NCRP report no 114 maintaining radiation protection records

Guidance for Systematic Generation and Retention of Records Relating to Radiation Protection To be useful for operational radiation safety programs, and for epidemiology and legal pur

NCRP REPORT No 11 4

MAINTAINING

RADIATION PROTECTION RECORDS

Recommendations of the

NATIONAL COUNCIL O N RADIATION

PROTECTION AND MEASUREMENTS

Issued November 30, 1992

National Council on Radiation Protection and Measurements

791 0 WOODMONT AVENUE 1 Bethesda, M D 20814

LEGAL NOTICE

This report was prepared by the National Council on Radiation Protection and Mea- surements (NCRP) The Council strives to provide accurate, complete and useful information in its reports However, neither the NCRP, the members of NCRP, other persons contributing to or assisting in the preparation of this Report, nor any person acting on the behalf of any of these parties: (a) makes any warranty or representation, express or implied, with respect to the accuracy, completeness or usefulness of the information contained in this Report, or that the use of any information, method or process disclosed in this Report may not infringe on privately owned rights; or (b)

assumes any liability with respect to the use of, or for damages resulting from the use of any information, method or process disclosed in this Report, under the Civil Rights Act of 1964, Section 701 et seq as amended 42 U.S.C Section 2000e et seq (Title VZZ) or any other statutory or common law theory governing liability

Library of Congress Cataloging-in-Publication Data

National Council on Radiation Protection and Measurements

Maintaining radiation protection records : recommendations of the National Council on Radiation Protection and Measurements

[DNLM: 1 Radiation Protection-standards 2 Records-standards

or reviews

Preface

This Report is part of a series prepared under the auspices of Scientific Committee 46 on Operational Radiation Safety It provides guidance on maintaining radiation protection records Record keep- ing is a n essential element of every radiation protection program This Report describes the elements that should enter into the design

of a program for the maintenance of operational radiation safety records The problems of the length of time for retention of records for operational, regulatory, epidemiologic and legal uses are discussed in detail

Serving on NCRP Scientific Committee 46-5 for the preparation

of the draft material were:

Roscoe M Hall, Jr.", Chairman

Westinghouse Savannah River Plant Aiken, South Carolina

Members

Defense Nuclear Facilities Yankee Atomic Electric Co

Washington, D.C

Epidemiology Resources, Inc Rockville, Maryland

Newton Lower Falls,

Massachusetts

Richard J Vetter

Mayo Clinic Rochester, Minnesota

Scientific Committee 46 Liaison Member

Thomas D Murphy

U.S Nuclear Regulatory Commission

Washington, D.C

E Ivan White (1983-1985)

Serving on Scientific Committee 46 on Operational Radiation Safety for the preparation of this Report were:

Kenneth R Kase, Chairman (1990-)

Stanford Linear Accelerator Center

Stanford, California

Charles B Meinhold, Chairman (1983-1990)

Brookhaven National Laboratory

Upton, New York

Members

Ernest A Belvin (1983-1987) David S Myers (1987-)

Tennessee Valley Authority Lawrence Livermore

Livermore, California

W Robert Casey (1983-1989) John W Poston (1991-)

Brookhaven National Laboratory Texas A&M University

Joyce P Davis (1990-) Ralph Thomas (1989-)

Defense Nuclear Facilities Lawrence Livermore

Medical College of Wisconsin 3M Company

Charles B Meinhold

President, NCRP

Bethesda, Maryland

15 August 1992

Table of Contents

1 Introduction

2 Guidance for Systematic Generation and Retention of Records Relating to Radiation Protection

2.1 Records System Design and Operation

2.1.1 Record Handling Procedures

2.1.2 Codes and Coding Conventions

2.1.3 Definitions

2.2 Records Generation

2.2.1 Specificity

2.2.2 Completeness

2.2.3 Ancillary Information 2.2.4 Identity of Originator of Records

2.2.5 Record Status Information

2.2.6 Radiation Dose

2.3 Records Linkage

2.4 Files

2.4.1 Introduction

2.4.2 Files for Individuals

2.4.3 File for Places and Activities

2.4.4 Other Files

2.4.5 Computer Files Derived from Original Records

2.4.6 Original and Reproduced Records

2.4.7 Backup Files

2.5 Storage and Maintenance of Records

2.5.1 Records Format

2.5.2 Records Retention

2.6 Records Retrieval

2.7 Quality Control :

2.7.1 Records Quality Control

2.7.2 File Storage and Retrieval Quality Control 2.8 Legal Aspects of Records Management

2.8.1 Evidentiary Considerations 2.8.2 Incorporation by Reference

2.8.3 Disposition of Records of Defunct Organizations

2.8.4 Privacy and Other Confidentiality Considerations

viii / CONTENTS

2.8.5 Documentation of Computer Programs 3 Radiation Protection Program Records

3.1 Objective

3.2 Records Management

3.3 Types of Program Records

3.3.1 Authorizing Documents

3.3.2 Accreditations and Certifications 3.3.3 Guidance Documents

3.3.3.1 External Documents

3.3.3.2 Internal Documents 3.3.4 Radiation Protection Organization and

Personnel 3.3.4.1 Personnel Identification and

Qualifications 3.3.4.2 Position Descriptions

3.3.4.3 Radiation Protection Personnel Training

3.3.5 Program for Quality Control and Assessment

of the Radiation Protection Program 3.3.6 Radiological Training Program for General

Workers

3.3.7 Source and Access Control Program 3.3.8 Radiological Measurement and Control Programs

3.3.9 Calibration Program

3.3.10 Respiratory Protection Program

3.3.11 Radiation Work Control Program

3.3.12 Dosimetry and Exposure Control Program 3.3.13 Ventilation Monitoring Program

3.3.14 Environmental Radiation Monitoring and Dose Assessment Program

3.3.15 Radioactive Waste Program

3.3.16 Radioactive Materials Receipt and Shipment

Program

3.3.17 Incident Response Programs 3.3.17.1 Emergency Response Planning

Program 3.3.17.2 Program for Notification Investigation Tracking and Follow-

Up of Incidents and Emergencies 3.3.18 Programs to Maintain Exposures As LOW As Reasonably Achievable (ALARA)

