College of Imaging Administrators 16 Annual Spring Assembly Sheraton – Lisle Hotel Lisle, Illinois...

College of Imaging Administrators16 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

greg.pilat@advocatehealth.com

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Radiation Dose ManagementWhat to do with the Data

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Disclosure

I have become passionate about safety

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Learning Objectives Review recent events of “over-exposure” Understand safety from a:

– regulatory perspective

– patient perspective

– facility perspective

– CT technologist perspective

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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

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In the news … 3Estimated 3 Million New Cancers From CT: 20-30 years

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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

Feds Get Involved

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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 2011June 18, 2011

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Child Over-radiated

How will we answerquestions from thisfamily?

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California: CT Technologist

How will we answerquestions from thisfamily?

The California radiologic technologistaccused of operating the CT scanner thatdelivered a massive radiation overdose toa 23-month-old boy in 2008 testified thatshe only pushed the CT scan button a fewtimes, and she doesn't understand how thetoddler received 151 scans in a singleimaging session…

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West Virginia Hospital Overradiated Brain Scan Patients, Records ShowPublished: March 5, 2011

A large West Virginia hospital seriously over-radiated 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

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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

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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 Gov. Arnold Schwarzenegger 1st Law of Its Kind Effective July 1, 2012 Requires Notification of state Dept Public

Health

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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

ProtocolsDocumentationReviewChange 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) Know the ranges of rad dose for high dose procedures

b) Routine radiation safety education Who has attended/who has not Documentation

c) Conduct routine/annual protocol review

d) Have a change control process to manage their protocols.

e) Have a “rapid” response process in place to manage and communicate an event.

a) 24/7

b) Assigned responsibilities

c) Identified communication pathways

f) Have a radiation dose management committee in place

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Summary

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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Did you have a CT study in 2014

Call

U Over Dosed 1-868-373-6733

Thank you

Questions

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