Issue Date: 08/24/11 1 87133

NRC INSPECTION MANUAL MSSA/RMSB

INSPECTION PROCEDURE 87133

MEDICAL GAMMA STEREOTACTIC RADIOSURGERY

AND TELETHERAPY PROGRAMS

PROGRAM APPLICABILITY: 2800

87133-01 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.

87133-02 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 
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be conducted such that the inspector’s presence does not interfere with patient care or 

a patient’s privacy.

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.

Some of the following areas may not be applicable to all medical gamma stereotactic 

radiosurgery and teletherapy licensees.

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 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.
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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 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, 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. 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 examines 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 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 uses, 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 FSME for further guidance.

87133-03 INSPECTION GUIDANCE

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 
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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.

Once an inspector has conducted a review of the applicable elements of a focus area in 

a broad capacity (e.g., looked at the “big 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 reviewed 

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 concerns, the records may or may not 

substantiate his/her concerns. 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 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 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 apprized 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 
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enforcement issues) identified during the course of the inspection. This will ensure that 

the inspector is following appropriate NRC guidance under such circumstances.

Specific Guidance.

03.01 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 is secured from 

unauthorized removal, and the licensee uses processes or other engineering 

controls to maintain exposures as low as is reasonably achievable (ALARA).

b. Adequate Equipment and Instrumentation. During the conduct of the inspection, 

the inspector should verify through discussions with cognizant licensee 

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

records, that equipment and instrumentation used to conduct licensed activities 

are appropriate, operable, calibrated, adequately maintained, and conform to 

those described in the license. If appropriate, the inspector should verify that 

these various systems and checks operate appropriately to ensure compliance 

to 10 CFR 35.61, 615, 632, 635, 642 and 645. The inspector should verify that 

the gamma stereotactic radiosurgery and teletherapy units have been inspected 

and serviced at the required frequencies by persons specifically licensed to 

conduct such licensed activities by NRC or an Agreement State.

The inspector should verify that the dosimetry system used to perform full 

calibration measurements is in accordance with NRC regulatory requirements; 

and that safety systems are checked as required by NRC regulatory 

requirements. The inspector should independently check interlock systems, 

beam condition indicators, and other systems for continuous observation of the 

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

keys. For teletherapy units, the inspector should check the operation of the 

source head in various orientations. 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 applicable, the inspector should check any

self-contained dry-source-storage irradiators and/or survey instrument 

calibrators. 

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

instrumentation that has failed to perform as designed, the inspector should 

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

this matter.

1. Gamma Stereotactic and Radiosurgery and Teletherapy 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 offthe-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. 

During the inspection, the inspector should ask cognizant licensee staff to 

demonstrate that stops and electronic controls used to limit the orientation 

of the head are operational.

During the inspection, the inspector should verify that proper calibration 

procedures are used for calibrating the gamma stereotactic radiosurgery 

and teletherapy unit, the unit is calibrated at the required intervals (not to 

exceed one year), and before first patient use and after source exchange, 

relocation, and major repair or modification. The calibration should 

include all items listed in 10 CFR 35.632 and 635. The inspector should 

verify that spot checks are conducted at the required frequency, and as 

required by 10 CFR 35.642 and 645. Furthermore, the inspector should 

verify that the licensee has performed acceptance testing on the treatment 

planning system in accordance with 10 CFR 35.657.

2. Additional Requirements for Licensees with Teletherapy Units. If the 

teletherapy unit observed by the inspector is a Theratron-60 or Theratron80 with a cast-iron arm, the licensee was required by NRC Bulletin 92-02, 

to commit to perform the special inspections per Theratronic’s revised 

"Survey and Inspection I 1024 G091G10 REV C."

If the teletherapy unit is a Picker model C-9 or an Advanced Medical 

System (AMS) model C-9, the inspector should be aware that a generic 

malfunction of the source retraction mechanism had been identified as 

described in Information Notice 99-27.

3. 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 
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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 verify that the licensee’s procedures for receiving replacement 

gamma stereotactic radiosurgery and teletherapy 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 recipients of replaced sources are licensed 

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

before the transfer). Generally, this is not a concern because sources are 

replaced by a service company authorized by NRC or an Agreement State.

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 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. However, this area is not a concern for most gamma stereotactic 

radiosurgery and teletherapy licensees because most of them are not authorized 

to perform these operations.

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. The inspector should determine through direct 

observations that the treatment room is under constant surveillance or physically 

secured when not in use. The inspector should discuss with appropriate 
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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 should observe 

and 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 consideration of 

the licensee’s implementation of a continuous improvement in the following 

processes: monitoring, identification, evaluation, corrective action, and 

preventative measures. If necessary, the inspector should review selected 

records of written directives to confirm that these issues are adequately 

addressed in accordance with 10 CFR 35.2040.

g. 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 NRC regulatory requirements. If 

necessary, the inspector should conduct a review of selected records to 

independently verify those discussions with such individuals. If from those 

reviews a previously unidentified medical event is identified by the inspector, 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 procedure for reactive inspections and 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.

h. 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. The 

inspector should verify that High radiation areas have been strictly controlled to 
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prevent unauthorized or inadvertent access. Such controls for gamma 

stereotactic radiosurgery and teletherapy units may include, but are not limited 

to, direct surveillance, locking the high radiation area, warning lights, and 

audible alarms. Many licenses have received exemptions from the requirement 

to post the treatment room with the sign “GRAVE DANGER, VERY HIGH 

RADIATION AREA,” required by 10 CFR 20.1902, because of its unsettling 

effect. This exemption will be noted in the license. 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.

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 are appropriately posted at the control console in accordance with 

10 CFR 35.610.

i. 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 semi-annual inventory of teletherapy sealed 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.

03.02 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. 

Through observations and interviews, an inspector should determine shielding of the 

treatment room and radiation levels in the adjacent areas. In an application for a 

license, an applicant must describe the adjacent areas and the structural shielding of 

the treatment room and indicate the location of doors, windows, conduits, and other 

penetrations and voids and provide calculations of estimated radiation levels in the 

adjacent areas. Applicants also indicate the orientations of the primary beam and the 

plane of rotation for an isocentric mode of use. A licensee should have maintained the 

structural shielding so that if the surrounding areas were renovated then the structural 

shielding of the treatment room was unchanged. In cases where an outside wall of a 

treatment room was backfilled with earth, an inspector should determine that the height 

of earth against the outside wall of a treatment room remains unexcavated. 

If facility shielding changes are evident, then the inspector should assess the licensee’s 

procedure and process to alter the shielding and the licensee’s further evaluation of 

radiation doses to workers and members of the public respectively under 10 CFR 
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20.1201, 20.1301, and 20.1302. The inspector should verify that the licensee instructed 

workers under 10 CFR 19.12 about facility shielding.

03.03 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.

03.04 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.

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 
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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.

03.05 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 been calibrated at the required frequency in 

accordance with 10 CFR 35.61. The inspector should have cognizant 

licensee staff demonstrate 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.

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

licensee has access to a dosimetry system for performing the full 

calibration and spot-check measurements of gamma stereotactic 

radiosurgery and teletherapy unit output. The system must be calibrated 

in accordance with the requirements of 10 CFR 35.632 and 635. During 

the inspection, the inspector should review selected dosimetry worksheets 

from the previous full calibration measurements required by 10 CFR 

35.632 and 635. Mistakes often made by licensees when performing 

these calibrations are misreading of barometric pressure and using the 

wrong value for the chamber composition and volume. 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 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 
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should independently verify the operability of permanent radiation 

monitors, availability of backup power supply, 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. 

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. When measuring dose rates near a gamma stereotactic 

radiosurgery and teletherapy unit head, the inspector should not use an open 

window Geiger-Muller tube, because the depleted uranium used in the trimmer 

bars, collimators, and shielding is a beta emitter that will cause the survey 

instrument to give a faulty measurement. 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 unit head 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.

c. Source Replacement Surveys. During the conduct of the inspection, the 

inspector should verify by independent measurement that shielding surveys of 

the unit head and treatment room are in compliance with the requirements of 10 

CFR 35.652. Indications of higher than expected dose levels by the inspector 

may indicate that the source is a higher activity than authorized or that the 

source is not fully shielded on retraction.