3.3.19 General and Administrative Programs

3.3.19.1 Reports

CONTENTS 1

3.3.19.2 Administrative Program

3.3.19.3 Record-Keeping Program

3.4 Changes in Guidance Procedures and Methods

4 Individual Records

4.1 Exposure Categories for Individuals

4.2 Personal Data

4.3 External Dosimetry

4.3.1 Dose Assessment Records

4.3.1.1 Whole Body Dose EquivaIent 4.3.1.2 Effective Dose Equivalent

4.3.1.3 Dose Equivalent to Skin

4.3.1.4 Dose Equivalent to the Lens of the Eye

4.3.1.5 Extremity Dose Equivalent

4.4 Individual Dose Records for Internal Dosimetry

4.5 Summation of Internal and External Exposure 4.6 Exposure History

4.7 Missing Dosimetry Results

4.8 Abnormal Exposures 4.9 Training Records

5 Workplace Records

5.1 Introduction

5.1.1 General Description 5.1.2 Controlled Areas

5.1.3 Ventilation and Exhaust Features

5.1.4 Access Control

5.2 Radiation Work Permits (RWP)

5.3 Area Radiation and Contamination Records 5.4 Instrumentation

5.5 Protective Equipment

5.5.1 General Description 5.5.2 Quality Assurance

5.6 As Low As Reasonably Achievable (ALARA) 5.7 Radioactive Material Shipments

5.8 Radioactive Material Inventory

5.9 Accidents and Incidents

6 Environmental Records

6.1 Introduction

6.2 Pre-Operational Monitoring Program 6.2.1 Climatic Topographic Land Use and Demographic Studies

6.2.2 Radiological Surveillance Records

6.3 Operational Environmental Monitoring Program

X 1 CONTENTS

6.4 Radioactive Materials Release and Dose

Assessment

6.4.1 Radioactive Material Release Reports

6.4.2 Dose Assessment Reports

6.5 Off-Site Incident Investigations and Special Studies

7 Radiation Protection Instrumentation

7.1 Introduction

7.2 Specifications

7.3 Calibration Facility Description and Source Certification

7.3.1 Calibration Facility

7.3.2 Source Certification

7.4 Calibration

7.5 Maintenance Records

7.6 Instrument Inventory Records

Appendix A Types of Linkages

A.1 Intrafile Linkages

A.2 Interfile Linkages

Appendix B Retention of Radiation Records

Glossary :

References

The NCRP

NCRP Publications

Index

1 Introduction

For many years the National Council on Radiation Protection and Measurements (NCRP) and its predecessors have provided recom- mendations dealing with many aspects of radiation protection The NCRP seeks to provide practical recommendations for the establish- ment of a radiation safety program and record keeping is an essential element of a radiation safety program (NCRP, 1978a; 1989a) The objective of this Report is to describe the elements that should enter into the design of a program for the maintenance of operational radiation safety records to:

aid in protection of individuals,

evaluate the effectiveness of radiation protection programs, and provide for accuracy, reliability, confidentiality and retriev- ability

This Report is offered a s a guide for the appropriate maintenance

of records a s required by the radiation protection program and should

be helpful in determining when a record is needed, what a particular record should contain and what records should be retained Decisions concerning how best to implement the recommendations of this Report are subject to an evaluation of the needs of the organization Factors that should be considered when judging which radiation safety records should be incorporated in any program are the: benefits of maintaining the record,

costs and resources required to maintain the record, and risks associated with not maintaining the record

Radiation safety records can be used for a variety of purposes, including:

evaluation of the radiation safety program to ensure effective program operation,

evidence of regulatory compliance,

data for epidemiologic studies, and

information for making or contesting claims for radiation- induced injury

An effective radiation safety program can do much to reduce expo- sures to a level as low as reasonably achievable (ALARA) within the

2 1 1 INTRODUCTION

NCRP-recommended dose limits (NCRP, 1987) and to control the potential for accidental exposures The ability to demonstrate trends and to reconstruct past exposures is invaluable in such a program This Report provides guidance for the establishment of a system

of operational radiation safety records and makes recommendations

on both the content and the management of records Not all records need be under the control of the same records custodian (person or organization), but all should be linked and retrievable This Report recommends techniques for systematic generation and retention of records, including record format, linkage, storage and quality con- trol It discusses the programmatic types of records needed for an operational radiation safety program Details are provided for records which must be kept for individuals, including external and internal exposure records, training and personal data records Records required to characterize the work environment, including facility descriptions, Radiation Work Permits (RWP), radiation sur- vey data and other information needed to document exposures are discussed Records needed for the protection of the public and the environment, including radiation monitoring programs, effluent monitoring and off-site dose assessments, are detailed Finally, a section on records needed to document the calibration and mainte- nance of radiation protection instrumentation is provided [See NCRP Report No 112 (NCRP, 1991a) for recommendations on cali- bration of portable radiation survey instruments.]

When an existing record-keeping program is to be modified or existing records are to be incorporated into anew system, the quality and compatibility of older records and the reasonableness of trying

to bring lower quality records up to current standards need to be considered This Report does not recommend that all records in exis-

tence prior to the adoption of the recommendations of this Report necessarily be converted to a new record-keeping system However, the older records should be maintained and linked as much as is possible to any new system developed using the guidance of this Report The guidance provided by this Report will be useful to the responsible organization in evaluating all of the needs of their partic- ular radiation protection program

Records required for epidemiologic and legal purposes are often identified and used long after they have been generated Subjects for epidemiologic investigations are selected for one or more of three reasons:

by virtue of membership in a group at or during a certain period

of time (e.g., all people employed at a nuclear facility between

1960 and 1970),

1 INTRODUCTION / 3

because they have developed a particular disease subsequent

to their radiation exposure (becoming "cases" for case-control studies), or

because they have not developed that disease (controls) Some of the same criteria that would make individuals suitable for epidemiologic study also might cause them (or their survivors) to initiate claims for compensation for an alleged occupationally- related injury or disease Each situation would require a detailed record review to recreate the circumstances surrounding the individ- ual's exposures to radiation

This Report discusses techniques for the linking of records main- tained in the workplace Records which are not properly linked may

be difficult to use in epidemiologic studies and litigation In many instances, the utility of existing record-keeping programs could be improved dramatically with a few simple changes such as maintain- ing supplementary master lists that identify which records are kept, where they are kept, and the relevant time period covered by the records The availability of these master lists would facilitate retrieval of records based on personal identification and time period and allow records of an individual's health, work and residence to

be linked

Good documentation of day-to-day operational radiation safety activities is necessary for reconstructing the information needed for epidemiologic or legal purposes years later When radiation records provide linkage with other historical data relating to the individual's health, work and residential environment, they can be used to respond to a wide variety of possible future needs

The current requirements of any regulatory agency relating to the content or keeping of records are not addressed explicitly in this Report Insofar as the responsible organization is subject to such requirements, they must be considered in addition to the recommen- dations of this Report However, the keeping of records that indicate compliance or describe efforts made to comply with regulatory requirements are addressed

This Report should be useful to all types and sizes of organizations using radioactive materials and radiation sources It can be used to assist in the development of an appropriate system of operational radiation safety records There is one note of caution however This Report is limited to a records program and should not be used as a recommendation for establishing a radiation safety program The NCRP Report No 59 (NCRP, 1978a) and other documents should

be consulted for these NCRP recommendations on the subject

2 Guidance for Systematic

Generation and Retention

of Records Relating to

Radiation Protection

To be useful for operational radiation safety programs, and for epidemiology and legal purposes, records should be maintained in accordance with the highest standards of the record-keeping disci- pline (Fienberg et al., 1985; ANSI, 1976) Information contained in individual records must be legible, accurate, reliable and interpret- able There should be a means for assuring confidentiality when appropriate Since files and records can be linked by routinely includ- ing information identifying individuals, facilities and relevant time periods in individual records, it is not necessary that all files be kept together The value of the entire record-keeping system rests on the ability to identify and retrieve records of interest according to person, place, technical factors such as type of radiation or radionuclide, time and other parameters

