Approved JA.pdf

Control No: 20-RHCO-C-421 Contractor: Biomeriuex

Program/Equipment: Vitek 2 XL and Vitek MS

Version –March 2017 FOR OFFICIAL USE ONLY

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS – SOLE

SOURCE JUSTIFICATION AND APPROVAL

Program/Equipment: This contract is for microbial identification and susceptibility detection for the Ft Bliss/El Paso area at William Beaumont Army Medical Center (WBAMC) Laboratory, Department of Pathology, Fort Bliss, Texas. This contract is for reagents, consumables and incidental support equipment, one (1) Vitek 2XL analyzer and one (1) Vitek MS analyzer, needed to perform the necessary testing listed in the Purchase Description (PD).

Authority: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5.

Amount:

Performance Time Frame Total Cost

1 Month Base September 1, 2020 - September 30, 2020 $45,301.37

Option 1 October 1, 2020 - September 30, 2021 $496,727.70

Option 2 October 1, 2021 - September 30, 2022 $599,006.24

Option 3 October 1, 2022 - September 30, 2023 $661,251.58

11 month;

Option 4 October 1, 2023 - August 31, 2024 $733,958.12

$2,536,245.01

Prepared by: Alicia Munoz Date: 11 August 2020 Chief Microbiology (Acting) Email: alicia.munoz2.civ@mail.mil

Contracting Officer: Randall P. Cummins Date: 11 August 2020 Contracting Officer Email: randall.p.cummins.civ@mail.mil

Technical: Alicia Munoz Date: 11 August 2020

Email: alicia.munoz2.civ@mail.mil

Requirements: Alicia Munoz Date: 11 August 2020

Email: alicia.munoz2.civ@mail.mil

Version –March 2017 FOR OFFICIAL USE ONLY

Reviews: I have reviewed this justification and find it adequate to support sole source.

Legal Counsel:

Eugene J. Smith Signature:

X Right-Click "Signature Setup"

Version – March 2017 FOR OFFICIAL USE ONLY

FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and

Approval

1. Contracting Activity: Regional Health Contracting Office – Central (RHCO-C), Fort Bliss, TX

2. Description of Action: This firm, fixed-price (FFP) contract is a follow-on contract to W81K0020P0095 for microbial identification and susceptibility detection for the Ft Bliss/El Paso area at William Beaumont Army Medical Center (WBAMC), Department of Pathology, Fort Bliss, Texas. This contract is for reagents, consumables and incidental support equipment, one (1) Vitek 2XL analyzer and one (1) Vitek MS analyzer, needed to perform gram-positive organism, gram-negative organism, anaerobic organism, yeast organisms and Niesseria-Haemophilus organisms on both analyzers and mycobacterium organism identification on the Vitek MS. The analyzers shall support susceptibility for Streptococcus, gram-positive, and gram-negative organisms in accordance with CLSI and the WBAMC algorithm provided in the market research documentation.

3. Description of Supplies/Services:

- Both analyzers (the mass spec and ID/susc analyzer) must identify gram-positive, gram-negative, yeast, Neisseria/Haemophilus specialty identification, and anaerobic organisms all with minimum hands-on time.

- The mass spectrometer shall be able to identify mycobacterium species.

- Susceptibility testing must be within one dilution or have an approved system to make them in accordance with CLSI standards of reporting.

- All reportable antibiotic susceptibility patterns shall flag and identify in the system:

o Methicillin Resistant Staphylococcus Aureus (MRSA) o Vancomycin Resistant Staphylococcus Aureus (VRSA) o Vancomycin Resistant Enterococci (VRE) o Multi Drug Resistant Organism (MDRO) o Extended Spectrum Beta-Lactamase (ESBL) Resistant Organisms

- The susceptibility analyzer shall be able to support a Streptococcus specialty susceptibility panel and meet all of the antibiotic requirements required by WBAMC/CLSI Pharmacy Antibiotic Reporting Algorithm. The following antibiotics must be available:

o Gram positive: Cefazolin, Clindamycin, Erythromycin, Levofloxacin, Nitrofurantoin, Penicillin, Tetracycline, Vancomycin, Ciprofloxacin, Trimethoprim/Sulfamethoxazole, Ampicillin, and Linezolid o Gram Negative: Ampicillin, Ampicillin/Sulbactam, Tobramycin, Ceftriaxone, Cefoxitin, Gentamicin, Ciprofloxacin, Trimethoprim/Sulfamethoxazole, Imipenem, Levofloxacin, Piperacillin/Tazobactam, Nitrofurantoin, Cefazolin, Ceftazidime.

o Streptococcus Panel: Erythromycin, Levofloxacin, and Penicillin.

