ML20195J421

From kanterella
Jump to navigation Jump to search
Report to the U.S. Nuclear Regulatory Commission on Analysis and Evaluation of Operational Data - 1987.Nonreactors
ML20195J421
Person / Time
Issue date: 10/31/1988
From:
NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:
References
NUREG-1272, NUREG-1272-V02-N02, NUREG-1272-V2-N2, NUDOCS 8812020172
Download: ML20195J421 (80)


Text

- - - - - -

NUREG-1272 Vol. 2, No. 2 Repod to the U.S. Nuclear Regulatory Cornmission on Analysis and Evaluation of Operational Data 1987 Nonreactors U.S. Nuclear Regulatory

. Commission Offico for Analysis e .,c Evaluation of Operational Data p= n%

h,l k I s,weO.

) - 3 k an u

o s NOTICE Availability of Reference Materials Cited in NRC Publications Most documenta lited in NRC publications wil! be available from one of the following sources:

1. The NRC Public Document Room,1717 H Street, N.W.

Wash!ngton, DC 20555

2. The Superintendent of Documents, U.S. Government Printing Office, Post Office Box 37082, Washington, DC 20013 7082
3. The Nationel Technical Information Service, Springfield, VA 22161 Although the listing that follows represents the majority of documents cited in NRC publications, it is not intended to be exhaustive.  ;

Referenced documents available for inspection and copying for a fee from the NRC Public Docu-ment Room !nclude NRC correspondence and internal NRC memoranda; N RC Of fice of Inspection  ;

and Enforcement bulletins, circulars, information notices, inspection and investigation notices:

Licensee Event Reports; vendor reports and correspondence; Commission papers; and applicant and licensee documents and correspondence.

The following documents in the NUREG series are available for purchase from the GPO Sales Program: formal NRC staff and contractor reports, NRC sponsored conference proceedings, and  !

I NRC booklets and brochures. Also available are Regulatory Guides, NRC regulations in the Codo of '

Federal Regulations, and Nuclear Regulatory Commission issuances.

Documents available from the N:,tional Technical information Service include NUREG series reports and ter.hnical reports prepared by other federal agencies and reports prepared by the Atomic .

Energy Commission, forerunner agency to the Nuclear Regulatory Commission.  !

1 Documents available from public and special technical libraries include all open literature items,  !

such as books, journal and periodical articles, and transactions. Federal Register notices, federa and I state legislation, and congressional reports can usually be obtained from these libraries. 7 Documents such as thetes, dissertations, foreign reports and translations, and non NRC conference proceedings are available for purchase from the organization sponsoring the publication cited.

Single copies of NRC draf t reports are available free, to the extent of supply, upon written request to the Division of information Support Services, Distribution Section, U.S. Nuclear Regulatory Commission. Washington, DC 20555.

Copies of indastry codes and standards used in a substantive manner in the NRC regulatory process are maintained at the NRC Library, 7920 Norfolk Avenue, Bethesda, Maryland, and are available there for reference use by the public. Codes and standards are usually copyrighted and may be ,

purchased from the originating organization or, if they are American National Standards, from the American National Standards institute,1430 Broadway, New York, NY 10018.

l l

l l I

l

(

l

NUREG-1272 AEOD/S804 Vol. 2, No. 2 l . - _ . _.- . -. - _ . .. __ _. -- __----_ ---

Report to the U.S. Nuclear Regulatory Commission on Analysis and hvaluation of Operational Data 1987 Nonreactors

$Ite ku Ysh [0ctobr j

Office for Analysis and Evaluation of Operational Data U.S. Nuclear Regulatory Commission Wc:hington, DC 20555

...a..,,

($ h) l l

l l

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 nucle 3r power industry, with comments regarding the trends of some key performance measures. The report also includes the principal findings and issues identified in AEOD studies over the past year, and summarizes infor-l Oation from Licersee 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  ;

l contains a list of the AEOD reports issued for 1980-1987.

I l

iii

EXECUTIVE

SUMMARY

AE00 activities include the review and evaluation of operating experience of nonreactor activities involving the use of HRC licensed materials, such as source material, natural and enriched uranium, and byproduct materials. The purpose of the AEOD review and evaluation is to identify safety significant events and concerns, their causes, and the trends displayed by the events.

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, while other licensees may elect to terminate their licenses. The majority of licensees (about 5600) are authorized to use byproduct materials for such applications as radiography, gauges, and well logging. An additional 2400  ;

licensees are authorized to administer byproduct materials or radiation from byproduct materials to individuals for medical diagnosis or therapy.

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

l the NRC by licensees did not have any reported impacts on public health and safety.

For medical misadministrations, nbe patients undergoing radiation therapy treatments received radiation doses that differed from the prescribed dose by greater than 10%; five patients were involved in diagnostic misadministrations where therapy-equivalent doses of iodine-131 were administered; and 445 patients were involved in other diagnostic misadministrations, typically involving milli-curies of technetium-99m compounds. The error rate for therapy and diagnostic risadministrations reported for 1987 is about 0.0001, the same as prior years, y

l AE00 ANNUAL REPORT NONREACTORS 1987 TABLE OF CONTENTS P,agg EXECUTIVE

SUMMARY

................................................... v

1.0 INTRODUCTION

................................................... 1 2.0 NONREACTOR LICENSEE OPERATIONAL EXPERIENCE FEEDBACK ............ 3 2.1 Overview of Operating Experience .......................... 3 2.1.1 Nonreactor Events .................................. 3 2.1.1.1 1987 Events ................................. 3 2.1.1,2 Radiation Overexposure Events ............... 3 2.1.1. 3 Othe r Type s o f Events . . . . . . . . . . . . . . . . . . . . . . . 6 2.1.2 Medical Misadministrations ......................... 6 2.1.2.1 Misadministrations Reported in 1987 ......... 8 2.1.2.1.1 Therapy Misadministrations ............ 8 2.1.2.1.2 Diagnostic Misadministrations ......... 9 2.1.2.1.3 Iodine Misadministrations ............. 10 2.1.2.2 Misadministrations Reported for 1981-1987.... 10 2.2 Abnormal Occurrences ...................................... 11 l 2.3 Results of Selected AEOD Studies .......................... 11 2.3.1 Review of the Data on Teletherapy i

Misadministrations Reported to the State of New York ........................................... 11 2.3.2 Diagnostic Misadministrations Involving the Administration of Millicurie Amounts of Iodine-131.. 12 2.3.3 Special Study Report on Overexposure Events Involving Industrial Field Radiography.............. 12 2.4 List of Selected Ongoing Technical Studies ................ 13 APPENDIX A REPORT ON 1987 NONREACTOR EVENTS ............................... A-1 1 APPENDIX B MEDICAL MISADMINISTRATION REPORT ............................... B-1 l APPENDIX C l SUMARY OF 1987 ABNORMAL OCCURRENCES ........................... C-1 i APPENDIX D LISTING OF AE00 REPORTS, 1980-1987 ............................. 0-1 vii

TABLE OF CONTENTS (continued)

Pgg APPENDIX E STATUS OF RECOMMENDATIONS ...................................... E-1 LIST OF (ABLES Table 1 - Types of Licensees that Submitted Nonreactor Reports During 1987 ............................................... 4 Table 2 - Categorization of Reports of Nonreactor Events Occurring During 1987 ............................................... 5 Table 3 - Error Rate for Misadministrations ......................... 7 Table 4 - Misadministration Reports for 1981-1987 ................... 10 i

l l

viii

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ J

1.0 INTRODUCTION

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 identify and resolve problems with potential safety-related implications. The Office, which reports directly to the Executim Director for Operations, is dedicated to the l 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 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 uranium and special nuclear material (predominantly in si.pport of the reactor fuel cycle) and byproduct materials. Of these licenseet, about 5600 are auth-orized to use byproduct materials for such applications as radiography, gauges, and well logging. Another 2400 medical licensees are authorized to administer byproduct materials or radiation from these materials to individuals for medical diagnosis or therapy. A relatively small number of '.icensees use uranium or SNM in fuel cycle operations.

I NRC nonreactor licensees are required to report evesnts such as those in which l i

there was: a personnel overexposure (10 CFR Part 7.0.405(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 Part 20.402); or abandoned well logging sources (10 CFR Part 39.77). Other events may also be reported as required by license condition or may be included in inspection reports. About 200 reports of such events are received annually, or about 4 events /100 licensees. Similarly, th's 2400 medical licenseesThere report about is gener-400 misadministrations annually or about 16 events /100 licensees.

l ally little impact from these licensed programs on public health and safety.

Role of AE00 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 the use of radioactive materials in nonreactor applications. AE00 publishes studies of specific operational events and, as appropriate, recommends agency c ons to reduce the probability of the occurrence of the event.

(

1

The recommendations contained in AE00 studies are tracked until resolved.

They are internal recommendations for action by the appropriate NRC program l

office or regional office. The office to which the recommendation is addressed l 15 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 I as the focal point for interaction with outside and foreign organizations perform nq similar work.

l l

2

i .

}

l i

f 2.0 NONREACTOR LICENSEE OPERATIONAL EXPERIENCE FEE 0BACK l 1

Ouring 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 i included in this report unless the event was published in a Preliminary Notice l' of Occurrence by one of the NRC's regional offices. A report on the events i

reported by Agreement States will be published separately, 1

j 2.1 Overview of Operating Experience l 1 2.1.1 Nonreactor Events

! The AEOD Nonreactor Event Report (NRER) database contains information on li-censed nuclear materials and fuel cycle operational events and on personnel ,

radiation e posure events. The NRER database management system provides for j input, storage, retrieval, and computer-assisted analyses of operational event j

data, and may be used to identify trends in operational safety events which i may cignal a need for remedirl actions by the NRC and/or licensees.

I i 2.1.1.1 1987 Events 1

The NRER database int.ludes 209 records of events that were entered into the

! database during 1987. Information on these events was contained in reports  !

l submitted by NRC licensees to the regional offices or in other documents, i primarily inspection reports. The NRER database does not include information ,

l reports of medical misac' ministrations. See Section 2.1.2 for a discussion of 1 the data on medical misadministrations for 1987. g i

i Table 1 provides information on the types of licensees for which information ,

was entered into the databasa. Table 2 provides information on how the  !

e nonreactor event information was categorized.

2.1.1.2 Radiation D.arexposure Events l

The NRER database contains information on 26 reports af events that weret received in 1987 in which there was the potential for or an actual radiation overexposure.

I

]

Of the 26 events, eleven involved actual overexposures. {

1  ;

V The types of licensees associated with the actual overexposures reported  ;

l during 1987 were:

i Number of Total Number of  :

Licensee Type Overexposure Events Individuals Exposed l

Medical / Academic 4 4 1 Radiography 2 2 i Commercial / Industrial 2 2 ,

{ 2 i Fuel Cycle 1 l Other 2 2 l

) Total T T  !

t I

i

! 3 I i I

4 j

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

  • ACADEMIC 8 HEDICAL 23 1

COMiERCIAL/ INDUSTRIAL MEASURING SYSTEMS 43 WELL LOGGING (21)

OTHER MEASURING SYSTEMS (22)

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

MULTIPLE LOCATIONS (FIELD) (10)

IRRADIATOR 12 1

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

UF FACILITIES (17)

OT$ER (0)

SPECIAL NUCLEAR MATERIAL (INCLUDING PLUTONIUM) 18 AGREEMENT STATE 7 i

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.

4

I t

1 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 PRODUCTS 2 FUEL CYCLE (e.g., MILLS, UF6 FACILITIES, 30  !

SPECIAL NdCLEAR MATF. RIAL) f INDUSTRIAL RADIOGRAPHY 15 l MANUFACTURING AND DISTRIBUTION 17 (INCLUDING MEDICAL) l l

l

! COMMERCIAL / INDUSTRIAL MEASURING SYSTEMS 28 l j (EXCLUDING WELL LOGGING) l OTHER** 83 f

! TOTAL 310 i

i l

l i l

! *AN NRER DATABASE ITEM MAY BE ASSOCIATED WITH MORE THAN ONE CATEGORY OF  !'

EVENT. FOR EXAMPLE, A REPORT FROM A RADIOGRAPHY LICENSEE CONCERNING A i PERSONNEL RADIATION EXPOSURE WOULO BE COUNTED IN THE TOTAL NUMBER OF '

J

) RADIATIJN EXPOSURE EVENTS AS WELL AS IN THE TOTAL NUMBER OF EVENTS

] INVOLVING RADIOGRAPHY.

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

)

1 l

i l

i i

I 5

1

i i.

l Medical /Acidemic i The four reports of overexposures at medical / academic licensees involved licensee personnel. The overexposures were: two extremity exposures of I approximately 23 and 36 rem; a thyroid burden of 0.18 microcuries; and a '

whole body exposure of 9 rem. The ruoorts came from different licensees.

! t Radiography .

i Both of the radiography overexposure reports involved licensee personnel.

l In one event, a radiographer received a dose of 180 rem to the thumb. In i this case, there was an equipment malfunction; the exposure device could be '

! locked with the source not fully retracted. Although the exposure device l 4

was locked, the radiographer did not perform a survey to datermine that the l

' source had been fully retracted, and received an exposure to his thumb from .

the incompletely retracted source. In the second radiography event, a '

i radiographer's badge read 3.1 rem. I c

{

Commercial / industrial f

! There were two exposure events at co9mercial/ industrial licensees. The first I i involved a dose of 650 rem over 1 cm to the skin of the thumb; the second i j event involved an extremity exposure of 20 rem during a calendar quarter of [

1987.

1 Fuel Cycle 4

l In an event at a fuel fabricator, equipment failure resulted in two  !

employees receiving 12.3 and 9.8 MPC-days of uranium. l t

Other Licensees

?

In two events, licensee employees received extremity doses of approximately '

j 42 and 22 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 [

l individual's previous exposure is on file, a limit of 3 rem / quarter. '

2.1.1.3 Other Types of Events I The nonreactor assessment staff reviewed other classes of event reports: lost i

or stolen sources; abandoned sources; leaking or contaminated sources; release  ?

! of materials; consumer products; fuel cycle facility event reports; industrial ,

radiography; manufacturing and distribution; and gauges / measuring systems. The I

! events in these categories did not have any reported impacts on public health ,

I and safety, t 1

] 2.1.2 Medical Hisadministrations l 1 '

The NRC regulates certain aspects of the uses of reactor produced radioisotopes  !

in nuclear medicine and therapeutic radiology. Certain diagnostic and therapy ,

t

]  !

J 6 I i

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 regul'.tions, 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 rad;oisotopes 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 Radiology, 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 uy 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, tcgether 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 irror 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 proceaures 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 misadninistrations from year to year. Most of the 1 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. Over311 the data do not show a discernible trend. As AEOD stated in prior years, relatively simple i

4 i l

i

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 Hisadministrations Rerorted in 1987 For 1987, 348 of the approximately 2400 NRP licensees authorized to perform J

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 Te.erny Misaaministrations Nine therapy misadministrations were reported in 1987. Six of the misadministrations involved teletherapy, and three involved brachytherapy.

Three of the teletheraphy misadministrations were caused by errors in dose calculations. AEOD's evaluation of the teletherapy errors involving errors in dose calculations indicates that redurdancy 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-1 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, AEOD/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, AE0D 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 Septemuer 30, 1986. The licensee associated with the 1987 event indicated that it was discovered because personnel had become aware of the potential for the j occurrence of such an event through the NRC information notice.

l A second 1987 brachytherapy misadministration was caused by sources of the wrong dCtivity being loaded into the source applicator; 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.

8

2.1.2.1.2 Diagnostic Misadministrations Like prior years, essentially all of the diagnostic misadministrations for 1987 kvolved either the administration of the wrong radiopharmaceutical or the adt.i.1istration of a radiopharmaceutical to the wrong patient. The number, type, and cause of diagnostic misadministrations are about the same as reported for 1985. 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 radiepharmaceutical 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 I 35.33, diagnostic misedministrations occurring after April 1, 1987 need be l reported only if: l the misadministration involved the use of radioactive material not intended for medical use; i

-- the administered dose was five-fold different from the prescribed I I

dosage; or

-- the critical organ radiation dose is likely to exceed 2 rem or the whole body dose is likely to exceed 500 millirem.

Even with the change in reporting requirements for diagnostic misadministrations, the number reported in 1987 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 iodine scan 9

on the patient, when the referring physician had ordered a thyroid uptase 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, AEOD 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. AE0D 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 was 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 ore given in Section 2.3.1.

2.1.2.2 Misadministrations 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 Misadministration Reports for 1981-1987 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 (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 repcrted 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 misadministrations 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 term of the radiopharmaceutical. In general, the causes of all of the t'1erapy mitadministrations were human errors involving dose calculations, patient set-up or treatment, and patient  !

identification, i

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

f 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 misadmiristrations that involved the administration of relatively large amounts of icdine-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 the 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 Reactots.

2.3 Resuits of Selected AE00 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.

After 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%. In the second hospital, about 43% of the treat-ment plans contained significant irrors. 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 AE00 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."

11

The AE00 review found that requirements in the proposed rule, "Basic Quality Assurance in Radiation Therapy," published on October 2, 19E7, 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 rationair for this proposed requirement is that an independent check of dose calculations would likely detect calculation errors.

2.3.2 Dia l MilknosticMisadministrationsInvolvingtheAdministrationof icurie Amounts of Iodine-131 (AE00/N701, January 1987)

In 1985, NRC issued an Information Notice entitled "Misadministrations 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 the 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 l 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 dir. gnosis in which the dosage of the radiopharmaceutical administered is in the cherapy dosage range for the radiopharmaceutical. The NRC staff incluaed 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 Industri31 Field Radiography (AE00/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 Office of Research. The review assessed the aggregated data to l

\ 12

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

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.

AE00 reviewed 34 events reported by NRC licensees and 52 events reported by Agreement State licensees. The exposures in the events ranged from 1.3 to 63.2 rem 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 i personnel error 9

) occupational exposures 7 unknown 5 l

The equipment probier.s 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 I 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 reguldtion.

2.4 List of Selected Ongoing Technical Studies

1. Review of Nonreactor Events in Agreement States, 1981-1987
2. Review of Events n' L.arge Pool-Type Irradiators
3. Evaluation of General Issues Involved in Medical Hisadministrations 13

i 1

l i

I l

P i

i.

APPENDIX A i REPORT ON 1987 NONREACTOR EVENTS i

,1

]

i.

?

I

,i  !

i l i 2

1 i

! 1 1

l L

1 1

/

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

l l

l l

1 l

l Prepared by:

Kathleen M. Black A-3

TABLE OF CONTENTS P,a g_e 1.0 NONREACTOR EVENT REPORT DATABASE.................................

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 E.1.3 LeakIngorContaminatedSources..................... 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 1

2. 2 Abnormal Occurrences........................................ A-23 3.0 FIN 0lNGS.........................................................

A-25 List of Tables:

1

- Table 1 - Types 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 Exposures, 1987................... A-11 Table 4 - (Part 1) Lost or Stolen Sources, Source Reports, 1987.. A-14 1987.................

Table 4 - (Part 2) Abandoned Well Logging A-16 '

Table 5 - Reports of Lesking Sources, 1987...................... A-17 '

Table 6 1987.............................. A-21 Table 7 -

- Radiography Manufacturing Events,istribution and D Events, 1987........... A-22 1

, Table 8 - Gauges / Measuring Systems Event Reports, 1987.......... A-24 ,

i r

I A-5 i

i 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

  • p) ,vides for input, storage, retrieval, and computer-assisted analyses of operat wnal 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.

AEOD 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 0F 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 Of fices or in other documants, prima-ily inspection reports. The database does not include information from certdin 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 Arnual 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 repcrts are 6sscciated with more than one event category, the total number of events exceeds the total number rf reports.

"The NRER database utilizes tIie System 1022 database management system which operates on the Oak Ridge National Laboratory (0RNL) DEC System-10 computer.

l A-7

Table 1 Types of Licansees that Submitted Reports During 1987 NUMBER OF LICENSE 1)fC REPORTS RECEIVED

  • ACADEMIC 8

MEDICAL 23 COMMERCIAL / INDUSTRIAL MEASURING SYSTEM 3 43 WELL LOGGING (21)

OTHER MEASURING SYSTEMS (22)

MANUFACTURING AND DISTRIBUTION (EXCLUDING MEDICAL) 10 INDUST 3IAL RADIOGRAPHY 11 SINGLE LOCATION (IN PLANT) (1)

MULTIPLE LOCATIONS (FIELD) (10)

IRRAh!ATOR 12 R&D 31 SOURCE MATERIALS ** 19 MILLS (2)

UF6 FACILITIES (17)

OTHER (0)

SPECIAL NUCLEAR MATERIAL (INCLUDING PLUTONIUM) 18 AGREEMENT STATE 7 OTHER***

27 TOTAL 209 i

  • MEDICAL MISADMINISTRATION REPORTS ARE NOT INCLUDED.
    • ROVIINE 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.

A-8

Table 2 Categorization of Nonreactor Event Reports Occurring During 1987 CATEGORY

  • NUMBER OF REPORTS ASSOCIATED PERSONNEL RADIA110N EXPOSURES 26 LOST, ABANDONED, AND STOLEN MATERIAL 81 LEAKING SOURCES 11 RELEASE OF MATERIAL 16 CONSUMER PRODUCTS 2 FUEL CYCLE (E.G., MILLS, UF6 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 1

i

  • AN NRER DATABASE ITEM MAY BE ASSOCIATED WITH MORE THAN ONE CATEGORY OF i EVENT. FOR EXAMPLE, A REPORT FROM A RADIOGRAPHY LICENSEE CONCERNING A

! PERSONNEL RADIATION EXPOSURE WOULD BE COUNTED IN THE TOTAL NUMBER OF l RADIATION EXPOSURE EVENTS AS WELL AS IN THE TOTAL NUMBER OF EVENTS 1

INVOLVING RADIOGRAPHY.

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

I l

l l

A-9 1

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

Restricted areas:  !

l whole body 1-1/4 rem / calendar quarter, or l 3 rem / calendar quarter, if the '

individual's prior occupational (

exposure is obtained in writing, i and the accumulated exposure I does not exceed 5 (N-18), where  !

N is the individual's age l extremity 18-3/4 rem / calendar qu4rter i skin 7-1/2 rem / calendar quarter  !

inhalation 40 HPC hours / week for 13 weeks, MPC (maximum permissible  !

concentration) is given in '

10 CFR Appendix B. Table I, Col. I minors 10% of above limits Unrestricted areas: l 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 durirg 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 l

Other 2 2 i Total 'TI Tl I i

I i

l A-10 l

L

(

I Table 3 P6rsonnel Radiation Exposures, 1987 ,

LICENSE EVENT NO TYPE NUMBER LOCATION DATE EXP EXP LICENSEE ,

bABC0CK & WILCOX OKT 70 LYNCHBURG VA 10/14/87 0 INHALATION

B10 MATRIX 292330801 RIDGEFIELO NJ 3/14/86 0 EXTREMITY i WHOLE BODY i BP OIL COMPANY 371005903 MARCUS HOOK PA 7/13/87 0 CINTICHEM DKT 70 TUXEDO NY 10/01/85 1 EXTREMITY
COMBUSTION ENGINEERING DKT 70 WINDS 0R CT 8/13/87 2 INHALATION ,

CONSOLIDATED NDE 292145201 PORT READING NJ 6/08/87 0 WHOLE BODY l E I OUPONT DE NiMOURS 200032021 N BILLERICA MA 4/09/87 1 EXTREMITY FOX CHASE CANCER CTR 370276601 PHILADELPHIA PA 6/15/87 0 BADGE l GAMA DIAGNOSTICS LABS 201521501 ATTLEBORO MA 7/01/87 1 EXTREMITY .

I H & G INSPECTION 422683801 2/01/87 1 WHOLE B00Y KS 8/05/87 0

! H. R. INSPECTION SERV 150620901 BADGE  :

l HOWARD UNIVERSITY 080038619 WASHINGTON DC 11/15/86 0 BADGE  ;

IRVINGTON GENERAL HOSP 290794802 IRVINGTON NJ 4/17/87 0 BADGE i j MASS INSTITUTE OF TECH 200153702 CAMBRIDGE MA 8/01/87 1 EXTREMITY  :

MASS GEN'L HOSP 200381480 BOSTON MA 2/13/87 1 THYROID 450942802 NEWPORT NEWS VA 1/09/87 1 EXTREMITY I 1 NEWPORT NEWS SHIPBLDG i PROGRAM RESOURCES INC 192109101 FREDERICK MO 9/01/87 1 EXTREMITY '

PTL-INSPECTORATE INC 370027625 HANNIBAL MO 2/09/87 0 WHOLE 800Y SEQUOYAH FUELS CORP OKT 40 GORE OK 2/06/87 0 INHALATION

$EQUOYAH FUELS CORP DKT 40 GORE OK 1/10/87 0 BADGE i l SEQUOYAH FUELS CORP OKT 40 GORE OK 3/03/87 0 INHALATION i SIhAI SAMARITAN M C 480328001 MILWAUKEE WI 11/01/87 0 BADGE ST JAMES HOSPITAL 291299701 NEWARK NJ 7/10/86 0 BADGE .

I ST LOUIS UNIV 240458119 ST LOUIS MO 10/27/87 1 WHOLE BODY I UNIV 0F MISSOURI 240051332 COLUMBIA MO 7/14/87 1 EXTREMITY i WESTERN NUCLEAR DKT 70 JEFFERSON C WY 0 INGESTION i

2 I

I J  ;

i i  !

t  !

l

} l 1  !

I i l i I L l l j A-11 '

l

)

Medical / Academic 1

The four reports of overexposures at medical / academic licensees involved

licensee personnel. The everexposures were
two extremity exposures of 23 and 36 rem; a thyroid burden of 0.18 microcuries and a whole body exposure
of 9 rem. All of the reports came from different licensees.

l --

Radiography i 1

1 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 i badge read 3.1 rem.

Commercial / industrial

!' There were two exposure events at commercial / industrial licensees. The 2

first involved a dose of 650 rem over 1 cm to the skin of the thumb; the second event involved an extraity exposure of 20.20 rem during the third quarter of 1987.

Fuel Cycle  !

I t

In an event at a fuel fabricator, equipment failure resulted in two employees receiving 12.26 acd 9.82 MPC-days of uranium.

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

l In 1987, most of the extremity exposures were less than 200 rem. The 200 rem  !

I extremity exposure is more than 10 times the allowable limit of 18.75 rem. l The whole body exposures reported were less than 10 rem; NRC regulations i

! permit a maximum quarterly exposure of 1.25 rem or, if additional data on the i l

individual's previous exposure is on file, a quarterly limit of 3 rem.  !

I

2.1.2 Lost, Abandoned, and Stolen Material l 1

l  !

)

Licensees are required to report the loss or theft of :ensed material that I has occurred in such quantities and under such circumstances that it appears j i to the licensee that a substantial hazard may result to persons in unrestricted l

) areas (10 CFR 20.402(a)(1)' '

l j Eighty-two events occurred during 1987 that involved lost, abandoned, or stolen i l licensed material. Tnese events are summarized in Table 4. These events con- L sist of 67 reports of lost or stolen material, plus 15 reports of abandoned, l l irretrievable well-logging sources. None of the 82 events resulted in a t radiation overexposure, f A-12 i

i

.- - =_- - - - . . - . .- _ - .

! l A  :

I  !

1  !

j i Lost or Stolen Source ,

i  !

j Of the 67 reports of lost or stolen sources, nineteen were found; three i pacemakers were buried; three sources were inadvertently sent to commercial i i 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. l, Generally, the sources whose whereabouts is unknown contained small amounts of I 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  !

I j not account for two compasses, each of which contained 190 millicuries of tritium; 4 and 37 generally licensed exit signs containing tritium were discovered to be [

missing from a garage in Atlantic City. j

, a There were a larger number of lost polonium 210 static eliminator sources re- i ported in 1987 than in prior years. Some of the reports described the loss of , f more than one static eliminator source, and some of the losses occurred prior to 1987, i

{' Nine reports were received of stolen moisture density gauges, and one report of l a stolea Lixiscope. Of the stolen moisture density gauges, two were later t reported as found. j j

j -- Abandoned Well-Logging Sourcer f 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 afy known releases.

l 2.1.3 Leaking or Contaminated Sources l 1

Certain licensees are required to leak test sources and to report lening

' 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 l contamination exceeding the most common test limit for removable contamination (0.005 microcurie) is considered evidence of leakage, and rust be reported to <

N'lC .

l Eleven events of leaking or contaminated sources werr. reported during 1987, f Information from the reports is included in Table 5. None of the events i resulted in a radiation overexposure. The isotopic sources found to be leaking j or contaminated contained americium, cesium, iodine, nickel, promethium and polonium, t

i Most events were reports of small, individual sources found to be leaking or  !

contaminated. Two source leakage events were attributed to damage to sources i during handling; another event was attributed to damage during removal of the {

sources from the source holders; and a fourth event concerned damage to a  ;

i source from overheating. One sealed source was discovered to have removable contamination after a fire in the facility. f

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

A-13 I

i

_ _ _ _ _ _ _ _ _ _ - - ____.___.o

Table 4 ,

(Part 1)

Lost or Stolen Sources. 1987 150- LICENSE TOPE LOCATION EVENT FINAL  !

LICENSEE OATE DISPOSITION NUMBQ AM241 JEFrERSON AL STATE OF ALABAMA AS 8/07/87 UNKNOWN AMNi MARTFORD CT l

HEUBLEIN (GENERAL LICENSEE) GL 5/29/87 UNKNOWN

""41 90LLING DC DEPT OF AIR FORCE 422353901 6/18/87 FOUND

' " . ATLANTA l GA MEAD CORP GL 1/01/84 UNKNOWN  ;

'241 GA MEAD CORPORATION GL 1/01/80 SCRAP ,

AM241 CHICAGO IL MEAD CORP GL 4/30/79 FOUND l-AC41 PINE MTN KY DOLLAR BRANCH C0AL COMPANY AS 8/14/87 UNKNOWil  !

AM241 DETROIT HI NEYER TISEO & HINDO, LTD 211489401 11/21/87 FOUND l AM241 FULTON MS US DEPT OF AGRICULTUR8 190091503 10/07/86 FOUND AM241 NEW YORK NY FLYING TIGERS NL 12/10/87 FOUND AM241 FINDLEY OH PROFES$10NAL SERV INC 121694101 8/06/87 UNKNOWN '

AM241 HORSHAM PA COMDUSTRIAL ROOFING CONTR 372084801 7/23/86 Com WASTE AM241 PHILADELPHIA PA MATERIALS ENGINEERING TEST 291771301 10/20/87 UNKNOWN  :

AM241 ALEXANDRIA PA MEAD CORP GL UNKNOWN L AM241 FT WORTH TX GEARHART INDUSTRIES INC 420645803 2/05/87 FOUND j AM241 OAKTON VA ATEC ASSOCIATES OF VIRGINIA 451654602 6/12/87 UNKNOWN '

C14 M JO LAKE CA DEPT OF INTERIOR 040667407 7/27/87 LAKE I CD109 TROY MI GTE VALENITE CORP 271743601 UNKNOWN  ;

CS137 PINE BLUFF AR EDWARDS PIPELINE INC. 352319301 10/09/87 FOUND CS137 OCALA FL PENINSULA ENGINEERING & TES AS 3/16/87 UNKNOWN  !

CS137 LAKE CHARLES LA CITCO PETROLEUM CORP AS 3/16/87 UNKNOWN CS137 CINCINNATI OH KAHN'S AND COMPANY 341855701 2/06/87 FOUND i CS137 JAMES RIVER VA VIRGINIA HIGHWAY DEPT 451338001 1/21/87 UNKNOWN r

i H3 0FFSHORE I

SCHLUMBERGER 11/01/87 OCEAN H3 GEORGE AFB CA DEPT OF AIR FORCE 422353901 3/27/87 UNKNOWN H3 GLASGOW DE E I DU PONT DE NEMOURS & CO 070045538 11/24/86 FOUND i H3 HANSCOM AF MA DEPT AIR FORCE 420538404 12/01/86 UNKNOWN i' l H3 ATLANTIC C NJ TRUMP PLAZA GL UNKNOWN H3 SWARTHMORE PA SWARTHMORE COLLEGE 370695802 11/12/87 FOUND H3 SHEPPARD TX DEPT OF AIR FORCE 420583404 7/13/87 UNKNOWN H3 MCCHORD AF WA DEPT OF AIR FORCE 422353901 6/27/87 FOUND  ;

1125 ST LOUIS MO VETERANS ADMIN MED CNTR 240014405 1/08/87 FOUND r 1125 EDISON NJ JOHN F. KENNEDY MEDICAL CTR 291261101 10/17/87 FOUND j 1125 CINCINNATI OH UNIVERSITY OF ClNCINNATI 340690311 12/09/87 UNKNOWN  !

1125 MILWAUKEE WI LIXI INC 121821501 3/10/87 UNKNOWN i 1125 MADISON WI MADISON OSTEOPOROSIS CENTER 402448601 6/23/87 COMM WASTE 1125 FT ATKINSON WI NORLAND INSTRUMENTS 481340301 11/30/86 FOUND ,

IR192 WEST HAVEN CT VETERANS ADMINISTRATION M C 060009200 FOUND l IR192 MINNEAPOLIS MN UNIV 0F HINNESOTA 220018724 3/09/87 UNKNOWN I IR192 BILLINGS NT NORTHERN ROCKIES REG CANCER 251716302 8/29/86 UNKNOWN i IR192 FARMINGTON OH NL 7/17/87 FOUND IR192 HERSHEY PA MILTON S HERSHEY CORP 371387104 7/07/87 UNKNOWN KR85 FT TILDEN NY DEPT OF ARMY 290102211 10/07/86 UNKNOWN l KR85 FORT MCC0Y WI DEPT OF ARMY 290102211 3/14/87 UNKNOWN ,

i A-14  !

i

4 Table 4 (Continued)

(Part 1) i Lost or Stolen Sources, 1987 LICENSE EVENT FINAL ISO-LOCATION LICENSEE NUMBER ST E _ DISPOSITION TOPE l P32 NEVARK NJ RUTGERS UNIVERSITY 290518528 10/13/87 UNKNOWN

P0210 COLUMBUS IN COMO PLASTICS CORP GL 2/13/87 UNKNOWN NJ AT&T TECHNOLOGIES GL UNKNOWN I

P0210 CLARK NJ DATASCOPE CORPORATION Gl. UNKNOWN  ;

P0210 PARAMUS DECORATING RESOURCES INC GL UNKNOWN P0210 PITMAN NJ 00RRAN PHOTONICS GL UNKNOWN d

P0210 /.TLANTIC C NJ 5/09/86 NJ LEHIGH PRESS GL UNKNOWN

< P0210 PENNSAUKEN NJ MICROWAVE SEMICONOVCTOR GL UNKNOWN l P0210 SOMERSET WARNER-LAMBERT C0 GL UNKNOWN  :

P0210 MORRIS PLAIN NJ P0210 CEDAR KNOLLS NJ WARNER-LAMBERT C0 GL 5/01/65 UNKNOWN l

! P0210 WINCHESTER VA CAPIT0L MAGNETIC PRODUCTS GL 1/27/87 UNKNOWN PU MONTCLAIR NJ CLARA MAASS MEMORIAL HOSP OKT 70 5/14/85 l

PU WRIGHT PAT OH OEPT OF AIR FORCE 422353901 7/16/87 FOUND

  • I

! PU PA ABINGTON MEM. HOSP. OKT 70 7/16/85 2

PU BRISTOL PA LOWER BUCKS HOSPITAL DKT 70 9/06/87 I S35 BLACKSBURG VA VA POLYTECHNIC INST & STATE 450947530 12/23/86 UNKNOWN i

TC99M DETROIT MI SYNCOR INTER CORP 211718901 12/08/87 UNKNOWN I i TH232 KIRTLAND NM DEPT OF AIR FORCE 422353901 7/07/87 UNKNOWN [

UNK OFFSHORE CA BOOTHE-TWINING 041952201 6/25/87 OCEAN j i

UNK WASHINGTON DC MERGENTIME-PERINI 082793601 4/14/87 UNKNOWN i UNK ATTLEBORD MA GAMA DIAGNOSTIC LABS 201521501 8/19/86 CO M WASTE l 2/25/87 TX GEARHART INDUSTRIES INC 420645803 FOUND

! UNK FT WORTH UNK ELKINS WV KERMIT BUTCHER 47175640 2/01/87 FOUND f I

J f i  !

l

! I

( l 1

1 v

j  !

) O PACEMAKER INTERRED WITH BODY.

l A-15 l

Table 4 (Pirt 2)

Abandoned Well Logging Source Reports, 1987 l

ISO- LICENSE EVENT TOPE

  • LOCATION LICENSEE NUMBER DATE  :

AM241 LA ORESSER INDUSTRIES 420296401 7/26/1987 AM241 JOHNSON CTTY 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 l' 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 CAMPB[LL C WY WELEX HALLIBURTON 420106807 12/17/1987 AM241 0FFSHORE LA WELEX HALLIBURTON 4?0106807 6/07/1987 -

AM241 WESTERN ATLAS CORP 420296401 7/26/1987 l C060 CONVERSE C WY BAKER PACKER'S CS137 NORTH SLOPE AK SCHLUH2ERGER TECH 420009003 1/29/1987 CS137 WOODWARD C OK DAVIS GREAT GUNS LOGGING 152133201 2/14/1987 I CS137 CANAWHA WV GEARHART INDUSTRIES 420645803 7/04/1987 l

l l

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

l 1

l l

l 1

l l

1

{

A-16

Table 5 i

Reports of Leaking Sources, 1987 l l  !

LICENSE EVENT 150-l TOPE LOCATION LICENSEE NUMBER DATE MANUFACTURER I

i AM241 UPTON W G00 DWELL INC 491299401 9/15/1987 i 1 CS137 SACRAMENTO CA DEPT OF ARMY 040427901 4/24/1987 -

l 3

1125 DOWNERS GROVE IL LIXI, INC 121821501 5/14/1987 LIXI l l 1185 PHILADELP!A PA THOMAS JEFFERSON UNIV 370014806 4/07/1987 -

492353901 5/11/1987 - l 1125 LACKLAND TX AIR FORCE N!63 KANSAS CITY M0 AZTEC LABS 241752901 3/25/1987 l i

MI63 B0ZEMAN MT MONTANA STAT 8, UNIV 250032601 5/20/1987 VARIAN l 310024502 3/12/1987 i NIG3 PITTSBURGH PA UNIV 0F PITTSBURGH NI63 HANOVER NJ SANDOZ RESEARCH INST 290897802 11/11/1986 HEWLETT  !

PACKARD [

] PM147 WHITE SANDS NM DEPT OF ARMY 301235001 5/04/1987 [

l P0210 PHILADELPHIA PA GENERAL ELECTRIC C0 370200605 7/23/1987 3M STATIC i r

1 ELIM.

i, l t

! f l

i I i

I i

I k

l I

i i

A-17  ;

1 l

4 i i . _ _ . _ _ ..- _ - __ ___..___-...__l

5 1

2.1.4 Release of Materials i

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 iere no common causes nor generic problems for the release events

{ reported in 1987. I i

j 2.1.5 Consumer Products An additional category, "consumer preducts," was defined for the database in 1985. These reports describe events in which radioactive material was found 1 in, or had a reasonable probability for being introduced into, nonlicensed consurer products.

i j There were two reports received in 1987 in which radioactive material was i 1

found in, or had & reasonable probability of being introduced into, j nonlicensed consumer products. These were:

I --

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

l --

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

j 2.1. 6 Fuel Cycle Facility Event Reports

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

j! Two of the events ccncerned mills or milling, 17 concerned UF manufacture, and 6

i 11 occurred at fuel fabrication facilities.

i j Mills and Milling Events:

1 {

]

In previous years, low specific activity waste was deposited at an  !

j unauthorized site. Some 2000 cubic yards of material was deposited as fill.

j i

A contractor employee inadvertently drank a s:nall amount of tailings  !

