Attachment 1 - QASP.docx

Quality Assurance Surveillance Plan

For

LAB-Radiologicals Sample Analysis-Service

Contract # - TBD

04 August 2025

TABLE OF CONTENTS

Subject 2

1. Overview

2. Description of Services

3. Roles and Responsibilities

4. Contract Quality Requirements

5. Government Surveillance

6. Non-Conforming Performance

7. Deduct Plan

8. Data Analysis

9. Acceptance of Services

10. COR Status Report

11. Service Contract Reporting

12. Contractor Performance Assessment Reporting System (CPARS)

13. Combating Trafficking In Persons

14. COR/Quality Assurance Surveillance Files

15. QASP Changes

1. Overview.

1.1. Purpose. The purpose of this Quality Assurance Surveillance Plan (QASP) is to identify the methods and procedures the Government will use to ensure it receives the services under this contract as identified in the Performance Work Statement (PWS).

1.2. Intent. The intent of this QASP is to: 1) ensure Contractor performance meets or exceeds contract terms, conditions and specifications; 2) hold the Contractor accountable for quality control; and 3) encourage the Contractor to take appropriate steps to control and improve quality. Accordingly, the Government will perform surveillance on the contract in accordance with this QASP but reserves the right to monitor the contract in any manner necessary, at any times necessary, and at all places necessary to ensure that the rendered services conform to contract requirements. The Government also reserves the right to perform quality assurance at the Subcontractor level and perform quality assurance at the contractor's place of business, if applicable. Resolution of non-conforming services discovered at the Subcontractor level will be addressed with the prime Contractor.

2. Description of Services.

2.1. Scope of Work. The Contractor shall provide non-personal services(s). The Defense Centers for Public Health – Aberdeen requires radiological analyses on environmental and biosurveillance samples and provide the results of various compounds in each sample. The data obtained under this contract shall be used to comply with Federal and State requirements. The Contractor shall perform the analyses to the standards and acceptable quality level identified in this PWS and associated contract documents.

2.2. Type of Contract. This is a Firm Fixed Price (FFP) contract.

3. Roles and Responsibilities.

3.1. Government.

3.1.1. Contracting Officer (CO). The CO is the only person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

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. Also the CO determines and documents the final assessment of the contractor’s performance in the Government’s past performance tracking system.

Assigned CO: TBD Organization or Agency: USAMRAA Email: TBD

The Contract Specialist (CS) – The CS acts as an acquisition consultant and serves as liaison between the contract office and DCPH-A.

Assigned CS: TBD Organization or Agency: USAMRAA Email: TBD

3.1.2. Contracting Officer’s Representative (COR). The COR will be identified by a letter of designation. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor's performance and notifies both the CO and Contractor of any deficiencies; coordinate availability of Government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.

Assigned COR: TBD Organization or Agency: DCPH-A Email: TBD

3.2. Contractor.

3.2.1. Contract Manager. TBD

3.2.2. Project Manager. The contractor shall designate a single Project Manager (PM) to be the contractor’s authorized point of contact with the COR. The PM will be responsible for formulating and enforcing performance standards, assigning contractor schedules, reviewing performance quality, communication policies, purposes and goals to subordinates. This will include coordination with the CO and the COR to resolve any issues that may arise, trends relating to the contract, or proposed changes or modifications to the contract. In addition, the Contractor representative/Project Manager shall document the transfer of possession from the courier to the contract lab facility including sample receipt temperature. The Contractor shall immediately report in writing to the COR all samples lost or broken in transit.

3.2.3. Quality Manager. TBD

4. Contract Quality Requirements.

4.1. Contractor’s Quality Control Program. The Contractor’s quality control program (in accordance with Federal Acquisition Regulation (FAR) Part 46 and applicable 52.246-(Clause(s))) is the means by which the Contractor assures that work complies with the requirement of the contract. The Contractor shall ensure services are performed in accordance with this PWS. The Contractor shall identify, prevent, and ensure non-recurrence of defective services.

4.2. Government Quality Assurance. The Government shall evaluate the Contractor’s performance under this contract in accordance with this QASP. This plan is primarily focused on what the Government must do to ensure that the Contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance and minimum acceptable defect rate(s).

5. Government Surveillance.

5.1. Methods of Surveillance. The Performance Requirements Summary (PRS) is the list of performance objectives and standards that must be performed by the contractor. This PRS details the method of surveillance the COR/ACOR will use to validate and inspect these performance elements. Inspection of each element will be documented in the COR file. Additionally, the following Methods of Surveillance will be utilized in monitoring the Contractors’ performance:

5.1.1. 100% Inspection. The Government shall technically and administratively review 100% of the radiological analyses on environmental and biosurveillance samples, sample analysis, final reporting and Electronic Data Deliverable (EDD) transmission within the specified turnaround times.

