ML20205P476

AEOD/N702 Medical Misadministrations Reported to NRC for Jan-Dec 1986

ML20205P476
Person / Time
Issue date:	03/31/1987
From:	Pettijohn S NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
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ML20205P439	List: ML20205P433 ML20205P476
References
FRN-52FR36942, RULE-PR-35, TASK-AE, TASK-N702 AC65-1-025, AC65-1-25, AC65-25, AEOD-N702, NUDOCS 8704030286
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AE0D/N702 MEDICAL MISADMINISTRATION REPORT MEDICAL MISADMINISTRATIONS REPORTED TO NRC r

FOR THE PERIOD JANUARY 1986'THROUGH DECEMBER 1986 by the Office for Analysis and Evaluation of Operational Data Nonreactor Assessment Staff March 1987 f

Prepared by:

Samuel L. Pettijohn 1

This report characterizes the Medical Misadministration database maintained by the Office for Analysis and Evaluation of Operational Data. This report does not contain detailed analyses of individual events, but focuses on an attempt to identify potential and actual problem areas, and address the status of NRC activities in those areas.

f f}23 PDR

. TABLE OF CONTENTS Page i

1. INTRODUCTION......................................................... 1

2. THERAPY AND DIAGNOSTIC MISADMINISTRATIONS REPORTED TO NRC IN 1986.... 3 2.1 Genera 1......................................................... 3 2.2 Therapy Misadministrations...................................... 5 2.2.1 Tele'herapy Misadministrations........................... 5 2.2.2 Brachytherapy and Radiopharmaceutical Misadministrations. 7

2. 3 Diagnostic Misadministrations................................... 8 2.3.1 Iodine Misadministrations................................ 10

3. PERSONNEL INVOLVED IN MISADMINISTRATIONS............................. 11

4. GE0 GRAPHIC DISTRIBUTION OF LICENSEES REPORTING MISADMINISTRATIONS.... 12 1

5. LICENSEE PROPOSED CORRECTIVE ACTI0NS................................. 14 i

6. PROPOSED AND PENDING REGULATORY CHANGES INVOLVING MISADMINISTRATIONS. 15

7. FINDINGS AND CONCLUSIONS............................................. 16 APPENDIX A -

Summary of Therapy Misadministrations Reported to NRC................................................ 17 APPENDIX B - Summary Description of Diagnostic Misadministrations Reported to NRC Involving the Administration of Millicurie Amounts of Iodine-131...................... 19 i

APPENDIX C - List of Previous AE0D Reports on Medical Misadministrations.................................... 21

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MEDICAL MISADMINISTRATIONS REPORTED TO NRC FOR THE PERIOD JANUARY 1986 THROUGH DECEMBER 1986

1. INTRODUCTION This is the sixth annual report documenting AE0D/NAS' review of medical mis-administrations involving radiopharmaceuticals or radiation from radioisotopes regulated by NRC* that were reported to NRC. A list of previous AE0D reports is contained in Appendix C.

Medical misadministrations are reported to NRC pursuant to the requirements contained in 10 CFR 35.41 through 10 CFR 35.43.

The regulations which became effective on November 10, 1980, define a r.isadministration to mean the administration of:

(e) 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 diagnostic dose of a radiopharmaceutical differing from the pre-scribed dose by more than 50%;

(e) A therapeutic dose of a radiopharmaceutical differing from the prescribed dose by more than 10%; or (f) a therapeutic radiation dose from a sealed source such that errors in the soitrce 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%.

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

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i 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. One dimension or event risk is the frequency of the event; a second is the magnitude of the potential impact of the event. AE00 has used the data collected on misadministrations for.6 years (1981-1986) to

, estimate error rates for certain of these misadministration events.

