JOFAC19003718_BioRad_Sep2019.pdf

Justification for Other than Full and Open Gompetition

"Source Selection lnformation - see FAR 2.101 and 3.104'

1. ldentification of the agency and contracting activity.

a. Federal agency and contracting activity. HHS. National lnstitutes of Health

b. Sponsoring organization. National lnstitute on Deafness and Other Communication Disorders, Division of lntramural Research, Laborato Molecular Genetics. non H lrmân Genetics

c. Project Officer information.

o Project Officer.

. Mailing address.

o E-mail address.

Thomas B. Friedman. PhD.

354 Convent Drive. Rm 1F141 , 20892-3729 friedmantOn idccl nih oov o Telephone number. 301-496-7882

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

a. Acquisition purpose and objectives.

The purpose of this acquisition is to purchase a yearly service contract for the Bio Rad QX200 AutoDG Droplet Digital PCR (ddPCR) Sysfem- QX200 Auto DG ddPCR reader, QX200 Auto DG droplet generator, and PX1 Plate sealer. Authorizing legislation: 41 United States Code (U.S.c.) 253(c) and (FAR) 6.302

b. Project background.

Droplet Digital PCR is used to detect and absolutely quantify target nucleic acid molecules such as the number of genomic DNA copies of a gene, the number of mRNA in a cell or tissue or the number of alternative transcripts in a cell/tissue and its changes during development. The lab has been doing these experiments for years using a different platform that provides relative concentrations to controls, which is tedious and dependent on many assumptions that may or may not be correct. This system is complex and must be placed under a service contract in order to keep it working at the specifications set by the manufacturer, Bio-Rad Laboratories. lt is currently being used by numerous NIDCD laboratories

3. Description of the supplies or serv¡ces required to meet the agency's needs (including the estimated value).

a. Project title. Purchase of a Service Contract for the QX200 Auto DG

Droplet Dioital PCR (ddPCR) svstem

b. Projectdescription.

The Laboratory of Molecular Genetics identifies variants of genes associated with deafness or syndromes involving deafness. After identifying a "deafness gene", we then study the function of the gene, which is necessary for normal hearing. To do this the LMG develops mouse models of the human deafness gene. One basic question regards the cell type that expresses the particular gene. We also need to know the levels of expression of the gene during development and the various alternative transcripts of the gene and when and where they are expressed. The BioRad QX200 can generate more precise and reproducible data on gene transcript levels during development and the timing and quantity of expression of alternative transcripts of the gene being studied. Droplet Digital PCR is a significant advance in terms of ease of training staff and operation of the instrument, speed with which data can be obtained (hours instead of days), sensitivity to detect very rare transcripts, robust quantification and reproducibility over the previous qRT- PCR, which we have been doing for years.

Requirement type.

E Research & development (R&D) tr R&Dsupportservices EJ Support services (non-R&D) tr Supplies/equipment E lnformation technology (lT)

E Construction tr Architect-engineer (A & E) services tr Design-build E Other (specify): Maintenance Service Aoreement. 1vr. for the

QX200 AutoDG Droplet Diqital PCR Svstem

Type of action.

tr New requirement tr Follow-on E Other (specify): contract renewal for 9/15/19 - 9/14120 a

• Proposed contract/order type.

t&l 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.

Quote# 19-Q34648V5 is from Bio-Rad Laboratories

c. Total estimated dollar value and performance/delivery period.

· The period of one year, 9/15/19 - 9/14/20.

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

t&l[]This acquisition is conducted under the authority of 41 United States Code (U.S.C.) 253(c)(_) 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).

Bio-Rad Laboratorie,s, at 2000 Alfred Nobel Drive, Hercules, CA 94547 is the proposed contractor and manufacturer.

b. Nature of the acquisition and proposed unique qualifications of the contractor(s).

Bio-Rad, the manufacturer of the instrument, is the only company qualified to perform repairs and preventative maintenance oñ it. Due to the specific and patented engineering of the QX200 ddPCR System, there are no oeneric parts that can be used for repairs and any technician providing service must be trained by Bio-Rad, the manufacturer. All of the instruments in this platform are too complex to be serviced in house by members of the laboratory or ORF.

6. Description of the efforts made to ensure that offers are solicited from as many potential sources as practicable. lndicate 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

The solicitation will be posted on FedBizOpps as required by FAR Subpart 5.2

7. Determination by the Contracting Officer that the anticipated cost/price to the Government will be fair and reasonable

There are no other ddPCR platforms on the market other than this one from Bio- Rad Laboratories. Since the system is on FSS contract GS-07F-5934R, Sin # 615-1 , the GSA system has determined that the quoted price is fair and reasonable for the purchase of a new system. lt can be reasoned that the corresponding service contract otfered on the ddPCR System by Bio-Rad Laboratories would also be fair and reasonable

8. Description of the market research conducted (see FAR Part l0) and the results, or a statement of the reasons market research was not conducted

Market research reveals that there are no other companies capable of providing service for the ddPCR system than the manufacturer, Bio-Rad Laboratories.

Mandatory sources such as DSEIS, Diversified Laboratory Repair, and NIH

Stock do not provide service for any of the three instruments in this þlatform.

Government Scientific Services, the vendor who sold us the instrument, does not provide service, Since the patented technology used in this platform is a trademark of BioRad laboratories, only vendors trained and supported by Bio-

Rad may sell or provide service for this system. A search of the web shows that other vendors sell traditional digital PCR platforms, but no other vendors sell the new droplet digital PCR platform.

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

This new technology is useful to labs in the NIDCD who work with biological molecules found in low abundances (Drs. Griffith, Friedman, Hoa, Wu, Kelley) and thèrefore, the rapidity with which data can be generated makes the instrument available to numerous investigators for their studies of specific genes necessary for development, function or maintenance of the auditory system. lf any other vendor other than the manufacturer is selected, ongoing work could be delayed while its technicians learn about the equipment or wait for the correct parts to arrive. NIDCD labs cannot afford to wait for the new vendor to acclimate itself to the ddPCR system. As all of the experiments that use this instrument are time sensitive and on-going, any disruption in service could compromise the data and publication of the research results.

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

No other sources have expressed an interest, in writing, in the proposed acquisition.

I l. 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.

The LMG will purchase lab supplies that are not specific to this system from small vendors and mandatory sources.

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.

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.

DateSignatureName & TitleOfficial

{/rþfurr"r4 ø¿ãkt/'

Thomas B. Friedman, PhD Section and Laboratory Chief

NIDCD/National lnstitutes of Health

I

Project Officer fft/*' W,frAæfffiþV;ry7%

Andrew Griffith, M.D., Ph.D.

Scientific Director

NIDCD/National lnstitutes of Health

Project Officer's lmmediate Supervisor

Head of the Sponsoring

Program Office

Official Name & Title Signature Date

Contracting Officer

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

15. CompetitionAdvocatesignature.

16. HHS Senior Procurement Executive signature.

Official Name & Title Signature Date

Chief of the Contracting

Office

Head of the Contracting

Activity

Official Name & Title Signature Date

Competition Advocate

Official Name & Title Signature Date

HHS Senior Procurement

Executive