PGI_213.5_JA PORTAL_Redacted.pdf

9/11/23, 4:31 PM JA -

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FOR OFFICIAL USE ONLY - Source Selection Information – See FAR 2.101 and 3.104

Justification and Approval (J&A) for Federal Acquisition Regulation (FAR) Subpart 13.5

Other than Full and Open Competition Sole Source Acquisition

Title: Lease of two (2) Vitros XT 7600 Chemistry Analyzers & Cost Per Reportable Results (CPRR) J&A Number: JA-23-0282 Created By: Nerida, Adrian M CIV DHA DHA CONTRACTING ACT (USA) Additional POCs:

1. Identification of the agency and contracting activity:

San Diego Contracting Division

This justification is executed by the Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division, San Diego, CA, on behalf of the Navy to meet the requirements of Naval Hospital Twenty-nine Palms (NHTP).

2. Nature and/or Description of Action being Approved:

new contract

NHTP, has a request for the procurement of two (2) Ortho Clinical Vitros XT 7600 Integrated Systems for the Laboratory Department.

3. Description of Supplies/ Services:

The Laboratory Department at Naval Hospital Twenty-nine Palms (NHTP) requires a lease of two (2) Chemistry Analyzers (Vitros XT 7600) and Cost Per Reportable Results (CPRR). Analytical chemistry is an integral and necessary part of the core laboratory testing. Chemistry tests such as Comprehensive Metabolic Panel and Thyroid Stimulating Hormone are important in helping diagnose and treat patients in both outpatient and emergency situations. Chemistry analysis conducted at NHTP ensures proper diagnosis and maintain combat readiness in support of command missions. NHTP currently process approximately 3000 samples per month utilizing two analyzers.

TOTAL Contract Value

POP: From 10/1/2023 to 9/30/2028

Estimated Value

BASE

POP: From 10/1/2023 to 9/30/2024

Estimated Value

Type of Contract (Primary):

FAR 16.202 Firm-Fixed-Price

Options: Yes

Number of Options: 4

POP (All options): From 10/1/2024 to 9/30/2028

Estimated Value (all options):

Funding Type: Extension of Services: No

DHA HEALTH.MIL TRICARE DHHQ

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Operations & Maintenance (O&M) Clause:

Estimated Value:

Number of Months:

NHTP requires two analyzers meeting the following requirements:

Must have a Laboratory Information System (LIS) with Bidirectional interface for ASTM and HL7 protocols with Broadcast download and Host Query.

No special requirements for off-board plumbing.

Read/ Write SSD drive for data input and archiving and USB flash (memory stick) capabilities with ability to archive and retrieve through CD-ROM or USB flash drive.\Must accommodate 0.5mL.

2.0mL, 5Ml, 7ml and 10ml collection tubes.

Must Auto discriminate by simultaneously recognizing all standard symbols include Code 128, IBST 128, Code 39, Codabar and Interleaved 2 and 5.

Must be able to run serum, plasma, urine, CSF, whole blood, and Amniotic fluid.

Must have color-coded graphical user interface with touchscreen monitor and numeric keypad.

Must have clot, bubble, low and high viscosity, thin layer fluid and short sample detection.

Must have continuous load and unload capabilities with ability to hold 80 samples and 10 STAT samples at all times.

Must require no manual primes, purges, washes, tubing maintenance and no daily calibrations or calibration checks.

Must support QNX or RMX operating system. Windows 7 will not be used.

Critical values feature:

Feature enables onscreen and printed notification of critical.

Chemistry results to enable easy identification and accelerated reporting of critical values. User-defined critical values and customized notification text add flexibility needed to support the differences in notification policies from one facility to another.

Must have capacity to process a minimum of 100,000 samples per year.

Local maintenance and repair support within 12 hours of notification, including weekends and holidays.

4. Statutory Authority Cited permitting other than full and open competition:

41 U.S.C. 1901 Simplified Acquisition Procedures

The statutory authority exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c) (l), as implemented by FAR Subpart 6.302-1, Only One Responsible Source and No Other Supplies or Services will Satisfy Agency Requirements (including brand name). The procedures in FAR Subpart 13.501 and 41 U.S.C. 1901, Simplified Acquisition Procedures were used.