Confidentiality is an issue that must be addressed in its broadest sense when designing record systems The confidentiality of personal and proprietary information must be protected Consideration of specific issues depends on the applicable law and is outside the scope

of this Report Safeguards should be taken to insure that access to the record system will be restricted appropriately

2.1 Records System Design and Operation

The radiation protection records system includes various files, containing specific kinds of information The basic unit of the file is

a record and the record consists of one or more fields Each record should have adequate identification to link it with other records into

a cohesive system This Section defines linkage and discusses how the records described in this Report can be linked The use of terms that may have specific meaning within the context of computer- maintained database management systems does not imply a recom-

2.2 RECORDSGENERATION / 5

mendation for use of a particular type of system or use of computers The terms are used only to describe concepts

2.1.1 Record Handling Procedures

Record handling system descriptions and written procedures should be provided to enable those responsible for record handling to retrieve information in a timely manner Procedures should address indexing records and provide directions for storage and control of documents A standard system of indexing all records is essential

to ensure that records are identifiable, accessible and retrievable

2.1.2 Codes and Coding Conventions

Whenever possible, standard codes and coding conventions should

be used For example, Standard Industrial Classifications Manual (1987) and Standard Occupational Classifications Manual (1980) have been used successfully in many situations Coding systems like these are useful because they are interpretable within and outside

an industry and do not vary with changes in management, federal regulations or union contracts

2.1.3 Definitions

The current operational definitions used for processing, storing and coding information should be documented Identification codes for each category of information should also be maintained All changes and corrections should be identified and recorded in such a manner that a trail is created that can be followed Obsolete defini- tions, codes or methods of calculation (eg., formulas) should be stored

in historical documentation files along with the reason for the change

or correction made

2.2 Records Generation

2.2.1 Specificity

Generally, information should be recorded in as specific a form

as is available, whatever that may be Information should not be

6 1 2 GUIDANCE FOR RECORDS GENERATIONIRETENTION

discarded, however, merely because it is known only qualitatively

or is otherwise uncertain For example, where a n accurate measure- ment of radiation dose is not available, there may be information

on the range bounding the likely dose It is desirable to specify the appropriate dose quantity for an individual as described in Section 4.3; however, in some cases the mere fact that a person might have been exposed to radiation may be important Such information should be recorded when quantitative measurements are not avail- able; it may be useful, eventually, in the context of an epidemiology study or litigation

2.2.2 Completeness

Where important quantities are derived or calculated from mea- sured quantities, both the measurement data and the quantities derived from them, along with references to the method and assump- tions used in the derivation should be maintained All information necessary for the interpretation of the measurement data should also be retained

It is important that documentation be maintained in a manner that specifically addresses missing information and data that have been estimated or calculated rather than measured directly This distinction is often overlooked in paper records a s well a s in computer files Information in a record should permit the unambiguous inter- pretation of an empty field or a zero as:

the value measured was zero,

the value measured or otherwise determined was within the definition of zero established for the records system,

the field is not applicable to a particular situation,

it is known that information is not available, or

the status of information availability is unknown

Similarly, for information that has been calculated or estimated, the record should indicate the method used to perform the calculation,

or to make the estimate This information may be needed to verify

or revise the calculation or estimate later, if necessary, and also

to distinguish these cases from actual measurements Records of measurements should also indicate whether the value recorded is the actual measurement or a value assigned because the measure- ment was a t or below the lower limit of detection for the measuring instrument

2.2 RECORDS GENERATION 1 7

2.2.3 Ancillary Information

In many instances, it may be neither possible nor desirable to include all ancillary or explanatory information within a particular file In such cases, it is vital to create some means to identify the fact that supplementary information exists and, if possible, to identify the location of such information For example, if an individual had an accidental radiation exposure that was not recorded by usual proce- dures, an indication of presence a t the site when an accident occurred

(i.e., had a potential for exposure) should be noted in the individual's

radiation protection files so that any supplementary data relating

to the accident could be retrieved, if necessary

Similarly, if relevant information is routinely maintained in other files in a program or organization, it need not be duplicated; instead specific reference to such other files should be provided For example, personnel files may contain extensive demographic information and prior history of employment that need not be duplicated in radiation protection files However, it is essential to evaluate,the record-keep- ing storage and retention policies of ancillary data systems before relying on their use (see Section 2.8.3 regarding transfer of custody

for records)

2.2.4 Identity of Originator of Records

Each record should contain a legible indication of the identity of the person or persons who generated it Where signatures are used, they should be readily identifiable, either by an additional printed name on the record or through an authorized signature file linked

to the master personnel file In the case where a record is changed after its original generation, the identity of the person or persons responsible for deciding on and executing the change in the record, should be indicated

2.2.5 Records Status Information

Records relating to individuals should indicate whether it is the first record for the individual, an update or a final report at the end

of a process or procedure, termination of employment, retirement or death Such record status information will facilitate interpreting the sequence of individual records Each record should include reference

to calendar date and to time of day if that is important starting and stopping dates Coy day, month and year) are essential The dates the

8 1 2 GUIDANCE FOR RECORDS GENERATION/RETENTION

record was created, updated, copied or otherwise processed, should

be documented

2.2.6 Radiation Dose

Radiation dosimetry records ideally should include the fact that

an individual was exposed to ionizing radiation, the place, the amount and relevant times and dates, in addition to linkage informa- tion (see Section 2.3) Records of occupational exposure to radiation should be supplemented by records describing facilities, radiation protection programs and equipment, and information about other potentially harmful exposures in the workplace Descriptions of the relevant radiation protection records are contained in the balance

of this Report If not otherwise accessible, information about toxic materials used in the workplace is usually available through Employee Right to Know and community relations programs As a minimum for occupational radiation dose records, it is essential to know the dates that radiation exposure first began and finally termi- nated Information about dose rates and accumulated organ dose

by calendar time is important Records of accidental irradiation or intakes of radioactive material are also essential As a general guide, even if specific dose equivalent assessment is not achievable for a particular event, it is important that the fact of exposure be recorded for each individual involved More detailed guidance on radiation exposure records is provided in Section 4 of this Report

2.3 Records Linkage

Since it may not be feasible to store a t a single location all informa- tion that eventually may be useful, it is necessary to have a small set of unique identification data that can be used to link specific individuals and events with exposures Linkage systems have been developed that maximize use of existing data resources (Pell, 1978; Kerr, 1978; Hoar et al., 1980; Hsieh et al., 1983) The concept of

record linkage is designed to build on existing record systems and

to identify all records pertaining to an individual, site or time period Various cross-linkages are necessary to match data that are stored

on an individual basis with those stored on a grouped basis For example, facility records should permit linkage of specific individuals

to training records Each dosimetry record should ideally be linked

to individuals, facilities, times and locations All identification data that are used for linkage must be unique without duplication or

