Lease of DiaSorin Chemiluminescent System with Reagents

Limited Sources Justification or
Sole Source Justification
for Acquisitions under the Simplified Acquisition Threshold
(Simplified Acquisition Threshold is $150K)

1. Contracting Activity: This requirement is for William Beaumont Army Medical Center (WBAMC), 5005 North Piedras, El Paso, TX 79920. The contracting activity is the Regional Health Contracting Office - Central. The Solicitation number is W91YU0-16-T-0018.

2. Description of Action:

Requirement: 0 New 1 Repeat
Pricing: 1 Firm-Fixed Price 0 Time & Materials 0 Cost
Funds: 0 OMA 1 Other Funds: DHP Total Dollar Value: $ 114,734

Name of Intended Contractor:
POC: DiaSorin, Inc.
David Trinh
Street Address: 1951 Northwestern Ave.
City, State, Zip: Stillwater, MN 55082
Phone: 812-276-1574

3. Description of Supplies/Services: This requirement is for fully random access to the DiaSorin chemiluminescent system, leased by WBAMC, for Vitamin D, Insulin, and Varicella-zoster virus testing reagents. The estimated total is $114,734 for the one year contract. This contract will be 1 November 2015 - 31 October 2016.

4. Authority Cited:

1 (a) FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

0 (b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

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

0 (d) FAR 8.405-6(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; OR

0 (e) FAR 8.405-6(a)(1)(i)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order not previously issued under sole-source or limited-sources procedures.
(1 October 2015)

5. Reason for Authority Cited: WBAMC currently leases the DiaSorin equipment in the Pathology Department. The requirement is for the testing reagents for Vitamin D, Insulin, and Varcella-zoster for an estimated total of $114,734. As stated by DiaSorin, their reagents are the only source that are authorized on the machines. No other reagents are compatible with the DiaSorin equipment.

6. Actions to Increase Competition: As long as WBAMC leases the equipment from DiaSorin, competition will be restricted as DiaSorin has proprietary rights to this equipment and the reagents that are used. However, when WBAMC moves into the new hospital, there will be new opportunities for competition at that time. This follow-on contract will expire on 31 October 2016.
7. Market Survey: This is for use in the Department of Pathology for more efficient cost per test and faster turnaround time. The contractor provides a DiaSorin Liasion Analyzer that is the only fully random access chemiluminescent system in the market that does Vitamin D testing, is FDA approved, and is allowing the treatment facilities to validate the instrument testing values to other FDA treatment facilities. Market research, completed on 7 October 2015, verifies that these supplies are offered on the commercial market. Companies generally engaged in providing these types of services are Quest and Roche. Quest can only provide reference testing from a patient sample and Roche does not have a Chemiluminescent system that can provide vitamin D testing. It will be more advantageous to the government to provide better, faster and less expensive testing for patient diagnosis. The DiaSorin analyzers are leased by the government. DiaSorin provided a statement as to why they believe they are the only organization who can provide these reagents. They stated "Please be advised that DiaSorin is the sole provider of service, including installation, preventative maintenance, software updates, and repairs for the LIASON® Chemiluminescent Analyzer which is used in conjunction with the following reagents: 310600 LIASON 25OH Vitamin D Total, 310601 LIASON Control 250H Vitamin D, 310360 LIASON Insulin, 310361 LIASON Control Insulin, 310495 LIASON VZV IgG, and 310496 LIASON Control VZV IgG. In addition, DiaSorin is the sole manufacturer of the reagents listed."
8. Procurement History:

Previous Contract or Purchase Order Number: W91YU0-11-P-0762
Previously competed? 0 N/A 1No 0Yes
Previous authority for less than Full & Open Competition: FAR 13.106-1(b)(1)(i): Only one source reasonably available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization)

9. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this mini-J&A are accurate and complete to the best of my knowledge and belief.

Signature:
Submitted By:
Jorge Munoz
Position Title : Contracting Officer Representative
Email address: Jorge.munoz2.civ@mail.mil
Date: 16 October 2015

10. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Signature:

Typed Name: John A. Kwiatkowski
Position Title: Contracting Officer
Email address: John.A.Kwiatkowski2.civ@mail.mil
Date: 14 October 2015
(1 October 2015)