United States Nuclear Regulatory Commission - Protecting People and the Environment

Information Notice No. 93-36: Notifications, Reports, and Records of Misadministrations

                                 UNITED STATES
                         NUCLEAR REGULATORY COMMISSION
               OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
                            WASHINGTON, D.C. 20555

                                  May 7, 1993


NRC INFORMATION NOTICE 93-36:  NOTIFICATIONS, REPORTS, AND RECORDS OF 
                               MISADMINISTRATIONS


Addressees

All U.S. Nuclear Regulatory Commission medical licensees.

Purpose

NRC is issuing this information notice to alert addressees to numerous
failures to satisfy all of the notification, reporting and recordkeeping
requirements in 10 CFR Part 35, "Medical Use of Byproduct Material," 
section 35.33, "Notifications, reports, and records of misadministrations,"
particularly as they relate to notification of patients.  It is expected that
recipients will review the information for applicability to their facilities,
or past required notifications with respect to misadministrations, and
consider appropriate actions to avoid or correct similar problems.  However,
information contained in this notice does not constitute new requirements, and
therefore, no specific action or written response is required.  

Description of Circumstances

The requirement to notify a patient of a misadministration has been part of 
10 CFR Part 35 since the NRC promulgated the "Misadministration Reporting
Requirements" in 1980.  The statements of consideration for the 1980 rule
declared that "patients have a right to know when they have been involved in a
serious misadministration, unless this information would be harmful to them." 
In promulgating the patient notification requirement, the Commission gave
explicit recognition to the fact that informing the patient might affect his
or her ability to assert legal rights.  Over the years, the rule has varied in
certain respects, e.g., the types of misadministrations for which notification
to the patient is required and the types of records to be retained, as well as
the retention periods for records.  However, the patient notification
requirement has been retained in the rulemakings modifying 10 CFR Part 35.

On January 27, 1992, the "Quality Management Program and Misadministrations"
(QM) rule became effective.  In addition to requiring the licensee to
establish and maintain a written quality management program, this rule
modified the definition of misadministration and the requirements for
notifications, reports, and records of misadministrations.  On 
January 7, 1993, Information Notice (IN) 93-04 was sent to all NRC medical
licensees on the investigation and reporting of misadministrations by the
Radiation Safety Officer.  IN 93-04 emphasized that information licensees
provide to the Commission, regarding misadministrations, must be complete and
accurate in all material aspects.  

9305070066.

                                                            IN 93-36
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Since that time, NRC staff conducted a survey of data on therapeutic
misadministrations occurring at NRC licensed facilities over the past three
years (CY90-92).  It revealed that, although the referring physician was
notified in 97 percent of misadministrations, the patient was verbally
notified in only 72 percent of misadministrations.  A medical judgment by the
referring physician that "informing the patient would be harmful" was only
cited in 32 percent of the misadministrations in which the patient was not
notified.  In the remaining 68 percent, licensees provided other reasons for
not informing the patient such as, "no adverse effects expected," or that "the
dose was within acceptable clinical limits."  These reasons are not part of
the exception to the requirement to notify the patient; therefore, the patient
should have been notified.  Furthermore, in cases where the patient was
notified verbally, a written report was provided to the patient only 
56 percent of the time.  Written reports to patients significantly increased
from 46 percent before January 27, 1992, to 76 percent after that date, which
may reflect a change in the rule language to emphasize the requirement for the
licensee to provide a written report to the patient.  

Discussion

The following discussion is to remind licensees of the specific requirements
contained in 10 CFR 35.33.  

o     10 CFR 35.33(a)(1) requires that NRC licensees notify by telephone the
      NRC Operations Center of a misadministration no later than the next
      calendar day after discovery.  Before January 27, 1992, licensees were
      required to notify the appropriate NRC regional office within 24 hours
      after discovery of a therapeutic misadministration.  

o     10 CFR 35.33(a)(2) requires that the licensee submit a written report to
      the appropriate NRC Regional Office within 15 days after discovery of
      the misadministration.  This written report must include the licensee's
      name; the prescribing physician's name; a brief description of the
      event; why the event occurred; the effect on the patient; what
      improvements are needed to prevent recurrence; actions taken to prevent
      recurrence; whether the licensee notified the patient, or the patient's
      responsible relative or guardian (this person will be subsequently
      referred to as "the patient" for the purpose of this information notice)
      and if not, why not; and if the patient was notified, what information
      was provided to the patient.  The report must not include the patient's
      name or other information that could lead to identification of the
      patient.  

o     10 CFR 35.33(a)(3) requires that, for a misadministration, the licensee
      notify the referring physician and the patient of the misadministration
      no later than 24 hours after its discovery, unless the referring
      physician personally informs the licensee either that he or she will
      inform the patient or that, based on medical judgment, telling the
      patient would be harmful.  
.

