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AFICA_AFMESA_Portable Point of Care Coagulation Monitor

Solicitation Number: AFICA_AFMESA_14_RFI_PortablePointofCareCoagulationMonitor
Agency: Department of the Air Force
Office: AFICA
Location: AFICA- CONUS
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AFICA_AFMESA_14_RFI_PortablePointofCareCoagulationMonitor
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Added: Mar 03, 2014 5:19 pm
THIS IS NOT A REQUEST FOR PROPOSALS OR A REQUEST FOR QUOTATIONS; IT IS STRICTLY A REQUEST FOR INFORMATION (RFI). NEITHER UNSOLICITED PROPOSALS NOR ANY OTHER KINDS OF OFFERS WILL BE CONSIDERED IN RESPONSE TO THIS RFI. NO CONTRACT WILL BE AWARDED PURSUANT TO THIS ANNOUNCEMENT.
1. SUBJECT: The Air Force Medical Evaluation Support Activity (AFMESA) is conducting market research on portable, point of care coagulation monitors suitable for use in assessing patients for trauma-induced coagulopathy in the expeditionary environment. Responses are due to this request for information (RFI) by 2:00 (EST) on 2 April 2014.
2. DISCLAIMER: This RFI is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this RFI. Responses to this notice are not offers and will not be accepted by the Government to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this RFI. All information received in response to this RFI marked as "proprietary" will be handled accordingly. Information provided as a response to the RFI will not be returned. AFMESA will not entertain any questions concerning the composition, requirements, or the nature of services to be performed under any future request for proposal (RFP).
3. BACKGROUND: The United States Army Medical Materiel Agency (USAMMA) and the Air Force Medical Support Agency (AFMSA) have identified a need for a portable, point of care coagulation monitor with the ability to assess coagulation status of critically ill and injured patients.
Coagulopathy is a serious medical condition affecting the bloods ability to coagulate (clot) and is commonly present in trauma patients. Early diagnosis of coagulopathy is critical for clinicians to properly treat the patient to prevent further blood loss. USAMMA and AFMSA are seeking a device with the ability to quickly and accurately detect coagulopathy at the point of care.
Manufacturers are encouraged to submit a response to this RFI, even if a system does not meet all the requirements at this time. For requirements that are not met, trade-off considerations will also be considered.
4. REQUIREMENTS: The coagulopathy monitor sought must operate in the military expeditionary environment with the ability to quickly and accurately detect trauma-induced coagulopathy at the point of care.
Responses should address the requirements identified in this RFI, particularly those outlined in 4A below.
4A. MANDATORY REQUIREMENTS:
The RFI response must indicate the devices ability to satisfy the following requirements and responses must include the attached survey:
• Device must be "approved for market" (PMA), "cleared to market" (510k), or "legally marketed" (as defined in the Code of Federal Regulations - 21 CFR807.92(a)(3) for class I and II devices)

• Device must be capable of obtaining DOD Air Worthiness Certification (AWC)
• Device must accurately detect coagulopathy
• Device must quickly detect coagulopathy
• Device must be rugged for use in the military expeditionary environment
• Device must be portable
• Device must be suitable for use at the point of care
• Device must be suitable for use through all roles of care*
Some examples of applicable technology include emerging biomarkers, thromboelastography, rotational thromboelastography, micro-viscometry, or other approaches. Information regarding devices intended for routine monitoring of PT/INR only is not currently being collected.
AFMESA seeks information about academic, prototype, developmental, foreign and domestic commercially available products that meet or can be readily modified to meet the requirements discussed above.
5. RESPONSE INFORMATION: Response to this RFI must be submitted to Ms. Ashley Fredlock, Market Research Analyst, via e-mail to AFMSA.SG5T.Market@us.af.mil. Email responses should be no larger than 10 MB in size. If larger attachments are required, please notify Ashley Fredlock at the above listed email address. Each RFI response will receive a confirmation email; if a confirmation is not received please call 301-619-8600. Please include a point of contact, phone number, e-mail address, website information, and indicate whether the company is a foreign or domestic entity in the contents of the e-mail.
Responses must be received by this office on or before 2:00 (EST) on 2 April 2014. This RFI is not a commercial solicitation. The Government will not pay for any information submitted, or for any costs associated with providing the information.
The response should describe the company's capability to offer, field, and sustain the coagulation monitor as characterized by the requirements addressed in this RFI. If unable to provide a coagulation monitor capable of meeting all requirements, the respondent should offer trade-off considerations.
Each response must include the attached survey in addition to supplemental product information.
6. LATE SUBMISSIONS: Failure to respond to this RFI does not preclude participation in any future competition, nor will information provided in response to this RFI be used to exclude anyone from responding to any future requests for proposals. Communications with AFMESA in regard to this RFI will only be permitted in writing during the RFI response period.
Responses to the RFI received by AFMESA after the submittal deadline and time indicated may be considered. The respondent assumes the risk of the method of dispatch chosen. Postmarking by the submittal date and time shall not substitute for actual response receipt.
7. OWNERSHIP OF RESPONSE TO RFI: All informational material submitted in response to this request becomes property of AFMESA. Physical samples will be returned to the vendor at the owner's expense.
8. RELEASE OF CLAIMS, LIABILITY, AND PREPARATION EXPENSES: Under no circumstances shall AFMESA be responsible for any response preparation expenses, submission costs, or any other expenses, costs, or damages of whatever nature incurred as a result of the respondent's participation in this RFI process. Respondent understands and agrees that they submit a response at their own risk and expense, and release AFMESA from any claim for damages or other liability arising out of the RFI process.
9. ERRORS IN RESPONSE: AFMESA shall not be liable for any errors in respondent's response. Respondent is responsible for careful review of its entire response to ensure that all information is correct and complete. Respondents are liable for all error or omissions contained in their responses.
10. ADDENDUM: AFMESA reserves the right to issue an addendum to this RFI at any time for any reason.
11. CONTACT INFORMATION: Ms. Ashley A. Fredlock
Air Force Medical Evaluation Support Activity (AFMESA)
1270 Montevue Lane (Area B)
Fort Detrick, MD 21702
Phone: 301-619-8600
AFMSA.SG5T.Market@us.af.mil

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RFI Response Form

Type:
Other (Draft RFPs/RFIs, Responses to Questions, etc..)
Label:
RFI Response Form
Posted Date:
March 3, 2014
Description: RFI Response Form
:
1940 Allbrook Dr
Bldg 1, Door 1, Room 300, Cubicle 481

Wright Patterson AFB, Ohio 45433-5344
United States
:
1270 Montevue Lane (Area B)

Fort Detrick, Maryland 21702
United States
:
Ashley Fredlock,
Market Research Analyst
Phone: 301-619-8600