2.4 FILES 1 9 overlap For an individual, the minimum basic set of identifying information that should be used on all pertinent records is name (first, middle initial, last), social security number and date of birth

In addition, maiden name should be included for women It is not sufficient to store only name or social security number or both Tran- scription errors can occur; first name, middle initial and date of birth can be used for identification if an erroneous social security number was recorded inadvertently Locational identifiers should include name or numerical code for organizational subdivisions and location

and should be linked to other records (e.g., see Sections 3,4, 5 and

6 ) More detailed information on intrafile and interfile linkages, with examples, are shown in Appendix A, Types of Linkages For more information, see the protocol for the U.K National Registry of Radia- tion Workers of the National Radiological Protection Board (Darby, 1981)

2.4 Files

2.4.1 Introduction

Two files should be created, one for individuals and one for facili-

ties See Sections 3, 4, 5 and 6 for more information about records

that should be maintained in these files Where appropriate, master files should be linked to other files that may contain information on

a variety of matters, including information relating to individuals, such as radiation exposure, exposures to potentially harmful sub- stances and health status Other files may also contain information about facilities and programs, such as instrument calibration and environmental monitoring

2.4.2 Files for Individuals

The identifying file for individuals (often held in the organization's personnel department) should contain sufficient information to per- mit unique identification In the United States, full name (first, middle initial, last, maiden), social security number, date of birth, place of birth, mother's name and father's name, and parents' birth- places complete the set of information needed to identify a match through Social Security or the National Death Index systems Link- age of personal identifiers with national data systems will permit follow-up for mortality, as is often done in epidemiologic studies

10 / 2 GUIDANCE FOR RECORDS GENERATION/RETENTION

Further, a complete set of personal identifiers has broader utility for health protection and litigation purposes since it helps ensure that the individual whose record has been retrieved is in fact the person whose record was sought A matching program for linkage

of records by name and number is presented by Newcombe (1974)

In addition to unique personal identifiers, records for currently employed individuals should contain information on their job or task assignment and should be updated a t least annually Position titles and position descriptions should become part of the individual record

to allow all people with a given job title to be enumerated and their enrollment in the system verified This approach adds important descriptive information that may be useful in identifying and quanti- fying work-related exposures

2.4.3 File for Places and Activities

In most instances, files referring to place concern the workplace and primary residential location Each location within a workplace facility should be identified uniquely When there is a change in locations or if locations are used only occasionally, it is important

to identify these facts, even if all locations are not documented on

a routine basis Other files should include a historical description

of the facility, its purpose, uses, programs, organizations and pro- cesses (see Sections 3, 5 and 6)

2.4.4 Other Files

Other existing files, such a s health records, if maintained, should

be linked to individuals and places In the case of health-related records, the place is where diagnosis or treatment occurred and where further records may be located Such files may be maintained

in the medical department of the employer Other relevant records may be found in a variety of places Illness and death records should contain the specific disease diagnosis and all causes of death If such specific information cannot be routinely included, as a minimum, the record should indicate that an event occurred and that follow-

up information is available or can be obtained in a given location For records of hospitalizations and out-patient surgery, it is important to include the name and address of the doctor and the facility so that medical records may be requested in the future, if necessary

On a broader basis, health files may be used to maintain records

of personal habits and family histories that may be relevant to epide-

2.4 FILES 1 11

miologic research and legal questions Records of baseline health interviews generally address smoking, family history of diseases, and sometimes diet, including use of alcohol Interim health informa- tion, obtained through visits to the medical department should be included in the health file

2.4.5 Computer Files Derived from Original Records

When computer-readable media are used to store data not origi- nally generated by computer, the responsible organization should consider maintaining the files containing the original or reproduced records from which computer files were derived Such information can assist in the interpretation of ambiguous computer data files These files also may serve as verification should the computer files become damaged or unreadable through obsolescence, mechanical failure or other casualty

2.4.6 Original and Reproduced Records

Because long retention is required for radiation protection records, consideration should be given to the use of reproduced copies of original records in primary files, particularly if the originals are bulky or would be subject to extensive deterioration in physical

quality or legibility over time Microform (e.g., microfilm, microfiche)

and other archival technologies are available that can, in the right circumstances, produce files that are essentially equivalent to the originals in content, and superior in storage qualities and longevity

If the need for documents as evidence in future litigation is likely, the responsible organizations that decide to replace original documents with microform or other archival technology should consult legal counsel before the originals are discarded

2.4.7 Backup Files

Whatever the format of the primary files (original documents, microform copies or computer-readable media), it is prudent to retain duplicates of all important records To enhance reliability, the responsible organization may wish to keep its backup files in aformat

12 / 2 GUIDANCE FOR RECORDS GENERATIONIRETENTION

different from that used for the primary files Backup files should

be stored in a location remote from the storage site of the primary files

2.5 Storage and Maintenance of Records

2.5.1 Records Format

Whenever possible, the forms used for data entry should be designed to facilitate easy entry of specific information Existing records may take the form of hard copy (e.g., paper), microform or computer-readable media (eg., punched cards, magnetic disks or tape, optical disks) Each method has its strengths and limitations

in terms of durability, storage requirements and accessibility For machine-readable data storage, attention must be paid to the hard- ware needed to retrieve and access the data When changes in com- puter hardware occur, old data should be transferred to a format that will be readable by the newer equipment The historical file structure, record layout and conversion program documentation should be maintained In cases where not all the old data have been transferred to the new format, the documentation on file structure and layout is critical for future data retrieval

2.5.2 Records Retention

The need for creating, storing and retrieving differs somewhat depending on the purpose for which the record is kept Retention of health and safety records, used primarily to document that appro- priate procedures have been followed, is frequently mandated by law In contrast, retention requirements for epidemiologic records and for records which may be used in litigation are seldom clearly defined in advance More detailed guidance for retention of radiation protection records is provided in Appendix B

The recommended retention period for individual health and safety records, based on program requirements, is 50 y from the date

of first exposure This generally covers the maximum exposure period for most radiation workers At least 75 y from first exposure is recommended as the time period for storing records for epidemiologic research because of the relatively long latent period between first exposure to carcinogens and the onset of clinically detectable disease Although many diseases, including certain forms of cancer, have

2.7 QUALITY CONTROL / 13 shorter induction periods, it is important to allow a lag time for an investigator to conceive the need for a study and then to carry it out Finally, 25 y afier the death of the individual, or, if the date of his death is unknown, 100 y after birth, is recommended for record storage for litigation purposes since it is unlikely that a claim by a worker or the worker's survivors could be legally brought after that time

Records that do not relate to a specific individual directly should

be retained until the 100th birth anniversary of every individual to whom those records are linked has passed

2.7 Quality Control

2.7.1 Records Quality Control

It is essential to examine and review the records that are being generated, collected and stored Basic quality control checks should include systematic checks of accuracy and completeness and, where possible, detailed examination of information Accuracy checks include verification of data stored in computer-readable form with originals or directly readable hard copy Completeness checks include evaluation to ensure that all data that should have been assembled are, in fact, present, legible and retrievable

