123A9422Q0013 Statement of Work.pdf

ATTACHMENT A

US Department of Agriculture (USDA)

Statement of Work

123A9422Q0013

Contents Project General Information

1.0 Scope of Work

2.0 Background

Contractor Requirements

3.0 Technical Requirements / Tasks

4.0 Government Furnished

5.0 Deliverables / Schedule

6.0 Travel

7.0 Contractor’s Key Personnel ............................................................................. Error! Bookmark not defined.

8.0 Security Requirements

9.0 Data Rights

10.0 Section 508 – Electronic and Information Technology Standards Attachment ......................................................................................................... Error! Bookmark not defined.

Project

High Pressure Liquid Chromatograph coupled with High Resolution Orbitrap Mass Spectrometer

General Information

1.0 Scope of Work

The objective of this procurement action is to acquire a single stage high resolution quadrupole - orbitrap mass spectrometer coupled with an ultra-high-pressure liquid chromatograph (UHPLC) and an operating system that is compatible with the security architecture of USDA Information Technology Enterprise. The high-resolution mass spectrometer will use Orbital trapping technology designed to do automated screening, confirmation and quantification analysis. It will provide high- resolution, accurate- mass (HR/AM) capabilities giving the instrument the ability to monitor the current targeted and non-targeted compounds. The instrument, software, and data base will allow for scrutinizing the acquired sample for non-targeted compounds in the same sample acquisition.

2.0 Background

The Food Safety and Inspection Service (FSIS), a public health regulatory agency of the U.S. Department of Agricultural (USDA), protects consumers by ensuring that meat, poultry, siluriform, and egg products are safe, wholesome, accurately labeled, and free of adulteration. The FSIS Western Laboratory (WL) is located at 800 Buchanan Street, Albany, CA 94710.

Contractor Requirements

3.0 Technical Requirements / Tasks

The Western Laboratory requires one Ultra High Pressure Liquid Chromatograph(UHPLC) coupled with a single stage high resolution quadrupole Orbitrap mass spectrometer which are controlled by fully integrated software capable of data acquisition, processing, and reporting that is compatible with the security architecture of USDA Information Technology Enterprise.

The UHPLC-MS/MS systems shall meet or exceed the following specifications:

a. Be a high-resolution bench-top system with a quadrupole-Orbitrap configuration.

b. Mass Range: m/z 40-3000.

c. Max Resolving Power: 120,000 (1.5 Hz) at m/z 200 (scan rate).

d. Max Scan Rate: Up to 22 Hz at resolution setting of 15,500 resolution @ m/z 200.

e. Mass Accuracy: < 1 ppm RMS error with internal calibration and < 3 ppm RMS error with external calibration.

f. Quadrupole Isolation: Step less precursor isolation from 0.4amu to full mass range.

g. Scan Modes: Full Scan, Selective Ion Monitoring (SIM), All Ion Fragmentation (AIF), MS/MS, and Data Independent Acquisition (DIA).

h. Sensitivity Full MS: 500 fg Buspirone on column signal to noise 100:1 or better. SIM: 50fg

Buspirone on column signal to noise 100:1 or better.

i. Polarity Switching: One full positive and negative scan cycle under 1 second at a resolution setting of 35,000 (at m/z 200).

j. Heated Electrospray Ionization (HESI) and Atmospheric Pressure Chemical Ionization (APCI).

k. Integrated sample/calibrant delivery system plus programmable divert valve.

l. The user must have read backs of all ion optical parts of the instrument and the data system must have extensive readouts of voltages, temperatures, and vacuum of the instrument.

