Bioness Gait & Safety System 640A59097 Tryco Incorporated

This acquisition is conducted under the authority of the Multiple Award Schedule Program. The material or service listed in par. 3 below is sole source, therefore, consideration of the number of contractors required by FAR Subpart 8.4 - Federal Supply Schedules, is precluded for the reasons indicated below.



(1) AGENCY AND CONTRACTING ACTIVITY: Department of Veterans Affairs

Network Contracting Office 21 - PAD

3801 Miranda Ave., Bldg. T-50

Palo Alto, CA 94304

VISN: 21





(2) (a) NATURE AND/OR DESCRIPTION OF ACTION BEING APPROVED:



This is a limited sources justification for firm-fixed price delivery order (no options) against VA National Acquisition Center (NAC) Contract #V797VP-4964A (MANDATORY Schedule 65 IIA) for new customized, ceiling-mounted gait training system (Bioness Vector Gait and Safety System®), with two (2) separate dynamic body weight support(s) into the new Recreation Therapy Facility (Bldg. 530)





(3) (a) A DESCRIPTION OF THE SUPPLIES OR SERVICES REQUIRED TO MEET THE AGENCY'S NEED:



VA Palo Alto Health Care System (VAPAHCS) is building a new Recreation Therapy Facility adjacent to the Aquatic Therapy Building and will contain gymnasium and fitness facilities in Palo Alto, CA. The requirement identifies a closed loop track (Bioness Vector Gait and Safety System®) capable of simultaneously accommodate two (2) patients at once while in the Recreation Therapy Facility (Room 100) the gymnasium.



The procurement action specially requires a ceiling mounted, customized (loop) track which can individually accommodate multiple patients at the same time; while dynamically monitoring/supporting an individual's body weight up to 200 lbs., and a 400 lbs. static weight capacity and collecting and recording individual patient results/reports (track outcomes, falls prevented, etc.).



The most critical features of the system include:

1) Support multiple patients simultaneously on the same track

2) Ability to provide customized training programs

3) Fall Prevention / Dynamic Weight Support

4) Robotic trolley

5) Movement detection systems

6) Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant database





(4) IDENTIFICATION OF THE JUSTIFICATION RATIONALE (SEE FAR 8.405-6), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED CONTRACTOR'S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE.



1 Specific characteristics of the material or service that limit the availability to a sole source (unique features, function of the item, etc.). Describe in detail why only this suggested source can furnish the requirements to the exclusion of other sources.



The Bioness Vector Gait and Safety System® is commercially available directly from Bioness as an open market acquisition, or from Tryco Incorporated (Small Woman Owned Business) who was awarded a VA NAC Contract #V797VP-4964A (Mandatory Source schedule (Medical FSC 65)).



Tryco Incorporated ™ is the ONLY authorized dealer/distributor of the Bioness Vector Gait and Safety System® equipment.





(5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.4 TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION:



CICA requirements have been met and all pricing under FSS contract V797VP-4964A (Mandatory Schedule 65 IIA) have been determined fair and reasonable IAW FAR Subpart 8.4 procedures.



In addition to meeting CICA requirements, the Bioness Vector Gait and Safety System® is ceiling mounted, which limits the floor foot print and potential floor obstructions; the system provides an extra sense of security, and instills confidence in Veterans rehabilitation programs facilitating faster recovery; the system minimizes risk for both the VA staff and Veterans; the system increases the overall efficiency because of the 1:1 ratio capabilities; and the system strictly adheres to established privacy principles, use of customer information guidelines and federal and state statutes and regulations regarding privacy and confidentiality, including those measures and practices required under the HIPAA.



It is the best value to the government to purchase this equipment from Mandatory Scheduled (FSC 65) - VA NAC Contract #V797VP-4964A.





(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:



Market research was conducted 09/02/2015 and the recommendation was "based on the information found during market research FAR 8.405-6 applies. This item is available on a VA NAC Mandatory Schedule 65IIA; therefore it is recommended to award a firm fixed price (FFP); limited source order against V797VP-4964A to Tryco Incorporated a Small Woman Owned Business."





(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION:



Equipment possesses the following quality standards & certifications:

- Underwritings Laboratories (UL® ) Certified

- International Organization of Standards (ISO) 13485 Compliant

- IEC 60601-1 3rd Edition

- CE Mark: Class I CE

- U.S. Food and Drug Administration (FDA) Listing Number: D203102





(8) A STATEMENT OF THE ACTIONS, IF ANY, THE AGENCY MAY TAKE TO REMOVE OR OVERCOME ANY BARRIERS THAT LED TO THE RESTRICTED CONSIDERATION BEFORE ANY SUBSEQUENT ACQUISITION FOR THE SUPPLIES OR SERVICES IS MADE:



MANDATORY SCHEDULE 65 IIA - has a National Acquisition Center (NAC) Contract IDIQ Contract (V797VP-4964A) available from 09/25/2006 to 09/19/2016. Based on the determination above, the Bioness Vector Gait and Safety System® is commercially available directly from Bioness as an open market acquisition, or from the sole dealer/distributor Tryco Incorporated (Small Woman Owned Business) who was awarded a VA NAC Contract #V797VP-4964A (Mandatory Source schedule (Medical FSC 65)).