Quality Assurance Project Plan for the 

Federal Lead (Pb) Performance Evaluation 

Program

U.S. Environmental Protection Agency

Office of Air Quality Planning and Standards

Research Triangle Park, NC
EPA-457/B-14-001a

September 2014

Quality Assurance Project Plan for the 

Federal Lead (Pb) Performance Evaluation Program

By:

Gregory W. Noah

U.S. Environmental Protection Agency

Research Triangle Park, North Carolina

U.S. Environmental Protection Agency

Office of Air Quality Planning and Standards

Air Quality Assessment Division

Ambient Air Monitoring Group

Research Triangle Park, North Carolina
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Foreword

U.S. Environmental Protection Agency (EPA) policy requires that all projects involving the 

generation, acquisition, and use of environmental data be planned and documented and have an 

Agency-approved Quality Assurance Project Plan (QAPP) before the start of data collection. The 

primary purpose of the QAPP is to provide a project overview, describe the need for the 

measurements, and define quality assurance/quality control (QA/QC) activities to be applied to 

the project, all within a single document. 

This document represents the QAPP for the environmental data operations involved in EPA’s 

Lead (Pb) Monitoring Network Performance Evaluation Program. This QAPP was generated 

using the following EPA monitoring and QA regulations and guidance:

 40 Code of Federal Regulations (CFR) Part 50 Appendix G

 40 CFR Part 58 Appendices A and C

 EPA QA/R-5, EPA Requirements for Quality Assurance Project Plans

 EPA QA/G-5, Guidance for Quality Assurance Project Plans.

All pertinent elements of the QAPP regulations and guidance are addressed in this QAPP.

This document has been reviewed by EPA Regional Work Assignment Managers responsible for 

implementing the performance evaluation program (PEP) in their respective regions and is 

considered acceptable (see the following approval page).

Mention of corporation names, trade names, or commercial products does not constitute 

endorsement or recommendation for use.
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Acknowledgments

This QAPP is the product of the combined efforts of the EPA’s Office of Air Quality Planning 

and Standards (OAQPS); and EPA Regional Offices. The review of the material in this 

document was accomplished through the activities of the Pb QA Workgroup. The following 

individuals are acknowledged for their contributions.

EPA Regions

Region 

1 Mary Jane Cuzzupe

2 Mark Winter

3 Loretta Hyden and Kia Hence

4 Richard Guillot, Mike Crowe

5 Basim Dihu, Scott Hamilton, Anthony Ross, Bilal Qazzaz

6 John Lay

7 Thien Bui and James Regehr

8 Joshua Rickard

9 Mathew Plate, Richard Bauer, Gwen Yoshimura

10 Christopher Hall

RTI International (RTI)

Jennifer Lloyd, Jeff Nichol, Ed Rickman, Cynthia Salmons, Emaly Simone

Battelle Memorial Institute

Thomas Kelly, Elizabeth Hanft

Office of Air Quality Planning and Standards

Dennis Crumpler, Greg Noah
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Acronyms and Abbreviations

AAMG Ambient Air Monitoring Group

ACS American Chemical Society

ADQ audit of data quality

AFC Agency File Code

AMTIC Ambient Monitoring Technology Information Center

ANOVA analysis of variance

ANSI American National Standards Institute

APTI Air Pollution Training Institute

AQAD Air Quality Assessment Division 

AQS Air Quality System

ASTM American Society for Testing and Materials

AWMA Air and Waste Management Association

CAA Clean Air Act

CAS Chemical Abstracts Service

CB calibration blank

CCV Continuing Calibration Verification

CFR Code of Federal Regulations

CMD Contracts Management Division

CO Contracting Officer

COC chain of custody

CV coefficient of variation

DOCOR Delivery Order Contracting Officer Representative

DOPO Delivery Order Project Manager

DQA data quality assessment

DQO data quality objective

EDD electronic data deliverable

EDO environmental data operation

ESAT Environmental Services Assistance Team

EPA Environmental Protection Agency

FB field blank

FCS failed collocated sample 

FDS field data sheet

FEM Federal equivalent method

FRM Federal reference method

FS field scientist

GLP good laboratory practice

ICP-MS inductively coupled plasma mass spectrometry 

ICV initial calibration verification

ID identification

LA laboratory analyst
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Acronyms and Abbreviations (continued)

LCS laboratory control standard

LIMS laboratory information management system

MB method blank

MD matrix duplicate

MDL minimum detection limit

MQO measurement quality objective

MS matrix spike

MSR management system review

NAAQS National Ambient Air Quality Standards

NCore National core monitoring network

NERL National Exposure Research Laboratory

NIST National Institute of Standards and Technology

NRMRL National Risk Management Research Laboratory

OAQPS Office of Air Quality Planning and Standards

OAR Office of Air and Radiation 

ORD Office of Research and Development

OSRTI Office of Superfund Remediation and Technology Innovation

P&A precision and accuracy 

PAMS Photochemical Assessment Monitoring Station

Pb lead

PE performance evaluation

PEP performance evaluation program

PM2.5 particulate matter < 2.5 microns aerodynamic diameter

PM10 particulate matter < 10 microns aerodynamic diameter

PM10-2.5 coarse particulate matter (aerodynamic diameter >2.5 and <10 microns)

POC parameter occurrence code

PQAO primary quality assurance organization

PTFE polytetrafluoroethylene

Qa sampler flow rate at ambient (actual) conditions of temperature and pressure.

Qs sampler flow rate adjusted to standard conditions (1atm and 25o C)

QA/QC quality assurance/quality control

QA quality assurance

QAM Quality Assurance Manager

QAPP Quality Assurance Project Plan

QL quantitation limit 

QLS Quantitation Limit Standard

RPD relative percent difference

RPO Regional Project Officer

RTP Research Triangle Park

SCV Source Calibration Verification

SIP State Implementation Plan

SLAMS state and local monitoring stations
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Acronyms and Abbreviations (continued)

SLT state/local/tribal

SOP standard operating procedure

SOW scope of work

SPMS special purpose monitoring stations

STAG State and Tribal Assistance Grant 

Ta temperature, ambient or actual 

TB trip blank

TOCOR Task Order Contracting Officer Representative

TOPO Task Order Project Officer

TSA technical system audit

TSP total suspended particulate

Va air volume, at ambient or actual conditions

WACOR Work Assignment Contracting Officer Representative

WAM Work Assignment Manager

XRF x-ray fluorescence
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1.0 QA Project Plan Identification and Approval

Title: Quality Assurance Project Plan- Federal Lead (Pb) Performance Evaluation Program

QAPP Category - 1

The attached Quality Assurance Project Plan (QAPP) for the Federal Pb Performance Evaluation 

Program (PEP) is hereby recommended for approval and commits the participants of the 

program to follow the elements described within.
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2.0 Table of Contents

Element No. – Page

Foreword......................................................................................................................................... ii

Acknowledgments..........................................................................................................................iii

Acronyms and Abbreviations ........................................................................................................ iv

1.0 QA Project Plan Identification and Approval.......................................................................... 7

2.0 Table of Contents..................................................................................................................... 9

3.0 Distribution ............................................................................................................................ 14

4.0 Project/Task Organization ..................................................................................................... 16

4.1 The PEP Workgroup................................................................................................... 16

4.2 EPA Office of Air Quality Planning and Standards ................................................... 16

4.3 ESAT Organization..................................................................................................... 17

4.4 EPA Regional Offices................................................................................................. 19

4.5 ESAT Contractors....................................................................................................... 20

4.6 State, Local, and Tribal Agencies............................................................................... 21

4.7 Other Affected Entities............................................................................................... 24

5.0 Problem Definition/Background............................................................................................ 26

5.1 Problem Statement and Background........................................................................... 26

6.0 Project/Task Description........................................................................................................ 31

6.1 Description of Work to be Performed......................................................................... 31

6.2 Field Activities............................................................................................................ 33

6.3 Laboratory Activities.................................................................................................. 39

6.4 Schedule of Activities................................................................................................. 41

6.5 Project Assessment Techniques.................................................................................. 49

6.6 Project Records........................................................................................................... 49

7.0 Data Quality Objectives and Criteria for Measurement ........................................................ 51

7.1 Data Quality Objectives.............................................................................................. 51

7.2 Pb-PEP Measurement Quality Objectives.................................................................. 53

8.0 Special Training Requirements/Certification ........................................................................ 57

8.1 OAQPS Training Facilities......................................................................................... 57

8.2 Training Program........................................................................................................ 58

8.3 Field Training.............................................................................................................. 58

8.4 Laboratory Training.................................................................................................... 59

8.5 Certification ................................................................................................................ 59

8.6 Additional Pb-PEP Field and Laboratory Training .................................................... 60

8.7 Additional Ambient Air Monitoring Training ............................................................ 60

9.0 Documentation and Records................................................................................................... 62
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9.1 Information Included in the Reporting Package ......................................................... 62

9.2 Reports to Management .............................................................................................. 67

9.3 Data Reporting Package Archiving and Retrieval...................................................... 68

10.0 Sampling Design................................................................................................................... 69

10.1 Scheduled Project Activities, Including Measurement Activities .............................. 69

10.2 Rationale for the Design ............................................................................................. 69

10.3 Design Assumptions ................................................................................................... 69

10.4 Procedure for Locating and Selecting Environmental Samples ................................. 70

10.5 Classification of Measurements as Critical/Noncritical ............................................. 71

10.6 Validation of Any Non-Standard Measurements........................................................ 72

11.0 Sampling Methods Requirements......................................................................................... 73

11.1 Sample Collection and Preparation............................................................................. 73

11.2 Support Facilities for Sampling Methods................................................................... 74

11.3 Sampling/Measurement System Corrective Action Process....................................... 75

11.4 Sampling Equipment, Preservation, and Holding Time Requirements...................... 79

12.0 Sample Handling and Custody............................................................................................. 81

13.0 Analytical Methods Requirements...................................................................................... 82

13.1 Inductively Coupled Plasma Mass Spectrometry Analysis ........................................ 82

13.2 X-Ray Fluorescence Analysis..................................................................................... 83

13.3 Internal QC and Corrective Action for Measurement System.................................... 84

13.4 Filter Sample Contamination Prevention.................................................................... 85

14.0 Quality Control Requirements............................................................................................. 86

14.1 QC Procedures............................................................................................................ 86

14.2 Sample Batching—QC Sample Distribution .............................................................. 95

15.0 Instrument/Equipment Testing, Inspection, and Maintenance Requirements.................... 97

15.1 Testing......................................................................................................................... 97

15.2 Inspection.................................................................................................................... 98

15.3 Maintenance................................................................................................................ 99

16.0 Instrument Calibration and Frequency............................................................................... 102

16.1 Instrumentation Requiring Calibration ..................................................................... 102

16.2 Calibration Method That Will Be Used for Each Instrument................................... 104

16.3 Calibration Standard Materials and Apparatus......................................................... 104

16.4 Calibration Frequency............................................................................................... 105

16.5 Standards Recertifications ........................................................................................ 106

17.0 Inspection/Acceptance for Supplies and Consumables ..................................................... 107

17.1 Purpose...................................................................................................................... 107

17.2 Critical Supplies and Consumables .......................................................................... 107

17.3 Acceptance Criteria................................................................................................... 111

17.4 Tracking and Quality Verification of Supplies and Consumables............................ 112

18.0 Data Acquisition Requirements......................................................................................... 115

18.1 Acquisition of Non-Direct Measurement Data ......................................................... 115
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19.0 Data Management .............................................................................................................. 117

19.1 Background and Overview ....................................................................................... 117

19.2 Information Management Flow ................................................................................ 118

19.3 Data Recording ......................................................................................................... 120

19.4 Performance Evaluation Data Transfer and Archiving............................................. 121

19.5 Data Validation ......................................................................................................... 121

19.6 Data Transformation ................................................................................................. 123

19.7 Data Transmittal........................................................................................................ 124

19.8 Data Reduction and Data Integrity ........................................................................... 126

19.9 Data Analysis............................................................................................................ 126

19.10 Data Flagging -Sample Qualifiers ............................................................................ 127

19.11 Data Tracking............................................................................................................ 128

19.12 Data Storage and Retrieval ....................................................................................... 128

19.13 Information Management Security ........................................................................... 129

20.0 Assessments and Response Actions................................................................................... 130

20.1 Assessment Activities and Project Planning............................................................. 130

20.2 Documentation of Assessments................................................................................ 137

21.0 Reports to Management ..................................................................................................... 138

21.1 Communication......................................................................................................... 138

21.2 Reports...................................................................................................................... 141

22.0 Data Review, Validation, and Verification Requirements................................................. 147

22.1 Sampling Design....................................................................................................... 147

22.2 Sample Collection Procedures.................................................................................. 148

22.3 Sample Handling....................................................................................................... 148

22.4 Analytical Procedures............................................................................................... 149

22.5 Quality Control ......................................................................................................... 150

22.6 Calibration................................................................................................................. 150

22.7 Data Reduction and Processing ................................................................................ 151

23.0 Validation and Verification Methods.................................................................................. 152

23.1 Process for Validating and Verifying Data............................................................... 152

24.0 Reconciliation with Data Quality Objectives .................................................................... 156

24.1 Preliminary Review of Available Data ..................................................................... 156

24.2 Evaluation of Data Collected While All Pb-PEP Samplers Collocated—Regional 

Level ......................................................................................................................... 156

24.3 Evaluation of Data Collected While All Pb-PEP Samplers Collocated—National 

Level ......................................................................................................................... 157

APPENDICES

1. Glossary

2. Training Certification Evaluation Forms

3. Data Qualifiers/Flags
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Tables

Element No. – Page

Table 6-1. Design/Performance Specifications............................................................................. 35

Table 6-2. Field Measurement Requirements............................................................................... 38

Table 6-3. Laboratory Performance Specifications...................................................................... 40

Table 6-4. Implementation Summary ........................................................................................... 46

Table 6-5. Data Reporting Schedule for AQS .............................................................................. 47

Table 6-6. Assessment Schedule................................................................................................... 49

Table 6-7. Critical Documents and Records................................................................................. 50

Table 7-1. Pb Performance Evaluation Program Field Measurement Quality Objectives ........... 54

Table 7-2. ICP-MS Laboratory Measurement Quality Objectives............................................... 55

Table 7-3. XRF Laboratory Measurement Quality Objectives..................................................... 56

Table 9-1. Pb-PEP Reporting Package Information ..................................................................... 63

Table 11-1. Field Corrective Action ............................................................................................. 77

Table 13-1. Filter Preparation and Analysis Checks .................................................................... 85

Table 14-1 QC Sample Distribution ............................................................................................. 96

Table 15-1. Inspections in the Laboratory .................................................................................... 98

Table 15-2. Inspection of Field Items........................................................................................... 99

Table 15-3. Maintenance for ICP-MS Pb-PEP Laboratories...................................................... 100

Table 15-4. Maintenance for XRF Pb-PEP Laboratories ........................................................... 100

Table 15-5. Preventive Maintenance of Field Items................................................................... 101

Table 16-1. Calibration Standards and/or Apparatus for Pb Calibration.................................... 105

Table 17-1. Laboratory Equipment............................................................................................ 108

Table 17-2. Field Equipment and Supplies................................................................................. 110

Table 19-1. PEP Data Management Structure ............................................................................ 117

Table 19-2. List of Pb-PEP Data Processing Operations for Critical Values............................. 121

Table 19-3 Data Transfer and Archiving .................................................................................... 121

Table 19-4. Validation Check Summaries.................................................................................. 123

Table 19-5. Raw Data Calculations............................................................................................ 124

Table 19-6. Data Transfer Operations ........................................................................................ 125

Table 19-7. Data Reporting Schedule......................................................................................... 125

Table 19-8. Report Equations..................................................................................................... 127

Table 19-9. Data Archive Policies.............................................................................................. 128

Table 20-1. Assessment Summary.............................................................................................. 137

Table 21-1. Communications Summary ..................................................................................... 139

Table 21-2. Control Charting Recommendations....................................................................... 145

Table 21-3. Report Summary...................................................................................................... 146

Table 23-1. AIRQA Critical Criteria Validation Template ........................................................ 154

Table 23-2. AIRQA Operational Evaluation Criteria Template................................................. 155
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Figures

Element No. – Page

Figure 4-1. Definition of an Independent Assessment.................................................................. 22

Figure 6-1. The Lead (Pb) PEP Overview.................................................................................... 32

Figure 11-1. Illustration of ESAT Workgroup Quality Bulletin................................................... 76

Figure 17-1 Field/Laboratory Inventory Form (INV-01) .......................................................... 113

Figure 17-2 Field/Laboratory Procurement Log Form (PRO-01) ............................................. 113

Figure 17-3. Field/Laboratory Equipment/Consumable Receiving Report Form (REC-01) ..... 114

Figure 19-1. Pb-PEP Information/Sample Flow........................................................................ 118

Figure 20-1. Audit Activities...................................................................................................... 131

Figure 20-2. Assessment Finding Form...................................................................................... 133

Figure 20-3. Assessment Fin ding Response Form .................................................................... 135

Figure 21-1. Lines of communication......................................................................................... 138
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3.0 Distribution

A copy of this QAPP will be distributed to the Regional Work Assignment Managers (WAMs), 

Task Order Project Officers (TOPOs), or Delivery Order Project Managers (DOPOs). Since there 

is personnel turnover, the list of WAM/TOPOs/DOPOs that will receive a copy of this document, 

as well as the document itself, will be posted on the Pb-PEP site on EPA’s Ambient Monitoring 

Technical Information Center (AMTIC)

1

. The AMTIC site will be updated annually. The 

WAM/TOPOs/DOPOs will be responsible for distributing the QAPP to each Environmental 

Services Assistance Team (ESAT) contractor participating in the environmental data operations 

of the PEP. The Regional WAMs/TOPOs/DOPOs should also provide a copy of this QAPP to 

their Regional Quality Assurance Managers (QAMs). Any monitoring organization selfimplementing the Pb-PEP will have access to this document on AMTIC. 

 

1 http://www.epa.gov/ttn/amtic/pbpep.html
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4.0 Project/Task Organization

This element will provide the EPA and other involved parties with a clear understanding of the 

role that each party plays in the Pb-PEP and will provide the lines of authority and reporting for 

the project.

The degree of complexity and the number of agencies involved with the Pb monitoring program 

and the subsequent Pb-PEP requires that the flow of information and associated communications 

be structured to optimize the collective resources. The only realistic perspective on implementing 

this program is one that recognizes that deployment and operation of this network is a shared 

responsibility among all the involved organizations. The purpose of the following role 

descriptions is to facilitate communications and to outline basic responsibilities. 

4.1 The PEP Workgroup

The PEP Workgroup consists of the EPA Regional Work Assignment Contracting Officer 

Representatives (WACORs), Task Order Contracting Officer Representatives (TOCORs), 

Delivery Order Contracting Officer Representatives (DOCORs), for the ESAT contract, and 

state/local/tribal (SLT) agencies that have opted to run at least the field operations component of 

the PEP in their jurisdictions. The PEP ESAT field and laboratory personnel are invited to 

participate in the conference calls. The PEP Workgroup, which is chaired by the Office of Air 

Quality Planning and Standards (OAQPS) National PEP Project Leader, meets at least twice per 

year and more often if needed. The PEP Workgroup serves in an advisory role and assists in the 

review and revision of PEP guidance documents, such as the PEP field and laboratory standard 

operating procedures (SOPs) and the PEP QAPP. Revisions to these documents, which may have 

national implications or issues that are national in scope, are reviewed by the National Ambient 

Monitoring QA Strategy Workgroup.

4.2 EPA Office of Air Quality Planning and Standards 

OAQPS has the overall responsibility for ensuring the quality of the nation’s ambient air 

monitoring data. OAQPS has developed specific regulations for the development of a quality 

system as found in 40 CFR Part 58, Appendix A. OAQPS has the following responsibilities to 

ensure the development of this Pb-PEP Program:

 Provide a contractual vehicle for the manufacturing and distribution of the Pb-PEP portable 

evaluation sampler.

 Develop and or continue the memorandum of understanding with the ESAT Office.

 Work with the EPA Regions to determine which monitoring organizations will utilize the 

federally implemented Pb-PEP and to determine how many Pb-PEP audits are required per 

PQAO.
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 Receive and allocate the appropriate State and Tribal Assistance Grant (STAG) funds to 

implement the federal Pb-PEP program.

 Transfer the necessary funds to the EPA Regional ESAT Contracts Management Division 

(CMD) to support the Pb-PEP and to the Region 9 office for laboratory equipment and 

consumables.

 Distribute filters to the regional field offices or Pb-PEP laboratories.

 Develop and update the Pb-PEP Implementation Plan, the Pb-PEP QAPP, the ESAT Scope 

of Work (SOW), and field SOPs. 

 Develop the field and laboratory personnel requirements.

 Develop the field and laboratory training activities, participate in training, and provide 

technical, support, and guidance to regional Pb-PEP contacts.

 Develop a list of primary quality assurance organizations (PQAOs) which are monitoring Pb 

at state and local air monitoring stations (SLAMS) and special purpose monitoring (SPM)

sites.

 Develop field and laboratory information management systems.

 Upload audit data to the air quality system (AQS) database.

 Assess the Pb-PEP concentration information and completeness data entered into AQS.

 Initiate and implement a communications network and act as a liaison to groups working on 

the Pb-PEP.

 Interact with the monitoring organizations concerning the setup, operation, and data results of 

the performance evaluations.

 Ensure the success of the program by performing various oversight activities such as 

management system reviews and/or technical systems audits (TSAs).

Most budgetary and technical planning activities are coordinated through OAQPS. The Ambient 

Air Monitoring Group (AAMG) within the Air Quality Assessment Division (AQAD) is 

ultimately responsible for this QAPP, most technical components (with support from the EPA 

Regional Offices and monitoring organizations), and the resource estimates underlying program 

implementation. Various forms of resource guidance necessary for the STAG distribution are 

coordinated through OAQPS. In addition, the OAQPS National Air Data Group is responsible 

for the AQS data management system. 

4.3 ESAT Organization

The ESAT contract is administered by the Office of Superfund Remediation and Technology 

Innovation (OSRTI) Technology Innovation and Field Services Division Analytical Services 

Branch. OAQPS has entered into a memorandum of understanding with this office in order for 

the ESAT contract to provide the services necessary for the Pb-PEP. The ESAT contractor is 

managed by contracting officers (COs) at the Headquarters office in Washington, D.C. and with 

WACORs/TOCORs/DOCORs, and Regional Project Officers (RPOs) within each Region. RPOs 

are necessary because each Region awards an ESAT contract to assist in the implementation and 
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execution of the program. The AMTIC Web site2 provides the current ESAT contacts list. Since 

the list may change, contact names will not be included in this document, but will be posted on 

AMTIC and updated on an annual basis.

Some important aspects of the ESAT contract include:

 Only the WACOR/TOCOR/DOCOR, RPO, and COs are authorized to give instructions or 

clarification (technical direction) to the ESAT contractor on the work to be performed. This 

technical direction is provided in writing.

 The work assignments will be prepared by the TOCOR/DOCOR and are effective only upon 

approval by the CO.

The EPA Contracts Manual describes the roles and responsibilities of COs, specialists, and 

project officers; these need not be explained here. The important roles and responsibilities for the 

Pb-PEP are described below.

Contracting Officers

 Work with OAQPS to secure, obligate, commit, and distribute funds for work performed 

under the ESAT contract (or other contract vehicle as appropriate).

 Ensure work assignment activities fall within ESAT’s SOW.

 Approve work assignments, task orders, and delivery orders.

Contracting Specialists

 Work with OAQPS or Regional ESAT WACOR/TOCOR/DOCORs to modify contracts or 

track the use of funds for work performed under the ESAT contract (or other contract vehicle 

as appropriate).

Headquarters Project Officers

 Serve as regional liaison between the RPO and the CO.

 Provide contract-wide administration.

 Develop a memorandum of understanding with OSRTI.

Regional Project Officers

 Provide overall management and oversee performance of respective regional ESAT 

personnel.

 Review region-specific invoices with input from WACORs, TOCORs, and DOCORs.

 Prepare (with WACOR/TOCOR/DOCOR) Pb-PEP work assignments, task orders, and 

delivery orders.

 Assist in developing ESAT work assignments, task orders, and delivery orders.

 

2 http://www.epa.gov/ttn/amtic/pbpep.html
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 Ensure that there are qualified contractual personnel available to implement the Pb-PEP.

 Provide administrative and logistical support for the ESAT contract.

 Regularly communicate with program participants (OAQPS, Region, etc.).

Work Assignment, Task Order, and Delivery Order Contracting Officer Representatives

In most cases, the WACOR/TOCOR/DOCOR, as a technical resource from the regional air 

monitoring branch/division, will be responsible for assisting in the technical implementation of 

the program. Some of the WACOR/TOCOR/DOCOR’s activities, as they relate to the ESAT 

contract, are the following: 

 Communicate with the National PEP Project Leader about the current status of funding for 

the federally implemented Pb-PEP.

 Prepare (with RPO) Pb-PEP work assignments, task orders, and delivery orders.

 Set up a file system containing all relevant documentation, including notes of conversations 

with the contractor and other items that will provide an audit trail of the contractor’s actions 

under the contract, as well as all technical information related to the Pb-PEP.

 Review the contractor’s work plan and prepare findings on proposed tasks, labor hours, skill 

mix, and materials and quantities.

 Monitor compliance with the work assignments.

 Track dollars and hours, provide technical direction (in accordance with the terms of the 

contract), and review monthly technical and financial reports.

 Verify contractor representations of deliverables received and accepted, and/or progress 

made.

 Communicate contractor performance, budgetary, and administrative/logistical issues to the 

RPO and to the National PEP Project Leader.

 Review validation data and accept or reject Pb-PEP audits.

4.4 EPA Regional Offices 

The EPA Regional Offices are the major communication link with monitoring organizations and 

OAQPS. This role is absolutely necessary for the development of effective policies and 

programs. For the Pb-PEP, the regional offices have the following specific responsibilities:

All Regions:

 Assist in the development of all pertinent Pb-PEP evaluation guidance documents.

 Review and approve the work plans submitted by the ESAT contractors.

 Identify WACORs/TOCORs/DOCORs to oversee the technical aspects of field activities that 

are performed by the ESAT contractors.

 Train and certify ESAT field personnel and/or self-implementing agencies after initial 

training.
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 Provide technical oversight of the field activities by performing annual TSAs of these 

activities.

 Work with monitoring organizations in developing a yearly schedule of site audits and 

provide this schedule to the ESAT contractors.

 Inform monitoring organizations of an upcoming performance evaluation.

 Evaluate the performance evaluation data and inform monitoring organizations of significant 

differences.

 Participate in training activities, including national and regional conferences, EPA satellite 

broadcasts, and other training vehicles.

 Attend conference calls and meetings on performance evaluation activities.

Region 9 (including items listed for all regions):

 Identify WAMs to oversee the technical aspects of laboratory activities related to high 

volume total suspended particulate (TSP) and low volume PM10 Pb analyses that are 

performed by the ESAT contractors.

 Develop and operate the primary laboratory for the Pb analyses with respect to logistical, 

technical, and analytical support, including necessary facilities to store and archive filters and 

extracts.

 Maintain and certify proficiency of ESAT laboratory personnel after initial training.

 Provide technical oversight of the laboratory activities by performing TSAs of these 

activities.

Region 4 (including items listed for all regions):

 Identify WAMs to oversee the technical aspects of laboratory activities related to low volume 

Pb-PM10 PEP filter preparation that are performed by the ESAT contractors. 

 As a secondary role, identify WAMs to oversee the technical aspects of laboratory activities 

related to low volume Pb-PM10 PEP filter preparation that are performed by the state, local, 

and tribal agencies.

 Develop the primary laboratory for the low volume Pb-PM10 filter loading with respect to 

logistical, technical, and analytical support, including necessary facilities to store, distribute, 

and receive filters. The laboratory will also provide for the cleaning of cassettes.

 Train and certify ESAT laboratory personnel after initial training.

 Provide technical oversight of the laboratory activities by performing TSAs of these 

activities.

4.5 ESAT Contractors

The ESAT contractors will perform the specific tasks associated with the Pb-PEP. Their 

responsibilities will include the following:
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 Develop a work plan and cost estimates for each work assignment, task order, or delivery 

order.

 Provide qualified staff to meet the contract requirements.

 Successfully implement the activities described in the work plan and work assignment, task 

order, or delivery order.

 Receive training and certification(s) to perform field and laboratory Pb-PEP activities, as 

appropriate.

 Understand government regulations as they relate to contracts and inherent government 

functions.

4.6 State, Local, and Tribal Agencies

EPA could not effectively plan and execute this program without SLT organization participation. 

The SLT agencies bear the heaviest responsibility for developing and implementing the national 

Pb Monitoring Program, as well as for optimizing the data quality. Conversely, the Pb-PEP 

provides an invaluable quality assurance/quality control (QA/QC) function on the overall 

performance of the network and often identifies potentially serious sampler performance 

problems, site problems, or laboratory issues. It is imperative that SLT organizations work with 

the EPA regional offices to make every Pb-PEP audit event successful. They should identify 

problems that will impede the mission of the Pb-PEP as early as possible and help find solutions. 

The SLT organizations have the following specific responsibilities:

General monitoring site accommodations:

 Ensure that there is sufficient space for collocating an audit monitor and low volume PbPM10 monitor or high volume Pb-TSP monitor, while still meeting siting requirements listed 

in 40 CFR Part 58, Appendix E and the Pb-PEP SOP.

 Ensure that each site is safely accessible for a Pb-PEP audit.

 Ensure that each site meets the applicable state or federal Occupational Safety and Health 

Administration safety requirements (includes providing secured ladders and appropriate 

safety rails and/or cages).

 Ensure that adequate power is available for the Pb-PEP samplers.

 If the above siting criteria cannot be met, the EPA Regional PEP leader must be consulted 

before continuing with the Pb-PEP audit.

 SLT monitoring programs are required to supply to the PEP analytical support laboratory 

either four or six samples annually from their collocated monitor at the collocated Pb 

monitoring sites.

If an SLT chooses to implement the Pb-PEP:

 Implement a comparable or equivalent Pb-PEP at the frequency prescribed by the federal 

regulations in 40 CFR Part 58, Appendix A.
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 Adhere to the definition of independent assessment (see Figure 4-1).

 Participate in consistent Pb-PEP specific training and certification activities.

 Procure necessary equipment and consumables.

Independent assessment—An assessment that is performed by a qualified individual, group, 

or organization that is not part of the organization that is directly performing and accountable 

for the work being assessed. This auditing organization must not be involved with generating 

the routine ambient air monitoring data. An independent organization could be another unit of 

the same agency, which is sufficiently separated in terms of organizational reporting and can 

provide for independent filter weighing and performance evaluation (PE) auditing.

An organization can conduct the PEP if it can meet the above definition and has a 

management structure that, at a minimum, will allow for the separation of its routine sampling 

personnel from its auditing personnel by two levels of management. In addition, the audit 

filters must be analyzed by separate laboratory facility using separate laboratory equipment. 

Field and laboratory personnel would be required to meet the PEP field and laboratory training 

and certification requirements. The SLT organizations are also asked to consider participating 

in the centralized field and laboratory standards certification process.

Organization

3rd Level 

Supervision

Organization

2nd Level 

Supervision

Organization 

1st Level 

Supervision

Organization

Personnel

QA Lab Analysis

Organization

1st Level 

Supervision

Organization

Personnel

QA Field Sampling

Organization

2nd Level 

Supervision

Organization

1st Level 

Supervision

Organization 

Personnel

Routine Lab Analysis

Organization

1st Level 

Supervision

Organization

Personnel 

Routine Field Sampling

Organizations that are planning to implement the PEP must submit a plan that demonstrates 

independence to the EPA regional office that is responsible for overseeing QA-related 

activities for the Ambient Air Quality Monitoring Network.

Figure 4-1. Definition of an Independent Assessment
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 Develop the necessary SOPs and QA procedures into their respective QAPPs.

 Participate in annual collocation precision studies of the SLT and federally deployed Pb-PEP 

samplers.

 If necessary, transmit data to the AQS according to the schedule outlined in the monitoring 

QA regulations and procedures provided by EPA. (If an SLT chooses the federal Pb-PEP, or 

chooses to use the PEP analytical support laboratory, the data are transmitted automatically.)

 Select the sites for evaluation.

 If using a third-party laboratory, require that laboratory to participate in an annual roundrobin PE if available. This is not required if the SLT uses EPA’s Pb-PEP laboratory for its 

filter analyses.

 Prepare a laboratory annual report in an EPA-specified format and submits it to EPA. This is 

not required if the SLT uses EPA’s Pb-PEP laboratory for its filter analyses.

 Submit to an annual TSA of their Pb-PEP activities by the EPA Regional PEP Leader or 

QAM.

If using the federal PEP:

 Operates the routine Pb federal reference method (FRM)/FEM monitoring network according 

to the established regulations and guidelines, including proper siting, operations, and QA 

procedures.

 Creates an accurate list of SLAMS, SPMS or tribal sites with addresses, AQS identifications 

(IDs), makes and models of routine sampling equipment, and sampling schedules.

 Assists, through PEP Workgroup activities, in the development of pertinent PEP guidance 

documents.

 On a yearly basis, determines whether to continue using the federal implementation of the 

PEP.

 Identifies the sites within the routine Pb FRM/FEM monitoring network for PEs and the 

associated sampling schedules.

 Ensures that an Agency representative is aware of when the PEP Field Scientist (FS) arrives 

and performs the evaluation. The evaluation includes communicating with the operator, 

operating the routine monitor in the normal operating mode (including posting site results to 

the AQS), and generally supporting the PEP.

 Conducts follow-up of the audit to ensure a valid routine concentration (for a routine PEP 

pair) is collected for comparison. If a valid pair has not been collected, a “make-up audit” is 

strongly encouraged).

 Ensures the program’s success by performing various internal oversight activities of the SLT 

monitoring networks, such as TSAs of field and laboratory activities.

 Participates in training activities, including multi-state conferences, EPA satellite broadcasts, 

and other training vehicles.

 Reviews routine and PE data and works with the EPA Region on corrective actions.
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4.7 Other Affected Entities

EPA Office of Research and Development (ORD)

The ORD’s primary role in the implementation of the Pb-PEP will be as a technical consultant, 

advisor, and arbiter of technical issues. This action will be primarily through the National 

Environmental Research Laboratory, which provides many of the applied research elements for 

the program. ORD also has the overall responsibility for designating all air monitors as an FRM 

or FEM. The FRM/FEM portable PM10 low volume audit samplers must be designated by ORD 

through its Federal Reference and Equivalency Program (40 CFR Part 53). The high volume 

TSP samplers are not given FRM/FEM designation. The method is described in 40 CFR 

Part 50, B as a specification that high volume TSP samplers must follow. The overall 

responsibilities of ORD include the following:

 Designate PM10 low volume Pb samplers as FRM/FEM and provide technical support.

