PWS Appendix 3.pdf

Appendix 3: Quality Assurance Surveillance Plan (QASP)

Pathology Services Contract: ___________________________ Contractor: __________________________

1.0 PURPOSE

This Quality Assurance Surveillance Plan (QASP) is a Government developed and applied document used to make sure that systematic quality assurance methods are used in the administration of the Performance-Based Acquisition (PBA) standards included in this contract. The intent is to ensure that the Contractor performs in accordance with performance metrics set forth in the contract documents, that the Government receives the quality of services called for in the contract, and that the Government only pays for the acceptable level of services received.

2.0 AUTHORITY

Authority for issuance of this QASP is provided under FAR 37.6 – Performance-Based Acquisition, FAR

46.4 – Government Contract Quality Assurance, and Inspection and Acceptance clause in the contract.

3.0 SCOPE

The Contractor, and not the Government, is responsible for management and quality control actions necessary to meet the quality standards set forth by the contract. The QASP is put in place to provide Government surveillance oversight of the Contractor’s quality control efforts to assure that they are timely, effective and are delivering the results specified in the contract. The QASP is not intended to duplicate or replace the Contractor’s Management Plan. The QASP is intended to support the Contractor’s efforts in developing its plan for maintaining the levels of quality required to be delivered under the terms of the contract.

4.0 GOVERNMENT RESOURCES

Contracting Officer (CO) – The CO ensures performance of all necessary actions for effective contracting, ensures compliance with the terms of the contract and safeguards the interests of the U.S.

Government in the contractual relationship. The CO is ultimately responsible for establishing the significance of a nonconformance that the Contracting Officer’s Representative (COR) cannot resolve with the contractor when considering the acceptability of services that do not meet contract requirements.

The CO is ultimately responsible for the final determination of the adequacy of the Contractor’s performance.

Contracting Officer’s Representative (COR) - An individual designated in writing by the CO to act as his authorized representative to assist in administering a contract. The source and authority for a COR is the Contracting Officer. COR limitations are contained in the written letter of appointment. The COR plays a major role in the monitoring, inspection and acceptance of the services performed under this contract. The COR assures that nonconformances are identified and remediated appropriately.

Principal Investigators (PIs) – The PI is a U.S Food and Drug Administration (FDA) researcher and is considered a customer. The PIs write research protocols that drive the services to be conducted;

therefore, PIs are in the best position to evaluate the quality, timeliness, and trustworthiness of research results that are of utmost importance to the FDA.

5.0 METHODS OF QA SURVEILLANCE

The below listed methods of surveillance shall be used in the administration of this QASP. The Performance Based Matrix table describes the methods of surveillance that will be used to monitor the services and deliverables to be provided under the contract.

● Customer Feedback – Customer feedback may be obtained either from the results of formal or informal customer satisfaction surveys or from random customer complaints. Customer complaints, considered to be valid, must clearly identify the detailed nature of the complaint in writing to the CO or COR. The COR will maintain a summary log of all received customer complaints as well as a copy of each complaint in a documentation file. The COR will also keep the tabulated results of all customer satisfaction surveys on file.

● Random Checks/Inspections on Completion of Workload/Tasks – Random checks will be conducted to ensure compliance with the Standard Operating Procedures (SOP) and the Performance Work Statement (PWS). The COR and/or the National Center for Toxicological Research Quality Assurance Unit (NCTR QAU) will conduct the random monitoring.

● Review of Files – The COR will review Contractor reports on monthly productivity and budget information (spending, reimbursements, and labor and materials per protocol), all QA reports and responses, and safety reports.

6.0 IDENTIFIED QA SURVEILLANCE ITEMS

The Performance Based Service Contract items that have been identified for surveillance are listed in the Performance Based Matrix and include the following:

● Review of documentation and procedures.

● Review of records.

● Review of contract requirements.

● Preparation of QASP report and, if applicable, a nonconformance report.

● Input received from PIs

Any nonconformance identified and unresolved by the COR during the quality assurance surveillance process will be documented and forwarded to the CO for action. The nonconformance will be categorized as critical, major or minor. The CO may issue a nonconformance report to the contractor. If any nonconformance is found, it is the responsibility of the contractor to make all necessary corrections as required by the COR and/or the CO. The CO will determine when the nonconformance has been resolved. If requested by the CO, the COR will follow-up to verify that corrective action(s) has been successfully taken.

7. DOCUMENTATION

In accordance with the PWS, the Contractor’s Quality Assurance Manager shall, in addition to providing documentation to the COR, maintain a complete Quality Assurance file. The file shall contain copies of all reports, evaluations, recommendations, and any actions related to the Government’s performance of the quality assurance function. All such records shall be retained for the life of this contract. The COR will forward these records to the Contracting Officer at termination or completion of the contract.

Quality Assurance Surveillance Plan (QASP)

Required Services (Tasks)

Performance Standards

Acceptable Quality Levels

Methods of

Surveillance

Schedule pathology work efficiently to ensure that work for all protocols is performed efficiently and in accordance with specifications and timelines in protocols, and make the schedule available for NCTR researchers to view (PWS 4.2.6)

100% of protocols are provided with pathology work as scheduled

100% Review of files (reports including Monthly Productivity and Monthly Labor & Materials/Supplies, and information systems including NEAT and PathTrack) and customer feedback

Provide accurate estimates of resources required to complete protocol requirements

(PWS 4.2.5)

Resources used to complete protocol requirements (labor hours and material costs) must be at or below the estimates provided (inclusive of revisions)

90% of occurrences Review of Monthly Labor and Materials/Supplies Report

(Tasks)

Performance Standards

Acceptable Quality Levels

Methods of

Surveillance

Provide Quality Assurance related activities for pathology elements of all research protocols, where pathology services are required (PWS 4.12)

Resolve QA findings from Contractor QA and from NCTR QAU (PWS 4.12.11)

Monitor 100% of protocols that have a pathology services element, to assure conformance with best data quality and integrity practices.

Maintain required records needed to confirm data quality and integrity was maintained throughout the collection, analysis, reporting and archiving of data

Provide results of QA audits/inspections to the appropriate Government personnel (described in PWS 4.12.6)

Ensure that all non-compliances are corrected within 2 weeks of the date of issue and send correction notice to appropriate Government personnel

95% of occurrences

100% of the time

100% of occurrences

100% of occurrences

Review of QA audits

Review of files

Review of files received by

COR

Review of QA audits and responses received by COR

(Tasks)

Performance Standards

Acceptable Quality Levels

Methods of

Surveillance

Submit accurate reports as required:

Monthly Cost Reports (PWS 6.3)

Quarterly Safety/Accident Report (PWS 6.4)

Pathology Reports (PWS 6.5)

Reports must accurately reflect labor and materials/supplies required for each protocol during the previous month and be submitted in a timely manner

Reports must reflect all safety incidents that occurred during the quarter and must be accompanied by the associated Form FDA 3696 – Non-motor Vehicle Accident Reports

Draft Pathology Reports must explain in detail the histopathological findings for each protocol

Submitted within 15 calendar days of the end of each month

Submitted within 15 calendar days of the end of each quarter

Submitted on or before deadlines established in the protocols, unless the Principal Investigator agrees to an extension

Review of reports received by

Review of reports received by

Customer feedback