ES&H Manual

Radiation Control Supplement

 

 

 

Chapter 7 – Radiological Records

 

 

 

 

Part 1 Requirements

 

 

711        Purpose

 

This chapter contains the prescribed practices for preparing and retaining radiologically related records.  Records are maintained to document compliance with applicable parts of 10 CFR 835 and specifically with radiation protection programs required by 10 CFR 835.101 [§835.701(a)].  Radiological control records are also needed to demonstrate the effectiveness of the overall program.  The work force and management are required to use records to document radiological safety afforded to personnel on-site.  Records of the Jefferson Lab radiological program may be required to support worker health studies and future disputes or claims.  Therefore, these records should be high quality, readily retrievable, and managed for the prescribed retention period.  Data necessary for future verification or reassessment of the recorded doses shall be recorded [§835.702(g)].  Unless otherwise specified in 10 CFR 835, records are retained until Department of Energy (DOE) authorizes final disposition [§835.701(b)].  Records shall be handled such that personal privacy is protected.

 

712        Records Management Program

 

712-01)         There are specific records maintenance requirements for occupational exposure in excess of any 10 CFR 835 threshold and doses received during planned special exposures, accidents, and emergency conditions.  A radiological records management program ensures that auditable records and reports are controlled through the stages of creation, distribution, use, arrangement, storage, retrieval, media conversion (if applicable) and disposition.  The records management program shall include the following [§835.704(b),(c),(e),(f)]:

a)               Radiological Control Policy Statements

b)               Radiological Control Procedures

c)               Individual Radiological Doses

d)               Internal and External Dosimetry Policies and Procedures (including Bases Documents)

e)               Personnel Training (course records and individual records)

f)                As Low As Reasonably Achievable (ALARA) Records

g)               Radiological Instrumentation Test, Repair, and Calibration Records

h)               Radiological Surveys

i)                Area Monitoring Dosimetry Results

j)                Radiological Work Permits

k)              Radiological Performance Indicators and Assessments

l)                Radiological Safety Analysis and Evaluation Reports

m)             Quality Assurance Records

n)               Radiological Incident and Occurrence Reports (and Critique Reports, if applicable)

o)               Accountability records for sealed sources

p)               Records for release of material to Controlled and Uncontrolled Areas

q)               Reports of loss of radioactive material

r)               Internal and External Audits

s)               Descriptions and/or records of changes in equipment, techniques, and procedures used for monitoring in the workplace.

712-02)         Recording of the non-uniform equivalent dose to the skin caused by contamination on the skin is not required if the dose is less than 2% of the limit specified for the skin in Table 2-1B [§835.702(b)].

712-03)         Where radiological services (for example, dosimetry and laboratory analyses) are purchased, there should be a clear agreement regarding records responsibility and auditability during performance of the service.  Records of results should reside with the Radiation Control Department (RCD).

712-04)         Records and reports containing private information should be locked when unattended.  Private information, for the purposes of this Chapter, is records or reports that contain information such as full social security number, age, sex, national origin, etc.  Magnetic media containing Privacy Act Information shall be stored in a locked container and shall have password protection applied for access to this information.

712-05)         Privacy Act information shall be controlled to prevent unauthorized release.

712-06)         Superseded or revised documents shall be archived for future retrieval.

712-07)         All records required by this Chapter shall be transferred to the DOE upon cessation of activities at the site that could cause exposure to individuals [§835.702(h)].

712-08)         The records specified in 10 CFR 835 that are identified with a specific individual shall be readily available to that individual [§835.702(f)].

 

713        Recordkeeping Standards

 

713-01)         Radiological control records shall be accurate and legible.  The records should include the following:

a)               Identification of the facility, specific location, function and process

b)               Signature or other identifying code of the preparer, date, and time (if applicable)

c)               Legible entries in blue or black ink

d)               Corrections identified by a single line-out, initialed and dated

e)               Supervisory signature to ensure review and proper completion of forms.

713-02)         The RCD should maintain a file of names, signatures and initials for future identification of the person who signed or initialed a record.

