36C25022A0011_2.docx

VHAPM Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >SAT

GENERAL INFORMATION

BASE NOTICE TYPE

Network Contracting Office 10

5500 Armstrong Rd.

Battle Creek MI 49037

POINT OF CONTACT*

Contract Specialist Brooke Hansen brooke.hansen@va.gov

AWARD INFORMATION

MODIFICATION NUMBER

LINE ITEM NUMBER

AWARDEE ADDRESS LINE 1*

AWARDEE ADDRESS LINE 2*

AWARDEE ADDRESS LINE 4*

ADDITIONAL INFORMATION

Justification and Approval Notice Justification and Approval Notice

DESCRIPTION

Justification and Approval Notice

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C250-22-AP-1270

(1) Contracting Activity: Department of Veterans Affairs, VISN 10, John D. Dingell Medical Center

PR 553-22-1-058-0261

(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). New Requirement

Order against: |X| FSS Contract Number: V797D-70105

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 406,632.45 A dedicated workstation is used to run, analyze, and print assay results generated by the associated instrumentation. The instrumentation is composed of the Roche Cobas AmpliPrep, which is used to prepare the patient sample for further processing. The other piece of equipment is the Roche Cobas TaqMan 48 which does molecular polymerase chain reaction (PCR) amplification of this material to generate viral load results.

The projected annual volume of test kits are as follows: HCV 32 kits (72 tests) and HIV 11 kits (48 tests). There are also routine consumables associated with the performance of these assays to include 31 system wash kits, 10 input tubes with barcodes, 7 k-tips, 10 specimen processing units and 3 k-tube.

This will be a base + 2 contract. The period of performance will be 12/18/2021 – 12/17/2024.

(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:

|X| 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; Utilizing the same vendor, associated instrumentation, and reagents will allow for continuity and prevent the need for revalidating or reestablishing baselines for patient test results. If the Government were to fulfill the requirement from a different manufacturer, results may vary due to the methodologies and targets used in the determination of viral loads. Maintaining the same vendor platform reduces assay run costs and clinician time over other vendors.

Roche’s assay performance, efficiency, and reliability meet the Government need. The competition utilizes a single molecular target which resides in an area susceptible to drug pressure, whereas the Roche assay utilizes dual targets which are not susceptible. The inherent vulnerability of utilizing a single molecular target in a susceptible drug increases the possibility of generating erroneous results by which clinical patient treatment and disease course decisions are made.

In the last five years the VA Ann Arbor Healthcare System has experienced no significant issues with this testing system, and the reliability has been outstanding as validated by our accreditation proficiency scoring.

|_| 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:

The continued use of the Roche testing equipment and supplies would enable VA to reduce risks associated with transitioning to new equipment, software, and re-establishing baselines and controls. This type of testing is also offered by Abbott (FSS contract V797P-7322A) and Siemens (FSS contract V797D-30175), who have both been reviewed by the service for this however, the Government intends to procure as a sole source based on the following review of competitors’ equipment.

The Abbott M2000 platform requires external calibration for every lot of reagents, whereas the Roche system has internal calibrators built into each individual assay run. Running calibrators for every lot of reagents increases the cost per test and technologist time performing the calibration independent of running patient testing. The Abbott M2000 utilizes a single target on the gene amplification sequence which is in a region which is susceptible to drug interference, whereas the Roche platform utilizes a dual target of detection which is not susceptible to the drug interference. The Abbott platform would require larger sample runs restricting the frequency of running the assay and will increase turn-around time to the Clinicians delaying clinical diagnosis for the Veterans in need of this service.

The current Siemens System is designed to run a greater number of samples (e.g., 96) and a broader menu of tests whereas the Roche system can run as few as 12 samples per run and is optimized to run HCV & HIV RNA viral load tests.

Furthermore, maintaining the Roche platform ensures no potential issues with the reliability of testing results as the platform is optimized for smaller labs running smaller batches of tests. The smaller batches allow the VA to reduce turnaround time enabling clinicians to provide a timelier diagnosis.

Lastly, switching vendors at this juncture would require every patient actively being monitored under our care to be re-baselined and would require running test in parallel on both vendor platforms causing potential confusion for the clinicians and patients.

Continuing with the Roche system will save time and money related to staff training, acclimation to a new system and offers the best value to the Federal Government.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Searched VIP database using NAICS 334516 keyword “Cobas AmpliPrep/TaqMan 48” and found zero (0) SDVOSB/VOSB vendors. An additional search of GSA Advantage was unable to locate any additional vendors who can provide the testing equipment and supplies.

The Government reviewed the offerings currently available in the marketplace and could not find any testing equipment and accompanying services that met the Government’s requirements as defined by the service.

There is no evidence that the VA Rule of Two can be met. Market research indicates there is only one source capable of providing the supplies and services required at the level of quality required because the supplies and services are unique and highly specialized.

(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:

Should a requisition of this nature reoccur in five years, the market will be surveyed for advances in the testing as well as the products/offerings of Roche, other current competitors, and any other testing labs/manufacturers not currently in the market who may enter between this award and a subsequent new requirement.

(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.)

John D. Dingell VA Medical Center

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.

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.

Diana J. Pittman________________________

NAME

NCO 10 | Contract Specialist Branch Chief, Supplies Team #3 VHAPM Part 808.405-6 Limiting Sources Page 7 of 7 Original Date: 08/30/2017 Revision 03 Eff Date: 03/18/2021