 Provide technical support for the national monitor procurement contracts.

 Arbitrate Pb-PEP technical issues.

 Provide guidance for field and analytical activities.

In addition, the ORD National Risk Management Research Laboratory (NRMRL) Metrology 

Laboratory will provide annual verification of the flow/pressure/temperature standards used for 

the Pb-PEP.

EPA Contracts Management Division Responsibilities

The CMD, within the Office of Acquisition Management, is responsible for issuing contracts and 

various national procurements. These contracts are developed in concert with OAQPS AQAD 

technical staff. The CMD is responsible for all communications with vendors and extramural 

contract organizations. The CMD’s responsibilities include the following:

 Developing national contracts for the sampler purchases and filter purchases and working 

with ORD and Office of Air and Radiation (OAR) contracts and technical staff to provide 

these products.

 Providing support to COs and contract support staff for national procurements for federal 

implementation of the Pb-PEP, major equipment repairs, and equipment upgrades.
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5.0 Problem Definition/Background

The background information provided in this element will place the problem in historical 

perspective, giving readers of the QAPP a sense of the project’s purpose and position relative to 

the Ambient Air Monitoring Program.

5.1 Problem Statement and Background

In 1970, the Clean Air Act (CAA) was signed into law. Under the CAA, the ambient 

concentrations of six criteria pollutants (particulate matter, sulfur dioxide, carbon monoxide, 

nitrogen dioxide, ozone, and lead) are regulated. The CAA requires monitoring organizations to 

monitor these criteria pollutants through the Ambient Air Quality Surveillance Program as 

defined in 40 CFR Part 58.

On November 12, 2008, EPA substantially strengthened the national ambient air quality 

standards (NAAQS) for Pb (see 73 FR 66934). EPA revised the level of the primary (healthbased) standard from 1.5 micrograms per cubic meter (μg/m3

) to 0.15 μg/m3, measured as TSP, 

and revised the secondary (welfare-based) standard to be identical in all respects to the primary 

standard. In conjunction with strengthening the Pb NAAQS, EPA identified the need for states to 

improve existing Pb monitoring networks by requiring monitors to be placed in areas with 

sources that emit one half ton per year or more of Pb and in urban areas with more than 500,000 

people. Depending on specific circumstances, states may have the option of using monitoring for 

either Pb in TSP (Pb-TSP) or Pb in PM10 (Pb-PM10) using approved FRMs or FEMs to 

demonstrate compliance. 

Due to the promulgation of the lower Pb NAAQS, EPA made some changes in the QA 

requirements in 40 CFR Part 58 Appendix A. The following are the highlights of the changes 

that occurred in 40 CFR Part 58 Appendix A:

 Data Quality Objective (DQO) Goals- Measurement uncertainty for precision will be 20% 

for a 90% confidence limit coefficient of variation and an overall absolute bias upper bound 

goal of 15%. Goals will be assessed on 3 years of data at the PQAO level of aggregation.

 Flow Rates-No changes occurred to flow rate. Flow rate verification will be implemented 

monthly (PM10 low volume) or quarterly (TSP high volume) and flow rate performance 

evaluations will be implemented every 6 months. 

 Collocated Monitoring-No changes occurred to the collocation requirements. Collocation 

will continue to be required at 15% of each method designation within a PQAO at a 1-in-12 

day sampling frequency. EPA added language encouraging monitoring organizations to site 

the first collocated sampler in each network at the highest concentration site. This will allow 

the site to operate over the longest time period. Since it may be the site that affects the 

NAAQS and it is allowable to substitute collocated data for missing data from the primary 

monitor, this siting would be advantageous for improving data completeness at a very 
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important site. Routine/collocated data pairs will be used when Pb concentrations of both 

samples are greater than or equal to 0.02 g/m3. Prior to 2008, this cutoff value was 0.15 

g/m3.

 Pb Strip Audits-The requirement for the analysis of six Pb audit strips per quarter (three

strips at two concentration ranges) has not changed. However, the audit concentration ranges 

have changed. The lower concentration range is 30 to 100% of the NAAQS and the higher 

concentration range is 200 to 300% of the NAAQS. This activity does not affect the Pb-PEP; 

however, the service lab for the PEP will participate in inter-laboratory comparative PEs.

 Pb-Performance Evaluation Program (Pb-PEP)-The implementation of an audit similar to 

the PM2.5 PEP is a new requirement and it provides some assessment of overall bias. An 

additional focus on the laboratory analysis and the local primary sampler operating 

proficiency is included in the new Pb-PEP. The program as a whole will be a mix of one or 

two conventional PEP-like independent audits with additional collocated sampling conducted 

by the state or local agency using an independent analytical laboratory. 

This QAPP focuses on one QA activity, the Pb-PEP, which is associated with Pb monitoring.

The background and rationale for the implementation of the Pb FRM/FEM monitoring network 

can be found on the Office of Air and Radiation web site3. 

With the end use of the air quality samples as a prime consideration, various networks can be 

designed to meet one of the following six basic monitoring objectives:

 Determine the highest concentrations to occur in the area covered by the network

 Determine representative concentrations in areas of high population density

 Determine the impact on ambient pollution levels of significant source or source categories 

 Determine general background concentration levels

 Determine the extent of regional pollutant transport among populated areas and in support of 

secondary standards

 Determine the welfare-related impacts in more rural and remote areas.

The monitoring network consists of four major categories of monitoring stations that measure the 

criteria pollutants. These stations are described below.

The SLAMS and Tribal Monitoring Network4consists of ~4,000 monitoring stations whose 

size and distribution are largely determined by the needs of tribal, state and local air pollution 

control agencies to meet their respective Tribal Implementation Plan and State Implementation 

Plan (SIP) requirements.

 

3 http://www.epa.gov/air/lead/

4 http://www.epa.gov/ttn/amtic/slams.html
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The NCore Network5is a multi-pollutant network that integrates several advanced 

measurement systems for particulate matter, gaseous pollutants, and meteorology. The NCore 

network is a relatively new network of approximately 80 sites that has been operating since 

January 2011.

The Special Purpose Monitoring Stations (SPMS) network provides for special studies needed 

by the monitoring organizations to support their SIPs and other air program activities. The SPMs 

are not permanently established and, thus, can be easily adjusted to accommodate changing 

needs and priorities. The SPMs are used to supplement the fixed monitoring network as 

circumstances require and resources permit. If the data from SPMs are used for SIP purposes, 

they must meet all QA and methodology requirements for SLAMS monitoring.

The Photochemical Assessment Monitoring Station6(PAMS) network is required to measure 

ozone precursors in each ozone non-attainment area that is designated as serious, severe, or 

extreme. The required networks have from two to five sites, depending on the population of the 

area. The current PAMS network has approximately 80 sites.

This QAPP only focuses on the QA activities of the SLAMS, Tribal, NCore, and SPM 

networks and the objectives of these networks, which include any Pb sampler used for 

comparison to the NAAQS.

Throughout this document, the term “decision maker” will be used. This term represents the 

individuals who are the ultimate users of ambient air monitoring data and, therefore, may be 

responsible for activities such as setting and making comparisons to the NAAQS and evaluating 

trends. Because there is more than one objective for these data and more than one decision 

maker, the quality of the data will be based on the highest priority objective, which was 

identified as the determination of attainment of the NAAQS.

Since the data for the monitoring networks can be used for NAAQS comparisons, the quality of 

these data is very important. Therefore, a system has been developed to control and evaluate the 

quality of data in order to make NAAQS determinations within an acceptable level of 

confidence. During the development of the Pb NAAQS, the EPA used the DQO process to 

determine the allowable measurement system imprecision and bias that would not significantly 

affect a decision maker’s ability to compare pollutant concentrations to the NAAQS. The 

precision requirement (20% coefficient of variation [CV]) and bias requirement (+15%) are 

based on total measurement uncertainty, which incorporates errors coming from all phases (e.g., 

field sampling, handling, analysis) of the measurement process. The collocated samples provide 

adequate estimates of precision and bias. The Pb-PEP, if properly implemented, can provide the 

bias estimate.

 

5 http://www.epa.gov/ttn/amtic/ncore/index.html

6 http://www.epa.gov/ttn/amtic/pamsmain.html
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Pb-PEP Description

A PE is defined as a type of audit in which the quantitative data generated in a measurement 

system are obtained independently and compared with routinely obtained data to evaluate the 

proficiency of the analyst or laboratory. In the case of the Pb-PEP, the goal is to evaluate total 

measurement system bias, which includes measurement uncertainties from the field and the 

laboratory activities. The pertinent regulations for this PE are found in 40 CFR Part 58, 

Appendix A, section 3.3.4.4. The number of audits required is based on the number of routine 

sites within a PQAO. The program will require the same number of audit samples as required 

for PM2.5, however the responsibility for collecting the PEP samples may be shared between 

EPA and the SLT monitoring agencies:

PQAOs with < 5 sites require five audits (one EPA or independent audit, four SLT sitecollocated audits)

PQAOs with > 5 sites require eight audits (two EPA or independent audits, six SLT sitecollocated audits) 

The Pb PEP QAPP focuses on one QA activity, the Pb-PEP, which is associated with Pb 

monitoring. The background and rationale for the implementation of the Pb FRM/FEM 

monitoring network can be found on the Office of Air and Radiation Web site7.

The strategy is to collocate a portable Pb air sampling instrument with a routine SLAMS or 

SPMS air monitoring instrument, operate both monitors in the same manner, and then compare 

the results. In addition to this collocation with an independent portable audit sampler, four or six

filter samples (depending on number of total sites within a PQAO) as described above and in 40 

CFR Part 58, Appendix A, Section 3.3.4.3 will be collected by SLTs from sites at which they 

operated their own collocated samplers for precision. EPA expects that these collocated samples 

would be collected and submitted as soon as possible to the EPA’s PEP analytical support 

laboratory.

The implementation of the Pb-PEP is a monitoring organization responsibility. However, similar 

to the PM2.5 PEP program, EPA has developed and implemented a federal Pb-PEP to acquire the 

independent PEP samples. Monitoring organizations have the option to self-implement the 

independent collection of PEP samples or they may utilize the federally implemented program. 

Self-implementation will require monitoring organizations to meet a level of independence and 

adequacy. 40 CFR Part 58 Appendix A and a guidance document by OAQPS at 

http://www.epa.gov/ttn/amtic/files/ambient/pm25/qa/pepadequacy.pdf provides the information 

on adequacy and independence. Since this information may change over the years, the guidance 

document will also be posted on AMTIC and will be reviewed annually and updated as 

necessary. 

 

7 http://www.epa.gov/air/lead/
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EPA will use the ESAT contract that is currently in place in each Region to provide the 

necessary field and laboratory activities for the federally implemented program. Each EPA 

Regional Office will implement the field component of this activity. The EPA Region 9 

Laboratory located in Richmond, CA, will be responsible for the lab analysis of high volume 

filters. An independent laboratory capable of performing X-ray fluorescence (XRF) analysis of 

the low volume PM10 Pb filters will be selected by OAQPS. In addition, the EPA NRMRL 

Metrology Laboratory will function as a field standards verification facility. The EPA Region 4 

laboratory will provide back-up capabilities for the high volume filter analysis if the Region 9 

laboratory requires assistance. OAQPS’s technical support contractor will provide data 

management support including development and maintenance of web-enabled data entry forms, 

web reporting utilities, and posting final results to AQS. Note that some Agencies can assume

the full responsibility of conducting the independent audits in their jurisdiction if they can meet 

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6.0 Project/Task Description

The purpose of this element is to provide the participants with a background understanding of the 

project and the types of activities to be conducted, including the measurements that will be taken 

and the associated QA/QC goals, procedures, and timetables for collecting the measurements.

6.1 Description of Work to be Performed

In general, the measurement goal of the Pb-PEP is to estimate the bias of routine Pb FRM/FEM 

national network, aggregated at various levels. These levels of aggregation are: local, tribal and 

state; PQAO; regional; and national levels. This is accomplished by: collocating a Pb-PEP 

sampler with a routine state, local or tribal Pb sampler; collecting a 24-hour sample; and 

comparing the two concentrations in units of micrograms per cubic meter (g/m3) measured at 

local conditions. The applicable regulations for this activity can be found in 40 CFR Part 58, 

Appendix A, Section 3.3.4.4.

The following sections describe the measurements required for the routine field and laboratory 

activities for the network. Independent field measurements will be performed by EPA’s 

Regional ESAT contractors or by independent SLT PEP auditors. The SLT agencies will also 

provide four or six sample filters from at least one collocated site in each PQAO’s network. 

High volume TSP samples will be analyzed with inductively coupled plasma mass spectrometry 

(ICP-MS) and low volume PM10 filters will be analyzed using XRF spectroscopy.

The following information provides a brief description of these activities. Detailed SOPs have 

been developed for all field and laboratory activities and have been distributed to all field, 

laboratory, and regional contacts identified on the distribution list described in Element 3.0, 

Distribution. These SOPs can be found on the AirQA Web site

(https://www.sdas.battelle.org/AirQA/) under Pb PEP, Documentation, and on the AMTIC Web 

site (http://www.epa.gov/ttnamti1/). Figure 6-1 provides a basic description of the Pb-PEP.
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Figure 6-1. The Lead (Pb) PEP Overview

 EPA procures 8 inch × 10 inch high volume glass fiber filters and 47 mm 

polytetrafluoroethylene (PTFE) filters for the Pb high volume TSP and low volume PM10

samplers, respectively, operating in the national network for the calendar year.

 EPA subjects the production lot of these filters to acceptance testing that is required by the 

applicable FRM (see 40 CFR Part 50 Appendices B, G and L). SLTs generally receive glass 

fiber and 47 mm filters by ordering from OAQPS for their monitoring programs. 

Consequently, the SLTs may use their own supply of filters for their collocated PEP samples 

if the filters originate with the production lots purchased and tested by OAQPS under the 

national contract.

 EPA will distribute high volume filters directly to EPA Regions where they will be 

inventoried, inspected, and prepared for the field. Low volume filters for the Federal 

independent audits will be loaded into cassettes and shipped upon request to the requestor by 

EPA’s designated handler, which is currently the EPA Region 4 Filter Weighing Lab.

 The auditor will initiate the electronic chain of custody (COC)/field data sheet (FDS) form on 

the AirQA Web site and print a hard copy to carry to the field. The SLT-collocated PEP 

sample COCs will be initiated by the operator or auditor designated by the SLT in the same 

manner.
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 The auditor or SLT collocated sampler operator will take the filters and COC/FDS form to 

the field and operate the collocated Pb audit sampler (TSP or low volume PM10).

 The auditor will collect and send high volume filters and signed copies of the COC/FDS 

forms to the Region 9 Pb-PEP Laboratory. Low volume filters will be collected and sent to 

EPA’s designated XRF laboratory along with signed copies of the COC/FDS forms. A copy 

of the field data, instrument download data, and associated sampling records for all audits 

will be kept at the auditor’s field office.

 The auditor or SLT collocated sampler operator will electronically enter the data from the 

COC/FDS form and upload the raw sampler data files on OAQPS’s Pb-PEP data 

management Web site, AirQA, which is hosted and maintained by the technical support 

contractor.

 The Region 9 Pb-PEP Laboratory will receive, inspect, and analyze the high volume filters. 

EPA’s designated XRF laboratory will receive, inspect, and analyze the low volume filters. 

Each support lab will validate their analytical results and submit analytical results along with 

electronic copies of the signed COC/FDS forms to OAQPS’s technical support contractor via 

the AirQA Web site. The low volume cassettes will be shipped back to the EPA Region 4 

Filter Weighing Lab to be washed and prepared for re-distribution.

 OAQPS’s technical support contractor will process the electronic data submitted by the field 

and lab, associate the related data elements in the Pb-PEP database, perform automated data 

validation checks against the Pb-PEP acceptance criteria, and submit data for EPA’s final 

review and approval.

 Each Region’s Pb-PEP Lead (or designated QA Officers) will review the automated Pb-PEP 

validation results, indicate approval or rejection, and initiate investigation of any 

questionable data.

 OAQPS’s technical support contractor will prepare and upload the approved data to EPA’s 

AQS.

 The OAQPS program lead will assess the data calculating the bias statistic to determine bias 

within the Pb monitoring network.

6.2 Field Activities

There are two types of field operations of the Pb-PEP: independent Pb-PEP collocated audits and 

additional SLT collocated sampling runs. The independent Pb-PEP audits are conducted by the 

ESAT contractor or approved organization that performs a completely independent sampling 

event once if the PQAO contains five monitoring sites or less or twice if the PQAO contains 

more than five monitoring sites. Additional SLT collocated audits are conducted by the SLT at 

an existing collocated site at a rate of four or six samples according to the criteria above. These 

samples are separate from the normal collocated runs prescribed by the monitoring collocation 

requirements. In other words, these samples cannot be counted as a normal collocated run and 

Pb-PEP audit sample. This process is repeated for both high volume sampling and low volume 

sampling. Both high volume and low volume sampling methods must be audited. Individual 

methods within the high volume and low volume groups should be grouped together as one for 
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the aggregate count to determine the number of audits necessary. All sampling must be 

conducted in conformance to the prescribed FRM. General instructions are found in this Pb-PEP 

QAPP and specific instructions are detailed in the Pb-PEP high volume and low volume field 

SOPs.

The following general requirements must be observed to ensure the quality of the data:

 Samples must be collected and handled in a manner that adheres to the specifications in this 

QAPP and the SOPs for field activities.

 The samplers must be operated in adherence to the manufacturers’ operating manuals, which 

discuss the sampler’s proper transport, assembly, calibration, verifications, operation, and 

maintenance. All deviations must be identified in the PEP or SLT’s SOP for that sampler 

and the applicable QAPP. Changes to the procedures of the independent audits will be vetted 

among and approved by the PEP work group.

 Siting criteria and operating schedules must adhere to specific site requirements defined in 40 

CFR Part 58 Appendices D and E for the identified sites. An exception may be where a 

sampler is not properly sited according to 40 CFR Part 58, but the monitoring organization 

has an approved waiver from the EPA Regional ambient air monitoring program.

 Personnel who perform the Federal and SLT independent PEP audits must complete the 

required initial training and then participate in recertification training at least every 2 years. 

This training may be provided by qualified PEP trainers in the 10 EPA regional offices or 

OAQPS.

 For SLT collocated audits, agencies that have personnel other than independent auditors to 

set up these sampling events and collect the filter samples should ensure that the operators 

have been fully trained on the applicable requirements of the Pb monitoring network 

“Implementation Plan”. The SLT auditors should be independent from the routine operators 

and preferably part of the QA staff.

The performance requirements of the Pb-PEP air sampler are specified in 40 CFR Part 50, 

Appendix B for TSP high-volume samplers and Appendix Q for PM10 low volume samplers. 

Appendix Q refers to the technical specifications for the low-volume samplers as stated in 

Appendix L; the only difference in the two methods is the absence of the PM2.5 separator. 

Required recovery times and shipping schedule are provided in Section 6.4.4. Table 6-1 

summarizes some of the more critical performance requirements.
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Table 6-1. Design/Performance Specifications

Equipment Acceptance Criteria Reference

Pb-TSP Filter Design Specifications (Certified by Vendor)

Size 20.3 ± 0.2 × 25.4 ± 0.2 cm 40 CFR Part 50, Appendix B, Section 

7.1.1

Exposed Area 406.5 cm2 40 CFR Part 50, Appendix B, Section 

7.1.2

Medium Glass Fiber 40 CFR Part 50, Appendix B, Section 

7.1.3

Collection efficiency 99% 40 CFR Part 50, Appendix B, Section 

7.1.4

Maximum pressure drop 42–54 mm Hg at 1.5 std m3/min 40 CFR Part 50, Appendix B, Section 

7.1.5 

pH 6–10 40 CFR Part 50, Appendix B, Section 

7.1.6

Integrity 2.4 mg maximum weight loss 40 CFR Part 50, Appendix B, Section 

7.1.7

Tear Strength 500g min for 20mm strip in 

weakest dimension

40 CFR Part 50, Appendix B, Section 

7.1.9

Pb-TSP Sampler Performance Specifications

Min/Max sampler flow rate

at actual conditions

1.1 to 1.7m3/min 40 CFR Part 50, Appendix B, Section 

7.2.2 and 7.2.3

Flow regulation 1.000 ±5% m3/hr 40 CFR Part 50, Appendix L, Section 7.4

Flow rate sensor Readable to nearest 0.02 m3/min 40 CFR Part 50, Appendix B, Section 

7.4.2

Ambient temperature 

sensor

-30C–45C

0.1C res. ±1.0C accuracy

Volume II–MS. 2.12

40 CFR Part 50, Appendix B, Section 7.5

Barometric pressure 500–800 mm Hg 

± 5 mm res

40 CFR Part 50, Appendix B, Section 

7.6.1 and 7.6.2 

Clock/timer ± 5 minutes/24-h sample No Reference

Pb-PM10 Filter Design Specifications (Certified by Vendor)

Size 46.2-mm diameter ± 0.25 mm 40 CFR Part 50, Appendix L, Section 6.1

Medium Polytetrafluoroethylene 40 CFR Part 50, Appendix L, Section 6.2

Support ring Polymethylpentene or 

equivalent inert material

0.38–± 0.04 mm thick

46.2 ± 0.25 mm outer diameter

3.68 (± 0.00 mm, -0.51 mm) 

width

40 CFR Part 50, Appendix L, Section 6.3

Pore size 2 μm 40 CFR Part 50, Appendix L, Section 6.4

Filter thickness 30–50 μm 40 CFR Part 50, Appendix L, Section 6.5

Maximum pressure drop 30 cm H2O at 16.67 LPM 40 CFR Part 50, Appendix L, Section 6.6

Maximum moisture pickup 10-μg increase in 24 hr 40 CFR Part 50, Appendix L, Section 6.7

Collection efficiency 99.7% 40 CFR Part 50, Appendix L, Section 6.8
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Equipment Acceptance Criteria Reference

Filter weight stability <20 μg 40 CFR Part 50, Appendix L, Sections 

6.9.1 and 6.9.2

Alkalinity <25.0 microequivalents/g 40 CFR Part 50, Appendix L, Section 

6.10

Pb-PM10 Sampler Performance Specifications

Sample flow rate 1.000 m3/hr 40 CFR Part 50, Appendix L, Section 7.4

Flow regulation 1.000 ± 5% m3/hr 40 CFR Part 50, Appendix L, Section 7.4

Flow rate precision 2% CV 40 CFR Part 50, Appendix L, Section 7.4

Flow rate accuracy ± 2% 40 CFR Part 50, Appendix L, Section 7.4

External leakage <80 mL/min 40 CFR Part 50, Appendix L, Section 7.4

Internal leakage <80 mL/min 40 CFR Part 50, Appendix L, Section 7.4

Ambient temperature 

sensor

−30C to 45C

0.1C resolution and ± 2C 

accuracy

Volume II–MS. 2.12

40 CFR Part 50, Appendix L, Section 7.4

Filter temperature sensor −30C–45C

0.1C resolution and ± 1.0C 

accuracy

Volume II–MS. 2.12

40 CFR Part 50, Appendix L, Section 7.4

Barometric pressure 600 mm Hg to 800 mm Hg 

5-mm resolution and ± 10-mm 

accuracy

Volume II–MS. 2.12

40 CFR Part 50, Appendix L, Section 7.4

Clock/timer Date/time

1 min resolution and ± 1 

min/mo accuracy

Volume II–MS. 2.12

40 CFR Part 50, Appendix L, Section 7.4

The independent air samplers used by ESAT contractors will be purchased and distributed by 

EPA OAQPS. The samplers procured must be designated as FRM or meet FRM specifications 

in 40 CFR Part 50, 

B (high volume) and Appendix L (low volume). SLT agencies that conduct independent audits 

must also use independent FRM samplers for their sampling events. The FRM-compliant 

sampling instruments should be intrinsically capable of accurately sampling for TSP- or PM10-

borne Pb. Nevertheless, the Pb-PEP auditors are responsible for verifying the performance 

parameters of the audit Pb samplers after assuming custody of the samplers. Quarterly internal 

audits of the samplers and annual verifications of calibrators are performed thereafter. Element 

15.0, Instrument/Equipment Testing, Inspection, and Maintenance Requirements, lists all the 

primary operational equipment requirements for the Pb-PEP data collection operations. All 

additional support equipment will be listed in the Pb-PEP high volume and low volume field 

SOPs. 

6.2.1 Independent PEP Sampling Events

The independent PEP sampling events are covered in detail in the Pb-PEP field SOPs for audits 

conducted by Federal ESAT contractors and SLT auditors. A summary of events is included in 
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this QAPP in Section 6.4.3.

6.2.2 SLT Collocated Site PEP sampling events

These events are performed at sites with collocated samplers that are owned and operated by 

SLT agencies. The samplers are routinely used to collect samples for precision measurements of 

the SLT’s network to which the site belongs. SLT agencies will follow their own SOPs for 

sample collection while adhering to the provisions regarding sample shipping, data upload to the 

AIRQA database and audit validation prescribed in the Pb-PEP SOP and Pb-PEP QAPP. 

6.2.3 Critical “Field Data” Measurements

The most critical measurement is the total amount of air drawn through the filter during a 

sampling event. The mass of Pb that has been deposited on the filter is divided by this value to 

determine the 24-hour average concentration of Pb during the sampling event. The PM10 is also 

dependent on the flow rate of the sampler, which determines how precisely the particulate matter 

separator at the inlet eliminates particles larger than PM10 from the filtrate. Table 6-2 lists the 

measurements that are made by the air sampler (or possibly other instruments) and are stored in 

the instrument for downloading during sample recovery. 
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Table 6-2. Field Measurement Requirements

Information to be Provided

Availability Format

Anytimea

End of 

Periodb

Visual 

Displayc

Data 

Outputd Digital Readinge Units

Pb-TSP Samplers

Flow rate, average for the sample period     XX.X m3/min

Sample volume, total     XX.X m3

Temperature, ambient, minimum, maximum, average for the 

sample period

   † XX.X oC

Barometric pressure, ambient, minimum, maximum, average 

for the sample period

   † XXX mm Hg

Date and time  —  — YY/MM/DD HH:mm Yr/mo/day hr min

Sample start and stop time settings     YY/MM/DD HH:mm Yr/mo/day hr min

Sample period start time —    YYYY/MM/DD 

HH:mm

Yr/mo/day hr min

Elapsed sample time     HH:mm Hr min

Elapsed sample time out of specificationf —    On/off

User-entered information, such as sampler and site 

identification

    As entered

Pb-PM10 Samplers

Flow rate, 30-second maximum interval  —   XX.X L/min

Flow rate, average for the sample period     XX.X L/min

Flow rate, coefficient of variation for the sample period     XX.X %CV

Flow rate, 5-minute average out of specificationf     On/off

Sample volume, total     XX.X m3

Temperature, ambient,

30-second interval

 —  — XX.X °C

Temperature, ambient, minimum, maximum, average for the 

sample period

    XX.X °C

Barometric pressure, ambient, 30-second interval  —  — XXX mm Hg

Barometric pressure, ambient, minimum, maximum, average 

for the sample period

    XXX mm Hg

Filter temperature, 30-second interval  —  — XX.X °C

Filter temperature, differential, 30-minute interval, out of 

specificationf

    ● On/off

Filter temperature, maximum differential from ambient, date, 

time of occurrence

    X.X, YY/MM/DD

HH:mm

°C, Yr/mo/day hr 

min

Date and time  —  — YY/MM/DD HH:mm Yr/mo/day hr min

Sample start and stop time settings     YY/MM/DD HH:mm Yr/mo/day hr min

Sample period start time —    ● YYYY/MM/DD 

HH:mm

Yr/mo/day hr min

Elapsed sample time     ● HH:mm Hr min

Elapsed sample time out of specificationf —    ● On/off

Power interruptions >1 min, start time of first 10 power 

interruptions

    1HH:mm, 2HH:mm, 

etc.

Hr min

User-entered information, such as sampler and site 

identification

    ● As entered

 Provision of this information is required.

† Legacy high volume samplers, if they use volumetric flow control, do not provide ambient temperature and barometric pressure. These values are necessary, 

however, to convert the flow rate recorded at standard conditions to flow rate at local conditions. The FRM allows a 24-hour average value supplied by the 

nearest National Weather Service reporting facility to be used if the ambient temperature and barometric pressure are not measured directly at the site. These 

measurements may also be made at the site with National Institute of Standards and Technology (NIST) Traceable instruments that have been certified to 

perform within acceptable accuracy within a year of the sampling event.

— Not applicable.

 Legacy high volume samplers do not provide very much real-time data. Provision of this information is optional. If information related to the entire sample 

period is optionally provided before the end of the sample period, the value provided should be the value calculated for the portion of the sample period

completed up to the time the information is provided.

a

Information must be available to the independent PEP auditor at any time the sampler is operating, whether it is sampling or not.

b

Information relates to the entire sample period and must be provided following the end of the sample period until the auditor manually resets the sampler or 

the sampler automatically resets itself upon the start of a new sample period.

c

Information shall be available to the auditor visually.

d

Information will be available as digital data at the sampler’s data output port following the end of the sample period until the auditor manually resets the 

sampler or the sampler automatically resets itself upon the start of a new sample period.

e Digital readings, both visual and data output, shall have no less than the number of significant digits and resolution specified.

f Flag warnings may be displayed to the auditor by a single-flag indicator or each flag may be displayed individually. Only a set (on) flag warning must be 

indicated; an unset (off) flag may be indicated by the absence of a flag warning. Sampler users should refer to Section 10.12 of Appendix L about the validity 

of samples for which the sampler provided an associated flag warning. 
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In addition to the measurements collected in Table 6-2, supporting field data will also be 

collected. These additional parameters are identified in the Pb-PEP high volume and low volume 

field SOPs and help to identify the samples, ensure proper COC, holding times, and data quality. 

The information may also be important for validating data that appear to be unusual or 

unexpected. This information is recorded on the COC/FDS Form.

6.3 Laboratory Activities

The Pb-PEP requires two separate analyses depending on the size range of the Pb particulate, the 

samplers which collect it, and the filter media on which it is collected.

ICP-MS Analysis for Glass Fiber Filters (High Volume TSP Sampling) 

The primary activities and steps are: 

 Preparation of extraction fluids and check standards for the ICP-MS

 Calibration and verification of ICP-MS

 Receipt of filter samples from the Federal and SLT independent auditors, and from the 

collocated sampler operators or auditors

 Recording COC data into the laboratory information management system (LIMS)

 Filter handling, 

 Sample extraction 

 Analysis of extracts with ICP-MS instrument 

 Resulting data entry and validation

 Sample filter and extract retention and archival, and

 Transmittal of the results and validation data to the AIRQA Web site.

EPA Region 9 operates the Pb-PEP laboratory for the high volume Pb-TSP samples. Specific 

detailed instructions will be available in the laboratory SOPs. They are attached as Appendix 3.

XRF Analysis for PTFE 47 mm Filters (Low-Volume PM10 Sampling) 

The primary activities and steps are:

 Receipt of filter samples from the Federal and SLT independent auditors, and from the 

collocated sampler operators

 Recording COC data into the LIMS

 Filter handling 

 Analyze check standards with the XRF instrument

 Load Filters into XRF sample holders

 Subject Filters and blanks to XRF analysis

 Resulting data entry/management, 

 Sample filter and extract retention and archival
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 Transmittal of the results and validation data to the AIRQA Web site.

 Returning filter cassettes to the designated originator of the filters, presumably EPA Region 4 

PEP support laboratory in Athens, GA.

EPA OAQPS will secure the Pb-PEP analytical XRF laboratory services for the low volume PbPM10 samples. Since this will be a commercial vendor, specific detailed instructions will be 

found in the laboratory SOPs. They are attached as Appendix 4.

The participating analytical support laboratories will implement an internal QA/QC program that 

incorporates the pertinent elements of good laboratory practices (GLPs). The GLP will include 

the following: 

 Establishing specific QA goals and implementing procedures for the particular analyses 

performed in support of the PEP.

 Adherence to the vendor’s operations manual for the proper operation of the extraction 

and/or analytical equipment (ICP-MS and XRF spectroscopy). 

 Adherence to the SOPs for the program.

 Adherence to the standards, principles, and practices outlined in the Pb-PEP QAPP.

 Special attention must also be given to any activity involving filter handling. This area 

contains the greatest potential for introducing measurement uncertainty, and care must be 

given to the proper handling of both TSP and PM10 filters.

Table 6-3 provides the performance specifications of the laboratory environment and equipment.

Table 6-3. Laboratory Performance Specifications

Equipment Acceptance Criteria

Pb-TSP Analyses

Inductively Coupled Plasma 

Mass Spectrometer

MDL </= 0.0075 g/m3

Reagent Water laboratory deionized water as described in EPA Region 9 Laboratory SOP 825.

Nitric Acid (HNO3) concentrated, trace metals grade or better (e.g. Baker Instra-Analyzed)

Argon gas supply high-purity grade, 99.99%

Pb-PM10 Analyses

X-Ray Fluorescence 

Spectrometer

MDL </= 0.0075 g/m3 
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6.3.1 Critical Laboratory Measurements

For generating a concentration, the critical lab measurement of high-volume TSP samples is the

Pb concentration in g/filter strip. This value is used to calculate the Pb concentration on the full 

TSP filter that, when divided by the air volume in cubic meters (m3) pulled through the filter, 

provides a final concentration (g/m3). With respect to the XRF analysis, the resulting value is 

expressed as g/cm2. This value is multiplied by a specified exposed area for the 46.2 mm (4.62 

cm) PTFE PM10 filter. Then it can be divided by the 24-hour volume of air sampled through it 

for the average concentration. In addition to these critical measurements, supporting laboratory 

data will also be collected to help identify the samples, ensure proper COC, holding times, and 

data quality. These additional parameters are described in more detail in Section13.0 Analytical 

Methods Requirements and in the laboratory SOPs.

6.4 Schedule of Activities

The Pb-PEP consists of laboratory and field activities that must be coordinated and completed in 

a timely and efficient manner for the program to be successful. This includes activities such as 

acquiring equipment and supplies, developing sampling and analytical schedules, initiating the 

COC/FDS forms, conducting the setup and sampling event at the site, extracting and analyzing 

filters, performing QC checks and data validation, and uploading to the AQS database. The 

sections below describe some of the time-critical components of conducting Pb-PEP audits. 

Additional detail is provided in the Pb-PEP SOPs. 

6.4.1 Pb-PEP Audit Frequency

The sampling design has been codified in 40 CFR Part 58, Appendix A, Section 3.3.4.4, as: 

“Each year, one performance evaluation audit, as described in section 3.2.7 of this appendix, 

must be performed at one Pb site in each primary quality assurance organization that has less 

than or equal to five sites and two audits at primary quality assurance organizations with 

greater than five sites. In addition, each year, four collocated samples from primary quality 

assurance organizations with less than or equal to 5 sites and six collocated samples at primary 

quality assurance organizations with greater than 5 sites must be sent to an independent 

laboratory, the same laboratory as the performance evaluation audit, for analysis.”

