Information Notice 1993-36, Notifications, Reports, and Records of Misadministrations

Notifications, Reports, and Records of Misadministrations

ML031070482
Person / Time
Site:	Beaver Valley, Millstone, Hatch, Monticello, Calvert Cliffs, Dresden, Davis Besse, Peach Bottom, Browns Ferry, Salem, Oconee, Mcguire, Nine Mile Point, Palisades, Palo Verde, Perry, Indian Point, Fermi, Kewaunee, Catawba, Harris, Wolf Creek, Saint Lucie, Point Beach, Oyster Creek, Watts Bar, Hope Creek, Grand Gulf, Cooper, Sequoyah, Byron, Pilgrim, Arkansas Nuclear, Three Mile Island, Braidwood, Susquehanna, Summer, Prairie Island, Columbia, Seabrook, Brunswick, Surry, Limerick, North Anna, Turkey Point, River Bend, Vermont Yankee, Crystal River, Haddam Neck, Ginna, Diablo Canyon, Callaway, Vogtle, Waterford, Duane Arnold, Farley, Robinson, Clinton, South Texas, San Onofre, Cook, Comanche Peak, Yankee Rowe, Maine Yankee, Quad Cities, Humboldt Bay, La Crosse, Big Rock Point, Rancho Seco, Zion, Midland, Bellefonte, Fort Calhoun, FitzPatrick, McGuire, LaSalle, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant
Issue date:	05/07/1993
From:	Bernero R Office of Nuclear Material Safety and Safeguards
To:
References
-RFPFR IN-93-036, NUDOCS 9305070066
Download: ML031070482 (10)

I

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 misadministrationsu

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 richt 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.

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'-2' IN 93-36 May 7, 1993 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 officewithin 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br />

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 Rerson will be subsequentlv

referred to as "the patient" for the Duroose 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 nDt 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 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> 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 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 o responsible

relative (or guardian) because the referring physician has personally

informed the licensee that, 'based on medical Judgment, telling the be

patient or the'patient's responsible relative (or guardian) would

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 IO'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.

V -' IN 93-36 May 7, 1993 o 10 CFR 35.33(b) requires the licensee to retain a record of each

misadministration for five years. This record must contain:

names of all individuals involved (including the prescribing 1) the

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 misadministratton; 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

by a licensee or information required by the Commission's Commission

regulations

maintained by the licensee must be complete and accurate in all to be

respects. The licensee must ensure, therefore, that the material

required by 10 CFR 35.33(a)(2) contains all the required written report

Information, including what information;was provided to the patient.

The licensee is reminded of the importance of the requirement-to notify

patient so that the patient, in consultation with their personal the

is allowed to make timely decisions regarding remedial and prospectivephysician, care. In the future, licensees should be aware that failure health

notification of a misadministration to the referring physician, to provide

patient's responsible relative (or guardian6) will be considered patient, or

enforcement action including possible civil penalties. The NRC for escalated

failure to make the required notifications of a misadministrationconsiders

significant regulatory concern. This information notice provides to be a

the

opportunity for licensees to review records of any past misadministrations

assure that all appropriate notifications have been made. and

This information notice requires no specific action or written response.

you have any questions about the information in this notice, please if

the technical contact listed below, or the appropriate NRC regional contact

office.

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

'-,tachment 1 IN 93-36 May 7, 1993 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

93-31 Training of Nurses 04/13/93 All U.S. Nuclear Regulatory

Responsible for the Commission medical

Care of Patients with licensees.

Brachytherapy Implants

93-30 NRC Requirements for 04/12/93 All U.S. Nuclear Regulatory

Evaluation of Wipe Commission medical

Test Results; Cali- licensees.

bration of Count Rate

Survey Instruments

93-19 Slab Hopper Bulging 03/17/93 All nuclear fuel cycle

licensees.

93-18 Portable Moisture-Density 03/10/93 All U.S. Nuclear Regulatory

Gauge User Responsibilities Commission licensees that

during Field Operations possess moisture-density

gauges.

93-14 Clarification of 02/18/93 All Licensees who possess

10 CFR 40.22, Small source material.

Quantities of Source

Material

93-10 Dose Calibrator Quality 02/02/93 All Nuclear Regulatory

Control Commission medical

licensees.

93-07 Classification of Trans- 02/01/93 All Licensees required to

portation Emergencies have an emergency plan.