Ultra-High Pressure Liquid Chromatograph shall include:

a) Binary pump designed for high-throughput and ultra-fast applications, and the use of less than 2 µm particle columns meeting or exceeding the following specifications:

i. Operating Flow Range of 0.010 to 2.000 milliliters per minute, in 0.001 milliliter increments.

ii. Effective system delay volume < 120 microliters.

iii. Composite Precision 0.15% RSD (Relative Standard Deviation).

iv. Flow Precision ± 0.02 min SD (Standard Deviation).

v. Flow Accuracy: ±1.0% at 0.5 milliliters per minute with Methanol.

vi. Maximum operating pressure up to 15,000 psi.

b) Auto sampler with standard vial and well plate capability and must be temperature controlled to maintain a set temperature over the range of 4°- 40°C

c) Temperature controlled column compartment capable of maintaining a temperature from 5°C above ambient temperature to 90°C.

d) The column oven shall accommodate 2.1 X 150 millimeter column.

e) Equipped with mobile phases and wash reagents vacuum degasser with solvent tray.

Software:

a) Operating System shall be Microsoft Windows 10 Enterprise edition, version 1809 or later.

b) Instrument software shall control LC-MS system, data acquisition, processing, and reporting.

c) Include quantification software capable of batch processing analyzed samples.

d) Configuration software for configuration of the initial system and later re-configurations if needed.

e) Automated tuning and calibration software shall be provided.

f) System software package shall include automated compound(s) optimization.

Computer System:

a) At least 3.0 to 4.7 gigahertz (GHz) processor.

b) At least 16 gigabyte (GB) 1x16GB 2666MHz DDR4 memory.

c) At least a 24-inch flat screen monitor, keyboard, and mouse.

d) At least TB solid state drive RAID.

e) An internal/external CD/DVD ± R/RW drive.

Onsite Training:

Training shall include:

(a) At least three days onsite of operators (6 people) training provided at the FSIS Western Laboratory, Albany, California, covering the following topics:

(i) Hardware operation and maintenance.

(ii) System software methods setup/use for data acquisition, processing, and reporting.

(iii) System calibration and tuning/optimization.

Service plan to include:

1. Contractor shall provide one-year warranty on service, parts, labor and any necessary return shipments (both ways) at no cost. Contractor shall include a return shipment process.

2. Contractor shall cover any travel-costs of service personnel if the instrument is serviced on-site during the one-year warranty period.

The instrument shall be installed, and all factory published specifications for sensitivity demonstrated upon installation. The warranty service shall include telephone support for hardware and software and supply for the consumable parts during repairs and maintenance. Maintenance/repair services shall be provided during normal working hours, 8:00 am to 4:30 pm, local time, Monday through Friday, excluding Federal Holidays.

4.0 Government Furnished

A. Government Furnished Information or Other Resources. None

B. Inspections and Acceptance

1. Inspection: The Government will review 100 percent of the deliverables.

2. Acceptance Criteria: In accordance with Section 5.B. Performance Indicators & Standards.

3. Written Acceptance or Rejection of Deliverables by the Government: The Contracting Officer or Contracting Officer's Representative (COR) will provide written notice of acceptance or rejection to the Contractor within 45 days of the end of the contract period.

C. Reporting Requirements: None

D. Access to Government Facilities:

a. Facility Location:

USDA FSIS OPHS Western Laboratory Attn: Kimberly Nguyen 800 Buchanan Street Albany, CA 94710

b. Location of Instrument Installation

i. Instrument laboratory of the Western Laboratory located in the Main Building, Albany, CA, first floor, room F106.

c. Closure of Government Facilities

i. The Federal Government observes the following days as holidays and government facilities will be closed.

LEGAL HOLIDAYS (JUN 2021)

New Year’s Day January 1st* Martin Luther King’s Birthday Third Monday in January Presidents’ Day Third Monday in February Memorial Day Last Monday in May Juneteenth June 19* Independence Day July 4th* Labor Day First Monday in September

Columbus Day Second Monday in October Veterans’ Day November 11th* Thanksgiving Day Fourth Thursday in November Christmas Day December 25th*

Note: If the date falls on a Saturday, the Government holiday is the preceding Friday. If the date falls on a Sunday, the Government holiday is the following Monday.

ii. In addition to the days designated above as holidays, the Government may observe additional days in accordance with 5 USC 6103.

