8.29.16_Attachment_B_QASP_16-T-0378.docx

Quality Assurance Surveillance Plan (QASP)

Neuro-Kinetic I-Portal® Neuro-Otologic Test Center (NOTC) Premimum Plan

Software and Service

1. Vision

USAARL is one of six (6) subordinate commands under the U.S. Army Medical Research and Material Command (USAMRMC). USAARL's research programs solve medical and health-related problems that compromise the safety or deter the mission performance of the aviator and Soldier. The laboratory conducts research on neurosensory injury, return-to-duty standards for wounded warriors, and equipment for the medical evacuation environment.

1. Mission

The USAARL mission has expanded to support the aviator, the airborne soldier, and the ground warrior. The Laboratory research focuses on aircrew health and performance; blunt, blast, and accelerative injury and protection; crew survival in military helicopters and combat vehicles; en route care; and sensory performance, injury, and protection.

1. 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. What will be monitored?

3.1.2. How monitoring will take place.

3.1.3. Who will conduct the monitoring.

3.1.4. How monitoring efforts and results will be documented.

3.2. 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. The 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 shall 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.

The QASP shall ensure early identification and resolution of performance issues to minimize impact on mission performance.

1. Authorities

The authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation (FAR), Inspection of Services clauses, which provide for inspection, acceptance and documentation of the service called for in the contract or task order. This acceptance is to be executed by the Contracting Officer or the COR.

1. Roles and Responsibilities

The following Government personnel shall oversee and coordinate surveillance activities.

5.1. Program / Project Manager

The Program / Project Manager (PM) 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 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: To be complete at time of award

Organization or Agency:

Telephone:

Email:

5.2. Contracting Officer

The Contracting Officer (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 the Contractor receives impartial, fair, and equitable treatment under this contract, and document the final assessment of the contractor's performance in the Government Contracting Performance Assessment Reporting System (CPARS).

Assigned KO: To be completed at time of award

Organization or Agency: U.S. Army Medical Research Acquisition Activity (USAMRAA)

Telephone:

Email:

5.3. Contracting Officer's Representative

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 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 make any contractual commitments or to authorize any contractual change on the Government's behalf.

Assigned COR: To be completed at time of award

Organization or Agency: U.S. Army Aeromedical Research Laboratory (USAARL)

Telephone:

Email:

5.4. 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: To be completed at time of award

Telephone:

Email:

Name: To be completed at time of award

Telephone:

Email:

5.5. Contractor Representatives

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

5.5.1. Program Manager

Name: To be completed at time of award

Telephone:

Email:

5.5.2. Task Manager – N/A

5.5.3. Other Key Contract Personnel – N/A

1. 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, 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 Quality Control (QC)/Quality Assurance (QA) actions to successfully meet the terms of the contract.

6.2. Surveillance Matrix

6.2.1. The Surveillance Matrix Table 2 identifies the 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 the contractor’s performance, Table 1 identifies the performance ratings that may be used.

Table 1: Performance Ratings Performance Rating

Criteria

Table 2: Surveillance Matrix

PWS Objective

Standards / AQL Inspection

Ratings

3.1. Objective 1 – Annual Preventative Maintenance and Calibration (PM&C)

COR-TO: TBD

The Contractor shall provide annual preventive maintenance and calibration for each contract year for the Neuro-Kinetic I-Portal® Neuro-Otologic Test Center NOTC System to include: software updates, calibration, preventive maintenance and full functional testing of the NOTC System. The annual PM&C service shall be documented to record the system is functioning within the defined OEM operational specifications. The Contractor shall coordinate the date and time of the PM&C with USAARL.

Performance Standards: The Performance Standard is NOTC System is fully functional after the Annual PM&C with an Accepted Quality Level of 100% and no down time.

Deliverable: Annual PM&C Service Report.

3.2. Objective 2 – Technical Telephone, E-Mail, and Remote Access Support

The Contractor shall provide unlimited technical telephone, e-mail, and remote access support. Telephone support shall occur during normal business hours from 8:00 AM to 4:30 PM EST and on-call support from 4:30 PM to 9:00 PM EST Monday through Friday.

Performance Standards: The Performance Standard is the support is provided as needed for the NOTC System during the hours identified under 3.2 above with an Accepted Quality Level of 100% and no down time.

Deliverable: Problem reported using telephone, e-mail, or remote access is resolved within four (4) hours from the date and time USAARL first reported the problem.

3.3. Objective 3 – On-Site Repairs

The Contractor shall provide on-site repairs at USAARL to include replacement of parts needed for repair of covered products.

Performance Standards: The Performance Standard is NOTC System is fully functional after the on-site repairs with an Accepted Quality Level of 100% and no down time.

Deliverables: Repair service receipt documenting the repairs and/or parts replaced.

3.4. Objective 4 – Software Subscription

The Contractor shall provide software updates and new version releases as they become available or 30 days after release. Any update or release that requires field modifications shall be installed in conjunction with the annual Preventative Maintenance and Calibration (PM&C).

Performance Standards: The Performance Standard is NOTC System is fully functional with the software updates and new version releases with an Accepted Quality Level of 100% and no down time.

Deliverable: Document with date of when USAARL received software updates and new version releases.

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

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