QASP.doc

W81XWH-XX-C-XXXX

Quality Assurance Surveillance Plan

For Off-Target Broad Panel Screening of Novel Therapeutic Candidates Contract Number: W81XWH-XX-C-XXXX Contractor Name: ENTER AT TIME OF AWARD

1. PURPOSE:

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

· What will be monitored

· How monitoring will take place

· Who will conduct the monitoring

· How monitoring efforts and results will be documented

This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

FAR 52.246-5 Inspection of Services – Cost-Reimbursement, applies to this effort

2. Authority

Authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation, Inspection of Services clauses, which provide for inspection, acceptance and documentation of the service called for in the contract or order. This acceptance is to be executed by the contracting officer or a duly authorized representative.

3. Roles and Responsibilities:

The following personnel shall oversee and coordinate surveillance activities.

3.1. Contracting Officer (KO) - The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship. The KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned KO: TO BE ENTERED AT TIME OF AWARD Organization or Agency: US Army Medical Research Acquisition Activity Telephone: Phone: TO BE ENETRED AT TIME OF AWARD Email: TO BE ENTERED AT TIME OF AWARD

3.2. Contracting Officer’s Representative (COR) – The COR will be located at the United States Army Medical Research Institute of Infectious Diseases (USAMRIID). The COR will be responsible for technical administration of the contract, and shall assure proper Government surveillance of the contractor’s performance with the assistance of two Contracting Officer’s Technical Representatives (COTRs). The COR shall keep a quality assurance file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. A COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

Assigned COR: TO BE ENETRED AT TIME OF AWARD

Title: Molecular and Translational Sciences Division Chief

Telephone:

TO BE ENETRED AT TIME OF AWARD

Email:

TO BE ENETRED AT TIME OF AWARD

3.3. Contracting Officer’s Technical Representative (COTR) – There will be one COTR responsible for assisting the COR in technical administration of the contract, and they shall assist the COR in assuring proper Government surveillance of the contractor’s performance. The COTRs may include performance monitors, inspectors, technical experts, or other who provide information the helps the COR monitor contractor performance. A COTR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action. The COTR is as follows:

Assigned COTR: TO BE ENTERED AT TIME OF AWARD Title: TO BE ENTERED AT TIME OF AWARD

Telephone: TO BE ENTERED AT TIME OF AWARD

Email: TO BE ENTERED AT TIME OF AWARD

3.4. Contractor Representatives – The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract.

Program Manager

Name: TO BE ENTERED AT TIME OF AWARD Title/Role: TO BE ENTERED AT TIME OF AWARD Telephone: TO BE ENTERED AT TIME OF AWARD Email: TO BE ENTERED AT TIME OF AWARD

Task Manager

Name: TO BE ENTERED AT TIME OF AWARD Title/Role: TO BE ENTERED AT TIME OF AWARD Telephone: TO BE ENTERED AT TIME OF AWARD Email: TO BE ENTERED AT TIME OF AWARD

Other Key Contract Personnel - TO BE ENTERED AT TIME OF AWARD

4. Performance Requirements and Method of Surveillance This section describes the special requirements for this effort. The following sub-sections provide details of various considerations on this effort.

4.1. Contract Surveillance:

The goal of the QASP is to ensure that contractor performance is effectively monitored and documented. The CORs contribution is their professional, non-adversarial relationships with the KO, PM and the contractor, which enables positive, open and timely communications. The foundation of this relationship is built upon objective, fair, and consistent COR evaluations of contractor performance against contract requirements. The COR uses the methods contained in this QASP to ensure the contractor is in compliance with contract requirements. The COR function is responsible for a wide range of surveillance requirements that effectively measure and evaluate the contractor's performance. Additionally, this QASP is based on the premise that the contractor, not the government, is responsible for management and QC/QA actions to successfully meet the terms of the contract.

4.2. Methods of Surveillance:

Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.

· Review of Summery Reports (various)

· Receipt of raw data files and analyzed data (various)

Regardless of the surveillance method, the COR shall always contact the contractor's task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.

· DIRECT OBSERVATION - Can be performed periodically or through 100% surveillance.

· MANAGEMENT INFORMATION SYSTEMS (MIS) - Evaluates outputs through the use of management information reports. Best used for general surveillance and may need to be supplemented by periodic inspections.

· PERIODIC INSPECTION - Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled as required.

