B. JOFOC Toxicology Test Services.DAPE.Approved.8-16-2024.pdf

“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 Institutes of Health National Institute of Mental Health

b. Sponsoring organization.

National Institute of Mental Health Office of Technology Development and Coordination NIH NeuroBioBank

c. Project Officer information.

Abigail Soyombo-Shoola, PhD 6001 Executive Blvd.

Rockville, MD 20852 abigailsoyombo@nih.gov

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

a. Acquisition purpose and objectives. The National Institutes of Health (NIH)

NeuroBioBank (NBB) has a requirement for postmortem toxicology testing for cases obtained by the NBB Brain and Tissue Repositories (BTR) for use by the scientific community.

b. Project background. The NIH NeuroBioBank (NBB) is a federated network of six

Brain and Tissue Repositories whose mission is to acquire, characterize, and distribute high-quality, well-characterized human post- mortem brain tissue for the research community. Since 2014, National Medical Services (NMS) Labs has provided toxicology testing services to the NBB BTR through IDIQ Contracts # HHSN271201400007I, that was competitively solicited and awarded by NIDA and IDIQ Contract # 75N95020D00002 that was sole sourced. The current IDIQ contract (N7595020D00002) was issued in 2020, and an estimated $1.5m has been spent to acquire postmortem toxicology testing services from NMS Labs.

The new IDIQ contract maximum aggregate amount is not to exceed $3,000,000 for the overall contract period of performance beginning September 18, 2024 through September 17, 2028 and the minimum aggregate amount of $1,000 for the same period of performance.

3. Description of the supplies or services required to meet the agency’s needs

(including the estimated value).

a. Project title. NIH NeuroBioBank (NBB) Tissue Toxicology Services

Justification and Approval for Sole Source mailto:abigailsoyombo@nih.gov mailto:bo@nih.gov

b. Project description. The National Institutes of Health (NIH) NeuroBioBank (NBB), comprised of the National Institute of Mental Health (NIMH), the National Institute of Neurological Diseases and Stroke (NINDS), the National Institute on Aging, the National Institute on Drug Abuse (NIDA), and the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), work together as the Brain and Tissue Repositories (BTRs) to make well-characterized human postmortem brain tissue and biospecimens more widely available for research on neurological, psychiatric, neurodevelopmental and substance use disorders.

Since its inception in 2013, the NIH NBB has sought to identify ways to centralize services and to enhance standardization to limit variability between the BTRs.

One way is to provide centralized toxicology testing support services for all brains acquired by the NBB BTRs. The NIH NBB requires a tissue testing facility that can provide validated, high-quality forensic toxicology testing support services on all human brain samples collected by the NBB in support of multiple NIMH Programs.

The objective of the NBB Tissue Toxicology Contract is to provide toxicology testing support services to detect the presence and abundance of drugs of abuse, therapeutic drugs, and environmental toxins in human postmortem tissues, including brain, blood, and hair. These data will be provided back to the NIH NBB and will constitute a component of the phenotypic characterization of these tissues which will serve to corroborate the donor’s medical history. More importantly this information will inform the design of the scientific investigations undertaken by researchers receiving tissue from the NIH NBB.

NMS Labs uses state-of-the-art methods (e.g. colorimetry, Enzyme- Linked Immunosorbent Assay, Gas Chromatography/Mass Spectrometry) to test over 200 analytes. In most cases, Drugs/ Drug classes reported as ‘positive’ can be reflexed to a second, more specific and sensitive test as needed. NMS Labs has been providing these services to the NIH NBB for the past 10 years.

• Requirement type.

Research & development (R&D) R & D support services X 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 X Follow-on

• 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 X Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): Indefinite quantity

Completion Form Term form

• Acquisition identification number.

POTS Requisition 24-003646 / Establish the main IDIQ contract.

POTS Requisition 24-005221 / NBS Requisition 6962996 for $299,108.00 to fund the first task order against the main IDIQ contract.

c. Total estimated dollar value and performance/ordering period. The ordering period of the IDIQ contract shall include a four-year period of performance not to exceed the stated maximum value of $3,000,000. The maximum is based on the increased needs that NIMH accounted for in its estimate of the number of toxicology testing of samples required during this ordering period. The first task order for toxicology testing of samples that will be issued at the time of the IDIQ contract award shall satisfy the IDIQ contract’s stated minimum value of $1,000. The anticipated task order shall require up to 5 months of testing needs totaling $300,000 (FY24) of the $700,000 estimated during the first 12-months of the contract. It is anticipated that additional task orders will be issued when needs arise for further toxicology testing of new samples during the effective ordering period of the contract.

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

X 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).

