Medical Event Reporting Scott Dube, MS DABR Morton Plant Hospital Clearwater, FL
New Voluntary Reporting System
For some, reporting is mandatory Radioactive materials are regulated by either the NRC or Agreement States Radiation producing equipment are regulated by the individual States
Radioactive Material The possession and use of radioactive material must be licensed with specific terms and conditions. Initially, the NRC granted all licenses.
NRC and Agreement States Today, 37 States are self regulating
Regulations Agreement States must enforce the same level of oversight as the NRC. That provides a National standard. So let us look at the NRC regulations with the understanding Agreement States enforce the same rules.
Nuclear Regulatory Commission 10 CFR 35.3045 - Report and notification of a medical event. - Total Dose differs from Prescribed Dose by 20% or more - Fractionated Dose differs from Prescribed Dose by 50% or more - Treatment to the wrong individual - Treatment by the wrong modality - Treatment to the wrong site
Radiation Producing Equipment Each State is independently responsible for regulating radiation equipment The regulations and practices vary widely among the fifty States There is no National standard
CRCPD Council of Radiation Control Program Directors (CRCPD) established in 1968, is a 501(c)(3) nonprofit organization, incorporated in the State of Kentucky, with its office located in Frankfort, KY www.crcpd.org
SSRCR Suggested State Regulations for Control of Radiation (SSRCR) designed by representatives from all fifty States to be the model for State regulations In reality, many States have not adopted the SSRCR for a variety of reasons such as lack of resources
Medical Event Reporting Approximately 50% of States have regulations with mandatory reporting requirements of medical events The others do not
CRCPD Reporting Program
Reported to CRCPD in 2012
http://www.floridahealth.gov/environmental-health/radiation-control/regulations.html
Florida Administrative Code F.A.C. 64E-5.101(85) Definition of Medical Event F.A.C. 64E-5.345(4) Reports of Medical Events Similar to NRC 10 CFR 35 and CRCPD SSRCR
F.A.C. Definition - Brachytherapy Total Dose differs by 20% or more Fractionated Dose differs by 50% or more Unintentional Organ Dose exceeds 50 rem Wrong mode of treatment Wrong individual Leaking source resulting in contamination
F.A.C. Definition - Teletherapy Unintended permanent functional damage Wrong individual Wrong mode of treatment Wrong treatment Wrong treatment site Total dose differs by more than 10% (1-3 Fx) Weekly dose is 30% greater Total dose differs by more than 20%
Dose versus Site Distinction Dose based incidents have an allowable deviation (e.g. calculated weekly administered dose is 30 percent greater than the weekly prescribed dose) Site based incidents have no allowable deviation What about partial miss?
F.A.C. Reporting Requirements Notify Agency, Referring Physician, and Patient by telephone no later than next calendar day Submit Written Report to Agency within 15 days Offer to submit Written Report to Patient
Written Report Registrant Name Prescribing Physician Brief description of event Why event occurred Effect on the patient Actions to prevent recurrence Certification the patient was notified
What will likely follow A site visit by inspectors Agonizing waiting period Possible Notice of Violation Possible Fines to Facility Possible Fines to Individuals
How to prepare for site visit Perform a thorough analysis of event Implement process improvements before the inspectors arrive Have report ready for inspection
Site Visit Entrance interview and overview of investigation process Results of facilities investigation and corrective actions Interviews with physicist, chief therapist, and dosimetrist or therapists involved. Interview with Oncologist if necessary or requested
Site Visit Review of 15-day reporting and patient notification requirements Documentation of existing or recommended procedures and training Exit interview with management Overview of administrative fine process
Example of true event Patient treated for bone metastasis in the sternum Returns six months later for treatment to a nearby rib IGRT is used for every fraction
Chain of events
Root Cause Analysis Interview everyone involved Individuals are never a root cause Was staff training or culture at fault? Were policies or procedures at fault? Was equipment or environment at fault? Was communication process at fault? Document everything!
Action Plan Next develop and implement an Action Plan which identifies the root causes, the effect of those causes which allowed the event to occur, and the actions taken to prevent a recurrence
Cause \ Effect \ Action - 1 The preexisting policy allowed therapists to make large shifts without approval from physician, dosimetrist, physicist Missed opportunity to identify that the setup was to the wrong tattoo on treatments prior to the medical event Policy shall be revised to require therapists to first obtain approval from the physician, physicist, or dosimetrist for any shift greater than 1 cm
Cause \ Effect \ Action - 2 Failure to document change of setup parameters in the Setup Notes to indicate a large shift had become routine The new pair of therapists did not realize large shifts had been necessary for the prior four treatments and so believed the small shifts were appropriate. Policy shall be revised to require the Setup Notes must be updated whenever any change in setup parameters occurs
Cause \ Effect \ Action - 3 Failure to communicate change in setup from one pair of therapists to a second pair of therapists when the patient switched machines. The new pair of therapists did not realize large shifts had been necessary for the prior four treatments and so believed the small shifts were appropriate. We shall implement a Handoff Procedure to be followed whenever there is a discontinuity in the therapists treating a patient.