In addition to the required criteria above, the Pb-PEP will audit all SLAMs and SPM Pb 

monitoring sites per PQAO over a 6-year period. 

Pb sampling in the NAAQS and NCore network may be conducted using either the high volume 

or low volume sampling method. In determining how many Pb-PEP audits are required for a 

PQAO, all Pb monitoring sites, regardless of sampling method, must be added together to 

determine the correct audit frequency. The one exception will be that low volume PM10 sites in 
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the NCore network are treated as one PQAO. In this situation, each primary NCore PM10 Pb 

sampler will be audited once per year.

6.4.1.1 Pb-PEP at NCore

The NCore network is treated as its own PQAO when planning low volume PM10 Pb-PEP audits. 

Every primary, low volume PM10 Pb sampler at an NCore site will receive one Pb-PEP audit 

annually. The reason this frequency of audits was instituted was because that the NCore network 

contains only 20 sites with PM10 Pb samplers. 15% of these would provide an insufficient 

number of audits to calculate bias with any degree of confidence. If a PQAO has agreed to selfimplement their Pb-PEP, they will be responsible to conduct an audit of each primary NCore 

PM10 Pb sampler in their jurisdiction. 

There are approximately five NCore sites that have collocated PM10 Pb samplers. EPA is 

requesting that each of these collocated sites provide four SLT collocated sampler samples to the

PEP analytical support laboratory during the course of a calendar year. 

To sum up for the Pb-PEP, TSP samplers at NCore sites are to be treated like any other Pb 

samplers in the individual monitoring organization PQAOs. In other words such samplers go

into the 6-year cycle, for one or two independent PEP audits, depending on the total number of 

Pb monitoring sites (which might include any non-NCore, low volume PM-10 Pb sites) in the 

PQAO.

6.4.2 Pb-PEP Sampling Schedule

On or before December 1, EPA Regions will work with monitoring organizations to select and 

develop a list of sites for the evaluations to be conducted for the next calendar year. The 

Regional WAM/TOPO/DOPOs, with the assistance of the ESAT contractors, will attempt to 

determine the most efficient site visit schedule. This schedule should be based upon the 

following:

 CFR requirements for audit frequency

 Network audit completeness (all sites audited in 6 years; all NCore PM10 Pb low volume 

samplers each year)

 Meeting the same monitoring schedule as the monitoring agency’s routine samplers to be 

evaluated

 Site proximity (the sites that are closest in proximity to each other may be visited within the 

same day or week)

 Coordination with other audit programs (PM2.5 and PM10-2.5 PEP, and NPAP) if possible.

PEP audits should be conducted on normal sampling days so that the evaluation does not create 

additional work for the monitoring organizations. However, if the monitoring organization is 

amenable to perform a PE on a day other than a routine sampling day and is willing to post the 
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result to AQS, the Pb-PEP visit can be scheduled for that day. 

SLT Collocated Sampling Events

SLTs have been instructed through the Pb monitoring QA Implementation Guidance to provide 

the collocated site samples from sampling events that are on different days than the precision 

sampling events. They are supposed to be seasonably distributed; however, if a make-up is 

needed the seasonality can be disregarded.

6.4.3 General Sequence of Pb-PEP Activities

6.4.3.1 “Independent” FRM Pb-PEP audit

Below is a list of activities, in general chronological order, that are performed by Pb-PEP field 

personnel (auditors) and the laboratory to conduct an “Independent” FRM Pb-PEP audit:

EPA, ESAT staff and independent SLT auditors who participate in the Pb-PEP are certified 

through hands-on exercises and a written examination in the operation, conduct, and 

management of the Pb-PEP activities. This activity is coordinated by the EPA OAQPS PEP 

program lead if the training event is conducted at the national level or by the EPA Regional PEP 

lead if conducted at the regional level. 

1. The EPA WAM/TOPO/DOPO selects the Pb sites to be audited for the current calendar 

year by the Pb-PEP.

2. The WAM/TOPO/DOPO, auditor, and monitoring organization coordinate scheduling 

site visits if needed.

3. The auditor and site operators coordinate the details of the audit. EPA distributes boxes 

of glass fiber filters for the high volume TSP sampling to each EPA regional office and 

each SLT independent auditing group. EPA or its designated handler ships the PM10

filters to the auditor.

4. Each high volume filter recipient pulls a randomly chosen filter from the box and ships to 

the ICP-MS laboratory for lot blank analysis. PM10 filter blanks are supplied to the XRF 

laboratory by OAQPS or the designated handler.

5. The auditor transports the audit sampler to the site and evaluates the site for safety prior 

to setup.

6. The auditor assembles the sampler and sets the date/time, then performs leak checks, 

barometric pressure verifications, temperature (ambient and filter) verifications, and flow 

rate verifications. 

7. The auditor performs the field blank exercise, if needed, and installs the sampling filter.

8. The auditor programs the sampler to run during a 24-hour sampling event (midnight to 

midnight).
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9. The sampler pulls ambient air through a filter over a 24-hour time period on the 

scheduled date/time.

10. The auditor recovers the filter and downloads recorded sampling event summary data 

11. The auditor disassembles the sampler.

12. The auditor packages the recovered filter and ships it along with the COC/ FDS forms to 

the analytical laboratory. 

13. The auditor will enter the data from the COC/ FDS form(s) and upload the raw sampler 

data files to the OAQPS Pb-PEP data management Web site.

14. The Pb-PEP laboratory receives filters, logs them in as appropriate, and performs 

extraction and/or analysis.

15. The Pb-PEP laboratory reviews and validates the laboratory data.

16. EPA’s technical support contractor will process the electronic field and laboratory data, 

associate related elements in the database, perform manual and automated data validation 

checks, and make the data available for review and approval.

17. The Regional Pb-PEP Leads (or designated QA Officers) approve data that are to be 

loaded into the AQS.

18. The OAQPS National Pb-PEP Lead ensures the Pb-PEP data are being validated on a 

timely basis and are acceptable and complete for AQS upload.

19. EPA’s technical support contractor loads data into the AQS.

20. The OAQPS National Pb-PEP Lead uses the data to calculate the annual bias estimate.

6.4.3.2 SLT-owned Collocated site PEP samples

1. The SLT collocated sites from which samples are collected will be selected by the SLT. 

If the resulting data suggest there may be an operational issue, the use of that site in 

subsequent years will be determined in consultation with the associated EPA regional 

office.

2. The EPA regional office Pb-PEP contact and monitoring organization coordinate 

scheduling site visits if needed.

3. The SLT’s site operators (and auditor(s), if utilized) coordinate the details of the 

sampling event used to collect the samples for the PEP. 

4. If the SLT requests a separate supply of filters for PEP use, EPA OAQPS will ship the 

glass fiber filters or PM10 filters to the contact supplied by the SLT. A random sample of 

the glass fiber filters is taken from the box and supplied to the ICP-MS laboratory for a 

lot/lab blank. Each year EPA will be supplying a supply of 10 unused 47 mm PTFE 

filters to the XRF lab for background analysis. If the SLT uses a separate box of filters 

supplied by EPA and it is used for more than one year, the SLT should send one filter 

from the box in every year it is used beyond the first year.
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5. If the SLT uses their own stock of filters, the person preparing the audit cassettes should 

send at least one randomly selected filter from the originating box of filters, whether 

glass fiber or 47 mm PTFE, to the appropriate ICP-MS lab or XRF laboratory. 

6. The SLT operator or independent operator should note any parameter of the monitoring 

site that does not comply with the applicable regulations for Pb sampling. This

information should be entered on the COC/FDS in the comment section. If a waiver has 

been issued for the site to be exempted for one or more requirements, the waiver should 

be noted also in the comments.

7. The SLT operator (or auditor) completes as much information as possible on the webenabled COC/FDS at the AIRQA Web site.

8. The SLT’s collocated sampler is typically permanently installed at the monitoring site; 

therefore transport and setup will not be necessary. The SLT operator (or auditor) 

performs leak checks, barometric pressure verifications, temperature (ambient and filter) 

verifications, and flow rate verifications. 

9. The SLT operator (or auditor) should perform at least one field blank exercise per year 

per site from which PEP samples are derived. 

10. The SLT operator (or auditor) installs the sampling filter.

11. The SLT operator (or auditor) programs the sampler to run during a 24-hour sampling 

event (midnight to midnight) that coincides with a routine sampling event of the site’s 

primary sampler, but that is on a different day than a normal precision measuring event.

12. The sampler pulls ambient air through a filter over a 24-hour time period on the 

scheduled date/time.

13. The SLT operator (or auditor) recovers the filter and downloads recorded sampling event 

summary data. Post-sampling verification checks may be requested dependent on the 

make and model of the audit sampler, or if pre-sampling verification checks were outside 

of expected operating parameters

14. The SLT operator (or auditor) packages the recovered filter and ships it with the COC/

FDS forms to the analytical laboratory. EPA will supply prepaid shipping labels if the 

SLT requests it.

15. The SLT operator (or auditor) will complete the data entry on the web-enabled COC/ 

FDS form(s) and upload the raw sampler data files to the OAQPS Pb-PEP data 

management Web site.

16. The Pb-PEP laboratory receives filters, logs them in as appropriate, and performs either 

the extraction and ICP-MS analysis or the XRF analysis. 

17. The Pb-PEP laboratory reviews and validates the analytical data and transfers it to the 

web-enabled QA Web site. 

18. EPA’s technical support contractor ensures the electronic field and laboratory data 

successfully merge, and the automated data validation checks occur. They make the data 

available for review and approval.

19. The Regional Pb-PEP Leads (or designated QA Officers and Independent SLT-PEP 

auditors) approve data that are to be loaded into the AQS.
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20. The OAQPS National Pb-PEP Lead ensures the Pb-PEP data are being validated on a 

timely basis and are acceptable and complete for AQS upload.

21. EPA’s technical support contractor loads data into the AQS.

6.4.4 Implementation Time Lines

There are some other important benchmarks that must be met during implementation activities. 

They involve both field and laboratory activities. 

6.4.4.1 Field Activities

For best practice, the independent PEP and SLT-PEP auditor should retrieve the filters within 24 

hours of the end of the sample exposure period. For independent PEP audits additional time 

should be minimized. A passive blank could be collected to determine potential passive 

contamination during long periods when the sampler is not running. Another way to avoid this 

potential contamination is to arrange to retrieve the filter at or near the same time that the SLT 

agency retrieves the routine primary filter for that site’s sampling event. Additional studies may 

be conducted to determine the potential impact of passive contamination over several days 

between the conclusion of the sampling event and retrieval. The SLT collocated site operator 

should retrieve the PEP sample at the same time the primary routine Pb filter sample is retrieved.

Ideally, the independent PEP and SLT-PEP auditor or SLT collocated site operator should ship 

PEP samples on the day of retrieval to the appropriate laboratory. However, the retrieval 

schedules for multi-site audit trips or long distances from offices may necessitate a need for more 

flexibility. The independent PEP auditor or SLT collocated site operator should ship the exposed 

filters within 48 hours of the end of the sampling period. Downloaded data from the portable 

sampler and COC/FDS data will be uploaded to the AIRQA Web site for Pb-PEP upon arrival 

back to the field office. Table 6-4 provides a summary of the key activities discussed above.

6.4.4.2 Laboratory Activities

Because Pb is very stable once deposited on a filter, the expedited analysis of individual samples

is not critical. It is more practical and economically desirable to accumulate a number of filters 

for batch processing. The batch holding time for all filters is set at a maximum of 30 calendar 

days from receipt by the laboratory until analysis is performed. Validation and transmittal of the 

laboratory results to the QA Web site should be complete within 15 days.

Table 6-4. Implementation Summary

Activity Holding Time From To

AUDITOR arrives on site 

and loads filter in the sampler NA AUDITOR Office Mounting in sampler

Filter exposure 24 hours Midnight (~12:00 a.m.) of 

prescribed sampling day

Midnight (~12:00 a.m.) 

following the sampling day

Filter collectiona ≤ 24 hours End of sampling period Recovery
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Sampler data collection NA Recovery Site exit

Shipped to laboratory

(best practice) ≤ 48 hours End of sampling period Shipment

Transmittal of sampler run 

data, FDS, and COC 24 hours Upon arrival at field office QA Web site

Laboratory analysis ≤ 30 days Sample Delivery Date at lab Analysis

Data Validation and Web 

Transmittal 15 days Completion of analysis Upload to AIRQA Web site

6.4.5 Assessment Time Lines

6.4.5.1 Data Availability

The Pb-PEP laboratories should complete data validation and transmit/upload it to the QA Web 

site within 15 days of the conclusion of the analysis of that batch. This data is immediately 

available to the PEP auditors, the SLT operators of the collocated site samplers, and Regional 

PEP leads. The Regional PEP leads are to review and approve or disapprove the recorded and 

posted results by the end of each month. This is so that additional audits may be scheduled in the 

event that a result has been invalidated due to circumstances associated with the conduct of the 

audit. Note that an ambient concentration below the validation threshold does not by itself 

constitute a reason for repeating an audit.

Each Pb-PEP audit result is posted to AQS as a conjugate to the monitoring site’s value as 

derived from the primary, routine sampler. In order for the Pb-PEP data to post in AQS, the 

site’s measured value must be already posted in AQS. SLT agencies are required to post 

SLAMS data to AQS within 90 days after the end of the quarter as shown in Table 6-5. 

The PEP technical support contractor will attempt to post available PEP data on or about the 15th 

of every month. PEP data that do not post will be placed back in the queue until the next posting 

date, at which time another attempt will be made to post it. Consequently, for SLT site data that 

are submitted after the quarterly due date, the PEP data will post at the next opportunity. If an 

SLT site’s data have been posted and they do not see PEP data within 45 days after the last 

posted sampling event, they should contact the Regional PEP contact to investigate the status of 

the PEP data. 

Table 6-5. Data Reporting Schedule for AQS

Reporting Period Due Date

January 1–March 31 June 30

April 1–June 30 September 30

July 1–September 30 December 31

October 1–December 31 March 31
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6.4.5.2 Data Assessments

The Regional ESAT contractors are tasked to provide initial reviews and assessments of the PbPEP field data. The Region 9 ESAT contractor and the Pb XRF analytical lab are tasked to 

provide full validation and assessments of the Pb-PEP laboratory data. The Regional EPA 

contacts are tasked to provide a final assessment of the Pb-PEP audit before it can be uploaded to 

AQS. Following the monitoring organization’s submittals of quarterly Pb FRM/FEM data, 

OAQPS (via the support contractor) will load the Pb-PEP data into the AQS. The Pb-PEP 

Laboratory Managers and the OAQPS technical support contractor(s) will review the Pb-PEP 

data. They will report to the ESAT Workgroup and QA Workgroup any significant Pb-PEP 

operations issues that are reflected by the data. Once both routine data and PE data for a site are 

in the AQS database, OAQPS, EPA regions, and monitoring organizations can use the AQS data 

evaluation programs, based on data quality assessment techniques, to assess this information. 

National bias is determined based on statistical equations given in 40 CFR Part 58, Appendix A, 

Section 4.

6.4.6 OAQPS Reporting Time Lines

6.4.6.1 QA Reports 

OAQPS will issue an Annual QA Summary Report through the use of the AQS AMP 255 

Report. Additional data will be available to the Regional PEP lead and participating SLT 

agencies through the QA Web site. It will include: 

 Basic statistics of the data including completeness; 

 Pb-PEP audit results vs. routine SLAMS results; 

 Results of collocation studies for precision of Pb-PEP samplers; 

 QC charts for the laboratory; 

 Pb-PEP sampler performance vs. acceptance criteria; and 

 Results of blank analyses. 

From the statistical analyses and results, Pb-PEP TSA findings, and a summary of the annual 

standard certifications, all collected over the course of each calendar year, a more comprehensive 

report will be generated. The Annual QA Report should be completed 6 months from the end of 

December of the calendar year which it represents. Every third annual report will be superseded 

by and incorporated into an interpretive 3-year QA Report drafted in the year following the third 

year in the evaluation period. In other words, this report is a composite of the third year’s data 

and information and two previous annual reports, but with a more narrative interpretation and 

evaluation of longer term trends with respect to Pb-PEP sampler and operational performance. 

The first three-year report for the Pb-PEP will be drafted in 2014 and cover years 2011-2013.
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6.4.6.2 Assessment Reports

OAQPS will perform a QA assessment of the Pb-PEP ESAT contractors and SLT organizations 

that have assumed some or all of the independent Pb-PEP activities as specified in Table 6-6. 

Initial assessment findings will be documented and reported back to the audited organization 

within 15 working days after the assessments. Final assessment reports, including responses to 

findings and follow-up activities, will be submitted to the National Pb-PEP Project Leader at 

OAQPS by the end of the first quarter of the following year to have the results summarized in the 

Annual QA Summary and 3-year QA Reports.

6.5 Project Assessment Techniques

An assessment is an evaluation process used to measure the performance or effectiveness of a 

system and its elements. As used here, “assessment” is an all-inclusive term used to denote any 

of the following: audit, PE, management systems review (MSR), peer review, inspection, or 

surveillance. Definitions for each of these activities can be found in the glossary (Appendix A). 

Section 20.0, Assessments and Response Actions, presents the details of the assessments.

Table 6-6 provides information on the organizations implementing the assessment and the 

frequency of these assessments.

Table 6-6. Assessment Schedule

Assessment Type Assessment Agency Frequency

TSA of auditor and field 

operations

EPA Regional office One per year

Surveillance of auditor’s

operations

OAQPS at annual recertification of 

auditors or by the EPA Regional 

office as needed

One per year unless there is a need 

for additional Regional surveillance

Performance test of supporting 

Analytical Laboratories

NAREL and OAQPS One per year 

TSA of the laboratory operations OAQPS or NAREL One every 3 years

Data quality assessment OAQPS Every year

6.6 Project Records

The field and laboratory programs will establish and maintain procedures for the timely 

preparation, review, approval, issuance, use, control, revision, and maintenance of documents 

and records. Table 6-7 represents the categories and types of records and documents that are 

applicable to document control for Pb-PEP information. Information on key documents in each 

category is explained in more detail in Element 9.0, Documentation and Records. 
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Table 6-7. Critical Documents and Records

Categories Record/Document Types

Management and 

organization

Reporting agency information 

Organizational structure

Personnel qualifications and training

Training certification

Quality management plan 

Document control plan

EPA directives

Grant allocations

Support contract

Site information Network description

Site characterization file

Site maps

Site pictures

Environmental data 

operations

Quality Assurance Project Plans 

Standard operating procedures

Field and laboratory notebooks

Sample handling/custody records

Inspection/maintenance records

Raw data Any original data (routine and quality control 

data) including data entry forms

Data reporting Air Quality Index Report

Annual state and local monitoring stations’ air 

quality information

Data/summary reports

Journal articles/papers/presentations

Data management Data algorithms

Data management plans/flowcharts

Data management systems

Quality assurance (QA) Good laboratory practices

Network reviews

Control charts

Data quality assessments

QA reports 

System audits

Response/corrective action reports

Site audits
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7.0 Data Quality Objectives and Criteria for Measurement 

The purpose of this element is to document the DQOs of the project and to establish performance 

criteria for the environmental data operation (EDO) that will be used in generating the data.

7.1 Data Quality Objectives

DQOs are qualitative and quantitative statements derived from the DQO process that clarify the 

monitoring objectives, define the appropriate type of data, and specify the tolerable levels of 

decision errors for the monitoring program. By applying the DQO process to the development of 

a quality system for Pb, EPA guards against committing resources to data collection efforts that 

do not support a defensible decision. 

During the process of revising the Pb NAAQS, the monitoring requirements for Pb were 

reviewed and included monitoring options such as: 

 Change in averaging time of the indicator from the fixed quarterly average to either a rolling 

quarterly or monthly average; and a

 Option in monitoring device from the current FRM, the high volume TSP sampler, to use the 

low volume PM10 sampler in some circumstances.

Using the DQO process, EPA explored how changes in design value averaging times, sampling 

frequency, data completeness, precision, and bias affect one’s ability to compare Pb estimates to 

a NAAQS value. A report on the DQO process can be found on the EPA AMTIC Web site8. 

Based on this evaluation, EPA identified a measurement quality objective (MQO) for precision 

of 20% for a 90% confidence limit CV and an overall absolute bias upper bound goal of 15%. 

The Pb-PEP provides the measurements upon which the bias component of the national network 

DQO is evaluated. In many environmental measurements, bias can be measured and evaluated 

by simply introducing standard reference material into a measurement phase and evaluating the 

results. Because there is no accurate way of introducing a known concentration of Pb particles 

into a Pb sampler, the Pb-PEP was developed to serve, as closely as possible, as a reference 

standard by which a relative network bias can be determined.

This value will be generated by the combined data from the independently acquired PEP filter 

samples and samples from SLT collocated samplers that are submitted to and analyzed by the 

PEP laboratory. The dataset will also include similarly acquired data from the low volume PM10

samplers at NCore and other sites. Goals will be assessed on 3 years of data at the PQAO level 

of aggregation. While not mandated by the regulations, the bias for the different types of 

samplers and origin of the filters will also be determined from the dataset.

 

8 http://www.epa.gov/ttn/naaqs/standards/pb/data/20080929DQO.pdf
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7.1.1 Proposed Measurement Quality Objectives for Precision and Bias Data Quality 

Indicators 

Once a DQO is established, the quality of the data must be evaluated and controlled to ensure 

that it is maintained within the established acceptance criteria. MQOs are designed to evaluate 

and control various phases (e.g., sampling, preparation, analysis) of the measurement process to 

ensure that total measurement uncertainty is within the range recommended by the DQOs. The 

MQOs can be defined in terms of the following data quality indicators:

Accuracy - A term that is frequently used to represent closeness to “truth” and includes a 

combination of precision and bias error components. The term “accuracy” has been used 

throughout the CFR and in some of the elements of this document. It is quite difficult if not 

impossible to make accurate real-time measurements of airborne Pb-containing particulate 

matter, therefore the accuracy of filter based measurements must be apportioned into 

measurement of precision and bias. 

Precision - A measure of mutual agreement among individual measurements of the same 

property usually under prescribed similar conditions. This is the random component of error. 

Bias - The systematic or persistent distortion of a measurement process, which causes error 

in one direction. Bias is determined by estimating the positive and negative deviations from 

the true or reference value as a percentage of the true or reference value. 

Representativeness—A measure of the degree in which data accurately and precisely 

represent a characteristic of a population, parameter variations at a sampling point, a process 

condition, or an environmental condition. 

Detectability—The determination of the low-range critical value of a characteristic that a 

method-specific procedure can reliably discern. 

Completeness—A measure of the amount of valid data obtained from a measurement system 

compared to the amount that was expected to be obtained under correct, normal conditions. 

Data completeness requirements are included in the reference methods (40 CFR Part 50). 

Comparability—A measure of confidence with which one dataset can be compared to 

another. Since the PEP data are generated in the same manner, with the small exception that 

PEP MQOs may be slightly tighter, comparability is not an issue at any level of aggregation. 

The PEP’s collocation events for precision will also provide an indication of the 

comparability of the data produced from independent PEP audits and the results of analyzing 

the filters from SLT-owned collocated samplers.
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7.2 Pb-PEP Measurement Quality Objectives

The Pb-PEP is, in essence, a small monitoring program. However, because it has the added 

importance of being the program used to estimate bias at the PQAO level, it must have a greater 

level of data quality than the national ambient air monitoring program. Tables 7-1, 7-2 and 7-3 

list the MQOs for the field and laboratory activities of the Pb-PEP. Acceptance criteria have 

been developed for each of these MQO attributes. In theory, if these MQOs are met, 

measurement uncertainty should be controlled to the levels that will provide high confidence that 

the values can be compared to the DQO. 

Some MQOs for Pb-PEP are more stringent than routine Pb measurement quality objectives of 

the national network. More detailed descriptions of these MQOs and how they will be used to 

control and assess measurement uncertainty will be described in other elements of this QAPP 

and in the SOPs.

The new Pb NAAQS requires that concentrations be reported at local or actual conditions. New 

samplers include temperature and pressure sensors in the sampling unit to record the flow rate at 

local conditions. Older model samplers without this capability may be used; however they 

require a conversion using a 24-hour average ambient temperature and pressure measurement. 

These data may be collected from other calibrated samplers that are at the monitoring site, or 

they may deploy separate NIST traceable instruments to take these measurements over the 24-

hour run period.
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Table 7-1. Pb Performance Evaluation Program Field Measurement Quality Objectives

Criteria Frequency Acceptable Range

Information (CFR, Method 2.2 

or 2.8)

Flag

Sample Recovery all filters 8–48 hours Part 50 App B 

Sampling Period all filters 1440 minutes ± 60 minutes 

midnight to midnight

Part 50 App B sec 8.15 

Sampling Instrument

Average Flow Rate every 24 hours of op 1.1-1.7 m3/min (40-60 CFM) Part 50 App B sec 8.8

Filter Part 50 App B sec 7.1

Visual Defect Check (unexposed) all filters see reference Part 50 App B sec 8.2

Collection Efficiency all filters 99 % Part 50 App B sec 7.1.4

Pressure Drop Range all filters 42-54 mm Hg Part 50 App B sec 7.1.5

pH all filters 6–10 Part 50, App B sec 7.1.6

Pb Content all filters pre-sampling batch check < 75 g/filter Part 50, App G sec 6.1.1

Method 2.8 sec 6.2.1

Verification/Calibration

One-point Flow Rate Verification During Set-up prior to every sample day ±7% from transfer standard; but within the range 1.1-1.7 m3/min local conditions Part 58 App A 

Method 2.2 sec 2.6 

One-point Temp Verification During set-up prior to every sample day + 2

oC of transfer standard

Pressure Verification During set-up prior to Every sample day ± 10 mm Hg of transfer standard

Verification/Calibration

System Leak Check During pre-calibration check Auditory inspection with faceplate blocked Method 2.2 sec 2.0

Flow Check (volumetric flow 

control)

After receipt, after motor maintenance or failure of 1-point check and 1/yr 5 points over range of 1.1 to 1.7 m3/min 

within ± 5% limits of linearity

Method 2.2 sec 2.6

Clock/timer Verification Every visit ± 5 min recommendation

Precision

PEP Collocated Samples 1/quarter/Region or Implementing SLT Agency; at least one will be at an 

SLT’s collocated sampler site

PD ≤ 10% of samples > 0.02 /m3 (cutoff value) Pb-PEP Requirement 

flow resistance platea

verification

2/yr Best fit curves from testing with 5 discs PD ≤5% at all points Method 2.2 sec 2.6

Audits

Semi Annual Internal Flow Rate 

Audit

2/yr ±10% of audit standard if the unit is mass flow controlled, or if volume flow controlled, the design 

value specified by the manufacturer 

Part 58, App A, sec 3.3.3 

Blanks

Field Filter Blank (FB) 1/sample batch < MDL recommendation

Trip Blank (TB) ≈ 10% of all filters < MDL per Field SOP

Monitor Maintenance

Inlet cleaning 1/3 mo cleaned recommendation

Motor/housing gaskets ~400 hours Inspected replaced Method 2.2 sec 7

Recommended Maintenance per manufacturers’ SOP per manufacturers’ SOP NA

Data Completeness annual 100%

Reporting Units all filters g/m3

at local temperature and pressure. Part 50 App R

Lower Detectable Limit 1/yr 0.02 g/m3 Part 50 App G sec 2.3

Verification/Calibration Standards and Recertifications - All standards should have multi-point certifications against NIST Traceable standards

Flow Rate Transfer Std. 1/yr Resolution 0.02 m3/min

± 2% reproducibility 

Part 50, App B sec 7.8

Field Thermometer 1/yr 2

o C resolution Part 50, App B sec 7.5

Field Barometer 1/yr ± 5 mm Hg resolution Part 50, App B sec 7.6

Verification/Calibration

aThe PEP samplers’ responses to pressure drop will be tested semi-annually by placing a series of plates with decreasing number of same size holes on the sampler. The curve generated by plotting the downstream flow rate against the number of holes can be compared to the previous curves to 

determine how the sampler is responding to pressure drop over time. This test can also be used to compare flow rates and performance of samplers across the PEP fleet. An action level of a 5% drop in flow has been temporarily established until the program has enough data to determine what the 

long-term performance behavior of the high volume samplers will exhibit.
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Table 7-2. ICP-MS Laboratory Measurement Quality Objectives

Parameter Code Frequency Criteria Corrective Action Upon Criteria Failure Flag

Initial Calibration ICAL Each day or every sample batch ≥ 0.995 Correlation 

Coefficient

No analysis until acceptable results NF

Instrument Calibration Verification ICV After ICAL 90–110% No analysis until acceptable results NF

Continuing Calibration Verification CCV Every 10 Samples 90–110% No analysis until acceptable results NF

Calibration Blank CB After each ICV/CCV < 1⁄2 QL Stop analysis, recalibration and analysis of samples bracketed 

by unacceptable result

NF

Second Source Calibration Verification SCV Each batch 90–110% No analysis until acceptable results NF

Quantitation Limit Standard QLS After ICAL & after every 40 

analytical samples

60–140% Determine the cause and re-analyze.

Method Blank MB Each Batch < 1⁄2 QL If sample results are non-detects or > 5 times MB accept 

results

If sample results detectable and < 5 times MB rerun extract or 

prepare new strips

NF

J

Lab Control Standard LCS Each Batch 85–115% Re-analyze once to verify. If the recovery is still 

unacceptable

(1) For PM10 filter, all associated results are reported and 

qualified 

(2) For TSP filter strip, the MB, LCS, and all associated 

samples must be re-prepared and re-analyzed if there is 

enough sample to work with. 

J

J

LCS Duplicate, Precision LCS-D Each Batch (PM 10Only) ≤ 20 RPD Re-analyze once to verify. If exceeded again flag J

Matrix Duplicate, Precision MD Every 20 samples (TSP Only) ≤ 20 RPD Re-analyze sample and duplicate once. If exceeded again flag J

Matrix Spike, Accuracy MS Every 20 samples

(TSP Only)

70–130% If the MS does not meet these criteria, examine other QC 

results to determine if a matrix problem exists. If laboratory 

performance is in control, the poor MS accuracy is likely to 

be matrix-related 

J

Internal Standard IS Every analysis 60–125% of initial 

CB

If the intensities of the internal standards for the ICV, CCV, 

or CB are out-of-control, recalibrate and re-analyze the 

samples affected 

If the intensities of the internal standards for the ICV, CCV, 

and CB are within control limits but sample internal 

standards are out-of-control, rerun the sample or rerun at an 

appropriate dilution.

Audit Strips 1/quarter 90–110% Re-analyze extract. If failure extract/run another set. 

Reagents (HNO3 and HCL) NA ACS reagent grade

Pb nitrate Pb (NO3)2 NA ACS reagent grade 

(99.0% purity)
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Table 7-3. XRF Laboratory Measurement Quality Objectives

Parameter Code Frequency Criteria Corrective Action Upon Criteria Failure Flag

Filter Visual Defect Check

(unexposed) FDC all filters

Correct type, size, no 

pinholes, defects or 

contamination

Discard filter and replace with filter meeting specifications.

Pb blank filter Acceptance 

Testing N/A ~ 20 test filters per lot 90% of filters < 4.8 ng Pb/cm2 Reject lot, request new filters from vendor.

Pre Sampling Filter Holding 

Time HTE all filters < 30 days before sampling

Required only if filters will be used for PM10 mass as well 

as Pb. If only used for Pb then 30 day

pre-sampling holding time not required. Reweigh filters 

that exceed pre holding time criteria.

Analysis Audits FAA 6 filters/quarter, 3 at each 

concentration range

10% (percent 

difference) Troubleshoot XRF unit and re-run samples.

Lab Filter Blank LFB 1/ sample run <.003 μg/m3

Investigate areas for contamination including XRF unit, 

work area, petri slides, and background Pb in filter. 

Investigate filter handling procedures.

Thin Film Standards (standard

reference materials) TFS Beginning and end of eachanalytical run

XRF conc. + 3x the 1 

sigma uncertainty 

overlaps the NIST 

certified conc.+ 1x its 

reported uncertainty

Troubleshoot and/or service the XRF unit. Recalibrate and 

rerun samples. Recertify thin film standards if necessary.

Run time quality control 

standards,

checking peak areas, 

background

areas, centroid and FWHM

RTS Beginning and end of each

analytical run Target value + 3 SD Troubleshoot and/or service the XRF unit. Recalibrate and rerun samples.

XRF analyzer calibration

(at least two thin film standards 

per element)

XAC

1/year or when significant

repairs or changes occur or

QC limits exceeded

XRF conc. + 3x the 1 

sigma uncertainty 

overlaps the NIST 

certified conc. + 1x its 

reported uncertainty.

Troubleshoot and recalibrate the XRF unit. Rerun samples.

XRF detector digital signal 

processor calibration XSP 1 per week Within manufacturer specifications Troubleshoot and recalibrate the XRF unit. Rerun samples.
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8.0 Special Training Requirements/Certification

The purpose of this element is to ensure that any specialized or unusual training requirements to 

conduct the Pb-PEP are implemented. Within this element, the procedures are described in 

sufficient detail to ensure that specific training skills can be verified, documented, and updated as 

necessary.

OAQPS has developed a two-fold Pb-PEP training program. The first aspect of the training 

program is to ensure all monitoring personnel have a baseline level of knowledge about the 

Ambient Air Monitoring Network, the principles and operation of the Pb-PEP, and the QA

procedures. This phase of training is ongoing and includes the following:

 National-level conferences and training workshops 

 An air training facility for hands-on experience

 National- and Regional-level conference calls

 Individual sessions upon request

 All documentation of SOPs and current materials used in Pb-PEP training are posted on the 

AMTIC website at http://www.epa.gov/ttnamti1/pbpep.html and on the AIRQA Web site at 

https://www.sdas.battelle.org/AirQA/

Focused training for the Pb-PEP includes the following, and is required at least once every two 

years for staff who conduct Pb-PEP audits.

 Specific, extensive hands-on field and laboratory training sessions, which are sponsored and 

developed by OAQPS, and involve the ESAT contractors, regional personnel, and 

monitoring organization personnel.

 A certification program to “certify” the ESAT field and laboratory personnel. This 

certification will involve a written test, as well as a performance test. Failure of either of 

these tests will result in retraining until the personnel achieve successful certification. 

8.1 OAQPS Training Facilities

EPA, through its regional laboratories and OAQPS, has multiple training facilities, which 

provide the capacity to:

 Develop internal expertise in Pb monitoring and analysis

 Have monitoring equipment readily accessible to EPA staff for questions and concerns 

 Perform field and laboratory training for personnel at EPA, regional, monitoring 

organizations, and ESAT

 Perform special studies (study monitor performance, evaluate measurement uncertainty)

 Perform research studies for future monitoring activities.
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8.2 Training Program

The field and laboratory Pb-PEP training program will involve the following four phases:

Classroom lecture. This will include an overall review of the Pb program and the 

consequential importance of the Pb-PEP. Classroom lectures will also be implemented 

for each training module. Revisions to the training modules and SOPs are made based on 

suggestions from Pb-PEP field scientists and a subsequent annual evaluation and 

consensus of the EPA Pb-PEP WAM/TOPO/DOPOs and the QA Workgroup.

