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 Chapter 4

 

Procurement of Items and Services (Extramural Actions)

NRMRL and EPA policies require that parties to procurement agreements or assistance agreements shall have in place a quality system consistent with EPA requirements. Procurement agreements include contracts and simplified acquisitions, and parties to these agreements include primary contractors, subcontractors (as passed through by the prime), and vendors. Assistance agreements include grants, cooperative agreements, and interagency agreements (IAGs). Other extramural agreements covered by this policy include Cooperative Research and Development Agreements (CRADAs). Compliance with this policy is achieved by including appropriate written requirements into solicitation, award, and/or agreement documents.

4.1 Scope and Application

It is NRMRL policy that any extramural action that falls into one of the following accounting and object classification structures must include a QA Review Form (QARF), with appropriate signatures, prior to forwarding to the Contracts Management Division (CMD) or the Office of Grants and Debarment (OGD).

25.32 Programmatic Research and Development Contracts
25.05 Program Contracts
25.63 Programmatic Occupational Health Monitoring
25.71 Programmatic - Research Interagency Agreements
41.00 Grants, Subsidies and Contributions

For contracts and IAGs (Object Class 25.XX), funding actions include the initial award funding and any modifications that add additional funds. For assistance agreements (Object Class 41.XX), funding actions include the initial award funding, incremental funding (partial funding, no new work) and supplemental funding (additional funding of new work).

For each funding action, NRMRL TLPs must incorporate a QARF into the funding package (see Appendix D). For CRADAs and IAGs, NRMRL TLPs must incorporate a QARF into the agreement documentation. The TLP is responsible for completing the QARF, but they have the option to consult with their QAM prior to submitting it with the funding package for the QAM's concurrence signature. The QARF identifies the required quality documentation that shall be included in the contract clauses by the Contracting Officer (CO). There must be adequate information in the statement of work (SOW) for the offeror to develop this documentation. Attachment #1 to the SOW (see Appendix D) is used to specify the guidance to be followed and must be referenced in the SOW when applicable. Attachment #1 to the SOW is not necessary when the contractor or cooperator will not be required to develop or revise any quality documentation (e.g., when they will only be implementing previously approved quality documentation).

All funding actions and agreement documents are reviewed by NRMRL QAMs or their designees to ensure the appropriate requirements are included in each action.

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4.2 Single-Project Effort

For a single-project effort, the TLP typically requires that an offeror or applicant address NRMRL's Quality System Specifications for Extramural Actions in their proposal (before award). The five specifications are:

  1. A description of the organization's Quality System (QS) and information regarding how their QS is documented, communicated and implemented,
  2. An organizational chart showing the position of the QA function,
  3. Delineation of the authority and responsibilities of the QA function,
  4. The background and experience of the QA personnel who will be assigned to the project, and
  5. The organization's general approach for accomplishing the QA specifications in the SOW.

After-award, the TLP typically requires the awardee to prepare a quality assurance project plan (QAPP) that meets the project-specific requirements specified on the QARF and Attachment 1 to the SOW. The before-award documentation, in concert with the after-award QAPP, constitutes a joint QMP/QAPP.

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4.3 Multiple-Project Effort

As part of the solicitation of a large contract with multiple work assignments and large assistance agreements with more than one level of development, the TLP typically requires that an offeror or applicant submit a Quality Management Plan (QMP) (before award).

The QMP needs to meet the requirements of EPA (which includes compliance with ANSI/ASQ E4-2004: Policy and Program Requirements for the Mandatory Agency-wide Quality System (PDF) (12 pp, 94 KB) - see EPA Order 5360.1 A2 and is submitted by the offeror/applicant as part of the proposal. NRMRL has developed a set of requirements (see Chapter 2 and Appendix B) based on EPA Requirements for Quality Management Plans (QA/R-2) (PDF) (30 pp, 87 KB), (EPA/240/B-01/002) March 2001. NRMRL's requirements are to be addressed in QMPs submitted as part of a proposal responding to a NRMRL solicitation. Each QMP is evaluated by the Technical Evaluation Panel (TEP), if convened, to determine its acceptability (see Section 4.4). The specific evaluation procedures are determined and agreed

After-award, the awardee must revise the QMP according to comments received from the TEP. For each subsequent funding action where environmental data are used, generated, or collected, the TLP typically requires the awardee to prepare a quality assurance project plan (QAPP) that meets the project-specific requirements specified on the QARF and Attachment 1 to the SOW.

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4.4 Additional Requirements for Competitive Extramural Actions Exceeding $500,000

In addition to the requirements in Section 4.1, the following requirements exist for competitive contract and assistance agreement solicitations exceeding $500,000.

In accordance with Section 46.1.5.2 of the EPA Contracts Management Manual (CMM), if the potential value of the procurement exceeds $500,000, or the estimate of the percentage of costs or level-of-effort allocated to activities requiring quality requirements exceeds 15%, then the quality documentation (i.e., the Quality Management Plan or equivalent documentation) shall be included as part of the Technical Evaluation Criteria if a Technical Evaluation Panel is convened by the CO. The QAM or authorized QA designee shall: (1) assist the Project Officer with development of the Technical Evaluation Criteria, and any associated technical instructions, for the Request for Proposal, and (2) serve as a member of the Technical Evaluation Panel for the purpose of evaluating the QA aspects of the technical proposals when a Technical Evaluation Panel is convened.

For assistance agreements, the QA Manager or designee shall perform a QA review of proposals being considered for award. This is in addition to other extramural and intramural reviews required by the Code of Federal Regulations.

The TLP shall consult with the QAM to establish QA evaluation standards for these solicitations. Typically, QA is evaluated as part of the technical evaluation criteria (approximately 10%-20% of the total points). The QARF and Attachment 1 to the SOW must be included in the funding package.

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4.5 QA Responsibilities on IAGs and CRADAs

If work on a project will be performed by EPA and one or more other organizations on an IAG or CRADA, the responsibility for QA must be negotiated within the agreement. The TLPs in consultation with the QAMs in each organization must agree on and document (in the agreement and on a QARF) which organization will take the lead for QA, the specific person from the organization who will be responsible, and the QA requirements that will be adhered to during the agreement.

4.6 Evaluation of Quality Deliverables

In order to ensure that extramural organizations provide quality services that satisfy EPA QA/QC requirements, NRMRL QAMs (or their designees) and TLPs review QMPs, QAPPs, SOPs, and final products and audit projects and programs. Review comments generated by the QAM (or designee) are provided to the TLP who is ultimately responsible for the quality of services provided.

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