Issue Date: 10/24/02 - 1 - 87130

NRC INSPECTION MANUAL IMNS/RGB

INSPECTION PROCEDURE 87130

NUCLEAR MEDICINE PROGRAMS,

WRITTEN DIRECTIVE NOT REQUIRED

PROGRAM APPLICABILITY: 2800

87130-01 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.

87130-02 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. 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.
87130 - 2 - Issue Date: 10/24/02

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.

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 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

NMSS for further guidance.

87130-03 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 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.
87130 - 4 - Issue Date: 10/24/02

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 MC 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.

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
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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

1. Through discussion 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 is appropriate to the scope of the licensed program.

The inspector should independently verify through direct observations that

survey instruments have been calibrated 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.

2. If appropriate, the inspector should verify that the licensee has established

and implemented procedures to identify and report safety component defects

in accordance with 10 CFR 21.

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 has methods for picking up, receiving, and opening

packages that address how and when packages will be picked up, radiation

surveys and wipe tests of packages to be done on receipt, and procedures for

opening packages (such as the location in the facility where packages are

received, surveyed, and opened). From those discussions, observations and

reviews, if necessary, the inspector should determine what actions are taken if

surveys reveal that packages are contaminated in excess of specified limits, and/or

radiation levels that are higher than expected. If packages arrive during the course

of an inspection, the inspector should observe, when practical, personnel

performing the package receipt surveys.

Through discussions with cognizant licensee representatives and if necessary, a

review of selected records, the inspector should review the licensee’s materials

accounting system. The inspector should note that sometimes, a relatively small

facility will generally need to maintain receipt records, disposal records, and

records of any transfers of material. However, a large facility may need a
87130 - 6 - Issue Date: 10/24/02

sophisticated accounting system which provides accurate information on the

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

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

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

inspector should determine if accounting systems consider radioactive material

held for decay-in-storage, near-term disposal, or transfer to other licensees. In

both types of accounting systems, the inspector should ensure that the licensee

has performed routine audits of those systems to ensure the accuracy of the

system.

Through discussions with cognizant licensee representatives and if necessary, a

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

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

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

current license before the transfer).

d. Transportation. Through discussions with cognizant licensee representatives,

direct observations made during the conduct of the inspection, and if necessary,

a review of selected transportation records, the inspector should verify that the

licensee's hazardous material training, packages and associated documentation,

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

papers are adequate and in accordance with NRC and DOT regulatory

requirements for transportation of radioactive materials. Furthermore, from those

discussions and reviews, if necessary, the inspector should verify if any incidents

had occurred and that they were appropriately reported to DOT and NRC.

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

of Transportation Activities." Inspectors should also refer closely to "Hazard

Communications for Class 7 (Radioactive) Materials," the NRC field reference

charts on hazard communications for transportation of radioactive materials, which

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

references for determining compliance with the transportation rules on labeling,

placarding, shipping papers, and package markings.

e. Material Security and Control. Through direct observations made during tours of

the licensee’s facility and discussions with cognizant licensee representatives, the

inspector should verify that the licensee has maintained adequate security and

control of licensed material. From those observations, the inspector should note

areas where radioactive materials are used and stored. From further observations

and discussions, the inspector should verify that licensed material in storage, in

controlled or unrestricted areas, is secured from unauthorized removal or access.

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

and controlled access. For licensed material not in storage, in controlled or

unrestricted areas, the inspector should verify that such material is controlled and

under constant surveillance or physically secured. Controls may include a

utilization log to indicate when, in what amount, and by whom, radioactive material

is taken from and returned to storage areas. In addition, the inspector should

verify that access to restricted areas is limited by the licensee.
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f. 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.

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 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.

g. 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 all sealed sources in accordance with 10 CFR 35.67(b).

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.

h. Waste Storage and Disposal. 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

radioactive waste is stored and controlled in a secure and safe manner, and that

radiation levels in unrestricted areas surrounding the storage area do not exceed

NRC regulatory limits. Through further discussions, observations, and reviews, if

necessary, the inspector should verify that disposals of decay-in-storage waste are

performed in accordance with NRC regulatory requirements.

The inspector should note that generally, radionuclides used in nuclear medicine

facilities have half-lives of 120 days or less and can be decayed in storage until

surveys are indistinguishable from background, then be disposed of as nonradioactive waste.

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 the following areas, when appropriate:

1. Waste disposed in accordance with 10 CFR 35.92;

2. Waste compacted in accordance with license conditions;
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3. Waste storage containers properly labeled and area properly posted in

accordance with 10 CFR 20.1902 and 20.1904; and

4. Waste was returned from a landfill due to radioactive contamination.

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

"Radioactive Waste Management-Inspection of Waste Generator Requirements

of 10 CFR Part 20 and 10 CFR Part 61" and Information Notice (IN) 94-07,

“Solubility Criteria for Liquid Effluent Releases to Sanitary Sewerage Under the

Revised 10 CFR Part 20.”

i. Effluents. Through discussions with cognizant licensee representatives and if

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

into a public sanitary sewerage system and septic tanks , if any, are consistent with

the form and quantity restrictions of NRC regulatory requirements. If the inspector

determines that a review of selected records is necessary, the inspector should

pay particular attention to the licensee’s documentation for demonstrating that the

material is readily soluble (or readily dispersible biological material) in water. If a

review of selected records is necessary, the inspector should examine the waste

release records generated since the last inspection, annual or semiannual reports,

pertinent nonroutine event reports, and a random selection of liquid and airborne

waste release records.

For liquid wastes, the inspector should determine through further discussions,

observations and reviews, if necessary, if the licensee has identified all sources of

liquid waste; evaluated treatment methods to minimize concentrations (such as the

use of retention tanks); and complies with the regulatory requirements for disposal

into sanitary sewerage.

Through further discussions, direct observations made during tours of the

licensee’s facility, and reviews, if necessary, the inspector should verify that

waste-handling equipment, monitoring equipment, and/or administrative controls

are adequate to maintain radioactive effluents within NRC regulatory requirements

and are ALARA (This should include xenon or other gas waste, also).

In addition, from those discussions, observations and reviews, if necessary, the

inspector should verify that effluent monitoring systems and the associated

analytical equipment are adequate to detect and quantify effluents with sufficient

sensitivity, and whether they are maintained, calibrated, and operated in

accordance with the manufacturer's recommendations.

Furthermore, from those discussions, observations and reviews, if necessary, the

inspector should verify that all significant release pathways are monitored, all

unmonitored pathways have been characterized, and all surveillance procedures

for effluents are being implemented by the licensee.

For further inspection guidance, the inspector should refer to IP 87102,

"Maintaining Effluents from Materials Facilities As Low As Is Reasonably

Achievable (ALARA).".
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03.02 Shielding of Licensed Material

In the application for the license, the licensee committed to develop and implement and

maintain procedures for safe use of unsealed byproduct material that meet the

requirements of 10 CFR 20.1101 and 10 CFR 20.1301. Through observations and

interviews, the inspector should assess the actual implementation of ALARA procedures

which include shielding of licensed material.

a. Syringe and Vial Shields. Determine a sufficient number, type, and condition of

syringe and vial shields are being used to protect workers and members of the

public from unnecessary radiation. Verify labeling of syringe and vial shields

required by 10 CFR 35.69.

b. Other Shielding. Determine use of shielding for waste receptacles, storage

containers, and work areas to protect workers in the hot lab.

If shielding is not evident, then the inspector should assess the licensee’s evaluation of

radiation doses to workers and members of the public respectively under 10 CFR 20.1201

and 1301. The licensee may have determined that shielding was not needed. The

inspector should verify that the licensee instructed workers under 10 CFR 19.12 about

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
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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.

Through discussions with cognizant licensee representatives and a review of

selected records, the inspector should evaluate the adequacy of the licensee's

methods used to assess the SDE to the portion of the skin of the extremity

expected to have received the highest dose. The inspector should give particular

attention to the distance between the location that is likely to have received the

highest dose when sources are manipulated manually (even when shields are

used) and where the extremity monitor is worn.

d. Internal Dosimetry Through interviews with cognizant licensee representatives,

and records review, if appropriate, verify that measurements for internal deposition

of licensed materials are performed and evaluated in accordance with 10 CFR

20.1501.

03.05 Radiation Instrumentation, Surveys, and Leak Tests

a. Equipment and Instrumentation

1. 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 to the

scope of the licensed program, operable, calibrated, and adequately
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maintained in accordance with NRC regulatory requirements and the

manufacturer’s recommendations. The inspector should verify that:

(a) the radiation survey instruments have been calibrated in accordance

with10 CFR 35.61;

(b) the instruments used to measure the activity of unsealed byproduct

material meet the requirements of 10 CFR 35.60;

(c) licensees that use molybdenum-99/technetium-99m generators

measure and record the molybdenum-99 concentration after the first

eluate, in accordance with 10 CFR 35.204, to ensure that humans are

not administered a pharmaceutical containing more than

0.15 microcuries of molybdenum-99 per millicurie of technetium-99m.

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. 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.

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

leak tests of sealed or contained sources are performed at the required frequency
87130 - 12 - Issue Date: 10/24/02

found in 10 CFR 35.67(b) or license conditions. Through discussions with

cognizant licensee representatives, direct observations, and if necessary, a review

of selected records, the inspector should verify that the leak test is analyzed in

accordance with 10 CFR 35.67(c). If records of leak test results show removable

contamination in excess of the regulatory requirements of 0.005 microcuries (185

becquerels) or approved level included in a license condition, the inspector should

verify that the licensee made the appropriate notifications per 10 CFR 35.67 (e)

and removed the source from service.

