United States Nuclear Regulatory Commission - Protecting People and the Environment

Information Notice No. 90-71: Effective Use of Radiation Safety Committees to Exercise Control Over Medical Use Programs

                                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.


9010310183 
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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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                                                            November 6, 1990
                                                            Page 1 of 2 

                   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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                                                            Attachment 1 
                                                            IN 90-71 
                                                            November 6, 1990
                                                            Page 2 of 2 

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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