5. Rationale Justifying Use of the Statutory Authority Cited:

Ortho-Clinical is the only chemistry analyzer and reagent manufacturer capable of meeting the government’s requirements. Ortho Clinical Diagnostics Vitros XT 7600 Integrated System does not require water, thereby, reducing costs and waste disposal. This greatly reduces the risk of cross-contamination when disposing of the waste material. The Vitros XT 7600 Integrated System also has a 96.5% first pass yield, delivering results without user intervention. It also has up to 25% faster turnaround time and low sample volume per test (2-80 μl). The Vitros XT 7600 Integrated System can deliver up to 40% higher throughput for greater lab efficiency and has a comprehensive testing menu including SARS-CoV-2 IgG and Total antibody, HIV combo, B·R·A·H·M·S procalcitonin, immunosuppressive drugs, and drugs of abuse. The Vitros XT 7600 Integrated System has dimensional width of 110 inches (2.79 m), a depth of 34.9 inches (0.89 m), a height of 68 inches (1.73 m), and weight of 2360lbs. (1070.5 kg).

The Vitros 7600 platform offers a wide range of general and esoteric chemistry and immunology testing that will afford NHTP Laboratory the ability to perform laboratory testing for its patients.

Some of the testing the Vitros 7600 analyzers can perform are cardiac, diabetes, liver function, anemia, and fertility testing. While some lab tests are sent to reference laboratories, NHTP must have the ability to perform chemistry and immunology testing in-house is critical to carry out the lab mission.

The Ortho Clinical Diagnostics chemical analyzer and reagents manufacturer can also provide the ability to standardize reagents across all platforms, which includes the Vitros XT 7600 has new, innovative technology with the capability to significantly increase the throughput proposed in this solution. The VITROS systems are also the only systems that do not require a water system, nor the associated drains and maintenance associated with such, allowing Naval Hospital Twentynine Palms to continue efforts for conserving water and protecting the environment from additional waste that is returned via the wastewater. The VITROS system offers the ease and accessibility of continued use in the case of a natural disaster due to no water or drainage being required. This capability is very important as the quality of the water source available at Twentynine Palms creates variance in the quality test results.

VITROS systems also have the lowest required maintenance, calibration and quality control frequency leading to the highest instrument availability in the industry.

The two Vitros chemistry analyzers are leased to Naval Hospital Twentynine Palms from Ortho Clinical Diagnostics and have been present in-house for approximately two years. Ortho Clinical Diagnostics is the only source that can provide preventative maintenance and corrective services for this equipment. No other vendor is authorized to provide preventative and corrective

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Ortho Clinical Diagnostics (hereinafter “Ortho") has certified it is the sole source manufacturer and supplier of the VITROS ® XT 7600 Analyzer, including the reagents calibrators, controls & supplies. Systems and reagents are FDA approved to work in unison to provide patient results.

6. Efforts to Obtain Competition:

Market research was conducted by technical experts in July 2023. The research consisted of reviews of similar previous procurements, using search engines to review open market contractors.

Search engines include google, GSA advantage and conducting a Dynamic Small business search. Eight manufacturer’s products were reviewed to determine whether products offered to the general public would meet the Government’s minimum requirement. A notice of intent to Sole Source was issued 31 July 2023 and closed 14 August 2023 allowing potential vendors to provide capability statements meeting Government’s minimum requirements. No additional parties submitted statements for the Government’s consideration. While there are multiple analyzer manufacturers on the market, only one Ortho-Clinical Diagnostics has a local entity of providing proprietary Dry Slide technology offering 6-month calibration stability on most clinical chemistry tests with a high level of precision, accuracy, and reproducibility. The Vitros system requires an environmentally controlled reagent supply, careful reagent lot management, manufacturer directed preventive maintenance, and ongoing laboratory staff training. Therefore, after thorough market research and assistance from the manufacturer, it was determined that the best approach to ensuring the supplies were of the highest quality standards, is to award to Ortho-Clinical Diagnostics.

