To: Sean Whalen cc: Shawn Nelson Topical Appraisal 2017 · PDF file30.08.2017 ·...

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To: Sean Whalen cc: Shawn Nelson

Topical Appraisal 2017 From: Michael McGuigan, Radiation Safety Officer, ESH&A Date: August 30, 2017

Subject: RPP Functional Element Area 9, Records. The Topical Appraisal is attached.

Interoffice Communication G40 TASF PH: 515/294-2153

Environment, Safety, Health & Assurance


Topical Appraisal - RPP Functional Element Area, Records

1.0 Scope This topical appraisal was conducted to review the Laboratory’s RPP functional element area of Record Keeping as it pertains to implementation of 10 CFR 835 Subpart H, requirements of maintaining radiation protection records. 2.0 Dates Topical appraisal was performed August 24, 2017 3.0 Methodology The Laboratory’s Radiation Protection Program’s organization was reviewed for implementing a program that meets DOE, 10CFR 835 Subpart H, requirements for generating, administering and retaining occupational radiation protection records and reports. Applicable regulations, guidance, and standards were reviewed to assure that the Laboratory is meeting current industry standards.

3.1 References The following references were reviewed for this appraisal:

• Title 10 of Code of Federal Regulations, Part 835 (10 CFR 835), Occupational Radiation

Protection • DOE Guide 441.1-1C, Radiation Protection Programs Guide • DOE Standard 1098-2008 Ch1, Radiological Control • Ames Laboratory, Iowa State University of Science and Technology contract with the U.S.

Department of Energy, Contract No. DE-AC02-07CH11358 • DOE Administration, Records Disposition Schedules

The regulatory requirements from 10 CFR 835.701-704, Subpart H, Records, have been placed in the matrix below. The Compliance/Comments column points to the documentation and coverage of the rule.

Subpart H- Records

§ 835.701 General provisions. Compliance/Comment

(a) Records shall be maintained to document compliance with this part and with radiation protection programs required by § 835.101.

As it pertains to radiation protection records, the requirements of 835.101, are met by: • Radiation Protection Program Plan

10202.004 Section 7.0, 9.5, • Ames Laboratory RSPD, Chapter 12,

Occupational radiation protection record-keeping and reporting, and

• The Lab follows the guidance provided in the ISU contract with the U.S. Department of Energy, Contract No. DE-AC02-07CH11358; GRS Records Schedule; Clause H.8 and Clause I.105.

(b) Unless otherwise specified in this subpart, records shall be retained until final disposition is authorized by DOE.

The Lab follows the guidance provided by the Iowa State University contract with the U.S. Department of Energy, Contract No. DE-AC02-07CH11358. Per contract, Ames Laboratory follows GRS Records Schedule; Clause H.8 and


Subpart H- Records Clause I.105.

§ 835.702 Individual monitoring records. Comments

(a) Except as authorized by § 835.702(b), records shall be maintained to document doses received by all individuals for whom monitoring was conducted and to document doses received during planned special exposures, unplanned doses exceeding the monitoring thresholds of § 835.402, and authorized emergency exposures.

• NRC Form 5s provided by Landauer Inc. (the dosimetry vendor) attachment one.

• As it pertains to special exposure see, the Ames Laboratory Radiological Safety Program Description (RSPD) Plan 10202.006 Section 1.3.5, Planned Special Exposures.

• Ames Laboratory RSPD, Chapter 12, “Occupational radiation protection record-keeping and reporting”.

• Plan 10202.005, External Dosimetry Technical Basis Document, and

• Plan 10202.001, Internal Dosimetry Technical Basis Document.

(b) Recording of the non-uniform equivalent dose to the skin is not required if the dose is less than 2 percent of the limit specified for the skin at § 835.202(a)(4). 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 0.01 rem (0.1 mSv) committed effective dose. The bioassay or air monitoring result used to make the estimate shall be maintained in accordance with § 835.703(b) and the unrecorded internal dose estimated for any individual in a year shall not exceed the applicable monitoring threshold at § 835.402(c).

Finding from the 2014 Radiological Protection Program assessment and also affirmed in a 2017 Radiological Protection Program assessment conducted by the Ames Site Office (This finding was corrected and closed): A specific mention of these exceptions is not documented. The following documents will be amended to address this finding: • External Dosimetry Technical Basis Document

Plan 10202.005, • External Dosimetry Program Implementation,

Procedure 10202.036, and • Internal Dosimetry Technical Basis Document,

Plan 10202.001 will be modified to address this Level 3 Finding.