5.0 Deliverables / Schedule

A. Deliverables / Milestones

Item Deliverable Name Due Date No. of

Copies Format Addressee

1 The contractor shall deliver one Orbitrap quadrupole UHPLC-MS that meets the above listed technical requirements.

Receipt at Western Laboratory no later than 30 days after purchase order is completed

NA NA USDA FSIS OPHS Western Laboratory Attn: Kimberly Nguyen 800 Buchanan Street

2 Installation performed by a factory trained field service engineer.

To be specified by the laboratory upon receipt of instrument and vendor installation requirements.

NA NA USDA FSIS OPHS Western Laboratory Albany, CA 94710

3 Initial configuration of the system. At time of installation.

NA NA USDA FSIS OPHS Western Laboratory

4 Demonstration of system functionality and performance

Upon qualification of installed instrument

NA NA USDA FSIS OPHS Western

5 Copies of system management and user manual(s).

Upon qualification of installed instrument.

2 Electronic PDF file and paper formats

USDA FSIS OPHS Western Laboratory Albany, CA 94710

6 User Training or Demonstration Upon qualification of installed instrument.

NA Visual USDA FSIS OPHS Western

B. Performance Indicators and Standards:

Performance Indicators Standards for Acceptable Performance Delivery of Mass spectrometer instrument and associated components

Instrument is received with no apparent damage and with all contracted components.

Installation and Configuration Instrument meets manufacturer specifications for installation and operational qualification.

Demonstration of system functionality and performance

Instruments meets or exceeds specifications identified above in this document and those of the manufacturer.

Management and user manual(s). Manuals are provided in the specified formats.

User Training or Demonstration Training delivered per specified requirements

6.0 Travel

Travel costs of service personnel if the instrument is serviced on-site during one-year warranty should be covered by the service plan.

7.0 Security Requirements

A. INFORMATION TECHNOLOGY SYSTEMS SECURITY

The activities covered under by this contract might require the Contractor’s access to Federal Automated Information System or systems, as well as the implementation of new systems. The Offeror’s proposal must include:

1. A detailed outline (commensurate with the size and complexity of the Statement of Work) of its present and proposed information technology systems security program. The response must demonstrate that it complies with the security requirements of the SOW, the Federal Information Security Management Act of 2002 (FISMA, Public Law 107-347, 44 U.S.C. 3531-3536); Office of Management and Budget (OMB) Circular A-130, Appendix III “Security of Federal Automated Information Systems” (http://www.whitehouse.gov/omb/circulars_a130_a130appendix_iii) and an acknowledgement of its understanding of the security requirements of the SOW.

2. A signed copy of the USDA FSIS IT Rules of Behavior shall be included with the Offeror’s proposal.

B. INFORMATION TECHNOLOGY SYSTEMS SECURITY CONTRACT REQUIREMENTS

1. The contractor shall establish and implement appropriate administrative, technical and physical safeguards to ensure the security and confidentiality of sensitive Government information, data, and/or equipment.

2. The contractor shall comply with IT systems security and/or privacy specifications set forth in FSIS and USDA directives, policy, and procedures; the Computer Security Act of 1987; Office of Management and Budget (OMB) Circular A-130; and the Federal Information Security Management Act of 2002 (FISMA).

3. Pursuant to FSIS policy, the contractor shall be responsible for assuring that each contractor employee who requires routine unaccompanied physical access to a Federally-controlled facility and/or unaccompanied access to a Federally-controlled information system, including an FSIS-issued computer, completes Computer Security Awareness training prior to performing any work under this contract.

4. The contractor is required to maintain a listing of all individuals who have completed Computer Security Awareness training and submit this listing to the COR with a copy to the Contracting Officer within ten (10) calendar days of an individual starting work on this contract.

