Four years ago, Sen. Jennings Randolph slipped into the budget reconciliation bill a provision that he had sought for more than a decade.
It required the government to set standards for certifying people other than doctors and dentists who administer X-rays, and the West Virginia Democrat figured it would help prevent a dangerous situation. "There are so many instances where people who give X-rays in hospitals and offices have no training," the now-retired senator said. "It can cause overexposure and health problems."
The legislation told the Health and Human Services Department to issue final regulations within a year, but since then HHS has done nothing more than publish them in proposed form. The case, critics say, provides a classic example of what can happen to a law when the administration in power opposes it.
"This situation reveals either the bureaucratic paralysis or the lawlessness that afflicts that department on matters relating to safety," said consumer-advocate Ralph Nader, who has been monitoring the situation. "It also shows that statutory deadlines are not enough. There have to be sanctions against the bureaucrats who violated them."
The American Society of Radiologic Technologists and HHS experts estimate that about a third of those who administer X-rays in this country are not certified by professional organizations. Randolph had intended that, in general, the standards require those who administer X-rays to have two years of training. Doctors and dentists were exempted because it was assumed that they already had sufficient training.
Under the legislation, federal agencies that provide medical services could not employ people who failed to meet the standards. While the law did not make the standards mandatory for the private sector, it was hoped that the states would adopt them. HHS was supposed to draft a model state standard.
The legislation spelled out five categories of X-ray technologists who would be covered by the rules, including dental hygienists and assistants, but authorized HHS to apply them to "such other kinds of health auxiliaries who administer [X-rays]ermines appropriate."
However, Edward Brandt, then assistant secretary for health, ordered that the proposed regulation be applied only to the technologists spelled out in the law, most of whom already met the training standards and were employed in hospitals or special X-ray clinics.
Thus, the rule would have excluded large numbers of nurses, secretaries, office assistants and chiropractic and podiatric assistants who often have little or no X-ray training.
Many groups, including the Environmental Protection Agency, state agencies, major hospitals and consumers, complained about the exclusion in comments to HHS. And Randolph said recently, "It was my intent to cover casual X-ray givers in doctors' offices."
HHS issued its proposed regulation in July 1983, but never issued it in final form. That year, department officials also drafted a model statute and sent it to Secretary Margaret M. Heckler. But it was never made public or sent to the states.
Last November Heckler wrote Randolph that she hoped the final standards could be published "within 60 days." They never came out, and instead Heckler asked Congress on July 29 to repeal the 1981 law.
Several current and former HHS officials said the department wants the law repealed because:
*HHS decided that the main danger of radiation overexposure comes from doctors who order excessive X-rays or from faulty machinery, not poorly trained technologists. A Food and Drug Administration program was already in place requiring new machines to meet quality and safety standards, and setting guidelines for proper films and exposure levels. In many states, machines in hospitals and medical offices are inspected.
*Of about 165,000 people administering X-rays, only 65,000 are not certified by recognized professional organizations. About 20 states have legislation regulating the certification of X-ray technicians. Most uncertified people work in doctors' offices, but the heaviest, health-endangering doses of radiation are administered in hospitals or clinics, which hire specially trained personnel.
A study by two HHS officials, Michael F. Audet and David W. Johnson, which was later published in the March 1985 American Journal of Public Health, found that 82 percent of all diagnostic X-rays and 90 percent of their dosage are administered by professionally certified operators whose training in most cases meets the standards the legislation had sought. (The study, however, did not cover dental, podiatric, chiropractic and certain other X-rays which probably account for at least one-fourth of all exposure.)
*Some doctors' groups and federal agencies opposed the idea that only technologists with two years of training would be allowed to give X-rays.
In written comments in 1983, the Army surgeon general's office told HHS that its training program for military personnel who give X-rays "does not begin to approach the length of the proposed curriculums. The proposed curriculum requirements are prohibitively costly and the payback period would be extreme," because the personnel who are trained may only administer X-rays for a few years.
The Army said it would also find difficulty hiring civilians because the regulations "would drastically reduce the pool of qualified candidates for a significant period and effectively dry up the ex-military as a major source of quality candidates. The only alternative would be to contract all radiographic services and this would be prohibitively expensive."
The American Hospital Association said the standards would be "particularly hard on small and rural hospitals." The American Society of Internal Medicine said, "Faulty and improperly maintained equipment poses a far greater risk." The Office of Personnel Management, American Medical Association and American Dental Association also objected.
HHS officials would not comment publicly on why the regulations were delayed because the matter is now before the courts. The radiologic technologists society filed suit here in August, trying to force the department to issue the rules.