exemption from Application of the Service Contract Act to Contacts for Maintenance, Calibration, or Repair of Certain Equipment Certification (FEB 2009) 52.222-51 Exemption from Application of the Service Contract Act to Contracts for Maintenance, Calibration, or Repair of Certain Equipment-Requirements (NOV 2007) 52.223-18 Contractor Policy to Ban Text Messaging while Driving (SEP 2010) 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008) 52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration (OCT 2003) 52.237-3 Continuity Of Services (JAN 1991) 52.252-2 Clauses Incorporated By Reference (FEB 1998) 252.204-7003 Control Of Government Personnel Work Product (APR1992) 252.204-7004 Alt A Central Contractor Registration (52.204-7) Alt A (SEP 2007) 252.212-7001 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Applicable to Defense Acquisitions of Commercial Items (APR 2007) 252.225-7001 Buy American Act and Balance of Payment Program (JAN 2009) 252.225-7002 Qualifying Country Sources As Subcontractors (APR 2003) 252.232-7003 Electronic Submission of Payment Requests (MAR 2008) All responsible sources may submit a quotation which shall be considered by the agency. STATEMENT OF WORK HYDROMAGNETIC MATERIAL TESTING FOR NOVEL JOINT REPLACEMENT TECHNOLOGY (CID#: NMCSD.NHU.201.0004) FOR RESEARCH FOR ORTHOPEDIC SURGERY DEPARTMENT, NAVAL MEDICAL CENTER, SAN DIEGO Part 1: Introduction Part 2: Performance Requirements Part 3: Quality Control Part 4: Government Furnished Facility Property Part 5: General Information Part 1: Introduction Performance Based Statement of Work. The contractor shall perform work as described in this Performance Based Statement of Work (PBSOW). The requirement is to provide equipment, expertise, and labor in order to perform analysis of a hydromagnetic spinal implant device. Overall 20 cadaver spines will be included in this study. The hydromagnetic device ™s ability to perform similar to the normal anatomy and resist axial load will be tested using a biaxial servohydraulic MTS 858 Machine (MTS Systems, Eden Prairie, Minnesota). Initially all spinal segments will be nondestructively tested for stiffness and range of motion to document the per-implant condition. Ten of the spines will then be tested to failure by constantly increasing the axial loading until failure occurs. The remaining ten spines will then be implanted with the new device. All surgeries will be supervised by an experienced fellowship trained spine surgeon from NMCSD. Initially, nondestructive testing for defining the construct stiffness (measured in Nmm/degree) and range of motion (ROM, measured in degrees) will be performed, in right and left torsion, and left lateral bending, Flexion and extension. Multi-level mechanics consisting of 4 vertabrae (2 on top and 2 below the artificial segment) will be tested with the free ends of the specimens embedded in polyester resin with custom fixation. Data on construct stiffness (measured in Nmm/degree) and range of motion (ROM, measured in degrees) will be obtained in right and left torsion, right and left bending, flexion, and extension. For flexion-extension and lateral bending, a cantilever beam will apply unconstrained moments of + 4.5 Nm with use of a displacement control rate of 2mm/sec. For axial torsion, each specimen will be mounted in-line with the machine actuator and a 100-N axial load will be applied with cyclic moments between + Nm at an angle control rate of 2 deg/sec. Before mechanical testing, each specimen will be prepared for kinematic analysis by rigidly attaching Kirschner wires (1.5 mm diameter) in the midline of each vertebral body parallel to the plane of motion. Retro-reflective markers (4mm diameter) will then be attached to the end of each wire to define a rigid coordinate system. All deformation is assumed to occur in the soft tissue (discs), so that the vertebral bodies act as rigid bodies. Relative motion between reflective markers will be measured with use of a four-camera noncontact motion-measurement system (Qualisys, Gothenburg, Sweden) to obtain kinematic data. A custom software program utilizing Euler angle calculation for the plane of motion being tested will be used to measure the range of motion in flexion-extension, right lateral bending, left lateral bending, and axial torsion. Kinematic data (measured in degrees) will be sampled at 10 Hz for the duration of each test. Specimen stability will then be evaluated by determining their moment-rotation behavior based on the biomechanical stiffness and range of motion. Mechanical data for displacement (measured in millimeters), force (Newtons), angle (degrees), torque (Newton-meters) will be sampled at 10 Hz for the duration of each test. Subsequently, destructive testing will be performed by axially loading the specimens till failure. Axial force will be increased till either the spine or the device fails. Mode of failure and force at failure will be recorded. Data of the entire construct (Nm/deg) and range of motion (degrees) will be reported as average + standard deviation. All calculations will be performed using a custom-designed MATLABTM (Mathworks, Inc. Natick, MA) program. The Contractor shall be solely responsible for any and all liability caused by the acts or omissions of its agents or employees. The Contractor shall not in any manner represent or infer that it is an instrumentality or agent of the United States Government. The Contractor shall recognize that the Commander, Naval Medical Center San Diego maintains administrative and operational responsibility for all activities carried on in support of the Medical Treatment Facility (MTF) and may take such actions as necessary to preserve and maintain the integrity of the MTF, subject to the limitations prescribed by law and U.S. Navy regulations and Federal law. This contract is a true performance based contract in that it states what needs to be done; the Performance Standards specify the outcomes and deliverables expected for and from these services; and the Contractor Quality Control (Part 3) tells how performance will be assessed. Scope of Work. The contactor will provide equipment, expertise, and