Hands-on activities. After a classroom lecture, personnel will be taken to the training area 

where the field/laboratory activities will be demonstrated, and then the trainees will 

perform the same activity under instruction.

Certification–written exam. A written test will be administered to trainees to cover the 

information and activities of importance in each of the training modules.

Certification–performance exam. This is a review of the actual field implementation 

activities by the trainer/evaluator. Appendix B contains PE forms for this review.

Trainers will include OAQPS personnel from the AAMG QA Team, as well as regional Pb-PEP 

QA staff and contractors who are certified by OAQPS to conduct Pb-PEP field and laboratory 

audits.

8.3 Field Training

All personnel, which include EPA Regional WAM/TOPO/DOPOs and ESAT contractors, will 

be trained before performing Pb-PEP field data collection activities. Representatives of 

monitoring organizations are welcome to attend this training to satisfy the training requirement 

for their implementation of the Pb-PEP.

Field training/recertification will be conducted at a facility designated by OAQPS. One full 

certification course (if needed) and one recertification course will be conducted at least every 

two years. Additional training may be arranged at the discretion of OAQPS.

Field training for full certification may last up to two full days. Trainers are usually required to 

be available after the training for any individual trainees requiring more instruction.

Field training will include the following topics:

 Introduction to the Pb-PEP

 Planning and preparation 

 Filter receipt, storage, and handling 

 Sampler transport, placement, and assembly

 System checks
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 Programming the run

 Filter exposure and concluding the sampling event

 COC 

 Use of FDS 

 Use of the online FDS entry forms and the OAQPS data management Web site

 Data verification via the AIRQA Web site

 QA/QC and information retention

 Troubleshooting in the field: When to perform multipoint verifications and calibrations (not 

typically performed in the field).

8.4 Laboratory Training

Region 9 performs Pb analysis on a routine basis for the Region 9 facilities. Consequently the 

Region 9 laboratory is required to have an established training program for ESAT contractors 

and will not need a separate specific Pb-PEP training related to filter extraction and analysis. 

However, personnel at the XRF contract laboratory are required to have their own training 

program. At both laboratories, personnel specifically used for the Pb-PEP filter analysis will be 

provided additional training related to the following topics that may be more ambient air related:

 Communications

 Filter handling

 COC and use of FDS

 Data entry and data transfer.

These topics could be covered through web-based training, attending the field certification 

training, or by EPA personnel.

8.5 Certification

Certification is required by EPA and will help ensure that field and laboratory personnel are 

sufficiently trained to perform the necessary Pb-PEP activities at a level that does not 

compromise data quality and also inspires confidence in the Pb-PEP by the monitoring 

organizations. This certification is required at least once every two years for EPA regional leads, 

SLT staff, and ESAT contractors who are involved in the Pb-PEP.

Both the written exam and the performance review are considered part of the certification 

requirements. The written exam is gauged to review the more critical aspects of the Pb-PEP and 

to identify where the individual requires additional training. The written test will be generated by 

OAQPS. A score of 90% is required for passing the written exam. The PE is focused on 

ensuring that the individual understands and follows the SOPs. The trainer(s) will evaluate the 

trainees’ implementation of the topics identified in the field and laboratory sections above. 

Appendix B provides the qualitative check forms that will be used during the evaluation of field 

and laboratory performance.
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The intent of the certification activities is not to fail individuals, but to determine where 

additional training is required to ensure that the Pb-PEP is implemented consistently across the 

nation. By testing and evaluating each module, the trainer(s) will be able to identify the areas 

where individuals will require additional training. If many individuals fail a particular 

component, this may indicate that the classroom or hands-on training is not adequate. In any 

case, failure by individuals of parts of either the written or hands-on PE will indicate that more 

training is required. Trainees will be required to attend additional training on these components. 

Trainers will be available for an additional day of field/laboratory training and will ensure that 

personnel are certified by the end of the training session.

If the certification or recertification activities identify individuals who appear to be incapable of

properly performing the field/laboratory activities, the ESAT WAM/TOPO/DOPOs and RPOs 

will be notified to initiate remedial action.

8.6 Additional Pb-PEP Field and Laboratory Training

Annual certifications and recertifications will be arranged and conducted by OAQPS. Personnel

turnover is expected among Pb-PEP contractors and monitoring organizations. Occasionally, the 

Pb-PEP contracts will be awarded to new contractors. This situation will dictate that a second 

full training course needs to be conducted in the same year. The WAM/TOPO/DOPOs will 

contact OAQPS as soon as possible when training is required. The following two options are 

available for training in these circumstances:

 Because WAM/TOPO/DOPOs will be trained and certified along with ESAT contractors, the 

WAM/TOPO/DOPOs are certified to train additional ESAT personnel.

 Individual training arranged at the discretion of OAQPS at its Research Triangle Park (RTP) 

air training facility.

OAQPS will work with the regional Pb-PEP leaders and the WAM/TOPO/DOPOs to determine 

the need for training and what method is logistically the most efficient for all involved.

8.7 Additional Ambient Air Monitoring Training 

Appropriate training will be available to personnel supporting the Ambient Air Monitoring 

Program, commensurate with their duties. Such training may consist of classroom lectures, 

workshops, teleconferences, and on-the-job training. Over the years, many courses have been 

developed for personnel involved in ambient air monitoring and QA aspects. Formal QA/QC 

training is offered through the following organizations:

 EPA, OAQPS, AQAD (http://www.epa.gov/air/oaqps/organization/aqad/io.html)

 Air & Waste Management Association (AWMA) (http://www.awma.org)

 EPA Air Pollution Training Institute (APTI) (http://www.epa.gov/apti)
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 EPA Office of Environmental Information (http://www.epa.gov/quality/trcourse.html)

 EPA regional offices 
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9.0 Documentation and Records 

The purpose of this element is to define the records critical to the project, the information to be 

included in reports, the data reporting format, and the document control procedures to be used.

A document, from a records management perspective, is a volume that contains information and 

describes, defines, specifies, reports, certifies, or provides data or results pertaining to

environmental programs. As defined in the Federal Records Act of 1950 and the Paperwork 

Reduction Act of 1995 (now 44 U.S.C. 3101-3107), records are: “...books, papers, maps, 

photographs, machine readable materials, or other documentary materials, regardless of physical 

form or characteristics, made or received by an agency of the U.S. Government under Federal 

Law or in connection with the transaction of public business and preserved or appropriate for 

preservation by that agency or its legitimate successor as evidence of the organization, functions, 

policies, decisions, procedures, operations, or other activities of the Government or because of 

the informational value of data in them...” 

The following information describes the document and records procedures for the Pb-PEP. In 

EPA’s QAPP regulation and guidance, EPA uses the term “reporting package,” which will be 

defined as all of the information required to support the concentration data reported to EPA. This 

information includes all data required to be collected, as well as data deemed important by the 

Pb-PEP.

9.1 Information Included in the Reporting Package

9.1.1 Data Reporting Package Format and Document Control 

The Pb-PEP has structured its records management system according to EPA’s File Plan Guide 

(see http://www.epa.gov/records/tools/toolkits/filecode). A file plan lists office records and

describes how they are organized and maintained. A good file plan is one of the essential 

components of a recordkeeping system and is key to a successful records management program, 

and can help complete the following:

 Document activities effectively

 Identify records consistently

 Retrieve records quickly

 Determine disposition of records no longer needed

 Meet statutory and regulatory requirements.

The Pb-PEP records management system uses the Agency File Codes (AFCs) to facilitate easy 

retrieval of information during EPA TSAs and reviews. The Pb-PEP records management also 

follows EPA records schedules, which constitute EPA’s official policy on how long to keep 
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Agency records (retention) and what to do with them afterwards (disposition). More information 

on EPA records schedules can be found at the EPA Web site9. 

Table 9-1 includes the documents and records that will be filed according to the statute of 

limitations discussed in Section 9.3, Data Reporting Package Archiving and Retrieval. To 

archive the information as a cohesive unit, all the Pb-PEP information will be filed under the 

major code “Pb-PEP,” followed by the AFC function code and schedule numbers listed in Table 

9-1. For example, Pb-PEP project plans would be filed under the heading “Pb-PEP/301-093-

006.1,” and COC forms would be filed under “Pb-PEP/301-093-006.3.” Each field and 

laboratory SOP provides instruction on the proper filing of data collected during the particular 

procedure.

Table 9-1. Pb-PEP Reporting Package Information

Agency File Code

Category Record/Document Types

Function No.

301-093

006 Program Management Files

006.1 Management

and organization

Organizational structure for the U.S. Environmental 

Protection Agency (EPA) and how the Regions and 

Environmental Services Assistance Team (ESAT) 

contractors fit into running the Pb-PEP Performance 

Evaluation Program (Pb-PEP)

Organizational structure for the support contractors

Pb-PEP project plans and subsequent revisions

Quality Management Plan

006.2 Monitoring site 

information

Site characterization file (site data sheets)

Site maps

Site pictures

Monitoring Organization site contact information

006.3 Field operations and data 

acquisition (by EPA 

Regional staff or 

contractors on behalf of 

EPA)

Quality Assurance Project Plans (QAPPs)

Standard operating procedures (SOPs)

Field logbooks and communications

Sample handling/Chain-of-Custody (COC) Forms

Documentation of instrument inspection

and maintenance

Field testing of Pb-PEP equipment

006.4 Communications 

(contractor technical 

project activity)

Telephone record and e-mail between ESAT contractor 

and monitoring organizations

Telephone record and e-mail between ESAT contractor 

and the Contract Officer’s Representative (COR)

 

9 http://www.epa.gov/records/policy/schedule
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Table 9-1. Pb-PEP Reporting Package Information (Continued)

Agency File Code

Category Record/Document Types

Function No.

301-093 006.5 Communications (EPA 

project activity)

Telephone record and e-mail between EPA Regional or 

headquarters staff and monitoring organizations and 

vice versa

Telephone record and e-mail between EPA Regional 

and other EPA personnel (headquarters to Regions 

and vice versa)

006.6 Equipment and instruments 

used by contractors in the 

Pb-PEP (records about 

charged time to the support 

of the program would 

reference AFC 405-202)

Procurement logs

Inventories of capital equipment, operating supplies, 

and consumables

Repair and maintenance (e.g., vendor service records, 

calibration records)

Retirement or scrapping

405 202 Contract Management Records

202.1 Contract administration Work assignments, task orders, delivery orders, and 

work plans

Contractor monthly reports

Technical directives from the COR to the contractor

Invoices for consumables

Requisite qualifications of field scientists (FSs) and 

laboratory analysts (LA) for Pb-PEP-related, 

contractor-implemented activities

Training records and certificates of ESAT contractors 

conducted and issued by the EPA Regional ESAT 

COR

404-142-01 179 Special Purpose Programs

179.1 Data administration

and integration

Data management plans/flowcharts

Raw data: any original data (routine and quality control 

[QC] data), including data entry forms

Data algorithms

Documentation of Pb-PEP database (PED) 

PM2.5 PED data

Field Data Sheets and COC Forms

404-142-01 173 Data Files Consisting of Summarized Information

173.1 Data summaries, special 

reports, and progress 

reports

Data/summary/monthly field activity reports

Journal articles/papers/presentations

Data validation summaries
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Table 9-1. Pb-PEP Reporting Package Information (Continued)

Agency File Code

Category Record/Document Types

Function No.

108-025-01-

01

237 State and Local Agency Air Monitoring Files

237.1 QA/QC Reports 3-year Pb-PEP QA reports

Pb-PEP data quality assessments

QA reports

Response/corrective action reports

Site audits

405 036 Routine Procurement

036.1 Acquisition of capital 

equipment and supplies by 

EPA (either headquarters 

or Regional office)

Needs assessments and reports

Program copies of purchase requests

Requests for bids or proposals

Proposals, bids, or quotations

Bills of lading

Warranties and certificates of performance

Evaluations of proposals, bids, quotations, or trial 

installations

403-256 122 Supervisors’ Personnel Files and Duplicate Official Personnel Folder 

Documentation

122.1 Personnel qualifications, 

training, and certifications

COR training certifications

Certification as a Pb-PEP FS and/or LA 

Certification as a Pb-PEP FS trainer and/or LA trainer

9.1.2 Notebooks

The following types of notebooks will be required of field and laboratory personnel.

Field/Laboratory Notebooks. The Pb-PEP will require each FS and Laboratory Analyst (LA) 

to keep a notebook. Each notebook will be uniquely numbered and associated with the 

individual and the Pb-PEP. Although data entry forms are associated with all routine 

environmental data operations, the notebooks can be used to record additional information about 

these operations. In the laboratory, notebooks may also be associated with the temperature and 

humidity recording instruments, the refrigerator, calibration equipment/standards, and the 

analytical balances used for this program.

Field/Laboratory Binders. Three-ring binders may be used by each FS and will contain the 

appropriate data forms for routine operations, as well as inspection and maintenance forms and 

SOPs. Laboratories may keep records in their own LIMS.

Sample Shipping/Receipt Notebook. The sample shipping notebook will be kept by the FS and 

include information pertaining to sample shipments to the laboratories. The notebook will be 
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uniquely numbered and associated with the Pb-PEP program. It will include standard forms and 

areas for free-form notes. The laboratories may keep these records as a part of their own LIMS.

Field/Laboratory Communications Notebook. One communications notebook will be issued 

to each FS and LA to record communications. Element 21.0, Reports to Management provides 

more information about this activity.

9.1.3 Electronic Data Collection

All raw data required for calculating Pb concentrations, including QA/QC data, are collected 

electronically or on the data forms that are included in the field and laboratory SOPs. Field 

measurements listed in Element 6.0, Table 6-2 will be collected. Both the primary field and 

laboratory data will be collected electronically and primary data will be used to electronically 

calculate a final concentration. More details about this process can be found in Element 18.0, 

Data Acquisition Requirements, and Element 19.0, Data Management.

Various hard copies are created from electronic systems, such as database reports and 

spreadsheets used by the FS and others. Hard copies that are determined to be permanent record 

(e.g., data that lead to significant findings or conclusions) should be filed as a data reporting 

package to ensure that all Pb-PEP data are properly archived. 

It is anticipated that other instruments will provide an automated means for collecting the 

information that would otherwise be recorded on data entry forms. Information on these systems 

is detailed in Element 18.0, Data Acquisition Requirements, and Element 19.0, Data 

Management. To reduce the potential for data entry errors, automated systems will be used 

where appropriate and will record the same information that is found on data entry forms. To 

provide a backup, a hard copy of automated data collection information will be stored as 

specified by EPA records schedules in project files.

9.1.4 Hand-Entered Data

Some data forms will be entered by hand. These forms can be found at the end of each field and 

laboratory SOP. All hard copy information will be completed in indelible ink. Corrections will 

be made by inserting one line through the incorrect entry, initialing and dating this correction, 

and placing the correct entry alongside the incorrect entry, if this can be accomplished legibly, or 

by providing the information on a new line. 

9.1.5 E-mail and Attachments

EPA and ESAT contractors should use their own in-house e-mail and archiving protocols. All 

Pb-PEP e-mails should be saved or backed up routinely on a network server. Any e-mails or 

attachments that provide documentation noteworthy to the program such as data validation 

investigations, site observations, or official inquiries should be printed and stored in the 

Field/Laboratory Communications Notebook.
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9.2 Reports to Management

In addition to the reporting package, various reports will be required by the Pb-PEP.

9.2.1 Laboratory Monthly Report

The laboratories will provide the oversight designee (TOPO/WACOR/DOCOR) with a written 

progress report at the end of each month. ESAT staffed laboratories will maintain a complete 

record of laboratory monthly progress reports or equivalent as required by the contract. Contract 

laboratories will adhere to the reporting stipulations in the current contract. The 

WACOR/TOCOR/DOCOR may request more information to be included in the monthly reports 

if he/she deems that it is necessary. 

9.2.2 Field Monthly Report

The FS will provide the WAM/TOPO/DOPO with a written progress report at the end of each 

month (the deadline is the 15th calendar day of the following month unless otherwise specified by 

the WAM/TOPO/DOPO). See the Pb-PEP Field SOPs for the details of this report. This monthly 

report will be filed according to the schedule outlined in Table 9-1. If the FS also conducts 

PM2.5 PEP audits, the Pb-PEP and PM2.5 PEP reports may be merged together to avoid 

duplicating work.

The Monthly Progress Report (Form COM-2 from Pb-PEP Hi-Vol Field SOP and Pb-PEP LoVol SOP) will convey the following information:

 Reporting date—The beginning and end date that the report covers

 Reporter—The person who is writing the reports

 Progress—Progress on field activities

 Evaluations scheduled within the reporting date

 Evaluations conducted within the reporting date

 Issues 

 Old issues—Issues reported in earlier reports that have not been resolved

 New issues—Issues that arise within the reporting date 

 Actions—The action necessary to resolve issues, including the person(s) responsible for 

resolving them and the anticipated dates when they will be resolved.

The WAMs/TOPOs/DOPOs may request more information to be included in the monthly reports 

if they deem that it is necessary.
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9.3 Data Reporting Package Archiving and Retrieval

The information listed in Table 9-1 will be retained by the ESAT contractor for 4 years, and it is 

based on a calendar year (i.e., all data from calendar year 2009 will be archived until December 

31, 2013). Upon reaching the 4-year archival date, the ESAT contractor will inform OAQPS and 

the regional Pb-PEP lead that the material has met the archive limit and will ask for a decision 

whether further archiving or disposal should be conducted.
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10.0 Sampling Design

The purpose of this element is to describe all of the relevant components of the Pb-PEP sampling 

design, the key parameters to be estimated, the number and types of samples to be expected, and 

how the samples are to be collected. 

10.1 Scheduled Project Activities, Including Measurement Activities

Element 6.0, Project/Task Description, Section 6.4 details the critical time lines and activities for 

the Pb-PEP.

10.2 Rationale for the Design

This QAPP reflects the EDOs for a QA activity, not a routine monitoring activity. The sampling 

design has been codified in 40 CFR Part 58, Appendix A, Section 3.3.4.4, as described below. 

Each year, one performance evaluation audit, as described in section 3.2.7 of this appendix must 

be performed at one Pb site in each primary quality assurance organization that has less than or 

equal to 5 sites and two audits at primary quality assurance organizations with greater than 5 

sites. In addition, each year, four collocated samples from PQAOs with less than or equal to 5 

sites and six collocated samples at primary quality assurance organizations with greater than 5 

sites must be sent to an independent laboratory, the same laboratory as the performance 

evaluation audit, for analysis.

On or before December 1, the regional WAM/TOPO/DOPOs will select the sites that meet the 

above criteria and compile a list of sites to be audited during the next calendar year. The 

Regional WAM/TOPO/DOPOs, with the assistance of the ESAT contractors, will determine the 

most efficient site visit schedule. This schedule will be based on

 CFR requirements for audit frequency

 Meeting the same monitoring schedule as the routine sampler being evaluated (this prevents 

the site from having to run and post an additional sample for the PE audit to AQS)

 Site proximity (the sites that are closest in proximity to each other can be visited within the 

same day or week).

10.3 Design Assumptions

The intent of the sampling design is to determine that the total measurement bias is within the 

DQOs described in Element 7.0, Data Quality Objectives and Criteria for Measurement. The 

sampling design will allow the Pb-PEP data to be statistically evaluated at various levels of 

aggregation to determine whether the DQOs have been attained. Data quality assessments will 

be aggregated at the following four levels:
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Monitor Type. Monitor/method designation.

PQAO. All monitors within a PQAO.

Region. All contained within an EPA region

National. All monitors and possibly aggregated by method designation.

OAQPS believes it is important to stratify monitors by method designation to assist in the 

determination of instrument-specific bias (i.e., a particular make and model).

The statistical calculations for the assessments are found in 40 CFR Part 58, Appendix A. Once 

both the routine and PE data are in the AQS database, these calculations will be performed on the 

data and will allow for the generation of reports at the levels specified above. 

The DQO for the Pb-PEP is based on how the NAAQS for Pb is determined. Attainment of the

NAAQS for Pb is based on a rolling 3 month average from data collected from individual 

monitors; therefore, it is important to assess the PE data against the DQO at the same frequency 

and level of aggregation. The Pb-PEP data have limited use at the unique monitor level of 

aggregation. At the PQAO and national levels of aggregation, a sufficient amount of Pb-PEP 

data will be available to evaluate bias. The uncertainty of the Pb-PEP data will be controlled and 

evaluated by using various QA/QC samples described in Element 7.0, Data Quality Objectives 

and Criteria for Measurement, and Element 14.0, Quality Control Requirements. For example, 

the aggregation of the collocated samplers over the 3-year period will determine the precision of 

the program. Use of various blanks, verification checks, and inter-laboratory comparison studies 

can help to determine bias.

10.3.1 Representativeness

Representativeness is a measure of the degree to which data accurately and precisely represent a 

characteristic of a population, parameter variations at a sampling point, a process condition, or an 

environmental condition. The Pb-PEP design attempts to represent parameter variations at a 

sampling point by locating a high volume Pb-PEP sampler within 2 to 4 meters of the primary 

routine sampler and by operating the Pb-PEP sampler on the same sampling schedule as the 

routine sampler. In the same way, the low volume Pb-PEP sampler will be placed within 1 to 4 

meters of the primary routine sampler and by operating the Pb-PEP sampler on the same 

sampling schedule as the routine sampler. The assumption is that the air within these areas is 

homogenous; therefore, both monitors will sample the same Pb load. 

10.4 Procedure for Locating and Selecting Environmental Samples

The physical location of the routine monitor is the responsibility of the monitoring organizations 

and does not affect the intent of the PE. Site location information is entered by the monitoring 

organization into the AQS database. The critical piece of information is the AQS site ID (state, 

county, unit, parameter occurrence code), which must be entered into AQS for primary data to be 

loaded into the database. The ESAT FS will have access to this information.
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For each site, the ESAT contractor will complete a Site Data Sheet (Form SD-01) that contains 

the following information:

 AQS site ID

 Monitor parameter occurrence code (POC)

 Method designation

 Monitor make and model

 Site coordinates 

 Network type (SLAMS/Ncore)

 Reporting organization

 Reporting organization contact

 Street address

 Directions to the site (from the Regional office)

 Directions to the site from a major thoroughfare

 Safety concerns 

 Additional equipment needed (ropes, ladders) 

 Closest hospital (address)

 Closest express mail facility

 Closest hardware store

 Recommended hotel (address/phone)

 Important free-form notes

 Closest Pb site 

 Closest PM2.5 site

The information listed above will be kept in a site file (filed by AQS site ID) and included in a 

site notebook for each FS. In addition, maps for each state and city where a monitor is located 

will be acquired. Sites can be placed on these maps along with the site IDs.

Sites will not be visited and samplers will not be set up in conditions that are deemed unsafe. 

Unsafe conditions may include bad weather or monitoring platforms where the FS feels that 

he/she cannot transport or set up the monitor without jeopardizing his/her personnel safety. The 

FS will document the occurrence of any unsafe conditions so that mechanisms can be instituted 

to address the issue. This information will be conveyed to the WAM/TOPO/DOPO.

10.5 Classification of Measurements as Critical/Noncritical

Sections 6.2.2 and 6.3.1 classify the critical field and laboratory measurements for the Pb-PEP. 

Although the field and laboratory SOPs contain many additional measurements, they are 

considered noncritical.
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10.6 Validation of Any Non-Standard Measurements

Because the Pb-PEP is deploying only FRM and FEM samplers and will be operating these 

samplers according to the established SOPs, there will not be any non-standard measurements. 

Also, because the Pb-PEP will be sending its filters to a certified laboratory using an FEM 

method for analysis, there will not be any non-standard measurements from the analysis of the 

filters. 
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11.0 Sampling Methods Requirements

The Pb-PEP provides for measurement of the mass concentration of Pb in ambient air over a

24-hour period. Two sets of SOPs for field sampling (Field Standard Operating Procedures for 

the Federal Lead (Pb) Performance Evaluation Program:Hi-Vol Pb-TSP Audits and Field 

Standard Operating Procedures for the Federal Lead (Pb) Performance Evaluation 

Program:Lo-Vol Pb-PM10 Audits) have been developed for the Pb-PEP and are to be used in all 

sampling activities under this QAPP. The following section will provide summaries of some of 

the more detailed information in the field SOPs. These summaries do not replace the SOPs.

11.1 Sample Collection and Preparation

The use of one portable FRM monitor is required for collecting Pb samples for the Pb-PEP. 

Because the goal is to provide comparable results across the nation, using one make and model 

of portable monitor to evaluate all of the routine monitors is advantageous. Using a single 

sampler model reduces the chances that bias and imprecision among different portable 

instrument models will confound the routine monitor comparisons. 

11.1.1 Preparation

Before conducting an evaluation excursion for the week, the sampling equipment and 

consumables will be inspected to ensure proper operation and adequate supplies are available

based upon the number of sites to be visited. Filters will be requested and stored per SOPs for 

transport to the sites. The filter COC/FDS will be initiated using the AIRQA Web site. Site data 

sheets, which contain information on characteristics for each site, will be available. For initial 

visits, some of the information on the site data sheets may be blank and must be completed 

during the first visit. The Pb-PEP FS will review the site schedule to be sure that they 

understand which tasks will be implemented at the sites they are visiting in a particular audit trip. 

11.1.2 Field Sample Collection

The FS will travel to the monitoring sites to conduct the audits. Access to the monitoring site 

may be granted to the FS via meeting on site or another pre-arrangement. It is recommended, 

but not required, that the site operator be present during the audit. The portable high volume 

FRM monitors will be transported to within 2 to 4 meters of the routine monitor, assembled, and 

systems verified per the Pb-PEP field SOPs. The portable low volume FRM monitors will be 

transported to within 1 to 4 meters of the routine monitor, assembled, and systems verified per 

the Pb-PEP field SOPs. The filters will be installed and the monitor will be set to run on a 

midnight-to-midnight local standard time schedule. The FS will then either perform additional 

tasks as required at this site or proceed to another site for sampling. If there are any delays in the 

sampling schedule, the ESAT FS will contact the affected monitoring organizations and will also 

notify the Regional WAM/TOPO/DOPO.
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Upon completion of sampling, the FS will return to the site(s), remove the sampling filter, 

visually inspect the filter, store it appropriately for transport to the laboratory, and download the 

data per the field SOPs. Each FS will have a laptop and digital data storage media to download 

and store sampler data. The FS should also contact the site operator to determine if the site 

sampler completed its run. If the run was not completed, the site should be re-audited at some 

point during the year.

11.1.3 Filter Transportation

It is important that the filters be properly stored and transported to the laboratory as soon as 

possible. Ideally, filters will be shipped the same day that they are removed from the monitors 

via next-day delivery. Filters and COC/FDSs will be included in the shipment. The FS will 

keep a copy of the FDS/COC Form (to file under Pb-PEP/301-093-006.3) and will record the 

number of filters shipped and the air bill number in the field notebook. On the day of shipping, 

the FS will contact the laboratory via email or phone to make its personnel aware of the shipment 

and to provide the laboratory with the number of filters shipped and the air bill number.

11.1.4 Return to Station

Upon completing a sampling excursion, the FS will return to the regional office and enter the 

FDS/COC data into the electronic form on the Web site. A second copy of the audit’s field 

data will be stored at the field office and provided to the EPA Regional WAM/TOPO/DOPO. 

The WAM/TOPO/DOPO will use the COC/FDS form to QC the FS’s data entry on the Web site. 

The WAM/TOPO/DOPO will mark the audit run as “Approved” if it passes the automated 

critical QC checks. The FS will also ensure that all equipment and consumables are properly 

stored and determine if ordering supplies or performing equipment maintenance are required. 

Vehicles will be serviced as required. The FS will debrief the WAM/TOPO/DOPO on the field 

excursion and will include information about whether the site visits remain on schedule. 

11.1.5 Field Maintenance

A maintenance list will be developed by the Pb-PEP field personnel for all sensitive capital 

equipment. The list will contain columns for item, maintenance schedule, and date that will be 

filled in when maintenance (scheduled or unscheduled) is performed. See Element 15.0, 

Instrument/Equipment Testing, Inspection, and Maintenance Requirements, for this information. 

11.2 Support Facilities for Sampling Methods

The analytical support facilities for the federally implemented Pb-PEP will be provided by the 

Region 9 laboratory in Richmond, CA for the high volume filters and by a contract laboratory 

selected by OAQPS for the low volume filters. These laboratories have been shown to meet the 

MQOs described in Tables 7-2 and 7-3, respectively.
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Revision No: 3

Date: 5/12/2014

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11.3 Sampling/Measurement System Corrective Action Process 

11.3.1 Corrections to the SOPs

The ESAT contractors are responsible for implementing this QAPP and the field SOPs and are 

responsible for the quality of the data. All methods will be reviewed and implemented by the 

ESAT contractors. If changes or corrections are required to the methods or QAPP, the ESAT 

contractor will notify the Regional WAM/TOPO/DOPO in writing. The Regional WAM/TOPO/ 

DOPO will then convey the issue to the Pb ESAT Workgroup, which will review the change and 

attempt to classify it according to the effect that the change would have on the data. The classes 

follow:

 Class 1—The change improves the data and the new procedure replaces the current 

procedure. If the change is found to be acceptable by the ESAT Workgroup, a new SOP 

section will be issued that can be inserted into the compendium. The document control 

information in the heading will contain a new revision number and date. A Quality Bulletin 

will be completed to describe the change, and it will be distributed to all Regional 

WAMs/TOPOs/DOPOs and ESAT personnel.

 Class 2—The change provides for an alternate method that does not affect the quality of the 

data but may provide for efficiencies in some circumstances or be more cost effective. If the 

change is found to be acceptable by the Pb-PEP community, the original SOP will not be 

altered, but an addendum to the procedure will be initiated by EPA OAQPS that describes the 

modification and provides an alternate method.

 Class 3—The change is grammatical in nature and does not reflect a change in the procedure. 

The changes will be highlighted and modified during a Class 1 change (where appropriate) or 

will be corrected during the development of a full revision to the document.

Upon agreement by the ESAT Workgroup to institute a change, hard copies of Class 1 and 2 

changes will be distributed using the Quality Bulletin illustrated in Figure 11-1.
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Revision No: 3

Date: 5/12/2014

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Quality Bulletin

Subject: Number __________________

Date _____________________

Page _________of_________

Supersedes No. ____________

Dated ____________________

Replace and Discard Original

Add Material to Document

Notes:

________________________

 Pb QA Coordinator 

Retain this bulletin until further notice 

Discard this bulletin after noting contents 

This bulletin will be invalid after (Date) _____________ 

This bulletin will be incorporated into quality 

Procedure No. ____________ by (Date) _____________ 

Figure 11-1. Illustration of ESAT Workgroup Quality Bulletin.
Project: PEP QAPP

Element No.: 6.0

Revision No.: 3

Date: 5/12/2014

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11.3.2 Data Operations

Corrective action measures in the Pb-PEP will be taken to ensure that the DQOs are attained. 

There is the potential for many types of sampling and measurement system corrective actions. 

Table 11-1 lists some of the expected problems and corrective actions needed for a well-run PbPEP. Some corrective actions can be addressed in the field while others are better addressed in a 

clean laboratory. This table does not attempt to dictate the appropriate location for repairs or 

troubleshooting but rather gives examples of potential issues and solutions. 

Table 11-1. Field Corrective Action

Item Problem Action Notification

Pre-Sampling Event Activities

Filter 

inspection 

Pinhole(s) or 

tear(s)

1) Additional filters will be brought to the 

site; use one of them. Void filters with 

pinholes or tears

1) Document on the FDS

Leak test Leak outside 

acceptable 

tolerance 

(Table 7-1)

1) Completely remove the flow rate 

measurement adapter, reconnect it, and 

perform the leak test again

2) Inspect all seals and O-rings, replace 

them as necessary, and perform the leak 

test again

3) Check sampler with different leak test 

device

4) Use back-up sampler

1) Document in a log book

2) Document in a log book; 

notify the Regional WAM/ 

TOPO/DOPO; flag the 

data since the last 

successful leak test

3) Document in a log book; 

notify the Regional 

WAM/TOPO/DOPO

Ambient 

pressure 

verification

Out of 

specification 

(Table 7-1)

1) Make sure pressure sensors are exposed 

to the ambient air and are not in direct 

sunlight

2) Call the local airport or other source of 

ambient pressure data and compare that 

pressure to pressure data from the 

monitor’s sensor. Pressure correction 

may be required

3) Connect a new pressure sensor

1) Document on the FDS

2) Document on the FDS

3) Document on the FDS; 

notify Regional 

WAM/TOPO/DOPO
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Table 11-1. Field Corrective Action (Continued)

Item Problem Action Notification

Ambient 

temperature 

verification.

Out of 

specification

(Table 7-1)

1) Make sure that thermocouples are 

immersed in the same liquid at same 

point without touching the sides or 

bottom of the container

2) Use ice bath or warm water bath to 

check a different temperature. If the 

temperature is acceptable, perform the 

ambient temperature verification again

3) Connect a new thermocouple

4) Check the ambient temperature with 

another National Institute of Standards 

and Technology-traceable thermometer

1) Document on the FDS

2) Document on the FDS

3) Document on the FDS; 

notify the Regional WAM/ 

TOPO/DOPO

4) Document on the FDS; 

notify the Regional 

WAM/TOPO/DOPO

Sample flow 

rate 

verification

Out of 

specification 

(Table 7-1)

1) Completely remove the flow rate 

measurement adapter, reconnect it, and 

perform the flow rate check again

2) Perform the leak test

3) Recalibrate the flow rate

4) Verify it again; flow rate must be within 

±5% of limits of linearity

1) Document on the FDS

2) Document on the FDS

3) Document on the FDS; 

notify the Regional 

WAM/TOPO/DOPO

4) Document on the FDS

Sample flow 

rate

Consistently low 

flows are 

documented during 

the sample run.

