Enhancing Quality Using the Inspection Program (EQUIP): A Primer for Radiologists

Abstract

The new Enhancing Quality Using the Inspection Program (EQUIP) law places more responsibility for quality assurance on the interpreting radiologists and the lead interpreting physician (LIP). Compliance with the law will require addressing three specific questions related to quality assurance and clinical image corrective action, continued compliance, and ensuring LIP oversight. This process enables the radiologist to exemplify added value through physician leadership, team integration, and improved patient care.

Introduction

In 1987, the American College of Radiology (ACR) implemented the Mammography Accreditation Program. This was a voluntary program designed to improve and standardize mammography quality (1). The efforts of the ACR and the importance of mammography quality in detecting early breast cancer was recognized by the United States government. Congress authorized the Mammography Quality and Standards Act (MQSA) in 1990, which required facilities to meet quality standards similar to the ACR Mammography Accreditation Program in order to be reimbursed by Medicare (2). In response to this governmental regulation, several states also passed legislation requiring the inspection of quality standards. Due to the varying requirements of these organizations, mammography quality continued to vary among facilities. Thus, the MQSA in use today was passed by the United States Congress on October 27, 1992, and signed into law by President George H.W. Bush. The MQSA intent was to standardize mammography quality and equipment maintenance throughout the country. All mammography units must be accredited by an approved accrediting body and certified by the Secretary of Health and Human Services under the auspice of the U.S. Food and Drug Administration (FDA) to legally provide mammogram services after October 1, 1994 (3–5).

The MQSA requires each mammography facility to be inspected and approved by either the FDA or a certifying body specifically approved by the FDA. These include the ACR and certain state certifying bodies such as Illinois, Iowa, South Carolina, and Texas (6, 7). The results from these inspections have shown that MQSA has successfully improved image quality. For example, the overall ACR pass rate for image quality increased from 70% in 1987–1991 to 88.3% in 2003. The overall pass rate in 2001–2003 increased from 94% to 98.2% (2).

Poor positioning is the most common deficiency in clinical image failure. The art of mammographic positioning and assessment of adequate mammographic image quality have been well-established in sentinel articles by Cardenosa and Eklund (8, 9). These principles still apply in the digital era (10). However, as technology and phantom image standardization improved, clinical causes of certification failures increased from 36.6% in 1987–1991 to 71% in 2001–2003 (2). Bassett et al assessed 2341 mammography unit failures and found that 1034 (44%) failed in their clinical imaging. Most of these clinical imaging failures (20%) were due to positioning (11). The importance of clinical positioning has captured the attention of federal regulators, and the FDA acknowledged that the sensitivity of mammography decreased from 84.4% to 66.3% for images that failed a positioning audit (12, 13). The FDA responded to these concerns of daily image quality deficiencies through the Enhancing Quality Using the Inspection Program (EQUIP) initiative, which was introduced on October 27, 2016 (14). While a facility’s best images from each mammography unit are submitted to the accrediting body for image quality compliance, there was no similar mechanism to ensure that daily quality assurance (QA) practices were in place at each facility. The new EQUIP requirement continues to emphasize the MQSA stance on the significance of clinical image quality in detecting early breast cancers.

To date, little information on the EQUIP regulatory process has been published in the literature. Most of the published information is in the radiology technologist literature and does not delve deeply into the radiologist’s roles and responsibilities of the EQUIP process (5, 15, 16). In 2017, 43% of the 8486 MQSA EQUIP inspections had deficiencies in one or more areas (16, 17).

Many radiologists are not aware of the extent of the responsibilities involved, and this has led some facilities to be noncompliant in the new EQUIP requirements. Enhancing Quality Using the Inspection Program places more responsibility and engagement by radiologists in the QA process. This paradigm shift places more responsibility on the facility’s interpreting physicians (IP) and in particular, the lead IP (LIP). The purpose of this article is to provide an overview of the EQUIP process and to highlight the leadership role and responsibilities breast radiologists have as LIPs.

Lead Interpreting Physician

An LIP is designated for each mammography facility. This physician is responsible for ensuring the QA requirements are met and performed by qualified personnel. These requirements per the Code of Federal Regulations include ensuring all personnel involved in any aspect of mammography meet FDA qualification specifications; oversee the facility equipment performance and operation; comply with mammography report and medical records requirements; establish and maintain a quality assurance program; maintain daily, weekly, semiannual, and annual QA on mammography equipment; maintain QA through the medical outcomes audit; address serious complaints; and monitor clinical image quality (17). Any other administrative titles or other supervisory duties are left to the discretion of the facility (18).

