ACR's breast imaging accreditation expands on MQSA

Oct 10, 2005

Mammography facilities have raised concerns about the American College of Radiology's (ACR) breast imaging accreditation questionnaire -- in particular, how a series of questions, which ask for information not required by the Mammography Quality Standards Act (MQSA), should be answered.

For example, the ACR full application asks facilities what percentage of the practice involves screening mammography, and whether there is a system in place to prevent sentinel events, according to Susanne Myers, senior vice president of Mammologix, a mammography business process outsourcing provider in Apopka, FL.

In some cases MQSA does not require such information, which may be difficult to obtain if a facility has not collected it all along.

Priscilla Butler, senior director of Breast Imaging Accreditation Programs for the ACR, said the ACR is asking some of these questions for data collection purposes, and that they will not affect the facility's accreditation status, even if they go unanswered.

"If it's not an FDA requirement, we're not going to tell them that they have to do it," Butler said.

But by the same token, facilities should not regard this information as unimportant. If facilities do not collect this information, they should because it is critical to ensuring quality at facilities, and MQSA may require the information later when it is reauthorized, Butler said.

Problem questions

The following are cited as the more troublesome ACR accreditation questions, along with Butler's comments about them:

What portion of your practice involves screening mammography when there are no present clinical signs or symptoms of breast cancer?

The ACR asks a similar question on its entry application and, for that reason, may remove it from the accreditation full application in the future, Butler said. The reason why the ACR asks this question is because when the Food and Drug Administration approved ACR to be an accrediting body, it requested that the organization collect this information.

It is good practice for a facility to know what types of examinations it performs, but MQSA does not mandate this information, she said.

What percentage of mammograms from the last complete one-year analysis falls into each of the six BI-RADS final assessment categories?

This question was intended to find out whether facilities perform medical audits as required under MQSA. The FDA requires all facilities to establish a system to collect and review outcome data on mammograms and perform follow-ups to document a positive correlation of mammography reports. The FDA regulations say the reports must be put into overall final assessment categories. When the FDA designed its final assessment categories, it based them on the BI-RADS categories.

This question was on former versions of the application, but the ACR adapted it to reflect changes to the BI-RADS atlas, which was updated to add a new category -- category 6 -- and to include information about breast ultrasound and MRI.

"We are very careful in our application to point out that the ACR does not require the use of BI-RADS for accreditation, but we do think it is a good practice and encourage it," Butler said.

Keep an eye on this question in the future, too, she said, because now that the Institute of Medicine has recommended new auditing requirements, the ACR will likely update this question to reflect that change in the future.

For what percentage of cases were you able to obtain results of surgical biopsies following mammograms?

The FDA also requires facilities to try to obtain the results of surgical biopsies. By asking this question, the ACR wants to gather information about how successful facilities are in obtaining this information, Butler explained.

"We hear lots of concern expressed by facilities that they can't get surgical biopsy results from physicians," she said. "One of the purposes behind this question was to find out what kind of response they are getting. Are they being successful?"

Some physicians tell sites that they can't have this information due to HIPAA privacy rules. As a result, the sites' success in obtaining this information varies greatly. Some sites have success rates well over 75%, Butler said. Other sites receive less than 50% of requested results.

"It depends on where you are, but overall I think most of them are fairly successful," she said.

Do you have policies or procedures to prevent complications and adverse events that may lead to sentinel events?

Some of the confusion with this question is because the ACR does not state what events qualify as sentinel events. The organization uses the definition developed by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO):

"A sentinel event is any unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof. Serious injuries specifically include a loss of limb or function. The phrase 'or the risk thereof' includes any process variation for which a recurrence would carry a significant chance of a serious adverse outcome."

Despite the definition, some sites wondered whether a sentinel event would include occurrences such as missed or delayed diagnoses or injuries from mammography equipment. According to Butler, both of those situations qualify as sentinel events.

An important aim of this question is to help organizations stay in touch with their consumer-compliant processes, Butler said. If patients report problems or injuries, organizations need to have a process in place to deal with them.

In addition to prompting facilities to look at customer service, focusing on this issue will also ensure that a facility's auditing system functions well and that the facility tracks false negatives, which may lead to sentinel events.

A trend toward improvement

Poor clinical image quality is the top reason that facilities fail to pass accreditation, according to a report this year in the Journal of the American College of Radiology (July 2005, Vol. 2:7, pp. 585-594).

More than 70% of facilities that failed accreditation on a first attempt between 2001 and 2003 had clinical image quality problems. Another 23% failed because of a phantom image quality problem, and 5.5% of failing facilities had deficiencies in both phantom and clinical images.

However, the number of phantom image quality problems has dropped over the years, according to the ACR, likely because of education programs the organization sponsored, which have helped to improve quality.

Overall, the quality of mammography has improved over the years, the ACR reported.

For example, consider the following statistics:

When ACR accreditation was voluntary, between 1987 and 1991, 70% of 2,954 units seeking accreditation passed on their first attempt.
When the program became mandatory during 1994-1995, that pass rate remained at approximately 70%.
The first time the pass rate shot up after 1996, to 85.7%, was when a majority of facilities had become accredited and certified under MQSA.
The ACR noted a small dip in that rate during the late 1990s when new clinical image review criteria in the 1999 ACR Mammography Quality Control Manual was approved.
Between 2001 and 2003, 15,477 mammography units completed a first attempt at accreditation. Of that number, 86% passed and 13% were deficient. After a second attempt, 96.7% of the group passed.

The numbers continued to improve.

"In 2003, 88.3% of the 5,466 mammography units completing this accreditation process passed on the first attempt," according to the ACR report. "This 18% improvement in pass rate is indicative of an overall improvement in the quality of mammography in the United States as a result of ACR mammography accreditation and MQSA. It's important to note that accreditation standards for passing had not been lowered over this time."

By Kelly Bilodeau
AuntMinnie.com contributing writer
October 11, 2005

This article originally appeared in Mammography Regulation and Reimbursement Report, a monthly newsletter designed specifically for mammographic technologists and their supervisors. It's a 12-page resource published by HC Pro that offers ideas for better practice management from peers, billing tips, MQSA regulatory updates and guidance, and business ideas related to breast imaging.

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