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 Start dateReporting criterionTitleEvent descriptionSystemLER
ENS 4286221 September 2006 04:00:0010 CFR 35.3045(a)(1)Medical Event - Only One Capsule of a Two Capsule Dose Administered

The licensee provided the following information via email: On 9/21/06 at Sewickley Valley Hospital, a technician removed a vial of I-131 therapy capsules and measured the dose in the dose calibrator to ensure that the dose measured the expected amount of 25 millicuries. The dose was administered to the patient by emptying the contents of the vial into the patient's hand. Only one of the I-131 capsules came out of the vial instead of two. The vial was placed back into the shipping container and returned to the pharmacy. On 9/25/06, the pharmacy notified Sewickley Valley Hospital that they had returned one of the two capsules to the pharmacy. One of the two capsules had apparently remained in the vial during the administration to the patient. The RSO reported that the dose to the patient was approximately 5 millicuries instead of the 25 millicurie prescribed dose. The hospital has already contacted the referring physician and plans on contacting the patient to make arrangements to administer the rest of the prescribed dose. The hospital will also institute changes in their procedures requiring the vial to be visually inspected and checked in the dose calibrator following use to prevent this from happening in the future. 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.

  • * * UPDATE FROM LICENSEE (PERNA) TO HUFFMAN AT 11:17 EDT ON 9/27/06 * * *

The licensee provided an e-mail edit to the original event report to correct some inaccuracies in the information originally reported to the NRC. R1DO (Hott) and NMSS (Wastler) notified.

  • * * UPDATE FROM CYNTHIA FLANNERY (NRC) TO GERRY WAIG ON 9/27/06 AT 1532 * * *

Then NRC Medical Radiation Safety reviewed this event and determined it to be a reportable medical event.

ENS 428631 September 2006 04:00:0010 CFR 35.3045(a)(1)Medical Event - Only One Capsule of a Two Capsule Dose Administered

On 9/1/06 at Sewickley Valley Hospital, a technician removed a vial of I-131 therapy capsules and measured the dose in the dose calibrator to ensure that the dose measured the expected amount of 100 millicuries. The dose was administered to the patient by emptying the contents of the vial into the patient's hand. Only one of the I-131 capsules came out of the vial instead of two. The vial was placed back into the shipping container and returned to the pharmacy. On 9/26/06, the pharmacy notified Sewickley Valley Hospital's RSO that the technicians at SVH had returned one of the two capsules to the pharmacy. The notification occurred during the RSO's investigation into a separate medical event that had occurred on 9/21/06 under similar circumstances. The pharmacy had discovered the second capsule on 9/11/06 but there are no records of the pharmacy contacting the hospital about it. The pharmacist who would have made the call is on vacation and not available for questioning until next week. One of the two capsules had apparently remained in the vial during the administration to the patient. The RSO reported that the dose to the patient was approximately 35 millicuries instead of the 100 millicurie prescribed dose. The hospital has already contacted the referring physician and plans on contacting the patient to make arrangements to administer the rest of the prescribed dose. The hospital will also institute changes in their procedures requiring the vial to be visually inspected and checked in the dose calibrator following use to prevent this from happening in the future. 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.

  • * * UPDATE FROM LICENSEE (PERNA) TO HUFFMAN AT 11:17 EDT ON 9/27/06 * * *

The licensee provided an e-mail edit to the original event report to correct some inaccuracies in the information originally reported to the NRC. R1DO (Hott) and NMSS (Wastler) notified.

  • * * UPDATE FROM CYNTHIA FLANNERY (NRC) TO GERRY WAIG ON 9/27/06 AT 1532 * * *

Then NRC Medical Radiation Safety reviewed this event and determined it to be a reportable medical event.