· Analysis of contractor's progress reports - Evaluate cost, schedule, etc.

· Performance reporting.

Surveillance results may be used as the basis for actions (to include payment deductions) against the contractor. In such cases, the Inspection of Services clause and the Inspection of Supplies clause in the Contract becomes the basis for the KO’s actions.

4.3. Surveillance Matrix:

The Surveillance Matrix Table 1 is the list of performance objectives and standards that must be performed by the contractor. This matrix details the method of surveillance the COR will use to validate and inspect these performance elements. Inspection of each element will be documented in the COR file.

Table 1. Surveillance Matrix for Arenavirus Mechanism of Action Evaluation

5. Ratings:

Performance Standards define the level of service required under the contract to successfully meet the performance objective. The inspection methodology defines how, when, and what will be assessed in measuring performance. The Government performs surveillance, using this QASP, to determine the quality of the contractor's performance as it relates to the performance element standards. The matrix should be used to form the foundation of the COR's inspection checklist. In evaluating the quality of contractor’s performance, the following performance ratings may be used.

Performance

Rating Criteria

6. DOCUMENTING PERFORMANCE:

6.1. Acceptable Performance - The Government shall document positive performance. A report template is attached. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.

6.2. Unacceptable Performance - When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.

When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to the contractor's task manager or on-site representative. A CDR template is attached to this QASP.

The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.

Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.

7. Frequency of Measurement:

7.1. Frequency of Measurement - During contract/order performance, the COR shall take periodic measurements, quarterly as specified in the AQL column of the Performance Standards Summary Matrix, and shall analyze whether the negotiated frequency of measurement is appropriate for the work being performed.

7.2. Frequency of Performance Assessment Meetings - The COR shall meet with the contractor quarterly to assess performance and shall provide a written assessment.

PERFORMANCE ASSESSMENT REPORT (PAR)

(If more space is needed, use reverse and identify by number)

I. PERFORMANCE

7. DEFICIENCY (CHECK ALL BOXES THAT APPLY)

NEW

REPEAT

NO DEFICIENCY NOTED

8. SERVICES SUMMARY or PWS PARAGRAPH ITEM REVIEWED

II. CONTRACTOR VALIDATION

11. CONTRACTOR REPRESENTATIVE NON-CONCUR

CONCUR

12. CORRECTIVE ACTION ESTIMATED COMPLETION DATE

13. CONTRACTOR REPRESENTATIVE CORRECTIVE ACTION AND PREVENTION OF RECURRENCE OR REASON FOR NON-CONCURRENCE OF COR CITED DEFICIENCY

III. ACTION CORRECTED

14. NON-CONCUR COR SIGNATURE AND DATE CONCUR

15. COR REMARKS (REQUIRED)

16. CONTRACTOR REPRESENTATIVE REMARKS

SOURCE OF COMPLAINT

ORGANIZATION

BUILDING NUMBER

INDIVIDUAL

PHONE NUMBER

NATURE OF COMPLAINT

CONTRACT REFERENCE

VALIDATION

DATE/TIME CONTRACTOR INFORMED OF COMPLAINT

ACTION TAKEN BY CONTRACTOR

RECEIVED/VALIDATED BY

CORRECTIVE ACTION REPORT (CAR)

(If more space is needed, use reverse and identify by number)

1. CONTRACTOR

2. CONTRACT NUMBER

3. TYPE OF SERVICES

4. FUNCTIONAL AREA

5. SUSPENSE DATE

6. CONTROL NUMBER

7. DEFICIENCY MINOR

MAJOR

FINDING:

FINDING IMPACT:

Please respond with a written corrective action plan that details the corrective action of the cited deficiency, the cause of the deficiency, and actions taken to prevent recurrence by Suspense Date in Block 5. If date was not entered in Block 5, the contractor is not required to provide a response.

8. QUALITY ASSURANCE PERSONNEL (COR)

TYPED NAME AND GRADE

SIGNATURE AND DATE

9. ISSUING AUTHORITY

TYPED NAME AND GRADE

SIGNATURE AND DATE

10. COR RESPONSE TO CONTRACTOR CORRECTIVE ACTION AND ACTION TAKEN TO PREVENT RECURRENCE

11. COR DETERMINATION

REJECTED ACCEPTED

12. CLOSE DATE

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W81XWH-XX-C-XXXX