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Serious Clinical Adverse Events
Monday, October 17, 2011

Serious Clinical Adverse Events

This article published by the Institute for Healthcare Improvement1 describes a roadmap of how health care organizations should prepare and respond to serious clinical adverse events. The article stresses the important role of transparency in managing events. It encourages institutions to admit to mistakes and be forthright to patients, families, and fellow workers. An important goal of creating improvement means learning from your mistakes and meeting long-term objectives to prevent recurrence of a similar event.2

The article stresses that institutions must first openly and publicly acknowledge errors in order to investigate what truly occurred. Communication must be open, frank, and timely. A corrective action plan must be formulated to avoid a future, similar error from occurring. The article further describes what key factors separate organizations from success or failure when a crisis emerges.3

The article includes three detailed tools as appendices for guiding institutions in dealing with serious clinical adverse events: (1) checklist, (2) work plan, and (3) disclosure culture assessment tool.4

1,2,3,4Conway J, Federico F, Stewart K, Campbell MJ. Respectful Management of Serious Clinical Adverse Events (Second Edition). IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement; 2011. (Available on www.IHI.org)

Source: http://www.ihi.org

Survey: MDs Avoid Online Error-Reporting
Wednesday, October 5, 2011

Survey: MDs Avoid Online Error-Reporting

Johns Hopkins investigators conducted a survey to determine why radiation oncology professionals "fail to use online error-reporting systems designed to improve patient safety and quality of care."1 Survey questioners were mailed to various radiation oncologists as well as medical physicists, nurses, dosimetrists, and therapists located at four radiation oncology institutions.

The results of the survey were published in Johns Hopkins News and Publications.2 The article reveals that most radiation oncologists and nurses do not enter data in online error-reporting systems. However, medical physicists, dosimetrists, and therapists report using these systems with the greatest frequency. Though most believed reporting of errors was necessary in their roles, radiation oncologists and residents feared embarrassment, getting other physicians into trouble, and liability as the most common reasons for not reporting errors online.3

The article describes the vast majority of survey respondents admitting to witnessing near-misses and mistakes in their clinical operations.4

The article states most respondents support reporting of errors and not assigning blame to individuals. The majority favor use of a nation-wide reporting system for radiation oncology.5

1,2,3,4,5Johns Hopkins Medical Institutions (2011, October 3). Survey reveals reasons doctors avoid online error-reporting tools. Johns Hopkins News and Publications.

Source: http://www.hopkinsmedicine.org/news/media/releases

Definition of Medical Event: ASTRO Report
Saturday, October 1, 2011

Definition of Medical Event: ASTRO Report

According to § 35.2 (Definitions) of the U.S. Nuclear Regulatory Commission (NRC), a medical event means an event that meets the criteria in § 35.3045 (Records and Notifications of a Medical Event). § 35.3045(a) states, in part, a licensee "shall report any event, except for an event that results from patient intervention, in which the administration of byproduct material or radiation from byproduct material results in--

(1) A dose that differs from the prescribed dose or dose that would have resulted from the prescribed dosage by more than 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

(i) The total dose delivered differs from the prescribed dose by 20 percent or more."

In permanent prostate brachytherapy, a medical event can be triggered if the total dose delivered differs from the prescribed dose by 20 percent or more [of the prescribed dose]. This definition has caused considerable concern by clinicians when performing permanent prostate brachytherapy procedures. An article published in Practical Radiation Oncology1 describes the deliberations and recommendations of a working group formed by the American Society for Radiation Oncology (ASTRO). The ASTRO working group was tasked with making recommendations for changing the definition of a medical event as it applies to permanent prostate brachytherapy.

The working group asserts the dose-based approach to defining a medical event under § 35.3045(a)(1)(i) is not acceptable for permanent prostate brachytherapy. Recommendations include drafting of a more appropriate definition for medical event in permanent prostate brachytherapy. In this effort, the working group suggests consideration of a source strength-based definition. The source strength-based approach uses a medical event trigger level of > than 20% of source strength (as intended in the post-implant written directive) that is implanted outside the intended target volume of the plan.2

1,2Naq S, Demanes DF, Hagan M, Rivard MJ, Thomadsen BR, Welsh JS, Williamson JF. Definition of medical event is to be based on the total source strength for evaluation of permanent prostate brachytherapy: A report from the American Society for Radiation Oncology, Prac Radiat Oncol. 2011;4:218-223

Source: http://www.practicalradonc.org

A 2-Yr. Review of NRC Brachytherapy Events
Friday, September 30, 2011

A 2-Yr. Review of NRC Brachytherapy Events

The U.S. Nuclear Regulatory Commission (NRC) oversees medical uses of nuclear material through licensing, inspection, and enforcement programs. An article published in Practical Radiation Oncology1 describes a review of brachytherapy errors reported by licensees to the NRC.

