Information Notice 1993-04, Investigation and Reporting of Misadministrations by the Radiation Safety Officer

Investigation and Reporting of Misadministrations by the Radiation Safety Officer
	ML031080049
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:	01/07/1993
From:	Cunningham R; Office of Nuclear Material Safety and Safeguards
To:	;
References
	IN-93-004, NUDOCS 9212300319
	Download: ML031080049 (7)
	v • d • e

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 January 7, 1993 NRC INFORMATION NOTICE NO. 93-04: INVESTIGATION AND REPORTING OF

MISADMINISTRATIONS BY THE RADIATION

SAFETY OFFICER

Addressees

All U.S. Nuclear Regulatory Commission medical licensees.

Purpose

. 4.

The NRC is issuing this information notice to provide guidance to licensees on

the investigation of events surrounding a misadministration. On January 27,

1992, the "Quality Management Program and Misadministrations" rule became

effective. The current (1992) 10 CFR 35.33(a)(2) requires that a report of a

misadministration must be submitted to NRC and must include, in part, why the

event occurred. This superseded the previous requirement in 10 CFR 35.33(c)

that the Radiation Safety Officer (RSO) should promptly investigate the cause

of a diagnostic misadministration and make a record for NRC review.

Furthermore, in 10 CFR 35.21(b)(1), the RSO is required, in part, to

investigate overexposures and misadministrations, and implement corrective

action, as necessary. Information contained in this notice does not

constitute a new requirement, and no written response is required.

Description of Circumstances

The following case of a diagnostic misadministration reported to the NRC

involved inaccurate information provided by the licensee and a failure of the

RSO to adequately investigate the incident.

A diagnostic misadministration report (DMR), submitted by the licensee, stated

that a nuclear medicine technologist, called in from vacation to administer a

dose of I-131 sodium iodide for a thyroid uptake study, inadvertently

administered 112 microcuries instead of the intended dose of 10 microcuries.

The DMR indicated that the error occurred because the technologist incorrectly

read the dose calibrator as 11.2 microcuries instead of 112 microcuries.

This implies that the technologist assayed a single iodine capsule, which she

subsequently administered to the patient. The DMR also stated that, instead

of five capsules for a total of 100 microcuries, an order was placed for five

capsules of 100 microcuries each. No explanation was provided for the order

of five 20 microcurie capsules for a diagnostic procedure utilizing

10 microcuries. During the inspection, the technologist indicated that she

had assayed five capsules at the same time and then mathematically determined

the activity of a single capsule. Thus the measured activity expressed on the

dose calibrator would have read 560 microcuries instead of 112 microcuries as

reported in the licensee's report. This inaccuracy of the DMR obscured a

9212300319 lase t% 93-OOy 9i°Pro

yet;~C

OWC-A -3 11 c '

CZcT

IN 93-04 January 7, 1992 violation of 10 CFR 35.53 involving a failure to assay each dosage

administration, which very likely contributed to the misadministration.before

RSO was also on vacation at the time of the incident and was not The

made aware of

it until his return. There were inconsistencies between the DMR

explanations of the misadministration event given by the licensee'sand verbal

technologists during an NRC inspection. The RSO indicated that

he performed

an investigation, but he did not personally make a report or maintain

records of the investigation, and his efforts did not uncover the any

fact

the DMR, which was prepared by the Chief Technologist, was inaccurate that

inconsistent. Thus, the violation of 10 CFR 35.53 remained uncorrected, and

could have resulted in future misadministrations. and

Discussion:

Although this event occurred before January 27, 1992, and therefore

defined as a misadministration under the old rule, it would continue was

the definition of a misadministration under the "Quality Management to meet

and Misadministrations' rule. Of greater importance, however, is Program

complete and accurate information in the misadministration report the lack of

failure of the RSO to identify and investigate the cause of the and the

misadministration and implement the necessary corrective action.

