ENS 46522
ENS Event | |
|---|---|
06:00 Jul 13, 2010 | |
| Title | Kentucky Agreement State Report - Medical Misadministration |
| Event Description | {{#Wiki_filter:The following information was obtained from the State of Kentucky via email:
The event timetable began on 12 July 2010 when the Medical Physicist entered the pre-treatment information into the facilities brachytherapy software package (VariSeed�, Varian Inc). The information included patient demographics, treatment date and radioisotope information; in this case I-125 encased in titanium for a treatment date of 13 July 2010. The medical procedure was carried out successfully and 97 seeds were implanted. This number of seeds is within the expected limit of what is normally encountered during these procedures and thus did not stand out as a triggering event for a double check. During a routine post-procedure review, conducted on 14 July 2010, the medical physicist identified a potential issue and began the chain of notification as required by the radiation safety office; medical, administrative and safety. The discrepancy arose from the identification of source activity, as indicated on the written directive versus the information printed on the post-procedure information sheet. The information had inadvertently been entered into the pre-procedure planning software in units of milliCurie while the units of measure were identified as units of 'U' [Air-Kerma], leading to a discrepancy in the delivered dose of approximately +27%. The specific information in this case indicated the strength was 0.410 U (0.323 mCi) while in reality the actual source strength was 0.521 U (0.410 mCi). The facility conducted a root-cause analysis that indicated two areas of concern for a root cause. The initial identified area of concern is the ability to enter information into an automated system in either of two separate units; 'U' or milliCurie. This was followed closely by the lack of a documented double verify means; which although always important to any therapeutic intervention, would have negated the incident in this case. Since the software does not allow for the exclusion of one unit in favor of the other, the root-cause is the failure to have in place a procedure that included the documented double-verification of the dose strength used in the calculations. In order to negate the recurrence of this type of error, the oncology physics section has implemented the following procedure. The therapeutic seeds will be ordered and received as is currently performed. The medical physicist will enter the information into the software package using the vendor supplied source strength of the implantable seeds; using the 'U' [Air-Kerma] value only. The Air-Kerma value has been chosen as the unit of preference because this is rapidly becoming the professional unit of choice by the medical physics community and is the default unit of the VariSeed� software package. Once in the operating room a time-out will be conducted between the medical physicist and the medical dosimetrist. The dosimetrist will observe the software settings while the medical physicist reads aloud the information contained in the 'Seed Count and Strength Verification' form including the seed strength; in 'U' [Air-Kerma], and procedure date. Both persons will then sign the form. The remainder of the process will remain unchanged. The patient was contacted by the radiation oncologist the morning of 15 July 2010 and returned for immediate CT imaging of the pelvis on 16 July 2010. The error was explained to the patient, as well as the urologist who assisted in the procedure, and additional monitoring of the prostate, rectum and urethra are to be conducted to better determine a dose distribution. At this point a general dose estimate is that the patient received 3,800 Rem greater than was intended. Although this estimate may be decreased or otherwise adjusted based on the serial monitoring to be conducted over the six months post-procedure. The procedure has been implemented and the physics section, including the radiation oncologist, have been in-serviced as of 26 July 2010. The State of Kentucky received the above notification from the licensee on July 28, 2010. According to the State of Kentucky, the licensee did not originally report this event (via telephone on July 15, 2010) as a medical event therefore the State did not report the event to the NRC Operations Center. During an interoffice review, the State determined that a miscommunication had occurred and they should have reported this event to the NRC. 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. }}[[Event description::Description::{{#Regex_clear:The following information was obtained from the State of Kentucky via email: The event timetable began on 12 July 2010 when the Medical Physicist entered the pre-treatment information into the facilities brachytherapy software package (VariSeed�, Varian Inc). The information included patient demographics, treatment date and radioisotope information; in this case I-125 encased in titanium for a treatment date of 13 July 2010. The medical procedure was carried out successfully and 97 seeds were implanted. This number of seeds is within the expected limit of what is normally encountered during these procedures and thus did not stand out as a triggering event for a double check. During a routine post-procedure review, conducted on 14 July 2010, the medical physicist identified a potential issue and began the chain of notification as required by the radiation safety office; medical, administrative and safety. The discrepancy arose from the identification of source activity, as indicated on the written directive versus the information printed on the post-procedure information sheet. The information had inadvertently been entered into the pre-procedure planning software in units of milliCurie while the units of measure were identified as units of 'U' [Air-Kerma], leading to a discrepancy in the delivered dose of approximately +27%. The specific information in this case indicated the strength was 0.410 U (0.323 mCi) while in reality the actual source strength was 0.521 U (0.410 mCi). The facility conducted a root-cause analysis that indicated two areas of concern for a root cause. The initial identified area of concern is the ability to enter information into an automated system in either of two separate units; 'U' or milliCurie. This was followed closely by the lack of a documented double verify means; which although always important to any therapeutic intervention, would have negated the incident in this case. Since the software does not allow for the exclusion of one unit in favor of the other, the root-cause is the failure to have in place a procedure that included the documented double-verification of the dose strength used in the calculations. In order to negate the recurrence of this type of error, the oncology physics section has implemented the following procedure. The therapeutic seeds will be ordered and received as is currently performed. The medical physicist will enter the information into the software package using the vendor supplied source strength of the implantable seeds; using the 'U' [Air-Kerma] value only. The Air-Kerma value has been chosen as the unit of preference because this is rapidly becoming the professional unit of choice by the medical physics community and is the default unit of the VariSeed� software package. Once in the operating room a time-out will be conducted between the medical physicist and the medical dosimetrist. The dosimetrist will observe the software settings while the medical physicist reads aloud the information contained in the 'Seed Count and Strength Verification' form including the seed strength; in 'U' [Air-Kerma], and procedure date. Both persons will then sign the form. The remainder of the process will remain unchanged. The patient was contacted by the radiation oncologist the morning of 15 July 2010 and returned for immediate CT imaging of the pelvis on 16 July 2010. The error was explained to the patient, as well as the urologist who assisted in the procedure, and additional monitoring of the prostate, rectum and urethra are to be conducted to better determine a dose distribution. At this point a general dose estimate is that the patient received 3,800 Rem greater than was intended. Although this estimate may be decreased or otherwise adjusted based on the serial monitoring to be conducted over the six months post-procedure. The procedure has been implemented and the physics section, including the radiation oncologist, have been in-serviced as of 26 July 2010. The State of Kentucky received the above notification from the licensee on July 28, 2010. According to the State of Kentucky, the licensee did not originally report this event (via telephone on July 15, 2010) as a medical event therefore the State did not report the event to the NRC Operations Center. During an interoffice review, the State determined that a miscommunication had occurred and they should have reported this event to the NRC. 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. }}| ]] |
| Where | |
|---|---|
| Medical Center At Bowling Green Bowling Green, Kentucky (NRC Region 1) | |
| License number: | 202-124-26 |
| Organization: | Kentucky Dept Of Radiation Control |
| Reporting | |
| Agreement State | |
| Time - Person (Reporting Time:+4233.85 h176.41 days <br />25.201 weeks <br />5.8 months <br />) | |
| Opened: | Marissa Vega Velez 16:51 Jan 5, 2011 |
| NRC Officer: | Howie Crouch |
| Last Updated: | Jan 5, 2011 |
| 46522 - NRC Website | |
Medical Center At Bowling Green with Agreement State | |
WEEKMONTHYEARENS 465222010-07-13T06:00:00013 July 2010 06:00:00
[Table view]Agreement State Kentucky Agreement State Report - Medical Misadministration 2010-07-13T06:00:00 | |