] solution. Calculations of the exposure and bioassay data show no 1 i

overesposures resulteu from the intake, i j '

}

l

! *NRER database does not include information from fuel cycle licensee reports of '

I routine effluent releases.

1 l A 18 I i

l  !

i i i

UF Mant.f acturing Events: '

j 6 ,

4 Seventeen UF manufacturing events - six at the Allied Metropolis, Il plant (

) 6 l

and eleven at the Sequoyah Fuels Gore, OK plant were entered into the database '

j in 1987. Three of the events at Allied and three of the events at Sequoyah concerned defects or problems with the UF6 cylinders. The defects did not con-j 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 1

arm of a cart towing a cylinder of solidified UF6 disengaged because an employee had failed to lock the coupling. In a second event, a small amount of UF6 **' l released whan 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 UF6 ' f some of which was liquid, wss being towed in a buggy across a railroad spur o.1 ,

the site. A rail tank car containing HF was being moved on the track. The 1

! 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 Jevice at the railroad l

spur. This event could be considered a precursor, since there might have been l some releases of UF t the atmosphere if the train had damaged the cylinder, j l 6 i

The extent of the potential release was not determined. The action proposed by f i

the licensee appears, however, to reduce significantly the probability of an l accid 1nt on the railroad spur. l J  :

9  :

Events at Sequoyah Fuels Gore OK plant

I i

l Hone of the eight operating events at the Gore plant that were entered into the I I database had any significant impact on the public health and safety. Three cf the events concerned equipment that did not contain radioactive materials; one  !

event concerned surface contamination of full face respirators; and four events l 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 t  !

l l

when a fill line was being evacuated. Surveys confiroed 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 r i

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 1

the cylinder was being rotated and about 40 gallons of solution spilled. The t contaminated area was cemented over, Uranium Fuel Fabrication Events:

' In an eveht at Advanced Nuclear Fuels Corporation, a steam lance failed and f

)

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 7 i

I I

There were three events reported at a Babcock and Wilcox facility. There was a leak in a drain line that permitted contaminated liquid to spill on the ground; a three employees wearing full face respirators were exposed to uranium dust whr

! they were pouring it into a bucket; and the evacuation alarm switch was tur +1

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

criticality signal, i i

There were two events at a Combustion Engineering facility. A broken '.huttle box resulted in two operators beir.g exposed to higher than normal concentrations of i

, uranium; and uranium contamination was discovered in an unrestricted area.  ;

In an event at the General Electric Morris fac " "y (storage of spent fuel), an I i

individual was contaminated when he inadverter. v oved a pipe cap from a y drain valve when it was open.  !

There were two events at Nuclear fuel Services nat were entered into the database in 1987. In one, nitrogen service to operaung equipment was interrupted, ,

i resulting in a series of small explosions when air replaced the nitrogen and j mixed with the hydrogen blanket on some of the equipment. A water line broke during recovery from the event and resulted in the accumulation of water in the l furnace pits. The explosiuns resulted in some equipment damage.

t In the second event at NFS, a scrap furnace exploded when combustible liquid

) was being processed. The furnace temperature was high enough to volatilize ,

l material but not high enough to ignite vapors. A ventilation failure resulted l

] from blockage of the ducting by solids.  !

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 determirad that a saw blade ignited some uranium chips by friction, the uranium i

chips in turn igniting the zirconium chips, i I

Westinghouse shipped a drum of waste that contained byproduct material and that i contained detectable standing liquid, j

2.1.7 Radiography Fifteen 1987 events involved radiography, all but one of which occurred at remote '

(fleid) radiography sites or during transportation. Information on the reported events is included in Table 6. t 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 differ subatanticily from the number of evehts reported during prior years. [

although there were fewer events reported that concerned real or potential i 2

overexposures,

)

2.1. 8 Manufacturing and Distribution Seventeen 1987 events (Table 7) were identified as being associated with manu-1 facturing and distribution from the program code 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.

]

A-20 I

i

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

  • TOPE LOCATION CS137 PINE BLUFF AR EDWARDS PIPELINE INC. 352319301 10/09/1987 LAS IR192 H & G INSPECTION 422683801 2/01/1987 EXP ID IDAHO NATIONAL ENGINEERING MAD IR192 IDAHO FALLS IR192 HANNIBAL M0 PTL-INSPECTORATE INC 370027625 2/09/1987 EXP ,

IR192 PORT READING NJ CONSOLIDATED NDE 292145201 6/08/1987 EXP i IR192 PENNSAUKEN NJ EASTERN TESTING & INSPECTION 290981401 4/03/1987 MSC NJ EASTERN TESTING & INSPECTION 290981401 10/26/1987 TRS IR192 HIGHTSTOWN IR192 FARMINGTON OH NL 7/17/1987 LAS IR192 NEWPORT NEWS VA AMERSHAM TECH-C?S 201283601 10/21/1986 MAD  !

IR192 YORKT0WN VA DEPARTMENT OF NAVY 311792801 2/18/1987 MAD i IR19? NEWPORT NEWS VA NEWPORT NEWS SHIPBUILDING 450942802 1/09/1987 EXP Z OFF SHORE CA BOOTHE-TWINING 041952201 6/25/1987 LAS Z SAN LEANDRO CA U S TESTING C0 INC 042324001 2/13/1987 MSC Z KS H. R. INSPECTION SERV, INC 150620901 8/05/1987 EXP 1 OK GLOBE X-RAY SERVICES INC 351519401 1/25/1987 MSC QTYPE EVENT EXP EXPOSU;E LAS LOST, ABANDONED, STOLEN SOURCE MAD MANUFACTURING AND DISTRIBUTION MSC MISCELLANEOUS TRS TRANSPORTATION l

i i

l l

A-21

- ' - - - ------v --

Table 7 Manufacturing and Distribution Events, 1987 150- LICENSE EVENT TYPE TOPE LOCATION LICENSEE NUMBER DATE EVENT

  • AM241 UPTON NY G00 DWELL INC 491290401 9/15/1987 LKS CS137 SACRAMENTO CA DEPT OF ARMY 040427901 4/24/1987 LKS CS137 E CHICAG0 IN INLAND STEEL COMPANY 130308603 10/25/2033 GAU 1125 LACKLAND DEPT OF AIR FORCE 422353901 5/11/1987 LKS 1125 DOWNERS GROVE IL LIXI, INC 121821501 5/14/1987 LKS 1125 PHILADELPHI A PA THOMAS JEFFERS0il UNIVERSITY 370014806 4/07/1987 LKS 1125 MILWAUKEE WI LIXI INC 121821501 3/10/1987 LAS 1125 FT ATKINSON WI NORLAND INSTRUMENTS 481340301 11/30/1986 LAS IR192 NEWPORT NEWS VA AMERSHAM TECH-OPS 201283601 10/21/1986 RAD M099 GAITHERSBURG MD DEPT COMMERCE BUR STDS 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 NI63 HANOVER NJ SANDOZ RESEARCH INSTITUTE 290897802 11/11/1987 LKS NI63 PITTSBURGH PA UNIV 0F PITTSBURGH 370024502 3/12/1987 LKS PM147 WHITE SANDS NM DEPT OF ARMY 301235001 5/04/1987 LKS P0210 PHILADELPHIA PA GENERAL ELECTRIC COMPANY 370200605 7/23/1987 LKS Z WASHINGTON DC MERGENTIME-PERINI 082793601 4/14/1987 LAS
  • TYPE EVENT GAU GAUGE LAS LOST, ABANDONED, STOLEN SOURCE LKS LEAKING RAD RADIOGRAPHY TRS TRANSPORTATION l

A-22

I 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 Zn 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 j overexposures and associated evaluations that were not reported to NRC. The ;

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

j A-23

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

  • AM241 EAST WINDSOR CI HENRY SOUTHER LABORATORIES 062078501 MSC GAU t AM241 DETROIT MI NEYER TISE0 & HINDO, LTD 211489401 LAS  !

AM241 FINDLEY OH PROFESSIONAL SERV. INC 121694101 LAS AM241 HORSHAM PA COMDUSTRIAL ROOFING CONTR. 372084801 MSC GAU LAS AM241 EMIGSVILLE PA COMMONWEALTH OF PENN. 370667701 MSC GAU AM241 PHILADELPHIA PA MATERIALS ENGINEERING TEST. 291773301 LAS AM241 PR REDONDO CONST C0 522483401 GAU AM241 OAKTON VA ATEC ASSOCIATES OF VIRGINIA 451654602 LAS AM241 STEELING VA S0IL CONSULTANTS INC 451520002 MSC GAU AM241 UPTON NY G000WELL 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 COLUMBUS 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

, 1125 DOWNERS GR0VE IL LIXI, INC 121821501 LKS IR192 HANNIBAL M0 PTL-INSPECTORATE INC 370027625 PAD 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 80ZEMAN MT MONTANA STATE UNIVERSITY 250032601 LKS NI63 HANOVER NJ SAND 0Z 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 CTYPE EVENT EXP EXPOSURE GAU GAUGE LAS LOST, ABANDONED OR STOLEN SOURCE LKS LEAKING SOURCE MSC MISCELLANE0US RAD RADIOGRAPHY 4

A-24

The Agreement State ebnor.aal occurrence events involved: 1 1

-- breakdown in management and proced'.mo controls at an industrial radiography licensee. 1ho A0 involved the same licensee as the last A0 listed abovt for the NRC iicensees 1

breakdown in management and procedural controls at an industrial radiographj licensee radiographer overexposures

-- contamination of hospital with iodine-131 The first A0 listed above for agreement states involved the overeAposure 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 180 rem to the lef t and right hand respectively. An assistant radiographer received smaller doses: L 3.4 rem whole body, 6 rem to the lens of the eye, and 20 rem tc tha 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.

1 L

I I

i 1

l l

( 1 l

r A-25 l '

t n

l t

APPENDIX B  ;

i MEDICAL MI5 ADMINISTRATION REPORT  !

MEDICAL MISA0 MINISTRATIONS REPORTED TO NRC '

FOR THE PERIOD JANUARY 1987 THROUGH DECEMBER 1987 ,

i i

4 J

4 1

l I

L 4

J

) l

,, -,-y --e..-.-,- m-- -,--r----y-..-,--mgw-- - -- ------c - - - = - ---.- ----- w,- -o,. < - -rwre- -wv-w ---wr- -- ---- ---- __

APPENDIX B AE00/N802 MEDICAL MISADMINISTRATION REPORT MEDICAL MISADMINISTRATIONS REPORTED TO NRC TOR THE PERIOD JANUARY 1987 THROUGH DECEMBER 1987 l by the Office for Analysis and Evaluation of Operational Data Nonreactor Asessment Staff ,

I i

1 Prepared by:

Samuel L. Pettijohn ,

l P

i B-3 t i  !

l t

TABLE OF CONTENTS

.P.aage

1.0 INTRODUCTION

........................................................ B-7 2.0 THERAPY AND DIAGNOSTIC MISADMINISTRATIONS REPORTED TO NRC IN 1987.... B-9  !

2.1 General ........................................................ B-9  ;

2.2 Therapy Misadministrations ..................................... B-9 i 2.2.1 Teletherapy Mis;dminir,trations .......................... B-10 2.2.2 Brachytherapy Hisadministrations......................... B-11

2. 3 Diagnostic Misadministrations .................................. B-12 ,

2.3.1 Iodine Misadministrations ............................... B-12  ;

2.3.2 Diagnostic Misadministrations Involving the Mislabeling of Radiopharmaceutical Doses by Radiopharmacies . . . . . . . . . B-13 3.0 LICENSEE PROPOSED CORRECTIVE ACTIONS ................................ B-14 r l 4.0 FINDINGS AND CONCLUSIONS ............................................ B-14 I

I J

B-S i

1

___ _ l

MEDICAL ADMINISTRATIONS REPORTED TO NRC FOR THE PERIOD JANUARY 1987 THROUGH DECEMBER 1987

1. 0 INTRODUCTION This is the seventh annual report documenting AE0D's review of medical mis-administrations involving radiopharmaceuticals r radiation from radioisotopes regulated by NRC* that were reported to NRC. a list of previous AEOD 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 1

(f) a therapeutic radiation dose from a sealed source such that errors in the source calibration, time of exposure, and treatment geometry result in a calculated total treatment dose differing from the final prescribed total treatment dose by more than 10%.

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 in radiation therapy.

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

  • i of the event. '

i I

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

B-7 <

l

- ---, , , - . - - , - , - , - - - , - , ,c --.--- . - , - . - - , . - - , - - - . . -- . ,.- --.

Regarding the frequency of events over the seven year period, there were 31 therapy mi> administration 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 reported 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 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 administration nf therapy amounts of radioisotopes (e.g., I to 5 mci of iodine-131 administered for a whole body iodine scan). Most diagnostic mis-administration reports are reviewed from a collective or statistical viewpoint.

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 sections: Therapy and Diagnostic Misadministrations Reported to NRC; Licensee Proposed Corrective Actions; and Findings and Conclusions.

)

I l

a B-8

2.0 THERAPY AND DIAGNOSTIC MISADMINISTRATIONS REPORTED TO NRC IN 1987 2.1 General 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 198/. 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 oindministrations, and 9 (2%) reported therapy misadministrations.

Table 1 Medical Hisadministrations 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 licensees reporting misadministrations 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 es the average number reported annually in 1981-1986 (7 reports). '

Table 2 Misadministration Reports for 1981-1987 Year 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 cf Patients 517 451 437 442 410 495 459 No. of Licensees Reporting 351 355 293 318 293 369 348 2.2 Therapy Misadministrations Nine therapy misadministrations were reported in 1987. Six of the misadmini-strations involved teletherapy, and three involved brachytherapy. Table 3 presents data on the type and probable cause of the misadministrations.

B-9

1 l

l l

Table 3 Type and Probable Cause of Therapy Misadministrations 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 1 Technologist misread the treatment time 1

Dose different from prescribed by > 10%

(Brachytherapy) l The wrong activity brachytherapy sources were used 1 i The incorrect number of brachytherapy sources were used 1 i A leaking iodine-125 source was used in a brain therapy I implant 1

l j 2.2.1 Teletherapy Misadministrations Three of the therapy misadministrations involved errors in either dose calcula- I tions or errors in calculating the treatment time. In one case, data from the 1 wrong teletherapf unit was used in the dose calculations. The treatment p;4nni1g i 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 after the completion of the tredtment. In the last case, although the dose calculations were done correctly, en error was made in transposing this information to the patient's chart resulting in the wrong treatment time being used. The 1987 teletherapy misadministrations had about the same relative fraction ascribable to errors in dose calculations as teletherapy misadministrations reported to NRC over the 1981-1986 period. The AE00 evaluation of the above teletherapy errors indicates that redundancy in l 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 previous therapy for current therapy markings. In the other case a technologist placed treatment marks on the patient's left hfp when the treatment was prescribed for the right hip. Another icchno'ogist used the treatment markings to administer two of 12 treatments before the error was discovered. Prior to the third treatment the patient informed the technologist that the wrong hip i was being treated. Although the specific causes identified for these two 1987 l misadministrations were different from one another, it is believed that a check of the prescription for the therapy before administering the therapy would have l shown the error.

I B-10 ,

I

! Tha remaining teletherapy misadministration resulted from the technologist  !

inisreading the treatment time. A treatment time of 1.67 minutes was mitread 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 iodint-125 {

brachytherapy source.

', l 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-4 scribed treatment. The patient received a radiation dose of approximately 50%

of the prescribed dose,

, In the second case, sources with an ac4 vity of 65 mg radiur equivalent were loaded into the source applicator wheri.ds the prescribed activity was 55 mg radium equivalent. The patient received a radiation dose of 2500 rads instead of 2000 rads as prescribed. i

, 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 mil 11 curies 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 thert 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 i catheter. This misadministration was similar to a misadministration that was i reported to NRC in 1984. AE00 performed a case study of that event which is documented in AE00 report AE0D/C601.

As a result of the case study, AE00 made three specific recommendations for pre- i ventirig the occurrence of this type of misadministration. Two of them were ~

implemented in 1937 (see Appendix E on AE00 recommendations): HRC sent an infor-  ;

mation notice to affected licensees informing them of the circumstances of the i event that occurred at the University of Cincinnati; and the 3M Company, the '

iodine-125 seed manufacturer, now provides specific instructions to users on j safety precautions for using the seeds. The AE00 recommendation that the  :

Office 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.

TN licensee associated with the event indicated that the event was discovered l i 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.

l i B-11 l

2. 3 D g r.ostic Misadministrations Of the 414 reports of diagnostic misadministrations received in 1987, 341 in-volved 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 type.a). The remain-ing diagnostic misadministrations involved 15 reports 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.

Effectively, all of the diagnostic misadministrations involving the wrong radiopharmaceutical or the wrong patient stem from human error.

The primary errors associated with tb administration or 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 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 l -

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 failure of the technologist to assay the patient's dose before administration cr the misinterpretation of the physician's order for the study.

l 2.3.1 Iodine Misadministrations f Although most of the diagnostic misadministrations involved the wrong technetium-99m i

compound, five diagnostic misadministrations involved the administration of j therapy-equivalent doses of loaine-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 thyroid uptake study or scan is 30 microcuries of iodine-131, or 5 to 10 millicuries of technetium-99m. The "fodine-131 whole body scan" is the only diagnostic study where this large amount of iodine-131 is used.

1 The radiation dose to a patient is significantly higher if he is administered '

a therapy-equivalent dose of iodine-131 ine,tead of a prescribed diagnostic dose B-12

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; t.

five millicurie dose of iodine-131 can produce a dose of 4000-9000 rads to the thyroid.

In 1987, AEOD 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). I

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 I to refer to different procedures j l

lack of technologist training I l lack of procedures failure of technologist to follow procedure.

l

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 misadministratior.s could likely have been prevented, despite the errors that icd 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, AE00 made the following suggestions which j were implemented by NMSS:  ;

1 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.

NMSS 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 dosay range for the radiopharmaceutical.

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

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 MDP**. 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 undergoing a bone scan the material was found to have accumulated in the patient's kidneys and bladder.

DTPA is used for renal scanning.