- All tests must be FDA approved.

-The analyzers must be able to accommodate upwards of 100 samples on a single test cartridge for the Mass Spectrometer and upwards of 100 tests for ID/SUSC at a given time on the microbial identification/susceptibility analyzer.

-The microbial identification/susceptibility analyzer must results within 12 hours and the mass spectrometer within 30 minutes.

-Must be able to interface with WBAMC current LIS system (CHCS).

- The organismal database must be extensive for BOTH analyzers and provide an AES or similar database that can extrapolate when an identification of an organism is less than 94% with a list of possible organisms to compare to culture

Program/Equipment: Vitek 2 XL and Vitek MS

Version – March 2017 FOR OFFICIAL USE ONLY

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5:

Unusual and compelling urgency

Exclusive licensing agreements

Industrial mobilization

Other: Only one responsible source

5. Reason for Authority Cited: Per documentation in PCF, a three-page MFR, BioMerieux is the sole-source provider of the VITEK MS and VITEK 2 equipment which include an analyzer, MYLA microbiology middleware and reagent consumables for microbial identification and susceptibility testing. WBAMC is no longer an Army MEDCOM facility. As of October 1, 2019 WBAMC is now a DHA facility and as such must follow DHA ATO/RMF policy further limiting available sources for this requirement. The equipment that BioMerieux will provide is the only known that already possesses an authority to operate (ATO) as required by DHA ATO/RMF policy.

6. Efforts to Obtain Competition: The Contracting Officer shall publish the notices required by FAR 5.201.

7. Actions to Increase Competition: A notice of intent will be posted on FedBizOpps and all vendors submitting responses with proper documentation of services available will be forwarded to the WBAMC, Ft. Bliss, TX for technical review and consideration in future requirements. WBAMC will continue to evaluate the capabilities of other vendors and continue to seek new resources that will satisfy the requirement through market research.

8. Market Research:

Biomerieux meets all of the stated requirements with the Vitek 2XL and Vitek-MS systems.

BD possess two analyzers that fit the initial description: BD Phoenix and Bruker Mass Spectrometer. BD does not meet all of the above requirements though:

- BD library for the Bruker and the Phoenix are not similar enough that if the Bruker was to be unusable the Phoenix could not support all of the testing requirements for Identification as a backup system. This would require WBAMC to utilize a reference laboratory for organisms that fit this category to include:

o Anaerobic Organism Identification o Neisseria/Haemophilus Specialty Identification Panel

- The BD Antibiotic list do not have a panel to support all of the antibiotics required for WBAMC:

o The GP Emerge Panel does not have Ciprofloxacin which is required for Enterococcus reporting at

WBAMC.

- I do not have any information on whether BD is able to meet the requirement for the system to flag and or notify the technologist of the required list of antibiotic susceptibility patterns other then they have an ESBL confirmatory on their susceptibility panel. This would need to be confirmed.

- The BD Phoenix GP Emerge Panel was not FDA approved upon discussion with the company while doing market research earlier this year.

- BD offers their own blood culture monitoring system FX 20 but, it is not FDA approved for platelets or sterile body fluids and WBAMC would need to lease or buy this new equipment when they already own the BacT Alert. This means that the BD Phoenix and Bruker will not interface with the BacT Alert already owned by WBAMC.

- The Bruker can only process 24 samples at a time and the Phoenix would require a minimum two instruments compared to Biomeriuex’s 1 Vitek 2XL instrument (not included on the quote) to meet the 100 onboard test at time requirement for WBAMC, unless they have a larger analyzer we are not aware of.

- Vendor does not have this instrumentation at another MTF and has not interfaced with CHCS which could pose a potential problem for reporting.