labor in order to perform the prototype hydromagnetic spinal implant analysis for research for the orthopedic surgery department at Naval Medical Center San Diego and report findings to LT Barlow or LCDR Carney quarterly throughout the period of performance. Contractor will be a PhD in Biomechanical Engineering, have previous research experience in the area of orthopedic biomechanical research, have published research experience with orthopedic biomechanical research design, have good communication and presentation skills, and fluency in English. Hours of Service: The proposed project has been designed by active duty physicians from the Naval Medical Center San Diego Orthopedic Surgery Department. Active duty physicians will be involved in prototype design and production. However, NMCSD currently lacks a biomechanics lab capable of supporting this research. Historically, there has been a positive working relationship between the NMCSD Orthopedic Surgery Department and the Orthopedic Biomechanical Research Center (San Diego, CA). The OBRC has been instrumental in carrying out biomechanical studies in conjunction with the NMCSD Orthopedic Surgery Department in the past. We look to build on this existing working relationship with the OBRC and use their equipment and expertise to conduct this biomechanical study. The grant funds will be applied to conducting the biomechanical study of the hydromagnetic device. Part 2. Performance Requirements Model testing as described above using MTS 858 bi-axial servo-hydraulic materials testing machine according to engineering standards and using RealTime (3.2, Motion Analysis Corporation, Santa Rosa, CA) and Orthotrak (5.03, Motion Analysis Corp.) biomechanical software to track the performance of the hydromagnetic vertebral implant. Perform statistical analysis of the performance of the native vertebral segment compared to the prototype hydromagnetic spinal implant device. In order to evaluate the influence of the implant on these parameters, a multivariate analysis of variance (MANOVA) will be incorporated. Statistical significance will be determined using an alpha level of 0.05. Since interactions are based on an optimal combination of several dependent variables in a MANOVA, no correction in the significance level is needed. Summarize results at six months after project initiation Comprehensive model analysis and interpretation Summarize findings into images, tables, reports, abstracts and manuscripts for acceptance into peer-reviewed scientific and medical journals Assist in the preparation of the presentation of findings at scientific meetings and conferences or other venues in the area of interest. Communicate with LT Barlow and/or LCDR Joseph Carney via phone, e-mail, or teleconference on a minimum of a biweekly basis and as needed regarding project progress, issues and guidance on ongoing project evolution, altering model when directed by LT Barlow or LCDR Carney. Part 3. Quality Control Contractor will provide summary report of analysis at six months after project initiation. Part 4. Government Furnished Facility Property The U.S. government will furnish no tangible or intangible property in support of this activity. The contractor will be required to supply, at no cost to the government, any tangible or intangible materials required for him to complete this work. The contractor is expected to maintain telephone and computer access at his expense so that NMCSD others associated with the project can communicate effectively and efficiently with the contractor in a timely fashion. Part 5: General Information NMCSD is bound by the United States Code, the Code of Federal Regulations and Department of Defense Federal Acquisition Regulations. Nothing in this Statement of Work overrides these aforementioned statutes, laws, directives, instructions, and guidelines, Contractor will be paid for: Engineering supervision performed at the Orthopedic Biomechanics Research by the Director, Diana Glaser, PhD. An experienced sub-engineer will be utilized for the study testing as well. In addition, a technician will be utilized to assist the investigators in tissue preparation, dissection, assistance with the implantation, building and modifying existing fixation for the MTS machine, performing the testing and analyzing the data. As the specimens arrive in OBRC facilities, we will CT scan them to ensure that all of free of bone diseases and do not show significant signs of arthritis. We will also determine the bone density, as this plays an important role in the failure characteristics. Each scan will be performed in Rady Children ™s hospital. In addition we will fluoroscope the spines after implantation and after failure to ensure the correct position of the implant and define the failure mode. Fluoroscopic video and CT scans are taken at Rady Children ™s Hospital according to a standardized protocol, de-identified, given a reference number and processed further for data analysis. There are flexion/extension, lateral bending, axial rotation and failure testing to be performed for the 10 spines without implantation, resulting in 4 tests per spine or a total of 40 tests. The 10 spines that require implantation will be tested before and after implantation for flexion/extension, lateral bending, axial rotation, resulting in 6 tests per spine, totaling 60 tests. Additionally, those spines will be tested after implantation till failure, resulting in another 10 tests. Our statistical analysis revealed that we need 10 lumber spines per group to ensure significance in the most variables. Each lumbar spine specimen will have serology testing performed in usual fashion. All tissue will be ordered to be from a similar population with no obvious recorded bone diseases or bone cancer. Additional hardware and supply costs are anticipated for a new load cell (required to capture the forces in the specified range more correctly); Hardware associated with this project (including a modification of the existing MTS fixation for the spinal testing to perform the required testing) and supplies and consumable expenses.
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