Information Notice 1994-17, Strontium-90 Eye Applicators: Submission of Quality Management Plan (Qmp), Calibration, and Use

Strontium-90 Eye Applicators: Submission of Quality Management Plan (Qmp), Calibration, and Use

ML031060614
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:	03/11/1994
From:	Paperiello C NRC/NMSS/IMNS
To:
References
IN-94-017, NUDOCS 9403080349
Download: ML031060614 (7)

UNITED STATES

NUCLEAR REGULATORY COMMISSION

OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS

WASHINGTON, D.C. 20555 March 11, 1994- NRC INFORMATION NOTICE 94-17: STRONTIUM-90 EYE APPLICATORS:

SUBMISSION OF QUALITY MANAGEMENT

PLAN (QMP), CALIBRATION, AND USE

Addressees

All U.S. Nuclear Regulatory Commission Medical Use Licensees.

Purpose

The NRC is issuing this Information Notice to remind licensees authorized to

possess Sr-90 for authorized uses described in 10 CFR 35.400(e) of the need

includes

to: (1)implement and submit a quality management plan (QMP)inthat 10 CFR 35.32;

policies and procedures to meet the requirements described

use and

and (2) inform all licensees of recent information regarding the

calibration of Sr-90 eye applicators.

Description of Circumstances

There has been confusion as to the need for a QMP for Sr-90 eye applicators

used for patient treatment procedures. The NRC's Office of the General

staff that because the QM program requirements

Counsel advised the technical use of Sr-90 eye

in 10 CFR 35.32 apply to many brachytherapy dose," the

submission of a QMP.

applicators, as described in 10 CFR 35.400(e), requires of the

This Information Notice reminds Sr-90 eye applicator licensees of 10

requirement to submit and implement a QMP that meets the requirements

CFR 35.32.

Additionally, this letter alerts licensees to possible discrepancies licensees

associated with the calibration of Sr-90 eye applicators and reminds and use.

of the regulatory requirements associated with their calibration

Discussion- Submissi0n of a Oualitv Management Plan

If you are licensed forAand using a Sr-90 eye applicator, the NRC's

you to submit a QMP that meets the requirements of 10 CFR

regulations require from the Sr-90

35.32. The QMP should provide high confidence that radiation user. The

eye applicator will be administered as directed by the authorized that meet the

submitted QMP should include written policies and procedures

five objectives, as described in 10 CFR 35.32(a):

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.-- AIN 94-17 March 11, 1994 directive, signed and dated

1. That prior to administration, a written each

by an authorized user, is prepared for applicable

administration.

(A written directive for Sr-90 eye-applicators means an order, in

and signed by an authorized

writing, for a specific patient, dated must include the

It

user prior to administration of radiation.strength (corrected for

radioisotope, the treatment site, source

decay), and exposure time (or equivalently, the total dose).

is identified by more

2. That prior to each administration, the patient the written directive.

than one method as the individual named in

3. That final plans of treatment and related calculations are in

accordance with the respective written directive.

the written

4. That each administration is in accordance with

directive.

directive is

5. That any unintended deviation from the written

identified and evaluated, and appropriate action taken.

Additionally, to meet the requirements of 10 CFR 35.32(b), you need policies

to verify compliance of all

and procedures for conducting a review of the QMPthan 12 months. The review is

aspects of the program at intervals no greater administrations, all recordable

to include a representative sample of patient actions taken.

events and all misadministrations, and any corrective

the program's

Licensees may make modifications to their QMPs toisincrease

not decreased.

efficiency provided the program's effectiveness to their QMP to the

10 CFR 35.32(e) requires licensees to submit modifications

the modification has been

appropriate NRC regional office within 30 days after

made.

are not, or do not intend

If you are licensed for a Sr-90 eye applicator, but in lieu of a QMP. This

to use it,you may submit a "negative declaration' of a QMP to NRC prior to

written declaration must commit to your submission procedures.

