ML20154Q584

Rept to NRC & AEOD - 1987,Nonreactors

ML20154Q584
Person / Time
Issue date:	08/31/1988
From:	NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:
Shared Package
ML20154Q574	List: ML20154Q572 ML20154Q580 ML20154Q584
References
TASK-AE, TASK-S806 AEOD-S806, NUDOCS 8810040005
Download: ML20154Q584 (77)

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O AE00/S806 Reaor: to <:le U.S. suc ear Regu a':ory Commission, on Ana ysis anc Eva uation of Oaera:iona Jo:a ' 987 sonreactors AUGUST 1988 9

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ABSTRACT This annual report of the U.S. Nuclear Regulatory Commission's Office for Anal-ysis and Evaluation of Operational Data (AE00) is devoted to the activities performed during 1987. The report is published in two volumes. NUREG 1272, Vol. 2, No.1, covers Power Reactors, and presents an overview of the operating experience of the nuclear power industry, with comments regarding the trends of some key performance measures. The report also includes the principal findings and issues identified in AE00 studies over the past year, and summarizes infor-mation from Licensee Event Reports, the NRC's Operations Center, and Diagnostic Evaluations. NUREG 1272, Vol. 2, No. 2, covers Nonreactors and presents a re-view of the nonreactor events and misadministration reports that were reported in 1987 and a brief synopsis of AE00 studies published in 1987. Each volume contains a list of the AE00 reports issued for 1980 1987.

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EXECUTIVE SUP94ARY  ;

l AE00 activities include the review and evaluation of operating experience of l nonreactor activities involving the use of NilC licensed mater.als, such as source material, natural and enriched uranium, and byproduct materials. The i purpose of the AE00 review and evaluation is to identify safety significant i

events and concerns, their causes, and the trends displayed by the events. i When a previously unrecognized safety concern is identified, AE00 recommends  ;

, agency actions to resolve the concern.

• There are approximately 8000 licensees authorized by NRC to possess and use .

licensed materials outside of reactors. New licensees are added annually, t while other licensees may elect to terminate their licenses. The majority of [

licensees (about 5600) are authorized to use byproduct materials for such l applications as radiography, gauges, and well logging. An additional 2400  :

Itcensees are authorized to administer byproduct materials or radiation from l

. byproduct materials to individuals for medical diagnosis or therapy. [

! The dominant health concern from the use of licensed materials arises from the '

l possible damage that can be caused by overexposure to radiation. In 1987, there were eleven events reported to NRC in which 12 individuals were overexposed. The number is about the same as was reported in prior years.

! Other classes of events, such as leaking sources and lost sources, reported to  :

the NRC by licensees did not have any reported impacts or,public health and safety.

I l For medical misadministrations, nine patients undergoing radiation therapy  !

l treatments rtceived radiation doses that differed from the prescribed dose by .

j greater than 10%; five patients were involved in diagnostic misadministrations  ;

j where therapy-equivalent doses of iodine 131 were administered; and 445 patients were involved in other diagnostic misadministrations, typically involving milli- ,

2 curies of technetium-993 compounds. The error rate for therapy and diagnostic r

misadministrations reported for 1987 is about 0.0001, the same as prior years.  ;

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AE00 ANNUAL REPORT l NONREACTORS l 1987  :

t TABLE OF CONTENTS l P.agg l

EXECUTIVE SUMARY ................................................... v

1.0 INTRODUCTION

................................................... 1 2.0 NONREACTOR LICENSEE OPERATIONAL EXPERIENCE FEE 08ACK ............ 3 2.1 Overview of Operating Experience .......................... 3 7

2.1.1 Nonreactor Events .................................. 3 2.1.1.1 1987 Events ................................. 3  :

l 2.1.1.2 Radiation Overexposure Events ............... 3 2.1.1. 3 Other Types of Events ....................... 6 l 2.1.2 Medical Misadministrations ......................... 6

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1 2.1.2.1 Misadministrations Reported in 1987 ......... 8  ;

2.1.2.1.1 Therapy Misadministrations ............ 8 I' l 2.1.2.1.2 Diagnostic Misadministrations ......... 9 l

1 2.1.2.1.3 Iodine Misadministrations ............. 10 E

l 2.1.2.2 Misadministrations Reported for 1981 1987.... 10 l 2.2 Abnormal Occurrences ...................................... 11 2.3 Results of Selected AE00 Studies .......................... 11 1

2.3.1 Review of the Data on Teletherapy [

Misadministrations Reported to the State of ,

New York ........................................... 11 {

2.3.2 Diagnostic Misadministrations Involving the ~

Administration of Millicurie Amounts of lodine-131.. 12 ,.

2.3.3 Special Study Report on Overenposure Events l Involving Industrial Field Radiography.............. 12 i 2.4 List of Sele.cted ongoing Technical Studies . . . . . . . . . . . . . . . . 13 r

APPENDIX A i RE PORT ON 1987 NONRE ACTOR EVENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-1 APPENDIX B -

l MEDICAL MISADMINISTRATION REPORT ............................... .B-1  :

APPENDIX C i Su m ARY OF ABNORMAL OCCURRENCES ................................ C-1 L l APPENDIX 0

• i LISTING OF AE00 REPORTS, 1980-1987 ............................. D-1  ;

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I TA8LE OF CONTENTS (continued)  !

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APPEN0!X E l STATUS OF AE00 RECOMMENDATIONS ................................. E-1 I LIST OF TA8LES l

Table 1 - Types of Licenses that Submitted Nonreactor Reports  !

in 1987 ................................................... 4 Table 2 - Categorization of Report of Nonreactor Events occurring During 1987 ............................................... 5 i Table 3 - Error Rate for Misadministrations ......................... 7 r Table 4 - Misadministration Report for 1981-1987 .................... 10 l

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1.0 INTRODUCTION

1 NRC's Office for Analysis and Evaluation of Operational Data (AE00) was established in 1979, as one of the Commission's earliest major steps toward improving the use of licensee operating experience to idsntify and resolve problems with potential safety-related implications. T',e Office, which reports directly to the Executive Director for Operati9ns, is dedicated to the collection, assessment, and feedback of operational data.

The NRC licenses the use of reactor-produced isotopes, milling of uranium, and subsequent processing of either natural or enriched uranium and special nuclear j material (SNM). Certain states, referred to as Agreement States, have the authority to regulate the possession and use of these materials, except for

the possession and use of large amounts of enriched uranium or SNM.

The NRC has approximately 8000 licensees authorized to possess and use natural l

uranium and special nuclear material (predominantly in support of the reactor

! fuel cycle) and byproduct materials. Of these licensees, about 5600 are auth-

] orized to use byproduct materials for such applications as radiography, gauges, p and well logging. Another 2400 medical licensees are authorized to administer I

byproduct materials or radiation from these materials to individuals for medical diagnosis or therapy. A relatively small number of licensees use uranium or SNM in fuel cycle operations.

NRC nonreactor licensees are required to report events such as those in which there was: a personnel overexposure (10 CFR Part 20.405(a)); a leaking or con-taminated source (10 CFR Part 34.25, 10 CFR Part 35.14, or license condition);

release of material (10 CFR Part 20.405(a)); lost or stolen materials (10 CFR I

Part 20.402); or abandoned well logging sources (10 CFR Part 39.77). Other events i may also be reported as required by license condition or may be included in j inspection reports. About 200 reports of such events are received annually, or

about 4 events /100 licensees. Similarly, the 2400 medical licensees report about 400 misadministrations annually or about 16 events /100 licensees. There is gener-vily little impact from these licensed programs on public health and safety.

Role _of AE00 a

The focus and role of AE00 in the regulatory process is to provide a capability

{ for the timely analysis of operating experience, independent of the routine regulatory activities associated with licensing, inspection, or enforcement, and

! to feed back the lessons learned to the appropriate offices of the NRC, the

affected portions of the industry, and the public. AE00 accomplishes this

through the analysis and evaluation of operational safety data associated with 1 the use of radioactive ma'erials in nonreactor applications. AE00 publishes j studies of specific operat.ional events and, as appropriate, recommends agency J

actions to reduce the prnoability of the occurrence of the event.

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The rect cerMc' ions contained in AE0D studies are tracked until resolved.

They are i ernal recommendations for action by the appropriate NRC program office or regional office. The office to which the recommendation is addressed is responsible for reviewing and implementing the recommendation as appropriate.

AE00 maintains an awareness of studies undertaken by other organizations within NRC and normally will not duplicate the study unless a particular need or special circumstance exists. Thus, the nonreactor staff of AE00 does not review in-depth all events or operating problems.

The Office also coordinates the overall NRC operational data program, and serves as the focal point for fnteraction with outside and foreign organizations performing similar work.

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i 2.0 NONREACTOR LICENSEE OPERATIONAL EXPERIENCE FEEDBACK During 1987, a large number of events involving NRC and Agreement States were received by the NRC. This section provides an overview and summary of reported events involving nonreactor facilities and medical misadministrations received in 1987. Generally, events reported by Agreement State licensees have not been included in this report unless the event was published in a Preliminary Notice of Occurrence by one of the NRC's regional offices. A report on the events reported by Agreement States will be published separately.

2.1 ,0verview of Operatino Experience 2.1.1 Nonreactor Events The AE00 Nonreactor Event Report (NRER) database contains infor,aation on li-censed nuclear materials and fuel cycle operational events and on personnel radiation exposure events. The NRER database management system provides for input, storage, retrieval, and computer-assisted analyses of operational event data, and may be used to identify trends in operational safety events which may signal a need for remedial actions by the NRC and/or licensees.

2.1.1.1 1987 Events The NRER database includes 209 records of events that were entered into the database during 1987. Information on these events was contained in reports submitted by NRC licensees to the regional offices or in other documents, primarily inspection reports. The NRER database does not include information reports of medical misadministrations. See Section 2.1.2 for a discussion of the data on medical misadministrations for 1987.

Table 1 provides information on the types of licensees for which information was entered into the database. Table 2 provides information on how the nonreactor event information was categorized.

2.1.1. 2 Radiation Overexposure Events The NRER database contains information on 26 reports of events that were received in 1987 in which there was the potential for or an actual radiation overexposure.

Of the 26 events, eleven involved actual overexposures.

The types of licensees associated with the actual overexposures reported during 1987 were:

Number of Total Number of Licensee Type Overexposure Events Individuals Exposed Medical / Academic 4 4 Radiography 2 2 Commercial /Industrid 2 2 -

Fuel Cycle 1 2 Other 2 2 Total T T 3

Table 1 Types of Licensees that Submitted Nonreactor Reports During 1987 NUMBER OF LICENSE TYPd REPORTS RECEIVED

• ACADEMIC 8 MEDICAL 23 COMMERCIAL / INDUSTRIAL MEASURING SYSTEMS 43 WELL LOGGING (21)

OTHER MEASURING SYSTEMS (22)

MANUFACTURING AND DISTRIBUTION (EXCLUDING MEDICAL) 10 INDUSTRIAL RADIOGRAPHY 11 SINGLE LOCATION (IN PLANT) (1)

MULTIPLE LOCATIONS (FIELD) (10)

IRRADIATOR 12 R&D 31 SOURCE MATERIALS ** 19 MILLS (2)

UFe FACILITIES (17)

OTMER (0)

SPECIAL NUCLEAR MATERIAL (INCLUCING PLUT0NIUM) 18 AGREEMENT STATE 7 OTHER*** 27 TOTAL 209

• MEDICAL MISADMINISTRATION REPORTS ARE NOT INCLUDED.

• • ROUTINE ENVIRONMENTAL EFFLUENT RELEASE REPORTS, E.G. , REPORTS REQUIRED BY 40.65 AND 70.59 WERE NOT INCLUDED IN THE TOTALS FOR SOURCE AND SPECIAL NUCLEAR MATERIALS LICENSEES.

• • • NUMBER INCLUDES REPORTS RECEIVED FOR WHICH NO PROGRAM CODE WAS AVAILABLE.

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0 Table 2 Categorization of Reports of Nonreactor Events Occurring During 1987 CATEGORY

• NUMBER OF REPORTS ASSOCIATED PERSONNEL RADIATION EXPOSURES 26 LOST, ABANDONED, AND STOLEN MATERIAL 82 LEAKING SOURCES 11 RELEASE OF MATERIAL 16 CONSUMER ~20 DUCTS 2 FUEL CYCLE (e.g., MILLS, UF 6 FACILITIES, 30 SPECIAL NUCLEAR MATERIAL)

INDUSTRIAL RADIOGRAPHY 15 MANUFACTURING AND DISTRIBUTION 17 (INCLUDING MEDICAL)

COMMERCIAL / INDUSTRIAL MEASURING SYSTEMS 28 (EXCLUDING WELL LOGGING)

OTHER** 83 TOTAL 310

• AN NRER DATABASE ITEM MAY BE ASSOCIATED WITH MORE THAN ONE CATEGORY OF EVENT. FOR EXAMPLE, A REPORT FROM A RADIOGRAPHY LICENSEE CONCERNING A PERSONNEL RADIATION EXPOSURE WOULD BE COUNTED IN THE TOTAL NUMBER OF RADIATION EXPOSURE EVENTS AS WELL AS IN THE TOTAL NUMBER OF EVENTS INVOLVING RADIOGRAPHY.

• • 0THER INCLUDES CATEGORIES SUCH AS HEDICAL, TRANSPORTATION, MISCELLANEOUS, ETC.

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1 Medical / Academic  ;

The four reports of overexposures at medical / academic licensees involved licensee personnel. The overexposures were: two extremity exposuret, of approximately 23 and 36 rem; a thyroid burden of 0.18 microcuries; and a whole body exposure of 9 rem. The reports came from different licensees.

Radiography Both of the radiography overexposure reports involved licensee personnel.

In one event, a radiographer received a dose of 180 rem to the thumb. In this case, there was an equipment malfunction; the exposure device could be locked with the source not fully retracted. Although the exposure device was locked, the radiographer did not perform a survey to determine that the source had been fully retracted, and received an exposure to his thumb from the incompletely retracted source. In the second radiography event, a radiographer's badge read 3.1 rem.

Commercial / industrial Thereweretwoexposureeventsatcopercial/industriallicensees. The first involved a dose of 650 rem over 1 cm to the skin of the thumb; the second event involved an extremity exposure of 20 rem during a calendar quarter of 1987.

Fuel Cycle In an event at a fuel fabricator, equipment failure resulted in two employees receiving 12.3 and 9.8 MPC-days of uranium.

Other Licensees In two events, licensee employees received extremity doses of approximately 42 and 22 mm.

The whole body exposures reported were less than 10 rem; NRC regulations permit a maximum quarterly exposure of 1.25 rem or, if additional data on the individual's previous exposure is on file, a limit of 3 rem / quarter.

