New Jersey is installing a detailed quality assurance program that applies to every health care facility performing procedures that employ ionizing radiation. The state plan will dovetail into some existing accreditation programs, and will absorb those of insurance companies to avoid competition or duplication.

Although there are fears the program will simply be another layer of bureaucracy, the state says implementation should be relatively simple and inexpensive.

The New Jersey program came about when officials saw what happened in mammography. The Mammography Quality Standards Act of 1992 (MQSA) is a program started by the American College of Radiology (ACR), but which is now administered by the Food and Drug Administration (FDA). New Jersey realized that radiation dosage and image quality would be the main issues for all modalities, according to Jill A. Lipoti, PhD, assistant director of that state’s Radiation Protection Program.

“We looked at mammography and saw that quality assurance (QA) would reduce radiation dose and improve image quality. We noticed trends at the insurance companies and decided that a unified statewide program of QA for x-ray would be beneficial to the citizens of New Jersey,” Lipoti says.

The New Jersey program covers all facilities performing diagnostic radiography procedures on humans – radiology, fluoroscopy, bone densitometry, and CT. The regulations apply to equipment in hospitals, schools, industry, government facilities, and offices of physicians, chiropractors, and podiatrists. Mammography is excluded, as it is covered under the MQSA, while MRI and ultrasound are exempt, as they do not emit ionizing radiation.

Radiologists are withholding judgment until the program is in place. Although Anthony McMahon, chief of New Jersey’s Bureau of Radiological Health, says the state mailed information to all affected facilities and put it on the Radiation Protection Web site, Larry Tannenbaum, MD, at Edison Imaging in Edison, NJ, says he only found out about the program in a recent newspaper article.

“I think it will create a decent amount of work for the traditional radiology practice,” Tannenbaum says, “but it will probably improve quality. There’s a very wide spectrum in the real world of quality assurance in doctors’ offices.”

Hospitals, on the other hand, tend to have more due diligence procedures in place, as well as physicists on site, or ongoing physicist and service contract visits. One radiology department administrator says he has been aware of the impending program for the past year.

“I can’t speak about what happens in private offices, especially those of nonradiologists,” notes Stephen Hiss, administrative director of Diagnostic Imaging for Solaris Healthcare in Edison. “The frame of reference for many of them is pretty narrow.”

Hiss says the up-front cost will not be a burden for his organization, as most of the testing equipment is already in place. “It may add half an FTE, 4 hours a day to do the required work,” Hiss believes. The diagnostic imaging group includes around six radiologists at any one time, as well as about 100 technical and nontechnical staff.

“I don’t see a significant benefit in reducing radiation, because our standard operating procedures are checked regularly by a physicist. A lot of x-ray equipment now is of a different design, so the electronics and internal mechanism are much more sophisticated and more reliable than the equipment of old. There’s more benefit from buying up-to-date equipment than from testing,” Hiss says, “because the new stuff is so reliable.”

Workshops Under way

Workshops for facilities and inspections began in February on a county-by-county basis, and are scheduled to be concluded by the end of November. The state is considering extending the program to veterinary sites.

Costs to the state are expected to be minimal, McMahon believes. He says the budget for radiologic health (medical and nonmedical radiography), technologist licensure, and mammography, is about $1.7 million a year. A similar program in the state of New York runs about $1.8 million a year.

“We charge fees from all facilities already, and that will cover our costs,” Lipoti says. “We’ve always regulated x-ray machines in New Jersey. In 1994 [the amount charged] was adjusted to the amount of time spent at each facility. With a QA program, it’s a different sort of inspection, so the first year or so we’ll keep track of time at each facility and adjust.”

Annual quality review

Part of the requirement is for a medical physicist to perform an annual quality control (QC) survey at every facility-a practice that has been in place in New York and other jurisdictions New Jersey surveyed. The state posted requirements for qualified medical physicists, going first to the American Association of Physicists in Medicine (AAPM) members in New Jersey and soliciting applications.

“We have a list of more than 50 [physicists],” McMahon says. “We charge a fee for an individual to be certified, and they negotiate a price with each facility.”

The average physicist fee is running from under $300 for a podiatrist’s x-ray machine to $500 for a larger office, he says, adding that if the physicist set up the QA manual, trained technologists, and organized teaching forums, the fees could range between $500 and $1,000.

New Jersey began developing its QA program several years ago. The state program requires testing and documentation of radiation dosage and image quality. This machine orientation differentiates it from nongovernmental programs that largely monitor clinicians and procedures.

“Our program has been better accepted [by insurance companies] because we met with all of the medical, chiropractic, and podiatric societies and boards and we listened,” McMahon says. “We based our program on national models. We did a spreadsheet of all existing QA programs [national recommendations, insurance and state programs] and considered program options and QC test frequencies before moving ahead.