1) Check programming of the sampler 

flow rate

2) Check the flow with a flow rate 

verification filter and determine if the 

actual flow is low

1) Document in the log book

2) Document in the log book

Post-Sampling Event Activities

Elapsed 

sample time

Out of 

specification 

(Table 7-1)

Check programming; verify power outages Notify the Regional WAM/ 

TOPO/DOPO

Elapsed 

sample time

Sample did not run 1) Check programming

2) Try programming the sample run to 

start while the operator is at the site

1) Document on the FDS; 

notify the Regional 

WAM/TOPO/DOPO

2) Document in the log book; 

notify the Regional 

WAM/TOPO/DOPO
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Table 11-1. Field Corrective Action (Continued)

Item Problem Action Notification

Power Power 

interruptions

Check line voltage Notify the Regional WAM/ 

TOPO/DOPO

Power Liquid crystal 

display (LCD) 

panel is on, but the

sampler is not 

working

Check the circuit breaker Document in the log book

Filter 

inspection 

Torn filter or 

otherwise suspect 

particulate matter 

on the filter

1) Inspect area downstream of where filter 

rests in the sampler and determine if 

particulate matter has been bypassing 

filter

1) Document on the FDS

Data 

downloading

Data will not 

transfer to laptop 

computer

Document key information on the sample 

data sheet; make sure the problem is 

resolved before data are written over in the 

sampler microprocessor

Notify the Regional WAM/ 

TOPO/DOPO

11.4 Sampling Equipment, Preservation, and Holding Time Requirements

This section details the requirements needed to prevent sample contamination, the volume of air 

to be sampled, temperature preservation requirements, and the permissible holding times to 

ensure against degradation of sample integrity. In addition, Element 15.0, Instrument/Equipment 

Testing, Inspection, and Maintenance Requirements, provides information on sampler 

maintenance to reduce the potential of contamination or the collection of samples that do not 

represent the population of interest.

11.4.1 Sample Contamination Prevention

The Pb-PEP has rigid requirements for preventing sample contamination. Powder-free, antistatic 

gloves are worn while handling filters in the laboratory and the field. Filters should remain in 

protective boxes or a container where a few can be taken in the field but remain protected. Upon 

removal of filters from the sampler, they are folded in half lengthwise, placed in a glassine 

envelope and then into a shipping envelope for filter shipping to the laboratory. 

11.4.2 Sample Volume

High volume Pb-PEP audit samplers operate at a rate of 1.1 m3/min to 1.7 m3/min to collect 

approximately 1750 m3of ambient air over a 24 hour period. Low volume Pb-PEP audit 

samplers operate at 16.67 liters per minute to collect approximately 24 m3of ambient air over a 

24-hour period. Sampling time is expected to be 24 hours (midnight to midnight). The sample 

period must not be less than 23 hours or greater than 25 hours. If this occurs, the sample will be 

flagged, the Regional WAM/TOPO/DOPO will be notified, and the audit will not be approved.
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Revision No: 3

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11.4.3 Temperature Preservation Requirements

The glass fiber and Teflon® Pb-PEP filters have no temperature preservation requirements. The 

best practice would be to avoid placing the filters in extreme heat or cold. 

11.4.4 Permissible Holding Times

The glass fiber and Teflon® filters used for the Pb-PEP have no specified holding time 

requirements for the laboratory. The general rule is for the filters to be analyzed within the 

month they are received so they may be validated and posted to the AIRQA Web site at the end 

of the month. In the field, there is no holding time to use the filters, but the 46.2 mm Teflon®

filters should be used within 30 days. After recovery, all filters should be shipped to the 

laboratory as soon as possible to allow the laboratory enough time to analyze the filters by the 

end of the month for validation and posting.
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Revision No: 3

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12.0 Sample Handling and Custody

Due to the potential use of the Pb-PEP data for comparison to the NAAQS and the requirement 

for care in handling the sample collection filters, sample COC procedures will be followed. The 

laboratory SOPs and the field SOPs provide detailed instruction on filter-handling and COC 

procedures, which will not be included in this section.

Due to the amount of PM that is expected on these filters, improper filter handling can be a 

major source of error. Care must be taken when handling both exposed and unexposed filters. 

Filters should be handled in a manner to prevent them from being damaged or contaminated. 

Similarly, rough handling of exposed filters should be avoided because this may dislodge 

collected PM on the filters.

COC forms are used to ensure that

 Filters are processed, transferred, stored, and analyzed by authorized personnel.

 Sample integrity is maintained during all laboratory phases of sample handling and analyses.

 An accurate written record is maintained of sample handling and treatment from the time of 

receipt from EPA, through laboratory procedures, to disposal.

Proper sample custody minimizes accidents by assigning responsibility at each stage of sample 

handling and ensures that problems will be detected and documented if they occur. A sample is 

in custody if it is in actual physical possession of authorized personnel or if it is in a secured area 

that is restricted to authorized personnel. As illustrated in Figure 6-1, which appears in Element 

6.0, Project/Task Description, the FDS/ COC form is printed from the AIRQA Web site and 

follows the filter into the field. The FDS/COC is completed at the end of the audit and is sent to 

the laboratory with the filter. Prior to shipping, the FDS/COC information is entered into the 

AIRQA Web site and the Pb-PEP laboratory’s sample tracking system, where electronic records 

will be kept. In addition, the ESAT auditor will retain a copy of the COC in the field office as a 

record.
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Element No: 13.0

Revision No: 3

Date: 5/12/2014

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13.0 Analytical Methods Requirements

The analytical methods described below provide for the analysis of either TSP glass fiber filters 

or 46.2 mm Teflon® filters in the Pb-PEP. High volume TSP samplers will be used to audit TSP 

monitoring sites and these samplers will use the glass fiber filters. Low volume PM10 samplers 

will be used at low volume PM10 monitoring sites and these samplers will use the 46.2 mm 

Teflon® filters. The Region 9 laboratory will receive and analyze the glass fiber filters using 

ICP/MS, and an OAQPS contract laboratory will receive and analyze the 46.2 mm Teflon® filters 

using XRF.

The Region 9 laboratory provides routine analysis of environmental samples for a number of 

media (air/water/soil) for Region 9. It maintains a compendium of methods for the specific 

analytical technique but also support activities such as glassware cleaning, waste management, 

sample archive etc. The primary analytical methods for the high volume Pb-PEP are the 

extraction technique Standard Operating Procedure 409 Digestion for Lead on Filters and the 

analysis technique Standard Operating Procedure 509 Determination of Lead on Filters by 

ICP/MS. The following sections summarize methods 409 and 509. The 409 and 509 methods 

listed above have passed EPA equivalency testing defined in 40 CFR Part 53 Section 33 and 

been deemed FEMs in accordance with the FRM for high volume sampling listed in 40 CFR Part

50 Appendix G and the FRM for low volume sampling listed in 40 CFR Part 50 Appendix Q. 

The OAQPS contract laboratory will be selected through the EPA contract laboratory 

mechanism. The contract laboratory selected will be required to use an approved FEM for the 

XRF analysis of the 46.2 mm Teflon® filters. The contract laboratory will provide a QAPP and 

an SOP to EPA, and the national Pb-PEP lead will review the documentation. In addition, the 

laboratory will be given audit filters to analyze to verify the laboratory’s precision and minimum 

detection limit (MDL) to ensure that they can provide acceptable precision and quantification. 

The laboratory must be able to demonstrate precision on the test filters to 10% and an MDL of at 

least 0.02 μg/m3. If the method, audit, and documentation are acceptable, EPA will enlist the 

laboratory’s services. 

13.1 Inductively Coupled Plasma Mass Spectrometry Analysis

13.1.1 Extraction of TSP Filters for ICP-MS Analysis (SOP 409) 

The Region 9 SOP 409 provides sample preparation procedures for the determination of lead on 

PM10 filters or TSP filters by ICP-MS. This SOP is based on 40 CFR Part 50, Appendix G—

Reference Method for the Determination of Lead in Suspended Particulate Matter Collected 

from Ambient Air. This SOP extends the scope of the procedure to the digestion of PM10 filters 

and makes further modifications to utilize disposable labware to minimize contamination. 

Deviations from the reference method are described in Appendix A of 409 and the analyte and 

Chemical Abstracts Service (CAS) number are listed in Appendix B of 409.
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In this method, nitric acid is dispensed into a digestion tube containing a PM10 filter or a 3/4 inch 

× 8 inch TSP filter strip. Lead in the filter paper is digested by covering the tube with a watch 

glass and refluxing the sample via a hot block in the dilute acid mixture for 60 minutes. After 

digestion, the tube is allowed to cool. The digestate is then brought up to a final volume of 50 

mL with reagent water, is capped, and shaken thoroughly. The digestate is set aside (with the 

filter in the digestion tube) for at least 30 minutes to allow the nitric acid trapped in the filter to 

diffuse into the digestate. The digestate is shaken thoroughly and allowed to settle for at least an 

hour. The sample is then ready for analysis by ICP-MS using SOP 509 Determination of Lead 

on Filters. 

13.1.2 Analysis of TSP Filters Using ICP-MS Analysis (SOP 509)

SOP 509 provides procedures for the determination of lead in PM10 filter or TSP filter strip by 

ICP-MS. This SOP is based on procedures in EPA Method 200.8, Determination of Trace 

Elements in Waters and Wastes by ICP–MS, Rev. 5.4, May 1994. Deviations from the reference 

method are described in Appendix A of Method 509 and the analyte, CAS number, and 

quantitation limit (QL) are listed in Appendix B of Method 509.

This SOP describes the determination of lead on filter samples by ICP-MS after digestion with 

nitric acid or nitric acid/hydrochloric acid solution. Sample solutions are introduced by 

pneumatic nebulization into a plasma, in which desolvation, atomization, and ionization occurs. 

Ions are extracted from the plasma through a differentially pumped vacuum interface and 

separated on the basis of their mass-to-charge ratio by a quadrupole mass spectrometer. The ions 

transmitted through the quadrupole are detected by an electron multiplier. Ion intensities at each 

mass are recorded and compared to those obtained from external calibration standards to 

generate concentration values for the samples. Results are corrected for instrument drift and 

matrix effects using certified internal quality control standards. Additional corrections are 

applied as necessary to correct for isobaric and polyatomic elemental interferences.

13.1.3 Analytical Equipment and Method

A complete listing of the analytical equipment is found in laboratory SOP 509.

13.2 X-Ray Fluorescence Analysis 

XRF analysis is based on energy dispersive X-ray fluorescence of elemental components in a 

thin film sample. The emissions of X-ray photons from the sample are integrated over time and 

yield quantitative measurements of elements ranging from aluminum (Al) through uranium (U) 

and semi-quantitative measurements of sodium (Na) and magnesium (Mg). A spectrum of X-ray 

counts versus photon energy is acquired and displayed during analysis, with individual peak 

energies corresponding to each element and peak areas corresponding to elemental 

concentrations.

As an example, the PANalytical Epsilon 5 XRF analyzer utilizes a side window dual anode Xray tube with both scandium (Sc) and tungsten (W) anodes. X-rays are focused on one of 11 
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secondary targets, which in turn emit polarized X-rays used to excite a sample. X-rays from a 

secondary target or the tube are absorbed by the sample, exciting electrons to high level orbitals. 

As the electrons return to their ground state, photons are emitted which are characteristic of the 

quantum level jumps made by the electron; the energy of the emitted photons are, therefore, 

characteristic of the elements contained in the sample. The fluoresced photons are detected in a 

solid state germanium X-ray detector. Each photon that enters the detector generates an electrical 

charge whose magnitude is proportional to the photon's energy. The electrical signals from the 

detector are sorted into energy channels, counted, and displayed. A sample spectrum consists of 

characteristic peaks superimposed on a background caused by the scatter of X-rays from the tube 

into the detector.

13.3 Internal QC and Corrective Action for Measurement System

13.3.1 Corrections to the SOPs

The Region 9 methods are reviewed and approved by Region 9 EPA personnel including the 

Region 9 Laboratory Team Lead, the Region 9 Laboratory QAM, and the Region 9 Laboratory 

Director. The ESAT contractors are responsible for implementing this QAPP and the laboratory 

SOPs, and they are responsible for the quality of the data. All methods will be reviewed and 

implemented by the ESAT contractors. If changes or corrections are required to the laboratory 

SOPs or QAPP, the ESAT contractor will notify the Regional WAM/TOPO/DOPO and the 

Laboratory Team Lead in writing. The WAM/TOPO/DOPO will then convey the issue(s) to the 

Pb ESAT Workgroup, which will review the changes and attempt to classify them according to 

the effect the changes would have on the data. 

The contract laboratory methods are reviewed and approved by the contract laboratory as 

needed. New revisions to the SOP will be forwarded to the National Pb-PEP lead at OAQPS. 

The contract laboratory will monitor and assess the changes in the SOP to ensure proper 

implementation.

13.3.2 Data Operations

A QC notebook or database (with electronic backups) will be maintained and will contain QC 

data and entry forms, calibration and maintenance information, and routine internal QC checks. 

Control charts will be maintained for a number of important QC components. These charts may 

allow for the discovery of excess drift that could signal an instrument malfunction. Corrective 

action measures in the Pb-PEP will be taken to ensure data of adequate quality. The laboratory’s

SOPs and Section 14 will provide additional information on these activities. Table 13-1 lists 

several filter preparation and analysis QC checks. 
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Table 13-1. Filter Preparation and Analysis Checks

Activity Method and Frequency Requirements

Action If the 

Requirements Are Not 

Met

Post-sampling 

inspection, 

documentation, and 

verification

Examine the filter and Field Data 

Sheets (FDSs) and COC for correct 

and complete entries.

No damage to filter; FDS/COC 

complete; sampler operated properly

Notify the Pb-PEP 

Laboratory Manager; flag 

filters in LIMS

Filter handling Observe handling procedures Use powder-free and antistatic 

gloves and smooth forceps

(Teflon®).

Flag any mishandled filter 

in the LIMS 

Filter integrity 

check

Visually inspect each filter No pinholes, separation, chaff, loose 

material, discoloration, or filter

non-uniformity

Flag any defective filter 

in the LIMS

Filter identification Ensure filter number of filter and 

FDS/COC are the same. 

Make sure the numbers are written 

legibly and compare

Flag any mislabeled 

sample in the LIMS and 

check with field 

personnel.

Internal QC See Section 14 and analytical SOPs Pass requirements May require repeat 

analysis on extracts or 

second extraction and 

analysis

13.4 Filter Sample Contamination Prevention

The analytical support component of the Pb-PEP has requirements for preventing sample 

contamination. Powder-free and antistatic gloves are worn while handling 46.2 mm Teflon®

filters, and TSP filters are only handled on unexposed edges. The 46.2 mm Teflon® filters are 

only handled with smooth non-serrated Teflon® forceps on the outer reinforcing support ring. 

Laboratory “Best Practices” should be employed while handling filters of any kind.

In the field component of the Pb-PEP, glass fiber filters are handled only on the edges, and the 

filters should be loaded in the transport cassette/carrier in a clean area in the office. The transport 

cassette should have a snap cover that should be in place during handling until the sample is 

loaded onto the high volume sampler. Each glass fiber filter should be packed for shipping in 

individual envelopes, and shipped in a protective envelope. The 46.2 mm Teflon® filters are 

shipped with a plastic lid covering the filter. The Teflon® filters should stay covered and in their 

cassettes to avoid contamination from the field. 46.2 mm Teflon® filters are covered with the 

plastic cap and kept in individual antistatic bags for shipping. Organizations outside the ESAT 

operated Pb-PEP may choose to remove the 46.2 mm Teflon® filters from the cassettes if 

facilities exist where this can be done without risk of contamination.
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14.0 Quality Control Requirements

To assure the quality of data from air monitoring measurements, two distinct and important 

interrelated functions must be performed. One function is the control of the measurement process 

through broad QA activities, such as establishing policies and procedures, developing DQOs, 

assigning roles and responsibilities, conducting oversight and reviews, and implementing 

corrective actions. The other function is the control of the measurement process through the 

implementation of specific QC procedures, such as audits, calibrations, checks, replicates, and 

routine self-assessments. In general, the greater the control that can be achieved of a given 

system, the better the resulting quality of the monitoring data. 

QC is the overall system of technical activities that measures the attributes and performance of a 

process, item, or service against defined standards to verify that the stated requirements 

established by the customer are met. In the case of the Ambient Air Quality Monitoring 

Network, QC activities are used to ensure that measurement uncertainty, as discussed in Element 

7.0, Quality Objectives and Criteria for Measurement Data, is maintained within acceptance 

criteria for the attainment of the DQO. 

14.1 QC Procedures

Day-to-day QC is implemented through various check samples or instruments that are used for 

comparison. The MQO tables (Tables 7-1 to 7-3) in Element 7.0, Quality Objectives and 

Criteria for Measurement Data, contains a complete listing of these QC samples, as well as other 

requirements for the Pb-PEP. The procedures for implementing the QC samples are included in 

the field and laboratory SOPs, respectively. The following information provides some additional 

descriptions of these QC activities, how they will be used in the evaluation process, and what 

corrective actions will be taken when they do not meet acceptance criteria. 

14.1.1 Calibrations

Calibration is the comparison of a measurement standard or instrument with another standard or 

instrument to report, or eliminate by adjustment, any variation (deviation) in the accuracy of the 

item being compared. The purpose of calibration is to minimize bias.

For the Pb-PEP, calibration activities follow a two-step process:

 Step 1. Certifying the calibration standard and/or transfer standard against an authoritative 

standard.

 Step 2. Comparing the calibration standard and/or transfer standard against the routine 

sampling/analytical instruments.
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Calibration requirements for the critical field and laboratory equipment are found in Tables 7-1 

through 7-3; the details of the calibration methods are included in the calibration section (Section

16.0, Instrument Calibration and Frequency) and in the field and laboratory SOPs.

14.1.1.1 Field Calibration Evaluation

Field equipment calibrations will be evaluated using independent NIST traceable standards.

Accuracy of field verification/calibration checks—Single check (quarterly) basis (di). The 

percentage difference, di, for a single calibration check, i, is calculated using 40 CFR Part 58, 

Appendix A, Equation 1, where Xi represents the standard value (known) and Yi represents the 

indicated (measured) value.

100





i

i i

i

X

Y X

d

In general, sampling or analysis will not be conducted unless verifications meet acceptance 

criteria. In the event of a failure, troubleshooting and corrective action will take place and the 

verification/calibration will be performed again. If the instrument cannot be calibrated, a spare 

will be used. If a field situation arises where a spare sampler cannot be used, the sample may be 

taken, but it will be flagged appropriately.

14.1.1.2 Initial and Continuing Laboratory Calibration Verification

An initial calibration is performed daily or for each batch of analysis using a blank and a 

minimum of three calibration standards. A linear calibration forced through zero is used for 

calculation. Refer to Section 7, Table 7.2 for acceptance criteria.

If an initial calibration fails because of one standard, a fresh solution of that standard may be 

reanalyzed and substituted for the standard that failed. If the failure is repeated (or the problem is 

not isolated to one calibration point), the system must be repaired so that the criteria are satisfied 

before any samples are analyzed.

The calibration is verified by the analysis of an initial calibration verification (ICV), calibration 

blank (CB), and source calibration verification (SCV). If the criteria for those standards are not 

met, take corrective action as needed before continuing with analysis, including reanalysis or repreparation and reanalysis of the initial calibration if necessary.

To check instrument performance and verify the accuracy and stability of the calibration, analyze 

an ICV and a continuing calibration verification (CCV) standard. The ICV is analyzed 

immediately following initial calibration and the CCV at a frequency of one per 10 analytical 

samples and at the end of the analytical run. The recovery of the analyte in the ICV and CCV 

are calculated as follows:
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%R

M

T

  100

where

%R = percent recovery of the standard

M = measured concentration of the analyte, μg/L

T = true concentration of the analyte in the ICV/CCV, μg/L

14.1.1.3 Second Source Calibration Verification

Analyze a second source calibration verification (SCV) daily to verify the calibration standards 

and acceptable instrument performance. If the measured concentration is not within + 10% of 

the true value, the method performance is unacceptable. The source of the problem must be 

identified and corrected before proceeding with analyses.

The recovery of the analyte in the SCV is calculated as:

%R

M

T

  100

where

%R = percent recovery of the standard

M = measured concentration of the analyte, μg/L

T = true concentration of the analyte in the SCV, μg/L

14.1.2 Blanks

Blank samples are used to determine contamination arising principally from the following four 

sources: the environment from which the sample was collected/analyzed, the reagents used in the 

analysis, the apparatus used, and the operator/analyst who performed the data operation. The 

following five types of blanks will be implemented in the Pb-PEP:

Field Blank - These provide an estimate of total measurement system contamination. By 

comparing information from laboratory blanks against the field blanks, the contamination from 

field activities can be assessed. Details about using field blanks can be found in the Field SOP. 

The acceptance goal for field blanks is for the blanks concentration to be less than the laboratory 

method detection limit. 

Trip Blank - These are used to measure possible contamination to filters during transportation to 

and from sampling locations. They provide a frame of reference in case field blanks exhibit mass 

gain higher than the acceptance levels. Trip blanks shall represent approximately 10% of all PbPEP filters. Trip blanks should be used in conjunction with field blanks but not at the same 

frequency. Details about using the trip blanks can be found in field SOPs. The acceptance goal 

for trip blanks is for the blanks concentration to be less than the laboratory method detection 

limit. 
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Laboratory Blank -These provide an estimate of contamination occurring at the analytical 

facility. Details about using the laboratory blanks can be found in lab SOP 509.

Calibration Blank - The stability of the baseline must be monitored by analyzing a CB 

immediately after every ICV/CCV standard. If the value of the CB result is less than one half

the QL, the result is acceptable. If the value of the CB result equals or exceeds one-half the QL, 

the analysis may not continue. The cause of the high CB result must be determined and the 

problem corrected. The instrument must be re-calibrated and all samples not bracketed by 

acceptable CB results must be re-analyzed.

Method Blank - Analyze at least one MB with each batch of 20 or fewer field samples in an 

SDG. MB values > 1⁄2 the QL indicate potential laboratory or reagent contamination. Use the 

following guidelines to determine when samples must be re-prepared, re-analyzed, and flagged 

as estimated:

 If the MB analyte value is > 1⁄2 the QL and the sample result is less than five times the MB 

analyte amount, rerun the MB once to verify and if still unacceptable: (1) For PM10 filter, all 

associated results are to be reported and qualified as estimated “J”, (2) For TSP filter strip, 

the MB and all associated samples must be re-prepared and re-analyzed if there is enough 

sample to work with. The associated sample results can also be reported but will be qualified 

as estimated “J”.

 If the MB analyte value is > 1⁄2 the QL and the sample result is non-detected or is greater than 

five times the MB analyte concentration, report sample results without qualification.

14.1.3 Precision Checks

Precision is the measure of mutual agreement among individual measurements of the same 

property, usually under prescribed similar conditions. To meet the DQOs for precision, the PbPEP must ensure the entire measurement process is within statistical control. The following two 

types of precision measurements will be made in the Pb Program:

 Collocated monitoring (see Section 14.1.3.1.)

 Filter duplicates (see Section 14.1.3.2.).

14.1.3.1 Collocated Monitoring

To evaluate the total measurement precision of the Pb-PEP fleet of samplers, collocated 

monitoring study will be implemented. Twice a year, the FS will complete a collocation study. 

One collocation study is defined as setting up and operating an extra Pb-PEP sampler at a routine

monitoring site; repeating the process in a 6 month period until all Pb-PEP samplers have been 

compared. The data from the two Pb-PEP samplers and the SLT sampler will be compared. If 

the Pb-PEP samplers differ by more than 10% using Equation 10 below, the FS will troubleshoot 

the sampler that has the highest percent difference from the SLT sampler. The SLT will be used 
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as a “referee” if there is a difference between the Pb-PEP samplers. This process will be 

completed twice per year. This study will assess bias among the Pb-PEP sampler fleet.

Evaluation of collocated data. Collocated measurement pairs are selected for use in the 

precision calculations only when both measurements are above 0.02 μg/m3. The following 

algorithms will be used to evaluate collocated data. 

Percent difference for a single check (di). The percentage difference, di, for each check is 

calculated by using 40 CFR Part 58 Appendix A, Equation 10, where Xi represents the 

concentration produced from the primary sampler and Yi represents the concentration reported 

for the duplicate sampler.

 

100

/ 2









i i

i i

i

Y X

Y X

d

CV for a Single Check (CVi). The coefficient of variation, CVi, for each check is calculated by 

dividing the absolute value of the percentage difference, di, by the square root of two.

2

i

i

d

CV 

Precision of a single sampler—semi-annual basis (CVj,q). For Pb sampler j, the individual 

coefficients of variation (CVj,q) during the semi-annual period are pooled using 40 CFR Part 58 

Appendix A, Equation 11, where nj,q is the number of pairs of measurements from collocated 

samplers during the semi-annual period.

The 90% confidence limits for the single sampler’s CV are calculated using 40 CFR Part 58, 

Appendix A, Equation 13 (upper confidence limit) and Equation 14 (lower confidence limit).

Precision of a single sampler—annual basis. For particulate sampler j, the individual 

coefficients of variation, CVi, produced during the calendar year are pooled using 40 CFR Part 

58 Appendix A, Equation 11, where nj is the number of checks made during the calendar year. 

The 90% confidence limits for the single sampler’s CV are calculated using Equations 13 and 14.
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Corrective action: Collocated Study. Samplers in a collocation study that measure a CV >10%

require corrective action. The FS will troubleshoot the sampler that has the highest percent 

difference from the SLT sampler. If the CV remains between 10 and 20%, the regional contact

will be alerted to the problem. Paired CVs and percent differences will be control charted to

determine trends. Problems and solutions will be reported as soon as possible to the EPA 

Regional WACOR/TOCOR/DOCOR and appropriately filed under response and corrective 

action reports (Pb-PEP/108-025-01-01-237.1, see Element 9.0, Documentation and Records).

14.1.3.2 Duplicate Laboratory Measurement

Matrix Duplicate (For TSP Filter Strip Only)

One matrix duplicate (MD) must be analyzed for every 20 or fewer field samples. Treat the MD 

as a routine sample.

Calculate the relative percent difference (RPD) using the following equation:

RPD C C

C C

md

md







|  |

( ) / 2

100

where

RPD = relative percent difference

Cmd = measured concentration in the MD, corrected for sample preparation and any dilutions

C = measured concentration in the routine sample, corrected for sample preparation and any 

dilutions

Apply precision criteria in Section 7, Table 7.2 for samples with analyte levels > QL. If control 

limits are exceeded, re-analyze the sample and duplicate once. If the control limits are exceeded 

again, flag the associated sample result as estimated (J).

Laboratory Control Standard Duplicate (For PM10 Filter Only)

Analyze one laboratory control standard (LCS) duplicate with each batch of 20 or fewer samples 

in an SDG. Recovery of analytes in the LCS is calculated as:

%R

M

T

  100xD

where

%R = percent recovery of the standard

M = measured concentration of the analyte, μg/L

T = true concentration of the analyte in the LCS, μg/L
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If the recovery of the LCS does not meet the recovery criteria in Section 7, Table 7.2, re-analyze 

once to verify. If the recovery is still unacceptable, the analyte is judged to be out- of-control 

and the source of the problem must be identified and resolved. All samples associated with the 

out-of-control LCS are to be reported and qualified as estimated “J”.

14.1.4 Accuracy or Bias Checks 

Accuracy is defined as the degree of agreement between an observed value and an accepted 

reference value and includes a combination of random error (precision) and systematic error 

(bias). The following three accuracy checks are implemented in the Pb-PEP Program:

 Field QC

o Flow, Barometric Pressure, Temperature

 Laboratory QC

o Quantitation Limit Standard, Lab Control Standard, Matrix Spike, Sample QC

1.4.1.4.1 Field Bias/Accuracy Quality Checks 

Flow Rate

The Pb-PEP FS will implement a flow rate verification with each setup. Details of the 

implementation aspects of the audit are included in Field SOP Pb-PEPF-5. The verification is 

implemented by measuring the analyzer’s normal operating flow rate using a certified flow rate 

transfer standard. The audit (actual) flow rate and the corresponding flow rate indicated or 

assumed by the sampler are reported. The procedures used to calculate measurement uncertainty 

are described below.

Accuracy of a single sampler—single check (quarterly) basis (di). The percentage difference, 

di, for a single flow rate audit, i, is calculated using 40 CFR Part 58, Appendix A, Equation 1, 

where Xi represents the audit standard flow rate (known), and Yi represents the indicated flow 

rate.

100





i

i i

i

X

Y X

d

Bias of a single sampler—annual basis (Dj). For an individual particulate sampler j, the 

average (Dj) of the individual percentage differences (di) during the calendar year is calculated 

using 40 CFR Part 58, Appendix A, Equation 4, where nj is the number of individual percentage 

differences produced for sampler j during the calendar year.



 

nj

i

i

j

d

n

Dj

1

1

The single sampler acceptance criterion is found in Table 7-1. If the verification violates the 

acceptance criterion, the FS will check the sampling instrument for internal and external leaks, 
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ensure that temperature and pressure are within acceptable ranges, and run the verification 

procedure a second time. If the verification result is still unacceptable, a multipoint verification 

should be performed by the FS. If the multi-point verification indicates that the sampler is 

operating outside of the acceptance criteria found in Table 7-1, a flow rate calibration is required. 

Then the single-point flow rate verification will be repeated. If the sampler fails to meet the 

acceptance requirement after calibration, or a flow rate calibration in the field is not possible, a 

back-up sampler will be used (assuming it meets the acceptance criteria) while the affected 

instrument is being evaluated/repaired.

Barometric Pressure

The TSP sampler has a built-in atmospheric pressure sensor. The sensor’s output is processed to 

allow control of the sampling flow rate to the design value under actual ambient conditions of 

temperature and pressure. 

To perform a routine verification, the barometric pressure sensor reading is verified at ambient 

pressure through comparison with the reading from an external standard of known accuracy. If a 

pressure difference of more than 10 mmHg is observed, a multipoint verification/calibration of 

the pressure-sensing and display system is required before the sampler may be used to perform 

an evaluation.

Temperature

The TSP sampler has a built-in atmospheric temperature sensor. The ambient temperature sensor 

is verified at a single point using an external temperature standard of known, NIST-traceable 

accuracy. If a temperature difference of more than 2oC is observed, a multipoint 

verification/calibration of the temperature sensor is required before the sampler may be used to 

perform an evaluation.

14.1.4.2 Laboratory Bias/Accuracy Checks

Quantitation Limit Standard 

To verify the ability to detect target analytes near the QL, a QL standard (QLS) must be analyzed 

at the beginning of the analytical run and after each 40 analytical samples. The recovery of 

analyte in the QLS is calculated as:

%R =

M

T

x 100

where

%R = percent recovery of the standard

M = measured concentration of the analyte, μg/L

T = true concentration of the analyte in the QLS, μg/L
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If the QLS recovery does not meet the criteria in Section 7, Table 7.2, determine the cause, take 

corrective action, and re-analyze the QLS.

Laboratory Control Standard 

Analyze one LCS with each batch of 20 or fewer samples in an SDG. Recovery of analytes in 

the LCS is calculated as:

%R =

M

T

x 100

where

%R = percent recovery of the standard

M = measured concentration of the analyte, μg/L

T = true concentration of the analyte in the LCS, μg/L

If the recovery of the LCS does not meet the recovery criteria in Section 7, Table 7.2, re-analyze 

once to verify. If the recovery is still unacceptable, the analyte is judged to be out- of-control 

and the source of the problem must be identified and resolved. (1) For PM10 filter, all associated 

results are to be reported and qualified as estimated “J”, (2) For TSP filter strip, the MB, LCS, 

and all associated samples must be re-prepared and re-analyzed if there is enough sample to 

work with. The associated sample results can also be reported but will be qualified as estimated 

“J”.

Matrix Spike (For TSP Filter Strip Only)

The matrix spike (MS) is designed to provide information about the effect of sample matrix on 

the measurement system. One MS sample must be prepared for every 20 field samples in an 

SDG. Spike a filter strip with lead prior to any sample preparation. The spiking level must be 

the same as that used for the LCS.

Samples identified as field blanks cannot be used for MS sample analysis. MS recovery is 

calculated as:

%R

Cms C

s

 



100

where

%R = percent recovery

Cms = measured concentration of analyte in the MS, corrected for sample preparation and any

dilutions

C = measured concentration of analyte in the routine sample corrected for sample preparation 

and any dilutions

s = expected spiked analyte concentration in the MS, corrected for sample preparation and any 
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dilutions

If the value of C is less than four times the value of s, apply accuracy and precision criteria in 40 

CFR Part 58 Section 4.4. If the value of C is greater than four times the value of s, %R is not 

calculated. If the MS does not meet these criteria, examine other QC results to determine if a 

matrix problem exists. If laboratory performance is in control, the poor MS accuracy is likely to 

be matrix-related. Flag any out-of-control results as estimated “J”.

Sample QC

Internal Standard Response - Monitor the signal intensity for the internal standard masses 

throughout the analytical run. This information is useful in detecting instrument drift, sensitivity 

shift; dissolved solids content, and inherent internal standard (i.e., a natural constituent in a 

sample). The absolute intensity of the internal standard must not deviate more than 60 to 125% 

from its original intensity in the calibration blank. If deviations greater than these are observed, 

examine the internal standard intensities with the following actions:

 If the intensities of the internal standards for the ICV, CCV, or CB are out of control, 

recalibrate and re-analyze the samples affected by the out-of-control internal standards.

 If the intensities of the internal standards for the ICV, CCV, and CB are within control limits 

but sample internal standards are out-of-control, rerun the sample or rerun at an appropriate 

dilution.

 Report results from the original, undiluted, or least diluted sample where the internal 

standards are within the acceptance limits.

14.2 Sample Batching—QC Sample Distribution

To ensure that the Pb-PEP includes all types of QC samples within an analysis session, the PbPEP will use the concept of sample batches. A batch of samples will consist of the samples 

indicated in Table 14-1. QC samples will be interspersed within the batch to provide data quality 

information throughout the analytical session. The definition for each QC sample and how they 

are developed can be found in the field SOP for the field and trip blanks (FB, TB) and in the 

Laboratory SOP-509 for the laboratory QC checks.
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 Table 14-1 QC Sample Distribution

Seq. Description1 Seq. Description Seq. Description

1 CB 15 S2 29 S14

2 Cal Std 1 16 S3 30 CCV

3 Cal Std 2 17 S4 31 CB

4 Cal Std 3 18 CCV 32 S15

5 Cal Std 4 19 CB 33 TB

6 ICV 20 S5 34 S17

7 CB 21 S6 35 S18

8 SCV 22 FB 36 S19

9 QLS 23 S8 37 S20

10 MB 24 S9 38 CCV

11 LCS 25 S10 39 CB

12 S1 26 S11 40 QLS *

13 S1-MD 27 S12 41

14 S1-MS or LCS-D 28 S13 42

1

- See Table 7-2 for QC Codes.

NOTE: *Analyze another QLS if more than 40 analytical samples are to be analyzed.
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 15.0 Instrument/Equipment Testing, Inspection, 

and Maintenance Requirements

The purpose of this element in the Pb-PEP QAPP is to discuss the procedures used to verify that 

all instruments and equipment are maintained in sound operating condition and are capable of 

operating at acceptable performance levels. All instrument inspection and maintenance activities 

are documented and filed under Pb-PEP/301-093-006.3. See Element 9.0, Documentation and 

Records, for document filing and record details.

