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Medical Events &BRC Update

Florida Department of HealthDivision of Emergency Preparedness and Community Support Bureau of Radiation Control

September 9, 2018Presented by: Clark Eldredge

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• Medical Event◦ Authority◦ Definitions◦ Reporting◦ Investigating Facilities◦ Recent examples◦ Violations & Penalties◦ Investigating Individuals

• Therapy Approval◦ Requirements for accelerators and electronic brachytherapy

• Future Considerations

Agenda

Medical Events

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• Each state is independently responsible for regulating radiation equipment.• The State of Florida, Bureau of Radiation Control (BRC) is responsible for

regulating radiation equipment in Florida.• Authorized under Chapter 404, Florida Statutes (F.S.), and Florida

Administrative Code (F.A.C), Chapter 64E-5.• As one of its responsibilities, BRC receives and evaluates reports of

medical events.• Medical event investigation and reporting regulations and practices vary

widely among the 50 states. From a 2016 survey:◦ 35 states require reporting for medical events◦ 22 states require reporting for diagnostic events

Authority for Regulation

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• Medical events are defined for:◦ Radioactive Materials ◦ Therapeutic X-ray Machine ◦ Particle Accelerator◦ Electronic Brachytherapy

• F.A.C., 64E-5.101(85) contains the definition for Radioactive Materials, Therapeutic X-ray Machine and Particle Acceleratorshttps://www.flrules.org/gateway/readFile.asp?sid=0&tid=13920584&type=1&file=64E-5.101.doc

• F.A.C., 64E-5.1601 (8) contains the definition for Electronic Brachytherapyhttps://www.flrules.org/gateway/readFile.asp?sid=0&tid=6848993&type=1&file=64E-5.1601.doc

Medical Events in F.A.C.

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For radioactive materials or radiation from radioactive materials requiring a written directive:• A dose that differs from the prescribed dose by:

◦ > 0.05 Sv (5 rem) effective dose equivalent,◦ > 0.5 Sv (50 rem) to an organ or tissue, or ◦ > 0.5 Sv (50 rem) shallow dose equivalent to the skin.

• Total dose > 20% of prescribed dose.• Single fraction of fractionated dose > 50% prescribed dose.

F.A.C., 64E-5.101(85)(a)

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• A dose that exceeds:◦ 0.05 Sv (5 rem) effective dose equivalent,◦ 0.5 Sv (50 rem) to an organ or tissue, or ◦ 0.5 Sv (50 rem) shallow dose equivalent to the skin.

• Wrong radioactive drug administered• Wrong route of administration• Wrong individual• Wrong mode of treatment

F.A.C., 64E-5.101(85)(a), continued

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• Human contamination from a leaking sealed source• A dose to other than the treatment site that exceeds:

◦ 0.5 Sv (50 rem), and◦ 50% or more than the written directive

• Unintended permanent functional damage to an individual’s organ or a physiological system, as determined by a physician

F.A.C., 64E-5.101(85)(a), continued

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Radioactive materials or radiation from radioactive materials not requiring a written directive:• A dose that differs from the prescribed dose by:

◦ > 0.05 Sv (5 rem) effective dose equivalent,◦ > 0.5 Sv (50 rem) to an organ or tissue, or ◦ > 0.5 Sv (50 rem) shallow dose equivalent to the skin;◦ And: When total dose off by > 20% of prescribed dose The total dosage falls outside the prescribed dosage range Single fraction of fractionated dose > 50% prescribed dose

F.A.C., 64E-5.101(85)(b)

(“Or” at end of third item of three)

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• A dose that exceeds:◦ > 0.05 Sv (5 rem) effective dose equivalent,◦ > 0.5 Sv (50 rem) to an organ or tissue, or ◦ > 0.5 Sv (50 rem) shallow dose equivalent to the skin;◦ And at least one of the following: Wrong radioactive drug Wrong route of administration Wrong individual Wrong mode of treatment Human contamination from a leaking sealed source

F.A.C., 64E-5.101(85)(b), continued

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Radiation from a therapeutic X-ray machine or particle accelerator that results in any of the following:• Unintended permanent functional damage to an individual’s organ or a

physiological system, as determined by a physician.• Wrong individual, mode of treatment, wrong treatment, or wrong treatment

site.• Fractionated treatment of fewer than three fractions where

total dose differs >10% of prescribed dose• Weekly dose difference >30% of prescribed weekly dose• Total dose difference >20% of prescribed dose

