ML20133B149
| ML20133B149 | |
| Person / Time | |
|---|---|
| Issue date: | 07/31/1985 |
| From: | Pettijohn S NRC OFFICE FOR ANALYSIS & EVALUATION OF OPERATIONAL DATA (AEOD) |
| To: | |
| Shared Package | |
| ML20133B118 | List: |
| References | |
| TASK-AE, TASK-N503 AEOD-N503, NUDOCS 8508060085 | |
| Download: ML20133B149 (15) | |
Text
- -. ..
o -
AEOD/N503 l
Report on Medical Misadministrations for January 1984 - December 1984 by the Office for Analysis and Evaluation of Operational Data Nonreactor Assessment Staff 4
~ ~ ~ ~ ~~
July 1985 Prepared by:
Samuel L. Pettijohn
N 8508060005 850714 PDR MISC 8500060075 PDR 3. .
iii TABLE OF CONTENTS Page
- 1. INTRODUCTION.............................................. 1
- 2. DISCUSSION................................................ 1
- 3. THERAPY MISADMINISTRATIONS................................ 1
. 4. DIAGNOSTIC MISADMINISTRATIONS............................. 2 1
4 5. LICENSEES REPORTING HULTIPLE MISADMINISTRATIONS........... 3 i
- 6. CORRECTIVE ACTI0NS........................................ 3
- 7. FI NDI NGS AND CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Appendix A..................................................... A-1 1
h i
e
, e -- - . , , , , es-- a- - -- -
- 1. INTRODUCTION This AE00 report on medical misadministratians_ orovides a compilation of data for 1984. The report includes a discussict::Ltherapeutic misadmints-trations, diagnostic misadministrations, licensees reporting multiple misadministrations, and licensee proposed corrective actions. Previous AE00 reports on medical misadministrations are AE0D/N204A, AE0D/N204B, AE0D/N204C, AE00/N204D and AE0D/N403.
- 2. DISCUSSION Table 1 summarizes the occurrences of misadministrations reported to NRC for 1984. For this period, 332 of the approximately 2200 NRC licensees authorized
~
to perfonn nuclear medicine studies and radiation therapy reported one or more misadministrations, a total of 424 reports involving 469 patients.*
Of the 424 reports of misadministrations for 1984, 412 reports (96%) were for diagnostic misadministrations, and 12 reports (4%) were for therapy misadministrations. Table 1A summarizes the occurrences of misadministrations reported to NRC for 1981 through 1984. The data for this period shows:
that the number of reports of diagnostic misadministrations for 1984 (412) is about the same as the number of reports received annually for the years 1981-1983.**
the therapy misadministration reporting rate for 1984 was higher than the annual reporting rate for 1982 and 1983 but was about the same as the reporting rate for 1981.
- 3. THERAPY MISADMINISTRATIONS Twelve therapy misadministrations were reported in 1984. Nine of the mis-administrations involved cobalt-60 teletherapy treatment. One involved brachytherapy treatment and two involved radiopharmaceutical therapy treatment.
Table 2 presents data on the type and probable causes of the misadministrations.
Appendix A contains a summary description of the misadministrations.
Six of the nine therapy misadministrations involving teletherapy machines resulted from errors in dose calculations. In three cases the dose calculation errors resulted from a misinterpretation of the physician's orders. In another case the therapy misadministration resulted from dose calculation errors, which among other causes were ascribed to the use of a computer treatment planning system. For the other two cases involving dose calculation errors no under-lying causes for the errors were determined.
, The other three teletherapy misadministrations, as well as the one brachy-therapy and two radiopharmaceutical therapy misadministrations, resulted from miscellaneous errors.
- Some misadministrations involved more than one patient.
- The misadministration reporting rule was effective November 1980.
l 1----______________________.___. . .-
While the number of therapy misadministrations reported for 1984 is higher than the annual rate for the previous. two years, we were not able to identify any specific causes for the increase.* A preliminary case study report
- On therapy misadministrations has been preparea uyM'Pca evaluate the causes of therapy misadministrations and recommend actions for minimizing therapy misadministrations. This Preliminary Case Study report was distributed for peer review in June 1985 to the NRC offices of NMSS, IE, RES, ELD, and several medical professional groups and government agencies involved with radiation therapy. We expect to issue the report in final form in late 1985.