8.0 Data Rights

A. ACCESS TO SENSITIVE INFORMATION

1. As used in this clause, “sensitive information” refers to information that a contractor has developed at private expense, or that the Government has generated that qualifies for an exception to the Freedom of Information Act, which is not currently in the public domain, and which may embody trade secrets or commercial or financial information, and which may be sensitive or privileged.

2. To assist the U. S. Department of Agriculture (USDA), Food Safety and Inspection Service (FSIS) in accomplishing management activities and administrative functions, the Contractor shall provide the services specified elsewhere in this contract.

3. If performing this contract entails access to sensitive information, as defined above, the Contractor agrees to

a. Utilize any sensitive information coming into its possession only for the purposes of performing the services specified in this contract, and not to improve its own competitive position in another procurement action.

b. Safeguard sensitive information coming into its possession from unauthorized use and disclosure.

c. Allow access to sensitive information only to those employees that need it to perform services under this contract.

d. Preclude access and disclosure of sensitive information to persons and entities outside of the

Contractor’s organization.

e. Train employees who may require access to sensitive information about their obligations to utilize it only to perform the services specified in this contract and to safeguard it from unauthorized use and disclosure.

f. Obtain a written affirmation from each employee that he/she has received and will comply with training on the authorized uses and mandatory protections of sensitive information needed in performing this contract.

g. Administer a monitoring process to ensure that employees comply with all reasonable security procedures, report any breaches to the Contracting Officer, and implement any necessary corrective actions.

4. The nature of the work on this contract may subject the Contractor and its employees to a variety of laws and regulations relating to ethics, conflicts of interest, corruption, and other criminal or civil matters relating to the award and administration of government contracts. Recognizing that this contract establishes a high standard of accountability and trust, the Government will carefully review the Contractor’s performance in relation to the mandates and restrictions found in these laws and regulations. Unauthorized uses or disclosures of sensitive information may result in termination of this contract for default, or in debarment of the Contractor for serious misconduct affecting present responsibility as a government contractor.

5. The Contractor shall include the substance of this clause, including this paragraph (e); suitably modified to reflect the relationship of the parties, in all subcontracts that may involve access to sensitive information.

9.0 Section 508 – Electronic and Information Technology Standards

508 COMPLIANCE ACCESSIBILITY OF ELECTRONIC AND INFORMATION TECHNOLOGY

(a) This SOW is subject to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by the workforce Investment Act of 1998 (P.L. 105-220). Specifically, subsection 508(a)(1) requires that when the Federal Government procures Electronic and Information Technology (EIT), the EIT must allow Federal employees and individuals of the public with disabilities comparable access to and use of information and data that is provided to Federal employees and individuals of the public without disabilities.

(b) The EIT accessibility standards at 36 CFR Part 1194 were developed by the Architectural and Transportation Barriers Compliance Board ("Access Board") and apply to contracts and task/delivery orders, awarded under indefinite quantity contracts on or after June 25, 2001.

(c) Each Electronic and Information Technology (EIT) product or service furnished under this contract shall comply with the Electronic and Information Technology Accessibility Standards (36 CFR 1194), as specified in the contract, as a minimum.

If the Contracting Officer determines any furnished product or service is not in compliance with the contract, the Contracting Officer will promptly inform the Contractor in writing. The Contractor shall, without charge to the Government, repair or replace the non-compliant products or services within the period of time to be specified by the Government in writing. If such repair or replacement is not completed within the time specified, the Government shall have the following recourses:

1. Cancellation of the contract, delivery or task order, purchase or line item without termination liabilities; or

2. In the case of custom Electronic and Information Technology (EIT) being developed by a contractor for the

Government, the Government shall have the right to have any necessary changes made or repairs performed by itself or by another firm for the noncompliant EIT, with the contractor liable for reimbursement to the Government for any expenses incurred thereby.

(d) The contractor must ensure that all EIT products that are less than fully compliant with the accessibility standards are provided pursuant to extensive market research and are the most current compliant products or services available to satisfy the contract requirements.

