RFQ LSJ_Redacted.pdf

Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C250-25-AP-1917

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C250-25-AP-1917

1. Contracting Activity: Department of Veterans Affairs, NCO10, Chillicothe VA Medical Center, 17273 State Route 104, Chillicothe, OH 45601, submitted 2237 #538-25-3-775-0043.

2. Description of Action: This is a new brand name requirement for 5 year option periods (Base + 4 options) for Immunochemical Fecal Occult Testing (iFOBT) analyzer and reagents for the Pathology and Laboratory Service.

Order against: FSS Contract Number: 36F797220D0016

Name of Proposed Contractor: Polymedco Cancer Diagnostics Products LLC Street Address: 510 Furnace Dock Road City, State, Zip: Cortland Manor, NY 10567-6220 Phone: 847-542-0925

3. Description of Supplies or Services:

This acquisition is for laboratory reagents and supplies necessary to perform patient testing on the Polymedco OC Auto Sensor iO Analyzer which is replacing the OC-80 Auto instrument located at Chillicothe VAMC. Polymedco OC-80 Auto reagents and supplies are required to perform immunochemical fecal occult blood testing used to screen veteran patients for colorectal cancer. The shipments need to be timely considering usage and expiration dates of these supplies.

Mfr # Description Qty# OCSIO OC Auto- Sensor iO FOBT Analyzer Includes Extended Service 1 VA-CPT1 Cost per Test (1 device per patient reportable) 1000 VAOC-CR Credit for Devices included OCIOL OC-Sensor iO Latex Reagent (2 x 100) included OCIOC OC-Sensor iO Calibration Kit (10 x 1ml, 2 x 45ml Diluent) included OCIOB OC-Sensor iO Buffer 200 ml (660 Tests/Bottle) included OCQN OC-Sensor iO Negative Control (5 x 1 ml) included OCIOQP OC-Sensor iO Positive Control (5 x 1 ml) included OCIOW OC-Sensor iO Wash Solution (1 x 120 ml) included OC80CUV OC-Auto Micro 80 Cuvettes (1 x 100) included TT-88 OC-Auto Micro 80 Instrument Cups (2 bags of 500) included

VHAPG Part 808.405-6 Limiting Sources Page 2 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C250-25-AP-1917

OCPUIO-VA1

220117

Customized Personal Mailers Cincinatti/ 20 per box (1 device per mailer)

OCSIO1 Sampling Bottles (4 x 50 Sampling Bottles) 1 OCSIO2 Sampling Bottles (20 x 50 Sampling Bottles) 1 TP-5 Thermal Paper (5 Rolls per Box) 5

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

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

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));

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405- 6(a)(1)(i)(C)); or

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

Rationale/explanation to support cited authority: Currently the Chillicothe VAMC Pathology and Laboratory Medicine Service (PLMS) uses the Polymedco OC-80 FIT testing instrument. The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing. The current analyzer will not be supported after year 2025. Therefore, the VA shall provide a replacement of OC-80 FIT testing analyzer with one (1) OC Auto Sensor iO Analyzer, all reagents/consumables/service and scheduled maintenance, service, and support on a firm fixed cost-per-result-reportable (CPRR) basis. The service participated in the VA National FIT initiative which currently utilizes Polymedco FIT kits custom made for the patients in the program. Only these reagents and supplies will allow the current equipment to operate properly and provide accurate results. These are also the only approved reagents per the FDA. The need for these and only these reagents and supplies constitutes a proprietary sole/limited source situation and to attempt to vary reagents for use with these

VHAPG Part 808.405-6 Limiting Sources Page 3 of 3 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C250-25-AP-1917 instruments would create tainted results and jeopardize patient care. No other supplier/vendor can accommodate the required instrumentation and custom U.S. mail test kits with return system.

DSBS queried using NAICS 334516 and keywords “Fecal Reagents” for SD/VOSB’s with zero vendors found. VetCert query by same NAICS with 234 results. Polymedco Cancer Diagnostic Products, LLC, (OEM) confirmed the Cost Per Tests reagents are proprietary property of Polymedco and there are no authorized resellers/distributors. Sole Source letter provided. OEM is a small business. The VA Rule of Two nor SBA Rule of Two could be satisfied. No solicitation will be made. CO Intent to sole source to OEM, small business, on FSS (GSA) contract number 36F79720D0016. Price is fair and reasonable.

Estimated delivery 4/1/2025.

5. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

Lonnelle Jones Dwight Petsche Contract Specialist Senior Contracting Officer Date: 2/26/2025 Date: 2/26/2025

LONNEL

LE JONES

Digitally signed by

LONNELLE JONES

Date: 2025.02.28 09:42:23 -05'00'

DWIGHT

PETSCHE

Digitally signed by

DWIGHT PETSCHE

Date: 2025.02.28 11:28:31 -05'00'