2.7.2 File Storage and Retrieval Quality Control

Backup and other archival materials should be reviewed annually

to check for completeness, availability and for safety of the archives

14 / 2 GUIDANCE FOR RECORDS GENERATIONIRETENTION

from damage by heat, cold, water, fire, infestation and other deleteri- ous conditions

2.8 Legal Aspects of Records Management

2.8.1 Evidentiary Considerations

Records may eventually have to be used a s evidence in legal pro- ceedings Most courts and other tribunals have rules of evidence that prescribe what constitutes evidence that can be used to convince the trier-of-fact Cjury, judge or hearing officer) of the truth of a proposition The law of evidence is constantly changing as new types

of records are developed, and it may be useful to have an attorney participate in the design and periodic review of the records system, since possible future use in litigation should be considered

Records that are routinely kept pursuant to standard procedures, that are dated and include identification of the record generator, and that are controlled to prevent unauthorized changes or fraudulent manipulation, would generally be admissible i n most tribunals It may be necessary to establish the degree of confidence to be placed

in the employers record-keeping techniques by presenting testimony concerning the methods of records generation, storage and retrieval, and the provisions made to ensure the integrity of the records Records entered into a computer file a s they are generated, or transferred to computer-readable media subsequent to their genera- tion, may present evidentiary problems For example, legal consider- ations have sometimes required contemporaneous generation and maintenance of a "hard copy" for every computer-generated record This is an area of the law that is developing rapidly a t the present time, and the guidance of an attorney should be sought in planning and reviewing such systems I t is likely that in the future, routinely- kept computerized records will be admissible as evidence provided their accuracy and integrity can be reasonably ensured The same considerations that apply to documentation and quality control of computer programs used to generate records (see Section 2.8.5) apply

as well to computers and programs used for information storage and retrieval Care should also be taken to ensure that the integrity of the media used to store computerized records can be reasonably ensured

2.8 LEGAL ASPECTS OF RECORDS MANAGEMENT 1 15

2.8.2 Incorporation by Reference

External documents that are readily available from standard ref- erence libraries, or from other identified repositories which can and will make copies available on demand, need not be physically included i n the radiation protection records system Such documents can be incorporated by reference by providing complete bibliographic citations and a n indication of the place or places from which a copy can be obtained A list of documents incorporated by reference should

be kept and reviewed periodically to ensure that each document continues to be available from the source cited or from another source that replaces it in the list

2.8.3 Disposition of Records of Defunct Organizations

Since records may be destroyed, dispersed or otherwise lost when the responsible organization is dissolved or goes out of existence, organizations that keep radiation protection records and are contem- plating dissolution should see that these records are transferred to

a responsible custodian When part of the responsible organization's records are maintained by others, the organization should arrange

to have custody of such records transferred either periodically or when the organization keeping those records goes out of business The contractual documents that relate the parties should contain provisions for the transfer of custody

2.8.4 Privacy and Other Confidentiality Considerations

Records relating to identified individuals may be subject to federal

or state laws that protect individual privacy Generally, the courts have opined that the Freedom of Information Act (Public Law No 90-23,1967) and its amendments (Public Law No 93-502,1974) and the Privacy Act of 1974 (Public Law No 93-579,1974) do not apply

to records maintained by private organizations supported by private funds Federal government organizations must take these statutes into account In the private sector, state statutes, contracts and other legal considerations may provide sanctions that limit disclosure In any case, it is important to safeguard the confidentiality of informa- tion about individuals

Where the law permits such release, relevant records containing personal information should be released to responsible researchers when three conditions are met:

16 / 2 GUIDANCE FOR RECORDS GENERATION/RETENTION

the importance of the research is such that the potential benefits

to society justify the risk to the individual in the revealing of information to the researcher;

the responsible organization is satisfied that the researcher has established adequate safeguards to protect the information dis- closed from unauthorized use, including a program for removal

or destruction of personal identifiers; and

the researcher agrees not to disclose or make further use of any information, the disclosure of which could reasonably be expected to lead to the identification of any individual, unless the researcher has obtained the prior written consent of the responsible organization

Individuals should receive an annual record of their exposure Detailed information should be available upon request of the individ- ual, but should not be released to a third party without the written consent of the individual Records of documents authorizing release should be maintained

There are other constraints on disclosure and copying that relate to proprietary commercial information (e.g., trade secrets) and material under copyright If commercial proprietary information is included

in radiation protection records, the rights of the owner of the informa- tion with regard to disclosure must be protected The rights of the copyright owner must be considered when copies are to be made of material under copyright

2.8.5 Documentation of Computer Programs

For the results of computer calculations to be considered credible,

a foundation must be laid describing the processes used and steps taken to ensure integrity of the information When computer pro- grams are used to perform calculations or control processes, the steps being carried out must be documented so that the operations of the computer can be understood and verified Where applicable, the guidance of appropriate standards-setting bodies for program docu- mentation should be followed (ANSIIASME, 1979) Detailed specifi- cations for input and output should be provided, as well as specifica- tion of the requirements for the system to run the program Changes

to computer programs must be recorded and dated so that the version

of the program which was used to generate any particular record can

be identified and its characteristics determined Quality control of

2.8 LEGAL ASPECTS OF RECORDS MANAGEMENT / 17 computer programs is also important to ensure that no undocu- mented changes are made to the program, to stored parameters or

to data Records of all versions of computer programs that have been used in the past must be kept as part of the radiation protection program record (see Section 3)

of the program and for documenting that it meets organizational and regulatory requirements for maintenance of the health and safety of the worker and the public Records relating to the program as it was

in the recent past may be useful in trend analysis and program management These historical records will allow retrospective opera- tional reviews as a part of an ongoing exposure control program It may be important to know how a particular job was performed, as well as how often, and with what radiological consequences Keeping records of the program beyond the period of their direct applicability provides information relevant to claims for radiation injury caused

by past exposures Such records may be of help in supplementing the information needed for epidemiologic purposes as well

3.2 Records Management

All radiation protection program records (program records) should

be maintained in accordance with the recommendations set forth in Section 2 of this Report Records relating to the records management program are discussed further in Section 3.3.19

3.3 Types of Program Records

3.3.1 Authorizing Documents

Program records include all authorizing documents This category

includes documents such a s federal and state licenses, individual

3.3 TYPES OF PROGRAM RECORDS / 19

authorizations under an institutional broad license, corporate orga- nizational and policy statements, and judicial or administrative agency orders Other records that document compliance with the authorizing documents should be linked to the authorizing docu- ments so that compliance, at any time in the past, with the authoriz- ing documents as they then were, can be determined

3.3.2 Accreditations and Certifications

Program records include all accreditations, certifications and simi- lar documents, insofar as they are applicable to the program or to specific aspects of the program, e.g., National Voluntary Laboratory Accreditation Program or Department of Energy Laboratory Accred- itation Program for accreditation of dosimetry, College of American Pathologists for laboratory accreditation, Joint Committee on Accreditation of Health Care Organizations for hospital accredita- tion or Institute of Nuclear Power Operations for accreditation of nuclear power plant training programs

