HHS LSJ(GSA-FSS)-RSC_SAMPosting_Redacted.pdf

The Task Areas for the Limited RSC Specialized Scientific Services Contract include:

Task Area 1 – Scientific and Technical Support Services Task Area 2 – Facilities and Equipment Maintenance

Due to the criticality of the services, i.e., protecting >$100 million of government assets and mitigating human health risks associated with hazardous or controlled substances, and devasting impact of a lapse it has been determined that a sole-source award to the existing vendor through the same GSA contract is needed.

b. Project Background.

NCATS DPI (Intramural) houses nearly 300 scientists, including medicinal chemists, biologists, and informaticians who collaborate with disease experts worldwide to discover potential therapeutics and translate those into more treatments, for all people, more quickly. RSC is a fundamental research and infrastructure core that manages technical capabilities and services, chemical repositories and storage, and complex instrumentation necessary to enable high-throughput screening platforms, pre-clinical drug discovery, and advanced translational science. RSC is comprised of four groups: Automation, Sample Management, Automated Cell Technologies, and Scientific Imaging Support. These four groups operate as a supportive unit to cover the current and future needs of DPI scientists in their efforts to develop novel therapeutics for a variety of human disease areas.

3. Description of the Supplies or Services Required to Meet the Agency’s Needs (including the Estimated Value).

a. Project Title - NCATS Research Services Core (RSC) Limited Specialized

Scientific Services

b. Project Description. See attached statement of work

Requirement Type.

Support services (non-research & development) Supplies/equipment Information technology (IT) Other (specify): ____________________

Type of Action.

New requirement

Follow-on Other (specify): ______________________

Proposed Contract/Order Type.

Firm-fixed-price Time and materials Indefinite delivery (specify whether indefinite quantity, definite quantity, or requirements): ___________ Other (specify):

Acquisition Identification Number.

POTS ID: 26-000049

c. Total Estimated Dollar Value and Performance/Delivery Period.

4. Identification of the Justification Rationale [see 8.405-6(a) and (b)] and, if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

a. Acquisition Authority.

This acquisition is conducted under the authority of the Multiple

Award Schedule Program. Consideration of schedule contractors will be restricted to fewer than the number required by Federal Acquisition Regulation (FAR) 8.405-6(a)(1).

FAR 8.405-6 Limiting Sources:

Orders placed or BPAs established under Federal Supply Schedules are exempt from the requirements in part 6. However, an ordering activity must justify its action when restricting consideration in accordance with paragraph (a) or (b) of this section—

(a) Orders or BPAs exceeding the micro-purchase threshold based on a limited sources justification.

(1) Circumstances justifying limiting the source.

(i) For a proposed order or BPA with an estimated value exceeding the micro-purchase threshold not placed or established in accordance with the procedures in, 8.405-2, or 8.405-3, the only circumstances that may justify the action are–

(A) An urgent and compelling need exists, and following the procedures would result in unacceptable delays;

(B) Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; or

(C) In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issued under sole-source or limited-sources procedures.

In accordance with FAR authorities listed above, the order must be issued on a sole-source basis because an urgent and compelling need exists, and in the immediate only one source is capable of providing services at the level of quality required because the supplies or services are unique or highly specialized.

An urgent and compelling need exists, and following the procedures would result in unacceptable delays. The critical services will lapse at the end of October 2025. The Limited RSC Specialized Scientific Services Contract will provide 10 full-time and 2 half-time contractors who conduct hands-on, in-laboratory scientific support and maintenance activities for the NCATS Intramural Research Program. Specifically, it provides high throughput screening support scientists, laboratory research technicians, instrument maintenance technicians, biomedical engineers, and laboratory automation engineers. These technical experts have the required training and certifications to safely operate and maintain the equipment necessary for delivering core services. RSC provides quality assurance/quality control for any DPI resources to ensure identity, purity, calibration, safety standards, and other factors for integrity and reproducibility of research.

