Redacted JA.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 4 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C250-21-AP-0817

(1) Contracting Activity: Department of Veterans Affairs, VISN 10, Ann Arbor Medical Center

PR 506-21-1-1030-0018

(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).

Order against: FSS Contract Number: V797D70105

Name of Proposed Contractor: Roche Diagnostics Corp

Street Address: 9115 Hague Rd

City, State, Zip: Indianapolis, IN 46256

Phone: 800-428-5076

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 392,907.80

This request is for a new FFP Base plus four cost per test BPA. The Pathology and Laboratory Medicine Services (P&LMS) department of VAAHS intends to lease an analyzer for Human papillomavirus (HPV) testing. The proposed action is for professional services (labor for installation and training), reagents, supplies and the maintenance of the analyzer.

This request is for a base plus four FFP BPA. The estimated annual cost for this lease includes:

Consumables-$10,548.40 Controls- $3,528.00 Reagents- $64,505.16 Total- $78,581.56 A total 5-year term total is estimated at $392,907.80.

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VHAPM Part 808.405-6 Limiting Sources Page 2 of 4 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

(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:

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; Only one responsible source, the Cobas 4800 platform manufactured by Roche, meets the testing needs of the cytology requirements as required by the P&LMS. Only the Cobas 4800 is approved by the FDA to perform HPV testing on both the ThinPrep and the SurePath specimen collection vials. The Cobas 4800 is also FDA approved for primary screening as well as the high-risk genotyping without the need of a reflex test. The Cobas 4800 also meets the testing volume demands of the P&LMS department, capable of 192 results per 8 hour shift.

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: Previous BPA VA528-14-A-0064 awarded for $268,000.00 (CPT unit pricing was the same, however quantity differed) on 9/15/2014 for a one year period was a justified and approved for award to Roche Diagnostics. In the time since, the need to include high risk genotypes and increase HPV testing, has only increased. Review of the capabilities of analyzers offered on GSA, Category 66, reveal the COBAS 4800 by Roche Diagnostics remains the only analyzer that can meet the complete requirement of VA Ann Arbor regarding HPV and high-risk genotype testing.

VHAPM Part 808.405-6 Limiting Sources Page 3 of 4 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

(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 via the VIP database with NAICS 334516 and received 122 results therefore, I narrowed down the results by using keyword “ROCHE” and received 0 results. The rule of two is not attainable. Then, market research was conducted by contacting sales representatives of three vendors that manufacture and support liquid-based cytology testing. Due to the nature of the COVID pandemic a questionnaire was provided to the vendors during the months of April and May of 2020. Of upmost importance was the requirement that the testing methodology must have been approved by the FDA to be performed on both of the aforementioned collection vials. The results confirmed there was only one responsible source, the Cobas 4800 platform manufactured by Roche, meets the testing needs of the cytology requirements as required by the P&LMS.

On 1/7/21 a source sought 36C25021Q0288 was posted on eBuy to confirm the results of the market research. Only Roche responded that they can provide the requirement and 12 “no quote” responses were received.

All market research has confirmed, only the Cobas 4800 is approved by the FDA to perform HPV testing on both the ThinPrep and the SurePath specimen collection vials. The Cobas 4800 is also FDA approved for primary screening as well as the high-risk genotyping without the need of a reflex test.

(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:

(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

NAME TITLE SERVICE LINE/SECTION

VHAPM Part 808.405-6 Limiting Sources Page 4 of 4 Original Date: 08/30/2017 Revision 02 Eff Date: 02/21/2020

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

Brooke L. Hansen NCO 10_____________________________

NAME AND TITLE FACILITY/NCO/PCO

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

Jason E. Lawson Supervisory Contract Specialist NCO10- Supply Team #3