Issue Date: 02/26/15 1 87132

NRC INSPECTION MANUAL MSEB

INSPECTION PROCEDURE 87132

BRACHYTHERAPY PROGRAMS

PROGRAM APPLICABILITY: 2800

87132-01 INSPECTION OBJECTIVES

01.01 To determine if licensed activities are being conducted in a manner that will protect the 

health and safety of workers, the general public and patients.

01.02 To determine if licensed activities are being conducted in accordance with U.S. Nuclear 

Regulatory Commission (NRC) requirements.

87132-02 INSPECTION REQUIREMENTS

The inspector should conduct the inspection in a manner that will allow him/her to develop 

conclusions about licensee performance relative to the following focus areas: 1) Security and 

control of licensed material; 2) Shielding of licensed material; 3) Comprehensive safety 

measures; 4) Radiation dosimetry program; 5) Radiation instrumentation and surveys; 6) 

Radiation safety training and practices; and 7) Management oversight; 8) Licensee review of 

licensed activities performed by contracted personnel; and 9) Other medical uses of byproduct 

material or radiation from byproduct material. Based on selected observations of licensed 

activities, discussions with licensee staff, and as appropriate, a review of selected records and 

procedures, the inspector should determine the adequacy of a licensee’s radiation safety 

program relative to each of the above focus areas. If the inspector concludes that licensee 

performance is satisfactory from a general review of selected aspects of the above focus areas, 

the inspection effort expended in reviewing that particular focus area will be complete. If the 

inspector determines that the licensee did not meet the performance expectation for a given 

focus area, the inspector should conduct a more thorough review of that aspect of the licensee’s 

program. The increased inspection effort may include additional sampling, determination of 

whether the licensee’s procedures are adequate, and a review of selected records maintained 

by the licensee documenting activities and outcomes. The above focus areas are structured as 

a performance expectation and address the activities or program areas most commonly 

associated with measures that prevent overexposures, medical events, or release, loss or 

unauthorized use of radioactive material.

The NRC inspector shall not under any circumstances knowingly allow an unsafe work practice 

or a violation which could lead to an unsafe situation to continue in his/her presence in order to 

provide a basis for enforcement action. Unless an inspector needs to intervene to prevent an 

unsafe situation, direct observation of work activities should be conducted such that the 

inspector’s presence does not interfere with patient care or a patient’s privacy.
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Discussion of the inspector’s observations and interviews with the workers should not occur 

during the preparation for, or delivery of medical treatment, if possible. When practicable, the 

inspector should exercise discretion when interviewing licensee staff in the presence of patients 

so that the discussions do not interfere with licensee staff administering patient care. However, 

there may be cases when it is appropriate to discuss such matters at such times that would 

allow an inspector to ascertain the adequacy of the licensee’s administration of the radiation 

safety program.

In reviewing the licensee's performance, the inspector should cover the period from the last to 

current inspection. However, older issues preceding the last inspection should be reviewed, if 

warranted by circumstances, such as incidents, noncompliance, or high radiation exposures.

This inspection procedure is applicable to all forms of brachytherapy (temporary and permanent 

implants, remote afterloaders, eye applicators and plaques, etc.). However, all the following 

areas may not be applicable to each brachytherapy program.

02.01 Security and Control of Licensed Material. The inspector should independently verify 

through direct observations of licensed activities, discussions with cognizant licensee 

representatives, and if necessary, a review of selected records, that the licensee’s performance 

has controlled access to and prevent loss of licensed material so as to limit radiation exposure 

to workers and members of the public to values below NRC regulatory limits.

02.02 Shielding of Licensed Material. The inspector should independently verify through 

direct observations of licensed activities, discussions with cognizant licensee representatives, 

and if necessary, a review of selected records that the licensee’s performance has maintained 

shielding of licensed materials in a manner consistent with operating procedures and design 

and performance criteria for devices and equipment.

02.03 Comprehensive Safety Measures. The inspector should independently verify through 

direct observations of licensed activities, discussions with cognizant licensee representatives, 

and if necessary, a review of selected records, that the licensee’s performance has 

implemented comprehensive safety measures to limit other hazards from compromising the 

safe use and storage of licensed material.

02.04 Radiation Dosimetry Program. The inspector should independently verify through direct 

observations of licensed activities, discussions with cognizant licensee representatives, and if 

necessary, a review of selected records, that the licensee’s performance has implemented a 

radiation dosimetry program to accurately measure and record radiation doses received by 

workers or members of the public as a result of licensed operations.

02.05 Radiation Instrumentation and Surveys. The inspector should independently verify 

through direct observations of licensed activities, discussions with cognizant licensee 

representatives, and if necessary, a review of selected records, that the licensee has 

implemented radiation instrumentation in sufficient number, condition, and location to accurately 

monitor radiation levels in areas where licensed material is used and stored.

02.06 Radiation Safety Training and Practices. The inspector should independently verify 

through direct observations of licensed activities, discussions with cognizant licensee 

representatives, and if necessary, a review of selected records, that the licensee’s performance 

has ensured that workers are knowledgeable of radiation uses and safety practices; skilled in 
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radiation safety practices under normal and accident conditions; and empowered to implement 

the radiation safety program.

02.07 Management Oversight. The inspector should independently verify through direct 

observations of licensed activities, discussions with cognizant licensee representatives, and if 

necessary, a review of selected records, that the licensee’s performance for implementing a 

management system is appropriate for the scope of use and is able to ensure awareness of the 

radiation protection program, as low as is reasonably achievable (ALARA) practices are 

implemented when appropriate, and assessments of past performance, present conditions and 

future needs are performed and that appropriate action is taken when needed.

02.08 Licensee Review of Licensed Activities Performed by Contracted Personnel. The 

inspector should independently verify through direct observations of licensed activities, 

discussions with cognizant licensee representatives, and if necessary, a review of selected 

records that the licensee is providing oversight of licensed activities performed by contracted 

personnel.

02.09 Other Medical Uses of Byproduct Material or Radiation from Byproduct Material.

Due to the advancements of medical research and development, new emerging medical 

technologies are always on the forefront of providing optimal medical care to patients. In 

accordance with NRC regulations, the licensee may use byproduct material or a radiation 

source approved for medical use which is not specifically addressed in subparts D through H of 

Part 35, if the licensee has submitted the information required by the Code of Federal 

Regulations (CFR) in 10 CFR 35.12(b) through (d), and the licensee has received written 

approval from the NRC in a license or license amendment and uses the material in accordance 

with the regulations and specific conditions the NRC considers necessary for the medical use of 

the material. During discussions with cognizant licensee representatives and direct 

observations made during the inspection, the inspector may encounter new emerging 

technologies being used that have not been specifically amended to a licensee’s license. If an 

inspector encounters such activity and use, the inspector should contact NRC regional 

management as soon as practicable to independently verify that such use is authorized under 

NRC regulatory requirements. If further verification of such use is needed, the region should 

contact the Office of Federal and State Materials and Environmental Management Programs 

(FSME) for further guidance.

87132-03 INSPECTION GUIDANCE

03.01 General Guidance. A determination regarding safety and compliance with NRC 

requirements should be based on direct observation of work activities; interviews with licensee 

workers, demonstrations by appropriate workers performing tasks regulated by NRC, 

independent measurements of radiation conditions at the licensee’s facility, and where 

appropriate, a review of selected records. A direct examination of these licensed activities and 

discussions with cognizant workers should be a better indicator of the performance of a 

licensee's overall radiation safety program than a review of selected records alone.

Some of the requirement and guidance sections of this procedure instruct the inspector to 

“verify” the adequacy of certain aspects of the licensee's program. Whenever possible, 

verification should be accomplished through discussions, direct observations, and 

demonstrations by appropriate licensee personnel.
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Once an inspector has conducted a review of the applicable elements of a focus area in a broad 

capacity (e.g., looked at the Abig picture@) and has not identified any safety significant concerns 

within that area, the inspector should conclude inspection of that focus area. The inspector 

should note that not all of the following elements outlined below in a particular focus area need 

to be reviewed by the inspector if he/she concludes from selected observations, discussions 

and reviews that the licensee’s performance is adequate for ensuring public health and safety.

However, if the inspector during a review of selected elements of one of the focus areas 

concludes that there may be a significant safety concern, a more detailed review may be 

appropriate. A more detailed review may include further observations, demonstrations, 

discussions and a review of selected records. In the records review, the inspector should look 

for trends in those areas of concerns, such as increasing radiation levels from area radiation 

and removable contamination surveys, and occupational radiation doses. Records such as 

surveys, receipt and transfer of licensed materials, survey instrument calibrations and training 

may be selectively examined until the inspector is satisfied that for those areas of concern, the 

records may or may not substantiate his/her concern. If the inspector substantiates a significant 

safety concern regarding a particular matter, it may be more appropriate to discuss this matter 

with NRC regional management. During the inspection, some records that are more closely 

related to health and safety (e.g., personnel occupational radiation exposure records, medical 

events and incident reports) may be examined in detail since a review of such records is 

necessary to ascertain the adequacy of the implementation of the radiation safety program for 

that particular element of a focus area.

If the inspector finds it appropriate when an apparent violation has been identified, the inspector 

should gather copies from the licensee, while onsite, of all records that are needed to support 

the apparent violation. In general, inspectors should use caution before retaining copies of 

licensee documents, unless they are needed to support apparent violations, expedite the 

inspection (e.g., licensee materials inventories), or make the licensing file more complete. In all 

cases where licensee documents are retained beyond the inspection, follow the requirements of 

Inspection Manual Chapter (IMC) 0620. Especially ensure that the licensee understands that 

the retained record will become publicly available, and give the licensee the opportunity to 

request withholding the information pursuant to the requirements of 10 CFR 2.790(b)(1).

The inspector should keep the licensee apprised of the inspection findings throughout the 

course of the onsite inspection and not wait until the exit meeting to inform licensee senior 

management.

Whenever possible the inspector should keep NRC regional management informed of 

significant findings (e.g., safety hazards, willful violations, and other potential escalated 

enforcement issues) identified during the course of the inspection. This will ensure that the 

inspector is following appropriate NRC guidance under such circumstances.

03.02 Security and Control of Licensed Material

a. Adequate and Authorized Facilities. Descriptions of the facilities are generally found in 

the application for a license and subsequent amendments that are usually tied down to 

a license condition as submitted by the licensee in accordance with 10 CFR 35.13. 

Based on direct observations made during tours of the licensee’s facility, the inspector 

should independently verify that access to licensed material received, used, and stored 
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is secured from unauthorized removal, and the licensee uses processes or other 

engineering controls to maintain ALARA exposures.

1. Additional Requirements for Licensees with Remote Afterloaders. Through direct 

observations made during tours of the licensee’s facility and discussions with 

cognizant licensee representatives, the inspector should verify that unauthorized 

individuals are prevented from entering the use area, that the device and all 

associated sources are stored against unauthorized use or removal, and console 

keys are inaccessible to unauthorized persons. The inspector should note 

remote afterloaders placed in treatment rooms with other radiation-producing 

devices and ask authorized licensee personnel to demonstrate that only one 

device can be placed in operation at a time.

2. Additional Requirements for Licensees with High-, Medium-, and Pulsed-DoseRate Remote Afterloaders. Through discussions with cognizant licensee 

representatives and direct observations, the inspector should verify that the use 

of the afterloaders is limited to the areas approved by the license. From those 

discussions and observations, the inspector should determine whether each 

dedicated treatment room is equipped with a continuous viewing and intercom 

system to allow for patient observation and communication during treatment. In 

addition, the inspector should verify that these systems are checked for operation 

at the beginning of each day of use, and that either a backup system is available 

or the licensee suspends further treatments if the primary system requires 

repairs.

Through further discussions and observations, the inspector should verify that 

electrical interlock systems are installed and operational at each entry. The 

activation of the interlock will result in the source automatically being retracted. 

Also, the inspector should verify that, once activated, the automatic interlock 

must be reset before the afterloading device can be activated. In addition, the 

inspector should determine whether interlocks are tested at the required 

frequency.

During the conduct of the inspection, the inspector should ask an authorized 

licensee representative to demonstrate that interlock systems are operational 

and should inquire about what action is taken by the staff when the interlock 

systems are found to be non-operational. The inspector should also confirm that 

the backup system used to observe patients is operational and inquire about 

what action is taken by licensee staff when the backup system is nonoperational.

3. Additional Requirements for Licensees with Low-Dose-Rate Remote 

Afterloaders. Through discussions with cognizant licensee representatives and 

direct observations, the inspector should determine whether the licensee has the 

capability to monitor the patient and device during treatment to ensure that the 

sources and catheter guide tubes are not disturbed during treatment/use.

b. Adequate Equipment and Instrumentation. Through discussions with cognizant 

licensee representatives, direct observations made during tours of the licensee’s facility, 

and if necessary, a review of selected records, the inspector should independently 
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check interlock systems and other systems for continuous observation of the patient. 

For unit operation, the inspector should check the control of console keys. These 

activities can best be reviewed by the inspector by having an appropriate licensee 

representative demonstrate how these systems operate while the inspector observes 

those actions to ensure that the systems operate as designed and that the individual 

conducting the activity is knowledgeable in those areas. If appropriate, the inspector 

should verify that these various systems and checks operate appropriately to ensure 

compliance to 10 CFR 35.61, 615, 633, and 643.

During the conduct of the inspection, the inspector should discuss with cognizant 

licensee representatives the routine maintenance and calibration performed on the 

units. If practicable, the inspector should ask appropriate licensee personnel to 

demonstrate some or all of the steps of the calibration procedure. If the inspector 

identifies concerns from those direct observations, a review of selected maintenance 

and calibration log may be necessary. If a review is necessary, the inspector should 

look for recurring problems/repairs and generic problems. If recurring problems are 

identified and of significance, the inspector should contact NRC regional management 

for further guidance. If applicable, the inspector should verify that the Radiation Safety 

Committee (RSC) was aware of the problem. The inspector should then review the 

matter with cognizant licensee representatives to determine if adequate action was 

taken by the licensee to address the problem. From those discussions and reviews, if 

necessary, the inspector should determine if any malfunctions should have been 

reported to the NRC, pursuant to 10 CFR 21.21.

1. Remote Afterloader Unit Inspection, Servicing, Calibration and Spot Checks. 

Through direct observations made during the onsite inspection, the inspector 

should visually inspect the control console and unit for indications that alterations 

may have been performed by unauthorized persons. These indications may 

include off-the-shelf switches and timers, as well as wire jumpers and taped 

micro switches to bypass safety systems of the unit. If the inspector determines 

that alterations have been performed by unauthorized persons, the inspector 

should contact NRC regional management as soon as practicable for further 

guidance.

Through discussions with cognizant licensee representatives, direct observations 

of licensed activities, and if necessary, a review of selected records, the 

inspector should verify that the licensee has properly calibrated the remote 

afterloader, the unit is calibrated at the required intervals (not to exceed one 

quarter or one year, whichever one is applicable), and before first patient use and 

after source exchange, relocation, and major repair or modification. The 

calibration of the unit should include all items listed in 10 CFR 35.633. In 

addition, the inspector should verify that spot checks are conducted on the unit at 

the required frequency, and as required by 10 CFR 643. Also, the inspector 

should verify that additional technical requirements are conducted on the unit at 

the required frequency as required by 10 CFR 35.647. Furthermore, the 

inspector should verify that the licensee has performed acceptance testing on the 

treatment planning system in accordance with 10 CFR 35.657.

During the conduct of the inspection, if the inspector identifies equipment or 

instrumentation that has failed to perform as designed, the inspector should 
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ensure that licensee operations are stopped immediately and that such 

equipment or instrumentation be appropriately repaired and tested prior to the 

next treatment. In some cases it may be appropriate to contact NRC regional 

management as soon as practicable to discuss the equipment or instrument 

failure and determine what appropriate steps should be taken to follow up on this 

matter.

2. Additional Requirements for all Licensees with Remote Afterloaders. 

During the conduct of the inspection, the inspector should visually inspect the 

remote afterloading device and/or any source storage devices to verify that only 

authorized devices are in use and that they are properly labeled.

In addition, during the inspection, the inspector should ask an appropriate 

licensee staff personnel to demonstrate how the backup battery for the device 

and the source position indicators are checked for proper operation.

During tours of the licensee’s facilities, the inspector should independently verify 

that emergency equipment is available near each treatment room to respond to a 

source dislodged from the patient or lodged within the patient following 

completion of the treatment. This equipment should include such items as 

shielded containers, remote handling tools, and if appropriate, supplies 

necessary to surgically remove applicators or sources from the patient, including 

scissors and cable cutters.

3. Additional Requirements for Licensees with Strontium-90 (Sr-90) Eye 

Applicators. Through discussions with cognizant licensee representatives, direct 

observations made during the conduct of the inspection, and a review of selected 

records, the inspector should verify that the licensee has in its possession, and 

uses, a certificate of calibration, or data from a manufacturer-supplied source 

identification plate, for each Sr-90 ophthalmic applicator in its possession. 

Certificates of calibration must be supplied by either:

(a) The manufacturer/vendor of the Sr-90 applicator; or

(b) A calibration laboratory with established traceability to the National 

Institute of Standards and Technology (NIST) for performing Sr-90 

ophthalmic applicator calibrations.

From those discussions, observations, and reviews, the inspector should verify 

that each certificate of calibration, or source identification plate, must match, by 

source serial number, the source for which its data are being used. 

Through further discussions, observations, and reviews, the inspector should 

verify that the source output (dose rate) is being properly corrected for source 

decay. The inspector should confirm this by independent calculation to ensure 

the adequacy of the licensee’s corrections for the radioactive decay of Sr-90 

sources.
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4. Licensee Evaluation of Equipment Defects or Failures to Comply That Are 

Associated with Significant Safety Hazards. The inspector should verify a 

licensee developed procedures under 10 CFR 21.21 to identify and report safety 

component defects and, when needed, the procedures were implemented and 

NRC is also aware of the report.

c. Receipt and Transfer of Licensed Materials. Through discussions with cognizant 

licensee representatives, direct observations made during tours of the licensee’s facility, 

and if necessary, a review of selected records, the inspector should verify that the

licensee has received and transferred licensed materials in accordance with NRC and 

applicable U.S. Department of Transportation (DOT) regulations and license conditions.

Through discussions with cognizant licensee representatives, direct observation of 

licensed activities, and if necessary, a review of selected records, the inspector should 

review the licensee’s materials accounting system. The inspector should note that 

sometimes, a relatively small facility will generally need to maintain receipt records, 

disposal records, and records of any transfers of material. However, a large facility may 

need a sophisticated accounting system which provides accurate information on the 

receipt of material, its location, the quantity used and disposed of, the amount 

transferred to other laboratories operating under the same license, and the amount 

remaining after decay. From those discussions and reviews, if necessary, the inspector 

should determine if accounting systems consider radioactive material held for decay-instorage, near-term disposal, or transfer to other licensees. In both types of accounting 

systems, the inspector should ensure that the licensee has performed routine audits of 

those systems to ensure the accuracy of the system.

If a records review is necessary, the inspector should verify that the licensee’s 

procedures for receiving replacement sealed sources include how and when they will 

be picked up, radiation surveys and wipe tests of source containers to be done upon 

receipt, and procedures for opening source containers (such as the location in the 

facility where they are received, surveyed, and opened). From those discussions, 

observations and reviews, if necessary, the inspector should determine what actions 

are to be taken if surveys reveal source containers that are contaminated in excess of 

specified limits, and/or radiation levels that are higher than expected. If replacement 

sources arrive during the course of an inspection, the inspector should observe, when 

practical, personnel perform the package receipt surveys as well as the area surveys.

Through discussions with cognizant licensee representatives and if necessary, a review 

of selected records, the inspector should ascertain if the licensee has an adequate 

method of determining that transfers of licensed material are made to recipients 

licensed to receive them (e.g., licensee obtains a copy of the recipient's current license 

before the transfer).

d. Transportation. Through discussions with cognizant licensee representatives, direct 

observations made during the conduct of the inspection, and if necessary, a review of 

selected transportation records, the inspector should verify that the licensee's 

hazardous material training, packages and associated documentation, vehicles 

(including placarding, cargo blocking, and bracing, etc.), and shipping papers are 

adequate and in accordance with NRC and DOT regulatory requirements for 
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transportation of radioactive materials. Furthermore, from those discussions and 

reviews, if necessary, the inspector should verify if any incidents had occurred and that 

they were appropriately reported to DOT and NRC.

For further inspection guidance, the inspector should refer to IP 86740, “Inspection of 

Transportation Activities.” Inspectors should also refer closely to “Hazard 

Communications for Class 7 (Radioactive) Materials,” the NRC field reference charts on 

hazard communications for transportation of radioactive materials, which contain 

references to the new transportation requirements, and are useful field references for 

determining compliance with the transportation rules on labeling, placarding, shipping 

papers, and package markings.

e. Material Security and Control. During tours of the licensee’s facilities, the inspector 

should note areas where radioactive materials are used and stored. From those direct 

observations, the inspector should verify that the storage areas are locked and have 

limited and controlled access. The inspector should verify that radioactive materials, 

afterloaders, and storage devices are properly labeled. If from those observations, the 

inspector identifies concerns regarding access to storage areas, a review of the 

licensee’s administrative controls may be necessary. For some licensee’s the controls 

may include a utilization log to indicate when radioactive material is taken from and 

returned to storage areas.

The inspector should determine through direct observations that the treatment rooms 

containing remote afterloaders are under constant surveillance or physically secured 

when not in use. The inspector should discuss with appropriate licensee 

representatives the licensee’s procedures for access controls in order to verify that 

adequate controls are in place and working effectively.

The inspector should note that for some licensees the key to the unit console is often 

left in the console over the course of the day dependent on the licensee’s patient work 

load. The inspector should interview appropriate licensee operators to determine their 

normal control of the console key during the periods that they are away from the 

console in accordance with 10 CFR 35.610.

f. Written Directives. During the onsite inspection, the inspector’s observation of the 

patient administration is contingent upon the patient’s acceptance of being observed. 

The inspector should interview individuals as they perform applicable duties to 

determine that individuals are knowledgeable about the need for written directives and if 

the licensee’s written directives, as implemented, effectively ensure that radiation from 

byproduct material will be administered as directed by the authorized user in 

accordance with 10 CFR 35.41. The review should include the licensee’s 

implementation of its written procedures to provide high confidence that each 

administration is administered in accordance with the written directive and associated 

treatment plan. The inspector should sample selected brachytherapy cases and 

determine if the licensee implements actions to verify that: (1) prior to treatment, the 

treatment plan, if applicable, is in accordance with the written directive; (2) prior to 

treatment, the treatment parameters (e.g., source positioning, high dose-rate remote 

afterloader (HDR) unit settings, applicator type and size, etc.) are in accordance with 

the written directive and the treatment plan; and (3) after treatment, the treatment 
Issue Date: 02/26/15 10 87132

parameters used were in accordance with the written directive and the treatment plan, if 

applicable (e.g., post treatment imaging to verify correct source positioning, etc.). If the 

inspector identifies a concern(s) regarding the licensee’s implementation of its written 

procedures to provide high confidence that each administration is in accordance with 

the written directive and associated treatment plan, then the inspector should review the 

licensee’s procedures to determine if they are adequate and/or not fully implemented.

See Appendix B (Reviewing Licensees’ Implementation of Procedures for Permanent 

Implant Brachytherapy Administrations) for more information.

g. Patient Release. Through discussions with cognizant licensee representatives and if 

necessary, a review of selected records, the inspector should verify the licensee’s 

methods for establishing compliance with 10 CFR 35.75.

1. The inspector should note that the patient release criteria permit licensees to 

release individuals from control if the total effective dose equivalent (TEDE) to 

any other individual is not likely to exceed 0.5 rem. Through discussions with 

cognizant licensee representatives and if necessary, a review of selected 

records, the inspector should verify that the licensee has taken adequate 

measures to ensure that patients have been released in accordance with 10 CFR 

35.75.

2. Through further discussions the inspector should verify that the licensee is 

familiar with the requirements in 10 CFR 35.75(b) to provide instructions to 

released individuals if the dose to any other individual is likely to exceed 0.1 rem. 

The inspector should note that, in general, the licensee is required to give 

instructions, including written instructions, on how to maintain doses to other 

individuals as low as is reasonably achievable. The inspector may determine 

how the licensee is demonstrating compliance with this requirement by 

discussing the content of the instructions with appropriate licensee staff. If 

concerns are identified from those discussions, the inspector may find it 

necessary to review the sample instructions given to patients. If the licensee is 

required by the rule to provide instructions to breast-feeding women, the 

inspector should verify through further discussions and reviews, if necessary, that 

the instructions include guidance on the interruption or discontinuation of breastfeeding and information on the potential consequences of failure to follow the 

guidance.

3. Through discussions with cognizant licensee representatives and if necessary, a 

review of selected records, the inspector should verify that if the TEDE to a

breast-feeding child could exceed 0.5 rem if the breast-feeding were continued, 

the licensee has maintained documentation that instructions were provided in 

accordance with 10 CFR 35.75(d).

h. Medical Events. Through discussions with cognizant licensee representatives, the 

inspector should determine if the licensee is knowledgeable of and in compliance with

the requirements for identification, notification, reports, and records for medical events 

as required by 10 CFR 35.3045. The inspector should assess the licensee’s ability to 

effectively identify and respond to different types of medical events (e.g., administered 

dose that differs by 20 percent or more from the prescribed dose) through interviews 

with selected staff and a review of selected records. The inspector should verify that 
Issue Date: 02/26/15 11 87132

licensee staff is aware of the person within the organization: 1) to whom they should 

report a medical event or treatments that may have resulted in a medical event; and 2)

who is responsible for reporting medical events to the NRC. If during the inspection a 

previously unidentified medical event is identified, the inspector should: 1) remind the 

licensee of the need to comply with the reporting requirements described in 10 CFR 

35.3045, “Report and Notification of a Medical Event;” and 2) follow the guidance 

provided in Management Directive 8.10, “NRC Medical Event Assessment Program.” 

Upon identification of such an event, the inspector should notify NRC regional 

management as soon as possible to ensure that appropriate guidance is given and 

matters are reviewed before completing the inspection. 

For permanent implant brachytherapy administrations, the inspector may use the 

criteria in the Interim Enforcement Policy “Enforcement Discretion for Permanent 

Implant Brachytherapy Medical Event Reporting (10 CFR 35.3045)”, henceforth 

abbreviated as IEP, and exercise discretion to not cite a violation in two situations. If 

the inspector determines that a licensee used total source strength and exposure time 

to evaluate the existence of medical event and the criteria in the IEP were met, the 

inspector may exercise enforcement discretion to not cite a violation for failure to use a 

dose-based calculation. If the inspector determines that the licensee used absorbed 

dose to evaluate the existence of a medical event, the total dose to the treatment site 

equaled or exceeded 120 percent of the prescribed dose, and the criteria in the IEP 

were met, the inspector may exercise enforcement discretion to not cite a violation for 

failure to report a medical event. The IEP does not require inspectors to document the 

use of this enforcement discretion. It also does not require the licensee to make a 

medical event report in accordance with 10 CFR 35.3045 or to take any corrective 

actions. See Appendix C (Use of the Interim Enforcement Policy for “Enforcement 

Discretion for Permanent Implant Brachytherapy Medical Event Reporting (10 CFR 

35.3045)”) for more information.

i. Posting and Labeling. During tours of the licensee’s facilities, the inspector should 

determine by direct observations whether proper caution signs are being used at 

access points to areas containing radioactive materials and radiation areas. The 

inspector should note that 10 CFR 20.1903 provides exceptions to posting caution 

signs. During those tours, the inspector should selectively examine signals and alarms 

to determine adequate operability. During the conduct of the inspection the inspector 

should observe labeling on packages or other containers to determine that proper 

information (e.g., isotope, quantity, and date of measurement) is recorded.

During tours of the licensee’s facilities, the inspector should verify that radiation areas 

have been conspicuously posted, as required by 10 CFR 20.1902. Depending on the 

associated hazard, the licensee’s controls may include tape, rope, or structural barriers 

to prevent access. The inspector should verify that high radiation areas have been 

strictly controlled to prevent unauthorized or inadvertent access. Such controls may 

include, but are not limited to, direct surveillance, locking the high radiation area, 

warning lights, and audible alarms. The inspector should determine that areas 

occupied by radiation workers for long periods of time and common-use areas have 

been controlled in accordance with licensee procedures and be consistent with the 

licensee's ALARA program.
Issue Date: 02/26/15 12 87132

During tours of the licensee’s facilities, the inspector should observe locations where 

notices to workers are posted. The inspector should verify that applicable documents, 

notices, or forms are posted in a sufficient number of places to permit individuals 

engaged in licensed activities to observe them on the way to or from any particular 

licensed activity location to which the postings would apply in accordance with 10 CFR 

19.11, 20.1902, and 21.6.

During tours of the licensee’s facility, the inspector should verify that emergency 

procedures for remote afterloaders are appropriately posted at the control console in 

accordance with 10 CFR 35.610.

j. Waste Storage and Disposal. Through discussions with cognizant licensee 

representatives and direct observations made during tours of the licensee’s facility, the 

inspector should verify that the licensee has appropriately disposed of brachytherapy 

sources. From those discussions and if necessary, a review of selected records, the 

inspector should ascertain if the licensee has an adequate method of determining that 

recipients of radioactive wastes are licensed to receive such waste (e.g., licensee 

obtains a copy of the waste recipient's current license before the transfer). Sealed 

sources, used in afterloaders, are exchanged on receipt of a new source. In addition, 

through further discussions, observations and reviews, if necessary, the inspector 

should verify that the licensee has appropriate methods to track the items in storage.

From those discussions and direct observations, the inspector should verify that 

radioactive wastes are disposed of in proper containers.

For further inspection guidance in this area, the inspector should refer to IP 84850, 

“Radioactive Waste Management-Inspection of Waste Generator Requirements of 10 

CFR Part 20 and 10 CFR Part 61.”

k. Inventories. Through discussions with cognizant licensee representatives, direct 

observations made during tours of the licensee’s facility, and if necessary, a review of 

selected records, the inspector should verify that the licensee is conducting a semiannual inventory of all sealed sources and brachytherapy sources in accordance with 

10 CFR 35.67(g). If appropriate, the inspector should independently verify through 

direct observations or a review of selected records of receipt and transfer to determine 

that the quantities and forms of licensed material possessed and used by the licensee 

are as authorized in the license.

03.03 Shielding of Licensed Material. An inspector should determine that a licensee

has maintained shielding of licensed materials in a manner consistent with operating

procedures and design and performance criteria for devices and equipment.

In an application for a license, an applicant must indicate the location and description of 

shielding along with calculations of estimated radiation levels. Through observations and 

interviews, an inspector should determine availability and placement of shielding, and inquire 

about unshielded activities and radiation exposure levels for the following areas:

a. Manual Brachytherapy. Determine use of manual brachytherapy source storage 

shields and body shields for applicator loading and unloading areas;
Issue Date: 02/26/15 13 87132

b. Patient Treatment Rooms. Facility shielding may have been installed for certain patient 

treatment rooms to reduce radiation levels in adjacent areas and areas above and 

below the room. If a viewing window is observed, check for leaded glass in the viewing 

window. Use of portable shielding in patient rooms may have been indicated. The 

inspector should visually confirm that the licensee has portable shields and should 

interview staff to confirm that the shields are set to the approved configuration for the 

room during procedures;

c. Sr-90 Eye Applicators. Determine the source is properly shielded or stored to prevent 

bremsstrahlung radiation or high ambient dose rates.

If shielding is not evident, then the inspector should assess the licensee’s procedure to use 

shielding and the licensee’s further evaluation of radiation doses to workers and members of the 

public respectively under 10 CFR 20.1201, 20.1301, and 20.1302. The inspector should verify 

that the licensee instructed workers under 10 CFR 19.12 about use of shielding. In certain 

cases, a licensee may have determined that shielding was not indicated under particular 

conditions to protect the patient or human research subject from a non-radiological hazard 

which has significant health and safety consequences to the patient or human research subject. 

03.04 Comprehensive Safety Measures. During tours of the licensee’s facilities, the inspector 

should be aware of potential industrial safety hazards for referral to the U. S. Department of 

Labor's Occupational Safety and Health Administration.

During tours of the facility and discussions with cognizant licensee representatives, the 

inspector should verify that the licensee’s radioactive waste and licensed material are protected 

from fire and the elements, the integrity of packages containing licensed material is adequately 

maintained, areas used to store licensed material are properly ventilated, and adequate controls 

are in effect to minimize the risk from other hazardous materials.

03.05 Radiation Dosimetry Program. The inspector can find specific inspection

guidance for this area in IP 83822, “Radiation Protection.”

a. Radiation Protection Program. Through discussions with cognizant licensee 

representatives and if necessary, a review of selected records, the inspector should 

verify that the licensee has developed, implemented and maintained an adequate 

radiation protection program commensurate with the licensee's activities, that the 

program includes ALARA provisions, and that the program is being reviewed by the 

licensee at least annually, both for content and implementation in accordance with 10 

CFR 20.1101.

b. Occupational Radiation Exposure. From a review of selected occupational radiation 

dosimetry reports and discussions with cognizant licensee representatives, the 

inspector should determine that occupational radiation exposures received by workers 

are within NRC regulatory limits (e.g., 10 CFR 20.1201, 1202, 1207, and 1208). If from 

those reviews and discussions the inspector determines that a worker had exceeded an 

NRC regulatory limit, the inspector should immediately contact NRC regional 

management to discuss the matter and determine what steps need to be taken in 

following up on this matter.
Issue Date: 02/26/15 14 87132

10 CFR 19.13(b) requires that each licensee shall advise each worker annually of the 

worker's dose, as shown in dose records maintained by the licensee. Through 

discussions with cognizant licensee staff and management, the inspector should verify 

that the licensee has advised workers of their doses annually. The licensee must 

advise all workers for whom monitoring is required. The licensee must advise these 

workers of doses from routine operations, and doses received during planned special 

exposures, accidents, and emergencies. If the inspector cannot conclude from those 

discussions that workers had been advised of their occupational dose annually, then a 

records review may be more appropriate to confirm that the licensee had conducted this 

required task. The report to the individual must be in writing and must contain all the 

information required in 10 CFR 19.13(a).

c. Personnel Dosimeters. Through direct observations made during the onsite inspection, 

the inspector should independently verify that appropriate personal dosimetry devices 

are worn by appropriate licensee personnel. The inspector should verify that dosimetry 

devices appropriate to the type, energy of emitted radiation, and the anticipated 

radiation fields have been issued to facility personnel. In addition, the inspector should 

verify that dosimeters are processed by a National Voluntary Laboratory Accreditation 

Program approved and accredited processor in accordance with 10 CFR 20.1501.

03.06 Radiation Instrumentation Surveys and Leak Tests.

a. Equipment and Instrumentation.

1. Through discussions with cognizant licensee representatives, direct observations 

of licensed activities, and if necessary, a review of selected records, the 

inspector should ensure that equipment and instrumentation used by the licensee 

to conduct licensed activities are appropriate to the scope of the licensed 

program, operable, calibrated, and adequately maintained in accordance with 

NRC regulatory requirements and the manufacturer’s recommendations.

The inspector should independently verify through direct observations that survey 

instruments have the appropriate range of use in accordance with 10 CFR 35.61. 

The inspector should also verify that the survey instruments are calibrated at the 

required frequency and checked for operability before use, in accordance with 10 

CFR 35.61. The inspector should have cognizant licensee staff conduct the 

check for operability to ensure that these individuals are knowledgeable in how 

the instrument works and performs. The inspector should ask the individuals 

what actions are taken when radiation detection equipment is non-functional. 

During the inspection, the inspector should independently verify that for those 

survey and monitoring instruments available for use have current calibrations 

appropriate to the types and energies of radiation to be detected. For those 

licensee’s that calibrate their own instruments, the inspector should have 

cognizant licensee staff perform or demonstrate how those activities are 

conducted in order to demonstrate the technical adequacy of the licensee’s 

calibration procedures.
Issue Date: 02/26/15 15 87132

2. During the inspection, the inspector should independently verify that the licensee 

has access to a dosimetry system for performing the full calibration and spotcheck measurements of remote afterloader unit output. The system must be 

calibrated in accordance with the requirements of 10 CFR 35.633 and 643. 

During the inspection, the inspector should review selected dosimetry 

worksheets from the previous full calibration measurements required by 10 CFR 

35.633 and 643. If the licensee participates in intercomparison of dosimetry 

measurements, the inspector should review the licensee's performance results to 

determine that systemic measurement errors are identified and corrected.

3. During the conduct of the inspection, the inspector should independently check 

the installed radiation monitors to ensure that they have been maintained in 

accordance with the applicable requirements. In addition, the inspector should 

independently verify the operability of permanent radiation monitors, availability 

of backup power supply for the source-retract systems, source position 

indicators, daily checks, service and maintenance of units. During the inspection, 

the inspector may have cognizant licensee staff demonstrate the operability of 

those devices to ensure that they perform as designed.

4. When appropriate, the inspectors should confirm that the licensee is 

knowledgeable in identifying and reporting defects in accordance with Part 21. 

This will vary dependent upon the scope of the licensee’s program.

b. Area Radiation Surveys. During tours of the licensee’s facility, the inspector should 

verify by direct observations and independent measurements, that area radiation levels 

are within NRC regulatory limits, and that those areas are properly posted. The 

inspector should have the licensee spot-check area radiation levels in selected areas 

using the licensee's own instrumentation. If during the conduct of the inspection a 

brachytherapy procedure is currently in progress, the inspector should make 

independent measurements in adjacent unrestricted areas to confirm that the 

requirements of 10 CFR 20.1301 are met. However, the inspector must use NRC 

radiation survey instruments for independent verification of the licensee's 

measurements. (The inspector's instruments shall be calibrated and source-checked 

before he/she leaves the NRC regional office.) The inspector should conduct such 

surveys as further discussed in Section 0312.

If practical and when appropriate, the inspector should observe licensee staff conduct 

area radiation and removable contamination surveys, to determine the adequacy of 

such surveys. The inspector should verify the types of instruments used, and whether 

they are designed and calibrated for the type of radiation being measured. The survey 

activities should be at a specified frequency, in accordance with the related licensee 

procedures. The inspector should also perform independent confirmatory 

measurements, as needed to verify licensee assumptions or measurements.

The inspector should verify by independent measurement that shielding surveys of the 

main source safe with the source in the shielded position and treatment room are in 

compliance with the requirements of 10 CFR 35.652. Indications of higher than 

expected dose levels by an inspector may indicate that the source is a higher activity 

than authorized or that the source is not fully shielded on retraction.
Issue Date: 02/26/15 16 87132

c. Source Replacement Surveys. Through discussions with cognizant licensee 

representatives and if necessary, a review of selected records, the inspector should 

verify that the licensee has performed surveys following source changes, device repair, 

or device maintenance for remote after loader programs.

Through further discussions, direct observations of license activities, and reviews, if 

necessary, the inspector should verify the licensee's performance in conducting timely 

patient and area surveys for brachytherapies (both permanent and temporary implants), 

as well as source-removal, patient-release, and room-release surveys. For temporary 

implant brachytherapy procedures, a radiation survey of the patient must be performed 

immediately after source removal.

If from those discussions and direct observations the inspector determines that 

individuals do not understand, perform checks or conduct activities appropriately to 

ensure compliance to NRC regulatory requirements, the inspector should discuss this 

matter with appropriate licensee representatives as soon as practicable to ensure that 

previous activities have been conducted appropriately and retraining of the individuals 

is conducted prior to using such instruments for such surveys.

d. Leak Tests. During the conduct of the inspection, the inspector should verify that leak 

tests of sealed or contained sources are performed at the required frequency found in 

10 CFR 35.67(b) or license conditions. Through discussions with cognizant licensee 

representatives, direct observations, and if necessary, a review of selected records, the 

inspector should verify that the leak test is analyzed in accordance with 10 CFR 

35.67(c). If records of leak test results show removable contamination in excess of the 

regulatory requirements of 0.005 microcuries (185 becquerels) or approved level 

included in a license condition, the inspector should verify that the licensee made the 

appropriate notifications per 10 CFR 35.67 (e) and removed the source from service.

03.07 Radiation Safety Training and Practices

a. General Training. During the onsite inspection, the inspector should discuss with 

cognizant licensee staff how, and by whom, training is conducted and the content of the 

training provided to workers.

Through discussions with cognizant licensee representatives and if necessary, a review 

of selected records, the inspector should verify, pursuant to 10 CFR 19.12, that 

instructions have been given to individuals who in the course of employment are likely 

to receive in a year an occupational dose in excess of 1 milliSievert (100 mrem). The 

inspector should note that it is the licensee’s management’s responsibility to inform the 

workers of precautions to take when entering a restricted area, kinds and uses of 

radioactive materials in that area, exposure levels, and the types of protective 

equipment to be used. The workers should also be informed of the pertinent provisions 

of NRC regulations and the license, and the requirement to notify management of 

conditions observed that may, if not corrected, result in a violation of NRC 

requirements. Also, the inspector should verify that authorized users and workers 

understand the mechanism for raising safety concerns.
Issue Date: 02/26/15 17 87132

Of the training program elements, training given to authorized users, and those 

individuals under the supervision of authorized users, is of primary importance. The 

inspector should interview one or more users of radioactive materials to independently 

verify that they have received the required training. The inspector should note that the 

training should be (and in most cases is required to be) provided to workers before the 

individual's performance of licensed activities.