713-03)         Radiological control records should not include:

a)               Opaque substances for corrections

b)               Shorthand or other nonstandardized terms.

 

All individual monitoring records must be sufficient to evaluate compliance with the limits in  Article 212, and must be sufficient to provide dose information necessary to complete reports required by Article 781 [§835.702(c)].

 

 

Part 2 Employee Records

 

 

721        Employment History

 

For Radiological Workers who are monitored in accordance with 10 CFR 835.402, reasonable efforts shall be made to obtain records of prior years’ occupational internal and external exposure [§835.702(e)].  Records obtained which detail an employee’s pre-employment and employment history and the associated radiation dose shall be maintained.  Where practical, the association between the radiation dose and job function should be preserved for trending purposes and future worker health studies.  The following information shall be maintained:

 

721-01)         Previous work history, detailing radiological work assignments and yearly doses at other facilities, to the extent practical.

721-02)         In the absence of formal records of previous occupational exposure during the current year, a written estimate signed by the individual may be accepted [§835.702(d)].

721-03)         Nuclear Regulatory Commission Form 4 or equivalent, which documents previous occupational radiation doses.

 

722        Personnel Radiological Records

 

722-01)         Except as provided in 722-02), records shall be maintained to document doses received by all individuals for whom monitoring was required pursuant to 10 CFR 835.402 and to document doses received during planned special exposures, unplanned doses exceeding the monitoring thresholds of 10 CFR 835.402, and authorized emergency exposures [§835.702(a)].

722-02)         The recording of internal dose (committed effective dose or committed equivalent dose) is not required for any monitoring result estimated to correspond to an individual receiving less than 10 mrem  committed effective dose.  The bioassay or air monitoring result used to make the estimate shall be maintained in accordance with 10 CFR 835.703(b) and the unrecorded internal dose estimate for any individual in a year shall not exceed the applicable threshold at 10 CFR 835.402(c),   Recording of the non-uniform equivalent dose to the skin is not required if the dose is less than 2% of the limit specified for the skin at Table 2-1B [§835.702(b)].

722-03)         Radiation dose records shall contain information sufficient to identify each person, including social security or employee number.

722-04)         Routine and special records related to radiation doses shall be retained for each person monitored.  This shall include records of zero dose.  Procedures, data and supporting information needed to reconfirm a person’s dose at a later date should be maintained.  Documentation of all routine occupational exposure received during the current year shall be obtained to demonstrate compliance with 10 CFR 835.202(a) . [§835.702(d)]

722-05)         The individual monitoring records shall include the following quantities for external dose received during the year:

a)               The effective dose  from external sources of radiation (equivalent dose to the whole body may be used as effective dose  for external exposure) [§835.702(c)(3)(i)];

b)               The lens of the eye equivalent dose [§835.702(c)(3)(ii)];

c)               The  equivalent dose to the skin [§835.702(c)(3)(iii)];

d)               The  equivalent dose to the extremities [§835.702(c)(3)(iv)];

e)               Evaluations resulting from anomalous dose results such as unexpected high or low doses;

f)                Dose reconstructions from lost or damaged dosimeters, or for  workers not assigned personnel dosimeters;

g)               The equivalent dose to the embryo/fetus of a declared pregnant worker [§835.702(c)(6)].

722-06)         The individual monitoring records shall include the following quantities for internal dose resulting from intakes received during the year:

a)               Committed effective dose [§835.702(c)(4)(i)];

b)               Committed equivalent dose to any organ or tissue of concern [§835.702(c)(4)(ii)];

c)               Estimated intake and identity of radionuclides [§835.702(c)(4)(iii)].

722-07)         The individual monitoring records shall include the following quantities for the summation of the external and internal dose:

a)               The total effective dose  in a year [§835.702(c)(5)(i)];

b)               For any organ or tissue assigned an internal dose during the year, the sum of the equivalent dose to the whole body from external exposures and the committed dose to that organ or tissue [§835.702(c)(5)(ii)];

c)               The cumulative total effective dose received from external and internal sources while employed at the site or facility, since January 1, 1989 [§835.702(c)(5)(iii)].

