A15 Justification Approval for OTFOC 6.103 redacted.pdf

J&A (Part 6) Control No. 26-6-2

Procurement Sensitive - See FAR 2.101 and 3.104 For Official Use Only

JUSTIFICATION & APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

UNDER FAR PART 6 AS AUTHORIZED BY 41 U.S.C. § 3304

Pursuant to the Competition in Contracting Act (CICA), as implemented by FAR Subpart 6.1, this Justification and Approval (J&A) supports the use of the statutory authority to limit competition under FAR

6.103. This J&A is based on the facts and rationale contained herein, as required by FAR 6.104-1. In accordance with FAR 6.104-1(a), each J&A shall, at a minimum, include the following information:

1. Identification of the Agency, Contracting Activity, and Specific Identification of the Document.

(a) Agency: Drug Enforcement Administration (DEA)

(b) Contracting Activity: DEA Office of Acquisition (FA)

(c) Requiring Activity: Office of Forensic Science (SS)

(d) Document Identification: J&A for Other Than Full and Open Competition

2. Nature and Description of the Action Being Approved:

This action is seeking a J&A to procure a BPA for the maintenance/certification/repair of the Mettler Toledo Balance Calibration instruments located in the field.

(a) Contractor Name: Mettler-Toledo, LLC

(b) Estimated Amount:

(c) Recurring Requirement: Yes No

(d) Period of Performance: From: 09/22/2026 To: 09/21/2031

(e) Description: Annual balance calibration

3. Description of Supplies or Services: The annual calibration of up to 550 Mettler Toledo laboratory balances per year by an ISO/IEC 17025 accredited calibration laboratory/vendor. Specific information required on the analytical balance calibration certificates (see SOW).

4. Identification of Statutory Authority Permitting Other Than Full and Open Competition:

FAR 6.103-1, Only One Responsible Source authorized by 41 U.S.C. 3304(a)(1)

FAR 6.103-2, Unusual and Compelling Urgency authorized by 41 U.S.C. 3304(a)(2)

FAR 6.103-3, Industrial Mobilization authorized by 41 U.S.C. 3304(a)(3)

FAR 6.103-4, International Agreement authorized by 41 U.S.C. 3304(a)(4)

FAR 6.103-5, Authorized or Required by Statute authorized by 41 U.S.C. 3304(a)(5)

FAR 6.103-6, National Security authorized by 41 U.S.C. 3304(a)(6)

FAR 6.103-7, Public Interest authorized by 41 U.S.C. 3304(a)(7).

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5. A Demonstration that the Proposed Contractor’s Unique Qualifications or the Nature of the Acquisition Requires using the Authority Cited: The DEA Laboratory System operates using Mettler Toledo balances. Balance sensitivity is maintained by performing internal adjustments which utilize an internal mass that only Mettler Toledo has the ability to adjust. The software required for this internal mass adjustment is only available to Mettler Toledo technicians and is not available to other contractors. To have another contractor calibrate the balances without the internal mass calibration would put DEA in non-compliance with accreditation standards. (sole source vendor letter in the file).

a. Name and address of the proposed contractor(s). Mettler-Toledo, LLC. 1900 Polaris Parkway, Columbus, OH 43240-4035

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). To mitigate risk of inaccurate results, SF requires the on-site annual calibration of all balances by an ISO/IEC 17025 – accredited calibration laboratory/vendor. For Mettler-Toledo balances, the external calibration must be performed by Mettler-Toledo calibration technicians as the Mettler-Toledo calibration process and software can challenge internal weights that are part of the balance; third party vendors are not situated to evaluate these internal weights.

6. Description of Efforts Made to Ensure that Offers are Solicited from as Many Potential Sources as Possible, Including Whether a Notice was or will be Publicized as Required by Part 5 and, if not, Which Exception under Part 5 Applies: Mettler Toledo is the sole proprietors of servicing the instruments. Mettler Toledo, LLC does not train any third parties on maintenance/certification/repair of their instruments needed to perform internal mass adjustment required under the BPA.

The following should also be addressed in this paragraph:

a. Sources Sought Synopsis. After conducting market research, it was revealed that Mettler Toledo, LLC is the sole provider for Balance Calibrations (maintenance/certification/repair). A Special Notice will be posted on SAM.gov. Interested bidders can respond if they are able to provide the required brand name.

b. Synopses of Proposed Contract Actions. A special notice will be published on sam.gov to confirm no other vendor can provide the service.

c. Other Actions. The AbilityOne Program was searched with no results.

d. Qualifying Country Sources. None

7. Contracting Officer’s Determination that the that the Anticipated Cost to the Government will be Fair and Reasonable: Prior to award, prices will be determined fair and reasonable based on historical data and discounts offered to the Government.

8. Market Research Conducted (See Part 10) and the Results or a Statement of the Reason Market Research was not Conducted:

Initial market research was conducted and reveled that Mettler Toledo, LLC is the sole provider and does not train third parties on maintaining their equipment. The features of the brand name are essential to the requirements and market research indicates other companies’ similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency’s needs. The calibration required to meet accreditation standards requires software only available to Mettler Toledo technicians and is not available through other sources. The brand name of the equipment requiring calibration is essential for connectivity to a Mettler Toledo’s LabX System which is incorporated in a Laboratory Information Management System (LIMS).

9. Any Other Facts Supporting Using Other than Full a Open Competition. A Statement of Work for balance calibration is available but the Mettler Toledo restrictions cannot be overcome by competition.

a. When 6.103-1 is cited for follow-on acquisitions as described in 6.103-1(c)(2), an estimate of the cost to the Government that would be duplicated and how the estimate was derived. Not applicable

b. When 6.103-2 is cited, data, estimated cost, or other rationale as to whether and how much the

Government would be harmed. Not applicable

10. A Listing of the Sources, if any, that Expressed an Interest in the Acquisition in Writing. None

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition Before any Subsequent Acquisition for the Supplies or Services Required. The Mettler Toledo laboratory balances requiring calibration are integrated into a Laboratory Information Management System (LIMS) through Mettler Toledo LabX Software. All three components are necessary for laboratory analysis. The internal weight calibration required for accreditation can only be conducted by the Mettler Toledo service technicians. To remove this barrier to competition, the Mettler Toledo balances would require replacement by another manufacturer. The agency evaluated the cost of replacing balances during previous acquisitions and determined that the Office of Forensic Sciences would incur over $4 million in additional purchases of balances and software. Furthermore, the LIMS contract does not allow for new development in the current LIMS system, so adding any other brand name would cause a reporting issue with weights that the lab reports. The same barrier to competition would be present for the calibration of balances for any other manufacturer. Competition will be considered for future requirements if in the best interest of the DEA/Government.

12. Technical / Requiring Office’s Certification:

Signature Date

13. Contracting Officer’s Certification that the Justification is Accurate and Complete to the Best of the Contracting Officer's Knowledge and Belief.

14. Approvals: The required levels of approval of this Justification depend on the estimated total value of the procurement. Approval must be obtained for that level and each previous level.

Contracting Officer (for actions ≤ $900,000)

Bureau Competition Advocate (for actions greater than $900,000 up to $20 million)

Bureau Procurement Chief (for actions over $900,000)

Head of the Contracting Agency of Designee (for actions of $20 million to $90 million)

Senior Procurement Executive (for actions over $90 million)