Sartorius_JA Redacted.pdf

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DHH

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.

DHHS/FDA

b. Sponsoring organization.

ORA/ORS/OHAFLO/SEAHAF (Seattle Human and Animal Food Laboratory)

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

i. Program Point of Contact Name: Peter Chow

ii. Mailing address: 22201 23rd Drive SE, Bothell, WA 98021

iii. E-mail address: Peter.Chow@fda.hhs.gov

iv. Telephone number: 425-487-5306

v. COR Name: Thomas Lamb

vi. Mailing address: 22201 23rd Drive SE, Bothell, WA 98021

vii. E-mail address: Thomas.Lamb@fda.hhs.gov Telephone number: 425-487-5314

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

a. Acquisition purpose and objectives.

The objective is to procure a preventative maintenance service contract to service and maintain seven Sartorius Arium laboratory water purification units.

b. Project background.

As part of a 2023 laboratory renovation at Seattle Human and Animal Food Laboratory (SEAHAF), the U.S. Food and Drug Administration (FDA) purchased and installed seven Sartorius Arium laboratory water purification units. These units purify and polish city tap water and/or processed water to American Society for Testing and Materials (ASTM) grade water for laboratory use.

SEAHAF requires the use of high-grade laboratory water for regulatory sample testing and research work to accomplish the agency’s mission of protecting the public health. A preventative maintenance (PM) service contract is required to maintain these units to consistently produce laboratory grade water.

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

Template mailto:Peter.Chow@fda.hhs.gov mailto:Thomas.Lamb@fda.hhs.gov

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a. Project title.

Preventative Maintenance Service for Sartorius Arium Laboratory Water Purification Units

b. Project Description.

See Statement of Work (SOW) 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:

Type of action.

☒ New requirement ☐ Follow-on ☐ Other:

Proposed contract/order type.

☒ Firm-fixed-price ☐ Other fixed-price:

☐ Cost-plus-fixed-fee ☐ Other cost reimbursement:

☐ Time and materials ☐ Indefinite delivery:

☐ Other:

☐ Completion Form ☐ Term Form

Acquisition identification number.

Preventative Maintenance Service for Sartorius Arium Laboratory Water Purification Units

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

05/10/2024 – 05/09/2025: $68,464.20 (Base Year) 05/10/2025 – 05/09/2026: $70,175.81 (Option Year 1) 05/10/2026 – 05/09/2027: $71,930.20 (Option Year 2)

Total (Base + Option Years): $210,570.21

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 agenc requirements. This acquisition is conducted under the authority of United States Cod (U.S.C.) 10 U.S.C. 2304(c)(1) or 41 U.S.C. 3304(a)(1).

https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-prelim-title41-chapter33&edition=prelim

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☐ 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 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).

Sartorius Corporation 565 Johnson Ave Bohemia, NY 11716

Pure Lab Solutions, Inc.

4901 Morena Blvd, Unit 118 San Diego, CA 92117

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

The seven government commercially purchased Sartorius Arium water purifying units are designed and constructed using patented technology to purify water to high quality laboratory grade water.

To maintain each unit as specified in the original equipment manufacturer’s (OEM) equipment manual, patented and licensed consumable filters, cartridges, and items must be used to ensure operability of the equipment and the equipment continues to produce high quality laboratory grade water. Additionally, the maintenance work involved require qualification and training due to the sophisticated technological characteristics of each unit to perform all the OEM required tasks. These qualifications and trainings can only be obtained from the OEM or OEM authorized licensed vendor(s).

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.

Outreach to the OEM, Sartorius Corp., to determine if they sell approved consumable filters, cartridges, and supplies as well as provide qualified technician to perform require maintenance work. Additional inquiries made to the OEM determined there is only one authorized licensed vendor, Pure Lab Solutions, Inc., that is licensed and qualified to sell approved consumables and provide qualified technician to perform the required maintenance work.

https://www.acquisition.gov/far/html/Subpart%206_3.html http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-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%3AUSC-prelim-title10-section2304c&num=0&edition=prelim http://uscode.house.gov/view.xhtml?req=granuleid%3AUSC-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%3AUSC-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%3AUSC-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%3AUSC-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%3AUSC-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 https://www.acquisition.gov/far/html/Subpart%2013_5.html http://uscode.house.gov/view.xhtml?req=(title%3A41%20section%3A1901%20edition%3Aprelim) http://uscode.house.gov/view.xhtml?req=(title%3A41%20section%3A1903%20edition%3Aprelim) https://www.acquisition.gov/far/html/Subpart%205_2.html https://www.acquisition.gov/far/html/Subpart%205_2.html

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

The Contracting Officer will determine prior to award that cost or pricing from the solicited vendors will be fair and reasonable by comparing submitted price quotes. The obtained pricing information will not be certified, nor will an audit be performed.

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.

Refer to HHS Market Research Report.

9. Any other facts supporting the use of other than full and open competition. None.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition. No other sources have expressed an interest as a result of the posted RFIs.

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.

Several efforts were attempted to remove barriers to competition. A sources sought was posted on SAM.gov on April 4, 2024 and closed on April 9, 2024 and an RFI was posted on GSA e-buy on April 4, 2024 and closed on April 10, 2024. Both postings yielded no interested vendors for this requirement. An RFI was sent to Sartorius Corporation (Large Business), the OEM. Sartorius indicated that they currently service the SEAHAF’s water purification units and are interested in continuing to provide the preventative maintenance on the seven units. Sartorius also provided a price estimate. They also indicated that they only authorize one company, Pure Lab Solutions, Inc., (WOSB) to sell and service their water purification units. Pure Lab Solutions was contacted to determine if they were capable and interested in performing PM services for this requirement.

They responded that they were interested; however, when asked, Pure Lab Solutions did not expressly confirm that they could perform the services as stated in the SOW. They were asked to provide price estimate for market research purposes on several occasions but were unresponsive by the requested submittal deadline.

The government anticipates acquiring these same services after the expiration of this contract due to the need for ongoing preventative maintenance services for these water purification units.

Future inquiries will be made to the OEM to determine if more OEM licensed vendors will be qualified and approved to provide consumables and technicians to perform the required equipment maintenance work.

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.

Digitally signed by Peter C. Chow -S

Signature: Peter C. Chow -S ADdatoeb:e2A02c4ro.0b4a.t26ve1r4s:i2o3n::59 -07'00' April 26, 2024 2023.008.20555

Peter Chow, Chemistry Branch Director Requiring Activity POC https://www.acquisition.gov/?q=browse/far/10

Last Modified: April 5, 2017 Page 5 of 5

Jinxin Hu -S Digitally signed by Jinxin Hu -S

Signature: Date: 2024.04.29 12:42:23 -07'00' April 29, 2024 Jinxin Hu, Laboratory Director Head of the Sponsoring Program Office

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.

Kathy A. Digitally signed by Kathy A.

Harrigan -S

Signature: Harrigan -S Date: 2024.04.30 14:02:41 -04'00'

Kathy Harrigan Contracting Officer

14. Competition Advocate signature.

Signature:

Competition Advocate

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

Division Director

Signature:

Head of the Contracting Activity

16. HHS Senior Procurement Executive signature.

HHS Senior Procurement Executive