Cobas 4800 LSJ .pdf

VHAPG Part 808.405-6 Limiting Sources Attachment 2: Request for Limited Sources Justification Format >250K

Effective Date: 02/01/2022 Page 1 of 4

LIMITED SOURCES JUSTIFICATION

ORDER >>$250,000

PATHOLOGY & LAB, COBAS 4800 REAGENTS

FAR PART 8.405-6

Acquisition Plan Action ID: _____________________

(1) Contracting Activity: Department of Veterans Affairs, Network/Program Contracting

Office 10, located at 2215 Fuller Road Ann Arbor, Michigan 48105., in support of VISN

10 VA Health Care System at Molecular section of Pathology and Laboratory-113, Richard L. Roudebush Veteran Health Administration, 1481 West 10th street, Indianapolis, IN 46202. 2237: 583-23-3-054-0059

(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). The materials listed in par. 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.

Order against: X FSS Contract Number: V797D-70105

Name of Proposed Contractor: ROCHE DIAGNOSTICS CORPORATION Street Address: 9115 HAGUE RD City, State, Zip: INDIANAPOLIS, IN, 46256‐1025 Phone: 317-521-2000

(3) Description of Supplies or Services:

The estimated value of the proposed action is $748,000

The Pathology & Laboratory Medicine Services, Molecular Department, performs MRSA, CT/NG and HPV HR, PCR based tests, screening and monitoring patients of the Indianapolis VA Medical Center, Community based outpatient clinics (CBOC) and some of the facilities of VISN 10. These testing are currently performed using Roche cobas4800 System which was acquired during FY2017 as a reagent/supplies contract. Instrument and services are included with the current contract. Test are validated using FDA approved reagents that are solely on use with cobas4800 system.

Molecular department seeks a Base plus 4year option reagent supply contract with included instrument and services to perform the MRSA, HPV and CT/NG testing on the COBAS 4800 system. This will continue to provide successful streamlining, labor reduction and elimination of outside service testing as well as improve consistent reporting with accuracy. The system performs full specimen set up, to include but not limited to, pipetting, use of barcode reading, the application of contamination controls, DNA concentration checks and use of FDA-approved reagents.

https://www.acquisition.gov/far/part-8#FAR_8_405_6 http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

Effective Date: 02/01/2022 Page 2 of 4

A detection process exists to forego manual analysis and an interpretive software assists in and ensures that conclusive results are transmitted via barcode data to DHCP using bi-directional LIS communication, reviewed by technologists, and reported into DHCP. Test Positive results are provided to the Physician and an RLR VAMC infection control coordinator.

All the items listed are peculiar to Roche Diagnostics Corporation, the sole distributor of the deliverables.

BASE YEAR $200,000 09/01/2023 08/31/2024

OPTION YEAR ONE $200,000 09/01/2024 08/31/2025

OPTION YEAR TWO $200,000 09/01/2025 08/31/2026

OPTION YEAR THREE $148,000 09/01/2026 03/31/2027

AGGREGATE COST: $748,000

(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 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. This procurement is based on 6.302‐1 ‐‐ Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements. The selected vendor is the only organization that can meet the requirements and does so through FSS contract V797D‐70105. The contractor’s products have undergone extensive validation by the Indianapolis VAMC and peer facilities. No other vendor, or any generic reagent, can be used with the instruments currently in use at the VA medical center that would perform, or report as reliable test results, that would follow local regulations and protocols.

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.

https://www.acquisition.gov/far/part-8#FAR_8_405_6

Effective Date: 02/01/2022 Page 3 of 4

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is: The OEM is the sole source supplier of the reagents and consumables for their analyzer with no authorized re-sellers.

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.

The current Roche cobas 4800 system installed since 2017 providing results efficiently without any errors. System is already connected to LIS All FDA approved tests went thru intense in-house validation with employee training and competencies maintained on this test system.

There will not be any changes in the system connect, interface, service, test validation or an employee retraining and competencies.

(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:

V797D‐70105 was awarded to address the needs of VA medical centers that have a requirement for the reliable pathological testing outlined above. The contract was awarded after extensive market research, competition, legal review and scrutiny by technical experts.

Thus, the choice is technically sound, leverages the Governments buying power and is in the best interest of the Government to use.

(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 performed by review of current contract, discussion with VA stakeholders, and review of FSS. The current cobas4800 system installed since 2017 providing results efficiently without any errors. All FDA approved tests went thru intense in-house validation with employee training and competencies maintained.

(7) Any Other Facts Supporting the Justification:

The contractor’s products are proprietary and have undergone extensive validation at the VA medical facility. No other vendor's reagents or equipment can be used as a substitute, and replacement of the entire system is not an economically sound decision that would benefit the Government.

(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: Not Applicable.

Effective Date: 02/01/2022 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.

_____ 5/20/2023

SIGNATURE DATE

Amanda Reuille Laboratory Manager Path & Lab Medicine Service

NAME TITLE SERVICE LINE/SECTION

Richard L. Roudebush 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.

CONTRACTING OFFICER DATE

NCO 10 Contracting Office https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx