ML24047A147
| ML24047A147 | |
| Person / Time | |
|---|---|
| Issue date: | 02/01/2024 |
| From: | Huda Akhavannik NRC/NMSS/DMSST |
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| References | |
| Download: ML24047A147 (1) | |
Text
RCP-901.1 11/29/2023 - Rev 0 Page 1 of 22
State of Connecticut Department of Energy and Environmental Protection Radioactive Materials Program RCP-901.1
Scheduling of Inspections
Prepared By: ______________________________________________Date:
Reviewed By: Date:
Approved By: Date:
RCP-901.1 Rev 0 11/29/2023 Page 1 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 2 of 22 Revision Date Description of Changes
RCP-901.1 Rev 0 11/29/2023 Page 2 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 3 of 22
TABLE OF CONTENTS SECTION TITLE PAGE TABLE OF CONTENTS 1.0 PURPOSE... 4 2.0 SCOPE 4 2.1 Applicability
3.0 REFERENCES
... 4 4.0 DEFINITIONS AND ABBREVIATIONS. 5 5.0 GENERAL.. 5 5.1 Equipment 5.2 Precautions and Limitations 5.3 Responsibilities 5.4 Prerequisites 5.5 Records 5.6 Attachments
6.0 PROCEDURE. 7 ATTACHMENTS
Attachment 1 - Reciprocity Applicant Inspection Evaluation & Processing Checklist.... 20
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1.0 PURPOSE
1.1 The purpose of this procedure is to provide an outline and checklists to inspec tors in order to conduct inspections of radioactive materials licensees compatible with the guidance contained in the NRC inspection procedures.
2.0 SCOPE
2.1 Applicability
2.1.1 This procedure applies to the scheduling of inspections based on the priorities assigned to the various licensed activities.
2.1.2 This procedure delineates core and non-core inspection priorities and establishes a program of special inspection activities for all licensees.
2.1.3 The program requires that inspections are conducted based upon performance. Inadequate compliancewill require inspections at a reduced interval.
3.0 REFERENCES
3.1 Sections 22a-148 through 22a-165(h) of Chapter 446a - Radiation and Radioactive Materials of the Connecticut General Statutes
3.2 Sections 22a-153-1 to 22a-153-150, inclusive, of the Regulations of Connecticut State Agencies
3.3 NRC Inspection Manual, Chapter 1220, Processing of NRC Form 241, Report of Proposed Activities in Non-Agreement States, Areas of Exclusive Federal Jurisdiction, and Offshore Waters, and Inspection of Agreement State Licensees Operating under 10 CFR 150.20
3.4 NRC Inspection Manual, Chapter 2800, Materials Inspection Program
3.5 NRC Inspection Procedures, 8700 Series
4.0 DEFIN IT IO NS & ABBREVIATIONS
RCP-901.1 Rev 0 11/29/2023 Page 4 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 5 of 22 4.1 NRC - Nuclear Regulatory Commission
4.2 RCPD - Radiation Control Program Director
4.3 RSRM - Risk Significant Radioactive Materials
4.4 SRCP - Supervising Radiation Control Physicist
4.5 WBL - Web -based Licensing
5.0 GENERAL
5.1 EQUIPMENT
5.2 PRECAUTIONS AND LIMITATIONS
5.3 RESPONSIBIL IT IES
5.3.1 Inspector
5.3.1.1 Maintains the files and the computer -based letters, forms, and report files.
5.3.1.2 Conducts inspections and if applicable, recommends reduction of inspection frequency based on performance.
5.3.1.3 Reviews licenses and recommends inspection priorities.
5.3.1.4 Shares appropriate information as necessary about inspections with qualified members of the inspection and licensing staff.
5.3.2 Supervising Radiation Control Physicist (SRCP)
5.3.2.1 Prepares inspection schedules and assigns inspectors, approves
RCP-901.1 Rev 0 11/29/2023 Page 5 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 6 of 22 reduction of inspection frequency, and approves the assignment of license priorities. Schedules are documented on the Inspections Due for the Next 6 Months-By Priority Report. The SRCP maintains the report.
5.3.2.2 Determines if a reduced inspection interval is warranted; a reactive, or special inspection should be performed promptly, or can be included in the next routine inspection; and initiates an inspection if appropriate.
5.3.2.3 Reports inspection and licensing statistics to the Radiation Control Program Director (RCPD) on a quarterly basis.
5.3.2.4 Reviews and approves inspection plans and reports.
5.3.2.5 Debriefs inspectors upon completion of inspections with significant findings.
5.3.3 Radiation Control Program Director (RCPD)
5.3.3.1 RCPD or designee manages the Agreement State inspection program.
5.3.3.2 Ensures that qualified staff is available to adequately perform the inspectionactivities.
5.3.3.3 Maintains oversight of the licensing inspection program.
5.4 PREREQUISITES
5.4.1 Inspectors must be qualified per RCP 903.1 Qualifications and Training.
5.5 RECORDS
5.5.1 Files
RCP-901.1 Rev 0 11/29/2023 Page 6 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 7 of 22 5.5.1.1 Records are filed electronically using Web -based Licensing (WBL).
5.6 ATTACHMENTS
5.6.1 Attachment 1 - Reciprocity Applicant Inspection Evaluation & Processing Checklist
6.0 PROCEDURE
6.1 Scheduling of inspections should be in accordance with this procedure and Office of Nuclear Materials Safety and Safeguards Program Code Descriptions and Inspection Priorities available in the Materials Licensees Toolkits Index, at https://www.nrc.gov/materials/miau/mat-toolkits.html. All inspections, except initial inspections, certain special inspections, and inspections determined by the SRCP, will be unannounced (less than 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> notice or no notice) unless otherwise justified. To achieve the goals of cost saving and efficient use of staff time and travel, inspections (other than initial inspections) may be scheduled and performed within a window around their inspection due date as defined in IMC 2800. Inspections will not be considered overdue until they exceed the inspection due date plus the window defined in IMC 2800. Inspections may be scheduled before their window if the inspector receives information that warrants earlier inspection.
6.2 License Priorities
6.2.1 Each license Program Code is assigned a Priority Code, which is the inspection frequency expressed in years. Priority Code 1 is to be inspected annually, Priority Code 2 is inspected every 2 years, Priority Code 3 is inspected every 3 years, Priority Code 4 is inspected every 4 years and Priority Code 5 is inspected every 5 years.
6.2.2 Office of Nuclear Materials Safety and Safeguards Program Code Descriptions and Inspection Priorities is available in the Materials Licensees Toolkits Index, at https://www.nrc.gov/materials/miau/mat-toolkits.html. It is a listing of materials programs and their associated inspection priorities.
6.2.3 The SRCP shall assign a primary program code which sets the inspection priority of each new license.
RCP-901.1 Rev 0 11/29/2023 Page 7 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 8 of 22 6.2.4 Some licenses authorize activities that can be classified under more than one program code. For example, a license for a medical institution (Program Code 02121, Priority Code 5) may be amended to authorize use of high dose rate (HDR) remote afterloader unit (Program Code 02230, Priority Code 2). The licensees primary program code would be Program Code 02230. However, both activities should be inspected simultaneously during the HDR inspection.
6.3 Inspection Priorities
6.3.1 An inspection priority code is assigned to each radioactive material license.
6.3.2 The same priority code is assigned to all initiallicenses that authorize that specific type of use.
6.3.3 The most current program codes (types of use) are available in the Materials Licensees Toolkits Index, as described in Section 6.2.2.
6.3.4 The priority represents the relative risk of radiation hazard. Priority Code 1 represents the greatest risk to the health and safety of workers, members of the public, and the environment, while Priority Code 5 represents the lowest risk.
6.3.5 Because a license may authorize multiple types of use (i.e., multiple program codes), the inspection priority code for the license is the code with the shortest routine inspection interval.
6.4 Routine Inspections
6.4.1 Routine Inspections: Inspectors should plan to conduct routine inspections close to the due date. To achieve the goals of cost saving and efficient use of staff time and travel, routine inspections may be scheduled within a window around their inspection due dates. Routine inspections of Priority 1 and 2 licensees may vary around their due date by +/- 50 percent. Routine inspections of Priority 3, 4, and 5 licensees may vary around their due dates by +/- 1 year. Inspections will not be considered overdue unti l they exceed the scheduling window.
6.4.2 Extension of Inspection Interval: The due date for the next inspection may be extended if, in the judgement of the inspector and the supervisor, the
RCP-901.1 Rev 0 11/29/2023 Page 8 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 9 of 22 licensee is determined to be a high performer. This decision is a matter of judgement because inspections are a snapshot of the licensees activities at the time the inspector is on site. As a result, the inspector and the supervisor will make this judgement based on the inspectors performance-based observations of the most risk-significant, authorized activities; high past performance; and confidence that the licensees performance will continue at a high level. If approved, Priority 1 and 2 licensees may be extended to 50 percent of the routine inspection interval and Priority 3 licensees may be extended for up to 1 year in circumstances where the licensee has demonstrated high performance. Priority 4 and 5 licensees are not eligible for this extension.
6.4.3 Temporary Job Site Inspections: For licensee authorized to work at a temporary job site, inspectors shall make every reasonable attempt to schedule an unannounced inspection of licensed activities at such location(s). If a temporary job site inspection is not performed, a brief note will be written in the inspection records, explaining the missed temporary job site inspection. In certain cases, the next inspection date data element in Web-based Licensing may indicate a reduced inspection interval.
6.4.4 Authorized Locations of Use / Storage: If a license authorizes licensed activities to be conducted at 1 to 5 facilities, at least 40 percent of the facilities should be inspected at the interval specified by the program code for the specific type of license. If a license authorizes licensed activities to be conducted from 6 to 20 facilities, at least 30 percent of the locations should be inspected. If a license authorizes more than 20 facilities, at least 20 percent of the facilities should be inspected. The number of locations to be inspected should be rounded to the nearest whole number greater than 0.
New or not previously inspected facilities should be given priority for inspection. Inspection of various field offices should be rotated to assess the licensees entire program over several inspection cycles.
6.5 Initial Inspections
6.5.1 All initial inspections, regardless of the license priority, are to be conducted within 1 year of license issuance. Initial inspections of a new license shall be announced and normally completed within 12 months of the date the new license was issued; however, if the licensee does not yet possess licensed materials or has not yet performed any principal activities the initial inspection may be rescheduled to within 18 months of license
RCP-901.1 Rev 0 11/29/2023 Page 9 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 10 of 22 issuance. Licensees arerequired by license condition t o notify the State of Connecticut Department of Energy and Environmental Protection (Department) of their first receipt of licensed material. Initial inspections of a new licensee or an existing licensee which obtained an amendment for Program Code 02240 (Medical Therapy-Other Emerging Technology) shall be announced.
6.5.2 To schedule the initial inspection, the date in the next inspection date data element in WBL shall be in 12 months from the date the new license or amendment was issued. The last inspection date data element in the licensee folder in WBL shall be blank. If it is determined that the licensee has not possessed licensed material or performed any principal activities, the inspector should ensure that the date in the next inspection date data element in the license folder in WBL is 12 months from the date of the onsite visit. If the licensee does not yet possess licensed material or has not yet performed any principal activities, the initial inspection may be rescheduled to within 18 months of the license issuance. If it is determined that the licensee does not possess licensed material or has not performed principal activities, the inspector should:
6.5.2.1 Determine the licensees plans for the future possession of licensed material or plans to perform principal activities. Use this opportunity to discuss the license and the applicable regulations with the licensee.
6.5.2.2 The inspector should discuss any unique license conditions and give the licensee an opportunity to askany regulatory questions.
6.5.2.3 Remind the licensee to notify the Department within 30 days after receipt of licensed material or initiation of principal activities, as required by license condition.
6.5.2.4 Document the contact and enter into the licensee file. The conversation record should include the licensees plans for the future possession of material or plans to perform principal activities.