(e) For every EIT product or service accepted under this contact by the Government that does not comply with 36 CFR 1194, the contractor shall, at the discretion of the Government, make every effort to replace or upgrade it with a compliant equivalent product or service, if commercially available and cost neutral, on either a contract specified refresh cycle for the product or service, or on a contract effective option/renewal date; whichever shall occur first.

Section 508 Compliance for Communications The vendor shall comply with the standards, policies, and procedures below. In the event of conflicts between the referenced documents and this SOW shall take precedence.

Rehabilitation Act, Section 508 Accessibility Standards

1. 29 U.S.C. 794d (Rehabilitation Act as amended)

2. 36 CFR 1194 (508 Standards)

3. www.access-board.gov/sec508/508standards.htm (508 standards)

4. FAR 39.2 (Section 508)

5. USDA Standards, policies and procedures (Section 508) In addition, all contract deliverables are subject to these 508 standards as applicable.

Regardless of format, all Web content or communications materials produced, including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents above. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW shall be the responsibility of the contractor or consultant.

The following Section 508 provisions apply to the content or communications material identified in this SOW:

36 CFR Part 1194.21 a - l 36 CFR Part 1194.22 a - p 36 CFR Part 1194.31 a - f 36 CFR Part 1194.41 a – c The contractor shall provide a completed Section 508 Product Assessment Template and the contractor shall state exactly how proposed EIT deliverable(s) meet or does not meet the applicable standards.

The following Section 508 provisions apply for software development material identified in this SOW, PWS, or TO:

For software development, software applications, and operating systems the Contractor/Developer/Vendor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards) 36 CFR Part 1194.21 (a – l) 36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

a. Information Technology – General Information http://www.ocio.usda.gov/508/index.html#resources

For web-based applications (intranet, internet information and applications, 16 rules), the Contractor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards) 36 CFR Part 1194.22 (a – p) 36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508) http://www.access-board.gov/sec508/508standards.htm%20(508 http://www.access-board.gov/sec508/508standards.htm http://www.ocio.usda.gov/508/index.html#resources http://www.access-board.gov/sec508/508standards.htm

(5) USDA Standards, policies and procedures (Section 508)

a. Information Technology – General Information http://www.ocio.usda.gov/508/index.html#resources For Telecommunication products the Contractor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards) 36 CFR Part 1194.23 (a – k) 36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

a. Information Technology – General Information http://www.ocio.usda.gov/508/index.html#resources

For video and multimedia applications (including training), the Contractor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards) 36 CFR Part 1194.24 (a – e) 36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

a. Information Technology – General Information http://www.ocio.usda.gov/508/index.html#resources

For self-contained, closed products, the Contractor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards) 36 CFR Part 1194.25 (a – j) 36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

a. Information Technology – General Information http://www.ocio.usda.gov/508/index.html#resources

For Desktop and portable computers, the Contractor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards) 36 CFR Part 1194.26(a – d) 36 CFR Part 1194.31 (a – f) 36 CFR Part 1194.41 (a – c)

(3) www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) USDA Standards, policies and procedures (Section 508)

a. Information Technology – General Information http://www.ocio.usda.gov/508/index.html#resources All Electronic Information Technology that is subject to the 36 CFR 1194 standards will have a Section 508 acceptance test and Section 508 will be validated upon acceptance.

All maintenance for Electronic Information Technology that requires upgrades, modifications, installations and purchases will adhere to the Section 508 Standards and 36 CFR 1194.

http://www.ocio.usda.gov/508/index.html#resources http://www.access-board.gov/sec508/508standards.htm http://www.ocio.usda.gov/508/index.html#resources http://www.access-board.gov/sec508/508standards.htm http://www.ocio.usda.gov/508/index.html#resources http://www.access-board.gov/sec508/508standards.htm http://www.ocio.usda.gov/508/index.html#resources http://www.access-board.gov/sec508/508standards.htm http://www.ocio.usda.gov/508/index.html#resources