HHS JOFOC for MiSeq_kcb_nc_bb.pdf

Justification for Other than Full and Open Competition

“Source Selection Information – see FAR 2.101 and 3.104”

1. Identification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS, National Institutes of

Health(NIH)

b. Sponsoring organization. Clinical Center (CC), Department of

Transfusion Medicine (DTM), Human Leukocyte Antigen (HLA)

Laboratory

c. Project Officer Information.

• Project Officer Name:

Kathleen C Barracchini, Certified Histocompatibility Specialist

(CHS), American Board of Histocompatibility and

Immunogenetics (ABHI)

Technical Specialist

• Mailing Address: DHHS/ NIH/CC / Department of Transfusion

Medicine/Human Leukocyte Antigen (HLA) Laboratory

Building 10, Room 1C744

10 Center Drive, MSC-1288

Bethesda, Maryland 20892-1288

• Email Address: kbarracchini@cc.nih.gov

• Telephone: (301) 496-8852

2. Nature and/or description of the action being approved.

a. Acquisition purpose and objectives. The purpose of this acquisition is to purchase an Illumina MiSeq Next Generation Sequencer. This instrument will be used by the NIH HLA Lab to produce high resolution HLA typing results for the numerous transplant protocols supported by the laboratory

b. Project background. The MiSeq is an integrated instrument that performs clonal amplification, genomic DNA sequencing, and data analysis with base calling, alignment, variant calling, and reporting in a single run. The MiSeq will provide the Lab with the highest HLA typing results possible. The transplant protocols served by the HLA Lab require highest resolution possible to increase the chance of a successful transplant.

mailto:kbarracchini@cc.nih.gov

The HLA Lab currently owns one MiSeq instrument, so the procedures and Quality Control assessments are in place. This acquisition is to be placed using CERC funds. The order will replace the ABI 3730 xL sequencer - s/n 17118-001. The Biomed number on this instrument is 34994. The MiSeq instrument is capable of much higher HLA typing resolution.

3. Description of the supplies or services required to meet the agency’s needs (including the estimated value).

a. Project title. Purchase of the Illumina MiSeq Next Generation Sequencer.

b. Project description. The vendor will provide the Illumina MiSeq Next Generation Sequencer.

• Requirement type.

❑ Research & development (R&D) ❑ R & D support services

❑ Support services (non-R&D)

X Supplies/equipment

❑ Information technology (IT)

❑ Construction

❑ Architect-engineer (A & E) services

❑ Design-build

❑ Other (specify): ____________________

• Type of action.

X New requirement ❑ Follow-on

❑ Other (specify): ______________________

• Proposed contract/order type. :

X Firm-fixed-price ❑ Other fixed-price (specify, e.g., fixed-price award-fee, fixed-price incentive-fee): __________ ❑ Cost-plus-fixed-fee ❑ Other cost reimbursement (specify, e.g., cost-plus-award-fee, cost-plus-incentive-fee): ___________ ❑ Time and materials ❑ Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________

❑ Other (specify): ___________

❑ Completion Form ❑ Term form

• Acquisition identification number. POTS 21-008488

c. Total estimated dollar value and performance/delivery period. The instrument will cost $94050.00. Shipping/Handling/Insurance will cost $1410.75. Total investment is $95,460.75. This includes delivery and set up of the instrument. The instrument will be available for delivery upon completion of the ordering process.

4. Identification of the statutory authority permitting other than full and open competition.

This acquisition is conducted under the authority of 41 United

States Code (U.S.C.) 253(c)(_1_) as set forth in Federal Acquisition Regulation (FAR) 6.302- _1_.

❑ This acquisition is conducted under the authority of section 4202 of the Clinger-Cohen Act of 1996.

❑ This acquisition is conducted under the authority of the Services Acquisition Reform Act of 2003 (41 U.S.C. 428a).

5. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited.

a. Name and address of the proposed contractor(s). Illumina, Inc. 5200 Illumina Way, San Diego CA 92122-4616

b. Nature of the acquisition and proposed unique qualifications of the contractor(s). Illumina Inc. is the manufacturer of this instrument, so it can only be purchased thru them. The HLA Lab requires this specific instrument because it currently has one in the lab, and all procedures and Quality Control assessments have been made for this instrument.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. Indicate whether a FedBizOpps notice was or will be publicized as required by FAR Subpart 5.2 and, if not, which exception under FAR 5.202 applies. Due to the fact that this instrument is only available thru this vendor, no other sources will be solicited.

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable. The vendor quote provided provides the instrument at the same cost as our original instrument cost in 2015.

This is a fair and reasonable price.

7. Description of the market research conducted (see FAR Part 10) and the results, or a statement of the reasons market research was not conducted.

Notice of intent HHSNCCOPC21-008488 published on 4/28/2021.

9. Any other facts supporting the use of other than full and open competition.

There are no other factors supporting the use of other than full and open competition.

10. Listing of sources, if any, that expressed, in writing, an interest in the acquisition.

11. Statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the required supplies or services. N/A

12. Program office certification.

This is to certify that the portions of this justification that have been developed by the undersigned program office personnel, including supporting information and/or data verifying the Government’s minimum needs, schedule requirements and other rationale for other than full and open competition, are accurate and complete.

Official Name & Title Signature Date

Project Officer

Project Officer’s

Immediate Supervisor

Head of the Sponsoring

Program Office

13. Contracting Officer certification.

This is to certify that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete.

Official Name & Title Signature Date

Contracting Officer

Anthony Hawley, Section Chief – Section National Institutes of Health (NIH) Clinical Center (CC)/Office of

Purchasing and Contracts (OPC)

14. Chief of the Contracting Office and Head of the Contracting Activity signature(s).

Official Name & Title Signature Date

Chief of the Contracting

Office

Head of the Contracting

Activity

15. Competition Advocate signature.

Official Name & Title Signature Date

Competition Advocate

16. HHS Senior Procurement Executive signature.

Official Name & Title Signature Date

HHS Senior Procurement

Executive