J_A Sole-Source (W81K02-20-Q-0122) RHCO-20-P-298 Pathology Lab Testing.pdf

Control No: RHCO-20-P-298

Contractor: Biomerieux Inc.

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: Madigan Army Medical Center (MAMC), Department of Pathology, Joint Base

Lewis-McChord, and Tacoma, WA is requesting a suite of instruments, reagents and supplies for the detection and appropriate work up of pathogenic microorganisms.

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

Subpart 13.5.

Amount: The estimated value of this effort is $$629,153.77 including all options.

Prepared by: Alfonso Nolasco

Contract Specialist

Email: alfonso.nolasco.civ@mail.mil

Contracting Officer: Richard J. Meadows

Contracting Officer

Email: Richard.j.meadows3.civ@mail.mil

Technical: Kurt Jerke

LTC, Chief, Microbiology

Email: kurt.h.jerke.mil@mail.mil

Requirements: Darin Houfek

Health System Specialist

Email: darin.e.houfek.civ@mail.mil

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

Contracting Officer:

Typed Name: Richard J. Meadows

Signature:

Local Advocate for Competition:

Typed Name: Larry A. Bradbury mailto:alfonso.nolasco.civ@mail.mil mailto:Richard.j.meadows3.civ@mail.mil mailto:kurt.h.jerke.mil@mail.mil mailto:darin.e.houfek.civ@mail.mil

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: JBLM-Health Contracting Cell (JBLM-HCC); Regional Health Contracting

Office – Pacific (JBLM); 673 Woodland Square Loop SE, Suite 101; Lacey, WA 98503

2. Description of Action: MAMC, Department of Pathology requests a firm-fixed-price contract with

BioMerieux Inc. The Government projects award for June 2020 and fiscal year 2021,OMA funds will be used.

3. Description of Supplies/Services: MAMC, Department of Pathology requires a cost per test contract for reagents and automated or semi-automated instrumentation for nucleic acid extraction, continuously monitored cultures in liquid media, mass spectrophotometry utilizing matrix assisted laser desorption ionization time of flight (MALDI-TOF) for identification of cultures, and biochemical identification and susceptibility of cultures..

Period of Performance (PoP) Value

Base 1 Oct 2020 to 30 Sept 2021 $204,560.84

Option Year 1 1 Oct 2021 to 30 Sept 2022 $209,674.78

Option Year 2 1 Oct 2022 to 30 Sept 2023 $214,918.15

(Estimate)Total $629,153.77

4. Authority Cited: Simplified Procedures for Certain Commercial Items, 41 U.S.C. 1901 (or 41 U.S.C.

1903 for Special Emergency Procurement) as implemented by FAR Subpart 13.5:

Unusual and compelling urgency

Exclusive licensing agreements

Industrial mobilization

Other: 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items

5. Reason for Authority Cited: Biomerieux’s Vitek2, Vitek MS, easyMAG and BacT/ALERT are the only instruments that can interface directly with the MHS-Genesis through the Observa middleware.

Moving forward the Vitek2, VitekMS and the Bact/Alert will connect to MHS-Genesis using the Myla middleware. An ATO for Myla has been initiated but is not yet in place. Switching instruments will result in the loss of the current interface on the Vitek2, this will present both an increase in labor and will present a potential patient safety hazard as identification and susceptibility data which are complex will need to be manually entered. In addition this may require additional ATOs to be submitted for any instruments not able to connect to Myla.

The instruments requested in this Justification and Approval are currently in use in the MAMC

Microbiology laboratory. Implementation of a new instrument and/assay is both expensive and labor intensive. In order to comply with the requirements of the College of American Pathologists, which accredits hospital laboratories, each new assay must have a verification study performed to verify the instruments and/or assays performance. This verification process involves writing a verification study, new testing protocols, training of laboratory staff and testing a number of known specimens to confirm system performance. Changing instrumentation will require the laboratory to run both instruments simultaneously until the verification of the new instrument is complete.

6. Efforts to Obtain Competition: A general competitive effort is made throughout the requirement review process which considers the applicability of products & services from various sources to determine the one that best meets the needs for the requirement and the patients.

A formal request for information was issued on beta.sam.gov that included a description of the requirement and an attachment with required salient features from 5 May to 20 May 2020. One vendor response was received. Biomerieux Inc replied stating they were capable of meeting all the salient features.

7. Actions to Increase Competition: This J & A will be posted to beta.sam.gov informing vendors of the proposed Sole Source action and, if they believe they are capable, to respond.

8. Market Research: In accordance with FAR 10.002(b)(2), the following searches were completed: Direct communication with knowledgeable people in government and industry, internet search, GSAebuy and beta.sam.gov . Research concluded on 20 May 2020.

9. Interested Sources: To date, no other sources have written to express interest in the acquisition.

10. Other Facts:

Procurement History: This is not a new requirement. This requirement will replace two current contracts: W91YU0-15-D-0007 and W91YU0-15-D-0012.

W91YU0-15-D-0007: The unrestricted solicitation resulted in an award to Biomerieux Inc. for a

FFP contract for a 1 year Base plus four option years that were exercised. This contract expires 30

Sep 2020. The awarded amount of this contract was $675,355.80

W91YU0-15-D-0012: The unrestricted solicitation resulted in an award to Biomerieux Inc. for a

FFP contract for a 1 year Base plus four option years that were exercised. This contract expires 30

Sep 2020. The awarded amount of this contract was $199,350.00

Date: 2020.05.29 12:34:12

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EUGENE.115298 152986951

HOUFEK.DARIN.EUGENE.1 HOUFEK.DARIN. Digitally signed by

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.

Typed Name:

Title: 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.

Typed Name:

Title: Signature:

Right-Click "Signature Setup"

Right-Click "Signature Setup"

JERKE.KURT.HARRY.1154765758

Date: 2020.05.29 09:00:52 -07'00'

X RY.1154765758

JERKE.KURT.HAR Digitally signed by

X

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

XX IGCE audit other:

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.

Title: Contracting Officer

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

Title: Contracting Officer