Niche extremity scanners exempted from initial testingAmerican College of Radiology officials returned from their holiday break to face the prospect of distributing application packets to some 700 facilities that have lined up for the college's
Niche extremity scanners exempted from initial testing
American College of Radiology officials returned from their holiday break to face the prospect of distributing application packets to some 700 facilities that have lined up for the college's new MRI accreditation program.
The first bulk mailing will be completed by mid-January, according to Marie Zinninger, assistant executive director. By that time, she expects the ACR will have determined how much accreditation will cost and which vendor will manufacture the custom phantom designed to test MRI equipment. These issues were still pending when Dr. William Bradley, chairman of the ACR's MRI site accreditation committee, announced the start of the long-awaited program on Dec. 2 at the Radiological Society of North America meeting. The ACR executive committee had unanimously endorsed the initiative the previous week (SCAN 11/6/96).
Patterned after ACR mammography site accreditation, MR accreditation aims at identifying the nation's top 85% MR sites by testing quality control and equipment performance. Qualifying facilities will be accredited for three years.
Accreditation involves completion of a 10-page application form, a phantom imaging test, and an off-site evaluation of clinical images. The form covers demographics, quality control assurance questions, and several "knockout" questions, Bradley said. It queries applicants on the qualification of their technologists, interpreting physicians, and medical physicists (when applicable), and quality control procedures.
Relevant safety policies include protocols for supervised administration of contrast agents and sedation, procedures for pulse oximetry, the screening of foreign bodies, and pregnancy.
To qualify, the physician must have completed a radiology residency or equivalent training and experience. The program requires a threshold of 120 hours of continuous medical education for physicians entering the field. Technologists can take any of four tracks to qualify, including a signed certificate of competence by the facility's responsible physician if they have routinely performed MR before 1997, Bradley said.
Facilities that pass the written exam are issued an ACR phantom to test their equipment. Signal-to-noise and image uniformity measurements will be acquired using a standard head coil during T1- and T2-weighted imaging. Filtration will be allowed, he said.
The clinical images portion of accreditation testing involves the submission of brain, cervical spine, lumbar spine, and knee images acquired from clinical studies performed by facility staff in the same week as the phantom test, Bradley said.
The ACR excluded niche MR scanners from consideration by requiring images from all four clinical procedures for every MR system at the site. Esaote's Artoscan and Magna-Lab's Magna SLniche MR systems cleared for U.S. useare designed exclusively for extremity applications.
Bradley announced that niche scanners are exempted at facilities equipped with both whole-body and niche MRI scanners. While those services can be accredited, facilities that operate only niche scanners will be excluded at least until 1998, when a test phantom will be ready for their equipment, he said. Sources familiar with the accreditation program disclosed in 1995 that the ACR phantom is too large to fit into the small bore of niche MRI scanners (SCAN 3/15/95).
In reaction to the ACR policy, Lunar, the U.S. distributor of Artoscan, formed an independent panel of consultants to develop a niche scanner test that covers the same performance characteristics measured by the ACR phantom test for whole-body scanners. The effort is intended to show the ACR that Lunar is serious about the image quality produced by its scanners, according to Walter O'Neill, national sales manager.
O'Neill said that ACR exclusion is potentially a problem for the niche scanner companies and their customers, especially if insurance carriers make accreditation a prerequisite for reimbursement.
"We feel it is a quality issue. If you want to retain managed-care contracts, you need to have that. We don't want to see the customers discriminated against," O'Neill said.