2.1.1.3 Other Types of Events The nonreactor assessment staff reviewed other classes of event reports: lost or stolen sources; abandoned sources; leaking or contaminated sources; release of materials; consumer products; fuel cycle facility event reports; industrial radiography; manufacturing and dir.tribution; and gauges / measuring systems. The events in these categories did not have any reported impacts on public health and safety.

2.1.2 Medical Misadministrations The NRC regulates certain aspects of the uses of reactor produced radioisotopes in nuclear medicine and therapeutic radiology. Certain diagnostic and therapy 6

misadministrations are reported to NRC pursuant to the requirements contained in 10 CFR 35.41 through 10 CFR 35.43. Diagnostic misadministration, as used in NRC regulations, refers to the misadministration of radioisotopes in nuclear medicine studies such as brain scans and bone scans. Therapy misadministration, as used in NRC regulations, refers to the misadministration of radiation from cobalt-60 teletherapy or radioisotopes used for radiation therapy.

Over the last seven years (1981-1987) medical facilities licensed by NRC for the human use of radioisotopes in nuclear medicine and radiotherapy have been required to report misadministrations. During that period, licensees have reported 52 misadministrations involving therapy procedures and 2811 involving diagnostic procedures. The NRC estimates, based on statistics from the "Patterns of Care" study of the American College of Ractiology, that approximately 300,000 therapies would have been performed by the NRC licensed facilities dur-ing the seven year period. The 52 misadministrations represent an error rate of 0.0003 per patient.

From data in a recent study by the Technologist Section of the Society of Nuclear Medicine, the NRC estimates that about 28 million diagnostic procedures would have been performed at NRC licensed facilities during the seven year period, giving an error rate of 0.0001 errors per procedure. Table 3 gives estimates of error rates for the various type of therapy procedures and for diagnostic procedures, together with the underlying data used to estimate the error rates.

Table 3 Error Rate for Misadministrations NRC Estimate of Number of Number of Patient Type Number of Studies Events Patients Error Rate Therapy Teletherapy 308,000 31 83 0.0003 Brachytherapy 154,000 12 12 0.0001 Radiopharma- 92,400 9 9 0.0001 ceutical Diagnostic 28 million 2811 3107 0.0001 Therapy misadministrations are associated with procedures in which large doses of radiation are administered to patients to achieve a therapeutic effect.

Diagnostic misadministrations are associated with procedures designed to permit a diagnosis to be made with little exposure to the patient. An exception is a diagnostic procedure known as an iodine-131 whole body scan, which may deliver doses to the thyroid that are equivalent to therapy doses.

When the data on misadministrations are reviewed on an annual basis, the number of events reported for therapy and diagnostic misadministrations show no signifi-cant change with time. For therapy misadministrations, there has been some .

variation in the causes of misadministrations from year to year. Most of the events, however, might have been avoided through the implementation of revised or new quality assurance procedures. For diagnostic misadministrations, the causes have essentially been the same over time. Overall the data do not show a discernible trend. As AE00 stated in prior years, relatively simple 7

procedures, such as checking the patient's identification against the procedure and asking the patient to state his name, might reduce the frequency of these diagnostic misadministrations.

In general, the low error rates calculated from reported data on misadmini-strations indicate that most licensed programs are operated to minimize misadministrations.

2.1.2.1 Misadministrations Reported in 1987 For 1987, 348 of the approximately 2400 NRC licensees authorized to perform nuclear medicine studies or radiation therapy reported one or more misadministrations, a total of 423 reports involving 459 patients. Of the 423 reports of misadministrations for 1987, 414 concerned diagnostic misadministra-tions, and 9 concerned therapy misadministrations.

2.1.2.1.1 Therapy Misadministrations Nine therapy misadministrations were reported in 1987. Six of the misadministrations involved teletherapy, and three involved brachytherapy.

Three of the teletheraphy mir, administrations were caused by errors in dose calculations. AEOD's evaluation of the teletherapy errors involving errors in dose calculations indicates that redundancy in verifying the accuracy of important measurements could likely have detected the errors before they led to misadministrations.

Of the remaining three teletherapy misadministrations, one of the events was caused by a technologist misreading the treatment time. Based on AEOD's evalu-ation, it could have been mitigated by the use of redundancy in verifying the accuracy of information. The remaining two misadministrations involved adminis-tering the teletherapy dose to the wrong part of the body. It is believed that a check of the prescription for the therapy before administering the therapy would have shown the error.

One of the three 1987 brachytherapy misadministrations resulted from a leaking iodine-125 seed being used in a brain therapy implant. A 1986 AE00 study, AE00/C601 "Case Study Report on the Rupture of an Iodine-125 Brachytherapy Source at the University of Cincinnati Medical Center," concerned a similar event that occurred in 1984. In the case study, AE00 recommended that NRC send an information notice to licensees informing them of the circumstances of the event at the University of Cincinnati. The information notice was published on September 30, 1986. The licensee associated with the 1987 event indicated that it was discovered because personnel had become aware of the potential for the occurrence of such an event through the NRC information notice.

A second 1987 brachytherapy misadministration was caused by sources of the wrong activity being loaded into the source applia.ator; and the third brachytherapy misadministration was caused by the wrong number of sources being loaded into -

the source applicator.

On October 2,1987, two rulemakings on quality assurance in medical use were published. One rulemaking concerned basic quality assurance and the other con-cerned comprehensive quality assurance. AE00 believes that improved quality assurance procedures might have prevented the type of therapy misadministrations that were reported in 1987.

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O 2.1.2.1.2 Diagnostic Misadministrations Like prior years, essentially all of the diagnostic misadministrations for 1987 involved either the administration of the wrong radiopharmaceutical or the administration of a radiopharmaceutical to the wrong patient. The number, type, and cause of diagnostic misadministrations are about the same as reported for 1986. The causes reported by licensees are generally the same as have been reported in the past, that is, simple errors associated with 1) preparation of radiopharmaceuticals, 2) processing nuclear medicine requisitions, and 3) patient identification.

Of the 414 reports of diagnostic misadministrations received in 1987, 341 involved the administration of the wrong radiopharmaceutical to a patient and 58 involved the administration of a radiopharmaceutical to the wrong patient (96% of the reported misadministrations were of these two types). The remaining diagnostic misadministrations involved 15 reports in which the diagnostic dose of a radiopharmaceutical differed from the prescribed dose by greater than 50%.

Of these, five involved the administration of therapy-equivalent dosages of iodine-131 to patients. These misadministrations are discussed in more detail in Section 2.1.2.1.3, Iodine Misadministrations.

It should be noted that the reporting requirements for diagnostic misadministrations were changed in 1987 to incorporate a change in the threshold for reporting. In accordance with the new requirements of 10 CFR 35.33, diagnostic misadministrations occurring after April 1,1987 need be reported only if:

the misadministration involved the use of radioactive material not intended for medical use; the administered dose was five-fold different from the prescribed dosage; or the critical organ radiation dose is likely to exceed 2 rem or the whole body dose is likely to exceed 500 millires.

Even with the change in reporting requirements for diagnostic misadministrations, the number reported in 1997 was not significantly different from the average num-ber reported in previous years. Since the critical organ dose for most commonly used radiopharmaceuticals is about 2 rem, and a misadministration that results in a critical organ dose of 2 rem is reportable, most of the misadministrations continue to be reportable.

As was noted earlier, relatively simple quality assurance procedures such as checking the patient's identification against the study and the patient's medical history or asking the patient to state his name might reduce the frequency of events involving administration of the wrong radiopharmaceutical or administering a procedure to the wrong patient.

2.1.2.1.3 Iodine Misadministrations -

Five of the diagnostic misadministrations reported to the NRC in 1987 involved the administration of iodine-131 in amounts that resulted in the delivery of thyroid doses to patients that were the equivalent of therapy doses. These misadministra-tions involved events in which the technologist performed a whole body 1odine scan 9

on the patient, when the referring physician had ordered a thyroid uptake or scan.

For this type of misadministration, the primary cause was the failure of licensees to exercise adequate control over the administration of millicurie amounts of iodine-131 to patients.

During 1987, AE00 issued an engineering evaluation of diagnostic misadministrations that involved administering therapy-equivalent amounts of iodine-131 to patients.

We found that licensees may exercise less control over the administration of millicurie amounts of iodine-131 if the iodine is being used for a diagnostic study than if it is being used for a therapeutic purpose. AEOD suggested that NRC update an earlier information notice (IEIN-85-61) on the same subject, and that the then proposed regulatory changes to 10 CFR Part 35 be assessed to determine whether requirements for quality assurance should cover this category of event. An update of the information notice ws issued and the requirements for quality assurance for this type of event were included in the proposed changes to 10 CFR Part 35. The details of the study are given in Section 2.3.1.

2.1.2.2 Hisadministrations Reported for 1981-1987 Table 4 compares the number of misadministration reports received in 1987 with those of prior years. The number of reports, the number of patients, and the number of licensees reporting misadministrations are listed.

Table 4 Hisadministration Reports for 1981-1987 1981 1982 1983 1984 1985 1986 1987 Therapy Hisadministrations 10 4 4 14 4 7 9 Diagnostic Misadministrations 2 3 2 3 3 5 5 (Involving Iodine-131)

Diagnostic Misadministrations 428 414 332 395 377 433 409 (Other)

Number of Patients 517 451 437 442 410 495 459 No. of Licensees Reporting 351 355 293 318 293 369 348 For the period 1981-1987, there were 52 therapy misadministrations reported to the NRC, or an average of 7 therapy misadministrations per year. Over the seven~ year period, 31 of these therapy misadministrations involved teletherapy, 12 involved brachytherapy, and 9 involved radiopharmaceutical therapy. The dominant causes for the teletherapy misadministrrtions were dose calculation errors and misreading or misunderstanding therapy prescriptions or orders. The dominant causes of the brachytherapy misadministrations were errors in dose calculation and use of the wrong activity sources. The nine radiopharmaceutical misadministrations were predominantly caused by failure to assay doses before administering them or the use of the wrong form of the radiopharmaceutical. In general, the causes of all of the therapy misadministrations were human errors .

involving dose calculations, patient set-up or treatment, and patient identification.

There were an average of 401 diagnostic misadministration reports received by the NRC annually over the seven year period from 1981 to 1987; the annual number 10

ranged from 334 to 438. The number of reports has not changed substantially over the seven years. Most (96%) of the diagnostic misadministrations involved the wrong radiopharmaceutical (administration of the wrong study) or the wrong patient, with the misadministrations stemming from human error.

In each of the seven years from 1981 to 1987, there have been a small number of diagnostic misadministrations that involved the administration of relatively large amounts of iodine-131. An average of three such events have been reported annually, with some increase in the number to 5/ year over time. The cause of these events was human error.

There has not been a substantial change in the number, type, or cause of any of tne types of medical misadministrations reported to the NRC over the seven-year period that reporting requirements have been in effect. Essentially all of the misadministrations resulted from human error.

2. 2 Abnormal Occurrences Each calendar quarter, AE00 prepares a Report to Congress on Abnormal Occurrences (A0s). A0s may be individual incidents, recurring events, generic concerns, or a series of incidents which the Commission determines are significant from the standpoint of public health and safety. A summary of all 1987 abnormal occurrences is provided in Appendix C. In addition to A0s for nonreactor licensees, the summary contains the A0s for power reactors. The latter category is discussed in the AE00 Annual Report, NUREG-1272, Vol. 2, No.1, Power Reactors.

2.3 Results of Selected AE0D Studies 2.3.1 Review of the Data on Teletherapy Misadministrations Reported to the State of New York (AE00/T711, November 1987)

The Office of Nuclear Material Safety and Safeguards requested that AE00 review the voluntary report made by the state of New York of several therapy misadminis-trations that were attributable to miscellaneous errors in dose calculations made by one individual, an employee of a consulting firm.

Af ter the initial discovery of the problem, several of the hospitals at which the individual had worked hired consultants to review his work. A total of 22 therapy misadministrations at two hospitals were identified by the consultants.

At one hospital, about 9% of the treatment plans contained errors large enough to have resulted in the patient receiving a dose that differed from the pre-scribed dose by more than 10%. It the second hospital, about 43% of the treat-ment plans contained significant errors. However, because these treatment plans were used for calculating only part of the dose, only two patients treated with erroneous plans received doses that exceeded 10% of the prescribed dose.

The information available to AEOD during its review indicated that the individual "

responsible for the miscalculations prepared the treatment plans without assis- -

tance from or supervision by other members of his firm. A consultant who reviewed the salient treatment plans observed that "[The errors] seem to demonstrate a fundamental lack of understanding of ... [a] computer system."

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The AEOD review found that requirements in the proposed rule, "Basic Quality Assurance in Radiation Therapy," published on October 2, 1987, addressed the primary causes identified in these misadministrations. The proposed rule addresses the causes of the misadministrations through the requirement that the accuracy of the patient dose calculations be verified by a second individual who did not do the calculations. The rationale for this proposed requirement is that an independent check of dose calculations would likely detect calculation errors.

2.3.2 Diagnostic Misadministrations Involving the Administration of Millicurie Amounts of Iodine-131 (AE00/N701, January 1987)

In 1985, NRC issued an Information Notice entitled "Misadininistrations to Patients Undergoing Thyroid Scans." AE00 found that several of the same type of event had occurred in 1986, prompting an evaluation of the safety implications of this type of misadministration and an assessment of whether further action should be taken to reduce the occurrence of this type of event.

A total of 14 diagnostic misadministrations were reviewed in which individual patients received from 1 to 10 millicuries of iodine-131. The average cal-culated radiation dose to th) thyroid of the patient was over 80 times the average calculated dose the individual would have received from the prescribed procedure. Information provided by licensees indicated that 5 of the 14 patients could have some degree of impairment of thyroid function.

The underlying cause of 11 of the 14 misadministrations appears to have been a lack of licensee control over the misadministration of millicurie amounts of iodine-131 to patients. These 11 misadministrations could likely have been prevented if the prescription had been verified for each patient before the large amount of iodine-131 was administered.

It was found that licensees may exercise less control over the administration of millicurie amounts of iodine-131 if the iodine is being administered for diagnostic studies than if it is being administered for a therapeutic treatment (e.g. , treatment of hyperthyroidism).

As a result of the 1987 evaluation, AE00 suggested that the NRC staff assess the proposed regulatory changes to 10 CFR Part 35 to determine whether the proposed requirements for quality assurance procedures for radiotherapy facilities should be expanded to include a requirement for quality assurance procedures for the administration of radiopharmaceuticals for therapy or for diagnosis in which the dosage of the radiopharmaceutical administered is in the therapy dosage range for the radiopharmaceutical. The NRC staff included the requirement in the scope of the proposed rule on quality assurance. In addition, an updated information notice, IEIN 85-61, Misadministrations to Patients Undergoing Thyroid Scans, was issued to inform licensees of the recent experience.

