JandA_OrthoVITROS XT 7600_final_Redacted.pdf

GENERAL SERVICES ADMINISTRATION

JUSTIFICATION AND APPROVAL FOR SOLE SOURCE ACQUISITION (J&A)

FAR 13.106-1(b)(2)

1. IDENTIFICATION OF THE AGENCY AND CONTRACTING ACTIVITY

Contracting Activity: General Services Administration (GSA)

Federal Acquisition Service (FAS) Southwest Supply Acquisition Center, Large SOP 819 Taylor St., Fort Worth, TX 76102

Requiring Activity: Naval Medical Logistics Command (NAVMEDLOGCOM) Fort Detrick, MD

Description of Requirement: Ortho Clinical Diagnostics Vitros XT 7600 Integrated System

Brand Name: Ortho Clinical Diagnostics, Inc.

GSA’s Acquisition PIID # Vendor: Ortho Clinical Diagnostics, Inc.

Procurement Vehicle: Open Market Purchase Order Delivery Terms: 90 days ARO or sooner Estimated Task Order Value:

2. DESCRIPTION OF THE ACTION BEING APPROVED

This J&A serves to support the sole source acquisition and establishment of a purchase order consisting of the Ortho-Clinical Diagnostics, Inc. Vitros XT 7600 integrated system onboard the USNS COMFORT (T-AH 20). This justification is conducted under the authority of FAR 13.106-1(b)(2), Soliciting from a single source, and FAR Part 12, Acquisition of Commercial Items.

Ortho-Clinical Diagnostics is the original equipment manufacturer (OEM) and sole distributor of the required product line. As this is a sole-source award, this requirement will not be set-aside for small business.

MIPR number has been submitted providing funding for the purchase order.

3. DESCRIPTION OF SUPPLIES/SERVICES REQUIRED TO MEET THE AGENCY’S NEEDS

The USNS COMFORT (T-AH 20) has a need for two (2) Ortho Clinical Vitros XT 7600 Integrated Systems onboard the USNS COMFORT in the Clinical Laboratory Department, authorized under Assemblage ID: 6232. The COMFORT medical staff require the Ortho Chemistry and Immunoassay tests onboard to provide critical treatment decisions during missions. The Ortho Vitros Chemistry, Immunoassay, and Integrated systems technology is used in medical laboratory for high capacity; 150 reagent position, 100 assays at a time, less maintenance, minimal calibration, reportable result efficiency, verify process results, and sample centered processing.

This acquisition will be a replacement of the current older Vitros 4600 Chemistry and ECi/ECiQ Analyzers currently being used on board USNS COMFORT (T-AH 20). The replacement consists of replacing the existing outdated Vitros 4600 Chemistry and ECi/ECiQ Analyzers models with the new

Vitros XT 7600 Integrated System Analyzer models and will utilize the same clinical laboratory Reagents as the obsolete equipment, which are already onboard the USNS COMFORT Navy hospital ship.

The item descriptions and estimated quantities are as follows:

Item Product Number Product Description U/I QTY 1 Vitros XT 7600 Integrated System EA 2 2 Included with Equipment

Hand Held Bar Code Scanner (optional)

EA 2

3 Barcode Scanner Holster EA 2 4 UPS (Powerware) – (9135/60kVA) EA 2 5 Seismic Anchor Kit EA 2 6 N/A Operating Manual EA 4 7 VITROS XT7600 Warranty (M-F 8-5 PM) MO 12 8 VITROS XT7600 Warranty (M-F 8-5 PM) MO 12 9 Vitros 4600 System Analyzers EA 2

10 Vitros ECi/ECiQ System Analyzers EA 2

Freight: FOB Destination

The NAVMEDLOGCOM will use Operation and Maintenance (O&M) Fiscal Year (FY) 2022 funds in the amount of to procure two (2) Vitros XT 7600 Integrated System and components, items 2-10. The required delivery schedule is 90 days ARO.

4. IDENTIFICATION OF STATUATORY AUTHORITY

This acquisition is conducted under the authority of FAR 13.106-(b)(2), Soliciting from a single source, as these specific product items are only available from one (1) source. IAW FAR Part 13.5 – Simplified Procedures for Certain Commercial Items – the Vitros XT 7600 integrated system meets the definition of Commercial Item in FAR Part 2.101 as they are, “…of a type customarily used by the general public or by non-governmental entities for purposes other than governmental purposes”. The Vitros XT 7600 are used in non-governmental hospitals and laboratories worldwide.

For purchases exceeding the simplified acquisition threshold, the requirements at 13.501(a) apply to sole source acquisitions of commercial items conducted pursuant to FAR subpart 13.5. IAW 13.501(a), the need for this sole source requirement is hereby justified in writing and will be approved at the specified levels in accordance with FAR 13.501(a)(2)(i) as this requirement exceeds the simplified acquisition, but not exceeding $750,000. The Contracting Officer completed this J&A for a sole source acquisition by utilizing the format listed in FAR 6.303-2 as required by FAR 13.501(a)(1)(ii) and modified to reflect that the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C.1901 or the authority of 41 U.S.C.1903.

This J&A will be made publicly available via the SAM.gov website within 14 days of award in accordance with FAR 13.501(a)(1)(iii)

5. DEMONSTRATION OF THE PROPOSED CONTRACTOR’S UNIQUE

QUALIFICATIONS

The circumstances that justify the restriction to the Ortho Clinical Diagnostics Vitros XT 7600 Integrated System is that the 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 2360 lbs. (1070.5 kg).

