A13 - JOFOC.pdf

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

Acquisition Title: Vantage Liquid Handling Robot Lab Equipment from Hamilton Robotics

Agency: CDC

Acquisition Year (FY): 2022

Author and Title: Janice Menuel / Management and Program Analyst

2. Description of Action:

Nature: New Requirement Follow-on Requirement

Modification to Existing Purchase Order/Contract Number:

Pricing: Firm-Fixed Price Time & Materials Cost

Other:

Funds: OMA Other Funds: Annual Funds

Name of Proposed Contractor(s): Hamilton Company

Street Address: 4970 Energy Way

City, State, Zip: Reno, NA 89502

3. Description of Services or Supplies:

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

The total estimated value of the proposed action, including all options is $ 2,586,812.09

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.

This requirement is to purchase 3 Hamilton Vantages MPEs (Main Power Enclosure) with Evaporators and 3 Hamilton Vantage MPEs.

The resulting award will also have the option to purchase 2 additional Vantage MPEs and a Hamilton AB 16 Channel. The government will have the right to exercise the option for up to 12 months following award.

This is a brand name requirement for Hamilton Robotics lab equipment. Delivery of the funded line items is to be on or before

9/30/2022. Delivery of the option line items (if exercised) is on or before 9/30/2023.

Lab Equipment 3 MPE with Evaporators 1 Hamilton Vantage 8 96 IPG MPE 1 Hamilton Vantage ABC 8 96 IPG MPE 1 Hamilton Vantage ABCD 8 96 MPE (Option) 1 Hamilton Vantage 8 96 MPE (Option) 1 Hamilton Vantage ABCD 8 96 MPE (Option) Hamilton Vantage 16 Channel

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):

FAR 6.302-1: Only one responsible source and no other supplies or services will satisfy agency requirements, 41 U.S.C.

3304(a)(1)

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.

To meet the needs of this Tobacco Exposure Biomarker assay, DLS requires a liquid handling robot that will assist in analyzing around 7,000 – 10,000 biological samples a year, primarily in support of the Population Assessment of Tobacco and Health (PATH) and NHANES study. While this sample load would be difficult to accurately process manually, Hamilton Robotics’ standard patented liquid level sensing and clot detection features are essential for quality specimen transfer in the Tobacco Exposure Biomarkers Laboratory. A crucial step of the DLS analytical detection method involves solid phase extraction and the subsequent drying of SPE plates and Hamilton Robotics offers an accessory, [MPE] 2, that automates this step. Automating solid phase extraction is essential for meeting the demands of the high sample load of the PATH study. Hamilton automated liquid handlers are capable of transferring liquid from a variety of source containers and vials to a number of vials and plates. Furthermore, this system has the ability to account for all actions and locations on the workstation as a standard function, a process that requires significant customization and cost with each of the other company products that were considered. DLS has also demonstrated with internal testing that the Hamilton Liquid handers allow for accurate volume delivery, precision, and the ability to be viable with a multitude of liquids. The Hamilton Vantage also has the capability to track of all errors and issues that arise. For these reasons, the Hamilton Vantage is the superior product with the highest value to the CDC.

FAR 6.302-2: Unusual and compelling urgency, 41 U.S.C. 3304(a)(2) 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.

FAR 6.302-5: Authorized or Required by Statute, 41 U.S.C. 3304(a)(5) Provide a citation to the statutory authorization and a brief description of its content, or identify the specified source or other agency.

Other (See FAR Subpart 6.3 for additional authority) 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.

Competition barriers are addressed by the DLS continued efforts to identify new and improved instrumentation/software and communicating the needs of our laboratory to both existing and potential vendors. CDC/NCEH laboratorians and health physicists have consulted with several instrument and software manufacturers, colleagues, and other federal agencies regarding needs confronted in the field of addictive and toxic compounds, specifically as it relates to tobacco use. Additional research and assessment of new and existing methods, instrumentation, and software conducted at CDC may serve as the foundation to eliminate some of the barriers currently limiting the use of services provided by other potential vendors in our laboratories.

However, currently, there are no other options available.

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.

This is not a bridge contract.

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.

Prior to the selection of the Hamilton Vantage, DLS reviewed product information at the Society for Laboratory Automation and Screening 2021 conference. This included demonstrations by vendors such as Tecan, Perkin Elmer, and Beckman Coulter.

