Transcript File - College Of Imaging Administrators

College of Imaging Administrators
16 Annual Spring Assembly
Sheraton – Lisle Hotel
Lisle , Illinois
Friday, May 2, 2014
Greg Pilat
System Director Radiology
Advocate Health Care
630-575-3366 office/voice
[email protected]
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Radiation Dose Management
What to do with the Data
2
Disclosure
I have become passionate about safety
3
Learning Objectives
 Review recent events of “over-exposure”
 Understand safety from a:
–
–
–
–
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regulatory perspective
patient perspective
facility perspective
CT technologist perspective
How we got here – where we are going…
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How we got here – where we are going…
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How we got here today…
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Hippocratic Oath
 “Primum Non Nocere”
– First Do No Harm
– 4th Century BC
 One of the oldest binding documents in
history
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January 2001
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November 2007
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November 2007
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November 2007
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November 2007
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November 2007
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November 2007
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FDA: 2009
 Symptoms of overdoses of radiation during
CT brain perfusion begin to appear
 October 8: FDA Alerts Medical Community
 December 7: FDA makes interim
recommendations to review
– Imaging protocols
– Check radiation levels on scanners displays
16
Estimated 3 Million New Cancers From CT: 20-30 years
In the news … 3
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October 2009
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October 2009
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October 2009
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October 26, 2010
 FDA aware of 385 patients from 6 hospitals
exposed to excessive radiation
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November 2009
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December 2009
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November 8 , 2010
 FDA sends letter to CT manufacturers
recommending HW and SW changes to
reduce “the chance of overexposure”
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November 9, 2010
 FDA Recommends to CT facilities that
technologists understand:
– dosing information on the display screen
– Dose-saving features on the scanner
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November 9 , 2010
FDA Issues Final Report
1. Most over-doses result of user error
2. Manufacturers need to do a better job of
training and educating those using CT
equipment
3. CT machines need to have more effective
way of warning operators radiation levels
are too high
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November 16, 2010
 Marcie Iseli receives
too much radiation
during CT scan
 Cabell Huntington
Hospital –
Huntington , W. VA.
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Cabell Huntington Hospital,
Huntington, W. VA.
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Marcie Iseli
Nerve weakness one side of face, nausea
“The only thing I can remember is the
weakness, being tired, my hair started
coming out in clumps, my head was burning,
my face was really hot…”
Marcie Iseli
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January 18, 2012
 Marcie Iseli receives
letter from Cabell
Huntington Hospital
that she received
too much radiation
during her CT scan
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Timeline: 15 months between event
and communication to the patient
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Ms. Iseli’s lawyer
“It is unfathomable that Cabell Huntington
Hospital could make these mistakes after the
entire radiology world and the universe was
aware of the problems”
Mr. Patterson
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Congress
 Dr. Rebecca Smith-Bindman, Professor of
Radiology
– Testifies before Congress
– Need for more controls over CT scans
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June 2011
June 18, 2011
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Child Over-radiated
How will we answer
questions from this
family?
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California: CT Technologist
How will we answer
questions from this
family?
The California radiologic technologist
accused of operating the CT scanner that
delivered a massive radiation overdose to
a 23-month-old boy in 2008 testified that
she only pushed the CT scan button a few
times, and she doesn't understand how the
toddler received 151 scans in a single
imaging session…
38
West Virginia Hospital Overradiated Brain Scan
Patients, Records Show
Published: March 5, 2011
A large West Virginia hospital seriously overradiated patients suspected of having strokes
with CT scans for more than a year after similar
episodes prompted federal officials to alert
nationwide to be especially careful when using
those types of scans, interviews and documents
show.
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FDA
“The events of the past year have certainly
raised awareness of the issue.”
“…We suspect that overexposures continue to
occur and that incidents are underreported.”
Karen Riley, Spokewomen FDA
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Where we’re going
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More comments…
… more needs to be done. “An underlying
problem here… is that there are almost no
federal regulations controlling radiation
exposure form medical X-Ray scans, and it
seems high time that we consider legislation.
