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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 52728 | 3 December 2015 04:00:00 | 10 CFR 35.3045(a)(1) | Administered Dosage Different from Prescribed Dosage | The following was received from the Veterans Affairs National Health Physics Program via email: As requested via a telephone conversation with the NRC Operation Center, this is a written notification, pursuant to 10 CFR 35.3045(a)(1), regarding a series of medical events that occurred at the VA New Jersey Health Care System in East Orange, New Jersey. A brief description of the events, cause of the events, and other required information are contained in the enclosure. The East Orange VA facility holds VHA Permit Number 29-04481-01 under our master material license, NRC License No. 03-23853-01VA. There are six apparent medical events with four resulting from the use of a pre-printed form with the incorrect unit selected; the first occurring on December 3, 2015 involving a dosage of 155 microCuries of radium-223 dichloride; the second on March 7, 2016 involving a dosage of 128 microCuries of radium-223 dichloride; the third on June 3, 2016 involving a dosage of 131 microCuries and the fourth on August 14, 2016 involving a dosage of 155 microCuries of radium-223 dichloride that was administered to patients for treatment of osseous metastases from prostate cancer. The written directives incorrectly stated the intended dosages as 155 milliCuries; 128 milliCuries; 131 milliCuries and 155 milliCuries, respectively. The fifth medical event occurred on February 20, 2016 involving a dosage of radium-223 dichloride 121 microCuries when the written directive stated 211 microCuries. The prescribed dose was 211 microCuries. The dose administered was 121 microCuries, which is a 43% variance. The whole body dose calculation is 85.50 rad/mCi x 0.09 mCi = 7.7 rem, which exceeds the 5 rem dose limit. However, the physician intended to administer 121 microCuries and had transposed the numbers on the written directive. The sixth occurred on March 28, 2017 with 25 milliCuries of sodium iodide iodine-131 where the written directive stated 25 milliCuries of radium-223 dichloride with the intended dose of 25 milliCuries of sodium iodide iodine-131 ordered and administered. No harm to the patients is expected since these treatments were successfully performed by administration of a dosage that was in accordance with the intentions of the authorized user physician. The details of corrective actions are being ascertained at the facility due to the absence of the Radiation Safety Officer at the time of discovery. NHPP (National Health Physics Program) staff was on site and discovered the events on May 2, 2017, during a routine inspection. We notified the NRC Operations Center by telephone on May 3, 2017. As part of our routine, we evaluated circumstances of the medical events, reviewed actions to prevent a recurrence, and assessed regulatory compliance. 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. |