Cause \ Effect \ Action - 4 Failure to recognize the KV matching was not correct because the field of view was limited such that the mismatch of the peripheral anatomy was not appreciated. Therapists were misled to thinking they were treating the correct area based on the ribs matching in the limited field of view. We shall provide remedial training for all therapists on the ideal techniques of performing IGRT matching using KV Planar as well as CBCT imaging.
Cause \ Effect \ Action - 5 Lack of double check verification of the KV matching by a second therapist. There was a missed opportunity for a second therapist to detect the error made by first therapist. Policy shall be revised to required that IGRT matching be verified by a second person (therapist, physician, dosimetrist, physicist) before the treatment is delivered.
Cause \ Effect \ Action - 6 Tattoo disappeared and a nearby prior tattoo was used Patient was setup to wrong tattoo Policy shall be revised to require a Triple tattoo be applied when the new tattoo is within 15 cm of any prior tattoo
Cause \ Effect \ Action - 7 Therapists proceeded to treat with large shifts while not fully understanding why the large shifts were necessary Missed opportunity to identify that the setup was to the wrong tattoo prior to the medical event We shall reinforce our No Fly Policy policy whereby the procedure is halted when there is uncertainty
Cause \ Effect \ Action - 8 Physician did not evaluate the magnitude of the shifts as part of his review process which would have been a flag that something was amiss Missed opportunity to identify that the setup was to the wrong tattoo on treatments prior to the medical event Physicians shall be instructed and required to assess the magnitude of shifts using Digital Graticule as part of their IGRT review.
Cause \ Effect \ Action - 9 Physicist did not evaluate the magnitude of the shifts as part of his weekly chart check which would have been a flag that something was amiss Missed opportunity to identify that the setup was to the wrong tattoo prior to the treatment event Physicist shall be required to assess the magnitude of shifts for each fraction using Digital Graticule during his weekly chart review.
Day of Investigation Two State investigators Introductory group discussion Individual interviews Therapists submit written statements Presented our Written Report Exit conference
Snag at Exit Conference State wanted new and revised policies and procedures to be reviewed by all staff and physicians with signed attestation of agreement Did not submit attestation until eleven weeks after investigation visit
After the Inspection Inspectors return to Tallahassee and deliberate over findings Consider potential violations rated at Severity Levels I through V
Severity Level I (Highest) Single exposure of worker in excess of five times the annual limit; making false statements; action taken which could cause bodily injury or harm; falsification of records
Severity Level II Single exposure of worker in excess of annual limits; exposure to member of general public in excess of annual limit; failure to make immediate notification; failure to make written report; a false statement or a reporting failure; deliberate falsification of records
Severity Level III Radiation level in unrestricted area in excess of 100 millirem in one hour; failure to make notification; substantial potential for excessive exposure; conduct by a technically unqualified person; chronic failure to perform periodic quality control or assurance; other false statement or falsification
Severity Level IV Other exposures in excess; failure to make notification; other failure to perform quality control or assurance; failure to provide reports to workers; other false statements
Severity Level V (Lowest) Failure to provide documentation of performance of quality assurance function; violations which have minor safety significance; interference with an inspection or investigation
Outcome Three Violations Failure to have adequate procedure F.A.C. 64E-5.804(1)(b) Severity Level I Failure to have adequate training F.A.C. 64E-5.802(5) Severity Level I Failure to not provide report including action taken to prevent recurrence within 15 days F.A.C. 64E-5.345(4)(b) Severity Level I
Potential Penalties to Facility http://www.flsenate.gov/laws/statutes/2014/404.162
Adminstrative Fines General Statement of Policy and Procedure for Radiation Machine Enforcement Actions August 1996
Amounts of Administrative Fines Severity Level Maximum Fine I $1000 II $ 750 III $500 IV $250 V $125
Taken into account Gravity of violation; registrant s efforts to promptly identify, report, and correct violations; management involvement in the registrant s operations; past performance; and the degree to which the violation is repeated during a particular time interval
Outcome Three Fines $1000 - Failure to have adequate procedure $1000 - Failure to have adequate training $2000 - Failure to not provide report including action taken to prevent recurrence within 15 days
But wait, there s more Department may impose discipline against individuals Could involve fines as well
Penalties to Therapists http://www.leg.state.fl.us/statutes/index.cfm?app_mode=display_statute&url=0400-0499/0468/0468partivcontentsindex.html&statuteyear=2014&title=-%3e2014- %3EChapter%20468-%3EPart%20IV
Penalties to Therapists https://www.flrules.org/gateway/chapterhome.asp?chapter=64e-3
Penalties to Physicists https://www.flrules.org/gateway/division.asp?divid=315
Our Options Pay the fines and case closed Protest the fines within thirty days either denying the violations or showing extenuating circumstances In any case, all records are public
Our response 11/18/14 Accept our procedures were lacking and paid $1000 Protest training was lacking Protest report was not timely Protest this was a wrong site event
Wrong Site objection Correct region despite misalignment Medical Event definitions regarding dose specify acceptable deviation Definition for wrong site should also specify acceptable deviation
FL BRC response 11/24/14 No other correspondence since that time
Why report? Right thing to do Welcome independent review Continuing Quality Improvement Opportunity for others to learn Clean conscience Honors the injured patient Protect future patients
Finale To err is human; to report, divine.