SOURCES SOUGHT
A -- Independent Third Party Performance Testing for Advanced Development of Next Generation Portable Ventilators
- Notice Date
- 4/16/2009
- Notice Type
- Sources Sought
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, Office of the Secretary, Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, 330 Independence Avenue, SW, Rm G640, Washington, District of Columbia, 20201, United States
- ZIP Code
- 20201
- Solicitation Number
- 09-100-SOL-00009
- Point of Contact
- Kim Hall,, Phone: 202-205-1587, Schuyler T Eldridge,, Phone: 202-260-1554
- E-Mail Address
-
kim.hall@hhs.gov, schuyler.eldridge@hhs.gov
- Small Business Set-Aside
- N/A
- Description
- THIS IS A SOURCES SOUGHT NOTICE ONLY. This Sources Sought Notice (SSN) is NOT a Request for Proposal (RFP) and does not constitute a commitment by the Government. The Government is currently conducting market research in accordance with Federal Acquisition Regulation, Part 10, to identify potential sources to provide the requirements and gather information on current capabilities within the market. All information submitted in response to this Sources Sought Notice is voluntary and the Government will not pay for information requested nor will it compensate any respondents for any cost incurred in developing information provided to the Government. Proprietary information submitted should be marked appropriately. All submitted information shall remain with the U.S. Government and will not be returned. The Department of Health and Human Services (HHS), Assistant Secretary for Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authroity (BARDA), Influenza and Emerging Diseases Division (IEDD) has a future requirement for independent third party performance testing to support other contracts for the advanced development of next generation fully kitted portable ventilators. Independently, the Contractor shall furnish all the necessary services, qualified personnel, materials, and facilities as needed to 1) develop or utilize existing appropriate testing protocols, 2) perform testing of the candidate ventilators, and document and analyze the Original Equipment Manufacturer (OEM) performance testing, 3) review all executed OEM software validation, and 4) report the third party testing results in a final report to the U.S. Government (USG). The fully kitted ventilators shall be tested in all operating modes for performance under simulated use conditions in the simulated environment in which the device is expected to be used. Ventilators from several different manufacturers are expected to be covered under this contract and the devices may require testing concurrently. Testing will be in accordance with the American Society for Testing and Materials (ASTM) F 1100-90 (Standards Specifications for Ventilators Intended for Use in Critical Care), International Electrical Commission (IEC) 60601-2-12(2001-10); Medical Electrical Equipment – Part 2-12: Particular Requirements for the Safety of Lung Ventilators – Critical Care Ventilators and ASTM F 1246-91 (Standard Specification for Electrically Powered Home Care Ventilators, Part 1-Positive-Pressure Ventilators and Ventilator Circuits). Operational, usability and functional performance tests shall be inclusive for neonate to adult patient populations. Operational performance includes but is not limited to electromagnetic interference (EMI), radio-frequency interference (RFI) and conductive interference testing, and full review of all executed software validation protocol as provided by the OEM. Usability performance testing shall include but not be limited to: 1) intuitive user interface for ease of use and set up type testing for inexperienced health care providers with limited or no respiratory support training, and 2) outlines all recommended characteristics and specifications that the OEM has incorporated into the design of the ventilator. Functional performance includes the performance protocol with full functional testing of the ventilator. Over-all performance testing shall be individualized according to the characteristics specified by the OEM. This contract also includes OEM protocol analysis and comparison of results with Standard Operating Procedures (SOPs) and protocols established by the independent third party testing Contractor. A potential Offeror must meet the following mandatory qualification criteria: a. The independent third party testing Contractor shall be able to draft protocols appropriate to meet BARDA IEDD criteria for operational, usability and functional performance testing with acceptance criteria suitable to meet all standards applicable to the ventilator. b. Contractor shall be able to conduct all performance testing and re-testing in one testing location without subcontracting to another facility; c. Contractor shall have adequate state-of-the-art testing equipment and data management tools and practices to maintain security of information related to results from reviews and testing activities. All information regarding the evaluation of test products shall be the property of the Federal Government/HHS and treated as such. It is anticipated that a Request for Proposal (RFP) will be announced approximately June 2009 with proposals due in July 2009. While the mandatory qualification criteria do not have to currently be met, all of the mandatory qualification criteria must be met by proposal submission. Proposals that do not meet the mandatory qualification criteria will not be considered for evaluation. Respondents to this Sources Sought Notice may identify their interest by submitting a capability statement, including how they plan to meet the mandatory qualification criteria, an anticipated delivery schedule of the service, and primary contact information at the organization (name, email, address and telephone number) handling this Sources Sought Notice in the event HHS has additional questions or requires clarification of the submitted information. Responses are limited to 10 pages. Data sets (i.e., tables, charts, graphs) and documents that are pertinent to the response can be submitted as appendices to the primary submission. Potential respondents are also requested to include whether or not they are a large or small business. Small businesses are encouraged to respond. All respondents and comments to this Sources Sought Notice shall reference 09-100-SSN-00009 and be submitted to Kim L. Hall, Contract Specialist at kim.hall@hhs.gov by 1:00 PM EST, May 1, 2009.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=aa000f9fe1f66834f7bbb48eb358b93c&tab=core&_cview=1)
- Record
- SN01794706-W 20090418/090416221317-aa000f9fe1f66834f7bbb48eb358b93c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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