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 
Issue Date: 08/24/11 13 87133

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 sources are performed at the required frequency found 

in 10 CFR 35.67(b). 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), the inspector should verify that the licensee made the 

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

service.

03.06 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.

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 
Issue Date: 08/24/11 14 87133

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, films, 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 gamma stereotactic radiosurgery and 

teletherapy 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.

Discuss with cognizant licensee representatives, or if practicable, observe 

licensee personnel conduct periodic tests, especially for scenarios involving 

events that would require reporting to the NRC under 10 CFR 20.2202.

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.

03.07 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 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, 
Issue Date: 08/24/11 15 87133

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. 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.

c. 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. 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 
Issue Date: 08/24/11 16 87133

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. 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 Radiation Safety Committee (RSC) 

representatives, the inspector should independently verify that topics of 

discussion during RSC meetings included ALARA reviews, incidents, 

generic communications, 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.

d. 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.
Issue Date: 08/24/11 17 87133

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.

e. 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 gamma stereotactic radiosurgery 

or teletherapy 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. The inspector 

should independently verify that the:

1. Gamma stereotactic radiosurgery and teletherapy source activities do not 

exceed the maximum activity authorized either in the license or in the 

design specifications of the device’s sealed source device registration 

certificate.

2. License authorizes depleted uranium shielding if used in the shielding of 

the gamma stereotactic radiosurgery or teletherapy unit.

f. Financial Assurance and Decommissioning. The decommissioning record 

keeping 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 
Issue Date: 08/24/11 18 87133

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%); 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 been 

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.

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.

g. 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 
Issue Date: 08/24/11 19 87133

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 Decommissioning Timeliness Rule became effective on August 15, 1994. If 

the license has expired or been revoked, or if the licensee has made a decision 

to permanently cease principal activities, and the licensee provided NRC 

notification before August 15, 1994, then August 15, 1994, is considered to be 

the date for initiating the decommissioning calendar (i.e., date of notification). If 

there has been a 24-month duration in which no principal activities have been 

conducted at the location before the effective date of the rule, but the licensee 

did not notify NRC, then the 24-month time period of inactivity is considered to 

be initiated on August 15, 1994, and the licensee must provide notification to 

NRC within either 30 or 60 days of August 15, 1996 (depending on whether the 

licensee requests a delay).

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/BR-0241, “NMSS Handbook for Decommissioning 

Fuel Cycle and Materials Licensees.”

h. 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., 
Issue Date: 08/24/11 20 87133

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.

i. 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, safetyrelated 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.

j. Special License Conditions. Some licenses will contain special license 

conditions that are unique to a particular practice or procedure, such as the use 

of teletherapy or gamma stereotactic radiosurgery equipment for nonmedical 

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.

k. 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 “Federal 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.

03.08 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 responsibilities, as well as the reporting and feedback
Issue Date: 08/24/11 21 87133

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 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; 6) Contract personnel 

are not able to dedicate time to fulfill the contract agreement.

03.09 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.

87133-04 REFERENCES

IMC 0620 – “Inspection Documents and Records”

NRC Bulletin 92-02 – “Survey and Inspection 1 1024 G091G10 Rev. C”

IP 83822 – “Radiation Protection”

IMC 2602 – “Decommissioning Inspection Program for Fuel Cycle Facilities And

Materials Licensees”

IMC 2800 – “Materials Inspection Program”

END
Issue Date: 08/24/11 Att. 1-1 87133

Attachment 1 – Revision History for Inspection Procedure 87133

Commitme

nt Tracking 

Number

Issue Date Description of Change Training 

Needed

Training 

Completion 

Date

Comment 

Resolution 

Accession Number

N/A 10/24/2002 New IP that incorporates the 

revised 10 CFR Part 35. Replaces 

IP 87116.

None N/A

N/A ML111610514

08/24/11

CN 11-014

Researched commitments for 4 

years and found none.

Revised to incorporate text 

regarding licensee responsibility 

for contract personnel.

None N/A ML112130509