Solicitation Attachment 2 - Quality Assurance Surveillance Plan_HDSA.pdf

DHA QASP Template V1 1

DEFENSE HEALTH AGENCY (DHA)

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

VERSION – 30 MARCH 2026

FOR HAZARDOUS DRUG SAMPLE ANALYSIS SERVICES

CONTRACTOR’S NAME: TBD

CONTRACT NUMBER: Contract Number will be entered upon Award

CONTRACT DESCRIPTION: Analysis of wipe/swab samples for the hazardous drugs listed in this PWS and identified on the outsource document that will accompany each set of samples sent to the contract laboratory. The Contractor shall employ safe handling techniques and quality assurance/quality control (QA/QC) protocol with strict adherence to chain-of-custody and quality control procedures being required at all times.

SECTION 1 – PURPOSE

1.1. Vision. To Serve as a premier, world-class provider of public health services throughout the Army and DoD.

1.2. Mission. To Identify, assess, and communicate public health threats while providing solutions to ensure the effectiveness of the Army and DoD Public Health Enterprise.

1.3. Focus Areas. Key focus areas include environmental health, toxicology, industrial hygiene, deployment medicine, and health communication.

1.4. Purpose. 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:

• What will be monitored

• How monitoring will take place

• Who will conduct the monitoring

• How monitoring efforts and results will be documented

1.4.1. 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 and their Quality Assurance/Quality Control (QA/QC) actions to assure they meet contract standards. It is the government’s responsibility to be objective, fair and consistent in evaluating contractor performance.

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1.4.2. 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.

1.4.3. 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.

1.4.4. Bottom line, the QASP should ensure early identification and resolution of performance issues to minimize impact on mission performance.

SECTION 2 – AUTHORITY

2.1. Authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation, Inspection of Services clauses, which provides 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.

SECTION 3 – ROLES AND RESPONSIBILITIES

3.1. The following personnel shall oversee and coordinate surveillance activities.

3.1.1. Program/Project Manager (PM) or Functional Services Manager (FSM). The PM/FSM 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/FSM 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/FSM: TBD Organization or Agency: DCPH-A Telephone: TBD Email: TBD

3.1.2. Contracting Officer (CO). The CO 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 CO shall also ensure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO shall also determine the final assessment of the contractor’s performance. Additionally, the CO shall include a requirement in the quality assurance surveillance plan to revalidate all key personnel annually to determine whether the contractors meet the labor categories specified in the contract. The CO shall maintain documentation in the contract files that demonstrates their review and approval of initial and replacement contractor employees in key personnel positions. The CO shall include a requirement in information technology service contracts QASPs to review a sample of non‑key

DHA QASP Template V1 3 personnel quarterly to determine whether the contractor personnel meet the labor categories specified in the contract.

Assigned CO: Jessica E. Greene Organization or Agency: DHACA, Medical R&D, CD2, CB10 Telephone: 301-619-7433 Email: jessica.e.greene9.civ@health.mil

3.1.3. 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 CO. The COR is required to provide an annual performance assessment to the CO which will be used in documenting past performance. The QASP is the primary tool for surveillance of the contractor’s quality program and help the COR to document 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: TBD Organization or Agency: DCPH-A Telephone: TBD Email: TBD

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

Contractor Program Manager: TBD Telephone: TBD Email: TBD

SECTION 4 – PERFORMANCE REQUIREMENTS AND METHOD OF

SURVEILLANCE

4.1. 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 CO, 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.

mailto:jessica.e.greene9.civ@health.mil

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4.2. Surveillance Matrix. The Surveillance Matrix is the list of performance objectives and standards that must be performed by the contractor. This matrix details the method of surveillance and frequency the COR will use to validate and inspect these performance elements.

Inspection of each element will be documented in the COR file. 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 Performance Requirement Summary (PRS) should be used to form the foundation of the COR’s inspection checklist.

SECTION 5 – PERFORMANCE RATING DEFINITIONS

5.1. The performance ratings below reflect definitions at FAR 42.1503 Table 42-1. The COR will use these rating to evaluate the quality of contractor’s performance.

RATING DEFINITION NOTE

Exceptional Performance meets contractual requirements and exceeds many to the Government's benefit. The contractual performance of the element or sub-element being evaluated was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective

To justify an Exceptional rating, identify multiple significant events and state how they were of benefit to the Government. A singular benefit, however, could be of such magnitude that it alone constitutes an Exceptional rating. Also, there should have been NO significant weaknesses identified.