5.1.2. Customer Feedback. The Customer Complaint Record, Attachment 3, will be used to document/record all complaints. The following procedures will be followed when a complaint is received.

· The COR will investigate and determine the validity of the complaint.

· If the complaint is determined to be invalid, the COR will inform the person who submitted the complaint of the reason(s) as soon as practical.

· For validated complaints that are true contractual non-conformances, the procedures in paragraph 6 below will be followed.

5.2. Surveillance Schedule. A Surveillance Schedule will be created for each month of Contractor performance utilizing the Surveillance Schedule Smart Form in the Procurement Integrated Enterprise Environment (PIEE) Surveillance and Performance Monitoring Module (https://piee.eb.mil/). The schedule is “FOR OFFICIAL USE ONLY” and is not releasable to anyone other than authorized Government personnel. A copy of the Surveillance Schedule will be uploaded into PIEE SPM (Either as an Attachment to the Monthly COR Status Reports or uploaded separately in the Miscellaneous Documents Section of the COR’s Online File).

5.3. Surveillance Instructions/Checklists. Surveillance Checklists will be utilized and completed when surveillances are conducted. Surveillance Checklists can be added in PIEE SPM as a Smart Form.

5.4. Surveillance Documentation. No later than the 15th of each month surveillance documentation for the preceding month will be uploaded in the PIEE SPM at https://piee.eb.mil/. Monthly surveillance documentation shall include the Monthly COR Status Report, the Surveillance Schedule and all completed Surveillance Checklist(s) for the preceding month. Surveillance Schedules and completed Surveillance Checklists may be uploaded in the SPM Module either as Attachments to Monthly Status Reports or uploaded separately in the Miscellaneous Documents Section of the COR’s Online File..

6. Non-Conforming Performance. Non-conformance occurs when a Contractor fails to meet Contract or Task Order terms, conditions and/or specifications. All instances of non-conformance will be documented, and the Contractor will be notified. Resolution of non-conformance discovered at the Subcontractor level will be addressed with the prime Contractor. Non-conformance is classified as either: Level I (Minor); Level II (Major); or Level III (Critical).

6.1. Level I (Minor). Level I non-conformance is not likely to materially reduce the usability of services for their intended purpose or is a departure from established standards having little bearing on completing the contract requirement. Minor non-conformances can usually be corrected on the spot and can be issued to the Contractor through either a verbal or written Contract Discrepancy Report (CDR). However, the Government is still required to document verbal Level I CDRs. The COR may issue verbal Level I CDRs directly to the appropriate level of Contractor management. The COR will notify the CO as soon as practical when a verbal Level I CDR is issued and document them in their Monthly Reports. If the non-conformance cannot be corrected on the spot, the Contractor shall be given a suspense date to correct the deficiency. The CO will issue, and sign written Level I CDRs, Attachment 5.

6.2. Level II (Major). Level II non-conformance is likely to result in failure of the services to meet contract requirements. Also, repeated discrepancies, a large number of documented Level I CDRs and trends indicating failure of the Contractor’s quality control program can be classified as Level II CDRs. The CO issues all Level II CDRs in writing, Attachment 5. The COR will notify the CO as soon as practical when a major non-conformance is identified.

6.3. Level III (Critical). Level III non-conformances result in hazardous or unsafe conditions due to the manner in which the services are performed; prevent or impact a vital agency mission as a result of performance; or are for repeated or uncorrected Level II CDRs. The Contracting Office Director or Deputy Director issues written Level III CDRs. The COR is responsible for notifying the CO immediately upon discovery of a critical non-conformance.

6.4. Documenting CDRs. Documentation, as a minimum, will include: the Contract or Task Order number; reference to the specific contract requirement; the specific discrepancy to the requirement; where it was discovered; the date and time it was discovered; Contractor representative who was notified; and the suspense date for Contractor response/corrective action.

6.5. Tracking and Resolving CDRs. All CDRs, verbal and written, regardless of issuer will be included in the COR’s Monthly Report. The COR and CO shall track CDRs to ensure the Contractor identifies and takes appropriate corrective action to the root cause and the specific non-conformance is corrected within the required timeline. The CO will make a final written determination of the Government’s remedies if the non-conformance is not corrected by the Contractor after receiving notice and a reasonable opportunity to correct the work.

7. Deduct Plan. This acquisition does not include a Deduct Plan.

8. Data Analysis. Data Analysis will be performed to identify trends in cost, schedule and/or performance risks. The results of Data Analysis will be documented in Monthly COR Status Reports and may be used to make adjustments to surveillance schedules, increase or decrease surveillance, if deemed appropriate. Negative trends noted using Government data/observations could result in issuing the Contractor a CDR. Trends noted using Contractor data will not result in a CDR unless the Contractor is not addressing the negative trend.

