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| Start date | Reporting criterion | Title | Event description | System | LER | |
|---|---|---|---|---|---|---|
| ENS 51670 | 9 November 2015 07:00:00 | Agreement State | Agreement State Report - Medical Event Involving High Dose Rate Therapy | The Department (Colorado Department of Public Health and Environment (CDPHE)) received a phone report from the Radiation Safety Officer for Saint Joseph Hospital regarding a medical event involving the HDR (high dose rate therapy). A patient was scheduled to receive three fractions of HDR treatment in November, 2015. It is believed the second fraction caused the medical event on November 9, 2015. In December, the patient reported to their primary care physician, burns to the leg. The authorized user was notified in December by the patient and/or primary care physician. The authorized medical physicist and radiation safety officer were notified of the event on January 19, 2016 and notified CDPHE on January 20, 2016. The intended dose to the treatment site was 6,000 cGy with all of the intended dose being delivered to the patient's leg. The preliminary cause was an error with the transfer tube-applicator interface, but the licensee is still conducting an internal investigation. The Department is expecting a full report from the licensee within 15 days and preparing for a visit to investigate the event. Colorado Event Report ID No.: CO16-M16-01 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. | ||
| ENS 48465 | 17 October 2012 22:37:00 | Agreement State | Agreement State Report - Possible Medical Event Involving Misadministration | On 10/17/12, the licensee notified RHB (Radiation Health Branch) of an issue related to prostate brachytherapy and questioned if this falls into the category of Medical Event (ME). RHB is currently investigating this matter to evaluate if a ME had occurred. The RSO called RHB for guidance about three permanent prostate seed implants for which post-implant dosimetry showed less than ideal dose coverage of the gland. The RSO reiterated that none of these deviations were a surprise all were expected based on intra-operative experience. In one Iodine-125 case, poor coverage of the lateral base resulted from significant pubic arch interference. In the other two cases, both Palladium-103, poor coverage of the base occurred from vendor failure to disclose an additional unplanned spacer at the end of each seed strand. As stated, the D90 value (minimum dose to 90% of the CT-defined prostate one month following the implant) for the I-125 case was 77% and for the two Pd-103 cases was 68% and 53% of the dose prescribed as a minimum peripheral dose to the ultrasound-defined prostate +margin prior to the implant. The RSO requested RHB read this statement carefully, as it compares apples to oranges 'The RSO will make the case that the post-plan D90 is relevant as an assessment of plan and programmatic quality but is irrelevant for definition of a medical event'. The RSO indicated that the hospital's physicians do not prescribe by D90. What is prescribed is a minimum peripheral dose (MPD) to the ultrasound-defined prostate gland plus planning margin (PTV). A pre-plan is generated to deliver the intended MPD (145 Gy for I-125 monotherapy and 125 Gy for Pd-103 monotherapy) to the PTV. The resulting planned combination of radionuclide, source strength, and number of sources is what is approved, prescribed, ordered, and implanted. Very often, changes are made intra-operatively to account for implantation difficulties and clinical factors (deviation of urethra from predicted path, pubic arch interference, presence of more aggressive disease in a specific part of the gland, etc). In addition, extra seeds are ordered for each case, to be implanted at the discretion of the Authorized User (AU). Extra seeds may be implanted to boost areas of sparse coverage following implantation of planned seeds. Extra seeds may also be implanted to boost areas of known aggressive disease to a dose higher than the initial MPD. It is impossible to mentally arrive at a new dose that might correlate to a D90 on post-implant dosimetry under these conditions. The AU recognizes that this will result in an increase to the D90 on the post-plan but does not alter the dose on the written directive but only the number of sources (in part to of the written directive following implant but prior to release of the patient) to reflect the intra-operative changes. This is because the prescribed dose refers to a MPD for the pre-implant ultrasound prostate volume with margin (as our policy states). It was never meant to correlate with a D90 on a CT-defined prostate volume (which volume may be double the ultrasound-defined pre-implant volume) a month after the implant. As a result of the clinically discretional implantation of extra seeds, many of our D90 results in post-implant dosimetry actually exceed 100% of the prescribed dose. Several even exceed 120% of the 'prescribed' dose, and this is intentional. Nevertheless, the radionuclide, source strength, number of seeds, and duration of implant (permanent) indicated on part 2 of each written directive (the part completed following implantation