The Limited RSC Specialized Scientific Services Contract is necessary to maintain the NCATS chemical library of over 500,000 compounds (including the National Toxicology Program collection of toxicants), most of which are biologically active and pose human health hazards. Failure to maintain storage facilities would increase the risk of a chemical breach and human exposure. Compound management support, including for screenings conducted in the NIAID BSL-3 facility, must be provided by trained and/or certified personnel to ensure the highest NIH safety standards. Failure to support these activities can be reasonably expected to significantly increase the risk associated with the NCATS chemical inventory and pose a significant human safety and biosafety risk. NCATS chemical repository and associated Intellectual Property, also represents a significant taxpayer investment that could not be easily reconstructed in the event of a catastrophic loss.

RSC contractors have expertise in maintenance of pre-clinical laboratory equipment which is critical for experimental data acquisition. Equipment serviced by this contract exceeds 135 individual instruments with an estimated total replacement value in excess of $100 million and requires regular preventative maintenance and repairs to ensure proper operation, scientific rigor and reproducibility of data generated by DPI scientists. In many cases, equipment maintenance is required daily even when not in use. If not maintained continuously, there is a high likelihood of failure and inability to restore to a working state. This includes equipment located within the NIAID BSL-3 facility, posing health and safety concerns and requiring certification for entry.

Additionally, contractors provide engineering and fabrication support for custom instrumentation applications and repairs. This equipment and service is not available on the commercial market, represents a significant investment of taxpayer funds, and would quickly deteriorate to an unusable state if not continuously maintained.

As noted in the SOW, the Limited RSC Specialized Scientific Services Contract will provide Scientific and Technical Support Services and conduct Facilities and Equipment Maintenance. The specific deliverables within the Limited SOW include:

Support ongoing, excepted research activities requiring compound management services; complete standard and submitted service and maintenance requests in a timely fashion that prevents loss of government resources;

provide reports detailing usage and current inventory amounts of all DEA Controlled Substances per federal requirements; maintain active and stored cell lines in accordance with standard operating procedures to ensure viability; and maintain QA/QC of NCATS chemical inventory.

Ensure proper handling, storage and disposal of over 500,000 chemicals within NCATS inventory by following all safety procedures as specified by each chemical’s Materials Safety Data Sheet (MSDS).

Support ongoing, excepted research activities requiring compound management services. It is anticipated that excepted work will constitute <5% of standard throughput.

Follow all Federal laws and regulations detailing the proper handling, storage, security and disposal of all 800 containers of Drug Enforcement Agency (DEA) Scheduled Substances within inventory by following chain of custody and reporting requirements.

Ensure proper documentation and tracking of samples while organizing and maintaining sample inventories using software such as Excel and other web-based applications.

Maintain detailed and accurate laboratory records of experiments and their results using the provided Electronic Laboratory Notebook (ELN, Revvity Signals ELN).

Maintain active and stored high-value cell lines of various lineages, such as iPSC, transformed, malignant and non-malignant.

Maintain all required trainings to utilize BSL2 laboratories and handle HHS Select Toxins. Trainings are required by NIH and other safety and oversight authorities. Trainings may be conducted online in most cases.

Prepare aliquots and processes samples, distribute specimens to testing or processing location according to established standard operating procedures.

Run liquid chromatography/mass spectroscopy or mycoplasma testing or assess short-tandem repeat (STR) profiling data for quality control purposes on samples as needed to ensure identity, purity and other factors for maintenance of stable cell lines and reproducibility of research.

Execute proper operation and maintenance of laboratory instruments such as PerkinElmer Janus (1 instrument), Biomek FXp (4 instruments), Biomek i7 (4 instruments), Beckman Echo 600 and 500 series acoustic dispensers (12 instruments), Agilent Liquid Chromatograpy/Mass

Spectroscopy (7 instruments) and Sirius Automation Mini (1 instrument) and Omni-Taskers (1 instrument).

Execute proper usage and maintenance of automated systems such as the Kalypsys Robotic Platform (17 instruments across 2 platforms), Beckman Access Systems (12 instruments across 3 systems), High-Res Biosolutions systems (3 instruments on 1 system), Azenta Automated Sample Stores (2 instruments), Beckman Sample Reformatting system (5 instruments on 1 system), and CellTrio Automated Screening System (3 instruments on 1 system).

Maintain laboratory supplies, including Personal Protective Equipment (PPE), by checking stock to determine in-house amounts, anticipating needed supplies, recommending orders to be placed from suppliers and verifying receipt of supplies.

