Information Notice 1986-85, Enforcement Actions Against Medical Licensees for Willful Failure to Report Misadministrations

Enforcement Actions Against Medical Licensees for Willful Failure to Report Misadministrations

ML031250284
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, 05000000, Zimmer, Fort Saint Vrain, Shoreham, Satsop, Trojan, Atlantic Nuclear Power Plant, Skagit, Marble Hill
Issue date:	10/03/1986
From:	Partlow J NRC/IE
To:
References
IN-86-085, NUDOCS 8609300125
Download: ML031250284 (4)

SSINS No.: 6835 IN 86-85 UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF INSPECTION AND ENFORCEMENT

WASHINGTON, D.C. 20555 October 3, 1986 IE INFORMATION NOTICE NO. 86-85: ENFORCEMENT ACTIONS AGAINST MEDICAL

LICENSEES FOR WILLFULL FAILURE TO

--- REPORT MISADMINISTRATIONS

Addressees

All NRC medical licensees*

Purpose

This notice is provided totalert all NRC medical licensees of enforcement

actions taken by NRC against medical licensees who willfully failed to report

misadministrations. It is suggested that addressees review this notice and

disseminate it to their-employees. However, suggestions contained in this

information notice do not constitute NRC requirements; therefore, no specific

action or written response is required.

Description of Circumstances

NRC recently has taken escalated enforcement action against two hospitals as

described below.

In the first case, several violations of NRC requirements were identified during

an NRC inspection at a hospital. An Enforcement Conference was conducted with

the licensee to discuss the violations. Subsequent to that conference and as a

result of an investigation conducted by the NRC's Office of Investigations, NRC

established that four diagnostic misadministrations had occurred before the NRC's

inspection and were not reported to the NRC as required by 10 CFR 35.43. Two

hospital employees stated to NRC investigators that the Radiation Safety

Officer (RSO), who also was the Director of the Nuclear Medicine Department, instructed them to inform NRC inspectors that diagnostic misadministrations

had not occurred. It also appeared that the RSO willfully concealed a film

of a nuclear medicine misadministration scan and thus impeded NRC's inspection

into whether mtsadministrations had occurred. As a result, on April 22, 1986, the NRC issued an Order to the hospital (1) to remove the RSO from that position

and from all involvement in the performance or supervision of NRC-licensed nuclear

medicine activities, and (2) to suspend all-licensed activities at the hospital

until the licensee demonstrates that a qualified individual has been appointed

as the RSO and authorized by the NRC.

8609300125

0,

IN 86-85 October 3, 1986 In the second case, an alleger stated that the Chief Nuclear

(CNMT) of a hospital did not report a misadministration Medicine Technologist

to either the'NRC or the

patient's referring physician as required by 10 CFR 35.43.

conducted by the NRC's Office of Investigations, the CNMT During an interview

a diagnostic misadministration and not being truthful with admitted performing

CNMT explained that the hospital RSO, who is also the Medical NRC inspectors. The

logy, instructed hervia a hospital radiologist not to report Director'of Radio- tion. During an interview with an NRC investigator, the the misadministra- although he was aware of the NRC requirement, he did not RSO admitted that

report the misadminis- tration because he did not think the incident was that serious.

As a result, on June 17, 1986 the NRC issued an Order to

show cause why the.

license should not be modified to prohibit these individuals

involvement in the performance or supervision of licensed from any further

activities.

ation was given to removing the CNMT from NRC-licensed activities Consider- ately effective Order. However, this was not considered by an immedi- CNMT had already left the hospital. In-addition, although necessary because the

occurred because of the deliberate, irresponsible actions the violations

uals, the NRC was concernedthat hospital management did of the two individ- sue an investigation of the alleged misadministration whennot aggressively pur- the NRC inspection, but rather awaited the initiation of informed of it during

the

Thus, the NRC issued a proposed Imposition of a Civil Penalty NRC investigation.

five thousand dollars ($5000). in the amount of

-.. scusson:

NRC requires the submittal of all misadministrations pursuant

since some misadministrations can have health effects on to 10 CFR 35.43 the

example, IE Information Notice 85-61 describes four diagnostic patient. For

in which the patient received.an unplanned significant dose misadministrations

one of those misadministrationsi.the patient received an of radiation. In

to 9000 rads to the thyroid instead of the 0.7 rads that estimated dose of 6500

would-have resulted

from the planned diagnostic procedure.

Normally, failure to report a medical diagnostic misadministration

characterized as a Severity Level IV violation. However, would be

actions were taken in these two cases because the failure escalated enforcement

istrations was willful and willful material false statements to report the misadmin- inspectors regarding the misadministrations. All licensee were made to NRC

aware of the importance of being truthful with NRC inspectors personnel should be

with NRC regulations. NRC has the authority to order the and of complying

personnel (such as RSOs or technologists) involved in willfulimmediate removal of

statements from NRC-licensed activities if the NRC determines material false

personnel have misled NRC inspectors and/or there is no that licensee

assurance that they can be relied on to comply with NRC longer reasonable

requirements.

• aIN 86-85 October 3, 1986 :No specific-action~or written response is required-by this information notice.

If you have any questionisregarding this matter, please contact the Regional

Administrator of the appropriate NRC regional office or this office.

Jame G. Partlow, Director

Divi ion of Inspection Programs

Office of Inspection and Enforcement

H. Karagiannis, IE

(301) 492-9655 Attachment: List of Recently Issued IE Information Notices

i I a .c .. ..

_ _

__ - t U O. -. w ax _~ _

, . .

K> ltt~nt

IN 86-85 t i . ,

October 3. 1985 LIST OF RECENTLY ISSUED

IE INFORMATION NOTICES

Inforomtron Iare

SU

Notice no. Subh14ec

---

-~i

fettle Issued to

85-84 Rupture Of A Nominal 9/30/86 All NRC medical

40-Millcurle Iodine-125 Institution licensess

Brachytherapy Seed Causing

Significant Spread Of

Radioactive Contamination

86-83 Underground Pathways Into 9/19186 All power reactor

Protected Areas. Vital Areas. facilities holding

Material Access Areas, And an OL or CU fuel

Controlled Access Areas fabrication and

processing facilities

8S-82 Failures Of Scram Discharge 9/16/86 All power reactor

Volua. Vent And Drain Valves facilities holding

an OL or CP

86-81 Broken Inner-External Closure 9/15/86 All power reactor

Springs On Atwood I Morrill facilities holding It

Main Steam Isolation Valves an OL or CP

86-80 UnIt"Startup 1ith'Degraded- -97I2/86 '-Allpower reactor

Nigh Pressure Safety InWection facilities holding

System an OL or CP.

86-79 Degradation Or Loss Of 9/2/86 All power reactor

Charging Systems At PWR facilities holding

Nuclear Power Plants Using an OL or CP

Swing-Pump Designs

86-78 Scram Solenoid Pilot Valve 9/2f86 All DldR facilities

(SSPV) Rebuild Kit Problems holding an OL or CP

86-77 Computer Program Error Report 8/28/88 All - r reactor

Handl ing fa*c111tcs holding

an OL or CP and

nuclear fuel man- utacturing facilities

86-76 Problems Noted tI Control 8/28/86 All power reactor -

faillities helding

Systems an OL or CP

OL

• Operating License

CP

• Construction Permit

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