If necessary, the inspector may need to review selected records of personnel training to 

the extent that the inspector is satisfied that the training program is being implemented 

as required.

During the inspection, the inspector should observe related activities and discuss the 

radiation safety training received by selected individuals to ensure that appropriate 

training was actually received by these individuals. From those observations and 

discussions, the inspector should verify that authorized users and supervised 

individuals understand the radiation protection requirements associated with their 

assigned activities. The licensee's radiation safety training may include, but is not 

limited to, demonstrations by cognizant facility personnel, formal lectures, testing, 

videos, and “dry runs” for more complex or hazardous operations.

b. Operating and Emergency Procedures. Emergency procedures will be developed, 

implemented and maintained by the licensee in accordance with 10 CFR 35.610 and 

may vary from step-by-step procedures to more generalized procedures. During the 

conduct of the inspection, the inspector should verify that these procedures are posted 

at the remote afterloader unit console in accordance with 10 CFR 35.610. During the 

inspection the inspector should interview operators of the unit to determine that actions 

required to be performed in the event of abnormal operation of the device are known by 

such individuals.

From those interviews, the inspector should determine if such individuals are aware of 

the location of the operating procedures and what procedures to follow in the event of 

an emergency. In particular the inspector should determine if cognizant licensee staff is 

aware of the requirement to carry functional radiation detection devices into the room if 

the room monitor is non-functional. The inspector should determine if such staff is 

aware of the location of the alternative radiation detection devices since in an 

emergency the staff would not have time to look for the monitor. From further 

discussions, the inspector should determine if the individuals are aware that radiation 

surveys of the device and the patient are to be performed after a procedure is 

completed. In addition, from those interviews, the inspector should determine if 

cognizant staff is aware of the location of emergency source-recovery equipment. In 

addition, the inspector should attempt to interview nurses who have been involved in 

treatments using the device to determine their familiarity with the licensee’s emergency 

procedures.

Some licensees may have agreements with other agencies (e.g., fire, law enforcement, 

and medical organizations) regarding response to emergencies. The inspector should 

discuss with cognizant licensee representatives what has been done to ensure that 

agencies (involved in such agreements) understand their roles in emergency 

responses.
Issue Date: 02/26/15 18 87132

c. Strontium-90 Eye Applicators

1. During the conduct of the inspection, the inspector should verify that the licensee 

is using the most recent calibration results. The inspector should note that a 

medical event has occurred if: 1) the licensee, in prescribing a dose and 

planning its delivery, does not use the most recent calibration results available to 

it at the time; and 2) the administered dose, calculated from the most recent 

calibration results available at the time of dose prescription, differs from the 

prescribed dose by greater than 20 percent. The inspector should not apply the 

dose rate results of a recent calibration to previous therapeutic administrations, 

for the purpose of identifying medical events, provided the previous calibration 

was considered valid at the time.

At this time, two calibration laboratories are known to be capable of providing the 

required NIST-traceable calibrations of Sr-90 ophthalmic applicators. They are 

NIST, itself, and the University of Wisconsin Accredited Dosimetry Calibration 

Laboratory. The inspector should note that the applicator is required to be a 10 

CFR 35.49 source.

2. The inspector should also refer to Information Notice (IN) 96-66, ARecent 

Misadministrations Caused by Incorrect Calibrations of Strontium-90 Eye 

Applicators,@ for additional inspection guidance. This IN discusses the need to 

ensure that the dose rate from the eye applicator is correct for assurance that the 

prescribed dose is the administered dose. The IN describes examples of 

medical events and includes a decay table for the source.

3. The inspector should note that for convenience and because of physical 

characteristics of the device, eye applicator sterilization is usually accomplished 

by immersion/dwell in appropriate liquid, such as isopropyl alcohol, or by gentle 

sweeping contact with a liquid-saturated gauze pad. During discussions with 

cognizant licensee representatives, the inspector should verify that the licensee 

is not using liquids containing halogenated compounds. These liquids are to be 

avoided, as corrosion of typically-constructed applicators can occur.

4. Through direct observations made during the conduct of the inspection, the 

inspector should ensure that the licensee has properly shielded or stored the 

source to prevent bremsstrahlung radiation or high ambient dose rates.

5. The inspector should note that requirements for monitoring occupational 

exposure are specified in 10 CFR 20.1502. From direct observations made 

during the conduct of the inspection and discussions with cognizant licensee 

representatives, the inspector should ensure that proper ALARA techniques are 

used. Some techniques may include a method, such as the use of an ophthalmic 

speculum, to hold the patient’s eye open during treatment, to minimize 

occupational exposure to the user’s fingers.

6. The inspector should note that in accordance with 10 CFR 71.9, the 

transportation of eye applicators between license-authorized offices or hospitals 

is to be conducted by a physician licensed by a State to dispense drugs in the 
Issue Date: 02/26/15 19 87132

practice of medicine, and licensed under 10 CFR part 35 or the equivalent 

Agreement State regulations.

03.08 Management Oversight. The inspector should interview cognizant licensee

representatives to gain information concerning organization, scope, and management 

oversight of the radiation safety program.

a. Organization. During the conduct of the inspection, the inspector should interview 

cognizant licensee representatives to discuss the current organization of the licensee’s 

program. The licensee's organizational structure will usually be found in the license 

application and may involve one or more individuals. The inspector should review with 

cognizant licensee representatives the licensee's organization with respect to changes 

that have occurred in personnel, functions, responsibilities, and authorities since the 

previous inspection. Through discussions with cognizant licensee representatives, the 

inspector should determine the reporting structure between executive management, the 

Radiation Safety Officer (RSO), and if applicable, the Chairperson of the RSC, and 

other members of the RSC. Through discussions with cognizant licensee staff, the 

inspector should determine whether the RSO has sufficient access to licensee 

management. Through further discussions with cognizant licensee representatives, the 

inspector should determine if changes in ownership or staffing have occurred. If the 

owner or individuals named in the license have changed, the inspector should 

determine whether the licensee has submitted appropriate notification to NRC. This 

information must be provided whenever changes in ownership or personnel named in 

the license are made. Through discussions with cognizant licensee management the 

inspector should determine if changes have occurred, or are anticipated, and ask 

personnel to confirm (to the inspector's satisfaction) that no changes have taken place. 

If there have been no changes in the organization since the previous inspection, there 

is no need to pursue this element in further detail. If there have been changes in 

ownership, the inspector should discuss this matter with appropriate licensee 

representatives and NRC regional staff (e.g., license reviewers) to ensure that proper 

actions will be taken in response to the changes in ownership.

Through discussions with cognizant licensee representatives, the inspector should 

review any organizational change in the RSO position, authorities, responsibilities, and 

reporting chains. The inspector should be sensitive to changes that reduce the ability of 

the RSO to resolve concerns or issues related to the safe conduct of the radiation 

protection program. The inspector should discuss with cognizant licensee management 

representatives and the RSO about the RSO's authority and about any changes that 

may impact upon the RSO's duties, responsibilities, or effectiveness.

b. Scope of Program. Through discussions with cognizant licensee staff and direct 

observations of licensed activities, the inspector can obtain useful information about the 

types and quantities of material, frequency of use, incidents, etc. From those 

discussions and direct observations made during tours of the licensee’s facilities, the 

inspector will be able to discern the actual size and scope of the licensee's program, 

and to determine if significant changes have occurred since the previous inspection. 

Through further discussions inspector should determine if multiple places of use are 

listed on the license. In cases where there are multiple sites/satellite facilities, the 

inspector should determine if inspections should be performed at all sites. This 

decision should be based on IMC 2800, “Materials Inspection Program,“ and regional 
Issue Date: 02/26/15 20 87132

c. policy for performing inspections at satellite facilities. From those observations and 

discussions, the inspector should verify that the locations of use are as authorized in 

the license. If the inspector determines that there are locations of use not authorized 

under the license, the inspector should discuss this matter with appropriate licensee 

representatives to ensure that the license is amended to allow the unauthorized location 

of use in accordance with 10 CFR 35.13 and/or 35.14. Furthermore, the inspector 

should determine if licensed activities conducted at such locations were conducted in 

accordance with NRC regulatory requirements and the licensee’s license. Also, the 

inspector should follow-up with this matter with appropriate NRC regional licensing staff 

to ensure that they apprised of this matter for proper licensing action.

d. Radiation Program Administration. In the course of interviewing cognizant licensee 

personnel, the inspector should determine if management oversight is sufficient to 

provide the licensee’s staff with adequate resources and authority to administer the 

licensed program. In the review to verify implementation of the radiation safety 

program, the inspector should pay particular attention to the scope of the program, 

frequency of licensee audits, and the use of qualified auditors. If necessary, the 

inspector should review selected procedures for recording and reporting deficiencies to 

management; and methods and completion of follow-up actions by management.

1. Radiation Safety Officer (RSO). The RSO is the individual, appointed by 

licensee management and identified on the license, who is responsible for 

implementing the radiation safety program. The inspector should independently 

verify through discussion and direct observations of licensed activities that this 

individual is knowledgeable about the program, and ensures that activities are 

being performed in accordance with approved procedures and the regulations. 

The inspector should verify that, when deficiencies are identified, the RSO has 

sufficient authority, without prior approval of the RSC, if applicable, to implement 

corrective actions, including termination of operations that pose a threat to health 

and safety.

2. Audits. The frequency and scope of audits of the licensed program will vary. 

However, the inspector should note that at a minimum, medical licensees are 

required by 10 CFR 20.1101(c) to review the radiation safety program content 

and implementation at least annually. The results of audits should be 

documented. If time permits, the inspector should examine these records with 

particular attention to deficiencies identified by the auditors, and note any 

corrective actions taken as a result of deficiencies found. If no corrective actions 

were taken, the inspector through discussions with cognizant licensee 

representatives should determine why the licensee disregarded deficiencies 

identified during audits, and whether the lack of corrective actions caused the 

licensee to be in non-compliance with regulatory requirements.

3. Radiation Safety Committee (RSC). Through discussions with cognizant 

licensee representatives, direct observations of licensed activities, and if 

necessary, a review of selected records, the inspector should note if the licensee 

is required to maintain an RSC in accordance with 10 CFR 35.24(f). If 

applicable, through discussions with cognizant RSC representatives, the 

inspector should independently verify that topics of discussion during RSC 

meetings included ALARA reviews, incidents, generic communications, 
Issue Date: 02/26/15 21 87132

authorized users and uses, safety evaluations, audits, and medical events, as 

defined in 10 CFR 35.2, etc. From those discussions, the inspector should verify 

that the committee is made up of representatives from each type of program 

area, the RSO, a representative of the nursing service, and a representative from 

management. If time permits, the inspector should review meeting minutes (and 

interview selected committee members when practical) to determine the 

committee's effectiveness.