All exposure data is maintained on file in the ESH&A Office, G40 TASF. The above 2014 RPP assessment, Level 3 Finding-1 Note: All document updates were completed and affirmed in the 2017 RPP assessment. See also Ames Laboratory RSPD, Chapter 12, “Occupational radiation protection record-keeping and reporting”.

(c) The records required by this section shall: • Ames Laboratory RSPD, Chapter 12,

“Occupational radiation protection record-keeping and reporting”.

(1) Be sufficient to evaluate compliance with subpart C of this part; (2) Be sufficient to provide dose information necessary to complete reports required by subpart I of this part; (3) Include the results of monitoring used to assess the following quantities for external dose received during the year:


Subpart H- Records (i) The effective dose from external sources of radiation (equivalent dose to the whole body may be used as effective dose for external exposure);

• NRC Form 5s provided by Landauer Inc. the dosimetry vendor (attachment one), The Form 5s fulfills all requirements for records information required in 10 CFR 835.702(c) (1-6).

• Plan 10202.005, External Dosimetry Technical Basis Document and


(ii) The equivalent dose to the lens of the eye; (iii) The equivalent dose to the skin; and (iv) The equivalent dose to the extremities. (4) Include the following information for internal dose resulting from intakes received during the year: (i) Committed effective dose; (ii) Committed equivalent dose to any organ or tissue of concern; and (iii) Identity of radionuclides. (5) Include the following quantities for the summation of the external and internal dose: (i) Total effective dose in a year; (ii) 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 equivalent dose to that organ or tissue; and (iii) Cumulative total effective dose. (6) Include the equivalent dose to the embryo/fetus of a declared pregnant worker. (d) Documentation of all occupational doses received during the current year, except for doses resulting from planned special exposures conducted in compliance with § 835.204 and emergency exposures authorized in accordance with § 835.1302(d), shall be obtained to demonstrate compliance with § 835.202(a). If complete records documenting previous occupational dose during the year cannot be obtained, a written estimate signed by the individual may be accepted to demonstrate compliance.

• Ames Laboratory RSPD, Chapter 12, “Occupational radiation protection record-keeping and reporting”.

• NRC Form 5s provided by Landauer Inc. the dosimetry vendor (Attachment One),

• Plan 10202.005, External Dosimetry Technical Basis Document and


(e) For radiological workers whose occupational dose is monitored in accordance with § 835.402, reasonable efforts shall be made to obtain complete records of prior years’ occupational internal and external doses.

Finding from the 2014 Radiological Protection Program assessment and also affirmed in a 2017 Radiological Protection Program assessment conducted by the Ames Site Office (This finding was corrected and closed): If a Radiation worker has prior radiation work at other facilities, a dose history request is completed and sent to the prior facilities to obtain history. This is not documented. The above 2014 RPP assessment, Level 3 Finding-2 Note: All document updates were completed and affirmed in the 2017 RPP assessment. See the Ames Laboratory RSPD, Chapter 12, “Occupational radiation protection record-keeping and reporting”.

(f) The records specified in this section that are identified with a specific individual shall be readily available to that

• Ames Laboratory RSPD, Chapter 12, “Occupational radiation protection


Subpart H- Records individual. record-keeping and reporting”:

Monitored personnel receive an annual occupational dose report and a report upon request by an individual following the provisions of the Privacy Act (5 U.S.C. 552a). Plan 10202.005, External Dosimetry Technical Basis Document. Plan 10202.001, Internal Dosimetry Technical Basis Document.

(g) Data necessary for future verification or reassessment of the recorded doses shall be recorded.

• Ames Laboratory RSPD, Chapter 12, “Occupational radiation protection record-keeping and reporting”: A permanent record is kept on file of this release information, dated and signed by the individual involved.

• The Health Physics Group (HPG) maintains the results of all radiation personnel monitoring on file and archived records are stored with Official Personnel Files (OPFs) and Employee Medical Records (EMRs) in accord with the GRS Record Schedules.

• The Lab follows the guidance provided by the ISU contract with the U.S. Department of Energy, Contract No. DE-AC02-07CH11358

• Plan 10202.005, External Dosimetry Technical Basis Document, and


(h) All records required by this section shall be transferred to the DOE upon cessation of activities at the site that could cause exposure to individuals.

• RSPD, Section 12.1, Radiological Records Management Program

• The Lab follows the guidance provided in the ISU contract with the U.S. Department of Energy, Contract No. DE-AC02-07CH11358 GRS Records Schedule; Clause H.8 and Clause I.105

§ 835.703 Other monitoring records. Comments The following information shall be documented and maintained:

• RSPD, Section 12.3, Records of Radiological Monitoring.

