Chuck Wissuchek, M.S. Chief Medical Physics Officer (CMPO) Western Reserve Medical Physics LLC

Chuck Wissuchek, M.S. Chief Medical Physics Officer (CMPO) Western Reserve Medical Physics LLC

Present some history of the Medical Event rule Discuss some problems with Interpretation for Multi-fraction Radiation Therapy Discuss recent Changes in the NRC Prostate Seed rule Suggested Changes to the Rule for External Beam Radiation Therapy

Medical event reporting required since 1980 (NRC) Protect patient safety without intruding on the practice of medicine

A goal: Medical Events should be based on potential clinical significance This necessitates a careful balance: - Avoiding overly sensitive clinicallyinsignificant definitions (which might overburden the system) - And ensuring that the definition will identify those procedures that are potentially harmful

State regulations typically focus on items that are easier to check, like machine QA Good machine QA does not necessarily mean a good treatment TG 100 is addressing FMEA, but that will take time to get into regulations, if ever Medical event reporting places some emphasis on quality of treatments

Ohio 3701:1-67-12 Reports and notifications of misadministrations. (A) in A handler shall report any misadministration resulting from intervention of a patient or human research subject which the administration of radiation from therapy equipment results, or will result in, unintended permanent functional damage to an organ or a physiological system as determined by a physician. (B) Other than misadministrations that result from intervention by a patient or human research subject, a handler shall report any event in which the administration of radiation from therapy equipment involves:

(1) The wrong patient; (2) The wrong treatment; (one fraction or all fractions?) (3) The wrong treatment site; (how much dose, harm?) (4) The calculated weekly administered dose differs from the weekly prescribed dose as prescribed in the treatment plan by more than thirty per cent; (5) The calculated total administered dose differs from the total prescribed dose as prescribed in the treatment plan by more than twenty per cent of the total prescribed dose; or (6) The calculated total administered dose differs from the total prescribed dose in the treatment plan by more than ten per cent of the total prescribed dose for treatments consisting of three or fewer fractions

U.S.NRC United States Nuclear Regulatory Commission Protecting People and the Environment Part 35 Reproposed Rule on Medical Event Definitions R. W. Borchardt Executive Director for Operations July 8, 2010

These new regulations would require reporting of an event in which there is actual or potential harm to a patient resulting from an ME. (from NRC Proposed Rule and Guidance Document for 10 CFR Part 35 for Permanent Seed Implants 7/21/14)

When 20% or more of the implanted sources are outside the intended implant location For normal tissue outside the implant location, 5 cc contiguous volume receives greater than 150% of the prescribed dose For intra-target tissue, 5 cc contiguous volume receives greater than 150%

William Ruck, ORVC Bryan Murray, REC, ORVC Paul Geis, REC, POC Valdir Colussi, POC Ray Kaczur, POC Doug Martin, M.D. (OSU) Chuck Wissuchek, REC, POC

3701:1-67-12 Unintended treatment deviations and notifications of medical events (A) Any unintended deviation from the treatment plan or written directive shall be identified, evaluated, documented, and appropriate action taken. In certain cases, these unintended deviations are reportable to the department as a medical event.

(B) A handler shall report, as a medical event, any treatment deviations, except for a treatment deviation that results from intervention by a patient or human research subject, in which the administration of radiation from therapy equipment involves: (1) The wrong patient; where wrong patient means administration of radiation using a treatment plan intended for another patient or human research subject; or

(2) The wrong treatment; where wrong treatment means administration of radiation to a patient or human research subject that does not conform to the written directive and the approved treatment plan except for unexpected disruptions in treatment; and (a) The administered dose over the entire treatment course differs from the prescribed dose as stated in the written directive by more than ten percent for treatment courses consisting of three or fewer fractions; or (b) The administered dose over the entire treatment course differs from the prescribed dose by more than twenty percent for treatment courses consisting of more than three fractions; or (c) The administered dose over any five consecutive fractions differs from the prescribed dose by more than thirty percent.

(3) In paragraphs (B)(2) of this rule, administered dose means: (a) For computer treatment plans the minimum dose to ninetyfive percent of the prescribed treatment volume; or (b) For treatments prescribed to a point, the dose to the prescription point.

(4) Wrong treatment also includes unplanned higher dose delivered to normal tissue identified as organ at risk (OAR) where: (a) The calculated administered dose to a critical structure over the entire treatment is greater than the calculated mean dose in the approved treatment plan by more than twenty percent; or (b) The calculated administered dose to a critical normal structure over the entire treatment course is greater than the calculated dose in the approved treatment plan by more than thirty percent over any five consecutive fractions; or (c) Unintended permanent functional damage to an organ or physiological system has occurred or is likely to occur as determined by a physician

(4) Wrong treatment also includes unplanned higher dose delivered to critical normal tissue structures where: (a) The calculated administered mean dose to a critical normal structure over the entire treatment is greater than the calculated mean dose in the approved treatment plan bymore than twenty percent; or (b) Unintended permanent functional damage to an organ or physiological system has occurred or is likely to occur as determined by a physician

Now this is where we could really use some practice guidelines