DOE-STD-1111-98, The Department of Energy Laboratory Accreditation Program Administration

TS NOT MEASUREMENT SENSITIVE DOE-STD-1111-98 December 1998 DOE STANDARD THE DEPARTMENT OF ENERGY LABORATORY ACCREDITATION PROGRAM ADMINISTRATION U.S. Department of Energy AREA SAFT Washington, D.C. 20585 DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited. This document has been reproduced from the best available copy. Available to DOE and DOE contractors from ES&H Technical Information Services, U.S. Department of Energy, (800) 473-4375, fax: (301) 903-9823. Available to the public from the U.S. Department of Commerce, Technology Administration, National Technical Information Service, Springfield, VA 22161; (703) 605-6000. DOE-STD-1111-98 iii FOREWORD 1. This Department of Energy (DOE) standard is approved for use by all DOE components and their contractors. 2. Beneficial comments (recommendations, additions, deletions) and any pertinent data that may improve this document should be sent the DOELAP Administrator, U.S. Department of Energy, EH- 52/GTN/270CC, 19901 Germantown Road, Germantown, MD 20874-1290, by letter or by using the self-addressed Document Improvement Proposal (DOE F 1300.3) appearing at the end of this document. 3. DOE technical standards, such as this technical standard, do not establish requirements. However, all or part of the provisions in a technical standard can become requirements under the following circumstances; (1) they are explicitly stated to be requirements by rule making or in a DOE requirements document; or (2) the organization makes a commitment to meet a standard in a contract or in a plan or program required by a DOE requirements document. The DOE Laboratory Accreditation Program (DOELAP) defined in this standard is the culmination of many years of effort by the DOE to provide a structured means for assuring the quality of radiation dosimetry measurement performance at DOE sites. DOELAP evaluates the respective DOE personnel dosimetry or radiobioassay program’s laboratory performance, based on performance testing criteria, and their operational competence, based on established “quality system” criteria regarding good laboratory practice. Performance testing criteria for DOE dosimetry programs are based on: • DOE-STD-1095-95, “Department of Energy Laboratory Accreditation Program for Personnel Dosimetry Systems;” • HPS N13.11-1993, “Personnel Dosimetry Performance - Criteria for Testing;” DOE-STD-1111-98 iv • HPS N13.30-1996, “Health Physics Society (HPS) American National Standard “Performance Criteria for Radiobioassay;” and • HPS N13.32-1995, “Performance Testing of Extremity Dosimeters.” Revisions to performance testing standards occur routinely to incorporate national and international considerations in testing criteria and to address technological advances in electronic, computer, and radiation detector technologies. DOELAP quality system criteria are based on the International Standards Organization (ISO) / International Electrotechnical Commission (IEC) Guide 25, “General Requirements for the Competence of Calibration and Testing Laboratories.” DOELAP was implemented in 1986 and currently accredits DOE and DOE contractors providing personnel dosimetry and radiobioassay measurement services, based on available performance testing standards. The DOELAP objective is to maintain and improve the competency of dosimetry measurement laboratories through performance evaluation test measurements, calibration intercomparisons, site assessments, and

applied research in areas where there is a technology shortfall. The DOE also expects the program to enhance cooperation and technical information exchange among its sites and facilities in order to provide a more standardized and uniform radiation dosimetry capability. DOE sites and facilities are expected to use standards and other technical guidance from the Department to assure that the performance of personnel dosimetry and radiobioassay measurements are adequate to meet the standards of Title 10, Code of Federal Regulations, Part 835, “Occupational Radiation Protection,” and related requirements and guidance. Throughout this standard, the word “shall” is used to denote actions which must be performed if the objectives of this standard are to be met. If the provisions in this standard are made requirements through one of the two ways discussed in note 3 above, then the “shall” statements would become requirements. It is not appropriate to consider that “should” statements would automatically be converted to “shall” statements as this action would violate the consensus process used to approve this technical standard. DOE-STD-1111-98 v TABLE OF CONTENTS GLOSSARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 ACRONYMS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 1.0 SCOPE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 2.0 PURPOSE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 3.0 APPLICABILITY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4.0 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4.1 Government Documents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 4.2 Non-Government Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5.0 PROGRAM ADMINISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5.1 Assistant Secretary for Environment, Safety and Health (EH-1) . . . . . . . . . . . . . . . . . . . . . . . 7 5.2 DOELAP Administrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 5.3 Performance Evaluation Program Administrator . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5.4 Oversight Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 5.5 Appeals Board . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 5.6 Cognizant Secretarial Officers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 5.7 DOE Field Organization Managers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 5.8 Managers of DOE and DOE Contractor Radiation Dosimetry and Radiobioassay Programs . . 10