From those discussions, the inspector should determine if the RSC has been 

aggressive in seeking out areas needing improvement, rather than just 

responding to events and information from outside sources. The inspector 

should also determine whether the RSC has recommended any specific actions 

and assess the implementation of those recommendations. The inspector's 

review should be of sufficient depth and detail to provide an overall assessment 

of the committee's ability to identify, assess, and resolve issues. Also, the 

inspector should determine the effectiveness of the RSC to communicate the 

results of audits and trending analyses to appropriate personnel performing 

licensed activities.

e. Authorized Users. Authorized users (physicians and medical physicists) may either be 

named in the license application or appointed by the licensee dependent upon the 

scope of the licensed program. For those appointed by the licensee, the inspector 

should independently verify that the authorized user is trained in accordance with the 

approved criteria and has knowledge commensurate with operational duties.

The inspector should noted that the regulations in 10 CFR 35.11(b) allow an individual 

to receive, possess, use, or transfer byproduct material for medical use “under the 

supervision of” the authorized user, unless prohibited by license condition. Also, these 

regulations do not specifically require that the authorized user be present at all times 

during the use of such materials. The authorized user/supervisor is responsible for 

assuring that personnel under his/her supervision have been properly trained and 

instructed, pursuant to 10 CFR 35.27(a), and is responsible for the supervision of 

operations involving the use of radioactive materials whether he/she is present or 

absent. Through discussions with cognizant licensee representatives, the inspector 

should verify that the appropriate individuals are present or available for assistance 

during remote afterloader treatments in accordance with 10 CFR 35.615(f).

f. Authorized Uses. Through discussions with cognizant licensee staff and direct 

observations made during tours of the licensee’s facilities, the inspector should 

independently verify that the licensee's use of byproduct material is limited to that which 

is authorized in the license. Uses of remote afterloader units for other than human use 

would require the licensee to comply with 10 CFR Part 36.

From direct observations of the use of licensed material, discussions with cognizant 

licensee personnel, and if necessary, a review of selected records, the inspector should 

determine that the type, quantity, and use of licensed material at the licensee's facility 

are as authorized by the license.
Issue Date: 02/26/15 22 87132

g. Financial Assurance and Decommissioning. The decommissioning recordkeeping 

requirements are applicable to all materials licensees, including licensees with only 

sealed sources, and are specified in 10 CFR 30.35(g). These records should contain, 

among other information: 1) records of unusual occurrences involving the spread of 

contamination in and around the facility, equipment, or site; 2) as-built drawings and 

modifications of structures and equipment in restricted areas where radioactive 

materials are used and/or stored, and locations of possible inaccessible contamination; 

and 3) records of the cost estimate performed for a decommissioning funding plan or 

the amount certified for decommissioning. This list is not all-inclusive of the information 

and requirements given in 10 CFR 30.35(g). The inspector should ensure that the 

licensee has such decommissioning records, that the records are complete, that they 

are updated as required, and that the decommissioning records are assembled or 

referenced in an identified location.

Some licensees may release rooms within a building for unrestricted use, without a 

license amendment. The release of these areas may fall outside of the reporting 

requirements in the Decommissioning Timeliness Rule if the licensee continues to 

conduct other activities in the same building. During the onsite inspection, the inspector 

should identify the rooms that have been released since the last inspection and perform 

random confirmatory measurements for selected rooms (e.g., randomly sample 

selected areas, not survey 100 percent); to verify that radiation and contamination 

levels are below release limits. Licensee survey records and other documentation 

should be reviewed to verify that the basis for releasing each room is adequately 

documented in the licensee's decommissioning records. If during the confirmatory 

survey, the inspector identifies levels above release limits, the inspector should inform 

appropriate licensee representatives as soon as practicable to review the matter, 

determine what appropriate actions need to be taken to address the matter, determine if 

members of the public have received radiation exposures that exceeded NRC 

regulatory limits, and assess those possible exposures. If the inspector determines 

that a member of the public may have received radiation exposures that exceeded NRC 

regulatory limits, the inspector should immediately contact NRC regional management 

for further guidance.

Licensees submit financial assurance instruments and/or decommissioning plans for a 

specific set of conditions. Occasionally, those conditions may change over time and the 

licensee may not notify NRC. The inspector should be aware of changes, in 

radiological conditions, while inspecting a licensee's facility, that would necessitate a 

change in the financial assurance instrument and/or decommissioning plan, especially 

where the radiological conditions deteriorate and the financial assurance instrument or 

decommissioning plan may no longer be sufficient. In preparation for the inspection, 

the inspector should determine the dates that the financial assurance instrument and 

decommissioning plan (if applicable) were submitted to NRC. During the inspection, 

through observations made during tours of the facilities, discussions with cognizant 

licensee personnel, and a review of selected records, the inspector should determine 

whether the radiological conditions at the licensee's facility have changed since the 

documents were submitted to NRC. If conditions have changed and the adequacy of 

the financial assurance instrument and/or decommissioning plan is in doubt, the 

inspector should contact regional management as soon as practicable from the 

licensee's site to discuss the situation.
Issue Date: 02/26/15 23 87132

Additionally, some licensees are required to maintain decommissioning cost estimates 

and funding methods on file. If the licensee uses a parent company guarantee or a 

self-guarantee as a funding method, the inspector should verify that the licensee has a 

Certified Public Accountant certify each year that the licensee passes a financial test. 

The financial test ratios for parent company guarantees and self-guarantees are 

specified in Section II, Appendix A and Appendix C, respectively, to Part 30.

h. Decommissioning Timeliness. Through discussions with cognizant licensee 

representatives and direct observations, the inspector should determine whether the 

license to conduct a principal activity has expired or been revoked. If the license 

remains in effect, the inspector should determine if the licensee has made a decision to 

cease principal activities at the site or in any separate building. Finally, the inspector 

should determine if there has been a 24-month duration in which no principal activities 

have been conducted in such areas. A principal activity is one which is essential to the 

purpose for which a license was issued or amended, and does not include storage 

incidental to decontamination or decommissioning. If the licensee meets any of the 

above conditions, the decommissioning timeliness requirements apply.

The inspector should note that the requirements of 10 CFR 30.36, 40.42 and 70.38 do 

not apply to released rooms within a building where principal activities are still on-going 

in other parts of the same building. Once principal activities have ceased in the entire 

building, then the decommissioning timeliness requirements will take effect.

The inspector should note that the NRC has a stringent enforcement policy with respect 

to violations of the decommissioning timeliness requirements. Failure to comply with 

the Decommissioning Timeliness Rule (failure to notify NRC, failure to meet 

decommissioning standards, failure to complete decommissioning activities in 

accordance with regulation or license condition, or failure to meet required 

decommissioning schedules without adequate justification) may be classified as a 

Severity Level III violation and may result in consideration of monetary civil penalties or 

other enforcement actions, as appropriate.

Decommissioning timeliness issues can be complex. For situations where an inspector 

has questions about the licensee's status and whether the decommissioning timeliness 

standards apply, he/she should contact NRC regional management as soon as 

practicable for further guidance.

For planning and conducting inspections of licensees undergoing decommissioning, the 

inspector should refer to IMC 2602, ” “Decommissioning Oversight and Inspection 

Program for Fuel Cycle Facilities and Materials Licensees;“ IP 87104, 

“Decommissioning Inspection Procedure for Materials Licensees;“ and NUREG-1757,

“Consolidated Decommissioning Guidance.“

i. Generic Communications of Information. Through discussions with cognizant licensee 

management and the RSO as well as through direct observations made during tours of 

the licensee’s facility, the inspector should verify that the licensee is receiving the 

applicable bulletins, information notices, FSME Newsletter, etc., and that the 

information contained in these documents is disseminated to appropriate staff 

personnel. The inspector should also verify that the licensee has taken appropriate 

action in response to these NRC communications, when a response is required.
Issue Date: 02/26/15 24 87132

j. Notifications and Reports. Through discussions with cognizant licensee representatives 

and if necessary, a review of selected records, the inspector should determine the 

licensee's compliance for notifications and reports to the Commission. The licensee 

may be required to make notifications following loss or theft of material, overexposures, 

incidents, high radiation levels, safety-related equipment failure, medical events, dose 

to an embryo/fetus or a nursing child, etc.

From those discussions and reviews, the inspector should verify that notifications 

and/or reports were appropriately submitted to NRC and individuals, if applicable. If the 

inspector determines that the licensee failed to submit such notifications and/or reports, 

the inspector should bring this matter to the attention of appropriate licensee 

representatives as soon as practicable for follow-up and compliance to the appropriate 

NRC regulatory requirements.

k. Special License Conditions. Some licenses will contain special license conditions that 

are unique to a particular practice or procedure, such as the use of remote afterloader 

equipment for non-medical purposes. In these instances, through discussions with 

cognizant licensee representatives, the inspector should verify that the licensee 

understands the additional requirements, and maintains compliance with the special 

license conditions. The inspector should also note that some special license conditions 

may state an exemption to a particular NRC requirement.

l. Research Involving Human Subjects. If applicable, the inspector must verify that this 

type of research satisfy the following conditions: 1) All research is conducted, 

supported, or regulated by another Federal Agency that has implemented AFederal 

Policy for Protection of Human Subjects@ (10 CFR 35.6), or the licensee is authorized 

to conduct such research; 2) the licensee obtains informed consent from the subjects, 

as defined and described in the Federal Policy; and 3) the licensee obtains prior review 

and approval from an Institutional Review Board, as defined and described in the 

Federal Policy.

03.09 Licensee Review of Licensed Activities Performed By Contracted Personnel. 

Licensees may contract personnel to perform licensed activities. The licensee is responsible for 

any violations of NRC regulatory requirements that result from activities conducted by contract 

personnel operating under the license. The inspector should independently verify through direct 

observations of licensed activities, discussions with cognizant licensee representatives, and as 

necessary, a review of selected records, that the licensee is reviewing work completed by 

contracted personnel who perform licensed activities in the same manner that all other licensed 

activities are reviewed. The inspector should verify that all parties to contractual arrangements 

are aware of their respective duties and are knowledgeable of and adhere to the licensee’s 

specific procedures. All parties should also be aware of, the reporting and feedback 

mechanisms implemented to ensure that appropriate actions are taken to address the 

contractor’s findings, particularly, potential regulatory violations.

