600R80102 GUIDELINES AND SPECIFICATIONS FOR IMPLEMENTING QUALITY ASSURANCE REQUIREMENTS FOR EPA CONTRACTS AND INTERAGENCY AGREEMENTS INVOLVING ENVIRONMENTAL MEASUREMENTS QAMS-002/80 Quality Assurance Management Staff l_ Office of Monitoring and Technical Support Office of Research and Development *• U.S. Environmental Protection Agency May 19, 1980 ------- TABLE OF CONTENTS ABSTRACT 1. INTRODUCTION 3 1.1 Purpose 3 L2 Authority 3 1.3 Scope 3 L4 Definitions 3 L4J Environmental Measurement 3 L4.2 Project Officer 4 L4.3 QA Officer 4 L4.4 Contracting Officer 4 L4.5 QA Program Plan 4 1.4.6 QA Project Plan 4 L4.7 QA Performance Audit 4 1.4.8 QA System Audit 5 2. QUALITY ASSURANCE REVIEW (Contracts) 5 2.1 Statement of Work 5 2.2 Contracts (Preaward) 6 2.2J QA Program Plan 7 2.2.2 QA Project Plan 7 2.2.3 QA System Audit 8 2.2.4 QA Performance Audits 9 2.2.5 Preaward QA Evaluation 9 2.3 Contracts (Award) 9 2.3.1 QA Requirements in the Contract 10 2.3.2 QA Reports 10 2.3.3 Level-of-Effort Type Contracts 11 3. QUALITY ASSURANCE REVIEW (Interagency Agreements) 11 4. BIBLIOGRAPHY 11 4.1 General • 11 4.2 Air 12 4.3 Water 12 4.4 Radiation 13 4.5 Solid Waste 13 4.6 Toxic Substances 13 4.7 Pesticides 13 4.8 Health Research 13 Appendix: Quality Assurance Review Forms L Form QAR-C, Quality Assurance Review for Extramural Projects (Contracts) 14 2. Form QAR-IA, Quality Assurance Review for Extramural Projects (Interagency Agreements^ 16 ------- Revision No. 1 Date: 5-19-80 Page 1 of 17 GUIDELINES AND SPECIFICATIONS FOR IMPLEMENTING QUALITY ASSURANCE REQUIREMENTS FOR EPA CONTRACTS AND INTERAGENCY AGREEMENTS INVOLVING ENVIRONMENTAL MEASUREMENTS ABSTRACT On May 30, 1979, the Administrator issued an EPA policy requiring all Regional Offices, Program Offices, EPA Laboratories, and the States to participate in a centrally-managed Agency-wide Quality Assurance (QA) Program. The stated goal of the Program is to ensure that all environmentally-related measurements which are funded by EPA or which generate data mandated by EPA are scientifically valid, defensible, and of known precision and accuracy. In a memorandum dated June 14, 1979, the Administrator specifically addressed the QA requirements for all EPA extramural projects, including contracts, interagency agreements, grants, and coopera- tive agreements, that involve environmental measurements. This document is to provide assistance to Project Officers, QA Officers, and other EPA personnel involved in the administration of contracts and interagency agreements to uniformly implement the Administrator's June 14, 1979 memorandum. The intent of this document is to ensure that QA requirements for these extramural projects are consistent and appropriate. • Guidance and review forms are provided to assist in the systematic review of QA requirements for projects covered by contracts and interagency agreements. For contracts, the steps of the review include: (1) Requirements of the Request for Proposal (RFP); (2) Evaluation of the offerers' proposals; and (3) Requirements of the contract. The RFP will state that a QA program plan must be submitted by offerers as a separately identified part of the technical proposal. In addition, the RFP will ------- Revision No. 1 Date: 5-19-80 Page 2 of 17 include requirements that offerers in the competitive range may be required to participate in appropriate EPA QA performance audits and that such offerers permit QA system audits by EPA as part of the evaluation and selection process. Each contract will require submittal of a QA program plan and a QA project plan to EPA for approval prior to the initiation of environmental measurements. The QA program plan and the QA project plan will become a part of the contract, incorporated by reference. The contract must also include requirements for the submission of separate periodic QA reports, the right of EPA to conduct QA system audits, and, as appropriate, requirements for participation in EPA performance audits. The awardee must extend requirements appropriately to all subcontractors. Level-of-effort type contracts will require a basic QA project plan which is ( amended or revised, as necessary, for each separate work assignment (i.e., technical directive) involving environmental measurements. The QA review for interagency agreements will be similar to those for awarded contracts. ------- Date: 5-19-80 Page 3 of 17 L INTRODUCTION By memoranda of May 30, 1979, and June 14, 1979, the Administrator established the goal of the EPA QA Program to ensure that all environmentally-related measure- ments funded or mandated by EPA and interagency agreements be scientifically valid, defensible, and of known precision and accuracy. 1.1 Purpose The purpose of this document is to assist Project Officers, QA Officers, Contracting Officers, and other involved EPA personnel in the uniform implementation of QA requirements for contracts and interagency agreements. 