6.0 ACCREDITATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 6.1 Application . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 6.2 Performance Evaluation Test . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 6.3 Site Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 6.3.1 Site Assessment Preparation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 6.3.2 Opening Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 6.3.3 Close-Out Meeting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 6.3.4 Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 6.3.5 Monitoring Visit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 6.4 Granting Accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 6.4.1 Partial Accreditation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 6.4.2 Technical Equivalence . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 6.4.3 Amendment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 6.5 Appeals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 DOE-STD-1111-98 vi 6.6 Extensions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 6.7 Suspension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 6.8 Revocation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 7.0 EXCEPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 APPENDICES Appendix A: DOELAP Oversight Board Charter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 Appendix B: DOELAP Process Flowchart . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-1 DOE-STD-1111-98 1 GLOSSARY Accreditation - the certification through the Department of Energy Laboratory Accreditation Program (DOELAP) that a personnel dosimetry and radiobioassay programs meet the criteria in this standard for specified measurements. The assessment for accreditation includes testing program performance and the evaluation of associated quality assurance, records, and calibration programs. The accreditation process includes the development of recommendations for any improvements needed to ensure continuing quality. The objective of the DOELAP is to accredit personnel dosimetry and radiobioassay programs of DOE/DOE contractors, regardless of whether the measurements are conducted at commercial, in-house facilities, or at another DOE facility.

Applicant - a DOE or DOE contractor facility which has submitted an application for DOELAP accreditation and is participating in the accreditation process (see Contractor). Certificate of Accreditation - a certificate, along with a the conditions of accreditation, issued by the HQ DOELAP Administrator, upon successful completion of the accreditation process. The effective date of accreditation is specified on the certificate. Conditions of Accreditation - a document that accompanies the Certificate of Accreditation that defines the categories and equipment for which the DOE or DOE contractor facility is accredited. The accreditation expiration date is specified in the conditions.. Contractor - a DOE or DOE contractor facility which has submitted an application for DOELAP accreditation and is participating in the accreditation process (see Applicant). Designated Representative - a person identified by the DOE or DOE contractor or applicant for accreditation which provides a single point of contact for administering contractor participation in the performance testing and the site assessment. Extremity Dosimetry - the assessment of dose equivalent resulting from external radiation to the extremities (i.e., hand, elbow, arm below the elbow, foot, knee, and leg below the knee). Personnel dosimetry - the assessment of dose equivalent resulting from external radiation to the skin and the whole-body (i.e., total body with the exception of hand, elbow, arm below the elbow, foot, knee, and leg below the knee). Radiobioassay - the measurement of the amount or concentration of radionuclide material in the body or in biological material excreted or removed from the body and analyzed for purposes of estimating the quantity of radioactive material in the body. Subcontractor - a contractor operating for the DOE contractor to provide radiobioassay, irradiation and/or dosimeter processing services. Subfacility - a laboratory operating under the technical direction and quality system of a main facility that is accredited. Testing Laboratory - a laboratory independent of the DOE contractor dosimetry programs, authorized by DOE to carry out DOELAP performance testing. DOE-STD-1111-98 2 THIS PAGE INTENTIONALLY LEFT BLANK DOE-STD-1111-98 3 ACRONYMS ANSI American National Standards Institute CFR Code of Federal Regulations DOE U.S. Department of Energy DOELAP Department of Energy Laboratory Accreditation Program HQ (DOE) Headquarters IEC International Electrotechnical Commission ISO International Standards Organization NAVLAP National Voluntary Laboratory Accreditation Program NIST National Institute of Standards and Technology PEPA Performance Evaluation Program Administrator PTL Performance Testing Laboratory DOE-STD-1111-98 4 THIS PAGE INTENTIONALLY LEFT BLANK DOE-STD-1111-98 5 1.0 SCOPE This technical standard describes the U.S. Department of Energy Laboratory Accreditation Program (DOELAP), organizational responsibilities, and the accreditation process. DOELAP evaluates and accredits personnel dosimetry and radiobioassay programs used for worker monitoring and protection at DOE and DOE contractor sites and facilities as required in Tile 10, Code of Federal Regulations, Part 835, “Occupational Radiation Protection.” 