~

Regarding the frequency of events caer the 6 year period,-there were 25 therapy misadministration reports that involved teletherapy machines. In these 25 events, a total of 77 patients were overtreated'or' undertreated. Using patient statistics from the " Patterns of Care" study of the American College of Radiol-ogy, the error rate per patient is estimated to be about 0.015%. For diagnos-tic misadministrations, there were about 2400 reported to NRC over this 6 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 22 of the 50 states, it is estimated that about 4 million procedures are performed annually by NRC licensees. The diagnostic error rate per procedure is estimated to be about O.01%. ,

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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 4

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can result in thyroid doses that are near'the therapy range. Since both-

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-teletherapy misadministrations and diagnostic misadministrations have about the j same estimated error rate, the therapy misadministrations and some iodine-131 misadministrations 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 of therapy amounts of radioisotopes '

l (e.g. 1-5 mci of iodine-131 administered for a whole body iodine scan). Most j diagnostic misadministration reports are reviewed from a collective or statis-j tical viewpoint.

i

.This report is a compilation of data on misadministrations reported to NRC for the period January 1986 through December 1986 and is divided into the following '

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sections: General; Therapy'and Diagnostic Misadministrations Reported to NRC; a

Personnel' Involved in Diagnostic Misadministrations; Geographic' Distribution of 1

! Licensees Reporting Misadministrations;' Licensee Proposed Corrective Actions;

and Proposed and Pending Regulatory Changes Insolving Misadministrations.

l Appendix A contains a summary of therapy misadministrations reported to NRC; I

Appendix B contains a summary of diagnostic misadministrations reported to NRC 4

that involved therapy doses of iodine-15s, and Appendix C contains a list of i previous AEOD reports on misadministrations.

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{ 2.0 THERAPY AND DIAGNOSTIC MISADi4INISTRATIONS REPORTED TO NRC IN 1986 I i-

! 2.1 General

?

For the period January 1986 through December 1986, NRC licensees involved in i

nuclear medicine and radiation therapy reported 8 therapy misadministrations and 438 diagnostic misadministrations.

Table 1 summarizes the statistics for the medical misadministrations reported  !

to the NRC for 1986. For this period, 369 of the approximately 2600 NRC licensees authorized to perform nuclear medicine studies or radiation therapy

reported one or more misadministrations, a total of 446 reports involving I 495 patients. Of the 446 reports of misadministrations for 1986, 438 (98%)

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-reported diagnostic misadministrations, and 8'(2%) reported therapy mis-administrations.

Table 1 Medical Misadministrations Reported to NRC in 1986 Misadministration Diagnostic Therapy Total Number of Reports *38 8 446 Number of Patients Involved 487 8 495 Number of Licensees Reporting 361 8 369 Table 2 compares the 1986 misadministration reports with those of prior years.

The number of reports, the number of patients involved, and the number of licensaas reporting misadministrations are given. From the table we see that about the same number of diagnostic misadministrations were reported for 1986 as were reported annually for the previous five years. The number of therapy '

misadministrations reported in 1986 was about the average number reported annually in 1981-1985 (7 reports).

Table 2 i

t Misadministration Reports for 1981-1986 1981 1982 1983 1984 1985 1986 Therapy Misadministrations Reported 10 4 4 12 4 8 Diagnostic Misadministrations Reported 430 417 334 397 380 438 Number of Patients 517 451 437 442 410 495 l Number of Licensees Reporting 351 355 293 318 293 369

2.2 Therapy Misadministrations Eight therapy misadministrations were reported in 1986. Four of the misadministrations involved teletherapy, two involved brachytherapy and two involved radiopharmaceutical therapy. Table 3 presents data on the type and probable cause of the misadministrations. Appendix A contains a summary description of each of the misadministrations.

Table 3 Type and Probable Cause of Therapy Misadministrations Reported for 1986 Dose different from prescribed by >10%

(Teletherapy)

Error in dose calculations 1 Wrong patient identified for therapy 1 A teletherapy treatment order for a linear accelerator was mistaken as a teletherapy treatment order for a cobalt-60 machine 1 The source head rotation switch was inadvertently left in the rotation mode position 1 Dose different from prescribed by >10%

(Brachytherapy)

Error in dose calculations 1 The wrong activity brachytherapy sources were loaded into the source applicator 1 Wrong radiopharmaceutical ,

(Radiopharmaceutical Therapy) '

Misunderstanding of verbal order 1 Dose different from the prescribed dose by >10%

(Radiopharmaceutical Therapy)

Failure to properly screen patient for pregnancy 1 ,

l 2.2.1 Teletherapy Misadministrations The teletherapy misadministration caused by a dose calculation error involved an error in the treatment time. The correct treatment was 5.31 minutes but the calculation error resulted in a treatment time of 8.72 minutes, l

6 The teletherapy misadministration involving the wrong patient involved an order for teletherapy treatment that was issued for the wrong patient. The patient received one treatment of 150 rads. A review of the licensee's and the medical consultant's reports for this misadministration revealed that the following factors may have contributed to the cause of the misadministration.

There was a procedure in the radiotherapy facility requiring that all kidney transplant patients receive a 150 rad treatment.

The patient involved in the misadministration had had a recent kidney transplant (albeit during a previous stay at the hospital).

The treatment was performed without a prescription for the treatment from the patient's physician indicating a quality assurance problem (either adequate quality procedures did not exist or the procedures were not followed).

A third teletherapy misadministration resulted from a radiation therapy order for a linear accelerator being mistaken as an order for treatment on a cobalt-f0 machine. A review of the licensee's report on this misadminis-tration indicated a quality assurance problem in that there was not a written order for the cobalt-60 treatment. The technologist apparently performed the treatment on the cobalt-60 machine because this type of treatment was normally performed on the cobalt-60 machine.

The fourth teletherapy misadministration resulted from the source head rotation switch inadvertently being left in the rotation mode position after a previous patient was treated. The next patient whose prescribed treatment called for a fixed head geometry was treated with a rotating head geometry.

Errors in dose calculations have previously been identified as a cause of teletherapy misadministrations. AEOD case study report, AEOD/C505, " Therapy Misadministrations Reported to the NRC Pursuant to 10 CFR 35.42," shows that 12 of 16 teletherapy misadministrations reported to Nr.C for the period November 1980 through July 1984 involved errors associated with the dose calculation phase of treatment. The errors involving the wrong patient; a patient being treated with the wrong teletherapy machine (cobalt-60 machine versus a linear accelerator); and the source head rotation switch being left in the wrong

7 position are types of errors that have not previously been identified as causes of teletherapy misadministrations. Although these causes are different from previously identified causes, the general conclusion drawn in the AE00 case study report, that is, the occurrence of therapy misadministrations can be reduced by improvements in licensee quality assurance procedures, appears to apply equally to preventing misadministrations from the three newly identified causes.

2.2.2 Brachytherapy and Radiopharmaceutical Misadministrations The brachytherapy misadministrations were caused by 1) an error in dose calculations; and 2) the wrong activity sources being loaded into the source applicator. In the former case the patient received an underdose of radiation while being treated with 36.85 mg radium equivalent iridium-192 brachytherapy seeds. In the latter case four 20.63 mg radium equivalent brachytherapy seeds were loaded into the source applicator instead of four 10.67 mg radium equivalent seeds as prescribed. In both misadministration cases the primary cause was human error.

There were two radiopharmaceutical misadministrations: one involved the administration of 15 millicuries of phosphorus-32 into the peritoneal cavity below the breastbone in a soluble rather than colloidal form. The cause of this misadministration was identified as " misunderstanding of verbal prescription."

The other radiopharmaceutical misadministration involved the administration of 12.4 millicuries of iodine-131 (for treatment of hyperthyroidism) to a patient who was between 4 and 6 weeks pregnant, resulting in an estimated 9-12 rad dose to the embryo. The cause of this misadministration was ascribed to a failure of the licensee to properly screen the patient for pregnancy. This is the only therapy misadministration of this type that we are aware of that has l been reported to NRC.