Potential Problems. Though contract personnel can provide significant support to a radiation 

safety program, potential problems may be associated with their use. Common problems 

include: 1) Failure of the contract personnel to complete all required tasks in the specified 

manner or time frame; 2) Licensee assumes that all work was completed and fails to review the 

work of the contract personnel; 3) Licensee fails to correct problems identified by the contract 
Issue Date: 02/26/15 25 87132

personnel; 4) Failure of licensee to review work performed by contract personnel who work 

outside of normal working hours; 5) Hiring contract personnel who are not qualified or 

experienced; and 6) Contract personnel are not able to dedicate time to fulfill the contract 

agreement.

03.10 Other Medical Uses of Byproduct Material or Radiation from Byproduct Material. 

Due to the advancements of medical research and development, a variety of new medical uses 

of byproduct material or radiation from byproduct material are always on the forefront of 

providing optimal medical care to patients. Due to the increase in these various new medical 

uses of byproduct material or radiation from byproduct material, the regulations were revised to 

allow licensees the ability to use such uses in order to provide optimal patient care. In 

accordance with the regulations in 10 CFR 35.1000, the licensee may use byproduct material or 

a radiation source approved for medical use which is not specifically addressed in subparts D 

through H of this part if the licensee has submitted the information required by 10 CFR 35.12(b) 

through (d); and the licensee has received written approval from the NRC in a license or license 

amendment and uses the material in accordance with the regulations and specific conditions the 

NRC considers necessary for the medical use of the material. During discussions with 

cognizant licensee representatives and direct observations made during inspections, the 

inspector may encounter various new medical uses of byproduct material or radiation from 

byproduct material being used that have not been specifically amended to a licensee’s license. 

If an inspector encounters such a use, the inspector should contact regional management as 

soon as practicable to independently verify that such use is authorized under the regulations. If 

further verification of such use is needed, the region should contact FSME for further guidance.

For further inspection guidance, refer to IMC 2800.

87132-04 REFERENCES

IMC 0620 – “Inspection Documents and Records“

IP 86740 – “Inspection of Transportation Activities“

Management Directive 8.10, “NRC Medical Event Assessment Program“

IP 84850 – “Radioactive Waste Management – Inspection of Waste Generators 

Requirements of 10 CFR Part 20 and 10 CFR Part 61“

IP 83822, “Radiation Protection“

IN 96-66, “Recent Misadministrations Caused by Incorrect Calibrations of Strontium-90 Eye 

Applicators“

IMC 2800 – “Materials Inspection Program“

IMC 2602 – “Decommissioning Inspection Program for Fuel Cycle Facilities And Material 

Licensees“

IP 87104 – “Decommissioning Inspection Procedure for Materials Licensees“

NUREG-1757 – “Consolidated Decommissioning Guidance“
Issue Date: 02/26/15 26 87132

Interim Enforcement Policy for “Enforcement Discretion for Permanent Implant Brachytherapy 

Medical Event Reporting (10 CFR 35.3045)”, located in Section 9 of the NRC Enforcement 

Policy

Appendices:

A. Table 1, “Decay Factors for Strontium-90 Sources”

B. Reviewing Licensees’ Implementation of Procedures for Permanent Implant 

Brachytherapy Administrations

C. Use of the Interim Enforcement Policy for “Enforcement Discretion for Permanent Implant 

Brachytherapy Medical Event Reporting (10 CFR 35.3045)”

END
Issue Date: 02/26/15 A-1 87132

APPENDIX A
Issue Date: 02/26/15 B-1 87132

APPENDIX B

Reviewing Licensees’ Implementation of Procedures for Permanent

Implant Brachytherapy Administrations

The inspector should perform a general assessment of the licensee’s radiation safety program 

for permanent implant brachytherapy based on discussions with licensee staff, a review of 

selected records and procedures, and selected observations of licensed activities (if available). 

If the inspector concludes from this general assessment that licensee performance is adequate 

to ensure public health and safety, no further inspection effort is required. If the inspector 

determines that the licensee did not meet performance expectations, the inspector should 

conduct a more thorough review of that aspect of the licensee’s program and consider 

expanding the items reviewed. The inspector should focus on determining whether the 

identified weakness resulted in a safety issue. If a previously unidentified medical event is 

found during the inspection, follow the steps described in section 03.02h of this inspection 

procedure.

The inspector should always attempt to review the following:

 Description of permanent implant brachytherapy program, including the method(s) used for 

treatment planning and treatment administration, and the roles and responsibilities of each 

member of the treatment team.

 Method used to verify that the target is accurately identified and sources are accurately 

positioned.

 A sampling of recent written directives. Confirm that written directives include all required 

information, including pre-implantation and post-implantation sections.

 Method used to verify that the treatment was administered in accordance with the written 

directive and, if applicable, the treatment plan. Include review of a sampling of recent 

records.

 Licensee staff’s knowledge of NRC medical event reporting requirements and ability to 

recognize medical events, including consideration of both the treatment site and other 

organs and tissues.

The inspector may also review:

 Source ordering, verification of source strength and loading pattern, and source calibration.

 If computerized treatment planning is used, acceptance testing and calculation doublechecks.

 Method used to verify patient identity.
Issue Date: 02/26/15 B-2 87132

 Method used to demonstrate compliance with patient release requirements 

 Response to unusual circumstances such as equipment malfunctions, unavailability of

personnel, atypical patient anatomy, or unexpected imaging results.

It is typically not possible for inspectors to observe permanent implant brachytherapy treatment 

administrations, however regulatory requirements can be verified pre- and post-procedure. 

Inspectors should note that source implantation is usually performed in a sterile, surgical 

environment. It may be necessary for an inspector to receive approvals in advance to observe 

a surgical procedure, including consent from the patient before they have been administered

any sedation or anesthesia. Some licensees may require the inspector to sign a non-disclosure 

agreement. In addition, inspectors must follow all applicable licensee procedures for entering 

and observing activities in a sterile environment, including any special training.
Issue Date: 02/26/15 C-1 87132

APPENDIX C

Use of the Interim Enforcement Policy for “Enforcement Discretion for Permanent 

Implant Brachytherapy Medical Event Reporting (10 CFR 35.3045)”

Note: The Questions and Answers (Q&As) in this Appendix replace/supersede the Q&As 

distributed as the enclosure to the memorandum to Division Directors dated May 17, 2011 

(ADAMS accession ML111360037) and the Q&As in the revision of Inspection Procedure 87132 

issued on April 16, 2012.

The following supplemental information is intended to clarify use of the Interim Enforcement 

Policy (IEP) for “Enforcement Discretion for Permanent Implant Brachytherapy Medical Event 

Reporting (10 CFR 35.3045).” Although the examples pertain to permanent prostate implants, 

this information applies to permanent implant brachytherapy administrations anywhere in the 

patient’s body.

Inspectors are reminded that IP 87132 provides all of the official inspection guidance for 

permanent implant brachytherapy programs and that this Appendix is designed only to 

provide the inspector with additional insight concerning application of the IEP. Please 

note that licensed programs are not required to “fit” the descriptions in the example 

cases and that these cases do not represent all possible scenarios in which the IEP may 

be applied.

In SRM-SECY-12-0053, Recommendations on Regulatory Changes for Permanent Implant 

Brachytherapy Programs, the Commission directed the staff to pursue rulemaking to modify the 

requirements in 10 CFR 35.3045 for permanent implant brachytherapy medical event reporting. 

This included defining separate medical event criteria for permanent implant brachytherapy for 

all treatment sites, with a source strength-based criterion for the treatment site and dose-based 

criterion for other organs and tissues. The Commission also directed the staff to develop an 

interim enforcement policy to allow use of enforcement discretion for existing and future 

violations of current Part 35 that do not result in the misapplication of byproduct material by 

those licensees that use total source strength and treatment time for determining the existence 

of a medical event. 

As directed by the Commission, the staff is currently revising the regulations in 10 CFR Part 35 

for permanent implant brachytherapy programs to eliminate dose-based medical event reporting 

for the treatment site. In Federal Register Notice (FRN) “Interim Enforcement Policy for 

Permanent Implant Brachytherapy Medical Event Reporting” (78 FR 41125), the NRC issued an 

Interim Enforcement Policy (IEP) allowing the staff to exercise discretion for certain violations of 

regulations for reporting medical events involving permanent implant brachytherapy. 

The IEP allows for effective and objective criteria for medical event reporting for permanent 

implant brachytherapy until the rulemaking is finalized. It provides the option for licensees to 

use total source strength and exposure time instead of absorbed dose when evaluating the 

difference between delivered dose and prescribed dose, when use of these values does not 

result in misapplication of byproduct material by the licensee. The IEP also allows discretion, 
Issue Date: 02/26/15 C-2 87132

only for licensees that use absorbed dose for determining the existence of a medical event, 

when the total dose to the treatment site equals or exceeds 120 percent of the prescribed dose 

and certain criteria are met. This discretion is offered because stakeholders have informed the 

NRC that absorbed dose is an unreliable metric for regulatory purposes and the clinical 

objective is to deliver as much dose to the treatment site as possible, without exceeding 

medically-recognized dose limits for nearby normal tissues and structures.

Following publication in the Federal Register, the IEP was incorporated into the Section 9 of 

NRC Enforcement Policy, with the title Interim Enforcement Policy for “Enforcement Discretion 

for Permanent Implant Brachytherapy Medical Event Reporting (10 CFR 35.3045).”

 

The IEP does not require the inspector to document use of this enforcement discretion. It also 

does not require the licensee to make a medical event report in accordance with 10 CFR 

35.3045 or to take any corrective actions. 

The following questions, answers, and example cases illustrate application of the IEP.

Question 1

Do the requirements in Title 10 of the Code of Federal Regulations (10 CFR) Part 35 require 

that the prescribed dose in the written directive be expressed in units of dose, or may licensees 

also express the prescribed dose in units of total source strength and exposure time?

Answer 1

In accordance with the definition of “prescribed dose” in 10 CFR 35.2, the licensee may express 

the dose in the written directive in terms of either 1) dose or 2) total source strength and 

exposure time. However, 10 CFR 35.3045(a)(1) requires that a licensee report as a medical 

event an administration involving a dose that differs from the prescribed dose by more than 0.05 

Sv (5 rem) effective dose equivalent, 0.5 Sv (50 rem) to an organ or tissue, or 0.5 Sv (50 rem)

shallow dose equivalent to the skin.