6.5.2.5 Ensure that the due date is set for 18 months from license issuance.
6.5.3 Performing initial inspections. During the initial inspection, the inspector should interview licensee staff (management and technical) to determine if
RCP-901.1 Rev 0 11/29/2023 Page 10 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 11 of 22 licensed material was received or if principal activities have been performed. Methods for determining if principal activities have been performed include, but are not limited to the following:
6.5.3.1 Performing a site tour,
6.5.3.2 Performing independent measurements, and/or
6.5.3.3 Contacting distributors of licensed material, such as local radiopharmacies, to see if they have distributed material to the licensee.
NOTE: If the licensee has possessed licensed materials or performed principal activities, then the inspector should conduct an inspection in accordance with this section and other applicable guidance.
6.5.4 If it is not determined that the licensee has not possessed licensed material or has not performed principal activities, the inspector should:
6.5.4.1 Determine the licensees plans for the future possession of licensed material or plans to perform principal activities. In assessing the licensees future plans, the inspector should determine if adequate facilities and equipment are in place to safely handle licensed material, as described in the license application.
NOTE: As defined in 10 CFR 30, principal activities, means activities authorized by the license which are essential to achieving the purpose(s) for which the license was issued or amended. Storage during which no licensed material is accessed for the use or disposal and activities incidental to decontamination or decommissioning are not principal activities.
6.5.4.2 Use this opportunity to discuss the license and the applicable regulations with the licensee. The inspector should discuss any unique license conditions and give the licensee an opportunity to as any regulatory questions.
6.5.4.3 Remind the licensee to notify the Department within 30 days after receipt of licensed material or initiation of principal activities, as required by license condition.
RCP-901.1 Rev 0 11/29/2023 Page 11 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 12 of 22 6.5.4.4 Remind the licensee of the requirement of 10 CFR 30.36(d) to provide written notification to the Department within 60 days if no principal activities under the license have been conducted for a period of 24 months.
6.5.4.5 Document the onsite inspection by completing the appropriate inspection record. The program scope description should include the licensees plans for the future possession of material or plans to perform principal activities.
6.5.4.6 Ensure that the due date is set for 12 months from the date of the onsite inspection. To achieve the goals of cost saving and efficient use of staff time and travel, the date of the next initial inspection attempt may vary by +/- 6 months.
6.6.1 Reactive inspections receive first priority in the inspection program.
6.6.2 Following the receipt of notification of an incident, allegation, or special information such as a medical event, The SRCP or the designee shall determine if an immediate inspection is warranted, or if the issue is best covered during the next scheduled inspection.
6.6.3 A reactive inspection will not substitute for a routine inspection unless the scope of the inspection is comprehensive.
6.7 Special Inspections 6.7.1 The following activities require special inspections:
6.7.1.1 Expired and Terminated Licenses: In accordance with the criteria outlined in RCP-900.3 License Terminations/Revocation,
notification that a license has expired or is being terminated may require that an inspection be conducted within 30 days of the date of notification. This is an announced inspection.
6.7.1.2 Reciprocity Inspections
Receipt of a request for reciprocity may require performance of an inspection. Reciprocity inspections do not follow the frequency
RCP-901.1 Rev 0 11/29/2023 Page 12 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 13 of 22 requirements for routine inspections. Reciprocity applicants receive routine inspections from the regulatory agency that issues their license. Reciprocity inspections shall be performed in a performance-based, risk-informed manner.
All reciprocity applicants are eligible for inspection. Reciprocity inspection candidates shall be selected in a risk -informed manner based on the following guidance:
- need for a reactive inspection based on on-going event;
- review of an allegation, as it relates to the work being conducted under reciprocity;
- inspection priority, scope and duration of work performed;
- inspection, enforcement, and incident history (e.g.,
discussions with regulatory agency that issued license, NMED, National Enforcement Database, etc.);
- knowledge of work in other regulatory jurisdictions (e.g.,
number of inspections of this entity in a given year under the National Materials Program);
- new or unique technology; or,
- any other situation as deemed appropriate by the regional management.
Each new reciprocity applicant will be evaluated for inspection utilizing the risk -informed method contained within Attachment
- 1. Information collected during the license verification process and scope of work considerations will determine whether or not a reciprocity licensee is a candidate for inspection in Connecticut.
All new and reciprocity licensee renewal applications will be processed in accordance with Attachment 1 - Reciprocity Applicant Inspection Evaluation and Processing Checklist.
