State and Federal Licensure Issues

Introduction

For millions of Americans, quality health care begins with quality radiologic care. Nearly 400 million medical imaging procedures are performed annually in the United States, giving health care providers the power to detect injury, diagnose disease and cure illness. Ultrasound scans provide 70 percent of the pregnant women in the United States with a first glimpse of their developing babies, offering important medical information as well as peace of mind. Screening mammography leads to the early detection and treatment of breast cancer, a disease that kills more than 45,000 U.S. women every year. And new interventional radiology procedures allow physicians to treat vascular diseases without invasive surgery, reducing recovery time and lowering costs.

But any radiologic procedure is only as effective as the person performing it. An underexposed chest x-ray cannot reveal tuberculosis or pneumonia; an improperly performed ultrasound study cannot detect spina bifida or other growth defects in a developing fetus; and inadequate mammography technique cannot help detect breast cancer. To be clinically useful, radiologic procedures must meet a high standard of quality. Accurate diagnosis is virtually impossible without quality medical imaging information, and quality information is best provided by radiologic personnel educated in anatomy, positioning, exposure technique and radiation safety.

Recognizing this need, the U.S. Congress voted in 1981 to adopt the Consumer-Patient Radiation Health and Safety Act. The Act directed the Secretary of Health and Human Services to develop minimum standards for state certification and licensure of personnel who administer ionizing or nonionizing radiation in medical and dental radiologic procedures. These standards were designed to ensure a basic level of education, knowledge and skill for operators of radiologic equipment.

Unfortunately, adoption of these standards was rendered discretionary with each state, and there are no sanctions for noncompliance. As a result, only 43 states have developed any regulatory guidelines for radiologic personnel, and standards vary dramatically from state to state. In the remaining 7 states and the District of Columbia, any individual is permitted to perform sophisticated radiologic procedures after only a few weeks' training. By comparison, a certified radiologic technologist must have at least two years of formal education in radiation protection and technique, pass a national certification exam and earn 24 hours of continuing education every two years.

The American Society of Radiologic Technologists, an association that represents more than 128,000 radiologic science professionals nationwide, believes that all Americans should have access to the highest quality radiologic care, provided by qualified radiologic personnel. One way to achieve that goal is to add an enforcement mechanism to the Consumer-Patient Radiation Health and Safety Act that encourages all states to follow its provisions. Currently, states and health care facilities that do not comply with the Act face no repercussions. An enforcement provision would require facilities providing medical imaging and radiation therapy services to patients to comply with the Act or risk losing Medicare reimbursements for radiologic services.

By requiring Medicare providers to comply with the education and certification standards contained within the Act, Congress will ensure that all Americans are cared for by properly educated and certified radiologic personnel. Lack of uniform standards nationwide for operators of radiologic equipment poses a hazard to the public and jeopardizes quality health care.

The American Society of Radiologic Technologists has joined with other health care organizations to form the Alliance for Quality Medical Imaging and Radiation Therapy in an effort to make mandatory the existing voluntary federal minimum standards for medical imaging and radiation therapy professionals. The proposed Consistency, Accuracy, Responsibility and Excellence (CARE) in Medical Imaging and Radiation Therapy Act will strengthen the Consumer-Patient Radiation Health and Safety Act of 1981 to ensure that the personnel who perform our nation's diagnostic imaging examinations and who plan and deliver radiation therapy procedures are properly educated and credentialed.

Background State Licensure of Radiologic Technologists

Professional licensure is a process by which a governmental agency grants permission to an individual to engage in a given occupation. To earn a license, the individual must prove that he or she has attained the minimum degree of competency required to ensure that the public health, safety and welfare will be protected. Dozens of professions and occupations are licensed at the state level, including teachers, architects, real estate agents, building contractors and barbers. Among the most heavily regulated, however, are individuals who provide health care services. Most states license nurses, pharmacists, chiropractors, physical therapists, dietitians and optometrists. For the patients of those medical professionals, licensure guarantees a basic level of education, knowledge and skill.

In 1965, New York became the first state to enact a licensure law for personnel who operated radiologic equipment. The state's intent was to minimize the public's unnecessary exposure to potentially hazardous radiation delivered during medical imaging procedures. However, the original New York law was weak. It did not include radiation therapists or nuclear medicine technologists, and its educational requirements were not equivalent to the two-year education program recommended by the American College of Radiology and the American Registry of Radiologic Technologists, the national certification body.

