JOFOC - GeneDx 09.08.2020-DLM.pdf

Justification and Approval for Sole Source

“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

b. Sponsoring organization.

Clinical Center (CC), Department of Laboratory Medicine (DLM)

c. Project Officer information.

• Project Officer name.

Heather Crum, Laboratory Manager

• Mailing address.

NIH/CC/DLM, Bldg. 10/2C306, Bethesda, MD 20892

• E-mail address.

Heather.Crum@nih.gov

• Telephone number.

301-496-5668

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

a. Acquisition purpose and objectives.

This is a request for other than full and open competition to establish a six month contract extension for molecular diagnostic (mutation analysis) testing services to be provided by GeneDx Inc as needed for laboratory testing throughout the hospital. Existing contract 75N90019D00014 with incumbent GeneDx for specialized molecular diagnostic testing services will be ending on September 29, 2020. To ensure continuity of testing services which is currently provided to multiple Institutes with the National Institutes of Health, an interim contract needs to be established.

b. Project background.

The existing contract 75N90019D00014 with incumbent contractor GeneDx for specialized molecular diagnostic testing services needs to be continued for an additional six months to ensure continuity of testing services which is currently provided to multiple Institutes within the National Institutes of Health. The current IDIQ contract 75N90019D00014 was extended an additional twelve months from 9/30/2019 – 9/30/2020.

Due to this contract ending, as well as the fact that many more molecular diagnostic testing laboratories have recently come onto the market, the government needs enough time to perform a full assessment of the current variety of services and availability of testing, which did not exist in the limited vendor pool in the past. Additional time is needed for a complete assessment of the current vendor pool as well as the rapidly evolving molecular diagnostic testing needs of the NIH. Due to the outbreak of the COVID-19 pandemic, DLM was unable to perform the aforementioned assessment. The estimated period of performance for this purchase order is September 30, 2020 through

March 31, 2021. This interim contract is needed to ensure there will be no break in service which will be damaging to the ongoing research for patient care. This extension is needed to perform current market research, develop a statement of work that meets the rapidly evolving needs of the government and award a new IDIQ contract for critical molecular diagnostic testing.

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

a. Project title.

Molecular Diagnostic Off-Site Laboratory Testing

b. Project description.

A mechanism is needed to provide a variety of molecular diagnostic tests to support clinical and research services at the NIH, Clinical Center. This requirement will provide service to the multiple Institutes maintaining a clinical research program within the National Institutes of Health through central local management in the Department of Laboratory Medicine of the Clinical Center.

Requirement type.

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

Support services (non-R&D)

Supplies/equipment

Information technology (IT)

Construction

Architect-engineer (A & E) services

Design-build

Other (specify): ____________________

Type of action.

New requirement

Follow-on

Other (specify): ______________________

Proposed contract/order type.

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): Indefinite quantity

Other (specify): ___________ Completion Form Term form

Acquisition identification number.

TBD

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

This is a six month performance period from 9/30/2020 – 3/31/2021.

The estimated dollar value shall not exceed $250,000.00.

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) 6.302-2.

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).

GeneDx, Inc 207 Perry Parkway Gaithersburg, MD 20877-2142 301-519-2100

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

The incumbent vendor is currently performing complicated molecular diagnostic (mutation analysis) testing for various institutes across the NIH campus, using the existing contractor, under contract 75N90019D00014 which is established by the Clinical Center’s Department of Laboratory Medicine. Any change in testing before validation of a new laboratory’s methods is performed can negatively impact patient care. Additional time is needed for assessment of current needs, re-competition, and the continuation of services.

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.

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

The 2019 negotiated contract pricing under contract 75N90019D00014 will be utilized for the interim contract period.

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

Due to the circumstances of a recent uptick in available vendors, plus rapidly evolving government use of molecular testing services, the Clinical Center needs to perform an extensive assessment of current molecular testing needs across the entire NIH campus. The Clinical Center has hired a contractor to perform a thorough needs assessment and business case for molecular testing. Because of the COVID-19 pandemic, the completed needs assessment has not been fully evaluated. There is a critical need for ongoing molecular diagnostic testing services to support patient care, so market research will not be performed for the interim contract period. Market research shall be performed for the re-competition of molecular diagnostic testing services.

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

n/a

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

n/a

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.

Market research, and competitive procedures will be pursued for the long term molecular diagnostic testing contract.

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 Heather Crum, Lab Manager, DLM

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

Barbara Taylor, Section Chief, CC

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 is