by Kathleen A. Franke
Chief, Accreditation and Certification Branch
Division of Mammography Quality and Radiation Programs
Office of Communications, Education, and Radiation Programs
The Mammography Quality Standards Act (MQSA) was signed into law on October 27, 1992, to establish national quality standards for mammography. The MQSA required that, to perform mammography legally after October 1, 1994, all facilities become certified by the Food and Drug Administration (FDA) (Section 900.12, MQSA Final Regulations) or by an FDA-approved Certifying Agency under the States-As-Certifiers (SAC) program.
As part of a facility's mammography life cycle, it goes through two important initial phases -- accreditation and certification. Once certified, a facility must fulfill certain requirements. It must be inspected annually, have an annual medical physics survey, perform periodic quality control tests, and take corrective action, where applicable. Described below are the stages entailed in the accreditation and certification processes.
To become certified, a facility first must be accredited by an Accreditation Body (AB) approved by the FDA (Section 900.11(b)(1)(ii)). To pass accreditation and subsequently qualify for a MQSA mammography facility certificate, a facility must meet baseline requirements relative to personnel qualifications, equipment performance specifications, quality assurance (QA) and quality control (QC) testing and recordkeeping, and clinical and phantom image reviews, as outlined in the MQSA Final Regulations (Section 900.12). A facility applying for accreditation is either categorized as provisional (new and or reinstating) or reaccrediting (i.e., renewing its existing accreditation).
Provisional Facility (New and/or Reinstating)
A facility applying for accreditation falls into one of three categories: a first-time (new) applicant, a reaccrediting applicant, or a reinstating applicant.
- New Facility
When a new facility submits an accreditation application to an AB, the AB initially reviews the submission for completeness. Upon determining that the facility has provided the requested information, the AB notifies the facility and its Certifying Agency that it has accepted that facility's application. Subsequently, the Certifying Agency issues a provisional MQSA certificate that is effective for six months. During this six-month period, the facility must submit clinical and phantom images and other required materials to the AB for its review. Upon passing this review, the AB again notifies the Certifying Agency who then issues a full MQSA certificate that is effective for three years.
- Reinstating Facility
A previously certified facility whose certificate has expired, whose accreditation was denied, whose certificate renewal was refused by its Certifying Agency, or whose certificate was suspended or revoked, may apply to have its certificate reinstated so that it may be eligible for a new provisional certificate. To be reinstated, a facility must work with its AB to determine the specific requirements it must satisfy to reapply for accreditation. A facility must then submit a corrective action plan describing how it has corrected the deficiencies noted by the AB. Upon passing these reviews, the AB notifies the Certifying Agency who then issues a new MQSA provisional certificate that is effective for six months.
- Reaccrediting Facility
A reaccrediting facility is one that has already been accredited and certified for three years, with an impending expiration date. As in the case of the original accreditation, a reaccrediting facility must again apply to its AB for accreditation renewal, described above. Upon approval by its AB, a reaccrediting facility receives a full MQSA certificate from a Certifying Agency that is effective for another three years. During these three years, the facility must meet the certification requirements described below.
MQSA certification, while closely linked to accreditation, is a separate process administered by a Certifying Agency, i.e., FDA or a SAC State. Currently, there are two SAC States, Illinois and Iowa, who only certify facilities within their respective State borders. Issuance of a MQSA certificate occurs after an AB notifies a Certifying Agency of a facility's accreditation approval. Subsequently, receipt and display of the MQSA certificate allow a facility to lawfully perform mammography up to the certificate expiration date.
Under MQSA, Certifying Agencies may grant a facility three types of certification: provisional, full, and a 90-day extension.
Provisional certification allows a facility to perform mammography for up to six months while its AB reviews all of its submitted materials and evaluates the quality of the facility's clinical and phantom images required in the accreditation process. Once a facility “passes” the review and evaluation of the accreditation application, its AB grants it a three-year accreditation and notifies its Certifying Agency of its approval.
Upon the AB's approval of a three-year accreditation, a facility receives an MQSA certificate from its Certifying Agency that is effective for another three-year period. During these three years, a facility must meet the requirements for accreditation as outlined above.