“We also pointed out that having multiple and differing QA requirements for [different] insurance companies was problematic,” McMahon says, “but a state program, universally required and accepted, was a plus. This helped sell our program.”

Payor support

The state’s biggest health insurance company got behind the New Jersey program in a big way. Horizon Blue Cross Blue Shield (BCBS), which insures 2.3 million patients in New Jersey, had earlier embarked on a QA program, reasoning that retaking radiographs and misdiagnosing patients were expensive.

“There was nothing at the state level at the time,” says Donald Stavis, MD, medical director of healthcare management for Horizon BCBS of New Jersey. “Our approach was unique. The premise was that an examination taken anywhere should be accepted. We were concerned with the quality of the examination, not subjective things such as whether it was done by a chiropractor or podiatrist. We decided we would institute this [the NJ program], and we made reimbursement for radiological services contingent upon compliance with standards.”

Stavis says New Jersey is taking a bit longer to gear up than BCBS expected, but even though he thinks the state program may not be completed by November, the insurance giant is buying into the concept.

“There would be confusion if everyone had to comply with various programs,” he says.

New Jersey follows New York, which began QA inspections in 1983, according to its chief of radiological equipment section, Maryanne Harvey. She says all aspects of that program were in place by 1991.

New York’s QA fees run somewhat higher than New Jersey’s. Harvey says New York has been charging $86 for the first tube and $40 for each additional tube. New York’s new annual fees will range from $15 to $1,300 a year. Depending on test volume, a medical physicist or service company tests equipment every year or two.

New Jersey’s fees are based on the cost to provide the required registration and inspection program, and range from $92 a year for dental equipment to $298 for a non-MQSA mammography machine (such as one used for stereotactic breast biopsy), according to McMahon.

McMahon says the average fee is $115 a year. He says that under the QA program, inspections should be shorter and, therefore, fees may be reduced in the future.

Maine also has a statewide QA system, but such programs are the exception. According to Cherrill Farnsworth, executive director of the National Coalition for Quality Diagnostic Imaging Services (NCQDIS), an industry lobbying group, more than 50% of state legislatures have no equipment QA and/or no verification of technologist licenses.

“No one checks,” says Farnsworth, who is also CEO of HealthHelp, a radiology management services organization that contracts with payors to evaluate ways to cut costs and improve quality. “There hasn’t been a lot of control. It’s becoming clear that a lot of waste happens because equipment is not working correctly.”

That may change, however. “A number of other states have contacted me for guidance,” Lipoti says. “At a meeting of all state program directors at the end of April in Alaska, Anthony McMahon, our bureau chief of radiological health, is presenting our program for all 50 states.”

Preventive Regulations

New Jersey is going with other radiation modalities where mammography went in the late 1980s, when the ACR and other organizations became aware of image problems and possible x-ray dose problems.

In 1992, the federal government adopted the ACR accreditation program and put it under the FDA, which is primarily concerned with equipment, but which has regulatory experience. The ACR remains the major MQSA accrediting body. ACR accreditations also cover stereotactic breast biopsy, breast ultrasound, ultrasound, MRI, nuclear medicine, and radiation oncology. The organization has plans to implement accreditation in CT, interventional radiology, and radiography/fluoroscopy by the end of this year.

“Our programs are entirely by mail,”? explains Marie Zinninger, ACR associate executive director for standards and accreditation.? “There are no on-site visits. It is meant to be educational, not punitive.”

The ACR, which has kept in close touch with New Jersey as it has developed its regulations, covers only programs associated with physicians, whether hospital-based or off-site, and does not concern itself with chiropractors and podiatrists. Another difference is that the ACR evaluates actual clinical as well as phantom images. New Jersey developed its own universal portable x-ray phantom for state inspectors to use at each facility. The New Jersey phantom is used to measure progress with an objective indicator. The goal is to reduce entrance skin exposure and improve quality.

“We needed to determine image quality objectively,” explains Lipoti. “We are only using our phantom for x-ray. Each facility has to have its own CT phantom.” The CT phantom is to be used by the medical physicist on site to determine if the scanners are properly calibrated. New Jersey will accept the ACR’s CT phantom.

If all this sounds like a bureaucratic nightmare of paperwork, McMahon begs to differ.

“To my knowledge, none of the [New Jersey] QA programs are duplicative of other required procedures,” McMahon says. “[There are] no requirements to submit reports to the Department of Environmental Protection and the record keeping is minimal. Look at the required tests and frequencies-they’re common sense.” n


Robert Bruce is a contributing writer for Decisions in Axis Imaging News.