ENS 44428
ENS Event | |
|---|---|
15:14 Jun 3, 2008 | |
| Title | Medical Event - Prescribed Dose Differed by More than 20 Percent |
| Event Description | A written directive, signed and dated on 5/30/08 by an authorized user was prepared. The directive noted that 2.0 mCi of I-131 was prescribed to be given orally on 6/3/08, for the performance of a Whole Body Scan to a patient previously diagnosed with thyroid carcinoma. An order of 2.0 mCi of Na I-131 was placed with Anazao Health on 5/30/08. On 6/02/08 at 1300 hours0.015 days <br />0.361 hours <br />0.00215 weeks <br />4.9465e-4 months <br />, an order of 2.17 mCi was dispensed by Anazao Health to Oakwood Hospital & Medical Center. A dosage calibration sheet from Anazao Health was supplied. On 6/03/08 the patient was properly identified, a negative pregnancy status was confirmed and the dosage assayed. A recorded dosage of 2.7 mCi was recorded in the hot lab computer and on the front of the written directive form. The hot lab computer with technologist data input produced a printed label of 2.7 mCi as of 6/03/08 at 1114 hours0.0129 days <br />0.309 hours <br />0.00184 weeks <br />4.23877e-4 months <br />. However, at the time of dosage administration the calculated dosage available was 2.00 mCi.
The dosage was administered to the patient and the patient was released with written radiation safety instructions for return 48 hours5.555556e-4 days <br />0.0133 hours <br />7.936508e-5 weeks <br />1.8264e-5 months <br /> post administration for performance of the actual scan. At interview today, the technologist confirms that all administrative dosage information was recorded by her and her alone. She could not give any reason as to why a dosage of 2.7 mCi could or would have been administered or recorded. A recreation of these events today notes that the hot lab computer advises the technologist that the +/-20% threshold has been exceeded with a visual warning which can be bypassed upon consultation with the authorized user. We can find no documentation of a consultation and neither the authorized user nor the technologist can confirm that one took place. A conservative estimate of organ and EDE doses was made using ICRP 53 and an ultra conservative estimate of a thyroid uptake of 5%. A "Medical Event" may indicate potential problems in a medical facility's use of radioactive materials. It does not necessarily result in harm to the patient.
Upon further investigation we have determined that a Medical Event did not occur at Oakwood Hospital and Medical Center. We do believe that a documentation error did occur instead and have taken steps internally to prevent a reoccurrence (see below). We would like to retract our report of a medical event. This is due to the following conclusions:
Upon further investigation, at the time of dosage administration the calculated dosage available was 2.00 mCi, though the documentation states the dosage given was 2.7mCi. We believe the documentation to be in error and not the actual dose given to the patient. Measures to Prevent Reoccurrence: 1. Prior to dosage administration, all documentation will be verified by either a second certified nuclear medicine technologist or an authorized user via review and signature on the written directive. 2. Extensive re-education for all technical staff will be conducted concerning the written directive program and patient release requirements. 3. A written internal time-out retrospective audit will be conducted on a random number of directives on a monthly basis. 4. Medical Physics Consultants, Inc. will continue to perform a full quarterly written directive program audit. Summary: It is our belief that the correct patient received the correct prescribed dosage for the ordered procedure, however our internal documentation notes otherwise. This documentation error would not constitute a Medical Event . Notified R3DO (Sonia Burgess) and FSME (Michele Burgess) |
| Where | |
|---|---|
| Oakwood Hospital & Medical Center Dearborn, Michigan (NRC Region 3) | |
| License number: | 21-04515-01 |
| Organization: | Oakwood Hospital & Medical Center |
| Reporting | |
| 10 CFR 35.3045(a)(1) | |
| Time - Person (Reporting Time:+1872.03 h78.001 days <br />11.143 weeks <br />2.564 months <br />) | |
| Opened: | Thomas Kumpuris 15:16 Aug 20, 2008 |
| NRC Officer: | John Knoke |
| Last Updated: | Aug 21, 2008 |
| 44428 - NRC Website | |
Oakwood Hospital & Medical Center with 10 CFR 35.3045(a)(1) | |
WEEKMONTHYEARENS 444282008-06-03T15:14:0003 June 2008 15:14:00
[Table view]10 CFR 35.3045(a)(1) Medical Event - Prescribed Dose Differed by More than 20 Percent 2008-06-03T15:14:00 | |