The LIP and IP designations are similar in that all IPs, including the LIP, are required to follow the facility procedures for corrective action if poor quality images are encountered and all IPs must participate in the medical outcomes audit program (17). However, the LIP designation differs in that the “lead” part of LIP implies an increased leadership role of the radiologist. The LIP is considered the person “most in charge.” Due to these increased QA responsibilities, LIP responsibilities may potentially meet future practice quality improvement (PQI) requirements for the American Board of Radiology.

The Law

The actual FDA law and the three questions added to the annual MQSA inspection to ensure facility compliance with EQUIP will be discussed. The LIP plays a central role in all three EQUIP compliance questions (19).

The actual EQUIP law reads as follows:

§ 900.12(i) Clinical image quality. Clinical images produced by any certified facility must continue to comply with the standards for clinical image quality established by that facility’s accreditation body.

§ 900.12 (d)(1)(ii)(A) [All interpreting physicians shall] follow the facility procedures for corrective action when the images they are asked to interpret are of poor quality.

§ 900.12(d)(2) Quality assurance records. The lead interpreting physician ... shall ensure that records concerning mammography technique and procedures, quality control (including monitoring data, problems detected by analysis of that data, corrective actions, and the effectiveness of the corrective actions), safety, protection and employee qualifications to meet assigned quality assurance tasks are properly maintained and updated.

EQUIP Question One: Quality Assurance and Clinical Image Corrective Action

1. Does the facility have procedures for corrective action (CA) when clinical images are of poor quality?

The first EQUIP inspection question is the inspector’s assessment to determine if the facility has image QA procedures in place. Specifically, the inspector will confirm a clinical image corrective action process is in place when images of poor quality are encountered in daily practice. This does not need to be a written policy, but it must be in place and described to the inspector.

To satisfy this requirement, there must be a mechanism for all IPs at the facility to provide ongoing image quality feedback to radiology technicians (RTs) or the designated facility personnel. The corrective actions taken and the effectiveness of the corrective action must be documented (20). Importantly, the inspector is not assessing the number of studies on “the list”; the inspector is simply documenting evidence that the facility has a process in place.

EQUIP Question Two: Continued Compliance

1. 2. Does the facility have procedures to ensure that clinical images continue to comply with the clinical image quality standards established by the facility’s accreditation body?

There must be a mechanism for regular image quality review for all active RTs, IPs, and the LIP at each facility. A sampling of mammograms are required to ensure that the daily clinical imaging quality continues to meet the accrediting body quality standards in routine clinical practice. This process needs to be documented and must be performed after the date of the last inspection. This documentation could include a summary report, a signed statement by the LIP that a review was performed, or clinical image review records or memos to RTs, and these records must be available to the inspector (20).

The “regular” image quality review and the number of mammograms reviewed is not defined by the FDA. The decision of the number of studies reviewed and the review frequency is left up to the facility. This review must be performed at least once a year and it must be dated after the prior inspection. The FDA acknowledges that more frequent reviews are preferable and more effective in generating ongoing improvement.

Each active RT and IP listed for the facility must be evaluated. The radiologists can evaluate the technologist’s images. The radiologists shall evaluate each other’s images that are accepted as adequate for interpretation. If there is only one radiologist on site, (presumably the LIP), then the LIP can evaluate themselves. However, the FDA acknowledges it is preferable if this review is performed by a different radiologist.

EQUIP Question Three: LIP Oversight

1. Does the facility have a procedure for LIP oversight of Quality Assurance/Quality Control (QA/QC) records and corrective actions?

   • (a) Does the procedure include requirements for LIP oversight of QA/QC records, including review of the frequency of performance of all required tests?

   • (b) Does the procedure include requirements for LIP review to determine whether appropriate corrective actions were performed when needed?

Quality control specifically refers to the technical aspects of the examination, which refers to measurements or acceptability standards. Quality assurance refers to the collective activities, which indicate quality mammography (21). Quality control is considered part of the QA process.

The LIP is responsible for overseeing that the QA and QC records are performed at the required frequency and that the records are in place. This includes the RT’s QC tests, medical physicist reports, and EQUIP image quality compliance. The LIP is also responsible for reviewing these records if any corrective actions are needed.

