ATTACHMENT_2_-_QASP.pdf

ATTACHMENT 2

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

for

Clinical Trial Support Services

Contract Number: TBD

Contractor's Name: TBD

1. VISION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter. Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation.

We host two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neurotrauma to malaria vaccine development.

2. BACKGROUND/MISSION

The Clinical Trials Center (CTC) was established as a clinical research unit in early 1992 to support Army and Navy investigators in their mission to develop new vaccines, drugs and diagnostics systems that will benefit not only the military, but all people. An average of 13-15 clinical studies are annually conducted by the CTC. To implement these studies, the CTC enrolls an estimated 350 volunteers per year, contacts more than 1,000 new volunteer per year, and nearly 5,000 clinical visits per year. While much of its work provides clinical research data for infectious disease threats, it works with any clinical warfighter-relevant medical countermeasure to include Traumatic Brain Injury and Sleep. There are approximately 9.4 million globally located DoD beneficiaries within the Military Healthcare System (MHS). This diverse population can benefit from biomedical research discoveries targeted to this population. In addition, military medical research has provided tremendous benefits not only to the military beneficiary population, but also the global population.

3. PURPOSE:

This Quality Assurance Surveillance Plan (QASP) is a government-developed document used to determine if the contractor's performance meets the performance standards contained in the contract. The QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process:

a. What will be monitored,

b. How monitoring will take place,

c. Who will conduct the monitoring, and

d. How monitoring efforts and results will be documented.

3.1. The contractor is responsible for implementing and delivering performance that meets contract standards using its Quality Control Plan. The QASP provides the structure for the government's surveillance of the contractor's performance to assure that it meets contract standards. It is the government's responsibility to be objective, fair and consistent in evaluating contractor performance.

3.2. The QASP is not part of the contract nor is it intended to duplicate the contractor's quality control plan. This

QASP is a living document. Flexibility in the QASP is required to allow for an increase or decrease in the level of surveillance necessary based on contractor performance.

3.3. The government may provide a copy of the QASP to the contractor to facilitate open communication. In addition, the QASP should recognize that unforeseen or uncontrollable circumstances might occur that are outside the control of the contractor.

Bottom line, the QASP should ensure early identification and resolution of performance issues to minimize impact on mission performance.

4. 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.

5. ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

5.1. 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 ensure that the contractor receives impartial, fair, and equitable treatment under this contract. Determine and document the final assessment of the contractor's performance in the governments past performance tracking system.

Assigned KO: This section is to be completed at time of award

Organization or Agency: To be completed at time of award

Telephone: This section is to be completed at time of award

Email: This section is to be completed at time of award

5.2. Contracting Officer's Representative (COR)

The COR is responsible for providing continuous technical oversight of the contractor's performance. The COR uses the QASP to conduct the oversight and surveillance process. The COR shall keep a Quality Assurance file that accurately documents the contractor's actual performance. The purpose is to ensure that the contractor meets the performance standards contained in the contract. The COR is responsible for reporting early identification of performance problems to the KO. The COR is required to provide an annual performance assessment to the KO which will be used in documenting past performance. The QASP is the primary tool for documenting contractor performance.

The COR is not empowered to many any contractual commitments or to authorize any contractual change on the Government's behalf.

Assigned COR: This section is to be completed at time of award

Organization or Agency: To be completed at time of award

Telephone: This section is to be completed at time of award

Email: This section is to be completed at time of award

5.3. Other Key Government Personnel

This may include performance monitors, inspectors, technical experts, or others who provide information that helps the COR monitor contractor performance.

The designated technical quality assurance personnel are:

Name: This section is to be completed at time of award

Telephone: This section is to be completed at time of award

Email: This section is to be completed at time of award

5.4. Contractor Representatives

The following employees of the contractor serve as the contractor's Program Manager and Task Manager for this contract.