6.7.1.3 Team Inspections: The SRCP shall schedule team inspections of major licensees (i.e. broad scope, large medical programs) within Connecticut on an as-needed basis.
6.8 Significantly Expanded Programs
6.8.1 A license reviewer may request a special inspection, if during the licensing review process, it is determined that the license es program has significantly expanded.
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6.8.2 The license reviewer should make the SRCP aware of the following examples of changes in a licensees scope of use and shall ensure that the next inspection date data element in WBL is changed.
The following are examples of significantly expanded programs:
6.8.2.1 A change in the Radiation Safety Officer.
6.8.2.2 A portable gauge user requesting to add new storage facility and/or requesting additional gauges not approved on the initial application.
6.8.2.3 A licensee has recently requested a significant increase in the types, quantities, or forms, and uses of radioactive material on the licenses and if these actions have resulted in the possession of Risk Significant Radioactive Material ( RSRM).
6.8.2.4 The licensee authorizes a physical move of a facility or a new use at a temporary jobsite.
6.8.2.5 The license authorizes new (i.e., since the previous inspection) satellite facilities where material will be used or stored.
6.8.2.6 The licensee has increased the types of uses or disposal (i.e.,
incineration or decay-in-storage) of a radioactive material;
6.8.2.7 The number of authorized users has significantly increased or decreased; and
6.8.2.8 The licensee has ceased activities at the entire site or in any building or area as defined in 10 CFR 30.36(d).
6.8.2.9 Requests for new medical procedure involving the use of a sealed or unsealed radioactive material Proposed revisions to licensees facilities, etc.
6.8.2.10 If during the licensing review process, the reviewer determines that the licensee will possess RSRM, the reviewer, in consultation
RCP-901.1 Rev 0 11/29/2023 Page 14 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 15 of 22 with management and administrative staff, should add Program Code 01000 in WBL. The license reviewer should complete the RSRM checklist to determine whether an on-site security review shouldbe conducted.
6.8.3 During routine inspections of licensed facilities, inspectors should evaluate if licensed activities have significantly increased or decreased since the last inspection. The SRCP may determine a special inspection is needed if there is a significant increase in activity discovered since the last inspection.
6.9 Abandonment of Licensed Activities
6.9.1 The SRCP will determine if an inspection will be scheduled based on the complexity of the licensed activities, and the types and quantities of licensed material if the licensed activities are abandoned. The SRCP and the RCPD must take steps to terminate the license in these cases.
6.9.2 When a licensee does not respond to the Department inquiries e.g., returned mail with no forwarding address and the licensee cannot be contacted by any other means, then, a license will be considered abandoned.
6.9.3 If telephone contact is not established, then an inspector should be sent to the licensees site.
6.10 Reduced Inspection
6.10.1 At the discretion of the SRCP, other changes in inspection interval may be made to achieve efficiencies in the use of inspection resources and reduce regulatory impact on the licensee.
6.10.1.1 This may include more frequent inspections to ensure that inspectors have the opportunity to sufficientlyobserve licensee operations, and increase public confidence by increasing the inspection focus on higher risk activities, without significantly increasing the regulatory burden on the licensees.
6.10.1.2 For example, rather than perform a single, large team, high impact inspection of the license at the normal interval, more frequent inspections may be performed by individuals or smaller teams that specifically focus on higher risk licensee activities.
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6.10.2 The inspection interval shall not be extended beyond that specified by the priority schedule indicated in section 6.1. The interval between inspections may be reduced and the inspections conducted more frequently than the specified priority schedule on the basis of poor licensee performance. The main consideration in reducing the inspection interval should be evidence of moderate to severe problems in the licensees radiation safety program.
Poor compliance history is also a consideration.
