B01_Attachment_2_QASP.pdf

Quality Assurance Surveillance Plan (QASP)

For

Lab Industrial Hygiene (IH) Sample Analysis

Contract # TBD

25 August 2023

PWS ATTACHMENT 2

ERIN J. MADDOX ARLINDA C. ADDERLEY

Contracting Officer Contracting Officer’s Representative

USAMRAA DCPH-Aberdeen

Fort Detrick, Maryland Aberdeen Proving Ground, Maryland

TABLE OF CONTENTS

Subject

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. Contractor Manpower Reporting Application (CMRA)

12. Contractor Performance Assessment Reporting System (CPARS)

13. Combating Trafficking In Persons

14. COR/Quality Assurance Surveillance Files

15. QASP Changes

1. Overview.

The Defense Centers for Public Health – Aberdeen (DCPH-A) is part of the Defense Health

Agency (DHA) and encompasses epidemiology, laboratory sciences, occupational health sciences, public health information and toxicology to enhance the military readiness and assure the quality and effectiveness of the Public Health Enterprise.

The mission of the DCPH-A is to enhance military readiness by identifying and assessing current and emerging health threats, developing, and communicating public health solutions, and assuring the quality and effectiveness of the Public Health Enterprise.

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 perform analyses on Industrial Hygiene and

Occupational Health samples and provide the results of various compounds in each sample.

The data obtained under this contract shall be used by the Defense Health Agency Defense

Centers for Public Health – Aberdeen (DCPH-A) to comply with Federal and State requirements of the Occupational Safety and Health Administration (OSHA).

2.2. Type of Contract. Firm Fixed Price (FFP)

3. Roles and Responsibilities.

3.1. Government.

3.1.1. Contracting Officer (KO). The KO 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 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:

Organization:

Telephone:

Email:

The Contract Specialist (CS) - The CS acts as an acquisition consultant and serves as liaison.

Assigned CS:

Organization:

Telephone:

Email:

3.1.2. Contracting Officer’s Representative (COR). The (COR) will be identified by separate letter. 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 Contracting Officer 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: Arlinda C. Adderley

Organization: Defense Centers for Public Health- Aberdeen (DCPH-A)

Email: arlinda.c.adderley.civ@health.mil

3.1.3. The DCPH-A will monitor the sample delivery groups for each set of samples to ensure on time delivery based on terms of the contract. This will also include the technical specification review to ensure quality results are reported from the Contractor.

3.1.4. The DCPH-A will review each invoice submitted with each sample delivery group to ensure accuracy and completeness. The DCPH-A technical Subject Matter Experts (SMEs) will perform the technical data reviews of each sample delivery group report and report any non-conformances to the COR for rectification with the Contractor. The Quality Compliance Office will routinely monitor the Contractor’s Lab Accreditations to ensure accreditation is maintained throughout the period of performance of the contract term.

3.1.5. The COR will document the invoice review and approval on an internal tracking mechanism (for example the Analytical Contract Service Invoice Log (ACSIL) to ensure there are sufficient funds available to continue working on this Contract. The SME technical data reviews will be documented on an internal review Checklist and archived internally with the data package.

3.2. Contractor.

The following employees of the contractor serve as the contractor’s Program or Project Manager and Task Manager for this contract. Communication should occur with them during

QASP development. It will help if they review the draft QASP and accept the final version.

Program or Project Manager – TBD <upon award, enter name>

Telephone: <enter number>

Email: <enter address>

Task Manager – TBD <upon award, enter name>

Other Contractor Personnel – TBD <upon award, enter name or delete these lines if not applicable>

Title: <enter title>

3.2.1. Program or Project Manager. Contract PM TBD

3.2.2. Quality Manager. Contractor QM TBD

3.2.3. The contractor is responsible for implementing and delivering performance that meets contract standards using its Quality Control Plan (QCP). 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.

4. Contract Quality Requirements.

4.1. Contractor’s Quality Control Program. The Contractor’s quality control program (IAW

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 the contracts Performance Work Statement (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 following Methods of Surveillance will be utilized in monitoring the Contractors’ performance. The Surveillance Matrix (Reference Below:

Attachment 3) 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.

5.1.1. 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.

5.1.2. Customer Feedback. The DA Form 5477, Customer Complaint Record, Reference

Below: Attachment 2, 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. The QASP Surveillance Guide defines the performance objective and shows the pertinent portion of the Performance Work Statement, the Performance Threshold, and the Government’s Method of Surveillance for this contract.