Except for the cause of the radiopharmaceutical misadministration involving the administration of iodine-131 to a pregnant patient, the causes of the other  !

brachytherapy and radiopharmaceutical misadministrations were the same as the a

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5 types of causes identified in a previous AEOD report on therapy misadminis-trations (AE0D Report AE0D/C505, " Therapy Misadministrations Reported to the J

NRC Pursuant to 10 CFR 35.42"). The general conclusion drawn from the analysis of previous therapy misadministration reports, i.e., the occurrence of therapy ,

! misadministrations can be reduced by improvements in licenseo quality assurance

- procedure, appears to apply equally to preventing all of the brachytherapy and i radiopharmaceutical misadministrations reported in 1986.

! 2.3 Diagnostic Misadministrations

Of the 438 reports of diagnostic misadministrations received in 1986, 337 involved the administration of the wrong radiopharmaceutical to a patient and i 80 involved the administration of a radiopharmaceutical to the wrong patient

!- (95% of the reported misadministrations were of these two types). The remaining diagnostic misadministrations involved eight reports of the wrong route of administration, and 13 reports in which the diagnostic dose of a radiopharmaceutical differed from the prescribed dose by greater than 50%.

] The number of reports for 1986 was about 10% higher.than the average rate for j the six-year period 1981-1986. The annual number of reports ranged from 334 (1983) to 438 (1986), with an average of 400. Without detailed data on the number of diagnostic procedures that were performed using radioisotopes no conclusion can be drawn about whether the higher number of reported misadministrations in 1986 represents a higher rate of misadministration, e constant rate of misadministration from a growing nurber of procedures or a

statistical fluctuation. In any case, the deviation of the 1986 number from the average was small. The types and causes of the diagnostic misadminis-trations were about the same as reported in prior years.

! Effectively, all of the diagnostic misadministrations involving the wrong f 4

radiopharmaceutical or the wrong patient stem from human error. With j regard to administration of the wrong radiopharmaceutical, the data show that 1 l 34 of the 337 events (10%) resulted from receipt of mislabeled doses from a f radiopharmacy. In the remainder of the events, 30 (9%) resulted from l misinterpretation of the physician's order, and errors in the preparation or j delivery of doses accounted for 175 (52%). Arother 98 reports (about 29%),

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9' had other causes or contained inadequate information from which to assign a cause.

The dominant causes for the wrong patient events were: the wrong patient's name on the requisition, 17 events (21%); the wrong patient was delivered to the nuclear medicine department, 18 events (23%); a failure to correlate the patient's identification with the study, 11 events (14%); and the patient answering to the wrong name, 13 events (16%). Relatively simple quality assur-ance procedures (checking the patient's identification against the study and the patient's medical history; asking the patient to state his name) might reduce the frequency of these events.

The remaining two types of diagnostic misadministrations, excess dose and wrong route of administrations, which represent about 5% of the misadministrations had diverse causes.

Table 4 presents data for 1986 on the number of diagnostic misadministrations by the type and cause of misadministration for misadministrations involving the wrong radiopharmaceuticals and misadministrations involving the wrong patient.

2.3.1 Iodine Misadministrations Although most of the diagnostic misadministrations involved the administration of the wrong technetium-99m compound to a patient or the administration of a technetium-99m compound to the wrong patient, five diagnostic misadministra-tions involved the administration of near therapy doses of iodine-131 to patier.ts. 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 thyroid uptake study or scan is 30 microcuries of iodine-131, or 5 to 10 millicuries of technetium-99m. The " iodine-131 whole body scan" is the only diagnostic study where this large amount of iodine-131 is used.

