SOW_9-4-2018_FINAL-_liquid_handler.docx

STATEMENT OF WORK

TITLE: Automated Liquid Handler for Cell Culture, Gene Editing and DNA/Protein Extraction and Protein Assays I. Background and Purpose:

The National Institute for Standards and Technology (NIST) Biosystems and Biomaterials Division has a requirement for an automated liquid handler laboratory instrument and associated instruments capable of preparing multiwell culture plates for combinatorial cell culture experiments, gene editing experiments (i.e. transfection, DNA extraction) and protein-based assays. Installation, component integration and training are also required.

II. Scope of Work:

The Contractor shall deliver and install an automated liquid handler instrument and associated instrumentation including operational software and computer controllers, and provide basic system training, meeting the specifications cited below. In addition, method programming for combinatorial cell culture or DNA extraction experiments, accessories to enhance instrument performance and training for programming of instrument control software, shall be provided if options described below are exercised.

III. Brand Name or Equal. Automated Liquid Handler Instrument, Hamilton Robotics Model Star/Star Plus, or brand name or equivalentequal Hamilton Robotics Model Star/Star Plus. The equal model must possess the salient characteristics below. Brand name or equal description is intended to be descriptive, but not restrictive and is to indicate the quality and characteristics of products that will be considered satisfactory to meet the agency’s needs.

IV. Salient Characteristics:

A. LINE ITEM 0001 – BASE LINE ITEM: Quantity One (1) Automated Liquid Handler Instrument

1. The instrument shall be capable of performing liquid transfers from tube reservoirs into many multiwell culture plates for the preparation of experimental designs that can test the robustness of cell-based assays and gene-editing assays. The instrument shall be able to accommodate during a single run at least ten (10) 96-position tip carriers, twenty (20) SBS formatted 96-well plates, and carriers that can hold at least sixty (48) 50 mL reagent (e.g. Falcon) tubes. The instrument shall also accommodate on-deck heater-shakers, cooling platforms and a magnetic separator as specified below. In addition, the liquid handler must be able to automatically transfer plates to a storage incubator, a centrifuge, an on-deck thermocycler and an electroporation unit as specified below.

2. The instrument shall include an eight-channel air displacement pipetting tool with the following specifications:

a. For use with disposable tips

b. Pipetting volume spanning at least the range from 0.5 uL to 1000 uL

c. Independent pipetting volume for each channel

d. Pipetting precision (with optimal tip size) of better than:

i. 6% at 0.5 uL

ii. 5% at 1 uL

iii. 1% at 10 uL

iv. 1% at 50 uL

v. 1% at 1000 uL

e. Pipetting accuracy (with optimal tip size) of better than:

i. 10% at 0.5 uL

ii. 6% at 1 uL

iii. 2% at 10 uL

iv. 2% at 50 uL

v. 1% at 1000 uL

f. Variable spacing and height (i.e. independent ‘Y’ and ‘Z’) for each channel

g. Pressure-based liquid level detection for each channel to detect the level of liquid in SBS plates, tubes, or other labware used with the system

h. Capacitance-based liquid level detection for each channel to detect the level of liquid in SBS plates, tubes, or other labware used with the system

i. Transfer volatile solvents (e.g. ethanol; methanol) without dripping

j. Zero force insertion on tip loading/ejection or other means to assure no aerosol dispersion

k. Pipetting channels positional accuracy of 0.1 mm or better in all 3 directions (X, Y, and Z)

3. Shall include at least four heater-shaker stations to accommodate the different labware formats, and each heater-shaker can be individually programmed to at least 100 degrees C which is required for cell culture preparation, assay reagent development, electroporation/transfection and DNA extraction.

4. Shall include at least one magnetic base for 96-well plates that is suitable for the magnetic bead-based DNA purification and manipulation steps required for extracting purified DNA from cell culture.

