JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION A2LA (002) signed.pdf

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the Agency and Contracting Activity:

Department of Energy, Idaho Operations Office Radiological & Environmental Sciences Laboratory (RESL)

In accordance with Federal Acquisition Regulations (FAR) 6.302-1, I hereby determine that laboratory accreditation services are available from only one source, American Association for Laboratory Accreditation (A2LA) and competition is precluded for the reasons indicated below.

2. Background nature and/or Description of the Action Being Approved:

This is a request for approval of a proposed firm-fixed-price contract with A2LA for the provision of operational accreditations for International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) and ISO standards.

RESL currently maintains accreditations for the following ISO/IEC and ISO standards:

1. ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories

2. ISO/IEC 17043:2023 — Conformity assessment – General requirements for the competence of proficiency testing providers

3. ISO 17034:2016 — General requirements for the competence of reference material producers

The estimated value of this proposed action is $77,450.00, covering a period of five (5) years.

This includes one (1) base year with four (4) option periods.

3. Description of the Supplies or Services Required to Meet the Agency's Needs:

The proposed acquisition is for accreditation services required to maintain continuous, uninterrupted operational accreditations for the agency. These services are essential to the overall mission and execution of operations, ensuring compliance with regulatory requirements and demonstrating competency in critical operational areas. The scope of services includes, but is not limited to, onsite assessments of operational facilities and processes, comprehensive document reviews for compliance verification, audit preparation and support activities, and ongoing maintenance of accreditation status. Failure to maintain continuous accreditations could result in severe implications, including risks to national security, public safety, mission continuity, and regulatory compliance. These services are integral to sustaining operational readiness and meeting statutory and regulatory obligations.

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

The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as implemented by FAR 6.302-1, "Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements."

5. Demonstration that the Proposed Contractor's Unique Qualifications or the Nature of the Acquisition Requires Use of the Authority Specified:

A2LA is uniquely qualified to provide the required accreditation services as they have continuously supplied these services to RESL since 2005 and remain the most cost-effective and operationally advantageous option to the government without any disruption or significant delays. The critical factor is the current provider’s existing accreditations and their in-depth understanding of the RESL's specific requirements and operational environment.

Specifically, the accreditation process for this type of service is highly rigorous and time-consuming. For any new contractor to provide these services, it would require RESL to face an extensive ramp up period thus causing significant disruptions and delays to operations. The extensive ramp-up period is estimated to be up to two years, to achieve the necessary accreditations and gain the specialized operational knowledge required to perform these services effectively. This transitional ramp up period would involve:

• Additional assessments and surveillances,

• Revisions to RESL’s management systems and procedures for compliance with the new provider’s internal policies and requirements,

• Staff training and qualifications to meet new policy requirements,

• Follow-up reviews and audits for verification,

• Acquiring proficiency in utilizing the new provider’s management systems,

• Establishing new communication channels and working relationships.

A break in these services, or a transition to a new provider requiring a two-year ramp-up, would result in unacceptable delays to the RESL’s ISO/IEC and ISO standards accreditations for operational purposes. These delays would directly impact the operational readiness of critical programs, the continuous provision of essential services, compliance with statutory mandates, and potentially expose the Government to financial, safety, and security risks. The critical nature of these services and the prohibitive timeline for a new provider to become proficient means that only A2LA can satisfy the agency's urgent and continuous requirements without causing serious injury or disruptions to program objectives.

6. Description of Efforts Made to Ensure that Offers are Solicited from As Many Potential Sources as is Practicable:

Market research conducted utilizing methods such as online databases, industry publications, previous procurement history, and direct inquiries to potential vendors—confirmed that no other providers possess the critical specific accreditations, historical context, or immediate operational readiness necessary to prevent a two-year transition delay. The unique interface requirements and specialized accreditations present significant barriers to entry for new providers within the agency's required timeframe. While a synopsis of the proposed contract action will be published on SAM.gov, it is not anticipated that other sources can meet these requirements without unacceptable delay, even considering potential responses.

Beyond international standard accreditations, all accrediting bodies impose their own supplemental policies and internal requirements that must be met for compliance. Consequently, transitioning to a new accrediting body would necessitate a complete overhaul of RESL's quality management system and require extensive mandatory assessments and surveillance activities to align with the new provider’s policies. This transition process alone is estimated to take a minimum of two years to complete and would impose significant operational challenges, disruptions, and costs on RESL that would outweigh any potential benefits of changing providers.

Would you like to explore how to further condense any specific sections or perhaps focus on strengthening the argument regarding the "unacceptable delay"?

7. Any Other Facts Supporting the Use of Other than Full and Open Competition:

The incumbent provider has consistently demonstrated exceptional performance in maintaining programmatic accreditation and successfully navigating complex regulatory landscapes. A change in provider at this juncture introduces an unacceptable level of risk to mission continuity.

8. List of Sources, if any, that Express Interest in the Acquisition:

None, other than the proposed provider.

9. Actions the Agency May Take to Remove or Overcome Barriers to Competition before Any Subsequent Acquisition:

Recognizing the current limitations, the agency will continue to monitor the market for new providers capable of meeting specialized accreditation requirements. Efforts will also focus on investigating alternative accreditation pathways that might reduce ramp-up times for new entrants, alongside engaging with industry to understand if technological advancements or standardized training programs could help overcome the existing two-year barrier.

CERTIFICATION

I certify that statements checked and information provided above are complete and correct to the best of my knowledge. In accordance with FAR 6.302-1, the processing of this sole-source justification precludes the use of full and open competition.

Andrew Hathaway Project Officer

Kendra Leatherwood Contracting Officer