2.0 PURPOSE The purpose of this technical standard is to establish procedures for administering DOELAP and acquiring accreditation. Specific performance testing requirements and site assessment criteria for accreditation are

contained in: DOE-STD-1095-95, “Department of Energy Laboratory Accreditation Program for Personnel Dosimetry Systems” and DOE-STD-1112-98, “Department of Energy Laboratory Accreditation for Radiobioassay.” 3.0 APPLICABILITY This technical standard applies to DOE Headquarters, field organizations, and contractors working to the requirements of Title 10, Code of Federal Regulations, Part 835, “Occupational Radiation Protection” (CFR 1998). 4.0 REFERENCES 4.1 Government Documents Code of Federal Regulation (CFR). Quality Assurance Requirements. Title 10 Part 830.120, U.S. Code of Federal Regulations, Vol 59, No. 65, pp. 15851-53, 1994. Code of Federal Regulation (CFR). Occupational Radiation Protection. Title 10 Part 835, U.S., Code of Federal Regulations, Vol. 63, No. 213, 59662-59689, 1998. DOE-STD-1111-98 6 U.S. Department of Energy (DOE). 1997. Department of Energy Laboratory Accreditation Program for Personnel Dosimetry Programs. DOE Technical Standard DOE-STD-1095-95, DOE, Washington, D.C. U.S. Department of Energy (DOE). 1998. Department of Energy Laboratory Accreditation Program for Radiobioassay. DOE Technical Standard DOE-STD-1112-98, DOE, Washington, D.C. U.S. Department of Energy (DOE). G441.2-1 Implementation Guide for Internal Dosimetry Programs. 1999. DOE, Washington, D.C. U.S. Department of Energy (DOE). G441.4-1 Implementation Guide for External Dosimetry Programs. 1999. DOE, Washington, D.C. 4.2 Non-Government Documents ISO/IEC Guide 25, General Requirements for the Competence of Calibration and Testing Laboratories, International Standards Organization, Geneva, Switzerland. American National Standards Institute (ANSI). 1993. Personnel Dosimetry Performance - Criteria for Testing. ANSI N13.11-1993. New York: ANSI. American National Standards Institute (ANSI). 1996. Performance Criteria for Radiobioassay. ANSI N13.30-1996. New York: ANSI. American National Standards Institute (ANSI). 1995. Performance Testing of Extremity Dosimeters. ANSI N13.32-1995. New York: ANSI. 5.0 PROGRAM ADMINISTRATION The DOELAP is administered by the Assistant Secretary for Environment, Safety and Health (EH-1) through the Office of Worker Protection Programs and Hazards Management (EH-52). The following organizations and individuals have supportive responsibilities: the DOELAP Administrator, the Performance Evaluation Program Administrator, the Oversight Board, the Appeals Board, cognizant DOE-STD-1111-98 7 Secretarial Officers, DOE field organization managers, and managers of DOE and DOE contractor personnel dosimetry and radiobioassay programs. The responsibilities of each are described below. 5.1 Assistant Secretary for Environment, Safety and Health (EH-1) The Assistant Secretary for Environment, Safety and Health (EH-1) shall: C establish and communicate DOELAP policy; C review and disposition requests for exception in accordance with 10 CFR 835.402(b)(2) and 835.402(d)(2); and C appoint the DOELAP Administrator. 5.2 DOELAP Administrator The DOELAP Administrator shall: C develop policies, procedures, protocols, and standards necessary to maintain and improve the DOELAP; C appoint members of the Oversight and Appeals Boards from the available group of technical experts (note: A technical expert shall not serve on the Oversight and Appeals Boards at the same time); C designate the Performance Evaluation Program Administrator(s);

C assess and make the final determination on recommendations from the Oversight and Appeals Boards and forward decisions and accreditation certificates to applicable DOE field organizations and DOE and DOE contractor programs; C assess and act on requests for exception and technical equivalency; C forward petitions for appeal to the Appeals Board; C periodically solicit field organization managers for nominees to participate as technical experts and from those nominees establish a group of technical experts; C issue “DOELAP Notices” regarding changes in technical standards and/or criteria; C maintain and improve the Performance Evaluation Program; and C designate the lead and alternate performance testing laboratories that meet the requirements of the appropriate DOELAP standards. DOE-STD-1111-98 8 5.3 Performance Evaluation Program Administrator The Performance Evaluation Program Administrator (PEPA) coordinates the accreditation process for personnel