5. Shall include an automated on-deck thermocycler suitable for polymerase chain reaction in 96-well plate format with the following capabilities and specifications:

a. Temperature control spanning at least the range from 4°C to 99°C

b. Temperature accuracy of ±0.3°C or better at 55°C

c. Temperature uniformity of ±0.2°C or better from 55°C to 95°C

d. Heating rate adjustable from 0.1 to 4.4 K/s

e. Cooling rate adjustable from 0.1 to 2.2 K/s

f. Lid heating with temperature control spanning at least the range from 5°C above ambient to 115°C

g. Compatible with 96-well skirted plates

h. Compatible with automation friendly sealing lids for the PCR plate (e.g. Bio-Rad Auto-Sealing Lid, Hamilton ComfotLid)

6. Shall include at least two on-deck SBS plate positions with cooling capability to 4°C or colder

7. Shall include capabilities for automated movement of SBS-format microplates between the different liquid handler deck positions, the thermocycler and additional accessories (centrifuge, electroporator, storage incubator) described in Line Items 0002 and 0003 and 0004.

a. The system shall be capable of moving SBS plates and pipette tip racks/boxes between positions on the liquid handler deck

b. The system shall be capable of automatically transferring SBS plates between the liquid handler deck, the thermocycler, a centrifuge, a storage incubator and an electroporation transfection system.

c. The system shall be capable of removing the lid from an SBS plate on the deck, pipetting to/from the plate and replacing the lid on the plate, all while keeping the plate and lid inside the envelope of the liquid handler.

8. Shall include a barcode scanner capable of automatically verifying that assay and cell culture reagents/carriers are loaded into the system correctly before starting a method

9. Shall include carriers/holders for reagents tubes, tips, culture ware and hardware listed in Specification 1, 3, 4, 5 and 6.

10. Shall include an enclosure around the liquid handler deck and the thermocycler with the following specifications:

a. HEPA filtration to provide positive pressure filtered air to the thermocycler and the pipetting space within the liquid handler to protect samples from the environment outside the instrument.

b. The HEPA air flow shall be controllable by the instrument software.

11. Shall include a supporting table with the following specifications:

a. The table surface shall be made of an inert, non-porous material suitable for use in a biological laboratory environment (e.g. phenolic resin, epoxy resin)

b. The table shall include casters for easy movement of the table and instrument within the laboratory

c. The table surface shall include cut-outs so that the automated liquid handler can drop waste pipette tips and labware through the cut-outs into a waste container located beneath the table surface

d. The table shall be structurally capable of supporting at least 900 lbs. of distributed weight

e. The table frame shall be made of a non-porous material with good corrosion resistance suitable for use is a biological laboratory environment (e.g. aluminum, stainless steel, powder coated steel)

12. The system must include an operations and maintenance manual covering proper operation, routine maintenance, and troubleshooting for the instrument and controlling software. The manual may be supplied in hard copy or electronic format (or both).

B. LINE ITEM 0002 – BASE LINE ITEM: Quantity One (1) Automation-Compatible Storage Incubator The Contractor shall deliver an automation-compatible storage incubator for the storage of cell cultures in SBS format labware during an experimental run. The storage incubator shall be integrated into Line Item 0001 such that the liquid handler robotics can deliver and remove a cell culture plate from the incubator automatically and place it on the operation deck. The incubator should be controlled by the general liquid handler control software. The incubator storage unit should meet the following specifications.

1. Incubator must hold at least 40 SBS format compatible culture ware plates.

2. Incubator must be able to hold SBS format culture plates at 37 degrees C with a 5% CO2 and a 95% relative humidity environment.

C. LINE ITEM 0003 – BASE LINE ITEM: Quantity One (1) Automation-Compatible Plate Centrifuge

The Contractor shall deliver an automation-compatible plate centrifuge for SBS-format cell culture labware. The centrifuge shall be integrated into Line Item 0001 (liquid handler) such that the liquid handler robotics can deliver and remove a cell culture plate automatically. The speed of the centrifuge should be controlled by the general liquid handler control software. The centrifuge unit should meet the following specifications.

1. Centrifuge should have active cooling such that the internal temperature remains less than 10 degrees C above a 25 degrees C ambient temperature.

2. Centrifuge should have sensors that record the internal temperature during the product run.

3. Centrifuge should be capable of spinning SBS format culture ware plates to achieve at least 4000 g centrifugal force.

D. LINE ITEM 0004 – BASE LINE ITEM: Quantity One (1) Automation-compatible 96-well cellular electroporation unit The Contractor shall deliver an automation-compatible 96-well electroporation unit for permeabilization of mammalian cells. The unit shall be integrated into ITEM 0001 (liquid handler) such that the liquid handler robotics can deliver and remove an electroporation plate automatically. The electroporation conditions in each well should be controlled by the general liquid handler control software. The electroporation unit should meet the following specifications.