                                                            IN 93-36
                                                            May 7, 1993
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      The referring physician may make a decision that, based on medical
      judgment, informing the patient would be harmful.  In this circumstance,
      the patient's responsible relative or guardian should be notified.  The
      regulatory history of the misadministration rule suggests that the
      referring physician may also consider whether, based on medical
      judgment, telling the responsible relative (or guardian) would be
      harmful to that individual.  Thus, there could be situations in which
      the licensee is not required to notify the patient or responsible
      relative (or guardian) because the referring physician has personally
      informed the licensee that, based on medical judgment, telling the
      patient or the patient's responsible relative (or guardian) would be
      harmful to one or the other, or both.  However, this does not include
      other reasons for not informing the patient, such as:  "no adverse
      effects were expected"; "dose was within acceptable clinical limits";
      "no medical benefit to the patient"; "not in the patient's best
      interest"; or "the patient has died."  Although the Commission's
      regulations do not define the terms "responsible relative" or
      "guardian," in the absence of a definition, the terms should be given
      their ordinary meanings:  "responsible relative" is the relative who
      makes decisions regarding a patient when the patient cannot (e.g.,
      patient is a minor; patient is unconscious or incapable of comprehending
      the information; or the patient has died), usually the next-of-kin; and
      "guardian" is that person legally responsible for the patient.  These
      ordinary definitions should be applied regardless of whether the patient
      is living or deceased.  If there is any confusion as to the identity of
      the responsible relative (or guardian), the licensee has the
      responsibility to determine the identity of that person.

      There is no basis in the language of 10 CFR 35.33 for the belief that
      the misadministration reporting requirements cease to apply upon the
      death of the patient.  The purposes of the rule are not limited to
      enabling the patient or responsible relative (or guardian) to give
      informed consent for further medical treatment, but include informing
      the patient or responsible relative (or guardian) about a
      misadministration so that they may assert the patient's legal rights
      with regard to the misadministration.  Therefore, if the patient has
      died, the family, in the person of the responsible relative (or
      guardian), is still entitled to have the information contained in the
      misadministration report.    

o     10 CFR 35.33(a)(4) requires that, if the patient was notified, the
      licensee furnish, within 15 days after discovery of the
      misadministration, a written report to the patient by sending either: 
      i) a copy of the report submitted to NRC; or ii) a brief description of
      both the event and the consequences as they may affect the patient,
      provided a statement is included that the report submitted to the NRC
      can be obtained from the licensee.  This written report is required
      whether the patient was notified by the licensee or the referring
      physician.  If the referring physician notifies the patient, the
      licensee is still required to inform the NRC as to what information was
      provided to the patient.  
.

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                                                            May 7, 1993
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      o   10 CFR 35.33(b) requires the licensee to retain a record of each
          misadministration for five years.  This record must contain:  1) the
          names of all individuals involved (including the prescribing
          physician, allied health personnel, the patient, and the patient's
          referring physician);  2) the patient's social security number or
          identification number if one has been assigned;  3) a brief
          description of and reason for the misadministration;  4) the effect
          on the patient; and 5) actions and improvements taken to prevent
          recurrence.  Although not required in 10 CFR 35.33(b), the licensee
          also may choose to maintain a copy of the written report that was
          sent to the patient, if the patient was notified.  

10 CFR 30.9(a) requires, in part, that information provided to the Commission
by a licensee or information required by the Commission's regulations to be
maintained by the licensee must be complete and accurate in all material
respects.  The licensee must ensure, therefore, that the written report
required by 10 CFR 35.33(a)(2) contains all the required information,
including what information was provided to the patient.    

The licensee is reminded of the importance of the requirement to notify the
patient so that the patient, in consultation with their personal physician, 
is allowed to make timely decisions regarding remedial and prospective health
care.  In the future, licensees should be aware that failure to provide 
notification of a misadministration to the referring physician, patient, or
patient's responsible relative (or guardian), will be considered for escalated
enforcement action including possible civil penalties.  The NRC considers
failure to make the required notifications of a misadministration to be a
significant regulatory concern.  This information notice provides the
opportunity for licensees to review records of any past misadministrations and
assure that all appropriate notifications have been made.  

This information notice requires no specific action or written response.  If
you have any questions about the information in this notice, please contact
the technical contact listed below, or the appropriate NRC regional office.


                                       ORIGINAL SIGNED BY


                                    Robert M. Bernero, Director
                                    Office of Nuclear Material Safety
                                      and Safeguards

Technical contact:  Janet R. Schlueter, NMSS 
                    (301) 504-2633

Attachments:
1.  List of Recently Issued NMSS Information Notices
2.  List of Recently Issued NRC Information Notices
.
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