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FBO DAILY - FEDBIZOPPS ISSUE OF MAY 05, 2016 FBO #5277
SOURCES SOUGHT

D -- Implant Tissue Tracking Technology (IT3)

Notice Date
5/3/2016
 
Notice Type
Sources Sought
 
NAICS
541519 — Other Computer Related Services
 
Contracting Office
Department of the Army, Army Contracting Command, ACC - APG (W911QY) Natick (SPS), BLDG 1 KANSAS ST, Natick, Massachusetts, 01760-5011, United States
 
ZIP Code
01760-5011
 
Solicitation Number
W911QY-16-R-0038
 
Archive Date
5/28/2016
 
Point of Contact
jeremy michaels, Phone: 3016197421
 
E-Mail Address
jeremy.d.michaels.civ@mail.mil
(jeremy.d.michaels.civ@mail.mil)
 
Small Business Set-Aside
N/A
 
Description
This is a Request for Information (RFI) for planning purposes only, as defined in Federal Acquisition Regulation (FAR) subpart 15.201(e). This is NOT a solicitation for proposals, proposal abstracts, or quotations. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. The Government will NOT pay for information and materials received in response to this RFI and is no way obligated by the information received. This notice is for market research purposes only, to obtain information regarding (1) the availability and capability of all qualified performer sources, (2) including small businesses; HUB Zone small businesses; service-disabled small businesses; veteran-owned small businesses; woman-owned small businesses; small disadvantaged businesses; and universities and educational institutions, (3) their size classification relative to the North American Industry Classification System (NAICS) Code for the proposed acquisition. The applicable NAICS Code is 541519 Other Computer Related Services. Your responses to the information requested will assist the Government in determining the appropriate acquisition method for Implant Tissue Tracking Technology (IT3). Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. If a solicitation is released, it will be synopsized on the Federal Business Opportunities (FedBizOpps) website. It is the responsibility of the potential offerors to monitor this website for additional information pertaining to this requirement. CAPABILITY SUMMARY: The Air Force Medical Service (AFMS) has a requirement for an effective and efficient electronic tracking and recall system that provides an intuitive and simplified way to manage bi-directional tracing and critical chain of custody for tissue and biological implants from the supplier to point of use. This bi-directional system shall include multiple technologies for locating and tracking items such as Wi-Fi based location finding, active and passive Radio Frequency Identification (RFID), and a number of other location technologies, including ultrasound and infrared. This system shall track all patients who have received recalled medical device/tissue implants within all 75 Medical Treatment Facilities (MTF). The MTF shall be able to identify and provide the manufacturerwithrequiredinformationforthemtonotifythepatientsaffected by their call in real time. The system shall address manufacturer recall of medical device/tissue implants and the ability to track and notify the manufacturer of the recalled item through bi-directional tracking of the implant. This system shall be FDA, Federal law, and Joint Commission compliance; as well as provide greater assurance of patient safety. General expectations are as follows: • Shipment data integrations with transplant-related organizations such as LifeNet, Allosource, and LifleLink • Automatic recall matching not be dependent on a third party recall notification service • Tissue supplier certifications kept up to date by vendor and available in program • One scan verification of implants for expiration and recall status at point of use • Tissue Instructions-For-Use (IFU) kept up to date by vendor and available in the program • Integrated RFID storage units available in Freezers, refrigerators and cabinets • Ability to generate and print GS1 barcode labels from program, utilizing the manufacture's unique identifier • Ability to scan and parse out multiple data fields in GS1, HIBBC and ISB-128 bar code labels CAPABILITY ATTRIBUTES: All data from a given facility must roll up into a single database, and be accessible via a single user interface. The solution shall provide following: • Unique Device Identification (UDI) Tracker that provides status and registration documents; as well as traces every step of the tissue graft inventory from receipt to disposition. • Wi-Fi-based technology. • A Recall Connect that supports FDA recalls within 24 hours; as well as receives notifications from any affected patients or inventory items. • Provide real time tracking and notify affected patients and reporting with complete inventory information of medical device/tissue implants. • Bi-directional tracking and recall of implanted medical device/tissues identifying patient demographics. • Identify if a recalled product is present or has been administered to patients. • Provide reports and logs within seconds; to include lot numbers, serial numbers, and model numbers of the recalled/expired devices. • Ensure tags are standardized and consistent from one facility to the next to ensure the ability to track assets as they are transported from one location to another. The solution shall meet the following capability areas: 1. Asset (Item) Tracking Capability 2. SPD Workflow Automation Capability 3. Inventory Management Capability 4. Automated Temperature Monitoring Capability 5. Business Process Workflow 6. National Data Repository RELATED SERVICES/DELIVERABLES: The Contractor shall provide services necessary to assess, acquire, configure, install, interface, and integrate the appropriate hardware and software to satisfy desired system capabilities and functions. The Contractor shall integrate all solutions and interface with existing AFMS systems. The solution shall include hardware, software, documentation (including user manual, project management plan, quality control plan, monthly status and financial reports, data deliverables), quality assurance, training, warranty and maintenance services (including any travel CONUS and OCONUS). SPECIAL OR REGULATORY REQUIREMENTS: NACLC, HIPAA, Privacy Act, Non-disclosure Agreement, Pass and Identification Items (e.g., CAC Card), DoD 8570.1M, DoDI 8500.2, DoDD 5200.2, Section 508, Data Rights, Intellectual Property FAR Subpart 52.227-11, Patent Rights, and Contractor Manpower Reporting. Submission Instructions: Responses shall be submitted and received via Email to Jeremy.d.michaels.civ@mail.mil no later than 1:00PM EST 13 May 2016. Documents shall be no more than 10 pages total, electronic in Microsoft Word, Excel, Power Point, and/or Adobe Portable Document Format (PDF) and provided as attachments to the Email. No telephonic responses to this RFI will be considered. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned. Responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Please be advised that Government support contractors will have access to any and all information submitted under this requirement. Please provide information on your organization (not counted towards page limitations shown above): 1. Company Name, Address and Single Point of Contact with Name, Title, Telephone Number and Email Address. 2. DUNS Number and CAGE Code. Confirmation of Current Active Registration in the System for Award Management (SAM) or SAM registration information may be found at the website: https://www.sam.gov/portal/public/SAM. 3. Primary NAICS Code(s) and Business Size (i.e., small/large) Contracting Office Address: Bldg 1 Kansas St, Natick Massachusetts 01760-5011, United States Primary Point of Contact: Jeremy Michaels, Contract Specialist, Jeremy.d.michaels.civ@mail.mil, phone 301-619-7421 Secondary Point of Contact: Sandra J. O'Connell, Contracting/Grants Officer, Sandra.j.oconnell.civ@mail.mil, phone 301-619-2895
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/notices/f951c1af354e66c284c360266e127bc1)
 
Record
SN04103544-W 20160505/160503234750-f951c1af354e66c284c360266e127bc1 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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