SPECIAL NOTICE
99 -- RFI - Medical Device Implant Tracking system (MDIT)
- Notice Date
- 8/15/2012
- Notice Type
- Special Notice
- Contracting Office
- P.O. Box 190022, North Charleston SC 29419-9022
- ZIP Code
- 29419-9022
- Solicitation Number
- N65236_SNOTE_0005772E
- Archive Date
- 9/5/2012
- E-Mail Address
-
Contract Specialist
(paula.somers@navy.mil)
- Small Business Set-Aside
- N/A
- Description
- Submissions are due not later than noon (EDT) on 5 September 2012. The Space and Naval Warfare Systems Center (SPAWARSYSCEN) Atlantic, Code 6.3.2.0 is seeking information on services to develop Air Force Medical Services (AFMS) for Medical Device Implant Tracking system (MDIT) and Tissue Tracking. The goal of this initiative is to improve patient care and safety in compliance with The Joint Commission, Accreditation Association for Ambulatory Healthcare (AAAHC) 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. 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, gastroenterology. However, there is no AFMS standardized system capable of bidirectional tracking of medical device and tissue implants/explants. 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/explants; (4) provide the medical device and tissue supplier 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; and (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 records 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; (8) and any other requirements from any state and federal regulatory agencies. This initiative aims to fill this critical MDIT and Tissue Tracking capability GAP with a solution that is secure and 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. SUBMITTALS: The information received shall be reviewed to conduct objective, comparative assessments and validation of commercial equipment and systems. This RFI is FOR INFORMATION GATHERING AND PLANNING PURPOSES ONLY, and should not be construed as a Request for Proposal (RFP) or solicitation of an offer. The Government DOES NOT INTEND TO AWARD A CONTRACT on the basis of this RFI or otherwise pay for the information solicited. All information received will be treated as public knowledge; therefore, vendors should not submit proprietary information in response to this RFI. SPECIFIC INFORMATION SOUGHT INCLUDES: 1. Company information, including name, address, and URL 2. Whether the company is a manufacturer, distributor, or service provider. 3. A point of contact for follow-up information, and the point of contacts phone number and e-mail address 4. A brief description (250 words or less) of capabilities and existing or related products. 5. Any relevant cost information such as purchase price and General Services Administration (GSA) schedule information. A word document with this same announcement are located on SSC LANT'S e-commerce web site: https://e-commerce.sscno.nmci.navy.mil. If you encounter issues regarding access to the website, please contact the webmaster. The Technical Point of Contact is Marc Pipkin, marc.pipkin@navy.mil, (843) 218-4219. E-mail your non-technical questions to the Contracts Specialist, Paula Somers at paula.somers@navy.mil. Submissions are due no later than noon on 5 September 2012.
- Web Link
-
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(https://www.fbo.gov/notices/c7a04979ae4c97ff7ed4406721c6b6af)
- Record
- SN02841851-W 20120817/120816001915-c7a04979ae4c97ff7ed4406721c6b6af (fbodaily.com)
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