15.1 Testing

All TSP samplers used in the Pb-PEP will be designated FRM monitors that have been certified 

as such by EPA; therefore, the samplers are assumed to be of sufficient quality for the data 

collection operation. Testing of such equipment is accomplished by EPA through the procedures 

described in 40 CFR Part 53. Annually, prior to deployment, the FSs within each region will 

assemble and run all the samplers at the regional site (full collocation). The FSs will perform 

temperature, time, date, pressure, and flow rate single-point verification checks every day of PE 

audit sampling. If any of these checks are out of specification (see Tables 7-1 and 7-2), the FS or 

WAM/TOPO/DOPO will initiate troubleshooting procedures, which may include multipoint 

verification checks and calibration. If the problem cannot be located and the sampler continues 

to fail the verification checks, the sampler cannot be used for the PE. The FS should use an 

alternate sampler and return the sampler to the laboratory for maintenance. If the sampling 

instrument meets the acceptance criteria, it will be assumed to be operating properly. If a new 

sampler is acquired for use in the Pb-PEP, it should be subject to a collocation with a sampler 

shown to be performing satisfactorily in a prior collocation. The results should comply with 

acceptance criteria for a routine collocation study. If new upgraded FRM sampler hardware is 

introduced, the same type of testing will be conducted. These tests will be properly documented 

and filed under Pb-PEP/301-093-006.3. 

The Pb-PEP laboratories will use ICP-MS for analyzing the glass fiber filters, and XRF for 

analyzing the 46.2 mm Teflon® filters for Pb in PM10. The ICP-MS method contains two general 

stages of operation; sample extraction and sample analysis. At the sample extraction stage, 

testing will include the analysis of reagents to ensure they are not contaminated. These tests 

occur in every sample batch. Also, the hot block equipment will be tested during each extraction 

with the use of a NIST traceable thermometer to ensure proper extraction temperatures. Prior to 

sample analysis, the laboratory will run a number of calibration checks to ensure proper 

operation of the analyzer. In addition the QC samples described in Table 7-2 can help to 

determine proper operation of the ICP-MS analyzer. The XRF method generally involves a 

sample analysis without extraction. Prior to sample analysis, the laboratory will run a number of 

calibration checks to ensure proper operation of the analyzer. In the same manner, the QC 

checks described in Table 7-3 can help to determine the proper operation of the XRF analyzer.
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15.2 Inspection

Inspection of various equipment and components can be subdivided into the laboratory and field 

activities. 

15.2.1 Inspection in the Laboratory

There are several items that need routine inspection in the laboratory. Table 15-1 details the 

items to inspect and summarizes how to appropriately document the inspection.

Table 15-1. Inspections in the Laboratory

Analysis 

Method Item

Inspection 

Frequency

Inspection

Parameter

Action If Item 

Fails Inspection

Documentation

Requirement

ICP-MS Pipettes, 

glassware

Weekly Certification 

status, physical 

condition

Recertify or 

replace 

glassware

Document in log 

book or bench sheet

Standards 

and reagents

Monthly Certification 

status

Recertify or 

discontinue use

Document in log 

book or bench sheet

Hot block Before and 

during 

digestion

Achieves proper 

temperature

Discontinue use 

and service hot 

block

Document in log 

book or bench sheet

ICP-MS 

Autosampler

Before each 

run

Physical 

operation, 

cleanliness

Clean and/or 

service unit

Document in log 

book or bench sheet

XRF XRF 

Analyzer

Before each 

run

Physical operation 

cleanliness

Clean and/or 

service unit

Document in log 

book or bench sheet

Thin film 

standards

Weekly Dents, scratches, 

discoloration

Verify film, 

replace if 

necessary

Document in log 

book or bench sheet

15.2.2 Inspection of Field Items

There are several FRM sampler parts to inspect in the field operation’s maintenance area and in 

the field before and after a Pb sample has been taken. Checks specific to high volume or low 

volume sampler are denoted by footnotes. Table 15-2 details these inspections.
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Table 15-2. Inspection of Field Items 

Item

Inspection 

Frequency

Inspection

Parameter

Action If Item Fails 

Inspection

Documentation 

Requirement

Sampler unit Prior to each 

sampling run

Contamination, 

particulate matter

Clean with 

laboratory wipe and 

water 

Document in the log 

book

Gasket 

inspection a

Before and after 

assembly

Not broken, seats 

correctly, no damage

Replace with new 

gasket

Document in the log 

book

Sample 

downtube b

Before each 

sampling event 

Visible particulate Clean with a dry 

cloth

Document in the log 

book

O-ringsb Before each 

sampling event

Not broken, seats 

correctly, no damage

Replace o-rings Document in log 

book

Calibration and 

working 

standards

Before each 

sampling event

Cleanliness, damage Clean the standard 

and verify 

calibration/ ship to 

vendor for repair

Document in log 

book and complete 

REC-01, REC-02 

forms (Pb-PEP SOP 

Section 2) 

Filter 

shipments

After each 

shipment 

receipt, before 

leaving on audit 

Correct number and 

COCs are present

Contact laboratory to 

reconcile 

discrepancy

Document in log 

book or COM-1 

(Pb-PEP SOP 

Section 2)

Filters Prior to each 

sampling event

No contamination, 

pinholes, 

discoloration

Void filters and 

return to laboratory

Document in log 

book 

a

 Applies to high volume sampler only

b

 Applies to low volume sampler only

15.3 Maintenance

There are many items that need maintenance attention in the Pb-PEP. This section describes 

those items according to whether they are laboratory or field activities.

15.3.1 Laboratory Maintenance Items

The successful execution of a maintenance program for the Pb-PEP laboratories is essential to 

the success of the Pb-PEP. Table 15-3 and 15-4 provide information on laboratory preventive 

maintenance. Maintenance is completed through the laboratory supervisor or the analyzer 

vendor.
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Table 15-3. Maintenance for ICP-MS Pb-PEP Laboratories 

Item Frequency Comments

Auto-sampler Rinse 

Station Reservoir

As needed Fill with 2% HN03.

Pump Tubing Daily Check for fatigue and wear. Replace as needed.

Cones Daily

Weekly

Inspect for sample residues. Wipe clean or replace 

with clean cone as needed.

Remove and inspect condition of cones. Replace if 

needed.

Torch Tip Daily Check for sample residues. Replace with clean 

glassware if needed.

Argon Dewar Daily Check for sufficient amount and pressure. Order as 

needed.

Autodiluter Daily Rinse thoroughly with reagent water after each use.

Auto-sampler and 

Peristaltic Pump

Weekly Wipe spills or residues.

Nebulizer Spray Weekly Check, unclog or replace if needed.

Glassware Weekly Inspect and clean if needed.

Glassware & Cone 

alignment

Weekly Perform X-Y alignment, if needed.

Air filters Monthly Clean or replace as needed.

Chiller Coolant Monthly Check level and top off as needed.

Vacuum Oil Monthly Check level and color, replace with fresh one if 

needed.

Table 15-4. Maintenance for XRF Pb-PEP Laboratories

Item Frequency Comments

Liquid nitrogen dewar Weekly Check level and top off as needed, calibrate nitrogen 

level

X-ray tube cooling water 

vessel

Weekly Check level and top off as needed per vendor direction

Vacuum pump oil Weekly Check level and top off as needed per vendor direction

A LIMS should be used to manage raw data from the analyzers. These LIMS systems should be 

backed up weekly to a central server to guard against data loss. A monthly backup of the 

network file shares used to store and operate the AIRQA database will be performed by EPA 

contractor(s) according to policies established by EPA Office of Administration and Resource 

Management. 

15.3.2 Field Maintenance Items

There are many items associated with appropriate preventive maintenance of a successful field 

program. The Pb-PEP field SOPs (high volume and low volume methods) provide procedures 

for cleaning important components of field equipment. These SOPs can be found on the AIRQA 

Web site under Pb-PEP, Documentation. Table 15-5 details the appropriate maintenance checks 
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of the Pb-PEP samplers and their frequency. Footnotes identify elements specific to the high 

volume or low volume samplers.

Table 15-5. Preventive Maintenance of Field Items

Frequency Maintenance item

Every visit 1. Inspect sampler and verification/calibration equipment for damage 

2. Inspect filter holder frame and rubber gasket for damage a

3. Inspect o-rings b

4. Inspect downtube b

Quarterly (every 3 months) 1.Clean sampler inlet surfaces

2.Clean interior of sampler unit

3.Check condition of sample transport containers

4.Inspect vacuum tubing, tube fittings, and other connections to pump and 

electrical components; service if necessary

5.Clean downtube b

a

 Applies to high volume sampler only

b

 Applies to low volume sampler only
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16.0 Instrument Calibration and Frequency

This element of the Pb-PEP QAPP concerns the calibration procedures that will be used for 

instruments involved in the environmental measurements. Tables 7-1 through 7-3 indicate the 

instruments that require verification and calibration, the required frequencies of these activities, 

and the acceptance criteria for these activities. All calibration activities/procedures are described 

in more detail in the Field and Laboratory SOPs. 

Calibrations that involve instrument adjustments should only be accomplished when it is obvious 

that calibration is required; therefore, the Pb-PEP uses a three-phase approach to calibration, 

which involves the following:

 One-point verification—These verifications ensure that the calibration is within acceptance 

limits by performing frequent one-point verifications that do not include instrument 

adjustments.

 Multipoint verification—Similar to one-point verifications, these occur at established 

frequencies, as well as when there is a failure of a one-point verification. These multipoint 

verifications do not include instrument adjustments.

 Calibration—This occurs when there is a failure of a verification. Instrument adjustment 

occurs at this point and is followed by a one-point verification. 

16.1 Instrumentation Requiring Calibration

16.1.1 Laboratory Equipment

ICP-MS

The Region 9 ICP-MS analyzer will require calibration. The lab will perform an initial 

calibration daily or for every analytical batch, whichever is more frequent and a continuing 

calibration verification. These calibrations are described in Section 14. Refer to Table 7-2 for 

frequency, acceptance criteria, and corrective action requirements.

XRF

XRF analyzers typically will require two calibrations; a detector calibration and an analyzer 

calibration. The detector contains a digital signal processor that is calibrated by repeatedly 

measuring the beam stop inside the unit. The detector calibration will be completed on a weekly 

basis. The analyzer is calibrated by analyzing thin film standards. Using at least two standards 

for each element, the unit calculates a linear regression line. A full analyzer calibration is 

completed if the daily quality control standard falls outside acceptable limits or when significant 

repair or maintenance is conducted on the unit. Refer to Table 7-3 for frequency, acceptance 

criteria, and corrective action requirements.
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16.1.2 Field Equipment

TSP Portable Sampler

Upon receipt of a new portable sampler, multipoint verifications will be performed. Multipoint 

verifications and calibrations typically occur at the field office or laboratory. Refer to Table 7-1 

for frequency, acceptance criteria, and corrective action requirements.

The following verifications are routinely performed in the field:

 Verification of the sampler’s temperature probes against the working temperature standard

 Verification of the sampler’s barometric pressure against the working pressure standard

 Verification of the sampler’s volumetric flow rate against the working flow standard

 Verification of the sampler’s internal clock against a known time standard. 

Temperature Probes

The portable sampler contains an ambient temperature probe. At every sampling event, the FS 

will perform a one-point field verification of the sensor using a digital NIST-traceable 

temperature probe (e.g., BGI HiVolCal Model HC-2). A different NIST-traceable calibration 

device will be used in the field office as a primary standard to perform multipoint temperature 

verifications once a year or after there has been a one-point verification failure. If the multipoint 

verification fails to meet the acceptance criteria, a temperature calibration will be performed. 

Following a calibration where an adjustment is necessary, the working standard will be used to 

verify the calibration.

Barometric Pressure

A NIST-traceable calibration device (e.g., BGI HiVolCal Model HC-2) will be used in the field 

for one-point verifications of the portable sampler’s pressure sensor during each sampling event. 

A different NIST-traceable calibration device will be used in the field office as a primary 

standard to perform multipoint pressure verifications once a year or after there has been a onepoint verification failure. If the multipoint verification fails to meet the acceptance criteria, a 

barometric pressure calibration will be performed. Following a calibration where an adjustment 

is necessary, the working standard will be used to verify the calibration.

Time Standard

The FS will check the time standard’s time and date using the atomic clock, which can be found 

on the Internet at http://www.time.gov or through a known time standard (e.g., cell phone). 

Times can be checked each day before heading to the field, particularly where there is no cell 

phone service at the sampler location(s). Samplers should be set up based on the local 

standard time.
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Date: 5/12/2014

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Flow Rate 

Before every sampling event, after leak checks, temperature, and pressure verifications are 

performed, a one-point flow rate verification will be performed using a NIST-traceable 

calibration device (e.g., BGI HiVolCal Model HC-2). It is essential that the flow check be 

performed after the other verifications because the total flow volume is calculated using the 

ambient temperature and pressure. A different NIST-traceable calibration device will be used in 

the field office as a primary standard to perform multipoint pressure verifications once a year or 

after there has been a one-point verification failure. If the multipoint verification fails to meet 

the acceptance criteria, a flow rate calibration will be performed. Following a calibration where 

an adjustment is necessary, the working standard will be used to verify the calibration.

16.2 Calibration Method That Will Be Used for Each Instrument

The calibration methods are described in detail in the field and laboratory SOPs. 

16.3 Calibration Standard Materials and Apparatus

Table 16-1 presents a summary of the specific standard materials and apparatus used in 

calibrating measurement systems for parameters necessary to generate the quality Pb data 

required. All of the standards meet the acceptance requirements for Tables 7-1 through 7-3 and 

will be NIST-traceable. 
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Table 16-1. Calibration Standards and/or Apparatus for Pb Calibration

Parameter

Standard (S) 

Apparatus (A) Description

Accuracy

or Resolution

Manufacturer’s 

Name Model Number

Field 

Equipment

Temperature A Multi-parameter 

calibrator

Accuracy ±0.2°C

Resolution 0.1°C

BGI HiVolCal HC-2

Pressure A Multi-parameter 

calibrator

Accuracy ±0.1%

Resolution 0.01 psig

BGI HiVolCal HC-2

Flow Rate A Multi-parameter 

calibrator

Accuracy 0.75% of 

reading

Resolution 

0.1mL/min

BGI HiVolCal HC-2

Lab Standards

Pipettes & 

Volumetric 

flasks

A Class Aa

Reagents

HNO3 S

trace metals grade or 

betterb Baker InstraAnalyzed

Stock Standards S NIST Traceablec Spex or Inorganic 

Ventures

Argon gas 

supply, 

S high-purity 

grade,99.99%

Film standards S 50 μg/cm2 thickness 

standards certified to 

±5%

Micromatter

a Class A Pipettes meet all the requirements of American Society for Testing and Materials (ASTM) E 969-95. Compliance with 

the Class A Pipette requirements and other laboratory certifying groups is indicated by the letter “A” near the top of each pipette. 

All pipettes are calibrated in accordance with ASTM E 542 and meet the accuracy requirements of ASTM E 969; borosilicate 

glass meets ASTM E 438 for Type I, Class A requirements.

b Only materials that conform to the American Chemical Society (ACS) specifications such as reagent grade or better will be 

used.

c

ICP & ICP-MS standards are assayed by validated ICP and wet chemical procedures to obtain the certified value. Every standard 

is traceable to a specified NIST SRM. The NIST-traceable density is available on the certificate.

16.4 Calibration Frequency

See Tables 7-1 through 7-3 for a summary of calibration frequencies.

All calibration events, as well as sampler and calibration equipment maintenance, will be 

documented in field/lab data records and notebooks as indicated in the field and laboratory 

SOPs. The records will normally be controlled by the ESAT FSs or LAs and located in the 

laboratory or field offices when in use. Eventually, all calibration records will be appropriately 

filed under Pb-PEP/301-093-006.6 (see Element 9.0, Documentation and Records).
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16.5 Standards Recertifications

16.5.1 Field Standards 

All primary/calibration and working standards will be certified every year as NIST-traceable 

using the EPA Metrology laboratory in RTP, NC. OAQPS will work with the regional offices to 

find an appropriate time frame to conduct re-certifications on the field instruments.

16.5.2 Lab Standards

All glassware will be calibrated in accordance with ASTM E 542 and meet the accuracy 

requirements of ASTM E 969; borosilicate glass meets ASTM E 438 for Type I, Class A 

requirements. ICP and ICP-MS standards are assayed by validated ICP and wet chemical 

procedures to obtain the certified value. Every standard is traceable to a specified NIST SRM. 

XRF thin film standards will be replaced when the stated manufacturer’s tolerances are outside 

of control limits. 
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17.0 Inspection/Acceptance for Supplies and Consumables

17.1 Purpose

The purpose of this element is to establish and document a system for inspecting and accepting 

all supplies and consumables that may directly or indirectly affect the quality of the Pb-PEP data. 

The Pb-PEP relies on various supplies and consumables that are critical to its operation. By 

having documented inspection and acceptance criteria, consistency of the supplies can be 

assured. This element details the supplies/consumables, their acceptance criteria, and the 

required documentation for tracking this process.

If the Pb-PEP program is being operated in conjunction with the PM2.5 PEP, the acceptance and 

testing of equipment, supplies and consumables may be inspected and documented with the 

PM2.5 PEP supplies using the requirements located in Section 17 of the PM2.5 QAPP. In the 

same way, equipment common to both programs should be shared. This practice will reduce the 

duplication of effort that could result by implementing the programs separately.

A number of forms will be discussed in the following sections. These forms are found in the 

Field and Laboratory SOPs, but examples of them are placed at the end of this section. They are:

 Field/Laboratory Inventory Form (INV-01) (Figure 17-1)

 Field/Laboratory Procurement Log Form (PRO-01) (Figure 17-2)

 Field/Laboratory Equipment/Consumable Receiving Report Form (REC-01)

(Figure 17-3).

17.2 Critical Supplies and Consumables

This section attempts to describe the needed supplies for the Pb-PEP and includes items for the 

laboratory and the field. Generally, critical field and laboratory equipment has been selected by 

the Pb-PEP organizers based on the required performance specifications of resolution, accuracy, 

and ease of use. 

17.2.1 Laboratory Supplies

Table 17-1 is a list of the laboratory equipment required for the ICP-MS analysis of glass fiber 

filters conducted by the Region 9 laboratory. Equipment that is not deemed critical (affecting 

data quality) has been left to the Laboratory Manager to select. To maintain consistency in the 

PE program, all consumables/equipment with a model number (as shown in Table 17-1) will be 

purchased using the same model number when supplies run low. The LA is required to keep an 

inventory of all equipment using Field/ Laboratory Inventory Form (INV-01), which is shown in 

Figure 17-1. A general list of equipment and consumables for the XRF analysis of the 46.2mm 

Teflon® filters is provided; however, the details may change according to vendor.
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Table 17-1. Laboratory Equipment

ICP-MS

Activity Description Details

Preparation Logbook

Hot Block Digestion System

Bound with numbered pages

Environmental Express or equivalent

Pipettors Variable volume for dispensing reagents and acids

Pipettes Calibrated fixed volume and digital variable volume with 

appropriate plastic tips

Nitric Acid (HNO3), concentrated ACS Reagent Grade or better, suitable for trace metals analysis.

Gloves Powder-free gloves

Tweezers Teflon non-serrated

Polypropylene Digestion Vessels Environmental Express P/N SC505 or equivalent

Ribbed Watch Glass, Environmental Express P/N SC505 or equivalent

Polycarbonate Transfer Racks Environmental Express P/N SC200 or equivalent

Paper cutter or scissors Any house wares vendor

Plastic or Teflon wash bottles Capable of dispensing reagent for cleaning

Glass Fiber Filter EPA National Filter Procurement

Teflon Filters EPA National Filter Procurement

Stock Standards Spex or Inorganic Ventures

Analysis ICP-MS Perkin Elmer Elan DRC Plus

Autosampler Cetac Autosampler, or equivalent

Autodilutor Cetac Autodilutor, or equivalent

Peristaltic Pump Gilson Minipuls3 Peristaltic Pump, or equivalent

Refrigerated Circulator Polyscience 6105 - Refrigerated Circulator, or equivalent

Argon gas supply High-purity grade, 99.99%

Auto-sampler tubes

Volumetric flasks, Class A graduated cylinders, and funnels (glass and/or metalfree plastic)

Volumetric pipettes Class A 

Storage bottles Narrow-mouth with screw closure, 125-mL to 1-L capacities

Automatic pipettes Capable of delivering volumes of 10 to 1,000 μL

Disposable pipette tips Metal-free

XRF

Activity Description Details

Preparation Logbook Bound with numbered pages, may include bench sheets

Methanol ACS Reagent Grade or better

Squeeze bottle Capable of dispensing reagent for cleaning

Stainless Steel Tweezers Millipore flat tipped tweezers P/N 62-000067 or equivalent

Kimwipes Large and small P/N 34255 and P/N 34155 or equivalent

Mylar sheets 2” x 2” precut squares

Vacuum oil Analyzer specific

Analysis X-ray Fluorescence PANalytical Epsilon 5 EDXRF or equivalent

Liquid Nitrogen Detector cooling
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As consumables run low or when new equipment purchases are necessary, the LA will be 

responsible for assisting in the procurement of these items following the policy and requirements 

described in the ESAT scope of work. The LA should continue purchasing consumable 

equipment with the same model numbers as the equipment initially procured unless the Pb-PEP 

Laboratory Manager suggests a different item due to improved quality, reduction in 

contamination, improved ease of use, or lower cost (without sacrificing quality). Such changes 

should be coordinated with the WACOR/TOCOR/DOCOR. The Pb-PEP Laboratory Manager 

will also present any such proposed equipment changes to the National Pb-PEP Project Lead for 

approval. The following procedures will be performed by the LA:

 Develop procurement requests as per EPA requirements.

 Upon order, add items to the Field/Laboratory Procurement Log Form (PRO-01).

 Once a month, provide a copy of the PRO-01 to the Pb-PEP Laboratory Manager and the 

laboratory services ESAT WACOR/TOCOR/DOCOR.

 File PRO-01 under Agency file code “Pb-PEP/301-093-006.6.”

17.2.2 Field Equipment and Supplies

The field equipment and supplies are listed in Table 17-2. Quantities for some items in Table 

17-2 are not shown because they will vary with the size of the field operation (number of 

samplers and auditors). The FS is required to keep and inventory all equipment, which include 

any warranty information.
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Table 17-2. Field Equipment and Supplies

Activity Required Equipment Identified Source

Initial Set-up Knife Available through PM2.5 PEP

Tool kit (screw driver, pliers, etc.) Available through PM2.5 PEP

Checks Transfer standards (1 per region) BGI Hi-Vol calibrator performs 

flow/temp/pressure

Watch/clock check device Available through PM2.5 PEP

Maintenance Cleaning solution Available through PM2.5 PEP

Soft bristle brush Available through PM2.5 PEP

Cotton swabs Available through PM2.5 PEP

Cleaning cloth Available through PM2.5 PEP

Distilled water Available through PM2.5 PEP

Isopropyl Rubbing Alcohol Available through PM2.5 PEP

Operation FRM portable high volume audit sampler Tisch TE-5170 or equivalent

Backup FRM portable high volume audit sampler Tisch TE-5170 or equivalent

FRM portable low volume audit sampler

Backup FRM portable low volume audit sampler

BGI PQ-200A or equivalent through 

PM2.5 PEP

BGI PQ-200A or equivalent through 

PM2.5 PEP 

Permanent marker Sharpie

Sampler transport cassette(1 set) Available from sampler vendor

Ropes Available through PM2.5 PEP

Folding ladder Available through PM2.5 PEP

Gloves (powder free) Fisher Scientific FB GLV LTX PF or 

equivalent

Laptop computer Available through PM2.5 PEP

Field data sheet (FDS)/ Chain of custody (COC) Begun electronically from AIRQA 

Web site

TSP filters EPA National Filter Procurement

Field blank filters EPA National Filter Procurement

Shipping Glassine envelope for 8” x 10” high volume filters

Manila envelope for 8” x 10” high volume filters 

www.clearbags.com 10 3/8 x 4 1/2 

Glassine Open Side [G25] or 

equivalent

www.officemax.com #12 Kraft 

Business Envelope P/N 21642199 or 

equivalent

Shipping Box for filters www.uline.com 12 x 6 x 4" Long 

Corrugated Box P/N S-4127 or 

equivalent

Plastic ziplock bags for field and COC sheet General house wares vendor

Pre-labeled shipping airbill EPA contract shipping vendor 

Data Transfer SD Memory Cards Sandisk (1 GB minimum) 

SD Memory Card Reader

Web access to the AIRQA Web site

Initial quantities will be worked out with the WACOR/TOCOR/DOCOR in each region. As 

consumables run low or when new equipment purchases are necessary, the FS will be 

responsible for assisting in the procurement of these items following the policy and requirements 

described in the ESAT scope of work. The FS should continue purchasing consumable 

equipment with the same model numbers as the equipment that was initially procured unless the 
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Regional WACOR/TOCOR/DOCOR suggests a different item due improved quality, reduction 

in contamination, increased ease of use, or lower cost (without sacrificing quality). The 

WACOR/TOCOR/DOCOR will report any equipment changes that could affect the results of 

sampling events to the National Pb-PEP Project Leader. The following procedures will be 

required:

 The FS will develop procurement requests as per EPA requirements.

 Upon order, add items to the Field/Laboratory Procurement Log Form (PRO-01).

 Monthly or upon request, provide a copy of the PRO-01 to the Regional 

WACOR/TOCOR/DOCOR.

 File PRO-01 under Agency file code “Pb-PEP/301-093-006.6.”

17.3 Acceptance Criteria

The major pieces of capital equipment are namely the following:

Laboratory Field

Perkin Elmer Elan DRC Plus ICP-MS Portable sampler

Hot Block digester

Cetac Autosampler, or equivalent

Calibration equipment (see Section 16.0, 

Instrument Calibration and Frequency)

CetaAutodilutor, or equivalent Laptop computer

Gilson Minipuls 3 Peristaltic Pump, or 

equivalent

Polyscience 6105 - Refrigerated 

Circulator, or equivalent

PANalytical Epsilon 5 EDXRF or equivalent

The equipment and consumables have been selected based upon their advertised specifications 

on accuracy and resolution, and the portable sampler has been built to FRM performance 

specifications and has been accepted as such. Upon receipt of equipment, the equipment will be 

inspected and tested using calibration standards (see Element 16.0, Instrument Calibration and 

Frequency) to ensure they operate within the performance parameters. All equipment is under 

warranty, and the equipment listed above will undergo yearly calibration and certification as 

discussed in Element 16.0, Instrument Calibration and Frequency.

Both field and laboratory personnel will use procurement logs (PRO-01) (Figure 17-2) to record 

the purchase of new equipment and consumables. These logs also indicate whether the items 

were accepted or rejected. In addition, the laboratory and field personnel are required to keep a 

Field/Laboratory Inventory Form (INV-01) (as shown in Figure 17-1), which lists each 

equipment item and their warranty dates.
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17.4 Tracking and Quality Verification of Supplies and Consumables

Tracking and quality verification of supplies and consumables have two main components. The 

first is the need of the end user of the supply or consumable to have an item of the required 

quality. The second need is for the purchasing department to accurately track goods received so 

that payment or credit of invoices can be approved. To address these two issues, the following 

procedures outline the proper tracking and documentation process to follow by receiving 

personnel:

1. Perform a rudimentary inspection of the packages as they are received from the courier or 

shipping company and note any obvious problems with a receiving shipment, such as crushed 

box or wet cardboard

2. Sign and date the appropriate purchase order for the incoming items from the files and send 

to the purchaser.

3. Fill out a Field/Laboratory Equipment/Consumable Receiving Report Form (REC-01) 

(Figure 17-3), comparing the items and quantity against the purchase order and inspecting the 

condition of each item

4. If the items received match the purchase order and the condition of the equipment or 

consumables is acceptable, signify this on the form and file under Agency file code “PbPEP/301-093-006.6”

5. If the quantity, items, or condition are not acceptable, complete REC-01 with remarks and 

send a copy of the form to the Regional WACOR/TOCOR/DOCOR

6. Call the vendor to report the problem with the package/contents

7. Add receipt information to the Field/Laboratory Procurement Log Form (PRO-01) and to the 

Field/Laboratory Inventory Form (INV-01).

In addition, any conversations that field or laboratory personnel have with vendors will be 

recorded on a phone communication form, which will also be filed. 

Capital equipment will be verified for quality prior to implementation into the program to ensure 

that they meet the minimum specifications for their intended use. This equipment will be tested 

to ensure that it meets the specifications published by the manufacturer and the criteria described 

in Section 7 of this QAPP. Ancillary equipment including consumables may also require testing 

such as shipping media (glassine envelopes, petri-slides) and data logging devices. Assessments 

of MQOs may assist in identifying these items. Filter media, both Teflon© low volume filters 

and glass fiber high volume filters are subjected to EPA specific acceptance testing prior to 

distribution to SLTs.
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Figure 17-1 Field/Laboratory Inventory Form (INV-01)

Field/Laboratory Inventory Form (INV-01)

Item Vendor Model 

Number

Quantity Purchase 

Date

Warranty

Figure 17-2 Field/Laboratory Procurement Log Form (PRO-01)

Field/Laboratory Procurement Log Form (PRO-01)

Item Model 

Number

Quantity PO# Vendor Date Cost Initials Accept/

Reject

Ordered Received
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Figure 17-3. Field/Laboratory Equipment/Consumable Receiving Report Form (REC-01)

Received From:

Shipped From::

Shipped Via:

Shipping Charge Prepaid Collect Freight Bill Number

Purchase Order Number

Quantity Description of Item Condition

Remarks: Accept Shipment _____ Problem________

Notes:
Project: Pb-PEP QAPP

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18.0 Data Acquisition Requirements

This element addresses data not obtained by direct measurement from the Pb-PEP. The majority 

of data used in the Pb-PEP will be direct measurements acquired by the FSs and LAs working 

for the Pb-PEP. 

18.1 Acquisition of Non-Direct Measurement Data

The Pb-PEP relies on data that are generated through field and laboratory operations; however, 

some data are obtained from sources outside the Pb-PEP. This element lists these data and 

addresses quality issues related to the Pb-PEP.

18.1.1 Chemical and Physical Properties Data

Physical and chemical properties data and conversion constants are often required in the 

processing of raw data into reporting units. This type of information, which has not already been 

specified in the monitoring regulations, will be obtained from nationally and internationally 

recognized sources. Other data sources may be used with approval from the National Pb-PEP 

Project Leader. The following sources may be used in the Pb-PEP without prior approval:

 NIST

 International Organization for Standardization, International Union of Pure and Applied 

Chemistry, American National Standards Institute (ANSI), and other widely recognized 

national and international standards organizations

 EPA

 QA Handbook for Air Pollution Measurement Systems: "Volume II: Ambient Air Quality 

Monitoring Program" EPA-454/B-13-003, May 2013 - Full Document and subsequent 

revisions

18.1.2 Sampler Operation and Manufacturers’ Literature

Manufacturers’ literature, which includes operations manuals and users’ manuals, are another 

important source of information needed for sampler operation because they frequently provide 

numerical information and equations pertaining to specific equipment. Pb-PEP personnel are 

cautioned that such information is sometimes in error and appropriate cross-checks will be made 

to verify the reasonableness of information in manuals. Whenever possible and especially during 

acceptance testing, the FSs will compare physical and chemical constants in the operator’s 

manuals to those given in the sources listed above. If discrepancies are found, the FS may raise 

these issues during Pb-PEP workgroup conference calls and during recertification training 

sessions. 

The following types of errors are commonly found in such manuals:
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 Insufficient precision

 Outdated values for physical constants

 Typographical errors

 Incorrectly specified units

 Inconsistent values within a manual

 Use of different reference conditions than those called for in EPA regulations.

18.1.3 Site Information

To determine the site and the monitor that the PE will be compared against, the FS must rely on 

the site information provided to him/her by the EPA region or the SLT monitoring agency. This 

information should be included in the site file and stored in the field office. This information 

will include the following parameters:

 AQS site ID 

 Monitor type

 Method designation (routine instrument)

 Parameter Occurrence Codes (POC)

 PQAO.

These values must be available in the AQS database and must be double-checked for 

accuracy before proceeding to a site. Audit data are very difficult or impossible to load into 

AQS if any of these parameters are recorded incorrectly during the audit.

18.1.4 External Monitoring Databases

It is the policy of the Pb-PEP that no data obtained from the Internet, computer bulletin boards, 

or databases from outside organizations shall be used in creating reportable data or published 

reports without approval from the National Pb-PEP Project Leader. Requests may be raised 

during the Pb-PEP workgroup conference calls or on an individual basis. This policy is intended 

to ensure the use of high-quality data in Pb-PEP publications.

Data from the EPA AQS database may be used in published reports with appropriate caution. 

Care must be taken in reviewing/using any data that contain flags or data qualifiers. If data are 

flagged, such data shall not be used unless it is clear that the data still meet critical QA/QC 

requirements. It is impossible to assure that a database, such as AQS, is completely free from 

errors, including outliers and biases, so caution and skepticism are called for in comparing 

routine data from other reporting agencies as reported in the AQS. Users will review available 

QA/QC information to assure that the external data are comparable with Pb-PEP measurements 

and that the original data generator had an acceptable QA program in place. 
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19.0 Data Management

19.1 Background and Overview

This element describes the data management operations, including data recording, 

transformation, transmittal, reduction, validation, analysis, management, storage, and retrieval, 

pertaining to Pb measurements for the Pb-PEP. This includes an overview of the mathematical 

operations and analyses performed on raw (“as-collected”) Pb data.

The Pb-PEP is dependent upon the collection of quality data which will come from several 

different sources, such as the Pb-PEP field and laboratory activities as well as the field and 

laboratory data collection activities for the routine sampling activities where a PE was 

performed.

Each of the individual stakeholders is responsible for collecting quality data from their area of 

influence and distributing the data to the appropriate participant. Table 19-1 represents the data 

management structure for the Pb-PEP.

Table 19-1. PEP Data Management Structure

STAKEHOLDER TYPE OF DATA DISTRIBUTION

Regional Pb-PEP 

Coordinator or SelfImplementer Lead

Sites to participate in the performance evaluation 

for the year

AQS Site ID of the Primary Pb monitor, POC, and 

Method Code of selected sites. Note: Method 

Code can be determined if sampler make and 

model are known

To monitoring organizations 

-To ESAT contractor

-To the ESAT field scientist conducting PbPEP

Field Performance 

Evaluation Operator

Data from the operation of the FRM portable audit 

sampler including chain of custody information 

for collocated sample. 

-To Regional TOPO/DOPO

-To monitoring organization staff.

-To Region 9 laboratory

Monitoring organization 

laboratory staff

Routine sample data Use same distribution and validation 

procedures as all other Pb data produced by 

the monitoring organization, then uploaded 

to AQS.

Performance Evaluation 

Laboratory Analyst

Pb Laboratory Data -To LIMS

-To AIRQA Web site

Performance Evaluation 

Laboratory Manager

Comprehensive Performance Evaluation Reports -To AQS via contractor
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19.2 Information Management Flow 

Figure 19-1 provides a flow of the information management system for the Pb-PEP. In general, 

hardcopy/electronic information will be collected at various stages of the field and laboratory 

activities. The field information will be stored at both the Regional field office and in Region 9. 

The required AQS fields, once verified and validated will be uploaded to AQS where it will be 

compared with the routine data that has been uploaded from the monitoring organizations. 

Figure 19-1. Pb-PEP Information/Sample Flow
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19.2.1 Field Data 

Information from the field will come from two sources: data from the Pb-PEP audit sampler and 

data from the monitoring organization’s primary or collocated sampler.

Pb Performance Evaluation Portable Audit Sampler Data

Before leaving for the audit, the FS will print a FDS/COC from the AIRQA Web site. Each type 

of filter (routine, field blank, trip blank) requires different information, and the correct type must 

be selected from the AIRQA Web site. Appropriate filter information should be filled in on the 

form before the audit. The Pb portable audit sampler, once appropriately programmed, provides 

all the required data that needs to be collected by the field scientist with the exception of the 

filter ID and site identifying information. Data download will be accomplished by utilizing a 

laptop computer immediately after recovery of the performance evaluation sample. Additional 

information may be documented to supplement the information collected automatically. Once 

the standard fields that will be automatically generated by the Pb portable sampler are 

downloaded to the field laptop, the filter ID, and AQS site ID and any freeform notes about the 

sampling activity will be input. The FS will use this information to complete the printed 

FDS/COC form. Upon arrival back to the field office, the FS will input the information on the 

hard copy FDS/COC to the online form in the AIRQA Web site. The original hard copy 

FDS/COC form will be sent along with the filters. The field verifications and site related data, 

although pertinent, does not need to be captured by the laboratory. 

Pb Monitoring Organization Primary Sampler Data

The primary sampler will be operated in accordance with its normal operational schedule. The 

data acquired by the routine field operator will follow its normal path as detailed in the 

monitoring organizations QAPP and SOPs. The PEP data will be concatenated with the primary 

sampler data in AQS where the data comparison will be made.

Pb Monitoring Organization Collocated Data

The monitoring organization will also perform four to six additional collocated samples at the 

collocated site(s) representing the PQAO. The monitoring organization will be required to 

submit the collocated sample with the COC and field data sheets to the Region 9 laboratory. 

Since EPA does not dictate the type of sampler the monitoring organization will use (other than 

the need for the sampler to have FRM/FEM status) the sampler may not be able to electronically 

record the same type of information as the PEP audit sampler. Therefore, the lab will be 

required to input information from either the monitoring organization’s field data sheet or COC 

form. 

19.2.2 Laboratory Data

Similarly to field data, laboratory data come from the Region 9 ICP-MS laboratory, the 

contracted XRF laboratory, and the monitoring organization laboratory.
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Region 9 ICP-MS Laboratory

The performance evaluation laboratory analyzing the glass fiber filters will be operated by ESAT 

personnel according to the appropriate laboratory SOPs. The data acquired by the laboratory 

will be collected and validated as detailed in the Pb-PEP SOPs. The data will be handled by a 

LIMS that acquires data both manually and automatically. The data will be electronically 

delivered to the AIRQA Web site upon validation. The laboratory deliverables to the AIRQA 

Web site are: chain of custody, analysis summary/report, and electronic data deliverable (EDD) 

in Excel format.

XRF Contract Laboratory

The contract laboratory selected to analyze the 46.2 mm Teflon® filters will operate according to 

the laboratory’s current SOP. The data acquired by the laboratory will be collected and validated 

as detailed in the SOP. The data should be handled by a LIMS that acquires data both manually 

and automatically. The data will be electronically delivered to the AIRQA Web site upon 

validation. The laboratory deliverables to the AIRQA Web site are: chain of custody, analysis 

summary/report, and EDD in Excel format.

Monitoring Organization Laboratory Data

The monitoring organization laboratory will be operated in accordance with its normal 

operational procedures. The data acquired by the laboratory should follow its normal path as 

detailed in the monitoring organizations QAPP and SOPs.

19.3 Data Recording

Each method that generates information in the Pb-PEP will have a data form available for hand 

recording this information. These forms are found at the end of the particular Field or Laboratory 

SOP that describes the data collection activity, as summarized in Table 19-2. 
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Table 19-2. List of Pb-PEP Data Processing Operations for Critical Values

Reference Title Description (Data Related)

Pb-PEP Field SOP Filter Exposure and Concluding

the Sampling Event

Describes how to program the sampler to start 

and end sampling for a 24-hour period, as well as 

the acquisition of data from the portable sampler

Pb-PEP Field SOP and

Pb-PEP Laboratory SOP

COC Form and Field Data Sheet Describes the field procedure for completing the 

field portions of the COC Form and Field Data 

Sheet

AQS Manuals and 

Guides Web site

User Guide – Air QA Reports Describes how to use the different reports within 

the AIRQA Web site.

AQS Manuals and 

Guides Web sitea

AQS Data Coding Manual (AQ2) Describes the coding of air quality data 

transactions; describes the various transactions 

used to create, update, or delete data in the AQS

AQS Manuals and 

Guides Web sitea

AQS User’s Guide Describes the installation of AQS software, 

accounts, data input (batch and online), 

maintenance, and data retrievals (standard 

reports)

N/A = Not applicable

a AQS reference documents can be found at http://www.epa.gov/ttn/airs/airsaqs/manuals/manuals.htm

19.4 Performance Evaluation Data Transfer and Archiving 

Table 19-3 presents information such as where various data are produced, and how/when it will 

be archived/transferred.

Table 19-3 Data Transfer and Archiving

Data Produced How to Archive When to Transfer

Performance Evaluation Field 

Sampler Data

Download each FDS/COC form to 

laptop computer or data link. Archive 

data to second computer or flash 

media at main field office.

Transfer data to the AIRQA Web 

site after each audit 

Performance Evaluation 

Laboratory

Back-up of database occurs each 

night as per laboratory computer 

network storage procedures

Validated data paired to field data in 

AIRQA once a month and upload to 

AQS the following month

Concentration data will be uploaded to the AQS database using the most current AQS transaction 

protocol. 

19.5 Data Validation

Data validation is a combination of checking that data processing operations have been correctly 

performed and of monitoring the quality of the field and laboratory operations. Data validation 

can identify problems in either of these areas. Once problems are identified, the data can be 
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corrected or invalidated, and corrective actions can be taken for field or laboratory operations. 

Numerical data stored in the PB-PEP LIMS are never internally overwritten by condition flags. 

Flags denoting error conditions or QA status are saved as separate fields in the database, so that 

it is possible to recover the original data. 

The following validation functions are incorporated into the PB-PEP LIMS to ensure the quality 

of data entry and data processing operations:

 100% data review. The FDS/COC forms are subjected to a 100% data review for accuracy 

and completeness by the FS after each audit. The COC information on the FDS/COC form 

and laboratory results/deliverables are subjected to a 100% data review by the LA monthly at 

a minimum. All completed audit records on the AIRQA Web site must be reviewed and, if 

acceptable, marked “APPROVED” once a month by regional Pb-PEP lead. 

 Range checks. Simple range checks are performed by the PB-PEP LIMS for almost all 

monitored parameters. For example, valid times must be between 00:00 and 23:59. 

Reasonableness checks may also be performed by the LA. For example, in most Regions the 

summer temperatures should be between 10 and 50°C. Because these range limits for data 

input are not regulatory requirements, the Pb-PEP Laboratory Manager may adjust them 

from time to time to better meet quality goals.

 Completeness checks. When the data are processed, certain completeness criteria must be 

met. For example, each sample event must have a start time, an end time, an average flow

rate, and operator and technician names. At a minimum, FDSs, COC forms, and pre- and 

post-weighing data entry forms must be completely filled out.

 Internal consistency and other reasonableness checks. Several other internal consistency 

checks are built into the PB-PEP LIMS. For example, the end time of a filter must be greater 

than the start time. Computed filter volume (integrated flow) must be approximately equal to 

the exposure time multiplied by the nominal flow. Additional consistency and other checks 

will be implemented as the result of problems encountered during data screening.

 Data retention. Raw data sheets are retained in the laboratory files for a minimum of four

calendar years and are readily available for audits and data verification activities. After 4 

years, the FS or LA may request instructions from OAQPS on the disposition of hard copy 

records and computer back-up media. Sample filters will be archived for 4 calendar years at 

ambient temperature. At the end of the fourth calendar year, the LA may request instructions 

from OAQPS on the disposition of archived sample filters. The time frame for retention and 

disposition of Agency records is determined by EPA records schedules (see Element 9.0, 

Documentation and Records); however records may need to be retained for longer periods 

(e.g., for legal discovery). Therefore, approval from OAQPS is required before the 

destruction of records.

 Statistical data checks. Errors found during statistical screening will be traced back to 

original data entry files and to the raw data sheets, if necessary. These checks shall be 

conducted on a monthly schedule and before any data are submitted to the AQS. 

 Sample batch data validation. This is discussed in Element 23.0, Validation and 

Verification Methods. Sample batch data validation associates flags, which are generated by 
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QC values outside of acceptance criteria, with a sample batch. Batches containing too many 

flags will be rerun and/or invalidated. 

Table 19-4 summarizes the validation checks applicable to the Pb-PEP data.

Table 19-4. Validation Check Summaries

Type of Data Check

Electronic 

Transmission 

and Storage

Manual 

Checks

Automated 

Checks

Data parity and transmission protocol checks ✔

Data review ✔ ✔

Date and time consistency ✔ ✔

Completeness of required fields ✔ ✔

Range checking ✔

Statistical outlier checking ✔

Manual inspection of charts and reports ✔

Sample batch data validation ✔

Two key operational criteria for Pb sampling are bias and precision. As defined in 40 CFR Part 

58, Appendix A, these are based on differences between collocated sampler results and FRM 

PEs. The national Pb-PEP lead will evaluate these data as early in the process as possible, so 

that potential operational problems can be addressed. An objective of the Pb-PEP will be to 

optimize the performance of its Pb monitoring equipment. Initially, the results of collocated 

operations were control charted (see Element 14.0, Quality Control Requirements) to establish 

limits to flag potential problems. As the data results accumulate over time, EPA may reassess 

data quality with higher confidence and adjust the control limits accordingly.

19.6 Data Transformation

Calculations for transforming raw data from measured units to final concentrations are relatively 

straightforward and many are performed in the sampler data processing unit before being 

recorded. The following relations in Table 19-5 pertain to Pb monitoring.
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Table 19-5. Raw Data Calculations

Parameter Units Type of Conversion Equation

Filter volume (Va)* m3 Calculated from average flow rate (Qave) in 

L/min and total elapsed time (t) in min 

multiplied by the unit conversion (m3/L)

3

10Va Qavet 

Mass on TSP filter 

strip or 46.2 mm filter

μg Calculated from measured concentration 

reported by instrument, in μg/L (M), the 

volume of sample solution after sample 

preparation, in mL (Vf ), the initial sample 

mL (Vi =either filter or strip) and the dilution 

factor, performed after sample preparation 

(D)

C M

V

V

D

f

i

  

TSP full filter mass μg Calculated from the filter strip mass (μg)

multiplied by the number of strips (9) in a 

TSP filter.

PbTSP C9

TSP Pb concentration 

(CPb)

μg/m3 Calculated from the laboratory mass (PbTSP)

data and sampler total volume (Va)

a

TSP

Pb V

Pb C 

PM10 Pb 

Concentration (CPb)

μg/m3 Calculated from the laboratory mass (Pb10)

data and sampler total volume (Va)

a

Pb V

Pb C10



* Federal Reference Method instruments will provide this value.

19.7 Data Transmittal

Data transmittal occurs when data are transferred from one person or location to another or when 

data are copied from one form to another. Some examples of data transmittal are copying raw 

data from a notebook onto a data entry form for keying into a computer file and electronic 

transfer of data over a telephone or computer network. Table 19-6 summarizes data transfer 

operations.
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Table 19-6. Data Transfer Operations

Description of Data 

Transfer Originator Recipient QA Measures Applied

Field data to AIRQA 

Web site

Field Scientist AIRQA Web 

site

Parity checking; transmission 

protocols, check against field data 

sheet information

Filter receiving, Chainof-Custody Forms, and 

Field Data Sheets

Field Scientist Laboratory 

Analyst

Filter numbers are automatically 

verified; reports indicate missing 

filters and/or incorrect data entries; 

FS checks data entry with 100% 

review

Laboratory results to 

AIRQA Web site

Laboratory Analyst AIRQA Web 

site

Laboratory data is paired with field 

data and a validation routine for all 

pertinent QC checks is completed

Audit data to AQS Laboratory Analyst AQS (EPA) Data transfer is checked by the 

technical support contractor for AQS 

The Pb-PEP will report all Pb ambient air quality data and information specified by the AQS 

Data Coding Manual10 in the required format for AQS. Such air quality data and information 

will be fully screened and validated and will be submitted directly to the AQS via electronic 

transmission, in the format of AQS, and in accordance with the monthly schedule to the AQS 

QA area since final Pb-PEP audit results are posted to the production AQS as data pairs. The 

data pair consists of the Pb-PEP audit measured value and the site’s measured (primary monitor) 

value. SLAMS and NCore sites are required to post their site data to the AQS on the schedule 

shown in Table 19-7. Because posting the Pb-PEP data requires first obtaining the site’s 

measured value from AQS, Pb-PEP data will not be posted to AQS production until after the due 

dates in Table 19-7. In cases where the site data have been uploaded to AQS and validated on or 

before the due date, the Pb-PEP audit data will also be uploaded. 

Table 19-7. Data Reporting Schedule

Reporting Period Due Date

January 1–March 31 June 30

April 1–June 30 September 30

July 1–September 30 December 31

October 1–December 31 March 31

 

10 http://www.epa.gov/ttn/airs/airsaqs/manuals/manuals.htm
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19.8 Data Reduction and Data Integrity

Data-reduction processes involve aggregating and summarizing results so that they can be 

understood and interpreted in different ways. The Pb monitoring regulations require certain 

summary data to be computed and reported regularly to EPA. Examples of data summaries 

include the following:

 Average Pb concentration

 Accuracy, bias, and precision statistics based on accumulated FRM/FEM data

 Data completeness reports based on numbers of valid samples collected during a specified 

period.

The integrity of Pb-PEP data reduction can be verified by independent review of the data and 

algorithms used. Verification of data integrity requires that Pb-PEP data be stored in a manner 

that permits any data modification to be detected. Detection of data changes is facilitated by the 

record keeping requirements of the Pb-PEP Laboratory SOPs, which require archiving of hardcopy records for important data (such as analytical batch reports, sample COC forms, and FDSs). 

These archived records enable EPA to trace raw data used in PEs to original documents, which 

have been dated and signed by program personnel. 

In addition, Pb-PEP Laboratory SOPs require that regular copies of the PB-PEP LIMS data are 

archived into read-only media (e.g., CD-ROM or back-up tape) and regularly stored at an off-site 

location. These archival database copies may also be used to evaluate data integrity and to check 

that data used in a particular PE match the data on hard-copy records.

19.9 Data Analysis

The Pb-PEP is currently implementing the data summary and analysis requirements contained in 

40 CFR Part 58, Appendix A. It is anticipated that as the Pb Monitoring Program develops, 

additional data analysis procedures may evolve. The following specific summary statistics will 

be tracked and reported for the Pb-PEP:

 Single sampler bias or accuracy (based on flow rate performance audits and the collocation 

study results)

 Single sampler precision (based on collocated data)

 Network-wide bias and precision (based on collocated data, flow rate performance audits)

 Data completeness.

Equations used for these reports are provided in the Table 19-8.
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Table 19-8. Report Equations 

Criterion Equation Reference

Accuracy of single sampler flow - single 

check (di) Xi is reference flow; Yi is 

measured flow

100 

i

i i

i

X

Y X

d

40 CFR 58, Appendix 

A, Section 4.1.1

Bias of a single sampler - annual basis 

(Dj)- average of individual percent 

differences between sampler and 

reference value; nj is the number of 

measurements over the period



 

j n

i

i

i

j d

n

D

1

1

40 CFR 58, Appendix 

A, Section 4.1.3

Percent difference for a single check (di) -

Xi and Yi are concentrations from the 

primary and duplicate samplers, 

respectively.

 

100

/ 2









i i

i i

i

Y X

Y X

d

40 CFR 58, Appendix 

A, Section 4.2.1

Coefficient of variation (CVi) for a single 

check

2

i

i

d

CV 

Not referenced in 

CFR

Pooled coefficient of variation, quarterly 

basis (CVj,q) - CVi will only be used when 

the two measurements are both greater 

than 6 μg/m3





j n

i j q

i

j q

n

CV CV

1 ,

2

,

40 CFR 58, Appendix 

A, Section 4.3.2.1

Completeness

 100

theoretical

valid

N

N

Completeness

Not referenced in 

CFR

19.10 Data Flagging -Sample Qualifiers

A sample qualifier or a result qualifier consists of alphanumeric characters which indicate both 

the fact and the reason why the data value:

 did not produce a numeric result,

 produced a valid numeric result, but it is qualified in some respect relating to the type or 

validity of the result, or

 produced an invalid numeric result that is not to be reported outside the laboratory. 

Qualifiers will be used in the field and the laboratory to signify data that may be suspect due to 

contamination, special events, or failure of QC limits. Appendix C contains a complete list of 

the data qualifiers for the field and laboratory activities. Qualifiers will be placed on field and 

laboratory data forms with additional explanations in free-form notes areas. Flags may be 

generated when sample batch information is entered into the Pb-LIMS and the validation process 

is run. During the sample validation process, which is discussed in Element 23.0, Validation and 

Verification Methods, the flags will be used to decide on validating or invalidating individual 

samples or batches of data.
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19.11 Data Tracking

The Pb-PEP LIMS contains the input functions and reports necessary to track and account for the 

whereabouts of filters and the status of data processing operations for specific data. Information 

about filter location is updated on distributed data entry terminals at the points of significant 

operations. The following input data are used to track filter location and status:

 Laboratory package receipt (package is opened and filter IDs are logged in)

 Laboratory filter storage/archive (post-analysis)

 Laboratory data reporting (to AQS QA)

Tracking reports may be generated by any personnel with access to the PB-PEP LIMS. The 

following tracking reports are available:

 List of all filters that have been received but have not been analyzed

 List of all filters analyzed

 List of all filters in the filter archive

 Ad hoc reports (as required by program)

The Pb-PEP Laboratory Manager or designee is responsible for tracking filter status at least once 

a month and following up on anomalies such as excessive holding time in the laboratory before 

reweighing.

19.12 Data Storage and Retrieval

Table 19-9 shows archival policies for the Pb data.

Table 19-9. Data Archive Policies

Data Type Medium Location Retention Time Final Disposition

Chain-of-Custody Forms

Field Data Sheets

Hard copy Laboratory 4 years Discarded, with 

permission from OAQPS

Laboratory notebooks Hard copy Laboratory 4 years N/A

Field notebooks Hard copy Air Quality 

Division 

4 years Discarded, with 

permission from OAQPS

PB-PEP LIMS 

(excluding audit trail 

records)

Electronic 

(online)

Air Quality 

Division 

Indefinite Back-up media retained 

indefinitely

PB-PEP LIMS audit trail 

records

Electronic

(back-up 

tapes)

Air Quality 

Division 

4 years Discarded, with 

permission from OAQPS
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Filters Filters Laboratory 4 years at ambient 

temperature

Discarded, with 

permission from OAQPS

The Pb data reside on a Microsoft® Windows-compatible computer in the Pb-PEP weighing 

laboratory. The security of data in the Pb-PEP LIMS is ensured by using the following controls:

 Network security passwords for access to the project and database files

 Regular password changes (as specified by EPA network security)

 Independent password protection on all dial-in lines

 Logging of all incoming communication sessions, including the originating telephone 

number, the user’s ID, and connect times

 Storage of media, including back-up tapes in locked, restricted access areas.

19.13 Information Management Security

The Pb-PEP LIMS is maintained on the EPA OAQPS QA support contractor’s server, and access 

is restricted to authorized personnel. Data can only be released with the express permission of 

the National Pb-PEP Project Leader. PE results should not be released for events that have not 

been posted by the PQAO to AQS. Only validated, approved data are loaded into AQS, where 

the information becomes public domain. In addition, hard copies of all weighing logs and 

routine back-up copies of the Pb-PEP LIMS are archived. Comparison of the archived Pb-PEP 

LIMS copies with current Pb-PEP LIMS permits the detection of unauthorized or altered entries 

in the current Pb-PEP LIMS. 
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20.0 Assessments and Response Actions

For the purposes of this QAPP, an assessment is defined as an evaluation process used to 

measure the performance or effectiveness of the quality system and various measurement phases 

of the data operation.

The results of assessments indicate whether the QC efforts are adequate or need to be improved. 

Documentation of all QA and QC efforts implemented during the data collection, analysis, and 

reporting phases are important to data users and decision makers who can then consider the 

impact of these control efforts on the data quality (see Element 21.0, Reports to Management). 

Both qualitative and quantitative assessments of the effectiveness of these control efforts will 

identify those areas most likely to impact the data quality. Periodic assessments of Pb-PEP data 

quality are required to be reported to EPA. However, the selection and extent of the QA and QC 

activities used by the Pb-PEP depend on a number of local factors, such as the field and 

laboratory conditions, the objectives for monitoring, the level of the data quality needed, the 

expertise of assigned personnel, the cost of control procedures, and pollutant concentration 

levels.

To ensure the adequate performance of the quality system, the Pb-PEP will perform the 

following assessments:

 TSAs

 Audits of data quality (ADQs)

 Data quality assessments (DQAs)

 Peer review.

20.1 Assessment Activities and Project Planning

20.1.1 Technical Systems Assessment 

A TSA is an evaluation of a data collection operation or organization to establish whether the 

policies, practices, and procedures are adequate for ensuring that the type and quality of data 

needed are obtained. TSAs are performed both for EPA Regions and monitoring organizations 

that implement Pb-PEP activities. The Pb-PEP regional TSAs allow OAQPS to assess 

consistency of operation among the Regions and to improve the quality system. TSAs will be 

performed for field and laboratory activities.

TSAs of the Pb-PEP laboratories and data management operations will be conducted by EPA 

(OAQPS, ORIA or a Region independent of Region 9) every two years and TSAs of the field 

operations will be conducted by the Regional WAM/TOPO/ DOPOs annually. This will include 

any monitoring organization-run Pb-PEP. It is possible that OAQPS would team with the 

Region during the TSAs of monitoring organization-run Pb-PEPs. TSAs may be conducted as a 

part of recertifying FSs, where appropriate.
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The TSA can be accomplished by a team or by an individual assessor. Key personnel to be 

interviewed during the assessment are those who have responsibilities for planning, conducting 

field operations, laboratory operations, QA/QC, data management, and reporting. The TSA will 

review the following three activities: 

 Field. Filter receipt, instrument setup, sampling, QA/QC, shipping and record keeping

 Laboratory. Sample receipt, sample preparation, analysis, archiving, QA/QC and record 

keeping.

 Data management. Information collection, flagging, data review, security, and upload.

The assessment activities are illustrated in Figure 20-1. To increase uniformity of the TSA, an 

assessment form will be used which can be found on the AIRQA website and the AMTIC Web 

site.

Figure 20-1. Audit Activities
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Audit Team Interview of Reporting Organization Director

Audit Group 1 Interview with Key Personnel

Interview Laboratory Manager

Visit Laboratory, Witness Operations

Review Sample Receiving and Custody

 Select Portion of Data, Initiate Audit Trail

Establish Data Audit Trail Through

 Laboratory Operations to Data 

 Management Function

Meet to

Discuss 

Findings

Interview Field Operations Manager

 Visit Sites

Visit Audit and Calibration Facility

Select Portion of Data, Initiate Audit Trail

Establish Trail Through Field

Operations to Data Management

Audit Group 2

Finalize Audit Trails and Complete Data Audit

 Prepare Audit Result Summary of:

(a) Overall operations (b) data audit findings

(c) laboratory operations (d) field operations

Complete audit finding forms and debreifing report 

Discuss Findings with Key Personnel 

On-Site Audit Complete
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TSAs will usually focus on either the field or lab component but rarely both (with the exception 

of Region 9). The TSA team will prepare a comprehensive written summary of findings 

organized into the following areas: planning, field operations, laboratory operations, QA/QC, 

data management, and reporting. Problems with specific areas will be discussed, and an attempt 

will be made to rank them in order of their potential impact on data quality. For the more serious 

of these problems, the TSA team will summarize assessment findings on the Assessment Finding 

Form (Figure 20-2).

Figure 20-2. Assessment Finding Form

Assessment Finding

Assessment Title: _____________ Assessment #: ______________

Finding #: _____________

_______________________________________________________

Finding:

_______________________________________________________

Discussion:

QA Lead Signature: _____________________ Date: ____________

Assessed Agencies 

Signature: ______________________ Date: _________________

By design, an Assessment Finding Form will be completed for each major deficiency that 

requires formal corrective action. This form will include information such as the finding impact, 

estimated time period of deficiency, site(s) affected, and reason for action. The Assessment 

Finding Form will notify the laboratory or field office of serious problems that may compromise 

the quality of the data and therefore require specific corrective actions. These forms are initiated 

by the TSA team and discussed at the debriefing. If the assessed group is in agreement with the 

finding, the form is signed by the ESAT organization during the debriefing. If a disagreement 

occurs, the TSA team will record the opinions of the group assessed and set a time at some later 

date to address the finding at issue. Assessment finding forms are filed under the AFC heading 

“Pb-PEP/108-025-01-01-237.1” (see Element 9.0, Documentation and Records).
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20.1.1.1 Post-Assessment Activities

The major post-assessment activity is the preparation of the assessment report. The report will 

include the following:

 Assessment title, number, and any other identifying information

 Assessment team leaders, assessment team participants, and assessed participants

 Background information about the project, purpose of the assessment, dates of the 

assessment, particular measurement phase or parameters that were assessed, and a brief 

description of the assessment process

 Summary and conclusions of the assessment and corrective action required

 Attachments or appendices that include all assessment evaluations and assessment finding 

forms.

To prepare the report, the TSA team will meet and compare observations with collected 

documents and results of interviews and discussions with key personnel. Expected QAPP 

implementation is compared with observed accomplishments and deficiencies, and the 

assessment findings are reviewed in detail. Within 30 calendar days of the completion of the 

assessment, a draft assessment report will be prepared and submitted. The TSA report will be 

submitted to the appropriate ESAT personnel and appropriately filed under the AFC heading 

“Pb-PEP/108-025-01-01-237.1.”

If the ESAT organization has written comments or questions about the TSA report, the TSA 

team will review and incorporate them as appropriate and prepare and resubmit a report in final 

form within 30 days of receiving the written comments. The report will include an agreed-upon 

schedule for corrective action implementation.

20.1.2.2 Follow-up and Corrective Action Requirements

The Regional office and ESAT may work together to solve required corrective actions. As part 

of corrective action and follow-up, an Assessment Finding Response Form (Figure 20-3) will be 

generated by the assessed organization for each Assessment Finding Form submitted by the TSA 

team. In addition, ESAT will include corrective action in its monthly progress reports. The 

Assessment Finding Response Form will be signed by the assessed organization and will be sent 

to the ESAT WAM/TOPO/DOPO, who reviews and accepts the corrective action. The 

Assessment Finding Response Form will be completed by the assessed organization within 30 

days of acceptance of the assessment report. Assessment Finding Response Forms are filed 

under the AFC heading “Pb-PEP/108-025-01-01-237.1.”
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Figure 20-3. Assessment Finding Response Form

Assessment Finding Response Form

Assessed Division:___________________

Assessment Title: ___________________ Assessment #: _________

Finding #: _______

________________________________________________________________________

Finding:

Cause of the problem:

Actions taken or planned for correction:

Responsibilities and timetable for the above actions:

Prepared by: _______________________ Date: _____________

Signed by: _________________________ Date: _____________

QA Division

Reviewed by: _______________________ Date: _____________

Remarks:

Is this assessment finding closed? ___________ When? _____________

File with official assessment records. Send copy to assessed organization.
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20.1.2 Audit of Data Quality 

An ADQ reveals how the data are handled, what judgments were made, and whether uncorrected 

mistakes were made. ADQs can often identify the means to correct systematic data reduction 

errors. An ADQ will be performed annually by OAQPS as part of the TSA. Thus, sufficient 

time and effort will be devoted to this activity so that the auditor or TSA team has a clear 

understanding and complete documentation of data flow. Pertinent ADQ questions will appear 

on the TSA check sheets to ensure that the data collected at each stage maintains its integrity. 

The ADQ will serve as an effective framework for organizing the extensive amount of 

information gathered during the audit of laboratory, field monitoring, and support functions 

within the agency. The ADQ will have the same reporting/corrective action requirements as the 

TSA.

20.1.3 Data Quality Assessments

A DQA is a statistical analysis of environmental data used to determine whether the quality of 

data is adequate to support a decision based on the DQOs. Data are appropriate if the level of 

uncertainty is acceptable for the decision based on the data. The DQA process is described in 

detail in Guidance for the Data Quality Assessment Process (EPA QA/G-9) and is summarized 

below. 

 Review the DQOs and sampling design of the program. Review the DQOs and define 

statistical hypothesis, tolerance limits, and/or confidence intervals

 Conduct preliminary data review. Review precision and accuracy (P&A) and other 

available QA reports. Calculate summary statistics, plots, and graphs. Look for patterns, 

relationships, and anomalies

 Select the statistical test. Select the best test for analysis based on the preliminary review 

and identify underlying assumptions about the data for that test

 Verify test assumptions. Decide whether the underlying assumptions made by the selected 

test hold true for the data and the consequences

 Perform the statistical test. Perform test and document inferences and evaluate the 

performance for future use.

A DQA will be included in the Pb-PEP Annual QA Report. Details of these reports are discussed 

in Element 21.0, Reports to Management. 

Measurement uncertainty will be estimated. Terminology associated with measurement 

uncertainty is found within 40 CFR Part 58 Appendix A and includes the following: 

 Precision. A measurement of mutual agreement among individual measurements of the 

same property usually under prescribed similar conditions, expressed generally in terms of 

the standard deviation.
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 Accuracy. The degree of agreement between an observed value and an accepted reference 

value; accuracy includes a combination of random error (precision) and systematic error 

(bias) components, which are due to sampling and analytical operations

 Bias. The systematic or persistent distortion of a measurement process, which causes errors 

in one direction; individual results of these tests for each method or analyzer shall be 

reported to EPA. 

Estimates of the data quality will be calculated on the basis of single monitors, PQAOs, regions, 

laboratory and will be aggregated to all monitors.

20.1.4 Peer Review 

Peer review is a documented critical review of work products. These reviews are conducted by 

qualified individuals who are independent of those performing the work but are collectively 

equivalent in technical expertise. OAQPS uses the peer-review process to assess its products and 

guidance. Any guidance documents or reports developed during the implementation of this 

program will be reviewed by EPA’s QA Strategy Workgroup (facilitated by AAMG), which will 

serve as a peer reviewer. OAQPS will document comments and responses received as part of the 

peer-review process. 

20.2 Documentation of Assessments

Table 20-1 summarizes each of the assessments discussed above.

Table 20-1. Assessment Summary

Assessment 

Activity Frequency Personnel Responsible

Report 

Completion Resolution

TSAs 1/yr OAQPS and Regional 

Work Assignment 

Manager/Task Order 

Project Officer/ Delivery 

Order Project Officer 

(WAM/TOPO/DOPO

30 days after the 

activity

Environmental Services 

Assistance Team (ESAT) or 

State, local, and Tribal 

(monitoring organization) 

ADQs 1/yr OAQPS (National Pb-PEP 

Project Leader)

30 days after the 

activity

WAM/TOPO/DOPOs

DQAs 1/yr OAQPS and U.S. 

Environmental Protection 

Agency (EPA) Regions

120 days after 

the end of 

calendar year 

EPA Regions and 

monitoring organization
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21.0 Reports to Management

This element describes the quality-related reports and communications to management necessary 

to support the Pb-PEP. 

Effective communication among all personnel is an integral part of a quality system. Regular, 

planned quality reporting provides a means for tracking the following:

 Adherence to scheduled delivery of equipment, data, and reports

 Documentation of deviations from approved QA and SOPs and the impact of these 

deviations on data quality

 Analysis of the potential uncertainties in decisions based on the data.

21.1 Communication

An organized communications framework facilitates the flow of information among the 

participating organizations and other users of the information produced by the Pb network. 

Figure 21-1 represents the principal communication pathways. 

Figure 21-1. Lines of communication.

In general, ESAT contractors will be responsible for informing the Pb-PEP Laboratory Manager, 

the ESAT WAM/TOPO/DOPO, and the POs about technical progress, issues, and contractual 

obligations. On the technical side, the ESAT WAM/TOPO/DOPO(s) will be responsible for 

communicating with monitoring organizations and for informing OAQPS about issues that 

require technical attention. Contractual issues will be conveyed from the ESAT contractor 

ESAT Contractors ESAT WAM/TOPO/DOPO ESAT PO Region Region

OAQPS ESAT (QA Workgroup)

Technical Contractual

Contracts Office

State/local/ Tribal

OAQPS 

Support 

Contractor
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through POs to the ESAT Contracts Office and, if necessary, to OAQPS. Table 21-1 lists key 

EPA ESAT contacts. 

The ESAT contractors will frequently communicate with the Pb-PEP Laboratory Manager and 

the ESAT WAM/TOPO/DOPO on the progress of their activities and any problems/issues 

associated with them. Resolution of these issues should take place in the Regions unless the 

issue could affect the implementation of the Pb-PEP at a national level. In those cases, it can be 

discussed and resolved through the ESAT Workgroup conference call. 

Communications among various participants in the Pb-PEP will be critical to the success of the 

program. The field and laboratory SOPs contain procedures for required communication and for 

documenting this information.

Table 21-1. Communications Summary

Person Communicates to Communication Function

Performance Evaluation Program (PbPEP) Laboratory Manager Office of Air Quality 

Planning and Standards 

(OAQPS)

Funding and resource needs

National contract performance issues

Regional Project Officer Contract performance issues

Laboratory Analyst (LA) Review of deliverables

Review of data

Corrective action

Schedule changes

Environmental Services Assistance 

Team (ESAT) Work Assignment 

Manager/Task Order Project 

Officer/Delivery Order Project Officer 

(WAM/TOPO/DOPO)

Field Scientist (FS) Audit site selection and scheduling

OAQPS Funding and resource needs

Regional PO Contract performance issues

LA (ESAT or OAQPS Contractor) Pb-PEP Laboratory Manager 

and Laboratory ESAT 

WAM/TOPO/DOPO

Laboratory progress

Problems and issues

Scheduling 

FS Field equipment shipment

Filter shipment receipt from field

Field procedure issues

OAQPS or approved 

contractor(s)

Database management and Air Quality 

System (AQS) uploads

FS LA Filter shipment from field

Electronic mailing of field data 

Filter/equipment requests

Schedule changes

Field data verification

OAQPS or approved contractor Pb-PEP Laboratory Manager Requests for Pb-PEP data

Data transfer to the AQS database

Data quality issues
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Person Communicates to Communication Function

National Pb-PEP Project Leader ESAT WAM/TOPO/DOPO Funding and resource needs

Contract performance issues

21.1.1 Field Communication

Field communications can take place by phone or by e-mail. Important phone messages or 

conversations should be recorded using the Phone Communication Form (COM-1) in the field 

communications notebook; however, it is understood that the FS may not be in a position where 

this is feasible or the conversation is not noteworthy. Using the COM-1 form is most appropriate 

in situations where important information is exchanged, problems are communicated, issues are 

resolved or other activities that may support information reported in the monthly report. It is 

highly encouraged notes will include the following:

 Date

 Time

 Personnel involved

 Issue(s)

 Decision(s)

 Follow-up action(s)

 Follow-up action responsibility

 Follow-up action completed by (date).

