Protecting People and the EnvironmentUNITED STATES NUCLEAR REGULATORY COMMISSION
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555
November 6, 1990
Information Notice No. 90-71: EFFECTIVE USE OF RADIATION SAFETY
COMMITTEES TO EXERCISE CONTROL OVER
MEDICAL USE PROGRAMS
Addressees:
All NRC licensees authorized to use byproduct material for medical purposes.
Purpose:
This information notice is provided to remind byproduct material licensees
of their responsibilities for ensuring that radiation safety activities are
performed in accordance with license conditions and other regulatory
requirements. It is expected that licensees will review this information
for applicability to their programs, distribute it to members of the
Radiation Safety Committee (RSC), responsible radiation safety staff, and
hospital management, and consider actions, if appropriate, to prevent
problems from occurring at their facilities. Hospital Administrators, Chief
Executive Officers, or Presidents are urged in particular to read carefully
the information contained in this notice. However, suggestions contained in
this information notice do not constitute new Nuclear Regulatory Commission
(NRC) requirements, and no written response is required.
Description of Circumstances:
Since the implementation of the revised 10 CFR Part 35, "Medical Use of
Byproduct Material," became effective on April 1, 1987, NRC has cited
numerous violations directly or indirectly related to RSC responsibilities.
The violations resulted from the various RSCs failing to exercise effective
oversight and control of their radiation safety programs. Many of the
NRC-identified violations should have been identified and corrected during
the RSC's required annual review of the licensed radiation safety program.
An analysis of the violations relating to RSC responsibilities identified
four common areas of weakness. These areas are:
o Failure of the RSC to consistently meet quarterly with the required
number of members present. NRC regulations require that at least half
of the members be present, including the Radiation Safety Officer (RSO)
and the management representative, to constitute a quorum and conduct
business.
o Failure to have management actively participate with the RSC. The
licensee's management must support the activities of the RSC by
ensuring that sufficient staff, time, and equipment resources are
allotted to the radiation safety program.
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o Failure of the RSC to review the functions of RSO, to ensure that: (1)
the RSO is vested with necessary authority and independence to carry
out program responsibilities; (2) the RSO does not have other duties
that prevent adequate attention to the safety program; (3) the RSO has
not delegated substantial responsibilities to other staff members or to
consultants, such that the RSO is unaware of program status; and (4)
the RSO is otherwise effective in managing the licensed program and in
carrying out the responsibilities identified in 10 CFR 35.21 of the
regulations.
o Failure of the RSC to perform its radiation safety program functions.
NRC regulations and license conditions require the RSC to review
summaries of the types and amounts of material used, all incidents
involving byproduct material, the ALARA (as low as is reasonably
achievable) program and occupational doses, changes in radiation safety
procedures, training and continuing education for the staff, and the
RSO's annual summary of the radiation safety program. Review of the
program should help to identify weak areas and areas that are not in
compliance with NRC regulations. Once these areas are identified,
effective corrective actions should be implemented immediately to avoid
violations.
Discussion:
The common weaknesses just described have resulted in numerous violations at
medical institutions with ineffective RSCs. Civil Penalties were assessed
against many of the hospitals where multiple violations of NRC requirements
were identified, or in cases where previously cited violations were not
corrected. Examples of such cases are described in Attachment 1.* The NRC
enforcement policy (10 CFR Part 2, Appendix C, Section V.B.) clearly states
that ineffective licensee programs for problem identification or correction
are unacceptable.
The RSC may seek qualified assistance from outside consultants if the
licensee staff does not possess the necessary experience or training to
perform the required review and implementation of corrective actions.
However, it is the licensee's responsibility to ensure that the review and
corrective actions meet the regulatory requirements.
To summarize, the purpose of the RSC is to: (1) identify radiation safety
problems; initiate, recommend or provide corrective actions; and verify
implementation of corrective actions; (2) review, on the basis of safety,
the training and experience of proposed authorized users, RSOs, or
Teletherapy Physicists; (3) review and approve or disapprove minor radiation
safety changes permitted by 10 CFR 35.31; (4) review quarterly a summary of
occupational dose records of all personnel working with radioactive material
and review recommendations on ways to maintain individual and collective
doses ALARA; (5) review quarterly, with the assistance of the RSO, all
incidents involving byproduct material, with respect to cause and subsequent
actions taken; and (6) review annually, with the assistance of the RSO, the
radiation safety program. These objectives can only be met by the RSC
working closely with the RSO, authorized users, and the technical and
ancillary staff.
* Full details of escalated enforcement actions against materials licensees
can be found in NUREG 0940, as well as the NMSS quarterly Newsletter.
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The licensee's management must actively participate in the RSC by attending
the committee meetings, extending sufficient authority to the committee's
decisions, and being aware of licensed activities, and regulatory and
license commitments.
Hospital management must assure that the RSC is meeting as required and
performing its required functions. In a few instances, medical personnel
have created false records of RSC meetings due to failure of the institution
to support the RSC. Providing false information to the NRC or creating a
false entry in a record required by the NRC is not tolerated. Hospitals
have received significant monetary penalties, authorized users have been
removed from licenses and criminal investigations have been conducted as the
result of false information provided to the NRC, and as a result of
licensees or their employers willfully failing to meet Commission
requirements.
