Technical Assistance

Subject: Technical Assistance Solicitation Number: FDA1058898 Response Date: 24 July 2009 DESCRIPTION: THIS IS A COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS PREPARED IN ACCORDANCE WITH THE FORMAT IN FAR SUBPART 12.6-STREAMLINED PROCEDURES FOR EVALUATION AND SOLICITATION FOR COMMERCIAL ITEMS-AS SUPPLEMENTED WITH ADDITIONAL INFORMATION INCLUDED IN THIS NOTICE. THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION; QUOTATIONS ARE BEING REQUESTED, AND A WRITTEN SOLICITATION DOCUMENT WILL NOT BE ISSUED. THIS SOLICITATION IS BEING ISSUED USING SIMPLIFIED ACQUISITION PROCEDURES 13.5. This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 05-33. The associated North American Industrial Classification System (NAICS) code for this procurement is 541330 for a 100% small business set-aside. Statement Of Work 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 functioning of medical devices in the presence of potential electromagnetic interference (EMI). 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 requirement is to ensure the availability of consultation services for the design, conduct, and documentation of medical device EMC tests; and assistance with the development of new test methods involving new medical devices or new electromagnetic emitters. 1.3 Project Scope This contractor shall provide services to CDRH's Electromagnetics and Wireless Laboratory in all phases of EMC testing of medical devices. 2.0 Description of Work The Contractor shall: a. Be knowledgeable of the following standards: -ANSI C63.18 Recommended Practice for an On-Site, Ad Hoc Test Method for Estimating Radiated Electromagnetic Immunity of Medical Devices to Specific Radio-Frequency Transmitters. -ANSI C63.19 Methods of Measurements of Compatibility between Wireless Communications Devices and Hearing Aids. -ANSI/AAMI PC69 Active implantable medical devices Electromagnetic compatibility EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators. b. Contractor shall have experience performing EMC tests with the following medical devices: Pacemakers Implantable Cardioverter Defibrillators (ICD) Neurostimulators Hearing Aids TENS Apnea monitors c. Contractor shall have experience performing EMC tests with the following emitters: Cellular telephones Police radar Radio Frequency Identification (RFID) systems Metal detectors Electronic Article Surveillance (EAS) security systems Citizens Band (CB) radio d. Contractor shall have experience using the following medical device programmers: Medtronics 7432 Programmer Medtronics 9790C Programmer e. Contractor shall have experience calibrating and using an EMCO Model 5317 Gigahertz Transverse Electromagnetic (GTEM) Cell. f. Contractor shall have experience writing and modifying QuickBasic programs to acquire data from laboratory instruments via the General Purpose Interface Bus (GPIB). g. Contractor shall have experience using the following laboratory instrumentation: HP8647A Signal Generator HP437B Power Meter HP8560E Spectrum Analyzer HP8753E Network Analyzer Amplifier Research optically isolated electric field measurement system consisting of FP2000 probes and FM2000 monitor. h. Contractor shall provide technical consultation and laboratory support to staff of the Electromagnetics and Wireless Laboratory, Division of Physics, as needed on electromagnetic compatibility (EMC) and electrical safety of medical devices. i. Contractor shall provide technical consultation and laboratory support as needed for the development of measurement protocols and standard test methods to evaluate the EMC of medical devices. The work shall include design and assembly of laboratory setups for simulating interfering emissions and measuring their effects on medical devices. The results obtained shall be further used for publications and development of new guidance/standard documents. j. Contractor shall provide technical consultation on the use and calibration of equipment in the Electromagnetic and Wireless Laboratory. Such equipment will include, but is not limited to; GTEM facility, spectrum analyzers, signal generators, RF amplifiers, and oscilloscopes. k. Preparation of scientific papers, reviews, and reports as needed to document the contractor's activities in support of the Electromagnetics and Wireless Laboratory. Coordinating Instructions a. All work will be performed on an as needed basis as determined by the FDA. The Division of Physics will contact the contractor and arrange a mutually agreeable schedule. b. With the exception of documentation, all tasks will be performed at facilities located in the Silver Spring, MD 20993. Documentation may, with the approval of the FDA Project Officer, be performed at the contractor's facility. 3.0 Task Deliverables and Milestones: Deliverables Task Due Date -Laboratory procedures. Prepare reports of laboratory procedures for EMC tests developed under this requirement. 30 days fromcompletion of task. -Laboratory test results. Compile data from laboratory tests performed under the terms of this requirement. 30 days from completion of task. -Laboratory test reports. When required, analyze data from laboratory tests performed under the terms of this requirement. Within 10 business days after completion of laboratory tests. Criteria for Acceptance Only the Project Officer 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. 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 requirement. In addition, if needed, office space, printing capability, telephone, and office supplies will be supplied. FDA can and will utilize the requirement by contacting the contractor project manager and informing him/her of the nature of the need and services required. The contractor(s) 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 160 per year. 4.0 Location, Work Schedule and Travel Unless otherwise directed, contractor(s) shall adhere to standard work hours, working no more than 40 hours per week and observe all U.S. Government holidays. 5.0 Security and Privacy It is not anticipated that the contractor will be exposed to sensitive Agency information or data. But, the contractor agrees that contractor personnel will not divulge or release information or data developed or obtained in connection with performance of this requirement, unless made public by FDA or upon written approval by the Project Officer. 6.0 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 . 7.0 Payment Terms & Period of Performance Payment shall be on an as invoiced basis with a brief report of work completed under that invoice. The maximum payment per year shall not exceed 160 hours. A resume is required for the position which measures the qualifications and experience of the proposed contractor detailed in the requirement. A - man year equates to 1880 hours. One resume is to be provided for the combined labor category as follows: Engineering (Occupation Code 11-9041) A total of one (1) resume shall be included with your proposal for evaluation. Resumes shall not be submitted for the labor categories containing zero hours. Personnel proposed by the offeror will be evaluated for their formal education/training, technical skills and years of experience against the desired qualifications set forth in the overall requirement. All resumes shall be weighted equally for evaluation purposes. Resumes that meet the desired qualifications will be scored in the acceptable range, while those that exceed the desired requirements of education and/or experience will be scored higher." For instance, if the requirement is for a Bachelor's degree and the proposed person has a Masters degree they would receive extra credit (i.e. Acceptable versus Exceptional). The resumes will be scored against the following criteria: 1. Formal Education and/or training. 2. General Experience. 3. Specialized Experience. 4. Previous work experience clearly indicates skill and ability to perform in the labor category for which he/she is being proposed. A price breakdown should be submitted in the following format for evaluation: Base Year: I. Fully Burdened Hourly Rate Item description: a. Consultant - Other Scientific and Technical Consulting Services: 160 hours at a rate of $____ per hour = $______ or $______/month or __ hours/month Total Fully Burdened Hourly labor costs = $_______ ($_______/month or ____ hours/month) Option Year 1: Total Fully Burdened Hourly labor costs (160 hours) $______ Option Year 2: Total Fully Burdened Hourly labor costs (160 hours) $______ Option Year 3: Total Fully Burdened Hourly labor costs (160 hours) $______ Option Year 4: Total Fully Burdened Hourly labor costs (160 hours) $______ Period of Performance: Base year and 4 option years. QUESTIONS DEADLINE: all questions must be received by email (contact@example.gov) before 4:30 pm (1630) EST on 16 July 2009. Delivery terms shall be FOB Destination. FOB Destination means the contractor shall pack and mark the shipment in conformance with carrier requirements, deliver the shipment in good order and condition to the point of delivery specified in the purchase order, be responsible for loss of and/or damage to the goods occurring before receipt and acceptance of the shipment by the consignee at the delivery point specified in the purchase order; and pay all charges to the specified point of delivery. The Government will evaluate offers for award purposes by adding the base price plus all options to arrive to the total price for the requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise an option line item. Award will be made to the party whose quote offers the best value to the Government, technical, price, and other factors considered. The Government may award this contract to other than the lowest price technically acceptable quote. The Government will evaluate information based on the following evaluation criteria: 1) Technical Capability factor described to "Meet or Exceed the Requirement," 2) Past Performance and 3) Price. Technical Capability and Past Performance when combined is significantly more important than price. 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 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. FAR provisions can be found on the following website: http://www.arnet.gov. The following provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors-Commercial Items; 52.212-4 Contract Terms and Conditions Commercial Items; 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items; 52.217-5 Evaluation of Options; 52.217-8 Option to Extend Services; 52.217-9 Option to Extend the Term of the Contract; 52.219-6 Notice of Small Business Set-Aside; Commercial Items including subparagraphs: 52.222-3, Convict Labor 52.222-6 Davis-Bacon Act 52.222-7 Withholding of Funds 52.222-8 Payrolls and Basic Records 52.222-12 Contract Termination-Debarment 52.222-13 Compliance with Davis-Bacon and Related Act Regulations 52.222-26 Equal Opportunity 52.222-19, Child Labor-Cooperation with Authorities and Remedies 52.222-21, Prohibition of Segregated Facilities 52.222-26, Equal Opportunity 52.222-36, Affirmative Action for Workers with Disabilities 52.222-50, Combating Trafficking in Persons 52.225-1, Buy American Act'Supplies; 52.225-2 Buy American Certificate; 52.225-13, Restrictions on Certain Foreign Purchases 52.232-33, Payment by Electronic Fund Transfer-Central Contractor Registration. The Government intends to award a labor hour contract as a result of this Combined Synopsis/Solicitation that will include the terms and conditions that are set forth herein. Additionally, all quotes shall include price (s); FOB point; a poc (name and telephone number); a statement from the offeror verifying that they are CCR Registered under NAICS code 541330; delivery date (delivery date is coordinated with the Project Officer); business size; and payment terms. Delivery shall be to FDA, Silver Spring, MD 20993. FDA intends to make an award soon after the response date of this notice and all bids must be submitted via email and be received by 4:30 PM (1630) EST on 24 July 2009 to the attention of David Kordel, contact@example.gov. Offerors shall ensure the RFQ number is visible in the header of the email. FAX QUOTES SHALL NOT BE ACCEPTED.