V797P-7347A-014.docx

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

CLASSIFICATION CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

BASE NOTICE TYPE

(Required when using Statutory Authority FAR 6.302-1(c))

ARCHIVE

DAYS AFTER THE POSTING DATE

RECOVERY ACT FUNDS

NAICS CODE

SET-ASIDE

CONTRACTING OFFICE

ADDRESS

DESCRIPTION

See Attachment

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

STATUTORY AUTHORITY

AWARD NUMBER

(Not required when using Statutory Authority FAR 6.302-1(c))

MODIFICATION NUMBER

AWARD AMOUNT

LINE ITEM NUMBER

AWARD DATE (MM-DD-YYYY)

(Not required when using Statutory Authority FAR 6.302-1(c))

AWARDEE NAME

AWARDEE ADDRESS LINE 1

AWARDEE ADDRESS LINE 2

AWARDEE ADDRESS LINE 3

AWARDEE ADDRESS LINE 4

AWARDEE CITY

AWARDEE STATE

AWARDEE ZIP CODE

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

AWARD INFORMATION

ADDITIONAL INFORMATION

GENERAL INFORMATION

* = Required Field FedBizOpps Justification and Approval Notice Rev. March 2010 Q Interim CPT Chemistry 35233 N 334516 Department of Veterans Affairs Birmingham VA Medical Center 700 South 19th Street Birmingham AL 35233

FAR 6.302-1

V797P-7347A 36C24718N1000 $564,735.72 04-11-2018

ROCHE DIAGNOSTICS CORPORATION

9115 HAGUE RD

INDIANAPOLIS

IN

46256 connie.ganier@va.gov Contracting Officer email address

LIMITED SOURCES JUSTIFICATION

ORDER >$150,000

FAR PART 8.405-6

Acquisition Plan Action ID: 521-18-2-072-0243

1. Contracting Activity: Department of Veterans Affairs, VISN 7, Birmingham VA Medical Center, 700 South 19th Street Birmingham, AL 35233

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).

Establish a 6-month Interim (24 April 2018 to 23 October 2018) requirement to retain the fully automated cost-per-reportable equipment/system currently in place to perform clinical chemistry testing on a cost-per-reportable (CPR) basis. This will be awarded as a New Requirement.

Order against: |X| FSS Contract Number: _V797P-7347A

(317-966-3516 Angie.cope@roche.com

3. Description of Supplies or Services:

The estimated value of the proposed action is $ 573,210.84 for the 6 month extension.

There is currently a Roche Diagnostics Corporation cost-per-reportable contract in place at VA Medical Center Birmingham, AL for a fully automated COBAS clinical chemistry testing system that will expire on April 23, 2018. A new contract is needed for BVAMC for this requirement so that uninterrupted patient testing can be provided as required. However, the new long-term contract is projected to be over a $10M requirement, and contracting is still working on the long-term requirement. Therefore, an Interim contract is needed to allow time for processing the Base-plus-4 requirement to be solicited/awarded.

This is a request for other than full and open competition to retain the fully automated COBAS cost-per-reportable equipment/system currently in place to continue clinical chemistry testing on a cost-per-reportable basis. The current equipment/system in place is a very large, very complex system. There is not sufficient time to obtain a different system, receive and install a different system, perform the required correlation studies (run the new/different system along with the current system to ensure results correlate), and ensure appropriate employee training/competency.

During this Interim requirement, it is projected that clinical chemistry will perform approximately 1.1M chemistry assays using serum, plasma, cerebrospinal fluid, and other body fluid samples to serve a large inpatient and emergency patient population while simultaneously supporting a network of outpatient practices and specialty services.

Cost-Per-Reportable is an all-inclusive price, covering equipment use, all reagents and supplies required for the proper operation of the contractor’s equipment and necessary for the generation of a patient reportable result, as well as all necessary preventive maintenance and repairs.

(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| 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;

As manufacturer and owner of the COBAS equipment/system currently in place for clinical chemistry cost-per-reportable testing, Roche Diagnostics is uniquely qualified to provide a 6-month Interim cost-per-reportable contract, as described.

|X| 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. 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 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:

Roche Diagnostics is the manufacturer and owner of the COBAS equipment/system currently in place for clinical chemistry cost-per-reportable testing. All costs have previously been determined to be fair and reasonable under contract V797P-7347A. Previous orders by Birmingham VAMC have been placed under this contract number as well as Task Order VA247-13-F-0924. Because of the complexity of the Interim cost-per-reportable requirement, it was determined that there is not sufficient time to obtain a different system, receive and install a different system, perform the required correlation studies, and ensure appropriate employee training/competency. This is necessary to continue our patient care mission. An RFI for intent to sole source was also posted to FBO with no responses.

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

We considered other companies/organizations available through GSA. However, due to the described complex nature of this requirement and the critical need to continue uninterrupted clinical chemistry testing, it is determined that Roche Diagnostics is the best option for the requirement. An intent to sole source was posted to FBO for this requirement to determine if there would be any responses to the Intent to sole source notice and none were received.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION:

The cost-per-reportable equipment/system in this contract is used daily in providing critical patient care/diagnostic results. The potential for downtime can significantly impact the mission of BVAMC Pathology & Laboratory Medicine Service. The BVAMC will continue to work with contracting to establish a new Base-plus-4.

(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:

This is a one-time purchase of clinical chemistry equipment/system through cost-per-reportable Interim contract to ensure uninterrupted patient testing during the finalization of a new base-plus-4 cost-per-reportable contract. There is no competitor for this particular Interim Requirement. It is not our intention to circumvent/prevent competition; however, this Interim contract with Roche Diagnostics will meet the Government’s entire requirement allowing continuation of uninterrupted patient care.

(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.)

Birmingham VA Medical Center #521

FACILITY

(10) APPROVALS IN ACCORDANCE WITH THE VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

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

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.

NAME AND TITLE

VHAPM Part 808.405-6 Limiting Sources Page 6 of 6 Original Date: 08/30/2017