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Information for mammography facility personnel, inspectors, and consumers               about the implementation of the Mammography Quality Standards Act of 1992 (MQSA)

This is an Archived Document - Not for Official Use

Document issued on July 8, 2002 This document modifies and updates guidance appearing in the Policy Guidance Help System.

U.S. Department Of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Inspection Support Branch Division of Mammography Quality and Radiation Programs Office of Health and Industry Programs

Comments and suggestions may be submitted at any time for Agency consideration to Dockets Management Branch, Division of Management Systems and Policy, Office of Human Resources and Management Services, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD, 20852. When submitting comments, please refer to the exact title of this guidance document. Comments may not be acted upon by the Agency until the document is next revised or updated.

For purposes of this document, additions to the Policy Guidance Help System (PGHS) are shown as highlighted text while deletions are shown by strikethroughs. Note: Questions and answers that are currently in the PGHS and are not being modified are not included in this document. For questions regarding the use or interpretation of this guidance contact Charles Finder at (301) 594-3332 or by email caf@cdrh.fda.gov.

Additional copies are available from the Internet at:
http://www.fda.gov/cdrh/mammography/pubs/1411.pdf, or CDRH Facts-On-Demand. In order to receive this document via your fax machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-tone telephone. Press 1 to enter the system. At the second voice prompt, press 1 to order a document. Enter the document number 1411 followed by the pound sign (#). Follow the remaining voice prompts to complete your request.

TABLE OF CONTENTS

Background
The Least Burdensome Approach
Introduction
Introduction to the PGHS
Accreditation and Certification Overview
Appeal of Adverse Accreditation or Reaccreditation Decisions That Preclude Certification or Recertification
Application for a Provisional Certificate
Application for Extension of Provisional Certificate
Application to an Accreditation Body
Definition of Certificate
General Requirements for Accreditation and Certification
Full Field Digital Mammography (FFDM) Certification
MQSA Facility Certification Requirements For Use Of Full Field Digital Mammography (FFDM)
Revocation of Accreditation
Additional Mammography Review and Patient Notification
AMR General Guidance
Approved Alternative Standards
Daily Processor QC Tests
Continuous Display of Override Status
Weekly Phantom Image Test
Post Exposure Focal Spot Indication
Manufacturer’s software modification of the AEC
Conducting the Mammography Equipment Evaluation After a Software Upgrade Under Medical Physicist Oversight
Correction Period When Components of the Senographe TM 2000D Full Field Digital Mammography (FFDM) System Fail Quality Control Tests
Alternative Requirements
Alternative Requirements Overview
Breast Implants
Consumer Complaints
States as Certifiers
Scope
Application for approval as a certification agency
Standards for certification agencies
Evaluation
Withdrawal of approval
Hearings and appeals

The Mammography Quality Standards Act was passed on October 27, 1992, to establish national quality standards for mammography. The MQSA required that to provide mammography services legally after October 1, 1994, all facilities, except facilities of the Department of Veterans Affairs, must be accredited by an approved accreditation body and certified by the Secretary of Health and Human Services (the Secretary) or by an approved State certification body. The authority to approve accreditation bodies and to certify facilities was delegated by the Secretary to the FDA. On October 28, 1997, the FDA published the MQSA final regulations in the Federal Register. The final regulations, under which mammography facilities are currently regulated, became effective April 28, 1999. The FDA compiled all final guidance referable to MQSA into a computerized searchable Policy Guidance Help System in November 1998. The Policy Guidance Help System is available on the Internet at:
http://www.fda.gov/cdrh/mammography/guidance-rev.html
This compliance guidance document serves to update the Policy Guidance Help System.

Guidance information is periodically updated. Individuals wishing to get automatic notification of such updates may subscribe to our E-mail ListServ by visiting http://list.nih.gov/cgi-bin/wa?SUBED1=mammography_cdrh-l&A=1 and following the directions there.

We believe we should consider the least burdensome approach in all areas of medical device regulation. This guidance reflects our careful review of the relevant scientific and legal requirements and what we believe is the least burdensome way for you to comply with those requirements. However, if you believe that an alternative approach would be less burdensome, please contact us so we can consider your point of view. You may send your written comments to the contact person listed in the preface to this guidance or to the CDRH Ombudsman. Comprehensive information on CDRH's Ombudsman, including ways to contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman/

This document is intended to provide guidance to mammography facilities and their personnel. It represents the Food and Drug Administration’s (FDA) current thinking on the final regulations implementing the Mammography Quality Standards Act (MQSA) (Pub. L. 102-539). The FDA uses mandatory language, such as shall, must, and require, when referring to statutory or regulatory requirements. The FDA uses non-mandatory language, such as should, may, can, and recommend when referring to guidance. It is the responsibility of the facility to read, understand, and follow the final regulations.

Under its own authority, a State may impose more stringent requirements beyond those specified under MQSA and its implementing regulations. A facility may want to check with the State or local authorities regarding their requirements.

It isWe recommended that you download the Policy Guidance Help System to run on your own computer. However, it is important to remember that the guidance is updated on a regular basis, so you should check FDA's Mammography website to make sure that you have the most current information. Individuals wishing to get automatic notification of such updates may subscribe to our E-mail ListServ by visiting http://list.nih.gov/cgi-bin/wa?SUBED1=mammography_cdrh-l&A=1 and following the directions there.

Welcome to the Policy Guidance Help System (PGHS).
The guidance presented here reflects FDA’s current thinking on the final regulations implementing the Mammography Quality Standards Act (MQSA) (Pub. L.102-539). The Policy Guidance Help System is intended to provide useful information to mammography facilities and their personnel. It represents the Food and Drug Administration’s (FDA) current thinking on the final regulations implementing the Mammography Quality Standards Act (MQSA) (Pub. L.102-539). The FDA uses mandatory language, such as shall, must, and require, when referring to statutory or regulatory requirements. The FDA uses non-mandatory language, such as should, may, can, and recommend when referring to guidance. It is the responsibility of the facility to read, understand, and follow the final regulations

The system is organized as a series of books or main topics (see the Contents tab to the left). To view the list of topic titles in a specific book click on the "+" symbol or double-click on the book icon. To see the contents of a topic, simply click on its title.

The Index consists of a list of keywords associated with appropriate topics. Click on the Index tab on the left side of this screen to display the list of keywords. You may scroll through all the keywords or type in a keyword in the box at the top of this list. To see topics associated with a specific keyword, click on it and the relevant topics will appear in a box. To go to one of these topics, click on its topic title.

To search for any word in the system, click on the Search tab. Follow the "Find Setup Wizard" instructions to generate the list of words. Once the word list has been generated, follow the keyword procedures.

All pages have a "non-scrolling" area at the top of the page. This area may contain references to sections within the topics, such as "Questions" or "Key Words/Related Topics." These references are hyperlinked - that is, you can click on them to quickly go to that section. Because this area does not scroll, it allows you to easily navigate within topics.

Many of the pages begin with the regulatory citation related to the selected topic, followed by a discussion and/or a series of questions and answers offering guidance about how FDA will implement the regulations.

The topics conclude with a list of key words and related topics. Clicking on a Keyword will bring up a pop-up box from which you can choose to see another topic by clicking on it. If there is only one topic for the key word, you will go directly to that topic. Clicking on a Related Topic will take you directly to the related topic.

If you want to make the font size on the screen larger or smaller, choose "Options" from the top menu, then "Font," then highlight the desired font size.

If you have comments or questions about the Policy Guidance Help System, please submit them via e-mail to dmqrp@scicomm.com.

900.11(a) General. After October 1, 1994, a certificate issued by FDA is required for lawful operation of all mammography facilities subject to the provisions of this subpart. To obtain a certificate from FDA, facilities are required to meet the quality standards in section 900.12 and to be accredited by an approved accreditation body or other entity as designated by FDA.

Discussion
Accreditation and certification are two separate processes and both are required of mammography facilities under MQSA. The Mammography Quality Standards Act (MQSA) requires that before Before a mammography facility can legally perform mammography, it must be certified. Before a facility can be certified, it must become accredited. To begin the process, it must first contact its selected accreditation body (the ACR or the States of Arkansas, California, Iowa, or Texas) and apply for accreditation.

Currently the FDA-approved accreditation bodies (AB) are:

When the application has been accepted for review, the accreditation body will notify FDA, which will then send the facility a six-month provisional certificate. The facility must collect the clinical images and other data that will be needed for completion of the accreditation process and respond to all requirements of the accreditation body in a timely manner. If the facility has not completed the accreditation process prior to the expiration of the provisional certificate, it must cease performing mammography. A facility that has adhered to the accreditation body process timeframes may qualify for a 90-day extension of the provisional certificate.

Interested parties may find out which mammography facilities are certified as follows:

• The FDA MQSA Website (http://www.fda.gov/cdrh/mammography) has a link to Listing of FDA Certified Mammography Facilities that lists facilities by selected sState or by specified three-digit zip code area. This information is updated weekly.
• The National Cancer Institute (NCI) has provides information regarding breast cancer and mammography, including a list of FDA-certified mammography facilities in a caller’s area through their hotline: 1-800-4-CANCER (1-800-422-6237).
• A complete listing of all certified facilities may be ordered from the National Technical Information Service (NTIS) for a fee. The information is updated quarterly and is provided on 3-1/2” diskettes in ASCII format. Call 1-800-363-2068 or 1-703-605-6060 to order either a single disk (SUB 5286/Code D01) or a one-year subscription (SUB-5386).

Question 1:What are 45 day interim notices and interim accreditation and when are they used Under what circumstances may FDA issue Interim Notices?

Facilities may call the FDA hotline to request assistance when they have not received a certificate or have other questions pertaining to certification, or they may contact their accreditation body with a similar request, and the accreditation body may contact FDA to request issuance of an interim notice. The following criteria will be used by FDA to determine whether an interim notice should be issued to a facility.

When a facility’s MQSA certificate has expired or is about to expire, FDA or the Certifying State may, under certain conditions, issue a 45 day interim notice that allows the facility to continue to perform mammography. FDA or a Certifying State may issue an a 45 day Interim Notice interim notice to a mammography facility under the following two sets of circumstances:

1.

REACCREDITATION COMPLETION DELAY: In cases where there has been a delay in the AB reaching a final reaccreditation decision, FDA or the Certifying State may issue a 45 day interim notice to a facility. This allows the facility to continue to perform mammography after its MQSA certificate has expired. Beginning in the summer of 2002, in order for a facility to be eligible to receive an interim notice, the facility must have been granted interim accreditation by its AB. A facility should submit its request for interim accreditation to its AB. The AB will apply its established criteria for interim accreditation and issue a decision regarding the request. If the interim accreditation request is approved by the AB, FDA or the Certifying State will be notified by the AB to fax the facility an interim notice. Upon receipt of the interim notice, the facility may perform or continue to perform mammography for up to 45 days. If full accreditation does not occur during this time period, contact the AB to discuss reinstatement. A facility whose interim notice has expired is considered no longer certified and must not perform mammography. If the AB does not grant the facility’s request for interim accreditation, the facility may apply for reinstatement in accordance with its AB’s policies. Once the current MQSA certificate and interim notice expire, a facility is considered no longer certified and must not perform mammography.

2.

CERTIFICATE DELAY: If the AB has already made a positive accreditation decision, FDA or the Certifying State may fax the facility a copy of its MQSA certificate or issue an interim notice in order to allow the facility to perform mammography while awaiting receipt of the original MQSA certificate as described below. Facilities Waiting for Receipt of their Provisional ( 6 month) MQSA Certificate (New Facilities) When the AB accepts the facility’s application for review, the AB will notify FDA or the Certifying State. The Certifying Agency will fax the facility an MQSA provisional certificate or a 45 day interim notice allowing it to begin performing mammography as soon as possible. The facility cannot perform mammography until it receives either of these documents. Facilities with questions about their accreditation/certification status should first contact their AB to see if their application has been accepted and if the Certifying Agency has been notified. If the facility still has not received its MQSA certificate or interim notice, the facility should contact FDA or the Certifying State. FDA may be contacted by fax at 1-410-290-6351 or by phone at 1-800-838-7715. Contact the Certifying State if your MQSA certificate is issued by the State. Facilities Waiting for Receipt of their Full (3 year), Reinstatement, or 90 Day Extension MQSA Certificates Upon AB notification to FDA or the Certifying State that a facility has successfully completed the accreditation process, the Certifying Agency will mail the facility an original MQSA certificate. Because there may be a delay in receipt of the MQSA certificate, the AB may request the Certifying Agency to fax the facility a 45 day interim notice or photocopy of the MQSA certificate allowing continued mammography performance in cases where the facility’s MQSA certificate has or is about to expire. Upon receipt of the interim notice or MQSA certificate, the facility may perform or continue to perform mammography. A facility that has questions about its accreditation status should contact its AB.

1. CERTIFICATE DELAY: There may be a delay in issuing or delivering a certificate to a facility that has met the requirements for a provisional or provisional reinstatement certificate, or has completed accreditation or reaccreditation and the facility’s certificate has or is about to expire.

2. REACCREDITATION OR ACCREDITATION COMPLETION DELAY: There may be a delay in completing reaccreditation or accreditation beyond the expiration date of a facility’s certificate for various reasons such as delay in completion of clinical image review. For a facility to be eligible to receive an interim notice, all of the following criteria should be met:

1. the facility has an expired or expiring three year FDA Mammography Facility Certificate, or the facility has an expired or expiring provisional certificate and accreditation is imminent;

2. the reaccrediting facility has applied for reaccreditation in a timely manner, i.e., at least six months prior to the expiration date of its certificate. Facilities receive ample notice from their AB’s several months prior to expiration of their accreditation, that they should apply for reaccreditation. FDA considers six months prior to certificate expiration to be a minimum time frame that is adequate for reaccreditation;

3. the facility has adhered to the accreditation body process timeframes, i.e., submitted its clinical images and other information in time to complete normal review within the six-month accreditation/reaccreditation window; and

4. the delay should not otherwise be due to inappropriate facility activities.

QUESTION 2: What should a facility do if its MQSA certificate expires before it is accredited or reaccredited?

If a facility’s MQSA certificate expires before it has been accredited or reaccredited, it must immediately stop performing mammography or it may be subject to civil monies money penalties of up to $10,000 per examination. Before the MQSA certificate expires, a facility should contact its accreditation body to discuss its options for continuing to perform mammography.

QUESTION 3: Our group practice interprets mammograms sent to us by other facilities under a contractual arrangement. This is the only service that we provide in the mammography area. Does my group practice need an MQSA certificate to interpret mammograms?

No. Partial providers (groups such as yours that provide only part of the services required for mammography) are certified as part of a "system" for producing, processing, and interpreting mammograms. The provider of some component of the system that performs mammography must take the lead in obtaining an MQSA certificate.

FDA expects that, in most cases, the owner of an x-ray unit or units will apply for accreditation and receive an MQSA certificate. However, anyone interested in providing mammography services may apply for accreditation leading to an MQSA certificate. Under the facility accreditation process, partial providers, such as your group practice, are included in the required documentation provided to the accreditation body. The application for accreditation must show that all components of the system used to produce, process, and interpret mammograms meet MQSA requirements. These components do not have to be in the same location. If one or more of the facilities for which you (or wish to) interpret (or wish to interpret) mammograms is applying for accreditation and certification (or reaccreditation and recertification), your responsibility will need be to provide them with information documenting that the physicians in your group meet MQSA quality standards requirements for interpreting physicians.

When the MQSA certificate is issued or renewed, all such partial providers are covered as providing services through that facility. Each partial provider must meet the MQSA quality standards that apply to its part of the mammography process. Each partial provider must provide adequate documentation to the certificate holder that the quality standards are met. Any partial provider providing services for more than one MQSA certified facility will be covered separately under each facility’s MQSA certificate. Conversely, if one of the facilities for which you interpret mammograms is not certified, it would be unlawful for that facility to continue to produce mammograms and for your group to interpret mammograms produced by them.

Your group practice could apply for accreditation and receive the MQSA certificate, as part of a system. In that case, your practice would be responsible for assuring not only that your practice meets MQSA quality standards for interpreting physicians, but also that the providers that produce and process the mammograms for your interpretation meet the quality standards that apply to them. Your practice would also be responsible for passing the review of clinical images from each facility that produces images for your interpretation, and for meeting the other requirements for accreditation. Finally, as an MQSA certificate holder, you would be responsible for paying an annual FDA MQSA inspection fee.

In summary, it is the MQSA certificate holder who is ultimately will be held responsible for assuring that all MQSA requirements are met.

QUESTION 4:What should a facility do if it closes or decides that it will no longer provide mammography services?

Before a facility permanently stops performing mammography, it should do the following:

1.	Inform its accreditation body that it will no longer be performing mammography;
2.	Notify its State radiation control program;
3.	Arrange transfer of each patient’s medical record (original mammography films and reports) to the mammography facility where the patient will be receiving future care, the patient’s referring physician or health care provider, or the patient. This transfer will address the requirement that the facility maintain the patient’s permanent medical record for a period of not less than 5 years, or not less than 10 years if no additional mammograms are performed at the facility, or longer if mandated by State or local law. The facility should make reasonable attempts to inform its former patients of how they can obtain their mammography records. Facilities should check with State or local agencies to determine if their requirements are more stringent. Note: Radiology practices and other medical facilities that still see patients but have permanently stopped performing mammography, may choose to keep the patients’ medical records rather than transfer them to another facility (unless the patient requests such a transfer).

If option 3 is not viable, facilities could store the medical records in a hospital, if appropriate, or make arrangements to warehouse the records. The facility should assure that there is a mechanism to release the films to the appropriate entity when requested and that former patients are made aware of that mechanism. It should be noted that if no one else is willing to accept the records, the facility remains responsible for them. Under MQSA, facilities will not be held responsible for maintenance of examinations performed before October 1, 1994; however, State and local regulations may require otherwise.

Once the facility ceases operation, the MQSA certificate should no longer be displayed. The facility may file or destroy its MQSA certificate.

Due to the fact that some facilities have not followed the above recommendations, FDA has received inquiries from patients complaining that their mammography facility has closed, that they were not informed, and that they cannot find out where or how to gain access to their mammography records. For this reason, FDA requests that a facility that plans to stop performing mammography notify its Certifying Agency of how it intends to fulfill its obligations with respect to medical records. Such information may be sent to:

FDA/CDRH/OHIP/DMQRP

Attention: Closed Facility Notification of Records Retention
1350 Piccard Drive, HFZ-240
Rockville, MD 20850

Facilities certified by States may send the above information to:

State of Iowa
Bureau of Radiological Health
Iowa Department of Public Health
401 SW 7th Street, Suite D
Des Moines, IA 50309
515-281-3478

State of Illinois
Office of Radiation Safety
Department of Nuclear Safety
1035 Outer Park Drive
Springfield, IL 62704
217-785-9974

Question 5: If a facility that fails to become accredited and certified continues to perform mammography, what penalties is it subject to? Can the facility be reimbursed by Medicare and insurance companies for mammography services?

Any facility that performs mammography without MQSA certification may be subject to civil money penalties of up to $10,000 per violation.

MQSA provides for civil money penalties for:

1.	Failure to obtain an MQSA certificate as required;
2.	Each failure by a facility to substantially comply with, or each day on which a facility fails to substantially comply with, the standards established; and
3.	Each violation, or for each aiding and abetting in a violation of any provision of, or regulation promulgated under MQSA, by an owner, operator, or any employee of a facility required to have an MQSA certificate.

Facilities that are not MQSA certified cannot be reimbursed by the federal government for mammography services. CMS will not reimburse facilities for Medicare screening and diagnostic mammography examinations if they do not have an MQSA certificate, or if their MQSA certificate has expired, been suspended, or been revoked. The amount and frequency of reimbursement is governed by CMS regulations. FDA has provided an efficient system for CMS to confirm the certification status of all mammography facilities. CMS will share this information with insurance carriers, who are committed to reimburse only for lawfully performed mammography procedures.

Question 104: We are a private radiology practice that applied for and became accredited and certified as a mammography facility. We do not own a mammography x-ray unit or employ a radiological technologist qualified to perform mammography. We had applied for accreditation using the x-ray unit and technologist from a certified mobile facility that visits our practice periodically. Do we have to be inspected separately from the mobile facility and who is responsible for correcting any problems found?

If your facility and the mobile facility are both certified, you are both required to be inspected annually. Your facility and the mobile facility may, under certain circumstances, qualify under our Inspection Fee Consolidation policy, which could reduce your inspection fee cost. Regarding who is responsible for correction of problems, both facilities would be responsible for assuring that all aspects of mammography are in compliance prior to performing examinations on patients.

Appeal of Adverse Accreditation or Reaccreditation Decisions That Preclude Certification or Recertification

900.15(d)(3)(4)(5)(6): (d) A facility that cannot achieve satisfactory resolution of an adverse accreditation decision through the accreditation body’s appeal process is entitled to further appeal in accordance with procedures set forth in this section and in regulations published in 42 CFR part 498.

	(3)	In accordance with the procedure set forth in subpart B of 42 CFR part 498, a facility that has been denied accreditation following appeal to the accreditation body may request reconsideration of that adverse decision from DMQRP (Division of Mammography Quality and Radiation Programs).
		(i)	A facility must request reconsideration by DMQRP within 60 days of the accreditation body’s adverse appeals decision, at the following address: Division of Mammography Quality and Radiation Programs (HFZ-240), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850, Attn: Facility Accreditation Review Committee.
		(ii)	The request for reconsideration shall include three copies of the following records:
			(A)	The accreditation body’s original denial of accreditation.
			(B)	All information the facility submitted to the accreditation body as part of the appeals process;
			(C)	A copy of the accreditation body’s adverse appeals decision; and
			(D)	A statement of the basis for the facility’s disagreement with the accreditation body’s decision.
		(iii)	Will conduct its reconsideration in accordance with the procedures set forth in subpart B of 42 CFR part 498.
	(4)	Will conduct its reconsideration in accordance with the procedures set forth in subpart B of 42 CFR part 498.
	(5)	Either the facility or FDA may request review of the hearing officer’s decision. Such review will be conducted by the Department of Appeals Board in accordance with subpart E of 42 CFR part 498.
	(6)	A facility cannot perform mammography services while an adverse accreditation decision is being appealed.

Discussion
A facility that has been denied accreditation is entitled to an appeal to the facility’s accreditation body (AB). A facility should avail itself of the AB's appeal process before requesting reconsideration from the Food and Drug Administration (FDA). If the facility cannot achieve satisfactory resolution of an adverse accreditation decision through its AB's appeal process, the facility may request reconsideration of that adverse decision by FDA through the Division of Mammography Quality and Radiation Programs (DMQRP).

NOTE: A facility cannot perform mammography services while an adverse accreditation decision is being appealed. For example, a facility that has been denied accreditation will receive a letter from the Certifying Agency notifying it that it must cease performing mammography. Once the facility receives that letter, it cannot perform mammography even if it is appealing the accreditation body’s decision.

The appropriate procedure for requesting reconsideration of an adverse decision on accreditation to DMQRP is as follows:
APPEALS PROCEDURE
A facility should make its request for reconsideration to DMQRP, within 60 days of the AB's adverse appeals decision, at the following address: Division of Mammography Quality and Radiation Programs (HFZ-240)

Center for Devices and Radiological Health
Food and Drug Administration
1350 Piccard Dr.
Rockville, MD 20850
Attn: Accreditation Body

The request for reconsideration should include 3 copies of the following records:

1. The AB's original denial of accreditation, including clinical or phantom image score sheets when applicable;
2. All information the facility submitted to the AB as part of the appeals process, including all original films submitted to the AB (additional copies of the films are not required);
3. A copy of the AB's adverse appeals decision including clinical or phantom image score sheets when applicable;
4. A statement of the bases for the facility's disagreement with the AB's decision.

The DMQRP will make a decision concerning the request for reconsideration within 60 days of receipt of all of the material specified above. The Division will provide the facility with written notification of its decision, and of the facility’s options as a consequence of that decision.

A facility that is dissatisfied with DMQRP's decision following reconsideration is entitled to a formal hearing before the Departmental Appeals Board (DAB) of the Department of Health and Human Services. Copies of the applicable regulations (subpart D of 42 CFR part 498) for formal hearings will be supplied upon written request.

Application for a Provisional Certificate

900.11(b)(2)(i) and (ii): Provisional certificates.

Discussion
A facility that has applied for accreditation will be issued a provisional MQSA certificate by FDA or the Certifying State after the accreditation body has 1) reviewed the facility's initial application and 2) informed FDA or the Certifying State that it has accepted the facility’s application. The provisional MQSA certificate will allows the facility to perform mammography lawfully for up to six months so it can complete the accreditation process. The facility cannot perform mammography until it receives its MQSA certificate or a 45 day interim notice.

in order to obtain the clinical images needed to complete accreditation, as well as for the accreditation body to complete the necessary clinical image reviews.

Application for Extension of Provisional Certificate

900.11(b)(3)(i), (ii), (iii), and (iv): Extension of provisional certificate.

	(i)	To apply for a 90-day extension to a provisional certificate, a facility shall submit to its accreditation body, or other entity designated by FDA, a statement of what the facility is doing to obtain certification and evidence that there would be a significant adverse impact on access to mammography in the geographic area served if such facility did not obtain an extension.
	(ii)	The accreditation body shall forward the request, with its recommendation, to FDA within 2 business days after receipt.
	(iii)	FDA may issue a 90-day extension for a provisional certificate upon determination that the extension meets the criteria set forth in 42 U.S.C. 263b(c)(2).
	(iv)	There can be no renewal of a provisional certificate beyond the 90-day extension.

