ML20116M961

NMSS Licensee Newsletter.Number 89-3

ML20116M961
Person / Time
Issue date:	09/30/1989
From:	NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-BR-0117, NUREG-BR-0117-N89-3, NUREG-BR-117, NUREG-BR-117-N89-3, NUDOCS 9608210191
Download: ML20116M961 (11)

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NMSS UcenseeMewsletter m

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i Regulatory Material Safety NO, 89-3 Q/

Commission and Safe 3Jards September 1989 l

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COMPLIANCE WITil NEW licenses with no total possession limit. Such licenses will need DECOMMISSIONING RULE to be amended to specify possession limits, or the financial assurance requirements will apply.

The U.S. Nuclear Regulatory Commission (NRC) published an important decommissioning rule on June 27,1988. By Holders of existing licenses must comply with these re-no later than July 27,1990, licensees authorized to possess quirements by July 27,1990. Applicants for new licenses certain quantities of byproduct, source, or special nuclear filed after June 27, 1988 are subject to the requirements material will need to either submit a decommissioning fund-immediately, ing plan or a certificate that financial assurance for decom-missioning has been provided in the prescribed amounts.

To terminate a license, licensees subject to the new rule must j

submit a final decommissioning plan to NRC for review and Not every licensee is required to provide a funding plan or approval, before decommissioning, if decommissioning ac-certification of financial assurance, but crery licensee will tivities could increase potential health and safety impacts on be required to keep records and drawings which may even-workers or the public. The final plan, if required, must con-tually be important to safe and effective decommissioning tain an updated cost estimate for decommissioning and a plan of facilities. Spills resulting in residual contamination must for assuring the availability of adequate funds.

be documented, and the records maintained. As-built draw-ings showing buried pipes, covered-up areas, or similar Copies of the new regulation were mailed to all licensees j

details must also be maintained. Licensees who are not plan-in 1988. Each NRC byproduct, source or special nuclear I

ning to terminate their licenses shortly and licensees whose materials licensee should review the appropriate sections of i

decommissioning is imminent both must comply with these 10 CFR Parts 30,40 and 70 to determine the impact of these requirements or be subject to enforcement action, rules. If authorizations on a license exceed actual needs, an l

amendment request could be submitted to reduce possession Licensees do not necessarily need to possess large activities limits. The licensing staff will consider special license con-of radioisotopes, to be required to assure funds. Those who ditions which preserse the form of the license of broad scope, possess as little as 10 microcuries of plutonium-239,100 but limit possession of long-lived (greater than 120 days) microcuries of strontium-90, I millicurie of cobalt-60,10 radioisotopes to activities below those requiring either a plan l

millicuries of cesium-137,100 millicuries of carbon-14, or or certification.

I 1 curie of tritium in unsealed form will require certification of funding in an amount of at least $150,000, or an equivalent Staff of the NRC Regional Offices may be contacted to plan. Those who possess 10 times those quantities would re-discuss the content of the rule and possible amendments to quire certification of funding of at least $750,000, or an reduce the need for financial assurance. Licensees may ob-l equivalent plan. At 100 times these quantities, a funding plan tain a copy of the rule froma would be required, based on anticipated, actual costs to carry i

out a decommissioning plan. As currently written, almost The U.S. Nuclear Regulatory Commission, Division of In-every license of broad scope issued pursuant to 10 CFR Part formation Support Services / Distribution Section, 33 will require a decommissioning plan or certification.

Washington, D.C. 20555 The thresholds for requiring a plan or certification for posses-Additional detailed guidance is available in NUREG-1336, sion of sealed sources are much higher than for unsealed Rev.1, " Standard Format and Content Guide for Financial sources. Those licensees who possess 100 curies of Assurance Mechanisms Required for Decommissioning plutonium-239 or americium-241, 1,000 curies of under 10 CFR Parts 30,40,70 and 72" and NUREG-1337, strontium-90, or 10,000 curies of cobalt-60, as scaled Rev.1, " Standard Review Plan for the Review of Financial 4

sources, will require certification of funding of at least Assurance Mechanisms for Decommissioning under Parts j

$75,000. Past practice has been to issue some sealed source 30,40,70 and 72." Copies of NUREG-1336, Rev. I and l

9608210191 890930

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a SEPTEMBER 1989 NMSS LICENSEE NUREG-1337, Rev. 1 may be purchased,from the.

NEWSLETTER CONTENTS Superintendent of Documents, U.S. Government Printing Of-fice, P.O. Box 37082, Washington, D.C. 20013-7082 and l

Page from the Technical Information Service,5285 Port Royal Road, Springfield, VA 22161. A copy of each document is

l. Compliance with New Decommissioning also available for inspection and/or copying, for a fee, in l

Rule (Contacts: Dr. John Glenn the NRC Public Document Room, 2120 L St. N.W.,

(301) 492/3418/ Louis Bykoski Washington, D.C.

l (301) 492-0572).

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2. Radiation Sterilizers Developments RADIATION STERILIZERS DEVELOPMENTS (Contacts: Mark Eliott (404) 242-7438/

Pat Vacca (301) 492-0615)..

.2 The recovery operations at is % tion Sterilizers. Inc. (RSI) in Decatur, Georgia, continue. Originally, RSI had 252 cap-j

3. Region 11 Workshop on Medical Use of sules that have now been identified as either normal-form l

Radioisotopes (Contact: Debra Seymour (91) or special-form (161). As of late August,15 normal-(404) 242-0426).

.2 form capsules have been shipped off-site, two capsules per cask and one cask per tmck. Three capsules are at Oak Ridge

4. Nuclear Pharmacy Workshop (Contact:

National Laboratory for analyses, and the other 12 were sent Bruce Mallett (312) 388-5612).

.3 to Richland, Washington.

j S. Transportation Regulations for Byproduct Special-form sources are shipped four per cask, and as many Materials Licensees (Contact: Chuck Cain as three casks per truck. As oflate August,52 special-form

.3 sources have been shipped off-site, all to Richland, l

(817) 860-8186).

Washington. The Department of Energy (DOE) and its con-j

6. U.S. Nuclear Regulatory Commission tractors, who are responsible for this work, estimate that all (NRC) Announces New NRC Rule for sources will be removed from RSI, Decatur by March 1990; Informal Hearing Procedures (Contact:

however, this date may change.

l William Thompson (301) 492-0529)

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The Governor of the State of Georgia created an RSI inci-

7. Selected Significant Events Reported to dent Evaluation Task Force to collect all available informa-the USNRC or Agreement States (Contact:

tion and prepare a report of " lessons learned," including l

Kathleen Black (301) 492-4995)

.4 any needed recommendations. On June 30,1989, the Task P

Force published its first interim report. DOE has appointed

8. Transfer of Licenses from One Entity to a board to investigate the cause of the capsule failure. The Another (Contact: Jack Metzger (301)

DOE Board's report has not been issued, because of delays i

492-3424)..

.5 in completing destructive testing of the failed capusle.

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9. Information Notices (Contact:

l same as above)

.6 REGION 11 WORKSHOP ON MEDICAL i

USE OF RADIOISOTOPES

10. Medical Quality Assurance Assessment (Contact: Scott Moore (301) 492-0514)

.7 On May 13,1989, Region 11 staff conducted a one-day

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Workshop on Medical Use of Radioisotopes for licensees in

11. Rulemakings Published (Contact:

West Virginia. The workshop was held in Charleston, WV, Paul Goldberg (301) 492-0631).

.7 and was attended by 75 people. West Virginia has 45 medical licensees.

12. Personnel Monitoring Reports (Contact:

Barbara Brooks (301) 492-3738).

.7 The Region 11 staff was joined by Norman McElroy, Head-(

quarters Chief, Medical and Academic Section, at the

13. Significant Enforcement Actions against workshop. The topics addressed at the workshop included:

Materials Licensees (Contact: Betty Part 35; recent changes in inspection frequencies; Perfor-Summers (301) 492-0741)

.8 matice Evaluation Factors implementation; the inspection and enforcement programs; and licensing. A highlight of the workshop was Regional Administrator Stewart Ebneter's presentation on licensee management responsibilities in the medical use of radioisotopes.

A similar workshop is being planned for Virginia licensees l

in FY90.

Send us your 35-to 50-word

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good-news fact or figure, and we'll spread the word!

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NUCLEAR PilARMACY WORKSIIOP material, special form, n.o.s.," this number is UN2974.

For materials shipped as " Radioactive material, n.o.s.,"

l On. lune 7,1989, the U.S. Nuclear Regulatory Commission this number is UN2982.

l (NRC) Office of Nuclear Materials Safety and Safeguards (NMSS) and Region ill hosted a workshop with nuclear phar-

3. The name of each radionuclide. (For example, "Co-60.")

i macy licensees from around the country, the Food and Drug l

Administration (FDA), several State Boards of Pharmacy,

4. A description of the physical and chemical form of the Agreement State regulators, and manufacturers of material. (For special-form sources, this description is radiopharmaceuticals.

"SPECIAL FORM.")

The focus of the workahop was regulatory agency expecta-

5. The activity contained in each package measured in curie tions of nuclear pharmacy programs in the area of quality units.

l assurance, to ensure that proper radiopharmaceuticals and I

doses are distributed to clients, to discuss recent health and

6. The category of label applied to each package l

safety problems, and to help resolve the question of"who"

(" RADIOACTIVE WHITE-1," " RADIOACTIVE l

should regulate quality assurance at nuclear pharmacies.

YELLOW-II," OR " RADIOACTIVE YELLOW.Ill").

The keynote speaker was Mr. Glen L. Sjoblom, Deputy

7. The transport index (radiation level at 1 meter) assigned l

Director of the Division of Industrial and Medical Nuclear to each package hearing YELLOW-ll or YELLOW-Ill Safety, NMSS. There were also other speakers from NMSS, labels.

FDA, and the Syncor nuclear pharmacy. There was a good exchange of views among regulators and regulated. Licensees

8. For shipments tendered to a common carrier, the ap-expressed two major views, during the workshop's propriate signed shipper's certification (49 CFR Section discussion:

172.204). For shipments by aircraft, the additional state-l ment as to acceptability for either passenger-carrying or i

1. Quality assurance problems are not sufficient to warrant cargo-only aircraft. For shipments by passenger-carrying l

additional regulations, but, rather, should be corrected aircraft, the additional statement of intended use in i

on a case-by-case basis at nuclear pharmacies; and -

research, medical diagnosis, or treatment must also be included.

2. NRC, the State Boards of Pharmacy, and FDA should work together more closely, to achieve a uniform ap-When licensees transport sealed sources in their own proach. This could include performing joint team inspec-packages repetitively, a reusable type of shipping paper tions of nuclear pharmacy programs.

documentation should be used that is specific to each par-i ticular package configuration. Such documentation can take the form of laminated cards retained in the cab of the vehi-i TRANSPORTATION REGULATIONS FOR cle, thereby eliminating the need for preparing a new ship-l HYPRODUCT MATERIALS LICENSEES ping paper document every time a shipment is made.

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This is the last article, in a series of articles, which have Shipping papers must be maintained in the vehicle, within been summarizing Department of Transportation (DOT) the immediate reach of the driver restrained by the lap belt.

regulations which U.S. Nuclear Regulatory Commission Ordinarily, a glove compartment does not meet this require-l (NRC) inspectors cite most often, and which appear most ment. (49 CFR Subsection 177.817(e) prevides detailed in-I troublesome to industrial, medical, and academic licensees formation on accessibility of shipping papers within vehicles.)

who package and ship radioactive materials only occa-sionally.

Licensees who transport packages in their own vehicles must provide for adequate bkicking, bracing, or tie-down of the l

A shipping paper is required for each transport of radioac-packages to prevent shifting or movement during normal tive material from the confm' es of the licensee's facility, transport. Licensees also are required to provide security whether transported by the licensee or delivered to a com-measures adequate to prevent the unauthorized removal of mon carrier for transport. The shipping paper indicates com-materials from the place of storage during transport pursuant pliance with DOT regulations and is useful to authorities in to 10 CFR Section 20.207. This may involve locking the case of an accident, loss, or theft. It must include the infor-packages within an extemal, permanently-attached compart-mation required by 49 CFR Sections 172.202-203, including ment of the vehicle, or within the cargo compartment, itself.

the following:

In either case, it is necessary to remove the keys from the vehicle.

1. The applicable DOT proper shipping name from 49 CFR Section 172.101. (For sources that are shipped as special All licensees who package or transport radioactive packages l

form, this will always be " Radioactive material, special are urged to avail themselves of up-to-date copies of the ap-j form n.o.s." For normal-form materials, the shipping plicable NRC and DOT regulations. Copies of these regula-j j

name will generally be " Radioactive material, n.o.s.")

tions (e.g., Title 49 of the Code of Federal Regulens) can i

be obtained from. Superintendent of Doc.ments, U.S.

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2. The applicable Identification Number from 49 CFR Sec-Government Printing Office, Washington, D.C. 20402-9371, tion 172.101. (For materials shipped as " Radioactive (202) 783-3238.

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U.S. NUCLEAR REGULATORY COM311SSION (NRC)

The individual who answered '

ANNOUNCFS NEW NRC RULE FOR INFORMAL to the wrong name was set up IIEARING PROCEDURES using freckles on his back, the freckles being mistaken for On February 28,1989, a new Subpart L to 10 CFR Part 2, tattoo marks. The individual

" Informal Hearing Procedures for Adjudications in Materials indicated that the set-up was Licensing Proceedings," was published in the Federal wrong; the technoh> gist called Register (38FR8269). The new rule became effective on the oncology physician to March 30,1989.

verify that the required treat-ment was correct on the pa-The opportunity to request a hearing on a materials licens-tient's chart. The physician ing proceeding has always existed in NRC regulations.

verified that the treatment was 110 wever, the new rule specifies the methods and timing for as intended, but did not speak requesting a hearing, and describes the procedures for con-to or examine the patient. The ducting a hearing. When NRC publishes an initial notice of patient was in the therapy a materials licensing application in the Federal Register, an-department for treatment of nouncement of the opportunity to request an informal hear-his right lung.

ing is now included. NRC publishes such notices for the more significant licensing actions, such as those needing an En-Event 2: Teletherapy Good Samaritan Hospital, an vironmental Assessment or an Environmental Impact State-Misadministrations Agreement State licensee, ment. The opportunity to request a hearing is available for reported that three patients 30 days after the notice is published. In the cases where no Licensee: Good Samaritan had been overexposed when notice of a materials license application is published, such liospital the wrong wedge correction as for routine licensing actions, and a requestor receives no Phoenix, AZ factor was used. Two of the other notice of the pending application, the opportunity to three patients needed corree-request an informal hearing is available for 180 days after Date Reported: July 26, tive surgery. The hospital's NRC takes action on the application.

1989 proposed corrective actions are to institute a system of A copy of the new rule has beca sent to all licensees. Pro-double-checks, including cedures for the conduct of the informal hearing process are point-dose calculations. NRC too detailed to be included here. The objective, however, is arranging for a consultant, is to make the process simple, recognizing that issues of who is a therapeutic physi-public health and safety related to the use oflicensed material cian, to provide an overview are not as significant as those involving nuclear power reac-of the case and to reconunend tors, for which the formal adjudication process was devised.

corrective actions to the State.

Copies of the new rule may be obtained from:

Event 3: Diagnostic A 300-microcurie dose of Misadministration iodine-123, an accelerator-The U.S. Nuclear Regulatory Commission produced isotope that the U.S.

Division of Information Support Licensee: Abott-Nuclear Regulatory Com-Distribution Center Northwestern mission (NRC) does not Washington, D.C. 20555 Hospital regulate, was prescribed for a Minneapolis, MN diagnostic thyroid procedure.

LICENSEES: Please note-The area code for the Region The patient was given three 111 Office will be changed from "312" to "708." Effec-Date Reported: May 23, nullicuries of iodme-131, a 1989 regulated isotope, mstead. The tive November 11,1989, the Region III telephone number licensee stated that the misad-will be 708-790-5500.

ministration occurred because the technologist misunder-SELECTED SIGNIFICANT EVENTS REPORTED TO stood the physician's request THE U.S. NUCLEAR REGULATORY COMMISSION as to what radiopharmaceu-(NRC) or AGREEMENT STATES tical and dosage should be Event 1: Teletherapy A therapy misadministration used.

Misadministration occurred when 250 rad were administered to the wrong Event 4: Brachytherapy A four-cm iridium-192 wire Licensee: Worcester City area (lumbar / sacral spine) of Event was being used for brachy-Hospital the wrong patient. The Separation of therapy treatment. The radia-Worcester, MA technologist called out the Iridium Wire tion oncologist exerted some correct person's name, but from Guidewire force when placing the wire in Date Reported: July 24, did not verify that the person the catheter. The catheter con-1989 who answered was the correct person. Photographic confir-mation could have been used.

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Licensee:, Methodist taining the wire was placed in tion field of the exposed t.

Hospital of position, and the wire was source. Chromosome studies Indiana removed about two and one-on the radiographer by a Indianapolis, IN half hours later. A survey of physician at a National the patient showed readings laboratory and a doctor Date Reported: July 7, were still above 200 mR/hr, showed an estimated equiva-1989 indicating the source had lent whole-body dose of ap-become detached from the proximately 5 to 8 rem had guidewire and had remained occurred, and no adverse ef-in the implanted catheter when feet on the radiographer would the guidewire was removed.

result at this level.

The catheter was immediately removed from the patient. The Note: The annual Office of Analysis and Evaluation of dose received by the patient Operational Data (AEOD) Non-Reactor Report, did not exceed the prescribed NUREG-1272 is available by calling AEOD on (301) dose by 10 percent.

492-4484 or by writing to:

No contamination was de-USNRC tected. Apparently the source AEOD became detached from the MNBB MS-3701 guidewire w hen it was remov-Washington, DC 20555 ed from the patient.

Event 5: Radiographer Glitsch Field Services TRANSFER OF LICENSES FROM ONE ENTITY Overexposure reported that the t he r-TO ANOTilER moluminescent dosimeter l

Licensee: Glitsch Field worn by a radiographer read U.S. Nuclear Regulatory Commission (NRC) Policy and Services 93.5 rem. The radiographer, Guidance Directive No. FC-86-2 was revised to provide up-NDE Inc working at a site in Erie, PA, dated guidelines for processing licensee applications involv-Erie, PA had been using an 88-curie ing change of ownership of licensed operations. The revi-iridium-192 source to perform sion incorporated additional specific guidance on informa-Date Reported: August 2, radiography. He had noted tion that should be submitted by applicants.

l 1989 that his pocket dosimeter was off-scale, indicating an ex-Recently, the NRC staff has noticed an increase in problems i

posure of more than 200 related to trrnsfer of ownership of businesses that control millirems. He had stopped all the use of licensed materials. Changes in ownerships are work. His badge had shown usually the result of mergers, buyouts, or majority stock an exposure of 93.42 rem.

transfers. It is therefore necessary for licensees to provide I

timely notification to NRC when decisions could involve l

A reenactment of the radio-changes in the corporate structure responsible for manage-grapher's actions at the time of ment oversight. NRC needs to be notified so that it can assure the exposure showed that the that radioactive materials are possessed, used, owned, or con-reported whole-body exposure trolled only by persons who validly are qualified to have an

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l was valid, and appeared to be NRC license. The appropriate NRC regulation for byproduct l

localized in the right hip area, materials may be found in 10 CFR Subsection 30.34(b). This where the radiographer's regulation states: "No license issued or granted pursuant to dosimeter was hicated.

the regulations in this Part and Parts 31 through 35, or any right under a license shall be transferred, assigned or in any l

The radiographer had com-manner disposed of, either voluntarily or involuntarily, pleted an exposure, and had directly or indirectly, through transfer of control of any retracted the source into its license to any person, unless the Commission shall, after shielded position within the securing full information, find that the transfer is in accor-l camera, but had neglected to dance with the provisions of the Act and shall give its con-l h)ck the source in the shield-sent in writing." Similar regulations are contained in 10 CFR

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ed position. The radiographer Sections 40.46 and 70.36, for source and special nuclear then had moved the device for material, respectively. Thus, the regulations state clearly that the next radiograph, and the control oflicenses cannot be transferred without written per-source apparently had moved mission from the Commission. The burden of adhering to out of the shielded position.

this requirement is on the existing licensee; however, it may While the radiographer was be necessary for the transferee to provide supporting setting up for the next information.

radiograph, he unknowingly had worked within the radia-t 5

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INFORMATION NOTICES, MAY 31, 1989 -

plan. Critioues of exercises must evaluate the ap-AUGUST 31,1989 propriateness of the plan, emergency procedures, facilities, equipment, training of personnel, and overall A. Confidentiality of Exercise Scenarios-IN 8946, Dated effectiveness of the response. Deficiencies found by the May 11,1989 critiques must be corrected."

This Information Notice was provided to alert fuel facili-B.

Potential Problem with Worn or Distorted Hose Clamps ty and certain byproduct material licensees to the unac-on Self-Contained Breathing Apparatus-IN 8947, ceptable practice of conducting the required annual Dated May 18, 1989.

radiological emergency response exercise using

" players" who are familiar with the details of the ex-This Notice was provided to alert addressees to poten-ercise scenarios.

tial problems with worn or distorted hose clamps on self-contained breathing apparatus (SCB A).

