ML20132A958

Rept on Medical Misadministrations for 801110-810930

ML20132A958
Person / Time
Issue date:	01/31/1982
From:	Pettijohn S NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD)
To:
Shared Package
ML19291G003	List: ML20132A958
References
TASK-AE, TASK-N201 AEOD-N201, NUDOCS 8202250318
Download: ML20132A958 (17)

Text

v i

REPORT ON MEDICAL MISADMINISTRATIONS FOR THE PERIOD NOVEMBER 10, 1980 SEPTEMBER 30, 1981 by the Of fice for Analysis and Evaluation of Operational Data January 1982 Prepared by: Samuel L. Pettijohn 8202250318 820201 CF SUDJ L-4-1PT35 CF

l TABLE OF CONTENTS Page ACKNOWLEDGMENT . . . . . . . . . . . . . . . . . . . . . . . 11 EXECUTIVE SUMKARY . . . . . . . . . . . . . . . . . . . . . iii

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

2. DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . 2 2.1 Types of Misadmini strations . . . . . . . . . . . . 3

2. 2 Contributing factors for Diagnostic Misadministrations ............... 3

2. 3 Contributing Factors for Therapeutic Misadministrations ............... 5 2.4 Corrective Actions ................ 5

3. FINDING AND CONCLUSIONS ................ 6 LIST OF TABLES

1. Summary Of Nuclear Medicine Misadministration Occur-rences Reported To NRC November 10, 1980 - September 30, 1981 . . . . . . . . . . . . . . . . . . . . . . 8

2. 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 . . . . . 11

ii ACKNOWLEDGMENT The author ,0f the report would like to acknowledge the contribution of Harriet Karagiannis, Of fice of Inspection and Enforcement, in the analysis of the misadministration data. Miss Karagiannis contributed to our under-standing of the day-to day functioning of a nuclear medicine department and assisted in formulating the list of contributing causes for the misadminis-trations.

=e 4

iii EXECUTIVE

SUMMARY

Approximately 2200 active licensees are authorized by the Nuclear Regulatory Commission to perform nuclear medicine studies. The Office for Analysis and Evaluation of Operational Data had received reports from 216 of these licensees, who reported one or more medical misadministrations for the period from November 10, 1980 through September 30, 1981, giving a total of 300 reports involving 360 patients (some misadministration events involved more than one patient).

Based on this reporting history, AE00 projects that the NRC would receive about 400 reports per year involving approximately 550 patients. Of these 400 reports, AE00 estimates that about ten would involve therapeutic misadminis-trations. 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 10% of the 2200 NRC licensed nuclear medicine facilities reported one or more misadministrations for the period November 10, 1980 through September 31, 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 radioph'armaceutical to the wrong patient. The eight reported therapeutic misadministrations came under the following categorieJ: wrong radiopharmaceutical (one), wrong patient (one),

and final dose differing from the prescribed dose by more than 10% (six reports).

Although many of the errors associated with the misadministrations are simple personnel errors, AE00 believes the current data highlight potential problem areas that licensees could review to assess the adequacy of their procedures

iv and training programs. For example, improvements in radiopharmaceutical handling prccedures and patient identification procedures have been proposed by many licensees who reported misadministrations in an ef fort to minimize the number of misedministrations.

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 ef fective November 10, 1980 The rule requires the immediate telephone reportin- of therapy misadminis.

trations, followed by a written report in 15 days. A quarterly written report is required for diagnostic misedministrations. This report is to be submitted within ten days af ter 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 Offire for Analysis and Evaluation of Operational Data

( AE00) logs the reports, prepares extracts, and reviews them for generic information.

The Connission's purpose in requiring the submittal of misadministration reports to the NRC is to verify that thedr 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 extracted from licensee reports for the period November 10, 1980 through September 30, 1981. Approximately 320 reports were received by the NRC Regional Offices during this period, of which 300 were reviewed by AE0D. AE00 had not yet received copies of about 20 reports for review at the time of preparation of this report.

1

~

2 1 -

Many of the licensee reports lacked detail; a clear description of the circum.

stances that led to the misadministration was of ten not provided. However, most reports provided a relatively clear description of the licensee's corrective action even when the cause of the event was not clearly stated.

2.0 PISCUSSION Each licensee mi$ adminstration report available to AE00 was reviewed to assign the misadminstration to one cf the types defined in the NRC regulations.

Sevaral 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 formulate several types of corrective actions that 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 conform to one of our standard categories, then it was assigned to the "other," "insuf ficient information," or "not speci fied" category.