722-08)         Counseling of individual persons about radiological concerns should be documented and this documentation retained.

722-09)         Records of authorization to exceed Administrative Control Levels shall be retained.

 

723        Other Personnel Radiological Records

 

723-01)         The complete records of radiological incidents and occurrences involving personnel dose shall be retained.

723-02)         Records of employee radiological safety concerns that have been formally investigated and documented shall be maintained.

723-03)         Written declarations of pregnancy, including the estimated date of conception, and revocations of declarations of pregnancy shall be maintained [§835.704(d)].  Records indicating that the pregnancy has concluded should also be maintained.

 

724        Medical Records

 

724-01)         Medical evaluations performed in support of the radiological program shall be documented.

724-02)         Records of non-occupational radiation doses, such as therapeutic or large amounts of diagnostic radiation doses for medical purposes, should be maintained when made available by the employee.

 

725        Radiological Training and Qualification Records

 

725-01)         Records of training and qualification in radiological control shall be maintained to demonstrate that a person received appropriate information to perform the work assignment in a safe manner and to document compliance with 10 CFR 835 [§835.704(a)].  Qualification standard records shall be retained for on-the-job and practical factor training as well as for formal classroom training.

725-02)         Formal records of training and qualification should be readily available to first-line supervision and management of involved personnel to aid in making work assignments.

725-03)         Personnel training records shall be controlled and retained to meet the requirements of 10 CFR 835.704 [§835.704(a)].  At a minimum, these records shall include the following:

a)               Course title

b)               Attendance sheets (or electronic record) with instructor’s name

c)               Employee’s name, identification number and signature

d)               Date of training

e)               Verification document or record confirming satisfaction of the training requirement

f)                Documentation related to exceptions for training requirements and extensions of qualification.

725-04)         Records shall be retained for the following types of training:

a)               General Employee Radiological Training (GERT)

b)               Radiological Worker Training (I and II)

c)               Assigned Radiation Monitor (ARM) training

d)               Radiation Control Technologist training

e)               Periodic retraining

f)                Orientation and training of visitors

g)               Training of emergency response personnel performed by the RCD.

725-05)         The following instructional materials shall be maintained:

a)               Course name, instructor’s manuals, course content, or lesson plans containing topical outlines, revisions, and approval date.

b)               Video and audio instructional materials, including the dates and lessons for which they were used.

c)               Handouts or other materials retained with the master copy of the course.

 

726        Exposure Investigations

 

When gaps in the dosimetry records occur or it is necessary to make adjustments to recorded exposures, an exposure investigation shall be performed to estimate the missing exposure or to document the reasons for the adjustment.  The exposure investigation form is placed into the person’s individual monitoring record in order to maintain an accurate and complete radiation exposure history.

 

 

Part 3 Visitors

 

 

731        Record Requirements

 

For visitors the following records shall be maintained if applicable:

731-01)         Documentation of completion of Visitor Orientation Training

731-02)         Individual monitoring records for monitoring conducted by Jefferson Lab.

 

732        Reports

 

Dose reports shall be provided to those visitors who request a report.

 

 

Part 4 Radiological Control Procedures

 

 

741        Policies, Procedures, and Radiological Work Permits

 

Records of the RCD (policy statements, procedures, Radiological Work Permits and supporting data) shall be maintained.  The records should be maintained in a chronological sequence that will allow correlation with the corresponding support information.  For example, procedures for performing radiation surveys should be identifiable with the survey results.  Completed Radiological Work Permits shall be maintained.

 

742        ALARA Records

 

Records of ALARA plans, goals, modifications to procedures and changes to facilities, and training shall be maintained to demonstrate the adequacy of the Jefferson Lab Radiation Protection Program, including ALARA efforts [§835.704(b)].

 

743        Quality Assurance Records

 

Records of quality assurance reviews and audits developed for radiological control function and records of other reviews shall be retained to ensure that sufficient records are specified, prepared, reviewed, approved, and maintained to accurately reflect completed work and to document program content and implementation.

