36C24419Q0853-003.pdf

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 >$250,000

FAR PART 8.405-6

Acquisition Plan Action ID: 36C244-19-AP-3614

1. Contracting Activity: Department of Veterans Affairs, VISN 4, Corporal Michael J. Crescenz Veterans Affairs Medical Center (CMC VAMC) located at 3900 Woodland Avenue, Philadelphia, PA. The 2237 associated with this procurement is 642-19-3-025-1512. The CMC VAMC’s Pathology and Laboratory Medicine Service, Microbiology Section, is requesting award of a delivery order on a limited source basis to Roche Diagnostics Corporation under their Federal Supply Class (FSC) 6630 Federal Supply Schedule (FSS) V797D-70105. The required delivery date is anticipated for July 2, 2019 for a base period of six months with FAR 52.217-8 Option to Extend Services (NOV 1999).

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). The material or service listed in Part 3 below is sole source, therefore, consideration of the number of contractors required by FAR Subpart 8.4 – Federal Supply Schedules, is precluded for the reasons indicated below. The delivery order will be awarded as a new requirement.

Order against: FSS Contract Number: __V797D-70105__

Name of Proposed Contractor: Roche Diagnostics Corporation (Roche) Street Address: 9115 Hague Road, P.O. Box 50457 City, State, Zip: Indianapolis, In 46250-0457 Phone: 317-521-2000

3. Description of Supplies or Services:

The estimated value of the proposed action is $314,000.00 for six months for reagents, supplies and instrument maintenance. Contemplated task order will be for the provision of laboratory reagents and supplies to perform Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) viral load testing. In addition to reagents and supplies, Roche will maintain the necessary instruments to perform the testing. See attached independent government cost estimate for a complete listing of quantities and prices for the reagents, supplies, and the cost per month to maintain the instruments. Instruments provided includes, the COBAS Taqman 48 Analyzer, and the COBAS AmpliPrep Instrument. Note that this equipment is currently on-site, but that Pathology and Laboratory Medicine Service has nearly exhausted its supplies of necessary reagents. Testing could be stalled if a new delivery order is not immediately awarded to Roche. Quantity of reagents and supplies to be ordered should meet testing needs for a period of six months, while a long-term competitive procurement is conducted. The CMC VAMC performs HIV and HCV Viral load testing for all VISN 4 sites.

VHAPM Part 808.405-6 Limiting Sources Page 2 of 4

(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.

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

Patient testing is generally performed daily. A lack of these reagents could result in delayed patient testing. Delays in testing are likely to result in delays in treatment of HIV and HCV. Viral load testing is used to monitor the patient’s response to the new therapeutic regimens now available for both of these viruses. Maintaining consistency in viral load testing is critical to timely and appropriate therapies.

Delays in viral load testing must be avoided. The quantity of reagents and supplies as listed on the attached independent government cost estimate, should meet testing needs for a period of six months;

which will ensure that testing continues in an uninterrupted fashion.

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;

Roche reagents and supplies are only compatible with the Roche testing instruments such as the COBAS Taqman 48 Analyzer, and the COBAS AmpliPrep. Roche is the only provider/manufacturer of compatible reagents for its equipment.

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.

VHAPM Part 808.405-6 Limiting Sources Page 3 of 4

Revision 01 Eff Date: 04/23/2018

Roche reagents and supplies are only compatible with the Roche testing instruments such as the COBAS Taqman 48 Analyzer, and the COBAS AmpliPrep. Availability of reagent and supplies must be limited to Roche as only procurement of the needed reagents from Roche will allow for uninterrupted continuance of viral load testing. Procurement from Roche will also allow the Pathology and Laboratory Medicine Service to avoid delays caused by having to remove existing equipment, install new equipment from a competitor, and learn a new testing protocol/ procedure for HIV and HCV viral load testing. Direct cutover to a new testing protocol would also create an immediate patient care problem because all patient’s currently being followed through viral load testing would need to be re-baselined (measured) which could cause delays in 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:

Award of the described delivery order to Roche represents the best value to the Government for the following reasons: (1) The price offered by Roche for reagents, supplies and instrument maintenance has been determined fair and reasonable by a VA contracting officer at time of award of Roche’s FSS V797D- 70105; (2) The supplies and equipment offered by Roche are the most expedient means to avoid a testing backlog and (3) The reagents, supplies and instruments offered by Roche are in wide use throughout the healthcare market place and are generally accepted to be accurate and reliable.

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

RESULTS OR A STATEMENT OF THE REASON MARKET RESEARCH WAS NOT CONDUCTED:

Market research was conducted among various FSS schedule holders. Results of market research indicate that provision of laboratory reagent supplies to perform HIV and HCV viral load testing can only be provided by Roche, as only Roche reagents and supplies are compatible with the CMC VAMC’s testing equipment such as the COBAS Taqman 48 Analyzer and the COBAS AmpliPrep. Roche is the only provider/manufacturer of compatible reagents for its equipment.

(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:

Since its current instruments are aging and due to be replaced within the next year; during the summer and Fall of 2019 the Pathology and Laboratory Medicine Service will conduct a competitive long-term contract for these testing protocols. The goal is to acquire advanced technology to provide greater automation of viral load testing.

VHAPM Part 808.405-6 Limiting Sources Page 4 of 4

(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

Sahil B. Patel Laboratory Supervisor Pathology & Laboratory Medicine/Microbiology

NAME TITLE SERVICE LINE/SECTION

CMC VAMC

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/DESIGNEE’S SIGNATURE DATE

Maureen Jordan, Contracting Officer NCO4, Clinical Support Services (Med 2)

NAME AND TITLE FACILITY

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

Nancy L. Porter, NAME AND TITLE

Branch Chief, NCO4/Clinical Support Services (Med 2)

07/01/2019NANCY L. PORTER 128170

Digitally signed by NANCY L. PORTER 128170 Date: 2019.07.01 13:54:03 -04'00'

MAUREEN

JORDAN

385898

Digitally signed by

MAUREEN JORDAN

385898 Date: 2019.07.01 14:10:02 -04'00'

Sahil B Patel 1007580

Digitally signed by Sahil B Patel 1007580 Date: 2019.07.01 14:18:27 -04'00'