Monday, February 22, 2010

Medicine + Technology + Telecommunications = Telemedicine

During the past decade, more and more people have been able to avoid physically going into work by telecommuting from their home computer. Medicine has taken a cue from this growing trend by combining telecommunications technology and medicine to create telemedicine and telehealthcare. While healthcare professionals have always communicated with one another over the telephone, telemedicine kicks things up a notch by utilizing sophisticated satellite technology to broadcast consultations between healthcare professionals who are oceans apart or only a few miles away. Videoconferencing equipment and robotic technology have helped to make doctor’s offices and medical facilities as close to one another as the nearest computer screen.

There are two popular types of technology used for telemedicine applications. The first of these is called “store and forward” which is used for transferring digital images from one location to another. A healthcare professional takes a picture of a subject or an area of concern with a digital camera. The information on the digital camera is “stored” and then “forwarded” by computer to another computer at a different location. This type of technology is utilized for non-emergent situations, when there’s time for a diagnosis or consultation to be made, usually within 24 to 48 hours, with the findings then sent back. The most common use of store and forward technology is with teleradiology, where x-rays, CT scans, and MRIs can be sent from within the same facility, between two buildings in the same city, or from one location to another anywhere in the world. There are hundreds of medical centers, clinics, and individual physicians who use some form of teleradiology. Many radiologists are even installing appropriate computer technology within their own homes, allowing them access to images sent directly to them for diagnosis, eliminating an unnecessary and possibly time-consuming trip back into to a hospital or clinic. Telepathology is also another common use of this type of technology, with images of pathology slides sent from one location to another for diagnostic consultation. Dermatology is one area that greatly benefits from the store and forward technology, with digital images of different skin conditions taken and sent to a dermatologist for diagnosis.

Utilized when a face-to-face consultation is necessary, the second most widely-used technology is two-way, interactive television (IATV). This is when the patient, along with their healthcare provider (a doctor or a nurse practitioner) and a telemedicine coordinator (or a combination of the three), gather at one site (the originating site), and a specialist is at another site (the referral site) which is usually at a large, metropolitan medical center. Videoconferencing equipment is placed at both locations allowing for a consultation to take place in “real-time”. Videoconferencing technology has decreased in price over the past few years, and many of the computer programs are no longer as complex as they once were, allowing for healthcare professionals to use nothing more than a simple desktop videoconferencing system. Almost all areas of medicine have been able to benefit from videoconferencing, including psychiatry, internal medicine, rehabilitation, cardiology, pediatrics, obstetrics, gynecology and neurology. Also, many different peripheral devices like otoscopes (which help doctors look inside the ear) and stethoscopes (which enable a doctor to listen to a person’s heartbeat) can be attached to computers, aiding with an interactive examination. Many healthcare professionals are becoming more creative with the technology that’s available to them in order to conduct telemedicine. For example, it's not unusual to use store-and-forward, interactive, audio, and video still images in a variety of combinations and applications. Use of the Web to transfer clinical information and data is also becoming more prevalent, and the use of wireless technology is being used to provide ambulances with mobile telemedicine services of all kinds.

Around the world, there are many programs being used in a variety of ways to provide technologically-advanced healthcare. Telemedicine can be used in the remotest parts of the world or in places as close as a correctional facility, helping to eliminate the dangers and costs associated with the transportation of prisoners to a medical center. Also on the horizon for telemedicine is the development of robotics equipment for telesurgery applications which would enable a surgeon in one location to remotely control a robotics arm for surgery in another location. The military has been at the forefront of development for this type of technology because of the obvious advantages it offers for use on the battlefield; however, some academic medical centers and research organizations are also testing and using telesurgery in order to continue the advancements in telemedicine.

