JOFOCGold_Standard_Diagnostics.pdf

Template for a Federal Supply Schedule (FSS) Limited-Sources Justification

Completion Instructions: HHS has established a standard template for the preparation of a Limited-Sources Justification (LSJ) pursuant to FAR Subpart 8.4. This template is for use with orders issued under the Federal Supply Schedule (FSS) program where the value exceeds simplified acquisition threshold and competition is restricted: (1) to fewer schedule contractors than required in FAR 8.405-1 or 8.405-2, or (2) to an item peculiar to one manufacturer. See FAR Subpart 8.4 for additional guidance. This template is not for use with acquisitions other than those under FAR Subpart 8.4.

Tailor all aspects of this template to the individual acquisition. Consult FAR 8.405-6 for guidance.

Delete the highlighted portions of this document prior to signature. Do not include these instructions in the final document or contract file.

FEDERAL SUPPLY SCHEDULE

LIMITED-SOURCES JUSTIFICATION

Acquisition Title: Gold Standard Diagnostics Laboratory Supplies

Agency: IHS

Acquisition Year: 2018

Author: Moses Akoju / Deana Thompson

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:

<For each proposed contractor if more than one (e.g., brand name):>

Name of Proposed Contractor(s): Gold Standard Diagnostics

Street Address: 2851 Spafford Street

City, State, Zip: Davis, CA 95618

Remove ContractorAdd Contractor

3. Description of Supplies or Services:

ID/IQ Contract is needed for reoccurring supplies which will decrease the amount of purchases on the PCard. The Contractors shall provide Gold Standard Diagnostics laboratory supplies for Phoenix Indian Medical Center (PIMC), Phoenix, Arizona, which include but not limited to the attached listing. The period of performance shall be for a Base Year plus Four (4) one (1)-year Option Years commencing from the date of award of the contract. Option year renewals are not executed unless by a written modification to the contract and approved by the Contracting Officer.

Gold Standard Diagnostics supply items are uniquely designed for the Gold Standard Diagnostics instrument. Gold Standard Diagnostics supplies are used for specimen processing that are being used in the Gold Standard Diagnostics instrument and only Gold Standard Diagnostics supplies can be used. There are no other supply items that are equal or can be used in the Gold Standard Diagnostics instruments.

The estimated value of the proposed action, including all options, is $ 96,000.00

Briefly describe the supplies or services to be provided, including make & model number where appropriate. Indicate whether the item to be procured is peculiar to one manufacturer (e.g., a particular brand name, product, or a feature of a product, peculiar to one manufacturer). If applicable, include quantities of supplies or period of performance for services. Provide information for any options included in the order. If the action is a modification to an existing order, distinguish clearly between the work covered by the basic order and the work to be obtained by the proposed modification.

ID/IQ Contract is needed for reoccurring supplies which will decrease the amount of purchases on the PCard. The Contractors shall provide Gold Standard Diagnostics laboratory supplies for Phoenix Indian Medical Center (PIMC), Phoenix, Arizona, which include but not limited to the attached listing. The period of performance shall be for a Base Year plus Four (4) one (1)-year Option Years commencing from the date of award of the contract. Option year renewals are not executed unless by a written modification to the contract and approved by the Contracting Officer.

Gold Standard Diagnostics supply items are uniquely designed for the Gold Standard Diagnostics instrument. Gold Standard Diagnostics supplies are used for specimen processing that are being used in the Gold Standard Diagnostics instrument and only Gold Standard Diagnostics supplies can be used. There are no other supply items that are equal or can be used in the Gold Standard Diagnostics instruments.

4. Authority:

ORDER AGAINST FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 U.S.C. 251, et seq.); Title 40 U.S.C. 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception and for each discuss how the cited authority applies in accordance with FAR 8.405-6(c)(2)(iv).

