1237323-_Justification for Other Than Full and Open Competition 04MAR21.pdf

Last Modified: April 5, 2017 Page 1 of 6

TMPLT 2016.06-011

Justification for Other than Full and Open Competition

1. Identification of the agency and contracting activity:

a. Federal agency and contracting activity.

ORA/ORS/OMPTSLO/WEAC

b. Sponsoring organization.

Winchester Engineering and Analytical Center

c. Contracting Officer’s Representative (COR)/Requiring Activity Point of Contact (POC) information.

i. Name: Crystal Nevins (POC); Jenny Lau (COR)

ii. Mailing address: 109 Holton Street Winchester, MA 01890

iii. E-mail address: crystal.nevins@fda.hhs.gov; jenny.lau@fda.hhs.gov

iv. Telephone number: 781-756-9822, 781-756-9704

2. Nature and/or description of the action being approved.

WEAC is in need of a preventative maintenance and repair contract for the Bruker MALDI TOF Mass Spectrometer for one base year and 4 option years.

a. Acquisition purpose and objectives.

Winchester Engineering and Analytical Center (WEAC) is in need of preventative maintenance and repair services for an existing Bruker MALDI TOF Mass Spectrometer. The contractor shall provide needed preventative maintenance as well as coverage for device malfunctions, software updates, and virtual and onsite support as needed.

b. Project background.

The MALDI TOF Mass Spectrometer service contract was previously fulfilled by Bruker- it included 1 base year and 4 option years. The final option year expired on 9/30/2020.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

Template mailto:crystal.nevins@fda.hhs.gov mailto:jenny.lau@fda.hhs.gov

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Routine preventative maintenance services will prolong the life of the instrument and ensure it functions properly. Any needed repairs for the instrument will be completed in a timely fashion, thus allowing WEAC to continue to perform its mission.

Through this contract the Government will obtain the following:

• One base year of preventative maintenance and repair services with an additional 4 option years.

• At least one (1) annual preventative maintenance visit per year

• On site and virtual support, as needed

• Emergency on-site repair visits

a. Project title.

Preventative Maintenance and Repair Services for Bruker MALDI TOF Mass Spectrometer

b. Project Description.

See Statement of Work.

Requirement type.

☐ Research & Development (R&D)

☐ R&D support services

☐ Support services (non-R&D)

☐ Supplies/equipment

☐ Information Technology (IT)

☐ Construction

☐ Architect-Engineer (A&E) services

☐ Design-build

☒ Other: Service

Type of action.

☒ New requirement

☐ Follow-on

☐ Other:

Proposed contract/order type.

☒ Firm-fixed-price

☐ Other fixed-price:

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☐ Cost-plus-fixed-fee

☐ Other cost reimbursement:

☐ Time and materials

☐ Indefinite delivery:

☐ Other:

☐ Completion Form

☐ Term Form

Acquisition identification number.

1237323

c. Total estimated dollar value and performance/delivery period.

Approximately $150,000:

Base year $30,000 Four Option years: $30,000 each

4. Identification of the statutory authority permitting other than full and open competition. Check the applicable block below based on the acquisition circumstance.

Federal Acquisition Regulation (FAR):

☐ 6.302-1 Only one responsible source and no other supplies or services will satisfy agency requirements. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

☐ 6.302-2 Unusual and compelling urgency. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(2) or 41 U.S.C. 3304(a)(2).

☐ 6.302-3 Industrial mobilization; engineering, developmental, or research capability; or expert services. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(3) or 41 U.S.C. 3304(a)(3).

☐ 6.302-4 International agreement. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(4) or 41 U.S.C. 3304(a)(4).

☐ 6.302-5 Authorized or required by statute. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(5) or 41 U.S.C. 3304(a)(5).

☐ 6.302-6 National security. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(6) or 41 U.S.C. 3304(a)(6).

☐ 6.302-7 Public interest. This acquisition is conducted under the authority of United States Code (U.S.C.) 10 U.S.C. 2304(c)(7) or 41 U.S.C. 3304(a)(7).

☒ 13.501(a)(1)(ii) Sole source, including brand name, under Simplified Procedures for Certain Commercial Items. This acquisition is using this justification format, modified to reflect that https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim https://www.acquisition.gov/far/html/Subpart%2013_5.html

Last Modified: April 5, 2017 Page 4 of 6 the procedures in FAR subpart 13.5 were used in accordance with 41 U.S.C. 1901 or the authority of 41 U.S.C. 1903.

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s).

Bruker Scientific, LLC 40 Manning Road Billerica, MA 01821 Phone: 978-663-3660

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Bruker is the manufacturer of this MALDI-TOF Mass Spectrometer and will be able to provide the most comprehensive service based on their expertise. Software upgrades and computer troubleshooting will only be able to be addressed by Bruker, therefore utilizing another company for this service agreement would incur additional costs to the government for these necessary services.

6. Description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by subpart 5.2 and, if not, which exception under 5.202 applies.

Soliciting offers outside the equipment manufacturer, Bruker, could potentially cause damage to the instrument due to maintenance and repairs being performed by a company without specialized experience.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable.

8. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

The MALDI-TOF Mass Spectrometer is a specialized piece of equipment that need specialized, experienced technicians to service it. Specialized technicians are difficult to find in the market and repairs and maintenance performed by someone lacking this specialization could cause potential damage to the instrument. Additionally, only the manufacturer will be able to provide necessary software updates and expansions- this would inevitable incur additional cost to the government as we would need to purchase these services separately.

9. Any other facts supporting the use of other than full and open competition.

The MALDI-TOF Mass Spectrometer is a specialized piece of equipment that need specialized, experienced technicians to service it. Repairs and maintenance performed by someone lacking this experience could cause potential damage to the instrument. Additionally, only the manufacturer will https://www.acquisition.gov/far/html/Subpart%2013_5.html http://uscode.house.gov/view.xhtml?req=(title:41%20section:1901%20edition:prelim) http://uscode.house.gov/view.xhtml?req=(title:41%20section:1903%20edition:prelim) https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/?q=browse/far/10

Last Modified: April 5, 2017 Page 5 of 6 be able to provide necessary software updates and expansions- this would inevitable incur additional cost to the government as we would need to purchase these services separately.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

N/A

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services.

N/A

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Signature:____________________________________

Crystal Nevins, POC

3/4/2021

Matthew Silverman POC Immediate Supervisor

[Enter name here.] Head of the Sponsoring Program Office

[Enter date here.]

13. Contracting Officer Certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Contracting Officer

14. Competition Advocate signature.

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Competition Advocate

15. Division Director and Head of the Contracting Activity signature(s).

Division Director

Head of the Contracting Activity

16. HHS Senior Procurement Executive signature.

HHS Senior Procurement Executive