ML20023A890

Rept on Medical Misadministrations for 1981

ML20023A890
Person / Time
Issue date:	03/31/1982
From:	Pettijohn S NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
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ML19277A861	List: ML20023A462 ML20023A890
References
TASK-AE, TASK-N204 AEOD-N204, NUDOCS 8211010029
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AE00/N204 REPORT ON MEDICAL MISADMINISTRATIONS FOR 1981 by the 1

Office for Analysis and Evaluation of Operational Data i

March 1982 1

Prepared by: Samuel L. Pettijohn

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TABLE OF CONTENTS Page ACKNOWLEDGMENT....................... 11 EXECUTIVE

SUMMARY

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INTRODUCTION...................... 1 2.

DISCUSSION....................... 2 2.1 Types of Misadministrations............ 3 2.2 Contributing Factors for Diagnostic Misadministrations 3

2.3 Contributing Factors for Therapeutic Misadministrations 5

i 2.4 Corrective Actions 5

3.

FINDING AND CONCLUSIONS 6

LIST OF TABLES 1.

Summary Of Nuclear Medicine Misadministration Occur-rences During 1981 Reported to NRC;........

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Number Of Reports By Type Of Misadministration ( As Defined In 10 CFR 35.41).............. 9 3.

Factors That Contributed To Diagnostic Misadmin-istrations Grouped By The Type Of Misadministration 10 4.

Corrective Actions Proposed By Licensees.....

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.a 11 ACKNOWLEDGMENT The author of the report would like to acknowledge the contribution of Harriet Karagiannis, Office of Inspecti6n and Enforcement, in the analysis of the misadmi'istration data. Miss Karagiannis contributed to our under-n standing of the day-to-day functioning of a nuclear medicine department and assisted in formulating the list of contributing causes for the misadmints-trations.

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iii EXECUTIVE

SUMMARY

Approximately 2200 active licensees are authorized by the Nuclear Regulatory Commission to perfom nuclear medicine studies. The Office for Analysis and Evaluation of Operational Data had received reports from 309 of these licensees, who reported one or more medical misadministrations for the year 1981 giving a total of 444 reports involving 532 patients (some misadministration eveats involved more than one patient). Of these 444 reports, ten involved therapeutic l

oisadministrations. Approximately six to nine million nuclear medicine studies are performed annually by the NRC licensed nuclear medicine facilities; thus, about 0.006 to 0.01 percent of the total are reported as misadministrations.

Approximately 14% of the 2200 NRC licensed nuclear medicine facilities reported one or more misadministrations for the year 1981.

Of the six types of misadminstrations defined in the Nuclear Regulatory Commission Regulations (10 CFR 35.41-45) about 70% of the reported misadminis-trations involved diagnostic adminstrations of the wrong radiopharmaceutical and about 25% were administrations of a radiophamaceutical to the wrong patient. The ten reported therapeutic misadministrations came under the following categories: wrong patient (one), and final dose differing from the prescribed dose by more than 10% (nine reports).

Although many of the errors associated with the misadministrations are simple p9rsonnel errors, AE00 believes the current data highlight potential problem areas that licensees could review to assess the adequacy of their procedures and training programs. For example, improvements in radiophamaceutical handling procedures and patient identification procedures have been proposed by many licensees who reported misadministrations in an effort to minimize the number of misadministrations.

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1.0 INTRODUCTION

Subsequent to receiving several reports of serious medical misadministrations throughout the 1970's, the NRC implemented the misadministration reporting rule as set forth in 10 CFR 35.41 through 35.45 effective November 10, 1980.

The rule requires the immediate telephone reporting of therapy misadminis-trations, followed by a written report in 15 days. A quarterly written report is required for diagnostic misadministrations. This report is to be submitted within ten days after the end of the calendar quarter in which the misadministration occurred. Misadministration reports are submitted by licensees to the appropriate NRC regional office which logs and forwards them to Headquarters. The Office for Analysis and Evaluation of Operational Data

( AEOD) logs the reports, prepares extracts, and reviews them for generic information.

The Commission's purpose in requiring the submittal of misadministration r

reports to the NRC is to verify that their causes are properly identified in order to correct them and to prevent their recurrence. The Commission can do this by (1) notifying other licensees if there is a possibility that they could make the same errors, and (2) changing its regulations to help minimize specific errors. The significance of the consequences of a diagnostic misadminstration goes beyond the unnecessary radiation exposure when it results in a misdiagnosis.

Seemingly isolated incidents at individual medical institutions can also reveal a generic problem when compared with data on a national scale.

This report is a compilation of data on medical misadministrations for the year 1981 extracted from licensee reports. Many of the licensee reports lacked detail; a clear description of the circumstances that led to the

. misadministration was often not provided. However, most reports provided a relatively clear description of the licensee's corrective action even I

when the cause of the event was not

• clearly stated.

2.0 DISCUSSION f

Each licensee misadminstration report available to AE0D was reviewed to assign the misadminstration to one of the types defined in the NRC regulations.

Several factors contributing to the misadministrations were identified, based on the most common contributing factors found in the licensee's reports. The same procedure was used to fomulate several types of corrective actions that l

l represented most of the corrective actions proposed by licensees.

In each case, if the contributing factor or corrective action associated with a report did not confom to one of our standard categories, then it was assigned to the "other," " insufficient infomation," or "not specified" category.

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Table 1-summarizes the occurrences of misadministrations reported to NRC for the year 1981. Of the approximately 2200 NRC licensees authorized to perfom nuclear medicine studies, 309 (approximately 14%) reported one or more misadministrations,for the period, giving a total of 444 reports involving 532 patients. Ten of the 444 reports involved therapeutic misadministrations.

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Tables begin on page 8.

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,. Using an estimate of 10 to 14 million nuclear medicine studies perfomed annually 2/

in the United States, AE00 estimates that 6 to 9 million nuclear medicine studies are perfomed by NRC licensees. The misadministration rate for NRC licensees is thus about 0.006 - 0.01%. The misadministration rate appears to be of the order of 1/100 - 1/1000 of the error rate for administration of 3/

medications in the United States, which is of the order of 1 - 15%.-

2.1 Types of Misadministrations Table 2 presents data on the number of reports by type of misadministration.

Of the 444 reports reviewed by AE00, 434 were reports of diagnostic misad-ministrations. Three hundred and one ( 70%) of the diagnostic misadministrations involved administrations of the wrong radiopharmaceutical, while 119 ( 25%)

involved administrations to the wrong patient. Seven of the ten therapeutic misadministrations involved a therapeutic dose of radiation from a sealed source differing by greater than 10% of the prescribed dose. Of the remaining three therapeutic misadministrations, one involved the wrong patient, and two involved the therapeutic dose of a radiopharmaceutical differing from the prescribed dose by greater than 10%.

2.2 Contributing Factors for Diagnostic Misadministrations Since over 90% of the diagnostic misadministrations were either use of the wrong radiopharmaceutical or administration to the wrong patient, our discussion of

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W. Briner, NRC Consultant, personal communication to H. Karagiannis, NRC.

3/John Spink, Esq., " Medication Errors in Hospitals," Medical Trial Technique Quarterly, 21, No. 3, pp. 271-296, Winter 1975.

(Reprinted from Scapel and Quill, VIII, No. 1, March 1974.)

2 6 contributing factors is limited to these two types of diagnostic misadminis-tations. Table 3 gives a distribution of diagnostic misadministrations by contributing factor.