During the U.S. Nuclear Regulatory Commission's (NRC's) observation and evaluation of a radiological A Department of flealth and Human Services "NIOSH emergency exercise at a fuel facility, the inspectors Respirator User's Notice" described two events in which learned that the licensee was planning to use a scenario retaining clamps on the breathing tube of a SCBA fail-that was familiar to the exercise players. The inspec-ed, causing the tube to separate from the facepiece.

tors also learned that a training handout was provided, These failures led to the death of one wearer and serious to members of the emergency organization, which in-injury to another. In both cases, the failure was attributed tentionally included the actual scenario to be used for to worn or deformed clamps that may have resulted from the exercise. The scenario and the various players' an-improper maintenance of the units.

ticipated roles were apparently discussed and "re-hearsed." The handout also offered applicable emer-Hose clamp failures on SCBAs can result in se,tus per-gency procedures (or portions thereof) for use by players sonnel safety hazards. To help prevent these failures, during the exercise. Failure to conduct a radiological it is important that personnel pay particular attention emergency exercise in a manner that adequately tests while performing maintenance on the SCBAs. It is im-a licensee's ability to implement the Radiological Con-portant that maintenance personnel perform careful tingency Plan could result in an NRC request to con-visual inspections of hose clamps, to identify worn or duct a remedial exercise, as occurred in the case just deformed ones and, when replacing these defective i

discussed.

clamps, adhere strictly to the manufacturer's instruc-tions. Care when disassembling or reassembling i

Fuel facility and major byproduct materials licensees breathing tube clamps will also minimize failures, j

were ordered, under a Generic Order published in the Federal Register (Vol. 46, No. 31, February 17, 1981)

C. Maintenance of Teletherapy Units-In 89-60, dated to submit radiological contingency plans to the NRC August 18, 1989 licensing staff for incorporation into their licenses. The emergency response plans submitted in response to this During a routine inspection, U.S. Nuclear Regulatory order were incorporated as license conditions for a Commission (NRC) personnel found that the licensee's number of years. These plans include requirements for teletherapy unit was in poor condition and significantly periodic training, drills, and exercises. The purpose of overdue for service and preventive maintenance, thus training and drills is to familiarize participants with the raising the question of whether the unit was safe to types of events that could take place in the facility, the operate. A service company had performed a five-year contents of the contingency plan, and procedures to inspection in August 1988, and found that many parts follow.

that the manufacturer considered critical components had not been replaced according to the recommended fre-However, for exercises, it was NRC's intention that par-quency. In fact, many of the critical components were ticipants not have prior knowledge of the specific exer-original parts, dating from when the unit was first plac-l cise scenario. Exercises are conducted to test response ed into service in 1974. Since teletherapy is a mature l

capabilities and ensure that radiological emergency per-technology, and since teletherapy devices are being sonnel are familiar with their duties. Observers of ex-replaced gradually by accelerators, the growing age of ercises cannot evaluate the effectiveness of personnel teletherapy devices makes proper preventive l

actions if the personnel have been briefed on the maintenance by a licensed company more important as scenarios before the exercise.

time passes.

The new final rule, effective April 7,1990 (Federal Examples of critical components needing permdic Register, Vol. 54, No. 66, published April 7,1989) replacements are: the field light cord rect, source drawer states, " Exercises must use accident scenarios postulated solenoids, air pressure switch, air hoses and fittings, and I

as most probable for the specific site and the scenarios treatment timer, if any of these components failed, it shall not be known to most exercise participants. The could significantly increase the possibility of the source licensee shall critique each exercise using individuals failing to return to the shielded position. This could lead not having direct implementation responsibility for the to unnecessary radiation exposures to both employees

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'and patients, or an overexposure or medical misad-both NRC-regulated and non-regulated aspects of the ministration. In fact, the field light cord reel on this unit licensee's operations. The questions concern equipment, i

had failed in 1983, and the source could not be fully computer use, staffing, patient load, the treatment process, I

retracted, continuing education, and miscellaneous subjects.

Although the service company informed the licensee of Licensees' efforts to provide complete, accurate information the critical need for service, the licensee had not taken on their programs will help NRC formulate a QA rule and any action to service the unit. Apparently, the licensee Regulatory Guide that address QA issues in an effective man-planned to eventually replace the entire unit.

ner. Licensees' cooperation with inspectors will speed com-pletion of the questionnaire during inspections.

As a result of the safety concerns raised by NRC, the licensee was required to complete the needed service on For further information about the questionnaire, contact i

an emergency basis. A heavy patient hiad was dismpted James H. Myers, NMSS, at (301) 492-0637.

temporarily.

10 CFR Section 35.647 requires licensees to have their RULEMAKINGS PUBLISifED teletherapy units fully inspected and serviced during teletherapy source replacements, or at intervals not to May 1,1989-July 27,1989 exceed five years, whichever comes first. The purpose of the inspection is to assure safe operation of the units, FINAL RULE specifically, proper functioning of the source exposure mechanism.

" Storage of Spent Nuclear Fuel in NRC-Approved Storage Casks at Nuclear Power Reactor Sites" Licensees should pay close attention to the results of their five-year inspections, and assure that recommended

1. Published: 5/5/89 service is performed promptly. Failure to maintain 2.

Contact:

William R. Pearson (301) 492-3764 teletherapy units in safe operating condition could result in radiation incidents.

