21-002495 - J and A_Signed.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. Department of Health and Human Services, National Institute of Mental Health

b. Sponsoring organization. Human Genetics Branch, NIMH DIRP

c. Project Officer information

Francis J. McMahon, MD Chief, Human Genetics Branch National Institute of Mental Health Intramural Research Program 35 Convent Drive, Rm 1A202 Bethesda, MD 20892-3719

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

Professional Services Contract for Clinical Genetics Research

a. Acquisition purpose and objectives.

The Genetic Basis of Mood and Anxiety Disorders Section, within the Human Genetics Branch, NIMH-IRP, is a clinical genetics research program with both human-subjects and laboratory components. Our leadership position in the field depends critically on recruitment of family study volunteers, competent performance of structured diagnostic assessments in the field, refinement of diagnostic procedures, and the collection of research specimens. Ongoing research is focused on volunteers of Amish or Mennonite ancestry, who must usually be ascertained, enrolled, and assessed in the field.

b. Project background.

We perform clinical genetics research aimed at elucidating the genetic basis of mood disorders. Our recruitment efforts are now focused on special populations living in remote rural areas, many without telephone service. Enrollment requires travel to the homes of research volunteers to carry out consent and interview procedures in field, as well as familiarity with the culture and language so that psychiatric information can be collected sensitively and reliably.

This project is a re-acquisition of a previous Professional Services Contract. The incumbent is Layla Kassem, PsyD.

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

a. Project title.

Mental Health Field Research in Amish and Mennonite Communities

b. Project description.

The contractor shall support clinical mental health genetics research work as directed by the Branch Chief. This shall include continual improvement of the Branch’s ongoing family volunteer recruitment effort and ascertainment strategies within targeted special populations, performance of diagnostic assessments in the field, assisting the Branch in the refinement of diagnostic procedures, and assisting the branch with collection of blood specimens from research volunteers in the field.

Because of their unique genetic and social circumstances, much of the work is done in the field with family volunteers of Amish or Mennonite ancestry. Thus, considerable travel, sensitivity to cultural differences, and independent professional judgement are required.

• 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): ___________

❑ Other (specify): ___________

❑ Completion Form ❑ Term form

• Acquisition identification number.

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

Total: $499,697.87. The period of performance will be one 12-month base year (from date of award) plus two 12-month option years

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).

Layla Kassem, PsyD 4801 Connecticut Ave. NW 912 Washington, DC 20008

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

In the past 11 years, our recruitment efforts have focused on populations of Amish and Mennonite individuals who often live in remote rural areas, are unfamiliar with modern customs, and may not use telephones or electricity. These individuals are difficult to access and recruit, especially in the setting of mental illness. Only people experienced in Amish/Mennonite customs can gain their trust and work appropriately with research volunteers.

Dr. Kassem is one of a handful of mental health research clinicians in the world with extensive experience working with Amish and Mennonite individuals in the field. She has over 11 years’ experience with this work and is well-known and accepted among the Amish and Mennonite communities in Pennsylvania, Ohio, New York, Maryland, Kansas, and Indiana. During this time, she has developed a unique and irreplaceable relationship with our enrolled study families, which we plan to follow longitudinally for several years. Any other contractor would need to gain the trust and build a new relationship with our study families, leading to increased attrition. Even if a new contractor could get some participants to continue, the inter-rater assessment differences would confound the longitudinal aspect of our ongoing study, which depend on serial evaluations by the same interviewer.

Dr. Kassem is uniquely qualified because of her experience and training.

She has acquired intensive training and is highly-skilled in performing field assessments of mental health, family study methods, and clinical data analysis. Dr. Kassem has been active in the field of mental health for over 15 years. In 1993, she obtained a PsyD degree in Clinical Psychology from the Chicago School of Professional Psychology, Chicago, IL. From 1999- 2001 she worked as Senior Project Coordinator for the Schizophrenia Genetics Research Program at the University of Chicago, where she acquired extensive family study experience directly relevant to the scope of this contract. Her ability to formulate and synthesize clinical data analyses into coherent reports is illustrated by her publication record, which includes several peer-reviewed publications, textbook chapters, and many presentations at scientific meetings.

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.

Notice of Intent to sole source was posted on March 16, 2021 on betaSAM.gov for 15 days. No responses were received.

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

Marketing research was conducted using Salary.com and similar information sources in order to establish the salary, which is near the 50th percentile for a senior clinical researcher with similar qualifications living in the Washington DC area. Travel costs were estimated based on published airfares, lodging costs, and recent experience in the field.

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.

We queried https://www.contractdirectory.gov/contractdirectory/, https://www.gsaelibrary.gsa.gov/ElibMain/home.do, http://www.abilityone.gov/, and http://dsbs.sba.gov/dsbs/search/dsp_dsbs.cfm, with the keywords ‘Amish’ or ‘Mennonite.’ The only service provider found was a company that operates nursing homes, Mennonite Brethren Homes, Inc., which does not meet our needs.

https://www.contractdirectory.gov/contractdirectory/ https://www.gsaelibrary.gsa.gov/ElibMain/home.do http://www.abilityone.gov/ http://dsbs.sba.gov/dsbs/search/dsp_dsbs.cfm

Based on these results, and our general familiarity with experts in this field, we conclude that no other company’s similar services meet, or can be modified to meet, our needs.

The IGCE was based on historical data from recent contractual efforts for similar work performed under contract HHSN271201800202P (Base Year 4/4/2018 – 4/3/2021).

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

This project is a re-acquisition of a previous Professional Services Contract. The incumbent is Layla Kassem, PsyD. She has performed the previous contract on time, within budget, and within or above the quality standards established for the work.

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.

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 Francis J. McMahon, MD, Chief, Human Genetics Branch, NIMH-IRP, NIH

02/22/2021

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

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

Official Name & Title Signature Date

Chief of the

Office

Head of the

Activity

15. Competition Advocate signature.

Competition Advocate

16. HHS Senior Procurement Executive signature.

HHS Senior Procurement

Executive