- 4. DIAGNOSTIC MISADMINISTRATIONS Table 3 presents data for 1984 on the number of diagnostic misadministrations by the type of misadministration and the causes of the misadministrations.
Two-hundred ninety-eight (298) (72%) of the reports involved the administration of the wrong radiopharmaceutical to a patient and 102 reports (2S%) involved the administration of a radiopharmaceutical to the wrong patient. (Ninety-seven percent of the reported misadministrations were of these two types.)
The remaining diagnostic misadministrations involved a diagnostic dose of a radiopharmaceutical differing from the prescribed dose by greater than 50%.
The distribution of causes for the diagnostic misadministrations reported for the 1984 period are generally consistent with the distribution of causes found in 1981, 1982, and 1983.
While most of the diagnostic misadministrations involved the administration u.- of the wrong technetius -99m compound to a patient or. the. administration of i
the correct technetium-99m compound to the wrong patient, two of the diagnostic misadministrations involved-the administration of therapy doses of iodine-131 to patients.** These misadministration cases resulted from a misinterpretation of the type of study to be performed in one case and an error in scheduling in the other case. Two patients scheduled for thyroid scans using technetium-99m and iodine-123, respectively, were administered 5 millicuries and 10 millicuries of iodine-131. In the first case the referring physician's order which was transmitted to the nuclear medicine department by telephone was misinterpreted. In the second case the patient was erroneously scheduled for the 10 millicurie therapy dose.
These cases met the Commission's criteria for abnormal occurrence reporting to Congress and will be included in Abnormal Occurrence Reports to Congress in the first and seccnd quarters of 1985.
- Preliminary Case Study Report on the Therapy Misadministrations Reported 4
to the NRC Pursuant to 10CFR35.42.
- Several similar misadministration cases have been reported since the misadministration reporting requirement became effective in November 1980.
. l l
The Office of Inspection and Enforcement (IE) is preparing an Information Notice to medical licensees describing.these events and the precautions that could prevent the occurrence of sucn events;n Thismuotice is scheduled to be issued by August 1985.
- 5. LICENSEES REPORTING NULTIPLE MISADMINISTRATIONS Table 4 presents data on licensee reporting of multiple diagnostic misadmints-trations for 1984. Seventeen (17) percent of the 320 licensees reporting misadministrations reported two misadministrations and about four of the licensees reported three. An AE0D study will address licensees reporting multiple misadministrations in detail.
6.
CORRECTIVE ACTIONS Table 5 shows the corrective actions proposed by licensees. Approximately 50% of these corrective actions proposed by licensees involved the retraining of personnel. This is about the same percentage as for comparable periods in 1981, 1982, and 1983. The other corrective actions proposed were: implement new procedures requiring technologists to check the patient's chart for physician's orders (6%); implement new radiopharmaceutical labeling and handling procedures (12%); implement new procedures for patient identification (4%); reprimand personnel involved (5%); improve supervision (2%); other (20%);
and not specified (2%).
- 7. FINDINGS AND CONCLUSIONS There were 12 therapy misadministrations reported in 1984. Most of these misadministrations involved teletherapy treatment. There were no clearly defined causes for the increase of therapy reports for 1984.
-- Most of the diagnostic misadministrations for 1984 involved either the administration of the wrong radiopharmaceutical or the adminis-tration of a radfopharmaceutical to the wrong patient.
-- There were two diagnostic misadministration cases involving the -
administration of millicurie dose of iodine-131. The administered doses were in the therapy range of iodine-131 doses.
The causes reported by licensees are generally the same as have been reported in the past, that is, simple errors associated with (1) labeling and identifying radiopharmaceuticals stored in lead shields or untagged reagent kits, (2) pro-cessing of nuclear medicine requisitions, and (3) patient identification. The number of reports that lacked detail to permit the determination of the cause of the misadministrations (17%) was about the same as for the last half of 1983 (22%).
l The number, types, and causes of diagnostic misadministrations are about the same as reported for 198L.through.1983. However, the number of therapy
, misadministrations reported for 1984,' while ibeut tbs came as the number reported for 1981, is noticeably higher than the numbers reported in 1982 or 1983. In addition, two of the reports of diagnostic misadministrations involving fodine-131 could be grouped with the therapy misadministrations insofar as the risk to the patients is concerned. The increase in the number of therapy misadministrations reported for 1984 and the reporting of additional examples of diagnostic misadministrations that could result in significant a
risk to patients is evidence of the need to continue monitoring diagnostic and therapy misadministrations.
a t
t l .
Table 1 Summary of Misadministratfort besh onces for 1984
, Diagnostic Therapy Total Number of Reports 412 12 424 Number of Patients Involved 457- 12 469 Number of Licensees Reporting 320 12 332
- I Table 1A Summary of Misadministration Occurrences for the Years 1981,1982,1983 and 1984 i
4 1981 1982 1983 1984 Number of Reports:
Diagnostic 450 462 353 412 Therapy 10 4 4 12 -
Number of Licensees Reporting 352 355 293 320 Number of Patients Involved 536 496 458 457 9
,< y _ _ . . _ ~ m-,% -.i- 4 -
Table 2 Therapy Misadministrations- Reported to NRC for 1984 The Number of Reports = 12 The Distribution of the Reports by Type and Cause is as Follows:
Wrong Radiopharmaceutical 1 RPT Error in ordering of radiopharmaceutical from supplier 1 Therapeutic Dose of a Radiopharmaceutical Differing from the Prescribed Dose by More Than 10% 1 RPT Failure to verify dose activity prior to administration 1 Therapeutic Dose of Radiation Differing from the Prescribed Dose by More Than 10% (10 Teletherapy; 1 BrachytherapyT 10 RPT Tumor depth entered incorrectly _ on patient log 1 Therapist failed to annotate radiotherapy treatment sheet to reflect a change in the therapy prescription requiring a reduction in the tumor treatment area 1 Erroneous data from a computer treatment plan 1 Errors in dose calculations 2 Misinterpretation of physician's orders (leading to errors in dose calculations) 3 Technologist micread the scheduled treatment time 1 Brachytherapy sources were not placed in the correct location in afterloading source applicator 1 N
Table 3 Diagnostic Misadministrations Reported to NRC for 1984 The Number of Reports = 412 The Distribution of the Reports by Type and Cause is as Follows:
Wrong Radiopharmaceutical 298 RPT Radiopharmaceutical received from radiopharmacy was mislabeled 31 Mixup of radiopharmaceutical doses stored in lead pigs 69 Physician's order misinterpreted 40 Wrong reagent kit used to prepare dose 24 Lead pigs or syringes were mislabeled 11 Mixup of syringes containing radiophannaceuticals 28 Nuclear medici..e requisition was not checked 5 Insufficient information 52 Other 38 2
Wrong Patient 102
, RPT Patient answered to wrong name 28 Wrong patient's name on requisition 25 Physician's order misinterpreted 1 Patient's ID was not correlated with type of study 13 Wrong patient delivered to nuclear medicine department 15 Insufficient information 12 Other 8 1
Diagnostic Dose Differing from the Prescribed Dose by 50% 12 RPT Error in calculation 2 Dose calibration range of function switch set to wrong position 1 Insufficient information 4 Other 5
. ~
Table 4 Summary of Licensees Reporting Multiple Diagnostic Misadministrations for 1984 Misadministrations No. of Licensees _ %,
1 248 78%
2 55 17%
3 14 4%
4 2 < 1%
5 1 < 1%
-- ___ -. - = __ _ . ___ - - _ , _ .
_g_
Table 5
~
Corrective Actions Proposed by Licensee Reports for 1984 Type Corrective Action Number of Reports Percent Implement new procedures requiring 25 6%
technologist to check patient's chart -
for physician order Implement new radiopharmaceutical 51 12%
labeling and handling procedures, e.g.,
color coding, segregation of radio-pharmaceuticals, etc.
