Attachment 1 Performance Work Statement and QASP.pdf

Attachment 1 Performance Work Statement and QASP

Device Service Plan, BARC, Beltsville MD

GENERAL INFORMATION

1. Scope of Work:

1.1. The Prime Contractor shall provide all personnel, equipment, transportation, and supervision necessary to deliver a Device Service Plan for a Vitros 4600 clinical chemistry analyzer manufactured by QuidelOrtho.

1.2. The contractor shall perform all work described in this Performance Work Statement in accordance with all applicable Federal, State, and local laws, regulations, codes, OEM technical specifications and OEM guidelines.

1.3. This is a performance-based requirement, the contractor shall perform to the requirements and standards as established by this PWS. The labor mix of employees to perform this contract remains the discretion of the Contractor for all services.

1.4. All in scope requirements are Firm Fixed Price. This is not a Time and Materials requirement. Out of scope requirements shall be addressed by the Government Technical

Monitor before proceeding.

1.5. Technical Details:

1.5.1. OEM: QuidelOrtho Model: Vitros 4600, Serial Number: 4600175.

1.5.2. The instrument lapsed in service coverage in early 2026.

2. Service performance is on site at a USDA Facility, NEA FOOD COMPONENTS AND

HEALTH LABORATORY 10300 BALTIMORE AVENUE BLDG 307B, RM 231, BARC-

EAST, BELTSVILLE MD 20705.

3. Period of Performance: One-year base period plus four one-year option periods.

4. Invoicing and Payment:

4.1. The "Submit Invoice-to" address for USDA orders is the Department of Treasury's Invoice

Processing Platform (IPP).

4.2. All invoices shall be submitted via the electronic Invoice Processing Platform. This is a mandatory requirement initiated by the U.S. Department of Treasury. More information is available at https://www.ipp.gov. The Department of Treasury is the point of contact for all IPP

Collector account inquiries.

4.3. Payment is in arrears pursuant to the clause at FAR 52.212-4. Note FAR 52.212-4 (i)(1)

Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

4.4. Payment will not be made for service in advance of delivery.

4.5. The invoice cycle shall be no less than monthly.

4.6. Advance invoice approval is not required, as required approval tiers exist in IPP.

5. Definitions:

5.1. OEM – Original Equipment Manufacturer. For the purposes of this requirement, the OEM is “QuidelOrtho”

5.2. CLIN – Contract Line Item, numbered. Established in the solicitation schedule, will start with “0001.”

5.3. Option CLIN - A unilateral right in a contract, exercisable for a specified time, allowing the

Government to purchase additional services or extend the period of performance. These CLINs represent separate line items with distinct pricing, performance periods, or quantities that the government may exercise without renegotiation.

5.4. Government Technical Monitor – USDA Employee Location representative appointed by the Contracting Officer to monitor, evaluate, and communicate to the CO the Contractor’s performance in complying with contract requirements in an efficient and timely manner.

5.5. Person - means a corporation, partnership, business association of any kind, trust, joint-stock company, or individual.

5.6. Prime contract - means a contract or contractual action entered into by the United States for the purpose of obtaining supplies, materials, equipment, or services of any kind.

5.7. Prime Contractor - means a person who has entered into a prime contract with the United

States.

5.8. Prime Contractor employee - means any officer, partner, employee, or agent of a prime contractor.

5.9. Privity of Contract - Contract employees shall be accountable solely to the Prime

Contractor, who, in turn, is responsible to the Government. For the purposes of this requirement, any reference to “contractor” is referring to the Prime Contractor.

5.10. Calendar Days - Every single day on the calendar (12 AM to 11:59 PM), including weekends, holidays, and non-working days.

5.11. Business Days – Standard business days 8AM to 5PM Eastern with holiday exceptions as noted:

Listed below are official Government holidays:

New Year’s Day January 1*

Martin L. King Birthday Third Monday in January

President's Day Third Monday in February

Memorial Day Last Monday in May

Juneteenth As Indicated

Independence Day July 4*

Labor Day First Monday in September

Columbus Day Second Monday in October

Veterans Day November 11*

Thanksgiving Day Fourth Thursday in November

Christmas Day December 25*

Or when the USDA-ARS facility is closed due to local or national emergencies, administrative closings, or similar government-directed facility closings

*In accordance with Federal regulations, if these holidays fall on a Saturday, the holiday will be observed on Friday, if Sunday, holiday will be observed on Monday.

CONTRACTOR PERFORMANCE REQUIREMENTS

6. Technical Requirements/Tasks

6.1. General:

6.1.1. In addition to OEM defined requirements, maintaining the instrument’s FDA certification throughout the duration of the period of performance is required.

6.1.2. Only new OEM parts and new OEM approved consumables shall be used in performance of this requirement.

6.1.3. The Firm Fixed Price for CLIN 0001-4001 is not itemized for service time minimums, overtime, tiers of service, multiple visits, etc. It is a ‘bundled” Firm Fixed Price per CLIN.

6.2. Specific Tasks CLIN 0001-4001:

6.2.1. Periodic Maintenance:

6.2.1.1. The contractor shall clean, test, and maintain the instrument at the intervals indicated by the equipment service manual.

6.2.1.2. Periodic Maintenance service includes the annual maintenance kit, the kit consumables, and any other parts required.

6.2.2. The contractor shall install Health and Safety related Modification Kits on the instrument.

6.2.3. Repairs not addressed in previous sections:

6.2.3.1. The contractor shall respond to repair requests required to maintain the instrument’s

FDA certification within five business days.

6.2.3.2. Parts and service overhead are included in the Firm Fixed Price.

6.2.3.3. Repairs outside of those required to maintain the instrument’s FDA certification are not in the scope of this requirement.

7. Contractor’s Key Personnel:

7.1. The contractor shall provide a repair service technician(s) that are authorized by the OEM manufacturer of the serial numbered equipment detailed in Section 1 above to perform and document the service requirements.

7.2. Documentation from the OEM of the first and last name authorization of identified service technicians, dated as effective by at least the first day of the contract period of performance, shall be presented only if requested in writing by the Contracting Officer at any point after contract award. This documentation shall be presented to the Contracting Officer in writing within one

(1) business day of the written request.

7.3. The Contracting Officer may verify the documentation with the OEM.

7.4. If contractor personnel are added beyond the initial names, after the first day of the contract period of performance, the first and last names with OEM documentation shall be provided within one (1) ‘business day’ of a Contracting Officer’s written request at any point after contract award.

8. Security Requirements: All contractor personnel shall always be in the presence of a USDA escort while on location. Any contractor employee access to USDA network systems shall be, without exception, supervised at all times by a USDA escort.

QUALITY CONTROL

9. Quality Assurance Surveillance Plan (QASP): The Government shall establish a QASP as a means of evaluating whether the Contractor is meeting the performance standards/quality levels identified in the PWS to ensure that the government pays only for the level of services received.

Tasks Standards Acceptable Quality Level

(AQL)

Technical Requirements and

Tasks identified in Section 6, 7, and 8

Standards as established in Technical requirements and tasks identified in

Section 6, 7, and 8.

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