Volume 33, Issue 6, June 2006
Index of content:
- Professional Course: Room 230A
Medical Errors I
33(2006); http://dx.doi.org/10.1118/1.2241523View Description Hide Description
There has developed, over the last few years, an increased awareness of the risks patient take when submitting themselves to medical procedures all of which are prone to errors. As a medical intervention, radiation therapy is no less susceptible to errors than any other branch of health care. Indeed in the case of radiation therapy both the consequences of errors and the number of patients affected can easily exceed those experienced elsewhere. A relatively small deviation from the prescription in either dose or volume irradiated can result in severe side effects or a failure to achieve the desired therapeutic outcome. Many patients are planned and/or treated on the same equipment facilitating the possible exposure to systematic effects.
In this presentation the current status of error prevention activities in radiation therapy will be reviewed. This will include initiatives in both North America and Europe. The AAPM has recently formed a working group to focus on this issue. In Europe, ESTRO is particularly active in this area through workshops, teaching courses and the ROSIS database. In addition there are less formal groups who are dealing with particular components of safety in radiation therapy.
If we are to live by the maxim “First, do no harm” then we need to do better than we are doing now. The degree of ambiguity in the available literature confounds interpretation in many cases. In particular we need to speak the same language when describing safety/quality issues. We need to have a metric for describing the severity of incidents in radiation therapy. One will be suggested for discussion. Ideally we should have a causal structure, which could be linked to a high level process map, for investigating incidents. With a causal structure we have a much better chance of learning from the actual and potential incidents which do occur. The learning component is one that we are particularly weak at. With a better understanding of the probability and severity of incidents we will make more informed decisions on the allocation of safety/quality resources. Finally, patient safety in radiation therapy is too big to deal with effectively on an individual clinic basis. While local issues undoubtedly influence the local risk of incidents, we will be able to give our patients a far better guarantee of both a safe and effective treatment if we work together across professional and geographic boundaries. To do this we need a common taxonomy, a degree of commonality in causal analysis and a common commitment to effective learning strategies.
1. To appreciate the current status of error reduction activities in radiation therapy.
2. To identify some of the limitations of current activities.
3. To consider approaches to improving error reduction strategies.
33(2006); http://dx.doi.org/10.1118/1.2241524View Description Hide Description
The purpose of this presentation is to discuss the philosophy and theory of error analysis and reduction. This talk will be equal parts conveyance of technical information and provocation to action on the important issue of medical errors. Although a somewhat obvious connection, we begin by providing a sound framework that relates errors and quality assurance. The scope of technical information within this presentation will be an attempt to wade through the myriad of theories and philosophy related to errors and quality, much of which is new to our field. For example, the JCAHO Lexicon describes quality as, “Designing a product or service as well as controlling its production so well that quality is inevitable.” What does it actually mean to control a product or service? This will be described. The leadership of the AAPM has taken the ambitious step to change the emphasis of quality assurance from simply checking specifications to investigating processes via the new quality assurance task group (TG100). This is a significant and necessary paradigm shift in our approach to medical errors and quality that deserves a detailed discussion. An understanding of how to reduce errors and improve quality begins with an appreciation of two realities: 1) everything we do involves a process, and 2) every process has unavoidable variation. If one controls variation in a process, then one will reduce errors and improve quality. The implementation of process identification and control to clinical practice will be discussed in detail and by example where appropriate. Furthermore, there is a significant history of error reduction and quality research and this context will be maintained throughout the presentation. In addition to specific techniques of error analysis and reduction such as failure modes and effects analysis (FMEA), root cause analysis (RCA), pareto charts, fishbone diagrams and statistical process control (SPC) we will discuss the philosophies of define, measure, analyze, improve, control (DMAIC) and total quality management by the six‐sigma approach.
Error analysis and reduction (and quality assurance in general) are built on a mature body of research from other fields. There is much work to do toward implementing these techniques in radiotherapy practices to minimize errors and optimize quality. There are no turn‐key solutions to quality. As will be described, the business world has become fanatical about quality to stay competitive. Why should the medical world be any different with our patients' well‐being at stake? Medical physicists, above anyone else in the typical department, have the analytical ability to understand and implement these techniques. We must accept the challenge and as a first step, future AAPM meetings should have a research session specific for quality, error analysis/reduction and cost analysis/reduction.
