V797D30183-004.pdf

LIMITED SOURCES JUSTIFICATION

ORDER >$150,000

FAR PART 8.405-6

Acquisition Plan Action ID: VA252-18-AP-3573

1. Contracting Activity: Department of Veterans Affairs, VISN 12.

2. Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 251 and 40 U.S.C. 501). VISN 12 has a requirement for a new Federal Supply Schedule (FSS) delivery order for CareFusion infusion pump system equipment.

Order against: FSS Contract Number: _V797D-30183

Name of Proposed Contractor: CareFusion

Street Address: 3750 Torrey View Ct

City, State, Zip: San Diego, CA, 92130-2635

Phone: Jason Butalla 262-888-0833

3. Description of Supplies or Services:

The estimated value of the proposed action is $

VISN 12 uses Alaris Infusion System in all facilities. VISN 12 only needs to replace obsolete components of the system, the remaining devices have residual useful life and will remain in operation. VISN 12 has a requirement to replace end-of-life infusion equipment; specifically, a quantity of 1,034 8015 Alaris PC Units. In addition to the 1,034 8015 Alaris PC Units, service to check in the new equipment will be included.

(4) IDENTIFY THE AUTHORITY AND SUPPORTING RATIONALE (see 8.405-6(a)(1)(i)(A), (B), and

(C) or 8.405-6(b)), AND IF APPLICABLE, A DEMONSTRATION OF THE PROPOSED

CONTRACTOR’S UNIQUE QUALIFICATIONS TO PROVIDE THE REQUIRED SUPPLY OR SERVICE.

An urgent and compelling need exists, and following the ordering procedures would result in unacceptable delays.

Only one source can provide the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

VISN 12 has a total inventory of 4,198 Alaris infusion system devices; 1,034 of these devices are Alaris PC Unit 8015s which were deployed in 2012 and have been deemed to be at their end-of-life. The VISN’s other 3000+ Alaris devices (Alaris EtC02 Module 8300, Alaris PCA module 8120, Alaris Syringe Module 8110, Alaris Pump Module 8100 and some newer Alaris PC Unit 8015s) are still supported and will be compatible only with the required successor 8015 next generation Alaris PC Units from CareFusion. VISN 12 also has an annual service agreement in place with CareFusion for its database that stores drug library quality data and for the software that resides on the Alaris PC Unit 8015s. To maintain standardization throughout the VISN, the VA requires Alaris PC Units.

No other manufacturer’s devices are compatible with the VISN’s Alaris infusion pump devices.

Using another manufacturer’s devices would require the purchase of an entirely new infusion pump system. The VISN has decided to maintain its current Alaris infusion pump system and the standardization that comes with it. Standardization of this equipment mitigates negative patient outcomes. Staff have been trained and are familiar with the equipment. Because this system is used for the administration of drugs, it is critical that clinical staff know how to use the equipment properly. Errors in the use of infusion pump systems can have devastating effects on patients. Also, familiarity is critical in cleaning medical equipment between patient use.

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order if the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is: (If FAR 8.405-6(a)(2)iii before posting. Do not include specific proprietary data.

Only mention the type of equipment, procedure, etc. to show that proprietary supplies or services are being procured.)

These are “direct replacements” parts/components for existing equipment.

The required next generation Alaris PC Units 8015s are replacing current PC Units that have passed their life expectancy.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. Describe the equipment/function you have now and how the new item/service must coordinate, connect, or interface with the existing system.

(5) DESCRIBE WHY YOU BELIEVE THE ORDER REPRESENTS THE BEST VALUE CONSISTENT WITH

FAR 8.404(d) TO AID THE CONTRACTING OFFICER IN MAKING THIS BEST VALUE DETERMINATION: The required equipment is on FSS contract V797D-30183 and in accordance with FAR 8.404(d), prices have been determined fair and reasonable. Although GSA has already negotiated fair and reasonable pricing, ordering activities may seek additional discounts before placing an order (8.405-4); CareFusion is providing a quantity discount of $x.

To maintain the current infusion pump system rather than replace it, the Government has elected to replace 1,034 Alaris PC Units 8015 devices that have been deemed to be at end-of-life. The estimated cost to replace the VISN’s entire inventory of infusion pump devices is estimated to be approximately $7 million and was determined to be cost prohibitive.

The ordering activity has concluded that placing an order against FSS represents the best value (as defined in FAR 2.101) and results in the lowest overall cost alternative to meet the Government's needs.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE

RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

A search on Vetbiz.gov and SBA websites using keyword “CareFusion” and NAICS 339112 both yielded one SDVOSB vendor (Progressive X-ray, Inc.) and one VOSB vendor (Medical Place, Inc).

CareFusion also has two SDVOSB open market distributors for these next generation Alaris PC Unit 8015s (Four Points Technology and Veterans Healthcare Supply Solutions, Inc).

The identified veteran owned distributors and any others small businesses cannot meet the VA “Rule of Two” because of the nonmanufacturing rule pursuant to the requirements of VAAR

819.7003 and FAR 19.102(f) and there is no class waiver for NAICS 339112. Accordingly, the Contracting Officer (CO) cannot use the sole source procedures found under VAAR 819.70 and the CO has no expectation of receiving two or more eligible, and qualified SDVOSB/VOSB offers to provide a fair and reasonable price. Thus, set-aside procedures will not be used.

Following procedures outlined in VA Procurement Policy Memorandum (2016-05) Sect. 8. b.2., the CO conducted a search of NAC’s “MedSurg” Catalog and GSA Ebuy and found that CareFusion is the only FSS source for the required devices.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: An Intent to sole source was posted to FBO on 9/22/2017 with a closing date of 9/26/2017. No vendors providing compatible equipment were identified.

(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: VISN 12 has been in discussions regarding future acquisitions of infusion pump systems. VHA Logistics has been discussing standardization of this technology at both the Regional and National levels and VISN 12 anticipates participation in any potential initiative. If a VHA-wide contract is not awarded, the VISN anticipates competitively soliciting a new infusion pump system when the current system requires replacement.

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

SIGNATURE DATE

Robert Steldt BIOMED

NAME TITLE SERVICE LINE/SECTION

NCO 12

FACILITY

Robert E Steldt 195270 Digitally signed by Robert E Steldt 195270 Date: 2018.03.26 14:33:03 -05'00'

(10) APPROVALS IN ACCORDANCE WITH THE VHAPM Part 806.3 OFOC SOP:

a. CONTRACTING OFFICER’S CERTIFICATION (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Ashley Johnson DATE Contracting Officer Network Contracting Office NCO 12 Great Lakes Acquisition Center

Ashley A Johnson 319134

Digitally signed by Ashley A Johnson 319134 Date: 2018.03.27 09:05:50 -05'00'

b. One Level Above the Contracting Officer (Required over$150K but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Paul Lauro DATE Director of Contracting Network Contracting Office NCO 12 Great Lakes Acquisition Center

HIGHER LEVEL APPROVAL (Required for orders over $700,000):

c. VHA SAO HCA REVIEW AND APPROVAL (over $700,000 to $68 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4.

DATE Randy Hays

Acting Director, SAO Central Region VHA Head of Contracting Activity (HCA)

29 March 2018 Paul M. Lauro 1463508

Digitally signed by Paul M. Lauro 1463508 Date: 2018.03.29 14:12:53 -05'00'

Randy L. Hays 534204

Digitally signed by Randy L. Hays 534204 Date: 2018.03.29 12:59:48 -07'00'