Attachment 1 - QASP.docx

DEFENSE HEALTH AGENCY

Quality Assurance Surveillance Plan (QASP) Version – <enter date or version #>

For: Pacific Region Force Health Protection Vector-borne Disease Agent Surveillance External Proficiency Testing Contract Number: < upon award, enter contract number> Contract Description: External Proficiency Testing Contractor’s Name: To be determined at contract award

1. Vision (import from the Automated Requirements Roadmap Tool Suite (ARRT) or Charter)

The purpose of this contract is to develop a standard for the use of external validation in the detecting of human pathogens in arthropods as part of a multi-layered framework of good laboratory practices, standardized protocols, and external quality assurance. Given the complexity of insect vectors and the pathogens they carry, a rigorous quality assurance program ensures that diagnostic testing results are reliable for public health decision-making. External Quality Assurance (EQA) programs are also known as proficiency testing. EQA programs involve laboratories periodically testing unknown samples sent by a third party. This independently verifies the laboratory's diagnostic capabilities and identifies areas for improvement. There is a need to develop external quality tests that utilize non-infectious agents to minimize risk and maximize implementation. Currently, laboratories in the Department of War that perform pathogen detection from arthropod specimens for use in force health protection do not perform EQA.

2. Mission (import from ARRT or Charter)

The mission/purpose of this contract is to develop safe and validated external proficiency testing for the detection of pathogens in arthropods (mosquitos) through the following objectives:

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:

· What will be monitored

· How monitoring will take place

· Who will conduct the monitoring

· How monitoring efforts and results will be documented

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 and their Quality Assurance/Quality Control (QA/QC) actions to assure they meet contract standards. It is the government’s responsibility to be objective, fair and consistent in evaluating contractor performance.

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.

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 provides 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.

Program/Project Manager (PM) or Functional Services Manager (FSM) – The PM/FSM provides primary program oversight, nominates the contracting officer’s representative (COR), ensures the COR is trained before performing any COR duties and supports the COR’s performance assessment activities. While the PM/FSM may serve as a direct conduit to provide Government guidance and feedback to the Contractor on technical matters, they are not empowered to make any contractual commitments or any contract changes on the government’s behalf.

Assigned PM/FSM: Lt Col Davis, Timothy J.

Organization or Agency: DHA/18MDG, Theater Preventive Medicine Flight Telephone: 315-634-2639 Email: timothy.j.davis3.mil@health.mil

Contracting Officer (CO) – The CO 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 CO shall also ensure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO shall also determine the final assessment of the contractor’s performance.

Additionally, the CO shall include a requirement in the quality assurance surveillance plan to revalidate all key personnel annually to determine whether the contractors meet the labor categories specified in the contract.

The CO shall maintain documentation in the contract files that demonstrates their review and approval of initial and replacement contractor employees in key personnel positions.

The CO shall include a requirement in information technology service contracts QASPs to review a sample of non‑key personnel quarterly to determine whether the contractor personnel meet the labor categories specified in the contract.

Assigned CO: Erin J. Maddox Organization or Agency: Defense Health Agency Contracting Activity (DHACA) Telephone: (410) 436-1272 Email: erin.j.maddox.civ@health.mil

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/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 CO. The COR is required to provide an annual performance assessment to the CO which will be used in documenting past performance. The QASP is the primary tool for surveillance of the contractor’s quality program and help the COR to document contractor performance. The COR is not empowered to make any contractual commitments or to authorize any contractual change on the Government’s behalf.

Assigned COR/WAWF Acceptor: Ms. Mika Kinjo Organization or Agency: DHA/18MDG, Theater Preventive Medicine Flight Telephone: 315-634-0299 Email: mika.kinjo.ln@health.mil

Other Key Government Personnel:

Contractor Representatives

The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract. (Complete this section after the contract award)

Contractor Program Manager - <upon award, enter name> Telephone: <enter number> Email: <enter address>

Contractor Task Manager - <upon award, enter name> Telephone: <enter number> Email: <enter address>

Other Key Contractor Personnel - <upon award, enter name or delete these lines if not applicable> Title: <enter title> Telephone: <enter number> Email: <enter address>

6. Performance Requirements and Method of Surveillance

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 CO, 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

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

DFARS 222.17 mandates including surveillance for ensuring compliance with Combatting Trafficking in Persons (CTIP) in the QASP. Use the CTIP sample checklist from PGI 222.17. See the DoD CTIP website.

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 Performance Requirement Summary (PRS) should be used to form the foundation of the COR’s inspection checklist.

6.3. Performance Rating Definitions

The performance ratings below reflect definitions at FAR 42.1503 Table 42-1. The COR will use these rating to evaluate the quality of contractor’s performance.

Performance Rating Definition

Note 1: Plus or minus signs may be used to indicate an improving (+) or worsening (-) trend insufficient to change the evaluation status.

Note 2: N/A (not applicable) should be used if the ratings are not going to be applied to a particular area for evaluation.

7. Performance Reporting

7.1. Corrective Action Report (CAR)

Describes how discrepancies are reported and resolved (see sample CAR below).

7.2. Customer Complaint Form

(See sample customer complaint form below)

7.3. Performance Assessment Report (PAR) (See sample customer PAR page 11)

DHA QASP Template V1 2 Appendix 1 - Surveillance Matrix

PWS 5.2, Deliverable #1:

Develop a Written Manual/Protocol for Safe External Proficiency Testing (Draft)

PWS 5.2, Deliverable #2:

Develop a Written Manual/Protocol for Safe External Proficiency Testing (Final)

PWS 5.2, Deliverable #3:

Validate the Proficiency Testing Protocol

PWS 5.2, Deliverable #4:

Demonstrate Proficiency Test Performance Characteristics

PWS 5.2, Deliverable #5:

Provide Analysis of Field-Expedient Capability in Austere Conditions

Inspection Metrologies:

M1: Inspection of Reports. All reports shall be reviewed upon receipt. The reviewer will report any flaws in the document and categorize the flaws (Editorial, Format, and/or Substance).

DHA QASP Template V1 8

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)

4. QUALITY ASSURANCE PERSONNEL (COR) SIGNATURE AND DATE

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 |_| 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

DHA QASP Template V1 11