1.2 Authority The Office of Research and Development (ORD) is delegated the responsibility to develop, implement, and manage the QA program for the Agency (Delegation of Authority Manual, Page _). 1.3 Scope This document is applicable to all contracts and interagency agreements involving environmentally-related measurements. 1.4 Definitions 1.4.1 Environmental Measurement - The term "environmental measurement" applies to essentially any field or laboratory investigations that generate data such as measuring the chemical, physical, or biological parameters in the environ- ment; determining the presence or absence of pollutants in waste streams; health and ecological effects studies; clinical and epidemiological investigations; engi- neering and process evaluations; studies involving laboratory simulation of environ- mental events; and studies or measurements on pollutant transport and fate; and modeling. ------- Revision No. 1 Date: 5-19-80 Page 4 of 17 1.4,2 Project Officer - That inc.vidual who is assigned technical responsibility from the inception of the requirement through its completion and close-out of the contract under which the requirement was satisfied. 1.4.3 QA Officer - That individual who is assigned the responsibility for overview and guidance of the QA program for an organization or for a specific project. The QA Officer must be in a position to provide independent and objective evaluations and assessments of the effectiveness of the QA program, and to provide timely feedback and recommendations, 1.4.4 Contracting Officer - That individual who is assigned the responsibility for assuring that contracting is done as authorized by law and regulation. 1.4.5 QA Program Plan - A written document prepared by offeror/awardee which presents, in general terms, the overall policies, organization, objectives, functional responsibilities (within the organization), and general procedures designed to achieve data quality goals. 1.4.6 QA Project Plan - A written document prepared by offeror/awardee for a specified project which details the policies, organization, objectives, functional activities, and specific QA and quality control (QC) procedures and activities designed to achieve data quality goals or requirements. The QA project plan includes procedures to be used to routinely assess data precision, accuracy, completeness, representativeness, and comparability of the measurements involved. 1.4.7 QA Performance Audit A quantitative analysis or check with a material or device with known properties or characteristics. Such audits are performed periodically to determine the accuracy of a measurement system. ------- QAMS-002/80 " Revision No. 1 Date: 5-19-80 Page 5 of 17 1.4.8 QA System Audit - A systematic on-site qualitative review of facilities, equipment, training, procedures, record-keeping, data validation, data management, and reporting aspects of the total (QA) system. QA plans and audits are required to assess the capability of the measurement system of offerer to generate data to the required quality or to determine compliance of an awardee with the QA requirements of the contract. 2. QUALITY ASSURANCE REVIEW (CONTRACTS) To assist Project Officers (PO) and QA Officers in planning and decision making concerning QA for their projects (contracts), QA Form, QAR-C, has been designed (Appendix). Although the PO has responsibility for his project and is the official contact with the Contracting Officer, the PO must obtain agreement from the appro- priate QA Officer on all matters affecting QA. The QA Officer for the contract requesting office should assure that the QA Officers of all other substantially involved Program and Regional offices and Labora- tories are notified and given a review opportunity if they desire. When several Regions are involved, the QAMS will serve as the review coordinator and will designate one or more representatives from the Regional QA Officers to assist in the review. 2.1 Statement of Work The QA Officer will assure that the Statement of Work includes as much specific guidance and criteria as possible about the quality of environmental measurements expected. Whenever possible, the following areas must be covered: L The intended use of the data and the associated acceptance criteria for data quality. ------- Revision No. 1 Date:. 5-19-80 Page 6 of 17 2.1 Statement of Work (Continued) 2. The minimum requirements for precision, accuracy, representa- tiveness, completeness, and comparability. 3. Selection of sampling sites and collection of samples. 4. Sample identification, preservation, transportation, and storage. 5. Selection of analytical methods. * 6. Standard QA/QC procedures to be followed. 7. Other Standard Operating Procedures and protocols to be followed by the contractor. 