1/

Table 1~ summarizes the occurrences of misadministrations reported to NRC for the period of November 10, 1980 to September 30, 1981. Of the approx.

imately 2200 NRC licensees authorized to perfonn nuclear medicine studies, 216 (approximately 107.) reported one or more misadministrations for the period, 2/

_ giving a total of 300 reports involving 360 patients.~ Based on this reporting history, AE00 projects that NRC would receive about 400 misadministration reports annually involving approximately 550 patients. We estimate that about ten of the 400 reports would involve therapeutic misadministrations.

1/

Tables begin on page 8.

-2/

Of the 320 reports received by NRC, only 300 were available for use in this report.

__________ - _ - - - - _ _ _ _ ---___i

Using an es'imate of 10 to 14 million nuclear medicine studies performed annually 3/

in the United States,~ AEDD (stimates that 6 to 9 million nuclear medicine studies are perf ormed by NRC licensees. Tre 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 medications in the United States, which is of the order of 1 - 15%.-4/

\

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

Of the 300 reports reviewed by AE00, 292 were reports of diagnostic misad-ministrations. Two hundred and four (m70%) of the diagnostic hisadministrations involved administrations of the wrong radiopnarmaceutical, while 75 (~25%)

involved administrations to the wrong patient. Five of the eight therapeutic misadministrations involved a therapeutic dose of radiation from a sealed source dif fering by greater than 10% of the prescribed dose. Of the remaining three therapeutic misadministrations, one involved the wrong radiopharmaceutical, one involved the wrong patient, and one involved the therapeutic dose of a raciopharmaceutical 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 f radiopharmaceutical or administration to the wrong patient, our discussion of 3/

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

4/

John Spink, Esq. , " Medication Errors in Hospitals " Medical Trial Technique Quarterly, 21, No. 3, pp. 271-296, Winter 1975. (Reprinted from Scapel and Quill, Vill, No.1, March 1974.)  :

1

4 ,

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

Twenty-five (12%) of the misadministrations involving use of the wrong radio-pharmaceutical resulted from mislabeled radiopharmaceuticals being received  !

from radiopharmacies. Eighty-three (40%) were equally distributed among:

a mixup of radiopharmaceutical 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 (5%) were due to the failure of the technologist to check the requisition to verify the type of nuclear medicine study to be conducted. Seventy-one (35%) of the reports contained insuf ficient ir.?ormation to permit assigning a contributing factor to the misadministration, and 15 reports (7%) had ,

contributing factors that fell into the "other" category. The fact that about one-third of the 204 reports contained insufficient information to determine a contributing factor demonstrates the lack of report detail.

Sixty-five (87%) of a total of 75 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 pctient being delivered to the nuclear medicine department. Three misadministrations (4%) were due to the misinterpretation of physician's orders; three (4%) were assigned to the

" insufficient information" category; and four (5%) were assigned to the "other" category.

2.3 Contributing factors for Therapeutic Misadministrations Of the eight therapeutic misadministrations reported to NRC, six involved delivery of doses that dif fered from the prescribed dose by more than 10%. Of these six misadministrations, four were ascribed to calculation errors. The factors contributing to the remaining four therapeutic misadministations were ascribed to: mixup of radiopharmaceuticals stored in lead pigs (wrong radiopharmaceutical); patient answered to wrong name (wrong patient); mixup of radiopharmaceutical doses stored in lead pigs (therapeutic dose of radiopharmaceutical dif fering from prescribed dose by greater than 10%); and source fell out of applicator and slipped under patient (therapeutic dose from sealed source dif foring from prescribed dose by greater than 10%).

2.4 Corrective Actions As noted previously, many reports that did not clearly describe the circumstances 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 307 corrective actions were proposed in the 300 reports. Seventy (23%) 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 twenty-two (40%) of the proposed corrective actions required the retraining of personnel in existing licensee procedures. Thirty-five (11%) of the proposed corrective actions involved either the reprimand of the

6- ,

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

3.0 FINDING AND CONCLUSIONS The data taken from reports over the period November 10, 1980 through September 30, 1981 indicate that most of the misadministrations involved the diagnostic administration of radiopharmaceuticals. This is expected, considering that the diagnostic application of radionuclides far exceeds the therapeutic application.

The administration of the wrong radiopharmaceutical to a patient or the administration of a radiopharmaceutical 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 radiopharmaceuticals stored in lead shields or untagged reagent kits (2) the processing of nucl6ar medicine requisitions, and (3) patient identifi-cation.

The mislabeling of radiopharmaceuticals by radiopharmacies would appear to have the same causal factors as the mislabeling of radiopharmaceuticals in hospital nuclear medicine departments. However, since several hospitals could receive mislabeled radiopharmaceutical preparations due to a single mislabeling event at a radiopharmacy, the impact could be far greater for radiopharmacy mislabeling than for hospital nuclear medicine department mislabeling.

Although many of the errors associated with the misadministrations are simple personnel errors, we believe the data highlight potential problems

, 7 l

areas that licensees could review to assess the adequacy of their procedures and training programs. For example improvements in radio-pharmaceutical handling procedures and patient identification procedures have been proposed by many licensees who reported mi$ administrations in an' effort to minimize the number of misadministrations.

8 .

Table 1

SUMMARY

OF NUCLEAR MEDICINE MISADMINISTRATIONS REPORTED TO NRC NOVEMBER 10, 1980 SEPTEMBER 30, 1981 Number of NRC Licensees (Nuclear Medicine) 2220 Number of NRC Licensees Reporting Misadministrations 216 Diagnostic Misedministrations 292(352 patients)

Therapeutic Misadministrations 8(8 patients)

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

Total Nuclear Medicine Misadminstrations by NRC Licensees 400/yr (est.)

Misadministration Rate .006 . 01% (est.)

m e 1

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

Type.Misadmistration Therapy Diagnostic Patients A radiopharmaceutical or radiation 1 204 264 f rom a sealed source other thai, the one intended A radiopharmaceutical or radiation 1 75 76 to the wrong patient A rsdiopharmaceutical or radiation 0 1 1 by a route of administration other than the one intended by the Dre-scribing physician A diagnostic dose of a radiophar- NA 12 13 maceutical dif fering from the prescribed dose by more than 50 percent A therapcetic dose of a radio. 1 NA 1 pharmaceutical dif fering from the prescribed dose by more than 10%

A therapeutic radiation dose from 5 NA 5 a sealed source such that the error in the source calibration, time of exposure, and treatment geometry results in a calculated total treatment dose dif fering f rom the final prescribed total treatment dose by more than 10%

- TOTAL 8 292 360

\ /

s

Tchio. - 3 FACTORS THAT CONTRIBUTED lu DIAGNOSTIC MISADMINISTRA310NS GROUPED BY THE TYPE OF MISADMINISTRATION Wrong Radiopharmaceutical, Contributing Factors Diagnostic Cases  % Number of Patients Radiopharmaceuticals received 25 12 46 from radiopharmacy were mis-labeled Mixup of radiopharmaceutical 21 10 22 doses stored in lead pigs Physician's order misinterpreted 16 8 16 Wrong reagent kit used to 18 9 35 prepare dose Mir.labled lead pigs or syringes 11 5 19 Mixup of syringes e.onining radiapharmaceuticals, 17 0 19 ,

Naclear medicine requisition 10 E 10 was not checked to verify type of study Insuf ficient information 71 35 79 Other 15 7 17 TOTAL 204 263 i

11

Table 3 (Continued)

FACTORS THAT CONTRIBUTED TO DIAGNOSTIC MISADMINISTRATIONS GROUPED BY THE TYPE OF MISADMINISTRATION

, Wroig_ Patient Contributing Factors Cases j' Number of Patients Patient answered to wrong name 20 27 20 Wrong patient's name on requisition 14 19 14 Patient's ID was not correlated with 13 17 13 type of study ordered Wroag patient delievered to nuc. med. 18 24 18 department Physician's order misinterpreted 3 4 3 Insuf ficient information 3 3 Other 4 5 4 TOTAL 75 75

-w

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ . _ ___ __ _ _ _ _ w

Table 4 CORRECTIVE ACTIONS PROPOSED BY LICENSEES Type Corrective Action Number of Reports Percent Implement new procedures requiring 20 7 technologist to check patient's chart for physician order Implement new radiopharmaceutical 38 12 labeling and handling procedures, e.g. ,

color coding, segregation of radio-pharmaceuticals, etc.

Implement new procedures for patient 12 4 ideritification, i.e. , ask patient to state or write name, check patient SSAN, use of secondary identification, as well as patient 10 bracelet Reinstruct personnel 122 4,0 Reprimand technologist or s':.er 21 7 personnel Improve supervision of personnel 14 4 Not specified 15 5 Other 65 21 TOTAL 307

=

-_--_-_-- --_----_-- --__ ----__-- - -- --_-- ----- _ ----- ----- --------- --