V797D30175-P00001000.docx

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >$150K FedBizOpps Justification and Approval Notice

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* = Required Field FedBizOpps Justification and Approval Notice Rev. March 2010 DO Lab Chemistry Siemens - MPLS Modification 56303 36C26318Q0117 N 334516 Department of Veterans Affairs NCO 23 - Saint Cloud 4801 Veterans Drive Attention: Dean Flanders Minneapolis MN 55415 Dean Flanders Dean.Flanders@va.gov

FAR 6.302-1

V797D30175 VA263-17-J-1377

P00001 550,000.00 12-20-2017

SIEMENS HEALTHCARE DIAGNOSTICS INC.

500 GBC DR

NEWARK

DE

19702 Dean.Flanders@va.gov Contracting Specialist email This Notice of Intent is provided to advise that the Government intends to negotiate a Sole Source, Firm-Fixed-Priced Delivery Order Modification with only one source, Siemens Healthcare Diagnostics. Vendor shall provide Chemistry/Immunochemistry Analyzer Cost per Reportable Result (CPRR)/Cost per Test (CPT) testing under FSS Schedule V797D-30175. The vendor is required to provide each participating facility with an FDA approved testing system. Contractor must supply all instrumentation, reagents, controls, calibrators, and replacement parts to perform testing at VISN 23 laboratories in Fargo, Ft. Meade, Hot Springs, Omaha, Lincoln, Sioux Falls, and St Cloud. Siemens Healthcare Diagnostic is the only authorized vendor capable of performing this requirement.

This contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 6.302-1. Interested persons may identify their interest and capability to respond to the requirement or submit proposals.

LIMITED SOURCES JUSTIFICATION

ORDER >$150,000

FAR PART 8.405-6

Acquisition Plan Action ID: VA263-18-AP-0228

1. Contracting Activity: Department of Veterans Affairs, VISN 23, NCO-23 Contracting, 4801 Veterans Drive, St Cloud MN.

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). Modification for Siemens Healthcare Diagnostics Cost per Reportable Tests and Cost per Test testing for VISN 23 facilities.

Order against: |X| FSS Contract Number: V797D-30175

3. Description of Supplies or Services:

The estimated value of the proposed action is $XXXXXX for a three-month period of performance. Vendor shall provide Chemistry/Immunochemistry Analyzer Cost per Reportable Result (CPRR)/Cost per Test (CPT) testing under FSS Schedule V797D-30175. The vendor is required to provide each participating facility with an FDA approved testing system. Contractor must supply all instrumentation, reagents, controls, calibrators, and replacement parts to perform testing at VISN 23 laboratories in Fargo, Ft. Meade, Hot Springs, Omaha, Lincoln, Sioux Falls, and St Cloud.

(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.

|X| 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.

|X| 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.

VISN 23 is requesting a three-month continuation of current equipment to allow contract award and equipment crossover per Regulatory Agency requirement. VISN 23 laboratories in Ft. Meade, Hot Springs, Fargo, Grand Island, Lincoln, Omaha, Sioux Falls, and St. Cloud have Siemens Healthcare Diagnostics Instrumentation systems that were placed five years ago and have been using these analyzers along with their products/reagents to perform Chemistry/Immunochemistry testing for the VISN 23 veterans. The reagents used only work with the existing equipment. Additionally, the process to change laboratory equipment is highly regulated by Joint Commission, College of American Pathologist, Food and Drug Administration, and CLIA. The process is extremely specific and failure to follow regulations will result in licensure revocation. For equipment of this magnitude, the crossover/transition period is typically 3-6 months. Failure to perform chemistry testing/immunochemistry testing will result in significant patient delays that may impact mortality. These analyzers perform STAT testing, such as cardiac testing, that when delayed, impact patient treatment.

(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 modification represents the best value to the Government as award will be made from a GSA-FSS contract V797D-30175 which includes fair and reasonable prices that have previously been negotiated. Further price discounts will be requested.

(6) DESCRIBE THE MARKET RESEARCH CONDUCTED AMONG SCHEDULE HOLDERS AND THE RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

GSA, FBO, SBDS, VETBIZ, SAM, FCO, FPDS were all searched for the delivery order. VETBIZ was searched using NAICS and keyword searches. No SDVOSB or VOSB vendors were identified that could complete the procurement. Based upon this information it was recommended that a sole source procurement be set up so Siemens Healthcare Diagnostics Inc could continue to provide services needed to Veterans and their families. The lab needs three more months of service to allow time for a new FSS-BPA to be completed. The scope and complexity of the requirements along with the technical qualification of the schedule holders needed for the CPRR procurement called for a sole source. A sole source to Siemens Healthcare Diagnostics Inc to continue the services and tests is needed for another three months. The equipment from Siemens Healthcare Diagnostics Inc is already set up at the existing sites. The reagents used only work with the existing equipment. By sole sourcing to them there will be no break in service thus will keep the labs up and running. A new solicitation, VA263-16-Q-0137, has already been posted to GSA eBuy.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION:

This sole source acquisition is to continue the Lab CPRR supplies and service provided by Siemens Healthcare Diagnostics Inc. This proposed modification will provide additional funds to the existing delivery order while a competitively awarded contract is being solicited under RFQ VA263-16-Q-0137. This modifcation will prevent an adverse impact on the mission of the agency, which would occur with the interruption of the work presently performed. The statement of work under the delivery order remains the same as the FY17 VISN order.

(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:

A follow-on contract has been solicited under VA263-16-Q-0137 so the barrier has been overcome. This modification to the sole source delivery order is needed to bridge the gap so there is no break in service until the follow-on solicitation is awarded.

(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.)

VISN 23

FACILITY

(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 NCO23-St. Cloud Minnesota

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.

Branch Chief NCO 23-St. Cloud Minnesota VHAPM Part 808.405-6 Limiting Sources Page 5 of 5 Original Date: 08/30/2017