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EN Revision Text: AGREEMENT STATE REPORT - PATIENT SKIN CONTAMINATION The following was received from the Commonwealth of Pennsylvania via email: On May 29, 2018, the Department's (Bureau of Radiation Protection) staff in Central Office became aware of a medical event (ME) at U PENN hospital in Philadelphia. The ME is reportable as per 10 CFR 35.3045(a)(1)(i) and also meets criteria for an Abnormal Occurrence. On May 25, 2018, a 17 year old pediatric patient underwent an 834 millicurie metaiodobenzylguanidine (MIBG) lodine-131 (I-131) treatment for brain cancer. The dose was delivered in a 30 ml syringe and infused via an automatic pump. The nuclear medical technician present during the infusion reported seeing a small amount of blood, but other than that, nothing unusual was noted. However, upon completion of the infusion, meter readings noted high activities on the patient's clothing and bed linen. The possible reason given being a faulty connection line on the automatic pump. The contamination is believed to have also been present on the skin all weekend. Due to the large dose of I-131 infused, the licensee's staff were not able to see the contamination on the patient's skin until he developed erythema. The licensee is in the process of doing a dose reconstruction for the skin contamination. Based on the reading from the patient and estimated activity in the various contaminated items, the licensee currently estimates that approximately 50% of the intended dosage was successfully infused. The authorized user has been informed and is currently notifying the patient's parents and the referring physician. A reactive inspection is planned by the Department. More information will be provided upon receipt. PA Event Report ID No: PA 180012 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 JOHN CHIPPO TO DONALD NORWOOD AT 1451 EDT ON 7/12/2018 * * *

The University of Pennsylvania (U Penn) reported that a patient's skin became contaminated during medical treatment on 5/25/2018. The 17-year-old pediatric patient was scheduled to receive 30.86 GBq (834 mCi) of I-131 metaiodobenzylguanidine (MIBG) for treatment of brain cancer. The dosage was delivered in a 30 ml syringe and infused via an automatic pump. The nuclear medicine technician present during the infusion saw a small amount of blood, but nothing unusual other than that was noted. However, upon completion of the infusion, radiation surveys revealed high activities of I-131 on the patient's clothing and bed linen. U Penn stated that the patient's upper right thigh was cleaned. On 5/27/2018, the patient reported discomfort and reddening (i.e. erythema) on the skin of his upper right thigh, which developed into a lesion and further into desquamation (grade 3) the next day. Radioactive contamination is believed to have been present on the patient's skin for 24 to 48 hours. Based on U Penn measurements, nuclear medicine imaging, and the patient's clinical symptoms, the dose to the skin was estimated to be between 50,000 and 120,000 cGy (rad) to a 15 cm2 area. Radiation safety staff consulted with U.S. DOE's REAC/TS in Oak Ridge TN, to verify dose calculations. Calculations of the activity in the waste and the exposure rate from the patient in previous treatments estimated the activity delivered at 15.54 GBq (420 mCi). It was calculated that approximately 7.77 GBq (210 mCi) went to the waste. The cause of the incident is believed to be a faulty connection line on the automatic pump. The patient was also disconnected from the infusion pump at the 'Spiros tube' to use the lavatory part way through the procedure. Due to the large dosage of I-131 infused, U Penn staff were unable to detect the contamination on the patient's skin until he developed erythema. The authorized user was informed and notified the patient's parents and referring physician. Pennsylvania DEP, Bureau of Radiation Protection, performed a reactive inspection on 6/7 and 6/13/2018. U Penn is conducting a full root cause analysis to develop and implement corrective actions. Procedures that have already been implemented for I-131 MIBG patients included placing absorbent chucks between all parts of the infusion line and the patient's body and requiring an authorized user to be contacted for approval if it is necessary to disconnect a patient during the infusion. Root Cause(s): possible equipment failure, training, and/or human error in connecting the line to the infusion pump. Actions: A reactive inspection has been completed by the Department. More information will be provided upon receipt from U Penn. Notified R1DO (Bower), NMSS Events Notification E-mail Group, and INES Coordinator (Milligan).

