V797P-4383B-021.pdf

VHAPM Part 808.405 6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPM Part 808.405 6 Limiting Sources Page 1 of 4 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405 6

Acquisition Plan Action ID: 36C256 19 AP 1573

1. Contracting Activity: Department of Veterans Affairs, VISN 16, Central Arkansas Veterans Healthcare System

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). We are requesting a review and approval of our request to limit sources for the acquisition of a new requirement for an automated sterile compounding robot for the new VA pharmacy hazardous cleanroom.

Order against: FSS Contract Number: V797P 4383B

Name of Proposed Contractor: Aesynt, Inc. (Omnicell)

Street Address: 500 Cranberry Woods Drive

City, State, Zip: Cranberry Township, PA 16066

Phone: 817 239 0308

3. Description of Supplies or Services:

The estimated value of the proposed action is $622,036.18, 2237 # 598 19 2 784 0094

CAVHS needs improved accuracy and precision in the compounding of non hazardous sterile compounded products to improve patient safety and decrease medication errors. To accomplish this, we require an automated robotics system for the aseptic preparation of non hazardous sterile drug compounded products which are in accordance with USP 797 guidelines.

(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.

(CHECK ALL THAT APPLY AND COMPLETE)

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

VHAPM Part 808.405 6 Limiting Sources Page 2 of 4 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized: CAVHS needs an automated IV robot that will fit within the clearances allowed in the limited cleanroom space which has been designed (Allowable clearance: 90” w x 105” d x 93”h). We also require a system which will integrate with the current IV ordering system (Omnicell IVX).

The current IV STATION is manufactured and proprietary to Aesynt (recently purchased by Omnicell Technologies, Inc) and is the only company which makes an automated IV robotic system for the preparation of non hazardous sterile compounded products compatible with our current IV automation program at CAVHS. There is one other automated robotics system for the aseptic preparation of non hazardous sterile drug compounded products on the market, but it does not interface with our existing system. In addition, our new cleanroom has been designed around a product the size of the IV STATION or smaller. This equipment is part of the activation equipment for the 7D Pharmacy Relocation Project. The current Omnicell System awarded has a total value of $2,186,741.00. Aesynt Inc. is the proprietor of the existing Omnicell equipment and the required equipment and has no authorized distributors. A letter of proprietorship has been obtained from Aesynt Inc.

In the interest of economy and efficiency, the new work is a logical follow on to an original Federal Supply Schedule order provided that 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: Omnicell Automated IV Compounding Robot System

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

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. See paragraph under “only One Source” section.

(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: This order is the only product that can be added to the existing equipment due to its proprietary limits. It is the best value to the Government to procure this equipment to add to the existing equipment, not only because the price reasonableness has been established within the FSS contract, but it is also not practicable nor fund efficient to procure/replace the full Omnicell equipment. The current Omnicell System awarded has a total value of $2,186,741.00.

VHAPM Part 808.405 6 Limiting Sources Page 3 of 4 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

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

RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCHWAS NOT CONDUCTED:

Only one product fulfills all the requirements.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION: RFI 36C25619Q0570 was placed on FBO seeking any other brand and/or distributor, but only Aesynt responded certifying their proprietary limits for the existing equipment.

(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: An evaluation of the current system versus any new equipment or different brand will be performed when there is expectancy of changing or updating the current equipment, and a determination to the best interest to the Government will be considered.

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

SIGNATURE DATE

NAME: Jerrell Johnson, PharmD Pharmacy Project Manager Central Arkansas VAHCS

05/31/2019

ATURE

VHAPM Part 808.405 6 Limiting Sources Page 4 of 4 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

(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.

CONTRACTING OFFICER/DESIGNEE’S SIGNATURE DATE

NAME: Clay K. Jones NCO 16 Contracting Officer

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $700K):

I certify the justification meets requirements for other than full and open competition.

SIGNATURE DATE

NAME: Susan E. Hayes NCO 16 Chief, Division III

CLAY K JONES 685130

Digitally signed by CLAY K JONES 685130 Date: 2019.05.31 10:14:56 -05'00'

SUSAN E HAYS

1046805

Digitally signed by SUSAN E

HAYS 1046805

Date: 2019.05.31 10:24:49 -05'00'