As wonderful as the advent of telemedicine is, there are still drawbacks that people need to know about, like the fact that many states will not allow out-of-state physicians to practice medicine unless they are licensed in that particular state. The Centers for Medicare and Medicaid (CMS) have placed restrictions on the amount given in reimbursements for telemedicine procedures, and many private insurance companies will not reimburse at all for this technology, although states such as California and Kentucky have legislated that insurers must reimburse the same amount for a telemedicine procedure as they would for an actual face-to-face consultation. There are also underlying fears of malpractice suits for physicians engaged in telemedicine because there is a lack of hands-on interaction with patients. However, several studies show that most people who have experienced long-distance healthcare via telemedicine have been quite satisfied with the care they received. There are also the technological problems which can hamper the progress of telemedicine, like the fact that regular telephone lines tend to be inadequate in handling many of the telemedical applications. Also, many rural areas still don’t have the cable wiring or other kinds of high bandwidth telecommunications needed to access the equipment required for more sophisticated medical uses. One other obstacle stands in the way of progress, and that’s the issue of funding. During 2005, the Technology Opportunity Program (TOP) will not receive funds for telemedicine/telehealth, and the Office for the Advancement of Telehealth (OAT) will not be able to fund any new programs either. The good news is that some private corporations and telecommunications companies are trying to fill the financial void created by the lack of funding.

All in all, the advantages of telemedicine definitely outweigh its detractors, with it soon being just another way to see a healthcare professional. The future of telemedicine will not only be advantageous for those in rural communities, but will also offer people who are homebound within metropolitan areas with a way to access specialty care. Eventually, everyone could have a personal diagnosis system through their home computers, and it will monitor our health status on a daily basis, as well as have the ability to automatically notify a medical professional when we become ill. Telemedicine, telehealth, and e-health will continue to combine the best of medicine, technology, and telecommunications, which will help make our lives healthier and safer.

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Training, Other Qualifications, and Advancement of Clinical Laboratory

Clinical laboratory technologists generally require a bachelor's degree in medical technology or in one of the life sciences; clinical laboratory technicians usually need an associate degree or a certificate.

Education and training. The usual requirement for an entry-level position as a clinical laboratory technologist is a bachelor's degree with a major in medical technology or one of the life sciences; however, it is possible to qualify for some jobs with a combination of education and on-the-job and specialized training. Universities and hospitals offer medical technology programs.

Bachelor's degree programs in medical technology include courses in chemistry, biological sciences, microbiology, mathematics, and statistics, as well as specialized courses devoted to knowledge and skills used in the clinical laboratory. Many programs also offer or require courses in management, business, and computer applications. The Clinical Laboratory Improvement Act requires technologists who perform highly complex tests to have at least an associate degree.

Medical and clinical laboratory technicians generally have either an associate degree from a community or junior college or a certificate from a hospital, a vocational or technical school, or the Armed Forces. A few technicians learn their skills on the job.

The National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) fully accredits about 479 programs for medical and clinical laboratory technologists, medical and clinical laboratory technicians, histotechnologists and histotechnicians, cytogenetic technologists, and diagnostic molecular scientists. NAACLS also approves about 60 programs in phlebotomy and clinical assisting. Other nationally recognized agencies that accredit specific areas for clinical laboratory workers include the Commission on Accreditation of Allied Health Education Programs and the Accrediting Bureau of Health Education Schools.

Licensure. Some States require laboratory personnel to be licensed or registered. Licensure of technologists often requires a bachelor's degree and the passing of an exam, but requirements vary by State and specialty. Information on licensure is available from State departments of health or boards of occupational licensing.

Certification and other qualifications. Many employers prefer applicants who are certified by a recognized professional association. Associations offering certification include the Board of Registry of the American Society for Clinical Pathology, the American Medical Technologists, the National Credentialing Agency for Laboratory Personnel, and the Board of Registry of the American Association of Bioanalysts. These agencies have different requirements for certification and different organizational sponsors.

In addition to certification, employers seek clinical laboratory personnel with good analytical judgment and the ability to work under pressure. Technologists in particular are expected to be good at problem solving. Close attention to detail is also essential for laboratory personnel because small differences or changes in test substances or numerical readouts can be crucial to a diagnosis. Manual dexterity and normal color vision are highly desirable, and with the widespread use of automated laboratory equipment, computer skills are important.

Advancement. Technicians can advance and become technologists through additional education and experience. Technologists may advance to supervisory positions in laboratory work or may become chief medical or clinical laboratory technologists or laboratory managers in hospitals. Manufacturers of home diagnostic testing kits and laboratory equipment and supplies also seek experienced technologists to work in product development, marketing, and sales.

Professional certification and a graduate degree in medical technology, one of the biological sciences, chemistry, management, or education usually speeds advancement. A doctorate usually is needed to become a laboratory director. Federal regulation requires directors of moderately complex laboratories to have either a master's degree or a bachelor's degree, combined with the appropriate amount of training and experience.