Medical Errors II
33(2006); http://dx.doi.org/10.1118/1.2241704View Description Hide Description
Routine quality assurance (QA) in brachytherapy developed quickly through the 1990s, and fairly standard practices became common. The reports of Task Groups 40, 56 and 59 established formalized, accepted standards for QA in brachytherapy, and textbooks covered QA procedures in detail (1). Why, with a solid understanding of QA procedures, were there still many reported brachytherapy medical events, and likely many more unreported or unrecognized? A review of such events (2) notes that for many cases, the facility had QA procedures in place, but they were ineffectual because they either did not cover the situations that evolved or, often, simply were not performed, frequently because of time constraints. Current high dose‐rate (HDR) brachytherapy QA focuses heavily on equipment and instrumentation. Very few events resulted from errors in the equipment (although, equipment failures often set the stage), due in part to the extremely high reliability built into the devices and, possibly in part, because of the attention paid to equipment QA by the medical physicists. A soon to be released report from the International Atomic Energy Agency will note that the greatest danger in radiotherapy is not equipment malfunctions but the human activities related to the procedures. (3) Much of the current QA for HDR brachytherapy stems from regulations of the Nuclear Regulatory Commission. Some of the regulations expend effort with little expected return. For example, daily QA requires a check of the door interlock at the room entrance. For many facilities, the operator has the door in clear view during treatments; the probability of a person trying to enter the room during a treatment with a failure of the interlock becomes vanishingly small. With each new source, the length and function of transfer tubes and applicators must be checked. Most of these instruments cannot change their length, and the functioning would be (and should be) determined at each use. Measuring exposure readings outside the HDR room with each source change wastes time. Such requirements divert resources from useful activities. The new paradigm for QA first assesses all the possible ways things can go wrong (and the list is a long one), rating the likelihood of occurrence, and severity of the result if it does happen, and the probability of detecting the failure before it propagates into the event. These ranking provide the priorities for allocating resources for activities to prevent failures This process will naturally place a greater emphasis on the human role in the procedures.
Learning Objectives: To understand
1. The problem with the current QA paradigm, and
2. The advantage of the new paradigm
33(2006); http://dx.doi.org/10.1118/1.2241705View Description Hide Description
The increasing complexity, functionality, and site‐to‐site variability of modern radiation therapy planning and delivery techniques challenge the traditional prescriptive quality control/quality assurance (QC/QA) programs that ensure safety and reliability of treatment planning and delivery systems under all clinical scenarios. The manufacturing industry has historically relied on extensive testing and use of techniques such as probabilistic reliability modeling for developing and maintaining new products. Among the most widely used method of risk analyses are Failure Modes and Effects Analysis (FMEA). This is a methodology for analyzing potential reliability problems early in the development cycle where it is easier to take actions to overcome these issues, thereby enhancing reliability through design. FMEA is used to identify potential failure modes, determine their effect on the operation of the product, and identify actions to mitigate the failures. From a manufacturer's perspective, FMEA is a valuable method to systematically evaluate a device design's potential for inducing user errors. User errors are defined as a pattern of predictable human errors that can be attributable to inadequate or improper design. When these risk analyses are done early in the development cycle, potential faults and their resulting hazards are identifiable and much easier to mitigate with error‐reducing designs. These risk management methods are excellent complements to other important user‐centered design best practices. Risk analysis, or hazard analysis, is a structured tool for the evaluation of potential problems which could be encountered in connection with the use of a device. The early and consistent use of FMEAs in the design process allows the engineers to design out failures and produce reliable and safe products. FMEAs also capture historical information for use in future product improvement.
We will first review current paradigms of QC/QA issues in IMRT with a goal to define the problems and challenges associated with the implementation of traditional methods of quality assurance. This will be followed by a second presentation, which will describe a step‐by‐step implementation of the aforementioned hazard analyses and error mitigation methodologies of industrial engineering in addressing QA/QC and safety issues in IMRT. Such an approach should result in a QA/QC program for IMRT that has a good scientific rationale and justification.
33(2006); http://dx.doi.org/10.1118/1.2241910View Description Hide Description
Medical physics services in medicine are reimbursed through the Current Procedural Terminology (CPT) Codes published by the American Medical Association in an annual publication. Although CPT codes for medical physics services appear explicitly in the radiation oncology series of CPT codes (77XXX), diagnostic radiological physicists may use several of these codes to cover patient specific work they may be called on to perform. This refresher course will trace the advent of the Centers for Medicare and Medicaid Services (CMS) relative value system for reimbursement for medical services and explain in detail how the complex system operates for current and new technology codes. Payments differ in various settings such as hospital, free‐standing center and ambulatory surgical center and these differences will be traced for each site of service.
Additionally, private health insurance carrier are not required to follow the precepts of the CPT formalism and these reimbursement entities will be described in their methodology of reimbursement for these services. Finally, ancillary publications that impinge on these reimbursement rules (eg. Correct Coding Initiative, CCI) will be referenced. Coding compliance guides such as those published by ASTRO and ACR will form the basis for this economics refresher course.