2.3.3 Special Study Report on Overexposure Events Involving Industrial Field Radiography (AEOD/S703, October 1987) .

AE00 undertook a review of reports of overexposure of radiographers working at field sites to characterize the cause of the events that resulted in the over-exposures in support of a rulemaking on radiography operations being developed by the NRC's Of fice of Research. The review assessed the aggregated data to 12

estimate the relative importance of various causes to the total number of over-exposures. The study was not intended to look at secular trends in the number of overexposures.

AE00 used data reported by NRC and Agreement States licensees. The latter have about twice as many field radiography licensees as the NRC. NRC licensees report about 6 events per year, whereas Agreement State licensees report about 11 events annually; thus both groups of licensees experience about the same rate of overexposure events.

AEOD reviewed 34 events re Agreement State licensees. ported by NRC licensees The exposures and 52ranged in the events eventsfrom reported 1.3 toby 63.2 ren whole body, and from 22 to 15,000 rem extremity.

The 34 reports of overexposure events from NRC licensees had the following causes:

equipment problems 13 personnel error 9 occupational exposures 7 unknown 5 The equipment problems included seven source disconnects, two lock mechanism failures and four miscellaneous problems. Personnel errors include four failures to retract the radiography source, another three failures to retract the source fully, and two failures to connect the source.

Reports from Agreement State licensees had similar causes. The causes of the 52 events were:

equipment problems 18 personnel error 12 occupational exposure 1 unknown 21 Equipment problems cited by Agreement State licensees included eight guide tubes that were crimped, four source disconnects, three lock mechanism failures, and three miscellaneous problems. Personnel errors include seven failures to re-tract the source, four failures to retract the source fully, and one failure to connect the source.

Data indicate that equipment problems are associated with about 40% of the overexposure events involving field radiographers. In addition, virtually all of the events could have been avoided if the radiographer had made a proper radiation survey, as required by regulation.

2.4 List of Selected Ongoing Technical Studies

1. Review of Nonreactor Events in Agreement States, 1981-1987

2. Review of Events at Large Pool-Type Irradiators

3. Evaluation of General Issues Involved in Medical Misadministrations 13

)

6 APPENDIX A REPORT ON 1987 NONREACTOR EVENTS G

e

APPENDIX A ,

AE00/N801 REPORT ON 1987 NONREACTOR EVENTS by the Nonreactor Assessment Staff Office for Analysis and Evaluation of Operational Data 9

Prepared by:

Kathleen M. Black I

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TABLE OF CONTENTS P_ alt 1.0 NONREACTOR EVENT REPORT 0ATABASE.............................. A-7 2.0 REVIEW OF 1987 NONREACTOR EVENTS.............................. A-7 2.1 Occurrences in 1987...................................... A-7 2.1.1 Radiation Exposure Events........................ A-10 2.1.2 Lost, Abandoned, and Stolen Material............. A-12 2.1. 3 Leaking or Contaminated Sources.................. A-13 2.1.4 Release of Materials............................. A-18 2.1.5 Consumer Products................................ A-18 2.1.6 Fuel Cycle Facility Event Reports................ A-18 2.1.7 Radiography...................................... A-20 2.1. 8 Manufacturing and Distribution................... A-20 2.1.9 Gauges / Measuring Systems......................... A-23 2.2 Abnormal Occurrences..................................... A-23 3.0 FINDINGS...................................................... A-26 List of Tables:

Table 1 - Type of Licensees that Submitted Reports During 1987.. A-8 Table 2 - Categorization of Nonreactor Event Reports Occurring During 1987........................................... A-9 Table 3 - Personnel Radiation Exposure, 1987.................... A-11 Table 4 - (Part 1) Lost or Stolen Sources, 1987................. A-14 Table 4 - (Part 2) Abandoned Well Logging Sources Reports,1987. A-16 Table 5 - Reports of Leaking Sources, 1987...................... A-17 Table 6 - Radiograp hy Events , 1987. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . A-21 Table 7 - Manufacturing and Distribution Events, 1987........... A-22 Table 8 - Gauges / Measuring Systems Event Reports, 1987.......... A-24 A-5

1.0 NONREACTOR EVENT REPORT DATABASE The AEOD Nonreactor Event Report (NRER) database contains information on licensed nuclear materials and fuel cycle operational events and on personnel radiation exposure events. The NRER database management system

• provides for input, storage, retrieval, and computer-assisted analyses of operational event data, and may be used to identify trends in operational safety events which may signal a need for remedial actions by the NRC and/or licensees.

AE00 generally does not incorporate information on transportation events into the NRER database since the Department of Energy funds a transportation incident file at Sandia. Their report on Radioactive Material (RAM) Transportation Accident / Incident Analysis (SAND-85-1016) contains information about this database, and summarizes data for the period 1971-1985, 2.0 REVIEW OF 1987 NONREACTOR EVENTS 2.1 Occurrences in 1987 The NRER database includes 209 records of events that were entered into the database during 1987. Information on these events was contained in reports submitted by nonreactor licensees to the Regional Offices or in other documents, primarily inspection reports. The database does not include information from certain fuel cycle licensee reports, such as those related to routine effluent releases, nor does it include information from reports of medical misadminis-trations, which are included as Appendix B of this Annual Report. Table 1 provides information on the types of licensees for which information was entered into the database.

Table 2 provides information on how the event information was categorized and entered into the database. An NRER database item may be associated with more than one category of event. For example, a report from a radiography licensee concerning a personnel radiation exposure would be counted in the total number of radiation exposure events as well as in the total number of events involving radiography. The 209 nonreactor licensee reports were cataloged as 310 entries in ten different areas. Note that, because some reports are associated with more than one event category, the total number of events exceeds the total number of reports.

d "The NRER database utilizes the System 1022 database management system which operates on the Oak Ridge National Laboratory (ORNL) DEC System-10 computer.

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1 Table 1 Types of Licensees that Submitted Reports During 1987 NUMBER OF LICENSE TYPE REPORTS RECEIVE 0*

ACADEMIC 8 MEDICAL 23 COMMERCIAL / INDUSTRIAL MEASURING SYSTEMS 43 WELL LOGGING (21)

OTHER MEASURING SYSTEMS (22)

MANUFACTURING AND DISTRIBUTION (EXCLUDING MEDICAL) 10 INDUSTRIAL RADIOGRAPHY 11 SINGLE LOCATION (IN PLANT) (1)

MULTIPLE LOCATIONS (FIELO) (10)

IRRADIATOR 12 R&U 31 SOURCE MATERIALS ** 19 MILLS (2)

UF6 FACILITIES (17)

OTHER (0)

SPECIAL NUCLEAR MATERIAL (INCLUDING PLUT0NIUM) 18 AGREEMENT STATE 7 OTHER*** 27 TOTAL 209

• MEDICAL MISADMINISTRATION REPORTS ARE NOT INCLUDED.

• • ROUTINE ENVIRONMENTAL EFFLUENT RELEASE REPORTS E.G., REPORTS REQUIRED BY 40.65 AND 70.59 WERE NOT INCLUDED IN THE TOTALS FOR SOURCE AND SPECIAL NUCLEAR MATERIALS LICENSEES.

• • • NUMBER INCLUDES REPORTS RECEIVED FOR WHICH NO PROGRAM CODE WAS AVAILABLE.

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Table 2 Categorization of Nonreactor Event Reports Occurring During 1987 CATEGORY

• NUM8ER OF REPORTS ASSOCIATED PERSONilEL RADIATION EXPOSURES 26 LOST, ABANDONED, AND STOLEN MATERIAL 81 LEAKING SOURCES 11 RELEASE OF MATERIAL 16 CONSUMER PRODUCTS 2 FUEL CYCLE (E.G., MILLS, UF 6 FACILITIES, 30 SPECIAL NUCLEAR MATERIAL)

INDUSTRIAL RADIOGRAPHY 15 MANUFACTURING AND DISTRIBUTION 17 (INCLUDING MEDICAL)

COMMERCIAL / INDUSTRIAL MEASURING SYSTEMS 28 (EXCLUDING WELL LOGGING)

OTHER** 83 TOTAL 310

• AN NRER DATABASE ITEM MAY BE ASSOCIATED WITH MORE THAN ONE CATEGORY OF EVENT. FOR EXAMPLE, A REPORT FROM A RADIOGRAPHY LICENSEE CONCERNING A PERSONNEL RADIATION EXPOSURE WOULO BE COUNTED IN THE TOTAL NUMBER OF RADIATION EXPOSURE EVENTS AS WELL AS IN THE TOTAL NUMBER OF EVENTS INVOLVING RADIOGRAPHY.

• • 0THER INCLUDES CATEGORIES SUCH AS MEDICAL, TRANSPORTATION, MISCELLANEOUS, ETC.

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2.1.1 Radiation Exposure Events The criteria that define overexposures are defined in 10 CFR 20.205 (a)(1).

The limits are:

Restricted areas:

whole body 1-1/4 rem / calendar quarter, or 3 rem / calendar quarter, if the individual's prior occupational exposure is obtained in writing, and the accumulated exposure does not exceed 5 (N-18), where N is the individual's age extremity 18-3/4 rem / calendar quarter skin 7-1/2 rem / calendar quarter inhalation 40 MPC hours / week for 13 weeks, MPC (maximum permissible ,

concentration) is given in 10 CFR Appendix 8. Table I, Col. 1 minors 10% of above limits Unrestricted areas:

individuals 0.5 rem / year, subject to rate limitations The NRER database contains information on 26 reports of events that were received in 1987 in which there was the potential for or an actual radiation overexposure.

Of the 26 events,11 involved actual overexposures. Information on the exposure reports is provided in Table 3.

The types of licensees associated with the actual overexposures reported during 1987 were:

Number of Total Number of Licensee Type Overexposure Events Individuals Exposed Medical / Academic 4 4 Radiography 2 2 Commercial / Industrial 2 2 Fuel Cycle 1 2 i Other 2 2 - '

Total ~TI T2 1

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Table 3 Personnel Radiation Exposures, 1987 LICENSE EVENT NO TYPE LICENSEE NUM8ER LOCATION DATE EXP EXP BABC0CK & WILCOX DKT 70 LYNCHBURG VA 10/14/87 0 INHALATION BIOMATRIX 292330801 RIDGEFIELD NJ 3/14/86 0 EXTREMITY BP OIL COMPANY 371005903 MARCUS HOOK PA 7/13/87 0 WHOLE BODY CINTICHEM DKT 70 TUXEDO NY 10/01/85 1 EXTREMITY COMBUSTION ENGINEERING DKT 70 WINDSOR CT 8/13/87 2 INHALATION CONSOLIDATED NDE 292145201 PORT READING NJ 6/08/87 0 WHOLE BODY E I DUPONT DE NEMOURS 200032021 N BILLERICA MA 4/09/87 1 EXTREMITY FOX CRASE CANCER CTR 370276601 PHILADELPHIA PA 6/15/87 0 BADGE GAMMA DIAGNOSTICS LABS 201521501 ATTLEBORO MA 7/01/87 1 EXTREMITY H & G INSPECTION 422683801 2/01/87 1 WHOLE BODY H. R. INSPECTION SERV 150620901 KS 8/05/87 0 BADGE HOWARD UNIVERSITY 080038619 WASHINGTON DC 11/15/86 0 BADGE IRVINGTON GENERAL HOSP 290794802 IRVINGTON NJ 4/17/87 0 BADGE MASS INSTITUTE OF TECH 200153702 CAMBRIDGE MA 8/01/87 1 EXTREMITY MASS GEN'l HOSP 200381480 BOSTON MA 2/13/87 1 THYROID NEWPORT NEWS SHIPBLOG 450942802 NEWPORT NEWS VA 1/09/87 1 EXTREMITY PROGRAM RESOURCES INC 192109101 FREDERICK MD 9/01/87 1 EXTREMITY PTL-INSPECTORATE INC 370027625 HANNIBAL M0 2/09/87 0 WHOLE BODY SEQUOYAH FUELS CORP DKT 40 GORE OK 2/06/87 0 INHALATION SEQUOYAH FUELS CORP DKT 40 GORE OK 1/10/87 0 BADGE SEQUOYAH FUELS CORP OKT 40 GORE OK 3/03/87 0 INHALATION SINAI SAMARITAN M C 480328001 MILWAUKEE WI 11/01/87 0 BADGE ST JAMES HOSPITAL 291299701 NEWARK NJ 7/10/86 0 BADGE ST LOUIS UNIV 240458119 ST LOUIS MO 10/27/87 1 WHOLE BODY UNIV 0F MISSOURI 240051332 COLUM8IA MO 7/14/87 1 EXTREMITY WESTERN NUCLEAR DKT 70 JEFFERSON C WY 0 INGESTION l

A-11

Medical / Academic The four reports of overexposures at medical / academic licensees involved licensee personnel. The overexposures were: two extremity exposures of 23 and 36 rem; a thyroid buroen of 0.18 microcuries and a whole body exposure of 9 rem. All of the reports came from different licensees.

Radiography Both of the radiography overexposure reports involved licensee presonnel.

In one event, a radiographer received a dose of 180 rem to the thumb.

In this case, the exposure device could be locked with the source not fully retracted. Although the radiographer locked the exposure device, the radiographer did not perform a survey to determine that the source had been fully retracted. In the second radiography event, a radiographer's badge read 3.1 rem.

Commercial / industrial There were two exposure events at commercial / industrial licensees. The first involved a dose of 650 rem over 1 cm2 to the skin of the thumb; the second event involved an extremity exposure of 20.20 rem during the third quarter of 1987.

Fuel Cycle In an event at a fuel fabricator, equipment failure resulted in two employees receiving 12.26 and 9.82 MpC-days of uranium.

Other Licensees In two events, licensee employees received extremity doses of 42 and 22 rem.

In 1987, most of the extremity exposures were less than 200 rem. The 200 rem extremity exposure is more than 10 times the allowable limit of 18.75 rem.

The whole body exposures reported were less than 10 rem; NRC regulations permit a maximum quarterly exposure of 1.25 rem or, if additional data on the individual's previous exposure is on file, a quarterly limit of 3 rem.

2.1.2 Lost, Abandoned, and Stolen Material Licensees are required to report the loss or theft of licensed material that has occurred in such quantities and under such circumstances that it appears to the licensee that a substantial hazard may result to persons in unrestricted areas (10 CFR 20.402(a)(1)).

Eighty-two events occurred during 1987 that involved lost, abandoned, or stolen '

licensed material. These events are summarized in Table 4. These events con-sist of 67 reports of lost or stolen material, plus 15 reports of abandoned, irretrievable well-logging sources. None of the 82 events resulted in a radiation overexposure.

A-12 l

Lost or Stolen Source Of the 67 reports of lost or stolen sources, nineteen were found; three pacemakers were buried; three sources were inadvertently sent to commercial waste disposal; two sources were lost at sea; one event involved the loss of radioactive material in a lake; and one report concerned sources con-tained in devices that were probably sent to a scrap dealer. The location of the remaining 38 lost or stolen sources in unknown.

Generally, the sources whose whereabouts is unknown contained small amounts of radioactive materials. There were two reports of lost (or misplaced) or stolen sources that contained more than 250 millicuries of tritium: the Air Force could not account for two compasses, each of which contained 190 millicuries of tritium; and 37 generally licensed exit signs containing tritium were discovered to be missing from a garage in Atlantic City.

There were a larger number of lost ported in 1987 than in prior years. polonium Some of210 thestatic eliminator reports sources described re-of the loss more than one static eliminator source, and some of the losses occurred prior to 1987.

Nine reports were received of stolen moisture density gauges, and one report of a stolen Lixiscope. Of the stolen moisture density gauges, two were later reported as found.

Abandoned Well-Logging Sources NRC licensees are required to report the location of abandoned well-logging sources to NRC. The 15 events shown in Table 4 (Part 2) did not result in any known releases.

2.1. 3 Leaking or Contaminated Sources Certain licensees are required to leak test sources and to report leaking sources under 10 CFR 34.25; others are required to leak test sources and to report leaking sources as a license condition. In both cases, a removable contamination exceeding the most common test limit for removable contamination (0.005 microcurie) is considered evidence of leakage, and must be reported to NRC.

Eleven events of leaking or contaminated sources were reported during 1987.

Information from the reports is included in Table 5. None of the events resulted in a radiation overexposure. The isotopic sources found to be leaking or contaminated contained americium, cesium, iodine, nickel, promethium and polonium.

l Most events were reports of small, individual sources found to be leaking or contaminated. Two source leakage events were attributed to damage to sources -

during handling; another event was attributed to damage during removal of the-I

' sources from the source holders; and a fourth event concerned damage to a source from overheating. One sealed source was discovered to have removable

contamination af ter a fire in the facility.

A preliminary overview of the reports did not show any generic problems.

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l L.

Table 4 (Part 1)

Lost or Stolen Sources, 1987 150-LICENSE EVENT FINAL TOPE LOCATION LICENSEE NUMBER DATE DISPOSITION AM241 JEFFERSON AL STATE OF ALABAMA AM241 HARTFORD AS 8/07/87 UNKNOWN CT HEUBLEIN (GENERAL LICENSEE) GL 5/29/87 UNKNOWN AM241 BOLLING DC DEPT OF AIR FORCE 422353901 6/18/87 FOUND AM241 ATLANTA GA MEAD CORP AM241 GL 1/01/84 UNKNOWN GA MEAD CORPORATION AM241 CHICAGO GL 1/01/80 SCRAP IL MEAD CORP GL 4/30/79 FOUND AM241 PINE MTN KY DOLLAR BRANCH COAL COMPANY AM241 DETROIT AS 8/14/87 UNKNOWN HI NEYER TISE0 & HINDO, LTD AM241 FULTON 211489401 11/21/87 FOUND MS US DEPT OF AGRICULTURE AM241 NEW YORK 190091503 10/07/86 FOUND NY FLYING TIGERS AM241 FINDLEY NL 12/10/87 FOUND OH PROFESSIONAL SERV. INC 121694101 AM241 HORSHAM 8/06/87 UNKNOWN PA COMDUSTRIAL ROOFING CONTR 372084801 7/23/86 COMM WASTE AM241 PHILADELPHIA PA MATERIALS ENGINEERING TEST AM241 ALEXANDRIA 291771301 10/20/87 UNKNOWN PA MEAD CORP GL UNKNOWN AM241 FT WORTH TX GEARHART INDUSTRIES INC 420645803 AM241 OAKTON 2/05/87 FOUND VA ATEC ASSOCIATES OF VIRGINIA 451654602 C14 6/12/87 UNKNOWN MONO LAKE CA DEPT OF INTERIOR 040667407 7/27/87 LAKE CD105 TROY MI GTE VALENITE CORP 271743601 UNKNOWN CS13? PINE BLUFF AR EDWARDS PIPELINE INC.

CS157 OCALA 352319301 10/09/87 FOUND FL PENINSULA ENGINEERING & TES AS 3/16/87 UNKNOWN CS137 LAKE CHARLES LA CITCO PETROLEUM CORP AS 3/16/87 UNKNOWN CS137 CINCINNATI OH KANN'S AND COMPANY 341855701 2/06/87 FOUND CS137 JAMES RIVER VA VIRGINIA HIGHWAY DEPT 451338001 1/21/87 UNKNOWN H3 0FFSHORE SCHLUMBERGER H3 11/01/87 OCEAN GEORGE AFB CA DEPT OF AIR FORCE 422353901 H3 3/27/87 UNKNOWN GLASG0W DE E I DU PONT DE NEMOURS & C0 H3 HANSCOM AF 070045538 11/24/86 FOUND MA DEPT AIR FORCE H3 420538404 12/01/86 UNKNOWN ATLANTIC C HJ TRUMP PLAZA GL H3 UNKNOWN SWARTHMORE PA SWARTHMORE COLLEGE H3 370695802 11/12/87 FOUND SHEPPARD TX DEPT OF AIR FORCE 420583404 H3 7/13/87 UNKNOWN MCCHORD AF WA DEPT OF AIR FORCE 422353901 6/27/87 FOUND I125 ST LOUIS MO VETERANS ADMIN MED CNTR 240014405 1125 1/08/87 FOUND EDISON NJ JOHN F. KENNEDY MEDICAL CTR 1125 291261101 10/17/87 FOUND CINCINNATI OH UNIVERSITY OF CINCINNATI 340690311 12/09/87 UNKNOWN 1125 MILWAUKEE WI LIXI INC I125 121821501 3/10/87 UNKNOWN MADISON WI MADISON OSTE 0 POROSIS CENTER 402448601 1125 6/23/87 COMM WASTE FT ATKINSON WI NORLAND INSTRUMENTS 481340301 11/30/86 FOUND IR192 WEST HAVEN CT VETERANS ADMINISTRATION M C 060009205 FOUND -

IR192 MINNEAPOLIS MN UNIV 0F MINNESOTA 220018724 3/09/87 UNKNOWN IR192 BILLINES MT NORTHERN ROCKIES REG CANCER 251716302 8/29/86 UNKNOWN IR192 FARMINGTON OH NL 7/17/87 FOUND IR192 HERSHEY PA MILTON 5 HERSHEY CORP 371387104 7/07/87 UNKNOWN KR85 FT TILDEN NY DEPT OF ARMY 290102211 10/07/86 UNKNOWN KR85 FORT MCC0Y WI DEPT OF ARMY 290102211 3/14/87 UNKNOWN A-14

Table 4 (Continued)

(Part 1)

Lost or Stolen Sources, 1987 ISO- LICENSE EVENT FINAL TOPE LOCATION LICENSEE NUMBER DATE DISPOSITION P32 NEWARK NJ RUTGERS UNIVERSITY 290518528 10/13/87 UNKNOWN P0210 COLUM8US IN COMO PLASTICS CORP GL 2/13/87 UNKNOWN P0210 CLARK NJ AT&T TECHNOLOGIES GL UNKNOWN P0210 PARAMUS NJ DATASCOPE CORPORATION GL UNKNOWN P0210 PITMAN NJ DECORATING RESOURCES INC GL UNKNOWN P0210 ATLANTIC C NJ DORRAN PHOTONICS GL UNKNOWN P0210 PENNSAUKEN NJ LEHIGH PRESS GL 5/09/86 UNKNOWN P0210 SOMERSET NJ MICROWAVE SEMICONDUCTOR GL UNKNOWN P0210 HORRIS PLAIN NJ WARNER-LAMBERT C0 GL UNKNOWN P0210 CEDAR KNOLLS NJ WARNER-LAM 8ERT C0 GL 5/01/85 llNKNOWN P0210 WINCHESTER VA CAPIT0L MAGNETIC PRODUCTS GL 1/27/87 UNKNOWN PU HONTCLAIR NJ

• CLARA MAASS MEMORIAL HOSP DKT 70 5/14/85 PU WRIGHT PAT OH DEPT OF AIR FORCE 422353901 7/16/87 FOUND PU PA ABINGTON MEM. HOSP. DKT 70 7/16/85

• PU BRISTOL PA LOWER BUCKS HOSPITAL DKT 70 9/06/87

• S35 BLACKSBURG VA VA POLYTECHNIC INST & STATE 450947530 12/23/86 UNKNOWN TC99M DETROIT HI SYNCOR INTER CORP 211718901 12/08/87 UNKNOWN TH232 KIRTLAND NM DEPT OF AIR FORCE 422353901 7/07/87 UNKNOWN UNK OFFSHORE CA BOOTHE-TWINING 041952201 6/25/87 OCEAN UNK WASHINGTON DC MERGENTIME-PERINI 082793601 4/14/87 UNKNOWN UNK ATTLEBORD MA GAMMA DIAGNOSTIC LABS 201521501 8/19/86 COMM WASTE UNK FT WORTH TX GEARHART INDUSTRIES INC 420645803 2/25/87 FOUND UNK ELKINS WV KERMIT BUTCHER 47175640 2/01/87 FOUND 8 PACEMAKER INTERRED WITH BODY.

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Table 4 (Part 2)

Abandoned Well Logging Source Reports, 1987 150- LICENSE EVENT TOPE

• LOCATION LICENSEE NUM8ER DATE AM241 LA DRESSER INDUSTRIES 420296401 7/26/1987 AM241 JOHNSON CITY WY GEARHART INDUSTRIES INC 420645803 3/03/1987 AM241 GULF MEXICO GEARHART INDUSTRIES INC 420645803 4/15/1987 AM241 0FF SHORE GEARHART INDUSTRIES INC 420445803 6/26/1987 AM241 0FF SHORE CA SCHLUMBERGER TECH 420009003 10/21/1987 AM241 0FFSHORE LA SCHLUMBERGER TECH 420009003 1/06/1987 AM241 0FFSHORE TX SCHLUMBERGER TECH 420009003 9/12/1987 AM241 0FFSHORE LA WELEX HALLIBURTON 420106807 6/07/1987 AM241 CAMPBELL C WY WELEX HALLIBURTON 420106807 12/17/1987 AM241 0FFSHORE LA WELEX HALLIBURTON 420106807 6/07/1987 AM241 WESTERN ATLAS CORP 420296401 7/26/1987 C060 CONVERSE C WY BAKER PACKER'S CS137 NORTH SLOPE AK SCHLUMBERGER TECH 420009003 1/29/1987 CS137 WOODWARD C OK DAVIS GREAT GUNS LOGGING 152133201 2/14/1987 CS137 CANAWHA WV GEARHART INDUSTRIES 420645803 7/04/1987

• IN MOST CASES, WHEN AN AM 241 SOURCE WAS LOST, A CS 137 SOURCE WAS ALSO LOST.

O A-16

Table 5 Reports of Leaking Sources, 1987 150-LICENSE EVENT TOPE LOCATION LICENSEE NUMBER DATE MANUFACTURER AM241 UPTON WY GOODWELL INC 491299401 9/15/1987 -

CS137 SACRAMENTO CA DEPT OF ARMY 040427901 4/24/1987 -

1125 DOWNERS GROVE IL LIXI, INC 121821501 5/14/1987 LIXI I125 PHILADELPIA PA THOMAS JEFFERSON UNIV 370014806 4/07/1987 -

1125 LACKLAND TX AIR FORCE 4@2353901 5/11/1987 -

NI63 KANSAS CITY M0 AZTEC LABS 241752901 3/25/1987 NI63 B0ZEMAN MT MONTANA STATE UNIV 250032601 5/20/1987 VARIAN NI63 PITTSBURGH PA UNIV 0F PITTSBURGH 370024502 3/12/1987 NI63 HANOVER NJ SANDOZ RESEARCH INST 290897802 11/11/1986 HEWLETT PACKARD PM147 WHITE SANDS NH DEPT OF ARMY 301235001 5/04/1987 P0210 PHILADELPHIA PA GENERAL ELECTRIC CO 370200605 7/23/1987 3M STATIC ELIM.

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2.1.4 Release of Materials Sixteen events were reported in 1987 in which radioactive materials were released.

Generally the events had little significant impact beyond the immediate area of the release. In one event, 2000 cubic yards of low specific activity waste had been deposited as fill in an unauthorized area. That material is being removed.

There were no common causes nor generic problems for the release events reported in 1987.

2.1.5 Consumer Products An additional category, "consumer products," was defined for the database in 1985. These reports describe events in which radioactive material was found in, or had a reasonable probability for being introduced into, nonlicensed consumer products.

There were two reports received in 1987 in which radioactive material was found in, or had a reasonable probability of being introduced into, nonlicensed consumer products. These were:

A cesium source used in a level detector in a coking oven was found to be missing. The licensee, a Louisiana licensee, presumed the source had been carried out in the coke product.

was' Three generally licensed static eliminator sources, containing polonium 210 may have been sent to a scrap dealer with the source holders.

2.1.6 Fuel Cycle Facility Event Reports

• There were 30 fuel cycle events entered into the nonreactor database in 1987.

Two of the events concerned mills or milling, 17 concerned UF manufacture, and 11 occurred at fuel fabrication facilities. 6 Mills and Milling Events:

In previous years, lo.v specific activity waste was deposited at an unauthorized site. Some 2000 cubic yards of material was deposited as fill.

A contractor employee inadvertently drank a small amount of tailings solution. Calculations of the exposure and bioassay data show no overexposures resulted from the intake.

i

• NRER database does not include information from fuel cycle licensee reports of routine effluent releases.

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! A-18 i

(

UF6 Manufacturing Events:

Seventeen UF6 manufacturing events - six at the Allied Metropolis, Il plant and eleven at the Sequoyah Fuels Gore, OK plant were entered into the database in 1987. Three of the events at Allied and three of the events at Sequoyah concerned defects or problems with the UF 6 cylinders. The defects did not con-tribute to any releases of material.

Events at the Allied Metropolis, IL plant:

None of the three operating events at the Allied plant caused any significant releases or impacts on the public health and safety. In one event, the towing arm of a cart towing a cylinder of solidified UF disengaged 6

because an employee had failed to lock the coupling. In a second event, a small amount of UF was 6

released when a cylinder was sampled. The root cause was human error; no overexposures occurred.

The third event at Allied had no impact on safety. A cylinder filled with UF '

6 some of which was liquid, was being towed in a buggy across a railroad spur on the site. A rail tank car containing HF was being moved on the track. The buggy driver did not hear the train; the train braked to a stop within three feet of the buggy. The licensee will install a signal device at the railroad spur. This event could be considered a precursor, since there might have been some releases of UF 6 to the atmosphere if the train had damaged the cylinder.

The extent of the potential release was not determined. The action proposed by the licensee appears, however, to reduce significantly the probability of an accident on the railroad spur.

Events at Sequoyah Fuels Gore, OK plant:

None of the eight operating events at the Gore plant that were entered into the database had any significant impact on the public health and safety. Three of the events concerned equipment that did not contain radioactive materials; one event concerned surface contamination of full face respirators; and four events concerned spills or releases of radioactive materials.

In one of the four spill events, about 1/2 pound of UF6 was spilled in an enclosure when a fill line was being evacuated. Surveys confirmed no releases to the general plant area. In a second event, 300 pounds of yellowcake spilled in the plant when a drum overturned. Bioassay results were below action levels; there were no overexposures. In a third event, one to two pounds of licensed material from a dust collector spilled on the ground. Again, there were no overexposures.

In the last event, while a cylinder was being washed out, a fitting broke as the cylinder was being rotated and about 40 gallons of solution spilled. The contaminated area was cemented over, ,

Uranium Fuel Fabrication Events:

In an event at Advanceri Nuclear Fuels Corporation, a steam lance failed and contributed to elevated but acceptable moisture limits from a criticality safety standpoint. The event showed a lack of procedural guidance on actions to be taken when a compromise of criticality safety contingency is suspected.

A~19

N There were three events reported at a Babcock and Wilcox facility. There was

! a leak in a crain line that permitted contaminated liquid to spill on the ground; i three employees wearing full face respirators were exposed te uranium dust when they were pouring it into a bucket; and the evacuation alarm switch was turned ,

off, requiring personnel to activate the alarm manually in the event of a criticality signal.

There were two events at a Co.ibustion Engineering facility. A broken shuttle box resulted in two operators being exposed to higher than normal concentrations of uranium; and .'tranium contamination was discovered in an unrestricted area.

In an event at the Gener11 Electric Morris facility (storage of spent fuel), an individual was contaminated when he inadvertently removed a pipe cap from a drain valve when it was open.

There were database two events at Nuclear Fuel Services (NFS) that were entered into the in 1987.  ;

In one, nitrogen service to operating equipment was interrupted, resulting in a series of small explosions when air replaced the nitrogen and mixed with the hydrogen blanket on some of the equipment. A water line broke during recovery from the event and resulted in the accumulation o* water in the furnace pits. The explosions resulted in some equipment damage.

In the second event at NFS, a scrap furnace exploded when combustible liquid was being processed. The furnace temperature was high enough to volatilize material but not high enough to ignite vapors. A ventilation failure resulted from blockage of the ducting by solids. i There was a zirconium chip fire in a hot cell at Rockwell International. The fire was extinguished by purging the hot cell with nitrogen. An investigation determined that a saw blade ignited some uranium chips by friction, the uranium chips in turn igniting the zirconium chips, j Wcitinghouse thioped a drum of waste that contained byproduct material and that 9

contained detectable standing liquid. l 4

l 2.1.7 Radiography j

Fif teen 1987 events involved radiogranhy, all but one of which occurred at remote i

(field) radiography sites or during transportation. Information on the reported events is included in Table 6. i Five of the reports concerned overexposure or potential overexposure events and have been listed in Table 3. The total number of radiography events do not i

differ substantially frce the number of events reported during prior years, j although there were fewer events reported that concerned real or potential overexposures.

2.1. 8 Manufacturing and Distribution - '

)

Seventeen 1987 events (Table 7) were identified a: being associated with manu-facturing and distribution faom the program codi of the licensee. These li- ,

censees have no unique reporting requirements for events involving health and  ;

safety unless the requirements are incorporated into a license condition or an order. None of the events was significant. '

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Table 6 Radiography Events, 1987 150- LICENSE EVENT TYPE TOPE LOCATION LICENSEE NUMBER DATE EVENT

• CS137 PINE BLUFF AR EDWARDS PIPELINE INC. 352319301 10/09/1987 LAS 1R192 H & G INSPECTION 422683801 2/01/1987 EXP IR192 10AHO FALLS ID IDAHO NATIONAL ENGINEERING MAD IR192 Hr. 4NIBAL M0 PTL-INSPECTORATE INC 370027625 2/09/1987 EXP IR192 . PORT READING NJ CONSOLIDATED NDE 292145201 6/08/1987 EXP IR192 PENNSAUKEN NJ EASTERN TESTING & INSPECTION 290981401 4/03/1987 MSC IR192 HIGHTSTOWN NJ EASTERN TESTING & INSPECTION 290981401 10/26/1987 TRS IR192 FARMINGTON OH NL 7/17/1987 LAS IR192 NEWPORT NEh5 VA AMERSHAM TECH-OPS 201283601 10/21/1986 MAD IR192 YORKTOWN VA DEPARTMENT OF NAVY 311792801 2/18/1987 MAD IR192 NEWPORT NEWS VA NEWPORT NEWS SHIPBUILDING 450942802 1/09/1987 EXP Z OFF SHORE CA BOOTHE-TWINING 041952201 6/25/1987 LAS 2 SAN LEANDRO CA U S TESTING CO INC 042324001 2/13/1987 MSC Z KS H. R. INSPECTION SERV, INC 150620901 8/05/1987 EXP Z OK GLOBE X-RAY SERVICES INC 351519401 1/25/1987 MSC

• TYPE EVENT EXP EXPOSURE LAS LOST, ABANDONED, STOLEN SOURCE MAD MANUFACTURING AND DISTRIBUTION MSC MISCELLANEOUS TRS TRANSPORTATION A-21

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Table 7 Manufacturing and Distribution Events, 1987 150-LICENSE EVENT TYPE TOPE LOCATION LICENSEE NUMBER DATE EVEN18 AM241 UPTON NY G00 DWELL INC 491299401 9/15/1987 LKS CS137 SACRAMENTO CA DEPT OF ARMY 040427901 4/24/1987 LKS CS137 E CHICAGO IN INLAND STEEL COMPANY 1125 LACKLAND 130308603 10/25/2033 GAU DEPT OF AIR FORCE 422353901 5/11/1987 LKS 1125 DOWNERS GROVE IL LIXI, INC 121821501 5/14/1987 LKS I125 PHILADELPHIA PA THOMAS JEFFERSON UNIVERSITY 370014806 4/07/1987 LKS 1125 MILWAUKEE WI LIXI INC 121821501 3/10/1987 LAS 1125 FT ATKINSON WI NORLAND INSTRUMENTS 18192 NEWPORT NEWS 481340301 11/30/1986 LAS VA AMERSHAM TECH-OPS 201283601 10/21/1986 RAD M099 GAITHERSBURG MD CEPT COMMERCE BUR STOS 192345401 2/23/1987 TRS NI63 KANSAS CITY M0 AZTEC LABS 241752901 3/25/1987 LKS NI63 B0ZEMAN MT MONTANA STATE UNIVERSITY 250032601 5/20/1987 LKS HI63 HANOVER NJ SAND 0Z RESEARCH INSTITUVE NI63 PITTSBURGH 290897802 11/11/1987 LKS PA UNIV 0F PITTSBURGH 370024502 3/12/1987 LKS PMI47 WHITE SANDS NM DEPT OF ARMY 301235001 5/04/1987 LKS P0210 PHILADELPHIA PA GENERAL ELECTRIC COMPANY 370200605 Z WASHINGTON 7/23/1987 LKS DC MERGENTIME-PERINI 082793601 4/14/1987 LAS

• TYPE EVENT GAU GAUGE LAS LOST, ABANDONED, STOLEN SOURCE LKS LEAKING RAD RADIOGRAPHY TRS TRANSPORTATION t

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2.1. 9 Gauges / Measuring Systems Holders of specific licenses to possess gauges are required to report failures of, or damage to, shielding, on/off mechanisms, or indicators of the gauge, or detection of removable contamination on the gauge. In addition, these licensees must make reports required pursuant to 10 CFR Part 20 (lost or stolen materials, releases of material, etc.). Gauge licensees that submitted reports of events occurring in 1987 were identified by the program codes of the licensee. None of the events was by itself significant.

Twenty eight events during 1987 were received from gauge licensees. Information from the reports is included in Table 8. Reports of 1987 gauge events also represent events reviewed in other sections of this report: exposures (2.1.1),

lost or stolen sources (2.1.2), leaking sources (2.1.3), and consumer products (2.1.5).

2. 2 Abnormal Occurrences In the Report to Congress on Abnormal Occurrences for 1987, nine events at NRC licensees and four events at Agreement State licensees were determined to be abnormal occurrences.

The abnormal occurrences at NRC licensees involved:

significant breakdown in management oversight and control of radiation program at two of a licensee's irradiators significant breakdown in management oversight and control of the radiation safety program at an industrial radiography licensee significant breakdown of management controls for radiographic operations NRC order to remove a hospital's radiation safety officer significant breakdown in management and procedure controls at an industrial radiography licensee suspension of a well logging company's license suspension of an industrial radiography company's license suspension of the license of an oil and gas well tracer company Most of the events stemmed from findings of routine inspections of the licensees, although the fifth event listed above was the result of a detailed, special inspection of the licensee. In that special inspection, there were three overexposures and associated evaluations that were not reported to NRC. The -

last event involved action taken by the NRC after the licensee faibd to respond to NRC Confirmative Action Letters and the company moved to an unknown location.

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Table 8 Gauges / Measuring Systems Event Reports, 1987 150- LICENSE TYPE TOPE LOCATION LICENSEE NUM8ER EVENT

• AM241 EAST WINDSOR CI HENRY SOUTHER LABORATORIES 062078501 MSC GAU AM241 DETROIT MI NEYER TISEO & HINDO, LTD 211489401 LAS AM241 FINDLEY OH PROFESSIONAL SERV. INC 121694101 LAS AM241 HORSHAM PA COM0USTRIAL ROOFING CONTR. 372084301 MSC GAU LAS AM241 EMIGSVILLE PA COMMONWEALTH OF PENN. 370667701 MSC GAU AM241 PHILADELPHIA PA MATERIALS ENGINEERING TEST. 291771301 LAS AM241 PR REDONDO CONST CO 522483401 GAU AM241 OAKTON VA ATEC ASSOCIATES OF VIRGINIA 451654602 LAS AM241 STEELING VA SOIL CONSULTANTS INC 451520002 MSC GAU AM241 UPTON NY G00 DWELL INC 491299401 LKS CD109 TROY MI GTE VALENITE CORP 271743601 LAS CS137 SACRAMENTO CA DEPT OF ARMY 040427901 LKS CS137 E CHICAGO IL INLAND STEEL COMPANY 130308603 GAU CS137 CINCINATTI OH KAHN'S AND COMPANY 341855701 LAS CS137 COLUM8US OH OHIO DEPT OF TRANSPORTATION 340523901 MSC GAU CS137 MARCUS HOOK PA BP OIL COMPANY 371005903 MSC GAU EXP CS137 JAMES RIVER VA VIRGINIA HIGHWAY DEPT 451338001 LAS I125 DOWNERS GROVE IL LIXI, INC 121821501 LKS IR192 HANNIBAL M0 PTL-INSPECTORATE INC 370027625 RAD EXP KR85 FORT TILDEN NY DEPT OF ARMY 290102211 LAS KR85 FORT MCC0Y WI DEPT OF ARMY 290102211 LAS NI63 KANSAS CITY M0 AZTEC LABS 241752901 MSC LKS NI63 B0ZEMAN MT MONTANA STATE UNIVERSITY 250032601 LKS NI63 HANOVER NJ SANDOZ RESEARCH INSTITUTE 290897802 LKS GAU NI63 PITTSBURGH PA UNIV 0F PITTSBURGH 370024502 LKS GAU PM147 WHITE SANDS NM DEPT OF ARMY 301235001 LKS Z WASHINGTON DC MERGENTIME-PERINI 082793601 LAS Z ELKINS WV KERMIT BUTCHER 4717564 LAS

• TYPE EVENT  !

EXP EXPOSURE GAU GAUGE LAS LOST, ABANDONED OR STOLEN SOURCE LKS LEAKl>G SOURCE MSC MISCELLANEOUS RAD RADIDGRAPHY A-24

The Agreement State abnormal occurrence events involved:

breakdown in management and procedure controls at an industrial radiography licensee. The A0 involved the same licensee as the last A0 listed above for the NRC licensees breakdown in management and procedural controls at an industrial radiography licensee radiographer overexposures contamination of hospital with iodine-131 The first A0 listed above for agreement states involved the overexposure of two individuals to estimated whole body exposures of 16.9 rem and 2.65 rem. The radiographer overexposure event involved the documented overexposure to a radio-grapher of 7.8 rem whole body, and estimated doses of 50 and 70 rem to the lens of the left and right eye respectively. In addition, it was estimated that the radiographer's hands received entrance doses of 500 and 380 rem to the left and right hand respectively. An assistant radiographer received smaller doses:

3.4 rem whole body, 6 rem to the lens of the eye, and 20 rem to the right hand.

3.0 FINDINGS As in prior years, most 1987 nonreactor events concerned reports of modest overexposures, lost or abandoned sources, or leaking sources. For these types of events, the 1987 data do not differ substantially from the same types of events reported in prior years. None of the operating events reported in 1987 was extremely significant from a public health and safety standpoint.

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l' APPENDIX 8 t

MEDICAL MISADMINISTRATION REPORT MEDICAL MISADMINISTRATIONS REPORTED TO NRC FOR THE PERIOD JANUARY 1987 THROUGH OECEMBER 1987 l

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APPENDIX B AE00/N802 1

MEDICAL MISADMINISTRATION REPORT MEDICAL MISADMINISTRATIONS REPORTED TO NRC FOR THE PERIOD JANUARY 1987 THROUGH DECEMBER 1987 by the Office for Analysis and Evaluation of Operational Data Nonreactor Asessment Staff Prepared by:

Samuel L. Pettijohn l

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TABLE OF CONTENTS P.*Rt

1.0 INTRODUCTION

........................................................ B-7 2.0 THERAPY AND DIAGNOSTIC MISADMINISTRATIONS REPORTED TOB-9 NRC IN 19 2.1 Therapy

2. 2 GeneralMisadministrations

..................................... B-9 B-9 2.2.1 Teletherapy Misadministrations .......................... B-10 2.2.2 Brachytherapy Mi sadmini s trations. . . . . . . . . . . . . . . . . . . . . . . . . B-11

2. 3 Diagnostic Hisadministrations .................................. B-12 2.3.1 Iodine Misadminis trations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . B-12 2.3.2 Diagnostic Misadministrations Involving the Mislabelin i of Radiopharmaceutical Doses by Radiopharmacies . .. . . .g. . . B-13 S

3.0 LICENSEE PROPOSED CORRECTIVE ACTIONS ................................ B-14 4.0 FINDINGS AND CONCLUSIONS ............................................ B-14 1

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O MEDICAL ADMINISTRATIONS REPORTED TO NRC FOR THE PERIOD JANUARY 1987 THROUGH OECEMBER 1987

1.0 INTRODUCTION

This is the seventh annual report documenting AE00's review of medical mis-administrations involving radiopharmaceuticals or radiation from radioisotopes regulated by NRC* that were reported to NRC. A list of previous AE00 reports is contained in Appendix C.

Medical misadministrations are reported to NRC pursuant to the requirements contained in 10 CFR 35. The regulations which became effective on November 10, 1980, define a misadministration to mean the administration of:

(a) a radiopharmaceutical or radiation from a sealed source other than the one intended; (b) a radiopharmaceutical or radiation to the wrong patient; (c) a radiopharmaceutical or radiation by a route of administration other than that intended by the prescribing physician; (d) a diagnosis dose of a radiopharmaceutical differing from the pre-scribed dose by more than 50%;

(e) a therapeutical dose of a radiopharmaceutical differing from the

prescribed dose by more than 10%; or (f) a therapeutic radiation dose from a sealed source such that errors in the source calibration, time of exposure, and treatment geometry l result in a calculated total treatment dose differing from the final i prescribed total treatment dose by more than 10%. i Diagnostic misadministration, as used in NRC regulations, refers to the misadministration of radioisotopes in nuclear medicine studies such as brain scans and bone scar.

. Therapy misadministration, as used in NRC regulations, refers to the misadministration of radiation from cobalt-60 teletherapy or radioisotopes in radiation therapy.

l The significance of any event stems from the potential impact of the event on

, public health and safety. Generally the total risk ascribed to an event is a function of the frequency of the event and the magnitude of the potential impact of the event.

"The Atomic Energy Act of 1954, as amended in 1974, limits the NRC's j regulation of radioactive materials to reactor produced isotopes.

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Regarding the frequency of events over the seven year period, there were 31 therapy misadministration reports that involved teletherapy machines. In these 31 events, a total of 83 patients were overtreated or undertreated. The NRC estimated, using patient statistics from the "Patterns of Care" study of the American College of Radiology, that the error rate per patient is about 0.0003.

There were about 2800 diagnostic misadministrations repnrted to NRC over the same seven year period. A recent study by the Technologist Section of the Society of Nuclear Medicine estimated that about 10 million diagnostic procedures are performed annually in the United States. Since NRC regulates only 21 of the 50 states, NRC estimates that about 4 million procedures are performed annually by NRC licensees. The estimated diagnostic error rate per procedure is 0.0001. ,

Regarding the magnitude of the potential or actual impact of the event, therapy misadministrations are associated with procedures in which large doses of radiation are administered to patients to achieve a therapeutic effect.

Diagnostic misadministrations are associated with procedures designed to permit a diagnosis to be made with little exposure to the patient. An exception is a i diagnostic procedure known as an iodine-131 whole body scan which is discussed in detail below.

Therapy misadministrations have larger potential impacts on the health of the patient than diagnostic misadministrations. Diagnostic misadministrations that result in the erroneous administration of an iodine-131 whole body scan can result in thyroid doses that are near the therapy range. Since both teletherapy misadministrations and diagnostic misadministrations have about the same esti-mated error rate, the therapy misadministrations and some iodine-131 misadminis-trations as a class appear to be individually and collectively more significant than diagnostic misadministrations. AE00, therefore, reviews in detail therapy misadministration reports and diagnostic misadministration reports that involve the adm nistration of therapy amounts of radioisotopes (e.g., 1 to 5 mci of i

, iodine-131 administered for a whole body iodine scan). Most diagnostic mis-j administration reports are reviewed from a collective or statistical viewpoint.

1 This report is a compilation of data on misadministrations reported to NRC for the period January 1987 through December 1987 and is divided into the following q sections: Therapy and Diagnostic Misadministrations Reported to NRC; Licensee Proposed Corrective Actions; and Findings and Conclusions.

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2. 0 THERAPY AND DIAGNOSTIC MISADMINISTRATIONS REPORTED TO NRC IN 19 2.1 General 4

For the period January 1987 through December 1987, NRC licensees involved in radiation therapy and nuclear medicine reported 9 therapy misadministrations and 414 diagnostic misadministrations.

Table 1 summarizes the statistics for the medical misadministrations reported to the NRC for 1987. For this period, 348 of the approximately 2400 NRC licensees authorized to perform nuclear medicine studies or radiation therapy reported one or more misadministrations, a total of 423 reports involving 459 patients. Of the 423 reports of misadministrations for 1987, 414 (98%) reported diagnostic misadministrations, and 9 (2%) reported therapy misadministrations.

Table 1  :

Medical Misadministrations Reported to NRC in 1987 '

Misadministration Diagnostic Therapy Total Number of Reports 414 9 423 Number of Patients Involved 450 9 459 Number of Licensees Reporting 337 9 348 Table 2 compares the 1987 misadministration reports with those of prior years.

The number of reports, the number of patients involved, and the number of 4

licensees reporting misadeinistrations are given. From the table we see that about the same number of diagnostic misadministrations were reported for 1987  :

as were reported annually for the previous six years. The number of therapy misadministrations reported in 1987 was about the same as the average number reported annually in 1981-1986 (7 reports).

Table 2 Misadministri. tion Reports for 1981-1987 Year  ;

1981 1982 1983 1984 1985 1986 1987 '

Therapy Misadministrations 10 4 4 14 4 7 9 Diagnostic Misadministrations 2 3 2 3 3 5 5 (Involving Iodine-131)

Diagnostic Misadministrations 428 414 332 395 377 433 409 i (Other)

Number of Patients 517 451 437 442 410 495 459 No. of Licensees Reporting 351 355 293 318 293 369 348 i

2. 2 Therapy Misadministrations - '

l Nine therapy misadministrations were reported in 1987. Six of the misadmini-

1. strations involved teletherapy, and three involved brachytherapy. Table 3 presents data on the type and probable cause of the misadministrations.

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Table 3 Type and Probable Cause of Therapy Hisadministrations Reported for 1987 Dose different from prescribed by > 10%

(Teletherapy)

Errors in calculating the dose or treatment time 3 The wrong tattoo mark was used to identify the treatment area 1 Technologist placed treatment marks on the wrong part of the body 1

Technologist misread the treatment time 1 Dose dif ferent from prescribed by > 10%

(Brachytherapy) ,

The wrong activity brachytherapy sources were used 1 The incorrect number of brachytherapy sources were used 1 A leaking lodine-125 source was used in a brain therapy implant 1

2.2.1 Teletherapy Misadministrations Three of the therapy misadministrations involved errors in either dose calcula-tions or errors in calculating the treatment time. In one case, data from the wrong teletherapy unit was used in the dose calculations. The treatment planning ,

was done at a different facility than the treatment and data on the teletherapy unit at the planning facility was used in the dose calculations instead of data for the unit at the treatment facility. In another event the wrong dose rate per treatment fraction was used in the dose calculations (200 rad / fraction instead of 300 rad / fraction as prescribed.) As a result of the error, the patient was given a 2000 rad treatment instead of a 3000 rad treatment as prescribed. The error was detected about three weeks af ter the completion of the treatment. In the last case, although the dose calculations were done correctly, an error was made in transposing this information to the patient's chart resulting in the i

wrong treatment time being used. The 1987 teletherapy misadministrations had about the same relative fraction ascribable to errors in dose calculations as i teletherapy misadministrations reported to NRC aver the 1981-1986 period. The  ;

AEOD evaluation of the above teletherapy errors indicates that redundancy in verifying the accuracy of important measurements could likely have detected the errors before they led to misadministrations.

Two of the teletherapy misadministrations involved treatment of the incorrect area of the body. In one case, the technologist mistook tattoo marks used in a a

previous therapy for current therapy markings. In the other case a technologist placed treatment marks on the patient's left hip when the treatment was prescribed for the right hip. Another technologist used the treatment markings to administer two of 12 treatments before the error was discovered. Prior to i the third treatment the patient informed the technologist that the wrong hip -

was being treated. Although the specific causes identified for these two 1987 misadministrations were different from one another, it is believed that a check of the prescription for the therapy before administering the therapy would have shown the error.

B-10

i The remaining teletherapy misadministration resulted from the technologist misreading the treatment time. A treatment time of 1.67 minutes was misread as 1.07 minutes. The patient was treated for the shorter time for 15 out of 25 treatments. The error was discovered during a chart review. Based on an AE00 evaluation, it could have been mitigated by the use of redundancy in verifying the accuracy of information.

2.2.2 Brachytherapy Misadministrations The 1987 brachytherapy misadministrations were caused by 1) sources with the wrong activity being loaded into the source applicator; 2) the wrong number of sources being loaded into the source applicator; and 3) a leaking iodine-125 brac5ytherapy source.

In the first case, two of the four brachtherapy sources required for the therapy were not loaded into the source applicator. The sources were found to be missing when the source applicator was dismantled following the completion of the pre-scribed treatment. The patient received a radiation dose of approximately 50%

of the prescribed dose.

In the second case, sources with an activitv sf 65 mg radium equivalent were loaded into the source applicator whereas ihe prescribed activity was 55 mg radium equivalent. The patient received a radiation dose of 2500 rads instead of 2000 rads as prescribed.

In the third case, a leaking 9 millicurie iodine-125 seed was used in a brain therapy protocol. The seed was one of 36 iodine seeds (nominal activity -7 to 9 millicuries per seed) that were used in the therapy. The 3M Company, manufacturer of the seeds, specified that the seeds could be used for removable brachytherapy implants. The 36 sources used in the therapy had been used in one or two previous therapies. The seeds are loaded into catheters for each use in temporary brachytherapy implants; therefore, each reuse of the seeds involves removing them from one catheter and loading them into a second catheter for reuse. The seed was likely ruptured during the removal of the seed from a catheter. This misadministration was similar to a misadministration that was reported to NRC in 1984. AE0D performed a case study of that event which is documented in AE00 report AE00/C601.

As a result of the case study, AE00 made three specific recommendations for pre-venting the occurrence of this type of misadministration. Two of them were implemented in 1987 (see Appendix E on AE0D recommendations): NRC sent an infor-mation notice to affected licensees informing them of the circumstances of the event that occurred at the University of Cincinnati; and the 3M Company, the iodine-125 seed manufacturer, now provides specific instructions to users on safety precautions for using the seeds. The AE00 recommendation that the Of fice of Nuclear Material Safety and Safeguards (NMSS) explore the option of addressing the reuse of the high activity iodine-125 seeds during the license issue, renewal, or amendment process is not yet resolved. -

The licensee associated with the event indicated that the event was discovered because personnel had become aware of the potential for such an event through the NRC information notice describing the event at the University of Cincinnati.

B-11

2.3 Diaanostic Misadministrations Of the 414 reports of diagnostic misadministrations received in 1987, 341 in- ,

volved the administration of the wrong radiopharmaceutical to a patient and j 58 involved the administration of a radiopharmaceutical to the wrong patient (96% of the reported misadministrations were of these two types). The remain-ing diagnostic misadministrations involved 15 rcports in which the diagnostic dose of a radiopharmaceutical differed from the prescribed dose by greater than 50%. The number of reports for 1987 was about equal to the average rate for the seven year period 1981-1987. The annual number of reports ranged from 334 (1983) to 438 (1986), with an average of 401. The types and causes of the diagnostic misadministrations were about the same as reported in prior years.

Ef fectively, all of the diagnostic misadministrations involving the wrong ,

radiopharmaceutical or the wrong patient stem from human error.

The primary errors associated with the administration of a radiopharmaceutical to a patient were:

errors in the preparation or delivery of radiopharmaceutical doses mislabeling of radiopharmaceutical doses, and misinterpretation of the physician's order i

The primary errors associated with the administration of a radiopharmaceutical to the wrong patient were:

the wrong patient's name was entered on the requisition the wrong patient was delivered to the nuclear medicine department the patient's identity was not correlated with the correct study, and the patient answered to the wrong name Relatively simple quality assurance procedures (checking the patient's identifi-cation against the study and the patient's medical history; asking the patient to state his name) might reduce the frequency of these events.

Excluding those misadministrations involving therapy-equivalent doses of iodine-131 which are discussed in Section 2.3.1, the remaining 5% of the diagnostic mis-administrations, those involving excess dose, were primarily caused by a f ailure of the technologist to assay the patient's dose before administration or the misinterpretation of the physician's order for the study.

2.3.1 Iodine Misadministrations Although most of the diagnostic misadministrations involved the wrong technetium-99m compound, five diagnostic misadministrations involved the administration of therapy-equivalent doses of iodine-131 to patients. These misadministrations typically involved events in which the technologist performed a whole body iodine scan on the patient, when the referring physician had ordered a thyroid uptake or scan. The dose for whole body iodine scans is typically 1 to 5 millicuries; -

the typical dose for a 15yroid uptake study or scan is 30 microcuries of iodine-131, or 5 to 10 millicuries' of technetium-99m. The "iodine-131 whole body scan" is the only diagnostic study where this large amount of iodine-131 is used.

The radiation dose to a patient is significantly higher if he is administered a the apy-equivalent dose of iodine-131 instead of a prescribed diagnostic dose B-12

o of a radiopharmaceutical. For example, a patient prescribed a 5-millicurie dose of technetium-99m for a "thyroid scan" would receive 0.7 rads to the thyroid; a five millicurie dose of lodine-131 can produce a dose of 4000-9000 rads to the thyroid.

In 1987, AE00 published an engineering evaluation of diagnostic misadministrations that involved administering therapy-equivalent amounts of iodine-131 to patients.

The findings of the study were:

1) The direct causes of 10 of 14 reported iodine misadministrations reviewed (71%) were ascribed to either the physician's order being misinterpreted by or miscommunicated to the technologist (7 cases),

or the technologist not knowing the correct dosage to administer for thyroid scan procedures that involved scanning the chest area (3 cases).

2) Causal factors associated with the misadministrations appeared to include:

' use of verbal orders for nuclear medicine studies use of similar terms by referring physicians and licensees

• to refer to dif ferent procedures 1ack of technologist training lack of procedures failure of technologist to follow procedure.

3) The underlying cause of 11 of 14 (79%) of the misadministrations appears to have been a lack of licensee control over the administra-tion of millicurie amounts of iodine-131 to patients. These 11 misadministrations could likely have been prevented, despite the errors that led to the misadministrations, if the prescription for the iodine 131 dosage had been verified for each patient before the iodine-131 was administered to the patient.

Based on the engineering evaluation, AEOD made the following suggestions which were implemented by NMSS:

An update to Information Notice IN-85-61 (Misadministrations to Patients Undergoing Thyroid Scans) be sent to the affected licensees informing them of the more recent misadministration events involving iodine-131.

NHSS assess the proposed regulatory changes to 10 CFR 35 to determine whether the requirements for quality assurance procedures for radiotherapy facilities should be expanded to include a requirement for quality assurance procedures for the administration of radiopharmaceuticals for therapy or for diagnosis in which the dosage of the radiopharmaceutical administrated is in the therapy dosage range for the radiopharmaceutical.