• * * UPDATE FROM JOHN CHIPPO TO HOWIE CROUCH AT 1102 EDT ON 8/7/18 * * *

The following update was received from the Commonwealth via fax: Licensee has provided additional information; Corrective Actions include: A complete evaluation is being performed of the infusion system used for this treatment to identify any deficiencies, including comparison of CT imaging of the Spiros connection used in this treatment and an unused one. A multidisciplinary I-131 MIBG team with representatives from Nuclear Medicine, Radiation Safety, Nursing and Oncology has been established. The team will meet regularly to review and update policies and procedures for I-131 MIBG therapies. Some immediate steps have included: (1) use of absorbent material under the administration line over the patient's body, (2) a change to the administration procedure to require that the infusion not be stopped unless medically necessary and determined by the Authorized User, (3) planned implementation of continuous patient observation during administration including evaluation of the use of portable video monitoring, (4) a new procedure has been implemented to address patient fluid management prior to and during infusion, (5) a review of the infusion system has commenced with focus on the Spiros connector, including additional training on their use. Patient specific decontamination procedures have been developed for each treatment treated since the incident. Since decontamination procedures must take into account the patient's age and medical condition, it has been necessary that the medical staff have major input into the procedures for these patients. The knowledge gained from the patient-specific decontamination procedures will be used to refine the decontamination SOP. For therapeutic doses in which an activity on the skin that would result in desquamation can be two thousandths of a percent of the dose. It is important to be able to make measurements in these difficult environments. Testing has begun to determine the capabilities of systems that might be used to measure betas in environments in which gammas are several orders of magnitude more abundant than betas. Radiation Safety incident response procedures have been revised to include a time out and immediate involvement of additional Health Physics staff during incidents, including during possible Medical Events. The procedure is aimed at refocusing the attention of Health Physicists on all aspects of the incident response, and to prevent the Medical Event reporting requirements from distracting attention from other aspects of the response. CAUSE OF THE EVENT: a) A leak in the system caused by a failure of the Spiros connection in the infusion line. b) Policies and procedures relating to I-131 MIBG dose administration lacked coordination and oversight. SOPs have been managed separately by each Department (Nursing, Nuclear Medicine, Oncology, and EHRS). c) Policies and procedures relating to patient contamination and decontamination during dose administration were incomplete. ACTIONS: A reactive inspection has been completed by the Department. Notified R1DO (Cahill), NMSS Events Notification (email), and INES Coordinator (Milligan).

• * * UPDATE FROM JOHN CHIPPO TO OSSY FONT AT 0833 EDT ON 10/12/2018 * * *

The following was received from the Commonwealth of Pennsylvania via email: UPDATE 3, clarifications: The written directive prescribed 30.23 GBq (817 mCi) of I-131. The dosage administered measured 30.86 GBq (834 mCi) and was delivered over the course of 90 minutes. The estimated activity delivered to the correct treatment site was determined to be 22.68 GBq (613 mCi), not 15.54 GBq (420 mCi) as previously reported. No decontamination of the patient (right upper thigh) was performed at the time the contamination of bed linens and pants was discovered. This wasn't completed until signs of erythema were present. PA Event Report ID No: PA 180012 NRC Item# 180252 Notified R1DO (Dentel), and NMSS Events Notification and INES Coordinator (Milligan) via email.

The following information was received via E-mail: During the process of shredding filters for cement solidification, the licensee had an unplanned contamination event. Loose surface contamination was spread throughout the building with an estimate of total activity being 2 milliCuries and the primary isotope being Cobalt-60. In addition to building surfaces, several personnel who were working in the area at the time were contaminated. It is unclear at this time the extent of the personnel contamination but inhalation and skin contamination are believed to have occurred. The licensee is currently decontaminating the area using protective clothing and respiratory protection, monitoring the individuals who were working in the area during the time of the event, and has sent a sample of the material to an independent lab for isotopic analysis. The licensee will be performing a root cause analysis and the state will perform a reactive inspection. The cause of the event is unknown at this time. PA Event Report ID No: PA180016