Addressing critical maintenance needs on all NCATS active instruments, as required, and responding to instrument service requests within 6 hours of receipt.

Monitor and perform critical maintenance of preclinical laboratory equipment to ensure proper operation and prevent functional failure. Instrumentation includes but is not limited to LGR BioRAPTR2 (25 instruments), Beckman Echo 600 and 500 series acoustic dispensers (12 instruments), PerkinElmer ViewLux (8 instruments) and Envision (5 instruments), BMG Labtech PHERAstar FSX (6 instruments), IonField Systems PureTIP (2 instruments), IonField Systems PurePLATE MCS (1 instruments), Revvity Opera Phenix (7 instruments), Grenova TipNovusMini (3 instruments). Azenta Cryostore (3 systems), Sartorius Select T Cell Automation (3 systems).

Maintain all equipment located in the BSL-3 laboratory in NIH Building 33 while following safety procedures and keep all required certifications to access that facility up to date.

Respond to and complete equipment repair service tickets submitted through the RSC Instrumentation site within a timely manner.

Attend Factory Acceptance testing and Site Acceptance testing for new NCATS equipment being installed as an EXCEPTED activity. This may include equipment purchased and/or contracted in FY2025 for future installation.

Provide engineering and fabrication support for NCATS DPI instrumentation or high-throughput screening platform including 3D printing, machining, and customizing equipment unavailable on the commercial market.

The Limited RSC Specialized Scientific Services Contract is necessary to ensure health and safety at NCATS. Failure to establish this contract would compromise NCATS ability to mitigate risks associated with storage and use of controlled substances and hazardous chemicals. Further, this contract provides technical experts, working in a team-based research environment, maintaining critical research capabilities and equipment which have been established over many years at great cost to the American taxpayer. Currently, the RSC supports greater than 80% of the NCATS intramural program and project portfolio, representing greater than $80 million in research annually. Without support from this contract, RSC’s capabilities and equipment (i.e., government property) would be compromised and/or placed at significant risk.

b. Demonstration of the proposed contractor(s) unique qualifications to provide the required supply or service.

Currently, to avoid a critical lapse in services only the incumbent can continue to perform these services.

c. Name and address of the proposed contractor(s).

5. Determination by the ordering activity Contracting Officer that the order represents the best value consistent with FAR 8.404(d).

Since (a) GSA has already determined the prices of the supplies and services under FSS contracts, including rates for services offered at fixed hourly rates, to be fair and reasonable; and (b) by placing an order against a schedule contract using the procedures in FAR 8.405, the ordering activity CO has concluded that the order represents the best value (see FAR 2.101) and results in the lowest overall cost alternative, the determination shall cite:

(i) whether any additional discounts will be sought before placing an order

(see FAR 8.405-4); - Yes – will seek discounts

(ii) the type of pricing information, if any, that will be obtained from the schedule contractor(s) in relation to seeking additional discounts; and

(iii) the extent of the price evaluation anticipated in order to determine that the total price is reasonable – see FAR 8.405-2(d).

The CO will evaluate the proposed price prior to award against its GSA schedule, historical rates, and historical actual invoiced costs.

6. Description of the market research conducted among schedule holders and the results, or a statement of the reasons market research was not conducted.

See Market Research Report in file.

7. Any other facts supporting the justification.

In projecting NCATS acquisition needs, we examined the relationship to the prior order and considered the minimum acceptable period necessary to meet mission requirements. 90 days was determined because it provides time needed to encourage and solicit competition for a future requirement without critically disrupting services.

8. Statement of the actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made.

a. Removal of barriers to competition. We do anticipate future needs for the same type of services. We plan to continue to examine ways to increase competition, while balancing small business goals, and category management.

b. Listing of sources, if any, that expressed an interest, in writing, in the acquisition. No other sources have expressed an interest, in writing, in the proposed acquisition.

9. 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 or requirements, or other rationale for limited sources, are accurate and complete.

*The Head of the Sponsoring program is the individual at least one level above the Project Officer’s Immediate Supervisor

10. 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

11. Chief of the Contracting Office and Head of the Contracting Activity Signature(s).

12. Competition Advocate Signature.

13. HHS Senior Procurement Executive Signature.