A02-JA22041148 Bioprocess Maintenance Final (1).pdf

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Bioprocess Systems “Fermenters” Maintenance, Walter Reed Army Institute of Research (WRAIR)
Solicitation number
W81XWH22R0043
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CUI//SP-SSEL

Control Number: JA-22-04-1148

JUSTIFICATION REVIEW DOCUMENT

FAR SUBPART 13.5 SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS – SOLE SOURCE (including BRAND NAME) JUSTIFICATION AND

APPROVAL

Program/Equipment: Bioprocess System Maintenance

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

Amount: $370,219.80

Prepared by:

SFC Carlos A. Nanez

DSN: 301-319-9559

Medical Maintenance NCOIC

Email: carlos.a.nanez2.mil@mail.mil Date: _4May2022_

Contracting Officer: Jennifer C. Jackson Contracting Officer

DSN: 301-619-2054

Date: _5May2022_

Email: Jennifer.c.jackson16.civ@mail.mil

Technical:

Email: carlos.a.nanez2.mil@mail.mil

Date: _4May2022_

Requirements:

Email: carlos.a.nanez2.mil@mail.mil

Date: 4May2022_

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

Program Manager:

Typed Name: SFC Carlos A. Nanez

DSN: 301-319-9559

NANEZ.CARLOS.A

LBERTO.12721949

Digitally signed by

NANEZ.CARLOS.ALBERTO.127

2194951 Date: 2022.05.04 15:49:15 -04'00'

Controlled by: Army CUI Category: Source Selection Information

Distribution/Limited Dissemination Control: FED ONLY POC: Jennifer Jackson, 301-619-2054

(Source Selection information - See FAR 2.101 and 3.104-4)

1 SEP 2021

Signature:

mailto:carlos.a.nanez2.mil@mail.mil mailto:Jennifer.c.jackson16.civ@mail.mil mailto:carlos.a.nanez2.mil@mail.mil mailto:carlos.a.nanez2.mil@mail.mil

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

SEP 2021

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

1. Contracting Activity: The contracting activity responsible for this action is the U.S.

Army Medical Research Acquisition Activity (USAMRAA). The requiring activity is the Walter Reed Army Institute of Research (WRAIR).

2. Description of Action: The scope of this requirement includes full maintenance services for Bioprocess systems. The work required under this contract shall include: (1) Planned Maintenance Service; (2) Repair Service; and (3) Technical Support Service.

☒ An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

☐ Contracting Officer approved an acquisition plan in accordance with DFARS 207.103(d)(i)(B) on (insert date).

☐ The required acquisition plan in accordance with DFARS 207.103(d)(i)(B) is currently awaiting (insert approval authority title) approval.

3. Description of Supplies/Services: The objective of this requirement is to acquire a non-personal services contract for preventive maintenance (PM) services full maintenance services for a 3 Bioprocess Systems. The work required under this contract shall include: (1) Planned Maintenance Service; (2) Repair Service; and (3) Technical Support Service

Base Period: 01 June 2022 to 31 May 2022 Value: $63,740.50 Option Period 1: 01 June 2023 to 31 May 2023 Value: $65,334.01 Option Period 2: 01 June 2024 to 31 May 2024 Value: $66,967.36 Option Period 3: 01 June 2025 to 31 May 2025 Value: $68,641.55 Option Period 4: 01 June 2026 to 31 May 2026 Value: $70,357.59 FAR Clause 52.217-8 option: 01 June 2027 to 31 December 2027 Value: $35,178.79

Total: $370,219.80

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: State the purpose.

5. Reason for Authority Cited:

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

Eppendorf North America is the only vendor that is certified to perform the bioprocessing system maintenance due to the systems being proprietary to Eppendorf North America. Only certified Eppendorf North America technicians are allowed to service the bioprocessing systems in order to maintain its warranty status. Non Eppendorf North America certified technicians that work on the system will void any warranty.

If this requirement is not awarded to the intended sole source contractor, it will jeopardize the operational capability of the bioprocess system. These bioprocess system must be maintained by certified Eppendorf North America technicians.

6. Efforts to Obtain Competition: A Request for Information (RFI) was posted on SAM on 6 April 2022. No responses were received for that notice, a Notice of Intent to sole source was then posted on 13 April 2022, and no responses were received from that notice. As a result of no responses being received Eppendorf North America is found to be the only source that can provide the services.

7. Actions to Increase Competition: Competition of this requirements is not possible since the proposed contractor Eppendorf North America is the only certified to perform the maintenance due to the systems being proprietary. At this time it is not feasible and reasonable to switch equipment, but when the equipment does have to be replace, the Government will assess the maintenance cost when selecting replacement equipment.

8. Market Research: Market research was conducted by Contracting Officer Representative (COR) on 24 August 2021 using internet searches to identify possible sources for the requirements. Only one vendor is certified to perform these services and are proprietary to that vendor.

9. Interested Sources: See paragraph 6 for the synopsis information to date, no other sources have written to express interest in the acquisition.

To date, only Eppendorf North America is capable of meeting the requirement.

10. Other Facts:

a. Procurement History: Not applicable

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

Title: Medical Maintenance NCOIC TO.1272194951Signature:

Title: Medical Maintenance NCOIC Signature: TO.1272194951

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: SFC Carlos A. Nanez Date: 4May2022

NANEZ.CARLOS.ALBER Digitally signed by

NANEZ.CARLOS.ALBERTO.1272194951

Date: 2022.05.04 15:49:45 -04'00'

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

Typed Name: SFC Carlos A. Nanez Date: 4May2022

NANEZ.CARLOS.ALBER Digitally signed by

NANEZ.CARLOS.ALBERTO.1272194951

Date: 2022.05.04 15:50:20 -04'00'

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

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: (identify the audit type) ☐ other: (identify the methodology or combination of methodologies that will be used)

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.

Typed Name: Jennifer C. Jackson Date: 5 May 2022 Title: Contracting Officer Signature: JACKSON.JENNIF Digitally signed by

JACKSON.JENNIFER.C.1229322580

Date: 2022.05.05 07:21:55 -04'00'

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

Typed Name: Date: 5 May 2022 Title: Contracting Officer Signature:

Digitally signed by

JACKSON.JENNIF JACKSON.JENNIFER.C.1229322

ER.C.1229322580 Date: 2022.05.05 07:22:59 -04'00'

ER.C.1229322580

JUSTIFICATION REVIEW DOCUMENT
Program Manager:
FAR Subpart 13.5 Simplified Procedures for Certain Commercial Items – Sole Source Justification and Approval
5. Reason for Authority Cited:
10. Other Facts:

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