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- Table 4 Type and Cause of Diagnostic Misadministrations Reported to NRC for 1986 Wrong Radiopharmaceutical 337 Radiopharmaceutical received from radiopharmacy was mislabeled 34 Physician's order misinterpreted 30 Errors in preparation or delivery of dose:

Mix-up of radiopharmaceutical doses stored in lead pigs 91 Wrong reagent kit used to prepare dose 38 Lead pigs or syringes were mislabeled 21 Mix-up of syringes containing radiopharmaceuticals 25 Other causes:

Nuclear medicine requisition was not checked 8 Insufficient information 57 Miscellaneous 33 J

Wrong Patient 80 Patient answered to wrong name 13 Wrong patient's name on requisition 17 Patient's ID was not correlated with type of study 11 Wrong patient delivered to nuclear medicine department 18 Insufficient information 8 Other 13 Total Number Reported 417 The radiation dose to a patient is significantly higher if he is administered a near therapy dose of iodine-131 instead of a prescribed diagnostic dose of a radiopharmaceutical. For example, a patient prescribed a 5 millicurie dose of technetium-99m for a " thyroid scan" would receive 0.7 rads to the thyroid; a five millicurie dose of iodine-131 can produce a dose of 4000-9000 rads to the thyroid.

During 1986, AE0D undertook an engineering evaluation study of diagnostic misadministrations that involved administering near therapy amounts of iodine-131 to patients.

1

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!' Preliminary findings of the study were:

f 1) The direct causes.of 10 of.the 14 reported iodine misadministrations I- (71%) were ascribed to either the physician's order'being ,

5 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 1

(3 cases).

1.

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

use of verbal orders for nuclear medicine studies -

j use of similar terms by referring physicians and licensees to refer to different procedures lack of technologist training-

! lack of procedures f

failure of technologist to follow procedure. >

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3) The underlying cause of 11 of 14 (79%) of the.misadministrations appears to have been a lack of-licensee control over the adminis-

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i tration of millicurie amounts of iodine-131 to patients. These

! 11 misadministrations could likely have been prevented, despite i

the errors that led to the misadministrations, if the prescription-f for the iodine-131 dosage had been verified for each patient before j

the iodine-131 was administered to the patient.

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3. PERSONNEL INVOLVED IN DIAGNOSTIC MISADMINISTRATIONS 1

Table 5 shows the distribution of reported diagnostic misadministrations for the various personnel involved in the misadministrations. By " involved in j.

the misadministration," we mean the primary personnel associated with the

! identified.cause of the misadministration. From the table, we see that'312 j' of the 438 misadministrations (71%) involved the technologist. Other' personnel involved were nursing staff, 18 events (4%); clerical personnel / transporters /-

aids, etc., 57 events (13%); student technologist, 9 events (2%); nuclear l i:

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12 pharmacies, 34 events (8%); and physicians, 2 events (<1%).

The personnel involved with 6 events (about 1%) was not determined. Based on the causes identified for most of the misadministrations (e.g., simple. errors associated with the preparation and delivery of radiopharmaceutical doses account for about 52% of the misadministrations), it follows that the technologist would be the person associated with most of the misadministrations. Nurses and other i personnel generally contribute to wrong patient events.

Table 5 Personnel Involved in Diagnostic Misadministrations Personnel Misadministrations Percent Technologist 312 71%

Student Technologist 9 2%

Nursing Staff 18 4%

Radiopharmacy 34 8%

Other Personnel

• 57 13%

. Physicians 2 <1%

1 Not Specified 6 1%

• Clerical personnel / transporters / aides.

4. GE0 GRAPHIC DISTRIBUTION OF LICENSEES REPORTING MISADMINISTRATIONS i

Figures 1 and 1A show the distribution of misadiainistrations reports by states and the distribution of radioisotope facilities, generally hospitals (though some are private practice clinics), by state for the 22 states regulated by the NRC and the District of Columbia. From the graphs, it can be seen that generally states having a higher number of radioisotope facilities (indicating a higher number of administrations of radiopharmaceuticals) are generally the ones that have reported a higher number of misadministrations, although the relation between the number of radioisotope facilities and the number of misadministrations reported is not linear.

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5. LICENSEE PROPOSED CORRECTIVE ACTIONS Table 6 shows the corrective actions proposed by licensees. The dominant corrective actions involved 1) the retraining of personnel, 197 events (45%);

2) implementing new radiopharmaceutical labeling and handling procedures, 75 events (17%); 3) implementing new procedures for patient identification, 22 events (5%); 4) implementing new procedures requiring the technologist to check the patient's chart for the physician's orders, 18 events (4%); and l

5) reprimand of technologist or other personnel, 27 events (6%).