5.3. Surveillance Instructions/Checklists. Surveillance Checklists, Reference Below:

Attachment 1, will be utilized and completed when surveillances are conducted.

5.4. Surveillance Documentation. Monthly surveillance documentation includes the COR

Monthly 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 Procurement Integrated Enterprise Environment (PIEE) either as Attachments to

Monthly Status Reports or uploaded separately in the Miscellaneous Documents Section of the

CORs’ Online File.).

6. Non-Conforming (Unacceptable) Performance.

When performance is deemed unacceptable, the COR will inform the Contractor POC for the situation to be addressed. If actions are not initiated to rectify the poor performance, the COR will inform the Contracting Officer (KO) and the management of the Contract

Laboratory for further action. The COR will notify the KO of subpar performance. If any services do not conform to contract requirements, the Government may require the Contractor to re perform the contract requirements at no increased cost to the Government. When sub-par performance cannot be corrected by re-performance the Government may require the Contractor to take action necessary to ensure future performance conforms to contract requirements.

Reduce the contract price to reflect the reduced value of the services performed.

Per the terms identified in the contract.

If the Contractor fails to promptly re-perform the services, or to take the necessary action to ensure that future performance conforms to contract requirements, the Government may, by separate contract or otherwise, perform the services and charge to the

Contractor any cost incurred by the Government that is directly related to the performance of such service or:

o Issue a Cure Notice o Issue a Show Cause Notice o Terminate the contract for Convenience o Terminate the contract for Default

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 (also abbreviated KO) 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/KO 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 KC (NOT SURE WHAT A KC IS..THIS WAS IN THE CMT

TEMPLATE) 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 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 Contract Discrepancy Report. 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 Wide Area WorkFlow, e-Business Suite, https://cac.piee.eb.mil/xhtml/unauth/home/login.xhtml

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 Contracting Officer via PIEE. 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 CORs’ Online file.

11. Contractor Manpower Reporting Application (CMRA). In accordance with Office of the Secretary of Defense Memorandum, Enterprise-wide Contractor Manpower Reporting

Application, dated 28 Nov 2012, the Contractor must report contractor manpower to the

Contractor Manpower Reporting website at https://cmra.army.mil.(CMRA LINK INCLUDED

IN THE CMT TEMPLATE…SHOULD IT STAY OR BE REMOVED) While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year. The COR shall verify that the Contactor has complied with the required contractor manpower reporting annually and document the results via PIEE

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 AFARS, Subpart 5142.15 – Contractor Performance Information. The COR shall document that CPARS, if required, was completed via PIEE

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 via PIEE, https://cac.piee.eb.mil/xhtml/unauth/home/login.xhtml, IAW DoDI 5000.72, DoD Standard 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/KO for approval and the CO/KO must approve all changes.

COR’S Signature Block

Arlinda C. Adderley

Supervisory Chemist

Contracting Officer’s Signature Block

Attachments:

1. Performance Requirements Summary (PRS)

2. Customer Complaint Record, DA Form 5477

3. Surveillance Matrix

4. COR/Quality Assurance Evaluator (QAE) Surveillance Schedule, DA Form 5475

5. Contract Discrepancy Report, DA Form 5479

Attachment 1 - Performance Requirements Summary (PRS)

Attachment 2 – Customer Complaint Record, DA Form 5477

DOES THIS GET REPORTED VIA LAB MASTERCONTROL?

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.

DA FORM 5477

Attachment 3 - Surveillance Matrix

Number

PWS

Reference

Performance

Objective

Standard

Acceptable

Quality

Level

Performance

Measure Incentive

1 6.2.1.2 The contractor shall provide on- time Final analytical reports

Per report calculation:

Requested

Number of Days

– Total Days at

Contractor

Exceeds: >0 days

Meets: 0 days

Does Not Meet:

< 0 days

Monitored via

Laboratory

Information

Management

(LIMs) statistics report

Frequency:

Monthly per analytical report

Past

Performance

2 6.2.1.2 The contractor shall provide on- time

Electronic Data

Deliverables

(EDD)

Per EDD calculation:

Requested

Number of Days

– Total Days at

Contractor

Exceeds: >0 days

Meets: 0 days

Does Not Meet:

< 0 days

Monitored via

Laboratory

Information

Management

(LIMs) statistics report

Frequency:

Monthly per analytical report

Past

Attachment 4 - COR/QAE SURVEILLANCE SCHEDULE (DA FORM 5475) (IS THE DA FORM STILL

NECESSARY)

DA FORM 5475

Attachment 5 - Contract Discrepancy Report, DA Form 5479