A notable observation regarding this event is that the delay in discovering the mislabeling was '.ikely influenced by the fact that the mislabeled doses were thought to be technetium-99m MDP, a bone scan agent, which normally is injected about two hours before the patient is scanned. For misadministrations involving the wrong radiophermaceutical and multiple patients (about 6% of the diagnostic misadministrations reported) about 85% 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 licensees were: the retraining of personnel; implementing new radiopharmaceutical labeling and handling procedures; implementing r.ew 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 effective 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 from 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 i

"technetium-99m diethylenetriamine pentaacetic acid

    • technetium-99m medronate sodium B-14

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 misadministra';ons involving the adminis-tration of millicurie amounts of iodine to patieits, the primary cause was the failure of licensees to exercise adequate control over the administration of millicurie amounts of iodine-131 to patients.

l

\

l l

B-15


- - , - - - - - , - - - - - - - , - - - - - - - - - - ~ - - - - - - - - - - - -

APPENDIX C

SUMMARY

OF 1987 ABNORMAL OCCURRENCES

Abnormal Occurrences CY 1987 Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description 87-1 NRC Order Suspends Vol. 10, No. 1 A-10 On March 31, 1987, the NRC issued an Order Power Operations and Suspending Power Operation and Order to of Peach Bottom A-11 Show Cause (Effective Immediately) to Facility Due to Philadelphia Electric Company. The Order Inattentiveness directed the licensee to r' ace Peach Bottom of the Control Unit 3, operating at about 100% power at the Room Staff time, in (.old shutdown (Unit 2 was already in cold shutdown for refueling) and maintain both j

' 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 licensed operators, senior licensed operators,

?

w and shif t 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 I l

duty or failure to adhere to procedures on the part of licensed operators in the control room at Peach Bottom. ll 87-2 Diagnostic Vol. 10, No. 1 G In a January 6, 1987 letter, Allegheny Valley Medical 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 ,

_ _ _ .__.__ ____ _ . _ _ _ _ . - _ - _ _ _ _ _ . _ . __ _ __ .__ __m . . _ _ _ . _ _ _ _ _ - _ _ _ _ _ _ _ _ .- _.- -

)

Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion i A0 # Title of A0 NUREG-0090 or Example Event Description i

1 87-2 (Continued) wall, 25 rads; thyroid, 13 rads; intestinal

wall, 6-7 rads; and bladder wall, 5 rads.

j These doses are about five times those which a would have been expected had the prescribed a

doses been administered. No significant j health effects are expected by the licensee.

i i 87-3 Diagnostic Vol. 10, No. 1 G On January 21, 1987, NRC Region IV was notified Medical by St. Anthony Hospital, Oklahoma City, Okla.

3 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

? dose of about 1490 rads. This may result in a e small increased risk cf reduction in thyroid function, and a small 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 j Misadministration February 19, 1987 a patient referred to the

Nuclear Medicine Department of the University I of Massachusetts Medical Center in Worchester, I

Mass., received a 5.5 millicurie dose of iodine-3 131 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 l effective half-life, the licensee estimated that j the radiation dose to the patient's thyroid was 730 rads and the total body dose was 3

1.7 rads. The effect on the thyroid, if any,

) would be of no importance because prior to the i event, the patient was scheduled for a thyroidectomy to be performed in March.

i N __ . - . - - - -- - - - - - - -

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 violations 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

? 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 Admir.istration Medical Center, Misadministration Boise, Idaho, that on April 1, 3987, 400 microcuries of I-131 was administered to an adult male for a total body scan; co 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, respectively. The physician user evaluated the exposure and concluded that the irradiation posed a small, but still significant, risk of reduction in thyroid function.

Abnormal 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 and Con- posed Imposition of Civil Penalties to Grede trol of Radiation Foundries, Inc., Milwaukee, Wis. This action Safety Program at was taken after an October 1986 inspection an Indt.strial 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-7 tion of NRC requirements and contrary to the e 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, 1987, the NRC issued an Order down of Manages.ent Temporarily Sus;,ending License (Effecti .e 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 .adiog-raphy while later he admitted to an investi-gator that he had. These actions indicated a

~

Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion l l A0 # Title of A0 NUREG-0090 or Example Event Description l 1

87-8 (Conti *ed) disregard for requirements and lack of reason- l able assurance that the licensee could be l trusted in the future.

AS87-1 Breakdewn in Vol. 10, No. 1 A-11 On February 17, 1987, the Arizona Radiation Management and Regulatory Agency issued an ordar to U.S. Test-Procedural Controls ing Company, Unitech Services Group, San at an Industrial Leandro, Cal., to cease all radiographic Radiography Licensee operations within the state of Arizona. The (Agreement State order was issued based on the findings of an Licensee) inspection performed on February 6 and 7, 1987, to investigate the circumstances associated with two employeer (a radiographer n and an assistant radiographer) of the licensee O 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 On February 27, 1987, an Emergency Order Management and suspending all radiographic operations was Procedural Controls issued by an inspector for the California at an Industrial Department of Industrial Relations to Radiography Cuntinental Testing and Inspection (CTI),

Licensee (Agree- 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.

  1. \ O s - x

Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description 87-9 Diagnostic Medical Vol. 10, No. 2 G On January 21,1987, a 66 yea:-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 to 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 S' a radiotherapy administration of 600 rads to

  • the lumbar spine area, which was not tne prescribed treatment site. The patient's referring physician and radiotherapist con-cluded that the dose would have no detrimental clinical effect 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, NRC 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 prescribea radio-pharmaceutical, 10 millicuries of gallium-67 citrate. The patient experienced no adverse effect 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.

a Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # Title of A0 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 Mferd 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 1icensee'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.

? On June 17, 1387, the NRC issued an Order

  • 87-13 Significant Break- Vol. 10, No. 2 A-ll i

l down in Management Modifying License (Effective Immediately) to and Procedural Con- 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 Agreement States to perform industrial radiog-raphy. In-depth special safety inspections identified numerous radiation safety viola-tions, including (1) allowing individuals to perform radiography after failing 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. f 1

Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description AS87-3 Radiographer Over- Vol. 10, No. 2 A-1 On December 9,1986, an industrial radiographer exposures (Agree- and a radiographer's assistant, employed by ment State Licensee) Northwest X-ray, Idaho Falls, Idahu, received overexposures while performing radiography in a multi-level hot cell at the Chemical Process-ing Plant at the Idaho National Engineering Laboratory (INEL) near Idaho Falls.

The assistant received a documented exposure of 3.4 rem whole body, and INEL-estimated ex-pasures of 6 rem to the lens of the eye, 5 rem to the left hand, and 20 rem to the right

,, hand. The radiographen received documented g, exposure of 7.8 rem whole body and INEL-c) estimated exposures of 50 rem to the lens of the left eye, 70 rem to the lens of the right eye, and entrance doses of 2000 and 1700 rem to the left and right hands, respec- l 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 months.

87-14 Significant Degra- Vol. 10, No. 3 8-5 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 hsd a loss of coolant accident (LOCA) occurred. 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

t Abnocmal 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 bycass of the suppression chamber, potentially resulting in containment over-pressurization for small, interneciate, 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 At approximately 6:35 a.m. on July 15, 1987, Tube Rupture at North Anna Unit I was manually tripped . rom

- North Anna Unit 1 100 percent power d e 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 caase was found to be due to fatigue.

It is estimated that a total of 1.59 X 10 1 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 than 1% of Technical Specification limits.

I J

}

{ Abnormal Occurrences CY 1987 (Ccntinued)

! Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description J

! 87-15 (Continuad) The primary-to-secondary leak in this event j was estimated to be between 550 to 637 gallons j per minute (gpm). The North Anna Updated Final l Safety Analysis Report estimated that a double- '

! ended rupture of a single tube at full power would result in a flow rate of 710 Spm. The

]

highest flow rate in the 1982 S/G tube .upture i 1

at Ginna was estimated to be 760 gps.

l This event was investigated by an NRC Augmented j Inspection Team.

l n 87-16 Therapeutic Vol. E0, No. 3 G On August 24, 1987, the NRC was r.otified that 4 Medical Misad- a 75 year-old patient at Parkview Memorial N ministration Hospital, Fort Wayne, Ind., received two '

therapeutic radiation exposures to the wrong

, part of the body. The patient was scheduled l to receive radiation therapy exposure of

250 rads per exposure per day to the right l hip, for a total of 3000 rads. However, two ,

exposures of 250 rads each was administered l before it was discovered that the left hip l was being treated instead of the right hip. .

j The patient was examined by a physician and no [

medical side effects were noted as a result of l the misadministration.

i l

i.

}

l l 2

3 i 1 i

2

...--___..--._c._, - , , , -- - , , - - , - - , ,a--_. -__ . , . _ _ _ _ _ _ _, _ _ , , , _ _

Abnormal Occurrences CY 1987 (Continued)

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

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

An NRC investigation determined that the Assistant Chief Physician of the Hospital's e,

Nuclear Medicine Service: faileo to ensure 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 investigation 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

_ _ _ _ _ _ --_ _ . _ _ _ _ _ _ _ __ _ .._ - - _ _ __ ._ _ . _ . . _ _ . - __ ._ _-.- ~. -

! i Abnormal Occurrences CY 1987 (Continued)

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

, l 87-18 (Continued) possession of sealed radioactive sources. I I 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 alsc l that he had used the sources after June of 1986.

Subsequently, in response to the licensee's [

request, the NRC is terminating the license.

i 87-19 Suspension of an Vol. 10, No. 3 A-11 On September 21, 1987, the NRC issued an  !

<? Industrial Radiog- Order Suspending License (effective immediately)  ;

3 raphy Company's to Finlay Testing Laboratories, Inc., Aiea, L License Hawaii. The Order required the licensee to l 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 I contrary to NRC and DOT regulations, licensee l employees had placed a radiographic exposure i

' desice 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.

t

j Abnormal Occurrences CY 1987 (Centinued) .

Report No. A0 Criterion A0 # Title of A0 NUREG-0090 or Example Event Description 4

AS87-4 Hospital Contami- Vol. 10, No. 3 A-11 and G On the morning of June 2,1987, an 87 year old nation Incident 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 l metastatic thyroid carcinoma. The patient had i had a total thyroidectomy in April 1987, and l l had a gastrostomy tube and a folev catheter in i

place. On the evening of June 3, .387, 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 i patient had a cardiopulmonary arrest and expired. During an attempt at resuscitation

,, in the patient's room by sixteen staff members,

, ,L which included insertion of a pacemaker, con- .

1 o' taminated blood and Grine were spilled and no  :

surveys of the clothing of thcse present were done. i Even though the contamination was extensive, ,

subsequent thyroid bioassay showed no uptakes  !

by involved staf f, and the highest personnel l monitoring badge readirq was 30 millires for one of the nurses.

1

AS87-5 Therapeutic Vol. 10, No. 3 G On August 5,1987, the New York State Depart-

, Neoical Misadmin- ment of Health, Bureau of Environmantal  ;

) istration Radiation Protection (State Agency) was i notified of a series of therapeutic medical ,

i misadministrations to patients at Northern l Westchester Medical Center, Westchester

! County, New York.

I i

i

1 1

i Abnormal Occurrences CY 1987 (Continued)

Report No. A0 Criterion A0 # Title of 30 NUREG-0090 or Example Event Description

! AS87-5 (Continued) 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.

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

The largest error found was an administered dose that was abcut 2.4 times the prescribed

! dose. Some patients receiving overtreatments

! had exhibited physical symptoms apparently due I to the exposures.

o O

87-20 Suspension of Vol. 10, No. 4 G On October 30, 1987, the NRC issued an Order

'l License of an Suspending License (Effective Immediately) and j Oil and Gas Well Order to Show Cause why the license should not Trae.er Company be revoked to Tracer Profiles, Inc. , of Oklahoma

- City, Okla.

During March 1987, several violations of NRC requirements were found. Contacts with the company to satisfactorily resolve the viola-tions were not successful. Subsequently, it was found that the company vacated its offices and moved to a new and unknown location with-out notifying the NRC. Therefore, the NRC is considering action to revoke the license.

APPENDIX D  !

LISTING OF AEOD NONREACTOR REPORTS 1980-1987 f

I l

't

t NONREACTOR REPORTS ISSUED IN 1987 Special Study Reports Date Subject No.

Author 1

10/87 Radiography Overexposure Events Involving S703 S. Pettijohn Industrial Field Radiography I

Engineering Evaluations

~

Date Subject No.o Author i 1/87 Diagnostic Misadministrations Involving N701 S. Pettijohn i

) the Administration of Millicurie Amounts l j of Iodine-131 l

) 3/87 Diagnostic Misadministrations Reported N702 S. Pettijohn to NRC for the Period January 1985 Through }

i December 1986  :

)  ;

i 3/87 Report on 1986 Nonreactor Events N703 K. Black i i,

f t

l l NONREACTOR REPORTS ISSUED IN 1986  !

Case Studies  !

I 1 Date Subject g. Author 8/86 Rupture of an Iodine-125 Brachytherapy C601 S. Pettijohn Source at the University of Cincinnati ,

Medical Center t

! I I

i l [

1 l [,

l D-3 l

NONREACTOR REPORTS ISSUED IN 1985 Case Studies Date Subject M. Author 12/85 Therapy Misadministrations Reported to C505 5. Pettijohn NRC Pursuant to 10 CFR 35.42 Engineering Evaluations Date Subject g. Author 5/85 Summary of the Nonreactor Event Report N501 K. Black Data Base for the Period January-June 1984 1 6/85 Summary of the Nonreactor Event Report N502 K. Black Data Base for the Period July-December 1984 7/85 Report on Medical Misadministrations for N503 S. Pettijohn January 1984-Decemiser 1984 t

l NONREACTOR REPORTS ISSUED IN 1984

! Case Studies Date Subject g. Author l

} 9/84 Breaching of the Encapsulation of Sealed 1405 S. Pettijohn l

Well Logging Sources ,

f 4

j 1

NONREACTOR REPORTS ISSUED IN 1983 l t

Nonreactor Engineering Evaluations Date Subject M. 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 D-4

1 NONREACTOR REPORTS ISSUED IN 1982 i

Engineering Evaluations Date Subject No. Author 1

l 2/82 Report on Medical Misadministrattuns for N201 S. Pettijohn 1 the Period November 10, 1980 - September 30, j 1981 1/82 Buildup of Uranium-Bearing Sludge in Waste N202 K. Black Retention Tanks 2/82 Lost Plutonium - 238 Source N203 K. Black i 3/82 Report on Medical Misadministrations for N204 S. Pettijohn j CY 1981 i

l 4/82 Preliminary AE00 Review of Iodine-125 N205 E. Trager  ;

Sealed Source Leakage Incidents i 5/82 Eberline Instrument Corporation - Part 21 N206 K. Black j Report a

) 5/82 AE00 Review of Iodine-125 Sealed Source N207 E. Trager i Leakage Incidents t

, 8/82 Potentially Leaking Plutonium-Beryllium N208 S. Pettijohn I Neutron Sources l  ;

i i i f i NONREACTOR REPORTS ISSUED IN 1981  !

i t

i  !

Engineering Evaluations l

, Date Subject No.

Author 1 (

l 3/81 Interim Report on Brown Boveri Betatron N101 E. Trager  !

Calibration Check Source i l  !

1 3/81 Irradiator Incident at an Agreement State N102 K. Black ,

l Licensee's Facility (Becton-Dickinson, (

Broken Bow, Nebraska) 6/P1, Interim Report on the October 1980 Fire N103 E. Trager r l at the Sweetwater Uranium Vill l

I 0-5 I

NONREACTOR REPORTS ISSUED IN 1981 (Cont'd)

Engineering 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. Tiager Liner Failure at the Sweetwater Uranium Hill 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 I

l L

l 0-6

APPENDIX E i

! STATUS OF .

AE00 RECOMMENDATIONS I 1,

I I

l I '

r l

.i i

I I II

STAlVS 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 hes been repeated in this appendix for convenience.

AE00's tracking system ensures that all formal AE00 recommendations are tracked until resolution is achieved. At this time, there are no issues involving AEOD 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 AE00 suggestions contained in engineering evaluations and special reports. These AE00 suggestions are not formally tracked or closed out by AEOD.

E-3

, Attachment E AE00 RECOMMENDATION TRACKING SYSTEM Qutstanding f.ecommendations" REC 0mENDATION j SOURCE: Case Study AEOD/C601 Responsible AE00 Engineer: S. Pettijohn 3 TITLE OR

SUBJECT:

"Rupture of an lodine-125 Brachytherapy Source at the i University of Cincinnati Medical Center" RECOMENDATION 2 j HMSS 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 3 0FFICE/DIV/BR CONTACT PRIORITY 1 NMSS/IMNS/AB V. Miller N/A f STATUS j T

Resolved. 3M Company, the manufceturer 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.

RECOMEN0ATION 3 NMSS should consider evaluating during the license issue, renewal, or  :

. amendment process licensee procedures for reusing high activity iodine-125 i j seeds in treating multiple patients. [

! RESPONSIBLE  !

0FFICE/DIV/BR CONTACT PRIORITY f i

! NMSS/IMNS/AB V. Miller N/A l I f 1 STATUS  !

.i Under consideration by NMSS.  ;

t 4

f i *In each case the recommendation numbers have been carried forward from the <

original document.

T l

E-4 1

RECOMENDATION SOURCE Case Study AE00/C505

} Responsible AE00 Engineer: S. Pettijohn

{

TITLE OR

SUBJECT:

"Therapy Misadministrations Reported to the NRC Pursuant to 10 CFR 35.42" RECOMMENDATION 2 NHSS 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 snd independent verification of tne activity of brachytherapy -

sources before the sources are implanted. )

! RESPONSIBLE  ;

j OFFICE /DIV/BR CONTACT PRIORITY l l'

NMS$/IMNS R. Conningham N/A i STATUS i  !

l Resolved. This reconnendation has been addressed in current rulemaking on i j quality assurance for radiotherapy facilities, "Basic Quality Assurance in i

) Radiation Therapy." l i

REC 0fENDATION3 o 10 CFR Part 35.21 shoJld be anended to include the calibration of beam i modifiers such as wedge filters, shaping filters, trays, etc. l RESPONSIBLE l OFFICE /DIV/BR CONTACT PRIORITY  !

I j NMSS/IMNS R. Cunninghan N/A i i i STATUS Resolved. This recommendation has been addressed satisfactorily in the  !

I current rulemaking on quality assurance for radiotherapy facilities, "Basic  !

j Quality Assurance in Radiation Therapy."  !

]  !

1  !

I i

i l

l l

i j E-5 4

l I

I RECOMMENDATION SOURCE: Case Study AE00/C505 (Continued)

Responsible AE00 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 Recommer.dation 3.

l l

E-6

g,.,, . . . . ~c m . .m . .. ..,.~-,m,,.~.,-

@,"i# BIBLIOGRAPHIC DATA SHEET NUREG-1272 se i ,..e,,o s o ,. . . . . Vol . 2. fio. 2

,,,i6i..u.... a 6 ..e 6...

Report to the U.S. Nuclear Regulatory Commission on Analysis and Evaluation of Operational Data - 1987 , ,,,,,,,,,, ,,,,,,,

Nonreactors y, , , ....

...-o... September 1933

. 0. i i . . .O.1 i. A i O

.x , . ,i..

October 1988

, . . . .. . w o. 2. . , . i .o % . . . . o . . . . c o. i i. .. .. i. e , . ..wices... .o.....i. - ei.

Office for Analysis and Evaluation of Operational Data ,,,,, g .,,, , ,,,

U.S. Nuclear Regulatory Comission Washington, DC 20555

.. o. . o. o o. . .. ,4. . .n . . .. . . . . +.. . oo. . . . e. t . ii. ...... .o.i h ual Same ac 7. aboye. . re.4.co.......

CY 1.987

, i .. . . . c i .u .

This annual report of the U.S. Nuclear Regulatory Comission's Office for Analysis 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 coments 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 information from Licensee Event Reports, the NRC's Operations Center, and Diagnostic Evaluations. NUREG-1272, Vol. 2, No. 2 covers Nonreactors and presents a review of the nonreactor events and misadministratio) reports that were reported in 1987 and a brief synopsis of AE00 studies published in 1987. Each volume contains a list of the AEOD Reports issued for 1980-1987.

"i. cm ..,............ .v...x..,c.. ,.- t.....,,

nonreactors nedical ciradministrations abnorr.a1 occurrences Unlimited AEOD recyrendations 1 ** cwa t ' c a $" 'c . ' *

  • AE03 ~

. .oi =,.. . .r ci e p o i s: e * " * **rt listing t!nc1 a s sif ied

,r..

Unclassified a ..~is . c. . .w

p. .c p

. w. l. GC et e sag g, #41t1 ts. csr Itt isisi 245 193:3322.

UNITED STATES NUCLEAR REGULATORY COMMISSION '";4t/R,*;';,ct,'Sl";

65=ac WASHINGTON, D.C. 20555 PipW:7 M G et OFFICIAL BUSINESS PENALTY POR PRIVATE USE. 62 i

l l

l l