Wednesday, September 29th, 2010
At a time when Americans are exposed to more medical radiation than ever, the patchwork regulation of technicians who perform imaging exams may be putting patients at risk. There is no national minimum standard for technicians’ training or competency or for the inspection of the medical X-ray machines they operate.
A review of state laws and regulations by the Investigative Reporting Workshop found that 12 states and the District of Columbia do not require medical X-ray operators to be credentialed or to meet specific competency standards. Of the 38 states that do license or accredit technologists, requirements vary greatly – from a mere 12 hours of operator training to a two-year accredited radiography program. The Workshop’s survey also found that some states do not conduct routine inspections of medical imaging machines. However, federal law requires “periodic inspection” of hospital machines.
“There are many states that have more stringent laws for individuals who are cosmetologists, estheticians, and tattoo artists than the individuals who perform medical imaging procedures,” said Jay Hicks, an accreditation specialist with the Joint Review Committee on Education in Radiologic Technology.
The lack of standardization increases a patient’s risk of misdiagnosis and excess exposure to radiation. These are the findings of the Investigative Reporting Workshop’s survey of radiological health and professional licensing departments.
The Food and Drug Administration got an earful about weaknesses in the imaging regulatory system during a two-day public meeting in March. Speakers called for expanded and more rigorous training for radiologic technologists, medical physicists and radiologists on X-ray equipment, such as CT scanners.
“We spend so much money and so much resources and so much time and so much brain power on building these fantastic machines,” said Dr. Marta Hernanz-Schulman, medical director of diagnostic imaging at Children’s Hospital at Vanderbilt. “And yet we don't spend that much effort in making sure people know how to use them.”
Recent data shows fewer than half of the people operating CT scanners nationally have met the requirements established by the American Registry of Radiologic Technologists, a credentialing organization.
“We’re hoping everyone is doing what they’re supposed to do,” said Sheela Puthumana, program director for Georgia’s Healthcare Facility Regulation Division. “It’s kind of scary, but what are you going to do? We don’t have the money.”
Because of budget cuts, Georgia no longer routinely inspects facilities after machines are installed nor is the state able to enforce a six-hour training requirement for operators.
Patients can suffer consequences when technicians lack training
The skill level of the technicians who operate the imaging machines has a direct bearing on whether a potentially fatal condition is identified and treated or missed entirely.
“If you give an internist a suboptimal chest exam, maybe they miss a lung cancer or pneumonia, and the patient can die or at least have more limited treatment options,” says John Langston, Missouri’s Radiation Control Program Supervisor. “Give an ER doc a suboptimal trauma neck exam, maybe they miss a spinal fracture, and the patient never walks again.”
Despite the risks, there is no guarantee every person operating a machine is qualified. Unqualified technicians often take more than one picture to get a satisfactory image, and the repeated X-rays increase a patient’s exposure to radiation and increase health care costs.
The problem is especially apparent in non-hospital settings, like doctors’ offices, Michael Raskin, a South Florida neuroradiologist said.
“Where I see it a lot is where you don’t have rad techs (certified radiologic technologists) at doctors’ offices or chiropractors’ offices taking films, and these are horrible suboptimal films. And they’re radiating the patient to death and not getting quality studies,” he said.
The state of Illinois fined more than 120 unqualified individuals and the facilities that allowed them to perform diagnostic exams from 2004 to 2009. The state fined 33 hospitals, 11 clinics and 24 doctors’ offices.
Two portable X-ray service providers were fined for sending unaccredited individuals to Chicago-area nursing homes. In addition, an anonymous letter to state officials alleged that at another portable X-ray company — U.S. Diagnostics — taxi cab drivers were impersonating accredited radiographers. In 2007, U.S. Diagnostics was fined $10,000, the maximum fine for knowingly allowing individuals without valid accreditation to perform medical radiation procedures. Company President Hussain Ghalib said the fine was paid but that he was not in a position to talk about it.
