QASP.pdf

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Attached to
Maintenance & Repair Service - AU5800 Series Clinical Analyzers
Solicitation number
N0018926QB019
Issued by

About this file

This is a Quality Assurance Surveillance Plan (QASP) for monitoring contractor performance on analytical equipment maintenance and repair services.

The QASP establishes performance metrics across four key risk factor categories: Preventive Maintenance, Corrective Maintenance, and Customer Service Response to Preventive and Corrective Maintenance Inquiries. For Preventive Maintenance, the contractor must complete 100% of maintenance per Original Equipment Manufacturer (OEM) specifications, submit accurate service reports to laboratory representatives within 2 business days and to the Contracting Officer's Representative (COR) or Alternate COR (ACOR) by the 10th of the following month, and maintain zero outdated findings during Quality Assurance Inspections. For Corrective Maintenance, downtime for any system or instrument shall not exceed thresholds specified in paragraph 5.9 of the Performance Work Statement (PWS), the contractor must complete equipment recall upgrades upon OEM, FDA, or COR/ACOR notification, and must use 100% new OEM-recommended parts (refurbished parts are prohibited). For Customer Service Response, the contractor must confirm service calls within two normal business hours and be compliant 98% of the time for both routine telephone and on-site response times as specified in PWS paragraph 5.8. All performance deficiencies must be remedied within 5 business days of COR/ACOR notification at no additional cost to the government. The government may require corrective action plans and meetings for substandard performance, and all contractor performance will be documented in the Contractor Performance Assessment Reporting System (CPARS).

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Text version

QUALITY ASSURANCE SURVEILLANCE PLAN

Risk Factors Performance Objective

Performance Standard

Acceptable Quality Level

Monitoring Method / Performance Assessment

Positive / Negative Incentives

Preventive Maintenance

Provide preventive maintenance services for analytical equipment covered under this contract.

Submit service reports for preventive maintenance and repair services.

Contractor must complete preventive maintenance per

OEM

specifications for all equipment

Systems must be fully operational;

system defects must be identified for timely repair;

OEM preventive maintenance, inspection, and calibration standards must be observed.

A complete and accurate service report must be submitted to the laboratory representative that includes all equipment serviced.

report must be submitted to the COR or ACOR that includes all complete 100% of preventive maintenance as defined by OEM specifications/ standards of all equipment covered under this contract.

Accurate service reports are delivered to the laboratory representative within 2 business days of service completion 100% of the time.

Accurate service reports are delivered to the COR or ACOR by the 10th day of the month following the performance of service completion 100% of the time.

Zero outdated preventive maintenance findings during Quality Assurance Inspections.

Continuous review of service reports by COR.

Communication between COR and laboratory representatives via phone, email, and in person during site visits.

When performance is below standard for the current month, Contractor must remedy the deficiency and meet or exceed the performance standard within the prescribed timeframe at no additional cost to the government.

Remedy must be completed within 5 business days of notification by the COR or ACOR.

If performance is below the performance standard, the Government may require a meeting with the contractor at no additional cost to the Government and may require the contractor to submit a corrective action plan at no additional cost to the Government to ensure their future performance meets or exceeds the performance standard.

Contractor performance will be documented in

CPARS.

Performance Standard

Acceptable Quality Level

Monitoring Method / Performance Assessment

Positive/Negative

Corrective corrective maintenance services and repairs for analytical equipment covered under this contract on an emergency or routine basis, or according to prescribed schedule.

Submit service reports for preventive maintenance and repair services.

complete corrective maintenance required for all equipment

Systems must be fully operational;

repairs must be in accordance with OEM specifications;

new OEM recommended parts shall be used to repair equipment, refurbished parts shall not be authorized for use in effecting repairs.

report must be submitted to the laboratory representative that includes all report must be submitted to the COR or ACOR that includes all

Downtime for any system or instrument shall not exceed that set forth in paragraph

5.9 of the PWS.

complete equipment recall upgrades and corrective measures upon OEM, FDA, or COR or ACOR notification.

Contractor shall use 100% new parts to restore equipment in accordance with OEM specifications.

provide accurate and complete service reports to the laboratory representative within 2 business days of service completion 100% of the time.

provide accurate and complete service reports to the COR or ACOR by the 10th day of the month following the performance of service 100% of the time.

review of service reports by COR.

and laboratory representatives via phone, email, and in person during site visits.

below standard for the current month, Contractor must remedy the deficiency by re-performing the service at no additional cost to the government.

business days of performance standard, the Government may require a meeting with the contractor at no additional cost to the Government and may require the contractor to submit a corrective action plan at no additional cost to the Government to ensure their future performance meets or exceeds the performance standard.

Performance Standard

Acceptable Quality Level

Monitoring Method / Performance Assessment

Positive/Negative

Customer Service Response to Preventive Maintenance and Corrective

Inquiries preventive and corrective maintenance services for all equipment

Provide access to a technical support customer service center.

Respond to technical service support and corrective maintenance inquiries through Internet-based on-line or phone technical service support center, or on-site routine/ repair service visit during the NBH at each laboratory.

The Contractor

Field Service Technician shall confirm the requested service call to the laboratory representative within two (2) normal business hour of service request notification to the Contractor’s Internet-based on-line or phone technical service support center.

If the equipment cannot be restored via phone technical support services, the technician shall arrive on-site and complete the service requested with the response time specified in paragraph 5.8 of the PWS.

prioritize corrective maintenance requests and be compliant 98% of the time for both routine telephone and on-site response time as specified in paragraph 5.8 of the PWS.

complete repair service within the response time specified in paragraph 5.8 of the PWS.

review of service reports by the

COR.

and laboratory representatives via phone, email, and in person during site visits.

below standard for the current month, Contractor must remedy the deficiency by re-performing the service at no additional cost to the government.

business days of performance standard, the Government may require a meeting with the contractor at no additional cost to the Government and may require the contractor to submit a corrective action plan at no additional cost to the Government to ensure their future performance meets or exceeds the performance standard.

Paragraph 5.9 of the PWS shall be used as applicable if the response times in paragraph 5.8 are not met.

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