F.A.C., 64E-5.101(85)(c)

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An event in electronic brachytherapy, except for one caused by patient intervention, that results in:• Total dose difference >20% of prescribed dose• Single fraction of fractionated dose off by >= 50%• Wrong individual• Wrong treatment site

F.A.C., 64E-5.1601 (8)

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Therapeutic X-ray or Particle Accelerator

Radioactive MaterialsWith Written Directive

Radioactive materialsNo Written Directive

Electronic Brachytherapy

Unintended damage to patient, as determined by physician

YES YES YES N/A

Wrong individual YES YES Over threshold dose YES

Wrong mode of treatment, wrong treatment or wrong treatment site

YES Wrong mode and wrong route

Wrong mode and wrong route over threshold dose

Wrong site

Weekly dose is >30%different from weekly prescribed dose

YES N/A N/A N/A

Definition Comparison

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Therapeutic X-ray or Particle Accelerator

Radioactive MaterialsWith Written Directive

Radioactive materialsNo Written Directive

Electronic Brachytherapy

Total dose differs >20% from total prescribed dose

YES YES YES YES

Three or fewer fractions and total dose differs from prescribed by >10%

YES N/A N/A N/A

The fractionated dose delivered differs from the prescribeddose, for a single fraction, by 50 % or more

N/A YES YES YES

Definition Comparison, continued

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Approximately 70% of states have regulations with mandatory reporting requirements of medical events.

Medical Event Reporting

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• Radiation Oncology Incident Learning System (ROILS)• Council of Radiation Control Program Directors (CRCPD)

Voluntary Reporting Programs

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• Sponsored by the American Association of Physicists in Medicine (AAPM) and the American Society for Radiation Oncology(ASTRO) for accredited facilities

• Mission is to provide shared learning in a secure and non-punitive environment

ROILS

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Severity levels:• Affected patient• Near-miss: event that would have affected patient if not caught• Unsafe condition: condition that increases probability of event

ROILS Reporting

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Event or condition characterization:• Omitted procedure• Wrong site, patient, procedure, modality, and/or laterality• Total or partial geometric miss• Wrong dose to all or part of tumor or to normal tissue• Mechanical failure

ROILS Reporting, continued

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• Organization of Regulatory States• CRCPD can accept events from any state or local agency with reporting

requirements in place• Reports submitted by states• Data compiled by Healing Arts Council H-38, Committee on Radiation

Medical Events• Goals of data collection:

◦ Share lessons learned◦ Prevent errors◦ Look for trends◦ Improve patient care and safety

CRCPD

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Reporting criteria for a therapeutic radiation machine medical event:• Wrong patient, treatment modality, or treatment site• Weekly dose differs by >30% from prescribed dose• Total dose differs by >20% from prescribed dose• Fraction dose differs by > 50% for any single fraction of a

multi-fraction treatment• Equipment failure, personnel error, accident, mishap or other unusual

occurrence that causes significant physical harm to the patient

CRCPD Medical Event Criteria

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Reported to CRCPD in 2016

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13

2

3

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5 Wrong PatientWrong SiteWeekly >30%Total >20%Single >50%Other

Eight states reported a total of 31 therapy events.

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• Moderate effects = 3• Minor effects = 17• No effects = 8• No data = 3

2016 Severity of Event

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F.A.C., 64E-5.345(4), Reports of Medical Eventshttps://www.flrules.org/gateway/readFile.asp?sid=0&tid=8227460&type=1&file=64E-5.345.doc

Notifications required after discovery of a medical event:• The Department by telephone no later than the next calendar day.• The individual, responsible relative or guardian within 24 hours unless:

◦ The referring physician performs the patient notification, or◦ The referring physician determines medically that the patient notification

would be harmful.Written report due to the Department in 15 days.

Reporting Requirements in F.A.C.

Investigation

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• A site visit by state investigators• Possible notice of violation• Possible fines to facility• Possible fines to individual

After Report, What Comes Next…

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• State investigators (two to four)• Entrance interview and overview of investigation process• Results of the facility’s investigation and corrective actions• Interviews with physicist, chief therapist, and dosimetrist or

therapists involved• Interview with Oncologist, if necessary or requested• Documentation of existing or recommended procedures and

training• Exit interview with management• Overview of administrative fine process

Site Visit

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• Draft investigation report prepared 15 days after site visit.Report includes:◦ Synopsis of the incident◦ Individual interview statements from therapists◦ Facility corrective actions◦ Facility written incident report◦ Any records obtained during the investigation

• Report used by agency to identify violations and their severity.

