Medical Events. Florida Department of Health Division of Emergency Preparedness and Community Support Bureau of Radiation Control

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1 Medical Events Florida Department of Health Division of Emergency Preparedness and Community Support Bureau of Radiation Control April 6, 2018 Presented by: Clark Eldredge

2 Authority for Regulation 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 2

3 Medical Events in F.A.C. 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 Accelerators F.A.C., 64E (8) contains the definition for Electronic Brachytherapy 3

4 F.A.C., 64E-5.101(85)(a) 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. 4

5 F.A.C., 64E-5.101(85)(a), continued 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 5

6 F.A.C., 64E-5.101(85)(a), continued 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 6

7 F.A.C., 64E-5.101(85)(b) 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 7 ( Or at end of third item of three)

8 F.A.C., 64E-5.101(85)(b), continued 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 8

9 F.A.C., 64E-5.101(85)(c) 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 9

10 F.A.C., 64E (8) 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 10

11 Definition Comparison Therapeutic X-ray or Particle Accelerator Radioactive Materials With Written Directive Radioactive materials No 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 11

12 Definition Comparison, continued Therapeutic X-ray or Particle Accelerator Radioactive Materials With Written Directive Radioactive materials No Written Directive Electronic Brachytherapy Total dose differs >20% from total prescribed dose Three or fewer fractions and total dose differs from prescribed by >10% The fractionated dose delivered differs from the prescribed dose, for a single fraction, by 50 % or more YES YES YES YES YES N/A N/A N/A N/A YES YES YES 12

13 Medical Event Reporting Approximately 50% of states have regulations with mandatory reporting requirements of medical events. 13

14 Voluntary Reporting Programs Radiation Oncology Incident Learning System (RO ILS) Council of Radiation Control Program Directors (CRCPD) 14

15 RO ILS 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 15

16 RO ILS Reporting Severity levels: Affected patient Near-miss: event that would have affected patient if not caught Unsafe condition: condition that increases probability of event 16

17 RO ILS Reporting, continued 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 17

18 CRCPD 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 18

19 CRCPD Medical Event Criteria 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 19

20 Reported to CRCPD in Wrong Patient Wrong Site 4 Weekly >30% Total >20% Single >50% Other Eight states reported a total of 31 therapy events. 20

21 2016 Severity of Event Moderate effects = 3 Minor effects = 17 No effects = 8 No data = 3 21

22 Reporting Requirements in F.A.C. F.A.C., 64E-5.345(4), Reports of Medical Events 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. 22

23 After Report, What Comes Next A site visit by state investigators Possible notice of violation Possible fines to facility Possible fines to individual 23

24 Site Visit 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 24

25 Decision Making 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. 25

26 Medical Events Reported in 2017 There were five medical events reported to BRC in 2017: Wrong Patient x 1 Wrong Site x 3 Wrong Dose x 1 26

27 Example: Wrong Patient 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 27

28 Wrong Patient Cause Effect Action 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 28

29 Example: Wrong Site Patient was to receive palliative treatment to the T7 spine Received the first fraction of treatment incorrectly to the T8 spine 29

30 Wrong Site Cause Effect Action 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 30

31 Example: Wrong Dose 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 31

32 Wrong Dose Cause Effect Action 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 32 Policy and Procedures updated 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)

33 Authorization for Enforcement Section , F.S., Administrative Penalties; Emergency Orders: 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 33

34 Violation Severity Level Examples General statement of Policy and Procedure for Radiation Machine Enforcement Actions, September 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. 34

35 Severity Level I (Highest) 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 35

36 Severity Level II 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 36

37 Severity Level III 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 37

38 Severity Level IV 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 38

39 Severity Level V (Lowest) Violations which have minor safety or environmental significance Failure to provide documentation of performance of quality assurance function Failure to maintain records 39

40 Amounts of Administrative Fines Severity Level Maximum Fine I $1000 II $900 III $750 IV $500 V $250 40

41 Individual Penalties BRC may impose discipline against individuals: Chapter 468, Part IV, F.S., Radiological Personnel Certification %20468%2D%3EPart%20IV F.A.C., 64E-3.011, Radiologic Technology Disciplinary Guidelines TECHNOLOGY&ID=64E

42 DOH Future Considerations Single fraction deviation limit What is no effect? What about partial miss? 42

43 Cumulative Dose Volume Histogram 43

44 Questions? Clark Eldredge, Environmental Administrator Bureau of Radiation Control, Radiation Machine Section 4052 Bald Cypress Way, Bin C21 Tallahassee, FL