use of the Sr-90 eye applicator for patient treatment

IN 94-17 March 11, 1994 Calibration and Use of Strontium-90 Eve aDplicators

correspondence from

The NRC staff has had discussions with and received and Technology (NIST) about

researchers at the National Institute of Standards to Sr-90 eye

large discrepancies among calibrated outputs assigned may have been in units

applicators. The manufacturer's original calibrations

to System Internationale

that are no longer used or have little relationshipunits from different

units in use today. Further, comparisons between

discrepancies

manufacturers may be meaningless and misleading. Finally, output measurements between

larger than 10 percent still exist when comparing

competent measurement labs using state-of-the-art techniques.

Committee on Medical Uses

The above information was provided to NRC's Advisorymeeting. The ACMUI members

of Isotopes (ACMUI) at its November 1 and 2, 1993, factor in the use of

advised the staff that calibration was not critical

a

licensees treat for

Sr-90 eye applicators for treating pterygium because

recommended that NRC inform

response rather than to tolerance. The ACHUI with calibration of Sr-90 eye

licensees of the potential problems associatedcautioning licensees that if they

applicators. The Committee also recommended possession or buy a

use an applicator, other than the one currently in theirto another device

new one, their current technique may not be applicable for the differenti

because of variances in stated and actual exposure rates

applicators.

eye applicators that

NIST offers a service for the calibration of Sr-90

rate, and (2)a mapping of the

provides: (1)the calculation of the emission in order to ascertain

Sr-90 distribution across the face of the applicator

on the NIST calibration service, uniformity of dose. For further information 975-5589 or Dr. Bert Coursey at

contact either Dr. Christopher Soares at (301)

knowledge, the

(301) 975-5584. Although NIST is, to the best of the staff'sNRC is not requiring

only provider of such a service, there may be others.

and accepts calculations of

that licensees participate in the NIST program,calibration, corrected for

exposure time based on the original vendor's

radioactive decay.

as a brachytherapy

Since 10 CFR 35.400(e) identifies the Sr-90 eye applicator

Requirements for possession

device, licensees are reminded that 10 CFR 35.59, does apply to Sr-90 eye

of sealed sources and brachytherapy sources," applicable leak tests and

applicators. Specifically, licensees must perform

surveys 4escrlbed in 10 CFR 35.59. Additionally, 10 CFR 35.400(e) limits the

eye conditions."

use of S"90-veye applicators to "treatment of superficial of a Sr-90 eye

LicenseebAtL6'reminded that NRC authorization for use

authorize its use on treatment

applicator'for'pattent procedures does not

sites other than the eye.

V. IN94-17 March 11, 1994 written response. If

This Information Notice requires no specific action or please contact the

you have questions about the information in this notice, appropriate-technical contact listed below.

Carl J. Paperiello, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contacts: Jim Dwyer, RI Jacqueline Burks, RIV

(215) 337-5309 (817) 860-8132 John Pelchat, RII James Montgomery, RV

(404) 331-5083 (510) 975-0249 Cassandra Frazier, RIII Sally L. Merchant, NMSS

(708) 790-5704 (301) 504-2637 Attachments: Notices

1. List of Recently Issued NMSS InformationNotices

2. List of Recently Issued NRC Information

• See previous concurrence

l IAB 'IMAB TechEd* IMOB* IMOB l

OI l IMAB

KRamsey FCombs

NAME SMerchantt 2 j AMCiamper JEGlenn EKraus

DATE l02/24/94C 12 Z - 24/94 12/29L93 0113/94 02/20/9 OiFC- ZE WBrach MI iMN

CP aiejiello _

NAME STreby

DATE 02/04/94 02/07/94 03/0/940

DOC NAME: 94-17.IN

OFFICIAL RECORD COPY

- S\f

s._J Attachment 1 IN 94-17 March 11, 1994 LIST OF RECENTLY ISSUED

NMSS INFORMATION NOTICES

Unformation Date of

Notice No. Subject Issuance Issued to

Recent Incidents Resulting 03/03/94 All U.S. Nuclear Regulatory

94-16 Commission material and fuel

in Offsite Contamination

cycle licensees.