In 1969, New Jersey and California became the second and third states to enact licensure laws for radiologic personnel. The New Jersey law closely paralleled the one in New York, but the California law created nine categories of radiologic technologists, with educational requirements varying from three months to two years. Adding to the confusion, in 1970 New York amended its licensure law to allow schools of radiologic technology to accept students who had neither a high school diploma nor its equivalent. Other states were poised to follow suit, creating the potential for a patchwork of state licensure laws that ignored the minimum educational standards recommended by the profession.

The Consumer-Patient Radiation Health and Safety Act of 1981

Alarmed at the disregard for education standards and concerned that state licensure would result in 50 different standards in each of the 50 states, ASRT started advocating federal standards in 1965. U.S. Senator Jennings Randolph, D-W.V., introduced legislation in 1970 to establish federal minimum standards for the education and licensure of radiologic technologists. Following the issuance of these standards, the states would have two years either to adopt them or enact their own, more stringent, standards.

Senator Randolph's original bill was not heard by the full Senate in 1970 and was reintroduced to Congress several times over the next decade. In 1978, the bill was retitled the Consumer-Patient Radiation Health and Safety Act, and it underwent congressional hearings in 1978, 1979 and 1980.

Supporters of Senator Randolph's bill found it ironic that the federal government saw fit to regulate radiologic equipment through agencies such as the Nuclear Regulatory Commission and the Food and Drug Administration's Bureau of Radiological Health yet did not regulate the personnel who operated the equipment. According to testimony before the House Subcommittee on Oversight and Investigations, in 1979 there were an estimated 130,000 to 170,000 operators of radiologic equipment in the United States. Of those, only 80,000 had demonstrated competence through certification. The remaining 50,000 to 90,000 had no recognized credential.

In addition, by 1979 only nine states had enacted licensure laws for radiologic personnel. Those laws were so varied that they created severe employment difficulties for radiologic technologists who relocated from one licensure state to another. For example, the California licensure law had nine limited permit classifications-chest, gastrointestinal, genitourinary, leg, musculoskeletal, photofluorographic chest, skull, extremities and dental. This created odd licensing categories such as skull technologist and leg technologist, who were licensed to perform only one particular type of radiographic examination. If such a limited permit technologist moved to another licensure state, he or she likely would not meet the qualifications for employment.

On Feb. 16, 1981, Senator Randolph reintroduced the Consumer-Patient Radiation Health and Safety Act in the U.S. Senate, and a month later it was reintroduced in the House of Representatives. As Congressional debate on the bill continued throughout the summer of 1981, Senator Randolph faced a difficult decision: Either change the proposal's mandatory licensure provision to an advisory status or risk defeat of the entire bill. Worried that the legislation would again die in committee, Senator Randolph agreed to make the bill voluntary. On Aug. 13, 1981, after 13 years of effort, both houses of Congress passed the Consumer-Patient Radiation Health and Safety Act of 1981 (Title IX of Public Law 97-35). The Act's Statement of Findings reads:

The Congress finds that

  1. It is in the interest of public health and safety to minimize unnecessary exposure to potentially hazardous radiation due to medical and dental radiologic procedures;
  2. It is in the interest of public health and safety to have a continuing supply of adequately educated persons and appropriate accreditation and certification programs administered by State governments;
  3. The protection of the public health and safety from unnecessary exposure to potentially hazardous radiation due to medical and dental radiologic procedures and the assurance of efficacious procedures are the responsibility of State and Federal governments;
  4. Persons who administer radiologic procedures, including procedures at Federal facilities, should be required to demonstrate competence by reason of education, training, and experience; and
  5. The administration of radiologic procedures and the effect on individuals of such procedures has a substantial and direct effect upon United States interstate commerce.

The Act required the Secretary of Health and Human Services to develop federal standards for the certification of radiologic personnel and the accreditation of educational programs in radiologic technology. It also required the federal government to provide the states with a model statute for licensure. The Secretary as a Notice of Proposed Rulemaking issued the standards on July 12, 1983, and the Final Rule was published in the Federal Register on Dec. 11, 1985.

Although the federal government provided the standards and a model statute, their adoption by the states was not mandatory. Instead, each state was free to establish its own guidelines, continue using its existing standards or take no action of any kind.