8. Data reduction and reporting. All appropriate publications must be identified and any specific EPA publications to be used should be included in the RFP. 2.2 Contracts (Preaward) Prior to release of the purchase request to Procurement and Contracts Management Division, the PO must determine if the project involves the generation of environmentally-related measurement data. If so, the PO must delineate the QA requirements, approved by the QA Officer, which each offerer must include in the • proposal. The following will be included as requirements of the special instructions and will be submitted as part of the offerers' proposals: o A QA program plan as described in Section 2.2.1. o Agreement to participate in Performance Audits using selected QC reference samples/devices or agreement to document recent performance on such samples. Such reference samples or devices will be supplied by EPA at no cost to the offerers.* *Please see footnote on following page. ------- Revision No. 1 Date: 5-19-80 Page 7 of 17 2.2 Contracts (Preavvard/Continued) o Agreement" to permit a QA System Audit by EPA of- the offerers' organization, and operations.* Each of these preaward requirements of the RFP must be included in the RFP evaluation criteria. The offerer will assure that the requirements for QA project plans, QA performance audits, and QA system audits are met by any proposed subcontractors. 2.2.1 QA Program Plan. The offerer will include in the proposal the following information concerning management of the QA program for the projects: 1. A statement of policy concerning the organization's commitment to implement a QA program to assure generation of measurement data of adequate quality to meet contract requirements. 2. An organizational chart showing the position of a QA person within the organization. It is highly desirable that the QA person be independent of the functional groups which generate measurement data. 3. A delineation of the authority and responsibilities of the QA person and the related data quality responsibilities of the functional groups of the organization. 2.2.2 QA Project Plan. The offerer may be required to submit, as part of the technical proposal, a proposed QA project plan for the effort required by the contract. This QA project plan will include the QA system of proposed sub- contractors. If not required as a part of the technical proposal, a QA project plan must be submitted as a separate, identifiable part of the A'.vardee's v:or'< plan (see Section 2.3). "The requirement for QA Performance Audits and QA System Audits may be limited to offerers in the competitive range. ------- QAMS-002/80 Revision No. 1 Date: 5-19-80 Page 8 of 17 EPA's "Guidelines and Specifications for Preparing Quality Assurance Project Plans" (QAMS-005/80) will be included as part of the RFP. A QA project plan must address the following: L Title Page, with provision for approval signatures 2. Table of Contents 3. Project Descriptions 4. Project Organization(s) and Responsibilities 5. QA Objectives for Measurement Data, in terms of precision, accu- racy, completeness, representativeness, and comparability 6. Sampling Procedures 7. Sample Custody 8. Calibration Procedures, References, and Frequency 9. Analytical Procedures 10. Data Reduction, Validation, and Reporting 1L Internal QC Checks and Frequency 12. QA Performance Audits, System Audits, and Frequency 13. QA Reports to Management 14. Preventive Maintenance Procedures and Schedule 15. Specific Procedures to be used to routinely assess data precision, representativeness, comparability, accuracy, and completeness of the specific measurement parameters involved. This section will be required for all QA project plans. 16. Corrective Action 2.2.3 QA System Audit. Offerers will be informed in the RFP that they may be required to permit an on-site system audit as a part of preaward evaluation and during the period of contract performance. ------- Date: 5-19-80 Page 9 of 17 2.2.4 OA Performance Audits. The inclusion of performance audits in the RFP and contract will depend on the availability of QC reference materials or devices for the measurements to be made. In the event that no routine QC reference materials or devices are available for the measurements involved, consideration should be given to the use of common samples (or split samples) for cross- comparisons of results from offerers with those of EPA. 2.2.5 Preaward QA Evaluation. Section IV of Form QAR-C is designed to plan for the evaluation of the QA aspects of the offerer's proposal, including the following: 1. QA Program Plan 2. QA Project Plan 3. QA Performance Audits 4. QA System Audits The relative weight of each required QA factor is determined and entered on forms such that the total of the required QA items is 100. In turn, the relative importance of these QA items must be specified in relation to the total of all evaluation factors. The contract proposals will be evaluated for the items indicated in Section IV of Form QAR-C. Further, the QA requirements will be e'valuated in relation to the other factors as indicated in Section IV of QAR-C. The proposal evaluation team will include the QA Officer. 