• * * UPDATE ON 8/29/2018 AT 1354 EDT FROM JOHN CHIPPO TO BRIAN LIN * * *

The following update was provided via E-mail: During the process for cement solidification of shredded filter materials the licensee's mixing unit auger became stuck. Technicians eventually, through the use of various manual and air tools, were able to remove the blockage and resume the solidification process. At this time the unit was run again with only a cement mixture with no filter media to create a cap in the disposal container. Upon completion of this procedure a crane operator entered the containment area to remove the filter media hopper from atop the unit. He had forgotten his hard hat and immediately left containment and the H-1 building to retrieve his hat. Upon entering the Personnel Contamination Monitor (PCM) he then set off the alarm. This was the first indication of contamination. The RSO was immediately contacted and all remaining personnel exited the building and were found to be contaminated. Immediately upon discovery of the incident, all doors to the contaminated building (the H-1 building) were locked, all operations equipment was placed in the off position, and the building was secured. Building access was then restricted. The plant manager stopped all work at the site and informed his chain of command. In the days following the event the licensee performed a detailed survey to assess the extent of contamination. The survey showed general distributed contamination of the horizontal surfaces within the building. The maximum contamination level identified with this survey was 800,000 dpm/100cm2. The primary isotope was Co-60 (-90%), with Mn-54 and Sb-125 as other contributors. Seven personnel exhibited general distributed contamination of varying amounts on their exterior clothing and/or shoes and had indication of inhalation of radioactive material. All showered in the onsite Decontamination Room and then were monitored with an extended count in the PCM and all were released with only gamma related upper torso activity. Nasal swabs from affected personnel were analyzed, however the license has yet to share these or any other personnel dose data. Daily extended PCM counts continue for available personnel who exhibit upper torso gamma activity. Four individuals continue to exhibit this activity. In addition, in-vivo and in-vitro bioassay measurements were initiated and are in progress to complete the internal dose assessment process. It is expected that the offsite laboratory bioassay measurement data will be available in 2-3 weeks and the internal dose assessment will then be completed. The H-1 Building Containment itself remains restricted. The H-1 Building Containment will remain restricted and the work activities related to the encapsulation of materials inside this containment have been suspended indefinitely. This status will continue until corrective actions have been implemented in order to prevent a reoccurrence of this incident. The licensee contends the initial root cause of the incident was inadequate procedure implementation and training regarding radiological containment inspection and certification. Corrective actions that are planned include: 1. H-1 Building Containment program overhaul. 2. Upgrade procedures to include routine containment inspections to be conducted and implement additional independent verification by Alaron's Radiation Safety staff. 3. Highlight Operational procedures to require signature requirement verifying proper ventilation alignment is functioning prior to commencement of work. 4. Alarming differential pressure gauges will be installed on the HEPA units to provide warning of both HEPA buildup and/or breakthrough. 5. The RSO will review the current application of constant air monitors against problematic conditions such as radon gas buildup to ensure alarm setpoints can adequately protect workers from excessive derived air concentrations in the work zone and retrain all staff. 6. The RSO will review and upgrade shield frisking stations to ensure proper contamination control in areas that have a high dose background. 7. Implement a recurring refresher training program in addition to the recertification training programs. 8. General Manager to conduct an all hands 1-day stand down to communicate priorities (i.e. Safety, Health and environmental stewardship are the top priorities; anyone can stop a job if they feel any of these are being compromised, etc.) The cause of the event is believed to be inadequate procedure implementation and training. RIDO (Lilliendahl) and NMSS were notified.

EN Revision Text: AGREEMENT STATE REPORT - FAILED MOISTURE GAUGE SHUTTER The following was received from the Commonwealth of Pennsylvania via e-mail: The licensee reported that on March 21, 2019, the Berthold Technologies Model LB-7 410 moisture gauge containing 300 milliCuries of americium-241 was not able to operate as designed; the shutter locking mechanism cylinder was able to be pulled out of the gauge. The gauge was being removed from the east side of #3 Blast Furnace to the storage area at the Blast Furnace spares building. A service provider was already scheduled on site to observe removal and transport of the gauge. A contract employee working with the service provider stated that the cylinder was able to be pulled out of the gauge. The cylinder was never fully removed, but if it was, this would allow the shutter to be manually opened or closed. The cylinder locking device was depressed by the service provider employee and it is currently in that condition. The shutter can't be moved with the cylinder depressed. The gauge is currently locked in the storage area at the Blast Furnace spares building. All work was performed using ALARA principles and at no point were employees exposed to excess levels of radiation. Survey results indicated no abnormal amounts of radiation in the area before, during, or after the removal of the device. Berthold has been contact for repair or replacement. PA Event Report ID No: PA19001

• * * RETRACTION FROM THE JOHN CHIPPO TO CATY NOLAN ON 4/24/19 AT 1059 EDT * * *

The following was received via fax: A follow-up interview and review of the operation of the locking mechanism was conducted with the contract employee. It was determined that the contract employee was unfamiliar with the operation of the locking mechanism at the time of the removal and that the cylinder never was able to be pulled out of the gauge. Based on this investigation, it has been determined that there was not a failure of the locking mechanism or shutter during the removal of the gauge on March 21, 2019. Therefore, this event should be retracted from NMED. Notified R1DO (Lilliendahl) and NMSS Events (via email).

The following was received by email from the Commonwealth of Pennsylvania: On Friday, June 14, 2019, the licensee experienced an equipment failure event during a brachytherapy treatment where the source failed to retract from the patient at the end of the treatment time. The catheter was immediately manually removed from the patient and placed in the emergency container and locked up. No harm is expected to the patient and no overexposures occurred. The HDR (High Dose Rate) unit, an Elekta Flexitron Model 136149A02, contained an iridium-192 source less than 12 Curies. The vendor, Best Vascular, was immediately notified and will be on site today, June 17, 2019, to retrieve the source and repair the device. The DEP (PA Department of Environmental Protection) will update this event as soon as more information is provided. The DEP will perform a reactive inspection. More information will be provided as received. PA Event Report ID No: PA-190014

• * * UPDATE FROM JOHN CHIPPO TO OSSY FONT ON 6/19/19 AT 1002 (EDT) * * *

The following information was received from the DEP via fax: On Monday, June 17, 2019, a service engineer from Best Vascular was able to drive the sources into the catheter and retract them into the device several times without incident. The licensee now believes the CVBT (CardioVascular BrachyTherapy) catheter was not fully seated into the device, causing a small leak and a subsequent pressure differential which does not allow the source to fully retract into the device. The cause of the event is believed to be operator error. The DEP will perform a reactive inspection. Notified R1DO (Greives) and NMSS Events Notification via email. 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.

EN Revision Text: AGREEMENT STATE REPORT - MEDICAL EVENT The following was received from the Commonwealth of Pennsylvania via email: The Department (Pennsylvania Department of Environmental Protection) received notification from a licensee on November 6, 2019 that on October 8, 2019 they performed a prostate seed implant on a patient including seventy (70) stranded I-125 seeds that were implanted into the prostate treatment volume. They were Best Medical, Model 2301, Lot 48917, at 0.350 mCi per seed and 24.5 mCi total activity. The patient had an appointment on November 5, 2019 for a 30-day post-plan analysis. The CT from November 5, 2019 noted 2 seeds that were outside the prostate volume in the peril-prostatic fat. The post-plan analysis showed that 68 of 70 seeds are within the treatment volume and 94.4 percent of the treatment volume is covered by the prescription dose, which are within appropriate specifications for a prostate seed implant. The two seeds in question are considered discontinuous from the treatment volume. The licensee believes when the needle was retracted, the strand of seeds drug back with the needle and was deposited inferior from their intended location. An analysis was performed by the licensee and no adverse effects to the patient are expected. Both the patient and referring physician were notified. The Department will update this event as soon as more information is provided. Pennsylvania Event Report ID No: PA190026 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.

• * * RETRACTION ON 11/19/19 AT 1148 EST FROM JOHN CHIPPO TO THOMAS KENDZIA * * *

The following was received from the Commonwealth of Pennsylvania via fax: As a result of a reactive inspection by the Department and an extensive review by the licensee, the licensee has determined the tissue containing the two seeds is within the contiguous peril-prostatic fat, which is actually physically adjacent to or touching the prostate, therefore this is not a reportable event. Further, changes noted in the radiograph taken on the day of the implant and the post-plan CT can be accounted for by the difference in patient positioning; from the lithotomy position for the implant image to the supine position for the post-plan image. Notified the R1DO (Cahill) and NMSS Event Notification via email.

EN Revision Imported Date : 1/10/2020 AGREEMENT STATE REPORT - HIGH DOSE RATE APPLICATOR DISLODGED The following was received from the PA Department Bureau of Radiation Protection (DEP) via fax: On December 16, 2019, the medical physicist for the licensee verbally reported that during an HDR (high dose rate) treatment using a Varian Model VariSource IX with a Tandem & Ovoid applicator, the applicator was found dislodged at the end of the treatment period. This was fraction 4 of 5 planned fractions. It is unknown at this time how long the applicator was not in the planned position or what caused it to move. The prescribed dose was 600 cGy from a 5.126 Ci Iridium-192 source. No further information is available at this time. The DEP will update this event as soon as more information is provided. Event Report ID No: PA190029 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 ON 1/9/20 AT 1:17 PM FROM JOHN CHIPPO TO KARL DIEDERICH * * *

The following information was received from the Agreement State via fax: The patient was seen on 12/27/2019, 12/30/2019, and 1/6/2020 for follow-up appointments. Observed skin effects were described as 'moist desquamation' due to the applicator being dislodged from the vaginal canal and positioned against the skin. The patient is being treated with Silvadene topical cream and will be followed up with regular skin checks. Based on the evidence observed, the licensee assumes that the applicator was against the skin long enough to deliver a skin dose in the range of 10-30 Gy. This dose makes the event a potential Abnormal Occurrence. The Department has performed a reactive inspection and continues to investigate the event. Notified R1DO (Schroeder) and NMSS group (via e-mail).

