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FBO DAILY - FEDBIZOPPS ISSUE OF APRIL 02, 2015 FBO #4877
DOCUMENT

J -- Medisafe Sonic Irrigator PM INTENT TO SOLE SOURCE - Attachment

Notice Date

3/31/2015
 

Notice Type

Attachment
 

NAICS

811219 — Other Electronic and Precision Equipment Repair and Maintenance
 

Contracting Office

Department of Veterans Affairs;Samuel S. Stratton VA Medical Center;113 Holland Avenue (2-90NCA);Albany NY 12208-3410
 

ZIP Code

12208-3410
 

Solicitation Number

VA52815P0403
 

Archive Date

4/15/2015
 

Point of Contact

BASTIANI, NICHOLAS
 

E-Mail Address

nicholas.bastiani@va.gov
(NICHOLAS.BASTIANI@VA.GOV)
 

Small Business Set-Aside

N/A
 

Description

DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Other Than Full and Open Competition Contracting Activity: Department of Veterans Affairs, VISN 02 Network Contracting Activity (2-90NCA) Stratton VA Medical Center, 113 Holland Avenue; Albany, NY 12208 VA2237 Purchase Requisition #528-15-1-4803-0550 1.Nature and/or Description of the Action Being Processed: This is a request for other than full and open competition for the procurement of a service contract for a government-owned Medisafe SI-PCF Sonic Irrigator to provide full service and maintenance including all parts, material and labor to be performed at the VISN 2 Western New York Health Care System, Buffalo Medical Center. All maintenance and repairs for this biomedical equipment shall be done at the direction of VA Medical Center personnel per manufacturer's specifications in accordance with the service agreement. This coverage shall include full support for all components, and software. The proposed contract action shall be provided by Medisafe America, LLC, 9423 Corporate Lake Drive, Tampa, FL 33634. The firm fixed-price contract shall be for a four (4) month, 23 day Base Period of performance from May 7, 2015 through September 30, 2015, plus four (4), one (1) year Option Periods. 2.Description of Supplies/Services Required to Meet the Agency's Needs: The VA of Western NY Operating Room Suite requires a contract for Routine Maintenance and Equipment Validation to include semi-annual preventive maintenance checks and three (3) on-site emergency service calls per year for the Medisafe SI-PCF Sonic Irrigator. The Sonic Irrigator is validated for and used to disinfect components of the daVinci Surgical Robot located at this facility, and is an integral part of the sterilization process for the system components. Using a combination of ultrasonic activity and irrigation to create a process of sonic irrigation, the SI PCF generates more power and greater flushing ability to enable it to clean some of the most complex instruments. This provides the facility the confidence that their instruments have been cleaned and disinfected using a process scrutinized under several international standards. The NAICS code for this procurement is 811219. Total Cost for Base plus four (4) Option Periods: REDACTED 3.Statutory Authority Permitting Other than Full and Open Competition: (X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per FAR 6.302-1; ( ) (2) Unusual and Compelling Urgency per FAR 6.302-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per FAR 6.302-3; ( ) (4) International Agreement per FAR 6.302-4 ( ) (5) Authorized or Required by Statute FAR 6.302-5; ( ) (6) National Security per FAR 6.302-6; ( ) (7) Public Interest per FAR 6.302-7; 4.Demonstration that the Contractor's Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): a. Only One Responsible Source (FAR 6.302-1): This critical system utilizes proprietary hardware and software, and is used in the VA of Western NY Buffalo's, Supply, Processing, and Sterilization (SPS) department to disinfect and sanitize components used in the Operating Room Suite. This system is unique and considered critical for accomplishing the mission of this facility. The Medisafe Sonic Irrigator uses a combination of ultrasonic activity and irrigation to create a process of Sonic Irrigation. The main purpose of the SI-PCF Sonic Irrigator is to ensure that critical components and instruments used by the daVinci Surgical Robot during operative procedures are properly disinfected and safe to use. Minimal down-time is required to provide adequate support to the OR and avoid delays in Veteran patient treatment. It is necessary for the OEM, Medisafe America, LLC to perform the preventative and periodic maintenance service as they are equipped with the specific diagnostic tools and proprietary software to maintain the medical equipment within IAW OEM specifications. Use of this system that has been validated by the daVinci Surgical Robot manufacturer, Intuitive, protects the Buffalo VA's substantial investment in this piece of capital equipment in the facility's Operating Room Suite. In addition, repair diagnostics requires access to service screen menus that are only available to Certified Medisafe America LLC Technical Specialists. Additionally, the service agreement will also decrease emergency repair costs, and eliminate testing and scheduling delays that could impact patient diagnosis that contributes to the overall level of quality patient care. 5.Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: This is a recurring requirement for preventative maintenance of the Medisafe America LLC SI-PCF Sonic Irrigator that involves proprietary hardware, software, and diagnostic tools. The equipment service and maintenance must be performed by certified Medisafe America LLC Field Technicians that are equipped with the necessary service menus to maintain the equipment within IAW OEM specifications. 6.Determination by the Contracting Officer that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost to the Government is REDACTED per year for the preventative maintenance services and equipment inspections as a firm fixed-price contract. The Biomedical Engineer at the Buffalo VA has provided a Government estimate based on his years of expertise within the industry, current fair market prices, historical prices and conditions that can be used to serve as a benchmark against which proposed prices can be compared (FAR 13.106-3(a)(2)(vi)). Additionally, Medisafe has provided a quote specifying REDACTED per year with no increases over a 4-year period. A search of FBO revealed that two other contracts for the same service have been awarded in April 2014 and March 2015 for the same service at other VA Medical Centers in the United States with the same price per year found to be fair and reasonable (FAR 13.106-3(a)(2)(ii). Utilizing the OEM's service agreement is the best value for the government as the Contracting Officer has determined the multi-year pricing to be fair and reasonable. 7.Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research was conducted using the Vet Biz (VIP) website and GSA e-Library under NAICS Code 811219. These searches yielded no valid results. No further market research was performed as Medisafe America LLC is the original equipment manufacturer and is also classified as small business. 8.Any Other Facts Supporting the Use of Other than Full and Open Competition: The Medisafe SI-PCF Sonic Irrigator that has been in service at the Buffalo VA is currently under the original manufacturer's warranty which expires on May 7, 2015. The preventative maintenance and emergency repairs performed by the Certified Service Technicians from Medisafe America, LLC under the original warranty have maintained the unit within IAW OEM specifications protecting VISN 2's financial investment in this asset. It is common for the OEM to perform the service maintenance and emergency repairs to their medical equipment since they possess the proprietary software and specific diagnostic tools to maintain the equipment within IAW OEM specifications. 9.Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None: see 5 & 7 above. 10.A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: In this situation, it is difficult to remove barriers to competition because the OEM is the most qualified in the repair and maintenance of its own specialized medical equipment. This is especially true where proprietary software, specific diagnostics tools, and specialized electronics are used to maintain the equipment IAW OEM specifications. 11.Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ John EcklDate Biomedical Engineer VA of Western NY, Buffalo 12.Contracting Officer's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ ________________________ Jason V. WhiteDate Contracting Officer VISN 2 NCO
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/AlVAMC500/AlVAMC500/VA52815P0403/listing.html)
 

Document(s)

Attachment
 

File Name: VA528-15-P-0403 VA528-15-P-0403.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1953813&FileName=-5524.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1953813&FileName=-5524.docx

 

File Name: VA528-15-P-0403 Sole Source Justification.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1953814&FileName=-5525.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=1953814&FileName=-5525.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Record

SN03684586-W 20150402/150331235432-59732875ab6e185d643696abd5707e28 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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