2.3 Contracts (Award) In reviewing the QA requirements for the awarded contract, the PO will, in accordance ------- Revision No. 1 Date: 3-19-80 Page 10 of 17 * with Section 2.1, delineate the needs of the project for various QA activities throughout the duration of the contract. The contractor will be required to extend the QA requirements of the contract to all subcontractors. A complete and detailed ?A project plan will be required to be submitted as a deliverable item. The QA project plan will be approved by the PO and the QA Officer and shall be adhered to. Provisions > will be made in the contract for formal approval of any subsequent revisions of the QA project plan. 2.3.1 Preaward QA Evaluation. Section IV of Form QARC will serve to show > that all preaward QA requirements have been fulfilled and the form will be sent to the Contracting Officer to be placed in the contract file. 2.3.2 QA Reports. Contracts of short duration may require only a final QA fc - report. Contracts of longer duration may require periodic QA reports. The QA reports will be separately identified from other contractually required reports and should contain such information as: * " 1. Changes to QA program plan 2. Status of completion of QA project plan 3. Measures of data quality from the project * 4. Significant quality problems, quality accomplishments, and status of corrective actions 5. Results of QA performance audits P 6. Results of QA system audits 7. Assessment of data quality in terms of precision, accuracy, completeness, representativeness, and comparability 8. Quality-related training ------- Date: 5-19-80 Page 11 of 17 2.3.3 Level of Effort Type Contracts. For work assignment (or technical directives) types of contracts, a basic QA project plan will initially be prepared by the contractor to cover, in general, the major types of tasks anticipated which involve environmental measurements. This basic QA project plan will be approved by the PO and QA Officer. For each work assignment, that portion of the basic QA project plan which is applicable will be identified and amended or revised, as necessary, and will be approved before measurements are initiated. As a very minimum, the procedures to be used to assess data precision, accuracy, and completeness must be specified. 3. QUALITY ASSURANCE REVIEW (INTERAGENCY AGREEMENTS) Form QAR-IA is to be used by the PO and the QA Officer in planning the QA requirements for interagency agreements. Although Interagency Agreements do not involve RFPs, the QA requirements are similar to those for awarded contracts. Therefore, the discussions and considerations included under Section 2, Contracts (Award), apply to interagency agreements. 4. BIBLIOGRAPHY The following EPA documents or regulations provide guidance on establishing QA programs for environmental measurement projects for various media or pollutants. There are many other reference works also available. 4J General 1. Strategy for the Implementation of the EPA's Mandatory Quality Assurance Program, QAMS-001/80 ------- Date: 5-19-80 Page 12 of 17 4.2 Air 1. EPA-600/9-76-005' 2. EPA-600/4-77-027a 3. EPA-600/4-77-027b 4. EPA-600/4-76-044 5. Regulation 4.3 Water 1. EPA-660/4-019 2. EPA-600/4-78-017 3. EPA-600/4-75-008 NTIS-PB-253258/AS 4. EPA-600/8-78-008 5. EPA-600/8-78-017 6. EPA-600/4-79-020 7. EPA-600/2-79-046 8. Regulation 9. Regulation 10. Regulation Quality Assurance Handbook for Air Pollution-Measurement Systems. Volume I, Principles O.]arc*, 1976) Quality Assurance Handbook for Air Pollution Measurement Systems. Volume n, Ambient Air Specific Methods (May, 1977) Quality Assurance Handbook for Air Pollution Measurment Systems. Volume in, Stationary Source Specific Methods (August, 1977) The EPA Program for the Standardization of Stationary Source Emission Test Methodology—A Review (August, 1976) Federal Register, May 10, 1979, Appendices A <5c B Handbook for Analytical Quality Control in Water and Wastewater Laboratories (March, 1979) Procedures for the Evaluation of Environmental Monitoring Laboratories (March, 1978) Interim Radiochemistry Methodology for Drinking Water (March, 1976) Manual for the Interim Certification of Laboratories Involved in Analyzing Public Drinking Water Supplies, Criteria, and Procedures (August, 1978) Microbiological Methods for Monitoring the Environment (December, 1978) Methods for Chemical Analysis -of Water and Wastes (March, 1979) Quality Assurance Guidelines for IERL-CI Project Officers (December, 1979) Federal Register, December 1, 1976 Federal Register, November 29, 1979 Federal Register, December 18, 1979 ------- 4.4 Radiation 1. EPA-600/4-78-033 • - NTIS-PB-288931/AS 2. EPA-600/4-78-032 NTIS-PB-284850/AS 3. EPA-600/7-77-088 TVA-E-EP-77-4 NTIS-PB-277254/9BE 4.5 Solid Wastes 4.6 Toxic Substances 