An urgent and compelling need exists, and following the procedures would result in unacceptable delays (FAR 8.405-6(a)(1)(i)(A));

Only one source is capable of providing the supplies or services required at the level or quality required because the supplies or services are unique or highly specialized (FAR 8.405-6(a)(1)(i)(B)); or

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited sources procedures (FAR 8.405-6(a)(1)(i)(C)); or

An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer. (FAR 8.405-6(b);

Describe in detail why a particular brand name, product, or a feature of a product, peculiar to one manufacturer must be used. Also, describe in detail the existence of other than the “Name Brand” product and discuss why they cannot be used.

Gold Standard Diagnostics supply items are uniquely designed for the Gold Standard Diagnostics instrument. Gold Standard Diagnostics supplies are used for specimen processing that are being used in the Gold Standard Diagnostics instrument and only Gold Standard Diagnostics supplies can be used. There are no other supply items that are equal or can be used in the Gold Standard Diagnostics instruments.

5. Market Research:

Describe the extent of the market research conducted among the schedule holders and the results, or a statement of the reason that market research was not conducted. Brand name specifications shall not be used unless the particular brand name, product, or feature is essential to the Government’s 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 need.

Market research was conducted on search of GSA e-Library and GSA advantage website, Gold Standard Diagnostics supplies are available on GSA. Authorized distributors for the supplies are required to perform the testing on Gold Standard Diagnostics instruments.

Gold Standard Diagnostics instruments in the Lab department only take supplies that are proprietary to those instruments.

6. Actions to Increase Competition:

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 or services is made. If no such actions have been taken, explain why.

N/A

7. Any other facts supporting the justification:

N/A

8. Technical / Requirements Certification: By my signature below, I certify that the supporting data under my review which is included in this Limited-Sources Justification is accurate and complete.

Program Manager

Name: Moses Akoju

Position Title: Supervisor - Chemistry

Email address: moses.akoju@ihs.gov

Phone: 602-263-1200

Program Manager Supervisor (or one level above Program Manager)

Name: Adrienne Frazier

Position Title: Lab Manager

Email address: adrienne.frazier@ihs.gov

Signature

Date: 8/1/2018

9. Best Value Determination. By my signature below, after review of the relevant documents, I have determined that the order subject to this Limited-Sources Justification represents the best value for the Government as set forth in FAR 8.404(d), and constitutes a fair and reasonable price. The basis for my determination is as follows:

Describe in detail the basis for the determination that this order providers the best value, and that the price is fair and reasonable.

Attach and/or summarize applicable market research, commercial prices lists, comparable GSA schedule pricing or other markers that were used in this determination.

This requirement will represent the best value to the government based on FAR Part 8.404(d). The prices have been determined fair and reasonable at time of negotiation and published pricelist and previous purchasing history will be used to determine price reasonableness and best value. Due to the unique nature of the components, it is the best value for the government to purchase the supply items for the instruments that are manufactured by Gold Standard Diagnostics.

10. 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 sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name: Barbara V. Bonnette Phone: 6023645018

Signature: Date: Aug 3, 2018

11. Legal Review:

All J&As equal to or 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.

12. 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:

13. 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:

14. 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:

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

HHS Senior Procurement Executive (SPE) Approval Based on the foregoing justification, I hereby approve the procurement of (state supplies/services being procured) on an other than full and open competition basis pursuant to the authority of (state the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 251), as implemented by FAR 8.405-6), subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

Name: Phone:

Signature: Date:

Template for a Federal Supply Schedule (FSS) Limited-Sources Justification

Completion Instructions: HHS has established a standard template for the preparation of a Limited-Sources Justification (LSJ) pursuant to FAR Subpart 8.4. This template is for use with orders issued under the Federal Supply Schedule (FSS) program where the value exceeds simplified acquisition threshold and competition is restricted: (1) to fewer schedule contractors than required in FAR 8.405-1 or 8.405-2, or (2) to an item peculiar to one manufacturer. See FAR Subpart 8.4 for additional guidance. This template is not for use with acquisitions other than those under FAR Subpart 8.4.

Tailor all aspects of this template to the individual acquisition. Consult FAR 8.405-6 for guidance.