dosimetry and/or radiobioassay programs. The PEPA shall: C establish site assessment procedures and schedule site assessments; C train site assessors from the available group of technical experts, coordinate their site visits, and evaluate their performance; C review and evaluate the results of performance evaluation tests and site assessments in accordance with appropriate DOELAP standards; C report performance evaluation test and site assessment results to cognizant field organizations and managers of DOE and DOE contractor programs; C make accreditation recommendations to the Oversight Board based on performance testing and site assessment results and dosimetry or radiobioassay program responses to those results; C review and evaluate requests for technical equivalence and amendment and make recommendations regarding such to the Oversight Board; and C recommend changes for improving the quality and efficiency of the Performance Evaluation Program to the DOELAP Administrator. 5.4 Oversight Board The Oversight Board consists of five members who each serve a five year term. The DOELAP Administrator may select a current member of the Oversight Board to serve additional terms. Members of the Oversight Board shall select one member to serve, for a three year period, as chairman. The Oversight Board shall: C review recommendations made by the PEPA and advise the DOELAP Administrator regarding approval or denial (note: An Oversight Board member shall be excused from evaluating and voting on any issue his or her employer has before the Oversight Board); DOE-STD-1111-98 9 C evaluate the performance testing laboratories biannually for traceability of equipment and standards to the National Institute of Standards and Technology (NIST) and conformance with operating facilities. DOELAP evaluates the respective DOE dosimetry program’s laboratory performance, based on performance testing criteria, and operational competence, based on established “quality system” criteria regarding good laboratory practice. Performance testing criteria for DOE dosimetry programs is based on: C DOE/EH procedures; C review remedial action plans for mitigating concerns or deficiencies in dosimetry or radiobioassay programs identified by DOELAP site assessors; and C review DOELAP procedures and recommend appropriate changes to the DOELAP Administrator. The voting criteria and quorum for the DOELAP Oversight Board functions shall be by simple

majority of at least three voting members. 5.5 Appeals Board The Appeals Board is established on an ad hoc basis and consists of five members who are not affiliated with a site making an appeal. Members of the Appeals Board shall select one member to serve as chairman. The sole responsibility of the Appeals Board is to review appeals and recommend to the DOELAP Administrator the affirmation or reversal of decisions concerning accreditation issues and the selection of site assessors. The quorum and voting criteria for DOELAP Appeals Board functions shall be by simple majority of the five members. 5.6 Cognizant Secretarial Officers Cognizant Secretarial Officers shall ensure that: C DOE and DOE contractor personnel dosimetry and radiobioassay programs under their administration are either accredited or excepted from DOELAP; and C personnel dosimetry and radiobioassay programs identified by the DOELAP as deficient are upgraded. DOE-STD-1111-98 10 5.7 DOE Field Organization Managers DOE field organization managers shall: C ensure that DOE and DOE contractor personnel dosimetry and radiobioassay programs under their administration receive and maintain accreditation as specified by the appropriate DOELAP standard; C communicate information concerning accreditation to appropriate sites and facilities; C ensure that personnel dosimetry programs under their administration select proper irradiation categories for accreditation; C review applications for DOELAP accreditation, technical equivalence, or amendment and, if concurring, forward them to the PEPA; accreditation applications must be submitted within 6 months of the inception of a new program: C review and, if concurring, submit petitions for an appeal or requests for exception to DOELAP accreditation to the DOELAP Administrator; C review and, if concurring, submit requests for exceptions to 10 CFR 835.402 (b) or (d) to the Assistant Secretary for Environment, Safety and Health; C review remedial action plans and, if concurring, forward to the PEPA within 45 days; and C ensure implementation of plans to effect changes needed to mitigate deficiencies in personnel dosimetry or radiobioassay programs. 5.8 Managers of DOE and DOE Contractor Personnel Dosimetry and Radiobioassay Programs Managers of DOE and DOE contractor personnel dosimetry and radiobioassay programs or their designated representatives shall: C complete and submit an application for DOELAP accreditation and complete a performance evaluation test and a site assessment in accordance with scheduling established by the Performance Evaluation Program, or submit a request for exception, amendment, technical equivalence, or a petition for an appeal to the appropriate field organization; an application for a personnel dosimetry, radiobioassay, or extremity dosimetry program is provided in the appropriate DOELAP standard; DOE-STD-1111-98 11 C allow site assessors to examine all aspects of a dosimetry or radiobioassay program including facilities, equipment, dosimeters, procedures, notebooks, records, reports, position descriptions, personnel qualifications, and training documentation; C submit a remedial action plan to the appropriate field organization regarding reported concerns within 30 days of receipt of a site assessment report; the response shall describe appropriate corrective action(s) and respective completion date(s); and

