Attachment 2 QASP-Small_Molecule_Compound_Library_Storage 4 November 2021.pdf

QUALITY ASSURANCE AND SURVEILLANCE PLAN

For Small Molecule Compound Library Storage Contract Number: < upon award, enter contract number>

Contract Description: The scope of this work is to provide secure storage of chemical samples under appropriate environmental conditions and to prepare and ship requested amounts of these chemical sample to WRAIR or its collaborators at various CONUS or OCONUS locations. The contractor shall maintain a full inventory of samples on hand that includes amount of material remaining. Approximately 400,000 samples shall be delivered to the contractor at the onset of the award with an additional average of approximately 2,000 new samples per year. The contractor shall distribute approximately 4,500 samples per year.

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

Contents

1. PURPOSE

2. GOVERNMENT ROLES AND RESPONSIBILITIES

3. CONTRACTOR REPRESENTATIVES

4. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

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:

52.246-4 Inspection of Services – Fixed-Price,

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: Patrick Harris Organization or Agency: USAMRAA Telephone: 301-619-2779 Email: patrick.k.harris11.civ@mail.mil

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

Assigned CS: Jaclyn Svincek Telephone: 301-619-2189 Email: Jaclyn.p.svincek.civ@mail.mil

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: To be determined at time of award Telephone:

Email:

mailto:patrick.k.harris11.civ@mail.mil mailto:Jaclyn.p.svincek.civ@mail.mil

Other Key Government Personnel - <enter name or delete these lines if not applicable. This may include Performance Monitors, Inspectors, etc. who act on behalf of the COR to monitor performance.> Title: <enter title> Telephone: <enter number> Email: <enter address>

3. CONTRACTOR REPRESENTATIVES

Program Manager - <upon award, enter name>

Task Manager - <upon award, enter name>

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

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. >

4. PERFORMANCE REQUIREMENTS SUMMARY MATRIX

PERFORMANCE REQUIREMENTS SUMMARY MATRIX

# PWS Ref. Performance Objective Acceptable Quality Level Method of Surveillance Incentive

6.5.7

Process receipt of new compounds within three (3) days of arrival

Greater than 95% of samples shall be process and placed inventory within 3 days of receipt by the contractor

Review of compound registration and shipping records

Frequency: Yearly.

Past Performance

6.6.8

Compounds and chemical samples stored under their individual required storage conditions

All compounds shall be stored under the condition designated by the Government

Review of LIMS records

Frequency: Upon completion of initial in processing and yearly

6.7.5

Ensure timely preparation and shipment of compound orders

Greater than 95% of samples shipped to locations in the Maryland, D.C., and Virginia areas shall be received within 3 business days and shipments to any other locations shall be shipped out within 2 business days.

Review of order and shipping order records

Frequency: Yearly.

6.7.6

Transfer the requested amount of compound or chemical sample to shipping containers

Amount of transferred chemical shall be within a 10 % CV from the requested amount for a set of compounds in a single shipment

User Complaints

Frequency: Upon complaint

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 DEFICIENCY 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