Role of LIP Radiologist during Inspections

The LIP must be available to answer the inspector’s three questions on inspection day. If the LIP cannot be available on-site or by telephone, there are two alternatives. The first is a signed attestation form, which is provided to the facility for the inspector. A second option is that the LIP may sign a written facility procedure form, which includes the provisions of the three EQUIP inspection questions, which is presented to the inspector.

During the actual inspection day, the LIP is responsible for demonstrating that the facility is in compliance and for answering the three EQUIP questions. While there are provisions for an LIP who is unable to be present, it is preferable for the LIP to demonstrate on-site active presence on inspection day to demonstrate team leadership. The LIP presence also allows for better engagement during the inspection process and availability to answer any questions or concerns that may arise. Additionally, the on-site LIP presence is a valuable learning opportunity for the LIP to learn about individual inspector preferences, process improvement, and methods to facilitate future compliance requirements.

Radiologist Team Leadership and Team Integration

The radiology team leader is an integral part of a successful QA/QC team integration. This team is comprised of the LIP, other IPs, facility administration, the lead technologist, the QC technologist, and the medical physicist. Ultimately, the radiologist is responsible for determining the acceptable image quality and will need the skills to effectively communicate these expectations and the importance of image quality to the team.

Inspection Outcomes

The EQUIP process was phased-in after its introduction in 2016. The field inspectors were first trained, and the effective date of introduction was January 1, 2017. The initial year was a grace period and citations related to clinical imaging quality were not issued. However, noncompliance at inspection in year two resulted in a level two citation. This citation requires a written response to the FDA district office within 30 days. During inspection year three, EQUIP violations generate a level two repeat citation, which requires a written response to the FDA district office within 15 days, and the facility will also be reported to its accrediting body for evaluation of the facility’s clinical images (20).

Implementation Example

There are a number of ways to meet these new EQUIP regulations. Each breast imaging center can implement a customized method that best suites their organization. One implementation example, which addresses the three EQUIP questions, is as follows:

The first EQUIP question requires the facility to perform QA and clinical image corrective action. A dual recording system is utilized to record studies requiring technical repeat imaging. The IP first records images needing corrective action and the reason on a form in the reading room. The images are reviewed by the technologist and radiologist to ensure an understanding of the technical repeat reason and this interaction is documented. When the patient returns for the technical repeat, the patient information is documented in the RT technical repeat log. This secondary list ensures that technical repeat data is also captured by the RT. In addition to addressing technical quality on an individual scale, some LIPs periodically select representative images and lead review sessions with the available RTs. This ongoing collective education allows the LIP to address and reinforce common imaging goals.

The second EQUIP question to document continued compliance is performed when the system mammography manager randomly selects five studies performed by each RT and five studies interpreted by each IP for each facility on a quarterly basis. The LIP radiologist is responsible for reviewing the images performed by each RT and the images interpreted by each IP. In turn, one IP will evaluate the images interpreted by the LIP. This mechanism ensures all RTs and IPs have ongoing feedback and ensures that clinical images continue to comply with the accreditation body standards.

The third EQUIP question to document LIP oversight is performed through a quarterly meeting with the facility LIP, lead RT, and facility manager. This frequency is selected to ensure that LIP oversight of the QA/QC records is documented and that any corrective actions have been reviewed. At the meeting’s conclusion, the group’s attendance and goals are documented.

Each of the previously described activities, the technical repeat list, the ongoing random clinical quality results for each RT and IP, and the quarterly meeting attendance is compiled in a binder, which is made available to the MQSA inspector. If there are any further questions or concerns, the LIP is available to answer the inspector’s questions.

Conclusions

The new EQUIP guidelines are an extension of the prior MQSA guidelines. Enhancing Quality Using the Inspection Program is designed to ensure that ongoing, daily compliance to clinical imaging quality is in effect in each facility. The EQUIP requirements are an opportunity for radiologists to take on additional leadership roles in the breast imaging QA process and educate administrators and technologists of the importance of clinical image quality in detecting early breast cancers. Radiologists will also need to be prepared to take on additional leadership and accountability through the new EQUIP inspection during the annual MQSA inspection day.

Funding

None declared.

Acknowledgments

The authors wish to acknowledge Nichole Hammond, MHA, and Lisa Garver for their assistance.

Conflict of interest statement

None declared.

References