LSJ Microbiology_Redacted.pdf

Justification and Approval (J&A) for Federal Acquisition Regulation (FAR) Subpart 8.405-6

Limited Sources Justification

Title: Microbiology Analyzer Services

J&A Number:

POCs: Ms. Narumon Sriwong, LT Sasha Tittel, ENS Pliniojoel Flores

1. Identification of the agency and contracting activity:

The requiring activity is Naval Hospital (NH) Jacksonville, FL; the contracting activity is Defense Health Agency Contracting Activity (DHACA) Healthcare Contracting Division- Southeast (HCD-

SE).

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

New Contract The proposed action is a limited sources justification to award a new order under V797D-40095 to the contractor identified in paragraph 3 below under the authority of the Multiple-Award Schedule Program. The placement of a Firm-Fixed Price, Cost per test is anticipated. The FSS Schedule ID Number (SIN) is 66 III (Clinical Analyzers, Laboratories, Cost-Per-Test), Category 605-5A, Clinical Microbiology Analyzers.

3. Description of Supplies/Services:

One (1) Antimicrobial Susceptibility Analyzer, one (1) MALDI-TOF microbial and yeast identification system, one (1) Blood culture incubation system and one (1) molecular testing system that is a fully automated platform that can perform nucleic acid extraction in real-time polymerase chain reaction (PCR) in support of NH Jacksonville Installation, validation testing, maintenance, and training for the analyzers are required as are all consumables necessary for testing. The analyzers shall be capable of performing the tests listed below with anticipated workload indicated below:

Location Test Type Estimated volume/ year Estimate Tests per Month

NH

Jacksonville

AST & ID 1320 110

Blood Culture 585 49 Clostridium Difficile 81 7 KOH/ Wet Prep 1126 94 Group B 301 25 Stool 110 9 Respiratory 2395 200

The analyzers shall be capable of processing 100% of the microbiology assays with sufficient capacity and throughput to handle the testing volumes and meet the performance characteristics for accuracy and precision as defined by the Clinical Laboratory Improvement Act (CLIA), the Food and Drug Administration (FDA), and the College of American Pathologists (CAP).

Analyzers shall have the ability to detect and classify Carbapenemase-Producing Organisms (CPOs) in order to curb the spread of multidrug-resistant organisms and keep the warfighter’s readiness at the highest possible levels.

NH Jacksonville, FL is a training facility with minimal staffing. For this reason, testing automation is a requisite. Final results are required to be automatically populated without additional processes or interpretation. The same staff operates both Microbiology and Chemistry labs, as such, individual labs and analyzers are unable to be monitored at all times or under specific intervals. Results shall be available no later than 24 hours from testing and not require specific timelines for reading panels. The 24-hour is required to provide clinicians with actionable information as quickly as possible to make informed decisions about patient management, leading to better outcomes, reduced complications, and more efficient use of healthcare resources which maintains and enhances military readiness, lethality, and overall military excellence.

TOTAL Contract Value BASE PoP: 10/1/2025 – 9/30/2029 PoP: 10/1/2025 – 9/30/2026 Estimated Value: Estimated Value:

Type of Contract (Primary): Number of Options: 4 FAR 16.202 Firm-Fixed-Price PoP (All options): 10/1/2026 –

9/30/2029

Estimated Value (all options):

Funding Type: Extension of Services-yes, 52.217-8 Operations & Maintenance (O&M) 6 months-

This contract will have an initial base year ordering period with four (4) subsequent option years.

Delivery of consumables is required a minimum of 12 months. The contract start date is anticipated to be 1 October 2025. Additional details of the requirement can be found in Enclosure 1 (PWS). The estimated total price of the order is DHA Operations and Maintenance (O&M) Fiscal Year 2026 funds in the amount of will be used to procure the requirement for the base period. The proposed source is Becton Dickinson and Company.

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):

5. Rationale Justifying Use of the Statutory Authority Cited:

Extensive market research was conducted to identify analyzers that could fulfill the minimum needs of the Government for this requirement. Several analyzers are available on the commercial marketplace. Market research identified five companies that could potentially meet the needs of the Government:

Beckman Coulter, Inc., Becton, Dickinson and Company, Biomerieux, Inc., Cepheid, and Siemens Healthcare Diagnostics. All companies listed have GSA Schedules contracts which contain analyzers and consumables.

Becton, Dickinson and Company is the only vendor that meets the testing capabilities, testing timelines, automation, and has the ability to seamlessly integrate with the LIS software, hardware, middleware to mitigate any Military Health System (MHS) Genesis compatibility issues. Becton, Dickinson and Company is the only vendor that can provide microbiology analyzers that meet the minimum requirements of the Government. Thus, Becton, Dickinson and Company is the only vendor that meets the minimum requirements of the Government and is available on the Federal Supply Schedule.