C submit a remedial action plan to the appropriate field organization regarding reported deficiencies within 30 days of receipt of a site assessment report; the response shall describe and provide an implementation schedule for appropriate changes to equipment, procedures, and/or personnel to achieve an accreditable program. 6.0 ACCREDITATION 6.1 Application The application requires a description of each personnel dosimetry processing system or radiobioassay program employed including specific apparatus and protocols used. The information submitted should be as descriptive as possible without divulging any proprietary information. Applications for DOELAP accreditation are provided in the respective DOELAP standards. 6.2 Performance Evaluation Test Information specific to the performance evaluation testing of personnel and extremity dosimeter programs and radiobioassay programs is provided in detail in the appropriate DOELAP standard. In general, the performance evaluation testing process compares the results of the applicant's dosimetry program in measuring known doses delivered to the applicant's dosimeters, or the radiobioassay program's assaying spiked biological samples and phantoms, and determines certain statistical variations of those results. A variation beyond that allowed provides a means for denying accreditation or granting only partial accreditation. DOE-STD-1111-98 12 6.3 Site Assessment The accreditation process requires a personnel dosimetry or radiobioassay program to demonstrate its ability to perform in a credible manner. For initial accreditation, a site assessment is conducted after performance testing has been completed. Otherwise, an accredited program undergoes a biennial site assessment for whole body and extremity dosimetry or a triennial site assessment for radiobioassay. 6.3.1 Site Assessment Preparation. The PEPA selects at least two technical experts, based primarily on their experience with the dosimetry system or radiobioassay program to be reviewed, to conduct a site assessment. The PEPA then informs the program manager of which site assessors that have been selected, notifies the cognizant field organization of the site assessment, and provides copies of documents concerning the program to the assessment team. The assessment team leader also contacts the program manager to schedule the site assessment and make other necessary arrangements. An assessment typically lasts two to three days. 6.3.2 Opening Meeting. The assessment team begins a site assessment with an opening meeting to explain the assessment process and agenda. The close-out meeting is also scheduled at this time. The primary components of a site assessment are described in detail in the appropriate DOELAP standard. 6.3.3 Close-Out Meeting. At the conclusion of an onsite visit, the assessors will discuss their visit and any findings with appropriate members of the dosimetry or radiobioassay program's management. A written summary of each finding discussed will be left with management's authorized representative. The assessors then forward the assessment forms to the PEPA for use in the technical evaluation of the program's accreditation application. The program may need to submit a remedial action plan through their cognizant field organization to the PEPA if a finding is identified. 6.3.4 Findings. There are 3 categories of findings:

Observation. This is either a suggested improvement that a personnel dosimetry or radiobioassay program may incorporate at its own discretion or the highlighting of a noteworthy practice. The suggestion is offered to help “fine tune” a program. No written response is required. DOE-STD-1111-98 13 Concern. This is for any aspect of a program that is considered marginal with respect to compliance with DOELAP criteria but does not adversely impact the quality of the applicant’s program. One or more concerns will not affect a program’s accreditation; however, any concern not remediated by a program’s next accreditation cycle will automatically be elevated to a deficiency thereby preventing the renewal of accreditation. A remedial action plan is required to be submitted through the appropriate field organization to the PEPA within 45 days of the close-out meeting. Deficiency. This is reserved for any aspect of a personnel dosimetry or radiobioassay program that an assessment team believes prevents the program from functioning competently. A deficiency will either suspend or revoke a current accreditation or suspend a new application for accreditation until the deficiency has been remediated. A remedial action plan is required to be submitted through the appropriate field organization to the PEPA within 45 days and should be corrected within 60 days of the close-out meeting. Remediation may be confirmed by an assessment team. 6.3.5 Monitoring Visit. In addition to a regularly scheduled onsite assessment, assessors may be assigned to make a monitoring visit at any time during an accreditation period. A monitoring visit may occur for cause or on a random basis. It serves to verify reported changes to a facility or operation or to explore any possible reason for poor performance during performance evaluation testing. The scope of a visit may range from a spot check to a complete programmatic review. 