**NRC INSPECTION MANUAL**MSSA/RMSB

INSPECTION PROCEDURE 87133

MEDICAL GAMMA STEREOTACTIC RADIOSURGERY

AND TELETHERAPY PROGRAMS

PROGRAM APPLICABILITY:  2800

87133-01INSPECTION OBJECTIVES

01.01To determine if licensed activities are being conducted in a manner that will protect the health and safety of workers, the general public and patients.

01.02To determine if licensed activities are being conducted in accordance with U.S. Nuclear Regulatory Commission (NRC) requirements.

87133-02INSPECTION 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.

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.

02.01Security 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.

02.02Shielding 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.

02.03Comprehensive 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.

02.04Radiation 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.

02.05Radiation 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.

02.06Radiation 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.

02.07Management 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.

02.08Licensee 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.

02.09Other 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.

87133-03INSPECTION 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 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 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.

03.01Security 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 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 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.  

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 Theratron-80 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 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 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 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.

03.02Shielding 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 20.1201, 20.1301, and 20.1302.  The inspector should verify that the licensee instructed workers under 10 CFR 19.12 about facility shielding.

03.03Comprehensive 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.

03.04Radiation 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 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.

03.05Radiation 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 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 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.

03.06Radiation 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 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.

03.07Management 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, 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 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.

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 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 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., 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, 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.

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 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.

03.09Other 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.

87133-04REFERENCES

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

Attachment 1 – Revision History for Inspection Procedure 87133

Issue Date:  08/24/11Att. 1-187133

Issue Date: 08/24/11187133