6. Determination by the ordering activity contracting officer that the order represents the best value consistent with FAR 8.404(d): VA has determined that the prices of supplies and services on the schedule contracts are fair and reasonable. Ordering activates are also responsible for making separate determinations of fair and reasonable pricing for individual orders. By placing an order against a schedule contract using the procedures in 8.405., the ordering activity has concluded that the order represents the best value (as defined in FAR 2.101) and results in the lowest overall alternative (considering pricing, special features, administrative costs, etc.) to meet the Government’s needs.

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?

June 2024 - December 2024

Description:

Based on the market research conducted, the Government reviewed analyzers from numerous manufacturers. The Government found five manufacturers that had the possibility of fulfilling the patient population’s needs. Below is a description for each manufacturer’s analyzer(s) and how they align with the hospital’s requirements for microbiology testing.

Biomerieux Vitek is the current analyzer in use at Naval Hospital Jacksonville. Although maintaining the same manufacturer and analyzer would be efficient for maintaining the same capability for training, utilization, and equipment requirements (i.e. voltage, space requirement, testing requirements), as of June 14th, 2024, DoD laboratories are discouraged from purchasing with the Biomerieux (manufacturer). This was a directive issued by the Director of Center for Laboratory Medicine Services (CLMS). Cyberlog and DHA J6 will not support the vendor as they are not aligning with mandatory cybersecurity requirements. Additionally, it was recognized by CLMS that hospital systems nationwide have been attacked due to cyber security breaches, holding BioMerieux responsible for maintaining compliance with cybersecurity standards. Based on the directive regarding cybersecurity, Biomerieux is unable to meet the Government needs.

Cepheid Genexpert are products that deliver PCR testing with high precision. Unfortunately, the analyzer does not comprehensively test all organisms that the laboratory seeks to find through PCR testing. Genexpert cannot do comprehensive panel for testing for stool organisms like Shigella and Salmonella. Additionally, there is no antimicrobial susceptibility testing for the analyzer, which is a significant testing requirement for the hospital and its tenant clinics.

Given that Cepheid does not offer antimicrobial susceptibility testing, cannot do comprehensive panel for testing for Shigella and Salmonella, and doesn’t offer fully comprehensive respiratory and blood culture testing, Cepheid is unable to meet the Government’s needs.

Siemens Healthcare Diagnostics is listed on GSA as providing clinical microbiology analyzers on a cost per test basis. Siemens does offer PCR capabilities, but it lacks the features to perform multiple tests on a single platform. For example, Siemens only provides Group B Streptococcus PCR and respiratory panel testing. Additionally, Siemens does not manufacture analyzers for bacterial, yeast, or mold identification and sensitivity testing. Given that the required testing is not supported by their line of analyzers, Siemens is unable to meet the Government’s needs.

The Beckman Coulter MicroScan 96 WalkAway Plus Analyzer presents several limitations regarding testing and operational efficiency. The system has a longer turnaround time for identification, which negatively impacts patient care by delaying critical diagnostic information. The Microscan manual indicates that definitive results from panel processing can take up to 48 hours, which does not adequately support NH Jacksonville’s time requirements.

MicroScan requires more hands-on operation, such as manual panel setup and inoculation, which increases the risk of human error and adds additional time to receive results. Microscan requires panels be read in specific window which the laboratory cannot support. For Gram-positive organisms, doxycycline is frequently prescribed for the treatment of Staphylococcus aureus infections at the Naval Hospital. The Microscan Gram positive panel does not have doxycycline in its drug panel standard.

Based on the Microscan user manual, the system requires the use of an external water source for its operation. The manual specifically recommends the Millipore 2.0 water purification system as a compatible external water supply. This would require the acquisition of supplementary equipment resulting in additional costs associated with consumables and maintenance, coupled with the logistical overhead of managing supplementary equipment.

Additionally, the MicroScan system’s antibiotic breakpoints are not updated, which can lead to the use of outdated guidelines for antimicrobial resistance. This issue, highlighted in an ASM article published in February 2022 by Andrea Prinzi, Ph.D., MPH, SM(ASCP), who works to bridge the gap between clinical diagnostics and clinical practice, can result in ineffective treatments and compromised patient care.1 These factors collectively highlight the need for a more precise and compatible analyzer to ensure accurate and timely diagnostic results. The limitations in accurate organism identification, turnaround times, lack of doxycycline gram positive panel testing capabilities, and outdated antibiotic breakpoints show that Beckman Coulter cannot meet Naval Hospital Jacksonville’s needs.