A REMINDER 'lO NRC LICENSEES MEDICAL QUALITY ASSURANCE ASSESSMENT Please note that the mailing address used for newsletter i

The U.S. Nuclear Regulatory Commission's (NRC's) inspec-distribution is the same as used for your 1icense. If you i

tors have begun using a new quality assurance (QA) ques.

desire a change of address or name (on the, A'ITN line tionnaire during most inspections of medical licensees. This f address) please return a copy of the mailing label, with one-time assessment will provide information on QA pro-cometions, to newsletter address. Remember that a grams and procedures currently used by licensees authorized change of address or rame might require a license for nuclear medicine, teletherapy, or brachytherapy func-amendment.

tions. NRC is panicularly interested in the existence and con-tent of QA policies and the basis for them. Information t be obtamed will also include statistics on equipment and staf-Comments, and suggestions you may have for informa-I fing levels for various techm, cal and professmnal speciahties' tion that is not currently being included, that might be l

The information is needed to help the Office of Nuclear helpful to licensees, should be sent to:

l Material Safety and Safeguards (NMSS), in its ongoing E. Kraus development of a QA rule and accompanying Regulatory NMSS Licensee Newsletter Editor Guide, ensure that the QA rule addresses current, relevant issues at licensees' medical facilities.

Office of Nuclear Material Safety and Safeguards t

One White Flint North, Mail Stop 6-A-4) l l

To complete the questionnaire, the appropriate licensee U.S. Nuclear Regulatory Commission Washington, D.C. 20555 l

representative orally provides mformation on each question, and the inspector records the licensee's response. For large medical programs, it should take about two hours to cover PERSONNEL MONITORING REPORTS l

the questionnaire. Smaller licensees may take less time. NRC Headquarters will evaluate the completed questionnaires.

Licensees whose activities place them in one of seven categories of licensees described in 10 CFR Subsection The questionnaire is divided into four major sections:

20.48(a) are reminded that their personnel monitoring report General. Teletherapy, Ilrachytherapy, and Nuclear Medicine.

for calendar year 1989 should be submitted to the U.S.

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All medical licensees will answer the " General" section of Nuclear Regulatory Commission (NRC) by March 31,1990.

the questionnaire, which requests information such as type The seven categories are: commercial nuclear power reac-of facility, misadministration history, and general QA tors; industrial radiographers; fuel processors, fabricators, policies. The te'etherapy, brachytherapy, and nuclear and reprocessors; manufacturers and distributors of by-medicine sections will only be completed if they apply to product material; independent spend fuel storage installations; the licensee. Each of these sections asks questions that cover facilities for land-disposal oflow-level waste; and geologic 7

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repositories for high-level waste. The format to be used in A Notice of Violation and Proposed Impositian of Civil.

preparing the report is given in 10 CFR Section 20.407. The Penalty in the amount of $500 was issued on May 5, reports should be sent to:

1989, to emphasize the importance of meeting all re-quirements associated with the safe use of radioactive The Director, materials and the importance of discontinuing the use Of6ce of Nuclear Regulatory Research, of licensed materials, when those requirements cannot U.S. Nuclear Regulatory Commission, be met. The action was based on the finding that the Washington, D.C. 20555.

licensee willfully failed to provide personnel dosimetry to well-logging operators for a 19-month period.

It should also be noted that the addressjust given is the same one to which termination reports, as required by 10 CFR 4.

Department of the Army, Albuquerque, New Mexico Subsection 20.408(b), should be sent. Licensees having ques-Supplement VI, EA 88-172 tions about either of the two types of reports should write or call B. Brooks (301) 492-3738, at the aforementioned A Notice of Violation and Proposed Imposition of Civil address.

Penalty in the amount of $1,000 was issued August 24, 1988, to emphasize the importance of: ensuring that re-SIGNIFICANT ENFORCEMENT ACTIONS AGAINST quirements essential to radiatioa safety are met, and im-MATERIALS LICENSEES proving the oversight of licensed programs. The action was based on violations involving: (1) failure to ade-One way to avoid regulatory problems is to be aware of en-quately secure one gauge against unauthorized removal; forcement problems others have faced. Thus, we have in-use of a Radiation Safety Officer unlisted on the license cluded here a discussion of some representative enforcement and lacking the requisite training; and failures to (3) con-actions against materials licensees. These enforcement ac-duct physical inventories of licensed material; (4) main-tions include civil penalties, orders of various types, and tain records pertaining to the receipt oflicensed material; notices of violations. Examples are also provided of enforce-(5) conduct leak tests of scaled sources of radioactive ment actions where no civil penalty was proposed, due to material; and (6) post copics of several necessary licensee identi6 cation of violations and prompt and thorough documents. The licensee responded on September 28 and licensee-initiated corrective actions.

November 10, 1988. After considering the licensec's responses, Violation I was withdrawn and the civil A. Civil Penalties and Orders penalty associated with that violation was withdrawn.

1.

Advex Corporation, Hampton, Virginia 5.

Michael F. Dimun, M.D., Carnegie, Pennsylvania Supplement IV, EA 88-315 EA 89-52 A Notice of Violation and Proposed Imposition of Civil An Order to Cease and Desist Use of Licensed Material, Penalty in the amount of $2,000 was issued March 16.