The article classified and evaluated the types and numbers of reported brachytherapy errors over a 2-year period of time. The modalities of treatment delivery included Gamma Knife, therapeutic radiopharmaceuticals, and high-dose and low-dose-rate rate brachytherapy. The types and causes of errors are presented.

The article states human error as the primary causative factor. The types of mistakes showing highest frequency involved wrong dose.2

The article concludes by stating a large number of errors are related to older, well established processes and technologies. Newer technologies were also associated with errors.3

1,2,3Richardson S. A 2-year review of recent Nuclear Regulatory Commission events: What errors occur in the modern brachytherapy era? Article in press:Prac Radiat Oncol. 2011

Source: http://www.practicalradonc.org

Six Sigma Tools for Patient Safety in Rad Onc
Monday, August 8, 2011

Six Sigma Tools for Patient Safety in Rad Onc

Six sigma originated as a set of practices designed to improve manufacturing processes and eliminate defects. It applications, over time, have extended to radiation oncology. This article published in Practical Radiation Oncology1 looks at establishing the principles of six sigma to improve patient safety in a paperless environment at multiple radiation oncology sites.

The article describes the use of metrics in reducing patient safety risk. Methodologies used to redesign process, proactively eliminate errors, and correct system weaknesses include failure mode and effects analysis (FMEA), a no-fly policy, and root cause analysis (RCA).2

The article explains how a mapping of process is used to outline steps in the entire patient treatment flow. Rules and tasks were formulated to create procedural steps. Conformance to processes are measured and analyzed.3

The article concludes by stating principles of six sigma work in reducing patient safety risk. In addition, six sigma improves efficiency in work and quality processes.4

1,2,3,4Kapur A, Potters L. Six sigma tools for a patient safety-oriented, quality-checklist driven radiation medicine department. Article in press:Prac Radiat Oncol. 2011

Source: http://www.practicalradonc.org

RadPhysics Publications

RadPhysics Publications

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RadPhysics Presentations

RadPhysics Presentations

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Resources / Links

Agency for Healthcare Research and Quality (AHRQ)

American Academy of Health Physics (AAHP)

American Association of Medical Administrators (AAMA)

American Association of Medical Dosimetrists (AAMD)

American Association for Medical Imaging Management (AHRA)

American Association of Medical Physicists of India (AMPI)

American Association of Physicists in Medicine (AAPM)

American Brachytherapy Society (ABS)

American College of Medical Physics (ACMP)

American Cancer Society (ACS)

American College of Radiology (ACR)

American College of Radiation Oncology (ACRO)

American Institute for Cancer Research (AICR)

American Medical Association (AMA)

American Registry of Radiologic Technologists (ARRT)

American Roentgen Ray Society (ARRS)

American Society of Clinical Oncology (ASCO)

American Society of Radiation Oncology (ASTRO)

American Society of Radiologic Technologists (ASRT)

Association of Community Cancer Centers (ACCC)

Australasian College of Physical Scientists & Engineers in Medicine (ACPSEM)

BMJ Quality & Safety (BMJ)

British Institute of Radiology (BIR)

Canadian Association of Medical Radiation Technologists (CAMRT)

Canadian College of Physicists in Medicine (CCPM)

Conference of Radiation Control Program Directors (CRCPD)

Council on Ionizing Radiation Measurements and Standards (CIRMS)

Eastern Cooperative Oncology Group (ECOG)

European Organisation for Research and Treatment of Cancer (EORTC)

European Federation of Organizations for Medical Physics (EFOMP)

European Society for Therapeutic Radiology and Oncology (ESTRO)

Health Physics Society (HPS)

U.K. Health Protection Agency (HPA)

U.K. Medicines and Healthcare Products Regulatory Agency (MHRA)

U.S. Drug and Food Administration (FDA)

U.S. Nuclear Regulatory Commission (NRC)

Institute of Physics and Engineering in Medicine (IPEM)

International Atomic Energy Agency (IAEA)

International Commission on Radiological Protection (ICRP)

International Commission on Radiation Units & Measurements (ICRU)

International Organization of Medical Physics (IOMP)

International Radiation and Health Physics (IRHP)

International Radiation Protection Association (IRPA)

Ionising Radiations Incident Database (IRID)

National Academy of State Health Policy (NASHP)

National Comprehensive Cancer Network (NCCN)

National Patient Safety Agency (NPSA)

National Patient Safety Foundation (NPSF)

Oncology Nursing Society (ONS)

Othea Relir (RELIR)

Patient Safety Authority - Commonwealth of Pennsylvania (PSA)

Radiology Business Management Association (RBMA)

Radiological Physics Center (RPC)

Radiological Society of North America (RSNA)

Radiation Therapy Oncology Group (RTOG)

Royal College of Radiologists (RCR)

Society of Interventional Radiology (SIR)

Society of Radiation Oncology Administrators (SROA)

The Joint Commission (JCAHO)

The Leapfrog Group (TLFG)

United Nations Scientific Committee on the Effects of Atomic Radiation (UNSCEAR)

World Health Organization (WHO)