1 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 nisadministration rates at specific licensees that reported several misadministrations. Because the highest misadministra-

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tion rate estimated for a sample of licensees was 0.1%, no detailed evaluation l of these rates and the associated corrective actions has been made. I Table 6 Corrective Actions Proposed by Licensees in 1986 Diagnostic Misadministration Reports Type of Corrective Action Number of Reports Implement new procedures requiring technologist to check patient's chart for physician order 18 Implement new radiopharmaceutical labeling and handling procedures, e.g., color coding, segregation of radiopharmaceuticals, etc. 75 Implement new procedures for patient identification, i.e., ask patient to state or write name, check patient SSAN, use of secondary identification, as well as patient ID bracelet 22 Reinstruct personnel 197 1

j Reprimand technologist or other personnel 27 Improve supervision of personnel 2 Not Specified 18 Other 79 Total 438 l

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6. PROPOSED AND PENDING REGULATORY CHANGES INVOLVING NISADMINISTRATIONS The Commission's purpose in requiring the submittal of misadministration reports to the NRC is to verify that their causes are properly identified and that licensees implement appropriate corrective actions to prevent recurrence. If potential generic problems are identified, the Comission notifies other licensees of the generic problem or concerns and assesses the need for additional actions, e.g., changes in regulations to reduce the occurrence of similar and perhaps more serious events.

In this regard as a result of the findings in AE0D case study report, AE0D/C505, " Therapy Misadministrations Reported to the NRC Pursuant to 10 CFR 35.42," and the findings from the investigation (by Regional Offices) of several recent misadministrations, the Commission directed NMSS to undertake rulerraking to require radiotherapy facilities to have quality assurance programs to, among other things, ensure the accuracy of patient doses. An ANPRV for this rulemaking is expected to be published in early 1987.

In addition, the reporting requirements for diagnostic misadministrations have been changed to incorporate a threshold for reporting. The new repcrting requirements are contained in section 10 CFR 35.33 of the final rule on

" Medical Use of Bvproduct Material" (10 CFR Parts 30, 31, 32, 35, and 40),

issued October 16, 1986 (FR/Vol. 51, No. 202). The effective date of the rule is April 1, 1987.

In accordance with the requirements of 10 CFR 35.33 diagnostic misadministra-tions are only to be reported if:

the misadministration involved the use of radioactive material

• not intended for medical use;

-- the administered dosage was five-fold different from the prescribed dosage; or

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

• Radioactive materials regulated by PRC pursuant to the Atomic Engery Act of 1954, as amended in 197t.

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- Under the previous reporting requirements for diagnostic misadministrations (contained in 10 CFR 35.43, January 1, 1986 edition), all diagnostic mis-administrations are required to be reported. The basis for changing the reporting requirements to incorporate a threshold for reporting is that the review of diagnostic misadministrations for 1984-1985 has shown that essentially no additionel information on the type and causes of diagnostic misadministrations is contained in the data on most (over 90%) of the diagnostic misadministrations being reported. That is, most (over 90%) of the diagnostic misadministrations either involve the administration of the wrong radiopharmaceutical to a patient or the administration of a radiopharmaceutical to the wrong patient, and the causes of these types of misadministrations have been documented in AE0D reports on medical misadministrations.

The new reporting requirements will ensure that diagnostic misadministrations that are not in the category described above continue to be reported.

7. FINDINGS AND CONCLUSIONS Eight therapy misadministrations were reported in 1986, a rate not too different from prior years. Both the teletherapy and the brachytherapy nisadministrations that occurred in 1986 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 1986 involved either the administration of the wrong radiopharmaceutical or the administration of a radiopharmaceutical to the wrong patient. The number, type, and cause of diagnostic misadministrations are about the same as reported for 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 radio-pharmaceuticals, 2) processing nuclear medicine requisitions, and 3) patient identification. In addition, for misadministrations involving the adminis-tration of millicurie amounts of iodine to patients, the primary cause was the failure of licensees to exercise adecuate control over the administration of millicurie amounts of iodire-131 to patients.