National Medical Services (NMS) 200 Welsh Rd, Horsham, PA 19044-2208

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

NMS Labs is the leading provider of postmortem laboratory toxicology testing services and has serviced the NIH NBB with its toxicology testing support services since 2014. As part of these support services, NMS Labs has provided customized assay results, secure data transfer services and discounted volume/bulk pricing to the Government.

NMS has provided advanced, sophisticated analytical toxicology services to several of the NBB BTRs, even prior to establishment of the consortium, resulting in over 15 years of cumulative data using ever more advanced analytical methodology for an ever expanding, non-standard suite of analytical parameters.

The methodology employed, requires very sophisticated analytical methodology which given the rather low level of analytes observed, requires utmost attention to strict adherence to intricate analytical chemistry protocols in order to minimize variability which hence can be quantitated. As in all science, over time these analytical methodologies have evolved, resulting in ever more sensitive analyses.

One of the basic tenets of analytical chemical toxicology is that analyte levels are related back to standards. As methodologies evolve and newer ones get introduced, historical data constantly is being compared to ensure that previous measurements are calibrated in such a way as to maintain analyte levels and sensitivities across time, thereby ensuring that historical analytical results can be compared to current data even though methods, and hence precision and sensitivity, may all have evolved.

As researchers constantly compare data generated across time with different methodologies it is imperative that cross-generational evaluation allow comparison of historic data with newer data generated with ever more sophisticated methodologies. Methodologies such as these are not standard and even though well described, cannot be duplicated by others at the exact same level of accuracy and sensitivity as employed at present. Abandonment of these techniques by selection of a different vendor would necessitate a massive reanalysis of historic data, which if even possible, would result in significant backlog in analysis time, thereby resulting in significant expenditures, i.e. millions, without direct benefit to the Government. Maintenance of ever exacting current methodology (as sensitivity of analysis improves so does complexity and hence variability) would thus be of significant benefit to the Government while minimizing commitment of funds.

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.

This acquisition is for a commercial service and is conducted under the authority of the Federal Acquisition Regulation (FAR) Subpart 13.5—Simplified Procedures for Certain Commercial Items and so the proposed action is exempt pursuant to FAR Subpart 5.202

A presolicitation notice of intent to award a contract without providing for full and open competition to National Medical Services was published on May 03, 2024, on the SAM.gov website. The published presolicitation notice of intent advised all interested parties of their right to identify their interest or capability to perform the subject support services by submitting a capability statement, proposal, or quotation for consideration.

Only one response to the presolicitation notice of intent was received, and the response was from NMS Labs, the incumbent/proposed vendor.

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

The Government anticipates award of a single-award Indefinite Delivery / Indefinite Quantity (IDIQ) contract type with payment based on the fully loaded unit prices.

Task/Delivery orders will be firm fixed-price.

To ensure that the cost to the Government for these services will be fair and reasonable, a separate price analysis for this proposed procurement will be conducted by the Contracting Officer, and award will only be made if the price is determined to be fair and reasonable.

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.

The Program Office conducted the initial market research by reviewing government supply sources, GSA Federal Supply Schedule, previous competitive contract, and consultation with several well-established brain banks as well as Medical Examiner offices.

Based on the market research conducted in accordance with FAR Part 10; NMS is identified as the only toxicology testing service with the broad capabilities and expertise required for brain tissue analysis and with a reputation of providing reliable reproducible results. Other vendors in this industry do not have the full range of analyses available that are required by the NIH NBB, and/or are not able to provide reliable data from brain tissue as a source material.

Consequently, due to the inherent variability in other vendor’s testing assays, standards, and methods, a continuity of service with NMS is essential to making the toxicology results comparable over time.

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

None

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

No responses were received by the due date in response to the posting.

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.

Should future service be required, new market research will be performed to ensure that capable contractors are not overlooked. If other contractors are capable, the requirement will be competitively sourced.

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 Abigail Soyombo- Shoola, PhD, DST Program Officer

Project Officer’s Immediate Supervisor

Greg Farber, PhD, Director of DST

Head of the Sponsoring

Program Office

Nicole Martino, Acting Executive Officer, NIMH

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

Rieka Plugge, Contracting Officer

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

Official Name & Title Signature Date

Chief of the Contracting

Office

Chris Belt, Director, Office of Acquisitions, NIDA

Head of the Contracting

Activity

Phillip D. Osborne, Acting Director, OALM Acting Head of the Contracting Activity, NIH

15. Competition Advocate signature.

Official Name & Title Signature Date

Competition Advocate

Dr. Kathryn Partin, Ph.D., Directory of Research Integrity, NIH

16. HHS Senior Procurement Executive signature.

Official Name & Title Signature Date

HHS Senior Procurement

Executive

N/A