Clinical Laboratory Technologists and Technicians

Clinical laboratory testing plays a crucial role in the detection, diagnosis, and treatment of disease. Clinical laboratory technologists, also referred to as clinical laboratory scientists or medical technologists, and clinical laboratory technicians, also known as medical technicians or medical laboratory technicians, perform most of these tests.

Clinical laboratory personnel examine and analyze body fluids, and cells. They look for bacteria, parasites, and other microorganisms; analyze the chemical content of fluids; match blood for transfusions; and test for drug levels in the blood that show how a patient is responding to treatment. Technologists also prepare specimens for examination, count cells, and look for abnormal cells in blood and body fluids. They use microscopes, cell counters, and other sophisticated laboratory equipment. They also use automated equipment and computerized instruments capable of performing a number of tests simultaneously. After testing and examining a specimen, they analyze the results and relay them to physicians.

With increasing automation and the use of computer technology, the work of technologists and technicians has become less hands-on and more analytical. The complexity of tests performed, the level of judgment needed, and the amount of responsibility workers assume depend largely on the amount of education and experience they have. Clinical laboratory technologists usually do more complex tasks than clinical laboratory technicians do.

Clinical laboratory technologists perform complex chemical, biological, hematological, immunologic, microscopic, and bacteriological tests. Technologists microscopically examine blood and other body fluids. They make cultures of body fluid and tissue samples, to determine the presence of bacteria, fungi, parasites, or other microorganisms. Technologists analyze samples for chemical content or a chemical reaction and determine concentrations of compounds such as blood glucose and cholesterol levels. They also type and cross match blood samples for transfusions.

Clinical laboratory technologists evaluate test results, develop and modify procedures, and establish and monitor programs, to ensure the accuracy of tests. Some technologists supervise clinical laboratory technicians.

Technologists in small laboratories perform many types of tests, whereas those in large laboratories generally specialize. Clinical chemistry technologists, for example, prepare specimens and analyze the chemical and hormonal contents of body fluids. Microbiology technologists examine and identify bacteria and other microorganisms. Blood bank technologists, or immunohematology technologists, collect, type, and prepare blood and its components for transfusions. Immunology technologists examine elements of the human immune system and its response to foreign bodies. Cytotechnologists prepare slides of body cells and examine these cells microscopically for abnormalities that may signal the beginning of a cancerous growth. Molecular biology technologists perform complex protein and nucleic acid testing on cell samples.

Clinical laboratory technicians perform less complex tests and laboratory procedures than technologists do. Technicians may prepare specimens and operate automated analyzers, for example, or they may perform manual tests in accordance with detailed instructions. They usually work under the supervision of medical and clinical laboratory technologists or laboratory managers. Like technologists, clinical laboratory technicians may work in several areas of the clinical laboratory or specialize in just one. Phlebotomists collect blood samples, for example, and histotechnicians cut and stain tissue specimens for microscopic examination by pathologists.

Work environment. Clinical laboratory personnel are trained to work with infectious specimens. When proper methods of infection control and sterilization are followed, few hazards exist. Protective masks, gloves, and goggles often are necessary to ensure the safety of laboratory personnel.

Working conditions vary with the size and type of employment setting. Laboratories usually are well lighted and clean; however, specimens, solutions, and reagents used in the laboratory sometimes produce fumes. Laboratory workers may spend a great deal of time on their feet.

Hours of clinical laboratory technologists and technicians vary with the size and type of employment setting. In large hospitals or in independent laboratories that operate continuously, personnel usually work the day, evening, or night shift and may work weekends and holidays. Laboratory personnel in small facilities may work on rotating shifts, rather than on a regular shift. In some facilities, laboratory personnel are on call several nights a week or on weekends, in case of an emergency



Evolution of Medical Technology

American Medical technologists

The American Medical Technologists (AMT) is a nonprofit certification agency and professional membership association representing over 45,000 individuals in allied health care. Established in 1939, AMT has been providing allied health professionals with professional certification services and membership programs to enhance their professional and personal growth. Upon certification, individuals automatically become members of AMT and start to receive valuable benefits.