3.3.3 Guidance Documents

Program records include guidance documents from sources both external and internal to the facility

3.3.3.1 External Documents This category includes NCRP and

International Commission on Radiological Protection (ICRP) recom- mendations; consensus standards; relevant governmental, industry

or professional guidance documents; and applicable radiation control regulations Some of these documents may be incorporated by refer- ence (see Section 2.8.2) Whenever the guidance of a document is used as the basis for a program action or for other program records, the external guidance document involved must be bibliographically described in program records with the specificity needed to ensure ready identification and retrieval of the document from the external source, if necessary That includes identification of version or revi- sion number or date of publication Because of their general and presumed continuing availability from external sources, it is not necessary to keep, as program records, previous versions of govern- ment issued documents (e.g., Code of Federal Regulations) with which the facility is no longer bound to comply

If program managers decide in some instances not to follow the guidance of an external guidance document, or to follow it in an

20 / 3 RADIATION PROTECTION PROGRAM RECORDS

unusual way, it would be helpful to have available a record docu- menting the reasons for the deviation from the guidance

Records of the continuing availability of up-to-date versions of such reference documents should be maintained at the facility as evidence that program personnel are familiar with current guidance

3.3.3.2 Internal Documents This category includes policy state-

ments and other guidance established within the organization to guide the program It also includes documentation of commitments relating to program activities and any other general documents of

a programmatic nature Records should document all aspects of a program (e.g., justification, application, deviation, exceptions)

Changes to internal guidance documents should be documented in accordance with the requirements of Section 3.4

3.3.4 Radiation Protection Organization and Personnel

Program records include records related to the radiation protection

organization and to the identification, qualifications, positions and training of personnel who are employed in the radiation protection program as radiation protection personnel

3.3.4.1 Personnel Identification and Qualifications Program records include all records kept to identify every person in the radia-

tion protection program, regardless of whether directly employed by the facility or not These records should show the dates of employ- ment at the facility and the positions held during that time Informa- tion on qualifications should be provided, including educational background, prior relevant experience and credentials held (e.g.,

board certification) Education and experience gained during employment a t the facility should also be documented These pro- gram records should be linked to the person's radiation exposure records, employment records, training records, medical records, secu- rity records and to program records relating to position descriptions

3.3.4.2 Position Descriptions Program records include position

descriptions stating the duties of each position, the qualifications required and listing the types of documents relevant to radiation protection the incumbent is authorized to issue, sign, review or authenticate Records should also be available to show the identity

of the persons who have held each position along with the dates of their incumbency These records should be linked to program records relating to radiation protection personnel

3.3 TYPES OF PROGRAM RECORDS / 21

3.3.4.3 Radiation Protection Personnel Training Program records include documentation of the training of radiation protection personnel Where possible, the records should include a description

of each course (e.g., outline, lesson plan, worksheets, problem sets,

visual aids, study guides) and identification of the personnel who

took the course ( e g , sign-in sheets or attendance lists), when they

did so, and the results of any examination, evaluation or other verifi- cation of the individual's understanding of the course material Each person's acknowledgement of the review of his graded examination should also be kept

If the course is accredited, the body providing the accreditation should be identified In addition, information on the criteria for accreditation applicable at the time accreditation was received should be provided or incorporated by reference The course material should be dated to help identify the version of the course that any particular individual took The identity of the instructors should also be ascertainable Where examinations are given, records of the graded examinations of those students for whom individual records are kept, as well as the examination answer keys and grading guide- lines, should be maintained

Program records include records relating to on-the-job training, special coaching, briefings, demonstrations and other educational and training activities To the extent possible, the content of these records should be similar to that described above for classroom training

These training records should be linked to program personnel qualification records

3.3.5 Program for Quality Control and Assessment of the

Radiation Protection Program

Program records include documentation of the program for control, review and assessment of the radiation protection program, includ- ing assessments made within the program and those carried out

by outside assessors and auditors Information on the schedule for carrying out such assessments and the procedures used should be provided, as well as documentation of the qualifications of the asses- sors Records should also be maintained on the procedures for track- ing audit findings and taking and verifying remedial actions

Program records include documentation of participation in studies and evaluations, such as inter-laboratory comparison studies, and the results of such studies

22 1 3 RADIATION PROTECTION PROGRAM RECORDS

These quality control and assessment records should be linked to radiation protection progam records

3.3.6 Radiological Training Program for General Workers

Program records include all records kept to document the training

on radiation protection provided to general workers [see Report No

71 (NCRP, 1983)l Records should include a description of each

course, identification of the personnel attending, date the course was completed and the results of each examination or evaluation Provisions should be made to retain any acknowledgments by train- ees of their review of the graded examination The course material should be dated to help identify the version of the course taken by

a particular individual

Program records for training general workers include records kept

to document classroom training, on-the-job training, special coach- ing, briefings, demonstrations and other training activities The con- tent of these records should be similar to that described above for radiation protection personnel training These training records should be linked to each individual's employment, medical and radia- tion exposure records

Program records may include documentation of training that takes place through more informal means, e.g., bulletin board postings, written material distributed or current events briefings

3.3.7 Source and Access Control Program

Program records include plans and procedures for identifying the presence, location, activity and disposition of licensed radioactive sources and other identifiable sources of radiation in the facility, including x-ray equipment and radioactive material contamination Records relating to sources used for calibration should include their calibration history (eg., traceable to the standards of the National Institute of Standards and Technology)

Program records also include criteria and procedures for posting radiation areas and controlling access to such areas, as well as for identifying, cleaning or otherwise treating areas that are contami- nated The criteria include action levels and guidance for decontami- nation efforts The content of records maintained pursuant to these program documents is described further in Sections 5 and 7 Source and access control program records should be linked to the records maintained pursuant to the program

3.3 TYPES OF PROGRAM RECORDS 1 23

3.3.8 Radiological Measurement and Control Programs

Program records include plans and procedures for sampling, mea- suring and monitoring radiation, radioactive materials and contami- nation in the facility, and for recording the results These include, for example, schedules for making routine measurements, criteria for deciding when special measurements are required, and measure- ment procedures for both normal and emergency situations They also include criteria for deciding what instrument or methodology

to use for a specific purpose

Program records also include procedures for performing calcula- tions and analyses, as well as any information needed to interpret the raw data obtained &om measurements If computer programs are involved, they should be adequately documented (see Section 2.8.5)

These program records should be linked to the calibration program records The content of records maintained pursuant to these pro- gram documents is described further in Section 5

3.3.9 Calibration Program

Program records include plans and procedures for calibrating the instruments used for sampling, measuring and monitoring radiation and radioactive materials in the facility and the equipment used for testing ventilation systems, respiratory protection devices and similar items This includes schedules for routine calibrations and

instrument quality control or operational checks as well as criteria

for deciding when special calibrations are called for and what sources and methods are to be used

