Attachment C Statement of Work.pdf

STATEMENT OF WORK (SOW)

Consumer Product Safety Commission (CPSC)

Liquid Chromatograph Triple Quadrupole Mass Spectrometer (LC/MS/MS)

1. Introduction and Overview

The US Consumer Product Safety Commission (CPSC) Laboratory Science Division-Chemistry (LSC) intends to make award for the purchase of a new LC/MS/MS (triple quad) system for chemical analysis of LSC samples. This will be a brand name or equal acquisition. This new system will be purposed for detection and quantification of potential hazardous chemicals in consumer products, which cannot be readily volatized via Gas Chromatography/Mass Spectrometry (GC/MS). The acquisition will include delivery, setup and training of staff at the CPSC National Product Testing and Evaluation Center (NPTEC), 5 Research Place, Rockville, MD 20850.

1.1 Anticipated Contract Type

This will be a firm-fixed-price contract.

1.2 Background

The primary use of the LC/MS/MS will be for the analysis of consumer products that contain nicotine (in vaping solutions), lidocaine (in patches and creams), and small-molecule active pharmaceutical ingredients (APIs) as pertains to the Poison Prevention Packaging Act.

Secondary uses include the analysis of chemicals regulated under the Federal Hazardous Substances Act. This instrument can separate and characterize complexed mixtures of large molecular weight compounds which are not readily volatized using GC/MS analysis.

1.3 Scope of Work

Only new equipment shall be considered for this procurement. The dimensions for the LC and MS components (combined) cannot exceed 60” (width) by 32” (depth) by 72” (height) with a combined weight of not more than 450 lbs. The noise level of the combined equipment (all components) cannot exceed 66 dB. The instrument must be compatible with LabVantage LIMS.

Contractors must provide a comprehensive site planning guide (included with their submission).

Contractors should provide a reference at a Federal agency who operates the offered equipment and can be contacted regarding equipment performance. The equipment must include the following listed items, with contractors verifying their system meets or exceeds the following requirements:

For the triple quadrupole mass spectrometer:

• System must be capable of analyzing nicotine, lidocaine, and small-molecule APIs.

• The system must have both electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI) capabilities with the ability to switch sources without the use of tools.

• Minimum sensitivity requirement for positive ion mode: signal/noise (S/N) 30,000:1, 1 picogram (pg) of reserpine on column. Minimum sensitivity requirement for negative ion mode: S/N 10,000:1, 1 pg of chloramphenicol on column.

• Must possess a maximum scan speed of at least 10,000 Da/s

• Must be capable of switching polarity in not more than 50 msec while conducting multiple reactions monitoring (MRM).

• Must possess a minimum dwell time of no greater than 1 msec.

• Must have an acquisition rate of at least 500 MRM/sec.

• Must cover a mass range (m/z) of at least 15-1500.

• Must have mass stability of 0.1 Da over 24 hours.

• Must have 5 orders of magnitude of dynamic range.

• Must be able to support a maximum LC flow rate of at least 2 mL/min.

For the liquid chromatograph:

• Column oven must be able to achieve 20°C to 80°C (for a room kept at 25°C +/- 2°C).

• Provide for the mixing of at least two solvents with a gradient

• Flow rates that at least cover the range of 0.5 mL/min to 2 mL/min.

• Injection volume range must cover 1µL to 50µL, with a 10µL injection volume precision of

< 0.3%.

• Must tolerate a pH range of 1 to 12.

• Must contain solvent degassers.

• Must have maximum operating pressure of at least 9,000 psi (620 Bar).

• Reliable autosampler capable of handling at least 75 standard 1.5 mL vials.

For the roughing pump:

• Must be able to meet the vacuum needs of the instrument.

• Pump dimensions cannot be greater than 16” (width) by 22” (depth) by 22” (height).

• The weight of the pump cannot exceed 100 lbs.

• The noise level of the pump cannot exceed 60 dB.

• A pump enclosure should only be listed as optional item (not included in price).

For the nitrogen generator:

• Must be able to achieve a maximum nitrogen flow of at least 18 L/min.

• Must be able to meet the nitrogen needs of the instrument.

• Generator dimensions cannot be greater than 24” (width) by 30” (depth) by 32” (height).

• The weight of the generator cannot exceed 250 lbs.

For the Uninterruptable Power Supply (UPS):

• All equipment associated with the LC/MS/MS must be powered off of the UPS. This includes the liquid chromatograph, mass spectrometer, roughing pump, nitrogen generator, computer, monitor, and any other associated equipment.

• The UPS must be compatible with an L6-30P (30 amp), 208 VAC (single phase) outlet.