6.4 Granting Accreditation When a program's technical evaluation has been completed the PEPA prepares a recommendation for the Oversight Board. The Oversight Board reviews the recommendation and proposes to the DOELAP Administrator that accreditation be either granted or denied. A denial will be accompanied by a description of the reasons for denial. 6.4.1 Partial Accreditation. A dosimetry or radiobioassay program may receive partial accreditation if a system is demonstrated to be satisfactory for one or more subsets of the DOELAP accreditation categories that were applied for. If a system did not satisfactorily demonstrate compliance with the test criteria for a particular accreditation category subset and if a remedial action plan was initiated by the program, then the accreditation process may continue for any other requested accreditation category. DOE-STD-1111-98 14 6.4.2 Technical Equivalence. An accredited program is responsible for notifying the DOELAP whenever a change is made in dosimeters used or other equipment, materials, software, analysis models, or techniques that were considered to be primary components of a dosimetry or radiobioassay program when accreditation was granted. The program must submit evidence supporting a conclusion that the modified system will be technically equivalent to the accredited system. 6.4.3 Amendment. If a change in the type or quality of a radiation field or radiological environment occurs or is anticipated for an accredited program, the program must submit a notice to the DOELAP

describing how the current accredited system is adequate or requesting an amendment to the current accreditation. A program may amend a current accreditation through additional performance evaluation testing of an existing system or performance evaluation testing a new or supplemental system. 6.5 Appeals A dosimetry or radiobioassay program manager may petition the DOELAP Administrator to have an adverse determination regarding accreditation, technical equivalence, amendment, exception, or an assessment finding, or the selection of an assessor, reviewed by the Appeals Board. A petition to appeal shall explain the reason(s) for the appeal and shall be submitted to the appropriate field organization for forwarding to the DOELAP Administrator. 6.6 Extensions Accreditation is automatically extended for a DOE Site exceeding the effective end date specified in the Conditions of Accreditation under one or ore of the following conditions: C the DOE Site is participating in their regularly assigned test cycle; C the DOE Site application for reaccreditation was submitted to the PEPA at least 90 days prior to the effective end date; C the DOE Site is engaged in the timely remediation of identified deficiencies; or C the DOE Site has exceeded the effective end date through no fault of its own. DOE-STD-1111-98 15 6.7 Suspension The DOELAP Administrator may suspend accreditation if a dosimetry or radiobioassay program is found to be out of compliance with the terms of its accreditation. The program will be notified of the reasons for and conditions of the suspension and actions to be taken by the program to have accreditation reinstated. 6.8 Revocation The DOELAP Administrator may revoke a program's accreditation if the program is found to have violated the terms of its accreditation. The program will be notified of the reasons for the revocation. 7.0 EXCEPTION The DOELAP will except a DOE or DOE contractor program from obtaining accreditation where either: (1) there is no resident personnel dosimetry program, the reported external radiation doses are not significant (typically less than 100 mrem), and either another DOELAP or a National Voluntary Laboratory Accreditation Program (NVLAP) accredited service is employed; or (2) it has been determined by the Assistant Secretary for Environment, Safety and Health that the personnel dosimetry or radiobioassay program has demonstrated performance substantially equivalent to that of programs accredited under DOELAP (10 CFR 835.402(b)(2) and 835.402(d)(2)). A request for exception under condition (1) above shall provide at least the following information: C The name and address of the personnel dosimetry service provider. If the processor is NVLAP accredited, a copy of the certificate shall also be provided; C The number of personnel participating in the dosimetry program and the number having a measurable dose; C For the last five years, the range of occupational doses received by personnel, the average annual external dose for all personnel monitored and those who had a measurable exposure; C A description of all applicable source terms; C A justification of the dosimeter selected (if applicable); C A description of the quality assurance program in effect; DOE-STD-1111-98 16 C A description of the documentation maintained pertinent to the dosimetry program; and C A description of the program's recordkeeping procedures.