03.06 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 nuclear

pharmacists, and those individuals under the supervision of authorized users and

nuclear pharmacists, 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,

authorized nuclear pharmacists 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.
Issue Date: 10/24/02 - 13 - 87130

b. Operating and Emergency Procedures. During the conduct of the inspection, the

inspector should verify through direct observations of licensed activities, if

practical, licensee personnel perform tasks at selected work stations to verify that

such licensed activities are performed in accordance with the licensee’s operating

procedures. Through discussions with cognizant licensee staff, the inspector

should verify that for those individuals interviewed understand and implement

procedures establish by the licensee and are aware of procedural revisions. If

appropriate, the inspector should review the licensee's emergency procedures to

determine that these procedures are adequate to ensure compliance to NRC

regulatory requirements.

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.

c. Protective Clothing. Through direct observations of licensed activities and

discussions with cognizant licensee representatives, the inspector should verify

that radiation workers are provided with, and wear, the appropriate protective

clothing commensurate with activities being performed. The observation of the

protective clothing that licensee staff wear during their work activities should

provide the inspector with an acceptable means of reviewing this requirement. If

the inspector identifies a concern with this practice, the inspector should discuss

this practice with appropriate licensee representatives to ensure that licensee staff

are following licensee procedures for wearing adequate protective clothing.

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 and the RSO. 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
87130 - 14 - Issue Date: 10/24/02

license have changed, the inspector should determine whether the licensee has

submitted appropriate notification to NRC. This information must be provided

whenever changes in ownership or personnel named in the license are made.

Through discussions with cognizant licensee management the inspector should

determine if changes have occurred, or are anticipated, and ask personnel to

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

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

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

ownership, the inspector should discuss this matter with appropriate licensee

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

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

Through discussions with cognizant licensee representatives, the inspector should

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

and reporting chains. The inspector should be sensitive to changes that reduce

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

the radiation protection program. The inspector should discuss with cognizant

licensee management representatives and the RSO about the RSO's authority and

about any changes that may impact upon the RSO's duties, responsibilities, or

effectiveness.

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

observations of licensed activities, the inspector can obtain useful information

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

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

facilities, the inspector will be able to discern the actual size and scope of the

licensee's program, and to determine if significant changes have occurred since

the previous inspection. Through further discussions inspector should determine

if multiple places of use are listed on the license. In cases where there are

multiple sites/satellite facilities, the inspector should determine if inspections

should be performed at all sites. This decision should be based on MC 2800,

"Materials Inspection Program," and regional policy for performing inspections at

satellite facilities. From those observations and discussions, the inspector should

verify that the locations of use are as authorized in the license. If the inspector

determines that there are locations of use not authorized under the license, the

inspector should discuss this matter with appropriate licensee representatives to

ensure that the license is amended to allow the unauthorized location of use in

accordance with 10 CFR 35.13 and/or 35.14. Furthermore, the inspector should

determine if licensed activities conducted at such locations were conducted in

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

In reviewing the scope of the licensee’s program in this area, the inspector should

discuss information that includes lab personnel, locations of use, human research

and medical use activities, mobile nuclear medicine services, distribution of

pharmaceuticals under 10 CFR Part 35 license, and principal types and quantities

of licensed materials used.

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
Issue Date: 10/24/02 - 15 - 87130

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 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.

d. Authorized Users. Authorized users (physicians, nuclear pharmacists, and medical

physicists) are named on the license. 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. The inspector should determine from observing the use of

licensed material, discussing the activities with cognizant licensee personnel, and

if necessary, from a review of selected records, that the type, quantity, and use of

licensed material at the licensee's facility are as authorized by the license. From

those observations, discussions, and reviews, if necessary, the inspector should

verify that the total activity of licensed material does not exceed the maximum

activity authorized either in the license or in the design specifications of the

device’s sealed source device registration certificate.
87130 - 16 - Issue Date: 10/24/02

f. Financial Assurance and Decommissioning. The decommissioning recordkeeping

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

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

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

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

drawings and modifications of structures and equipment in restricted areas where

radioactive materials are used and/or stored, and locations of possible

inaccessible contamination; and 3) records of the cost estimate performed for a

decommissioning funding plan or the amount certified for decommissioning. This

list is not all-inclusive of the information and requirements given in 10 CFR

30.35(g). The inspector should ensure that the licensee has such

decommissioning records, that the records are complete, that they are updated as

required, and that the decommissioning records are assembled or referenced in

an identified location.

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

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

requirements in the Decommissioning Timeliness Rule if the licensee continues to

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

inspector should identify the rooms that have been released since the last

inspection and perform random confirmatory measurements for selected rooms

(e.g., randomly sample selected areas, not survey 100%), 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
Issue Date: 10/24/02 - 17 - 87130

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.
87130 - 18 - Issue Date: 10/24/02

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 MC 2602, "Decommissioning

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, NMSS 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 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.
Issue Date: 10/24/02 - 19 - 87130

03.08 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 NMSS for further guidance.

For further inspection guidance, refer to MC 2800.

END