If follow-up action is required by the FS, these actions will be included in the monthly progress 

reports (see Section 9.0, Documentation and Records, Section 9.2.2, Field Monthly Report). At 

a minimum, the FS will keep the original hardcopy in the field communications notebook. The 

FS may also choose to keep an electronic record of this information on a PC.

Field communication between the FS and the Regional WAM/TOPO/DOPO may be required. 

Cellular phones have been provided to each FS for calls related to Pb-PEP activities. The 

Regional WAM/TOPO/DOPOs should also identify alternates to receive field communications 

when he or she is not in the office.

21.1.1.1 Equipment Shipment Receipt

Upon request, the laboratory will ship filter media and cassettes to the field offices. On the day 

of receipt, the FS will contact the LA and will provide the following information to verify 

receipt:

 Date of shipment

 Number of boxes in shipment

 Tracking number.
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21.1.1.2 Pb-PEP Conference Calls

The FS may be asked to participate in Pb-PEP conference calls to discuss progress or resolution 

of issues. The ESAT WAM/TOPO/DOPO will inform the FS of information that needs to be 

prepared for the call at least 3 days before the call if possible. During the call, the FS may use 

the Phone Communication Form (COM-1) to record issues and action items that pertain to his or 

her activities. These items will be included in the next monthly progress report. 

21.1.1.3 Communicating with Monitoring Organizations and Site Operators

Dates for the Pb-PEP audits should be coordinated with the site’s normal operating schedule. 

This coordination must be completed in advance so that the FS and the site operator have ample 

advanced notice and time to prepare for the audit. The procedure for such communications 

includes the following:

 The Regional WAM/TOPO/DOPO (or FS, as delegated by the Regional 

WAM/TOPO/DOPO) will contact each site operator before the audit. Contact must be made 

by phone if it is within 30 days of the audit, but e-mail is sufficient otherwise.

 About 1 week before the actual evaluation, the FS will call the site operator to confirm that 

the audit remains on schedule and to confirm meeting arrangements.

21.1.2 Laboratory Communications

Laboratory personnel will use the Phone Communications Form (COM-1) in the same manner as 

the FS, as described in Section 21.1.1.

21.1.2.1 Equipment Shipment

Once a month or as needed, the laboratory will ship filter media and cassettes to the Regional 

offices via EPA’s contract carrier. On the day of shipment, the LA will communicate with the 

field contact and will provide the following information by e-mail:

 Date of shipment

 Number of boxes in shipment

 Tracking number.

21.2 Reports

The following section will discuss the various types of reports that will be generated in the PbPEP. Table 21-3 provides a summary of this information.
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21.2.1 Progress Reports

Field Progress Reports

The FS will provide a written progress report to his or her Regional WAM/TOPO/DOPO at the 

end of each month (Pb-PEPF-2). The deadline is the 15th calendar day of the following month, 

unless otherwise specified by the Regional WAM/TOPO/DOPO. The Progress Report Form 

(COM-2) will be used to convey the following information:

 Reporting date. Beginning and end date that is covered in the report

 Reporter. Person writing the reports

 Progress. Progress on field activities, including evaluations scheduled within reporting date 

and evaluations conducted within reporting date

 Issues. Old issues reported in earlier reports that have not been resolved and new issues 

arising within the reporting date 

 Actions. Action necessary to resolve issues, the person(s) responsible for resolving them, and 

the anticipated dates when they will be resolved.

Laboratory Progress Report

The LA will provide a written progress report to the Pb-PEP Laboratory Manager and the ESAT 

WAM/TOPO/DOPO at the end of each month (Pb-PEPF-2). The deadline is the 15th calendar 

day of the following month, unless otherwise specified by the Regional WAM/TOPO/DOPO. 

Progress Report Form (COM-2) will be used to convey the following information:

 Reporting date. Beginning and end dates covered in the report

 Reporter. Person writing the reports

 Progress. Progress on field activities

 Receipt - Total number of filters received within a reporting date 

 Analysis- Filters analyzed within a reporting date 

 Data Submission - Valid data submitted to AQS

 Shipments- Shipments made to each Region within a reporting date

 Issues.

 Old issues. Issues reported in earlier reports that have not been resolved

 New issues. Issues arising within a reporting date 

 Actions. Action necessary to resolve issues, including the person(s) responsible for resolving 

them and the anticipated dates when they will be resolved.

The LA will maintain a complete record of the weekly progress reports in a three-ring binder.
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21.2.2 QA Reports

Various QA reports will be developed to document the quality of data for the Pb-PEP. For more 

information about reporting time lines, please see Element 6.0, Project/Task Description, Section 

6.4.6. The types of reports include the following:

DQA. This assessment is a scientific and statistical evaluation to determine if data are of the 

right type, quality, and quantity to support their intended use. The Pb-PEP QA/QC data can be 

statistically assessed at various levels of aggregation to determine its quality. Element 24.0, 

Reconciliation with Data Quality Objectives, discusses the statistics to be used to evaluate the 

data in relation to the DQOs. DQAs will primarily be the responsibility of the EPA Regions 

(Regional assessments) and OAQPS (national assessments). A DQA will be performed 

annually.

P&A Reports. These reports will be generated quarterly and annually and will evaluate the 

precision, accuracy, and bias data against the acceptance criteria using the statistics documented 

in 40 CFR Part 58. These reports will be generated through AQS and will be the responsibility of 

OAQPS.

Assessment Reports. TSAs will be on file at the EPA Regional offices and OAQPS. 

National QA Reports. A QA report provides an evaluation of QA/QC data for a given time 

period to determine whether the DQOs were met. QA reports will be more evaluative in nature 

than the P&A reports in that they will combine the various assessments and the QA data to report 

on the overall quality system. OAQPS will generate Annual QA Summary Reports and 3-year 

QA Reports on the Pb-PEP and its resultant data quality.

The Annual QA Summary Reports will include the following:

 Program overview and update 

 Quality objectives for measurement data

 Implementation aspects

 Training and certifications

 Laboratory QA requirements (QC checks, TSAs, and data validation)

 Field QA requirements (QC checks, standards certifications, and TSAs)

 DQAs

 Laboratory and field controls

 Precision (based on collocated data)

 Accuracy and bias (based on collocated data, flow rate performance audits)

 Completeness (Pb-PEP results versus FRM/FEM results)

 Summary
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The 3-year QA Report is a composite of the annual reports, but with a more narrative 

interpretation and evaluation of longer term trends with respect to Pb-PEP sampler and 

operational performance.

21.2.3 Response/Corrective Action Reports

During TSAs, the response/corrective action reporting procedure will be followed whenever 

there is a finding in which OAQPS and/or the Region determines may affect data quality. The 

reporting procedure is designed as a closed-loop system. The Response/Corrective Action 

Report Form identifies the originator (who reported and identified the problem), states the 

problem, and may suggest a solution. The form also indicates the name of the person(s) assigned 

to correct the problem. The assignment of personnel to address the problem and the schedule for 

completion will be filled in by the appropriate supervisor. The reporting procedure closes the 

loop by requiring that the recipient state on the form how the problem was resolved and the 

effectiveness of the solution. Copies of the completed Response/Corrective Action Report Form 

will be distributed twice: first when the problem has been identified and the action has been 

scheduled; and second when the correction has been completed. The originator, the Regional 

WAM/TOPO/DOPO, and the National Pb-PEP Project Leader will be included in both 

distributions.

21.2.4 Control Charts with Summary 

Control charts for field and laboratory instruments will be updated after every new calibration or 

standardization as defined in the relevant Field and Laboratory SOPs. FSs and LAs are 

responsible for reviewing each control chart immediately after it is updated and for taking 

corrective actions whenever an out-of-control condition is observed. Control charts are to be 

reviewed at least quarterly by the Pb-PEP Laboratory Manager (laboratory instruments) and the 

ESAT WAM/TOPO/DOPO. Control charts are also subject to inspection during TSAs, and 

laboratory personnel are responsible for maintaining a readily accessible file of control charts for 

each instrument. Due to the relatively small number of audits completed, the frequencies may 

need to be decreased for statistical significance. Minimally, the QC checks should in Table 21-2 

should be control charted:
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Table 21-2. Control Charting Recommendations

Activity Quality Control Parameter Frequencya

Field Operations Average sampler flow rate for a 

sampling run

Quarterly

Sampler flow rate verification Quarterly

Sampler temperature verification Quarterly

Sampler barometric pressure 

verification

Quarterly

Collocation study results After each collocation

Field and trip blank data Quarterly

Laboratory Analysis – ICP-MS Initial calibration blank Monthly

Initial calibration verification Monthly

Lower level calibration verification Monthly

Continuing calibration blank Monthly

Continuing calibration verification Monthly

Laboratory Analysis - XRF Thin film calibration Annually if necessary

Digital signal processor calibration 

(DSP)

Monthly

Quality control filters Monthly

a - Due to the relatively small number of audits completed, the frequencies may need to be decreased for statistical significance.

21.2.5 Data Reporting

The data reporting requirements of 40 CFR Part 58.35 apply to those stations designated as 

SLAMS or NCore. Required accuracy and precision data are to be reported, at a minimum, on 

the same schedule as quarterly routine monitoring data submittals; however, it is anticipated that 

data will be reported to AQS no later than ~45 days of receiving the filter from the field. The 

required reporting periods and due dates for SLAMS and NCore sites are listed in Table 19-7.

Pb-PEP audit results are posted to AQS as paired data. The data pair comprises the Pb-PEP audit 

measurement and the site sampler’s routine measurement. The site measurement value is taken 

from the site’s posted AQS data for the date of the audit at the primary sampler. Because both 
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measured values are needed to report Pb-PEP audits to the AQS, the Pb-PEP audit results will 

not be available until the routine data is submitted. 

In cases where the Pb-PEP audit results are available, but the routine measurements are not 

available before the deadlines in Table 19-7, the Pb-PEP audit results will not be posted until the 

next quarter’s posting. For example, for a routine sample collected on March 31 and posted by 

the state on or before June 30, the associated Pb-PEP audit results should be posted to AQS by 

approximately July 31. If the same routine sample’s result were not available in the AQS until 

September 1, the Pb-PEP audit results would not be posted until approximately January 31. 

Air quality data submitted for each reporting period will be edited, validated, and entered into the 

AQS using the procedures described in the AQS User Guide and the AQS Data Coding 

Manual11.

Table 21-3. Report Summary

Report Type Frequency Reporting Organization Distribution

Field progress Monthly Environmental Services 

Assistance Team (ESAT) 

contractor

Regional Work Assignment 

Manager/Task Order Project 

Officer/Delivery Order Project 

Officer (WAM/TOPO/DOPO) 

Laboratory progress Monthly ESAT contractor Performance Evaluation Program 

(Pb-PEP) Laboratory Manager, 

ESAT WAM/TOPO/DOPO

Data Quality Assessment 

(DQA) 

1/yr Office of Air Quality Planning 

and Standards (OAQPS) and 

U.S. Environmental Protection 

Agency (EPA) Regions

ESAT contractor, Regional 

WAM/TOPO/DOPO, Ambient 

Monitoring Technology 

Information Center (AMTIC)

Pb-PEP audit results Quarterly OAQPS and authorized 

contractor

Air Quality System

Pb-PEP precision and 

accuracy (P&A) 

(collocation study results)

2/yr National Pb-PEP Project Leader Field Scientist, Regional 

WAM/TOPO/DOPO, AMTIC 

TSA of monitoring 

organization or ESAT PbPEP

1/yr EPA Region ESAT contractor, assessed 

agency, National Pb-PEP Project 

Leader 

QA Report 1/3 years OAQPS and authorized 

contractor

Internal/external organizations 

through AMTIC

OAQPS systems audit 1/yr OAQPS ESAT contractor, Regional 

WAM/TOPO/DOPO

Response/corrective action 1/finding ESAT contractor ESAT contractor, Regional 

WAM/TOPO/DOPO, National 

Pb-PEP Project Leader 

 

11

 http://www.epa.gov/ttn/airs/airsaqs/manuals/
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22.0 Data Review, Validation, and Verification Requirements 

This element describes how the Pb-PEP will verify and validate the data collection operations 

associated with the program. “Verification” can be defined as confirmation by examination and 

provision of objective evidence that specified requirements have been fulfilled. “Validation” can 

be defined as confirmation by examination and provision of objective evidence that the particular 

requirements for a specific intended use are fulfilled. The major objective for the Pb-PEP is to 

provide data of adequate quality to use in the comparison to routine data. This section will 

describe the verification and validation activities that occur during a number of the important 

data collection phases. Earlier elements of this QAPP and the Pb-PEP Field and Laboratory 

SOPs describe how the activities in these data collection phases will be implemented to meet the 

DQOs of the program. Review and approval of this QAPP provide initial agreement that the 

processes described in the QAPP, if implemented, will provide data of adequate quality. To 

verify and validate the phases of the data collection operation, the Pb-PEP will use various 

qualitative assessments (e.g., technical systems assessments, network reviews) to verify that the 

QAPP is being followed and will rely on the various QC samples, inserted at various phases of 

the data collection operation, to validate that the data will meet the DQOs described in Element 

7.0, Data Quality Objectives and Criteria for Measurement. 

22.1 Sampling Design

Element 10.0, Sampling Design, describes the sampling design for the network established by the 

Pb-PEP. It covers the number of PEs required for each PQAO, as well as the frequency of data 

collection. These requirements have been described in the CFR; however, it is the responsibility 

of Pb-PEP to ensure that the intent of the regulations are properly administered and performed. 

22.1.1 Sampling Design Verification

Monitoring organizations will work with the EPA Regions to select and develop a list of sites for 

the evaluations conducted in each calendar year on or before December 1 of the previous year. 

The Regional WAM/TOPO/DOPOs, with the assistance of the ESAT contractors, will attempt to 

determine the most efficient site visit schedule. This schedule should be based upon the 

following:

 CFR requirements for audit frequency as discussed in Element 10.0, Sampling Design

 Meeting the same monitoring schedule as the routine sampler being evaluated (to prevent the 

need for the site to run and post an additional sample for the evaluation)

 Site proximity (the sites that are closest in proximity to each other can be visited within the 

same day or week).

The Pb-PEP implementation plan can then be reviewed and compared to the AQS data of active 

SLAMS/Tribal and NCore sites aggregated by PQAO. This can ensure that the Pb-PEP design is 
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being followed. The implementation plan will also be reviewed during OAQPS and Regional 

TSAs.

22.2 Sample Collection Procedures 

22.2.1 Sample Collection Verification

Sample collection procedures are described in Element 11.0, Sampling Methods Requirements, 

and in detail in the Pb-PEP Field SOPs to ensure proper sampling and to maintain sample 

integrity. The following processes will be used to verify the sampling collection activities:

 TSAs. Will be required by OAQPS and by the EPA Regions annually, as described in 

Element 20.0, Assessments and Response Actions

 Surveillance. Will be conducted as required by the EPA Regions and will be used for 

frequent monitoring of specific data collection phases if deemed necessary. 

Both types of assessments will be used to verify that the sample collection activities are being 

performed as described in this QAPP and in the field and laboratory SOPs. Deviations from the 

sample collection activity will be noted in Assessment Finding Forms and will be corrected using 

the procedures described in Element 20.0, Assessments and Response Actions.

22.2.2 Sample Collection Validation

The sample collection activity is just one phase of the measurement process. Using QC samples 

throughout the measurement process can help validate the activities occurring at each phase. 

The review of QC data (e.g., collocated sampling data, field/laboratory/trip blanks, and 

sampling/ laboratory equipment verification checks) that are described in Element 14.0, Quality 

Control Requirements, and Element 16.0, Instrument Calibration and Frequency, can be used to 

validate the data collection activities. Any data that indicate unacceptable levels of bias or 

precision or a tendency (trend on a control chart) will be flagged and investigated. This 

investigation could lead to a discovery of inappropriate sampling activities. 

22.3 Sample Handling

Element 11.0, Sampling Methods Requirements, and Element 12.0, Sample Handling and 

Custody, detail the requirements for sampling handling; however, greater detail for both field and 

laboratory sample handling procedures occur in the Field and Laboratory SOPs, including the 

types of sample containers and the preservation methods used to ensure that they are appropriate 

to the nature of the sample and the type of data generated from the sample. There are unique 

handling concerns with both types of filters and the nature of the collected particles; therefore, 

sample handling is one of the phases where inappropriate techniques can have a significant effect 

on sample integrity and data quality. 
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22.3.1 Verification of Sample Handling

As mentioned in the above section, TSAs and surveillance will be performed to ensure that the 

specifications mentioned in the QAPP and SOPs are being followed. The assessments would 

include checks on the identity of the sample (e.g., proper labeling and COC records), packaging 

in the field, and proper storage conditions (e.g., COC and storage records) to ensure that the 

sample continues to be representative of its native environment as it moves through the data 

collection operation. 

22.3.2 Validation of Sample Handling

Similar to the validation of sampling activities, the review of data from the collocated sampling 

and field, trip, and laboratory blanks (described in Element 14.0, Quality Control Requirements, 

and Element 16.0, Instrument Calibration and Frequency) and the use of control charts can be 

used to validate the sample handling activities. Acceptable precision and bias in these samples 

would lead one to believe that the sample handling activities are adequate. Any data that 

indicates unacceptable levels of bias or precision or a tendency (trend on a control chart) will be 

flagged and investigated. This investigation could lead to a discovery of inappropriate sampling 

handling activities that would require corrective action. 

22.4 Analytical Procedures

Element 13.0, Analytical Methods Requirements, details the requirements for the analytical 

methods, while referent to the specific extraction and analysis SOPs. The methods include 

acceptance criteria (Element 13.0, Analytical Methods Requirements, and Element 14.0, Quality 

Control Requirements) for important components of the procedures, along with suitable codes 

for characterizing and flagging a sample’s deviation from the procedure.

22.4.1 Verification of Analytical Procedures

As mentioned in the above sections, both TSAs and surveillance will be performed to ensure that 

the analytical method specifications mentioned in the QAPP and SOPs are being followed. The 

assessments will include checks on the identity of the sample. Deviations from the analytical 

procedures will be noted in Assessment Finding Forms and will be corrected using the 

procedures described in Element 20.0, Assessments and Response Actions.

22.4.2 Validation of Analytical Procedures

Similar to the validation of sampling activities, the following can be used to validate the 

analytical procedures: reviewing data from laboratory blanks, calibration checks, laboratory 

duplicates, and other laboratory QC activities described in Element 14.0 (Quality Control 

Requirements), Element 16.0 (Instrument Calibration and Frequency), and in the Pb-PEP 

Laboratory SOPs. Acceptable precision and bias in these samples would lead one to believe that 

the analytical procedures are adequate. Any data that indicate unacceptable levels of bias or 

precision or a tendency (trend on a control chart) will be flagged and investigated as described in 
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Element 14.0, Quality Control Requirements. This investigation could lead to a discovery of 

inappropriate analytical procedures, requiring corrective action. 

22.5 Quality Control

Element 14.0, Quality Control Requirements, and Element 16.0, Instrument Calibration and 

Frequency of this QAPP specify the QC checks that are to be performed during sample 

collection, handling, and analysis. These include analyses of check standards, blanks, and 

duplicates, which indicate the quality of data being produced by specified components of the 

measurement process. For each specified QC check, the procedure, acceptance criteria, and 

corrective action are specified in field and laboratory SOPs. 

22.5.1 Verification of Quality Control Procedures

As mentioned in the above sections, TSAs and surveillance will be performed to ensure that the 

QC method specifications mentioned in the QAPP are being followed. 

22.5.2 Validation of Quality Control Procedures

Validation activities of many of the other data collection phases mentioned in this subsection use 

the QC data to validate the proper and adequate implementation of that phase. Therefore, 

validation of QC procedures will require a review of the documentation of the corrective actions 

that were taken when QC samples failed to meet the acceptance criteria and a review of the 

potential effect of the corrective actions on the validity of the routine data. Element 14.0,

Quality Control Requirements, describes the techniques used to document QC review/corrective 

action activities. 

22.6 Calibration

Element 16.0, Instrument Calibration and Frequency, as well as the field (Element 11.0, 

Sampling Methods Requirements) and the analytical (Element 13.0, Analytical Methods 

Requirements) sections of this QAPP detail the calibration activities and requirements for the 

critical pieces of equipment for the Pb-PEP. The Pb-PEP Field SOPs and the Pb-PEP Laboratory 

SOPs provide detailed calibration techniques.

22.6.1 Verification of Calibration Procedures

As mentioned in the above sections, TSAs and surveillance will be performed to ensure the 

calibration specifications and corrective actions mentioned in the QAPP are being followed. 

Deviations from the calibration procedures will be noted in Assessment Finding Forms and will 

be corrected using the procedures described in Element 20.0, Assessments and Response Actions.
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22.6.2 Validation of Calibration Procedures

Similar to the validation of sampling activities, the review of the calibration data described in 

Element 14.0, Quality Control Requirements, and Element 16.0, Instrument Calibration and 

Frequency can be used to validate calibration procedures. Calibration data within the acceptance 

requirements would lead one to believe that the sample collection measurement devices are 

operating properly. Any data that indicate unacceptable levels of bias or precision or a tendency 

(trend on a control chart) will be flagged and investigated as described in Element 14.0, Quality 

Control Requirements, and Element 16.0, Instrument Calibration and Frequency. This 

investigation could lead to a discovery of inappropriate calibration procedures or equipment 

problems requiring corrective action as detailed in the element. Validation would include the 

review of the documentation to ensure that corrective action was taken as prescribed in the 

QAPP. 

22.7 Data Reduction and Processing

22.7.1 Verification of Data Reduction and Processing Procedures

As mentioned in the above sections, TSAs and surveillance will be performed to ensure that the 

data reduction and processing activities mentioned in the QAPP are being followed. 

22.7.2 Validation of Data Reduction and Processing Procedures

Data validation is initially completed by the Pb-PEP database on the AIRQA Web site. AIRQA 

pairs the field data component with the laboratory analysis result to create the final concentration 

for the sample. The AIRQA database also performs calculations for the required QC activities 

across the lifetime of the sample. AIRQA completes and produces an automated “verified 

dataset” that must then be validated by the regional and/or national Pb-PEP leads. This 

validation is recorded in AIRQA creating a record of the validation. As part of the ADQ 

discussed in Element 20.0, Assessments and Response Actions, the data used for these automated 

checks will be reviewed to ensure that:

 All audit records conducted are present

 No blanks are in the dataset/records are complete

 QC parameters have been met

 Sampling periods are correct 

 Site data is correct

 Sample analysis was performed

 Appropriate qualifiers/flags are properly assigned 

 Audits are completed and documented by the regional Pb-PEP leads
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23.0 Validation and Verification Methods 

Many of the processes for verifying and validating the measurement phases of the Pb-PEP data 

collection operation have been discussed in Element 22.0, Data Review, Validation, and 

Verification Requirements. If these processes, as written in the QAPP, are followed, the Pb-PEP 

should obtain the necessary data quality to permit comparison of Pb-PEP with the routine 

primary samplers. However, exceptional field events may occur and field and laboratory 

activities may negatively affect the integrity of samples. In addition, it is expected that some of 

the QC checks will fail to meet the acceptance criteria. Information on problems that affect the 

integrity of data is identified in the form of flags (Appendix C). It is important to determine how 

these failures affect the routine data. The review of this routine data and their associated QC 

data will be verified and validated on a sample basis, on groups of samples, and on a sample 

batch basis. Element 14.0, Quality Control Requirements, discusses the concept and use of 

sample batching. 

23.1 Process for Validating and Verifying Data

23.1.1 Verification of Samples/Audits

The FS initiates the COC for the Pb-PEP audits on the AIRQA Web site. After the audit, the FS 

enters the field data into the AIRQA Web site. After each interaction with the AIRQA Web site, 

the FS will review and verify that the information entered on the site is accurate and complete. 

At the end of each month, a thorough review of the data will be conducted for completeness and 

data entry accuracy by the laboratory analyst. Data used in the calculation of Pb concentrations 

or used for evaluating critical validation criteria that are recorded on data sheets by hand will be 

100% verified. After verification, these data will be reported electronically to the AIRQA Web 

site for validation by the Regional Pb-PEP contacts.

23.1.2 Validation of Samples/Audits

Validation of measurement data will occur at two stages during the audit process; after the 

laboratory analysis, and after the final pairing of the laboratory data with the field data in 

AIRQA. At different points in the process, the laboratory analyst or FS or may observe instances 

where the data quality may be affected, and they will document these events or observations in 

the bench sheets, LIMS or AIRQA Web site. In the case of the laboratory, the laboratory 

manager will review the data against the laboratory Pb-PEP validation QC criteria listed in 

Section 7, Tables 7-2 and 7-3 and notations made on the bench sheets and/or LIMS and make a 

decision regarding validation. In the same manner, the Regional Pb-PEP leads will review the 

final audit data against the field Pb-PEP validation QC criteria and notations made by the FS 

using the AIRQA Web site. The AIRQA Web site creates a report that shows the validation 

criteria, the recorded data for those criteria, and an assessment on if the criteria passed the check. 

These checks are classified into “critical criteria” and “operational evaluation criteria”. The 
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“critical criteria” and “operational evaluation criteria” are listed in Table 23-1 AIRQA Critical 

Criteria Validation Template and Table 23-2 AIRQA Operational Evaluation Criteria Template.

As described above, validation will occur at the end of the analytical process and after the 

analytical data has been uploaded to the AIRQA Web site and the automated validation routine 

has been conducted. The laboratory manager, Regional Pb-PEP leads and National Pb-PEP lead 

will have validation authority for Pb-PEP data. However, to avoid a waste of time and money, 

the laboratory analyst and FS may request immediate invalidation of a sample in the event of a 

significant failure or event. Some examples of a significant failure or event may be: malfunction 

of laboratory analyzer resulting in a total shutdown, malfunction of field sampler, or 

compromised filters (dropped, damaged, contaminated). Another important situation is a case 

where an audit is conducted and the SLT sampler does not complete the sample run. In this case, 

the FS will notify the Regional Pb-PEP lead and reschedule the audit.

23.1.3 Validation Acceptance and Reporting

The Pb-PEP Laboratory Manager will be responsible for determining that data have been 

validated before submittal to the AIRQA Web site. A summary report documenting all data that 

was validated and invalidated will be submitted to the Pb-PEP Laboratory Manager and National 

Pb-PEP lead each month. The Regional Pb-PEP lead will be responsible for validating the final 

audit concentration generated by the AIRQA Web site. All samples marked as “Approved” will 

then be entered into AQS by the OAQPS support contractor. The Regional Pb-PEP leads will 

follow the process described in Element 22 to approve and validate the audits. Audits that fail 

critical criteria flags or do not meet the weight of evidence consideration will not be marked as 

“Approved”.

Audits that are not marked as “Approved” cannot be posted to the AQS because there is 

currently no provision in the AQS precision data record format for adding null value codes or 

data qualifiers.
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Table 23-1. AIRQA Critical Criteria Validation Template 

Criteria Frequency Acceptable Range Reference

Void Sample/Visual Defect Check all filters Sample integrity protected during handling and transport (no 

contamination, mishandling, etc.)

Part 50 App B sec 8.2

Sampling Period all filters 1440 minutes ± 60 minutes

midnight to midnight Part 50 App B sec 8.15

Average Flow Rate every 24 hours of op

1.1-1.70 m3/min (varies with instrument) in

actual condition Part 50 App B sec 8.8

One-point Flow Rate Verification 

(High Volume TSP Sampling) During Set-up prior to every sample day ±7% from transfer standard Part 58 App AMethod 2.2 sec 2.6

One-point Flow Rate Verification 

(Low Volume Sampling) During Set-up prior to every sample day ±4% from transfer standard ±4% from design set point (16.67LPM)a

40 CFR Part 50, App L, Sec 9.2.5 and 

7.4.3.1 and 40 CFR Part 58, Appendix A 

Sec 3.2.3 & 3.3.2

Flow rate percent coefficient of 

variance (low volume sampling 

only)

Following each sampling run CV < 2% 40 CFR Part 50, App L Sec 7.4.3.2

a

 One-point flow rate verification is more stringent than the cited reference
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Table 23-2. AIRQA Operational Evaluation Criteria Template

Criteria Frequency Acceptable Range Reference

System Leak Check During precalibration check Visual and Auditory inspection with faceplate blocked 1) Recommendation

Monitor Siting 1/year Meets siting criteria or waiver documented 1) 40 CFR Part 58 App E, sections 2-5

Flow Rate Transfer Std. 1/yr Resolution 0.02 m3

/min

+ 2% reproducibility

1) 40 CFR Part 50, App B sec 7.8

2) Method 2.2 section 2.5

Field Thermometer 1/yr 2

o C resolution 1) 40 CFR Part 50, App B sec 7.5

Field Barometer 1/yr + 5 mm Hg resolution 1) 40 CFR Part 50, App B sec 7.6

Clock/timer Verification 1/3 mo. + 2 min/24-hour 1) Method 2.2. section 2.3

Flow Rate Verification Prior to each run ≤ ± 4% of target flow rate 1) Part 50 App L Sec 7.4.3.1

Barometric Pressure 

Verification Prior to each run + 10 mm Hg 1) 40 CFR Part 50, App L, Sec 9.32) Method 2.12 Table 6-1

Temperature Verification Prior to each sampling run + 2

oC

1) 40 CFR Part 50, App L, Sec 9.3

2) Method 2.12 Table 6-1

Filter Check After each sampling run No contamination, pinholes, discoloration 1) Method 2.12 section 8

Time Check Prior to each sampling run + 2 min/24 hours 1) Method 2.2. section 2.3
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24.0 Reconciliation with Data Quality Objectives

The DQOs for the Pb-PEP are described in Element 7.0, Data Quality Objectives and Criteria 

for Measurement. This element of the QAPP outlines the procedures that Pb-PEP will follow to 

determine whether the monitors and laboratory analyses are producing data that are sufficiently 

consistent to evaluate the bias of the National Pb network. For the data from the Pb-PEP to be 

used for estimating the bias associated with the National Pb network, the data must be internally 

consistent, meaning that the data should be precise and unbiased. The following outline is 

conceptual, and it will be updated with formal statistical procedures once they have been 

completely developed. For example, the amount of imprecision and bias that is tolerable in the 

Pb-PEP, while maintaining confidence in the estimates of bias for the National Pb FRM/FEM 

network, remains to be determined. An assessment of the quality of the data will be made at the 

PQAO level. The Regional offices and the OAQPS have responsibilities in the DQA.

24.1 Preliminary Review of Available Data

Element 7.0, Data Quality Objectives and Criteria for Measurement, of this QAPP contains the 

details for the development of the DQOs. Element 10.0, Sampling Design, of this QAPP 

contains the details for the sampling design, including the rationale for the design, the design 

assumptions, and the sampling locations and frequency. If changes in the DQOs or sampling 

design occur, the potential effect should be considered throughout the entire DQA.

A preliminary data review should be performed to uncover potential limitations to using the data, 

to reveal outliers, and generally to explore the basic structure of the data. The first step is to 

review the QA reports. The second step is to calculate basic summary statistics, generate 

graphical presentations of the data, and review these summary statistics and graphs. This review 

will be completed by the National Pb-PEP Lead.

24.2 Evaluation of Data Collected While All Pb-PEP Samplers Collocated—

Regional Level

Twice per year (semi-annually), all of the Pb-PEP samplers used by a single FS, Region or a 

number of Regions must be collocated and run at the same location over the same time period. 

These are often referred to as “parking lot collocations.”

The primary objective for collocating all of the samplers of the same method (high volume/low 

volume) is to determine whether one of the samplers is biased relative to the average of all the 

samplers and to estimate the repeatability of the instruments. An analysis of variance (ANOVA) 

will be used to evaluate the first objective. Additionally, an output of the ANOVA is an estimate 

of the repeatability. The conclusions from the ANOVA will allow EPA to determine whether 

there is a Pb-PEP sampler that produces results sufficiently different from the average. If this is 

the case, the instrument should not be used in the Pb-PEP. The estimate of the repeatability can 
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be used to evaluate the certainty with which the bias of the routine program within the Region 

can be estimated. Since there may be only two TSP Pb-PEP samplers in each Region, EPA may 

ask Regions to work together to consolidate samplers at a common area equidistant from 

Regional Headquarters but in an area with measurable Pb concentrations in order to run a more 

robust evaluation. 

24.3 Evaluation of Data Collected While All Pb-PEP Samplers Collocated—

National Level 

A major goal of the national review of the data from the collocation of all the Pb-PEP samplers is 

to determine if the repeatability of the samplers varies greatly by region. OAQPS will check for 

equal variances across all regions by using standard statistical tests, such as the Bartlett test (an 

all-purpose statistical test that can be used for equal and unequal sample sizes), the Hartley test 

(a statistical test that requires equal sample sizes but is designed to find differences between the 

largest and smallest variances), and Levene’s test (an alternative to Bartlett’s test for testing for 

differences among the dispersions of several groups. Levene’s test has greater power than 

Bartlett’s for non-normal distributions of data)12,13. The conclusions from these tests will allow 

OAQPS to determine whether corrective action must be taken to reduce the variability for any of 

the Regions or laboratories. Corrective action will include a formal review of the training and 

operations to see if the cause for the disparity can be uncovered and corrected. With these data, 

OAQPS will also be able to evaluate with what certainty the bias of the routine program can be 

estimated.

 

12 Neter, J., W. Wasserman, and M.H. Kutner. 1985. Applied Linear Statistical Models (2nd edition). Homewood, 

IL: Richard D. Irwin, Inc.

13 U.S. EPA (Environmental Protection Agency). 2000. Guidance for Data Quality Assessment: Practical Methods 

for Data Analysis; EPA QA/G-9,QA00 UPDATE. United States Environmental Protection Agency, Office of 

Environmental Information, Washington, DC, EPA/600/R-96/084. July.
United States

Environmental Protection

Agency

Office of Air Quality Planning and Standards

Air Quality Assessment Division

Research Triangle Park, NC

Publication No. EPA-457/B-14-001a

September 2014