Implement new procedures for patient 16 4%
identification, i.e., ask patient to state or write name, check patient SSAN,
! use of secondary identification, as well as patient ID bracelet Reinstruct personnel 215 50%
Reprimand technologist or other 20 5%-
personnel Improve supervision of personnel 9 2%
Not specified 11 2%
Other 88 20%
Total ' 435 101%
1 e
Appendix A 1
Summary Description of Therapy Hisadministrations Reported Case 1:
A patient undergoing teletherapy treatment of the brain received a dose of 8700 rads instead of the prescribed dose of 6000 rads. Tne treatment prescribed for the patient was 200 rads total dose per day to the midline of the brain via two lateral radiation beams. Thus, each lateral field should have contributed 100 rads per day total dose delivered to the midline of the brain. The patient received 15 treatments at an actual rate of 400/ day (200 rads / day per field) for a cumulative dose of 6000 rads. The patient developed erythema (severe
, reddening of the skin) during the treatment course. Because this condition was more severe than anticipated, the attending physician reduced the pr'escribed dose to ISO rads per treatment af ter the 15th treatment. A second dosimetrist calculated a new exposure time, repeating the original error. The dosimetrist wno calculated the original treatment dose erred in calculating the exposure time so that 200 rads was administered to each side of the head (twice the intended amount of radiation per treatment).
The severity of the erythema continued to increased and after nine treatments at the reduced level the physician asked for a review of the dose calculations.
The recheck identified the error and the treatment was stopped. The patient had received a total of 8700 rads which was 45% in excess of the-prescribed dose.
Case 2:
A patient undergoing teletherapy radiation therapy treatment of tne brain with a prescribed dose of 4000 rads received a 6400 rads dose to the treatment area.
The prescribed dose was to be administered from both the front and the side of the head (100 rads per side). Hospital therapy personnel erroneously
{'
calculated the exposure time so that the patient received 200 rads from the front and 200 rads from the side. The total exposure for each treatment was therefore twice that intended.
The patient received 16 treatments at the elevated level for a total of 6400 rads compared to the intended total of 4000 rads. The error was found during a review of the patient's treatment record by the attending physician.
The licensee had quality control procedures to el eck the exposure calculations, but the checks apparently failed to detect the error in this case in a timely manner.
A-2 Case 3:
A treatment of 3000 rads to the midline of the brain in 12 equal fractions of 250 rads each via two lateral beams was prescribed. The treatment time for each beam was calculated to be 1.39 minutes.
Tne dosimetrist calculated the treatment time on the physics calculation sheet and then entered it in pencil in the first treatment column on the daily treatment record sheet. The calculations were then checked by a physicist who initialed both the physics calculation sheet and the chart check column in the daily treatment record sheet, in the hospital procedures, when a patient is treated for the first time, the treatment time and the doses which have been written in with pencil by the dosimetrist are over-written in ink by the technologist who administers the treatment.
In this case, the first treatment was administered for 1.89 minutes instead of 1.39 minutes. This mistake was then carried on for 10 more treatments.
Tne mistake was discovered after the llth treatment. The 12th treatment was canceled. The patient received 3753 rads instead of the prescribed 3000 rads.
Case 4:
, _ A patient prescribed a dose of 4500 rads, was administered a dose.in excess of 6000 rads. The misadministration occurred because the treatment depth to be used in the dose calculation was incorrectly entered on the patient's chart. This was discovered as calculations were being prepared for a second treatment for the patient.
Case 5:
A teletherapy misadministration resulted in administering about 3060 rads to a portion of a lung rather than the originally prescribed 1500-1800 rads.
The original prescription called for administering 3000 rads to all sites of the initial disease in the lung. Because the therapist felt that the volume of lung involved could not tolerate the dose, he elected to reduce the area of lung irradiated after 1500-1800 rads had been administered. A filter block to reduce the area being irradiated was not inserted as intended by the therapist, because the prescription had not been updated by the therapist prior to this phase of the treatment.
A-3 Case 6:
A patient undergoing teletherapy treatment to the right posterior chest was administered a radiation therapy dose of 3200<cvis.hstead of the prescribed !
dose of 2000 rads. The treatment was administered in two treatments of i 400 rads and three treatments of 800 rads. The misadministration apparently occurred because of a combination of erroneous data from the treatment planning system computers and a miscalculation based on those data. The error was discovered when the calculations were rechecked after completion of the treatments.
