PMID- 30503282
OWN - NLM
STAT- MEDLINE
DCOM- 20191216
LR  - 20191217
IS  - 1873-1449 (Electronic)
IS  - 1538-4721 (Linking)
VI  - 18
IP  - 3
DP  - 2019 May-Jun
TI  - Risk analysis of electronic intraoperative radiation therapy for breast cancer.
PG  - 271-276
LID - S1538-4721(18)30624-X [pii]
LID - 10.1016/j.brachy.2018.10.007 [doi]
AB  - PURPOSE: To evaluate the process and improve safety of intraoperative radiation 
      therapy (IORT) for early-stage breast cancers treated with electronic 
      brachytherapy. METHODS AND MATERIALS: A multidisciplinary team conducted a 
      failure mode and effects analysis (FMEA) for IORT breast cancer treatments by 
      first developing a process map. This map was then used to identify failure modes 
      for all steps in the treatment workflow. Risk priority numbers (RPNs) were 
      assigned to each failure mode and were calculated as the product of the failure 
      mode's probability of occurrence (O), severity (S), and lack of detectability 
      (D). Corrective steps were implemented to address failure modes with the highest 
      risk, and a revised process was generated. RESULTS: The steps with the highest 
      risk failure modes were related to source calibration, use of correct plan and 
      dwell times, and the correct site and intent. The introduction of a physician 
      calibration check and an extended time-out checklist reduced the risk of these 
      failure modes. The highest risk steps in the Xoft breast IORT treatment process 
      are associated with source calibration and manual entry of dwell positions for 
      each balloon size and volume combination. High-risk failure modes that could be 
      mitigated with improved hardware and software interlocks were identified. 
      CONCLUSION: High-risk failure modes are identified with FMEA and addressed with 
      corrective steps. This application of FMEA can be used in principle for clinical 
      processes throughout breast cancer care. This analysis demonstrates the 
      importance of well-designed QC policies, procedures, and oversight in a Xoft 
      electronic brachytherapy program for breast cancer IORT.
CI  - Copyright (c) 2018 American Brachytherapy Society. Published by Elsevier Inc. All 
      rights reserved.
FAU - Rash, Dominique
AU  - Rash D
AD  - UC San Diego Radiation Medicine and Applied Sciences, La Jolla, CA.
FAU - Hoffman, David
AU  - Hoffman D
AD  - UC San Diego Radiation Medicine and Applied Sciences, La Jolla, CA.
FAU - Manger, Ryan
AU  - Manger R
AD  - UC San Diego Radiation Medicine and Applied Sciences, La Jolla, CA.
FAU - Dragojevic, Irena
AU  - Dragojevic I
AD  - UC San Diego Radiation Medicine and Applied Sciences, La Jolla, CA. Electronic 
      address: idragojevic@ucsd.edu.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20181130
PL  - United States
TA  - Brachytherapy
JT  - Brachytherapy
JID - 101137600
SB  - IM
MH  - Algorithms
MH  - Brachytherapy/adverse effects/*methods
MH  - Breast Neoplasms/pathology/*therapy
MH  - Calibration/standards
MH  - Electronics
MH  - Female
MH  - *Healthcare Failure Mode and Effect Analysis
MH  - Humans
MH  - Medical Errors/prevention & control
MH  - Probability
MH  - *Process Assessment, Health Care
MH  - Risk Assessment
MH  - Time Factors
MH  - Workflow
OTO - NOTNLM
OT  - Breast radiation therapy
OT  - Electronic brachytherapy
OT  - Intraoperative radiation therapy
OT  - Safety improvement
EDAT- 2018/12/07 06:00
MHDA- 2019/12/18 06:00
CRDT- 2018/12/04 06:00
PHST- 2018/09/12 00:00 [received]
PHST- 2018/10/29 00:00 [revised]
PHST- 2018/10/31 00:00 [accepted]
PHST- 2018/12/07 06:00 [pubmed]
PHST- 2019/12/18 06:00 [medline]
PHST- 2018/12/04 06:00 [entrez]
AID - S1538-4721(18)30624-X [pii]
AID - 10.1016/j.brachy.2018.10.007 [doi]
PST - ppublish
SO  - Brachytherapy. 2019 May-Jun;18(3):271-276. doi: 10.1016/j.brachy.2018.10.007. 
      Epub 2018 Nov 30.