These calibration program records should be linked to the radiolog- ical measurement program records, source and access control pro- gram records, and respiratory protection program records They should be linked to the records made pursuant to calibration program procedures The content of records maintained pursuant to these program documents is described further in Section 7

3.3.10 Respiratory Protection Program

Program records include plans and procedures for the facility respi- ratory protection program This includes procedures for qualifying personnel for the use of respiratory protection devices, fitting and testing the devices and using them It also includes criteria for decid-

24 1 3 RADIATION PROTECTION PROGRAM RECORDS

ing when respiratory protection is needed, and which type of device

is appropriate in particular circumstances

These records should be linked to calibration records and dosime- try program records They should also be linked to the records made pursuant to respiratory protection program procedures The content

of records maintained pursuant to these program documents is described further in Section 5

3.3.11 Radiation Work Control Program

Program records include plans and procedures to maintain control

over the radiological conditions of work within radiologically con- trolled areas

The procedures for issuing and controlling Radiation Work Per- mits (RWP) or similar work control documents should include crite- ria for selection of the protective equipment and other protective conditions of work and should make it clear who has the authority

to issue, modify and revoke such documents

Radiation work control program records should be linked to work- place records (see Section 5) The content of records maintained pursuant to these program documents is described further in Section 5

3.3.12 Dosimetry and Exposure Control Program

Program records include the criteria and procedures used to deter-

mine the dose limits applicable to particular individuals, and to obtain, process and evaluate data for determining and controlling external and internal exposures They also include any applicable criteria for medical selection of personnel fit to work in radiation areas Records of the methods used to determine an individual's exposure, for both exposure control purposes and actual dose estima- tion purposes, should refer to pertinent published documents or reports and should show the period of applicability of the methods used These records should be linked to the records made pursuant

to dosimetry and exposure control program procedures The content

of records maintained pursuant to these program documents is described further in Section 4

Examples of criteria and procedures that should be maintained relative to radiation dose records for individuals include:

criteria for estimating types and number of detectors needed to monitor the individual's exposure to beta, gamma, neutrons and other types of ionizing radiation;

3.3 TYPES OF PROGRAM RECORDS 1 25

criteria for location of primary monitoring device and supple- mental dosimeters, if required;

procedure for estimation of the whole body dose equivalent for individuals uniformly irradiated to one type of radiation; procedure for estimation of effective dose equivalent;

procedure for estimation of the dose equivalent to red bone mar- row, breast, lungs, gonads and other organs or tissues;

procedure for estimation of the dose equivalent to the skin of the whole body;

procedure for estimation of the dose equivalent to the lens of the eye;

procedure for estimation of the dose equivalent to extremities; and

procedure for estimation of the dose equivalent to the embryo- fetus carried by an expectant mother

The content of records maintained pursuant to these program documents is described further i n Section 5

3.3.13 Ventilation Monitoring Program

Program records include criteria and procedures for monitoring air flow i n ventilation systems that could affect the concentration

of radioactive materials i n work areas or effluents These records should be linked to the records made pursuant to ventilation monitor- ing program procedures

3.3.14 Environmental Radiation Monitoring and Dose

Assessment Program

Program records include the criteria and procedures used to obtain, process and evaluate data related to external and internal environ- mental exposures Records of the methods used to obtain and evaluate information on environmental exposures should refer to per- tinent published documents or reports and should show the period of applicability of the methods used The models and computer codes used should be documented in accordance with the recommendations

of Section 2.8.5 These records should be linked to the environmental monitoring and dose assessment records and the records made pursu- ant to radioactive waste program procedures The content of records maintained pursuant to these program documents is described fur- ther in Section 6

26 / 3 RADIATION PROTECTION PROGRAM RECORDS

3.3.15 Radioactive Waste Program

Program records include the criteria and procedures used to moni-

tor the radioactivity, hazards, processing, storage and disposition of radioactive waste materials, and to maintain records of wastes shipped from or otherwise disposed of by the facility These records should be linked to radioactive waste records, the content of which

is described further in Section 5

3.3.16 Radioactive Materials Receipt and Shipment Program Program records include the criteria and procedures used to moni-

tor the radioactivity, hazards, processing, storage and disposition of radioactive materials received at the facility and materials shipped from the facility These records should be linked to records main- tained pursuant to materials receipt and shipment procedures, the content of which is described further in Section 5

3.3.17 Incident Response Programs

Program records include records relating to the organization of

the emergency planning program and to the response to and investi- gation of incidents and emergencies

3.3.17.1 Emergency Response Planning Program Program records include the criteria and procedures used in emergency plan-

ning, including types and frequency of training drills as well as records of the information on emergency planning and response sup- plied to facility personnel, to governmental responders and to the public They should be linked to the records maintained pursuant to program procedures and to other incident response program records

3.3.17.2 Program for Notification, Investigation, Tracking and Follow-Up of Incidents and Emergencies Program records include

criteria, plans and procedures for handling incidents and emergen- cies, including criteria for deciding whether and when regulatory agencies should be notified, what response should be made, when investigations are necessary, and the extent of such investigations Also included are procedures for documenting agency notification, tracking the findings of investigations and auditing follow-up correc- tive actions

These records should be linked to the individual records of all persons involved in the incident, in the response to it, in its investiga-

3.4 CHANGES IN GUIDANCE, PROCEDURES AND METHODS / 27 tion, and in any notifications made They should also be linked to the records maintained pursuant to program procedures (see Section 4.8)

3.3.18 Programs to Maintain Exposures As Low As Reasonably

Achievable (ALARA)

Program records include documentation of corporate and facility commitment to the ALARA principle, as well as criteria and proce- dures for ensuring that radiation exposures of workers and the public are maintained ALARA Both design and operational ALARA proce- dures should be included These records should be linked to the records maintained pursuant to them, the content of which is described further in Section 5

3.3.19 General and Administrative Programs

3.3.19.1 Reports Program records include substantive revisions

of the radiation protection program General and administrative program records document internal guidance directives, including changes to procedures, methods of evaluation and policies Such

records should be linked to the reports made The content of records

maintained pursuant to these program documents is described fur- ther in Sections 4 and 5

3.3.19.2 Administrative Program Program records include the criteria and procedures used for administrative purposes within the radiation protection organization, including, for example, the proce- dures used to revise other program documents

3.3.19.3 Record-Keeping Program Program records include the criteria and procedures used for maintaining records of all types covered by this Report Guidance for the record-keeping program is

provided in Section 2

3.4 Changes in Guidance, Procedures and Methods

Radiation protection program records should include substantive

revisions of the radiation protection program, including changes to

internal guidance documents, procedures, methods of evaluation or policies Where pertinent, the reasons for such changes should also

be recorded

Individual Records

Occupational radiation safety and dosimetry records constitute the formal documentation of an individual's history of radiation exposure during employment Dosimetry records should be main- tained to provide a quantitative description of the occupational radia- tion exposure received by the individual Occupational radiation exposure received during visits made on behalf of t h e employer should be included In addition to an individual's measured exposure, records should be maintained of the assigned dose equivalent, organ

or tissue dose equivalents, devices used to measure exposure or absorbed dose, and methods used to determine the dose equivalent including radiation weighting factors, tissue weighting factors, assumptions, etc and procedures used to obtain these values A zero dose result is important to record Routine dose equivalent reports such as annual dose equivalent summaries should be recorded in a manner to allow comparison with established radiation control guides This Section provides recommendations for occupational exposure records