Thirty-four (11%) of the misadministrations involving use of the wrong radio-phamaceutical resulted from mislabeled radiophamaceuticals being received from radiophamacies. One hundred and nineteen (39%) were about equally distributed among: a mixup of radiophamaceutical preparations stored in lead pigs; misinter-pretation of the physician's orders; use of the wrong reagent kit to prepare the dose; mislabeling of lead pigs or syringes; and a mixup of syringes. Ten (3%) were due to the failure of the technologist to check the requisition to verify the type of nuclear medicine study to be conducted. One hundred and thirteen (38%) of the reports contained insufficient information to pemit assigning a contributing factor to the misadministration, and 25 reports (8%) had contributing factors that fell into the "other" category. The fact that about one-third of the 301 reports contained insufficient infomation to detemine a contributing factor demonstrates the lack of report detail.

One hundred (84%) of a total of 119 reports of misadministrations involving the wrong patient were distributed equally among: the patient answering to the wrong name; the wrong patient's name being on the nuclear medicine requisition; the patient's identification not being correlated with the the type of study ordered; and the wrong patient being delivered to the

- nuclear medicine department. Three misadministrations (3%) were due to the misinterpretation of physician's orders; eleven (9%) were assigned to the

" insufficient infomation" category; and five (4%) were assigned to the "other" category.

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, 2.3 Contributing Factors for Therapeutic Misadministrations Of the ten therapeutic misadministrations reported to NRC, nine involved delivery of doses that differed from the prescribed dose by more than 10%. Of these'nine misadministrations, six were ascribed to calculation errors. The factors contributing to the remaining four therapeutic cisadministations were ascribed to: patient answered to wrong name (wrong patient); wrong capsule used to prepare dosage, resulting in administration of less than prescribed dose (dose of radiophamaceutical differing from prescribed dose by more than 10%); source fell out of applicator and slipped under patient (therapeutic dose from sealed source differing from prescribed dose by greater than 10%); and dose rate constant for wrong machine used in calculation (therapeutic dose from sealed source differing from prescribed dose by greater than 10%).

2.4 Corrective Actions j

As noted previously, many reports that did not clearly describe the circumstances

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that caused the misadministration event did explicitly describe corrective actions to prevent the recurrence of the event.

Table 4 shows the corrective actions proposed by licensees in their misadmin-istration reports. A total,of 451 corrective actions were proposed in the 444 reports. Ninety-one (20%) of the proposed corrective actions involved the development and implementation of new procedures requiring the technol-ogist to check the patient's chart, color coding or other new labeling methods, and improved techniques for patient identification. One hundred eighty-five (41%) of the proposed corrective actions required the retraining l

l of personnel in existing licensee procedures. Thirty-eight (9%) of the proposed corrective actions involved either the reprimand of the

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. responsible personnel or improved supervision of personnel. Twenty-six percent of the reports were assigned to the category "other"; only 5% did not specify the type of corrective action.

3.0 FINDING AND CONCLUSIONS i

The data taken from reports for 1981 indicate that most of the misadministrations f

I involved the diagnostic administration of radiophamaceuticals. This is expected, j

considering that the diagnostic application of radionuclides far exceeds the therapeutic application.

The administration of the wrong radiopharmaceutical to a patient or the l

administration of a radiophamaceutical to the wrong patient accounted for over 90% of the diagnostic misadministrations. The primary contributing factors appear to be simple errors associated with (1) labeling and identifying

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radiopharmaceuticals stored in lead shields or untagged reagent kits, (2) f the processing of nuclear medicine requisitions, and (3) patient identifi-i cation.

The mislabeling of radiophamaceuticals by radiophamacies would appear to have the same causal factors as the mislabeling of radiophamaceuticals in l

hospital nuclear medicine departments. However, since several hospitals could receive mislabeled radiophamaceutical preparations due to a single nislabeling event at a radiophamacy, the impact could be far greater for l

radiophamacy mislabeling than for hospital nuclear medicine department i

oislabeling.

