The U.S. Food and Drug Administration's (FDA) Division of Mammography Quality Standards (DMQS) has released a six-month analysis of inspections performed under the pilot year of the Enhancing Quality Using the Inspection Program (EQUIP) initiative.
The analysis covers the period between January and June. As of June 30, there have been 4,166 annual MQSA inspections performed. Of these, 44% had one or more shortcomings, according to the DMQS.
| Deficiencies identified | |
| EQUIP question | Percent of total inspections |
| Question 1(a): There is no system in place that includes a mechanism for providing ongoing interpreting physician feedback on image quality. | 13% |
| Question 1(b): There is no system in place that includes a mechanism for documenting any needed corrective action and the effectiveness of any corrective action taken. | 25% |
| Question 2(a): There is no mechanism in place for regular reviews of image quality attributes of a sample of mammograms performed by each active radiologic technologist and a sample of mammograms accepted for interpretation by each active interpreting physician. | 34% |
| Question 2(b): There is no documentation of review since the last inspection. | 30% |
| Question 3(a): There is no system in place for lead interpreting physician oversight, including review of the frequency of performance of all required tests. | 19% |
| Question 3(b): There is no system in place for lead interpreting physician review to determine whether appropriate corrective actions were performed when needed. | 22% |
The DMQS anticipated that the requirements for question 2 could be the most difficult for facilities to meet. While many facilities engage in daily feedback, not all of them assess image quality for the facility as a whole, it said in a statement released by the FDA.
During this first year of the EQUIP program, facilities will not receive citations related to its new questions, although inspectors will record facility responses and note any EQUIP deficiencies in their report. This will give facilities the opportunity to address these deficiencies before citations are issued during inspections performed on or after January 1, 2018.
"Please take time to engage with your inspector during this educational year to learn how EQUIP can help your facility maintain image quality," the DMQS said.
EQUIP information can be found here.