 

 

Part 5 Radiological Monitoring

 

 

751        General Requirements

 

The following information shall be documented and maintained:

 

751-01)         Results of monitoring for radiation and radioactive materials as required by Articles 422, 432, 511, 512, 521, 551, and 554 [§835.703(a)].

751-02)         Results of monitoring used to determine individual occupational exposure from external and internal sources [§835.703(b)].

751-03)         Results of surveys for the release of material and equipment as required by 10 CFR 835.1101 [§835.703(c)].

751-04)         Results of sealed radioactive source leak tests and inventories as required by Articles 451 and 452 [§835.704(f)].

751-05)         Results of maintenance and calibration performed on instruments and equipment as required by 10 CFR 835.401(b) [§835.703(d)].

751-06)         Results of continuous computer logging of Controlled Area Radiation Monitors (CARMs), and other associated instrumentation used in monitoring radiological conditions.

 

752        Radiation Surveys

 

The Jefferson Lab Radiological Control Program requires the performance of radiation and contamination surveys (as appropriate) to determine existing conditions in a given location.  Maps with sufficient detail to permit identification of original survey and sampling locations shall be maintained.  Records should contain sufficient detail to be meaningful even after the originator is no longer available.  Radiological surveys shall be recorded on appropriate standard forms and should include the following common elements:

 

752-01)         Date, time and purpose of the survey.

752-02)         General and specific location of the survey.

752-03)         Name and signature of the surveyor or analyst.

752-04)         Pertinent information needed to interpret the survey results.

752-05)         Reference to a specific Radiological Work Permit if the survey is performed to support the permit.

752-06)         Instrument model and serial number.

752-07)         Results of the measurements of area dose rates.

 

753        Contamination Surveys

 

In addition to the elements required by Article 752, records of contamination surveys should include, at a minimum, the following information:

 

753-01)         Contamination levels (using appropriate units) and appropriate supporting parameters, including counting efficiency, counting time, correction factors, type of radiation and whether the contamination was fixed or removable.

753-02)         Location of areas found to contain high concentrations of localized contamination.

753-03)         Follow-up survey results for decontamination processes cross-referenced to the original survey.

 

754        Airborne Radioactivity

 

In addition to the elements provided in Article 752, records of airborne radioactivity shall include, at a minimum, the following information:

 

754-01)         Model and serial number of the sampler or location of fixed sampler.

754-02)         Air concentrations in general areas.

754-03)         Supporting parameters, including collection efficiency, flow rate, duration of sampling, correction factors and filter medium.

754-04)         Identification of individuals in the area for whom DAC-hour exposure should be calculated.

 

 

Part 6 Instrumentation and Calibration Records

 

 

761        Calibration and Operational Checks

 

761-01)         Calibration records shall be maintained and include frequencies, method, dates, personnel, training and traceability of calibration sources to National Institute of Science and Technology or other acceptable standards.  Calibration records shall be maintained for the following equipment:

a)               Portable survey instruments

b)               Fixed radiation measuring equipment

c)               Process and effluent monitors and sampling equipment

d)               Area Radiation monitors

e)               Pocket and electronic dosimeters

f)                Air sampling equipment

g)               Tool and waste monitoring equipment

h)               Laboratory radiation measuring equipment

761-02)         Documentation of instrument operational checks should be maintained for a period not less than the calibration period of the instrument.

761-03)         Maintenance histories, including the nature of any defects and corrective actions taken, and calibration results for each instrument shall be created and retained.

 

762        Special Calibration Records

 

Records of additional tests and checks of instrumentation used in conjunction with a suspected overexposure, questionable indication or unusual occurrence shall be retained.  In addition, records of special instrument calibrations and modifications made in accordance with Article 563 should be retained.

 

 

Part 7 Records Management

 

 

771        Media

 

A combination of media may be used for a comprehensive records system.  For records that have long-term retention requirements and are stored on media subject to degradation or obsolescence, the records system should provide for conversion to a more stable medium.  All records shall be stored in a manner that ensures their integrity, retrievability and security.