The appropriate DOELAP standard should be used as a guide for preparing responses to the last four items. The request for exception shall be forwarded through the cognizant field organization to the DOELAP Administrator. Requests for exception under condition (2) above shall provide sufficient documentation to demonstrate that the site participates in a routine performance testing program that demonstrates that they maintain a level of performance substantially equivalent to that of programs accredited under DOELAP. Requests for exception shall be forwarded through the cognizant field organization to the Assistant Secretary for Environment, Safety and Health. DOE-STD-1111-98 A-1 Appendix A DOELAP OVERSIGHT BOARD CHARTER PURPOSE The DOE Laboratory Accreditation Program (DOELAP) Oversight Board is established to advise the DOELAP Administrator with respect to technical dosimetry issues, review of recommendations by the DOELAP Performance Evaluation Program Administrator (PEPA) with respect to accreditation of DOE site personnel dosimetry or radiobioassay programs, review of the Performance Testing Laboratory (PTL) and review of DOELAP technical standards and site assessment criteria. The primary purpose of the Board is support to the DOELAP Administrator to maintain long term continuity of DOE site dosimetry or radiobioassay programs. Another purpose is to ensure technical quality and consistency of DOELAP technical standards and site assessments. ORGANIZATION Membership on the Board shall be appointed by the DOELAP Administrator. Candidates are selected from nominations by the respective DOE field organizations. The Oversight Board typically consists of five members who each serve a five year term. Members of the Oversight Board shall select one member to serve, for a three year period, as chairman. Reappointment of members to subsequent terms may occur. Members of the committee shall have expert knowledge of personnel dosimetry or radiobioassay practices and regulatory requirements. MEETINGS The Board for the Personnel Dosimetry DOELAP normally meets twice a year to review laboratory accreditation documentation. The Board for the Radiobioassay DOELAP normally meets once per year. The voting criteria and quorum for the DOELAP Oversight Board functions shall be by simple majority of at least three voting members. DOE-STD-1111-98 A-2 RESPONSIBILITIES The Oversight Board shall: C Review recommendations made by the PEPA and advise the DOELAP Administrator regarding approval or denial of DOE or DOE contractor dosimetry or radiobioassay programs. An Oversight Board member shall be excused from evaluating and voting on any issue where there may be a conflict of interest; C Evaluate the performance testing laboratories biannually for traceability of equipment and standards to the National Institute of Standards and Technology (NIST) and conformance with operating procedures; C Review remedial action plans for mitigating concerns or deficiencies in dosimetry or radiobioassay programs identified by DOELAP site assessors; and C Recommend appropriate changes to the DOELAP Administrator based on review of DOELAP documentation, site assessment criteria, and standards. RECORDS Records of Board meetings and recommendations for accreditation or denial of DOE site dosimetry or radiobioassay programs are maintained by the PEPA. AUTHORITY The Board is established as an advisory body. Therefore, decisions and recommendations made by the

Board will not be binding on the DOELAP Administrator, but will carry significant weight in the conduct of the DOELAP. Site Application Field Office Approval PEPA Performance Testing Pass Remedial Action Plan Field Org. Approval PEPA Actions Completed Site Assessment Concerns Deficiency No Yes No 30d* 45d* 60d* (NOTE: Retesting may occur in parallel with the below actions.) Remedial Action Plan Field Org. Approval PEPA Actions Completed 30d* 45d*Yes Remedial Action Plan Field Org. Approval PEPA 30d* 45d*Yes 60d* No Oversight Board Rec. HQ Approval Yes No Next step determined on case by case basis (e.g. Appeals Board) DOELAP Process Flowchart *NOTE: Days are total days post formal notification at on-site inspection out briefing. Appendix B PEPA Rec. B-1 DOE-STD-1111-98 Accredited DOE-STD-1111-98 B-2 THIS PAGE INTENTIONALLY LEFT BLANK DOE-STD-1111-98 Concluding Material Review Activity: Preparing Activity: DOE DOE-EH-52 DP EH EM ER FM Project Number: GC SAFT-0062 NE RW Operations Offices AA AL AR CH FERMI ID LAAO MAO OAK OH OR RL Laboratories Fermi National Accelerator Laboratory INEEL ORNL Pantex Plant PNNL External Agency DNFSB FOREWORD