The Becton Dickinson (BD) Bactec Blood Culture System is highly effective and reliable for sepsis testing. It combines the performance of BD Bactec Perfect Media Pair with BD Bactec FX instrumentation to optimize time to microorganism detection. The system includes a complete line of blood culture media formulations designed to detect aerobes, anaerobes, facultative anaerobes, yeast, fungi, and mycobacteria. This comprehensive detection capability ensures accurate and timely identification of pathogens, which is crucial for initiating appropriate antimicrobial therapy. The BD Bactec system also supports faster time to detection and organism recovery, which is essential for reducing the time to appropriate treatment. Its scalable and modular design allows for deployment near the point of collection, further reducing turnaround times and enabling earlier decision-making regarding antimicrobial treatment. Additionally, the system integrates with informatics solutions that provide actionable insights and improve overall patient outcomes.

The BD Phoenix and Bruker MALDI systems are highly complementary and deliver exceptional results when used together in microbiology testing. The BD Phoenix excels at detecting antimicrobial resistance through automated and reliable susceptibility testing, significantly reducing technologist error and ensuring consistent results. It utilizes a high level of automation, reducing the need for manual intervention. Results are auto populated and do not require additional hands-on processes or results be read at any specific timelines. Its wide range of testing panels covers various bacteria and yeast, enhancing laboratory workflow efficiency. The BD PMIC-110 panel includes doxycycline, enabling precise susceptibility testing for a commonly used antibiotic at NH Jacksonville, FL. Meanwhile, the Bruker MALDI uses Matrix-Assisted Laser Desorption/Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS) to identify microorganisms rapidly and accurately by analyzing their unique proteomic fingerprints. This technology is highly versatile, making it suitable for clinical testing. The system’s quick and precise results improve diagnostic accuracy and laboratory efficiency. Together, these systems provide a comprehensive solution for microbiology testing. The BD Phoenix handles robust antimicrobial susceptibility testing, while the Bruker MALDI Biotyper offers rapid and precise microbial identification. This combination ensures the Government can deliver high-quality, accurate, and timely diagnostic results, meeting all microbiological testing needs.

The BD MAX System offers several advantages in microbiology testing. It is a fully integrated, automated platform that performs nucleic acid extraction and real-time PCR, providing results for up to 24 samples across multiple syndromes in less than three hours. This automation significantly reduces hands-on time, reduces turn-around time, and increases laboratory efficiency which is critical in this facility where microbiology workups can be labor-intensive. The system is versatile, running both FDA-cleared and open system assays, which allows for a broad and expanding suite of molecular solutions to address emerging diagnostic requirements. Its real-time PCR technology ensures highly sensitive and specific results, providing consistent and reliable outcomes.

Becton Dickinson (BD) is the sole manufacturer that meets all the government's microbiology testing requirements, allowing for the required patient care while operating a training facility with limited laboratory staffing levels, and does not require additional equipment costs to be fully operational.

1 Updating Breakpoints in Antimicrobial Susceptibility Testing https://asm.org/articles/2022/february/updating-breakpoints-in-antimicrobial-susceptibili

8. Other Facts:

a. Only one source, Becton, Dickinson, and company was found to offer the microbiology analyzers, consumables and meet government’s minimum requirements with a cost per test solution.

b. IAW FAR 8.004 agencies are encouraged to satisfy the requirement through a FSS before considering commercial sources.

c. There is only one capable source Becton, Dickinson, and company that meets the Governments minimum requirements and holds a schedule V797D-40095 under VA FSS 66 III (Clinical Analyzers, Laboratories, Cost-Per-Test), Category 605-5A (Clinical Microbiology Analyzers).

9. Actions to overcome barriers: Future requirements will be assessed based on the requirement’s need and the essential characteristics of acceptable vendors that can provide it. Also, future requirements will be reviewed to see if there are additional avenues to overcome the barriers to competition to include market research and if market conditions have changed that allow for competition such as new analyzers or updated capabilities of existing analyzers.

10. 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: Narumon Sriwong Title:

Microbiology Supervisor

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

Name: Sasha Tittel

Laboratory Department Hea

12. Fair and reasonable Cost Determination: The Contracting Officer will determine the anticipated cost to the Government of the supplies covered by this justification to be fair and reasonable by utilizing the supporting IGCE, review of historical prices, and conducting additional pricing analysis. Certified cost and pricing data is not required per 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: Jessica L. Horst

Contracting Officer

13. Legal Review: I have reviewed this justification and have found it to be legally sufficient.

Name: Peter B. Rose Title: Assistant General Counsel

JA-25-0157 Amendment to JA-25-0388

14. Contracting Officer: This certification shall be made by the contracting officer who will sign the contract resulting from this justification and approval (J&A). Include the following statement: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Name: Jessica L. Horst Title: Contracting Officer

15. Competition Advocate: Based on the foregoing justification, I hereby approve the procurement of microbiology analyzer services on an other than full and open competition basis pursuant to the authority of 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., subject to availability of funds, and provided that the supplies and/or services herein described have otherwise been authorized for acquisition.

Name: