LSJ Chemistry and Immunoassay Analyzers (Cost Per Reportable) CO signed REDACTED.pdf

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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 8.405-6

Limited Source Justification

Title: Chemistry and Immunoassay Analyzers (Cost Per Reportable)

J&A Number: JA-24-0255

Created By: Mattingly, Marcus

1, Identification of the agency and contracting activity:

San Antonio Contracting Division place an order

Additional POCs: Brinkmann, Robert

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Defense Health Agency (DHA), Defense Health Agency Contracting Activity (DHACA), Healthcare Contracting Division - South (HCD-S), 7800 IH-10 West, Ste 235, San Antonio, Texas 78230

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

new contract Individual

This Limited Sources Justification is to establish a new one (1) year, firm-fixed priced contract with Siemens Healthcare Diagnostics, Inc. (Cage: 1 K2V6) in support of the 96th Medical Group (96th MDG) clinical laboratory located at Eglin, Air Force Base. This action will be utilizing the vendor's Veteran Affairs Federal Supply Schedule V797D-30175.

3. Description of Supplies/ Services:

96th Medical Group (MDG) laboratory, Eglin AFB is requesting a new requirement to provide and deliver, on a Cost-per-reportable (CPR) or Cost-per-kit (CPT) basis, a fully integrated chemical and immunoassay platform, to include all reagents, consumables and supplies, capable of performing approximately 40,800 each fluid samples per month in order to support the 96th MDG laboratory operations.

The main objective within this requirement is for the contractor to provide and deliver two chemistry and immunoassay analyzers, reagents and consumables, on a CPR or CPT basis, that analyze bodily fluids and measure the presence or concentration of macromolecules or small molecules in a solution through the use of antibodies or the use of potentiometric and colorimetric methods. The vendor shall provide and maintain analyzers and/or middleware with a bidirectional, bar-coded interface to MHS GENESIS, along with a current Authority to Operate (ATO) for the life of the contract and separate internet connectivity for remote troubleshooting access to maintain instrumentation functionality.

The analyzers must have high throughput, capable of processing at least 1,800 tests per hour with integrated multisensor technology (IMT), and offer a comprehensive test menu including general chemistry, drugs of abuse/toxicology, immunosuppressant drugs, specific proteins, specimen validity testing, and therapeutic drug monitoring. The analyzers should also process >90% of blood tests on the master list using l�hium heparin tubes. The ability to process the majority of tests using a single type of tube significantly streamlines validation processes, reduces handling errors, and improves overall laboratory efficiency. This capability ensures consistent and reliable results, directly impacting patient care while reducing the number of specimen requirements for provider teams. Additionally, the analyzers must seamlessly integrate with existing Laboratory Information Systems (LIS) to ensure efficient data management and reduce manual data entry errors.

The system must feature real-time monitoring of patient moving averages and use liquid calibrators with over 90% of tests ready to use. Comprehensive customer support and training must be provided by the vendor to ensure the laboratory staff can efficiently operate the analyzers and troubleshoot any issues promptly. The integrated chemistry and immunoassay platform must fit entirely within a 22.5' by 16' space to avoid any laboratory renovation for space, plumbing, or electrical setups. The chemistry and immunoassay analyzers will perform an average of 490,000 tests annually. These tests are critical for the management, diagnosis, and treatment of various diseases and infections, as well as for the medical readiness of patients worldwide. Furthermore, the Government is requesting technical support and maintenance to be included in the requirement throughout the period of performance.

TOTAL Contract Value

POP: From 10/1/2024 to 9/30/2025

Estimated Value

Type of Contract (Primary):

FAR 16.202 Firm-Fixed-Price

Funding Type:

Operations & Maintenance (O&M)

BASE

POP: From 10/1/2024 to 9/30/2025

Estimated Value

QRtions: No

Number of Options:

POP (All options): From

Estimated Value (all options):

Extension of Services: No

Clause:

Estimated Value:

Number of Months:

to

4. This acquisition is conducted under the authority of the Multiple Award Schedule Program, 41 U.S.C. 152(3) and 40 U.S.C. 501, and Regulatory Authority (see FAR 8.405-6 Limited

Sources):

FAR 8.405-6(a)(1 )(i)(B) - Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.

FAR 8.405-6 requires an ordering activity to justify its actions when restricting consideration of schedule contractors to fewer than required in FAR 8.405-1 or 8.405-2, and it is concluded that IAW FAR 8.405-6(a)(1 )(i)(B), "Only one source is capable of providing the supplies/services required at the level of quality required because the supplies/services are unique and highly specialized."

5. Rationale Justifying Use of the Statutory Authority Cited:

i The 96th MDG requests the use of a limited source justification IAW FAR 8.405-6(a)(1 )(i)(B) to provide and deliver, on a Cost-per-reportable (CPR) or Cost-per-kit (CPT) basis, a fully integrated chemical and immunoassay platform, to include all reagents, consumables and supplies, with Siemens Healthcare Diagnostics, Inc., Atellica analyzers to perform approximately 40,800 tests per month.

The Government requires the chemical and immunoassay analyzer platform with the following critical characteristics:

(1) capability to process >90% of blood tests on master test List using lithium heparin tubes;

(2) current authorization to operate with the connectivity to the MHS GENESIS platform, ensuring seamless integration with the existing Electronic Medical Record (EMR) system;

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(3) liquid calibrators with >90% of tests ready to use and continuous reagent loading without interrupting patient sampling/testing;

(4) comprehensive test menu including general chemistry, drugs of abuse/toxicology, immunosuppressant drugs, specific proteins, specimen validity testing, and therapeutic drug monitoring;

(5) capability of processing at least 1,800 tests per hour with integrated multisensor technology (IMT), making them suitable for high-volume testing environments;

(6) provide advanced automation features to enhance lab efficiency by automating sample handling, reducing manual interventions, and ensuring precise and accurate data management;

(7) capability to perform onboard linearity to ensure accurate and consistent 24/7 online support and continuous technical support;

(8) integrated chemistry and immunoassay platform must fit entirely within a 22.5' by 16' space to avoid any laboratory renovation for space, plumbing, or electrical setups.

It is evident through market research that there are alternative chemical and immunoassay analyzers in the commercial marketplace oomparable to the Siemens Atellica analyzers, such as chemical and immunoassay equipment from Abbott Diagnostics, Beckman Coulter and Roche Diagnositics. The 96th Medical Group laboratory reviewed other comparable chemistry analyzers and products with similar attributes of integrated chemistry platforms and approximate size/sample test volumes. Results concluded that other comparable products reviewed from these various other manufacturers stated above could not perform the necessary testing required by the Government in the time frame needed to provide a quick sample-to-result turnaround for the volume of tests oonducted monthly (Abbott Diagnostics, Beckman Coulter and Roche Diagnositics), nor could the other analyzer equipment fit within the existing MTF laboratory without renovation to the facilities (Abbott Diagnostics, Beckman Coulter and Roche Diagnositics L

6. Determination by the ordering activity contracting officer that the order represents the best value consistent with FAR 8.404(d):

Price analysis techniques, outinlined in FAR 15.404-1(b), will be oonducted to ensure the Government receives a fair and reasonable price in accordance with FAR 8.404(d). Additionally, IAW FAR 8.405-3, discounts will be sought prior to the establishment of the delivery order.

7. Description of the market research conducted among schedule holders and the results or a statement of the reason market research was not conducted:

Market Research Conducted? Yes When was it conducted? 8/8/2024 Description:

to 8/13/2024

Market research was conducted utilizing Sam.gov, FPDS-NG.gov, GSA Advantage and other Government/commercial sources in order to locate alternative brands and/or sources to support the supplies required at the level and quality required by the Government Other manufacturers/brands for chemical and immunoassay analyzers and associated products were identified via market research; however, due to the aforementioned critical characteristics, deviation from the Siemens Atellica analyzers would be detrimental to the Government's need. The Government will issue a notice of award on the Government Point of Entry (POE), Contract Opportunities, within 14 days after award IAW FAR 8.405-6(a)(2) to enoourage small business participation and foster competition.

8. Other Facts:

Siemens Healthcare Diagnostics, Inc. is the original manufacturer and sole vendor for the Atellica analyzers, reagents and consumables; therefore, the technical specifications of the items are proprietary and are only available from the manufacturer. The associated technical specifications of the products cannot be made available to other sources in the commercial marketplace since the Government and/or other commercial entities do not own or have legal access to the intellectual property owned by Siemens Healthcare Diagnostics, Inc.

9. Actions to overcome barriers:

The MTF located at Eglin, AFB, Florida will continue to evaluate other products capabilities from other distributors through continuing market research. Additionally, if the Government's requirement changes in the future, the intent of the Government would be to issue a full and open competitive solicitation in order to provide the greatest amount of competition as practicable. Continued efforts in this regard will ensure that Government is receiving the best value at a fair and reasonable price by ensuring the Government utilizes the most efficient and economical means possible.

Coordination & Approval

12. Technlcal/Functlonal Representative:

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

Title: AF 4T Associate Career Field Manager

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

Title:

J-Directorate Office:

Clinical Lab & Pathology Flight Commander

Price analysis techniques, outinlined in FAR 15.404-1(b), will be oonducted to ensure the Government receives a fair and reasonable price in accordance with FAR 8.404(d). Additionally, IAW FAR 8.405-3, discounts will be sought prior to the establishment of the delivery order.

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

Tille: Contracting Officer, San Antonio Contracting Division

Trtle: Office of General Counsel ts evidence by my signature below, I have determined this document to be both accurate and oomplete to the best of my knowledge and belief.

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

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9/3/24, 11 :50 AM

Name: Mattingly, Marcus

Approved: Mattingly, Marcus - 3 Sept 2024, 11 :35:48

Comments:

Version: 291.0

Created at 8/16/2024 11 :25 AM by Mattingly, Marcus

Last modified at 9/3/2024 12:38 PM by Workflow on behalf of https://info.health.mil/sites/DOP/PAC/SitePages/JA/MyForms.aspx

JA-

Title: Contracting Officer, San Antonio Contracting Division

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