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FBO DAILY - FEDBIZOPPS ISSUE OF SEPTEMBER 20, 2015 FBO #5049
SOURCES SOUGHT

65 -- AFMSA/SG5 and DHA MEDLOG “Big-Data” PM BioBank Solution & Medical Device Implant Tracker/Tissue

Notice Date
9/18/2015
 
Notice Type
Sources Sought
 
NAICS
621511 — Medical Laboratories
 
Contracting Office
AFICA - AFICA- CONUS
 
ZIP Code
00000
 
Solicitation Number
FA8052-FY15-RFIVendorDayDHA
 
Archive Date
10/20/2015
 
Point of Contact
Daniel J. Duke,
 
E-Mail Address
daniel.j.duke2.civ@mail.mil
(daniel.j.duke2.civ@mail.mil)
 
Small Business Set-Aside
N/A
 
Description
1. SUBJECT: The Air Force Medical Support Agency Research and Acquisition Directorate (AFMSA/SG5) and DHA Medical Logistics (DHA MEDLOG) are conducting a Vendor Day for prospective vendors to showcase new and/or emerging technologies within the Operational Medicine (OM) and Personalized Medicine (PM) areas. Responses are due to this request for information (RFI) by 8 :00 AM EDT on 05 October 2015. Space will be limited to one 6-foot table per vendor (accommodations may be considered if additional space is needed). Please provide the dimensions of the equipment being demonstrated (height, width, depth) for building ingress, egress, and logistics considerations. Vendors are allowed no more than three (3) representatives total for an entire company and AFMSA/SG5 and DHA MEDLOG reserve the right to reduce that number to two (2) in order to mitigate overcrowding. Individual divisions or groups of a single company are considered a single parent company, and that individual will be issued a ticket for entry to the event. Registration is also required at: http://www.eventbrite.com/e/mhs-vendor-day-tickets-14943141338?aff=es2. It is strongly recommended that at least one (1) of the participants be from one of the vendor's technical division(s). If approved, you will receive confirmation along with additional information. Vendors selected will be notified NLT 05 October 2015. The Vendor Day will be held at the Defense Medical Agency (DHA) Medical Logistics (MEDLOG) Division Facility, 693 Neiman Street, Fort Detrick, MD, 21702 from 0800-1200 EDT on 6 October 2015. 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. AFMSA/SG5 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 : AFMSA/SG5 and DHA MEDLOG have identified a need for medical modernization in the following areas Operational Medicine and Personalized Medicine: •1. Operational Medicine - Focus is on an Air Force Medical Services (AFMS) standardized system for the Medical Device Implant Tracking and Tissue Tracking (MDIT/TT) initiative. The goal of this initiative is to improve patient care and safety in compliance with The Joint Commission Accreditation Association for Ambulatory Healthcare and Food and Drug Administration regulations through standardized automated bi-directional tracking of medical devices and tissue implants/explants, especially in the event of a recall. •2. Medical devices and tissue, including those that are implanted in patients, are currently being used extensively. Medical devices and tissue include those used by general surgery, orthopedic surgery, plastic surgery, otolaryngology, cardiology, and gastroenterology. However, there is no AFMS standardized system capable of bi-directional tracking of medical device and tissue implants/explants. •3. The objective of this program is to (1) track medical devices and tissue implants/explants; (2) archive and track patients who have received medical devices and tissue implants/explants; (3) leverage capability to provide a list of patients that have received a manufacturers' medical device and tissue implant/explant; (4) provide the medical device and tissue supplier a list of patients who have been affected by a particular recall; (5) notify patients affected by medical device and/or tissue recall in a timely manner; (6) track patient social security numbers or unique identifier and document patient refusal to release Personal Identification Information (PII) or Electronic Personal Health Information (EPHI); (7) maintain reports for a minimum of ten years on device and tissue suppliers, condition of devices or tissues on receipt, documentation of required environmental control, and documentation of tissue supplier qualifications; and (8) any other requirements from any state and federal regulatory agencies. This initiative aims to fill this critical MDIT/TT capability gap with a solution that is Web-based and secured through encryption and meeting the DOD and USAF requirements for computer software and network solutions. It will be able to track all federally mandated implantable tissues across all clinical departments and at all AFMS MTFs. Any item with a model, lot, serial or UDI number can be tracked by it. Personalized Medicine - Focus is on a "big-data" PM BioBank