1. The unit shall have the capability for up to 96 different electroporation programs per plate.

2. The unit should be able to accommodate transfection volumes between 10 uL and 30 uL.

E. LINE ITEM 0005 – BASE LINE ITEM: Quantity One (1) Software for Control of Instrument The Contractor shall deliver software for the control of the instrument of Line Item 0001. The control software must meet all the following specifications.

1. The software must allow for flexible programming of new instrument methods and must integrate with the thermocycler and the additional instruments in Line Item 0002, 0003, 0004

2. The software must be capable of developing programing methods for the procedures listed in Line Item 0001, Specification 1

3. The software shall be compatible with either Microsoft Windows 7 or Windows 10 operating system

4. Hardware/computers with the necessary Windows operating systems will be supplied by the Contractor.

F. LINE ITEM 0006 – BASE LINE ITEM: Quantity One (1) System Delivery and Installation The Contractor shall deliver the instrument to the NIST campus in Gaithersburg, MD, and install the instrument in Building 227, at NIST Gaithersburg, MD. Installation will occur during normal business hours defined as Monday through Friday, 8:30 a.m. to 5:00 p.m. except for federal holidays. Installation will be scheduled in coordination with the Technical Point of Contact (TPOC). The instrument system will meet the specifications above post installation.

G. LINE ITEM 0007– BASE LINE ITEM: Quantity One (1) Basic System and Instrument Training The Contractor shall provide basic training for up to two NIST personnel in the use of the instrument for the basic cell transfection assay listed in Line Item 0001, Specification 1. Basic System Training shall take place at NIST, Gaithersburg, MD. The training may be completed immediately after completion of installation.

H. LINE ITEM 0008 – OPTIONAL LINE ITEM: Quantity One (1) 96-well Multichannel Pipette Adaptor (Optional) The Contractor shall provide a 96-well multichannel pipette adaptor that shall be integrated into the liquid handler robotics (Line Item 0001) and allow both delivery and removal of liquid from 96 well plates in a single action event. The multichannel pipette adaptor should meet the following specifications.

1. The adaptor must have a method to detect the liquid levels in 96 well plates to determine pipette tip positioning.

2. The adaptor must be able to transfer from 10 to 1000 uL in each pipette position.

I. LINE ITEM 0009 – OPTIONAL LINE ITEM: Quantity One (1) Software Programming Training (Optional) The Contractor shall provide training for one NIST personnel in the use of the instrument control software for the development and programming of new methods. The Software Programming Training shall take place either at NIST in Gaithersburg, MD, or at a contractor training facility within the United States.

This option shall remain valid for a period of twelve (12) months from the date of award.

J. LINE ITEM 0010 – OPTIONAL LINE ITEM: Quantity One (1) Additional Software Programming Training (Optional) The Contractor shall provide training for one additional NIST personnel in the use of the instrument control software for the development and programming of new methods. The Software Programming Training shall take place either at NIST in Gaithersburg, MD, or at a contractor training facility within the United States.

This option shall remain valid for a period of twelve (12) months from the date of award.

K. LINE ITEMS 0011, 0012, 0013, 0014– OPTIONAL LINE ITEM: Quantity One (1) Year Extended Warranty and Preventative Maintenance (Beginning one -year after the date of the award) The contractor shall provide maintenance services for the liquid handling instrument and associated software. The services include all parts, labor, software, one preventative maintenance visit, and travel costs associated with all visits. The contractor shall contact the NIST Technical Point of Contact to schedule the preventive maintenance visit at least 10 days prior to the visit.

The contractor shall respond to an unlimited number of requests for service calls in the event of instrument failure which requires immediate repair. The contractor shall provide travel, labor, and any factory-certified parts that require replacement.

A service technician shall provide on-site service at NIST Gaithersburg, MD location within three business days after a service call is placed. In the event that the Contractor is unable to resolve the problem during the service call, the Contractor shall provide telephone support and on-site support as needed to expedite a solution for NIST. The Contractor is responsible for obtaining all parts required for all repairs and maintenance. The Contractor shall make a reasonable effort to secure parts within 24 hours after identifying the need for a replacement part for the covered equipment.

All repairs must result in the instruments meeting manufacturer’s specifications.