Effective immediately, was issued March 17,1989. The 1989, to emphasize the importance of the need to en-action was based on the fact that Dr. Dimun's license i

sure implementation of effective controls of tM licens-expired without a request for timely renewal on February l

ed program. The action was based on failures to con-28, 1987, and the licensee continued to possess a trol an individual's occupational exposure to less than radioactive source containing strontium-90. Subsequent-1.25 rem and to perform adequate surveys (which would ly, the source was transferred to an authorized recipient, have prevented the exposure).

in accordance with the terms of the Order.

2.

Computerized Medical Imaging, Inc., Eau Claire, 6.

General Electric Company, Wilmington, North Carolina Wisconsin Supplement VII, EA 88-302

]

Supplements IV and VI. EA 89-14 A Notice of Violation and Proposed imposition of Civil

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A Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $20,000 was issued March 13, Penalty in the amount of $2,500 was issued March 8, 1989, to emphasize that acts of discrimination against 1989, to emphasize the importance of ensuring that, in an employee who raises safety concerns or who com-the future, the licensee will exercise greater control over municates with NRC will not be tolerated. The action all U.S. Nuclear Regulatory Commission- (NRC-)

was based on the improper transfer of an employee, and 1

licensed activities. The action was based on the failures subsequent termination, due to the employee's participa-to: secure or maintain constant surveillance and im-tion in protected activities. The evidentiary basis for the improper conduct was a Recommended Decision and mediate control of radioactive materials in an unrestricted area, resulting in the theft of the material; Order issued by an Administrative Law Judge from the j

secure used generators stored in an unrestricted area; Depanment of Labor.

j properly evaluate personnel radiation doses; and use lab coats or other protective clothing when handling radioac-7.

Anna Jaques Hospital, Newburyport, Massachusetts tive material.

Supplements IV and VI, EA 89-48 j

3.

Cornish Wireline Service, Inc., Chanute, Kansas Supplement VI, EA 89-15 8

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A No6 ice of Violation and Proposed Imposition of Civil which were neither prompt nor comprehensive, and 100

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Penalty in the amount of $1,250 was issued March 28, percent for poor prior performance.

l 1989, to emphasize the importance of management, and, l

in particular, the importance of the Radiation Safety Of-

11. James River Corporation, Richmond, Virginia l

ficer continually maintaining adequate control over the Supplement IV, EA 89-62.

l radiation safety program. The action was based on failures to: (1) notify NRC of a diagnostic misadministra-A Notice of Violation and Proposed Imposition of Civil i

tion; (2) label certain syringes containing radiophar-Penalty in the amount of $1.250 and an Order Modify-l maceuticals; (3) perform required constancy, linearity ing License was issued June 2,1989, to emphasize the and geometrical variation tests of the dose calibrator; need to ensure that adequate oversight and control of j

j and (4) perform certain required surveys and maintain generally licensed material are maintained at all of the i

certain records of some of these activities. The base civil licensee's facilities throughout the country. The action penalty was mitigated by 50 percent, because of good was based on an incident in which a generally-licensed l

past performance.

device containing 22.5 millieuries of americium-241 was inadvenently disposed of in a sanitary landfill. The 8.

Niagara of Wisconsin Paper Corporation, Niagara, Order required the licensee to conduct an audit and Wisconsin develop a corporate plan to ensure compliance with the Supplement VI, EA 89-65 terms of the general license.

A Notice of Violation and Proposed Imposition of Civil

12. St. Agnes Medical Center, Philadelphia, Pennsylvania Penalty in the amount of $750 was issued on May 31, Supplement VI, EA 88-298 1989, to emphasize the importance of maintaining ade-quate control over gauges containing radioactive A Notice of Violation and Proposed imposition of Civil material. The action was based on two violations, which Penalty in the amount of $2,500 was issued February involved failure to have licensed individuals perform the 2,1989, to emphasize the importance of increased and removal of a generally-licensed radioactive gauge from improved management attention to activities authorized its installed location and transfer of a radioactive gauge by the license. The action was based on failures to per-to an unlicensed metal salvage yard. The base civil penal-form required constancy tests, before the use of dose ty was increased by 50 percent, because the licensee's calibrators, on two occasions, to perform three different cerrective actions were not timely.

types of required surveys, and use of the dose calibrator to assay patient doses, for numerous days, after a 9 P&L Trucks, Inc., McAlester, Oklahoma linearity test of the instrument indicated erroneous EA 89-67 responses. The licensee responded on February 23, 1989, and after considering the responses, an Order Im-An Order to Show Cause Why License Should Not Be posing a Civil Monetary Penalty was issued.

Suspended and Revoked (Effective immediately) was issued May 11, 1989, based on numerous violations

13. St. Joseph's Hospital, Huntingburg, Indiana which indicated that the licensee had made little or no Supplements IV and VI, EA 89-20 effort to develop and maintain a program for ensuring l

compliance with the NRC license and regulations. The A Notice of Violation and Proposed imposition of Civil Order required the licensee to transfer all licensed Penalty in the amount of $2,500 was issued March 16, material to an authorized recipient, and, thereafter, 1989, to emphasize the importance of ensuring that, in revoked the license.

the future, the licensee will exercise greater control over all NRC-licensed activities. The action was based on