Certifications are offered in the following categories: Medical Technologists, Medical Laboratory Technicians, Medical Lab Assistants, Medical Assistants, Medical Administrative Specialists, Phlebotomy Technicians, Dental Assistants, Allied Health Instructors, Clinical Laboratory Consultants

Founded in 1939, American Medical Technologists (AMT) is a nationally and internationally recognized certification agency and membership society for the following allied health professionals:

Medical and Dental Office

Medical Assistant

Medical Administrative Specialist

Dental Assistant

Laboratory

Medical Technologist

Medical Laboratory Technician

Medical Laboratory Assistant

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Clinical Laboratory Consultant

Health Education

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AMT certification examinations are developed, administered, and analyzed using industry standards and state-of-the-art methodologies. Each examination is developed by a committee of subject-matter experts. As the tests provide only one source of information regarding examinee competence, they are used in conjunction with other indicators of training and experience in the granting of certification. Once certification is granted, applicants automatically become members of AMT and have a host of member benefits at their disposal.

AMT is accredited by the National Commission for Certifying Agencies (NCCA). Not all healthcare certification organizations are NCCA accredited -- in fact, very few have received such recognition. Only organizations meeting rigorous NCCA Standards bear the NCCA seal of approval.

AMT Mission Statement

The mission of AMT is to manage, promote, expand upon and continuously improve our certification programs for allied health professionals who work in a variety of disciplines and settings, to administer certification examinations in accordance with the highest standards of accreditation, and to provide continuing education, information, advocacy services and other benefits to our AMT members.

AMT Vision Statement

Our vision is for American Medical Technologists to be acknowledged and recognized by the world as truly being THE premier certification and membership organization for allied health professionals, particularly those in the professions of medical technology, phlebotomy, medical assisting, dental assisting and medical office administration.

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Error and Injury in Computers & Medical Devices

Computers are playing an increasing role in everyday life, so it is not surprising that incidents involving computers have become a common matter of litigation. In a wide variety of technical, financial and other situations, people make decisions and perform responses based on the appearance of a computer screen. The increased reliance of computer controlled devices in medicine is particularly noteworthy because of the critical safety issues involved. As I will discuss below, this produces a conflict between the usual goal of interface design, intuitiveness and ease-of-use, and the safety of patients.

When error occurs, the question naturally arises as to how one can apportion responsibility between the human and the computer: was the computer poorly designed or was the human negligent?

In many cases, the critical component of the computer is its interface. Users/operators generally do not understand the computer's inner world of bits, bytes, files, ram, etc. Rather, they understand the computer through its interface, the text and images that appears on the screen. Hence, a popular saying in the computer world is that for the user:

"The Interface Is The System"

User/operator actions can only be evaluated in the context of the interface. As an analogy, suppose a driver fails to see a STOP sign, runs an intersection and hits another car. Is it the driver's fault? If the STOP were highly visible, the answer would likely be "yes." If the STOP sign were hidden by foliage, then the answer is likely "no" because the information were beyond human ability to perceive and to respond. Similarly, the actions of a computer user can only be evaluated in reference to the quality interface design.

In order to assess responsibility, it is important to understand how interfaces are designed. Below, I provide a brief outline of the methods which designers use in creating and evaluating computer and other man-machine interfaces.

Standard Practice in Interface Design

There are two principal issues which should be investigated when there is an accident involving computers. First, the computer interface should be evaluated for adequacy of design. Faulty design could be construed as negligence on the part of the designers. As discussed below, there are a number of standard criteria available for evaluating adequacy. Second, the interface design procedure should be closely examined. Just as there are standards for nursing practice and for medical care, there is standard practice for interface design. Although not formally codified, the standard practice is generally understood by interface professionals and is described in most design texts. Failure to follow the generally agreed practice is also a possible source of negligence.

Most interface design occurs in 4 overlapping phases. In addition, there is a 5th optional phase, which may or may not be performed.

1. Requirements gathering

The designer studies users and their tasks and attempts to develop a set of requirements, which state what the interface should do. This stage is critical, since misunderstanding the users (or user classes if there are different groups) will guarantee a flawed interface design.

2. Prototype development:

The next step is to develop a prototype with which to test users. In most cases, the initial prototypes are crude (sometimes even paper and pencil) and become more refined with user testing. (See next phase.)

3. Formative Usability Evaluation:

A good designer will continually test users in order to validate design and to test assumptions. Each design is really a guess until it has been tested and found adequate by a representative set of users (although there are other useful techniques - see below). The designer uses data obtained from each evaluation to refine and form (hence the name "formative") the design and prototype. The design is retested (looping the procedure back to phase 2), and the design further refined. In theory, testing stops when a predetermined set of benchmarks is reached and/or when the designer is simply satisfied. In reality, design typically ceases when time or money run out.