17 APPENDIX A Summary of Therapy Misadministrations Reported to NRC MISAD #1 The wrong patient was administered a 150 rad dose of radiation. The patient had received a kidney transplant six months prior to the event which appeared to be a factor in the occurrence of the misadministration. At the time of the misadministration the patient had been admitted to the hospital for treatment of hypertension, however, an order for radiation therapy for the patient was entered into the department's computer erroneously. The patient was examined by a radiation therapy physician, who consulted the patient's chart and noted that there was no order in the chart from the attending physician for radiation therapy. The physician decided to proceed with the treatment anyway. The protocol for kidney transplant patients at the licensee's facility included radiation therapy for all patients receiving a transplant.

MISAD #2 A 15 millicurie dosage of phosphorus-32 was administered peritoneally (into the peritoneal cavity below the breastbone), in soluble rather than colloidal form, to a patient with carcinoma of the kidney with ascites (excess fluid in the cavity similar to edema). The misadministration occurred as a result of misunderstanding of verbal prescription. The red blood marrow dose may range from 350 to 550 rads.

MISAD #3 An error in calculations of a dose to a patient implanted with iridium-192 for therapeutic treatment of throat cancer resulted in an underdose of 700 rads.

A total of 103 iridium-192 seeds with an activity of 36.85 milligrams radium equivalent was used in the implant.

MISAD #4 A patient undergoing radiation treatment to the upper torso with a prescribed j

, dose of 1200 rads was administered a radiation dose of 1968 rads. The treat- '

ment plan called for six treatments of 200 rads to the upper torso. The correct exposure time would have been 5.31 minutes, but the calculational error resulted in an exposure time of 8.72 minutes. The long exposure resulted in a 1 dosage of 328 rads or approximately 1968 rads over the six treatments instead l of the 1200 rads. The patient died about a month after the therapy was per- )

formed. [The cause of death was not determined at the time of the writing of this report.]

l 1

l

18 MISAD #5 A patient scheduled for treatment on a 15 MV linear accelerator was given two treatments on a cobalt-60 teletherapy unit. The error in treatment apparently resulted from the technologist confusing simulation information for the patient for the linear accelerator with the cobalt unit since similar treatments were frequently done on the cobalt unit.

MISAD #6 A patient who was between 4 and 6 weeks pregnant was treated with 12.4 mci of iodine-131 for Graves disease. This resulted in an estimated 9-12 rad dose to the embryo. The unintentional radiation dose to the embryo was considered by the licensee to be a possible misadministration. As a result of this event the licensee indicated that better procedures for screening potentially pregnant patients are being implemented.

MISAD #7 A patient undergoing brachytherapy treatment for carcinoma of the uterine cervix as part of a radiation therapy protocol that involved both brachytherapy and teletherapy treatment received an amount of radiation from the brachy-therapy treatment that was more than 10% of the prescribed dose. One area was ov'ertreated by 16% (13,015 rads instead of 11,285 rads) for brachytherapy and teletherapy treatment; and one area was overtreated by 6% (7387 rads instead of 6947 rads) for brachytherapy and teletherapy treatment.

The overtreatrent occurred as a result of 20.63 mg radium equivalent sources beino loaded into the source applicator instead of 10.67 mg radium equivalent sources as prescribed. The person who loaded the sources indicated that the error resulted from a failure to follow established quality assurance procedures for verifying the accuracy of the source loading. The error was discovered when the sources were unloaded.

MISAD #8 A patient undergoing teletherapy radiation treatment was administered a dose with the treatment geometry different than the prescribed geometry. The patient was being treated with an AECL Theratron-80 and the source head rotation switch was inadvertently left in the rotation mode after a previous patient's treatment. This resulted in the subsequent patient, whose prescribed treatment was for a fixed head geometry, being treated with a rotating head geometry. The administered dose durino the rotation was 42 rads (12 seconds elapsed before the treatment was terminated).

. 19 O

-APPENDIX B Summary Description of Diagnostic Misadministrations Reported to NRC Involving the Administration of Millicurie Amounts of Iodine-131 MISAD #1

.escribed Radiopharmaceutical Tc-99m MDP Prescribed Dosage 20.0 mci Administered Radiopharnaceutical I-131 Administered Dosage 10.0 mci

Description:

The patient was mistakenly scheduled for an iodine-131 "whole body scan."

The prescribed study for the patient was "whole body bone scan." The patient was scheduled for the study by telephone. At the tine of scheduling, a verbal confirmation for an iodine-131 "whole body scan" was received from the doctor's office. The technologist administered the iodine-131 dose without written orders which was contrary to licensee policy.

MISAD #2

, Prescribed Radiopharmaceutical I-131 Prescribed Dosage 0.05 uCi Administered Radiopharmaceutical I-131 Administered Dosage 3.09 mci

Description:

The technologist misread the physician's consult (order for the study) and administered a patient a 3.09 nillicurie dosage of iodine-131 instead of a 50 microcurie dosage of iodine-131 for a thyroid scan. The licensee's report did not specify exactly what was misread to cause the technologist to administer the high dosage of iodine-131.

1

l j

. 20 MISAD #3 Prescribed Radiopharmaceutical I-131 Prescribed Dosage 0.1 - 0.2 uCi Administered Radiopharmaceutical I-131 Administered Dosage 1 mci

Description:

A patient was administered a 1 millicurie dosage of iodine-131 instead of the usual 100-200 microcurie dosage of iodine-131 administered for a thyroid scan.

Based on the doctor's office request and the notation in the schedule book, the technologist thought the doctor was looking for the residual thyroid tissue and administered one millicurie of iodine to a patient.

j MISAD #4 Prescribed Radiopharmaceutical I-131 Prescribeo Dosage 0.03-0.05 uCi Administered Radiopharmaceutical I-131 Administered Dosage 1.53 mci

Description:

A patient was administered a 1.53 millicurie dosage of iodine-131 instead of the prescribed dosage of 30 to 50 microcuries of iodine-131. The thyroid scan was to diagnose possible substernal thyroid tissue and the technologist thouaht that a whole body scan was ordered to look for metastatic disease and adminis-tered 1.53 millicuries of iodine-131 to the patient.

MISAD #5

Prescribed Radiopharmaceutical Tc-99m MDP Prescribed Dosage 20 mci Administered Radiopharmaceutical I-131 i Administered Dosage 20 mci

Description:

A patient for whom a bone scan was prescribed was administered 20 millicuries of iodine-131 instead of 20 millicuries of technetium-99m methylene-disphos-1 phonate as prescribed. The bone scan had been prescribed verbally and was not clearly described on the nuclear medicine department's calendar. The

! technologist interpreted the ambiguous test description as a request for a thyroid scan.

21 APPENDIX C List of Previous AEOD Reports on Medical Misadministrations Report on Medical Misadministrations for the Period November 10, 1980 - September 30, 1981, dated January 1982.

AE0D/N204A, Report on Medical Misadministrations for 1981, dated March 1982.

AE0D/N2048, Report on Medical Misadministrations for January 1981 - June 1982, dated November 1982.

AE0D/N204C, Report on Medical Misadministrations for .

January 1981 - December 1982, dated July 1983 AEOD/N204D, Report on Medical Misadministrations for January 1983 - June 1983, dated May 1984.

AE0D/N403, Report on Medical Misadministrations for July 1983 - December 1983, dated June 1984.

AE0D/N503, Report on Medical Misadministrations for January 1984 - December 1984, dated July 1985.

AE00/N602, Medical Misadministration Report -

Medical Misadministrations Reported for 1985 and Five-Year Assessment of 1981-1985 Reports, dated June 1986.

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