7. Determination that Anticipated Cost to the Government will be Fair and Reasonable:

In accordance with the basis for award procedures at FAR 13.106-3, the Contracting Officer will utilize a comparison of the proposed price with prices found reasonable on previous purchases and a comparison of the price to the independent Government estimate provided by the requiring activity to determine the vendor's quoted price fair and reasonable.

8. Market Research:

Market Research Conducted? Yes When was it conducted? 3/26/2023 to 7/21/2023 Description:

A variety of market research methods were used to include reviews of similar previous procurements, using search engines to review open market contractors, and conducting dynamic business search. Further research consisted of reviews of similar previous procurements and using search engines to review open market contractors. Search engines and websites utilized include Google, FPDS-NG, Ability One, Unicor, DSBS, GSA Advantage, GSA Xcess, ECAT, Medical Master Catalog, Defense Logistics Agency, and Department of Veterans Affairs. A notice of intent to Sole Source was issued 31 July 2023 and closed 14 August 2023 allowing potential vendors to provide capability statements meeting Government's minimum requirements. No additional parties submitted statements for the Government's consideration. While there are multiple analyzer manufacturers on the market, only one Ortho-Clinical Diagnostics has a local entity of providing proprietary Dry Slide technology offering 6-month calibration stability on most clinical chemistry tests with a high level of precision, accuracy, and reproducibility.

9. Other Facts:

None.

10. Interested Sources:

Ortho-Clinical is the only source identified that can meet the Government's minimum requirements. Additional market research and the posting of a notice of intent to a sole source did not identify and additional interested parties.

11. Actions to overcome barriers:

Naval Hospital Twentynine Palms and the DHA Western Markets Contracting Division will continue to survey and engage the market of Vitros XT 7600 Analyzer and consider competing future requirements if there are other vendors capable of meeting the requirements and interested in providing the required services. If another potential source emerges, DHA will assess whether competition for future requirements is feasible.

Coordination & Approval

12. Technical/Functional Representative:

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

Name: Title:

Approved: - 16 Aug 2023, 07:47:57

Comments:

13. Requirements Certification:

I certify that the information provided in this justification is accurate and complete to the best of my knowledge and belief

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CONTACT US: Web & Mobile Technology PMO | No FEAR Act | Accessibility/Section 508

CONTACT GSC: 800-600-9332 or Visit the Global Service Center site here: https://gsc.health.mil/

Name: Maritim, Stanley K. Title:

J-Directorate Office:

Approved: - 16 Aug 2023, 07:48:07

Comments:

14. Fair and Reasonable Cost Determination:

This procurement will utilize simplified acquisition procedures under FAR Subpart 13.5. The Vitros XT 7600 Analyzer is commercially available and have been previously procured, which establishes current and historical information that will be used as a basis for fair and reasonableness. Certified cost or pricing data will not be required in accordance with FAR 15.403-1(b)(3).

I have determined that the anticipated cost to the Government for this contract action is fair and reasonable.

Name: Title: Contracting Officer, San Diego Contracting Division

Approved: - 15 Aug 2023, 15:11:35

Comments:

15. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

Name: Title: Office of General Counsel

Approved: - 16 Aug 2023, 12:41:23

Comments:

16. Contracting Officer:

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

Name: Title: Contracting Officer, San Diego Contracting Division

Approved: - 17 Aug 2023, 10:41:33

Comments:

17. Competition Advocate: Based on the foregoing justification, I hereby approve the procurement of Lease of two (2) Vitros XT 7600 Chemistry Analyzers & Cost Per Reportable Results (CPRR) on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 Simplified Acquisition Procedures, subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.

Name: Title: Competition Advocate (DAD-P&C)

Approved: - 17 Aug 2023, 18:02:58

Comments:

Attachments PGI_213.5_JA.pdf Delete

Version: 127.0 Created at 8/15/2023 1:36 PM by Nerida, Adrian M CIV DHA DHA CONTRACTING ACT (USA) Last modified at 8/17/2023 6:03 PM by Workflow on behalf of

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