Delete the highlighted portions of this document prior to signature. Do not include these instructions in the final document or contract file.

FEDERAL SUPPLY SCHEDULE

LIMITED-SOURCES JUSTIFICATION

2. Description of Action:

Nature:

Pricing:

Funds:

<For each proposed contractor if more than one (e.g., brand name):>

3. Description of Supplies or Services:

Briefly describe the supplies or services to be provided, including make & model number where appropriate. Indicate whether the item to be procured is peculiar to one manufacturer (e.g., a particular brand name, product, or a feature of a product, peculiar to one manufacturer). If applicable, include quantities of supplies or period of performance for services. Provide information for any options included in the order. If the action is a modification to an existing order, distinguish clearly between the work covered by the basic order and the work to be obtained by the proposed modification.

4. Authority:

Describe in detail why a particular brand name, product, or a feature of a product, peculiar to one manufacturer must be used. Also, describe in detail the existence of other than the “Name Brand” product and discuss why they cannot be used.

5. Market Research:

Describe the extent of the market research conducted among the schedule holders and the results, or a statement of the reason that market research was not conducted. Brand name specifications shall not be used unless the particular brand name, product, or feature is essential to the Government’s 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 need.

6. Actions to Increase Competition:

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 or services is made. If no such actions have been taken, explain why.

7. Any other facts supporting the justification:

8. Technical / Requirements Certification: By my signature below, I certify that the supporting data under my review which is included in this Limited-Sources Justification 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:

9. Best Value Determination. By my signature below, after review of the relevant documents, I have determined that the order subject to this Limited-Sources Justification represents the best value for the Government as set forth in FAR 8.404(d), and constitutes a fair and reasonable price. The basis for my determination is as follows:

Describe in detail the basis for the determination that this order providers the best value, and that the price is fair and reasonable. Attach and/or summarize applicable market research, commercial prices lists, comparable GSA schedule pricing or other markers that were used in this determination.

10. 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 sole source justification subject to availability of funds, and provided that the services and supplies herein described have otherwise been authorized for acquisition.

Name:

Phone:

Signature:

Date:

11. Legal Review:

All J&As equal to or 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.

12. 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:

13. 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:

14. 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:

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

HHS Senior Procurement Executive (SPE) Approval Based on the foregoing justification, I hereby approve the procurement of (state supplies/services being procured) on an other than full and open competition basis pursuant to the authority of (state the full statutory authority and FAR cite and title, consistent with paragraph 4, e.g. 41 U.S.C. 251), as implemented by FAR 8.405-6), subject to the availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

Name:

Phone:

Signature:

Date:

11.0.0.20130303.1.892433.887364 Justification & Approval - Federal Supply Schedule Health and Human Services Justification & Approval - Federal Supply Schedule

Gold Standard Diagnostics supply items are uniquely designed for the Gold Standard Diagnostics instrument. Gold Standard Diagnostics supplies are used for specimen processing that are being used in the Gold Standard Diagnostics instrument and only Gold Standard Diagnostics supplies can be used. There are no other supply items that are equal or can be used in the Gold Standard Diagnostics instruments.

TextField8: ID/IQ Contract is needed for reoccurring supplies which will decrease the amount of purchases on the PCard. The Contractors shall provide Gold Standard Diagnostics laboratory supplies for Phoenix Indian Medical Center (PIMC), Phoenix, Arizona, which include but not limited to the attached listing. The period of performance shall be for a Base Year plus Four (4) one (1)-year Option Years commencing from the date of award of the contract. Option year renewals are not executed unless by a written modification to the contract and approved by the Contracting Officer.

Gold Standard Diagnostics supply items are uniquely designed for the Gold Standard Diagnostics instrument. Gold Standard Diagnostics supplies are used for specimen processing that are being used in the Gold Standard Diagnostics instrument and only Gold Standard Diagnostics supplies can be used. There are no other supply items that are equal or can be used in the Gold Standard Diagnostics instruments.

Gold Standard Diagnostics instruments in the Lab department only take supplies that are proprietary to those instruments.