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l Although many of the errors associated with the misadministrations are t

simple personnel errors, we believe the data highlight potential problems f

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7 areas that licensees could review to assess the adequacy of their I

procedures and training programs. For example improvements in radio-pharmaceutical handling procedures and patient identification procedures I

have been proposed by many licensees who reported misadministrations in an effort to minimize the number of misadministrations.

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. Table 1 SU MARY OF NUCLEAR MEDICINE MISADMINISTRATION OCCURRENCESDURINd1981REPORTEDTONRC Number of NRC Licensees (Nuclear Medicine) 2220 Number of NRC Licensees Reporting Misadministrations 309 Diagnostic Misadministrations 434 (522 patients)

Therapeutic Misadministrations 10 (10 patients)

Total Nuclear Medicine Administrations by NRC Licensees 6 - 9 million/yr (est.)

Total Nuclear Medicine Misadminstrations by NRC Licensees 444/yr Misadministration Rate

.006

.01% (est.)

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., Table 2 NUMBER OF REPORTS BY TYPE OF MISADMINISTRATION ( AS DEFINED IN 10 CFR 35.41)

Type Misadmistration Therapy Diagnostic Patients A radiophamaceutical or radiation 0

301 388 from a. sealed source other than the one intended l

A radiophamaceutical or radiation 1

119 120 to the wrong patient l

A radiopharmaceutical or radiation 0

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l by a route of administration other than the one intended by the pre-l l

scribing physician l

A diagnostic dose of a radiophar-NA 12 13 maceutical differing from the l

prescribed dose by more than 50 percent A therapeutic dose of a radio-2 NA 2

phamaceutical differing from the prescribed dose by more than 10%

A therapeutic radiation dose from 7

NA 7

a sealed source such that the error in the source calibration, time of exposure, and treatment geometry results in a calculated total treatment dose differing from the final prescribed total treatment dose by more than 10%

TOTAL 10 434 532 h

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b Table 3 FACTORS THAT CONTRIBUTED TO DIAGNOSTIC MISADMINISTRATIONS GROUPED BY THE TYPE OF MISADMINISTRATION Wrong Radiopharmaceutical Contributing Factors Diagnostic Cases Number of Patients Radiophannaceuticals received 34 11 64 from radiopharmacy were mis-labeled Mixup of radiophamaceutical 36 12 40 doses stored in lead pigs Physician's order misinterpreted 23 8

23 Wrong reagent kit used to 25 8

46 prepare dose Mislabeled lead pigs or syringes 19 6

35 Mixup of syringes containing radiopharmaceuticals.

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19 Nuclear medicine requisition 10 3

-10 was not checked to verify type of study Insufficient information 113 38 123 Other 25 8

28 TOTAL 301 388 q

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. Table 3 (Continued)

FACTORS THAT CONTRIBUTED TO DIAGNOSTIC MISADMINISTRATIONS GROUPED BY THE TYPE OF MISADMINISTRATION Wrong Patient Contributing Factors Cases Number of Patients Patient answered to wrong name 29 24 29 Wrong patient's name on requisition 28 24 28 Patient's ID was not correlated with 19 16 19 type of study ordered Wrong patient delievered to nuc. med.

24 20 24 department Physician's order misinterpreted 3

3 3

insufficient information 11 9

11 Other 5

4 5

TOTAL 119 119

ie i Table 4 CORRECTIVE ACTIONS PROPOSED BY LICENSEES Type Corrective Action Number of Reports Percent Implement new procedures requiring 30 7

technologist to check patient's chart for physician order Implement new radiopharmaceutical 46 10 labeling and handling procedures, e.g.,

color coding, segregation of radio-phamaceuticals, etc.

Implement new procedures for patient 15 3

identification, i.e., ask patient to state or. write name, check patient SSAN, use of secondary identification, as well l

as patient ID bracelet Reinstruct personnel 185 41 Reprimand technologist or other 21 5

personnel Improve supervision of personnel 17 4

Not specified 21 5

Other 116 26 TOTAL 451

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