A13. JA_3.6.24.pdf signed.pdf

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Template for Justification and Approval for Other Than Full and Open Competition Completion Instructions: The Department of Health and Human Services (HHS) has established a standard template for the preparation of a J&A for Other Than Full and Open Competition. If this is an 8(a) set-aside, please note this form is not required unless the acquisition is valued (including all options) at greater than $22 million. This template is NOT applicable for actions using simplified acquisition procedures (FAR Part 13), Federal Supply Schedule orders (FAR 8.4) or task or delivery orders subject to fair opportunity (FAR 16.505).

Tailor all aspects of this template to the individual acquisition. Consult FAR Subpart 6.3 for guidance. An addendum may be added in case additional space is needed.

When this document is printed, the blue italic instructions are automatically deleted on the printed version.

JUSTIFICATION AND APPROVAL FOR OTHER THAN FULL AND OPEN COMPETITION

2. Description of Action:

Nature:

Pricing:

Funds:

3. Description of Services or Supplies:

Basis for Approval (FAR 6.303-1(d)):

As applicable, briefly describe the services or supplies required to meet the agency's needs, including make & model number where appropriate. Include quantities of supplies or period of performance for services. Provide information for any options included. If the action is a modification to an existing contract, distinguish clearly between the work covered by the original contract and the work to be obtained by the proposed modification.

4. Authority and Rationale: Identify the statutory authority, FAR title and FAR citation permitting other than full and open competition. It may be one of the following most commonly used citations by the operating divisions of the Department of Health and Human Services (HHS), but other exceptions may apply per FAR Subpart 6.3.

Actions other than simplified acquisition procedures (select only one and provide an explanation):

Explain why the intended contractor is the only responsible source who can provide the required supplies or services. Discuss the unique capabilities, expertise, etc. that support the lack of competition/why no other type of supplies or services will satisfy agency requirements. Explain factors/unique qualifications such as proprietary data or exclusive licensing rights, if applicable. When competition is limited to items particular to one manufacturer, this justification must explain why the particular brand name, product, or feature is essential to the Government's requirements, and that 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 in accordance with FAR 11.105. If in connection with a follow-on contract for continued development or production of highly specialized equipment, detail the substantial duplication of cost or unacceptable delays. May not Exceed one year, including all options, unless the head of the agency (Secretary of HHS) determines that exceptional circumstances apply.

If unusual and compelling urgency is the basis for the justification, explain the chronological events leading up to the requirement and explain why time constraints cannot permit even a limited competition. Describe the detrimental effects/serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved. Describe impact of required delivery/performance date. Describe the detrimental effects/serious injury to the mission of the requiring activity or to the government, financial or otherwise, that will result if this justification is not approved and the product or service cannot be provided by the intended sole source contractor. Failure to plan for expiring funds is not a valid reason for citing this exception. May not exceed one year, including all options, unless the head of the agency determines that exceptional circumstances apply.

Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.

Provide the authority and citation to the applicable section of FAR 6.3.

Provide a full explanation to justify use of the exception.

5. Agency Actions to Take or Remove Barriers That Led to Other Than Full and Open Competition (If applicable):

Describe the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration prior to any subsequent acquisition for the supplies of services is made. If no such actions have been taken, explain why.

6. Bridge Contracts:

For contract extensions or bridge contracts when a competitive follow-on is in the process of being developed, summarize history of current contract and explain the reasons for any delays in the acquisition. Include discussion of the milestones for the follow-on action; the milestones should be as efficient as possible. Discuss why it would be neither cost effective nor realistic to expect another contractor to perform during the brief interim period; include issues such as start-up costs, phase-in, transfer of GFP, recruitment and staffing, etc. If the action is because of a protest, provide a brief discussion of the protest including the date the protest was filed and the basis of the protest. Explain that the action will provide the minimum quantity or performance period.

7. Actions to Increase Competition:

Describe efforts made to compete the action, including whether a notice was or will be publicized as required by FAR Subpart 5.2 or which exception under FAR 5.202 applies. If a notice was publicized, discuss the number of written responses to the synopsis and the results of the assessment of the written responses. List sources, if any, that expressed, in writing, an interest in the acquisition. Provide rationale if interested sources were rejected. If applicable, state that no other sources have expressed interest, but all offers received shall be considered. Describe what actions will be taken to increase competition before subsequent acquisition of the supplies or services is required. You may state that an action is a one-time requirement, but if a similar requirement arises, every effort will be made to compete it to the maximum extent possible. If action is sole source because of proprietary data or licensing rights and there will be a continuing need for the requirement, there must be evidence that advanced planning has been initiated to overcome the barriers to competition, or there should be documentation to support an analysis that replacement costs/licensing purchase costs outweigh the benefits of competition. If the action is a contract extension or bridge, explain actions to compete the follow-on. If action is an urgent new requirement and a competitive follow-on is anticipated, explain that efforts are underway to facilitate a full and open competition.

8. Market Research:

Describe the extent of the market research conducted to identify all qualified sources and the results thereof. “Market Research” is defined as those attempts you made to ascertain whether other qualified sources exist, and can include contact with knowledgeable experts regarding similar or duplicate requirements, contact with industry, results of a sources sought synopsis, or draft solicitations. Research of the marketplace may consist of written, electronic (i.e. email) telephonic, or world wide web inquiries. Lack of advanced planning is not an acceptable reason for the lack of market research, but true urgency may necessitate abbreviated market research that is limited to readily available historical and commercial information. If action is a contract extension or bridge contract, describe the market research efforts underway or completed for the follow-on. See FAR 10.002(b)(2).

9. Procurement History:

Was action competed?

If action was not competed, state the cited authority, summarize rationale, and describe the actions that were supposed to be taken to increase competition and the results thereof:

10. Additional Information to support the justification:

If applicable, explain why technical packages or specifications to facilitate competition were not developed or available; describe actions taken to remedy the situation.

11. Technical / Requirements Certification: By my signature below, I certify that the supporting data included in this J&A is accurate and complete.

Program Manager Name:

Position Title:

Email address:

Phone:

Program Manager Supervisor (or one level above Program Manager) Name:

Position Title:

Email address:

Signature:

Date:

12. Fair and Reasonable Price/Cost Determination: As Contracting Officer, by my signature below, I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable.

Provide the basis for this determination, e.g., describe techniques to be used to determine fair and reasonable price (FAR Subpart 15.402), such as price analysis, cost analysis, cost realism. Per FAR Subpart 15.403-4(a)(1), the threshold for obtaining cost or pricing data is $750,000.

Name:

Phone:

Signature:

Date:

13. Contracting Officer's Approval (Required for proposed contract not to exceed $700,000 (value calculated including all options)): I hereby certify that this justification is accurate and complete to the best of my knowledge. I approve this justification subject to availability of funds, and provided that the services and supplies herin describe have otherwise been authorized for acquisition.

Name:

Phone:

Signature:

Date:

14. Legal Review:

All J&As greater than $68 million must have a legal review from the General Law Division of the Office of the General Counsel prior to sending it to the Department.

15. OPDIV Competition Advocate Approval (Required for proposed contract over $700,000 but not exceeding $13.5 million value calculated including all options)):

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name:

Phone:

Signature:

Date:

16. Office of Small and Disadvantaged Business Utilization:

I have reviewed this justification and find that it adequately supports other than full and open competition.

Name:

Phone:

Signature:

Date:

17. OPDIV HCA Approval (Required for proposed contract over $13.5 million but not exceeding $68 million value calculated including all options)):

Name:

Phone:

Signature:

Date:

18. Department Competition Advocate:

Concur:

Non-Concur:

Name:

Phone:

Signature:

Date:

(The below approval paragraph is required if the cumulative contract value, including all options, exceeds $68 million.)

19. HHS Senior Procurement Executive (SPE) Approval:

Based on the foregoing justification, I hereby approve other than full and open competition for the above stated procurement, subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

State supplies/services being procured:

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304:

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304 Name:

Phone:

Signature:

Date:

11.0.0.20130303.1.892433.887364 Justification & Approval - Other Than Full and Open Competition Health and Human Services Justification & Approval - Other Than Full and Open Competition

NCIRD/ID owns a significant number of Illumina next-generation sequencing instruments, including MiSeq, MiSeqDX and NextSeq 550 instruments.. The NextSeq 550 System has a maximum output of 120 Gb and 400 million reads per run. The MiSeq system has a maximum output of 15 Gb and 25 million reads per run. These instruments are used in analyses performed for high-throughput influenza surveillance, emergency response, and research and development in preventing the spread of influenza viruses, reducing the severity of the disease, and protecting vulnerable populations from serious complications. These instruments are highly complex, and maintenance/repair requires a high degree of technical proficiency and training. In order to ensure readiness to respond to the event of an emergency response it is crucial that these instruments are able to run 95% of the time. The period of performance will be for five (5) years between Apr 1, 2024 – Mar 31, 2029.

Base Period: Apr 1, 2024 – Mar 31, 2025 Option Period One: Apr 1, 2025 – Mar 31, 2026 Option Period Two: Apr 1, 2026 – Mar 31, 2027 Option Period Three: Apr 1, 2027 – Mar 31, 2028 Option Period Four: Apr 1, 2028 – Mar 31, 2029

As per Policy's guidance due to the lack of a formal FAR PART 13.5 template, this template is being used for this sole source justification to comply with the requirements as listed FAR PART 13.501.

Illumina, Inc. manufactures 50% of all parts directly. The majority of these parts cannot be alternatively sourced. Illumina, Inc. manufactures its parts using specific quality standards and packages under proprietary critical clean conditions. Illumina, Inc. stocks the appropriate inventory of parts so that global supply is assured. regarding technical expertise, Illumina, Inc. provides a comprehensive customer technical support and expertise on all Illumina, Inc. instruments, informatics, and chemistry only available from Illumina, Inc. and its systems. Illumina, Inc. offers a platform of tools capable of remotely diagnosing issues to ensure maximum uptime. Illumina, Inc. does not provide software and firmware coverage to any other company. Many fixes for system issues are through software and firmware that are not available to other companies. Only Illumina, Inc. service engineers have access to Illumina, Inc. engineering and development teams for global, expert support when resolving any issues. Regarding training, Illumina, Inc. service engineers are factory-certified who are up to date on all system upgrades and customer feedback. Illumina, Inc. certified customer training is only available from Illumina, Inc. Regarding upgrades, Illumina, Inc. instruments may be entitled to factory directed updates which are provided only by Illumina, Inc. Any instrument and software upgrades for Illumina, Inc. systems are only available from Illumina, Inc. For compliance, Illumina, Inc. provides automated and streamlined qualification protocols for all Illumina, Inc. systems. Customers with an Illumina, Inc. maintenance agreement are provided priority response times for preventative maintenance and repair services. The services required by this contract are not available from a current Best-In-Class mechanism. The services do not fall under a FAR Part 8 mandatory sources.

Illumina is the manufacturer of the equipment, who can provide certified trained personnel and original manufacturer parts. Also, Illuimina is the only vendor who can continue the exact protocols required to service the equipment in the laboratory.

Future requirements will be re-evaluated to determine if additional sources can meet the requirement.

State the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 3304: NCIRD-ID conducted comprehensive market research that began in October 2023 and concluded in November 2023. The research included internet searches of businesses with the same NAICS code and searches specifically for Illumina, Inc. instruments repair and service. Also reviews of GovCB site, SAM.gov site, and GSA schedule site.

Using NAICS Code 334516 (Analytical Laboratory Instrument Manufacturing) to identify contractors having the capabilities to support the required level of service. Among the laboratory vendors who populated the search who are known instrument distributors and could potentially provide maintenance to laboratory instruments included: AB Sciex, Inc., Abbott Laboratories, Inc., Agilent Technologies, Inc., Luminex Corp., Roche Diagnostics Corporation, Shimadzu Scientific Instruments, Inc. Siemens Healthcare Diagnostics, Inc., Thermo Electron North America LLC, and Waters Technologies Corporation. To narrow the search, NAICS code 334516 was combined with the key word ‘Illumina’ which generated one small business named Geo-Med, LLC, which was a medical equipment and supply company, but they did not offer on-site preventative maintenance of Illumina laboratory equipment.

The most recent market research conducted confirmed details identified earlier in regards that Illumina, Inc. is the best option for meeting the needs of NCIRD/ID.

A review of potential contractors on GSA Schedule 66, SIN 502; SIN 615 5000 was conducted and yielded that no other GSA contract holders were capable of the technical requirements. Illumina, Inc. has performed this current work under contract 75D301-22-P-14467 awarded in FY 2022 with a 1-year period of performance (9/9/2022 – 9/8/2023). Contract -75D301-22-P-13835 awarded in FY 2022 with a 1-year period of performance (5/1/2022 – 4/30/2023). Contract 75D301-19-P-05080 awarded in FY 2019 with a 3-year period of performance (8/17/2019 – 8/16/2022). Contract 75D301-19-F-04535 awarded in FY 2019 with a 5-year period of performance (4/1/2019 – 3/31/2024) and contract 75D301-18-P-01933 awarded in FY 2018 with a 5-year period of performance (7/1/2018 – 6/30/2023). Most contracts were awarded using a Justification and Approval for Other than Full and Open Competition document.(J&A) The J&As were posted in accordance with FAR procedures.

NCIRD/ID owns a significant number of Illumina next-generation sequencing instruments, including MiSeq, MiSeqDX and NextSeq 550 instruments.. The NextSeq 550 System has a maximum output of 120 Gb and 400 million reads per run. The MiSeq system has a maximum output of 15 Gb and 25 million reads per run. These instruments are used in analyses performed for high-throughput influenza surveillance, emergency response, and research and development in preventing the spread of influenza viruses, reducing the severity of the disease, and protecting vulnerable populations from serious complications. These instruments are highly complex, and maintenance/repair requires a high degree of technical proficiency and training. In order to ensure readiness to respond to the event of an emergency response it is crucial that these instruments are able to run 95% of the time. The period of performance will be for five (5) years between Apr 1, 2024 – Mar 31, 2029.

Base Period: Apr 1, 2024 – Mar 31, 2025 Option Period One: Apr 1, 2025 – Mar 31, 2026 Option Period Two: Apr 1, 2026 – Mar 31, 2027 Option Period Three: Apr 1, 2027 – Mar 31, 2028 Option Period Four: Apr 1, 2028 – Mar 31, 2029

As per Policy's guidance due to the lack of a formal FAR PART 13.5 template, this template is being used for this sole source justification to comply with the requirements as listed FAR PART 13.501.