Discussion
A facility operating under a six-month provisional MQSA certificate (including a provisional reinstatement MQSA certificate) may be eligible for a single 90-day extension to its provisional MQSA certificate. (A facility operating under a three-year MQSA certificate is not eligible for a 90-day extension.)

If the accreditation process is not completed within the six-month provisional period, a facility may apply to FDA or the Certifying State, through its accreditation body, for a 90-day extension. To be eligible for a 90-day extension, a facility should have adhered to the accreditation body’s schedule in submitting the necessary images and information (i.e., to have completed accreditation in the six month provisional period) and provide evidence that there would be a significant adverse impact on access to mammography in the geographic area served if such facility did not obtain an extension.

To apply for a 90-day extension, a facility should contact its accreditation body. Note: The MQSA Facility Hotline no longer answers questions related to 90-day extensions. Consult with the accreditation body on this issue.

The accreditation body will review the request and forward it, with its recommendation for or against the extension, to the FDA or the Certifying State for a decision. FDA or the Certifying State will then review the request and inform the facility and the accreditation body of its decision.

A facility that does not receive a 90-day extension must cease performing mammography when its provisional MQSA certificate expires, or when notified by FDA or the Certifying State that they are no longer certified based on the accreditation body’s denial of accreditation has been denied, whichever is first. Additionally, the facility should contact its accreditation body about how to resume the accreditation process.

Application to an Accreditation Body

900.11(b)(1)(i)(ii): Application.

	(1)	Certificates
		(i)	In order to qualify for a certificate, a facility must apply to an FDA-approved accreditation body, or to another entity designated by FDA. The facility shall submit to such body or entity the information required in 42 U.S.C. 263b(d)(1).
		(ii)	Following the agency’s receipt of the accreditation body’s decision to accredit a facility, or an equivalent decision by another entity designated by FDA, the agency may issue a certificate to the facility, or renew an existing certificate, if the agency determines that the facility has satisfied the requirements for certification or recertification.

Discussion
Facilities should not apply directly to FDA or the Certifying State for certification. To be FDA MQSA certified, a facility must first apply to, and become accredited by, an FDA-approved accreditation body. Currently these are:

• American College of Radiology (ACR)
  Mammography Accreditation Program
  1-800-227-6440
• Arkansas Department of Health
  Division of Radiation Control and Emergency Management
  1-501-661-2301
• California Department of Health Services
  Radiological Health Branch
  1-916-323-2772 1-916-322-6268
• Iowa Department of Health
  Bureau of Radiological Health
  1-515-281-3478
• Texas Department of Health
  Bureau of Radiation Control
  1-512-281-3478 1-512-834-6688 extension 2246

Currently, to To be accredited by the States of Arkansas, California, Iowa, or Texas a facility must be located in that accreditation body’s respective State state. Under MQSA regulations, a facility located in a state State approved by FDA as an accreditation body may be accredited by the State state or by the ACR. However, state State law may require every facility facilities to have state State accreditation or State state certification. These State state requirements are independent of MQSA, and facilities must satisfy all such regulations in addition to MQSA requirements. You may want to contact your State about its requirements.

The accreditation body will notify FDA or the Certifying State after it has determined the initial accreditation application is acceptable or when a facility has successfully completed its application for accreditation, or has been accredited. The FDA or the Certifying State will then issue a six-month provisional, or a three-year MQSA certificate to the facility, as appropriate. The MQSA certificate must be displayed prominently where patients can easily see it, such as the patient reception area. A facility may not lawfully perform mammography unless it has received its MQSA certificate (or a 45-day Interim Notice to be displayed temporarily in lieu of an MQSA certificate.)

Accreditation and certification are normally valid for up to three years. Facilities must reaccredit prior to expiration of their MQSA certificates. Renewal MQSA certificates will be issued automatically upon completion of reaccreditation and notification of FDA or the Certifying State by the accreditation body. Facilities should allow at least six months for the reaccreditation process to be completed, since reaccreditation should be expected to take as long as initial accreditation. It is the responsibility of each facility to apply for and complete reaccreditation before its MQSA certificate expires. Failure to do so may result in the facility being uncertified and unable to lawfully perform mammography.

Question 1: Should mammography units that are used exclusively for special purposes other than screening or diagnostic mammography (localization, biopsy, specimen radiography, and/or research) be accredited under MQSA? Must a facility that limits its activities to these special purposes only be accredited and certified?
Not at this time. Although these procedures do involve radiography of the breast, special procedures are currently exempted from MQSA regulations.

Note that any X-ray units or personnel involved even occasionally in routine screening or diagnostic mammography must meet the MQSA quality standards. These units must be included in the accreditation process and will be covered under the MQSA certificate.

Question 5: Since loaner, demonstration, and prototype mammography units are temporary, must these units be accredited? What steps should a facility take to ensure that it remains in compliance if they use these units for mammography?
A loaner, demonstration, or prototype mammography unit may be used for a limited time period before a facility is required to apply to have the unit(s) included under its accreditation. However, a facility should always contact its accreditation body before using such units on patients to determine whether such use is in accord with current policy.

Loaner units (placed in a facility while the facility's unit is undergoing in-house or off-site repair) should not be used for more than 30 days. This period may be extended upon written verification from a repair service that there is a legitimate cause for repairs to exceed 30 days with the concurrence of the accreditation body.

Demonstration units under consideration for purchase by a facility and prototype units that are being tested prior to marketing can be used for up to 90 days. However, a facility should contact its accrediting body and follow its requirements for accreditation, prior to use of any demonstration unit on patients. MQSA inspectors will need to see this documentation during any inspection.

If a facility wishes to continue use of such a unit after the specified time period is up, it should apply to its accreditation body to have the unit included under the facility’s accreditation.

Note that the unit still must have passed a mammography equipment evaluation prior to patient use and each such unit will be tested by the MQSA inspector during the MQSA inspection, regardless of its accreditation or ownership status. The discussion above describes of the requirements to comply with MQSA; States may have more stringent requirements regarding the use of these systems.

Question 7: When a certified facility purchases a new mammography unit, what steps must the facility take will the unit need to be accredited before it the unit can be used for mammography?

Yes. All mammography units in an FDA certified facility must be accredited by an FDA approved accreditation body. In an already certified facility, a newly installed unit can be used only after a mammography equipment evaluation has been conducted and the requirements of the accreditation body are satisfied. The facility must immediately contact its accreditation body and follow its guidelines for newly installed mammography units before use on patients. After the new unit meets all the specified requirements, it may be used to make the clinical images for review by the accreditation body.

Question 8: What are the requirements for accreditation and certification of mobile units? Can mobile units be accredited as additional units of a fixed-sitestationary facility?
An x-ray unit may be deemed to be mobile if it is wheeled or located in a van or truck for the purpose of providing mammography service to various locations. Accreditation and certification requirements for mobile units are the same as the requirements for fixed-site stationary units. They must be accredited by an FDA-approved accreditation body.

Whether multiple mobile units or a mobile unit operated by a fixed-site stationary facility may be included under a single accreditation and MQSA certificate depends on the policy of the accreditation body. Currently, the ACR’s policy is to accredit each mobile unit as a unique separate facility, with a unique ACR MAP number. Consequently FDA or the Certifying State certifies ACR accredited mobile units as unique separate facilities with unique FDA MQSA identification numbers, and each is issued its own MQSA certificate.

Other accreditation bodies may accredit multiple units or mobile units belonging to a fixed-site stationary facility as additional units. In this case there would be one identification number for the entire facility and an additional MQSA certificate (with the same ID number)have to be requested for each mobile unit. Additional MQSA certificates may be requested by contacting the FDA MQSA Facility Hotline at 1-800-838-7715. Facilities with State issued MQSA certificates should check with their State agencies for their policies regarding additional MQSA certificates.

Question 9: A facility moves or relocates and the address on its MQSA certificate is no longer correct. Is the MQSA certificate still valid?
Your MQSA certificate is still valid. However, when When a facility moves or relocates, it must notify its accreditation body. The accreditation body will direct the facility regarding any additional information and/or testing that it may require. Once those requirements are satisfied, the The accreditation body will then inform FDA or the Certifying State of the facility’s new address. FDA or the Certifying State will then issue a new MQSA certificate to the facility reflecting the new address. The facility is reminded that any mammography unit or processor that is disassembled and reassembled at the same or different location must have a mammography equipment evaluation. Any failures of a regulatory requirement found during the mammography equipment evaluation must be corrected before that piece of equipment is used for patient examinations.

Until the new MQSA certificate is received, the facility must prominently display its original MQSA certificate. The expiration date of the new MQSA certificate will be the same as the original since the facility has not been reaccredited or recertified. After the new MQSA certificate arrives, the original MQSA certificate should not be displayed. The facility should file or destroy the original MQSA certificate after it receives the new MQSA certificate.

Question 10: The individual who signed the facility’s application for accreditation resigns or retires and a replacement is named. Should the facility notify its accreditation body, or the FDA or the Certifying State regarding the change of a designated facility contact?
The facility should notify its accreditation body immediately. All official notifications from both the accreditation body and the FDA or the Certifying State are addressed to the designated facility contact. If the addressed individual is no longer associated with the facility, mail may be rejected by the facility’s mail room and/or the post office.

Only the accreditation bodies have the authority to modify the facility mailing list. Therefore, a facility that fails to notify its accreditation body of this change may not receive either MQSA mailings, (such as MQSA certificates and Federal Register notices) or mailings from its accreditation body.

Question 11: Is xeroradiography banned under MQSA?
No. The accreditation bodies will accredit facilities with xeromammography units that meet the dose limit and other accreditation requirements. However, some states States have banned or intend to ban xeroradiography for mammography.

Definition of Certificate

900.2(h) Certificate means the certificate described in section 900.11(a).

Discussion
After October 1, 1994, all mammography facilities are required to have a n MQSA certificate issued by FDA or the Certifying State is required for lawful operation of all to legally perform mammography facilities. To obtain a n MQSA certificate from FDA or the Certifying State, facilities are required to be accredited by an approved accreditation body or other entity, as designated by FDA, and to meet the quality standards as published in 900.12.

By law, FDA MQSA certificates must be prominently displayed in all patient reception areas where they can be viewed by mammography patients examinees.

Question 1: Where does a facility with more than one patient/examinee reception area display its certificate?
FDA MQSA certification is facility based. Therefore, if a facility has more than one patient reception area, it may request an additional MQSA certificate for each reception area from FDA. All MQSA certificates issued to a facility will share that facility’s unique 6-digit identification number. Contact the FDA MQSA Facility Hotline at 1-800-838-7715 to request the additional MQSA certificates. Facilities with State issued MQSA certificates should check with their State agencies for their policies regarding additional MQSA certificates.

Question 2: Can a facility with a large Spanish-speaking population get a Spanish-language MQSA certificate?
FDA will issue an additionalMQSA certificate translated into Spanish for those facilities serving a Spanish-speaking population for each patient reception area. The Spanish-language MQSA certificate(s) and the English-language MQSA certificate(s) must both be prominently displayed where they can be viewed by mammography examinees patients. Contact the FDA MQSA Facility Hotline at 1-800-838-7715 to request a Spanish-language MQSA certificate. Facilities with State issued MQSA certificates should check with their State agencies for their policies regarding additional MQSA certificates.

Question 3: A facility has changed its name but has the same owner, personnel, and equipment. Is the MQSA certificate still valid even though the facility name is different?
Your MQSA certificate is still valid. However, Wwhen a facility changes just its name, it must notify its accreditation body even though it still has the same owner, personnel, and equipment. Once the facility has complied with the accreditation body’s requirements, the The accreditation body will then inform FDA or the Certifying State of the facility’s new name. FDA or the Certifying State will then issue a new MQSA certificate to the facility.
Until the new MQSA certificate is received, the facility must prominently display its original MQSA certificate. The expiration date of the new MQSA certificate will be the same as the original since the facility has not been reaccredited or recertified. After the new MQSA certificate arrives, the original MQSA certificate should not be displayed. The facility should file or destroy the original MQSA certificate after it receives the new MQSA certificate.

Question 4: A facility moves or relocates and the address on its certificate is no longer correct. Is the MQSA certificate still valid?
Your MQSA certificate is still valid. However, Wwhen a facility moves or relocates, it must notify its accreditation body. The facility is reminded that any mammography unit or processor that is disassembled and reassembled at the same or different location must have a mammography equipment evaluation. Any failures of a regulatory requirement found during the mammography equipment evaluation must be corrected before that piece of equipment is used for patient examinations. The accreditation body will direct the facility regarding any additional information and/or testing that it may require. Once those requirements are satisfied, the The accreditation body will then inform FDA or the Certifying State of the facility’s new address. FDA or the Certifying State will then issue a new MQSA certificate to the facility reflecting the new address.

Until the new MQSA certificate is received, the facility must prominently display its original MQSA certificate. The expiration date of the new MQSA certificate will be the same as the original since the facility has not been reaccredited or recertified. After the new MQSA certificate arrives, the original MQSA certificate should not be displayed. The facility should file or destroy the original MQSA certificate after it receives the new MQSA certificate.

Question 5: What should a facility do if it closes or decides that it will no longer provide mammography services?
The facility should contact its accreditation body and inform it that the facility is no longer practicing mammography. The MQSA certificate should no longer be displayed. The facility may file or destroy its MQSA certificate. Before a facility permanently stops performing mammography, it should do the following:

If option 3 is not viable, facilities could store the medical records in a hospital, if appropriate, or make arrangements to warehouse the records. The facility should assure that there is a mechanism to release the films to the appropriate entity when requested and that former patients are made aware of that mechanism. It should be noted that if no one else is willing to accept the records, the facility remains responsible for them. Under MQSA, facilities will not be held responsible for maintenance of examinations performed before October 1, 1994; however, State and local regulations may require otherwise.

Once the facility ceases operation, the MQSA certificate should no longer be displayed. The facility may file or destroy its MQSA certificate.

Due to the fact that some facilities have not followed the above recommendations, FDA has received inquiries from patients complaining that their mammography facility has closed, that they were not informed, and that they cannot find out where or how to gain access to their mammography records. For this reason, FDA requests that a facility that plans to stop performing mammography notify its Certifying Agency of how it intends to fulfill its obligations with respect to medical records. Such information may be sent to:

FDA/CDRH/OHIP/DMQRP

Attention: Closed Facility Notification of Records Retention
1350 Piccard Drive, HFZ-240
Rockville, MD 20850

Facilities certified by States may send the above information to:

State of Iowa
Bureau of Radiological Health
Iowa Department of Public Health
401 SW 7th Street, Suite D
Des Moines, IA 50309
515-281-3478

State of Illinois
Office of Radiation Safety
Department of Nuclear Safety
1035 Outer Park Drive
Springfield, IL 62704
217-785-9974

Question 6: Our facility has several patient waiting areas. Can I photocopy our facility MQSA certificate and place copies in each area?
While the Statute requires that the original MQSA certificate be prominently displayed, the photocopying of the MQSA certificate so that it may be displayed in additional areas is not prohibited. However, we recommend that facilities wishing to display their MQSA certificate in several different areas obtain additional MQSA certificates (at no charge) by contacting FDA at 1-800-838-7715 or writing to: FDA MQSA Program, P.O. Box 6057, Columbia, MD 21045-6057. Facilities with State-issued MQSA certificates should check with their Certifying State agencies for their policies regarding additional MQSA certificates. Facilities are reminded that, at a minimum, they must have the original MQSA certificate displayed even if they choose to display additional copies of the MQSA certificate. Mobile facilities must have at least one original MQSA certificate displayed whenever the mobile unit is performing mammography.

General Requirements for Accreditation and Certification

900.11(a) General. After October 1, 1994, a certificate issued by FDA is required for lawful operation of all mammography facilities subject to the provisions of this subpart. To obtain a certificate from FDA, facilities are required to meet the quality standards in section 900.12 and to be accredited by an approved accreditation body or other entity as designated by FDA.

Full Field Digital Mammography (FFDM) Certification

Discussion

Until accreditation bodies are prepared to accredit full field digital mammography (FFDM) units, FDA has implemented a process for extending the certification of an already certified screen-film facility to include FFDM units. Until otherwise notified by FDA, a facility with an FFDM unit will be exempt from the MQSA accreditation requirement but must request FDA to extend its screen-film certification to cover its FFDM unit. Requests for FFDM certification extension need to supply all the information listed in the document MQSA Facility Certification Requirements For Use Of Full Field Digital Mammography (FFDM) and should be forwarded to:

Question 9: What will happen when the accreditation bodies start to accredit FFDM units?
Once the accreditation bodies begin accrediting your specific model of FFDM unit, your facility will have to apply to and go through the AB’s accreditation process, similar to what you would have to do for screen film units. During this transition period, your facility can continue to use the FFDM unit. Because of the different technologies used by FFDM unit manufacturers, the accreditation bodies may have to develop different programs for the different types of units. As a result, it is likely that not all FFDM unit types will be accredited at the same time. For example, if an AB implements a program to accredit the GE Senographe 2000D but not other types of units, then facilities having this GE unit have to get them accredited. Facilities having other types of FFDM units will not have to get them accredited until an accreditation process is implemented for their unit. However, the facility will be able to continue to use their unit under FDA’s FFDM certification extension policy.

MQSA Facility Certification Requirements For Use Of Full Field Digital Mammography (FFDM)

1. Facility Status Information
a. Facility Name and FDA Facility ID Number
b. FDA Certificate Expiration Date
c. Current Accreditation Body for Screen-Film Unit(s)
d. Accreditation Expiration Date
e. Facility Contact Person for FFDM (if different from screen-film contact)
f. Contact Person’s Title
g. Contact Person’s Telephone, Fax, E-mail
h. Facility Address
i. Facility Owner

8. Report of Mammography Equipment Evaluation (must have been conducted in accordance with 900.12(e)(10) within the 6 months prior to request for use approval)

a. Statement that equipment performance, as required under the following sections of the MQSA final regulation 21 CFR 900.12(b), is met:

(1) Prohibited Equipment
(2) Specifically Designed for Mammography
(3) Motion of Tube-Image Receptor Assembly
(4)(iii) Removable Grid (if applicable to the FFDM system used)
(5) Beam Limitation and Light Fields
(6) Magnification
(7) Focal Spot Selection
(8) Compression
(9) Technique Factor Selection and Display (GE system may use AOP instead of AEC in this requirement)
(10) Automatic Exposure Control (GE system may use AOP instead of AEC in this requirement)
(14) Lighting (if hard copy display is used for image evaluation)
(15) Film Masking Devices (if hard copy display is used for image evaluation)

b. The results of quality control tests as required under the following sections of the MQSA final regulations 21CFR 900.12(e):

(4)(iii) Compression Device Performance
(5)(i) Automatic Exposure Control Performance (if applicable to the FFDM system used)
(5)(ii) Kilovoltage Peak Accuracy and Reproducibility
(5)(iii) Focal Spot Condition
(5)(iv) Beam Quality and Half-Value Layer
(5)(v) Breast Entrance Air Kerma and AEC Reproducibility (if applicable to the FFDM system used)
(5)(vi) Dosimetry
(5)(vii) X-Ray Field/Light field/Image receptor/Compression paddle alignment
(5)(ix) System Artifacts
(5)(x) Radiation Output
(5)(xi) Decompression (or alternative standards allowed for these requirements)
(6) Quality Control Tests - Other Modalities (Facilities must perform all FFDM manufacturer recommended quality control tests including the medical physicist’s tests for Soft Copy Display system)

c. The results of the phantom image quality tests, including a sample image
d. If any of the requirements in 8 a, b, or c are not met, submit documentation of successful corrective action
e. If any of the requirements in 8 a or b are not performed, explain why the requirement is not applicable
f. Date of the evaluation
g. Name and address of the physicist(s) who performed the evaluation

9. Manufacturer’s Quality Control Program

a. Name of the Quality Control Manual
b. Year published
c. Revision number, if not the original
d. Printing number, if not the original

PERSONNEL QUALIFICATIONS: INTERPRETING PHYSICIANS WHO ARE
QUALIFIED TO INTERPRET DIGITAL MAMMOGRAMS
List the current interpreting physicians who:
(1) meet all the requirements of CFR 900.12(a)(1) "Mammography Quality
Standards; Final Rule" that became effective on April 28, 1999 *; AND
(2) began interpreting digital mammograms prior to April 28, 1999.
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
List the current interpreting physicians who:
(1) meet all the requirements of 21 CFR 900.12(a)(1) "Mammography Quality
Standards; Final Rule" that became effective on April 28, 1999 *;
(2) began interpreting digital mammograms after April 28, 1999; AND
(3) have 8 hours of initial training in Full Field Digital Mammography*.
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
* Supporting documentation for these requirements will be checked during annual MQSA inspections.

PERSONNEL QUALIFICATIONS: RADIOLOGIC TECHNOLOGISTS WHO
ARE QUALIFIED TO PERFORM DIGITAL MAMMOGRAMS
List the current radiologic technologists who:
(1) meet all the requirements of 21 CFR 900.12(a)(2) "Mammography Quality
Standards; Final Rule" that became effective on April 28, 1999 *; AND
(2) began performing digital mammography examinations prior to April 28, 1999.
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________

List the current radiologic technologists who:
(1) meet all the requirements of 21 CFR 900.12(a)(2) "Mammography Quality
Standards; Final Rule" that became effective on April 28, 1999 *;
(2) began performing digital mammography examinations after April 28, 1999;
AND
(3) have 8 hours of initial training in Full Field Digital Mammography*.
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
*Supporting documentation for these requirements will be checked during annual MQSA inspections.

PERSONNEL QUALIFICATIONS: MEDICAL PHYSICISTS WHO ARE
QUALIFIED TO PERFORM FFDM SURVEYS
List the current medical physicists who:
(1) meet all the requirements of 21 CFR 900.12(a)(3) "Mammography Quality
Standards; Final Rule" that became effective on April 28, 1999 *; AND
(2) began performing equipment evaluations and/or surveys of digital
mammography units prior to April 28, 1999
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
List the current medical physicists who:
(1) meet all the requirements of 21 CFR 900.12(a)(3) "Mammography Quality
Standards; Final Rule" that became effective on April 28, 1999 *;
(2) began performing equipment evaluations and/or surveys of digital
mammography units after April 28, 1999; AND
(3) have 8 hours of initial training in Full Field Digital Mammography*.
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
_____________________________________________________________________
* Supporting documentation for these requirements will be checked during annual MQSA inspections.

To the best of my knowledge and my belief, the information provided in this document is true and correct. I understand that FDA may request additional information to substantiate the statements made in the document. I understand that knowingly providing false information in a matter within the jurisdiction of an agency of the United States could result in criminal liability, punishable by up to $10,000 fine and imprisonment of up to five years, or civil liability under MQSA, or both.
Signature (Lead Interpreting Physician) __________________________
Print Name__________________________________________________
Date_______________________________________________________

Revocation of Accreditation

900.13(a) FDA action following revocation of accreditation. If a facility’s accreditation is revoked by an accreditation body, the agency may conduct an investigation into the reasons for the revocation. Following such investigation, the agency may determine that the facility’s certificate shall no longer be in effect or the agency may take whatever other action or combination of actions will best protect the public health, including the establishment and implementation of a corrective plan of action that will permit the certificate to continue in effect while the facility seeks reaccreditation. A facility whose certificate is no longer in effect because it has lost its accreditation may not practice mammography.

Discussion
When a facility’s accreditation is revoked, its MQSA certificate should remain in effect unless the FDA or the Certifying State determines that the MQSA certificate shall no longer be in effect. If FDA or the Certifying State determines that the revocation of accreditation was justified, it may determine that the MQSA certificate is no longer in effect, that the facility should take corrective action, or that other action may be appropriate while the facility seeks reaccreditation.

Additional Mammography Review and Patient Notification

900.12(j)(1)(2): Additional mammography review and patient notification.

	(1)	If FDA believes that mammography quality at a facility has been compromised and may present a serious risk to human health, the facility shall provide clinical images and other relevant information, as specified by FDA, for review by the accreditation body or other entity designated by FDA. This additional mammography review will help the agency to determine whether the facility is in compliance with this section and, if not, whether there is a need to notify affected patients, their physicians, or the public that the reliability, clarity, and accuracy of interpretation of mammograms has been compromised.
	(2)	If FDA determines that the quality of mammography performed by a facility, whether or not certified under Sec. 900.11, was so inconsistent with the quality standards established in this section as to present a significant risk to individual or public health, FDA may require such facility to notify patients who received mammograms at such facility, and their referring physicians, of the deficiencies presenting such risk, the potential harm resulting, appropriate remedial measures, and such other relevant information as FDA may require.

Discussion
Question 1: Is an How are additional mammography reviews (AMR) used for the same purpose as different from the reviews that are performed for accreditation, reaccreditation, or random clinical image review?
No. AMRs is are performed in cases where FDA or the Certifying State has reason to believe that mammography quality has been compromised and may present a serious risk to human health. An example of such a circumstance would might be the detection of a Level 1 phantom image failure during an inspection. Accreditation bodies do not use the clinical image reviews (CIRs) performed during accreditation, re-accreditation, and random clinical image review to investigate possible problems at facilities. Accreditation bodies use these types of CIRs to evaluate the ongoing quality of mammography at all facilities.

Question 2: Who is responsible for performing can perform an AMR?
Either an An FDA approved accreditation body or an entity approved by FDA may be responsible for performing can perform an AMR.

Question 4: Will the facility be responsible for patient/physician notification that may result following the AMR?
Yes. If the AMR indicates that patient notification of patients and physicians is among the necessary corrective actions, the facility will be required to notify patients and physicians of the identified problems, consult with FDA or the Certifying State in developing the patient/physician notification, and ensure that the appropriate audience is reached. The facility may request the Certifying Agency to review its has the right to have a determination about that patient/physician notification is required reviewed within the agency.

