NCRP report no 114 maintaining radiation protection records

NCRP REPORT No. 114

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
7910 WOODMONT AVENUE
1
Bethesda, M D 20814


LEGAL NOTICE
This report was prepared by the National Council on Radiation Protection and Measurements (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-PublicationData

National Council on Radiation Protection and Measurements.
Maintaining radiation protection records : recommendations of the National
Council on Radiation Protection and Measurements.
cm.-(NCRP report ; no. 114)
p.
Prepared under the auspices of Scientific Committee 46 on Operational Radiation
Safety.
"Issued November 30, 1992."
Includes bibliographical references and index.
ISBN 0-929600-27-4
1. Radiation-Safety measures. 2. Files (Records)-Management. 3. Radiation-Dosage-Reporting.
I. National Council on Radiation Protection and
Measurements. Scientific Committee 46 on Operational Radiation
Safety. 11. Title. III. Series.
2. Records-standards.
[DNLM: 1. Radiation Protection-standards.
WN 650 N2775ml
RA569.N353 1992
363.17'996-dc20
DNWDLC
92-49562
for Library of Congress
CIP

Copyright O National Council on Radiation
Protection and Measurements 1992
All rights reserved. This publication is protected by copyright. No part of this
publicationmay be reproduced in any formor by any means, includingphotocopying, or utilized by any information storage and retrieval system without written
permission from the copyright owner, except for brief quotation in critical articles
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 keeping 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

Joyce P. Davis
Defense Nuclear Facilities
Safety Board
Washington, D.C.

Peter S. Littlefield
Yankee Atomic Electric Co.
Bolton, Massachusetts

Nancy A. Dreyer
Epidemiology Resources, Inc.

Newton Lower Falls,
Massachusetts

Bette L. Murphy
Rockville, Maryland

Richard J. Vetter
Mayo Clinic
Rochester, Minnesota
Scientific Committee 46 Liaison Member

Thomas D. Murphy
U.S. Nuclear Regulatory Commission
Washington, D.C.


iv

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PREFACE

Consultant

Richard J. 'll'raub
Battelle Pacific Northwest Laboratories
Richland, Washington

NCRP Secretariat
James A. Spahn, Jr. (1986-1992)

Robert T. Wangemann (1986)
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)
Tennessee Valley Authority
Chattanooga, Tennessee

David S. Myers (1987-)
Lawrence Livermore
National Laboratory
Livermore, California

W. Robert Casey (1983-1989)
Brookhaven National Laboratory
Upton, New York

John W. Poston (1991-)
Texas A&M University
College Station, Texas

Robert Catlin
University of Texas
Houston, Texas

Keith Schiager
University of Utah
Salt Lake City, Utah

Joyce P. Davis (1990-)
Defense Nuclear Facilities
Safety Board
Washington, D.C.

Ralph Thomas (1989-)
Lawrence Livermore
National Laboratory
Livermore, California

William R. Hendee
Medical College of Wisconsin
Milwaukee, Wisconsin

Robert G. Wissink
3M Company
St. Paul, Minnesota


PREFACE

James E. McLaughlin

Canoga Park, California

I

v

Paul L. Ziemer
(1983-1990)
Purdue University
West Lafayette, Indiana

Thomas D. Murphy

U.S.Nuclear Regulatory Commission
Washington, D.C.
The Council wishes to express its appreciation to the Committee
members for the time and effort devoted to the preparation of this
Report.
Charles B. Meinhold
President, NCRP
Bethesda, Maryland
15August 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

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CONTENTS

...............
3. Radiation Protection Program Records ........................
2.8.5 Documentation of Computer Programs

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 FollowUp of Incidents and Emergencies ....
3.3.18 Programs to Maintain Exposures As LOWAs
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

.....................

Individual Dose Records for Internal Dosimetry ..........
Summation of Internal and External Exposure ...........
Exposure History .............................................................
Missing Dosimetry Results .............................................
Abnormal Exposures .......................................................
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 ........
4.4
4.5
4.6
4.7
4.8
4.9

.


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 recommendations dealing with many aspects of radiation protection. The
NCRP seeks to provide practical recommendations for the establishment 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 retrievability.
This Report is offered as a guide for the appropriate maintenance
of records as 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 radiationinduced injury.
An effective radiation safety program can do much to reduce exposures to a level as low as reasonably achievable (ALARA) within the


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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 control. 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 survey 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 maintenance of radiation protection instrumentation is provided. [See
NCRP Report No. 112 (NCRP, 1991a)for recommendations on calibration 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 existence 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 particular 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 occupationallyrelated injury or disease. Each situation would require a detailed
record review to recreate the circumstances surrounding the individual's exposures to radiation.
This Report discusses techniques for the linking of records maintained 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 maintaining 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 recommendations 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 discipline (Fienberg et al., 1985; ANSI, 1976). Information contained in
individual records must be legible, accurate, reliable and interpretable. There should be a means for assuring confidentiality when
appropriate. Since files and records can be linked by routinely including 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 confidentialityof personal
and proprietary information must be protected. Consideration of
specificissues 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 computermaintained 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 definitions, 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

1

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2. GUIDANCE FOR RECORDS GENERATIONIRETENTION

discarded, however, merely because it is known only qualitatively
or is otherwise uncertain. For example, where a n accurate measurement 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 available; 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 measured quantities, both the measurement data and the quantities
derived from them, along with references to the method and assumptions 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 as well as in computer
files. Information in a record should permit the unambiguous interpretation 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 measurement 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 procedures, 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-keeping 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 information (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 terminated. 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 at a single location all information 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. Transcription 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 Radiation 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 facilities. 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 substances 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 (oftenheld in the organization's
personnel department) should contain sufficient information to permit 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' birthplaces complete the set of information needed to identify a match
through Social Security or the National Death Index systems. Linkage of personal identifiers with national data systems will permit
follow-up for mortality, as is often done in epidemiologic studies.

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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 quantifying 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 processes (see Sections 3, 5 and 6).

2.4.4

Other Files

Other existing files, such as 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 followup 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 information, 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 originally 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


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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 hardware needed to retrieve and access the data. When changes in computer 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 appropriate 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
definedin 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 exposureperiod
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

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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.

2.6 Records Retrieval

A listing of the content and location of all files, including backup
files, should be maintained. Each file should be completely indexed
to a level commensurate with the type of information to be retrieved.
Where appropriate, a system of flags, labels or other identifying
marks can be used to facilitate the identification of the content of a
particular document.

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


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2. GUIDANCE FOR RECORDS GENERATIONIRETENTION

from damage by heat, cold, water, fire, infestation and other deleterious conditions.

2.8 Legal Aspects of Records Management

2.8.1 Evidentiary Considerations
Records may eventually have to be used as evidence in legal proceedings. 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 in 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 as they are generated, or
transferred to computer-readable media subsequent to their generation, may present evidentiary problems. For example, legal considerations 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. It is likely that in the future, routinelykept 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

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2.8.2 Incorporation by Reference

External documents that are readily available from standard reference libraries, or from other identified repositories which can and
will make copies available on demand, need not be physically
included in 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 contemplating 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 information about individuals.
Where the law permits such release, relevant records containing
personal information should be released to responsible researchers
when three conditions are met:


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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 disclosed 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 individual, 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 information 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 programs 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 documentation should be followed (ANSIIASME, 1979).Detailed specifications for input and output should be provided, as well as specification 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