W81XWH-19-R-0051_Attachment 1 - QASP_12-04-2019.pdf

ATTACHMENT 1

Quality Assurance Surveillance Plan (QASP)

Small Laboratory Research Animals MA-BPA

1. Background

The U.S. Army Medical Research and Development Command (USAMRDC) is the Army’s medical materiel developer, with responsibility for medical research, development, and acquisition. The USAMRDC’s expertise in these critical areas help establish and maintain the capabilities the Army needs remain ready and lethal on the battlefield.

Madigan Army Medical Center (MAMC) is the U.S. Army’s second largest medical treatment facility and a state-of-the-art and technologically advanced medical center, one of only two designated Level II trauma centers in Army Medicine.

The Dwight David Eisenhower Army Medical Center (DDEAMC) mission is to provide high quality, complex, patient-centered healthcare services and delivers military readiness through sustained medical education and multidisciplinary care.

2. Vision

USAMRDC’s vision is to lead the advancement of military medicine.

MAMC’s vision is to proudly generate a ready medical force and a medically ready force by delivering innovative, highlight reliable healthcare in support of America’s Military Family.

DDEAMC’s Vision is to delivery readiness while providing a 5-Star Patient Experience.

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. What will be monitored?

3.1.2. How monitoring will take place.

3.1.3. Who will be conducting the monitoring?

3.1.4. How monitoring efforts and results will be documented.

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. Authorities

The 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. Roles and Responsibilities

The following personnel shall oversee and coordinate surveillance activities.

5.1 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 ensure that the contractor receives impartial, fair, and equitable treatment under this contract. Determine and document the final assessment of the contractor's performance in the Governments past performance tracking system.

Assigned KO: TBD Organization or Agency: U.S. Army Medical Research Acquisition Activity (USAMRAA) Telephone:

Email:

Contract Specialist: TBD Organization or Agency: USAMRAA Telephone:

Email:

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

Assigned COR: TBD Organization or Agency:

Telephone:

Email:

5.3 Contractor Representatives

The following employees of the contractor serve as the contractor’s Technical Point of Contact for the BPA.

5.3.1 Contractor Technical Points of Contact

Name: TBD Organization or Agency:

Telephone:

Email:

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 BPA 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 BPA requirements. The COR uses the methods contained in this QASP to ensure the contractor is in compliance with BPA 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 BPA.

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.

Table 1: Performance Ratings 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.

Table 2 - Surveillance Matrix SoN Delivery

Objectives Delivery Standard Acceptable Quality Level Method of Surveillance

SoN, Section 1.2.5 AAALAC or CCAC Certification Meets Delivery

Standard 100%.

100% inspection by the COR.

Inspected through functionality and operational specifications.

SoN, Section 1.2.6 Certification of USDA License Meets Delivery Standard 100%.

100% inspection by the COR.

Review of document

SoN, Section 5 Monthly GPC Order Report Meets Delivery Standard 100%.

100% inspection by the COR.

Review of document.

SoN, Section 6 Delivery Ticket Meets Delivery Standard 100%.

100% inspection by the COR.

Review of document.

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

INDIVIDUAL

PHONE

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)

6. CONTRACTOR REPRESENTATIVE REMARKS