NJ Blood Gas J_A - Radiometer.pdf

VHAPM Part 806.3 Other Than Full and Open Competition (OFOC) SOP Attachment 5: Request for Sole Source Justification Format >SAT

OFOC SOP Revision 11 Original Date: 03/22/11 Revision 11 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: 36C242-21-AP-1122

1. Contracting Activity: Department of Veterans Affairs

Veterans Integrated Services Network (VISN) Region 2 South New Jersey Health Care System 385 Tremont Avenue East Orange, NJ 07018 2237: 561-21-2-040-0061

2. Nature and/or Description of the Action Being Processed: The Department of Veterans Affairs, Network Contracting Office 2, and the VA New Jersey Healthcare System (VANJHCS) Laboratory is requesting a sole source award for three Radiometer ABL90 Blood Gas/Critical Care Metabolites Analyzer Systems. The contract will be a five-year (base plus four option years) firm fixed price award for the lease and support of three blood gas analyzer systems.

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

Medical Center at East Orange requires three portable Radiometer ABL90 Flex Plus whole blood, arterial blood, capillary, and venous blood gas/critical care metabolites analytical analyzer systems to conduct a variety of tests on the patient population, both within the main laboratory and at the point of care (POC) sites in the Emergency Department and Operating Rooms. The leased systems shall include supplies, repairs, maintenance, and training in accordance with the statement of work and estimated testing quantities contained therein. Systems are required to meet the routine and emergency needs for patient care at these sites and are especially critical for intraoperative patient assessment. The Indefinite Delivery Indefinite Quantity contract will be for a total of five years, inclusive of options.

Description Qty/Duration

ABL90 Flex Plus Systems (3) 60 Months AQURE Management System 60 Months

Base Year Price - $78,565 Total Price - $392,825 (if all options exercised)

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 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

OFOC SOP Revision 11 Original Date: 03/22/11

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by 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): The Radiometer ABL90 Flex Plus system provides for the entire range of test requirements in a portable blood gas analyzer. Based on root cause analysis results in which system analyzer availability and timely results proved critical to patient outcomes, a review of existing blood gas analyzers was conducted. The Radiometer ABL90 FLEX Analyzer can produce a result in 35 seconds using only a 65ul sample. The units are fully operational on battery power and can be connected to the hospital network via WiFi. The ABL90 Flex Analyzer reduces maintenance time with a 30 day in-use lifetime of consumables. The Veterans Affairs Medical Center at East Orange has used Radiometer medical equipment in their ED and OR for over sixteen years. The facility determined that Radiometer is the best product to meet their needs. Along with the new Radiometer software called AQURE IT, the East Orange facility is already set up on the Laboratory Information System/Hospital Information System approved by VA IT professionals. To make changes to these systems, software and hardware is not economically feasible at this time. Additionally, data monitored and provided by another vendor will not integrate with the existing system and brand name software.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted, details of which are in the market research section of this document. This effort did not yield additional sources that can meet the Government’s requirements for processing time, minimal sample size, portability, and onboard storage of consumables. In accordance with FAR 5.301 this action will be synopsized on Contract Opportunities and the justification will be made publicly available. Consideration will be given for future competitive opportunities based on any changes to requirements or market conditions.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: In accordance with FAR Part 19.1406 Sole source awards to service-disabled veteran-owned small business concerns, paragraph a, subsections 3, 4 and 5 a fair and reasonable price has been determined by using an IGCE from the using service and comparing prices from a manufacturer’s price list.

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

Research Was Not Conducted: The Veterans Affairs Medical Center at East Orange has used Radiometer medical equipment in their ER and OR for over sixteen years. The facility reviewed other systems and determined that Radiometer most effectively meets their needs. The Medical Center already possessed stores of Radiometer safePICO syringes that support multiple systems. Along with the new Radiometer software called AQURE IT, the East Orange facility is already set up on the Laboratory Information System/Hospital Information System approved by VA IT professionals. To make changes to these systems, software and hardware is not economically feasible at this time.

Radiometer does not sell any of its equipment directly, all sales are through an approved vendor.

Radiometer has provided a letter of authorization stating that The Janz Corporation, an SDVOSB vendor, is their authorized provider. The Janz Corporation is verified on VIP and is a long-standing

OFOC SOP Revision 11 Original Date: 03/22/11 business with the VISN2 VA hospital network.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: A complicated surgery case occurred a year ago and laboratory test results were not available as quickly as required, contributing to delays in patient management. The patient died. Recent cases have also demonstrated the need for immediately available results to manage patients suffering critical events during surgery.

There is a crucial need to expedite laboratory testing with results called to the OR as quickly as possible and results entered in the electronic medical record. Current lab testing requires some specimens to be manipulated and prepared first, taking at least 10-15 minutes before actual testing begins. Turn- around -time for those types of tests takes 30-40 minutes. Transport of specimens requires runners between the OR and laboratory and adds time to testing results.

Under the current system there will be continued delays in getting critical lab results for patients suffering unexpected or life-threatening conditions during surgery, jeopardizing rapid interventions and potentially resulting in death or permanent disability.

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

Janz Corporation.

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 Government will continue to conduct market research to ascertain if there are changes in the market place that would enable future actions to be further competed.

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.

Elise Tomczak 115153

Digitally signed by Elise Tomczak 115153 Date: 2021.03.22 11:36:05 -04'00'

Elise Tomczak Date Medical Technologist VA New Jersey HCS - East Orange Campus

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.

Sam A DeMuzio Digitally signed by Sam A DeMuzio 375167 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

OFOC SOP Revision 11 Original Date: 03/22/11

375167 Date: 2021.03.22 11:55:13 -04'00'

Sam DeMuzio Date Contracting Officer Canandaigua VAMC

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.

David Warunek Date NCO2 / Branch Chief

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Name Date VHA Head of Contracting Activity (HCA)