9. Acceptance of Services. When all services have been deemed acceptable and there is documented objective quality evidence to support acceptable performance the COR will accept the services provided and authorize payment of the Contractor. This is accomplished by approving the Contractor’s Receiving Reports in the Procurement Integrated Enterprise Environment, https://piee.eb.mil, Wide Area Workflow (WAWF) Module.

10. COR Status Report. COR Status Reports will be submitted on a Monthly basis, no later than the 15th of each month for the preceding month, to the CO via the PIEE Surveillance and Performance Monitoring Module https://piee.eb.mil/. COR Status Reports will provide a synopsis of the Contractors performance for the inclusive dates of the report. The synopsis will contain a summary of: surveillances performed; Customer Feedback, if any; CDRs, if any; an analysis of the Contractors performance; recommended adjustments to surveillance schedules; and any other pertinent contract information. Completed Surveillance Checklists and CDRs, if any, will be included as attachments to COR Status Reports or uploaded separately in the Miscellaneous Documents Section of the COR’s Online file.

11. Service Contract Reporting (SCR). Not Applicable

12. Contractor Performance Assessment Reporting System (CPARS). Documented surveillance data (COR Status Reports, Completed Surveillance Checklists, Customer Feedback and CDRs, if any) will be used to support CPARS ratings. CPARS will be completed in accordance with Federal Acquisition Regulation (FAR), Subpart 42.1502 – Policy. The COR shall document that CPARS, if required, was completed in the PIEE Surveillance and Performance Monitoring Module https://piee.eb.mil/.

13. Combating Trafficking In Persons (CTIP). In accordance with PGI 222.17 and FAR 52.222-50, the CO will be notified immediately of any information from any source that alleges a contractor employee, subcontractor and/or subcontractor employee has engaged in conduct that violates the United States Government “zero” tolerance policy regarding trafficking in persons.

14. COR/Quality Assurance Surveillance Files. The official COR/Quality Assurance Surveillance File will be maintained in in the PIEE SPM Module https://piee.eb.mil/, for COR Certification.

15. QASP Changes. This QASP is a living document and, as such, may be changed as needed based on Data Analysis (trends), contract modifications, etc. The COR will send any recommended changes to the CO for approval and the CO must approve all changes.

Contracting Officer’s Signature Block

TBD

Contracting Officer US Army Medical Research Acquisition Activity (USAMRAA)

Contracting Officer’s Representative (COR) Signature Block

TBD

Supervisory Chemist, Contracting Officer’s Representative (COR) Defense Centers for Public Health-Aberdeen (DCPH-A)

Attachments:

1. Performance Requirements Summary (PRS)

2. Corrective Action Report (CAR)

3. Customer Complaint Record

4. Performance Assessment Report (PAR)

Attachment 1 Performance Requirements Summary (PRS)

PRS#1 - PWS para 1.8

Post Award Conference.

The Contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5.

PRS#2 - PWS para 1.18

The Contractor shall provide signed non-disclosure agreements to the Government.

PRS#3 - PWS para 1.23.1

The contractor shall submit certificates of completion for each affected contractor employee and subcontractor employee, to the COR for the Anti-Terrorism Level 1 Training.

PRS#4 - PWS para 1.23.3

The contractor and all associated sub‐contractors shall brief all employees on the local iWATCH Army program.

PRS#5 - PWS para 5.2.1.1

If applicable, the Contractor’s courier shall be responsible for pickup (from DCPH-A), packaging and delivery of samples.

PRS#6 - PWS para 5.2.2

The Contractor shall complete the sample analysis, final reporting and Electronic Data Deliverable (EDD) transmission within the specified turnaround times.

STANDARD PRIORITY: 21 days from date of sample receipt.

HIGH PRIORITY: 12 days from the date of sample receipt.

TOP PRIORITY: 8 days from the date of sample receipt.

PRS#7 - PWS para 5.2.4.1

The Contractor shall be required to dispose of unused sample volumes and used Radiological sampling media (excluding carbon disulfide which shall be disposed immediately).

PRS#8 - PWS para 5.2.4.2

The Contractor shall return all Government shipping containers, unless otherwise specified, to the COR.

PRS#9 - PWS para 5.4.1

Laboratory Accreditation The contract laboratory shall be ISO 17025 accredited and in compliance with The NELAC Institute (TNI) standards for analyzing Radiological samples for all analysis required in this contract PWS.

PRS#10 - PWS para 5.5.1

The Contractor shall provide a spreadsheet with detail of real time expenditure levels of every contract line-item number (CLIN).

PRS#11 - PWS para 5.5.2

The Contractor shall provide a weekly summary of all DCPH-A analysis currently being analyzed by the Contractor (to include analysis sent to the subcontractor).

Attachment 2 Corrective Action Report (CAR)

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

Attachment 3 Customer Complaint Record

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

Attachment 4 Performance Assessment Report (PAR)

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

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