• Control of Radioactive Contamination Procedure 10202.008: Contamination Measurements, Monitoring and Surveys Section 4.2 reads; Area surveys shall be performed to document radiological conditions in the workplace.

(a) Results of monitoring for radiation and radioactive material as required by subparts E and L of this part, except for monitoring required by § 835.1102(d);

(b) Results of monitoring used to determine individual occupational dose from external and internal sources;

• RSPD, Section 12, Occupation Radiation Protection Record-Keeping and Reporting. Plan 10202.005, External Dosimetry Technical Basis Document.


Subpart H- Records • Plan 10202.001, Internal Dosimetry

Technical Basis Document.

(c) Results of monitoring for the release and control of material and equipment as required by § 835.1101; and

• RSPD, Section 12, Occupation Radiation Protection Record-Keeping and Reporting.

• Survey of Equipment Material for Transfer Procedure 10202.054, Receipt & Transfer of Radioactive Materials Procedure 10202.014

(d) Results of maintenance and calibration performed on instruments and equipment as required by § 835.401(b).

• RSPD, Section 12.3.4, Records of Monitoring for Radioactive Contamination.

• Calibration of Portable Survey Instruments procedure 10202.011,

• Counting Room SOP Procedure 10202.053, • Gas Proportional Instrument Calibration

Procedure 10202.056, • Conducting Radiological Surveys Procedure

10202.060

§ 835.704 Administrative records. Comments

(a) Training records shall be maintained, as necessary, to demonstrate compliance with § 835.901.

• Manual 48202.001, Training Program Manual.

• RSPD, Section 12, Occupation Radiation Protection Record-Keeping and Reporting,

• Each respective lesson plan for; GERT, RWI and RWII has 835.901 topics covered.

• All personnel training records have an indefinite retention time. FINDING, OFI-1: Radiological Protection Program training modules lesson plans should be updated. Several lesson plans have not been updated for over 5 years. Although the lesson plans cover all 835.901 required subject areas they should be reviewed and updated periodically, best management practice.

(b) Actions taken to maintain occupational exposures as low as reasonably achievable, including the actions required for this purpose by § 835.101, as well as facility design and control actions required by §§ 835.1001, 835.1002 and 835.1003, shall be documented.

• RSPD, Section 12, Occupation Radiation Protection Record-Keeping and Reporting,

• ALARA Policy 10202.001, • ALARA Procedure 10202.001

(c) Records shall be maintained to document the results of internal audits and other reviews of program content and implementation.

• Corrective Action Development, Tracking, and Verification Procedure 10200.039 (Ames Laboratory Corrective Action Tracking System, ALCATS, is the program used to accomplish tracking of corrective actions).

• RSPD, Section 12, Occupation Radiation Protection Record-Keeping and Reporting, and

• ISU contract with the U.S. Department of Energy, Contract No. DE-AC02-07CH11358.

(d) Written declarations of pregnancy, including the estimated date of conception, and revocations of • RSPD, Section 12, Occupation Radiation


Subpart H- Records declarations of pregnancy shall be maintained. Protection Record-Keeping and Reporting,

• Declaration of Pregnancy Form 10202.008 • Memo to Ames Laboratory Female Radiation

Workers, Form 10202.007, is given to every Female Radiation Worker on initial training.

(e) Changes in equipment, techniques, and procedures used for monitoring shall be documented.

• Calibration procedures and calibration certificates are kept on file for each portable instrument.

• Lab/bench top instrumentation calibration data are kept in the Health Physics lab near each respective instrument.

• RSPD, Section 12, Occupation Radiation Protection Record-Keeping and Reporting.

• Calibration of Portable Survey Instruments procedure 10202.011.

• Counting Room SOP Procedure 10202.053, • Gas Proportional Instrument Calibration

Procedure 10202.056. • Conducting Radiological Surveys Procedure

10202.060.

(f) Records shall be maintained as necessary to demonstrate compliance with the requirements of §§ 835.1201 and 835.1202 for sealed radioactive source control, inventory, and source leak tests.

• RSPD, Section 12, Occupation Radiation Protection Record-Keeping and Reporting. Sealed radioactive source control, inventory and source leak test paperwork is kept on file in G40 TASF.

• Sealed Source Accountability & Control Procedure 10202.015. This procedure in part is the implementation of the Radiation Protection Program (RPP) functional element, sealed radioactive sources accountability and control, the regulatory provisions of which are detailed in 10 CFR 835, Subpart M (835.1201,1202).

