Redacted LSJ.pdf

LOG#: 20-00022

Form 02.4G.AA/N6264520RC97001 18 Apr 2016

LIMITED SOURCE JUSTIFICATION

FOR FEDERAL SUPPLY SCHEDULE ORDER

1. Identification of agency and contracting activity, and specific identification of the document as a

“Limited Source Justification (LSJ).”

This is a Limited Source Justification. The requiring activities are Naval Medical Center (NMC) Portsmouth and

NMC San Diego; the contracting activity is the Naval Medical Logistics Command, Ft. Detrick, MD.

2. Nature and/or description of contract action being approved.

The proposed action is a limited source justification to award a new Federal Supply Schedule (FSS) order from an existing contract to the contractor identified in paragraph 3 below. The placement of a Firm, Fixed-Price order is anticipated.

3. Description of the supplies or services required to meet the agency's needs (including the estimated value).

Naval Medical Center (NMC) Portsmouth and NMC San Diego both have a requirement for one (1) irradiator, blood

[Device Code: 17-437]. The units shall be FDA-approved for irradiation of blood and blood products for prevention of Graft Versus Host Disease. The units shall use X-Ray irradiation to irradiate blood and blood products packaged in transfusion bags. The units shall be able to irradiate whole blood, platelets, and loaded syringes in the same cycle.

The units shall not use radioactive materials. The units shall be self-contained and shall not require external water or any facility modifications. Each unit shall include a bar code reading system, and two sets of carbon filter canisters.

The vendor shall provide on-site operator and biomedical engineer technician (BMET) training for at least two (2) individuals for each medical treatment facility. The vendor shall include installation for each unit. Each unit shall include a one (1) year manufacturer’s warranty. The power requirements are 220 VAC, 60 Hz.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, such that OEM warranty and service are provided and maintained by the

OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

The system, including claims made for the product, shall be compliant with FDA regulations, with respect to marketing and delivering medical products for use in the United States of America. These requirements shall apply even if delivery is requested outside of the United States of America. The system shall be installed in compliance with OSHA requirements.

The proposed source is Rad Source Technologies, Inc. (Rad Source) of 4907 Golden Parkway Suite 400, Buford, GA 30518-5856.

4. The authority and supporting rational (see 8.405-6(a)(1)(i) and (b)(1)) and, if applicable, a demonstration of the proposed contractor's unique qualifications to provide the required supply or service.

The statutory authority which permits restricting consideration of schedule contractors to fewer than that required is

FAR 8.405-1(a)(1)(i)(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.

Rad Source is the only vendor that can provide a blood irradiator via the Federal Supply Schedule. Additionally, Rad Source is the only vendor that can provide an FDA-approved self-contained blood irradiator that does not use radioactive materials or require facility modifications. No other vendor can provide a blood irradiator that is self-contained and does not require facility modifications or radioactive materials. Thus, Rad Source is the only vendor that meets the minimum requirements of the Government and is available on the Federal Supply Schedule.

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/08.htm#P286_49080

LOG#: 20-00022

Form 02.4G.AA/N6264520RC97001 18 Apr 2016

5. A determination by the ordering activity contracting officer that the order represents the best value consistent with 8.404(d).

GSA has determined the prices of supplies and the schedule contracts to be fair and reasonable for the purpose of establishing the schedule contract. Therefore, ordering activities are responsible to make a separate determination of fair and reasonable pricing for individual orders. By placing an order against a schedule contract using the procedures in 8.405, the ordering activity has concluded that the order represents the best value (as defined in FAR

2.101) and results in the lowest overall cost alternative (considering price, special features, administrative costs, etc.)

to meet the Government's needs. The Contracting Officer will determine the anticipated cost to the Government of the supplies covered by this justification to be fair and reasonable by conducting a price analysis before an award is made.

6. A description of the market research conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market research was conducted in October and November 2019 and January 2020. It included a search of the

Internet using Google, GSA Advantage, and the ECRI Sourcebook. Based on market research, there are no other blood irradiator suppliers available on FSS. Vendors that can provide a blood irradiator for use in irradiation of blood and blood products for prevention of Graft Versus Host Disease include Rad Source Technologies, Inc. (Rad

Source), Hitachi Ltd. (Hitachi), and Best Theratronics, Ltd. (Theratronics). Only Rad Source is able to provide a unit on the Federal Supply Schedule (FSS). Units provided by Hitachi and Theratronics are not available on FSS.

Additionally, units provided by Hitachi and Theratronics are not self-contained and require water flow and drainage for cooling, which would require facility modifications. Facility modifications would unnecessarily increase the cost and time required to complete this requirement. Theratronics can also provide a unit which requires radioactive materials, which does not meet the minimum requirements. Only Rad Source can provide a self-contained system that does not require facility modifications or use of nuclear material and is available on the Federal Supply

Schedule. Rad Source is the only vendor that can meet the present requirements of the Government.

7. Any other facts supporting the justification.

This procurement uses a GSA Schedule and will be solicited and awarded in accordance with FAR Subpart 8.4.

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.

All future requirements will be handled on a case-by-case basis.

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/08.htm#P83_13798