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Implant Tissue Tracking Technology (IT3)

General Information

Document Type:SNOTE
Posted Date:Sep 05, 2017
Category: Professional, Administrative and Management Support Services
Set Aside:N/A

Contracting Office Address

Department of the Army, Army Contracting Command, ACC - APG (W911QY) Natick (SPS), BLDG 1 KANSAS ST, Natick, Massachusetts, 01760-5011, United States

Description

The U.S. Army Contracting Command - Aberdeen Proving Ground (ACCAPG), Natick Contracting Division (NCD) in support of the Program Manager - Air Force Medical Support Agency (AFMSA) intends to award an Indefinite Delivery Indefinite Quantity (IDIQ) firm fixed price contract on a sole source basis to Champion Healthcare Technologies located at 765 Ela Road, STE 200, Lake Zurich, IL 60047, under the authority as prescribed in 10 USC 2304 (c)(1) and FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The requirement is for (1) the development of an electronic system that provides bi-directional tracking and recall of implanted medical devices (referred to herein as Implant Tissue Tracking Technology) and (2) implementation of Implant Tissue Tracking Technology (IT3) into Air Force Medical Treatment Facilities (MTFs). The requirement calls for a solution that meets the following criteria: a) The solution shall be a cloud-based IT3 software application that can leverage existing storage locations. b) The solution shall utilize Unique Device Identification (UDI) Tracker technology that provides status and registration documents; as well as traces every step of the tissue graft inventory from receipt to disposition. c) The solution shall have a recall matching support function that supports FDA recalls within 24 hours; as well as receive notifications from any affected patients or inventory items. Recall matching should be effective in matching the recalls to both the patient and the storage location. d) The solution shall provide real time tracking and notify affected patients and reporting with complete inventory information of medical device/tissue implants. e) The solution shall have bi-directional tracking and recall capabilities of implanted medical device/tissues identifying patient demographics. f) The solution shall identify if a recalled product is present or has been administered to patients. g) The solution shall provide reports and logs within seconds; to include lot numbers, serial numbers, and model numbers of the recalled/expired devices. h) The solution shall contain tissue compliance services that can manage: Supplier registrations, AATB, FDA, State license (both current and legacy), Tissue/Implant Utilization forms submitted electronically post-case, and Tissue Prep Instructions. i) The Medical Treatment Facilities (MTFs) and Dental Treatment Facilities (DTFs) shall be able to identify and provide the manufacturer with required information for them to notify the patients affected by the recall in real time. j) 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. k) The solution shall meet or exceed U.S. Food and Drug Administration (FDA) and Accreditation Association for Ambulatory Health Care (AAAHC) requirements for a tracking and reporting process for medical device/tissue implant recalls. l) The solution shall contain UDI Barcode Scanning capabilities that scan data elements directly into UDI Tracker. m) The solution shall provide RFID storage solutions for tracking all activity occurring at the unit or in an area, owner on record, and time item was removed or returned. n) The solution shall automate the inventory management process, thereby reducing the effective level of effort exerted by facility staff, enhancing the granularity of consumables tracking, and reducing the number of errors with respect to patient-consumable/implant interaction. o) The solution shall be FDA federal law and Joint Commission compliance; as well as provide greater assurance of patient safety. p) The MTFs/DTFs shall be able to identify and provide the manufacturer with required information for them to notify the patients affected by the recall in real time. q) 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. r) The solution shall be able to relate the recalled items to a list of patients who interacted with such items within the past 12 months of recall acknowledgement. s) The solution shall contain warranty tracking support functions to protect against potential overpayments, OIG audits, and to retain revenues. t) The solution shall provide clinical and materials system integration with current government security approval process to be integrated with existing systems. u) The contractor must provide technical training for the operation and maintenance of the tracking and recall system. v) Contractor personnel are prohibited from releasing any personnel or medical/patient information to include patient/person-level content with personal health information during the course of this contract. w) Publication of findings and reports of the prototype outcomes. The North American Industry Classification System (NAICS) code is 541712. The Federal Supply Code is R499 and the Small Business Size Standard is 1000 employees. Telephone calls will not be accepted. Questions may be sent to Jason Bow at Jason.r.bow2.ctr@mail.mil

Original Point of Contact

POC Roberta F. Boswell,

Place of Performance

Address:
Air Force Medical Treatment Facilities (MTFs) - TBD, TBD, United States
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Link: FBO.gov Permalink
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