Today, 42 states have enacted licensure laws or regulatory processes, many in accordance with the model statute provided by the federal government. In several states, however, it is questionable whether the laws developed to regulate radiologic personnel are sufficient to safeguard the public and uphold the original intention of the federal legislation. Licensure laws or regulations vary widely in the 43 states that regulate medical imaging personnel. According to a 1995 report from the Pew Health Professions Commission, one of the biggest barriers to effective and fair use of health professionals in the United States is the lack of uniform personnel regulations across state lines. The report states, "Standardized in neither form nor substance, the variations in language, laws and regulations are more than confusing. They inhibit access by consumers to health practitioners, unfairly restrict practitioners and prohibit the use of emerging health technologies across state lines." To solve this problem, the Pew Commission recommends that states begin adopting common terms in their licensing and regulatory language.

Although the varying licensure laws or regulations that regulate radiologic technologists in 43 states are confusing and inefficient, the situation is even more dire in the District of Columbia and the 7 states that do not have any type of licensure law at all for radiologic personnel. In those states, individuals are not required to demonstrate any level of competence or complete any formal educational process before being allowed to administer potentially dangerous doses of radiation to patients.

To protect patients from unnecessary radiation exposure and ensure the quality of radiologic procedures, the federal government must encourage all 50 states as well as all health care providers to uphold the educational and certification standards for radiologic personnel that have already been established by the Consumer-Patient Radiation Health and Safety Act of 1981. This law is already on the books; it simply needs an effective enforcement mechanism. Additional legislation enforcing the provisions of the Consumer-Patient Radiation Health and Safety Act of 1981 would:

Increase Quality

Today, radiology plays a role in the assessment of virtually every injury and many forms of disease. In fact, it is estimated that seven of every 10 Americans undergo some type of radiologic procedure annually whether it is something as common as a dental x-ray or something as cutting-edge as magnetic resonance angiography.

The success of any radiologic procedure no matter whether it is conventional x-ray, computed tomography, magnetic resonance imaging, nuclear medicine, mammography, sonography or radiation therapy depends on the skill and education of the person performing it. That individual controls the intensity of the x-ray beam, the duration of exposure, the shielding of the patient's reproductive organs and, ultimately, the quality of the resulting image. An image of poor quality can mean that illness and disease go undetected or that patients are misdiagnosed, possibly leading to delays in treatment and tragic consequences.

Uncertified personnel often do not have the education or experience to perform quality imaging exams that produce clinically useful information. If the patient is improperly positioned or the wrong exposure technique is chosen, the diagnostic quality of the resultant image is compromised.

Competence of personnel is important not only during imaging examinations such as radiography, CT, MR and ultrasound, but also in therapeutic procedures. The accurate delivery of cancer-killing radiation depends heavily upon the skill of the person operating the equipment. Just as a certified mammographer who practices under the Mammography Quality Standards Act (MQSA) knows which views and positioning techniques to use to produce the best image, radiologic technologists who are certified in radiation therapy know how to deliver the precise dose of radiation to a diseased area while sparing surrounding tissues.

Increase Safety

Administered properly, radiation is an invaluable tool in the diagnosis, treatment and management of disease. But most radiologic procedures also carry a potential health risk, and radiation can be harmful or even deadly if misadministered. According to the National Academy of Sciences/National Research Council's Committee on Biological Effects of Ionizing Radiation, medical diagnostic radiology accounts for about 90 percent of the total man-made radiation dose to the U.S. population. In many cases, much of this radiation is excessive and unnecessary because it is inappropriately or inaccurately delivered.

Exposure to any radiation holds the potential for harm, and because dosages are cumulative, the effects of low-level radiation can take as long as 20 years to show up. Biomedical research shows that exposure to excessive levels of radiation can cause spontaneous abortion, genetic damage, skin burns and other types of injuries, as well as increase the likelihood of leukemia and other cancers. Arthur Upton, M.D., former director of the National Cancer Institute, has estimated that the long-term effects of overexposure to radiation during diagnostic x-ray examinations may be responsible for more than 3,500 cancer deaths a year.

To reduce those numbers, we first must reduce exposure levels. A 1979 Canadian study of 30 radiology facilities found significant variations in x-ray exposure to patients during common diagnostic procedures. For example, dose to the skin for a lateral chest x-ray ranged from 24 millirads to 150 millirads; radiation dose during x-ray examinations of the upper gastrointestinal tract ranged from 1.6 rads to 90 rads; and dose delivered during gallbladder examinations ranged from 4 rads to 48 rads. The authors of the study directly attributed the variation in dosage to the knowledge and technique used by the equipment operator.

