Medical Event Reporting

Size: px

Start display at page:

Download "Medical Event Reporting"

Cecil Hunter
5 years ago
Views:

1 Medical Event Reporting Scott Dube, MS DABR Morton Plant Hospital Clearwater, FL

2 New Voluntary Reporting System

3 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

4 Radioactive Material The possession and use of radioactive material must be licensed with specific terms and conditions. Initially, the NRC granted all licenses.

5 NRC and Agreement States Today, 37 States are self regulating

6 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.

7 Nuclear Regulatory Commission 10 CFR 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

8 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

9 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

10 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

11 Medical Event Reporting Approximately 50% of States have regulations with mandatory reporting requirements of medical events The others do not

12 CRCPD Reporting Program

13 Reported to CRCPD in 2012

15 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

16 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

17 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%

18 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?

19 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

20 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

21 What will likely follow A site visit by inspectors Agonizing waiting period Possible Notice of Violation Possible Fines to Facility Possible Fines to Individuals

22 How to prepare for site visit Perform a thorough analysis of event Implement process improvements before the inspectors arrive Have report ready for inspection

23 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

24 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

25 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

26 Chain of events

27 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!

28 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

29 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

30 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

31 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.

32 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.

33 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.

34 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

35 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

36 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.

37 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.

38 Day of Investigation Two State investigators Introductory group discussion Individual interviews Therapists submit written statements Presented our Written Report Exit conference

39 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

40 After the Inspection Inspectors return to Tallahassee and deliberate over findings Consider potential violations rated at Severity Levels I through V

41 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

42 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

43 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

44 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

45 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

46 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

47 Potential Penalties to Facility

48 Adminstrative Fines General Statement of Policy and Procedure for Radiation Machine Enforcement Actions August 1996

49 Amounts of Administrative Fines Severity Level Maximum Fine I $1000 II $ 750 III $500 IV $250 V $125

50 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

51 Outcome Three Fines $ Failure to have adequate procedure $ Failure to have adequate training $ Failure to not provide report including action taken to prevent recurrence within 15 days

52 But wait, there s more Department may impose discipline against individuals Could involve fines as well

53 Penalties to Therapists %3EChapter%20468-%3EPart%20IV

54 Penalties to Therapists

55 Penalties to Physicists

56 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

57 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

58 Wrong Site objection Correct region despite misalignment Medical Event definitions regarding dose specify acceptable deviation Definition for wrong site should also specify acceptable deviation

59 FL BRC response 11/24/14 No other correspondence since that time

60 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

61 Finale To err is human; to report, divine.

Medical Errors in Radiation Therapy

Medical Errors in Radiation Therapy 2014-2015 T. Yvette Forrest Division of Emergency Preparedness and Community Support Bureau of Radiation Control Florida Department of Health 1 Reportable Medical Events