Radiation Exposures during 03/02/94 All U.S. Nuclear Regulatory

94-15 Commission licensees author- an Event Involving a Fixed

Nuclear Gauge ized to possess, use, manu- facture, or distribute

industrial nuclear gauges.

Release of Patients with 02/03/94 All U.S. Nuclear Regulatory

94-09 Commission medical

Residual Radioactivity

from Medical Treatment and licensees.

Control of Areas due to

Presence of Patients Con- taining Radioactivity

Following Implementation

of Revised 10 CFR Part 20

Solubility Criteria for 01/28/94 All byproduct material and

94-07 fuel cycle licensees with

Liquid Effluent Releases

to Sanitary Sewerage under the exception of licensees

the Revised 10 CFR Part 20 authorized solely for

sealed sources.

Reporting Requirements 12/22/93 All U.S. Nuclear Regulatory

93-100 Commission licensees.

for Bankruptcy

Implimentation of the 10/08/93 All byproduct, source, and

93-80 special nuclear material

dRevised-10 COR Part 20

licensees.

27i a'h rsrt-that Result 10/04/93 All nuclear fuel cycle

93-77 in InadVertent Transfers licensees.

of Special Nuclear Material

at Fuel Cycle Facilities

K- I ..JAttachment 2 IN 94-17 March 11, 1994 LIST OF RECENTLY ISSUED

4_' NRC INFORMATION NOTICES

Information Date of

Subject Issuance Issued to

Notice No.

Recent Incidents Resulting 03/03/94 All U.S. Nuclear Regulatory

94-16 in Offsite Contamination Commission material and fuel

cycle licensees.

Radiation Exposures during 03/02/94 All U.S. Nuclear Regulatory

94-15 Commission licensees author- an Event Involving a Fixed

Nuclear Gauge ized to possess, use, manu- facture, or distribute

industrial nuclear gauges.

Failure to Implement 02/24/94 All holders of OLs qr CPs

94-14 for nuclear power and non- Requirements for Biennial

Medical Examinations and power reactors and ll

Notification to the NRC licensed reactor operators

of Changes in Licensed and senior reactor

Operator Medical Conditions operators.

Intersystem LOCA 02/22/94 All holders of OLs or CPs

92-36, for nuclear power reactors.

Supp. 1 Outside Containment

Unanticipated and Un-

• 02/22/94 All holders of OLs or CPs

94-13 for nuclear power reactors.

intended Movement of

Fuel Assemblies and

Other Components due to

Improper Operation of

Refueling Equipment

02/09/94 All holders of OLs or CPs

94-12 Insights Gained from for nuclear power reactors.

Resolving Generic

4Ijsue.57; Effects of

i~jNmrotecton System

- ~n. 6n Safety- t 4tqp ent

Turbine Overspeed and 02/08/94 All holders of OLs or CPs

94-11 for nuclear power reactors.

Reactor Cooldown during

Shutdown Evolution

OL - Operating License

CP - Construction Permit

K../VIN 94-17 March 11, 1994 or written response. If

This Information Notice requires no specific action notice, please contact the

you have questions about the information in this

appropriate'technical contact listed below.

Carl J. Paperiello, Director

Division of Industrial and

Medical Nuclear Safety

Office of Nuclear Material Safety

and Safeguards

Technical contacts: Jim Dwyer, RI Jacqueline Burks, RIV

(215) 337-5309 (817) 860-8132 John Pelchat, RII James Montgomery, RV

(404) 331-5083 (510) 975-0249 Cassandra Frazier, RIII Sally L. Merchant, NMSS

(708) 790-5704 (301) 504-2637 Attachments: Notices

1. List of Recently Issued NMSS Information Notices

2. List of Recently Issued NRC Information

63j1 b