3.2 Program Documentation The following programmatic documents and records were reviewed: • Radiation Protection Program Plan (10202.004), • Radiological Safety Program Description Plan (10202.006), • Ames Laboratory, Iowa State University of Science and Technology contract with the U.S.

Department of Energy, Contract No. DE-AC02-07CH11358, • Ames Laboratory ESH&A Program Manual (10200.002), • Ames Laboratory Training Program Manual (48202.001), • Documents and Records process documents (Ames Lab contract No. DE-AC02-07CH11358), • Dosimetry, NRC, Form 5s provided by Landauer Inc.(dosimetry vendor), • Radiological surveys data and hard copies on file in G40 TASF, and • X-ray system exposure survey files located in G40 TASF.


In addition documents and program areas reviewed, the documents listed in the matrix were also scrutinized for compliance to 10 CFR 835, subpart H.

3.3 Personnel Interviewed Rhonda DeShong, Records Management

Molly Granseth, Training, Documents & Quality Assurance Coordinator The Records Manager, Rhonda Deshong, presented the process of archiving radiation exposure personnel files. Radiation worker dosimetry files are archived once a year by the Health Physics group. Terminated dosimetry participant files are consigned to records archive after participant files have complete exposure records. Dosimetry records retention cycle is indefinite. No issue or concerns were expressed by Rhonda DeShong. The Training, Documents and Quality Assurance Coordinator, Molly Granseth presented the new Training Course Review Procedure. Radiological Protection training module lesson plans were reviewed. It was noted that lesson plans were complete (covering all 10 CFR 835.901 required subject areas) but had not been updated for over 5 years. In one case the lesson plan had not be updated for over ten years. The Training Course Review procedure is systematically updating training modules. Radiological Protection training modules should be reviewed and updated. Molly advised that the course initiation form would be a good mechanism to review and update the modules. Concerning training records Molly Granseth informed me that individual training records retention cycle is indefinite. No issues or concerns were expressed by Molly Granseth. 4.0 Assessment Results & Discussion Radiological Protection Program records functional element area was last reviewed via topical appraisal in 2014. At the time the Training, Documents & Records department had a plan to scan archived dosimetry and radiation survey documents into ISU Content Management. It was surmised that this would have made the documents more readily available for future review in cases when a former worker requests their radiation exposure history. Molly Granseth informed me that the USDOE did not approve the plan and it was not implemented. 2014 Topical Appraisal Findings Note that all findings listed below have been corrected and closed. The ALCAT system was checked and closure of each finding was confirmed. Affirmation of corrections and closure of findings were accepted during the 2017 Radiological Protection Program Assessment conducted by the Ames Site Office.

• Level 3 Finding (#1) The rule exceptions in 10 CFR 835.702(b) are not specifically mentioned in Laboratory Radiation Protection Program documentation. 10 CFR 835.702(b) states, Recording of the non-uniform equivalent dose to the skin is not required if the dose is less than 2 percent of the limit specified for the skin at § 835.202(a)(4). 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 0.01 rem (0.1 mSv) committed effective dose. The bioassay or air monitoring result used to make the estimate shall be maintained in accordance with § 835.703(b) and the unrecorded internal dose estimated for any individual in a year shall not exceed the applicable monitoring threshold at § 835.402(c).


Corrective Action: External Dosimetry Technical Basis Document Plan 10202.005, External Dosimetry Program Implementation, Procedure 10202.036, and Internal Dosimetry Technical Basis Document, Plan 10202.001 will be modified to address this Level 3 Finding.

• Level 3 Finding (#2) The requirement in10 CFR 835.702(e) is followed in practice but is not documented fully. 10 CFR 835.702(e) states, for radiological workers whose occupational dose is monitored in accordance with § 835.402, reasonable efforts shall be made to obtain complete records of prior years’ occupational internal and external doses.

Corrective Action: Dosimetry History Request Letter, Form 10202.033, is used to obtain dose history from a RW’s former employer (attachment three). There is no documentation outlining the procedure for obtaining a new RW’s former radiation exposure history. Procedures will be added to the following documents; Plan 10202.005, External Dosimetry Technical Basis Document, and Procedure 10202.036, External dosimetry Program Implementation.

4.1 Strengths None noted. 4.2 Noteworthy Practices None noted. 4.3 Findings OFI-1: Radiological Protection Program training modules lesson plans should be review and updated. Several lesson plans have not been updated for over 5 years. Although the lesson plans do cover all 835.901 required subject areas the plans should be review. This finding is outside the scope of this topical appraisal. This opportunity for improvement was found tangentially while reviewing personnel training records retention policies and practices.