10. Pesara Pushpamala Reddy, M.D.,

Kittanning, numerous violations, including: (1) use of licensed Pennsylvania material by unauthorized individuals; (2) failure of the Supplement VI, EA 88-291 Radiation Safety Committee to meet and review the radiation safety program; and failures to (3) check and A Notice of Violation and Proposed Imposition of Civil test the dose calibrator; (4) measure the ventilation rates Penalty in the amount of $1,500 was issued May 12, in areas where radioactive gases are used; (5) perform 1989, to emphasize the need for increasing and main-surveys; (6) control licensed material in an unrestricted taining adequate management oversight of licensed ac-area; and (7) calibrate radiation survey instruments, as tivities, to ensure that activities are conducted safe!y and required.

l in accordance with the terms of the license. The action was based on violations involving failures to: (1) pro-

14. Saturn Services, Inc., Tulsa, Oklahoma vide training; (2) perform required package receipt EA 89-07 surveys; (3) perform dose calibrator constancy and linearity testing; (4) perform sufficiently sensitive An Order to ConGrm Transfer of Regulated Material analysis on survey wipe samples; and (5) provide (Effective immediately) was issued February 8,1989.

notification of change in mailing address. The base civil The action was based on the findings of an inspection j

penalty was escalated by 200 percent: 50 percent due which determined that the licensee regularly had been I

to NRC identification,50 percent for corrective actions using, contrary to its commitments to NRC, its radioac-l 9

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, 2 a, tive sources for gas and oil well-logging activities, secure licensed material stored in an unrestrteted area;'

without a valid NRC license.

(3) use of licensed material by a physician on a number of occasions, without wearing the required ring

15. The liospital Center, Orange, New Jersey dosimeter; and (4) use of material by an individual before Supplements IV and VI EA 89-51 being authorized for such use by the Radiation Safety Committee (RSC). A civil penalty was not proposed A Notice of Violation and Proposed imposition of Civil because the violations which caused the misadministra-Penalty in the amount of $3,750 was issued April 5, tions were identified by the licensee's staff, reported to 1989, to emphasize the need for increased management NRC, and the corrective actions taken were prompt and attention to the radiation safety program, to assure that extensive.

licensed activities are conducted safely and in accordance with the terms of the license. The action was based on 2.

Alpena General llospital, Alpena, Michigan a number of violations, including failures to: (1) per.

Supplement VI, EA 89-97 form certain required surveys; (2) maintain proper con-trol and surveillance of certain unsecured materials; (3)

A Notice of Violation was issued June 28,1989, based perform the required constancy, linearity and on violations involving: (1) ordering a therapy dosage geometrical variation tests on a dose calibrator; and (4) ofiodine-131 without a written request from the physi-wear appropriate protective clothing and desices, while cian who was going to perform the procedure; and handling radioactive material. The base civil penalty was failures to: (2) consistently meet at required intervals increased by 50 percent, because NRC identified the from 1984 to 1987 (RSC); (3) include a representative violations.

of the nursing service on the RSC; (4) consistently test a Capintec CRC-12 dose calibrator for instrument

16. V.A. Medical Center, Loma Linda, California linearity at required intervals during 1984 and 1987; and Supplements IV and VI, EA 88-39 (5) measure the thyroid burden of an individual who helped prepare and administer a therapy dosage of A Notice of Violation and Proposed imposition of Civil iodine-131. A civil penalty was not proposed because Penalties in the amount of $6,500 was issued May 10, of prior good performance.

1989, to emphasize the importance of complying with license and regulatory requirements. The action was 3.

Zacharia Mikros, D.O.. Garden City, Michigan based on violations involving failures to: (1) evaluate Supplement VI, EA 89-24 radiation exposures; (2) perform annual refresher train-ing; (3) perform various surveys; (4) evaluate dose A Notice of Violation and Termination of License was calibrator results; and (5) review and renew research issued May 24,1989, based on numerous violations in-projects, using licensed materials, on an annual basis, dicative of a significant breakdown in control of licens-The base civil penalty was increased by 100 percent ed activities. The licensee requested termination of the l

because of the licensee's poor prior performance.

license before NRC undertook further escalated enforce-ment action.

I

17. Jeffrey Weisman, M.D., Philadelphia, Pennsylvania Supplements IV and VI EA 89-23 4.

Schlumberger Technology Corporation, liouston, Texas Supplements IV and VI. EA 89-84 A Notice of Violation and Proposed Imposition of Civil Penalty in the amount of $1,250 was issued March 13, A Notice of Violation was issued June 14,1989, based

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1989, to emphasize the need for maintaining continued on violations involving material inventory and control management attention and oversight of the radiation of licensed material. A civil penalty was not proposed safety program, to ensure that activities are conducted because of the licensee's identification of the problem, i

safely and in accordance with the terms of the license, prompt reporting, and prompt and extensive corrective The action was based on the failures of the Radiation actions.

i Safety Officer to implement the radiation safety pro-gram, to provide training to individuals, and to perform i

several instrument calibration checks. The base civil i

penalty was increased by 150 percent because NRC iden-i tified the violations and because of prior notice.

B.

Severity Level 111 Violation, No Civil Penalty 1.

Allegheny General llospital, Pittsburgh, Pennsylvania Supplements IV and VI, EA 89-89 A Notice of Violation was issued May 25,1989, based on violations involving: (1) failure to properly label

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radiopharmaceuticals on two occasions, resulting in three diagnostic misadministrations; (2) failure to properly 10

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ADO'. EAR REGULATORY COMMISSION PosTAss e ries paio

*"C WASHINGTON, D.C. 20555 PERMIT No G $7 OFFICIAL BUSINESS PENALTY FOR PRIVATE USE, $300 4

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