E_JA_TDP_17-278_Chem_Analyzer_(Guam)2_Redacted.pdf

Log #18-10004

Form 02.4G.AB 18 Apr 2016

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a “Justification for other than full and open competition.”

This justification is executed by the Naval Medical Logistics Command, Fort Detrick, MD, on behalf of the Navy, to meet the requirements of U.S. Naval Hospital (USNH) Guam.

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

The proposed action is for a contract for two (2) analyzers, laboratory, clinical chemistry/immunoassay, reagents, quality control, maintenance, and consumables for U.S. Naval Hospital Guam. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Ortho-Clinical Diagnostics, Inc. of 1001 US Highway 202, Raritan NJ, 08869-1424.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

The Navy has a requirement for a 5-year Indefinite Delivery, Indefinite Quantity, cost-per-test contract for a Chemistry/Immunoassay Analyzer that includes equipment, reagents, quality control, maintenance support, and consumable supplies for two (2) analyzers, laboratory, clinical chemistry/immunoassay [20- 821] for U.S. Naval Hospital (USNH) Guam. The systems shall be capable of performing a minimum throughput of 150 tests per hour. Sample and calibrator dilutions shall be performed automatically. The systems shall be capable of performing all of the required tests at the listed minimum annual test volume.

1. The system shall not require an external water source for operation.

2. The system shall be capable of adding new third party tests.

3. The system shall be capable of utilizing the following sample types without the need for pre-treatments: serum, plasma, urine, and cerebrospinal fluid (CSF).

4. The system shall be capable of pre-calibrating and storing at least 2 lots onboard the unit.

5. The system shall have sufficient onboard storage to accommodate daily workload as outlined above.

6. The system shall complete STAT (urgent) requests in, at most, 60 minutes.

7. The system shall be capable of auto-dilution.

8. The system shall be capable of utilizing sample tube bar codes for accurate sample identification.

9. The system shall be capable of interfacing with the Composite Health Care System (CHCS) laboratory information management system.

10. The system shall include programmable panels to accommodate in-house needs.

11. The system shall be capable of starting up without priming or washes.

12. The system shall be capable of external data storage in compliance with Navy/Department of

Defense (DoD) Information Assurance (IA) regulations.

13. The system shall include an uninterruptible power supply (UPS) that is compatible with all system components, is capable of conditioning the power to the system, and allows the system a minimum of 30 minutes run time in case of a power outage.

14. The power requirement is 220 VAC, 60 Hz, single phase.

The system, including claims made for the product, shall be compliant with Food and Drug Administration (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.

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.

4. An identification of the statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is FAR 13.106-1(b)(1) soliciting from a single source.

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

Ortho-Clinical Diagnostics, Inc. is the only vendor that is capable of providing a contract for clinical chemistry/immunoassay laboratory analyzers, reagents, quality control, maintenance, and consumables capable of meeting the needs of USNH Guam. Ortho-Clinical Diagnostics is the only source that is capable of providing an analyzer that does not require an external water source for operation. A requirement for an external water source would increase the required footprint and waste. The analyzer’s operational status would be dependent on the external water source, which cannot be guaranteed, due to the remote location of U.S. Naval Hospital Guam. Additionally, due to the location of the hospital, test outsourcing options are extremely limited and costly. Ortho-Clinical Diagnostics is the only vendor that can meet the minimum requirements of the Government.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart

5.2 and, if not, which exception under 5.202 applies.

Market research was performed, the results of which are in paragraph 8. This requirement was posted to FedBizOpps beginning 15 December 2017 and expired 02 January 2018 in accordance with FAR 5.202, with no response.

7. A 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. A description of the market research conducted (see Part 10) and the results, or a statement of the reason market survey was not conducted.

Market research was conducted in September 2017. It included a search of the Internet using Google, GSA Advantage, and the ECRI Sourcebook. Vendors who can potentially provide contracts for clinical chemistry/immunoassay laboratory analyzers include Abbot Laboratories, Beckman Coulter, Ortho- Clinical Diagnostics, Inc., Randox Laboratories, Roche Diagnostics, and Siemens Healthcare Diagnostics.

Abbott Laboratories, Beckman Coulter, Randox Laboratories, Roche Diagnostics and Siemens Healthcare Diagnostics are capable of providing clinical chemistry/immunoassay laboratory analyzers, but the analyzers offered by these vendors require an external water source for operation. Thus, they do not meet the minimum requirements of the Government. Ortho-Clinical Diagnostics is the only vendor that does not require an external water source to operate their clinical chemistry/immunoassay laboratory analyzers.

Therefore, Ortho-Clinical Diagnostics is the only vendor that meets the minimum requirements of the Government.

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

None.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. Any sources expressing interest in response to the synopsis will receive consideration.

11. A statement of the 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. For the reasons set forth in Paragraph 5, Naval Medical Logistics Command has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMLC) will assess whether competition for future requirements is feasible.

TECHNICAL AND REQUIREMENTS CERTIFICATION REQUIRED

BY NAVSUP 4200.83 series

I certify that the facts and representations under my cognizance which are included in this justification and approval and which form a basis for this justification are complete and accurate.

Technical Cognizance

Code 03/ NAVMEDLOGCOM FTD MD

Requirements Cognizance

Code 03/ NAVMEDLOGCOM FTD MD

CONTRACTING OFFICER CERTIFICATION

I certify that this justification is accurate and complete to the best of my knowledge.

Date Code 05 Contracting Officer

LEGAL SUFFICIENCY REVIEW AND CONCURRENCE

I have reviewed the facts set forth in the above Justification and Approval and found to be legally sufficient, based on these facts, to the best of my knowledge and belief.

Counsel Phone Date Code 00L

APPROVAL BLOCK COMPETITION ADVOCATE

($650,000 to $12.5M)

Phone Date Competition Advocate