In summary, the number of enforcement actions involving civil penalties have
increased from 9 in 1987, to 13 in 1988, and 21 in 1989. It is imperative
that hospital administrators be aware of the regulations described in 10 CFR
Part 35 and the conditions of the hospital's license. In addition, a
responsible RSO and good functioning RSC can minimize the potential for
adverse NRC inspection results, and thereby avoiding civil penalties which
are accompanied by subsequent press releases giving the hospital adverse
publicity.
No written response is required by this information notice. If you have any
questions , please telephone the contact listed below or the appropriate
regional office.
Richard E. Cunningham, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material
Safety and Safeguards
Technical Contact: Janet R. Schlueter
(301) 492-0633
Sandra Waldron, RII
(404) 331-2687
Attachments:
1. Examples of Escalated Enforcement Cases
Involving RSCs at Medical Institutions
2. List of Recently Issued NMSS Information Notices
3. List of Recently Issued NRC Information Notices
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Attachment 1
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EXAMPLES OF ESCALATED ENFORCEMENT CASES
INVOLVING RADIATION SAFETY COMMITTEES (RSC)
AT MEDICAL FACILITIES
Case A:
An NRC inspection identified 24 violations covering a wide range of issues,
including the failure of the RSC to meet quarterly, failure to conduct
annual reviews of the radiation safety program, failure to review the
training and experience of all users of radioctive material and ensure
sufficient qualifications are met, and failure to determine whether current
procedures are maintaining radiation exposures ALARA. Numerous other
violations were cited involving other program areas, including providing
adequate radiation safety equipment to the staff.
It was determined by the NRC that the root cause of the violations going
undetected was that the RSO had been intentionally remiss in performance of
his RSO and RSC Chairman duties. A $10,000 civil penalty was assessed.
Case B:
An NRC inspection identified 14 violations, eight of these had been cited
previously, including two cited twice and one cited three times. The
fundamental problem appeared to be the lack of sufficient time and attention
to the radiation safety program by the RSO due to other duties assigned to
him at the facility. Licensee management was not aware of the importance and
needs of the radiation safety program. The RSC failed to support the RSO in
ensuring that sufficient staff, time and equipment resources were alloted to
the radiation safety program by management. The RSO had expressed concerns
about these inadequacies to the RSC on several occasions, but the RSC failed
to support the RSO in these matters. A $2,500 civil penalty was assessed.
Case C:
An NRC inspection identified 12 violations at a medical facility. No
violations were identified during the previous inspection. The degradation
of the radiation safety program began when two technologists terminated
employment with the facility. The RSO indicated that he allowed the two
technologists to implement the radiation safety program and that he had
little involvement with the day-to-day activities. Of particular concern
was that the licensee relied on the technologists to make the program
function rather than a viable management control system. It was determined
that the RSC needed to be more aggressive in their audit and review of the
program, and ensure that deficiencies are promptly identified and corrected.
A $4,375 civil penalty was assessed.
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Case D:
An NRC inspection identified 38 violations covering a range of issues in the
nuclear medicine and teletherapy radiation safety programs including the
RSC's failure to review the qualifications of individuals who acted as
teletherapy physicists. The lack of adequate authority vested in the RSO,
inadequate involvement of the RSO and RSC in oversight of the radiation
safety program, and failure of management to ensure the RSO and RSC
performed as expected contributed to the violations. A $7,500 civil penalty
was assessed.
Case E:
An NRC inspection identified 26 violations covering a range of issues
including the RSC's failure to meet for 4 consecutive calendar quarters from
1988 to 1989. Twenty of the 26 violations occurred and continued during the
year the RSC did not meet. A root cause of the violations was lack of
management oversight, as well as, RSC oversight of the radiation safety
program and the RSO, to ensure the functions of the RSO were carried out. A
$3,125 civil penalty was assessed.
Case F:
An NRC inspection identified 19 violations involving a wide range of issues
in the nuclear medicine program (16 violations) and the teletherapy program
(3). The root cause of the violations appeared to be the failure of the RSO
and the RSC to exercise adequate control over the radiation safety program
and ensure that NRC requirements were being followed. A $5,000 civil
penalty was assessed.
Case G:
An NRC investigation identified 2 violations involving the failure of the
RSC to meet quarterly except for two occasions during the time interval of
January 27, 1983 to September 6, 1989, and the willful fabrication of RSC
minutes by a contract nuclear medicine technologist to appear that the
meetings had taken place. A $6,250 civil penalty was assessed.
Case H:
An NRC inspection identified 5 violations involving the licensee's
brachytherapy and radiopharmaceutical therapy program including radiation
levels in unrestricted areas exceeding regulatory limits and the failure of
the RSC to perform an annual review of the entire radiation safety program.
A root cause of the violations appeared to be the RSO's focus on the
diagnostic rather than the therapeutic portions of the licensee's program.
As a result, hospital management, the RSC and RSO were not effective in
aggressively monitoring and evaluating licensed activities, and in
particular those activities involving the Radiation Therapy program. A $625
civil penalty was assessed.
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