American College of Radiology efforts to produce mammography reportingsoftware have several commercial software developers crying foul.The vendors claim that the college's potential status as an accreditationbody under the Mammography Quality Standards
American College of Radiology efforts to produce mammography reportingsoftware have several commercial software developers crying foul.The vendors claim that the college's potential status as an accreditationbody under the Mammography Quality Standards Act of 1992 wouldrepresent a conflict of interest and provide unfair competition.
"The organization that accredits facilities would alsobe selling a product which, from a practical standpoint, is expectedto be required for accreditation," said Richard Graves, presidentof Mammography Reporting System and point man for the commercialsoftware developers' combined effort.
The ACR claims that there is no conflict of interest in producingthe Breast Imaging Reporting and Database (BIRD) software program.
"We believe that (the BIRD program) is addressing a needof our members," said Nick Croce, ACR assistant executivedirector and CEO.
Regulatory requirements under the MQSA will be provided byan advisory committee. The committee's charter still has to befiled with Congress before committee nominations can be requested,according to Joseph S. Arcarese, interim director of the Foodand Drug Administration's MQSA program (see related story, page2).
The ACR hopes to have a member of the college on the committee,Croce said. A Senate report accompanying the act recommended thatthe ACR, along with several other organizations, be consideredfor membership on the committee.
In that case, the software vendors should also be represented,Graves said.
"As long as they're developing software, either they shouldnot participate or if they're going to participate, every otherdeveloper of commercial software should be given an equal voice,"Graves said.
Once standards are set by the advisory committee, the ACR willapply to be an MQSA accreditation body, Croce said.
The developers would support the ACR's becoming an accreditationbody under MQSA if it would cease offering its software in competitionwith private industry.
"I think they're the logical and best organization toset the standards for auditing and quality control in mammography,"said Bob Herring, president of Radiologic Data Systems.
The ACR's voluntary accreditation program has been in placesince 1987. Responding to what it felt was a need to standardizereporting of mammograms, the ACR developed the Breast ImagingReporting and Data System (BI-RADS), which includes a lexiconof standardized terminology, report organization structure, codingsystem and data collection structure. BI-RADS is incorporatedinto the BIRD program, Croce said.
The structure of the lexicon will allow it to provide the basisfor a planned national database. The lexicon is licensed freeof charge to software developers. However, they must sign a licensingagreement not to modify it in order to maintain consistency, Crocesaid. The lexicon's availability has been announced to ACR members.
"Anyone who wants a copy can ask for a copy," Crocesaid.
Graves acknowledged that his company had received a licensefor BI-RADS.
"We think the proper role of the ACR is to establish thingslike BI-RADS," he said. "To turn around and includethat in a commercial product, we think is inappropriate."
Some of the vendors claim that sales have already been affectedby the ACR's yet-to-be released BIRD program. The ACR began takingorders in early June and expects to begin shipping the programin mid-to-late July, Croce said.
"Every day during our sales efforts, we run into peoplewho say flat out that they are waiting for the ACR product,"Graves said.
Graves estimates that only 3% of mammography sites use computerizedreporting software.
"That percentage would have been a lot greater had theACR years ago set about adopting standards for quality assuranceaudits and data collecting, rather than setting about developingits own product, which caused many people to put the whole conceptof mammography reporting software on hold," Graves said.
Croce denied that the ACR has delayed in releasing audit standards.
"There are no plans to include audits for accreditationin the near future," he said.
Gerald M. Timpe, president of Diversified Diagnostic Products,saw his sales drop off to zero during what is usually his company'speak sales period.
"Immediately after the RSNA (Radiological Society of NorthAmerica) conference (in December), we're always busy filling orders,"Timpe said. "This year we didn't get a single order for thatparticular product for six months after the close of the RSNA."
The vendors believe it is not appropriate for a nonprofit societyto sell commercial products.
"The separation of industry and professional organizationshas been fairly well-defined over the years and has worked verywell," Timpe said. "Now they're muddying up the waterby trying to get in the commercial end."
Croce points to the Joint Commission on Accreditation of HealthcareOrganizations as an example of a nonprofit organization with commercialinvolvements. The JCAHO sells a hospital accreditation manualon disk as well as an aggregation manual that helps hospitalsdetermine if they're on track for accreditation, according toa JCAHO spokesperson.
In any event, this issue will not be ignored as MQSA is implemented.
"The software companies have raised an issue worthy ofsome concern and it will be addressed once we develop accreditationstandards," Arcarese said.