There is a measure of oversight when it comes to hospitals. Most hospitals require techs to be registered by the American Registry of Radiologic Technologists, a national, professional, standards association whose certification is accepted by states that do require licensure.
Hospitals seeking accreditation by The Joint Committee, the national hospital accrediting body, must show that their X-ray operators have the appropriate education and experience.
Even so, when regulators travel their respective states, many see uncertified techs working in some hospitals, clinics and doctors’ offices.
“There appears to be little concern about radiation or its potential biological effects on humans, given the documented abuses that have been observed in the state,” said Clyde Pearce, chief of Alaska’s radiological health program.
About seven years ago, an Alaska patient received 64 times the normal radiation dose for an abdominal X-ray. Neither the operator nor the supervisor at the Anchorage clinic had been trained, Pearce said.
“Non-techs are generally just given a formula,” Missouri supervisor Langston said. “Measure the patient here, change these knobs here, push this button there, then develop the film and hand it over to the doc.”
He said non-techs typically have little or no training on how to position the patient to get the best image or how to recognize when they’re producing suboptimal images.
Langston’s experience is not unique. The majority of officials in states that don’t regulate training say it is needed, and they point to the power wielded by state medical associations in hindering legislative attempts to enact standards.
In Alaska, several attempts to pass a licensing law have failed in recent years. Pearce said the measures met with sharp opposition from physicians and physicians assistants.
The Investigative Reporting Workshop found rural hospitals and clinics have difficulty attracting nationally certified techs, and doctors don’t want to or can’t afford to pay certified techs to work at their offices.
“It is very important to avoid excessive regulations that might hinder access to care,” said Tom Holloway of the Missouri State Medical Association.
Machine inspections non-existent in some states
In addition to regulating operators, each state also decides how often to inspect diagnostic imaging machines such as X-ray or CT-scanners. Federal regulations only mandate annual inspections of mammography equipment.
In most states, the frequency of inspections depends on the type of machine and whether it’s being used in a hospital. Thirty-one states inspect hospital X-ray machines every two years or less.
Five states do not routinely inspect machines. Montana does not inspect X-ray machines after they are installed. The state legislature eliminated its lone health physicist position 12 years ago when it couldn’t find someone qualified and willing to travel to do the inspections, said Roy Kemp of the Montana Department of Health and Human Services. Wyoming’s legislature killed its radiological oversight program in the late 1980s. Georgia only investigates complaints after the initial installation of machines.
The lack of standardization is compounded by a rapid increase in diagnostic imaging technology, which regulators say is unprecedented. New types of diagnostic machines get installed at hospitals and other facilities, and state officials say they have to write or revise regulations after the fact.
Inspections are time-intensive: testing a CT unit to determine a patient’s radiation dose is complicated and takes inspectors one to two hours per machine. As a result, inspectors and health physicists often pay more attention to the operator’s exposure to radiation than the patient’s, said Ray Dielman, a medical health physicist and liaison between The Joint Committee and the Conference of Radiation Control Program Directors.
Some say improvements aren’t happening fast enough. The Joint Committee, which accredits 87 percent of hospitals nationwide, does not inspect equipment. The Conference, which drafts model rules to help states establish minimum standards, has had discussions with the Committee for the past three years to assess the scope of its radiation survey. The goal is to help surveyors, without technology backgrounds, to ask more precise questions and identify when they need to look deeper into a hospital’s practices.
The new survey process has yet to be implemented. But, there’s been an uptick in activity since February when the Centers for Medicare and Medicaid Services tapped the Commission and two other organizations to accredit imaging facilities, other than hospitals, beginning in 2012.
The agency’s move to allow one of three bodies to do certifications has raised questions of whether facilities will go shopping for the least-stringent regulatory process.
“The user will choose the easiest pathway to get qualified, and it will negate the whole purpose of accreditation,” said Mahadevappa Mahesh, chief physicist at Johns Hopkins Hospital.