D1 SOW.pdf

STATEMENT OF WORK (SOW)

General Information

Title of Project:

Annual Maintenance Agreement for On-chip Sort microfluidic cell sorter for the Stem Cell

Translation Laboratory (SCTL) within the National Center for Advancing Translational Sciences

(NCATS) Division of Preclinical Innovation (DPI)

Statement of Need and Purpose:

The National Center for Advancing Translational Sciences (NCATS) Division of Preclinical

Innovation (DPI) previously purchased the On-chip Sort microfluidic cell sorter.

The On-chip Sort microfluidic cell sorter allows SCTL scientists to perform damage-free sorting of sensitive pluripotent stem cells for a range of end-point assays that require the highest possible level of viability preservation, especially single-cell genomic analyses like RNA sequencing and DNA copy number variant analysis. The SCTL uses an integrated technological approach to better understand pluripotent stem cell biology and thereby leverage drug discovery and regenerative medicine. Ongoing SCTL research projects focus on understanding molecular mechanisms regulating stem cell pluripotency and their multi-lineage differentiation capabilities, with a focus on defining optimum culture conditions for maintaining pluripotent stem cells and their conversion to homogeneous and mature population of differentiated cells. To achieve these aims, high throughput screening is employed to identify mechanisms/small molecules that aid in single cell cloning of stem cells. In addition, detailed high-resolution analysis of intermediate cell types during conversion of stem cells to differentiated cell types is being carried out to better understand regulators of directed differentiation. These projects will facilitate stem cell-based drug discovery and disease modeling in addition to meeting project milestones. The service plan ensures that the instrument is operating optimally, serviced at regular intervals, and assistance is readily available when necessary.

To maintain the instrument in fully functioning, peak condition, scheduled preventive maintenance and service are required.

Background Information and Objective:

The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

The National Center for Advancing Translational Sciences (NCATS) is a part of the National

Institutes of Health (NIH), which mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

The Division of Preclinical Innovation (DPI) plans, conducts and uses both internal and contract resources to advance collaborative research projects across the preclinical phases of the translational science spectrum.

The DPI requires annual maintenance agreement for On-chip Sort microfluidic cell sorter to be maintained in fully functioning order via preventative maintenance for one 12-month base year and two (2) 12-month successive option years. Without such a contract in place, repair costs are extremely high and instrument downtime is much longer causing a significant decrease in scientific productivity.

Period of Performance:

The anticipated period of performance is:

Base Period: September 26, 2022 – September 25, 2023 (12-months)

Option Period 1: September 26, 2023 – September 25, 2024 (12-months)

Option Period 2: September 26, 2024 – September 25, 2025 (12-months)

Place of Performance:

The place of performance shall be:

NCATS/NIH

9800 Medical Center Dr

[Building and Room to be indicated at time of award]

Rockville, MD 20850

Scope of Work

General Requirements:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below:

1. Instrument: On-chip Sort microfluidic cell sorter

Specific Requirements:

The Contractor shall provide one (1) preventative maintenance visit per period, if services and or repairs are not required within the period, replacement of parts for when a problem or deterioration occurs.

At the preventative maintenance the following services shall be performed:

1. Application of oil and cleaning of parts

2. Inspection and adjustment of optical parts

3. Replacement of necessary parts (if applicable at time of inspection)

4. Overall operational inspection

5. Software updates installation

6. Cleaning of chip holder

7. Laser replacement

Contractor shall use only OEM-certified parts and components for all preventive maintenance and repairs, except for consumables, at no additional cost to the Government.

Contractor shall be responsible for shipping and handling costs of each equipment instrument’s replacement parts and components.

The Contractor shall provide at no additional cost to the Government all necessary documentation, repair parts, spare parts, accessories, maintenance supplies, special tools, test and support equipment, travel and transportation, personnel skill requirements, and other related services required to maintain each instrument in fully functioning condition, except for costs of repairs occasioned by fault or negligence of the Government.

The services and preventive maintenance shall be performed by an authorized manufacturer service engineer in order to assure proper repair and operation of the system in accordance with manufacturer guidelines.

Government Responsibilities:

The Government will provide Contractor personnel reasonable facility access to the instrument for preventive maintenance, repair, and support services. Access will be restricted during federal holidays and after business hours.

Delivery or Deliverables:

Preventive maintenance and repairs as needed, as described in the “Specific Requirements” section above.

Reporting Requirements:

The Contractor shall provide one (1) validation report at the completion of each maintenance, repair or service visit to the instrument that describes the services performed on the instruments or components and certifies it to be in fully functioning, good condition.

Other Considerations:

Travel:

Travel and accommodation costs shall be covered by Contractor at no additional cost to the

Government.