2013 Medical Errors Radioac3ve Materials

Transcription

1 2013 Medical Errors Radioac3ve Materials Mike Stephens, M.S. Florida Bureau of Radia8on Control HPS- AAPM Fall Mee8ng October 2014

2 Topics What is a Medical Error FY 2013 data Trending Future Regulatory Issues Examples

3 What is Medical Error Nuclear Materials Event Database (NMED) 10 CFR Medical Events 10 CFR (a) or (b) (a) More that 0.05 Sv (5 rem) EDE or 0.50 Sv (50 rem) to an organ, tissue or skin: AND > 20% Difference Total Dose Delivered Vs. Prescribed (or Range) Dose > 50% (any single fractionated dose) Vs. Prescribed Dose Wrong Drug Wrong Person Wrong Mode of Treatment Leaking Source > 50% of prescribed dose (excluding permanent implants that migrate) (b) Events where administration of radiation results in unintended permanent functional damage to an organ or physiological system, as determined by a physician.

4 2013 Medical Events of Interest 6 Significant Medical Events (33 total) 1 Overexposure Medical Event 1 Medical Equipment Failure Event 2 Medical Other Events

5 Medical Events Trending Na8onwide Total No Sta8s8cally Significant Trend Slight increase for Agreement States Slight decrease for NRC

6 Significant Trending Equipment not possible to discern from CFR repor8ng Other not possible to discern from CFR repor8ng Radia8on Overexposure - No sta8s8cally significant trends

7 Future Regulatory Issues Things to track 10 CFR Part 37 (78 FR Due in States by ) Physical Protec8on of Byproduct Material (See NUREG Implementa8on Guidance: hbp:// rm/doc- collec8ons/nuregs/staff/sr2155/) Security addi8on to Senate Energy and Water Development Appropria8ons Bill???? hbp:// Public access to NMED?

8 NMED (Abnormal Occurrence) Loca8on: University of Toledo (OH) Procedure: Prostate Seed Implant. Received 36% of prescribed D90 (6,400 cgy instead of 16,000 cgy) Event: Scan) Six I- 125 seeds implanted in the perineum that received 1,000 cgy. (Discovered during post- implant CT Root Cause: HUMAN ERROR. Inadequate ultrasound image during procedures, involvement of urology resident during procedure & poten8al tensioning adjustment issue on Mick Applicator. Outcome/CA: Pa8ent re- implanted later procedure, University revised procedures

9 NMED (Abnormal Occurrence) Loca8on: Rosa of North Dallas (TX) Procedure: HDR. Received less than 50% of prescribed dose (mean cervix dose of 1,390 cgy instead of 5,139 cgy ) Event: Physicist used 132 cm guide tubes instead of prescribed 120 cm for 3 of 4 frac8ons Root Cause: HUMAN ERROR. (Discovered aker 3 of 4 frac8ons) Correc8ve Act: Changes in procedures, equipment and training programs

10 NMED (Abnormal Occurrence) Loca8on: Abbot NW Hospital (MN) Procedure: HDR. Received zero dose (of 400 cgy) on 2 nd of 6 frac8ons Event: Treatment planning data entry error (Incorrect catheter length entered for 2 nd frac8on) Small bowel received 1,600 cgy Root Cause: HUMAN ERROR. Correc8ve Act: Remaining frac8ons adjusted to deliver prescribed dose. Procedures modified to add catheter length varia8ons in pre/post treatment checklist.

11 NMED (Abnormal Occurrence) Loca8on: Tuffs Medical Center (MA) Procedure: Gamma Knife. Treatment to wrong site. Event: Data entry error. On 2 nd treatment the Oncologist mistakenly entered coordinates for the right side of brain while lek side was prescribed. Right side treatment area received 7,500 cgy. (Discovered when Oncologist was dicta8ng end of treatment notes) Root Cause: HUMAN ERROR. Correc8ve Act: Implemented addi8onal 8me- out procedures and develop an updated gamma knife safety checklist.

12 NMED (Abnormal Occurrence) Loca8on: Cleveland Clinic Founda8on (OH) Procedure: Y- 90 microspheres. Treatment to wrong site. Event: A small shunt of microspheres occurred and duodenum received 6,200 cgy. Root Cause: Failure to iden8fy small shunt of microspheres not iden8fied at 8me of procedure. collateral vessels around planning and delivery of (Changes in or development of tumor between treatment microspheres.) Correc8ve Act: None listed in NMED report. Outcome: Endoscopy revealed ulcers in poten8ally affected areas.

13 NMED (Poten8al Abnormal Occurrence) Loca8on:?? (NY) Procedure: I MBq (225 microcurie) seed used for axillar node localiza8on. Event: I- 125 seed used for localiza8on procedure migrated and not recoverable. Es8mated dose at 0.5 cm from seed is 2,290 cgy. Root Cause: None iden8fied in report. (Reason given for not removing seed was due to excessive scarring from previous procedures.) Correc8ve Act: Facility no longer uses radioac8ve seeds for axillar node lesions.

14 NMED (Embryo/Fetus Poten8al Abnormal Occurrence) Loca8on: Bap8st Medical Center - Princeton (AL) Procedure: I GBq (50 millicuries) for thyroidectomy on 3/26 pa8ent pregnant. Es8mated dose to embryo/fetus 12.6 csv Event: 3/6 nega8ve pregnancy test & a posi8ve test before I- 131 procedure on 3/26. Technician not informed of test results. Pa8ent 4-5 weeks pregnant. Root Cause: Lack of procedures and aben8on to detail Correc8ve Act: New procedures, improved supervision and reprimanding involved personnel.

15 NMED (Embryo/Fetus Poten8al Abnormal Occurrence) Loca8on: Radiology Associates of Sacramento (CA) Procedure: I GBq (177 millicuries) Event: 2/18 a nega8ve pregnancy test & I- 131 administered on 2/20. On 4/22 pa8ent endocrinologist called to inform them pa8ent was pregnant. Based a 3/18 ultrasound they es8mate pa8ent was 2 week pregnant at 8me of I- 131 procedure. Es8mated dose to embryo/fetus was determined to be 47 cgy. Root Cause: None iden8fied in report. Correc8ve Act: None iden8fied in report.

16 Ques8ons? Contact Mike Stephens, Environmental Health Program Consultant Bureau of Radia8on Control 4052 Bald Cypress Way, Bin C21 Tallahassee, FL (Data Source: U.S.NRC Nuclear Materials Events Database Annual Report Fiscal Year 2013 hbps://nmed.inl.gov/)