36C25720A0001-001.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 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

LIMITED SOURCE JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C257-19-AP-2120

1. Agency: Department of Veteran Affairs (VA)

Contracting Activity: Network Contracting Office 17 (NCO-17) 7201 W. Interstate 40, Ste. 100 Amarillo, TX 79106-2616

Purchase Request #: 671-20-1-121-0009

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).

NCO-17 intends to place a sole source delivery order against Roche Diagnostic Corporation’s VA National Acquisition Center (NAC) Federal Supply Schedule (FSS) for the acquisition of reagents and consumable items. The action will be awarded as a new contract action. The proposed period of performance for the action will be for one year and two one-year option periods. The estimated base period of performance is 10/1/2019 through 9/30/2020.

Order against: FSS Contract Number: V797D-70105

Name of Proposed Contractor: Roche Diagnostic Corporation

Street Address: 9115 Hague Rd.

City, State, Zip: Indianapolis, IN 46250-0456

Phone: 800-722-7552

3. Description of Supplies or Services:

Item Description Item Number Est. Annual QTY Sample Input Tubes with Barcode Clips 03137040001 20 K-Tips, Racks, 12 X 36 03287343001 15 SPUs, 12 X 24 03755525001 20 K-Tubes, Rack, 12 X 96 03137082001 7 HCV Test, V2.0 05480442190 104 https://www.gpo.gov/fdsys/pkg/USCODE-2009-title41/pdf/USCODE-2009-title41-chap4-subchapIV-sec251.pdf https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

VHAPM Part 808.405-6 Limiting Sources Page 2 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018

HIV-1 Test, V2.0 05212308190 44 HPV Amplification/Detection Kit 05235880190 12 HPV Controls Kit 05235855190 12 Sample Preparation Kit 05235782190 12 Liquid Cytology Preparation Kit 05235812190 12 System Wash Buffer Kit 05235863190 12 CO-RE Tips, 1000 uL 04639642001 8 System Extraction Plate, 24 X 50 05232716001 3 Reagent Reservoir, 50 mL, 6 X 200 05232732001 5 Reagent Reservoir, 200 mL, 12 X 100 05232759001 5 Microwell Plate and Sealing Film, 24 X 50 05232724001 15 CT/NG Amplification/Detection Kit, V2.0 07102569190 10 CT/NG Controls Kit 05235928190 10 PCR Urine Kit 05170486190 6 System Control Diluent Kit 05235847190 10 HBV Test Kit 05027012190 26 PCR Female Swab Kit 05170516190 18 System Wash Reagent, 5.1L 03587797190 80

Estimated annual quantities. The resultant contract will be considered a standing order. Items in the delivery order will be ordered on an as-needed basis throughout each period of performance.

The estimated value of the proposed action, to include all options, is $REDACTED

(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.

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;

The South Texas Veterans Health Care System, Pathology and Laboratory Medicine Service, owns and operates a Roche Diagnostics Corporation COBAS 4800 system. The requested reagents and consumable supplies are the only supplies compatible with Roche COBAS systems.

Roche is the only VA NAC vendor that offers hepatitis B (HBV) reagents on an FSS.

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 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%208_4.html#wp1091891 https://www.acquisition.gov/sites/default/files/current/far/html/Subpart%208_4.html#wp1091891

VHAPM Part 808.405-6 Limiting Sources Page 3 of 5 Original Date: 08/30/2017 Revision 01 Eff Date: 04/23/2018 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 redacted (If FAR 8.405-6(a)(2)iii) before posting.

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.

The requested reagents and consumable supplies are manufactured (packaging) to meet all aspects of function, fit and form for Roche COBAS systems. Roche is the sole manufacturer and distributor for all assays performed on COBAS systems in the United States.

(5) DETERMINATION BY THE ORDERING CONTRACTING OFFICER THAT THE ORDER

REPRESENTS THE BEST VALUE CONSISTENT WITH FAR 8.404(d):

The Contracting Officer has determined that placing a delivery order with Roche Diagnostics Corporation for the requested supplies is a best value consistent with FAR 8.404(d). The Contracting Officer will compare the proposed prices with the vendor pricelist and may compare the prices of past delivery orders to verify the proposed prices are a best value.

(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 of all Special Item Number (SIN) 66 III (Clinical Analyzers, Laboratory, Cost-Per-Test), category 605-6A/B (Clinical Immunochemistry Analyzers), VA NAC vendor pricelists revealed that Roche Diagnostic Corporation is the only vendor that offers the HBV reagent on an FSS pricelist.

(7) ANY OTHER FACTS SUPPORTING THE JUSTIFICATION:

N/A

(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:

VHAPM Part 808.405-6 Limiting Sources Page 4 of 5 Original Date: 08/30/2017

The government ownership of a Roche COBAS 4800 system restricts the purchase of reagents and consumable supplies to only those compatible with the COBAS systems. The Pathology and Laboratory Medicine Service will conduct market research prior to future procurements to consider any advances in the marketplace.

(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:

//SIGNED//_____________________8/6/2019___

REDACTED Date:

Laboratory Manager Pathology & Laboratory Medicine Service South Texas Veterans Health Care System

(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.

//SIGNED//_____________________8/5/2019___

Contracting Officer https://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx https://vaww.pclo.infoshare.va.gov/PMWeb/VHAPM_Part_806.3.aspx

VHAPM Part 808.405-6 Limiting Sources Page 5 of 5 Original Date: 08/30/2017

b. One Level Above the Contracting Officer:

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

//SIGNED//______________________8/6/2019___

Chief, Division I Network Contracting Office 17

c. Two Levels Above the Contracting Officer:

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

//SIGNED//______________________8/22/2019___

Director of Contracting Network Contracting Office 17

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

d. 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.

//SIGNED//_____________________8/29/2019___

Executive Director, Regional Procurement Office (RPO) – West Head of Contracting Activity (HCA)