P03 - LSJ FSS Ortho Vitros 5600 MD- KC.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

Page 1 of 4 VHAPG Part 808.405-6 Limiting Sources Revision: 01 Effective Date:

09/01/2024 Acquisition ID#: 36C262-26-

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LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C262-26-AP-0582

(1) Contracting Activity:

Department of Veterans Affairs, Network/Program Contracting Office 22, located at 4811 Airport Plaza Dr. STE 600, Long Beach, CA 90815, in support of Northern Arizona VA Healthcare System (Prescott) at 500 HW 89N, Prescott AZ 86313.

2237 #: 649-26-1-422-0001

(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).

This action is for a 6 month Bridge Contract for Reagent Supplies and Services for the Prescott Healthcare System. A new, needed Chemistry Immunoassay contract is being fully competed and finalized and still needs to .

Order against: FSS Contract Number: V797D-60637

Name of Proposed Contractor: ORTHO-CLINICAL DIAGNOSTICS, INC (Ortho) Street Address: 1001 US HIGHWAY 202 City, State, Zip: RARITAN, NJ 08869 Phone: (585) 453 4265

(3) Description of Supplies or Services:

The estimated value of the proposed action is $ 521,548.35

Request is for the purchase of Reagent Rental Agreement to include service contract under the cost per reportable test program, for chemistry / immunoassay testing supplies from Ortho for VA Prescott Pathology and Laboratory department. This is needed to maintain continuity of service and accessibility for testing in place at VA Prescott through the Core lab. This equipment was previously brought into the lab under earlier contract. The service requests a contract for VITROS 5600 Analyzer Equipment of the Ortho-Clinical chemistry immunochemistry system. PALMS is awaiting a new multi-year contract resulting from a competitive procurement that is in progress. This is needed to keep the current equipment and veteran patient care in operational status.

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(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed .

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

The Vitros 5600 system is already in place and operational in the Prescott location and working under existing contract V797D-60637 / 36C26225F0030 with Ortho Clinical Diagnostics, INC (Ortho).

A new contract is being competed and will require additional time to deliver and install all instruments and equipment once awarded. Additionally, the new contract will be followed by validation before finally being ready for implementation. This process generally takes months to complete. Until the new contract is in place, we need to keep the current equipment and service in operational status. The new contract is following all of the standard procurement procedures for competition, this bridge contract will help continuance of essential patient care services. Delay or interruption of the urgent and compelling need of this service caused by following the standard procedures would result in unacceptable delays and possible negative effects in patient care.

Ortho currently has all equipment and supplies in place needed to continue the services needed.

This action is for a 6 month bridge contract intended to cover the period in between contract V797D-60637 / 36C26225F0030 end of operations on 09/30/2025 and when the new 5 year contract is fully implemented.

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;

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 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:

To conduct the customary contracting process would not be an efficient use of time, effort and resources. Any contract for these services and supplies from any other vendor will take up to a year to implement and is not realistic or efficient in the available timeframe before the end of operations on 09/30/2025 of the current contract. This bridge contract is essential to continue uninterrupted Medical services to patients and avoid a lapse in that care.

consistent with FAR8.404(d) to aid the contracting officer in making this best value determination:

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The GSA Contracting Officer of this FSS contract has already established fair and reasonable prices.

No further determination is required.

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

Search of potential vendors on SBA Small Business Dynamic Search resulted in 119 businesses.

Search on GSA eLibrary resulted in 9 large businesses and 1 small business with FSS contracts FSC Group 66III.

Ortho-Clinical offers the systems and supplies required to continue uninterrupted via FSS Contract #:

V797D-60637.

VA Prescott currently utilizes the Ortho-Clinical VITROS 5600 systems on a Cost-Per-Reportable- Result basis for chemistry and immunochemistry related patient testing. There is a multi-year, IDIQ contract in the award phase of its procurement. In the meantime, continuation of supplies/services is required on the Ortho system until the Go-Live of the new chemistry system.

Due to the immediate need and the fact that a new, fully competed contract is in the award phase, it is not cost or effort efficient to conduct a full review nor to compete this award. To solicit this procurement through the normal process would cause a delay in essential patient care.

A full Market Research report is included in the eCMS Briefcase as P02 - MR Streamlined Chemistry.

(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:

There is a forthcoming IDIQ contract for chemistryimmunochemistry system resulting in competition at the maximum level.

(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.

fund control point official, chief of service or someone with responsibility and accountability.)

Adrienne Wright

Administrative Officer Parth & Lab VA Northern Arizona HCS (Prescott)

TITLE SERVICE LINE/SECTION FACILITY

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(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

a. (required):

I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Marcos Diaz Contracting Officer

NCO 22

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.

Kevin Ceponis NCO 22 / Branch Chief Pathology and Laboratory

HIGHER LEVEL APPROVAL (Required for orders over $750,000):

c. VHA RPO HCA Review and Approval (over $750,000 to $75 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.

NAME

VHA Head of Contracting Activity (HCA)

d. Senior Procurement Executive Approval (over $75 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 other than full and open competition.

Angela Billups, Ph.D.

Deputy Assistant Secretary Office of Acquisition and Logistics Senior Procurement Executive (SPE)