4.7 Pesticides 1. EPA-600/1-79-008 2. Environmental Toxicology Division, Health Effects Research Laboratory, U.S. EPA, Research Triangle Park, NC 4.8 Health Research L EPA-600/1-79-013 Revision xxlo. 1 Date: 5-19-80 Paje 13 of 17 Radioactivity Standards Distribution Program 1978-1979 (June, 1973) Environmental Radioactivity Laboratory Intercomparison Studies Program 1978-1979 (June, 1978) Handbook for Analytical Quality Control and Radioactivity Analytical Laboratories (August, 1977) Manual of Analytical Quality Control for Pesticides and Related Compounds in Human and Environmental Samples (January, 1979) Analysis of Pesticide Residues in Human and Environmental Samples—A Compilation of Methods Selected for Use in Pesticide Monitoring Programs Guides for Quality Assurance in Environmental Health Research (January, 1979) ------- APPENDIX QUALITY ASSURANCE REVIEW FORMS ------- ATTACHMENT 18 QUALITY ASSURANCE REVIEW FOR'INTERAGENCY AGREEMENTS I. GENERAL INFORMATION 1. Descriptive Title: 2. Sponsoring Program Office: 3. Approximate Dollar Amount: 4. Duration: II. DESCRIPTION OF WORK THIS AGREEMENT REQUIRES ENVIRONMENTAL MEASUREMENTS Yes No III. QUALITY ASSURANCE INTERAGENCY AGREEMENT REQUIREMENTS (Projects requiring environmental measurements) Yes No 1. A written QA plan is required and is to be included in , the interagency agreement or identified by reference in the interagency agreement. X 2. Audit samples or devices are available for the parameters relevant to this project (see list on reverse side). 3. Performance on available audit samples or devices are required: Prior to agreement During project performance (See schedule on reverse side) 4. An on-site evaluation of performing agency's facilities will be made to determine that a QA system is operational and the capability exists for successful completion of this project: Prior to agreement During project performance (see schedule on reverse side) 5. Periodic and final QA reports are required. QAMS Form QAR-IA, Revision No. 1, 1983 (For EPA Internal Use Only) ------- Side 2 of Form QAR-IA QA Performance Audits or Split Sample Comparisons Parameter Measured 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. QC Reference Sample or Device Available (Yes or No) Split Samples for Cross-Comparison (Yes or No) Planned Schedule During Interagency Agreement (Performance (On-site Eval.) Eval.) Planned Dates for QA Systems Audits Preaward During Agreements Planned Audit Team QA Reports Schedule; Progress Reports Final Report Project Officer; QA Officer: Signature Date Signature Date After signatures, a copy of this form must accompany the funding package sent to the Grants Administration Office and a copy placed on file with the QA Officer. QAMS Form QAR-IA (For EPA Internal Use Only) ------- QUALITY ASSURANCE REVIEW'FOR CONTRACTS I. GENERAL" INFORMATION Descriptive Title: Sponsoring Program Office: Approximate Dollar Amount: Duration: II. THIS CONTRACT REQUIRES ENVIRONMENTAL MEASUREMENTS (If yes, complete form; if no, sign form and submit Yes No with procurement request) III. QUALITY ASSURANCE REQUIREMENTS (Project involving environmental measurements) Yes No a. Submission of a written quality assurance (QA) program plan (commitment of the offerer's management to meet the QA requirements of the scope of work) is to be included in the contract proposal. b. Submission of a written QA project plan is to be included in the contract proposal or be a deliverable within a time specified by the Agency. c. Performance on available audit samples or devices shall be required as part of the evaluation criteria (see list on reverse side). d. On-site evaluation of proposer's facilities will be made to ensure that a QA program is operational and exhibits the capability for successful completion of this project (see schedule on reverse side). e. OA reports will be required (see schedule on reverse side). QAMS Form QAR-C, Revision No. 2, 1983 (For EPA Internal Use Only) ------- U.S. En- •••< Agency Reg!-:.- ' C ------- Side 2 of Form QAR-C IV. DETERMINATION (Projects involving environmental measurements) Percentage of technical evaluation points assigned to QA Project Officer estimate of percentage of cost allocated to environmental measurements V. Audit Requirements Parameter Measured QC Reference Sample or Device Available (Yes or No) Split Samples for Cross-Comparison (Yes or No) Required for Preward (Yes or No) FREQUENCY During Contract (Perfor- (On-site mance Eval.) Eval.) during contract: QA System Audits are required: Preward : QA Reports are required: With Progress Reports _ The signatures below verify that the QA requirements have been established. : with Final Report Project Officer; QA Officer: Signature Date Signature Date After signatures, a copy of this form must be sent to the Contracts Office and a copy placed on file with the QA Officer. QAMS Form QAR-C (For EPA Internal Use Only) ------- |