- The Taxa listing for the organisms from the Bruker to the Phoenix are very different and cannot be used to substitute testing for ID on the Mass Spec 100% of the time as they do not have the same species and genus listing because they are made by two separate companies. This would mean organisms unable to ID on the Bruker may require additional testing increasing the TAT for testing on the Phoenix or reference lab identification costing extra money and time per test. Based on Medical Director approval the Bruker may not be able to be used for ID at all depending on the morphology of the organism not allowing the instrumentation to meet the requirement for minimal hands on time and identification processing on the Bruker as a primary method. Examples of this include the following:

o Bruker MS library 212 organisms listed vs Phoenix library 424 organisms o Bruker does not claim the Bacillus genus at all for gram positive ID while the Phoenix claims 9 species for this genus (commonly seen at WBAMC).

o Bruker claims 21 species for Staphylococcus while the Phoenix claims 27.

o Bruker does not claim Listeria genus at all for gram positive ID while the Phoenix claims the genus along with 5 species.

o Neither analyzer has Neisseria gonorrhea or Neisseria species.

o The Bruker does not claim the Shigella genus while the Phoenix claims the genus and 5 species.

o The Bruker claims the Salmonella sp. only while the Phoenix claims the genus and 7 species. This would require double work increasing the cost of the testing.

- It is not acceptable to have an identification analyzer that is unable to detect Neisseria gonorrhea, or Neisseria species especially meningitides. These are two organisms routinely recovered from culture at WBAMC. These are reportable microorganisms required for tracking and critical results in compliance with the local and state health department of Texas along with MEDCOM tracking with Army Public Health.

Since Listeria and Shigella two other reportables are only able to be identified on one and not both analyzers by BD this is also a risk for not being in compliance with local, state, and Army regulations.

The other vendor identified in the Market Research, Beckman Coulter, Microscan does not have the identification panels and antibiotics needed for WBAMC and has the same problems with Bruker, the Mass Spectrometer offered by

BD.

9. Interested Sources: The notice of intent to award a sole-source contract for this requirement will be published on FedBizOps and responses received shall be considered. To date, no other sources have written to express an interest with the capability of supporting the requirement in full.

10. Other Facts:

a. Procurement History:

(1) Contract numbers and dates of the last several contracts for these same requirements.

W81K0019C0364, awarded 1 October 2019.

(2) The competitive status of these actions.

1) Currently have a Sole Source with Biomeriuex but, it is only awarded for 6 months. Due to requirements for the new hospital location a new contract is required that will overlap during the transition from one testing location to the other.

(3) Authority previously cited if less than full and open competition was used.

Program/Equipment: Vitek 2 XL and Vitek MS

Version – March 2017 FOR OFFICIAL USE ONLY

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

a. Summary of para 7: A notice of intent will be posted on FedBizOps and all vendors submitting responses with the proper documentation of services available will be forwarded to WBAMC for review and consideration for future requirements. No responses were received as the result of that posting.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

11. Technical Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Alicia Munoz Date:

Chief Microbiology (Acting) Signature:

12. Requirements Certification: I certify that the supporting data under my cognizance which are included in the justification are accurate and complete to the best of my knowledge and belief.

Alicia Munoz Date:

Chief Microbiology (Acting) Signature:

Program/Equipment: Vitek 2 XL and Vitek MS

Version – March 2017 FOR OFFICIAL USE ONLY

13. Fair and Reasonable Cost Determination: I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable.

This determination will be made using the following: price analysis cost analysis IGCE audit:

other: Market research and historical contract pricing.

As a part of this basis, certified cost or pricing data is not required because the item and/or services being acquired are considered commercial.

Randall P. Cummins Date:

Contracting Officer Signature:

14. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Randall P. Cummins Date:

Contracting Officer Signature:

Program/Equipment: Vitek 2 XL and Vitek MS

Approval

Based on the foregoing justification, I hereby approve the procurement of microbial reagents, consumables and incidental support equipment (contractor-owned) in the amount of $2,536,245.01 on a sole-source basis pursuant to the authority of the Simplified Acquisition Procedures for Certain Commercial Items, 41 U.S.C. 1901 as implemented by FAR Subpart 13.5, subject to availability of funds, and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Liza J. Esmond Date:

Command Advocate for Competition Signature: