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{{#Wiki_filter:U.S. NUCLEAR REGULATORY  
{{#Wiki_filter:U.S. NUCLEAR REGULATORY COMMISSION                                                                                       December 1977 kREGULATORY GUIDE
COMMISSION
                                    OFFICE OF STANDARDS DEVELOPMENT
December 1977 kREGULATORY  
                                                                    REGULATORY GUIDE 4.15 QUALITY ASSURANCE FOR RADIOLOGICAL MONITORING PROGRAMS
GUIDE OFFICE OF STANDARDS  
                      (NORMAL OPERATIONS)-EFFLUENT STREAMS AND THE ENVIRONMENT
DEVELOPMENT
REGULATORY  
GUIDE 4.15 QUALITY ASSURANCE  
FOR RADIOLOGICAL  
MONITORING  
PROGRAMS (NORMAL OPERATIONS)-EFFLUENT  
STREAMS AND THE ENVIRONMENT


==A. INTRODUCTION==
==A. INTRODUCTION==
This guide describes a method acceptable to the NRC staff for designing a program to assure the qual-ity of the results of measurements of radioactive ma-terials in the effluents and the environment outside of nuclear facilities during normal operations.
Section 30.34. ''Terms and Conditions of This guide describes a method acceptable to the                                               Licenses," of 10 CFR Part 30. "Rules of General NRC staff for designing a program to assure the qual-                                               Applicability to Licensing of Byproduct Material."
ity of the results of measurements of radioactive ma-                                             provides that the Commission mayý.incorporate in any terials in the effluents and the environment outside of                                             byproduct material license such'týrnis and conditions nuclear facilities during normal operations.                                                      as it deems appropriate or neccssary. in order to pro- ttr-t hn'ii,: h'*.                                      ",T,
    The NRC regulations that require the control of re-                                              Section 40.41. *.Terms".-nd Conditions of leases of radioactive materials from nuclear facilities,                                            Licenscs,' Licene  of I0.CFR'Part
                                                                                                                                  -            402...Licensing
                                                                                                                                                      "Licesingof        ofSorcSource that require the measurements of radioactive mate-                                                  Material," provides that'tihe Commission may incor- rials in the effluents and environment outside of these                                            porate in any source material license such terms and facilities, or that authorize license conditions not                                              conditionsaasit d8ims appropriate or necessar) to otherwise authorized in the regulations are as                                                    protect heaih',
follows:                                                flSeW1i0 ws:                                        *:.,.':..,, 50o '"-Issuance of Licenses and Con- Section 20.106, "Radioactivity in Effluents to Un-                                          ý,vucttor,1Permits," of 10 CFR Part 50, "Licensing restricted Areas," of 10 CFR Part 20, "Standards for                                                    production  'Iq and Utilization Facilities." provides Protection Against Radiation." provides that a licen-r,                                                t each operating license for a nuclear power plant see shall not release to an unrestricted area radioac- *A' ssued by the Nuclear Regulatory Commission will
                                                                                      "is ,* ~'*;.coitain tire materials .~ý;        in . concentrations
                                ."                      that exceed                          .*:, * .
                                                                                                                such conditions and limitations as the Com- specified in 10 CFR Part 20 or as other%ýRe aui                                            t -Mission deems appropriate and necessary.


Section 30.34. ''Terms and Conditions of Licenses," of 10 CFR Part 30. "Rules of General Applicability to Licensing of Byproduct Material." provides that the Commission mayý.incorporate in any byproduct material license such'týrnis and conditions as it deems appropriate or neccssary.
thorized in a license issued by the Comnssio*.ýec-,.                                                  Section 70.32, "Conditions of Licenses," of 10
tion 20.201, "Surveys." of 10 CFR Pflýt'' fORti                                                  CFR Part 70. "Special Nuclear Material." provides requiresmeaurmetsofleel that a licenseeo conduct    raito        surv.ys, or;' ... including
                                                                            .    .ton            that the Commission may incorporate such terms and measurements of levels of radiation oroncentrations                                              conditions as it deems appropriate or necessary to of radioactive materials, as necessary to i onstrate                                                rotect health.


in order to pro-ttr-t hn'ii,: ",T, The NRC regulations that require the control of re- Section 40.41. *.Terms".-nd Conditions of leases of radioactive materials from nuclear facilities, Licenscs,'
compliance with the regulations in 10 CFR Part 20.
of I0.CFR'Part
402...Licensing ofSorc Licene -"Licesingof Source that require the measurements of radioactive mate- Material," provides that'tihe Commission may incor-rials in the effluents and environment outside of these porate in any source material license such terms and facilities, or that authorize license conditions not conditionsaasit d8ims appropriate or necessar)
to otherwise authorized in the regulations are as protect heaih', follows:  flSeW1i0 ws: 50o '"-Issuance of Licenses and Con-Section 20.106, "Radioactivity in Effluents to Un- ý,vucttor,1Permits," of 10 CFR Part 50, "Licensing restricted Areas," of 10 CFR Part 20, "Standards for 'Iq production and Utilization Facilities." provides Protection Against Radiation." provides that a licen-r, t each operating license for a nuclear power plant see shall not release to an unrestricted area radioac- ssued by the Nuclear Regulatory Commission will tire materials in concentrations that exceed ,
such conditions and limitations as the Com-.~ý; .." "is * .specified in 10 CFR Part 20 or as other%ýRe aui t -Mission deems appropriate and necessary.


thorized in a license issued by the Comnssio Section 70.32, "Conditions of Licenses," of 10 tion 20.201, "Surveys." of 10 CFR Pflýt'' fORti CFR Part 70. "Special Nuclear Material." provides requires that a licensee conduct surv.ys, including meaurmetsofleel o raito or;' ... ..ton that the Commission may incorporate such terms and measurements of levels of radiation oroncentrations conditions as it deems appropriate or necessary to of radioactive materials, as necessary to i onstrate rotect health.compliance with the regulations in 10 CFR Part 20.Section IV.B. of Appendix i, "Numerical Guides Paragraph (c) of S4 n. /. "',Purpose," of 10 for Design Objectives and Limiting Conditions for CFR Part 20 states that r nable effort should Operation to Meet the Criterion  
Section IV.B. of Appendix i, "Numerical Guides Paragraph (c) of S4 n.                         /. "',Purpose," of 10                         for Design Objectives and Limiting Conditions for CFR Part 20 states that                         r       nable effort should                     Operation to Meet the Criterion 'As Low As Is Rea- be made by N P-                       se       o maintain radiation ex-                         sonably Achievable' for Radioactive Material in posure, and                 ease*. f rdmoactive materials in                                     Light-Water-Cooled Nuclear Power Reactor effluents t             a ricted reas, as far below the limits                                   Effluents," to 10 CFR Part 50, "Licensing of Pro.
'As Low As Is Rea-be made by N P- se o maintain radiation ex- sonably Achievable'  
for Radioactive Material in posure, and f rdmoactive materials in Light-Water-Cooled Nuclear Power Reactor effluents t a ricted reas, as far below the limits Effluents," to 10 CFR Part 50, "Licensing of Pro.-is reasonably achievable, tak- duction and Utilization Facilities," requires that ing into " nt the state of technology and the eco- licensees establish an appropriate surveillance and nomics of " ' ovements in relation to public health monitoring program to provide data on quantities of and safety an to the utilization of atomic energy in radioactive material released in liquid and gaseous the public interest, effluents and to provide data on measurable levels of USNRC REGULATORY
GUIDES Comments should be sent to the Secretary at he Comn,$n,,,n.UOS.Nutlea, Regu Regulatory Guides are Issued to desctbe and make available to the public method0 1iotry Commission.


Washington.
specfi*ie P*                          -is reasonably achievable, tak-                            duction and Utilization Facilities," requires that ing into " nt the state of technology and the eco-                                                licensees establish an appropriate surveillance and nomics of"                'ovements in relation to public health                                  monitoring program to provide data on quantities of and safety an to the utilization of atomic energy in                                              radioactive material released in liquid and gaseous the public interest,                                                                              effluents and to provide data on measurable levels of USNRC REGULATORY GUIDES                                                    Comments should be sent to the Secretary at he Comn,$n,,,n.UOS.Nutlea, Regu Regulatory Guides are Issued to desctbe and make available to the public method0                1iotry Commission. Washington. D.C. 20555. Attention Dorheting i,,d Service acceplable to the NRC staff of implementing specific parts of the Commiusion's                Brfanct .
regulations, to delineate techniques used by the talfl in evaluating specific problems        The guides are issued .n the tollow tnqten broad d-%1.13 or poltulated accidents, or to provide guidance to applicants. Regulatory Guides are not tubssltult for regulations. and compliance with them is not required.                  1.  Power Reactors                          6  Protuclts Met',dt end solutions different from those set out in the guides will be accept.              2.  Research and Test Reactors              7. Tans4tjrlit.tn able if they provide a basis for Ithefindings requisite to the issuance or continuance        3.  Fuels and Materials Faclittes            8. Occuluational Health of e permit or license by the Commli.son.                                                      4.  Enviros',,ental and Siting              9. Antitrust Rerty.v
                                                                                                5.  Materials and Plant Protection          tO. General Comments and suggestions for improvements in thete guides ae encouraged at all times, and guides will be revisad. as apsrotortate. to accommodate comments and                Requests Ifo singlecopies of issued g*i$es (which mavyb. ertsL'Acovll at gotelace to reflect new informatiots or eaperierrce. Howe*er, cOmmlnts on this guide,if                ment on an automatic dctlic'butlon list tO tirngle Coli.es el luture quidtr &it
                                                                                                                                                                            'tieleci-c taceived within about two months alter its jauance, will be partlcularly useful in            div*s*ons should he mnde in writing to the US. Nuclear Regulatory Crmmoissot.


D.C. 20555. Attention Dorheting i,,d Service acceplable to the NRC staff of implementing specific parts of the Commiusion's Brfanct .regulations, to delineate techniques used by the talfl in evaluating specific problems The guides are issued .n the tollow tnq ten broad d-%1.13 or poltulated accidents, or to provide guidance to applicants.
evaluating the need lot an early revision,                                                    Washington. D.C. 20555. Attention. Directo,, Onvruon of DOcument Cunttol


Regulatory Guides are not tubssltult for regulations.
radiation and radioactive materials in the environ-            ing, and this need has been widely recognized. Regu- ment. Section lll.B of Appendix I to 10 CFR Part 50            latory Guide 1.21, "Measuring, Evaluating, and Re- provides certain effluent and environmental monitor-          porting Radioactivity in Solid Wastes and Releases of ing requirements. with respect to radioactive iodine if        Radioactive Materials in Liquid and Gaseous estimates of exposure are made on the basis of exist-          Effluents from Light-Water-Cooled Nuclear Power ing conditions and if potential changes in land and            Plants," Regulatory Guide 4.1. "Programs for water usage and food pathways could result in expo-            Monitoring Radioactivity in the Environs of Nuclear sures in excess of the guidelines of Appendix I to 10          Power Plants:" Regulatory Guide 4,8. "Environmen- CFR Part 50.                                                    tal Technical Specifications for Nuclear Power General Design Criterion 60. "'Control of releases          Plants;" and Regulatory Guide 4.14, "Measuring, Evaluating, and Reporting Radioactivity in Releases of radioactive materials to the environment," of Ap- pendix A. "General Design Criteria for Nuclear                  of Radioactive Material in Liquid and Airborne Power Plants." to 10 CFR Part 50 requires that nu-              Effluents from Uranium Mills," all give some guid- clear power plant designs provide means to control              ance on means for assuring the quality of the meas- suitably the release of radioactive materials in gase-          urements of radioactive materials in effluents and the ous a:nd liquid effluents. General Design Criterion            environment outside of nuclear facilities. More com-
64. "Monitoring radioactivity releases." of Appen-              plete and extensive guidance on this subject is pro- vided in this document for nuclear power reactor dix A to 10 CFR Part 50 requires that nuclear power plant designs provide means for monitoring effluent            facilities and for other facilities for which radiologi- discharge paths and the plant environs for radioactiv-          cal monitoring is required by the NRC. This guidance ity that may be released from normal operations, in-            applies both to monitoring that is safety-related and cluding anticipated operational occurrences, and from          monitoring that is not. For safety-related monitoring of nuclear power plants and fuel reprocessing plants, postulated accidents.


and compliance with them is not required.
other regulatory guides on quality assurance (in the General Design Criterion 1. "'Quality standards              Division I and the Division 3 series of regulatory and records." of Appendix A to 10 CFR Part 50 re-              guides) should be consulted to determine their quires that a quality assurance program be established          applicability, if any. to the radiological monitoring for those structures, systems. and components of a            activities.


1. Power Reactors 6 Protuclts Met',dt end solutions different from those set out in the guides will be accept. 2. Research and Test Reactors 7. Tans4tjrlit.tn able if they provide a basis for Ithe findings requisite to the issuance or continuance
nuclear power plant that are important to safety in  
3. Fuels and Materials Faclittes
8. Occuluational Health of e permit or license by the Commli.son.


4. Enviros',,ental and Siting 9. Antitrust Rerty.v 5. Materials and Plant Protection tO. General Comments and suggestions for improvements in thete guides ae encouraged at all times, and guides will be revisad. as apsrotortate.
==B. DISCUSSION==
*
order to provide adequate assurance that they will satisfactorily perform their safety functions.                    To assure that radiological monitoring meas- Appendix B. "Quality Assurance Criteria for Nu-            urements are reasonably valid, organizations per- clear Power Plants and Fuel Reprocessing Plants," to            forming these measurements have found it necessary
10 CFR Part 50 establishes quality assurance re-              to establish quality assurance programs. These pro- quirements for the design, construction, and opera-            grams are needed for the following reasons: (1) to tion of those structures, systems, and components of            identify deficiencies in the sampling and measure- these facilities that prevent or mitigate the conse-            ment processes to those responsible for these opera- quences of postulated accidents that could cause                tions so that corrective action can be taken, (2) to uridue risk to the health and safety of the pitblic. The        provide a means of relating the results of a particular monitoring program to the National Bureau of Stand- pertinent requirements of this Appendix apply to all safety-related functions of these structures. systems,          ards and thereby to provide a common basis for com- and components. This guide describes a method ac-              paring the results of various programs, and (3) to ob- ceptable to the NRC staff for the design and opera-            tain some measure of confidence in the results of the tion of a program to meet the requirements of Ap-              monitoring programs in order to assure the regulatory pendix B to 10 CFR Part 50, for the safety functions            agencies and the public that the results are valid.


to accommodate comments and Requests Ifo single copies of issued (which mavy b. ertsL'Acovll at got elace to reflect new informatiots or eaperierrce. cOmmlnts on this guide,if ment on an automatic dctlic'butlon list tO tirngle Coli.es el luture quidtr &it 'tieleci-c taceived within about two months alter its jauance, will be partlcularly useful in should he mnde in writing to the US. Nuclear Regulatory Crmmoissot.
of radiological monitoring of effluents and the                    Existing published guidance on specific quality as- environment.                                                    surance actions which are applicable to radiological As used in the context of this guide. quality assur-       monitoring is limited and, in general, is restricted to ance comprises all those planned and systematic ac-            quality control practices for radioanalytical labora.


evaluating the need lot an early revision, Washington.
tions that are necessary to provide adequate confi-            tories (Refs. 1-3). However, quality assurance should dence in the results of a monitoring program, and              be applied to all steps of the monitoring process that quality control comprises those quality assurance ac-          may include sampling, shipment of samples, receipt tions that provide a means to control and measure the          of samples in the laboratory, preparation of samples, characteristics of measurement equipment and proc-              measurement of radioactivity (counting), data reduc- esses to established requirements; therefore, quality          tion, data evaluation, and reporting of the monitoring assurance includes quality cot,,arol.                          results.


D.C. 20555. Attention.
The need for quality assurance is implicit in all re-      *Definitions of special terms used in this guide are given in a quirements for effluent and environmental monitor-            glossary in Appendix A.


Directo,, Onvruon of DOcument Cunttol radiation and radioactive materials in the environ-ment. Section lll.B of Appendix I to 10 CFR Part 50 provides certain effluent and environmental monitor-ing requirements.
4.15-2


with respect to radioactive iodine if estimates of exposure are made on the basis of exist-ing conditions and if potential changes in land and water usage and food pathways could result in expo-sures in excess of the guidelines of Appendix I to 10 CFR Part 50.General Design Criterion
The scope of this guide is limited to the elements          2. Specification of Qualifications of Personnel of a quality assurance program, which is a planned.
60. "'Control of releases of radioactive materials to the environment," of Ap-pendix A. "General Design Criteria for Nuclear Power Plants." to 10 CFR Part 50 requires that nu-clear power plant designs provide means to control suitably the release of radioactive materials in gase-ous a:nd liquid effluents.


General Design Criterion 64. "Monitoring radioactivity releases." of Appen-dix A to 10 CFR Part 50 requires that nuclear power plant designs provide means for monitoring effluent discharge paths and the plant environs for radioactiv- ity that may be released from normal operations, in-cluding anticipated operational occurrences, and from postulated accidents.
systematic, and documented program that includes                    The qualification of. individuals performing quality control. Guidance on principles and good                radiological monitoring to perform their assigned practice in the monitoring process itself and guidance          functions should be specified and documented. Speci.


General Design Criterion
on activities that can affect the quality of the monitor-        fication of these qualifications in terms of previous ing results (e.g., design of facilities and equipment)          training and performance on the job or satisfactory are outside the scope of this guide. However, some              completion of proficiency testing is prclerred to spec- references are provided to documents that do provide             ification of education and experience levels.
1. "'Quality standards and records." of Appendix A to 10 CFR Part 50 re-quires that a quality assurance program be established for those structures, systems. and components of a nuclear power plant that are important to safety in order to provide adequate assurance that they will satisfactorily perform their safety functions.


Appendix B. "Quality Assurance Criteria for Nu-clear Power Plants and Fuel Reprocessing Plants," to 10 CFR Part 50 establishes quality assurance re-quirements for the design, construction, and opera-tion of those structures, systems, and components of these facilities that prevent or mitigate the conse-quences of postulated accidents that could cause uridue risk to the health and safety of the pitblic. The pertinent requirements of this Appendix apply to all safety-related functions of these structures.
some guidance in these areas. The citation of these references does not constitute an endorsement of all An introduction and orientation program, appro- of the guidance in these documents by the NRC staff.


systems, and components.
Rather, these references are provided as sources of            priate to the size and complexity of the organization.


This guide describes a method ac-ceptable to the NRC staff for the design and opera-tion of a program to meet the requirements of Ap-pendix B to 10 CFR Part 50, for the safety functions of radiological monitoring of effluents and the environment.
information to aid the licensee and the licensee's con-        should provide that (a) personnel performing tractors in developing and maintaining a monitoring            quality-related activities are trained and qualified in program.                                                        the principles and techniques of the activities per- formed. and (b) proficiency of personnel who per- form activities affecting quality is maintained by re- Every organization actually performing effluent training, reexamining. and recertifying. as appropriate and environmental monitoring, whether an NRC
licensee or the licensee's contractor, should include          to the activity performed.


As used in the context of this guide. quality assur-ance comprises all those planned and systematic ac-tions that are necessary to provide adequate confi-dence in the results of a monitoring program, and quality control comprises those quality assurance ac-tions that provide a means to control and measure the characteristics of measurement equipment and proc-esses to established requirements;
the quality assurance program elements presented in this guide.
therefore, quality assurance includes quality cot,,arol.


The need for quality assurance is implicit in all re-quirements for effluent and environmental monitor-ing, and this need has been widely recognized.
3. Operating Procedures and Instructions Written procedures should be prepared. reviewed.


Regu-latory Guide 1.21, "Measuring, Evaluating, and Re-porting Radioactivity in Solid Wastes and Releases of Radioactive Materials in Liquid and Gaseous Effluents from Light-Water-Cooled Nuclear Power Plants," Regulatory Guide 4.1. "Programs for Monitoring Radioactivity in the Environs of Nuclear Power Plants:" Regulatory Guide 4,8. "Environmen- tal Technical Specifications for Nuclear Power Plants;" and Regulatory Guide 4.14, "Measuring, Evaluating, and Reporting Radioactivity in Releases of Radioactive Material in Liquid and Airborne Effluents from Uranium Mills," all give some guid-ance on means for assuring the quality of the meas-urements of radioactive materials in effluents and the environment outside of nuclear facilities.
==C. REGULATORY POSITION==
and approved for activities involved in carrying out the monitoring program. including sample collection:
    The quality assurance program of each organiza-             packaging. shipment. and receipt of samples for offsite analysis: preparation and analysis of samples:
tion performing effluent or environmental monitoring of nuclear facilities for normal operations should be            maintenance, storage. and use of radioactive refer- documented by written policies and procedures and                ence standards; calibration and checks of radiation records. These documents should include the ele-                and radioactivity measurement systems: and reduc- ments given in this section.                                    tion. evaluation, and reporting of data. Individuals who review and approve these procedures should be knowledgeable in the subjects of the procedures.


More com-plete and extensive guidance on this subject is pro-vided in this document for nuclear power reactor facilities and for other facilities for which radiologi- cal monitoring is required by the NRC. This guidance applies both to monitoring that is safety-related and monitoring that is not. For safety-related monitoring of nuclear power plants and fuel reprocessing plants, other regulatory guides on quality assurance (in the Division I and the Division 3 series of regulatory guides) should be consulted to determine their applicability, if any. to the radiological monitoring activities.
In addition to its own program, a licensee should require any contractor or subcontractor performing monitoring activities for the licensee to provide a                  Guidance on principles and good practice in many quality assurance program consistent with the provi-            of these activities is presented in NRC regulatory sions of this guide, as follows:                                guides (Refs.4-7) and other publications (Refs. 2.3.


==B. DISCUSSION==
8-25). In addition to these publications, the American Public Health Association is preparing a book on
*
1. Organizational Structure and Responsibilities                quality assurance practices in health laboratories that of Managerial and Operational Personnel                      will include a chapter on radiochemistry. and Scien- tific Committee 18A of the NCRP is preparing a The structure of the organization as it relates to the      manual of radioactivity measurement procedures that management and operation of the monitoring pro.                  will be a revision of NCRP Report 28, NBS Hand- gram(s), including quality assurance policy and func-            book 80, "'A Manual of Radioactivity Procedures."
To assure that radiological monitoring meas-urements are reasonably valid, organizations per-forming these measurements have found it necessary to establish quality assurance programs.
tions, should be presented. The authorities, duties, and responsibilities of the persons holding specified positions within this organization should be stated, including responsibilities for review and approval of            4. Records written procedures and for preparation, review, and evaluation of monitoring data and reports.                          The records necessary to document the activities performed in the monitoring program should be spec- Persons and organizations performing quality as-            ified in the quality assurance program.
 
surance functions should have sufficient authority and organizational freedom to identify quality prob-                One key aspect of quality control is maintaining lems; to initiate, recommend, or provide solutions;              the ability to track and control a sample in its prog- and to verify implementation of solutions.                      ress through the sequence of monitoring processes.
 
4.15-3
 
Records to accomplish this should cover the follow-              Procedures for sampling, packaging, shipping, and
*    ing proce.sses: field and inplant sample collection and      storage of samples should be designed to maintair (l;!:
    sample description; sample receipt and laboratory              integrity of the sample from time of collection t, timc identification coding, sample preparation and                  of analysis. Aqueous samples may present a particu-
*  radiochcmical processing (e.g., laboratory note-               lar problem in this regard, and one of the most severe books); radioactivity measurements (counting) of              problems has been encountered with aqueous samples
*  samples, instrument backgrounds. and analytical                of radioactive wastes from operating nuclear reactors blanks. and data reduction and verification.                  (Ref. 2 ).
        Quality control records for laboratory counting sys-          Guidance on the principles and practice of sam- tems should include the results of measurements of            pling in environmental monitoring is provided in sev- radioactive check sources, calibration sources, back-          eral publications (Refs. 2,9.19). In addition, workers grounds. and blanks.                                          at the National Bureau of Standards (NBS) have pub- lished the results of a survey of information on sam- Records relating to overall laboratory performance        pling, sample handling, and long-term storage for should include the results of analysis of quality con-        environmental materials (Ref. 13). Some guidance on trol samples such as analytical blanks, duplicates,            the principles and practice of air sampling is provided interlaboratory cross-check samples and other quality         in References 15, 17, and 22. Guidance on the prin- control analyses; use of standard (radioactive) refer-        ciples and practice of water sampling is provided in ence materials to prepare working standards; prepara-          numerous publications (Refs. II, 12, 23-25).
    tion and standardization of carrier solutions; and            6. Quality Control in the Radioanalytical Labora- calibration of analytical balances.                                tory Additional records that are needed should include              6.1 Radionuclide Reference Standards-Use for the calibration of inline radiation detection equip-                    Calibration of Radiation Measuretnenit ment. air samplers, and thermoluminescence                            Systemns dosimetry systems; verification and documentation of              Reference standards are used to determine counting computer programs; qualifications of personnel; and            efficiencies for specific radionuclides or, in the case results of. audits.                                            of gamma-ray spectrometry systems, to determine counting efficiency as a function of gamma-ray The minimum period of retention of the records            energy. A counting efficiency value is used to con- should be specified. Only the final results of the            vert a sample counting rate to the disintegration rate monitoring programs need be retained for the life of          of a radionuclide or to a radionuclide concentration.


These pro-grams are needed for the following reasons: (1) to identify deficiencies in the sampling and measure-ment processes to those responsible for these opera-tions so that corrective action can be taken, (2) to provide a means of relating the results of a particular monitoring program to the National Bureau of Stand-ards and thereby to provide a common basis for com-paring the results of various programs, and (3) to ob-tain some measure of confidence in the results of the monitoring programs in order to assure the regulatory agencies and the public that the results are valid.Existing published guidance on specific quality as-surance actions which are applicable to radiological monitoring is limited and, in general, is restricted to quality control practices for radioanalytical labora.tories (Refs. 1-3). However, quality assurance should be applied to all steps of the monitoring process that may include sampling, shipment of samples, receipt of samples in the laboratory, preparation of samples, measurement of radioactivity (counting), data reduc-tion, data evaluation, and reporting of the monitoring results.*Definitions of special terms used in this guide are given in a glossary in Appendix A.4.15-2 The scope of this guide is limited to the elements of a quality assurance program, which is a planned.systematic, and documented program that includes quality control. Guidance on principles and good practice in the monitoring process itself and guidance on activities that can affect the quality of the monitor-ing results (e.g., design of facilities and equipment)
the facility.                                                  (Guidance on calibration and usage of germanium de- tectors for measurement of gamma-ray emission rates of radionuclides is being prepared by a writing group of the Health Physics Society Standards Committee
are outside the scope of this guide. However, some references are provided to documents that do provide some guidance in these areas. The citation of these references does not constitute an endorsement of all of the guidance in these documents by the NRC staff.Rather, these references are provided as sources of information to aid the licensee and the licensee's con-tractors in developing and maintaining a monitoring program.Every organization actually performing effluent and environmental monitoring, whether an NRC licensee or the licensee's contractor, should include the quality assurance program elements presented in this guide.C. REGULATORY
  5. Quality Control in Sampling (Including Packag-             for publication as an ANSI Standard.)
POSITION The quality assurance program of each organiza-tion performing effluent or environmental monitoring of nuclear facilities for normal operations should be documented by written policies and procedures and records. These documents should include the ele-ments given in this section.In addition to its own program, a licensee should require any contractor or subcontractor performing monitoring activities for the licensee to provide a quality assurance program consistent with the provi-sions of this guide, as follows: 1. Organizational Structure and Responsibilities of Managerial and Operational Personnel The structure of the organization as it relates to the management and operation of the monitoring pro.gram(s), including quality assurance policy and func-tions, should be presented.
      Ing, Shipping, and Storage of Samples)
                                                                      Radionuclide standards that have been certified by Continuous sampling of liquids and gases involves          the NBS, or standards that have been standardized the measurement of sample flow rates and/or sample            using a measurement system that is traceable to that volumcs. The accuracy of the devices used for this             of the NBS,* should be used when such standards are purpose should be determined on a regularly sched- uled basis, and adjustments should be made as                  *For a discussion by NBS staff members of the concept of needed to bring the performance of the devices within          traceability of radioactivity measurements to NBS, see Refer- specified limits. The results of these calibrations            ence 27.A brief summary of this discussion is as follows: There should be recorded. The frequency of these calibra-            are both direct and indirect traceability. Direct traceability to NBS exists when. any outside laboratory prepares a batch of tions should be specified and should be based on the           calibrated radioactivity standards and submits several randomly required accuracy, purpose, degree of usage, stability        selected samples to NBS for confirmation or verification. Indi.


The authorities, duties, and responsibilities of the persons holding specified positions within this organization should be stated, including responsibilities for review and approval of written procedures and for preparation, review, and evaluation of monitoring data and reports.Persons and organizations performing quality as-surance functions should have sufficient authority and organizational freedom to identify quality prob-lems; to initiate, recommend, or provide solutions;
characteristics, and other conditions affecting the            rect traceability to NBS exists when NBS provides "unknown"
and to verify implementation of solutions.
*  measurement. Continuous sampling should be dem-                calibrate radioactivity samples to one or more laboratories which in turn make measurements of activity that agree within certain onstrably representative of the material volumes sam-          specified limits with those of NBS. Thus there can be 1%, etc.,
  pled. The collection efficiencies of the samplers used        traceability. Regular use of NBS radioactivity standards by an should be documented.                                          outside laboratory to calibrate its measuring equipment does not, in the view of the NBS staff, constitute traceability. Only when Grab samples should be demonstrably representa-           the outside laboratory can measure the activity of an unknown sample and send back values to NBS that agree with NBS values tive of the material sampled, and replicate samples            within a certain specified range of error does NBS consider that should be taken periodically to demonstrate the re-            traceability has been established. NBS notes that this condition producibility of sampling.                                    can be achieved without using a single NBS standard.


2. Specification of Qualifications of Personnel The qualification of. individuals performing radiological monitoring to perform their assigned functions should be specified and documented.
4.15-4


Speci.fication of these qualifications in terms of previous training and performance on the job or satisfactory completion of proficiency testing is prclerred to spec-ification of education and experience levels.An introduction and orientation program, appro-priate to the size and complexity of the organization.
available. Otherwise, standards should be obtained            with automatic sample changers, background mncas- from other reputable suppliers. An "International Di-         urements should be included within each counting rectory of Certified Radioactive Materials" has been          cycle.


should provide that (a) personnel performing quality-related activities are trained and qualified in the principles and techniques of the activities per-formed. and (b) proficiency of personnel who per-form activities affecting quality is maintained by re-training, reexamining.
publi.;hcd by the International Atomic Energy Agency (Ref. 26).                                                  For alpha- and gamma-ray spectrometry systems, energy-calibration sources (i.e.. a source containing a Acceptable standards for certain natural radionuc-          radionuclide. or mixture of radionuclides. emitting lides may be prepared from commercially available              two or more alpha or gamma rays of known energies)
high-purity chemicals. For example, potassium-40              arc counted to determine the relationship between standards for gross beta measurements or gamma-ray            channel number and alpha- or gamma-ray energy.


and recertifying.
spectrometry may be prepared from dried reagent-              The frequency of these energy calibration checks de- grade potassium chloride.                                      pends on the stability of the system but usually is in the range of daily to weekly. The results of these The details of the preparation of working standards          *l.ci,,uienlents should be recorded and compared to from certified standard solutions should be recorded.          predetermined limits in order to determine whether or The working standard should be prepared in the same            noi system gain and zero level need adjustment. Ad- form as the unknown samples, or close approxima-              justmients should be made as necessary.


as appropriate to the activity performed.
tion thereto.


3. Operating Procedures and Instructions Written procedures should be prepared.
Additional checks needed for spectrometry systems Efficiency calibrations should he checked periodi-          are the energy resolution of the system and the count cally (typically monthly tc yearly) with standard              rate (or counting efficiency) of a check source. These sources. In addition, these checks should be made              should be determined periodically (usually weekly to whenever the need is indicated, such as when a sig-            nmonthly for energy resolution and daily to weekly for nificant change in the measurement system is de-              count rate) and after system changes, such as power tected by routine measurements with a check source.            failures or repairs, to determine if there has been any significant change in the system. The results of these measurements should be recorded.


reviewed.and approved for activities involved in carrying out the monitoring program. including sample collection:
6.2 Performance Checks of Radiation Measure- Inenit Systems                                            6.3 Analysis of Quality' Control Samples Determination of the background counting rate and              The analysis of quality control samples provides a the response of each radiation detection system to ap-        means to determine the precision and accuracy of the propriate check sources should be performed on a              monitoring processes and include!, both intralabora- scheduled basis for systems in routine use. The re-          tory and interlaboratory measurements.
packaging.


shipment.
sults of these measurements should be recorded in a log and/or plotted on a control chart. Appropriate in-            The analysis of replicate samples provides a means vestigative and corrective action should be taken              to determine precision: the analysis of samples con- when the measurement value falls outside the pre-              taining known concentrations of radionuclides pro- determined control value.                                      vides a means to deter'mine accuracy. The analysis of laboratory blanks provides a means to detect and A check source for determining changes in count-            measure radioactive contamination of analytical sam- ing rate or counting efficiency should be of sufficient      ples, a common source of error in radiochemical radiochemical purity to allow correction for decay but        analysis of low-level samples. The analysis of analyt- need not have an accurately known disintegration              ical blanks also provides information on the adequacy rate, i.e., need not be a standard source.                    of background subtraction, particularly for samples measured by gamma-ray spectrometry.


and receipt of samples for offsite analysis:
For systems in which samples are changed manu- ally, check sources are usually measured daily. For              The fraction of the analytical effort needed for the systems with automatic sample changers, it may be            analysis of quality control samples depends to a large more convenient to include the check source within            extent on (I) the mixture of sample types in a particu- each batch of samples and thus obtain a measurement           lar laboratory in a particular time period and (2) the of this source within each counting cycle. For propor-       history of performance of that laboratory in the anal- tional counter systems, the plateau(s) should be              ysis of quality control samples. H6wever, in general checked after each gas change. Background meas-              it is found that at least 5%, and typically 10%, of the urements should be made frequently to ensure that            analytical load should consist of quality control levels arc within the expected range. For systems            samples.
preparation and analysis of samples: maintenance, storage. and use of radioactive refer-ence standards;
calibration and checks of radiation and radioactivity measurement systems: and reduc-tion. evaluation, and reporting of data. Individuals who review and approve these procedures should be knowledgeable in the subjects of the procedures.


Guidance on principles and good practice in many of these activities is presented in NRC regulatory guides (Refs.4-7)
4.15-5
and other publications (Refs. 2.3.8-25). In addition to these publications, the American Public Health Association is preparing a book on quality assurance practices in health laboratories that will include a chapter on radiochemistry.


and Scien-tific Committee
6.3.1 IntralaboratoryAnalyses                              grams to provide an independent test of the ability to measure radionuclides at the very low concentrations Replicate samples, usually duplicates, should be           present in most environmental samples.
18A of the NCRP is preparing a manual of radioactivity measurement procedures that will be a revision of NCRP Report 28, NBS Hand-book 80, "'A Manual of Radioactivity Procedures." 4. Records The records necessary to document the activities performed in the monitoring program should be spec-ified in the quality assurance program.One key aspect of quality control is maintaining the ability to track and control a sample in its prog-ress through the sequence of monitoring processes.


4.15-3 Records to accomplish this should cover the follow-* ing proce.sses:
analyzed routinely. These replicates should be pre- pared from samples that are as homogeneous as pos-                 The NRC Office of Inspection and Enforcement sible, such as well-stirred or mixed liquids (water or conducts a Ccnfirmatory Measurements Program for milk) and solids (dried, ground, or screened soil, sed- laboratories of licensees that measure nuclear reactor iment, or vegetation; or the ash of these materials).
field and inplant sample collection and sample description;
                                                                effluents. The analyses of liquid waste holdup tank The size and other physical and chemical characteris-          samples, gas samples, charcoal cartridges, and stack tics of the replicate samples should be similar to particulate filters are included in this program. The those of single samples analyzed routinely.
sample receipt and laboratory identification coding, sample preparation and* radiochcmical processing (e.g., laboratory note-books); radioactivity measurements (counting)  
of* samples, instrument backgrounds.


and analytical blanks. and data reduction and verification.
results of the licensee's measurements of samples split with the NRC are compared to those of an NRC
    The analysis of the replicate samples as blind re-          reference laboratory whose measurements are trace- plicates is desirable but is not practicable for all lab-      able to the National Bureau of Standards (Ref. 27).
oratories or for all types of samples. For example, in          Thus the results of this comparison provide to the small laboratories it may not be practicable to prevent        NRC an objective measure of the accuracy of the the analysts from being aware that particular samples          licensee's analyses.


Quality control records for laboratory counting sys-tems should include the results of measurements of radioactive check sources, calibration sources, back-grounds. and blanks.Records relating to overall laboratory performance should include the results of analysis of quality con-trol samples such as analytical blanks, duplicates, interlaboratory cross-check samples and other quality control analyses;
are replicates of one another.
use of standard (radioactive)
refer-ence materials to prepare working standards;
prepara-tion and standardization of carrier solutions;
and calibration of analytical balances.Additional records that are needed should include the calibration of inline radiation detection equip-ment. air samplers, and thermoluminescence dosimetry systems; verification and documentation of computer programs;
qualifications of personnel;
and results of. audits.The minimum period of retention of the records should be specified.


Only the final results of the monitoring programs need be retained for the life of the facility.5. Quality Control in Sampling (Including Packag-Ing, Shipping, and Storage of Samples)Continuous sampling of liquids and gases involves the measurement of sample flow rates and/or sample volumcs. The accuracy of the devices used for this purpose should be determined on a regularly sched-uled basis, and adjustments should be made as needed to bring the performance of the devices within specified limits. The results of these calibrations should be recorded.
Laboratories of licensees or their contractors that Obtaining true replicates of all types .of samples          perform environmental measurements should partici- also is not practicable. For example, obtaining repli-          pate in the EPA's Environmental Radioactivity Lab- cate samples of airborne materials usually is not prac-        oratory Intercomparison Studies (Cross-check) Pro- ticable on a routine basis because it requires either a        gram, or an equivalent program. This participation separate sampling system or splitting a single sample          should include all of the determinations (sample (e.g., cutting a filter in half). Use of replicate              medium/radionuclide combinations) that are both of- samplers usually is not economically feasible and               fered by EPA and included in the licensee's environ- splitting of samples results in replicates that do not          mental monitoring program. Participation in the EPA
represent the usual sample size or measurement con-            program provides an objective measure of the accu- figuration (counting geometry) for direct measure-              racy of the analyses because the EPA measurements ment. However, simulated samples of airborne mate-              are traceable to the National Bureau of Standards. If rials may be prepared in replicate and submitted for            the mean result of a cross-check analysis exceeds the analysis as unknowns.                                          control limit as defined by EPA (Ref. 28), an investi- gation should be made to determine the reason for Analysis of intralaboratory blank and spiked sam-          this deviation and corrective action should be taken ples is an important part of each laboratory's quality          as necessary. Similarly, an investigation and any control program. A known analytical blank sample                necessary corrective action should take place if the should be analyzed with each group of unknown                  "normalized range." as calculated by EPA, exceeds samples that is processed radiochemically to deter-            the control limit, as defined by EPA. A series of re- mine a specific radionuclide or radionuclides. Spiked          sults that is within the control limits but that exhibits and blank samples should be submitted for analysis              a trend toward these limits may indicate a need for an as unknowns to provide an intralaboratory basis for            investigation to determine the reason for the trend.


The frequency of these calibra-tions should be specified and should be based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the* measurement.
estimating the accuracy of the analytical results.


Continuous sampling should be dem-onstrably representative of the material volumes sam-pled. The collection efficiencies of the samplers used should be documented.
These blanks and spikes may include blind replicates.


Grab samples should be demonstrably representa- tive of the material sampled, and replicate samples should be taken periodically to demonstrate the re-producibility of sampling.Procedures for sampling, packaging, shipping, and storage of samples should be designed to maintair (l;!: integrity of the sample from time of collection t, timc of analysis.
6.4 Compuitational Checks
    6.3.2 InterlaboratvryAnalyses                                  Procedures for the computation of the concentra- tion of radioactive materials should include the inde- Analysis of effluent and environmental samples             pendent verification of a substantial fraction of the split with one or more independent laboratories is an          results of the computation by a person other than the important part of the quality assurance program be-            one performing the original computat'on. For com- cause it provides a means to detect errors that might          puter calculations, the input data should be verified not be detected by intralaboratory measurements                by a knowledgeable individual. All computer pro- alone. When possible, these independent laboratories            grams should be documented and verified before ini- should be those whose measurements are traceable to             tial routine use and after each modification of the NBS (Ref. 27).                                                  program. The verification process should include ver- ification, by a knowledgeable individual, of the al- Analysis of split field samples, such as samples of         gorithm used and test runs in which the output of the milk, water, soil or sediment, and vegetation, is par-          computer computation for given input can be com- ticularly important in environmental monitoring pro-            pared to "true" values that are known or determined
                                                          4.15-6


Aqueous samples may present a particu-lar problem in this regard, and one of the most severe problems has been encountered with aqueous samples of radioactive wastes from operating nuclear reactors (Ref. 2 ).Guidance on the principles and practice of sam-pling in environmental monitoring is provided in sev-eral publications (Refs. 2,9.19). In addition, workers at the National Bureau of Standards (NBS) have pub-lished the results of a survey of information on sam-pling, sample handling, and long-term storage for environmental materials (Ref. 13). Some guidance on the principles and practice of air sampling is provided in References
independently of the computer calculation. Documen-           under which the system will be optrated. These flow tation of the program should include a description of         rate devices should be recalibrated periodically.
15, 17, and 22. Guidance on the prin-ciples and practice of water sampling is provided in numerous publications (Refs. II, 12, 23-25).6. Quality Control in the Radioanalytical Labora-tory 6.1 Radionuclide Reference Standards-Use for Calibration of Radiation Measuretnenit Systemns Reference standards are used to determine counting efficiencies for specific radionuclides or, in the case of gamma-ray spectrometry systems, to determine counting efficiency as a function of gamma-ray energy. A counting efficiency value is used to con-vert a sample counting rate to the disintegration rate of a radionuclide or to a radionuclide concentration.(Guidance on calibration and usage of germanium de-tectors for measurement of gamma-ray emission rates of radionuclides is being prepared by a writing group of the Health Physics Society Standards Committee for publication as an ANSI Standard.)
Radionuclide standards that have been certified by the NBS, or standards that have been standardized using a measurement system that is traceable to that of the NBS,* should be used when such standards are*For a discussion by NBS staff members of the concept of traceability of radioactivity measurements to NBS, see Refer-ence 27.A brief summary of this discussion is as follows: There are both direct and indirect traceability.


Direct traceability to NBS exists when. any outside laboratory prepares a batch of calibrated radioactivity standards and submits several randomly selected samples to NBS for confirmation or verification.
the algorithm and a current listing of the program.


Indi.rect traceability to NBS exists when NBS provides "unknown" calibrate radioactivity samples to one or more laboratories which in turn make measurements of activity that agree within certain specified limits with those of NBS. Thus there can be 1%, etc., traceability.
Guidelines for the documentation of digital computer              Whenever practicable, a check source that is ac- programs are given in ANSI N413-1974 (Ref. 29).               tuated remotely should be installed for integrity cheeks of the detector and the associated electrical
7. Quality Control for Continuous Effluent                    system.


Regular use of NBS radioactivity standards by an outside laboratory to calibrate its measuring equipment does not, in the view of the NBS staff, constitute traceability.
Monitoring Systems                                        8. Review, Analysis, and Reporting Data The specified frequency of calibration for a par-            Procedures for review, analysis, and reporting of ticular system should he based on considerations of the       data should include examinatiuns for reasonableness nature and stability of that system. For nuclear power        and consistency of the data and investigative and plants, specific requirements for calibrations and corrective actions to be taken under specified checks of particular effluent monitoring systems usu-        circumstances.


Only when the outside laboratory can measure the activity of an unknown sample and send back values to NBS that agree with NBS values within a certain specified range of error does NBS consider that traceability has been established.
ally are included in the technical specifications for the plant.                                                    9. Audits Initial calibration of each measuring system should          Planned and periodic audits should be made to ver- be performed using one or more of the reference                ify implementation of the quality assurance program.


NBS notes that this condition can be achieved without using a single NBS standard.4.15-4 available.
standards that are certified by the National Bureau of        The audits should be performed by qualified indi- Standards or that are calibrated by a measurement            viduals who do not have direct responsibilities in the system that is traceable to that of the National Bureau      areas being audited.


Otherwise, standards should be obtained from other reputable suppliers.
of Standards (Ref. 27). For nuclear power plants, Audit results should be documented and reviewed these calibrations are usually repeated at least annu- by management having responsibility in the area au- ally. The radionuclide standards should permit calib- dited. Followup action, including reaudit of deficient rating the system over its intended range of energy areas, should be taken where indicated.


An "International Di-rectory of Certified Radioactive Materials" has been publi.;hcd by the International Atomic Energy Agency (Ref. 26).Acceptable standards for certain natural radionuc-lides may be prepared from commercially available high-purity chemicals.
and rate capabilities. Periodic inplant calibration should be performed using a secondary source or                             


For example, potassium-40
==D. IMPLEMENTATION==
standards for gross beta measurements or gamma-ray spectrometry may be prepared from dried reagent-grade potassium chloride.The details of the preparation of working standards from certified standard solutions should be recorded.The working standard should be prepared in the same form as the unknown samples, or close approxima- tion thereto.Efficiency calibrations should he checked periodi-cally (typically monthly tc yearly) with standard sources. In addition, these checks should be made whenever the need is indicated, such as when a sig-nificant change in the measurement system is de-tected by routine measurements with a check source.6.2 Performance Checks of Radiation Measure-Inenit Systems Determination of the background counting rate and the response of each radiation detection system to ap-propriate check sources should be performed on a scheduled basis for systems in routine use. The re-sults of these measurements should be recorded in a log and/or plotted on a control chart. Appropriate in-vestigative and corrective action should be taken when the measurement value falls outside the pre-determined control value.A check source for determining changes in count-ing rate or counting efficiency should be of sufficient radiochemical purity to allow correction for decay but need not have an accurately known disintegration rate, i.e., need not be a standard source.For systems in which samples are changed manu-ally, check sources are usually measured daily. For systems with automatic sample changers, it may be more convenient to include the check source within each batch of samples and thus obtain a measurement of this source within each counting cycle. For propor-tional counter systems, the plateau(s)
method that has been related to the initial calibration.
should be checked after each gas change. Background meas-urements should be made frequently to ensure that levels arc within the expected range. For systems with automatic sample changers, background mncas-urements should be included within each counting cycle.For alpha- and gamma-ray spectrometry systems, energy-calibration sources (i.e.. a source containing a radionuclide.


or mixture of radionuclides.
For nuclear power plants, these calibrations are usu-            The purpose of this section is to provide informa- ally performed at least monthly.                              tion to applicants and licensees regarding the NRC
                                                              staff's plans for using this regulatory guide.


emitting two or more alpha or gamma rays of known energies)arc counted to determine the relationship between channel number and alpha- or gamma-ray energy.The frequency of these energy calibration checks de-pends on the stability of the system but usually is in the range of daily to weekly. The results of these should be recorded and compared to predetermined limits in order to determine whether or noi system gain and zero level need adjustment.
Periodic correlations should be made during opera- This guide reflects current NRC staff practice.


Ad-justmients should be made as necessary.
tion to relate monitor readings to the concentrations Therefore, except in those cases in which the appli- and/or release rates of radioactive material in the monitored release path. These correlations should be           cant or licensee proposes an acceptable alternative method, the staff will use the method described based on the results of analyses for specific radionuc- herein in evaluating an applicant's or licensee's ca- lides in grab samples from the release path.


Additional checks needed for spectrometry systems are the energy resolution of the system and the count rate (or counting efficiency)
pability for and performance in complying with spec- Flow-rate measuring devices associated with the           ified portions of the Commission's regulations until system should be calibrated to determine actual flow          this guide is revised as a result of suggestions from rates at the conditions of temperature and pressure            the public or additional staff review.
of a check source. These should be determined periodically (usually weekly to nmonthly for energy resolution and daily to weekly for count rate) and after system changes, such as power failures or repairs, to determine if there has been any significant change in the system. The results of these measurements should be recorded.6.3 Analysis of Quality' Control Samples The analysis of quality control samples provides a means to determine the precision and accuracy of the monitoring processes and include!, both intralabora- tory and interlaboratory measurements.


The analysis of replicate samples provides a means to determine precision:
4.15-7
the analysis of samples con-taining known concentrations of radionuclides pro-vides a means to deter'mine accuracy.


The analysis of laboratory blanks provides a means to detect and measure radioactive contamination of analytical sam-ples, a common source of error in radiochemical analysis of low-level samples. The analysis of analyt-ical blanks also provides information on the adequacy of background subtraction, particularly for samples measured by gamma-ray spectrometry.
REFERENCES
  I. Section 6.2, "Validation of Analyses," Chapter        Interface 5 (#4), 49-62 (1976). Also available from
6, "Validity of Results," Methods of Radiochewnical        the Superintendent of Documents, U.S. Government Analysis, World l-ealth Organization, Geneva, 1966.       Printing Office, Washington, D.C. 20402, as NBS
                                                          Technical Note #929, October 1976, C 13.46:929,
2. "Analytical Quality Control Methods," Environ-        S/N 003.003-01694-2.


The fraction of the analytical effort needed for the analysis of quality control samples depends to a large extent on (I) the mixture of sample types in a particu-lar laboratory in a particular time period and (2) the history of performance of that laboratory in the anal-ysis of quality control samples. H6wever, in general it is found that at least 5%, and typically
mental Radioactivity Surveillance Guide, U.S. En-         14. Tritium Measure.'ent Techniques, Report of vironniental Protection Agency Report, ORP/SID
10%, of the analytical load should consist of quality control samples.4.15-5
72-2, June 1972.                                           NCRP SC-36, NCRP Report No. 47, 1976.
6.3.1 Intralaboratory Analyses Replicate samples, usually duplicates, should be analyzed routinely.


These replicates should be pre-pared from samples that are as homogeneous as pos-sible, such as well-stirred or mixed liquids (water or milk) and solids (dried, ground, or screened soil, sed-iment, or vegetation;
3. Environmental Ra,.'iation Measurements, Report          15. "Guide to Sampling Airborne Radioactive Mate- of NCRP SC.35, NCRP Report No. 50, 1976.                  rials in Nuclear Facilities," ANSI N 13.1-1969.
or the ash of these materials).
The size and other physical and chemical characteris- tics of the replicate samples should be similar to those of single samples analyzed routinely.


The analysis of the replicate samples as blind re-plicates is desirable but is not practicable for all lab-oratories or for all types of samples. For example, in small laboratories it may not be practicable to prevent the analysts from being aware that particular samples are replicates of one another.Obtaining true replicates of all types .of samples also is not practicable.
4. Regulatory Guide 1.21, "Measuring, Evaluating,          16. "Specification and Performance of On-Site In- and Reporting Radioactivity in Solid Wastes and Re-        strumentation for Continuously Monitoring Radioac- leases of Radioactive Materials in Liquid and Gase-      tivity in Effluents," ANSI N13.10-1974.


For example, obtaining repli-cate samples of airborne materials usually is not prac-ticable on a routine basis because it requires either a separate sampling system or splitting a single sample (e.g., cutting a filter in half). Use of replicate samplers usually is not economically feasible and splitting of samples results in replicates that do not represent the usual sample size or measurement con-figuration (counting geometry)
ous Effluents from Light-Water-Cooled Nuclear              17. Air Sampling Instruments for Evaluation of At- Power Plants."                                            mospheric Contaminants, Fourth Edition, American
for direct measure-ment. However, simulated samples of airborne mate-rials may be prepared in replicate and submitted for analysis as unknowns.Analysis of intralaboratory blank and spiked sam-ples is an important part of each laboratory's quality control program. A known analytical blank sample should be analyzed with each group of unknown samples that is processed radiochemically to deter-mine a specific radionuclide or radionuclides.
5. Regulatory Guide 4.5, "Measurements of                 Conference of Industrial Hygienists, 1972.


Spiked and blank samples should be submitted for analysis as unknowns to provide an intralaboratory basis for estimating the accuracy of the analytical results.These blanks and spikes may include blind replicates.
Radionuclides in the Environment-Sampling and
                                                            18. Users' Guide for Radioactivity Standards. Sub- Analyses of Plutonium in Soil."
                                                          committee on Radiochemistry and Subcommittee on
6. Regulatory Guide 4.6, "Measurements of                  the Use of Radioactivity Standards, Committee on Radionuclides in the Environment-Strontium-89 and          Nuclear Science, National Academy of Sciences- Strontium-90 Analyses."                                    National Research Council Report, NAS-NS-3115, February 1974.


6.3.2 Interlaboratvry Analyses Analysis of effluent and environmental samples split with one or more independent laboratories is an important part of the quality assurance program be-cause it provides a means to detect errors that might not be detected by intralaboratory measurements alone. When possible, these independent laboratories should be those whose measurements are traceable to NBS (Ref. 27).Analysis of split field samples, such as samples of milk, water, soil or sediment, and vegetation, is par-ticularly important in environmental monitoring pro-grams to provide an independent test of the ability to measure radionuclides at the very low concentrations present in most environmental samples.The NRC Office of Inspection and Enforcement conducts a Ccnfirmatory Measurements Program for laboratories of licensees that measure nuclear reactor effluents.
7. Regulatory Cuide 4.13, "Performance, Testing, and Procedural Specifications for Thermolumines-           19. Environmental Impact Monitoring for Nuclear cence Dosimetry: Environmental Applications."              Power Plants, Source Book of Monitoring Methods, Vol. I, Atomic Industrial Forum Report, AIF/
8. HASL Procedures Manual, U.S. Energy Research NESP-004, February 1975.


The analyses of liquid waste holdup tank samples, gas samples, charcoal cartridges, and stack particulate filters are included in this program. The results of the licensee's measurements of samples split with the NRC are compared to those of an NRC reference laboratory whose measurements are trace-able to the National Bureau of Standards (Ref. 27).Thus the results of this comparison provide to the NRC an objective measure of the accuracy of the licensee's analyses.Laboratories of licensees or their contractors that perform environmental measurements should partici-pate in the EPA's Environmental Radioactivity Lab-oratory Intercomparison Studies (Cross-check)
and Development Administration Report, HASL-300,
Pro-gram, or an equivalent program. This participation should include all of the determinations (sample medium/radionuclide combinations)
1972 (updated annually).                                 20. Instrumentation for Environmental Monitoring:
that are both of-fered by EPA and included in the licensee's environ-mental monitoring program. Participation in the EPA program provides an objective measure of the accu-racy of the analyses because the EPA measurements are traceable to the National Bureau of Standards.
                                                          Radiation, Lawrence Berkeley Laboratory Report,
9. A Guide for Environmental Radiological Surveil-         LBL-l, Vol. 3, First Ed., May 1972; First update, lance at ERDA Installations, Energy Research and          February 1973; Second update, October 1973.


If the mean result of a cross-check analysis exceeds the control limit as defined by EPA (Ref. 28), an investi-gation should be made to determine the reason for this deviation and corrective action should be taken as necessary.
Development Administration Report, ERDA 77-24, March 1977.                                                21. C. W. Sill, "Problems in Sample Treatment in Trace Analysis." National Bureau of Standards Spe-
10. Handbook of Radiochemical Analytical Methods,         cial Publication 4-22, Accuracy in Trace Analysis:
U.S. Environmental Protection Agency Report,              Sampling, Sample Handling. and Analysis, pp. 463- EPA-680/4-75-001, February 1975.                          490, August 1976.


Similarly, an investigation and any necessary corrective action should take place if the"normalized range." as calculated by EPA, exceeds the control limit, as defined by EPA. A series of re-sults that is within the control limits but that exhibits a trend toward these limits may indicate a need for an investigation to determine the reason for the trend.6.4 Compuitational Checks Procedures for the computation of the concentra- tion of radioactive materials should include the inde-pendent verification of a substantial fraction of the results of the computation by a person other than the one performing the original computat'on.
I1. Standard Methods for the Examination of Water        22. "General Principles for Sampling Airborne and Wastewater, Thirteenth Edition, American Pub-         Radioactive Materials," International Standard, lic Health Association, 1975.                             ISO-2889, 1975.


For com-puter calculations, the input data should be verified by a knowledgeable individual.
12. Handbookfor Sampling and Sample Preservation          23. Manual of Methods for Chemical Analysis of of Water and Wastewater, U.S. Environmental Pro-          Water and Wastes, EPA-625/6-74-003, U.S. En- tection Agency Report, Office of Research and De-          vironmental Protection Agency, Office of Technol- velopment, Environmental Monitoring Support Lab-          ogy Transfer, Washington, D.C. 20460, 1974.


All computer pro-grams should be documented and verified before ini-tial routine use and after each modification of the program. The verification process should include ver-ification, by a knowledgeable individual, of the al-gorithm used and test runs in which the output of the computer computation for given input can be com-pared to "true" values that are known or determined
oratory, EPA-200/4-76-049. September 1976i
4.15-6 independently of the computer calculation.
                                                          24. Annual Book of ASTM Standards (Part31), Wa-
13. E. J. Maienthal and D. A. Becker, "A Survey on        ter, American Society for Testing and Materials, Current Literature on Sampling, Sample Handling,          Method D, 3370, pp. 71-82, Philadelphia, PA, July and Long-Term Storage for Environmental Materials,"         1975.


Documen-tation of the program should include a description of the algorithm and a current listing of the program.Guidelines for the documentation of digital computer programs are given in ANSI N413-1974 (Ref. 29).7. Quality Control for Continuous Effluent Monitoring Systems The specified frequency of calibration for a par-ticular system should he based on considerations of the nature and stability of that system. For nuclear power plants, specific requirements for calibrations and checks of particular effluent monitoring systems usu-ally are included in the technical specifications for the plant.Initial calibration of each measuring system should be performed using one or more of the reference standards that are certified by the National Bureau of Standards or that are calibrated by a measurement system that is traceable to that of the National Bureau of Standards (Ref. 27). For nuclear power plants, these calibrations are usually repeated at least annu-ally. The radionuclide standards should permit calib-rating the system over its intended range of energy and rate capabilities.
4.15-8


Periodic inplant calibration should be performed using a secondary source or method that has been related to the initial calibration.
25. Biological Field and Laboratory, Methods for          Standards and Measurements in Different Fields,"
Measuring the Quality of Surface Waters and              Nuclear Instruments and Methods, Vol. 112, pp.


For nuclear power plants, these calibrations are usu-ally performed at least monthly.Periodic correlations should be made during opera-tion to relate monitor readings to the concentrations and/or release rates of radioactive material in the monitored release path. These correlations should be based on the results of analyses for specific radionuc-lides in grab samples from the release path.Flow-rate measuring devices associated with the system should be calibrated to determine actual flow rates at the conditions of temperature and pressure under which the system will be optrated.
Effluents, EPA-670/4-73-001, Office of Research and       5-18, 1973.


These flow rate devices should be recalibrated periodically.
Development, U.S. Environmental Protection Agency, Cincinnati, Ohio, July 1973.                      28. Environmental Radioactivity Laboratory Inter- comparison Studies Program, FY 1977, EPA-600/4.


Whenever practicable, a check source that is ac-tuated remotely should be installed for integrity cheeks of the detector and the associated electrical system.8. Review, Analysis, and Reporting Data Procedures for review, analysis, and reporting of data should include examinatiuns for reasonableness and consistency of the data and investigative and corrective actions to be taken under specified circumstances.
26. International Directory of Certified Radioactive      77-001, January 1977.


9. Audits Planned and periodic audits should be made to ver-ify implementation of the quality assurance program.The audits should be performed by qualified indi-viduals who do not have direct responsibilities in the areas being audited.Audit results should be documented and reviewed by management having responsibility in the area au-dited. Followup action, including reaudit of deficient areas, should be taken where indicated.
Materials, International Atomic Energy Agency Re- port, STI/PUB/398, 1975.                                 29. "Guidelines for the Documentation of Digital
27. L. M. Cavallo et al.. "Needs for Radioactivity        Computer Programs," ANSI N413- 1974.


==D. IMPLEMENTATION==
4.15-9
The purpose of this section is to provide informa-tion to applicants and licensees regarding the NRC staff's plans for using this regulatory guide.This guide reflects current NRC staff practice.Therefore, except in those cases in which the appli-cant or licensee proposes an acceptable alternative method, the staff will use the method described herein in evaluating an applicant's or licensee's ca-pability for and performance in complying with spec-ified portions of the Commission's regulations until this guide is revised as a result of suggestions from the public or additional staff review.4.15-7 REFERENCES
I. Section 6.2, "Validation of Analyses," Chapter 6, "Validity of Results," Methods of Radiochewnical Analysis, World l-ealth Organization, Geneva, 1966.2. "Analytical Quality Control Methods," Environ-mental Radioactivity Surveillance Guide, U.S. En-vironniental Protection Agency Report, ORP/SID 72-2, June 1972.3. Environmental Ra,.'iation Measurements, Report of NCRP SC.35, NCRP Report No. 50, 1976.4. Regulatory Guide 1.21, "Measuring, Evaluating, and Reporting Radioactivity in Solid Wastes and Re-leases of Radioactive Materials in Liquid and Gase-ous Effluents from Light-Water-Cooled Nuclear Power Plants." 5. Regulatory Guide 4.5, "Measurements of Radionuclides in the Environment-Sampling and Analyses of Plutonium in Soil." 6. Regulatory Guide 4.6, "Measurements of Radionuclides in the Environment-Strontium-89 and Strontium-90
Analyses." 7. Regulatory Cuide 4.13, "Performance, Testing, and Procedural Specifications for Thermolumines- cence Dosimetry:
Environmental Applications." 8. HASL Procedures Manual, U.S. Energy Research and Development Administration Report, HASL-300, 1972 (updated annually).
9. A Guide for Environmental Radiological Surveil-lance at ERDA Installations, Energy Research and Development Administration Report, ERDA 77-24, March 1977.10. Handbook of Radiochemical Analytical Methods, U.S. Environmental Protection Agency Report, EPA-680/4-75-001, February 1975.I1. Standard Methods for the Examination of Water and Wastewater, Thirteenth Edition, American Pub-lic Health Association, 1975.12. Handbook for Sampling and Sample Preservation of Water and Wastewater, U.S. Environmental Pro-tection Agency Report, Office of Research and De-velopment, Environmental Monitoring Support Lab-oratory, EPA-200/4-76-049.


September
APPENDIX A
1976i 13. E. J. Maienthal and D. A. Becker, "A Survey on Current Literature on Sampling, Sample Handling, and Long-Term Storage for Environmental Materials," Interface
                                                    GLOSSARY
5 (#4), 49-62 (1976). Also available from the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402, as NBS Technical Note #929, October 1976, C 13.46:929, S/N 003.003-01694-2.
A-ccurac'yv-normally refers to the difference (error or      electronic components of the system are operating bias) between tile mean, K. of the set of results and        correctly.


14. Tritium Measure.'ent Techniques, Report of NCRP SC-36, NCRP Report No. 47, 1976.15. "Guide to Sampling Airborne Radioactive Mate-rials in Nuclear Facilities," ANSI N 13.1-1969.
the value *. which is accepted as the true or correct Instrument Batckground--the response of the instru- value for the quantity measured. It is also used as the ment in the absence of a radioactive sample or other difference between an individual value X, and X.


16. "Specification and Performance of On-Site In-strumentation for Continuously Monitoring Radioac-tivity in Effluents," ANSI N13.10-1974.
radioactive source.


17. Air Sampling Instruments for Evaluation of At-mospheric Contaminants, Fourth Edition, American Conference of Industrial Hygienists, 1972.18. Users' Guide for Radioactivity Standards.
Absolhte acciuracy of the mean is given by "-,*
                                                              Precision-relates to the reproducibility (f meas- and of an individual value by XrT.


Sub-committee on Radiochemistry and Subcommittee on the Use of Radioactivity Standards, Committee on Nuclear Science, National Academy of Sciences-National Research Council Report, NAS-NS-3115, February 1974.19. Environmental Impact Monitoring for Nuclear Power Plants, Source Book of Monitoring Methods, Vol. I, Atomic Industrial Forum Report, AIF/NESP-004, February 1975.20. Instrumentation for Environmental Monitoring:
urements within a set, that is. to the scatter or disper- Relative accrwvr  of the mean is given by t.-,)/:.       son of a set about its central value.
Radiation, Lawrence Berkeley Laboratory Report, LBL-l, Vol. 3, First Ed., May 1972; First update, February 1973; Second update, October 1973.21. C. W. Sill, "Problems in Sample Treatment in Trace Analysis." National Bureau of Standards Spe-cial Publication
4-22, Accuracy in Trace Analysis: Sampling, Sample Handling.


and Analysis, pp. 463-490, August 1976.22. "General Principles for Sampling Airborne Radioactive Materials," International Standard, ISO-2889, 1975.23. Manual of Methods for Chemical Analysis of Water and Wastes, EPA-625/6-74-003, U.S. En-vironmental Protection Agency, Office of Technol-ogy Transfer, Washington, D.C. 20460, 1974.24. Annual Book of ASTM Standards (Part 31), Wa-ter, American Society for Testing and Materials, Method D, 3370, pp. 71-82, Philadelphia, PA, July 1975.4.15-8
Pr'rcentageaccurac*y is given by 100 (X-0)/*.           Quality Assurance (QA )-(the planned and systematic actions that are necessary to provide adequate confi-
25. Biological Field and Laboratory, Methods for Measuring the Quality of Surface Waters and Effluents, EPA-670/4-73-001, Office of Research and Development, U.S. Environmental Protection Agency, Cincinnati, Ohio, July 1973.26. International Directory of Certified Radioactive Materials, International Atomic Energy Agency Re-port, STI/PUB/398, 1975.27. L. M. Cavallo et al.. "Needs for Radioactivity Standards and Measurements in Different Fields," Nuclear Instruments and Methods, Vol. 112, pp.5-18, 1973.28. Environmental Radioactivity Laboratory Inter-comparison Studies Program, FY 1977, EPA-600/4.
,Imd Vtic*'l Blank (Sample)-ideally. a sample having          dence in the results of a monitoring program.


77-001, January 1977.29. "Guidelines for the Documentation of Digital Computer Programs," ANSI N413- 1974.4.15-9 APPENDIX A GLOSSARY A-ccurac'yv-normally refers to the difference (error or bias) between tile mean, K. of the set of results and the value *. which is accepted as the true or correct value for the quantity measured.
all of the constituents of the unknown sample except those to be determined. In radioanalytical practice.         Quaitiy Control (QC)-those quality assurance ac- the term often refers it) the radiochemical processing        tions that provide a means to control and measure the of carrier(s) or tracers without the sample matrix ma-        characteristics of measurement equipment and proc- terial.                                                      esses to established requirements. Thus. quality as- surance includes quality control.


It is also used as the difference between an individual value X, and X.Absolhte acciuracy of the mean is given by and of an individual value by XrT.Relative accrwvr of the mean is given by t.-,)/:.Pr'rcentage is given by 100 ,Imd Blank (Sample) -ideally.
"Blind" Replivcat (Sample)-replicate samples that are not identified as replicates to the persons pcrform-      Spiketd Sample-a sample to which a known amount ing the analysis.                                             of radioactive material has been added. Generally.


a sample having all of the constituents of the unknown sample except those to be determined.
spiked samples are submitted as unknowns to the Calibrainon-the process of determining the numeri- analysts.


In radioanalytical practice.the term often refers it) the radiochemical processing of carrier(s)
cal relationship between the observed output of a measurement system and the value, based on refer-             Split Sample-a sample that is divided into parts.
or tracers without the sample matrix ma-terial."Blind" Replivcat (Sample)-replicate samples that are not identified as replicates to the persons pcrform-ing the analysis.Calibrainon-the process of determining the numeri-cal relationship between the observed output of a measurement system and the value, based on refer-ence standards, of the characteristics being measured.Calibration Source-any radioactive source that is used for calibration of a measurement system.Check Source (or instrumnent check source, perform-anlce check source, or referJence source)-a radioac-tive source used to determine if the detector and all electronic components of the system are operating correctly.


Instrument Batckground--the response of the instru-ment in the absence of a radioactive sample or other radioactive source.Precision-relates to the reproducibility (f meas-urements within a set, that is. to the scatter or disper-son of a set about its central value.Quality Assurance (QA )-(the planned and systematic actions that are necessary to provide adequate confi-dence in the results of a monitoring program.Quaitiy Control (QC)-those quality assurance ac-tions that provide a means to control and measure the characteristics of measurement equipment and proc-esses to established requirements.
ence standards, of the characteristics being measured.        each of which is analyzed independently by separate Calibration Source-any radioactive source that is             laboratory organizations.


Thus. quality as-surance includes quality control.Spiketd Sample-a sample to which a known amount of radioactive material has been added. Generally.
used for calibration of a measurement system.


spiked samples are submitted as unknowns to the analysts.Split Sample-a sample that is divided into parts.each of which is analyzed independently by separate laboratory organizations.
Standard (radioactive) Source-a radioactive source Check Source (or instrumnent check source, perform-          having an accurately known radionuclide content and anlce check source, or referJence source)-a radioac-          radioactive disintegration rate or particle or photon tive source used to determine if the detector and all        emission rate.


Standard (radioactive)
4.15-10}}
Source-a radioactive source having an accurately known radionuclide content and radioactive disintegration rate or particle or photon emission rate.4.15-10}}


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Latest revision as of 00:28, 20 March 2020

Quality Assurance for Radiological Monitoring Programs (Normal Operations)-Effluent Streams and the Environment
ML13350A203
Person / Time
Issue date: 12/31/1977
From:
Office of Nuclear Regulatory Research
To:
References
RG-4.015
Download: ML13350A203 (10)


U.S. NUCLEAR REGULATORY COMMISSION December 1977 kREGULATORY GUIDE

OFFICE OF STANDARDS DEVELOPMENT

REGULATORY GUIDE 4.15 QUALITY ASSURANCE FOR RADIOLOGICAL MONITORING PROGRAMS

(NORMAL OPERATIONS)-EFFLUENT STREAMS AND THE ENVIRONMENT

A. INTRODUCTION

Section 30.34. Terms and Conditions of This guide describes a method acceptable to the Licenses," of 10 CFR Part 30. "Rules of General NRC staff for designing a program to assure the qual- Applicability to Licensing of Byproduct Material."

ity of the results of measurements of radioactive ma- provides that the Commission mayý.incorporate in any terials in the effluents and the environment outside of byproduct material license such'týrnis and conditions nuclear facilities during normal operations. as it deems appropriate or neccssary. in order to pro- ttr-t hn'ii,: h'*. ",T,

The NRC regulations that require the control of re- Section 40.41. *.Terms".-nd Conditions of leases of radioactive materials from nuclear facilities, Licenscs,' Licene of I0.CFR'Part

- 402...Licensing

"Licesingof ofSorcSource that require the measurements of radioactive mate- Material," provides that'tihe Commission may incor- rials in the effluents and environment outside of these porate in any source material license such terms and facilities, or that authorize license conditions not conditionsaasit d8ims appropriate or necessar) to otherwise authorized in the regulations are as protect heaih',

follows: flSeW1i0 ws: *:.,.':..,, 50o '"-Issuance of Licenses and Con- Section 20.106, "Radioactivity in Effluents to Un- ý,vucttor,1Permits," of 10 CFR Part 50, "Licensing restricted Areas," of 10 CFR Part 20, "Standards for production 'Iq and Utilization Facilities." provides Protection Against Radiation." provides that a licen-r, t each operating license for a nuclear power plant see shall not release to an unrestricted area radioac- *A' ssued by the Nuclear Regulatory Commission will

"is ,* ~'*;.coitain tire materials .~ý; in . concentrations

." that exceed .*:, * .

such conditions and limitations as the Com- specified in 10 CFR Part 20 or as other%ýRe aui t -Mission deems appropriate and necessary.

thorized in a license issued by the Comnssio*.ýec-,. Section 70.32, "Conditions of Licenses," of 10

tion 20.201, "Surveys." of 10 CFR Pflýt fORti CFR Part 70. "Special Nuclear Material." provides requiresmeaurmetsofleel that a licenseeo conduct raito surv.ys, or;' ... including

. .ton that the Commission may incorporate such terms and measurements of levels of radiation oroncentrations conditions as it deems appropriate or necessary to of radioactive materials, as necessary to i onstrate rotect health.

compliance with the regulations in 10 CFR Part 20.

Section IV.B. of Appendix i, "Numerical Guides Paragraph (c) of S4 n. /. "',Purpose," of 10 for Design Objectives and Limiting Conditions for CFR Part 20 states that r nable effort should Operation to Meet the Criterion 'As Low As Is Rea- be made by N P- se o maintain radiation ex- sonably Achievable' for Radioactive Material in posure, and ease*. f rdmoactive materials in Light-Water-Cooled Nuclear Power Reactor effluents t a ricted reas, as far below the limits Effluents," to 10 CFR Part 50, "Licensing of Pro.

specfi*ie P* -is reasonably achievable, tak- duction and Utilization Facilities," requires that ing into " nt the state of technology and the eco- licensees establish an appropriate surveillance and nomics of" 'ovements in relation to public health monitoring program to provide data on quantities of and safety an to the utilization of atomic energy in radioactive material released in liquid and gaseous the public interest, effluents and to provide data on measurable levels of USNRC REGULATORY GUIDES Comments should be sent to the Secretary at he Comn,$n,,,n.UOS.Nutlea, Regu Regulatory Guides are Issued to desctbe and make available to the public method0 1iotry Commission. Washington. D.C. 20555. Attention Dorheting i,,d Service acceplable to the NRC staff of implementing specific parts of the Commiusion's Brfanct .

regulations, to delineate techniques used by the talfl in evaluating specific problems The guides are issued .n the tollow tnqten broad d-%1.13 or poltulated accidents, or to provide guidance to applicants. Regulatory Guides are not tubssltult for regulations. and compliance with them is not required. 1. Power Reactors 6 Protuclts Met',dt end solutions different from those set out in the guides will be accept. 2. Research and Test Reactors 7. Tans4tjrlit.tn able if they provide a basis for Ithefindings requisite to the issuance or continuance 3. Fuels and Materials Faclittes 8. Occuluational Health of e permit or license by the Commli.son. 4. Enviros',,ental and Siting 9. Antitrust Rerty.v

5. Materials and Plant Protection tO. General Comments and suggestions for improvements in thete guides ae encouraged at all times, and guides will be revisad. as apsrotortate. to accommodate comments and Requests Ifo singlecopies of issued g*i$es (which mavyb. ertsL'Acovll at gotelace to reflect new informatiots or eaperierrce. Howe*er, cOmmlnts on this guide,if ment on an automatic dctlic'butlon list tO tirngle Coli.es el luture quidtr &it

'tieleci-c taceived within about two months alter its jauance, will be partlcularly useful in div*s*ons should he mnde in writing to the US. Nuclear Regulatory Crmmoissot.

evaluating the need lot an early revision, Washington. D.C. 20555. Attention. Directo,, Onvruon of DOcument Cunttol

radiation and radioactive materials in the environ- ing, and this need has been widely recognized. Regu- ment. Section lll.B of Appendix I to 10 CFR Part 50 latory Guide 1.21, "Measuring, Evaluating, and Re- provides certain effluent and environmental monitor- porting Radioactivity in Solid Wastes and Releases of ing requirements. with respect to radioactive iodine if Radioactive Materials in Liquid and Gaseous estimates of exposure are made on the basis of exist- Effluents from Light-Water-Cooled Nuclear Power ing conditions and if potential changes in land and Plants," Regulatory Guide 4.1. "Programs for water usage and food pathways could result in expo- Monitoring Radioactivity in the Environs of Nuclear sures in excess of the guidelines of Appendix I to 10 Power Plants:" Regulatory Guide 4,8. "Environmen- CFR Part 50. tal Technical Specifications for Nuclear Power General Design Criterion 60. "'Control of releases Plants;" and Regulatory Guide 4.14, "Measuring, Evaluating, and Reporting Radioactivity in Releases of radioactive materials to the environment," of Ap- pendix A. "General Design Criteria for Nuclear of Radioactive Material in Liquid and Airborne Power Plants." to 10 CFR Part 50 requires that nu- Effluents from Uranium Mills," all give some guid- clear power plant designs provide means to control ance on means for assuring the quality of the meas- suitably the release of radioactive materials in gase- urements of radioactive materials in effluents and the ous a:nd liquid effluents. General Design Criterion environment outside of nuclear facilities. More com-

64. "Monitoring radioactivity releases." of Appen- plete and extensive guidance on this subject is pro- vided in this document for nuclear power reactor dix A to 10 CFR Part 50 requires that nuclear power plant designs provide means for monitoring effluent facilities and for other facilities for which radiologi- discharge paths and the plant environs for radioactiv- cal monitoring is required by the NRC. This guidance ity that may be released from normal operations, in- applies both to monitoring that is safety-related and cluding anticipated operational occurrences, and from monitoring that is not. For safety-related monitoring of nuclear power plants and fuel reprocessing plants, postulated accidents.

other regulatory guides on quality assurance (in the General Design Criterion 1. "'Quality standards Division I and the Division 3 series of regulatory and records." of Appendix A to 10 CFR Part 50 re- guides) should be consulted to determine their quires that a quality assurance program be established applicability, if any. to the radiological monitoring for those structures, systems. and components of a activities.

nuclear power plant that are important to safety in

B. DISCUSSION

order to provide adequate assurance that they will satisfactorily perform their safety functions. To assure that radiological monitoring meas- Appendix B. "Quality Assurance Criteria for Nu- urements are reasonably valid, organizations per- clear Power Plants and Fuel Reprocessing Plants," to forming these measurements have found it necessary

10 CFR Part 50 establishes quality assurance re- to establish quality assurance programs. These pro- quirements for the design, construction, and opera- grams are needed for the following reasons: (1) to tion of those structures, systems, and components of identify deficiencies in the sampling and measure- these facilities that prevent or mitigate the conse- ment processes to those responsible for these opera- quences of postulated accidents that could cause tions so that corrective action can be taken, (2) to uridue risk to the health and safety of the pitblic. The provide a means of relating the results of a particular monitoring program to the National Bureau of Stand- pertinent requirements of this Appendix apply to all safety-related functions of these structures. systems, ards and thereby to provide a common basis for com- and components. This guide describes a method ac- paring the results of various programs, and (3) to ob- ceptable to the NRC staff for the design and opera- tain some measure of confidence in the results of the tion of a program to meet the requirements of Ap- monitoring programs in order to assure the regulatory pendix B to 10 CFR Part 50, for the safety functions agencies and the public that the results are valid.

of radiological monitoring of effluents and the Existing published guidance on specific quality as- environment. surance actions which are applicable to radiological As used in the context of this guide. quality assur- monitoring is limited and, in general, is restricted to ance comprises all those planned and systematic ac- quality control practices for radioanalytical labora.

tions that are necessary to provide adequate confi- tories (Refs. 1-3). However, quality assurance should dence in the results of a monitoring program, and be applied to all steps of the monitoring process that quality control comprises those quality assurance ac- may include sampling, shipment of samples, receipt tions that provide a means to control and measure the of samples in the laboratory, preparation of samples, characteristics of measurement equipment and proc- measurement of radioactivity (counting), data reduc- esses to established requirements; therefore, quality tion, data evaluation, and reporting of the monitoring assurance includes quality cot,,arol. results.

The need for quality assurance is implicit in all re- *Definitions of special terms used in this guide are given in a quirements for effluent and environmental monitor- glossary in Appendix A.

4.15-2

The scope of this guide is limited to the elements 2. Specification of Qualifications of Personnel of a quality assurance program, which is a planned.

systematic, and documented program that includes The qualification of. individuals performing quality control. Guidance on principles and good radiological monitoring to perform their assigned practice in the monitoring process itself and guidance functions should be specified and documented. Speci.

on activities that can affect the quality of the monitor- fication of these qualifications in terms of previous ing results (e.g., design of facilities and equipment) training and performance on the job or satisfactory are outside the scope of this guide. However, some completion of proficiency testing is prclerred to spec- references are provided to documents that do provide ification of education and experience levels.

some guidance in these areas. The citation of these references does not constitute an endorsement of all An introduction and orientation program, appro- of the guidance in these documents by the NRC staff.

Rather, these references are provided as sources of priate to the size and complexity of the organization.

information to aid the licensee and the licensee's con- should provide that (a) personnel performing tractors in developing and maintaining a monitoring quality-related activities are trained and qualified in program. the principles and techniques of the activities per- formed. and (b) proficiency of personnel who per- form activities affecting quality is maintained by re- Every organization actually performing effluent training, reexamining. and recertifying. as appropriate and environmental monitoring, whether an NRC

licensee or the licensee's contractor, should include to the activity performed.

the quality assurance program elements presented in this guide.

3. Operating Procedures and Instructions Written procedures should be prepared. reviewed.

C. REGULATORY POSITION

and approved for activities involved in carrying out the monitoring program. including sample collection:

The quality assurance program of each organiza- packaging. shipment. and receipt of samples for offsite analysis: preparation and analysis of samples:

tion performing effluent or environmental monitoring of nuclear facilities for normal operations should be maintenance, storage. and use of radioactive refer- documented by written policies and procedures and ence standards; calibration and checks of radiation records. These documents should include the ele- and radioactivity measurement systems: and reduc- ments given in this section. tion. evaluation, and reporting of data. Individuals who review and approve these procedures should be knowledgeable in the subjects of the procedures.

In addition to its own program, a licensee should require any contractor or subcontractor performing monitoring activities for the licensee to provide a Guidance on principles and good practice in many quality assurance program consistent with the provi- of these activities is presented in NRC regulatory sions of this guide, as follows: guides (Refs.4-7) and other publications (Refs. 2.3.

8-25). In addition to these publications, the American Public Health Association is preparing a book on

1. Organizational Structure and Responsibilities quality assurance practices in health laboratories that of Managerial and Operational Personnel will include a chapter on radiochemistry. and Scien- tific Committee 18A of the NCRP is preparing a The structure of the organization as it relates to the manual of radioactivity measurement procedures that management and operation of the monitoring pro. will be a revision of NCRP Report 28, NBS Hand- gram(s), including quality assurance policy and func- book 80, "'A Manual of Radioactivity Procedures."

tions, should be presented. The authorities, duties, and responsibilities of the persons holding specified positions within this organization should be stated, including responsibilities for review and approval of 4. Records written procedures and for preparation, review, and evaluation of monitoring data and reports. The records necessary to document the activities performed in the monitoring program should be spec- Persons and organizations performing quality as- ified in the quality assurance program.

surance functions should have sufficient authority and organizational freedom to identify quality prob- One key aspect of quality control is maintaining lems; to initiate, recommend, or provide solutions; the ability to track and control a sample in its prog- and to verify implementation of solutions. ress through the sequence of monitoring processes.

4.15-3

Records to accomplish this should cover the follow- Procedures for sampling, packaging, shipping, and

  • ing proce.sses: field and inplant sample collection and storage of samples should be designed to maintair (l;!:

sample description; sample receipt and laboratory integrity of the sample from time of collection t, timc identification coding, sample preparation and of analysis. Aqueous samples may present a particu-

  • radiochcmical processing (e.g., laboratory note- lar problem in this regard, and one of the most severe books); radioactivity measurements (counting) of problems has been encountered with aqueous samples
  • samples, instrument backgrounds. and analytical of radioactive wastes from operating nuclear reactors blanks. and data reduction and verification. (Ref. 2 ).

Quality control records for laboratory counting sys- Guidance on the principles and practice of sam- tems should include the results of measurements of pling in environmental monitoring is provided in sev- radioactive check sources, calibration sources, back- eral publications (Refs. 2,9.19). In addition, workers grounds. and blanks. at the National Bureau of Standards (NBS) have pub- lished the results of a survey of information on sam- Records relating to overall laboratory performance pling, sample handling, and long-term storage for should include the results of analysis of quality con- environmental materials (Ref. 13). Some guidance on trol samples such as analytical blanks, duplicates, the principles and practice of air sampling is provided interlaboratory cross-check samples and other quality in References 15, 17, and 22. Guidance on the prin- control analyses; use of standard (radioactive) refer- ciples and practice of water sampling is provided in ence materials to prepare working standards; prepara- numerous publications (Refs. II, 12, 23-25).

tion and standardization of carrier solutions; and 6. Quality Control in the Radioanalytical Labora- calibration of analytical balances. tory Additional records that are needed should include 6.1 Radionuclide Reference Standards-Use for the calibration of inline radiation detection equip- Calibration of Radiation Measuretnenit ment. air samplers, and thermoluminescence Systemns dosimetry systems; verification and documentation of Reference standards are used to determine counting computer programs; qualifications of personnel; and efficiencies for specific radionuclides or, in the case results of. audits. of gamma-ray spectrometry systems, to determine counting efficiency as a function of gamma-ray The minimum period of retention of the records energy. A counting efficiency value is used to con- should be specified. Only the final results of the vert a sample counting rate to the disintegration rate monitoring programs need be retained for the life of of a radionuclide or to a radionuclide concentration.

the facility. (Guidance on calibration and usage of germanium de- tectors for measurement of gamma-ray emission rates of radionuclides is being prepared by a writing group of the Health Physics Society Standards Committee

5. Quality Control in Sampling (Including Packag- for publication as an ANSI Standard.)

Ing, Shipping, and Storage of Samples)

Radionuclide standards that have been certified by Continuous sampling of liquids and gases involves the NBS, or standards that have been standardized the measurement of sample flow rates and/or sample using a measurement system that is traceable to that volumcs. The accuracy of the devices used for this of the NBS,* should be used when such standards are purpose should be determined on a regularly sched- uled basis, and adjustments should be made as *For a discussion by NBS staff members of the concept of needed to bring the performance of the devices within traceability of radioactivity measurements to NBS, see Refer- specified limits. The results of these calibrations ence 27.A brief summary of this discussion is as follows: There should be recorded. The frequency of these calibra- are both direct and indirect traceability. Direct traceability to NBS exists when. any outside laboratory prepares a batch of tions should be specified and should be based on the calibrated radioactivity standards and submits several randomly required accuracy, purpose, degree of usage, stability selected samples to NBS for confirmation or verification. Indi.

characteristics, and other conditions affecting the rect traceability to NBS exists when NBS provides "unknown"

  • measurement. Continuous sampling should be dem- calibrate radioactivity samples to one or more laboratories which in turn make measurements of activity that agree within certain onstrably representative of the material volumes sam- specified limits with those of NBS. Thus there can be 1%, etc.,

pled. The collection efficiencies of the samplers used traceability. Regular use of NBS radioactivity standards by an should be documented. outside laboratory to calibrate its measuring equipment does not, in the view of the NBS staff, constitute traceability. Only when Grab samples should be demonstrably representa- the outside laboratory can measure the activity of an unknown sample and send back values to NBS that agree with NBS values tive of the material sampled, and replicate samples within a certain specified range of error does NBS consider that should be taken periodically to demonstrate the re- traceability has been established. NBS notes that this condition producibility of sampling. can be achieved without using a single NBS standard.

4.15-4

available. Otherwise, standards should be obtained with automatic sample changers, background mncas- from other reputable suppliers. An "International Di- urements should be included within each counting rectory of Certified Radioactive Materials" has been cycle.

publi.;hcd by the International Atomic Energy Agency (Ref. 26). For alpha- and gamma-ray spectrometry systems, energy-calibration sources (i.e.. a source containing a Acceptable standards for certain natural radionuc- radionuclide. or mixture of radionuclides. emitting lides may be prepared from commercially available two or more alpha or gamma rays of known energies)

high-purity chemicals. For example, potassium-40 arc counted to determine the relationship between standards for gross beta measurements or gamma-ray channel number and alpha- or gamma-ray energy.

spectrometry may be prepared from dried reagent- The frequency of these energy calibration checks de- grade potassium chloride. pends on the stability of the system but usually is in the range of daily to weekly. The results of these The details of the preparation of working standards *l.ci,,uienlents should be recorded and compared to from certified standard solutions should be recorded. predetermined limits in order to determine whether or The working standard should be prepared in the same noi system gain and zero level need adjustment. Ad- form as the unknown samples, or close approxima- justmients should be made as necessary.

tion thereto.

Additional checks needed for spectrometry systems Efficiency calibrations should he checked periodi- are the energy resolution of the system and the count cally (typically monthly tc yearly) with standard rate (or counting efficiency) of a check source. These sources. In addition, these checks should be made should be determined periodically (usually weekly to whenever the need is indicated, such as when a sig- nmonthly for energy resolution and daily to weekly for nificant change in the measurement system is de- count rate) and after system changes, such as power tected by routine measurements with a check source. failures or repairs, to determine if there has been any significant change in the system. The results of these measurements should be recorded.

6.2 Performance Checks of Radiation Measure- Inenit Systems 6.3 Analysis of Quality' Control Samples Determination of the background counting rate and The analysis of quality control samples provides a the response of each radiation detection system to ap- means to determine the precision and accuracy of the propriate check sources should be performed on a monitoring processes and include!, both intralabora- scheduled basis for systems in routine use. The re- tory and interlaboratory measurements.

sults of these measurements should be recorded in a log and/or plotted on a control chart. Appropriate in- The analysis of replicate samples provides a means vestigative and corrective action should be taken to determine precision: the analysis of samples con- when the measurement value falls outside the pre- taining known concentrations of radionuclides pro- determined control value. vides a means to deter'mine accuracy. The analysis of laboratory blanks provides a means to detect and A check source for determining changes in count- measure radioactive contamination of analytical sam- ing rate or counting efficiency should be of sufficient ples, a common source of error in radiochemical radiochemical purity to allow correction for decay but analysis of low-level samples. The analysis of analyt- need not have an accurately known disintegration ical blanks also provides information on the adequacy rate, i.e., need not be a standard source. of background subtraction, particularly for samples measured by gamma-ray spectrometry.

For systems in which samples are changed manu- ally, check sources are usually measured daily. For The fraction of the analytical effort needed for the systems with automatic sample changers, it may be analysis of quality control samples depends to a large more convenient to include the check source within extent on (I) the mixture of sample types in a particu- each batch of samples and thus obtain a measurement lar laboratory in a particular time period and (2) the of this source within each counting cycle. For propor- history of performance of that laboratory in the anal- tional counter systems, the plateau(s) should be ysis of quality control samples. H6wever, in general checked after each gas change. Background meas- it is found that at least 5%, and typically 10%, of the urements should be made frequently to ensure that analytical load should consist of quality control levels arc within the expected range. For systems samples.

4.15-5

6.3.1 IntralaboratoryAnalyses grams to provide an independent test of the ability to measure radionuclides at the very low concentrations Replicate samples, usually duplicates, should be present in most environmental samples.

analyzed routinely. These replicates should be pre- pared from samples that are as homogeneous as pos- The NRC Office of Inspection and Enforcement sible, such as well-stirred or mixed liquids (water or conducts a Ccnfirmatory Measurements Program for milk) and solids (dried, ground, or screened soil, sed- laboratories of licensees that measure nuclear reactor iment, or vegetation; or the ash of these materials).

effluents. The analyses of liquid waste holdup tank The size and other physical and chemical characteris- samples, gas samples, charcoal cartridges, and stack tics of the replicate samples should be similar to particulate filters are included in this program. The those of single samples analyzed routinely.

results of the licensee's measurements of samples split with the NRC are compared to those of an NRC

The analysis of the replicate samples as blind re- reference laboratory whose measurements are trace- plicates is desirable but is not practicable for all lab- able to the National Bureau of Standards (Ref. 27).

oratories or for all types of samples. For example, in Thus the results of this comparison provide to the small laboratories it may not be practicable to prevent NRC an objective measure of the accuracy of the the analysts from being aware that particular samples licensee's analyses.

are replicates of one another.

Laboratories of licensees or their contractors that Obtaining true replicates of all types .of samples perform environmental measurements should partici- also is not practicable. For example, obtaining repli- pate in the EPA's Environmental Radioactivity Lab- cate samples of airborne materials usually is not prac- oratory Intercomparison Studies (Cross-check) Pro- ticable on a routine basis because it requires either a gram, or an equivalent program. This participation separate sampling system or splitting a single sample should include all of the determinations (sample (e.g., cutting a filter in half). Use of replicate medium/radionuclide combinations) that are both of- samplers usually is not economically feasible and fered by EPA and included in the licensee's environ- splitting of samples results in replicates that do not mental monitoring program. Participation in the EPA

represent the usual sample size or measurement con- program provides an objective measure of the accu- figuration (counting geometry) for direct measure- racy of the analyses because the EPA measurements ment. However, simulated samples of airborne mate- are traceable to the National Bureau of Standards. If rials may be prepared in replicate and submitted for the mean result of a cross-check analysis exceeds the analysis as unknowns. control limit as defined by EPA (Ref. 28), an investi- gation should be made to determine the reason for Analysis of intralaboratory blank and spiked sam- this deviation and corrective action should be taken ples is an important part of each laboratory's quality as necessary. Similarly, an investigation and any control program. A known analytical blank sample necessary corrective action should take place if the should be analyzed with each group of unknown "normalized range." as calculated by EPA, exceeds samples that is processed radiochemically to deter- the control limit, as defined by EPA. A series of re- mine a specific radionuclide or radionuclides. Spiked sults that is within the control limits but that exhibits and blank samples should be submitted for analysis a trend toward these limits may indicate a need for an as unknowns to provide an intralaboratory basis for investigation to determine the reason for the trend.

estimating the accuracy of the analytical results.

These blanks and spikes may include blind replicates.

6.4 Compuitational Checks

6.3.2 InterlaboratvryAnalyses Procedures for the computation of the concentra- tion of radioactive materials should include the inde- Analysis of effluent and environmental samples pendent verification of a substantial fraction of the split with one or more independent laboratories is an results of the computation by a person other than the important part of the quality assurance program be- one performing the original computat'on. For com- cause it provides a means to detect errors that might puter calculations, the input data should be verified not be detected by intralaboratory measurements by a knowledgeable individual. All computer pro- alone. When possible, these independent laboratories grams should be documented and verified before ini- should be those whose measurements are traceable to tial routine use and after each modification of the NBS (Ref. 27). program. The verification process should include ver- ification, by a knowledgeable individual, of the al- Analysis of split field samples, such as samples of gorithm used and test runs in which the output of the milk, water, soil or sediment, and vegetation, is par- computer computation for given input can be com- ticularly important in environmental monitoring pro- pared to "true" values that are known or determined

4.15-6

independently of the computer calculation. Documen- under which the system will be optrated. These flow tation of the program should include a description of rate devices should be recalibrated periodically.

the algorithm and a current listing of the program.

Guidelines for the documentation of digital computer Whenever practicable, a check source that is ac- programs are given in ANSI N413-1974 (Ref. 29). tuated remotely should be installed for integrity cheeks of the detector and the associated electrical

7. Quality Control for Continuous Effluent system.

Monitoring Systems 8. Review, Analysis, and Reporting Data The specified frequency of calibration for a par- Procedures for review, analysis, and reporting of ticular system should he based on considerations of the data should include examinatiuns for reasonableness nature and stability of that system. For nuclear power and consistency of the data and investigative and plants, specific requirements for calibrations and corrective actions to be taken under specified checks of particular effluent monitoring systems usu- circumstances.

ally are included in the technical specifications for the plant. 9. Audits Initial calibration of each measuring system should Planned and periodic audits should be made to ver- be performed using one or more of the reference ify implementation of the quality assurance program.

standards that are certified by the National Bureau of The audits should be performed by qualified indi- Standards or that are calibrated by a measurement viduals who do not have direct responsibilities in the system that is traceable to that of the National Bureau areas being audited.

of Standards (Ref. 27). For nuclear power plants, Audit results should be documented and reviewed these calibrations are usually repeated at least annu- by management having responsibility in the area au- ally. The radionuclide standards should permit calib- dited. Followup action, including reaudit of deficient rating the system over its intended range of energy areas, should be taken where indicated.

and rate capabilities. Periodic inplant calibration should be performed using a secondary source or

D. IMPLEMENTATION

method that has been related to the initial calibration.

For nuclear power plants, these calibrations are usu- The purpose of this section is to provide informa- ally performed at least monthly. tion to applicants and licensees regarding the NRC

staff's plans for using this regulatory guide.

Periodic correlations should be made during opera- This guide reflects current NRC staff practice.

tion to relate monitor readings to the concentrations Therefore, except in those cases in which the appli- and/or release rates of radioactive material in the monitored release path. These correlations should be cant or licensee proposes an acceptable alternative method, the staff will use the method described based on the results of analyses for specific radionuc- herein in evaluating an applicant's or licensee's ca- lides in grab samples from the release path.

pability for and performance in complying with spec- Flow-rate measuring devices associated with the ified portions of the Commission's regulations until system should be calibrated to determine actual flow this guide is revised as a result of suggestions from rates at the conditions of temperature and pressure the public or additional staff review.

4.15-7

REFERENCES

I. Section 6.2, "Validation of Analyses," Chapter Interface 5 (#4), 49-62 (1976). Also available from

6, "Validity of Results," Methods of Radiochewnical the Superintendent of Documents, U.S. Government Analysis, World l-ealth Organization, Geneva, 1966. Printing Office, Washington, D.C. 20402, as NBS

Technical Note #929, October 1976, C 13.46:929,

2. "Analytical Quality Control Methods," Environ- S/N 003.003-01694-2.

mental Radioactivity Surveillance Guide, U.S. En- 14. Tritium Measure.'ent Techniques, Report of vironniental Protection Agency Report, ORP/SID

72-2, June 1972. NCRP SC-36, NCRP Report No. 47, 1976.

3. Environmental Ra,.'iation Measurements, Report 15. "Guide to Sampling Airborne Radioactive Mate- of NCRP SC.35, NCRP Report No. 50, 1976. rials in Nuclear Facilities," ANSI N 13.1-1969.

4. Regulatory Guide 1.21, "Measuring, Evaluating, 16. "Specification and Performance of On-Site In- and Reporting Radioactivity in Solid Wastes and Re- strumentation for Continuously Monitoring Radioac- leases of Radioactive Materials in Liquid and Gase- tivity in Effluents," ANSI N13.10-1974.

ous Effluents from Light-Water-Cooled Nuclear 17. Air Sampling Instruments for Evaluation of At- Power Plants." mospheric Contaminants, Fourth Edition, American

5. Regulatory Guide 4.5, "Measurements of Conference of Industrial Hygienists, 1972.

Radionuclides in the Environment-Sampling and

18. Users' Guide for Radioactivity Standards. Sub- Analyses of Plutonium in Soil."

committee on Radiochemistry and Subcommittee on

6. Regulatory Guide 4.6, "Measurements of the Use of Radioactivity Standards, Committee on Radionuclides in the Environment-Strontium-89 and Nuclear Science, National Academy of Sciences- Strontium-90 Analyses." National Research Council Report, NAS-NS-3115, February 1974.

7. Regulatory Cuide 4.13, "Performance, Testing, and Procedural Specifications for Thermolumines- 19. Environmental Impact Monitoring for Nuclear cence Dosimetry: Environmental Applications." Power Plants, Source Book of Monitoring Methods, Vol. I, Atomic Industrial Forum Report, AIF/

8. HASL Procedures Manual, U.S. Energy Research NESP-004, February 1975.

and Development Administration Report, HASL-300,

1972 (updated annually). 20. Instrumentation for Environmental Monitoring:

Radiation, Lawrence Berkeley Laboratory Report,

9. A Guide for Environmental Radiological Surveil- LBL-l, Vol. 3, First Ed., May 1972; First update, lance at ERDA Installations, Energy Research and February 1973; Second update, October 1973.

Development Administration Report, ERDA 77-24, March 1977. 21. C. W. Sill, "Problems in Sample Treatment in Trace Analysis." National Bureau of Standards Spe-

10. Handbook of Radiochemical Analytical Methods, cial Publication 4-22, Accuracy in Trace Analysis:

U.S. Environmental Protection Agency Report, Sampling, Sample Handling. and Analysis, pp. 463- EPA-680/4-75-001, February 1975. 490, August 1976.

I1. Standard Methods for the Examination of Water 22. "General Principles for Sampling Airborne and Wastewater, Thirteenth Edition, American Pub- Radioactive Materials," International Standard, lic Health Association, 1975. ISO-2889, 1975.

12. Handbookfor Sampling and Sample Preservation 23. Manual of Methods for Chemical Analysis of of Water and Wastewater, U.S. Environmental Pro- Water and Wastes, EPA-625/6-74-003, U.S. En- tection Agency Report, Office of Research and De- vironmental Protection Agency, Office of Technol- velopment, Environmental Monitoring Support Lab- ogy Transfer, Washington, D.C. 20460, 1974.

oratory, EPA-200/4-76-049. September 1976i

24. Annual Book of ASTM Standards (Part31), Wa-

13. E. J. Maienthal and D. A. Becker, "A Survey on ter, American Society for Testing and Materials, Current Literature on Sampling, Sample Handling, Method D, 3370, pp. 71-82, Philadelphia, PA, July and Long-Term Storage for Environmental Materials," 1975.

4.15-8

25. Biological Field and Laboratory, Methods for Standards and Measurements in Different Fields,"

Measuring the Quality of Surface Waters and Nuclear Instruments and Methods, Vol. 112, pp.

Effluents, EPA-670/4-73-001, Office of Research and 5-18, 1973.

Development, U.S. Environmental Protection Agency, Cincinnati, Ohio, July 1973. 28. Environmental Radioactivity Laboratory Inter- comparison Studies Program, FY 1977, EPA-600/4.

26. International Directory of Certified Radioactive 77-001, January 1977.

Materials, International Atomic Energy Agency Re- port, STI/PUB/398, 1975. 29. "Guidelines for the Documentation of Digital

27. L. M. Cavallo et al.. "Needs for Radioactivity Computer Programs," ANSI N413- 1974.

4.15-9

APPENDIX A

GLOSSARY

A-ccurac'yv-normally refers to the difference (error or electronic components of the system are operating bias) between tile mean, K. of the set of results and correctly.

the value *. which is accepted as the true or correct Instrument Batckground--the response of the instru- value for the quantity measured. It is also used as the ment in the absence of a radioactive sample or other difference between an individual value X, and X.

radioactive source.

Absolhte acciuracy of the mean is given by "-,*

Precision-relates to the reproducibility (f meas- and of an individual value by XrT.

urements within a set, that is. to the scatter or disper- Relative accrwvr of the mean is given by t.-,)/:. son of a set about its central value.

Pr'rcentageaccurac*y is given by 100 (X-0)/*. Quality Assurance (QA )-(the planned and systematic actions that are necessary to provide adequate confi-

,Imd Vtic*'l Blank (Sample)-ideally. a sample having dence in the results of a monitoring program.

all of the constituents of the unknown sample except those to be determined. In radioanalytical practice. Quaitiy Control (QC)-those quality assurance ac- the term often refers it) the radiochemical processing tions that provide a means to control and measure the of carrier(s) or tracers without the sample matrix ma- characteristics of measurement equipment and proc- terial. esses to established requirements. Thus. quality as- surance includes quality control.

"Blind" Replivcat (Sample)-replicate samples that are not identified as replicates to the persons pcrform- Spiketd Sample-a sample to which a known amount ing the analysis. of radioactive material has been added. Generally.

spiked samples are submitted as unknowns to the Calibrainon-the process of determining the numeri- analysts.

cal relationship between the observed output of a measurement system and the value, based on refer- Split Sample-a sample that is divided into parts.

ence standards, of the characteristics being measured. each of which is analyzed independently by separate Calibration Source-any radioactive source that is laboratory organizations.

used for calibration of a measurement system.

Standard (radioactive) Source-a radioactive source Check Source (or instrumnent check source, perform- having an accurately known radionuclide content and anlce check source, or referJence source)-a radioac- radioactive disintegration rate or particle or photon tive source used to determine if the detector and all emission rate.

4.15-10