JOFOC Chem_Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 5

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: ___36C261-22-AP-5338___ JOFOC Log Number: __ 2022-07-15T06:04:15__

(1) Contracting Activity: Department of Veterans Affairs, Regional Procurement Office West (RPOW), Network Contracting Office (NCO) 21, on behalf of VA Southern Nevada Healthcare System (VASNHCS).

2237: 593-23-1-968-0012

(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). Pursuant to Federal Supply Schedule (FSS) Group 66 III and FSS Contract Clause I-FSS-646, it is the intent of the Department of Veterans Affairs (VA), Network Contracting Office 21 (NCO 21) to establish a new requirement for a Cost-Per-Reportable-Result (CPRR) delivery order for automated clinical laboratory chemistry analyzers for a period of 12 months.

Order against: FSS Contract Number: ___V797D-70260____

Name of Proposed Contractor: Beckman Coulter, Inc.

Street Address: 250 S. Kramer Blvd.

City, State, Zip: Brea, CA 92821 Phone: 714-872-6271

(3) Description of Supplies or Services:

The estimated value of the proposed action is $

The intent of the Government is to establish a 12-month contract with current Contractor, Beckman Coulter, for chemistry testing while awaiting a new Veterans Integrated Services Network (VISN) 21 Indefinite Delivery, Indefinite quantity (IDIQ) solicitation award.

Current instrumentation, software, ancillary equipment, and analyzer specific reagents will be used. The Contractor is required to provide a continuously stocked inventory of reagents, standards, controls supplies, disposables and any other materials required to properly perform tests on the equipment such that equipment operations are not interrupted. These items shall be of the highest quality, sensitivity, specificity and tested to assure precision and accuracy.

Unexpected changes in methodology/technology shall be at the expense of the Contractor.

Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, prior to or simultaneously with field alerts should be forwarded to the Contracting Officer Representatives. These individuals shall be identified upon award of the delivery order/s.

Effective Date: 02/01/2022 Page 2 of 5

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a d 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;

The contractor is the current incumbent providing the supplies and services to the VASNHCS and has been performing satisfactorily. There is no other vendor that can mobilize and perform this requirement without a lapse in performance. Failure to obtain and provide the required reagents and supplies could be detrimental to Veteran patient care and the VA's efforts to provide early detection, accurate, reliable, and precise diagnosis for various medical conditions. The completion of an overhaul of the current chemistry analyzer system would not be in the best interest of the government, would require extensive manpower and funds to execute, and would not be in the best interest of taxpayer dollars considering a new long-term procurement is currently in the solicitation phase.

VASNHCS is requesting a short-term contract with Beckman Coulter to continue with their current two (2) DxC 700 AUs chemistry analyzers until the new long-term contract is awarded.

Any new equipment delivered requires installation, calibration, validation, and approval for reporting patient testing.

The laboratory has specific regulatory and accreditation guidelines for evaluating the many technical factors that could be affected any time there is a change in the way a test is performed.

This evaluation must be completed and reviewed prior to any patient results being reported.

Changes in test performance include, but are not limited to: different reagent manufacturer, different method of performing test, different analyzer.

If the contract for the chemistry analyzer for the current Beckman Coulter DxC 700 AU analyzers is awarded to another vendor, the laboratory would be required to perform a complete method validation for each test performed. Method validation includes studies of accuracy, linearity, precision, sensitivity, specificity, carryover, verifying critical values and reference ranges, developing new quality control ranges, writing new Standing Operating Procedures, changing the information in the lab information package, ensuring the same sample type and units of measurement, just to name a few. Most of these require the use of reagents, greatly increasing the amount needed even before patient testing can begin. During this time, the station will still need to purchase reagents from Beckman Coulter until the process is complete which can take a couple of months depending on the number of tests and staffing of the laboratory.

Due to the limitations placed on the laboratory by accreditation standards and the ongoing project to replace all chemistry and immunochemistry analyzers as soon as possible, it would

Effective Date: 02/01/2022 Page 3 of 5 place an undue burden on the laboratory at this time to award a contract for the chemistry analyzers to anyone but Beckman Coulter in the short-term.

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:

Per the authority cited in number 4 above, pricing awarded under this contract will be consistent with and/or better than current Federal Supply Schedule (FSS) pricing. By placing a short-term order with the current manufacturer, there are significant cost savings to the Government by procuring on a sole source basis to avoid added administrative work associated with using a different chemistry provider.

(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 not conducted. Concurrently with this short-term extension, VASNHCS is part of the VISN Chemistry Immunoassay Cost-Per-Reportable-Result (CPRR) Indefinite Delivery, Indefinite Quantity (IDIQ) seeking a long-term contract for the same supplies and services, which is currently solicited and pending vendor responses.

(7) Any Other Facts Supporting the Justification:

The Network Contracting Office (NCO) 21 is actively working on a long-term contract. In the interim the supplies and services must continue for the veterans who obtain care from the VASNHCS. The supplies and services are critical for VASNHCS, there is no other viable alternative available to avoid disruption in patient care.

(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:

Effective Date: 02/01/2022 Page 4 of 5

As previously described, the long-term replacement contract is actively being worked and is in the solicitation phase.

(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.

SIGNATURE DATE

Derrick Witherspoon Core Lab Supervisor P&LMS

VA Southern Nevada HCS

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

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

CONTRACTING OFFICER SIGNATURE DATE

Mandy Thompson Network Contracting Office 21 (NCO 21)

Effective Date: 02/01/2022 Page 5 of 5

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.

SIGNATURE DATE

Brooke Robison Director of Contracting Network Contracting Office 21 (NCO 21)

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.

Curtis M. Jordan DATE Executive Director, Regional Procurement Office West Head of Contract Activity (HCA)

15 JUL 22