Moreover, Ortho-Clinical Diagnostics is the sole manufacturer and distributor of the equipment outlined in Section 3 of this document. The USNS COMFORT currently has an Ortho Clinical Diagnostics service maintenance contract GSA: 47QSWC21P0015-47QSWC21Q0258 and 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 maintenance services to this equipment. Ortho-Clinical is the only source capable of providing OEM trained technicians and parts and therefore is the only source capable of meeting the requirements of the Government.

Also, from a cost perspective, it is not advantageous to the Government to procure a new medical grade equipment from another source. The Vitros XT 7600 Integrated System is approved and listed in the Authorized Parts List (APL). The APL is used to analyze, procure, operate, maintain, and sustain equipment for operations at sea and in expeditionary ashore environments. The Integrated Logistics Support (ILS) documentation was developed to support the Ortho-Clinical Vitros XT 7600 Integrated System Analyzers which also includes Preventative Maintenance System (PMS) procedures, Navy Technical Manual number assignment to the vendor to provide Commercial Off the Shelf (COTS) operator and service manuals. APL development costs the Government between $2K and $6K per APL depending on complexity of equipment. PMS development costs the Government between $4K and $8K depending on complexity of equipment. The assignment of Navy Technical Manual numbers incurs Government costs of approximately $1K and $5K per manual depending on the size of manuals. These ILS products are a requirement for onboard equipment in accordance with OPNAV INST 4790.4D (Ship’s Maintenance and Material Management (3M) System Policy).

Purchases of any other manufacturer’s equipment would incur additional and unnecessary time and expenses in developing new Integrated Logistics Support (ILS) documentation. Additionally, this would require retraining of staff, new Standard Operating Procedures, and competency. This would cause serious delays in patient care. Maintaining standardization and continuity will maximize the USNS COMFORT ability to provide critical and timely healthcare service to military personnel throughout the area of responsibility. Conclusively, deviating from the approved manufacturer/source can result in not meeting the form, fit and function of the approved medical grade equipment for shipboard application.

6. DESCRIPTION OF EFFORTS TO ENSURE THAT OFFERS ARE SOLICITED FROM AS

MANY POTENTIAL SOURCES AS PRACTICABLE, INCLUDING IF A NOTICE WILL BE

PUBLICIZED AS REQUIRED BY SUBPART 5.2

The market research conducted by the Contracting Officer and information submitted by the customer for review indicates that only one (1) source is available. It was determined that the required supplies are only available from Ortho-Clinical Diagnostics. Ortho-Clinical Diagnostics has the sole legal rights to its proprietary designs, patents, system architecture, specialized tools, and analytical equipment.

In accordance with FAR subpart 5.203(a)(1), a notice of intent to sole source has been posted to beta.SAM.gov for a period of 3 days prior to issuance of the solicitation. Also, IAW FAR Part 5, GSA Acquisition Letter V-09-02 and FAR subpart 13.501(a)(1)(iii), this Justification and Approval (J&A) will be posted to the beta.SAM.gov website within 14 days after award.

7. DETERMINATION THAT THE ANTICIPATED AWARD WILL BE FAIR AND

REASONABLE

Because this requirement is being sole sourced, the Government is utilizing two methods by which to determine pricing submitted by Ortho-Clinical Diagnostics to be fair and reasonable. The Government intends to use a comparison to an independent Government estimate IAW FAR Part 13.106-3(a)(2)(vi) and by market research IAW FAR Part 13.106-3(a)(2)(i).

8. DESCRIPTION OF THE MARKET RESEARCH CONDUCTED

Market research was conducted by NAVMEDLOGCOM Equipment Management Logistics technical experts in March - April 2022 timeframe. This research consisted of reviews of similar previous procurements and a market survey through search engines of open market contractors and Federal Supply Schedule contractors. Search engines utilized include Google, Bing, GSA Advantage and Emergency Care Research Institute (ECRI) sourcebook catalog using the following search word: “Ortho-Clinical authorized equipment and servicers”. ECRI only synopsizes original equipment end items and does not include preventative maintenance in its reporting. Ortho-Clinical Diagnostics is the Original Equipment Manufacturer (OEM) and sole service provider of the Vitros XT 7600 Integrated System. There are vendors advertising Ortho-Clinical equipment, but they are not authorized to provide OEM parts.

9. OTHER FACTS SUPPORTING THE JUSTIFICATION

The circumstances that justify the restriction to the Ortho Clinical Diagnostics Vitros XT 7600 Integrated System is that the 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 2360 lbs. (1070.5 kg).

10. LIST OF SOURCES THAT EXPRESSED AN INTEREST IN THE ACQUISITION

None

11. STATEMENTS OF ACTION TO OVERCOME BARRIERS TO COMPETITION

BEFORE ANY SUBSEQUENT ACQUISITION

Prior to any subsequent procurement the market will be reviewed to assess whether any other qualified sources are available and are able to meet the Government’s requirements. However, for the reasons set forth in Section 5 of this document the U.S. Naval Forces Fleet Command currently has no plans to replace the Vitros XT 7600 system. If another potential source emerges, U.S. Naval Forces Fleet Command will assess whether competition for future requirements is feasible.

The Government will continue to review products and solutions in the commercial marketplace that are provided by other medical and surgical instruments in the event their needs change.

TECHNICAL/REQUIREMENTS CERTIFICATION

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

01AUG�2022

Date

10. CONTRACTING OFFICER CERTIFICATION AND APPROVAL

The ordering activity Contracting Officer has determined that the actions taken under this acquisition meet the conditions described in FAR 13.501(a)(2)(i) I certify that this justification is accurate and complete to the best of my knowledge and belief.

Date