solution. This BioBank should be focused on Air Force (AF) needs with appropriate accessibility concerns for academic, nonprofit, and industry partners of the AF Medical Service (AFMS). The BioBank should initially be prototyped using synthetic data to test the architecture to provide for the necessary data storage, access, analysis and security. Potential development of a Digital BioBank is envisioned to close a capability gap in the use of genomic data for research studies and personalized health care. At this time, a centralized database does not exist that securely stores AFMS genomic data and electronic health record data while simultaneously providing an analytical interface for PM research. Furthermore, researchers and clinicians must be able to use this BioBank in order to merge genomic variants with associated phenotypic data, evaluate evidence and parameters of their association, and establish clinical guidelines for clinical care. The operational outcome digital BioBank will help collaborators to extract and transfer data in a virtual portal and create a test bed for methodologies and protocols for security, storage and integration of genomic data. This will have a transformative effect on healthcare and could be used to improve patient outcomes and reduce healthcare costs. 4. REQUIREMENTS/REQUESTED INFORMATION: AFMSA/SG5 and DHA MEDLOG are interested in commercial off-the-shelf (COTS) or Government off-the-shelf (GOTS) products as well as research and development (R&D) opportunities that fulfill the capabilities outlined above. Vendors should furnish the following information to AFMSA/SG5: a. Capability Statement: Outline how your organization would perform the services and/or how your organizations product(s) and/or technology map. Vendors are highly encouraged to submit a capability statement (10 pages or less and no marketing material) that address their ability to deliver the required product and/or solution. Vendors interested in specific solution sets must submit a capability statement that addresses specific solution sets. Additionally, vendors should provide minimal amount of space (dimensions) required to present these potential solution sets at the event. Please list company GSA Schedule number (if applicable), b. White Paper: Vendors should submit a separate document (10 pages or less) that summarizes the vendor's comments and capabilities. Vendors should identify any gaps in the documentation and approach, including areas known to require further technology and/or solutions, missing or ambiguous requirements, and any other general comments or concerns. Feedback in the white paper should also include specific comments and suggestions for refining the documents to reflect clear guidance to industry and industry best practices. AFMSA/SG5 and DHA MEDLOG seek information about academic, prototype, developmental, and domestic commercially available products that meet or can be readily modified to meet the requirements discussed above. 5. CONTACT INFORMATION: Response to this RFI must be submitted to Mr. Daniel Duke, Program Analyst, AFMSA/SG5P, 7700 Arlington Blvd., Suite 3NW232C, Falls Church VA 22042 or, via e-mail to daniel.j.duke2.civ@mail.mil. The DHA MEDLOG point of contact for the EventBrite registration is Mr. Steve Burrows via email at Judson.s.burrows.civ@mail.mil. Responses to the RFI and registration on EventBrite must be received by these offices on or before 8:00 AM EDT on 05 October 2015. 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. Companies/vendors are limited to 1 ticket. 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. 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 AFMSA/SG5 with regard to this RFI will only be permitted in writing during the RFI response period. Responses to the RFI received by AFMSA/SG5 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 become property of AFMSA/SG5. Physical samples will be returned to vendor at the owner's expense. 8. RELEASE OF CLAIMS, LIABILITY, AND PREPARATION EXPENSES: Under no circumstances shall AFMSA/SG5 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 it submits its response at its own risk and expense, and releases AFMSA/SG5 from any claim for damages or other liability arising out of this RFI. 9. ERRORS IN RESPONSE: AFMSA/SG5 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: AFMSA/SG5 reserves the right to issue an addendum to this RFI at any time for any reason.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/notices/9ad897f510e7d519a2105e8fdede9d9a)
 
Place of Performance
Address: 7700 Arlington Blvd., Suite 3NW232C, Falls Church, Virginia, 22042, United States
Zip Code: 22042
 
Record
SN03893513-W 20150920/150918235427-9ad897f510e7d519a2105e8fdede9d9a (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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