John F. Wochos and John R. Cameron, M.D. performed another study that linked operator skill to the safety and quality of diagnostic exams in 1976 from data obtained in the Nationwide Evaluation of X-ray Trends (NEXT) program. The results of their study showed that certified radiologic technologists delivered a significantly lower radiation dose to the patient than untrained operators during x-ray examinations of the lumbosacral spine, cervical spine, lateral skull and abdomen.

The paper evaluated patient exposure from more than 2,900 x-ray units involving 1,789 certified radiologic technologists, 692 operators with no education or certification in radiologic technology and 453 practitioner(physician) operators. It found that certified R.T.s delivered a significantly lower average exposure area product than untrained or practitioner operators, primarily because they used better collimation, resulting in a closer fit between the beam size and the film size. The authors of this study concluded, These data give clear evidence of the need for trained operators and the need for continuing education of radiologic technologists.

Further proof that properly educated radiologic technologists deliver safer radiologic examinations can be demonstrated by comparing the number of radiation misadministrations in licensure states with those of nonlicensure states. The Nuclear Regulatory Commission oversees medical procedures that use nuclear byproducts, including radiopharmaceuticals used during nuclear medicine and radiation therapy procedures. According to NRC records, states with nonexistent or lenient licensure of radiologic technologists generally have higher numbers of technologist misadministrations of radiation or radiopharmaceuticals during nuclear medicine procedures.

For example, Alabama, a state that does not license radiologic technologists, reported 42 misadministrations to the NRC between 1981 and 1997. By comparison, California, a state that licenses radiologic technologists, reported only 29 misadministrations during the same period of time. Those figures are even more sobering when considering the population difference between Alabama, with slightly more than 4 million residents, and California, with 30 million.

Data from the NRC also support the theory that a state's establishment of mandatory licensing and certification for radiologic technologists reduces the number of misadministrations. For example, Ohio enacted licensure laws for radiologic technologists in 1995. From 1981 to 1995, Ohio reported 47 radiation misadministrations during nuclear medicine procedures to the NRC. Since licensure was enacted in 1995, the state has reported only one misadministration. In addition, the number of misadministrations significantly decreased in Massachusetts after the state began licensing radiologic technologists. From 1981 to 1990, Massachusetts reported 55 misadministrations an average of 5.5 per year. A licensure law for radiologic personnel was approved in Massachusetts in 1990. In the period from 1991 to today, the state has reported only seven misadministrations less than one per year. Minnesota, which had one of the highest levels of radiopharmaceutical misadministrations in the nation, has seen a similar drop in error rates since it enacted a law in January 1997 requiring registration of personnel performing radiologic procedures in the state. Results seen in Ohio, Massachusetts and Minnesota prove that enactment of a comprehensive licensure and certification program for radiologic personnel can reduce the number of examination errors, thus ensuring exam quality and improving patient safety.

Public awareness of the safety issues involved in radiologic procedures was heightened in 1993, when Sen. John Glenn held congressional hearings to investigate reports of patients being mutilated, paralyzed and even killed by overdoses of radiation - radiation that was supposed to cure them. The stories Congress heard during Sen. Glenn's hearings included the account of one Ohio woman who had a hole burned into her chest while being treated for breast cancer in 1989. Another widely publicized case involved a 9-year-old child who died of radiation-induced respiratory failure in 1988 after receiving accidental double-doses of cobalt-60 radiation to treat a tumor in his sinus cavity. In both cases, the medical personnel delivering the radiation treatments were not certified in radiation therapy.

To ensure patient safety and reduce radiation exposure dose during radiologic procedures, in 1977 the United Nations Scientific Committee on the Effects of Atomic Radiation made the following recommendations:

  • Reduce the number of radiographs per patient.
  • Reduce the time and intensity of exposure.
  • When fluoroscopy is not essential, use conventional radiography.
  • Use the smallest possible field size.
  • Avoid inclusion of the gonads in the primary beam.
  • Protect testicles with gonadal shields.
  • Properly train and supervise staff engaged in these examinations.

