Attachment_VI-JA-N6609716RC05027-N6809516RC05052-Base-CPRR_Oak_HarborBremerton_Redacted.pdf

LOG# 16-10208

TDP 16-222-16/PR N6609716RC05027/N6809516RC05052Page 1 of 4 1 Nov 12

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity.

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD on behalf of Naval

Hospital Bremerton and Naval Hospital Oak Harbor to meet their requirements.

2. Nature and/or description of the action.

The proposed action is for a contract which includes equipment, maintenance support, and consumable supplies for one (1) Analyzer, Laboratory, Hematology, Blood Grouping, Automated [16-817] for Naval Hospital Bremerton and one (1) Analyzer, Laboratory, Hematology, Blood Grouping, Automated [16-817] for Naval Hospital Oak Harbor.

The Government intends on awarding a Firm Fixed Price (FFP) contract. The proposed source is Ortho Clinical

Diagnostics, 1001 US Highway 202, Raritan, NJ 08869.

3. Description of the supplies/services required.

The requirement is for a contract which includes equipment, maintenance support, and consumable supplies for one

(1) Analyzer, Laboratory, Hematology, Blood Grouping, Automated [16-817] for Naval Hospital Bremerton and one

(1) Analyzer, Laboratory, Hematology, Blood Grouping, Automated [16-817] for Naval Hospital Oak Harbor. The system shall be capable of performing at least the tests listed below for a minimum annual workload of 9,200 specimens for Naval Hospital Bremerton and 5,000 specimens for Naval Hospital Oak Harbor.

TEST

ABO/Rh Grouping

ABO/Rh Confirmation

Antibody Screens

Antibody Identification

Selected Cell Panel

Rh Phenotype (C,c,E,c)

Donor Confirmation

Crossmatch (AHG)

Antigen Typing

Serial Dilutions for Titration Studies

DAT (Polyspecific)

DAT (IGG)

Cord Blood Testing

The system shall be capable of performing blood bank testing using gel technology. The system shall be fully automated and provide functions including liquid pipetting, serial dilution, reagent handling, incubation, reaction grading, reaction interpretation, and data management. The system shall provide critical process monitoring and allow for management of system maintenance and quality control. The system shall be capable of using the following sample types: centrifuged whole blood, plasma, serum, and packed red blood cells. The system shall be capable of barcode tracking. The system shall be capable of identifying reagents and specimens. The system shall be capable of continuous, random, STAT access, and batch specimen processing modes. The system shall accommodate batch processing interruptions to insert STAT specimens into the workflow. The system shall be capable of holding test tubes of various sizes. The system shall include a manual backup workstation. The system shall be benchtop with maximum physical dimensions of 36” tall, 42” wide, 32” deep, and shall weigh at most 450 lbs. The electrical requirements are 100VAC, 60 Hz. System installation, validation, correlation, onsite and offsite training, and preventive maintenance coverage shall be included. Yearly off-site training for key operator staff shall be provided. On-site assistance during validation shall be provided. Corrective system maintenance coverage shall include response times as specified in the Statement of Work. Support shall be provided for a period of performance for one year with option years available for four (4) consecutive year terms after the base year term.

The units shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United

TDP 16-222-16/PR N6609716RC05027/N6809516RC05052Page 2 of 4 1 Nov 12

States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. The system shall be installed in compliance with OSHA requirements.

Contractor 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.

Upon delivery, the contractor shall be responsible for uncrating the unit/system, transporting it through the facility to the location of intended use for installation, and removing of all trash created in this process. If interim storage is required, the vendor shall make arrangements for the storage.

4. Identification of the statutory exceptions permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 USC 2304(c)(1) and FAR 13.501(a), Sole Source Acquisitions. This acquisition is being conducted under simplified acquisition procedures FAR 13.501 under the authority of the test program for commercial items (section 4202 of the Clinger-

Cohen Act of 1996).

5. Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Ortho Clinical Diagnostics is the only vendor that can provide a contract which includes equipment, maintenance support, and consumable supplies for a system capable of performing blood bank testing using gel technology and automated serial dilutions, thus being fully automated. Gel technology has been shown to provide a high level of antibody sensitivity and specificity with a high level of repeatability, even when operated by relatively less experienced technicians. Given the combination of testing requirements and staffing expertise at Naval Hospital

Bremerton and Naval Hospital Oak Harbor, gel technology is the only blood bank analyzer technology which meets the minimum requirements. The capability of performing automated serial dilutions is required for workflow, because otherwise time intensive dilutions by laboratory technicians would be required. Automated serial dilution allows the technicians to perform other, potentially time sensitive tasks. Ortho Clinical Diagnostics is the only vendor which offers fully automated systems which use gel technology. No other vendor can provide a fully automated system which uses gel technology.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to the

NECO and/or FedBizOpps in accordance with FAR 5.202.

7. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. Description of the market survey conducted and the results, or statement of the reasons a market survey was not conducted.

Market research was conducted in April 2016. It included a search of the Internet using Google, Bing, GSA

Advantage, and the ECRI Sourcebook. Manufacturers who can provide blood bank analyzers include Ortho Clinical

Diagnostics, Immucor, Bio-Rad, Beckman Coulter, and Grifols USA. The analyzers available from Immucor, Bio-

TDP 16-222-16/PR N6609716RC05027/N6809516RC05052Page 3 of 4 1 Nov 12

Rad, and Beckman Coulter are not capable of gel technology and thus do not meet the minimum requirements.

There are two analyzers available from Grifols USA which do use gel technology. The smaller of the two is not capable of automated serial dilution and thus does not meet the minimum requirements. The larger of the two is not a bench top instrument and does not conform to size requirements, thus does not meet the minimum requirements.

Ortho Clinical Diagnostics is the only vendor which offers benchtop systems which use gel technology and feature automated serial dilution.

9. Other facts supporting the use of other than full and open competition.

N/A

10. Listing of Sources, if any, which expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. This requirement will be posted on FedBizOpps in accordance with FAR 5.202. Any sources expressing interest in response to the synopsis will receive consideration.

11. Statement of actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203.

TDP 16-222-16/PR N6609716RC05027/N6809516RC05052Page 4 of 4 1 Nov 12