Emergency Justification Posting.pdf

Contract Opportunity Special Notice

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GENERAL INFORMATION

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* = Required Field Contract Opportunity Special Notice

XPER Equipment and System Emergency Procurement

28301

N

339112

Department of Veterans Affairs Network Contracting Office 6 201 Hay Street, Suite 304 Fayetteville NC 28301

Contract Specialist Isaac Hernandez Isaac.Hernandez@hotmail.com

(910) 488-2120 x: 5862 https://www.va.gov

VA.gov

Isaac.Hernandez@va.gov

VA.gov

See attached document: P03 JA for Xper Equipment and System.

PM Part 813.5 SAP for Certain Commercial Items Page 1 of 6 Original Date: 08/30/17 Revision 03 Date: 02/11/2021

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C246-21-AP-2252

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 6, on behalf of Durham VA Medical Center; PR # 558-21-2-102-0015.

2. Nature and/or Description of the Action Being Processed: This is an emergency, open market, Firm-Fixed-Price procurement for the Xper physio monitoring system in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This will be a new contract, sole source award to the manufacturer a large business for the delivery and install of the Xper equipment and system. Estimated value of this requirement is $638,998.80.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: For the delivery and install of a Xper physio monitoring system. This system is a hemodynamic monitoring system for cardiac monitoring where interventional procedures are performed in the Cardiac Cath, electrophysiology and interventional radiology labs. The system displays and analyzes surgace ECG, respirations, invasive pressures, pulse oximetry end tidal CO2, FFR, non-invasive blood pressure, surface body temperature and thermal cardiac output. The system also provides for clinical data acquisition, medical image and data processing and analytical assessments. Typical delivery and install of this complex system takes sixty or more days.

Product Description Part Number Quantity

NITD903 Xper IM Data Center SW w/1 CU NITD903 1

FIT3750 Xper IM Client SW Site License FIT3750 1

NITD904 Xper IM Doc Wkflow Modules NITD904 1

NITD910 Xper IM Charting NITD910 1

NITD911 Xper IM Hemo Calculations NITD911 1

NITD912 Xper IM Vitals Capture NITD912 1

Hemo App Generic Workflow FIT4187 4

Abbott FFR Analogue Hemo App FIT4190 2

ET CO2 Side Stream Hemo App FIT4193 4

PM Part 813.5 SAP for Certain Commercial Items Page 2 of 6

Revision 03 Date: 02/11/2021

Philips Hemo Control Room FIT4143 4

Philips Hemo Nurse Station FIT4146 4

FIT4007 Side Stream ET CO2 Cables FIT4007 4

FIT3961 Xper Flex Cardio 2010 FIT3961 1

Accessory Kit A Philips Hemo FIT4152 4

FIT3980 Xper Flex Cardio Table Mount FIT3980 4

FIT3981 XDS Wall Mount FIT3981 4

NITD591 New CV Solutions Core License NITD591-2 1

NITD947 New Cath Theme License NITD947 1

FIT3241 HL7 ADT Interface FIT3241-1 1

FIT3244 HL7 Orders Interface FIT3244-1 1

FIT3802 Xper IM End of Case Report FIT3802 1

FIT3808 Xper IM Study Notification FIT3808 1

FIT3809 Xper IM Labs Interface FIT3809 1

FIT3810 Xper IM IntelliVue Interface FIT3810 1

FIT3813 Xper IM Outbound Inventory FIT3813 1

FIT4022 Xper IM Inbound Inventory IF FIT4022 1

FIT4024 Xper IM GE CardioLab EP IF FIT4024 1

FIT3174 DMWL 1-10 FIT3174-1 4

XPER Install Cable Kit-Ctrl Rm for CI 989803203431 4

Orders IF Impl Services 89801200789-1 1

ADT Interface Impl Services 989801200796-1

Xper Weekend Upgrade Services

989801200737

Xper ICL Training

989801200907

PM Part 813.5 SAP for Certain Commercial Items Page 3 of 6

Xper IM Clinical Super User ILT Course

989801200730

Remote XPER Training/Consulting (8 Hrs)

989801200903-1

Onsite XPER Training/Consulting (8 Hrs)