but prior to release of the patient) correctly reflects what was done, as required by 10 CFR 35.41. The RSO called RHB about these three cases because the dose delivered to parts of these prostate glands was less than intended, an anticipated but initially unplanned result due to known but unplanned and uncontrollable outside factors. The Authorized Users for these cases are still reviewing the clinical data to determine what, if any, additional medical actions will be taken. Note that none of these cases meet the criteria for a medical event as recommended by the Nuclear Regulatory Commission's Advisory Committee on the Medical Use of Isotopes on October 18, 2011 (see attached). These criteria analyze the spatial distribution of seeds within octants of the gland as well as the overall D90 (threshold for which is lowered to 60% of prescription dose, and only in conjunction with failure of the spatial analysis). In each of these cases (and in contrast to what happened in the VA cases), very few seeds (only a few percent) were implanted outside the planning margin of the prostate CTV. Even by the older document the state reference, the May 18, 2011 Prostate Permanent Implant Brachytherapy and Associated Medical Event Questions and Answers from Clarification of Current Guidance for Prostate Permanent Implant Brachytherapy, the hospital assert (as in Case 2) that ' in accordance with NRC regulations, a ME has not occurred, since the delivered activity is equal to the prescribed activity for the treatment site (as defined by the AU). Even though the D90 values differ by more than 20 percent; the AU does not use D90 to prescribe dose, and is therefore, not required to use D90 to perform the regulatory evaluation of the prescribed dose'. CA 5010 Number: 101712 | ||
| ENS 48058 | 2 May 2012 07:00:00 | Agreement State | Agreement State Report - Potential Medical Event Due to Leaking I-125 Seeds | The following was received via e-mail: On 6/28/12 Saint Joseph Hospital personnel were surveying a packing materials used to ship I-125 seeds, for a procedure conducted earlier that day, when they noted elevated readings. Further surveys revealed that the elevated readings were not coming from the packing material associated with the 6/28/12 procedure but from packing material that was used to ship I-125 seeds for a previous procedure, which was in the area of the survey. Surveys of the packing material revealed no loose contamination on the exterior or interior of the box but elevated readings of 2500-350000 cpm and .2 mrem/hr. Receipt and post procedure surveys of the procedure associated with contaminated box did not reveal any abnormal readings. The Saint Joseph RSO assumes the material is I-125 but they do not have the capability to verify this. No loose seeds were found in any of the packing material. The I-125 seeds were accompanied by the manufacturers leak test report which indicated no contamination. The patient, whose procedure was associated with the contaminated packing material, will be evaluated on Monday 7/2/12 to determine if there was any uptake in his urine or thyroid of I-125 as a result of leaking seeds. CA Report Number: 062912 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.
This is a follow up of an incident, as information only, on Friday, June 29, 2012. Radiologic Health Branch reference would be 5010 #062912. The notification was about contaminated packaging that had contained Best Medical I-125 seeds. A thyroid count was performed on the patient who had the seeds implanted in May. The thyroid count verified that there had been an uptake of iodine by the thyroid. Below is the write up and preliminary dose estimate from the licensee regarding. Based upon this morning's patient measurements, instrument-manufacturer supplied efficiency data, and reference data for dose conversion, we estimate the patient involved received a thyroid uptake of 0.1 mCi of I-125 and a dose to the thyroid of 300 cGy. 1) Conversion of counts per minute (cpm) to activity Two(Pi) counting efficiency for I-125 (per manufacturer) is 133.5% fraction of 2(Pi) solid angle subtended by a 2 inch diameter detector at a distance of 30 cm from the thyroid is 10.13 squared cm / 5654.9 squared cm = 0.00179 overall efficiency = 1.335 x 0.00179 = 0.00239 (190493 - 30) net cpm / 0.00239 x 4.505x10-10 mCi/dpm = 0.0359 mCi present thyroid burden. Back-correcting 60 days to time of implantation (conservatively assuming that all uptake occurred at that time) with 42-day effective half-life, initial uptake given by 0.0359 / 0.3715 = 0.0967 approximately 0.1 mCi 2) Taking the value quoted by Chen et.al. (attached) from NUREG/CR-6345, we assume the dose to thyroid is 780 cGy per mCi of I-125 administered, and this value assumes 25% uptake into the thyroid. Our calculated estimated thyroid burden of 0.1 mCi then gives an estimated absorbed dose of 0.0967 mCi x 780 cGy/mCi / 0.25 (since we measured actual thyroid burden v. amount administered) = 302 cGy approximately 300 cGy (rad) to thyroid. 3) Whole body committed effective dose equivalent (CEDE) from a 300 rad dose to the thyroid (using a thyroid weighting factor of 0.04) would be 12 rem. Notified R4DO (Allen) and FSME (Einberg).
EVENT SUMMARY: While surveying an empty brachytherapy seeds package for return to Best Medical hospital personnel discovered contamination on the interior of the package. Follow up thyroid scans of the patient who was implanted with the seeds associated with the package verified an uptake of I-125 by the patient's thyroid. The initial report to RHB was intended, by the licensee, to be a notification of a Medical Event. REPORTING: This event was reported to the NRC, by phone, on 4/13/12, at 8:50 am via email. HEALTH AND SAFETY: Based on surveys of the packing material all contamination was contained within the package and did not pose a threat to hospital personnel. The estimated dose to the patient's thyroid was calculated to be approximately 330 rad with a CEDE of 12 rem. ADDITIONAL DETAILS: The RSO conducted an investigation of the incident and could not find any indication that there were any irregularities with the implantation procedures. Hospital personnel associated with the procedure indicated to the RHB inspector that there were no irregularities with the procedure. In addition receipt surveys of the package did not reveal any contamination of any of the packaging material. The RSO concluded that the cause of the contamination was due to a manufacturing error. The RSO of Best Medical conducted an investigation of the production of the seeds implanted in the patient. All records at Best Medical indicate that all QC tests of the seeds were done satisfactorily. The RSO concluded that the seeds had been damaged in transit or that Saint Joseph personnel must have damaged the seeds either during the initial surveys or during the implantation. The Best Medical RSO was unable to explain how the seeds could have been damaged and still be implantable. The Virginia Department of Health inspected the Best Medical facility and concluded that all QC testing on the seeds had been completed satisfactorily with no abnormalities noted. After interviewing Saint Joseph and Best Medical personnel RHB personnel concluded that the most logical explanation for the leaking seeds was a manufacturing error, however, without samples from the same lot of seeds implanted available for analysis this can not be proven conclusively. The hospital has changed suppliers for the brachytherapy seeds. In addition they have initiated a procedure where the needles containing the seeds are wiped after they have been removed from the shipping container. ENFORCEMENT ACTIONS: The hospital was not cited for this incident. INVESTIGATION STATUS: This investigation is closed. Notified R4DO (Spitzberg) and FSME Event Resource via email. | ||
| ENS 47831 | 4 April 2012 07:00:00 | Agreement State | Agreement State Report - Tc-99M Generator Inadvertantly Sent to Non-Licensed Recipient | The following information was received from the State of California by email: The hospital had sent a depleted Tc-99m generator to an incorrect recipient, a non-licensee. They had intended to return it to Mallinckrodt in St. Louis, (Missouri). He (RSO) thought the generator still contained about 100 mCi. The package was shipped on 4/4/12, and was retrieved on 4/6/12 after the mistake was discovered. The package was returned to Saint Joseph Hospital and the following week the hospital resent the package to the correct recipient, Mallinckrodt. | ||
| ENS 47484 | 25 November 2011 08:00:00 | Agreement State | Agreement State Report - Package Containing Radioactive Material Left Unattended | The following was received from the State of California via email: During the holiday weekend, November 26, 2011, (a carrier) delivered a source containing 11.35 Ci of Ir-192 to Saint Joseph Hospital in Eureka, CA. There were no radiation safety personnel on site to receive the package and (the carrier) left the package with the receptionist, who is not authorized to receive radioactive material. The package was stored in the shipping and receiving area over the weekend. On Monday, November 28, 2011, the RSO became aware that the package had been sitting unsecured in the shipping and receiving area all weekend and notified the CA/RHB (California Radiation Health Branch). CA 5010 Number: 112811 |