Additionally, online information was reviewed including product literature and vendor sponsored YouTube videos that detail functionality. Finally, CDC laboratories that possess Tecan, Perkin Elmer, and Beckman Coulter equipment were visited, and these systems were observed in action in similar laboratory settings. Through this detailed market research, DLS were able to determine that the Hamilton Vantage is the only system that will satisfy the stated needs for this acquisition.

If other vendors are able to manufacture and make available for sale lab equipment comparable to the Hamilton Robotics systems that allow for the same methods as well as interoperability with existing lab equipment then DLS will consider.

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).

Other systems considered were:

- Tecan Fluent

- Perkin Elmer JANUS G3

- Beckman Coulter I Series systems These systems were rejected because they do not share interoperability with the current Hamilton platform that is currently used to process Cotinine urine/serum samples. There is no hardware or software cross compatibility between these potential products and current platforms, making the transfer of existing methods difficult and time consuming. These systems do not use similar lab ware, meaning that new hardware will have to be purchased for their operation. Additionally there is no internal knowledge of the similar operation or method development on these systems.

This requirement was initially submitted as a brand name competitive GSA delivery order. The requirement was posted but received no responses. Hamilton Company, the original equipment manufacturer, provided a letter indicating it is the sole source manufacturer and service provider. As a result, the government intends to negotiate and award a contract directly to Hamilton Company.

9. Procurement History:

Purchase order or contract number: N/A

Was action competed? Yes No

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: Janice Menuel

Position Title: Management and Program Analyst

(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:

This requirement is to purchase 3 Hamilton Vantages MPEs (Main Power Enclosure) with Evaporators and 3 Hamilton Vantage MPEs.

The resulting award will also have the option to purchase 2 additional Vantage MPEs and a Hamilton AB 16 Channel. The government will have the right to exercise the option for up to 12 months following award.

This is a brand name requirement for Hamilton Robotics lab equipment. Delivery of the funded line items is to be on or before 9/30/2022. Delivery of the option line items (if exercised) is on or before 9/30/2023.

Lab Equipment 3 MPE with Evaporators 1 Hamilton Vantage 8 96 IPG MPE 1 Hamilton Vantage ABC 8 96 IPG MPE 1 Hamilton Vantage ABCD 8 96 MPE (Option) 1 Hamilton Vantage 8 96 MPE (Option) 1 Hamilton Vantage ABCD 8 96 MPE (Option) Hamilton Vantage 16 Channel

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:

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

This is a brand name requirement for Hamilton Robotics lab equipment. Delivery of the funded line items is to be on or before 9/30/2022. Delivery of the option line items (if exercised) is on or before 9/30/2023.

Lab Equipment 3 MPE with Evaporators 1 Hamilton Vantage 8 96 IPG MPE 1 Hamilton Vantage ABC 8 96 IPG MPE 1 Hamilton Vantage ABCD 8 96 MPE (Option) 1 Hamilton Vantage 8 96 MPE (Option) 1 Hamilton Vantage ABCD 8 96 MPE (Option) Hamilton Vantage 16 Channel

If other vendors are able to manufacture and make available for sale lab equipment comparable to the Hamilton Robotics systems that allow for the same methods as well as interoperability with existing lab equipment then DLS will consider.

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

- Tecan Fluent

- Perkin Elmer JANUS G3

- Beckman Coulter I Series systems These systems were rejected because they do not share interoperability with the current Hamilton platform that is currently used to process Cotinine urine/serum samples. There is no hardware or software cross compatibility between these potential products and current platforms, making the transfer of existing methods difficult and time consuming. These systems do not use similar lab ware, meaning that new hardware will have to be purchased for their operation. Additionally there is no internal knowledge of the similar operation or method development on these systems.

This requirement was initially submitted as a brand name competitive GSA delivery order. The requirement was posted but received no responses. Hamilton Company, the original equipment manufacturer, provided a letter indicating it is the sole source manufacturer and service provider. As a result, the government intends to negotiate and award a contract directly to Hamilton Company.

This is a brand name requirement for Hamilton Robotics lab equipment. Delivery of the funded line items is to be on or before 9/30/2022. Delivery of the option line items (if exercised) is on or before 9/30/2023.

Lab Equipment 3 MPE with Evaporators 1 Hamilton Vantage 8 96 IPG MPE 1 Hamilton Vantage ABC 8 96 IPG MPE 1 Hamilton Vantage ABCD 8 96 MPE (Option) 1 Hamilton Vantage 8 96 MPE (Option) 1 Hamilton Vantage ABCD 8 96 MPE (Option) Hamilton Vantage 16 Channel