989801200902

Xper IM Flex Cardio Biomed Course

989801200721-1

Xper IM Outbound Inventory Imp

989801200943

Xper IM Inbound Inventory Imp

989801200988

Xper IM Outbound/Inbound IF (NEW PS Hrs)

989801200922-1

Xper IM GE CardioLab EP IF New PS Hours

989801200931-1

GE CardioLab EP I/F Implementation

989801200954

Xper IM PIIC iX/IntelliVue IF PS Hours

989801200937-1

PIIC iX/IntelliVue IF Implementation

989801200950

Xper IM Labs Implementation

989801200985

Xper IM Labs I/F (PS Project hours)

989801200921

Xper IM Study Notification Imp

989801200948

Xper IM End of Case Report Imp

989801200946

Xper App Support (New/S4) 4-6 Rms

989801200899-

VA

Xper IM Doc Wkflow Modules Imp

989801200959

Xper IM Charting Implementation

989801200965

Xper IM Hemo Calculations Imp

989801200966

PM Part 813.5 SAP for Certain Commercial Items Page 4 of 6

Xper IM Vitals Capture Implementation

989801200967

Xper FC Nurse/Bedside/Central Install

989801200976

Additional Room Install/Imp

989801200977

Xper IM Data Center SW Imp

989801200958

Cable Install Service

989801202008

Hemo Implementation and Training Srvs

989801202046

CV Solutions Core Implementation Services

989801200779-1

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( X ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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 is an urgent and compelling need for cardiology due to patient safety. The current equipment and system in use is creating errors in the representation of information from the EKG leads. As a result of this artifact in EKG leads, a patient ended up being in V-fib (not sustainable heart rhythm) and there was a delay in treating this patient because the EKG tracings on the current system were not readable and clear.

Patient had to be resuscitated through external defib. Continuation to rely on the current system will put our Veteran patients at risk and is dangerous. Bio-med is constantly trying to piece together patches/fixes for this system to work. It is in the services best interest of Durham VAMC to replace this system immidiately. Any delays in the procurement of this system could have catastrophic consequences to our Veterans needing emergency life saving services.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: This requirement is for a direct upgrade and replacement of current equipment and system that is in use by Durham VA Medical Center. The manufacturer has authorized distributors for this system, but this would cause delay’s in the procurement due to

PM Part 813.5 SAP for Certain Commercial Items Page 5 of 6

Revision 03 Date: 02/11/2021 seeking an individual waiver from the Small Business Administration. These delays would unnecessarily put our Veteran population at risk.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer anticipates cost will be considered fair and reasonable. The Contracting Officer will request invoices of what other Government or Civilian hospitals have paid for this equipment and system in the past.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: VA Vendor Information Pages (VIP) was searched and a review of the query yielded no company’s able to provide the requested Xper equipment and system. A telephonic conversation with the manufacturer Philips Healthcare suggested using Four Points Technology a Service Disabled Veteran Owned Small Business as their authorized distributor.

It was explained that contracting would need to seek approval from Small Business Administration for a waiver to the non-manufacturer rule and that this requirement is so urgent and compelling that this would cause undue harm to the service. The Contract Specialist searched various Federal Supply Schedules for the Xper equipment and system and did not find any existing contracts for this equipment and system. A sources sought notice was not published on Beta.SAM.gov due to the urgent and compelling need of this requirement.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: Four Points Technology an SDVOSB vendor but due to urgency, and mandatory compliance with the NMR rule. The Government will not seek to utilize Small Business.

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: The agency will continue to conduct market research to overcome barriers to competition in the future.

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.

Nakisha Atkins Date Nurse Manager Durham VAMC

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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.

Date

NAKISHA N.

ATKINS 379125

Digitally signed by

NAKISHA N. ATKINS 379125

Date: 2021.03.10 07:41:56 -05'00'

Cherisse A. Hall 613334

Digitally signed by Cherisse A.

Hall 613334 Date: 2021.03.10 11:03:57 -05'00'

PM Part 813.5 SAP for Certain Commercial Items Page 6 of 6

Revision 03 Date: 02/11/2021

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Date

NCO/PCO 06

KEESHIA R

NEWMAN

254911

Digitally signed by

KEESHIA R NEWMAN

254911 Date: 2021.03.10 11:40:17 -05'00'