JOFOC.pdf

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: 36C261-20-AP-4998

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

PR: 593-21-1-497-0015.

(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) for a sole source delivery order with Polymedco, Inc. for the acquisition of an immunochemistry cost-per-test (CPT) program. The proposed action will be a standing order; where the requested supplies will be ordered on an as needed basis throughout the period of the contract. The proposed order will be awarded as a new firm-fixed price action. The order will consist of a base period of performance of one year an have four option year periods. The base period of performance: 10/01/2020 09/30/2021.

Order against: FSS Contract Number: 36F79720D0016

Company Name: POLYMEDCO, INC.

DUNS: 024798555

Address:

510 FURNACE DOCK ROAD

CORTLANDT MANOR, NY 10567

UNITED STATES

Government Business POC:

Richard Mahoney Instrument@polymedco.com rmahoney@polymedco.com 914-739-5400 x299

1-800-431-2123

(3) Description of Supplies or Services:

The estimated value of the base year is . The estimated base plus all option value is

The Southern Nevada Health Care System (VASNHCS) Pathology and Laboratory Medicine Service requires an FDA approved automated immunochemistry analyzer capable of Fecal Immunochemistry Tests (FIT), which is used for the diagnosis of gastrointestinal (GI) disorders (colitis, polys and colorectal cancer) of patients. The VASNHCS immunochemistry requirement also includes all of the reagents, VHAPM Part 808.405-6 Limiting Sources Page 2 of 4

Revision 02 Eff Date: 02/21/2020 controls, consumable supplies and equipment maintenance services necessary to perform approximately 12,033 annual FIT tests of veteran patients.

Polymendco, Inc. offers their FDA approved OC Auto Micro 80 immunochemistry analyzer through a CPT programs available on their federal supply schedule (FSS). In the CPT program, Polymedco provides use of the OC Auto Micro 80 analyzer with all required reagents, controls, consumable supplies, training and equipment maintenance services at a firm-fixed price, per test.

The VASNHCS also requires the following Polymedco items, which are not included in the CPT program:

Catalog No. Product Estimated quantity OCPU-VA1 Personal Mailers/20 per box 1 Each OCS1 Sampling Bottles (4 x 50) 1 Each OCS2 Sampling Bottles (20 x 50) 1 Each TP-5 Thermal Paper (5 Rolls per Box) 1 Each

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

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)(i)(B)).

Market research conducted by the requesting facility and the contract specialist did not find an alternate procurement source for the immunochemistry requirement. The Polymedco OC Auto Micro 80 automated immunochemistry analyzer is the only instrument identified as FDA approved and available in the United States.

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 eplacem 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 Contracting Officer has compared the proposed prices against the Federal Supply Schedule (FSS) price list costs to ensure the costs quoted are equal to or less than the FSS. The comparison costs as listed on the FSS and of historical costs paid for previous acquisitions with Polymedco, Inc. the Contracting

VHAPM Part 808.405-6 Limiting Sources Page 3 of 4

Revision 02 Eff Date: 02/21/2020 officer has determined that the anticipated costs to be fair and reasonable and in the best interest of the government.

(6) Describe the Market Research Conducted: Market research conducted by the requesting facility and the contract specialist did not find an alternate procurement source for the immunochemistry requirement. The Polymedco OC Auto Micro 80 automated immunochemistry analyzer is the only instrument identified as FDA approved and available in the United States.

A search of the mandatory sources for procurement of supplies, UNICOR and Ability One, identified that they do not offer the requested supplies and services.

A search of GSA Advantage revealed that there are four (4) large business VA National Acquisition Center (NAC) FSS vendors that offer immunochemistry CPT or Cost-Per-Reportable Result (CPRR) programs under SIN 66 III, category 605-6B. A search of the test menus for the analyzers offered in category 605-6B did not find an analyzer that provides FIT capability.

A search of the Of Pages (VIP) did not find a Service-Disabled Veteran-Owned Small Business or Veteran-Owned Small Business that can provide the requested supplies and services. A search of VIP with North American Industry Classification System (NAICS) code 334516 zero

(0) results.

DSBS) tool did not identify a small business that can provide the requested supplies and services. A search with DSBS with NAICS 334516 and keywords zero (0) results.

(7) Any Other Facts Supporting the Justification: A notice of intent to sole source was issued to opportunities under 36C26120Q0975 on August 15, 2020 with responses due by August 21, 2020, yielding zero (0) responses from any interested and/or qualified sources.

(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:

Polymedco, Inc. is the only known firm capable of providing the requested supplies and services. Market research will be conducted prior to the exercise of options and for new requirements to determine if there have been any changes in the marketplace.

(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.

September 8, 2020

SIGNATURE DATE

Acquisition and Utilization Specialist Logistics Office

NAME TITLE SERVICE LINE/SECTION

VA Southern Nevada Healthcare System

FACILITY

VHAPM Part 808.405-6 Limiting Sources Page 4 of 4

Revision 02 Eff Date: 02/21/2020

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

a. Contracting Office (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

CONTRACTING OFFICER DATE

NCO 21

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