10 CFR 30.9(a) requires, in part, that information provided to the

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

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

respects. material

Currently, 10 CFR 35.33(a)(2) requires, in part, that the licensee

submit a

written report within 15 days after the discovery of a misadministration

include a brief description of the event, why the event occurred, to

effect

the patient, necessary improvements to prevent recurrence, and actions on

to prevent recurrence as well as other information. 10 CFR 35.21(a) taken

in part, that the licensee, through the RSO, shall ensure that radiation states, safety activities are being performed in accordance with approved

and regulatory requirements in the daily operation of th? licensee'sprocedures

material program. Furthermore, 10 CFR 35.21(b)(1) requires, in byproduct

RSO shall investigate misadministrations, and implement correctivepart, that the

necessary. An investigation may include: 1) talking to all persons action, as

in the misadministration, to include the technologists, authorized involved

patient (if acceptable to the referring physician and necessary user, and

to the

investigation), in order to determine the correct details and

events; 2) reviewing the records associated with the procedure sequence of

requesting physician's order(s) and/or the written directive; 3) including the

independent assessment of the dose delivered to the patient; and performing a,

4) reviewing

any other circumstances associated with the incident. This information

be used to identify the best course of corrective action. If there would

be any discrepancies, the RSO should reexamine all the available appear to

to resolve these discrepancies and make the best determination of information

cause of the misadministration. the root

Licensees should ensure that the RSO at their facility is aware

of and

understands the requirements to: 1) conduct a thorough investigation

IN 93-04 January 7, 1992 following a misadministration; 2) determine improvements needed to prevent

recurrence; 3) implement any necessary corrective action; 4) submit a written

report of the investigation as stated above; and 5) retain a record for five

years of the written report and any other records required by 10 CFR 35.33.

Furthermore, it is essential that the RSO provide sufficient time and

attention to fulfill properly his/her radiation safety program

responsibilities, including all of the requirements in 10 CFR 35.21.

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, NMSS

(301) 504-2694 Attachments:

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information Notices

5s-~ 1 / MLsA(

Attachment 2 IN 93-04 January 7, 1993 LIST OF RECENTLY ISSUED

NRC INFORMATION NOTICES

Information Date of

Notice No. Subject Issuance Issued to

93-03 Recent Revision to 01/05/93 All byproduct, source, and

10 CFR Part 20 and special nuclear material

Change of Implementa- licensees.

tion Date to

January 1, 1994

93-02 Malfunction of A Pres- 01/04/93 All holders of OLs or CPs

surizer Code Safety for nuclear power reactors.

Valve

93-01 Accuracy of Motor- 01/04/93 All holders of OLs or CPs

Operated Valve Diagnostic for nuclear power reactors.

Equipment Manufactures

by Liberty Technologies

92-86 Unexpected Restriction 12/24/92 All holders of OLs or CPs

to Thermal Growth of for nuclear power reactors.

Reactor Coolant Piping

92-85 Potential Failures of 12/23/92 All holders of OLs or CPs

Emergency Core Cooling for nuclear power reactors.

Systems Caused by

Foreign Material Blockage

92-84 Release of Patients 12/17/92 All Nuclear Regulatory

Treated with Temporary Commission Medical Licensees

Implants

88-23, Potential for Gas 12/18/92 All holders of OLs or CPs

Supp. 4 Binding of High-Pres- for nuclear power reactors.

sure Safety Injection

Pumps during A Design

Basis Accident

92-83 Thrust Limits for 12/17/92 All holders of OLs or OPs

Limitorque Actuators for nuclear power reactors.

and Potential Over- stressing of Motor- Operated Valves

OL = Operating License

CP = Construction Permit

Attachment 1 IN 93-04 January 7, 1993 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

I_ z __ _._

InTormation Date of

Notice No. Subject Issuance Issued to

93-03 Recent Revision to 01/05/93 All byproduct, source, and

10 CFR Part 20 and special nuclear material

Change of Implementa- licensees.

tion Date to

January 1, 1994

92-84 Release of Patients 12/17/92 All Nuclear Regulatory Com- Treated with Temporary mission Medical Licensees.

Implants

92-72 Employee Training 10/18/92 All U.S. Nuclear Regulatory

and Shipper Registra- Commission Licensees.

tion Requirements for

Transporting Radioactive

Materials

92-62 Emergency Response 08/24/92 All U.S. Nuclear Regulatory

Information Require- Commission Licensees.

ments for Radioactive

Material Shipments

92-58 Uranium Hexafluoride 08/12/92 All fuel cycle licensees.

Cylinders - Deviations

in Coupling Welds

92-38 Implementation Date for 05/12/92 All holders of OLs or CPs

the Revision to the EPA for-nuclear power reactors.

Manual of Protective non-power reactors and

Action Guides and Pro- materials licensees author- tective Actions for ized to possess large

Nuclear Incidents quantities of radioactive

material.

9.-37 Implementation of the 05/08/92 All Nuclear Regulatory

Deliberate Misconduct Rule Commission Licensees.

92-34 New Exposure Limits for 05/06/92 All licensees whose opera- Airborne Uranium and tions can cause airborne

Thorium concentrations of uranium

and thorium.