P03 IV Compounding Workstations JA-Corrected-Signed - Redacted.pdf

36C246-21-AP-3518

VHAPM Part 808.405-6 Limiting Sources Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C246-21-AP-3518

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office (NCO) 06 on behalf of Durham VA Medical Center, PR/2237 # 558-21-3-102-0041.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). NCO 6 intends to award a new, firm-fixed-price, delivery order with a base and 4 option years. This will be a sole source order to Omnicell, Inc.

Order against: FSS Contract Number: V797D-30111

Name of Proposed Contractor: Omnicell, Inc.

Street Address: 590 E. Middlefield Rd.

City, State, Zip: Mountain View, CA 94043

Phone: (800) 850-6664

(3) Description of Supplies or Services:

The estimated value of the proposed action: Base Year: , Option Year (OY) 1:

, OY 2: , OY 3: , OY 4: , Total including option years $1,019,252.03.

The Durham VAMC requires the delivery and installation of 13 IVX Workflow systems model no.

IVS-HDW-001. These workflow systems will assist our Pharmacy Technicians by automating the process of medication preparation through compounding. Through automation it is expected to reduce the number of manual compounding errors and reduce the potential for adverse drug events. The workflow system requires supporting equipment 6 label printers, and 6 barcode scanners. Delivery and installation are estimated to be completed 4 months after receipt of order

Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): 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; Omnicell’s pharmacy systems are all interoperable and are designed this way to ensure safety and compliance to stringent state and federal regulations regarding controlled substances. Omnicell Inc. IVX Workflow system is the only system that is compatible with Health Level 7 (HL7) and Simplifi 797 software that is currently in use at Durham VAMC.

The Health Level 7 (HL-7) is a software solution that enables healthcare workers to exchange, and retrieve health information electronically within the Durham VAMC. Simplifi 797 is a pharmacy compliance software that automates operations required to comply with United States Pharmacopeia (USP) chapters 797. Omnicell Inc. IVX Workflow stations is the only system that is compatible with both software HL-7 and Simplifi 797 software.

FAR 8.405-6(a)(1)(C): 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.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

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.

(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: Durham VAMC require IV compounding workstation system that is compatible with software that is already in place HL-7 and Simplifi 797. Omnicell Inc. is able to meet the Government’s requirement with their IVX Workflow system. The entirety of this order can be procured via GSA contract no.

V797D-30111. GSA has already negotiated fair and reasonable pricing. Additional discounts will be sought prior to placing an order and a price analysis of the proposed contract price will be performed and documented to sufficiently determine that the total price of the proposed

Original Date: 08/30/2017 acquisition will be reasonable.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. The following market research was conducted to identify potential sources to fulfill the requirement for Durham VAMC.

a. A search was conducted querying Government-wide database of contracts, other procurement instruments, and commercial databases. The requirement was not available via VA inventories including the VA supply stock program and VA excess, excess from other agencies, Federal Prison Industries, AbilityOne program, Wholesale Supply Sources, and Medical Surgical Prime Vendor program.

b. Veterans Information Pages (VIP): Search conducted on 5/14/2021 utilizing NAICS code

339113 and keywords “IV Compounding Workstations.” This query resulted in 228 Service Disabled Veteran Owned Small Businesses (SDVOSB) and 31 Veteran Owned Small Businesses (VOSB). A sources sought notice was sent to the businesses that populated from this search. Two responses were received from this notice Four Points Technology LLC and TrillaMed LLC both are registered on VIP as SDVOSBs.

Four Points Technology LLC responded with a comparable system called the Pyxis.

Correspondence was sent to Four Points Technology LLC to ascertain if the Pyxis IV Prep Medication Workflow Solutions system was compatible with HL-7 and Simplifi 797 software that is currently in use at Durham VAMC. Their response is that the Pyxis system is compatible with HL-7 but not Simplifi 797. TrillaMed LLC responded that they are authorized distributors of Omnicell Inc. a large business manufacturer.

Correspondence was sent to Omnicell, Inc. to ascertain the validity of the authorized distributor letter. Omnicell, Inc. Client Success Executive stated that TrillaMed are not authorized for requirements that require subscriptions and or leases.

c. Sources sought notice 36C24621Q0683 was posted on Contract Opportunites on

5/14/2021 with a closing date of 5/19/2021. No responses were received from this notice other than the ones mentioned above. Intent to sole source notice 36C24621Q0683_2 was posted to Contract Opportunities on 5/28/2021 with a closing date of 6/03/2021 with no responses.

d. GSA Advantage and Supply Chain Master Catalog (SCMC) were searched and did not find any IV workflow systems that would satisfy the Governments need.

(7) Any Other Facts Supporting the Justification: None.

(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: NCO 6 will continue to conduct market research to ascertain if there are changes in the marketplace that would enable competition for future actions.

Original Date: 08/30/2017

(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.

Tonya S. Jones

Digitally signed by Tonya S. Jones 204384

204384 Date: 2021.07.26 10:33:57 -04'00'

SIGNATURE DATE

Tonya Jones Administrative Officer Pharmacy

NAME TITLE SERVICE LINE/SECTION

Durham VAMC

FACILITY

Original Date: 08/30/2017

(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.

Digitally signed by Cherisse A. Hall 613334 Date: 2021.08.24 15:42:50 -0400

Cherisse Hall, Contracting Officer Date Branch Chief Supply 1, NCO 6

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

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

KEESHIA R

NEWMAN

254911

Digitally signed by

KEESHIA R NEWMAN

254911 Date 2021 08 24 15 46 13 -04'00'

Keeshia Newman Division Chief 1, NCO 6

Date

c. Director of Contracting: I certify the justification meets requirements for other than full and open competition.

Nancy L. Bailey, Date Director of Contracting, NCO 6

d. VHA RPO HCA Review and Approval (over $750,000 to $75 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.

Joseph P. Maletta DATE Executive Director, RPO-East VHA Head of Contracting Activity (HCA)

Cherisse A. Hall 613334

Nancy L. Bailey 407136 Digitally signed by Nancy L. Bailey 407136 Date: 2021.08.26 15:11:49 -04'00'

JOSEPH MALETTA

1347841

Digitally signed by JOSEPH

MALETTA 1347841

Date: 2021.08.30 16:31:58 -04'00'