36C24219Q1040-001.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 2: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 08 Page 1 of 5 Original Date: 03/22/11 Revision 08 Date: 04/18/2018

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C242-19-AP-1583

1. Contracting Activity: Department of Veterans Affairs, VISN 2, GI Department, Brooklyn VA Medical Center, 800 Poly Place, Brooklyn, NY 11209

PR Number: 630-19-2-3086-0052

2. Nature and/or Description of the Action Being Processed:

Emergency purchase of one Pentax Prosound Processor.

New contract.

Firm-Fixed-Price.

This request is an “Unusual & Compelling Urgency” need to upgrade the current GI system that is at end of life in order to maintain the highest level of patient care throughout the Ne York Harbor healthcare System facility, especially the most critically ill patients requiring GI procedures, ultrasounds, monitoring of the GI tract and tissue imaging needed for overall wellness. The intent of this initiative is to provide VA patientswith optimal care by optimizing the equipment used to treat or detect certain illnesses.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The estimated value of the proposed action is $289,680.00

This is a one time purchase. Estimated delivery is 30 Days ARO.

Procurement of one Pentax EUS Processor. The Pentax EUS Processor provides VA patients with optimal care by optimizing the equipment used to treat or detect certain illnesses, especially the most critically ill patients requiring GI procedures, ultrasounds, monitoring of the GI tract and tissue imaging needed for overall wellness.

4. 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;

(X) (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

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( ) (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;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

This request is an “Unusual and Compelling Urgency” need to upgrade the current GI system that is at end of life in order to maintain the highest level of patient care throughout the NYHHS facility, especially the most critically ill patients requiring GI procedures, ultrasounds, monitoring of the GI tract and tissue imaging needed for overall wellness. The intent of this initiative is to provide VA patients with optimal care by optimizing the equipment used to treat or detect certain illnesses. The VA has a system which is composed of equipment aged beyond the years that the manufacturer will not support. Performance of the current system is undermined by the transmission lags and without the manufacturer’s technical support: any system downtime would immediately result in ultimate failure. Hitachi is the original manufacturer of the new equipment and the upgrade will replace the obsolete equipment in order to be able to care for patients. There are upcoming procedures pending procurement of this equipment. The current equipment is no longer working. Ordering it now would ensure the Veteran patients that are scheduled will not have to be rescheduled for the procedures.

This request is also “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.” Pentax America as the sole source distributor for the procurement based upon the following criteria:

a. The existing system is no longer working and an upgrade is needed.

b. Real-time assesses tissue Real-time tissue elastography (RTE) strain in real time and displays the measured difference in tissue stiffness as a color map.

c. Strain histogram measurement feature which displays, in real time, the direction of tissue displacement with respect to the probe surface.

d. Supports a variety of procedures from imaging EUS to interventional EUS (Endoscopic Ultrasound)

e. Redesigned scope and forceps elevator for more reliable control over device pass through.

Based on the above criteria, the facility’s investment is greatly reduced by not using a different manufacturer, as all of the equipment communicates through a dedicated and proprietary critical care backbone infrastructure that exists within the facility.

Additionally, a new Original Equipment Manufacturer (OEM) would require higher investment costs for network cabling, and support to the equipment as well as software components. Biomed and staff training will be easier and require less of a learning curve, if the equipment is purchased from Pentax, since it is currently being used by VA NYHHS staff. This procurement will be awarded thru Pentax through VA NAC Federal Supply Schedule 65II A, which will provide the best value to the Government.

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6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

This is a sole source “Unusual and Compelling Urgency” procurement. Market research was conducted to identify any other vendors capable of fulfilling the needs of Veterans Affairs.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Cost is determined to be fair and reasonable and the proposed contract action will represent the best value to the Government. Pentax offered price discounts and special pricing on all components and parts as well as a discount for a trade-in on the old, outdated model being replaced. All line items for this action are listed on the budgetary proposal quote with unit price. The unit price represents an average reduction by approximately 9%. Price is a significant factor since changing to a completely new system would make this purchase cost significantly more.

List Price = $367,475.00 Discounted Price = $289,680.00

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

Conducted search on VIP using NAICS Code 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing) and Keywords Arietta, Elastography, and Hitachi. Results were no vendors found.

Conducted search on SBA (SDBS) using NAICS Code 334510 (Electromedical and Electrotherapeutic Apparatus Manufacturing) and Keywords Arietta, Elastography, and Hitachi. Results as follows.

o Arietta - No profiles met your search criteria.

o Hitachi – two vendors identified.

1.) Digital Display Solutions, Inc. - specialize in audio visual systems for conference rooms.

2.) Mercom Incorporated – specialize in teleconferencing and electronic surveillance o Elastography – one vendor identified.

1.) Supersonic Imagine, Inc. – specialize in elastography for breast imaging.

Summary: No qualifying veteran owned small businesses or small businesses were identified as being capable to provide these supplies.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

IAW FAR 5.202 exceptions to synopsis, this procurement is a proprietary emergency and would cause serious injury to the patients, if they have to have their procedures rescheduled waiting for competition process.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

PENTAX Medical Company a Division of PENTAX America

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11. 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 order to remove or overcome barriers to competition in future acquisitions for this requirement, the agency would have to replace the entire physiological Gastroenterology (GI) system. The time and cost to replace all equipment and the down time associated with training technicians would not be cost effective. Therefore, no other source is capable of providing the proprietary components required to meet the Government’s need.

12. 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.

(This signature is the requestor’s supervisor, fund control point official, chief of service, someone with responsibility and accountability)

SIGNATURE DATE

NAME TITLE SERVICE LINE/SECTION

FACILITY

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

http://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx

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b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.