SOLICITATION NOTICE
B -- Biomedical Engineer Services
- Notice Date
- 4/7/2010
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- JS1066759
- Archive Date
- 5/7/2010
- Point of Contact
- Jaclyn Stielper, Phone: 301-827-7153, Doreen Williams,
- E-Mail Address
-
jaclyn.stielper@fda.hhs.gov, doreen.williams@fda.hhs.gov
(jaclyn.stielper@fda.hhs.gov, doreen.williams@fda.hhs.gov)
- Small Business Set-Aside
- N/A
- Description
- PART I: PRICING AND TYPE OF CONTRACT This is a solicitation for commercial services and the resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-38 under Part 12 and Part 15. This announcement constitutes the only full and open competition solicitation. This synopsis, NAICS code 541711, is to notify contractors that the government intends to issue a Labor Hour Contract for the following statement of work, under the simplified acquisition procedures. Any firm that believes it is capable of providing the required service as stated herein may submit a capability statement to document its ability to provide the required services. A determination to compete this procurement based on a response to this notice is solely within the discretion of the Government. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. This solicitation is issued as a Request for Quotation (RFQ). The Food and Drug Administration (FDA) intends to award a purchase order for engineering support services for electromagnetic and wireless laboratory. PART II: STATEMENT OF WORK / SALIENT CHARACTERISTICS 1.0 Introduction 1.1 Background FDA regulates the safety and effectiveness of active (electrically powered) medical devices that may be put at risk from the emissions of radio transmitters, cell phones, security systems, and a variety of wireless devices. The Electromagnetics and Wireless Laboratory, in the Center for Devices and Radiological Health (CDRH), is frequently called on to confirm the normal and safe functioning of medical devices in the presence of potential electromagnetic interference (EMI) from a wide variety of sources including Magnetic Resonance Imaging (MRI) systems. The Lab also participates with international standards groups in the development and maintenance of standard test methods for electromagnetic compatibility (EMC). 1.2 Objective The purpose of this contract is to maintain the continuity of our ongoing test programs. The services required to maintain our test programs are assistance in the design, conduct and documentation of medical device EMC and medical device MRI safety tests; and with computer modeling to support those tests. In order to maintain continuity over the course of this contract the services should, to the maximum extent possible, be provided by a single individual with at least a Masters degree in an applicable field of science or engineering. 1.3 Project Scope This contract will provide services to CDRH's Electromagnetics and Wireless Laboratory in all phases of EMC and MRI safety testing of medical devices. 2.0 Description of Work Task 1: Design of experiments to be performed with implanted and other medical devices exposed to electromagnetic fields. Consult with FDA project officer regarding identifying and obtaining implanted medical devices (i.e. cardiac pacemakers, defibrillators, spinal cord stimulators) and externally worn devices to be studied in the FDA white Oak MD labs. The devices and all equipment and supplies will be provided by the FDA. Design experiments to test the effects of exposure to specific electromagnetic fields and the resulting unintended stimulation, electromagnetic interference, and radiofrequency (RF) heating by intense magnetic fields from Magnetic Resonance Imaging (MRI) systems including Gradient fields and RF fields emitted by simulated and actual clinical MR systems on certain implanted medical devices identified above. Design experiments to test the effects of exposure to specific RFID systems on certain implanted and non-implanted medical devices identified above. Estimated level of effort: 250 hrs. Task 2: Develop experimental protocols for testing medical devices in intense electric and magnetic fields Develop detailed written experimental protocols for developing tests of the devices identified in task 1. Prepare a written test protocol for conducting said experiments the protocols will include all technical details, test equipment identification, and methods needed to ascertain if electromagnetic interference caused failures in the electronics of these devices produces potentially harmful conditions in physical and computer models of patients. Estimated level of effort: 300 hrs. Task 3: Develop and calibrate experimental MR exposure systems obtained by FDA for testing medical devices. Prepare the FDA labs for power, cooling, measuring SAR distribution produced by FDA's dual frequency 3T MRI RF body coil. Design, develop calibrate and use the new exposure systems to simulate MRI gradient and radiofrequency (RF) fields. These systems include the FDA's newly ordered dual frequency 3 Tesla (3T) RF whole body coil and a new MRI gradient field simulator. Set-up, test, and calibrate the FDA's 3T RF whole body coil and gradient field simulator in the FDA White Oak lab. Learn to operate these complex systems, calibrate them, validate the performance specifications including spatial maps of the RF E field, B1 (RMS) and gradient B fields using the FDA's computer controlled, on-site Dasy5 robotic scanner, FDA's Easy-4-MRI measurement systems and E and H field probes. Estimated level of effort: 600 hrs. Task 4: Develop computer models and analyses of results for MHD modeling for cardiac disease diagnoses techniques initiated and partially completed by FDA in prior years. Complete the analyses of results of MHD computer modeling. Write detailed laboratory reports with plots, charts, tables of the specified parameters of this task. Estimated level of effort: 200 hrs. Task 5: Hearing Aid Compatibility (HAC) with cellular phones. Implement methods for mapping measured electromagnetic emissions and evaluating the undesired effects of these emissions from nearby, test-enabled cellular phones on hearing aids. Mapping will be performed with the FDA's DASY5 automated system by SPEAG AG Estimated level of effort: 270 hrs. Task 6: Prepare written manuscripts, as assigned, for tasks 1 - 5. Perform analyses, determine critical factors and parameters affecting performance, and develop manuscripts of research results suitable for submission to technical journals (i.e. IEEE or biomedical engineering online). Estimated level of effort: 300 hrs. Coordinating Instructions With the exception of documentation, all tasks will be performed at facilities located in the Electromagnetics and Wireless Laboratory, Division of Physics (Building 62, 10903 New Hampshire Avenue, Silver Spring, MD 20993). Documentation tasks may, with the approval of the Division of Physics, be performed in part at the contractor's facility. Materials and resources to be supplied by FDA The Electromagnetics and Wireless Laboratory, Division of Physics will supply the laboratory facilities, instruments, test items, and expendables necessary to perform the EMC tests required under the terms of the contract. In addition, office space, computers, printing capability, telephone, and office supplies will be provided. Period of Performance Base Year: 12 months from Date Of Award Option Year 1: 12 months to follow the base year Option Year 2: 12 months to follow Option Year 1 Location, Work Schedule and Travel Unless otherwise directed, contractors will adhere to standard work hours, working no more than 40 hours per week and observe all U.S. Government holidays. The contractor will schedule work Monday through Friday on site at 10903 New Hampshire Avenue, Building 62, Silver Spring, MD 20993 between the hours of 0700 and 1900, excluding federal holidays, not to exceed a total of 1920 hours per year. Contractor Conformance with Applicable Laws, Regulations, Policies and Standards The Contractor shall be responsible for knowledge of and compliance with all applicable federal information technology and information management laws, regulations, policies and standards at the government-wide, HHS and FDA levels. At the government-wide level, these include Office of Management and Budget (OMB), National Institute of Standards and Technology (NIST) and Government Accountability Office (GAO). These can be primarily found at or through the Federal CIO Council website at: http://www.cio.gov. Past Experience The contractor must be able to demonstrate past experience directly relevant to the types of work needed. Such experience includes projects performed in the past five years similar in scope to the requirements of this Statement of Work. PART III: PACKAGING N/A PART IV: INSPECTION AND ACCEPTANCE Deliverables for Task#1 in PART II above: Experimental design approved by project officer. Deliverables for Task#2 in PART II above: Develop written experimental protocols to be approved by FDA project officer. Deliverables for Task#3 in PART II above: Complete and ensure the operational status of the systems in task 3. Write detailed laboratory reports with plots, charts, and tables of the specified parameters of this task. Deliverables for Task#4 in PART II above: Complete detailed laboratory reports detailing results of the specified requirements of this task. Deliverables for Task#5 in PART II above: Write detailed laboratory reports on the results of these measurements and tests. Deliverables for Task#6 in PART II above: Detailed manuscripts of findings from tasks 1-5. Deliverables Task Due Date Experimental design. Task 1: Design of experiments to be performed with implanted and other medical devices exposed to electromagnetic fields. At completion of task. Experimental protocols. Task 2: Develop experimental protocols for testing medical devices in intense electric and magnetic fields. At completion of task. Laboratory test reports. Task 3: Develop and calibrate experimental MR exposure systems obtained by FDA for testing medical devices. Within 10 business days after completion of laboratory tests. Analysis report. Task 4: Develop computer models and analyses of results for MHD modeling for cardiac disease diagnoses techniques initiated and partially completed by FDA in prior years. Within 10 business days after completion of analysis. Laboratory test reports. Task 5: Hearing Aid Compatibility (HAC) with cellular phones. Within 10 business days after completion of laboratory tests. Manuscripts Task 6: Prepare written manuscripts, as assigned, for tasks 1 - 5. Within 30 business days after assignment. Criteria for Acceptance Only the Project Officer/COTR that initiated the tasking or designated manager has the authority to accept or reject deliverables. The