• The dimensions of the UPS cannot exceed 12” (width) by 34” (depth) by 34” (height).

• The weight of the UPS cannot exceed 300 lbs.

The following additional items are required:

• Computer required for running LC/MS/MS.

• Standard monitor for viewing LC/MS/MS software and results.

• Keyboard and mouse supplied with computer.

• Windows 10 (or comparable) or newer version of Windows (or comparable).

• All software required for the operation of equipment and full data analysis.

Warranty, maintenance and repair:

• Minimum 1-year warranty covering all parts, labor, and travel and lodging (but not consumables such as vials, solvents, columns, etc.) is required for the liquid chromatograph, mass spectrometer, nitrogen generator, and their associated equipment/accessories.

• Contractor must provide on-site repair of instrument within 72 hours.

All equipment must be delivered and installed on site by the contractor, and proof of operability must be demonstrated.

Training of Personnel - The following training elements must be included:

• Within 60 days of LC/MS/MS complete installation, staff (at least three staff members) will require three days (24 training hours) of onsite training at the customer location to educate the staff. Training components should include:

o Hands on operation of the system.

o Hands on data analysis.

o Hands on routine maintenance.

o An introduction to method development.

Prior to this training, staff must have access to online (preferred) and/or manual training materials to obtain background knowledge. If a local training facility is available, training can be held at such facility instead with agreement from both parties.

Consumables and spare parts – Some initial consumables and spare parts should be provided:

• A column should be supplied for initial analysis (proof of functionality).

• Initial consumables and spare parts.

• Additional accessories (e.g., maintenance tool kit).

Note: Any consumables not provided but required for proof of instrument functionality must be stipulated in the site planning guide or clearly communicated in writing.

1.4 Period of Performance

The anticipated contract performance period shall begin on the effective date of the anticipated award. The period of performance will include one (1) 12-month base year and three (3) 12-month option periods. The base period will include the purchase of the Liquid Chromatograph Triple Quadrupole Mass Spectrometer (LC/MS/MS), Nitrogen Generator, Uninterruptable Power Supply (UPS), one-year warranty, and three (3) days (24 hours total) of employee training and additional items listed in the RFQ. The three (3) option periods will follow the one (1) year warranty (included) and be for as-needed servicing AND annual preventative maintenance of the Liquid Chromatograph, Triple Quadrupole Mass Spectrometer, and the Nitrogen Generator.

1.5 Delivery & Performance

The following deliverable items for the anticipated contract shall be performed or delivered in accordance with the following schedule:

ITEM DESCRIPTION OF ITEM QUANTITY DELIVERY & PERFORMANCE

a. LC/MS/MS and associated equipment 1 ea. Shipped within 30 calendar days from award date

b. LC/MS/MS install and proof of operability

1 ea. Within 15 calendar days from arrival of LC/MS/MS at CPSC

NPTEC

c. Training 1 ea. Within 60 calendar days from install of LC/MS/MS at CPSC

NPTEC

d. Warranty Support (included with base year)

1 ea. For 365 calendar days from installation of LC/MS/MS at CPSC

NPTEC

1.6 Government Furnished Property

Conference rooms for training personnel will be provided. Additionally, based on a site planning guide, which must be provided by the contractor, the following will be provided:

• Laboratory space for required equipment.

• Proper ventilation for required equipment.

• One L6-30P (30 amp), 208 VAC (single phase) outlet for supplying power to the UPS.

• If required, a single cylinder of Argon and any necessary regulators (per contractor-provided site planning guide).

• Any required solvents for initial functionality (types & specifications as per contractor-provided site planning guide).

• Any other consumables required per site planning guide.

1.7 Optional Year Servicing

Pricing must be quoted for the option of full service for at least Year 1, Year 2, and Year 3 following the end of the original warranty on the LC/MS/MS. This anticipated optional service contract (by year) must cover one annual Preventative Maintenance (PM) on the triple quadrupole mass spectrometer, nitrogen generator and liquid chromatograph. It must also cover all parts, labor, and travel (but not consumables) for the full servicing needs of the triple quadrupole mass spectrometer, nitrogen generator, liquid chromatograph, and their associated equipment/accessories. During optional service years, contractor must provide on-site repair of instrument within 72 hours.

1.8 Withholding of Contract Payment

Notwithstanding any other payment provision of this contract, failure of the Contractor to perform or deliver required work, supplies, services or failure to complete the percentage of work claimed, will result in the withholding of payments under this contract unless such failure arises out of causes beyond the control, and without the fault or negligence of, the Contractor. The Government must promptly notify the Contractor of its intention to withhold payment of any invoice or voucher submitted.