Case 7:
A patient undergoing teletherapy treatment to the left shoulder with a prescribed dose of 3500 rads in 10 treatments was administered a dose of .
4432 rads in 10 treatments. This misadministration resulted from errors in tne machine setting calculations (dose calculations). The calculations were not rechecked as required by licensee procedures within a few days of the beginning of the therapy.
Case 8: I An error in calculating the machine on-time led to a patient undergoing teletherapy treatment receiving a radiation dose that differed from the prescribed dose by more than 10%. The prescribed dose was 66 Gray (6600 rads) and the administered dose was 74 Gray (7400 rads). The licensee's report indicated that the machine on-time calculations were not independently verified as required by procedures. .
Case 9:
A patient undergoing the second of two courses of teletherapy treatment '
(therapy to ninth and tenth ribs) received a dose of 3584 rads instead of the prescribed dose of 2000 rads. '
The first course of therapy was 2000 rads in five treatments and was completed without any problems. The second course of treatment prescribed was 2000 rads to be delivered in 10 treatments. However, when the treatment dose for the second treatment course was calculated, the dosimetrist assumed that the prescription was the same as the earlier one. The dosimetrist failed to prepare new calculations as required by hospital procedures but ,
corrected the output from relied the on verbal first communications treatment. and As a result the only patient decags treatment was began at twice the prescribed rate. The licensee's procedures required that a new requisition be completed and new calculations be done. This error was not discovered until the patient had received 3584 rads in the second course of therapy when one of the treatment technologists noticed that the delivered dose differed from the prescribed dose by greater than 10%.
J
.' .' A-4 i Case 10:
A patient scheduled to receive a 10 millicurie dose of iodine-131 for treatment of hyperthyroidism was administered a dose of 15 millicuries.
A 10 millicurie iodine-131 dose had been ordered.for this patient and a 5 millicurie dose for another patient. The Nuclear Phamacy dispensed both patients doses in the same bottle (three 5 millicurie capsules).
When the first patient arrived the technologist opened the bottle containing the capsules and administered the capsules without verifying the activity or the number of capsules. The patient was administered three 5 millicurie iodine-131 capsules.
Case 11:
A patient undergoing therapy treatment of vaginal cuff following a hysterectomy for an adenocarcinoma of the endometrium was administered a dose of 1000 rads instead of a prescribed dose of 3825 rads. The treatment used two cesium-137 sources of 30 mg radium equivalent and 15 mg radium equivalent loaded in an applicator. The estimated lower dose received was based on a review of the source placement in the applicator following completion of the treatment.
The therapist believes that two radioactive sources were not placed exactly at the intended location in the applicator. While loading the sources in the applicator which had been placed in the vagina, the radiation therapist experienced some difficulty inserting the active source. The applicator was examined and it was found that the dome part of the applicator had changed its shape from circular to somewhat elliptical. This made the plastic tube source carrier difficult to insert into the applicator.
Case 12:
A patient with widely disseminated malignant melanoma with extensive brain metastases developed malignant ascites. In an attempt to help alleviate the symptoms, on May 22 an intra-abdominal dose of 13.4 millicuries of phosphorus-32 in the fom of chromic phosphate was ordered from the radio-phamaceutical company. The radiopharmaceutical received consisted of the correct amount of phosphorus-32, but in the sodium phosphate fom. Thus the patient was injected with phosphorus-32 as sodium phosphate instead of the prescribed radiophamaceutical chromic phosphate.
The chemical significance of the use of sodium phosphate instead of chromic phosphate results from the greater solubility of the sodium fom as compared to the insolubility of the latter. In the intended treatment with P-32 chromic phosphate, a substantial amount of the radioactive P-32 is retained within the abdominal cavity until decay. With the use of sodium phosphate, some of the P-32 will be eliminated from the body and some will enter the bloodstream.
The principal clinical effects of the use of P-32 as sodium phosphate are a somewhat reduced dose to the abdominal areas and an increased dose to the bone marrow. Any effects on the bone marrow would appear several months after the dose as abnomal blood parameters.
.