The MQSA has a provision whereby a Certifying Agency can grant a facility a one-time, 90-day extension to an existing provisional certificate. An AB grants a 90-day extension only when a facility is unable to complete (through no fault of its own) the accreditation process within the prescribed six months. This extension requires a facility to state what it is doing to become certified and to provide evidence that there would be a significant adverse impact on access to mammography in the geographic areas it serves were it not to obtain this extension. For additional information about applying for a 90-day extension in these circumstances, a facility should contact its AB. If a Certifying Agency grants the extension, the facility receives an MQSA certificate that extends its existing provisional certificate expiration date by 90 days.
In addition to its authority to certify facilities under the MQSA, a Certifying Agency can deny, suspend, or revoke a facility's certification. Also, if a facility operates without MQSA certification, it may be subject to civil money penalties of up to $10,000 per day per violation. Without a valid certificate, a facility will not be reimbursed by the Centers for Medicare and Medicaid Services (CMS) for screening and diagnostic mammography examinations under Medicare.
Currently, Certifying Agencies do not charge certification fees, nor do they require separate application for certification. Rather, they charge fees to cover the costs associated with MQSA inspections.
As part of a certified facility's responsibilities under the MQSA, it is (1) required to undergo an annual inspection conducted by a Certifying Agency or its agents under contract; (2) undergo random onsite visits by its AB; (3) undergo random clinical image reviews by its AB; (4) have a medical physicist perform an annual medical physics survey; (5) perform periodic QC tests; and (6) satisfactorily correct inspection observations and any failures uncovered during the physics survey, or other QC tests, within the specified time frames. Additionally, a certified facility must ensure that its personnel meet all initial qualifications and maintain continuing education and experience requirements to fulfill its obligations under the MQSA regulations.
The goal for all facilities is to become accredited during the accreditation/reaccreditation application process. Data from 2003, indicated that of the nearly 3,800 facilities that applied for accreditation/reaccreditation, there were 5,726 units mammography units. Approximately 0.1 percent of these units failed accreditation. These data further indicated that poor clinical image quality was the primary reason for the failure. This small percentage of failed attempts is directly related to the efforts of ABs working closely with their facilities. ABs normally allow a facility more than one attempt at correcting deficiencies that may come up through the accreditation process. It is only in those instances when a facility fails to correct its deficiencies after working with its AB that the facility fails to become accredited. In order for this corrective process to work, there must be adequate time remaining on a certificate's time line to undertake these actions.
When a facility fails to satisfactorily correct the deficiencies identified during the accreditation process, the AB denies accreditation status. Upon denial, a facility that wants to continue to provide mammography services must apply to its AB for provisional reinstatement.
A facility that successfully completes the accreditation process has
- provided its AB with complete, accurate, and timely information, as specified;
- maintained practices that produce good quality clinical and phantom images; and
- selected its best images that reflect the quality mammography service it provides.
Additionally, throughout its accreditation and certification, a facility should
- apply for accreditation for new units added to its facility since becoming accredited and before using these units on patients;
- take appropriate QA measures, including the annual medical physicist's survey;
- perform QC tests correctly and at the designated intervals (e.g., daily, weekly, monthly, quarterly, semiannually);
- maintain complete and accurate QA/QC records;
- allow for and provide continuing experience and educational opportunities for mammography personnel so that they can maintain their technical competence and enhance the quality of their mammography practices;
- take appropriate corrective action as needed;
- cooperate with its AB during random AB onsite visits;
- keep its AB informed of any changes to its operational status, e.g., ownership, address changes, personnel and equipment changes or additions;
- have an adequate consumer complaints mechanism in place;
- provide patients with adequate directions for filing serious complaints;
- resolve all complaints from its patients in a timely manner;
- keep its AB informed of serious, unresolved consumer complaints;
- adequately prepare for and undergo annual inspections;
- take appropriate and timely corrective action to resolve inspectional findings; and
- pay accreditation and inspections fees on time.
To satisfactorily pass the accreditation process, a facility needs to (1) understand and meet its responsibilities and obligations specified in the MQSA; (2) submit complete and accurate materials required by its AB in the time frames indicated; (3) maintain good practices throughout its accreditation/certification cycle; and (4) correct deficiencies identified in both the accreditation and certification processes.
Simply stated, a facility that wants to legally perform mammography services must be informed, willing, and prepared to take the appropriate steps to successfully achieve accreditation and certification under the MQSA.