4. Conversion of Prototype to Final Software

Software engineers (programmers with little or no interface design experience in most cases) convert the prototype to a final form, usually in a faster and more efficient programming language. It is not uncommon for the design to change significantly in this process. Sometimes the software engineer makes what he/she considers small changes (which may, in fact, be major changes) in order to make programming easier and sometimes the efficient programming language simply cannot produce the design exactly.

5. Summative Usability Testing

Usability testers evaluate the final interface functionality. This may occur in-house, or the testers may go to customers in the field. Results are then used to improve the next software revision.

The scheme outlined here, with some variation, is standard practice by interface design and usability experts. However, this is not how all interfaces are designed. In many companies, people with little or no design, usability or human factors experience often create the interface. Some companies are run by techies who simply slap untested interfaces together as an afterthought, with software engineers performing interface "design." Graphic artists often design interfaces, especially on web sites, although they have no psychology or human factors training. Lastly, usability testing is expensive, so companies may skimp on this part of the project budget. Although the importance of human factors is becoming better understood in the technology world, inadequate design procedures are still common.

A properly conducted design procedure generates a series of standard documents. The most important are the "requirements document," "design specification" and the "change control" documents. The requirements document says what the interface ought to do. The design specification document describes the interface in detail. It is usually written by the designer(s) so that the people programming the production code know what the design should be. There is often a deviation between the design and final product for the reasons already described. Lastly, the change control document is a formal notation of all changes in the design, usually after the design specification is written. There are almost invariably some design changes made up until the last possible second. Usually, there are specific people who must "sign off" on each document.

Standard Evaluation of Interfaces

Usability testing of the prototype is a critical part of design. There are many techniques for testing, but they fall into two general classes:

  • Those that that involve actual users
  • Those that do not involve actual users.
The first method, which has many variations, has users sitting at a computer and working with a prototype. At early development stages, the user may be merely exploring the software - viewing screen, clicking buttons, entering numbers, etc. With more refined prototypes, the user may be solving a simulated task which resembles his/her real work. The tester may simply write qualitative observations or may record quantitative data, such as number of errors and time required for task completion, and perform statistical analysis. Videotaping of users is common.

The second method is sometimes used to supplement, and occasionally replace the first if users are hard to obtain. This occurs if the users' time is very valuable (physicians, lawyers, or very highly skilled technical employees, etc) or if the users are geographically remote. Moreover, it is sometimes difficult to know who the users will be, so it may be misleading to test with any particular group.

A common nonuser method is called "Heuristic Evaluation." A group of 3-5 usability experts and/or nonexperts judges the interface based on a set of specific criteria. Here are some criteria, which would be used to judge most interfaces:

  • Simplicity: make the interface easy to use:
  • Design For Error: assume that the user will make errors. Make errors easy to reverse and/or find a way to prevent them, e. g., ask for confirmation on important actions.
  • Make System State Visible: the user should know what is happening inside the computer from looking at the interface.
  • Speak the user's language: use concepts with which the user is familiar. If there are different classes of user (say, novices and experts in the work), then be sure that both groups understand the interface.
  • Minimize Human Memory Load: human memory is fallible and people are likely to make errors if they must remember information. Where possible have the critical information on the screen. Recognition and selection from a list are easier than memory recall.
  • Provide feedback to the user: when the user makes an action, provide feedback that something happened. At the most basic level, the feedback may simply be a beep to indicate that a button press was recorded. At a higher level, the feedback may be a message that describes the consequences off the action in detail.
  • Provide good error messages: When errors occur, provide the user with good information about the problem. Poor error messages can be disastrous, as in the Therac-25 case.
  • Be Consistent: Similar actions should produce similar results and objects, which are the same visually (colors, shapes), should be related in an important way. Conversely different objects should be indicated by different visual appearance.
These same criteria can be used to judge the responsibility of the interface design in an accident. From experience, I'd guess the most common problems are lack of consistency, hiding of the system state and failure to design for error. (Most interface designers have never head of a Failure Mode and Effects Analysis.)