Decision Making…

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There were five medical events reported to BRC in 2017:

• Wrong Patient x 1 • Wrong Site x 3• Wrong Dose x 1

Medical Events Reported in 2017

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• Patient arrived early for appointment and was taken back for treatment

• Treatment table and computer system had been set-up for the next scheduled patient who had not shown up yet

• Therapists proceeded to treat the patient that came in early with the wrong patient information and treatment plan

Example: Wrong Patient

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Failure to perform the “time-out” procedure to verify correct patient information / treatment plan

Missed opportunity to identify that the wrong patient information / treatment plan was loaded in the computer system before proceeding to treat the patient

The “time-out” procedure must be correctly followed for every patient and shall be performed anytime a patient crosses the threshold of the treatment room

Wrong Patient

Cause Effect Action

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• Patient was to receive palliative treatment to the T7 spine

• Received the first fraction of treatment incorrectly to the T8 spine

Example: Wrong Site

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Wrong Site

Failure to correctly identify anatomical structures

Treatment site was incorrect, physician approved the IGRT report post treatment

Policy and Procedures updated to include physician approval prior to treatment

Cause Effect Action

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Wrong Site

Insufficient view of alignment images

Neither Techs or the physician was able to accurately identify anatomical structures

Update to policy on alignment imaging.

Root Cause Effect Action

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• Treatment prescribed QD (daily) for 20 fractions

• Administered BID (twice daily) for 19 fractions

• Treatment terminated at 3800 cGy versus actual prescribed dose of 4000 cGy

Example: Wrong Dose

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Wrong Dose

Policy and Procedures did not address the possible scenarios that led to the medical event. No check for frequency of treatment, i.e. QD vs. BID.

Treatment was entered incorrectly in the scheduling system

Information was not verified correctly by physician, physicist, or therapists

Policy and Proceduresupdated to include:- Weekly chart verification

by physician, physicist, and therapists

- EMR prescription and document verification

- Continuing Physics Form corrected to include prescription fractionation (QD vs. BID)

Cause Effect Action

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• Space on treatment plan cover sheet for QD vs. BID was left blank.

• Hand written Rx included in plan identified QD.

• Physicist, dosimetrist, therapists never looked.

Wrong Dose Continued

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Section 404.062, F.S., Administrative Penalties; Emergency Orders:http://leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&Search_String=&URL=0400-0499/0404/Sections/0404.162.html

• Modify, deny, suspend, or revoke a license or a registration.• Administrative fine not to exceed $1,000 per violation per day.• Factors shall be considered:

◦ Severity of the violation ◦ Actions taken to correct the violation◦ Any previous violations

Authorization for Enforcement

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General statement of Policy and Procedure for Radiation Machine Enforcement Actions, September 2014http://www.floridahealth.gov/environmental-health/radiation-control/_documents/regs/64e-511-gen-statement-of-p-and-p-for-radiation-mach-enforcement-sept-2014-6-3-2015.pdf

• Primarily administrative fines; but, has the potential for criminal penalties.• Severity levels I through V:

◦ Fines generally imposed for initial severity levels I and II violations.◦ Fines for severity levels III through V unlikely, but possible for repeat

offenders or failure to take effective corrective action.

Violation Severity Level Examples

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• Single exposure of worker in excess of five times the annual limit

• Failure to make immediate notification• Exposure to members of general public in excess of

annual limit• Making false statements• Falsification of records

Severity Level I (Highest)

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• A total effective dose equivalent exceeding 5 rem (annual limit)

• Failure to make 24-hour notification • Failure to make written report• Failure to report to the Department by telephone

Severity Level II

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• Radiation level in unrestricted area in excess of 2 millirem in a one-hour period

• Substantial potential for excessive exposure• Chronic failure to perform periodic quality control or

assurance• Failure to apply for registration within 30 days of

acquiring machine and before use

Severity Level III

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• Failure to make notification within 30 days• Failure to make a written report within 30 days• Failure to provide personnel monitoring reports to

workers• Making unintentional false statements

Severity Level IV

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• Violations which have minor safety or environmental significance

• Failure to provide documentation of performance of quality assurance function

• Failure to maintain records

Severity Level V (Lowest)

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Severity Level Maximum FineI $1000II $900III $750IV $500V $250

Amounts of Administrative Fines

Individuals

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BRC may impose discipline against individuals:

• Chapter 468, Part IV, F.S., Radiological Personnel Certificationhttp://leg.state.fl.us/Statutes/index.cfm?App_mode=Display_Statute&URL=0400-0499/0468/0468PartIVContentsIndex.html&StatuteYear=2017&Title=%2D%3E2017%2D%3EChapter%20468%2D%3EPart%20IV

• F.A.C., 64E-3.011, Radiologic Technology Disciplinary Guidelineshttps://www.flrules.org/gateway/RuleNo.asp?title=RADIOLOGIC TECHNOLOGY&ID=64E-3.011

Individual Penalties

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• Radiation Machine Section report is forwarded to the Radiologic Technology Section for review.

• Potential infractions of any health care practitioner disciplinary statute, a complaint will be submitted to the Division of Medical Quality Assurance (MQA).

• MQA:◦ Case number assigned ◦ Case forwarded to the Consumer Services Unit (CSU)◦ To the Investigative Services Unit (ISU) ◦ Ends up with Prosecution Services Unit (PSU)

Investigation of Individual(s)

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• CSU responsible for: ◦ initial intake of complaints◦ analysis of complaints to determine legal sufficiency

• ISU responsible for ◦ investigating ◦ interviews, collect documents and evidence

• PSU is responsible for:◦ providing legal services in the regulation of all health care boards

and councils

Investigation of Individual(s)

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• PSU attorneys will:◦ review the complaint ◦ recommend a course of action, which may include: Emergency Order Expert Review Closing Order Administrative Complaint

Investigation of Individual(s)

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• Cases are reviewed and tracked on a routine basis

• Currently, there are 91 open cases*with MQA◦ CSU 10%◦ ISU 30%◦ PSU 60%

*Radiologic technologists, unlicensed individuals and facilities.

Technology Related Cases with MQA

10%

30%60%

Open Cases

CSU ISU PSU

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• Examples of Radiologic Technology cases open with MQA:◦ Medical Events – Unprofessional Conduct◦ Unlicensed Activity (ULA)◦ ARRT Sanction◦ Default on Student Loan◦ Impairment – Drugs, DUI, Positive Drug Screening, etc.◦ Sexual Misconduct◦ Fraud

Cases continued

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Possible violation of section 468.3101(1)(f) and (i), F.S., engaging in unprofessional conduct.

*****Received complaint from Radiation Technology Office. In 2013, a 59-year-old patient received one fraction of radiation treatment delivered to an unintended site. This medical event was not reported for more than four months.

Case Example

Therapy Approval

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• Prior to Operations◦ Registration certificate◦ Accelerator: Authorization letter accepting documentation required in

Rule 64E-5 Part 8 ◦ Electronic Brachytherapy: Authorization letter accepting documentation

required in Rule 64E-5 Part 16 • Time line

◦ Registration – at the discretion of facility, but at lest 30 days prior to start.◦ Authorization letter documentation - ASAP, submit documentation when

available.

Therapy Registration

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• Shielding design◦ Include plans and specifications, assumptions and calculations ◦ Signed by Florida licensed medical physicist

• Radiation safety officer• Attestation of a medical committee• Verification of training of authorized users• Final survey

Accelerator Documentation

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• Surveys, calculations and quality assurance checks• Quality management program• Quality assurance program• Device manufacturer’s U.S. Food and Drug Administration

certification

Electronic Brachytherapy Documents 1

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• Facility design information:◦ A diagram of the physical facility◦ Whether the facility is a new structure or a modification to an existing

structure◦ Type and thickness of the shielding used for compliance ◦ A procedure demonstrating the use of the shielding prior to treatment

Electronic Brachytherapy Documents 1

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• Florida Statute 120 standards:◦ 30 days for initial review and request for additional information◦ 90 days for decision once application complete

• 17 current applications pending• First in – first out priority

Authorization Letter Times

Future Considerations

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• Add single fraction deviation limit• Clarify what is no effect?• What about partial miss?

Medical Event Considerations …

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Cumulative Dose Volume Histogram

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Clark Eldredge, Environmental AdministratorBureau of Radiation Control, Radiation Machine Section4052 Bald Cypress Way, Bin C21Tallahassee, FL 32399850-245-4888

Questions?