Patient Safety Self-Assessment Tool Protects Practices from Liability
Regular Annual Mammograms Could Reduce Unnecessary Biopsies

Patient Safety Self-Assessment Tool Protects Practices from Liability

By Cat Vasko

A new tool created by the Medical Group Management Association (MGMA), Englewood, Colo; the Health Research and Educational Trust (HRET), Chicago; and the Institute for Safe Medication Practices (ISMP), Huntingdon Valley, Pa, allows medical practices to evaluate daily practices affecting patient safety via a Web-based self-assessment.

The Physician Practice Patient Safety Assessment (PPPSA) allows practices to evaluate their effectiveness and minimize risk in such areas as medications, handoffs and transitions of patients between clinicians or locations, surgery and invasive procedures, personnel qualifications and competency, patient education and communication, and practice management and culture. Practices that complete the assessment will be given a workbook that can help identify problem areas and provide suggestions for improvement.

In a future phase of the project, the data—which is attained with complete confidentiality—will be used to analyze trends in safety protocols across practices, and will help with the development of resources and tools to assist practices in preventing medical errors. The first 164 assessments have been compiled already. For key findings relating to practice management and culture, see Table 1; additional findings include:

  • nearly 60% of practices did not have up-to-date written information about medications for non-English-speaking patients;
  • only 28% of practices consistently tracked patients after referring them to another practice;
  • only 40% of practices consistently communicated the full results of laboratory, pathology, and imaging tests to patients within 48 hours;
  • only 36% of practices consistently provided patients with easy access to their consultative, laboratory, imaging, and other results, and educated patients on how to obtain this information;
  • only 30% of practices assessed physician competency periodically (at least annually);
  • only 14% of practices consistently asked patients to repeat back what the clinician told them, giving the clinician the opportunity to clarify any instructions; and
  • only 16% of practices consistently asked patients to repeat back diagnostic test or laboratory results over the phone to ensure that these results had been fully understood.

Failing to identify and address these issues puts a practice at risk for liability, and the MGMA recommends that the assessment be completed by a multidisciplinary team of staff members, including a medical director or other physician, an administrator or office manager, a nursing supervisor or nurse clinician, a nonphysician provider, a laboratory supervisor, a radiology or imaging supervisor, a pharmacist, a risk manager, and an administrative support staff member.

Creation of the PPPSA was funded partially with a grant from the Commonwealth Fund, New York City. Areas for evaluation were developed by a panel of experts and an advisory committee.

Cat Vasko is associate editor of  Axis Imaging News. For more information, contact .

Regular Annual Mammograms Could Reduce Unnecessary Biopsies

By Tor Valenza

A new 10-year retrospective database study suggests that the risk of having a false-positive mammogram may be reduced for women who have consistent annual mammography screenings.

James Michaelson, PhD, a member of the Department of Pathology at Harvard Medical School and the Division of Surgical Oncology at Massachusetts General Hospital, Boston, is senior author of the paper, entitled “Long-term Risk of False-Positive Screening Results and Subsequent Biopsy as a Function of Mammography Use.”1 The lead researcher was Karen Blanchard, a former undergraduate student at Dartmouth College, Hanover, NH, who is now attending Emory University’s School of Medicine, Atlanta.

The purpose of the study was to “retrospectively determine the long-term risk of false-positive mammographic assessments and to evaluate the effect of screening regularity on the risk of false-positive events.” Michaelson says that he and his co-authors initiated the study because of several published reports that showed a high rate of false-positive biopsies associated with mammography, and another study suggesting that physicians who did not have access to a recent prior mammogram were more likely to call for a biopsy that ultimately did not reveal disease.

“We wondered how much of the burden of false positives could be ascribed to the failure of women to come regularly for screenings,” Michaelson says. “So, we said, ‘Let’s see what the rate of biopsies that don’t reveal cancer is among these groups of women who chose to come in at different numbers of times over the decade.’ ”

Materials and Methods

The study used a database from the Massachusetts General Hospital Avon Comprehensive Breast Center, which documents 83,511 patients who underwent a total of 314,185 breast-screening examinations from January 1, 1985 to February 19, 2002. Of these women, the researchers looked at three different overlapping groups:

  1. a 5-year group, which examined 16,853 women who received a positive or negative screening result in 1996, and whose subsequent results were followed for 5 years afterward;
  2. an 8-year group, which examined 13,877 women who received a positive or negative screening result in 1993 and were followed for 8 years afterward; and
  3. a 10-year group, which examined 12,972 women who received a negative screening result in 1992, and were followed for 10 years afterward.

The database includes each patient’s mammogram result, which was assigned a Breast Imaging Reporting and Data System (BI-RADS) assessment code given by the radiologist at the time of the examination. The researchers defined false-positive events as both biopsies that did not reveal cancer and false-positive mammographic assessments.

Michaelson credits MGH radiologist Daniel Kopans, MD, for compiling the database. “He kept this wonderful record of all the screening use that was carried out at Mass General, which was the largest resource of information on mammography use and its consequences anywhere,” Michaelson says. The same database is being used for other retrospective breast cancer studies, as well.

Results and Recommendations

By analyzing the retrospective data, the researchers found that among women who received a negative screening result in 1991, a total of 8.04% had a biopsy that did not reveal cancer within the next 10 years. Of those women, among those who underwent 10 annual mammograms in 10 years, only nine women per 1,00 mammograms had subsequent biopsy results that did not reveal cancer. However, among those women who had only one mammogram screening within the 10-year period, 57 women per 1,000 mammograms underwent a subsequent biopsy that did not reveal cancer.

In the 5-year group, 2.9% of women who had annual mammograms within 5 years had a false-positive mammogram, which led to a biopsy that revealed no disease. However, the percentage of women who had unnecessary biopsies increased to 4.6% when these women had only three mammograms within the 5-year period.

BI-RADS Codes

  • 0: Incomplete assessment and the need for additional imaging
  • 1: Negative findings
  • 2: Benign findings
  • 3: Probably benign findings and a recommendation for short-interval follow-up
  • 4: Suspicious abnormalities (biopsy should be considered)
  • 5: Highly suggestive of malignancy

The study also found that for those women who had regular, annual mammogram screenings over 8 years, the risk of undergoing a biopsy that did not reveal disease on the first year’s visit was 3%. However, that risk was reduced substantially to .25% in the seventh and eighth years.

In terms of the BI-RADS assessment, most of the false positives were derived from BI-RADS category 0 (incomplete assessment and the need for additional imaging). There were fewer false positives in categories 3 and 4, and very low false-positive results for those assessments that were coded as category 5, in which a malignant cancer is highly suspected (“BI-RADS Codes”).

Based on this analysis, the authors recommend prompt annual mammogram screenings in order to reduce the potential for false-positive mammographic results that may lead to unnecessary biopsies.

Tor Valenza is a staff writer for  Axis Imaging News. For more information, contact .

Reference

  1. Blanchard K, Colbert JA, Kopans DB, et al. Long-term risk of false-positive screening results and subsequent biopsy as a function of mammography use. Radiology. 2006;240(2):335–342. Available at: radiology.rsnajnls.org/cgi/content/abstract/240/2/335. Accessed December 6, 2006.