Ease of Use vs. Safety: An Example of Medical Device Error

One problem in evaluating interface design is that safety and ease-of-use sometimes conflict. Interface designers are taught to make the interface "user friendly" and intuitive. Being intuitive, however, is a two-edged sword. The good news is that users learn the interface quickly and make fewer errors. In addition, an intuitive interface is more likely to be properly operated when the user is under stress, the time when people unconsciously fall back their innate and highly learned behavior.

The bad news is that very notion of "intuitive" means that the user/operator won't have to think too much. In safety critical situations, this is not always desirable. People have a tendency to minimize their workload by using more and more general cues. For example, instead of reading a red warning label, they may learn to simply respond when they see the red text - it is much easier and faster to recognize color than to read text. If there is an unusual or unexpected message in red, the user will not notice the change because the cue is color, not the actual text. Similarly, users learn to make their responses "automatic" when they occur with great frequency.

The classic example of ease-safety conflict is the Therac-25, which was a computer-controlled device for delivering measured bursts of radiation to cancer patients. Several patients being treated with the machine accidentally received fatal doses of radiation.

There were many problems with the Therac-25 (including poor error messages which failed to make the machine state visible), but I'll just comment on one aspect of the interface design. In the original version of the machine, the operator had to enter control parameters twice. First, they were typed into the computer and sent with by hitting the "enter" key. Second, the user entered the values into a control panel. This provided redundancy for a critical task. It seemed less likely that the operator would enter the same wrong values twice. Moreover, the computer could check to make sure that the values were the same.

From an ease-of-use standpoint, this was a clumsy design. The interface designers decided make the users life easier by removing the need to confirm values with the control board. As before, the user typed numbers and then hit the enter key to send the values. Instead of going to the control board, the values appeared again on the screen, and the user could confirm them by hitting the "enter" key a second time. This second confirmation was a replacement for the control board data entry. It was much a faster and more efficient interface design.

Users soon began entering the values and then simply hitting the "enter" key twice without looking at the screen. The new system was easier, but the redundant check on the values was gone.

This was highly predictable because of phenomena called "automaticity" and "response chaining." When a person repeatedly performs a task requiring a standard and unvarying series of responses, then the responses chain together and effectively become a single response. Once started, the chain of responses runs off automatically. For example, a pianist learning a new piece might have to think about every note before hitting the key. After practice, the pianist simply runs off the series of responses without thinking. This reliance on "muscle memory" is obviously much easier, but thinking is removed from the task. The Therac-25 case was a particular bad example because the enter and confirmation responses were identical, which facilitates response linking.

Such errors are common. In another case, a nurse, accidentally turned off the alarm on computerized equipment monitoring a critically ill patient. Normal operation required her to set the alarm to "on" and then to confirm the choice with several more responses on computer keyboard. She viewed a series of computer screens containing information about the alarm system. After each, she was to press the enter key again to confirm and to see the next screen. With experience, the responses chained and became automatic. She would set the alarm and begin merely hitting the enter key rapidly - tap, tap, tap - without really monitoring the screen information. She had done this many times before and the screens had never revealed any important information, so she began (unconsciously) conserving attention and increasing efficiency by ignoring the "irrelevant" information. On this one occasion, she missed the screen saying that the alarm was still off. The response chain, once started, had run off without supervision.

Summary

Since "The Interface is the system", an attorney investigating any accident involving a computer should examine the interface design. The first questions that should always be asked about an accident involving computers are:

  • Did the interface design meet the requirements of the task?
  • Did the interface meet standard evaluation criteria?
  • Was standard practice followed in the interface design?
  • Was testing adequate?
  • Were the test users appropriate?
  • Were the usability test results properly interpreted and incorporated in the design?
  • Were there "Change Control" and other formal documents on the design procedure?
  • Who designed the interface and what were his/her credentials?
  • If a safety critical situation, what was the tradeoff between ease-of-use and safety?
There are also secondary issues which should also be examined, such as "Was user training adequate?", "If the user/operator could customize the interface, did he/she reduce interface quality?," etc.

In this article, I have outlined the issues involved in determining responsibility in accidents involving computers. Computers and similar devices are truly "man-machine systems," where both components must function properly to avoid error. It is perhaps natural to examine only the user/operator actions, since they represent the visible "sharp end" of the system. In many cases, however, the major fault lies with the machine and/or the process used to develop the most important part, the user interface.