 

Under the provisions of the IEP, inspectors may exercise enforcement discretion for licensees 

using total source strength and exposure time to compare the treatment site delivered dose to 

the prescribed dose to determine if a medical event has occurred for permanent implant 

brachytherapy administrations. Despite the criterion In 10 CFR 35.3045(a)(1), the FRN for the 

IEP noted that it is not necessary for the licensee to perform an assessment to compare the

delivered dose to the prescribed dose, with both doses in units of Sv or rem. The treatment site 

doses for therapeutic uses are large enough that a 20 percent variance in total source strength 

and exposure time will always result in a dose variance exceeding the values in 10 CFR 

35.3045(a)(1). 

This enforcement discretion may be used if all of the following criteria are met:

a. The licensee’s documented procedures required under 10 CFR 35.41 specify total source 

strength and exposure time as the regulatory evaluation values for treatment site dose 

comparisons;

b. The licensee entered both the prescribed dose and the delivered dose into the written 

directive as total source strength and exposure time; and

c. Per 10 CFR 35.3045, the licensee timely reported the event, if applicable, based on the

treatment site dose comparison in terms of source strength and exposure time.
Issue Date: 02/26/15 C-3 87132

Note that the IEP applies only to medical event determination for the treatment site. If the dose 

to other organs and tissues exceeded the criteria in 10 CFR 35.3045(a)(3), a medical event has 

occurred and the IEP does not apply.

To further illustrate Question 1, Answer 1, the following hypothetical cases are provided:

Case Number 1-1

Pre-treatment imaging was performed six weeks in advance of a permanent prostate 

implant. The authorized user approved a treatment plan that called for permanent 

implantation of 75 sources of Iodine-125 (I-125), source strength of 0.5 millicuries (mCi) 

per source, and 37.5 mCi total source strength. The licensee’s written program called for 

comparison of total source strength and exposure time. The authorized user signed a 

pre-implantation written directive for 75 sources of I-125, total source strength 37.5 mCi, 

and exposure time stated as “permanent.” During the surgical implant procedure, the 

authorized user found that the size of patient’s prostate had decreased and implanted a 

total of 65 sources. The authorized user signed a post-implantation written directive for 

65 sources of I-125, total source strength 32.5 mCi, and exposure time stated as 

“permanent.” A CT scan performed 30 days post-implant showed 65 sources within the 

prostate and a dose calculation showed that the dose to other organs and tissues did not 

exceed the medical event criteria in 10 CFR 35.3045(a)(3). 

Enforcement discretion may be used in this hypothetical case. The case did not involve 

misapplication of byproduct material—the authorized user made a conscious decision to 

decrease the number of sources to be implanted. The licensee’s documented procedures 

specified total source strength and exposure time as the regulatory evaluation values for 

treatment site dose comparisons; the authorized user entered both the prescribed dose 

and delivered dose into the written directive as total source strength and exposure time;

post-implant evaluation showed that the source strength implanted into the treatment site 

was within 20 percent of the source strength in the written directive; and the dose to other 

organs and tissues did not exceed the medical event criteria in 10 CFR 35.3045(a)(3). It 

is not necessary for the licensee to perform an assessment to compare the delivered 

dose to the prescribed dose, with both doses in units of Sv or rem.

Case Number 1-2

The licensee performed permanent prostate implants using real-time intraoperative 

planning. The sources that were ordered and implanted each contained 0.43 mCi of I125, however the physicist entered source strength into the treatment planning computer 

system in units of air kerma strength (μGy x m2/hr, abbreviated as U) instead of mCi. An 

individual source strength of 0.43 U (equivalent to 0.34 mCi) was entered instead of the 

correct value of 0.43 mCi. The plan approved by the AU called for 100 sources totaling 

34 mCi. The licensee’s written program called for comparison of total source strength

and exposure time and the authorized user signed a pre-implantation written directive for 

100 sources of I-125, total source strength 34 mCi, and exposure time stated as 

“permanent.” The authorized user implanted 100 sources. He then signed a 

post-implantation written directive for 100 sources of I-125, total source strength 34 mCi, 

and exposure time stated as “permanent.” Licensee staff noticed the discrepancy later 

and realized that 43 mCi was implanted rather than 34 mCi, This was a 26 percent
Issue Date: 02/26/15 C-4 87132

variance from the source strength in the written directive. 

Enforcement discretion may not be used in this hypothetical case in which the licensee 

used total source strength and exposure time as the regulatory evaluation values for 

treatment site dose comparisons. The criteria for application of the IEP were not met 

because the source strength implanted into the treatment site differed from the source 

strength in the written directive by more than 20 percent. It is not necessary for the 

licensee to perform an assessment to compare the delivered dose to the prescribed dose, 

with both doses in units of Sv or rem. Because this treatment meets the definition of a 

medical event in 10 CFR 35.3045(a)(1), it is not mandatory to perform an assessment of 

dose to other organs and tissues in comparison with the medical event criteria in 10 CFR 

35.3045(a)(3).

Question 2

What relief can be provided to licensees from the requirement to report as a medical event an 

administration in which the dose delivered to the treatment site differs from the prescribed dose 

by 20 percent or more?

Answer 2

In accordance with the requirements found in 10 CFR 35.3045, if the dose that is ultimately 

delivered to the treatment site differs from the prescribed dose by 20 percent or more, the 

licensee is required to report that instance as a medical event. This applies to the treatment site 

defined by the authorized user in the written directive.

However, under the provisions of the IEP, inspectors can exercise enforcement discretion when 

the total dose delivered to the treatment site equals or exceeds 120 percent of the prescribed 

dose. This discretion applies only to licensees using absorbed dose to compare the treatment 

site delivered dose to the prescribed dose to determine if a medical event has occurred.

This enforcement discretion may be used if all of the following criteria are met:

a. The licensee used absorbed dose to compare the dose delivered to the treatment site 

with the prescribed dose;

b. Doses to normal tissues and structures did not exceed the regulatory dose limits for 

reporting medical events specified in 10 CFR 35.3045(a)(3); and

c. The total dose for the treatment site was expressed in the written directive as absorbed 

dose.

Note that this policy does not provide enforcement discretion for a delivered dose to the 

treatment site that is less than or equal to 80 percent of the prescribed dose. In addition, this 

discretion may not be exercised for licensees using total source strength and exposure time to 

compare the dose delivered to the treatment site to the prescribed dose. 

To further illustrate Question 2, Answer 2, the following hypothetical cases are provided:

Case Number 2-1

The authorized user signed a pre-implantation written directive for a minimum dose of 145 

Gy to be delivered to the treatment site for a permanent prostate implant. The medical 
Issue Date: 02/26/15 C-5 87132

physicist prepared a treatment plan with 100 percent of the prostate volume receiving a 

minimum dose of 145 Gy and a minimum dose to 90 percent of the prostate of 165 Gy 

(e.g., D90 of 165 Gy) and the authorized user approved the treatment plan. The sources 

were implanted and the authorized user signed a post-implantation written directive for a 

minimum dose of 145 Gy to the treatment site. The licensee’s written program called for 

comparison of absorbed dose, with D90 used to characterize the delivered dose. Postimplant CT imaging was performed 30 days later. Dose calculations based on this CT 

showed that 100 percent of the prostate volume received a minimum dose of 145 Gy and 

D90 was 180 Gy. The D90 for dose delivered to the treatment site was 124 percent of 

the prescribed dose documented in the written directive. The dose to other organs and 

tissues did not exceed the medical event criteria in 10 CFR 35.3045(a)(3).

Enforcement discretion may be used in this hypothetical case involving delivered dose to 

the treatment site that equaled or exceeded 120 percent of the prescribed dose. The 

authorized user’s goal was to administer at least 145 Gy to the entire treatment site and 

this was achieved. The total dose for the treatment site was expressed in the written 

directive as absorbed dose; the licensee used absorbed dose to compare the dose 

delivered to the treatment site with the prescribed dose; and doses to normal tissues and 

structures did not exceed the regulatory dose limits for reporting medical events specified 

in 10 CFR 35.3045(a)(3).

Case Number 2-2

The authorized user signed a pre-implantation written directive for a dose of 110 Gy to be 

delivered to the treatment site for a permanent prostate implant. A treatment plan was 

developed based on ultrasound images obtained five weeks prior to treatment. During 

the surgical implant procedure, the authorized user noted that the patient’s prostate was 

significantly larger than expected and chose to implant 20 percent more sources than 

originally planned. The authorized user signed a post-implantation written directive for a 

minimum dose of 110 Gy to the prostate. The licensee’s written program specified

absorbed dose as the regulatory evaluation parameter, with D90 used to characterize the 

administered dose. Post-implant CT imaging was performed 30 days later. The

calculated delivered dose to the prostate was 137.5 Gy and there was a bunching of 

sources in one section of the prostate. The D90 for dose delivered to the treatment site 

was 125 percent of the prescribed dose documented in the written directive. The dose to 

a volume of normal tissue outside the treatment site, near the bunched sources, 

exceeded the medical event criteria in 10 CFR 35.3045(a)(3).

Enforcement discretion may not be used in this hypothetical case involving delivered dose to a 

treatment site dose that equaled or exceeded 120 percent of the prescribed dose. The criteria 

for application of the IEP were not met because dose to normal tissue exceeded the regulatory 

dose limits for reporting medical events specified in 10 CFR 35.3045(a)(3). 
Issue Date: 02/26/15 Att 1-1 87132

Attachment 1 - Revision History for Inspection Procedure 87132

Commitment 

Tracking 

Number

Accession 

Number

Issue Date 

Change Notice Description of Change

Description of 

Training Required 

and Completion 

Date

Comment and 

Feedback 

Resolution 

Accession Number

(Pre-Decisional, 

Non-Public)

N/A 12/06/05 Revised to reflect current regulations in 

10 CFR Part 35.633

N/A

N/A 10/24/02 New IP that incorporates the revised 10 CFR 

Part 35. Replaces IP 87117

N/A

N/A ML111610511

08/24/11

CN 11-014

Researched commitments for 4 years and 

found none.

Revised to incorporate text regarding licensee 

responsibility for contract personnel.

N/A ML112093348

N/A ML12006A148

04/16/12

CN 12-006

Revised to add directions specific to permanent 

implant brachytherapy.

Yes

4/2012

ML12006A148

N/A ML14346A208

02/26/15

CN 15-003

Revised to reflect the Interim Enforcement 

Policy for “Enforcement Discretion for 

Permanent Implant Brachytherapy Medical 

Event Reporting (10 CFR 35.3045)”

Near-complete rewrite of Appendices B and C.

N/A ML14346A212

ML14346A311