Notice of Intent to Sole Source Ortho-Clinical Diagnostics Reagents and Consumables for Naval Hospital Okinawa

Notice of Intent to Sole Source

HT941023N0074

THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE SUPPLY CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. The Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division (WMCD), San Diego, intends to negotiate and award a firm fixed price contract for Ortho-Clinical Diagnostics reagents and supplies in accordance with Federal Acquisition Regulation (FAR) 13.501(a) Sole Source acquisitions and FAR 13.106-1(b)(1)(i), only one source being available to meet the Government’s needs, to:

Ortho-Clinical Diagnostics, Inc.

1001 Us Highway 202

Raritan, NJ 08869-1424

The North American Industry Classification System (NAICS) code for this requirement is 325413 - In Vitro Diagnostic Substance Manufacturing; the business size standard is 1,250 Employees. The Product Service Code (PSC) is 6550 - In Vitro Diagnostic Substances, Reagents, Test Kits and Sets.

The objective of this sole source award is to procure MTS Ortho reagents and consumables for U. S. Naval Hospital Okinawa Pacific Command Armed Services Blood Bank Center (USNHO PACOM ASBBC).  USNHO PACOM ASBBC requires various types of MTS Ortho reagents and consumables. These MTS Ortho reagents are used as a part of a large continuous blood testing system that all ASBBC are mandated to perform for each and every donor blood collected. The reagents are to be dropshipped directly by the contractor to USNHO. Delivery schedule will be on a monthly basis starting on 21 November 2023 until 20 September 2024 for base year and will include four (4) option years.

Supplies Required for Base Year:

Delivery Schedule: 23 November 2023 to 20 September 2024

 

Annual

Item#

Description

CAT#

QTY(PG)

 

1

A/B/D Mono & Reverse Group Card (5x20)

MTS080515

67

 

2

Buffered Gel Card (5x20)

MTS085014

50

 

3

A/B/D Mono Group Card (5x20)

MTS081115

36

 

4

Anti-IgG Card (5x20)

MTS04024

11

 

5

0.8% Affirmagen (2x10ml)

719201

110

 

6

Alba Q-check simulated whole blood control

Z498

110

 

7

0.8% Pooled screen (2x10ml)

6902314

44

 

8

Ortho 7% BSA

6844285

44

 

Supplies required For Option Year 1-4:

Delivery Schedule:

Option Year 1: 24 October 2024 to 23 September 2025

Option Year 2:   24 October 2025 to 21 September 2026

Option Year 3:   22 October 2026 to 21 September 2027

Option Year 4:   22 October 2027 to 21 September 2028

 

Annual

Item#

Description

CAT#

QTY(PG)

 

1

A/B/D Mono & Reverse Group Card (5x20)

MTS080515

70

 

2

Buffered Gel Card (5x20)

MTS085014

50

 

3

A/B/D Mono Group Card (5x20)

MTS081115

36

 

4

Anti-IgG Card (5x20)

MTS04024

12

 

5

0.8% Affirmagen (2x10ml)

719201

120

 

6

Alba Q-check simulated whole blood control

Z498

120

 

7

0.8% Pooled screen (2x10ml)

6902314

48

 

8

Ortho 7% BSA

6844285

48

 

Ortho Clinical Diagnostics, Inc. is the Original Equipment Manufacturer (OEM) of Ortho Vision Immunohematology Analyzer and sole proprietor of the requested reagents and consumables. Ortho Clinical Diagnostics does not guarantee test accuracy with the use of any unauthorized source of testing reagents and consumables. This may cause malfunction or damage to the analyzer system. Ortho Clinical Diagnostics is “the only” manufacturer of the requested reagents that are compatible with the Ortho Clinical Diagnostics manufactured Ortho Vision Immunohematology analyzer.

The Ortho Vision system is the only FDA-cleared analyzer to provide Andi-A/Anti-B titers, which is used to produce low-titer type O whole blood and/or determine eligibility for emergency blood collection teams. If USNHO PACOM ASBBC is unable to test samples caused by any failure or malfunction of this machine due to non-OEM reagent use, USNHO PACOM ASBBC cannot supply blood products to support transfusion services. USNHO PACOM ASBBC is the only source of blood products supporting the Pacific Area of Responsibility (AOR), supporting all U.S DoD agencies and organizations.

The work shall be performed at:

U. S. Naval Hospital Okinawa

Pacific Command Armed Services Blood Bank Center

Camp Foster BLDG 968

Tarawa Road

Ginowan Shi, Isa

Okinawa Japan. 901-2202

Based on market research, Ortho-Clinical Diagnostics, Inc. is the only source that can meet the Government’s minimum requirements to dropship reagents and consumables to USNHO.

This notice of intent is not a request for competitive proposals, and no solicitation document exists for this requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to provide the required supplies to at USNHO. Capability statements shall not exceed six (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source purchase order.

If a vendor challenges the basis of this requirement, please email capability statements as a Microsoft Word or Adobe PDF attachment to April L. Burbage at april.l.burbage.civ@health.mil. The closing date for challenges is no later than 10:00am Pacific Time, 29 August 2023.