The following was received from the State of Pennsylvania via E-mail: The (PA DEP Bureau of Radiation Protection) Department received notification from a licensee on April 3, 2020 of a medical event involving Y-90 TheraSphere microspheres. The licensee believes a patient undergoing a multiple lobe injection of the liver received only 62.7 percent of the prescribed dose in one of the lobes. The second lobe is believed to have received the correct dose. The DEP is currently in contact with the licensee and will update this event as soon as more information is provided. The Department will perform a reactive inspection as soon as possible. Pennsylvania Event Report ID No.: PA200007

• * * UPDATE ON 04/07/2020 AT 1353 EDT FROM JOHN CHIPPO TO JEFFREY WHITED * * *

The following was received from the State of Pennsylvania via E-mail: The patient was prescribed TheraSphere Y-90 Microspheres at 2.47 GBq total with 2.25 Gbq prescribed to the liver because of 9.1 percent lung shunt. The licensee reports total dose 1.536 GBq, and 1.4 GBq to liver. Ultimately only 62.7 percent (75.3 Gy) of the planned dose was able to be administered to segment 6 of the liver. While attempting to administer the Y-90 dose to treat a lesion in Segment 6 of the liver there was significant resistance to flow. The AU evaluated the microcatheter system to ensure that there were no kinks along the catheter course external to the patient or visualized internally under fluoroscopy. The licensee believes the issue came from blockage at or before the 'E' site on the labeled tubing of the administration set, given that when it was disconnected from the microcatheter at that location, they were able to successfully flush the catheter. The patient then had a subsequent segment 7 segmentectomy using tubing from a box set from a different lot number without incident. No adverse effects to the patient are anticipated and the patient and referring physician were notified the day of the event. Notified R1DO (Lilliendahl) and NMSS Events Notification via email. 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.

The following information was received via email: The Department (Pennsylvania Bureau of Radiation Protection) received notification from a licensee on May 5, 2020, of a medical event involving a Varian GammMedplus iX high dose rate remote afterloader (HDR) containing 8.6 Ci of iridium 192. The patient was set to receive 10 fractions (channels) of breast cancer treatment. An error was noted when treatment from the third channel was attempted. The source was retracted back into the safe position upon the error indication. Staff reset the unit and rebooted. The unit functioned normally for the fourth channel. During the fifth channel the machine experienced another fault, but the source did not automatically retract. Staff then attempted two emergency stop procedures; however, both failed. Staff were finally able to manually retract the source after approximately two to four minutes; however, it hasn't been determined if the source was completely retracted into the shielded safe on the HDR due to catheter interference. The patient was quickly disconnected from the catheter, everyone was immediately removed, and the room was secured from entry. No dose is expected outside the HDR room as it is housed within an accelerator vault. The manufacturer has been contacted. The licensee has also requested the log files from the manufacturer for dose reconstruction of those involved. The department is currently in contact with the licensee and will update this event as soon as more information is provided. PA Event Report ID No: PA200011

• * * UPDATE ON 5/7/20 AT 1208 EDT FROM JOHN CHIPPO TO ANDREW WAUGH * * *

The following information was received via email: Manufacturer service technicians removed the wire/source from the afterloader on 5/6/2020. Preliminarily, it appears the source became stuck approximately 4 to 5 inches from the shielded park position (inside the afterloader, but outside the shielded safe). Dosimetry badges have been sent for emergency read, results are expected today, and those results are expected to be minimal. The patient and all personnel involved were surveyed after the incident and readings were at background levels. Notified R1DO (Dentel) and NMSS Event Notifications (email).

• * * UPDATE ON 5/12/20 AT 1158 EDT FROM JOHN CHIPPO TO JEFFREY WHITED * * *

The following information was received via email: The preliminary dosimetry report indicates three staff members involved in the event. The technologist received 4 mrem whole body dose, the authorized user received 3 mrem whole body dose and the AMP received 3 mrem whole body dose and a 15 mrem dose on their finger dosimeter. No other dose information was received at this time. Notified R1DO (Lally) and NMSS Event Notifications (email). 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.