 

Records required under this chapter should be duplicated with the duplicate maintained in a location remote from the original records.

 

Unless otherwise specified in subpart H of 10 CFR 835, all required records shall be retained until final disposition is authorized by DOE [§835.701(b), §835.702(h)].

 

772        Computerization of Records

 

772-01)         Records may be transferred to electronic storage media provided certain precautions are taken to ensure that the information is maintained in a retrievable configuration.

772-02)         Controls for the use and handling of electronic storage media should include the following:

a)               A master index of documents on the electronic storage medium

b)               A program to ensure back-up and retrievability of information

c)               Quality control during data entry and analysis

d)               Prevention of unauthorized manipulation of data

e)               Assurance that previously stored information is retrievable and useable after system modifications.

772-03)         Optical disks may be used to store records if the optical disks satisfy the following:

a)               A reliable system is in place to prevent overwriting or erasure of records

b)               Software and user controls are consistent with Article 772-02.

c)               Manufacturer recommendations relating to software control, disk life expectancy, environmental storage conditions and maintenance are incorporated into policies and procedures

d)               Quality controls on the imaging processes are implemented.

 

773        Physical Protection of Records

 

773-01)         Methods for protecting documents shall include, at a minimum, fire rated cabinets, duplicate storage, or combinations of these.

773-02)         Storage arrangements should address physical damage that could be caused by temperature extremes, moisture, infestation, electromagnetic fields, excessive light, stacking, theft and vandalism.

773-03)         Records should, as a minimum, be protected from:

a)               Exposure to fire, equivalent to an Underwriters Laboratories, Inc., 1.5-hour, or greater, fire resistance rating

b)               Exposure to water damage caused by a 100-year flood

c)               Exposure to windstorm velocities of 100-year recurrence.

 

 

Part 8 Radiological Reporting

 

 

781        Reports to Individuals

 

Radiation exposure data for individuals monitored in accordance with 10 CFR 835, subpart I shall be reported as specified in this section.  The information shall include the data required under Article 722-05 and -06.  Each notification and report shall be in writing and include: the Department of Energy (DOE) site or facility name, the name of the individual, and the individual’s social security number, employee number, or other unique identification number [§835.801]

 

781-01)         Jefferson Lab shall, on an annual basis, provide a radiation dose report to each individual monitored during the year at the lab in accordance with 10 CFR 835.402 [§835.801(c)].

781-02)         Upon the request from an individual terminating employment, records of exposure shall be provided to that individual as soon as the data are available, but not later than 90 days after termination.  A written estimate of the radiation dose received by that employee based on available information shall be provided at the time of termination, if requested [§835.801(b)].

781-03)         Detailed information concerning any individual’s exposure shall be made available to the individual upon request of that individual, consistent with the provisions of the Privacy Act (5 U.S.C. 552a) [§835.801(d)].

781-04)         When Jefferson Lab is required to report to the DOE, pursuant to Departmental requirements for occurrence reporting and processing, any exposure of an individual to radiation and/or radioactive material, or planned special exposure in accordance with Article 213, Jefferson Lab shall also provide that individual with a report of his or her exposure data included therein.  Such report shall be transmitted at a time not later than the transmittal to the Department [§835.801(e)].

 

782        Annual Radiation Report

 

782-01)         DOE M 231.1-1A, Environment, Safety and Health Reporting Manual, provides reporting requirements for the Annual Radiation Dose Summary.  This report includes internal and external dose results for monitored DOE and DOE contractor employees, and for monitored members of the public.

 

 

 

ISSUING AUTHORITY

CHAPTER AUTHOR

APPROVAL DATE

EFFECTIVE DATE

EXPIRATION DATE

REV.

 

 

 

RadCon Dept

Keith Welch

07/01/10

07/01/10

07/01/13

4

 

This document is controlled as an on line file.  It may be printed but the print copy is not a controlled document.  It is the user’s responsibility to ensure that the document is the same revision as the current on line file.  This copy was printed on 7/6/2010.