Attachment 001 Performance Work Statement and QASP.pdf

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Device Service Plan - Davis CA
Solicitation number
1232SA25Q0732
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This Performance Work Statement (PWS) details a Device Service Plan for a Roche Cobas e 4111 fully automated, high-throughput electrochemiluminescence immunoanalyzer located at the USDA Western Human Nutrition Research Center (WHNRC) in Davis, California. The contract includes a base period plus four option periods, requiring two annual on-site preventative maintenance visits with at least five months between visits, software and firmware updates, and comprehensive technical support covering all repair expenses including parts, travel, and labor.

Key service requirements include OEM-authorized technician visits, corrective repair within 3-5 business days, proper alignment of device components after service, and delivery of service reports within five business days. The contractor must always be escorted by USDA personnel while on-site, and the Quality Assurance Surveillance Plan (QASP) mandates 100% compliance with all technical requirements and tasks specified in the document. The device's serial number is 1388-40, and the service plan is designed to maintain the equipment within original manufacturer specifications.

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Attachment 001 Performance Work Statement and QASP

Device Service Plan, WHNRC Davis CA

GENERAL INFORMATION

1. Scope of Work:

1.1. Device Service Plan for the device as detailed in Section 2.

1.2. Device is located at a PWA WHNRC,430 WEST HEALTH SCIENCES DRIVE, ONE

SHIELDS AVENUE, UC DAVIS, DAVIS CA 95616.

1.3. Period of Performance: Base period plus four option periods.

2. Technical Information:

Devices covered by this scope of work:

Manufacturer Device Description Serial Number Quantity

ROCHE Cobas e 4111 fully automated, high-throughput electrochemiluminescence immunoanalyzer

1388-40 1

3. Definitions:

3.1. CLIN – Contract Line Item, numbered. Established in the solicitation, example “0001.”

3.2. Business Days – Standard business days 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*

If a Sunday, the next succeeding day is selected.

*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

4. Technical Requirements/Tasks

4.1. The contractor shall provide a service plan for the device detailed in Section 2 for all CLIN periods that includes:

4.1.1. Two on-site annual preventative maintenance visits

4.1.1.1. There shall be no less than five months between the preventative maintenance visits within the CLIN performance period

4.1.1.2. Visits shall be scheduled and agreed to in advance with USDA technical point of contact.

4.1.1.3. Cleaning internal and external components of the device shall be a part of the preventative maintenance visits in addition to the OEM required system checks and tests.

4.1.2. Technical support for the performance period that includes:

4.1.2.1. Software and firmware updates required to keep the device current within the OEM specifications.

4.1.2.2. All replacement parts shall be approved by the OEM manufacturer.

4.1.2.3. Corrective repair onsite arrival response within three to five business days of initial contact.

4.1.2.4. All device repair expense coverage including parts, travel, labor, and any shipping/handling.

4.2. Upon completion of any service visit, mixing paddles and probes shall be properly aligned.

4.3. Service report for all service visits to be delivered to the USDA technical point of contact within five business days of any inspection visit.

5. Contractor’s Key Personnel: The contractor shall provide a repair service technician that is authorized by the OEM manufacturer of the serial numbered equipment detailed in Section 2 above to perform and document the service requirements.

6. Security Requirements: All contractor personnel shall always be in the presence of a USDA escort while on location.

7. 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 4, 5, and 6

Standards as established in Technical requirements and tasks identified in

Section 4, 5, and 6.

100%

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