6.10.2.1 Poor Licensee Performance: Based on poor licensee performance the interval between inspections may be reduced and inspections conducted more frequently than the specified priority schedule. Poor performance is evidenced by moderate to severe problems in the licensees radiation safety program, poor compliance history, or lack of management involvement or control over radiation safety program. Reduction of inspection interval shall be considered for licensees that meet one or more of the following conditions:
6.10.2.1.1 An Escalated Enforcement (Very High, High, or Moderate) Severity level violation on the most recent inspection (violations subject to civil penalties as determined by RCSA 22a-6b);
6.10.2.1.2 Issuance of an order or escalated enforcement on the most recent inspection;
6.10.2.1.3 Management Paragraph appears on the cover letter transmitting the notice of violation from the most recent inspection (management paragraph is a paragraph that requires the licensee to address adequate management control over the licensed program);
6.10.2.1.4 An event requiring a reactive inspection;
6.10.2.1.5 Repetitive violations;
6.10.2.1.6 Enforcement conference where outcome did not include escalated enforcement but did indicate the need for the licensee to improve some aspect(s) of its compliance
RCP-901.1 Rev 0 11/29/2023 Page 16 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 17 of 22 program;
6.10.2.1.7 Industrial radiography licensee who is authorized to use radioactive material at temporary job sites and the current inspection, was limited to an office inspection and no temporary job site inspection was performed.
6.10.2.1.8 The RCPD or SRCP have determined that a reduced inspection is required.
6.10.2.2 Follow-up Inspections: Licensees that meet the above criteria may have their inspection interval reduced by any length. A follow-up inspection should be conducted within 6 months of receipt of a licensees corrective action(s) following an escalated enforcement action. (see RCP-902.1)
6.10.2.3 Reduction Time Frame: The reduction shall be valid only until the next inspection, but the SRCP shall consider the results of the inspection and determine if the reduced frequency should be continued, changed, or returned to normal. The recommendation to reduce the inspection interval must be documented on the inspection report by the inspector and signed by the SRCP.
6.10.2.4 Recording and Identifying Change in Inspection Priority: The designated inspection priority for these licensees should not be changed in the license folder in WBL. However, the next inspection date field in WBL should be changed to contain the reduced date for the next inspection.
6.11 Pre-Licensing Site Visit
6.11.1 Generally, pre-licensing visits shall be conducted for new entities that do not have an existing Agreement State or NRC license, licensees changing ownership to an unknown entity, or licensees that are significantly expanding the size of their existing license.
6.11.2 Reviewers must use the Pre-Licensing Checklist and guidance in (RCP-900.1) to determine if pre -licensing visits are needed.
6.11.3 The purpose of the pre-licensing site visit is to evaluate the applicants
RCP-901.1 Rev 0 11/29/2023 Page 17 of 22 RCP-901.1 11/29/2023 - Rev 0 Page 18 of 22 intentions regarding the use of radioactive materials and to forward the suspicious applications to the appropriate authority for follow-up, per guidance in the Pre-Licensing Guidance Checklist. At a minimum, all storage and use locations must be visited.
6.11.4 By the end of the visit, the reviewer should have observed, collected, and documented sufficient information to provide a basis of confidence that the applicant will use the radioactive materials as specified in its license application. Pre-licensing site visits must be completed before the issuance of a license.
6.11.5 The new license should not be provided to the licensee/applicant during the site visit.
6.12 Change of Control
6.12.1 New License: New licenses that are issued solely as a result of a licensees change of mailing address are not required to receive an initial inspection, if the licensees place of use remains the same as on the previous license.
The last inspection date and next inspection date data elements in WBL should remain the same as for the licensees previous license.
6.12.2 Change of Control: New licenses that are issued as a result of a change of ownership or transfer of control are not required to receive an initial inspection unless:
6.12.2.1 The organization controlling the licensed activities changes substantially (i.e., changes in key personnel, authorities, or resources associated with the radiation safety program);
6.12.2.2 The licensee significantly increases the types, quantities, or forms of radioactive materials on the license;
6.12.2.3 The licensee significantly increases the different uses authorized on the license (i.e., adds brachytherapy to diagnostic nuclear medicine license);
6.12.2.4 The licensee significantly increases the number of authorized users; or
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6.12.2.5 The new licensee authorizes one or more new facilities.
6.12.2.6 If none of these conditions apply, then the last inspection date and the next inspection date fields in WBL should remain the same as for the previous license.
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Reciprocity Applicant Inspection Evaluation Checklist
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