AMR General Guidance

Background
The Food and Drug Administration (FDA) developed this Additional Mammography Review (AMR) guidance to inform facilities of possible FDA actions assist FDA officials in determining the appropriate agency response when MQSA inspections show a Level 1 finding for phantom image testing or interpreting physician qualifications. A Level 1 finding represents a deviation from MQSA standards that may seriously compromise the quality of mammography services offered by the facility. FDA has determined that these specific Level 1 findings are indicators that serious quality problems may be present at the facility and require further evaluation. An assessment of the quality of mammograms produced by the facility should indicate whether the equipment problems that resulted in the Level 1 phantom image finding have affected clinical image quality. A Level 1 finding for the phantom image test exists when the score is less than 3 fibers, less than 2 speck groups, and/or less than 2 masses. Regarding interpreting physician qualifications, an assessment of mammograms and mammography reports may indicate whether failure to meet specific personnel standards has affected the quality of mammographic findings.

In addition to these While this policy only identifies two specific inspection findings, other problems that could result in FDA requiring AMR for a facility., there may be other evidence or information that could convince FDA to require AMR. This For example, evidence or information may not be obtained from a routine MQSA inspection, but from another source, such as the facility’s accreditation body or patient or physician complaints that could convince FDA to require an AMR. This guidance provides specific criteria to assist the agency in determining the appropriate type and scope of assessment that would be necessary, how and by whom the action should be conducted, and whether there is a need to notify affected patients, their physicians, or the public that the reliability, clarity, and/or accuracy of interpretation of mammograms may have been compromised. In the case where serious quality problems are suspected at a facility of Level 1 inspection findings, FDA may require that the facility undertake an investigation of the impact of these findings on the clinical images produced by the facility or of the interpretations rendered by the interpreting physician. If FDA determines that the problems rise to the level of a serious risk to human health, FDA may require the facility to undertake patient/physician notification. This policy is effective April 28, 1999. when the authority to require a facility to undergo AMR is also effective. This authority is stated as follows (21 C.F.R. Part 900.12(j)):

Additional mammography review and patient notification.

	(1)	If FDA believes that mammography quality at a facility has been compromised and may present a serious risk to human health, the facility shall provide clinical images and other relevant information, as specified by FDA, for review by the accreditation body or other entity designated by FDA. This additional mammography review will help the agency to determine whether the facility is in compliance with this section and, if not, whether there is a need to notify affected patients, their physicians, or the public that the reliability, clarity, and accuracy of interpretation of mammograms has been compromised.
	(2)	If FDA determines that any activity related to the provision of mammography at a facility may present a serious risk to human health such that patient notification is necessary, the facility shall notify patients or their designees, their physicians, or the public of action that may be taken to minimize the effects of the risk. Such notification shall occur within a timeframe and in a manner specified by FDA.

There are two specific types of AMR identified in this policy. These are AMR Conducted by the Facility (AMRF) and AMR Conducted by the Accreditation Body (AMRAB). Under AMRF, FDA would work with the facility to identify a qualified interpreting physician(s) who would perform the AMR. The physician(s) would be subject to FDA approval. Under AMRAB, the facility’s accreditation body would be asked to conduct the AMR.

This policy does not prevent FDA from taking legal actions against facilities, in addition to AMR, where the use of an MQSA sanction may be necessary to compel a facility to comply with FDA regulatory requirements. As an example, FDA may issue a Directed Plan of Correction (DPC) to a facility to address serious problems at the facility. The DPC may require the facility to take specific corrective actions. , in addition to specific corrective actions that the facility must take, that FDA may require the facility to undergo AMR and notify patients and/or their referring physicians of facility problems, in the event the AMR indicates mammography quality problems are present that would justify such a notification.

Note: The interpreting physician(s) conducting the image review for AMRF or AMRAB should not have a relationship with the facility, conduct the review when it would otherwise be a conflict of interest for them to do so, or when they have a bias in favor of or against the facility. Before the facility's accreditation body (AB) conducts AMRAB, the AB may require reimbursement of their expenses for the AMRAB. In this case, the AB should notify the facility accordingly, including an estimate of the cost to conduct the AMRAB. The AB may also require payment prior to the start of the AMRAB.

Phantom Image - Level 1 Findings

Criteria - Phantom Imagephanimgcriteria
Procedure for AMR - Phantom Imagephanimgamrprocedure
Follow-up Actions by FDA with the Facilityphanimgfollowup

AMR Conducted by the Accreditation Body (AMRAB)
If a facility has a Level 1 phantom image finding or a Level 1 interpreting physician finding, and there is other evidence of serious problems relating to image quality or it refuses to conduct AMRF, then FDA may require the facility to undergo AMRAB an AMR. Because the AB already has procedures and personnel in place for performing AMRs, this generally will be the preferred method. However, if FDA considers it appropriate, it may propose an AMRF. The facility would then provide FDA with specific details as to how the AMR would be conducted, how the patient exams would be selected and the qualifications of the proposed interpreting physician (including the physician’s specialized training in evaluating clinical image quality). If FDA does not approve the facility’s proposal, the facility must undergo AMRAB.

 Evaluation of Inspection Findings Leading to an AMR and Patient/Physician Notification

• All phantom image test results at Level 1 will be confirmed through a second review by the MQSA auditor or an FDA MQSA inspector (or by the State, if the State has a thorough phantom image quality assurance (QA) program in place). For those cases where there are no second reviewers in the FDA district or regional office, the Division of Mammography Quality and Radiation Programs (DMQRP) will provide the second review.
• After confirmation that a physician was not board certified and did not have initial training in mammography and/or never had a valid license or the license to practice medicine was revoked, FDA will evaluate the findings to determine whether an AMR is appropriate.
• After confirmation of the Level 1 finding(s), a Warning Letter may be sent to the facility.
• The Warning Letter should advise the facility that they are required to undergo an AMR, that they will be responsible for the cost of the AMR, and that further details (including whether an AMRF or AMRAB will be required) will follow in a letter from FDA and/or the AB. The type (AMRAB or AMRF) and scope of the AMR will be determined by FDA (usually after consultation with the facility’s AB).
• If the results of the AMR indicate that the quality of mammographic images or interpretations at the facility represent a serious risk to human health, FDA may require the facility to undertake notification of patients and/or referring physicians.
• If the results of the AMR do not indicate a serious risk to human health, FDA will evaluate the results of the AMR to determine if additional follow-up or monitoring is necessary.

 Examples of types of other serious problems are listed below. Also, in the event that the facility cannot obtain the services of an interpreting physician to perform the review, or all of the available physicians have inappropriate conflicts (see note at end of Background section), FDA may require the facility to undergo AMRAB. FDA, in conjunction with the AB, would rely primarily on the following criteria, by themselves or in combination, to evaluate whether quality at the facility may be sufficiently impaired for FDA to require the facility to undergo AMRAB.

• Level 1 finding for phantom image was not due to artifacts and failing phantom image raw score was less than 6.
• Review of phantom images performed by the technologist for the weekly quality control (QC) testing for the time period back to the previous inspection demonstrates more than one Level 1 phantom image failure without corrective action.
• Other Level 1, Level 2, and/or numerous Level 3 findings related to equipment QC testing are detected during the inspection.
• Other indications of quality problems may be present at the facility (examples: prior or pending serious patient complaints to FDA or the State; Level 1 or Level 2 findings or numerous Level 3 findings related to equipment QC testing in the previous annual inspection).
Note: Serious complaint means a report of an adverse event that may significantly compromise clinical outcomes, or an adverse event for which a facility fails to take appropriate corrective action in a timely manner. Each complaint should be evaluated carefully to assure that information in the complaint is valid.
• FDA determines that the facility would not be able to or is unwilling to undergo AMR conducted by the facility.

Interpreting Physician - Level 1 Findings

Criteria - Interpreting Physicianipcriteria
Procedure for AMR - Interpreting Physicianipamrprocedure
Follow-up Actions by FDA with the Facilityipfollowup

Procedure for AMR - Interpreting Physician
Evaluation of Inspection Findings and Other Information

1. Level 1 finding only: If a physician was not board certified nor had initial training in mammography and/or never had a valid license to practice medicine, the district should confirm that the Level 1 finding is correct. FDA should evaluate the findings, along with any other information, including complaints about the physician, to determine whether AMRF or AMRAB is appropriate.
2. The district should download the inspection reports (including the detail report containing all of the inspection data) to evaluate all the findings of the inspection. The district should contact DMQRP with their evaluation and determine whether the findings meet the criteria for AMRF or AMRAB.
3. Level 1 finding with Level 2 findings and/or complaints: In the event that the facility has a Level 1 finding for a physician and there are other serious problems or complaints identified with this physician (examples could include Level 2 findings for initial and/or continuing qualifications or the AB or FDA has received serious complaints about the quality of the physician’s interpretation accuracy (i.e., missed cancers or incorrect interpretations)), FDA may confer with the AB as to whether the AB should undertake AMRAB.
4. If the facility does not agree to conduct AMRF or the conditions for AMRAB are met, FDA may confer with the AB about implementation of the AMRAB. The district may send a Warning Letter to the facility which would indicate that the facility’s AB has been asked to conduct AMRAB in response to the findings. Also, in the event that the facility cannot obtain the services of an interpreting physician to perform the review, or all of the available physicians have inappropriate conflicts (see note regarding expenses for AMRAB in the background section), FDA may require the facility undergo AMRAB.