With the exception of the final recommendation, all of these factors are under the direct control of the person performing the examination. Properly educated, certified and licensed radiologic technologists understand the importance of protecting patients from overexposure to radiation, and they take steps to control the size and intensity of the x-ray beam.

In 1999, the Institute of Medicine released their report To Err is Human, detailing medical errors occurring in a variety of health care settings. Of particular interest is Recommendation 7.2 in the report that deals with performance standards and expectations for health professionals. This recommendation suggests, Health Professional licensing bodies should: (1) implement periodic reexaminations and relicensing of doctors, nurses and other key providers, based on both competence and knowledge of safety practices; and (2) work with certifying and credentialing organizations to develop more effective methods to identify unsafe providers and take action. By ensuring that medical imaging and radiation therapy professionals are properly educated and credentialed, medical errors may be reduced.

Lower Cost

According to numerous studies published in professional journals, between 4 percent and 7 percent of all x-ray examinations performed in the United States must be repeated because of technical errors. Improper positioning, incorrect exposure, use of the wrong technique, poor patient instructions or errors in film processing and development all can lead to repetition of the exam, thus exposing the patient to double the original level of radiation. A repeat exposure represents a 100 percent increase in radiation dose to the patient, with no clinical benefit. Repeated radiologic examinations, quite literally, do more harm than good. According to a 1992 analysis of radiographic repeat rate data, exposure errors account for about 50 percent of repeated images; positioning errors are to blame for nearly 30 percent of repeated procedures. Both of these factors are within the control of the person performing the exam, and both can be solved by allowing only properly educated, certified personnel to administer radiologic procedures.

In addition to exposing patients to unnecessary radiation, repeated radiologic exams cost the U.S. health care system millions of dollars in needless medical bills. Radiographic film, processing chemicals, labor and time are wasted when an exam must be repeated. The United States spends approximately $100 billion a year on diagnostic medical imaging examinations, representing 17 percent of the nation's total spending on health care. Using even a conservative repeat rate of 5 percent, that means more than $5 billion is wasted every year on unnecessary x-ray procedures.

Additionally, delays in diagnosis or misdiagnoses caused by poor quality exams not only exacerbate patient pain and suffering, but also ultimately drive up health care costs. A 1997 study conducted at the Brooke Army Medical Center, Fort Sam Houston, Texas, showed that regular screening mammography for women older than 40 more than pays for itself by detecting breast cancer in its earliest stages, when it may be treated less expensively and more effectively. The study showed that every 40 cents spent on screening mammography saved $1 in managing breast disease. But in order to realize those savings, the mammograms must be performed and interpreted correctly.

Another 1997 study showed that accurate radiologic imaging of patients with chest pain can decrease the misdiagnosis of heart attack. The study showed that chest x-rays, nuclear medicine scans, ultrasound exams, magnetic resonance imaging scans or computed tomography procedures can be used to accurately determine the cause of a patient's chest pain, in many cases ruling out heart attacks or other dangerous conditions. By offering prompt radiologic imaging of patients experiencing chest pain at just one hospital in Miami, misdiagnoses of heart attacks were reduced and $5.2 million was saved during an 18-month period.

Accurate radiologic procedures that are properly performed by educated personnel can save health care dollars in the long run. Some have argued in the past that the establishment of federal minimum standards and state licensure laws for personnel who operate radiologic equipment would reduce the number of radiologic personnel and drive up health care costs because it would cause salaries to rise. Experience shows this is not true. A 1976 study of three states that established licensure laws for radiologic personnel in the 1960s - New York, New Jersey and California; showed that mandatory state licensure had no significant impact upon technologist manpower in terms of recruitment, availability or compensation. Regulation of radiologic personnel would not increase health care costs; rather, it would reduce costs by ensuring quality exams.

Conclusion

With the passage of proposed federal legislation and state licensure laws, the public will benefit from being cared for by properly educated and certified radiologic personnel. No matter what the radiologic procedure, the technologist's detailed knowledge of anatomy, careful application of radiation and skillful operation of sophisticated medical equipment are the keys to its success. To be clinically useful, diagnostic imaging exams must be accurate. To stop invasive cancers, radiation therapy treatments must be precise.

The current lack of uniform educational standards nationwide for operators of radiologic equipment poses a hazard to the public. State and federal standards will ensure a minimum level of education, knowledge and skill for the operators of radiologic equipment. Ultimately, they will reflect the radiologic technologist's ability to provide the highest quality of patient care.

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