Very Good Performance meets contractual requirements and exceeds some to the Government's benefit. The contractual performance of the element or sub-element being evaluated was accomplished with some minor problems for which corrective actions taken by the contractor were effective

To justify a Very Good rating, identify a significant event and state how it was a benefit to the Government. There should have been no significant weaknesses identified.

Satisfactory Performance meets contractual requirements. The contractual performance of the element or sub-element contains some minor problems for which corrective actions taken by the contractor appear or were satisfactory

To justify a Satisfactory rating, there should have been only minor problems, or major problems the contractor recovered from without impact to the contract/order. There should have been NO significant weaknesses identified. A fundamental principle of assigning ratings is that contractors will not be evaluated with a rating lower than Satisfactory solely for not performing beyond the requirements of the contract/order.

Marginal Performance does not meet some contractual requirements. The contractual performance of the element or sub-element being evaluated reflects a serious problem for which the contractor has not yet identified corrective actions. The contractor's proposed actions appear only marginally effective or were not fully implemented

To justify Marginal performance, identify a significant event in each category that the contractor had trouble overcoming and state how it impacted the Government. A Marginal rating should be supported by referencing the management tool that notified the contractor of the contractual deficiency (e.g., management, quality, safety, or environmental deficiency report or letter).

Unsatisfactory Performance does not meet most contractual requirements, and recovery is not likely in a timely manner. The contractual performance of the element or sub-element contains a serious

To justify an Unsatisfactory rating, identify multiple significant events in each category that the contractor had trouble overcoming and state how it impacted the Government. A singular

DHA QASP Template V1 5 problem(s) for which the contractor's corrective actions appear or were ineffective problem, however, could be of such serious magnitude that it alone constitutes an unsatisfactory rating. An Unsatisfactory rating should be supported by referencing the management tools used to notify the contractor of the contractual deficiencies (e.g., management, quality, safety, or environmental deficiency reports, or letters).

SECTION 6 – PERFORMANCE REPORTING

6.1. Reports. The following documents will be used to measure performance, report deficiencies, and describe corrective actions under this contract.

6.1.1. Corrective Action Report (CAR) – See Blank Form on the Next Page.

6.1.2. Customer Complaint Form - See Blank Form on the Next Page.

6.1.3. Performance Assessment Report (PAR) – See Blank Form on the Next Page.

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6.2. Corrective Action Report (CAR).

CORRECTIVE ACTION REPORT (CAR)

(IF MORE SPACE IS NEEDED, USE AN ADDITIONAL PAGE, AND IDENTIFY CONTRACT NUMBER)

1. CONTRACTOR 2. CONTRACT NUMBER 3. TYPE OF SERVICES

4. FUNCTIONAL AREA 5. SUSPENSE DATE 6. CONTROL NUMBER

I. DEFICIENCY

MAJOR FINDING

MINOR FINDING

II. 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.

III. QUALITY ASSURANCE PERSONNEL (COR)

TYPED NAME AND GRADE SIGNATURE AND DATE

IV. ISSUING AUTHORITY

TYPED NAME AND GRADE SIGNATURE AND DATE

V. ACTION CORRECTED

10. COR RESPONSE TO CONTRACTOR CORRECTIVE ACTION AND ACTION TAKEN TO PREVENT RECURRENCE

11. COR DETERMINATION

12. CLOSE DATE

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6.3. Customer Complaint Form.

CUSTOMER COMPLAINT RECORD DATE/TIME OF COMPLAINT

I. SOURCE OF COMPLAINT

ORGANIZATION BUILDING NUMBER INDIVIDUAL PHONE NUMBER

II. NATURE OF COMPLAINT

DESCRIBE INCIDENT HERE:

CONTRACT REFERENCE

VALIDATION

III. ACTION CORRECTED

DATE/TIME CONTRACTOR INFORMED OF COMPLAINT

ACTION TAKEN BY CONTRACTOR

RECEIVED / VALIDATED BY:

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6.4. Performance Assessment Report (PAR).

PERFORMANCE ASSESSMENT REPORT (PAR)

(IF MORE SPACE IS NEEDED, USE AN ADDITIONAL PAGE, AND IDENTIFY CONTRACT 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. (CHECK ALL BOXES THAT APPLY)

DEFICIENCY

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

14A.

CONCUR NON-CONCUR

14B. COR SIGNATURE AND DATE:

15. COR REMARKS (REQUIRED)

16. CONTRACTOR REPRESENTATIVE REMARKS