Any parts or components removed for replacement shall become the property of the Contractor unless otherwise agreed to by the parties. The Contractor shall remove the parts from the NIST site at the time of the service call, orcall, or provide shipping instructions and return shipping information that NIST may return the parts to the Contractor within 3 days after the service visit is completed. The Contractor shall assume all charges and liability for all shipments.

L. SYSTEM INTEGRATION:

The Contractor shall provide a design of the proposed system integration for review by the NIST TPOC and the NIST Contracting Officer Representative (COR). The Contractor shall amend the design package and resubmit as necessary until acceptance by the NIST TPOC and COR. Designs shall be provided in AutoCAD or Solidworks for drawings and Microsoft Word or Portable Data Format (PDF) for text documents.

By accepting the design, NIST does not assume responsibility that the system integration design will work. The responsibility for whether the design and provided equipment meet all requirements remains with the Contractor.

V. PLACE OF PERFORMANCE:

Installation of the instrument and Basic System and Instrument Training shall be accomplished at NIST, Gaithersburg, Maryland. Normal duty hours are Monday through Friday, 8:30 a.m. to 5:00 p.m. except for Federal holidays.

The Software Programming Training shall take place either at NIST in Gaithersburg, MD, or at a contractor training facility within the United States.

VI. PERIOD OF PERFORMANCE:

Delivery of III. A-G and L shall be completed within 180 calendar days after award Delivery of III. H, I, and J shall be completed within 60 days after exercise of option or 60 days after completion of system installation, whichever is later.

Delivery of III. K shall be completed if exercised within one year after the period of performance start date of the option period.

VII. WARRANTY

The contractor shall provide a one-year warranty for the instrument that includes all parts, labor, software, one preventative maintenance visit, and travel costs associated with all visits. The contractor shall contact the NIST Technical Point of Contact to schedule the preventive maintenance visit at least 10 days prior to the visit.

VIII. SUBMISSION OF SERVICE REPORT

The Contractor shall submit a service report to the designated TPOC prior to departure from NIST on any given service call for maintenance and repairs. The service report shall include the following for all instrument repairs and maintenance:

1. Model number.

2. Serial number.

3. Date and time of arrival to NIST.

4. Description of service performed.

5. Name and quantity of any parts that were repaired.

6. Name and quantity of any parts that were replaced.

7. Date and time of departure from NIST.

8. Diagnostic test results or narrative summary demonstrating that the instrument is meeting the performance standards.

9. Any additional comments or recommendations.

10. Printed name and signature of service technician 11. Signature block for NIST personnel accepting the services rendered.

IX. ACCEPTANCE CRITERIA

Formal acceptance of the system will be given at the time that NIST determines all performance standards in this statement of work have been met. NIST will have 60 days following completed delivery, installation, and training to make this evaluation. During this time, the system will be evaluated to determine if it meets the minimum requirements of technical capability outlined in section IV of this SOW (Salient Characteristics) in conjunction with the information in the Contractor-provided quotation on how the system can be used to meet these requirements. The ability to meet these specifications will be validated by way of demonstrating the instrument has the salient characteristics listed in Section III above. The system shall demonstrate the ability to control all the parts with software and that all the equipment is integrated into one instrument.

X. GENERAL INFORMATION

A. Payment Schedule: Advance payment is not authorized. The contractor may invoice after receipt and acceptance of the required deliverables. Partial payments are authorized, provided the deliverables being invoiced have been accepted by NIST. For the optional maintenance periods, the contractor may bill monthly or quarterly in arrears.

B. Safety: The Contractor employee shall be responsible for knowing and complying with NIST installation safety prevention regulations. Such regulations include, but are not limited to, general safety, fire prevention, and waste disposal.

C. Security: NIST is a restricted campus. An identification badge is required for access for entry into buildings and also is shown to the armed Security Police when entering the campus.

D. Identification Badges: Contractor employees shall comply with NIST identification and access requirements. Each Contractor employee shall wear a visible identification badge provided by the NIST Security Office.

E. Vehicle Registration: All Contractor employees must register their vehicles with the NIST Security Office to gain access to the campus. A valid driver’s license, Government-furnished civilian ID, proof of insurance and current registration must be presented to the NIST Security Office, at which time a NIST vehicle pass will be issued. The pass shall be displayed on the vehicle’s rear-view mirror in accordance with instructions.