Dr. David J. Brenner, Director, Center for
Radiological Research, Columbia University
Medical Center
42
Los Angeles
“I cannot believe that this is not occurring in the
rest of the country…”
“ That’s why we are so keen on the rest of the
states to go look at this”
Kathleen Kaufman, Head of Radiation
Management, Los Angeles Country Dept of
Public Health
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MITA: Medical Imaging & Technology Alliance
 Integration of Appropriateness Criteria into Physician
Decision-Making
 National Dose Registry
 Storage of Diagnostic Information (Images/Dose) Within
the EHR
 Establish Minimum Standards of Training & Education
 Development of Operational Safety Checklist
 Standardization of Reporting Medical Errors Associated
with Radiation
44
MITA
 ALARA
 Image Gently: Alliance for Radiation Safety in Pediatric
Imaging
– (targeted training in pediatric CT)
 CT Dose Check Initiative (Dx/RT CT)
– Reduce cumulative dose (deploying notifications to
CT technologist when recommended dose levels will
be exceeded
– Reduce medical errors (dose alerts/auto shutoff)
– Consistent documentation of dose information
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Radiation Therapy Readiness Check
Initiative
 AdvaMed (Advanced Medical Technology
Association and MITA
– Patient protection for radiation therapy
equipment
– Treatment plans delivered as intended
– Proper patient positioning
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CA Governor Signs Radiation Overdose
Bill into Law – October 1, 2010
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Gov. Arnold Schwarzenegger
1st Law of Its Kind
Effective July 1, 2012
Requires Notification of state Dept Public
Health
The CA Laws Requires
 Record (if possible) the dose of radiation on every CT
procedure
 Dose verified annually (unless facility accredited) by a
health physicist
 Technical factors and dose sent to PACS
 Reporting within 5 days of any event
– Administration of Radiation results in a repeat exam
(unless ordered by MD or radiologists)
– Radiation of a body part other than that intended (if
certain dosages are exceeded)
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CA Law: Embryonic/Fetal Exposure
 >50 mSv (5 rem) dose equivalent
 Result of radiation to a known pregnant
individual unless
– Dose to embryo or fetus was specifically
approved, in advance by a qualified MD
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Collaborations
 FDA, NEMA, MITA
– Development of safeguards to prevent
overexposure
– Dose check notifications/time outs before the
delivery of high exposure
– Access control standard
• Privileges, verification of changes, tracking of
modifications
 AAPM: Physics Testing
 IEC: International Electrotechnical Commission
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My personal struggle
 What is my responsibility?
 What is my accountability?
 How do I get others to listen to me? To work
with me?
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Where do I start?
What is the “real” risk to radiation exposure?
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Answer: it is debatable
 Physicists argue from both a practical as well
as a theoretic perspective.
 We still use data from Hiroshima (1945) to
estimate the effects of radiation exposure on
todays populations.
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My answer
We must assume there is “risk” in all we do.
 Large or small
 Real or theoretical
As a “professional” I must work to mitigate that
risk where ever it exists.
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Back to CT
1. Create the baseline
 We collected dose data on every CT
 Top 5 Adult Procedures by Volume
 Top 5 Pediatric Procedures by Volume
 Reviewed data with health physicist
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Baseline Findings
 Significant variation in dose:
– Manufacturer to manufacturer
– Site to site
– Protocol to protocol
– Radiologists to radiologist
– Technologists to technologists
– Shift to shift
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Other Findings
 Training
 Not all technologists/radiologists participated
 No competency assessment
 Check-off
 Documentation lacking
 Protocols
Documentation
Review
Change Control
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The “Administrative Plan”
 Assess technologists understanding (aka competency)
– Equipment safety features
– Knowledge of risk factors
– Communication of risk to:
• Patients
• Referring Physicians
 Protocol selection
– Review/reduce variation where possible
– Expectation to challenge the status quo
– Establish a change control process and communication plan
 Install dose reducing software (OEM, 3rd Party)
– Conduct the dose vs. image quality (IQ) debate
 Participate in the ACR Dose Index Registry (DIR)
 Increase associate/physician education
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The “Patient Plan”
 Be prepared to answer patient FAQ questions
– Script responses
– Provide analogies to “risk”
 Over-exposure communication plan: Patient/ordering physician,
other:
– Who: will communication
– What: information will you communicate
– Where: face-to-face, phone or
– When: how soon after the event
 Documentation
 Collect data on patient questions
– What are their concerns/FAQs
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By show of hands…
a)
b)
Know the ranges of rad dose for high dose
procedures
Routine radiation safety education


c)
d)
e)
Conduct routine/annual protocol review
Have a change control process to manage
their protocols.
Have a “rapid” response process in place to
manage and communicate an event.
a)
b)
c)
f)
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Who has attended/who has not
Documentation
24/7
Assigned responsibilities
Identified communication pathways
Have a radiation dose management
committee in place
Summary
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
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Greater public awareness of radiation dose
Greater state and federal regulation
Improvements in equipment safeguards
Reporting of radiation doses in
– PACS
– National Registries
– Diagnostic Reports
 Greater CT Operator Training/Certification
 Risk Management
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Ten Years From Now,,,
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Thank you
Questions
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