5.4.1. Contract Manager

Name: To be completed at time of award

Telephone: This section is to be completed at time of award

Email: This section is to be completed at time of award

5.4.2. Other Key Contract Personnel – This section is to be completed at time of award

6. 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.

6.1. Contract Surveillance

The goal of the QASP is to ensure that contractor performance is effectively monitored and documented. The COR's 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.

6.2. Surveillance Matrix

6.2.1. 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.

6.2.2. Performance objectives define the desired outcomes. 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

Exceptional Performance meets contractual requirements and exceeds many to the Government’s benefit. The element being assessed was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective.

Very Good Performance meets contractual requirements and exceeds some to the Government’s benefit.

The element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were effective.

Satisfactory Performance meets contractual requirements. The element being assessed contains some minor problems for which corrective actions taken by the contractor appear or were satisfactory.

Marginal Performance does not meet some contractual requirements. The element being assessed reflects a serious problem for which the contractor has not yet identified corrective actions.

Unsatisfactory Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The element being assessed contains a serious problem(s) for which the contractor’s corrective actions appear or were ineffective.

7. PERFORMANCE STANDARDS:

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards. The Performance Requirements Standard Summary, shown below, includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level.

Table 1. Performance Requirements Standards Summary – Base Level

PWS Ref. Deliverable Performance Standard Acceptable

Quality Level Method of

Surveillance Incentive

6.0, Task 10

Deliverable No. 1 and 2

Statistical Analysis Plan & Program Validation Plan

Include data populated TLFs (for the study CSR, the DMC, the FDA annual reports, and other sponsor/FDA statistical requests) and

Includes stat programs used to create CDISC data set & programming specs

95% Inspection of programming specs and the statistical programs used to produce the tables, listings and figures (TLFs)

CPARS/Past Performance

7.1 Deliverable No. 4

Contractor Manpower Reporting

Timely reporting of CMR by 31 Oct annually

100% Confirmation of reporting by Contractor to COR and KO

CPARS/Past Performance

7.2 Deliverable No. 5

Quality Control Plan

Inspection plan outlining the procedures the Contractor will use to maintain high quality

95% Annual inspection of the QCP

CPARS/Past

7.3

Deliverable No. 6

Program Management Plan

Provide qualified staff for conducting clinical trials

95%

Receipt of annual updates from the Contractor

10.2

Deliverable No. 13

Transition-out Plan

Timely delivery of tangible and intangible knowledge and material products

Review upon 45 calendar day delivery

7.5

Deliverable No. 8

Current description of the contractor’s contingent

Receipt of semi-annual updates/edits to this Plan

PWS Ref. Deliverable Performance Standard Acceptable

Quality Level Method of

Surveillance Incentive

Contingency Operations Plan management procedures and policies

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 MAJOR MINOR

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

ACCEPTED REJECTED

12. CLOSE DATE

CUSTOMER COMPLAINT RECORD

DATE/TIME OF

COMPLAINT

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

PERFORMANCE ASSESSMENT REPORT (PAR)

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

1. CONTRACT/TASK ORDER

NUMBER

2. CONTRACTOR 3. TYPE OF SERVICES

4. QUALITY ASSURANCE PERSONNEL (COR) SIGNATURE AND

DATE

5. COR PHONE 6.

SUSPENSE

DATE

I. PERFORMANCE

7. DEFICIENCY (CHECK ALL BOXES THAT

APPLY)

NEW

REPEAT

NO DEFICIENCY NOTED

8. SERVICES SUMMARY or PWS

PARAGRAPH ITEM REVIEWED

9. BRIEF DESCRIPTION OF DEFICIENCY (IF

DEFICIENCY BOX WAS CHECKED)

10. DETAILED PERFORMANCE

ASSESSMENT

II. CONTRACTOR VALIDATION

11. CONTRACTOR REPRESENTATIVE CONCUR

NON-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. CONCUR NON-CONCUR COR SIGNATURE AND DATE

15. COR REMARKS (REQUIRED)

16. CONTRACTOR REPRESENTATIVE REMARKS