The New York State Breast and Cervical Cancer Screening Program (NYSBCCSP) is funded in part through the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) (1,2). A total of 292 mammography facilities participate in NYSBCCSP. In 1998, NYSBCCSP began reviewing the clinical outcomes of clients screened through the program to identify facilities that might need more intensive assessment of quality assurance and corrections of deficiencies. This report describes the quality assurance process of NYSBCCSP, which provides methods for monitoring and assessing the quality of clinical care by program providers. These outcome-based methods can be useful to other programs and providers of breast cancer screening.
NYSBCCSP routinely compares the proportion of abnormal clinical breast examinations (CBE), abnormal screening mammography outcomes, and positive predictive values of breast cancer biopsies (ppvB) for individual program facilities with overall figures generated by the state and national programs (NYSBCCSP and NBCCEDP, unpublished data, 1995-2003). Facilities with proportions of abnormal mammography * , abnormal CBEs ([dagger]) , or ppvB ([section]) significantly ([paragraph]) different from the lower or upper bounds of expected ranges (i.e., outliers) are identified for further evaluation. The expected ranges for abnormal CBEs are based on the NBCCEDP Data Quality Indicator Guide, a program management tool; the ranges for abnormal mammography and ppvB are commonly accepted parameters in mammography (4).
NYSBCCSP compiles additional patient data for the facilities identified with outlier results, including the age, race/ ethnicity, and previous screening history of clients served; the proportion of abnormal screenings or ppvB over time; and the diagnostic procedures performed after abnormal screening results. The cancer detection rate also is calculated and compared with rates in the state and national programs. In addition, cross tabulations of screening mammography results by CBE results are reviewed.
The facility and local screening project responsible for coordinating screening and related services in a community are contacted to determine potential explanations for the outliers. A random sample of medical records is reviewed to identify data-reporting errors. If data-reporting errors cannot explain the outlier results, the clinical interpretive skills of providers at the facility are assessed. A board-certified radiologist performs the mammography assessment by evaluating the technical and interpretive quality of the mammograms. A clinician performs the CBE assessment by reviewing the position of patients during examinations, areas of breast tissue examined, search pattern used, and quality of documentation and communication skills of providers.
NYSBCCSP collaborates with the facility and local screening project to develop, implement, and evaluate an action plan to correct any deficiencies identified. The following two examples describe this quality assessment process.
Case Reports
Case l. During 1996-1999, facility A, a medium-sized hospital (300-400 inpatient beds), provided mammography screening to 544 NYSBCCSP-enrolled women. A total of 73 (13.4%) of the 544 mammograms performed at facility A were classified as Breast Imaging Reporting and Data System (BI-RADS [R]) category 4 (i.e., suspicious abnormalities that indicating biopsy should be considered), whereas 3,750 (1.5%) of an estimated 250,000 mammograms performed at other Facilities in NYSBCCSP during the same period were classified as category 4. Five (3.0%) of 166 women at facility A with abnormal mammograms underwent additional imaging, compared with 13,500 (45.0%) of approximately 30,000 women with abnormal mammograms screened at other NYSBCCSP facilities. In addition, the 166 women at facility A with abnormal mammograms were more than three times as likely to receive a breast biopsy as women at other facilities (52.0% versus 15.0%, respectively). The ppvB for detecting breast cancer from imaging at facility A was 6.9%, compared with 23.9% at other facilities.
On the basis of review of medical records and independent review of mammograms at Facility A, two staff radiologists had higher biopsy recommendation rates and use of stereotactic biopsy than those of three other readers at the facility. Facility A agreed to the following corrective plan of action: 1) conduct in-service training for all five radiologists on the use of the BI-RADS [R] reporting system; 2) obtain a second reading by a different radiologist of all mammograms reported as a BI-RADS [R] category 4 for 6 months, with final resolutions by the chief of radiology; and 3) obtain facility accreditation for its stereotactic biopsy program.
During January 2001-December2002 (approximately 4-28 months after completion of the action plan), the proportion of mammograms reported at facility A classified as BI-RADS [R] category 4 decreased from 13.4% to 4.3%, the proportion of women with abnormal mammograms receiving additional imaging increased from 3.0% to 7.0%, the proportion of women undergoing breast biopsies decreased from 52.0% to 28.0%, and the ppvB increased from 6.9% to 19.0%.