5.0 Overall Conclusions Affirmation of corrections and closure of 2014 Radiological Protection Program assessment findings were accepted during the 2017 Radiological Protection Program Assessment conducted by the Ames Site Office. Ames Laboratory is fulfilling its obligations pertaining to Radiological Protection Program organization for implementing a program that meets DOE, 10 CFR 835, requirements for generating, administering and retaining occupational radiation protection records and reports. 6.0 Attachments Attachment One: NRC, Form 5, Occupational Dose Record for a Monitoring Period. Attachment Two: List of RPP documents Attachment Three: Form 10202.033, Dosimetry History Request letter Attachment Four: Form 10202.038, Ames Laboratory Dosimetry Authorization Form.

Attachment One: NRC, Form 5, Occupational Dose Record for a Monitoring Period


Attachment One: NRC, Form 5, Occupational Dose Record for a Monitoring Period


Attachment Two: List of RPP documents


DocNum DocType Current Title 10202.043 Form MC&A Check List 10202.021 Form Exchange of Quarterly TLD Badges 10202.034 Form Occupational Radiation Exposure Record 10202.016 Form Radiological Work Permit Guidance and Checklist 10202.025 Form RWP Summary & Close Out Form 10202.047 Form Radiological Material Datapage 10202.018 Form General RWP Format Template 10202.044 Form Lost Dosimeter Report 10202.041 Form Materials Balance Area Inventory and Report Form 10202.019 Form Specific RWP Format Template 10202.006 Form Checklist for Initiating the use of Rad Mat/Rad Pro devices 10202.012 Form Radiation Survey Instrument Training (AL-157) 10202.024 Form Sealed Source Accountability Form 10202.028 Form Ames Laboratory Air Monitoring Record 10202.023 Form Sealed Source Inventory Form 10202.022 Form Analytical X-Ray System Inspection and Survey Record 10202.042 Form MC&A Nuclear Material Transfer Form 10202.003 Guide Rad Worker Study Guide for Support Staff 10202.002 Manual Radiological Worker Study Guide 10202.002 Plan Materials Control and Accountability Program Plan 10202.001 Plan Internal Radiation Dosimetry Contingency Plan 10202.005 Plan External Dosimetry Technical Basis Document 10202.012 Policy Walk Down of Posted General Radiological Work Permits 10202.015 Procedure Sealed Radioactive Source Accountability and Control 10202.031 Procedure Health Physics Group Review of Service Order Requisitions 10202.008 Procedure Control of Radioactive Contamination 10202.064 Procedure Facility Categorization for Radiological Material 10202.011 Procedure Calibration of Portable Survey Instruments 10202.016 Procedure Posting and Labeling for Radiological Control 10202.021 Procedure Workplace Air Monitoring 10202.036 Procedure External Dosimetry Program Implementation 10202.060 Procedure Conducting Contamination and Area Monitoring Surveys 10202.014 Procedure Receipt, Transfer, & Shipment of Radioactive Materials 10202.001 Charter ALARA Committee Charter 10202.002 Charter Laser Safety Committee Charter 10202.003 Form Application for Use of Radioactive Materials 10202.005 Form Application for Use of Radiation Producing Devices 10202.008 Form Declaration of Pregnancy 10202.033 Form Dosimetry History Request Form 10202.037 Form Employee Radiation Dosimetry Badge Agreements and Commitments 10202.038 Form Ames Laboratory Dosimetry Authorization Form 10202.048 Form RW I/II (AL-207) Practical Factors Exam Employee Sign-off Record.

Attachment Two: List of RPP documents


10202.049 Form Laser Hazard Assessment Form 10202.052 Form Rad Worker II (Rad Materials) Learning Assessment b (AL-077)

10202.054 Form Learning Assessment "General Employee Radiological Training (GERT) (AL-074)

48202.014 Form Laser User Authorization Form 10202.001 Guide Radiation Safety Study Guide for Users of Radiation Generating Devices 10202.001 Procedure ALARA Procedure 10202.001 Handout Standard for Protection Against Radiation - Notice 10202.002 Handout Radiation Protection Program 10200.002 Manual ESH&A Manual "Radiation Protection" 10202.002 Manual Radiological Worker Study Guide 10202.004 Plan Radiation Protection Program (RPP) 10202.006 Plan Radiological Safety Program Description (RSPD) 10202.001 Policy ALARA Policy

Attachment Three: Form 10202.033, Dosimetry History Request letter


Attachment Four: Form 10202.038, Ames Laboratory Dosimetry Authorization Form


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