   Note:  Complaints may come from a facility, patient, inspector, or other source. If the AB suspects an interpretation problem may be present, due to complaints or other information, the AB should provide FDA with all the pertinent information in their possession. In the absence of any inspection findings regarding the physician, the AB will conduct follow-up for any complaints received according to its existing complaint procedures.

Approved Alternative Standards

Daily Processor QC Tests

Conducting the daily processor QC tests when the sensitometer is not available

This alternative standard was approved on October 18, 1999 and was made retroactive to April 28, 1999. The alternative to sensitometric-densitometric testing of processor performance can be used for a period of up to two weeks when the facility’s sensitometer is unavailable. This alternative is based on evaluating a phantom image through measurements described in 21 CFR 900.12(e)(1) and (2).
The final regulation and its alternative standard are stated below:
21 CFR 900.12(e)(1) and (2) states that:

	(1)	Daily quality control tests. Film processors used to develop mammograms shall be adjusted and maintained to meet the technical development specifications for the mammography film in use. A processor performance test shall be performed on each day that clinical films are processed before any clinical films are processed that day. The test shall include an assessment of base plus fog density, mid-density, and density difference, using the mammography film used clinically at the facility.
		(i)	The base plus fog density shall be within + 0.03 of the established operating level.
		(ii)	The mid-density shall be within +/- 0.15 of the established operating level.
		(iii)	The density difference shall be within +/- 0.15 of the established operating level.
	(2)	Weekly quality control tests. Facilities with screen-film systems shall perform an image quality evaluation test, using an FDA-approved phantom, at least weekly.
		(i)	The optical density of the film at the center of an image of a standard FDA-accepted phantom shall be at least 1.20 when exposed under a typical clinical condition.
		(ii)	The optical density of the film at the center of the phantom image shall not change by more than +/- 0.20 from the established operating level.
		(iii)	The phantom image shall achieve at least the minimum score established by the accreditation body and accepted by FDA in accordance with Sec. 900.3(d) or Sec. 900.4(a)(8).
		(iv)	The density difference between the background of the phantom and an added test object, used to assess image contrast, shall be measured and shall not vary by more than +/- 0.05 from the established operating level.

When using the alternative test, processor performance is considered satisfactory if:

1. The optical density of the film at the center of an image of a standard FDA-accepted phantom is at least 1.20 when exposed under typical clinical conditions.
2. The optical density of the film at the center of the phantom image changes no more than +/- 0.20 from the established operating level.
3. The density difference between the background of the phantom and an added test object, used to assess image contrast, is measured and does not vary by more than +/-0.05 from the established operating level.
   In addition:
4. To evaluate base + fog, an additional measurement of density must be made either of a shielded portion of the phantom image film or of an unexposed film. In accordance with 21 CFR 900.12(e)(1)(i), the base plus fog density must be within + 0.03 of the established operating level.

This alternative test must be conducted "each day clinical films are processed, but before processing of clinical films.” All results must be recorded and charted. If processor performance fails to meet any part of the alternative test, the problem must be corrected before processing is resumed.

Continuous Display of Override Status

Continuous display of the override status for machines with decompression devices

This alternative standard was approved on June 22, 1999 and was made retroactive to April 28, 1999. It has no time limit.
The final regulation and its alternative standard are stated below:
21 CFR 900.12(e)(5)(xi) states that:

	(xi)	Decompression. If the system is equipped with a provision for automatic decompression after completion of an exposure or interruption of power to the system, the system shall be tested to confirm that it provides:
		(A)	An override capability to allow maintenance of compression;
		(B)	A continuous display of the override status; and
		(C)	A manual emergency compression release that can be activated in the event of power or automatic release failure.

The approved alternative standard to 21 CFR 900.12(e)(5)(xi)(B) allows facilities having machines equipped with automatic decompression devices that are never disabled to permanently place a label on the panel indicating that the unit must always be operated in the automatic decompression mode, in lieu of a continuous display of the automatic decompression override status required in 21 CFR 900.12(e)(5)(xi)(B). The wording of this label must be:

"Unit always to be used in auto release mode. If auto release is overridden this status will not be displayed."

Weekly Phantom Image Test

Conducting the weekly phantom image test at facilities with intermittent mammography operation

This alternative standard was approved on May 24, 1999 and was made retroactive to April 28, 1999. It applies to facilities that do not conduct mammography every week. Rather, they may conduct mammography during some, but not all, weeks in a given month.
The final regulation and its alternative standard are stated below:
21 CFR 900.12(e)(2) states that:

(2)

Weekly Quality Control Tests. Facilities with screen-film systems shall perform an image quality evaluation test, using a FDA-approved phantom, at least weekly.

The approved alternative standard is:

(2)

Weekly Quality Control Tests. Facilities with screen-film systems shall perform an image quality evaluation test, using an FDA-approved phantom, in each week that clinical mammography examinations are performed, prior to the performance of such examinations.

The alternative standard requires that if the number of weeks per month in which clinical mammography is performed increases or decreases, the frequency of the performance of the phantom image quality test must automatically undergo a corresponding increase or decrease. Because of this automatic adjustment to changing facility conditions, no time limit has been placed upon the period of approval.

Post Exposure Focal Spot Indication

Post exposure indication of the machine pre-selected focal spot and or target material

This alternative standard was approved on April 19, 1999, and became effective on April 28, 1999, for Senographe^TM DMR GE machines.
The final regulation and its alternative standard are stated below:
21 CFR 900.12(b)(7) states that:

	(7)	Focal spot selection.
		(i)	When more than one focal spot is provided, the system shall indicate, prior to exposure, which focal spot is selected.
		(ii)	When more than one target material is provided, the system shall indicate, prior to exposure, the preselected target material.
		(iii)	When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall display, after the exposure, the target material and/or focal spot actually used during the exposure.

The approved alternative is:

	(7)	Focal spot selection.
		(i)	When more than one focal spot and/or more than one target material is provided, the system shall indicate, prior to exposure, the pre-selected focal spot and target material, and shall indicate, after the exposure, the focal spot and target material actually used during the exposure; or
		(ii)	When the target material and/or focal spot is selected by a system algorithm that is based on the exposure or on a test exposure, the system shall indicate, after the exposure, the target material and/or focal spot actually used during the exposure.

Under the approved alternative, an indication of the pre-exposure focal spot and target material would no longer be required when the pre-exposure target material and focal spot are set by a system algorithm based on exposure and the user has no control over that selection. In operating modes where the user has control of the pre-selected focal spot and/or target material, indication of the pre-selected values would still be required. In all cases, indication of the focal spot and/or target material actually used during the exposure would be required.

Manufacturer’s software modification of the AEC

Manufacturer’s software modification of the AEC

This alternative standard was approved on September 24, 2001. It has no time limit.
The final regulation and its alternative standard are stated below:

21 CFR 900.12(e)(10) states:

(10) Mammography equipment evaluations. Additional evaluations of mammography units or image processors shall be conducted whenever a unit or processor is installed, a unit or processor is dissembled and reassembled at the same or a new location, or major components of a mammography unit or processor equipment are changed or repaired. These evaluations shall be used to determine whether the new or changed equipment meets the requirements of applicable standards in paragraphs (b) and (e) of this section. All problems shall be corrected before the new or changed equipment is put into service for examinations or film processing. The mammography equipment evaluation shall be performed by a medical physicist or by an individual under the direct supervision of a medical physicist.

Verification testing to demonstrate that the affected equipment meets the applicable standards must be carried out after these actions are completed. However, the verification testing may be performed under Medical Physicist Oversight. Medical Physicist Oversight means that the medical physicist is consulted as to whether an on-site visit is required or if other personnel can verify that the standards are met, with direction by telephone or printed material from the medical physicist as needed.

Conducting the Mammography Equipment Evaluation After a Software Upgrade Under Medical Physicist Oversight

Conducting the Mammography Equipment Evaluation After a Software Upgrade Under Medical Physicist Oversight