PRODUCT NOTES

MQSA EQUIP Module

 
 
 

Background

On October 27, 2016, the FDA introduced the EQUIP initiative—Enhancing Quality Using the Inspection Program. The EQUIP initiative includes three new requirements which will reviewed during the annual FDA inspection:

  1. Regular reviews of sample images from each technologist and each interpreting physician
  2. Corrective procedures when clinical images are of poor quality, including a mechanism for providing ongoing physician feedback to technologists
  3. Oversight by the lead interpreting physician over the image reviews and corrective action
 
 

This increased focus on imaging quality is based on the findings previously reported in the MQSA Insights publication:

Poor positioning has been found to be the cause of most clinical image deficiencies and most failures of accreditation. In 2015, the American College of Radiology (ACR), the largest FDA–approved accreditation body found that of all clinical images which were deficient on the first attempt at accreditation, 92% were deficient in positioning. Also, in ACR-accredited facilities, 79% of all unit accreditation failures in 2015 were due to positioning. Similar results were noted by the Iowa and Texas state ABs: in 2015, positioning was a cause of 91% of clinical image failures in Iowa and 100% of clinical image failures in Texas."
 
 
 

The EQUIP Corrective Action screen allows the technologist to document corrective action for the noted deficiency.

Product Overview

In response to the new FDA requirements, MagView has introduced the MagView EQUIP Module, which can help your facility comply with the new FDA requirements in the most efficient way. The EQUIP Module includes the following features:

Image Review Worklist

The Image Review Worklist allows the radiologist to review sample images as required, document deficiencies and indicate required corrective action.

Corrective Action Worklist

The Corrective Action Worklist allows the technologist to review films which have been selected by the radiologist for corrective action, and document the appropriate corrective action.

EQUIP Compliance Report

The Compliance report allows the lead interpreting physician to report on the image review and corrective action for a date range, as required by the EQUIP program.

 
 
 

Frequently Asked Questions

Several relevant questions were submitted and answered by the FDA in response to the new requirements:

Is a regular review required and how often?
Yes. Since the reviews are discussed at the time of the inspection and need to have been done since the last inspection, by default the review needs to be done at least annually. More frequent review (i.e., monthly, quarterly) is encouraged.

Is written documentation of the review required?
Yes. A verbal demonstration or discussion will not be accepted. Documentation can include such things as a summary report, signed statement by LIP that a review was performed, clinical image review meeting records, memos of review results to RTs and IPs, etc.

Does repeat analysis QC count as a review?
No. Repeat/reject rates are not necessarily directly linked to poor quality images presented for
interpretation to the physician.

 
 

For more information about the MagView MQSA EQUIP Module, please contact your MagView Account Manager.

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