acceptance of deliverables and satisfactory work performance required herein shall be based upon the timeliness, accuracy and suitability of the deliverable. The specific deliverables and schedule for delivery shall be as agreed upon and documented. All data and documents are to be submitted solely in electronic form and in the native file format of MS Word, MS Excel, or MS Power Point. Raw scientific data from laboratory tests should be compiled and submitted in the format generated by the laboratory instrument used to acquire the data. Deliverables will be submitted to the Electromagnetics and Wireless Laboratory, Laboratory Leader. PART V: COTR/CO/CS ASSIGNMENTS Project Officer and COTR (Contracting Officer Technical Representative): Brian Beard Contract Officer: Doreen Williams Contract Specialist: Jaclyn Stielper PART VI: INVOICES Payment Terms Payment shall be on an as invoiced basis with a brief report of work completed under that invoice. Invoices must be submitting to the address that will be included in the contract. PART VII: KEY PERSONNEL, NONDISCLOSURE FORMS, FINANCE TERMS Security and Privacy It is not anticipated that the contractor will be exposed to sensitive Agency information or data. But, the contractor agrees that contract personnel will not divulge or release information or data developed or obtained in connection with performance of this contract, unless made public by FDA or upon written approval by the Project Officer. The contractor will sign a Non Public Information document upon being awarded the contract and prior to starting work under this contract. PART VIII: TERMS AND CONDITIONS CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.217-9, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. PART IX: INSTRUCTIONS QUESTIONS DEADLINE: All questions are to be submitted via email to Jaclyn.Stielper@fda.hhs.gov no later than April 19, 2010 at 3:00 PM EST. Telephone calls will not be accepted. QUOTATIONS DUE: All quotations are due, via email to: Jaclyn.Stielper@fda.hhs.gov, no later than 3:00 PM EST on April 22, 2010. The contractor shall submit a quote for the hourly rate of a Biomedical Engineer for each year: base, option 1, and option 2. PART X: EVALUATION Award will be made to the party whose quote offers the best value to the Government, technical, price, and evaluation factors considered. The Government may award this purchase order to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria to meet or exceed the requirements: 1) Technical Capability, 2) Relevant Experience and 3) Price. Technical Capability and Relevant Experience when combined is significantly more important than price. The offeror shall provide a detailed description of the relevant qualifications, experience and expertise in no more than 25 pages. Evaluation of Technical Capability shall be based on the requirements provided in the quotation. Offerors shall include their understanding of the requirement, technical approach and past performance that can clearly support your quote. The contractor must be able to demonstrate relevant experience directly relevant to the types of work needed. Such experience includes projects performed in the past three years similar in scope to the requirements of this Statement of Work. Relevant Experience: The offeror shall identify up to five (5) most relevant contracts currently being performed or contracts that have been completed but performed with the last three (3) years from the issuance of this solicitation. Contracts may be either government or commercial. For each relevant contract, the offeror shall list the following: the contract name, description of relevant experience, period of performance, place of performance, project contact name and telephone number. Task 1 Technical factors: The contractor shall demonstrate knowledge of, and experience with: active implantable medical devices, RFID systems, and MRI RF subsystems. Task 2 Technical factors: The contractor shall demonstrate knowledge of, and experience with: making electrical measurements in intense electric and magnetic fields, design of experimental protocols, and failure analysis of electronic devices. Task 3 Technical factors: The contractor shall demonstrate knowledge of, and experience with: MRI RF and gradient field subsystems and measurements of electric and magnetic field produced by these subsystems. Task 4 Technical factors: The contractor shall demonstrate familiarity with, and experience using, SEMCAD or other software programs specifically intended for bio-electromagnetic modeling. Task 5 Technical factors: The contractor shall demonstrate knowledge of hearing aids and basic electromagnetic compatibility measurements including mapping electromagnetic emissions near cellular phones using the DASY5 automated system by SPEAG AG. Task 6 Technical factors: The contractor shall demonstrate experience with analysis and documentation of complex experimental data and developing manuscripts of research results suitable for submission to technical journals.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/FDA/DCASC/JS1066759/listing.html)
- Place of Performance
- Address: 10903 New Hampshire Avenue, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN02115894-W 20100409/100407235827-b65aa80d939f7010df2fa6e7d4b7ee87 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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