B08 Attachment 2-QASP Estrogen (1).pdf

QUALITY ASSURANCE SURVEILLANCE PLAN

For

Research Services to Explore the Role of Estrogen Deficiency on Heat Acclimation and Organ Damage in Exertional Heat Stroke in Mice

1. VISION

The Thermal and Mountain Medicine Division is one of four research divisions within the U.S. Army Research Institute of Environmental Medicine (USARIEM). USARIEM's mission is to optimize Warfighter health and performance through medical research. USARIEM is internationally recognized as the premiere DoD laboratory for Warfighter health and performance research and focuses on environmental medicine, physiology, physical and cognitive performance, and nutrition research.

USARIEM publishes guidance for DOD operations for both hot and cold weather, high-altitude environments, and nutrition for optimal health and performance.

2. MISSION

The mission of the Thermal and Mountain Medicine Division is to conduct field and laboratory research on medical and physiological problems encountered by military personnel during acute and chronic exposure to environmental extremes. Research goals include: to determine the limits of physical exercise including nutritional and metabolic factors; to investigate new methods to improve those decrements;

and to assess relative changes in normal physiological and psychological functions as evidenced in the related effects on overall performance. The division is responsible for investigating and developing new approaches to improve military effectiveness based on scientific knowledge in the areas of physiology, biochemistry, pharmacology, and nutrition.

3. PURPOSE

3.1. 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:

3.1.1. The Government will monitor the performance of the contractor’s completion of the work required to ensure the final products fulfill the government’s needs.

3.1.2. The Contracting Officer’s Representative (COR) will use direct observation techniques for monitoring the completion of work by the contractor. The COR will also elicit input from the GML’s Lead Librarian to determine whether the work products provided meets the requirements of various research directorates within and/or supporting WRAIR.

3.1.3. The COR will document the monitoring on the monthly COR report.

3.2. 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.

3.3. 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.

3.4. 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.

5.1 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: Jennifer Jackson Organization or Agency: United States Army Medical Research Acquisition Activity Telephone: (301) 619-2054 Email:

Jennifer.c.jackson18.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: Nathaniel Reus Telephone: (301) 619- 9209 Email: nathaniel.a.reus.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:

Telephone:

mailto:nathaniel.a.reus.civ@mail.mil

Other Key Government Personnel Technical POC:

CONTRACTOR REPRESENTATIVES

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

Program Manager:

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.

6.2.3. 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 Summary matrix, shown in Table 1 below and continued within the Performance Work Statement (PWS) for this contract in Section 3, includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

# Performance Requirement. Performance Standard Acceptable

Quality Level Performance Measurement Frequency

1 Contractor will conduct survival surgeries to implant telemetry devices and induce ovariectomy/sham

In accordance with lab standard procedures

100% Complete Periodic Surveillance by

COR

Monthly

2 Contractor will conduct survival surgeries to implant telemetry devices and induce ovariectomy/sham

In accordance with lab standard procedures

100% Complete Periodic Surveillance by

COR

Monthly

3 Conduct experiments using a mouse EHS model, where forced wheel running is combined with heat stress

In accordance with lab standard procedures

100% Complete Periodic Surveillance by

COR

Monthly

4 Determine cytokine and heat shock protein levels in plasma and/or tissues and the extent of histological injury in heat stroked mice

In accordance with lab standard procedures

100% Complete Periodic Surveillance by

COR

Monthly

5 Analyze the thermoregulatory profiles during EHS recovery to establish the role of estrogen on acclimation

In accordance with lab standard procedures

100% Complete Periodic Surveillance by

COR

Monthly

6 Write a technical report on research findings

In accordance with lab standard procedures

100% Complete 100% Inspection by COR

NLT last day of POP

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