Attachment 2 QASP LAOS.docx

QUALITY ASSURANCE AND SURVEILLANCE PLAN

For IDS in Laos Contract Number: TBD <enter upon award> Contract Description: AFRIMS seeks to initiate and continue ongoing research projects involving surveillance for emerging infectious diseases and conduct clinical trials within Laos with a specific focus on malarial prevalence and antimalarial drug resistance together within the ranks of the Lao People’s Armed Forces (LPAF).

Contractor’s name: TBD <enter upon award> (hereafter referred to as the contractor)

Contents

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; and

· 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.

The following FAR clauses may apply depending on contract type:

52.246-6 Inspection of Services – Time-and-Material and Labor-Hour, or 52.212-4 –Contract Terms and Conditions – Commercial Items

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

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:

Organization or Agency: USAMRAA Telephone:

Email:

Contract Specialist (KS) - The CS acts as an acquisition consultant and serves as liaison between the contract office and Walter Reed Army Institute of Research (WRAIR).

Assigned KS:

Telephone:

Email:

Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a “QASP and Performance” file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. The 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: MAJ Daniel Boudreaux Telephone: NA Email: Daniel.boudreaux.mil@afrims.org

Other Key Government Personnel – N/A

2. CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract. <Communication should occur with them during QASP development. It will help if they review the draft QASP and accept the final version. You may delete the stated roles or change the naming convention if applicable. >

Contractor POC:

Phone:

Cell:

Email:

4. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

PRS#1 - PWS para 5.2.2 Identify potentially eligible subjects residing, working, or visiting within Laos, using study inclusion criteria

99%

PRS#2 - PWS para 5.2.5 Identify best possible shipping methods and ship/deliver these samples to AFRIMS

99%

PRS#3 - PWS para 5.2.6 Conduct laboratory procedures that meet research-use-only standards for public health purposes for non-human subject research protocols for bio-surveillance

99%

PERFORMANCE REPORT

Contract Number: <insert number>

Prepared by: (Name of COR) <insert name>

Date and time of observation: <insert date>

Observation:

<Examples of items to include in a report are:

· Method of surveillance.

· How frequently you conducted surveillance.

· Surveillance results (Exceeds, Meets, Does Not Meet).

· Number of observations.>

Prepared by: <Enter COR’s name>

COR’s Signature

Date

CONTRACT DISCREPANCY REPORT (CDR)

< The COR may initiate a CDR at any time, including whenever the number of monthly recorded defects for a performance standard exceeds the allowable number of defects; anytime unacceptable performance is determined critical in nature and requires formal corrective action; and whenever an unfavorable trend is detected in contractor performance.>

Contract Number: <insert number>

Contractor Project Manager: <insert name>

From: <insert name of COR>

Date and time observed discrepancy:

Contract Discrepancy:

<Describe in detail. Identify any attachments.>

Corrective action plan:

A written corrective action plan < is / is not > required.

< If a written corrective action plan is required include the following. > The contractor shall provide the COR with the Corrective Action Plan not later than < # days after receipt of this CDR. >

Prepared by: <Enter COR’s name>

COR’s Signature

Date

Received by: <Enter contractor project manager’s name>

Contractor Project Manager’s Signature

Date