93-05 Locking of Radiography 01/14/93 All Nuclear Regulatory

Exposure Devices Commission industrial

radiography licensees.

93-04 Investigation and Re- 01/07/93 All U.S. Nuclear Regulatory

porting of Misadministra- Commission medical

tions by the Radiation licensees.

Safety Officer

K' V Schment 2 I 93-36 May 7, 1993 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

93-35 Insights from Common- 05/12/93 All holders of OLs or CPs

Cause Failure Events for nuclear power plants

(NPPs).

93-34, Potential for Loss of 04/06/93 All holders of OLs or CPs

Supp. 1 Emergency Cooling. for nuclear power reactors.

Function Due to A

Combination of

Operational and Post- Loca Debris in Contain- ment

93-34 Potential for Loss of 04/26/93 All holders of OLs or CPs

Emergency Cooling for nuclear power reactors.

Function Due to A

Combination of

Operational and Post- Loca Debris in Contain- ment

93-33 Potential Deficiency 04/28/93 All holders of OLs or CPs

of Certain Class 1E for nuclear power reactors.

Instrumentation and

Control Cables

93-32 Nonconservative Inputs 04/21/93 All holders of OLs or CPs

for Boron Dilution .for pressurized water

Event Analysis reactors (PWRs).

93-31 Training of Nurses 04/13/93 All U.S. Nuclear Regulatory

Responsible for the Commission medical

Care of Patients with licensees.

Brachytherapy Implants

93-30 NRC Requirements for 04/12/93 All U.S. Nuclear Regulatory

Evaluation of Wipe Commission medical

Test Results; Cali- licensees.

bration of Count Rate

Survey Instruments

OL - Operating License

CP- Construction Permit

IN 93-36

<~' May 7, 1993 a 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.

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 HRC Information Notices

Se pevious concurrence . L&:berman /07/93 Tech Ed: EKraus 03/01/9 OF '-JKAB ) I MB* lE IMAB* lE IMOB*

NAME ueter LWCamper JEGlenn FCombs

DATE '/09/0/93 03/09/93 03/15/93 03/18/93 OR OGC* D/IMNS DD/NMSS lD/NMSS Iv

NAME STreby RECunningham GArlotto RMBer ero

DATE 05/05/93 05/07/93 05/07/93 05/07/93 OFFICIAL RECORD COPY

G: IN.93-36

IV93- May , 1993 provided to the patient

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, a focus of NRC inspections will be to ensure that

licensees comply with all notification requirements in the event of a

misadministration. 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.

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

See previous concurrence

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NAME JRSchlueter LWCamper JEGlenn l FCombs

DATE 04/ /93 03/09/93 03/15/93 1 03/18/93 OFC lvlD/IMNS l TechEd l

NAME I

rebyRECunningham EKraus

DATE P& -/5'93 05/ /93 03/01/93 C . COVER E . COVER & ENCLOSURE N . NO COPY

OFFICIAL RECORD COPY/G:\NOTIF.IN

v>

IN 93- March , 1993 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. In addition, the

licensee must retain a record for five years of the misadministration as

required by 10 CFR 35.33(b).

The licensee is reminded of the importance of the requirement to notify the

patients so that they, in consultation with their personal physician, are

allowed to make timely decisions regarding remedial and prospective health

care. In the future, a focus of NRC inspections will be to ensure that

licensees comply with all notification requirements in the event of a

misadministration.

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.

Richard E. Cunningham, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contact: Patricia K. Holahan, Ph.D., NMSS

(301) 504-2694 C'(S.,, F J 'tc .

Attachments.

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

• See previous concurrence

OF 1 IM l': IMAAB* I IMAB* l +/-F-IMOB I

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DATE . 03//:193 03/09/93 03/15/93 I 03/9/93 OFC OGC l DIMNS I _ TechEd l I

NAME STreby RECunningham EKraus

DATE 1 03/ /93 03/ /93 1 03/01/93 1 C = COVER E = COVER & ENCLOSURE N = NO COPY

OFFICIAL RECORD COPY/G:\NOTIF.IN

IN 93- March , 1993 On January 27, 1992, the *Quality Management Program and Misadministrations'

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. Regional inspectors will inspect

to ensure that licensees comply with all notification requirements in the

event of a misadministration.

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.

Richard E. Cunningham, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contact: Patricia K. Holahan, Ph.D., NMSS

(301) 504-2694 Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

15 I

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