2.3.2 Diagnostic Misadministrations Involving the Hislabeling of Radiopharma-ceutical Doses by Radiopharmacies The mislabeling of radiopharmaceutical doses account for approximately 10% of the reported misakinistrations. About 60% of these diagnostic misadministra-tions result from mislabeled doses being dispensed by radiopharmacies. The B-13

O causal factors associated with the mislabeling of radiopharmaceutical doses by radiopharmacies (simple human error resulting from inattention to details) are generally the same as for hospitals. However, because radiopharmacies can supply many hospitals, a single mislabeling event could result in multiple patients being administered the wrong radiopharmaceutical. Such an event occurred in September 1987 and involved the dispensing by a radiopharmacy of 33 unit doses of technetium-99m DTPA* as technetium-99m MOP **. Of the 33 doses delivered to the users, 25 were administered to patients. The mislabeling errors were dis-covered when a hospital noted that for a patient under material was found to have accumulated in the patient'sgoing a bone kidneys scan the and bladder.

DTPA is used for renal scanning.

A notable observation regarding this event is that the delay in discovering the mislabeling was likely influenced by the fact that the mislabeled doses were thought to be technetium-99m MOP, a bone scan agent, which normally is injected about two hours before the patient is scanned. For misadministrations involving the wrong radiopharmaceutical and multiple patients (about 6% of the diagnostic misadministrations reported) about 854 involved technetium-99m MDP (a bone scan agent) as the prescribed dose.

As previously indicated in this report, the error rate for diagnostic misadmini-strations as calculated from reported data is very low (.01%); however, the above observations identify a possible area in radiopharmacy practice where efforts expended to reduce human errors could be productive.

3.0 LICENSEE PROPOSED CORRECTIVE ACTIONS The dominant corrective actions proposed by licenseas were: the retraining of personnel; implementing new radiopharmaceutical labeling and handling procedures; implementing new procedures for patient identification; implementing new proce-dures requiring the technologist to check the patient's chart for the physician's orders; and reprimand of technologist or other personnel.

Since the corrective actions and their effectiveness are licensee specific, a meaningful determination of whether corrective actions were ef fective would have to focus on the trend in misadministration rates at specific licensees that reported several misadministrations. Because the highest misadministra-tion rate estimated for a sample of licensees was 0.1%, no detailed evaluation of these rates and the associated corrective actions has been made.

4.0 FINDINGS AND CONCLUSIONS Nine therapy misadministrations were reported in 1987, a rate not too different f rom prior years. Both the teletherapy and the brachytherapy misadministrations that occurred in 1987 might have been prevented by quality assurance procedures directed to verifying dose calculations, type of treatment, and patient identification.

Essentially all of the diagnostic misadministrations for 1987 involved either the administration of the wrong radiopharmaceutical or the administration of "technetium-993 diethylenetriamine pentaacetic acid

• • technetium-99m medrenate sodium B-14

O a radiopharmaceutical to the wrong patient. The number, type, and cause of diagnostic misadministrations are about the same as reported for 1986. The causes reported by licensees are generally the same as have been reported in the past; that is, simple errors associated with 1) preparation of radio-pharmaceuticals, 2) processing nuclear medicine requisitions, and 3) patient identification. In addition, for misadministrations involving the adminis-tration of millicurie amounts of iodine to patients, the primary cause was the failure of licensees to exercise adequate control over the administration of millicurie amounts of iodine-131 to patients.

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APPENDIX C SUNRY OF 1987 ABNORMAL OCCURRENCES 9

Abnormal Occurrences CY 1987 Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description 87-1 NRC Order b oends Vol. 10, No. 1 A-10 Power Op<: rations On March 31, 1987, the NRC issued an Order and Suspending Power Operation and Order to of Peach Botton A-11 Show Cause (Effective Immediately) to facility Due to Inattentiveness Philadelphia Electric Company. The Order of the Control directed the licensee to place Peach Bottom Room Staff Unit 3 operating at about 100% power at the time, in cold shutdown (Unit 2 was already in cold shutdown for refueling) and maintain both Units in cold shutdown pending further Order.

The Order was based on the fact that at times during various shifts one or more of the Peach

? Bottom operations control room staff (including w licensed operators, senior licensed operators, and shift supervisors) had for at least five months periodically slept or had been other-wise inattentive to licensed duties. In addition, plant management either knew of or condoned this inattentiveness, or should have known of these facts, and either took no action or inadequate action to correct this situation. Prior NRC inspections had identified other instances of inattention to duty or failure to adhere to procedures on the part of licensed operators in the control room at Peach Bottom.

87-2 Diagnostic Vol. 10 No. 1 G Medical Yn a January 6,1987 letter, Allegheny Valley Hospital, Natrona Heights Pa, notified NRC Misadministration Region 1 that on November 21, 1986, a patient received an intravenous dose of 100 millicuries of technetium-99m rather than the prescribed dose of 20 millicuries. Estimated doses to various organs of the patient were: stomach

Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description 87-2 (Continued) wall, 25 rads; thyroid, 13 rads; intestinal wall, 6-7 rads; and bladder wall, S rads.

These doses are about five times those which would have been expected had the prescribed doses been administered. ?6 significant health effects are expected by the licensee.

87-3 , Diagnostic Vol. 10, No. 1 G On January 21, 1987, NRC Region I':' wa notified Medical by St. Anthony Hospital, Oklahoma City Okla.

Misadministration that on January 12,1987, a 15 year old female was administered 400 microcuries of I-131 rather than the prescribed dose of 400 microcuries of I-123, resulting in a thyroid

?* <1ose of about 1490 rads. This may result in a small increased risk of reduction in thyroid function, and a sma11 increased risk of latent thyroid cancer.

87-4 Diagnostic Vol. 10, No. 1 G In a letter dated March 2,1987, the NRC Medical received written notification that on Misadministration February 19, 1987 a patient referred to the Nuclear Medicine Department of the University of Massachusetts Medical Center in Worchester, Mass., received a 5.5 millicurie dose of iodine-131 rather than the prescribed 5.0 microcuries.

Based upon the 24 hour2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> uptake and the measured effective half-life, the licensee estimated that the radiation dose to the patient's thyroid was 730 rads and the total body dose was 1.7 rads. The effect on the thyroid, if any, would be of no importance because prior to the event, the patient was scheduled for a thyroidectomy to be performed in March.

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Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description 87-5 Significant Vol. 10, No. 1 A-11 On March 17, 1987, the NRC issued a Notice of Breakdown in Violation and Proposed Imposition of Civil Management Penalty in the amount of $10,000 (later reduced Oversight and to $7,500) to Radiation Sterilizers, Inc. of Control of Menlo Park, Cal. The violations were found at Radiation Safety the licensee's irradiatior facilities in Program at Two Schaumburg Ill. and Westerville, Ohio. Some of a Licensee's of the violaticns related to unsafe practices Irradiator which could have resulted in serious overexpo-Facilities sures of licensee personnel. The base civil penalty for the violations would be $5,000.

However, this was escalated because of: the licensee's prior knowledge of the problems; the 7

licensee's failure to take prompt and effective corrective measures for previously identified violations; and the duration of some of the violations (some had existed for several months).

87-6 Diagnostic Vol. 10, No. 1 G On April 27, 1987, NRC Region IV was notified Medical by Veterans Administration Medical C-anter, Misadministration Boise, Idaho, that on April 1, 1987, 400 microcuries of I-131 was administered to an adult male for a total body scan; on April 6, 1987, it was discovered that a bone scan using technetium-99m was the desired study.

The licensee calculated that the patient received a whole body and thyroid dose of about 0.47 and 400 rads, respactively. The physician user evaluated the exposure and concluded that the irradiation posed a small, but still significant, risk of reduction in thyroid function.

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Abnonnal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description 87-7 Significant Break- Vol. 10. No. 1 A-11 On April 1, 1987, the NRC issued a Demand for down in Management Information and Notice of Violation and Pro-Oversight ami Con- posed Imposition of Civil Penalties to Grede trol of Radiation Foundries, Inc., Milwaukee, Wis. This action Safety Program at was taken af ter an October 1986 inspection an Industrial Radiog- showed a significant breakdown in the raphy Licensee licensee's oversight and control of its radia-tion safety program. The inspection showed not only that the Radiation Safety Officer was not familiar with NRC requirements for the training, but also that an unqualified / untrained radiographer made 43 radiographic exposures on August 6, 7, and 8, 1986, which was in viola-

?

e tion of MRC requirements and contrary to the conditions of Grede's license. In addition, the individual made the exposures with the knowledge of an authorized radiographer, who in turn entered the information into a log and signed off on it as though he had made the exposures himself.

87-8 Significant Break- Vol. 10, No. 1 A-11 On April 10, 1967, the NRC issued an Order down of Management Temporarily Suspending License (Effective Controls for Radio- Immediately) and Order to Show Cause why the graphic Operations license should not be revoked to A-1 Inspec-tion Incorporated, of Evanston, Wyo. The Order was based on NRC inspections which identified two instances where the licensee permitted unauthorized individuals to conduct radiography. In one instance, the licensee stated to an NRC inspector that he had not employed such individuals to conduct radiog-raphy while later he admitted to an investi-gator that he had. These actions indicated a

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Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description 87-8 (Continued) disregard for requirements and lack of reason-able assurance that the licensee could be trusted in the future.

A587-1 Breakdown in A-11 Vol. 10 No. 1 On February 17, 1987, the Arizona Radiation Management and Regulatory Agency issued an order to U.S. Test-Procedural Controls ing Company, Unitech Services Group, San at an Industrial Leandro, Cal. , to cease all radiographic Radiography ticensee operations w* thin the state of Arizona.

(Agreement State The order was issued based on the findings of an Licensee) inspection performed on February 6 and 7, 1987, to investigate the circumstances es associated with two employees (a radiographer

'a and an assistant radiographer) of the licensee receiving radiation exposures in excess of regulatory limits while performing radiographic operations at the Navajo Generating Station, Page, Ariz. The licensee had not properly trained the radiographers.

AS87-2 Breakdown in Vol. 10. No. 1 A-11 Management and On February 27, 1987, an Emergency Order suspending all radiographic operations was Procedural Controls issued by an inspector for the California at an Industrial Departmest of Industrial Relations to Radiography Licensee (Agree- Continental Testing and Inspection (CTI),

Signal Hill, Cal. During a routine compliance ment State Licensee) inspection of CTI's licensed radiographic operations, it was determined that individuals acting as radiographers may have lacked the required training and experience, since sub-stantiating records were not available for inspection.

S

Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description 87-9 Olegnostic Medical Vol. 10 No. 2 G On January 21,1987, a 66 year-old female at Misadministration Halifax-South Boston Community Hospital, South Boston, Va., received 782 microcuries of I-131 instead of a 100-microcurie dose usually given for a thyroid scan. No adverse effects to the patient are expected from the reported mis-administration. The dose te the whole body was estimated as 0.37 rem and a thyroid tissue dose of 625 rem.

87-10 Therapeutic Vol. 10 No. 2 G From April 20-22, 1987, a patient treated on Medical Misadmin- the cobalt-60 teletherapy unit at St. Peter's istration Medical Center, New Brunswick, N.J., received

?

• a radiotherapy administration of 600 rads to the lumbar spine arei, which was not the prescribed treatment site. The patient's referring physician and radiotherapist con-cluded that the dose would have no detrimental clinical ef fect due to the patient's current disease state (i.e., breast cancer with metastasis to the bone).

87-11 Diagnostic Medical Vol. 10. No. 2 G On June 3, 1987, MRC received written notifica-Misadministration tion that on May 20, 1987, a patient at the National Institutes of Health, Bethesda, Md.,

received 120 millicuries of technetium-99m pertechnetate rather than the prescribed radio-pharmaceutical, 10 millicuries of ga11ium-67 citrate. The patient experienced no adverse ef fect from this misadministration but received the following unwarranted approximate organ doses (rads): bladder wall, 10.2; stomach wall, 6.1; upper large intestinal wall,14.4; lower large intestinal wall,13.2; thyroid, 15.6; and red marrow, 2.0.

o Abnormal Occurrences CV 1987 (Continued)

Report No. A0 Criterion A0 # Title of f.0 NUREG-0090 or Example Event Description 87-12 NRC Order Issued Vol. 10. No. 2 A-11 On June 15, 1987, an Order Modifying License, to Remove a Hos- Effective Immediately, was issued to Milford pital's Radiation Memorial Hospital, Milford, Del. The action Safety Officer was based on (1) the falsification of daily constancy checks of the dose calibrator by the licensee's two technologists, and (2) the falsification of records of Radiation Safety Committee meetings by the Radiation Safety Officer for about 15 years. The consequence of these occurrences was a reduction in the level of safety associated with the use of licensed material by this licensee. No specific hazard was identified.

87-13 Significant Break- Vol. 10, No. 2 A-11 On June 17, 1987, the NRC issued an Order down in Management and Procedural Con-Modifying License (Effective Immediately) to United States Testing Company, Inc., Unitech trols at an Indus- Services Group (USTU), San Leandro, Cal.,

trial Radiography which required the licensee to temporarily Licensee cease all operations until certain specified corrective actions were taken. At the time, USTU was licensed by the NRC and several Agre ment States to perform industrial radiog-raphy. In-depth special Mfety inspections identified numerous radiation safety viola-tions, including (1) allowing individuals to perform radiography af ter falling one or more certification examinations, (2) allowing individuals to perform radiography before all training and examinations were completed, and (3) allowing individuals with expired certifi-cations to perform radiography.

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Atmormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # Titic of A0 NUREG-0090 or Example Event Description l

A587-3 Radiographer Over- Vol. 10. Ma. 2 A-1 On December 9, 1966, an industrial radiographer i exposures (Agree- and a radiographer's assistant, employed by i ment State Licensee) Northwest X-ray, Idaho Falls, Idaho, received overexposures while performing radiography in a multi-level hot cell at the Chemical Process-ing Plant at the Idaho National Engineering i Laboratory (INEL) near Idaho Falls. '

The assistant received a documented exposure of 3.4 rem whole body, and INEt-estimated ex- i' posures of 6 ree to the lens of the eye, 5 ren to the left hand, and 20 ree to the right n hand. The radiographer received documented 4

o exposure of 7.8 ree whole body and INEL- i estimated exposures of 50 rem to the lens of the left eye, 70 ree to the lens of the right eye, and entrance doses of 2000 and 1700 rem to the left and right hands, respec-tively. Both individuals were examined by INEL's Medical Director. No signs of injury were found. The assistant was released and the radiographer will be followed medically for several armths.

87-14 Significant Degra- Vol. 10, No. 3 B-5 and On April 24, 1987, while the reactor was being dation of Plant A-11 shut down, personnel errors resulted in a Safety at Oyster condition which could have resulted in Creek containment failure had a loss of coolant accident (LOCA) sccurred. With reactor power at about 23%, the licensee began to purge the containment nitrogen atmosphere so that entry could be made into the drywell. In order to ,

accelerate the deinerting process, the group

a Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description 87-14 (Continued) shif t supervisor authorized the blocking open of the torus-to-drywell vacuum breaker valves.

However, this rendered the containment vulner-able to steam bypass of the suppression chamber, potentially resulting in containment over-pressurization for small, intermediate, and large LOCAs. Furthermore, blocking open of the suppression chamber-drywell vacuum breakers resulted in the plant being in an unanalyzed condition.

87-15 Steam Generator Vol. 10 No. 3 B-2 n

e Tube Rupture at At approximetely 6:35 a.m. on July 15, 1987, U North Anna Unit I was manually tripped from North Anna Unit 1 100 percent power due to indications of a steam generator tube rupture. Inspection showed that a tube had failed over 360 degrees of its circumference, and the fractured ends were displaced in the axial direction approxi-mately one-half inch. The cat.se was found to be due to fatigue.

It is estimated that a total of 1.59 X 10 5 curies was released, which consisted primarily of radiogases. There was no detectable increase in normal background levels of radioactivity at the site boundary in the affected sector (s). The release was less tian 1% of Technical Specification limits.

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Abnormal Occurrences CY 1987 (Continued)

Reper, No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description 87-15 (Continued) The primary-to-secondary leak in this event was estimated to be between 550 to 637 gallons per minute f -) . The North Anna Updated Final Safety Ar i Report estimated that a double-endeo rup ;f a single tube at full power would res... in a flow rate of 710 gpm. The highest flow in the 1982 S/G tube rupture at Ginna was . ,stmated to be 760 gpe.

This event was investigated by an NRC Augmented Inspection Team.

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,, 87-16 Therapeutic Vol. 10, No. 3 G On August 24, 1987, the NRC was notified that

f, Mcdical Misad- a 75 year-old patient at Parkview Memorial j no ministration Hospital, Fort Wayne, Ind., received two

therapeutic radiation exposures to the wrong l

part of the body. The patient was scheduled to receive radiation therapy exposure of 250 rads per exposure per day to the right hip, for a total of 3000 rads. However, two exposures of 250 rads each was administered before it was discovered that the left hip was being treated instead of the right hip.

The patient was examined by a physician and no medical side effects were noted as a result of the misadministraticas.

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O Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description 87-17 Failure to Report Vol. 10, No. 3 A-11 On August 24, 1987, the NRC issued an Order to Diagnostic Medical Show Cause Why the License Should Not Be Misadministrations Modified to the Edward Hines, Jr. , Veterans l

l Administration Hospital, Hines, Ill., '

directing that a hospital staff member be removed from NRC-licensed activities and that the hospital take certain steps to I improve its control over its nuclear medicine l program.

An NRC investigation determined that the Assistant Chief Physician of the Hospital's l ,3 Nuclear Medicine Service: failed to ensure f,

u>

that two diagnostic misadministrations of radioactive pharmaceuticals were reported to the NRC as required; made a false statement to a Veterans Administration Investigatory Board and to NRC investigators; destroyed evidence; and attempted to impede the NRC investigatiori by influencing the testimony of a witness.

87-18 Suspension of a Vol. 10, No. 3 A-11 On September 8, 1987, the NRC issued an Well Logging immediately effective order to Log-Tec of Company's License Cleveland, Okla., that suspended the NRC license, ordered all byproduct material be placed in locked storage, and ordered the licensee to show cause why the license should not be revoked.

During August 1987, an inspection showed several apparent violations associated with use and O

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Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # 'O sf A0 NUREG-0090 or Example Event Description 87-18 (Con _o) possession of sealed radioactive sources.

When these violations were discussed with the company's sole proprietor, the NRC inspector was told that the sources had not been used since about June of 1986. Later, when confronted with evidence to the contrary, he not only admitted the violations, but also that he had used the sources af ter June of 1986.

Subsequently, in response to the licensee's request, the NRC is terminating the license.

87-19 Suspension of an Vol. 10, No. 3 A-11 On September 21, 1987, the NRC issued an q> Industrial Radiog- Order Suspending License (effective immediately)

raphy Company's to Finlay Testing Laboratories, Inc., Aiea, License Hawaii. The Order required the licensee to suspend all activities authorized by the license and to place all byproduct material in the licensee's possession in locked storage.

During inspections and investigations conducted in September 1987, it was determined that contrary to NRC and DOT regulations, licensee employees had placed a radiographic exposure device containing radioactive material in lug-gage which was loaded and transported on commercial passenger and military cargo / passenger aircraft. It was further noted that: licensee personnel failed to prepare and use required shipping papers and labels for these shipments; and licensee representatives (including the Radiation Safety Officer) had failed to maintain required records of licensed activities.

4

Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion AD # Title of A0 NUREG-0090 or Example Event Description AS87-4 Hospital Contami- Vol. 10, No. 3 A-11 and G nation Incident On the morning of June 2,1987, an 87 year old patient at Buffalo General Hospital, Buffalo, New York, was administered a 200-millicurie therapy dose of iodine-131 in the hope of relieving esophageal compression caused by i

metastatic thyroid carcinoma. The patient had

! had a total thyroidectomy in April 1987, and l

had a gastrostomy tube and a foley catheter in i

place. On the evening of June 3, 1987, approxi-mately 34 hours3.935185e-4 days <br />0.00944 hours <br />5.621693e-5 weeks <br />1.2937e-5 months <br /> after receiving the dose, the patient had & cardiopulmonary arrest and

,3 expired. During an attempt at resuscitation in the patient's room by sixteen staff members, j,

on which included insertion of a pacemaker, con-taminated blood and urine were spilled and no surveys of the clothing of those present were done.

Even though the contamination was extensive, subsequent thyroid bioassay showed no uptakes by involved staff, and the highest personnel monitoring badge reading was 30 millires for one of the nurses.

AS87-5 Therapeutic Vol. 10, No. 3 G Medical Misadmin- On August 5, 1987, the New York State Depart-ment of Health, Bureau of Environmental istration Radiation Protection (State Agency) was notified of a series of therapeutic medical misadministrations to patients at Northern Westchester Medical Center, Westchester County, New York.

d Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Descriptiun AS87-5 (Continued) i It was found that a dosimetrist, employed by a consulting group for the hospital, had made numerous serious errors in calculating cobalt

, teletherapy treatment times for patients.

i There were 22 cases in which the therapy doses i delivered to patients differed from the pre-scribed doses by more than 10% (this included l overtreatments as well as undertreatments).

The largest error found was an administered dose th tt was about 2.4 times the prescribed dose. Some patients receiving overtreatments

,3 had exhibited physical symptoms apparently due to the exposures.

h 87-20 Suspension of Vol. 10, No. 4 G License of an On October 30, 1987, the NRC issued an Order Oil and Gas Well Suspending License (Effective Immediately) and Tracer Company Order to Show Cause why the license should not be revoked to Tracer Profiles, Inc., of Oklahoma City, Okla.

During March 1987, several violations of NRC i

requirements were found. Contacts with the company to satisfactorily resolve the viola-tions were not successful. Subsequently, it l was found that the company vacated its offices 1 and moved to a new and unknown location with-out notifying the NRC. Therefore, the NRC is considering action to revoke the license.

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APPENDIX D LISTING OF AE00 NONREACTOR REPORTS 1980-1987

O AE00 NONREACTOR REPORTS ISSUED IN 1987 Special Study Reports Date Subject No. Author 10/87 Radiography Overexposuro Events Involving S703 S. Pettijohn Industrial Field Radiography Enaineering Evaluations Date Subject No. Author 1/87 Diagnostic Misadministrations Involving N701 S. Pettijohn the Administration of Millicurie Amounts of Iodine-131 3/87 Diagnostic Misadministrations Reported N702 S. Pettijohn to NRC for the Period January 1986 Through December 1986 3/87 Report on 1986 Nonreactor Events N703 K. Black NONREACTOR REPORTS ISSUED IN 1986 Case Studies Date Subject No. Author 8/86 Rupture of in Iodine-125 Brachytherapy C601 S. Pettijohn Source at the University of Cincinnati Medical Center i

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0 NONREACTOR REPORTS ISSUED IN 1985 Case Studies Date Subject No. Author 12/85 Therapy Misadministrations Reported to C505 S. Pettijohn NRC Pursuant to 10 CFR 35.42 Engineering Evaluations Date Subject No. Author 5/85 Summary of the Nonreactor Event Report N501 K. Black Data Base for the Period January-June 1984 6/85 Summary of the Nonreactor Event Report N502 K. Black Data Base for the Period July-December 1984 7/85 Report on Medical Hisadministrations for N503 S. Pettijohn January 1984-December 1984 NONREACTOR REPORTS ISSUED IN 1984 Case Studies Date Subject No. Author 9/84 Breaching of the Encapsulation of Sealed C405 S. Pettijohn Well Logging Sources REPORTS ISSUED IN 1983 Nonreactor Engineering Evaluations Date Subject No. Author -

1/83 Nonreactor Event Report Database for the N209A E. Trager Period January-June 1982 3/83 1125/1131 Effluent Releases by Material N301 S. Pettijohn Licensees 0-4

O NONREACTOR REPORTS ISSUED IN 1982 Engineerina Evaluations Date Subject No. Author 2/82 Report on Medical Misadministrations for N201 S. Pettijohn the Period November 10, 1980 - September 30, 1981 1/82 Buildup of Uranium-Bearing Sludge in Waste N202 K. Black Retention Tanks 2/82 Lost Plutonium'- 238 Source N203 K. Black 3/82 Report on Medical Misadministrations for N204 S. Pettijohn CY 1981 4/82 Preliminary AE00 Review of Iodine-125 N205 E. Trager Sealed Source Leakage Incidents 5/82 Eberline Instrument Corporation - Part 21 N206 X. Black Report S/82 AE00 Review of Iodine-125 Sealed Source N207 E. Trager Leakage Incidents 8/82 Potentially Leaking Plutonium-Beryllium N208 S. Pettijohn Neutron Sources NONREACTOR REPORTS ISSUED IN 1981 Engineerina Evaluations Date Subject No. Author 3/81 Interim Report on Brown Boveri Betatron N101 E. Trager Calibration Check Source 3/81 Irradiator Incident at an Agreement State N102 X. Black Licensee's Facility (Becton-Dickinson, -

Broken Bow, Nebraska) 4/81 Interia Report on the October 1980 Fire N103 E. Trager at the Sweetwater Uranium Mill 0-5

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REPORTS ISSUE 0 IN 1981 (Cont'd)

Engineerina Evaluations Date Subject No. Author 4/81 Interim Report on the January 2,1981 N104 E. Trager Fire at the Atlas Uranium Mill 5/81 Interim Report on Tailings Impoundment N105 E. Trager Liner Failure at the Sweetwater Uranium Mill 8/81 Review of Reports of Leaking Radioactive N106 E. Trager Sources 12/81 Engineering Evaluation of Fire Protection N107 E. Trager at Nonreactor Facilities 12/81 Notes on AE00 Review of Emissions from N108 E. Trager Tritium Manufacturing and Distribution Licensees  !

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APPENDIX E STATUS OF AE00 RECOMMENDATIONS i

O

STATUS OF RECOMMENDATIONS The status of the recommendations included in nonreactor case studies and special studies has been included in Section E, NUREG-1272, Vol. 2, No. 1, Power Reactors; the status has been repeated in this appendix for convenience.

AE00's tracking system ensures that all formal AEOD recommendations are tracked until resolution is achieved. At this time, there are no issues involving AE00 recommendations which would warrant EDO attention. In addition to the formal recommendations which are tracked and included in this section, additional actions are routinely implemented by NRC program offices on AEOD suggestions contained in engineering evaluations and special reports. These AE0D suggestions are not formally tracked or closed out by AE00.

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J Attachment E AE00 RECOMMENDATION TRACKING SYSTEM Outstanding Recommendations" RECOMMENDATION SOURCE: Case Study AE00/C601 Responsible AE00 Engineer: S. Pettijohn TITLE OR

SUBJECT:

"Rupture of an Iodine-125 Brachytherapy Source at the University of Cincinnati Medical Center" RECOMMENDATION 2 NHSS in conjunction with the appropriate regional office should insure that manufacturers of high intensity iodine-125 seeds provide in the manufacturer's "package insert" specific instructions and safety precautions for reusing the seeds to treat several patients.

RESPONSIBLE OFFICE /DIV/BR CONTACT PRIORITY NMSS/IMNS/AB V. Miller N/A STATUS i Resolved. 3M Company, the manufacturer of high intensity iodine-125 seeds, modified package inserts for iodine-125 seeds to provide clearer information to licensees regarding the safe use of the seeds.

RECOMMENDATION 3 NMSS should consider evaluating during the license issuo, renewal, or amendment process licensee procedures for reusing high .ictivity fodine-125 seeds in treating multiple patients.

RESPONSIBLE OFFICE /0!V/8R CONTACT PRIORITY NMSS/IMNS/AB V. Miller N/A STATUS Under consideration by NHSS.

"In each case the recommendation numbers have been carried forward from the original document.

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o RECOMMENDATION SOURCE Case Study AE00/C505 Responsible AE0D Engineer: S. Pettijohn TITLE OR

SUBJECT:

"Therapy Misadministrations Reported to the NRC Pursuant to 10 CFR 35.42" RECOMMENDATION 2 NMSS should consider contacting professional organizations to encourage and support the initiation of a voluntary, industry-directed physical quality assurance program for radiotherapy. The voluntary quality assurance program should contain at least procedures for verification of patient dose calcu-lations and independent verification of the activity of brachytherapy sources before the sources are implanted.

RESPONSIBLE OFFICE /DIV/8R CONTACT PRIORITY NMSS/IMNS R. Cunningham N/A STATUS Resolved. This recommendation has been addressed in current rulemaking on quality assurance for radiotherapy facilities, "Basic Quality Assurance in (

Radiation Therapy."

RECOMMENDATION 3 10 CFR Part 35.21 should be amended to include the calibration of beam modifiers such as wedge filters, shaping filters, trays, etc.

RESPONSIBLE OFFICE /0!V/8R CONTACT PRIORITY NMSS/IMNS R. Cunningham N/A STATUS Resolved. This recommendation has been addressed satisfactorily in the current rulemaking on quality assurance for radiotherapy facilities, "Basic Quality Assurance in Radiation Therapy."

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c U RECOMMENDATION SOURCE: Case Study AE00/C505 (Continued)

Responsible AEOD Engineer: S. Pettijohn TITLE OR

SUBJECT:

"Therapy Misadministrations Reported to the NRC Pursuant to 10 CFR 35.42" RECOMMENDATION 4 In addition, to the extent that the NRC implements recommendation 3, the action should be made an item of compatibility for Agreement States.

RESPONSIBLE OFFICE /DIV/BR CONTACT PRIORITY GPA/SLITP D. Nussbaumer N/A STATUS Action will be taken subsequent to Recommendation 3.

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