4.1 Exposure Categories for Individuals

Records should identify the exposure category of each person for whom records are kept a t each point in time The content of records maintained for an individual is dependent on the nature of the activ- ity and the magnitude of potential risk

Site specific requirements may necessitate the maintenance of records for various categories of individuals including those who are occupationally exposed, occasionally exposed, management and supervisory personnel, contractor personnel, visitors, emergency personnel and others (NCRP, 1983) Radiation records for these indi- viduals should be linked to the records of the radiation expos'ke conditions a t the location and time of exposure

4.2 Personal Data

Current dosimetry records should identify former employers and each period of employment if occupational radiation exposure may

4.3 EXTERNAL DOSIMETRY 1 29 have been received by an individual during previous civilian employ- ment or during periods of military service Radiation exposure records received from a prior employer should be linked to a specific period of employment

Exposure information should be uniquely identified to an individ- ual so that exposure records are available when necessary for trans- fer to other employers Some personal data are additionally useful for trend analysis, to assess control procedures and for epidemiologic studies Thus, exposure information should be linked to personnel and medical records

4.3 External Dosimetry

External dosimetry records should be maintained for results obtained from the use of radiation measurement instruments and dosimeters used to assess external exposures Records should include relevant information on whole body, skin, lens of eye and extremity exposures Procedures used to convert absorbed dose to effective dose equivalent should be documented Records of organ or tissue dose equivalent and effective dose equivalent should also be maintained Where feasible, the dose record should distinguish between types

of radiation, e.g., gamma, neutron, beta If possible, exposures to thermal, intermediate and fast neutrons should be distinguished in the dose records to meet the scientific requirements of epidemiology and to allow adjustments for changes in the recommended values of the quality factor At the least, the source($ of neutron exposure and, if available, the neutron energies should be recorded

4.3.1 Dose Assessment Records

For each monitored individual exposed to workplace sources of ionizing radiation in the course of assigned duties, the whole body dose equivalent or effective dose equivalent should be recorded In addition, records of organ and tissue dose equivalent should be main- tained when the dose equivalent differs markedly for various tissues Dosimetry records should be linked to the procedures used to deter- mine the whole body and organ or tissue dose equivalent

4.3.1.1 Whole Body Dose Equivalent The whole body exposure should be recorded as the individual dose equivalent, penetrating (ICRU, 1988), which in the case of uniform exposure, is usually obtained from a single dosimeter worn on the trunk of the body in

30 / 4 INDIVIDUALRECORDS

the position of maximum likely exposure The position of the dosi- meter and any other supplemental information such as whether the dosimeter is worn under a lead apron should be recorded Addition- ally, when non-uniformity of the radiation field necessitates the use

of supplemental dosimeters to assess non-uniformity of exposure

of the organs and tissues of the body, information concerning the placement of supplementary dosimeters should be recorded Proce- dures used to evaluate the whole body dose equivalent, including the depth a t which it is determined, should be recorded

4.3.1.2 Effective Dose Equivalent The effective dose equivalent

from non-uniform irradiations, such as beta radiation exposure to the skin of the whole body, should be recorded The sum of the effective dose equivalent from non-uniform irradiations and the whole body dose equivalent from uniform irradiations should be recorded a s the effective dose equivalent from external sources

4.3.1.3 Dose Equivalent to Skin The exposure to the skin of the

whole body is usually obtained from a single dosimeter worn in the position of maximum likely exposure The position of the dosimeter and the criteria for use of supplemental dosimeters should be recorded when the skin dose equivalent is evaluated

Under conditions of uniform dose equivalent, exposure to the skin

is generally evaluated a t a depth of 0.07 mm (ICRU, 1988) In prac- tice, a dosimeter measures the radiation dose a t a specific depth in soft tissue, because of the thickness of the dosimeter window and the thickness of the dosimeter itself The method used to convert a dosimeter reading to skin dose equivalent should be recorded When the skin is contaminated with radioactive material, the location, size of the contaminated area and the dose equivalent should be recorded Procedures used for determination of the dose equivalent and assessment of dose equivalent to the skin should be documented In the case of exposure from "hot particles" refer to NCRP Report No 106 (NCRP, 1989b) For "hot particle" exposure the location, size of the contaminated area and activity of the "hot particle" should be recorded

4.3.1.4 Dose Equivalent to the Lens of the Eye The dose equivalent

to the lens of the eye is usually estimated on the basis of data from

a single dosimeter worn on the trunk of the body The position of the dosimeter, eye protection required and criteria for use of supple- mental dosimeters should be recorded The dose equivalent to the lens of the eye is generally evaluated a t a depth of 3 mm (ICRP,

1977) When the dose equivalent to the lens of the eye is measured, a record of the assessment should be kept along with the supplemental

4.4 INDIVIDUAL DOSE RECORDS FOR INTERNAL DOSIMETRY / 31 measurement data and assumptions used to determine dose equiva- lent Procedures used to evaluate the dose equivalent, including depth a t which it is determined should be recorded

4.3.1.5 Extremity Dose Equivalent Extremity dose equivalent

should be recorded when extremities are monitored The part of the body monitored by an extremity dosimeter should be recorded Separate records of the exposure of each extremity should be kept Records of the procedure used to determine absorbed dose or dose equivalent from each type of radiation should be maintained

In those situations where the extremity dosimeters are worn only occasionally, procedures for the estimation of dose equivalent to the extremity for the entire year should be maintained The sum of the estimates from the extremity dosimeters in the periods when they were worn, and the estimates of the extremity dose based on the radiation survey data and dose from the body dosimeter in those periods when extremity dosimeters were not used, should be recorded

as the annual extremity dose If extremity dosimeters do not measure all types of radiation, a record of supplemental measurements required to determine the ratio of the total dose equivalent to the dose measured by the extremity dosimeter should be linked to individual extremity dose equivalent records

4.4 Individual Dose Records for Internal Dosimetry

For each intake of radioactive material, the committed effective dose equivalent for each radionuclide, and, where determined, the annual effective dose equivalent should be recorded The record for each individual should contain the basic physical measurement (e.g.,

of activity or absorbed dose) used to determine the dose equivalent

In the case of exposure to radionuclides with long effective half- lives, if annual assessments of the dose received from radionuclides deposited in the body in past years are made, the results should be recorded Individual records should additionally include mode of intake and, where applicable, particle size distribution, chemical form, and records of chelation or decorporation therapy

Procedures, bioassay data, biokinetic and dosimetric models and other biological parameters used to determine internal dose equiva- lent should be linked to each individual's radiation exposure file This may be accomplished by a reference in the individual file to a program file or by placing the appropriate documentation in the individual's file

Examples of records that should be maintained include: