**This is an Archived Document - Not for Official Use**

**The Mammography Quality Standards Act Final Regulations Modifications
and Additions to Policy Guidance Help System #5;** **Guidance for
Industry and FDA**

**Document issued on July 8, 2002**

This document modifies and updates guidance appearing in the Policy
Guidance Help System.

![](media/image1.png){width="0.9631944444444445in"
height="1.0763888888888888in"}

**U.S. Department Of Health and Human Services**

**Food and Drug Administration**

**Center for Devices and Radiological Health**

**Division of Mammography Quality**

**and Radiation Programs**

**Office of Health and Industry Programs**

**Preface**

**Public Comment**

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]{.underline}. 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**

Additional copies are available from the Internet at:
[http://www.fda.gov/cdrh/](http://www.fda.gov/cdrh/%5Bspecific)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.

The Mammography Quality Standards Act Final Regulations: Modifications
and Additions to Policy Guidance Help System #5

***This document is intended to provide guidance. It represents the
Agency's current thinking on this topic. It does not create or confer
any rights for or on any person and does not operate to bind the Food
and Drug Administration (FDA) or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statute and regulations.***

TABLE OF CONTENTS

### 

Background [1](#background)

The Least Burdensome Approach [1](#the-least-burdensome-approach)

Introduction [2](#introduction)

Introduction to the PGHS [3](#introduction-to-the-pghs)

Accreditation and Certification Overview
[5](#accreditation-and-certification-overview)

Appeal of Adverse Accreditation or Reaccreditation Decisions That
Preclude Certification or Recertification
[15](#appeal-of-adverse-accreditation-or-reaccreditation-decisions-that-preclude-certification-or-recertification)

Application for a Provisional Certificate
[18](#application-for-a-provisional-certificate)

Application for Extension of Provisional Certificate
[20](#application-for-extension-of-provisional-certificate)

Application to an Accreditation Body
[21](#application-to-an-accreditation-body)

Definition of Certificate [25](#definition-of-certificate)

~~General Requirements for Accreditation and Certification~~
[29](#general-requirements-for-accreditation-and-certification)

[Full Field Digital Mammography (FFDM) Certification]{.mark}
[32](#full-field-digital-mammography-ffdm-certification)

[MQSA Facility Certification Requirements For Use Of Full Field Digital
Mammography (FFDM)]{.mark}
[35](#mqsa-facility-certification-requirements-for-use-of-full-field-digital-mammography-ffdm)

Revocation of Accreditation [42](#revocation-of-accreditation)

Additional Mammography Review and Patient Notification
[43](#additional-mammography-review-and-patient-notification)

AMR General Guidance [44](#amr-general-guidance)

Approved Alternative Standards [52](#approved-alternative-standards)

Daily Processor QC Tests [52](#daily-processor-qc-tests)

Continuous Display of Override Status
[54](#continuous-display-of-override-status)

Weekly Phantom Image Test [55](#weekly-phantom-image-test)

Post Exposure Focal Spot Indication
[56](#post-exposure-focal-spot-indication)

[Manufacturer's software modification of the AEC]{.mark}
[57](#manufacturers-software-modification-of-the-aec)

[Conducting the Mammography Equipment Evaluation After a Software
Upgrade Under Medical Physicist Oversight]{.mark}
[58](#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]{.mark}
[60](#correction-period-when-components-of-the-senographetm-2000d-full-field-digital-mammography-ffdm-system-fail-quality-control-tests)

Alternative Requirements [62](#alternative-requirements)

Alternative Requirements Overview
[62](#alternative-requirements-overview)

Breast Implants [63](#breast-implants)

Consumer Complaints [64](#consumer-complaints)

[States as Certifiers]{.mark} [67](#states-as-certifiers)

[Scope]{.mark} [67](#scope)

[Application for approval as a certification agency]{.mark}
[67](#application-for-approval-as-a-certification-agency)

[Standards for certification agencies]{.mark}
[68](#standards-for-certification-agencies)

[Evaluation]{.mark} [69](#evaluation)

[Withdrawal of approval]{.mark} [69](#withdrawal-of-approval)

[Hearings and appeals]{.mark} [70](#hearings-and-appeals)

#  {#section-1 .unnumbered}

# Background

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:

[www.fda.gov/cdrh/mammography/guidance-rev.html](http://www.FDA.gov/cdrh/mammography/guidance.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.

# The Least Burdensome Approach

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/>

# Introduction

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.

# Introduction to the PGHS

~~It is~~ [We]{.mark} recommend~~ed~~ that you download the Policy
Guidance Help
System!Inet(\`http://www.fda.gov/cdrh/mammography/guidance.exe\') 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!Inet(\`http://www.fda.gov/cdrh/mammography\') 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.]{.mark}

**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.]{.mark}

[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.]{.mark}

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[.]{.mark}

[]{.mark}

[T]{.mark}he 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[.]{.mark}

[]{.mark}

[T]{.mark}o 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[.]{.mark}

[]{.mark}

[M]{.mark}any 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[.]{.mark}

[]{.mark}

[T]{.mark}he 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[.]{.mark}

[]{.mark}

[I]{.mark}f 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!Inet(\`http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMQSA/mail/contactus.cfm\').

# Accreditation and Certification Overview

[]{.mark}

[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.]{.mark}

**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]{.mark} ~~Before~~ a
mammography facility can legally perform mammography, it must be
certified. [Before a facility can be certified, it must become
accredited.]{.mark} 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:]{.mark}

[]{.mark}

[American College of Radiology (ACR)]{.mark}

[Mammography Accreditation Program]{.mark}

[1-800-227-6440]{.mark}

[]{.mark}

[Arkansas Department of Health]{.mark}

[Division of Radiation Control and Emergency Management]{.mark}

[1-501-661-2301]{.mark}

[]{.mark}

[California Department of Health Services]{.mark}

[Radiological Health Branch]{.mark}

[1-916-322-6268]{.mark}

[]{.mark}

[Iowa Department of Health]{.mark}

[Bureau of Radiological Health]{.mark}

[1-515-281-3478]{.mark}

[]{.mark}

[Texas Department of Health]{.mark}

[Bureau of Radiation Control]{.mark}

[1-512-834-6688 extension 2246]{.mark}

[]{.mark}

[Note: Under MQSA regulations, a facility located in a State approved by
FDA as an AB may be accredited by the State or by the ACR. However,
State law may require facilities to have State accreditation or State
certification. State requirements are independent of MQSA. You may want
to contact your State about their requirements.]{.mark}

[]{.mark}

[The regulations require the AB to review a mammography facility\'s
equipment, personnel (interpreting physicians, radiologic technologists,
and medical physicists), and practices. The AB will accredit the
facility if its review establishes that the mammography facility meets
the quality standards established under MQSA.]{.mark}

[]{.mark}

[Certification is a process separate from accreditation. It is
administered by a Certifying Agency (FDA or an FDA-approved Certifying
State). [FDA will not certify facilities in approved Certifying States.
Certifying States only certify facilities within their State
borders.]{.underline} Currently the FDA-approved Certifying States
are:]{.mark}

[]{.mark}

[State of Illinois]{.mark}

[Office of Radiation Safety]{.mark}

[Department of Nuclear Safety]{.mark}

[1035 Outer Park Drive]{.mark}

[Springfield, IL 62704]{.mark}

[217-785-9974]{.mark}

[]{.mark}

[State of Iowa]{.mark}

[Bureau of Radiological Health]{.mark}

[Iowa Department of Public Health]{.mark}

[401 SW 7th Street, Suite D]{.mark}

[Des Moines, IA 50309]{.mark}

[515-281-3478]{.mark}

[]{.mark}

[Issuance of an MQSA certificate occurs after the AB notifies the
Certifying Agency of the facility's accreditation. Only MQSA certified
facilities can lawfully provide mammography services. The Centers for
Medicare and Medicaid Services (CMS) will only reimburse for mammography
performed at an MQSA certified facility.]{.mark}

[]{.mark}

#### [Facilities Waiting for Receipt of their Provisional (6 month) MQSA Certificate (New Facilities)]{.mark}

[]{.mark}

[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]{.underline}. 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.]{.mark}

[]{.mark}

[During the six month provisional period, the facility must collect
clinical images and other data needed for completion of the
accreditation process (within the AB required timeframes) and adhere to
all requirements of the AB. If the facility has not completed the
accreditation process prior to the expiration of the provisional MQSA
certificate, it must cease performing mammography or apply for and
receive reinstatement of the facility's MQSA certificate. Alternatively,
a facility that meets certain criteria may qualify for a one-time
**90-day extension** of the provisional MQSA certificate. Contact your
AB for further information regarding reinstatement or a 90-day extension
of the MQSA provisional certificate.]{.mark}

[]{.mark}

##### [Facilities Waiting for Receipt of their Full (3 year), Reinstatement, or 90 Day Extension MQSA Certificates]{.mark} 

> []{.mark}

[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.]{.mark}

~~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.~~

~~A new facility whose application has been accepted by an accreditation
body should receive its FDA certificate within 7 to 10 days after FDA
has been notified. Prior to that, the facility will receive an Interim
Notice within 2 to 3 business days. A facility that has not received its
Interim Notice after 3 business days should notify the Mammography
Quality Assurance Program by fax at 1-410-290-6351. The facility should
prominently display this interim notice until it receives its FDA
Mammography Facility Certificate.~~

~~Certification is valid for three years and can be renewed as long as
the facility remains properly accredited and successfully demonstrates
during its annual inspections that it continues to meet the MQSA quality
standards.~~

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

-   The FDA MQSA Website
    (http://www.fda.gov/cdrh/mammography!Inet(\`http://www.fda.gov/cdrh/mammography\'))
    has a link to "Listing of FDA Certified Mammography
    Facilities!Inet(\`http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMQSA/search.cfm\')"
    that lists facilities by selected ~~s~~[S]{.mark}tate or by
    specified three-digit zi[p c]{.mark}ode area. This information is
    updated weekly.

-   The National Cancer Institute (NCI) ~~has~~ [provides]{.mark}
    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]{.mark} ~~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.]{.mark} FDA [or a Certifying State]{.mark} may issue ~~an~~
[a 45 day]{.mark} ~~Interim Notice~~ [interim notice]{.mark} 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.]{.mark}

> []{.mark}
>
> [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.]{.mark}
>
> []{.mark}
>
> [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.]{.mark}

[]{.mark}

[]{.mark}

[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.]{.mark}

[]{.mark}

#### [Facilities Waiting for Receipt of their Provisional ( 6 month) MQSA Certificate (New Facilities)]{.mark}

[]{.mark}

> [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]{.underline}. 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.]{.mark}
>
> []{.mark}

##### [Facilities Waiting for Receipt of their Full (3 year), Reinstatement, or 90 Day Extension MQSA Certificates]{.mark} 

> []{.mark}
>
> [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.]{.mark}

~~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:~~

~~a) 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;~~

~~b) 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;~~

~~c) 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~~

~~d) the delay should not otherwise be due to inappropriate facility
activities.~~

## Question 2: What should a facility do if its [MQSA]{.mark} certificate expires before it is ~~accredited or~~ reaccredited?

If a facility's [MQSA]{.mark} certificate expires before it has been
~~accredited or~~ reaccredited, it must immediately stop performing
mammography or it may be subject to civil ~~monies~~ [money]{.mark}
penalties of up to \$10,000 ~~per examination~~. Before the
[MQSA]{.mark} 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[.]{.mark}

[]{.mark}

[F]{.mark}DA 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)]{.mark} mammograms is applying for
accreditation and certification (or reaccreditation and
recertification), you~~r~~ ~~responsibility~~ will [need]{.mark} ~~be~~
to provide them with information documenting that the physicians in your
group meet MQSA quality standards requirements for interpreting
physicians[.]{.mark}

[]{.mark}

[W]{.mark}hen 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.]{.mark} 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[.]{.mark}

[]{.mark}

[Y]{.mark}our 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[.]{.mark}

[]{.mark}

[I]{.mark}n summary, ~~it is~~ the MQSA certificate holder ~~who~~
[is]{.mark} ultimately ~~will be held~~ responsible for assuring that
[all]{.underline} MQSA requirements are met.

## [Question 4: [What should a facility do if it closes or decides that it will no longer provide mammography services?](../gen_accred-cert_require.htm#genrecq1)]{.mark}

[]{.mark}

[Before a facility permanently stops performing mammography, it should
do the following:]{.mark}

[]{.mark}

[1. Inform its accreditation body that it will no longer be performing
mammography;]{.mark}

[2. Notify its State radiation control program;]{.mark}

[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).]{.mark}

[]{.mark}

[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.]{.mark}

[]{.mark}

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

[]{.mark}

[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:]{.mark}

[]{.mark}

[FDA/CDRH/OHIP/DMQRP]{.mark}

[]{.mark}

[Attention: Closed Facility Notification of Records Retention]{.mark}

[1350 Piccard Drive, HFZ-240]{.mark}

[Rockville, MD 20850]{.mark}

[]{.mark}

[Facilities certified by States may send the above information
to:]{.mark}

[]{.mark}

[State of Iowa]{.mark}

[Bureau of Radiological Health]{.mark}

[Iowa Department of Public Health]{.mark}

[401 SW 7th Street, Suite D]{.mark}

[Des Moines, IA 50309]{.mark}

[515-281-3478]{.mark}

[]{.mark}

[State of Illinois]{.mark}

[Office of Radiation Safety]{.mark}

[Department of Nuclear Safety]{.mark}

[1035 Outer Park Drive]{.mark}

[Springfield, IL 62704]{.mark}

[217-785-9974]{.mark}

[]{.mark}

## [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?]{.mark}

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

[MQSA provides for civil money penalties for:]{.mark}

> [1) Failure to obtain an MQSA certificate as required;]{.mark}
>
> [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]{.mark}
>
> [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.]{.mark}

[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.]{.mark}

[]{.mark}

## [Question 6: Since accreditation and certification are so closely linked, how will FDA or the Certifying State synchronize its certification period with a facility's accreditation period?]{.mark}

[Certification is linked to the accreditation of the first mammography
unit in a facility. The accreditation body notifies FDA or the
Certifying State of a facility's first unit accreditation, which is for
three years. FDA or the Certifying State issues an initial MQSA
certificate that is effective on the date provided by the accreditation
body and expires three years from that date.]{.mark}

[]{.mark}

[Facilities that wish to continue to lawfully provide mammography
services must be reaccredited [before]{.underline} the initial MQSA
certificate expires. Certificates that are issued following the initial
MQSA certificate are effective for three years. The expiration date of
the subsequent MQSA certificates is three years from the expiration date
of the initial certification.]{.mark}

[]{.mark}

## [Question 7: By law, MQSA certificates must be prominently displayed in all facilities. Where should they be displayed?]{.mark} 

[An MQSA certificate should be displayed prominently where mammography
patients can easily see it, such as the patient reception area. 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 additional MQSA certificates. Facilities with
State issued MQSA certificates should check with their State agencies
for their policies regarding additional MQSA certificates.]{.mark}

[]{.mark}

## [Question 8: Are Spanish-language MQSA certificates available for facilities providing mammography services to a Spanish-speaking population?]{.mark}

[Yes. FDA will issue an additional MQSA certificate translated into
Spanish for those facilities serving a Spanish-speaking population. To
obtain this additional MQSA certificate, contact the FDA MQSA Facility
Hotline at 1-800-838-7715. The Spanish-language MQSA certificate and the
English-language MQSA certificate should both be prominently displayed
where they can be viewed by mammography patients. Facilities with State
issued MQSA certificates should check with their State agencies for
their policies regarding additional MQSA certificates.]{.mark}

[]{.mark}

## [Question 9: Our facility has several patient waiting areas. Can I photocopy our facility MQSA certificate and place copies in each area?]{.mark}

[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 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.]{.mark}

## Question [10]{.mark}~~4~~: 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 policyInspection_Fee_Consolidation, 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) A facility that is dissatisfied with DMQRP's decision following
> reconsideration is entitled to a formal hearing in accordance with
> procedures set forth in subpart D 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[).]{.mark}

[]{.mark}

[[N]{.mark}OTE: A facility cannot perform mammography services while an
adverse accreditation decision is being appealed]{.underline}. [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.]{.mark}

[]{.mark}

[T]{.mark}he 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~~

[U.S. Food and Drug Administration]{.mark}

[Center for Devices and Radiological Health]{.mark}

[Division of Mammography Quality and Radiation Programs]{.mark}

[Attention: Accreditation and Certification Branch]{.mark}

[Room 220, HFZ-240]{.mark}

[1350 Piccard Drive]{.mark}

[Rockville, MD 20850]{.mark}

[Phone: (301) 594-3332]{.mark}

[Fax: (301) 594-3306]{.mark}

[]{.mark}

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]{.underline}
    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[.]{.mark}

[]{.mark}

[T]{.mark}he 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.

\(i\) A new facility beginning operation after October 1, 1994, is
eligible to apply for a provisional certificate. The provisional
certificate will enable the facility to perform mammography and to
obtain the clinical images needed to complete the accreditation process.
To apply for and receive a provisional certificate, a facility must meet
the requirements of 42 U.S. C. 263b(c)(2) and submit the necessary
information to an approved accreditation body or other entity designated
by FDA.

\(ii\) Following the agency's receipt of the accreditation body's
decision that a facility has submitted the required information, FDA may
issue a provisional certificate to a facility upon determination that
the facility has satisfied the requirements of section 900.11(b)(2)(i).
A provisional certificate shall be effective for up to 6 months from the
date of issuance. A provisional certificate cannot be renewed, but a
facility may apply for a 90-day extension of the provisional
certificate.

**Discussion:**

A facility that has applied for accreditation will be issued a
provisional [MQSA]{.mark} certificate by FDA [or the Certifying
State]{.mark} after the accreditation body has 1) reviewed the
facility\'s initial application and 2) informed FDA [or the Certifying
State]{.mark} that it has accepted the facility's application. The
provisional [MQSA]{.mark} certificate ~~will~~ allow[s]{.mark} 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.]{.underline}]{.mark}

[]{.mark}

[During the six month provisional period, the facility must collect
clinical images and other data needed for completion of the
accreditation process (within the AB required timeframes) and adhere to
all requirements of the AB. If the facility has not completed the
accreditation process prior to the expiration of the provisional MQSA
certificate, it must cease performing mammography or apply for and
receive reinstatement of the facility's MQSA certificate. Alternatively,
a facility that meets certain criteria may qualify for a one-time
**90-day extension** of the provisional MQSA certificate. Contact your
AB for further information regarding reinstatement or a 90-day extension
of the MQSA certificate.]{.mark}

####### []{.mark}

#### [Facilities Waiting for Receipt of their Provisional (6 month) MQSA Certificate (New Facilities)]{.mark}

[]{.mark}

####### [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.]{.mark}

[]{.mark}

~~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.~~

~~Because this time period is limited and facilities cannot operate
lawfully beyond the six-month period of provisional certification, it is
essential that facilities promptly provide all required information,
including clinical images, to the accreditation body so that the reviews
required for accreditation can be completed. There are only limited
circumstances under which a facility may receive additional time to
complete the accreditation process.~~

# 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]{.mark}
certificate (including a provisional reinstatement [MQSA]{.mark}
certificate) may be eligible for a single 90-day extension to its
provisional [MQSA]{.mark} certificate. (A facility operating under a
three-year [MQSA]{.mark} certificate is not eligible for a 90-day
extension[.)]{.mark}

[]{.mark}

[I]{.mark}f the accreditation process is not completed within the
six-month provisional period, a facility may apply to FDA [or the
Certifying State]{.mark}, 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]{.underline}]{.mark} 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[.]{.mark}

[]{.mark}

[T]{.mark}he accreditation body will review the request and forward it,
with its recommendation for or against the extension, to the FDA [or the
Certifying State]{.mark} for a decision. FDA [or the Certifying
State]{.mark} will then review the request and inform the facility and
the accreditation body of its decision[.]{.mark}

[]{.mark}

[A]{.mark} facility that does not receive a 90-day extension must cease
performing mammography when its provisional [MQSA]{.mark} certificate
expires, or when notified by FDA [or the Certifying State]{.mark} that
[they are no longer certified based on the accreditation body's denial
of]{.mark} 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]{.mark} for certification. To be ~~FDA~~ [MQSA]{.mark} 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]{.mark}

-   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]{.mark}

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

[]{.mark}

[T]{.mark}he accreditation body will notify FDA [or the Certifying
State]{.mark} [after it has determined the initial accreditation
application is acceptable or]{.mark} when a facility has ~~successfully
completed its application for accreditation, or has~~ been accredited.
The FDA [or the Certifying State]{.mark} will then issue a six-month
provisional, or a three-year [MQSA]{.mark} certificate to the
facility[,]{.mark} as appropriate. The [MQSA]{.mark} 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]{.mark} certificate (or a 45-day
Interim Notice to be displayed temporarily in lieu of a[n]{.mark}
[MQSA]{.mark} certificate[.)]{.mark}

[]{.mark}

[A]{.mark}ccreditation and certification are ~~normally~~ valid for [up
to]{.mark} three years. Facilities must reaccredit prior to expiration
of their [MQSA]{.mark} certificates. Renewal [MQSA]{.mark} certificates
will be issued ~~automatically~~ upon completion of reaccreditation and
notification of FDA [or the Certifying State]{.mark} 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]{.mark} 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[.]{.mark}

[]{.mark}

[P]{.mark}ersonnel who are not involved with screening or diagnostic
mammography may also be excluded from the application for accreditation.
However, an accredited and certified facility that also has a
mammography unit dedicated to such special purpose usage must be
prepared to provide the MQSA inspector with proper attestation that such
equipment and personnel are used [only]{.underline} for these special
purposes, and are not used for screening or diagnostic mammography.

Note that any X-ray units or personnel involved [even
occasionally]{.underline} 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]{.mark}
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[,]{.mark} 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[.]{.mark}

[]{.mark}

[L]{.mark}oaner 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[.]{.mark}

[]{.mark}

[D]{.mark}emonstration 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[.]{.mark}

[]{.mark}

[I]{.mark}f 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.

[]{.mark}

[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.]{.mark}

## Question 7: When a certified facility purchases a new mammography unit, [what steps must the facility take]{.mark} ~~will the unit need to be accredited~~ before ~~it~~ [the unit]{.mark} 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]{.mark} specified requirements[,]{.mark} 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-site~~ [stationary]{.mark} 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]{.mark} units. They must be accredited by an FDA-approved
accreditation body[.]{.mark}

[]{.mark}

[W]{.mark}hether multiple mobile units or a mobile unit operated by a
~~fixed-site~~ [stationary]{.mark} facility may be included under a
single accreditation and [MQSA]{.mark} 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]{.mark} certifies
ACR accredited mobile units as ~~unique~~ [separate]{.mark} facilities
with unique FDA [MQSA]{.mark} identification numbers, and each is issued
its own [MQSA]{.mark} certificate[.]{.mark}

[]{.mark}

[O]{.mark}ther accreditation bodies may accredit multiple units or
mobile units belonging to a ~~fixed-site~~ [stationary]{.mark} facility
as additional units. In this case there would be one identification
number for the entire facility and a[n]{.mark} additional [MQSA]{.mark}
certificate [(with the same ID number)]{.mark} would have to be
requested for each mobile unit. Additional [MQSA]{.mark} 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]{.mark} [certificates.]{.mark}

## Question 9: A facility moves or relocates and the address on its [MQSA]{.mark} certificate is no longer correct. Is the [MQSA]{.mark} certificate still valid? 

[Your MQSA certificate is still valid. However, when]{.mark} ~~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]{.mark} accreditation body will
[then]{.mark} inform FDA [or the Certifying State]{.mark} of the
facility's new address. FDA [or the Certifying State]{.mark} will then
issue a new [MQSA]{.mark} 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.]{.mark}

[]{.mark}

[U]{.mark}ntil the new [MQSA]{.mark} certificate is received, the
facility must prominently display its original [MQSA]{.mark}
certificate. The expiration date of the new [MQSA]{.mark} certificate
will be the same as the original since the facility has not been
reaccredited or recertified. After the new [MQSA]{.mark} certificate
arrives, the original [MQSA]{.mark} certificate should not be displayed.
The facility should file or destroy the original [MQSA]{.mark}
certificate after it receives the new [MQSA]{.mark} 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[,]{.mark} ~~or~~ the FDA [or the Certifying State]{.mark} 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]{.mark} 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[.]{.mark}

[]{.mark}

[O]{.mark}nly 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~~,~~ [(]{.mark}such as [MQSA certificates]{.mark} [and]{.mark}
*Federal Register* notices[)]{.mark} 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]{.mark} 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]{.mark} a[n]{.mark} [MQSA]{.mark} certificate issued by FDA [or the
Certifying State]{.mark} ~~is required for lawful operation of all~~ [to
legally perform]{.mark} mammography ~~facilities~~. To obtain
a[n]{.mark} [MQSA]{.mark} certificate from FDA [or the Certifying
State]{.mark}, 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]{.mark} certificates must be prominently displayed
~~in all patient reception areas~~ where they can be viewed by
mammography [patients]{.mark} ~~examinees~~.

## Question 1: Where does a facility with more than one patient~~/examinee~~ reception area display its certificate?

~~FDA~~ [MQSA]{.mark} certification is facility based. Therefore, if a
facility has more than one patient reception area, it may request an
additional [MQSA]{.mark} certificate for each reception area from FDA.
All [MQSA]{.mark} 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]{.mark} certificates. [Facilities with State issued MQSA
certificates should check with their State agencies for their policies
regarding additional MQSA]{.mark} [certificates.]{.mark}

## Question 2: Can a facility with a ~~large~~ Spanish-speaking population get a Spanish-language [MQSA]{.mark} certificate?

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

## Question 3: A facility has changed its name but has the same owner, personnel, and equipment. Is the [MQSA]{.mark} certificate still valid even though the facility name is different? 

[Your MQSA certificate is still valid. However,]{.mark}
~~W~~[w]{.mark}hen 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]{.mark} accreditation body will
[then]{.mark} inform FDA [or the Certifying State]{.mark} of the
facility's new name. FDA [or the Certifying State]{.mark} will then
issue a new [MQSA]{.mark} certificate to the facility.

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

## Question 4: A facility moves or relocates and the address on its certificate is no longer correct. Is the [MQSA]{.mark} certificate still valid? 

[Your MQSA certificate is still valid. However,]{.mark}
~~W~~[w]{.mark}hen 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.]{.mark} 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]{.mark} accreditation body will [then]{.mark} inform FDA [or the
Certifying State]{.mark} of the facility's new address. FDA [or the
Certifying State]{.mark} will then issue a new [MQSA]{.mark} certificate
to the facility reflecting the new address.

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

[]{.mark}

[1. Inform its accreditation body that it will no longer be performing
mammography;]{.mark}

[2. Notify its State radiation control program;]{.mark}

[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).]{.mark}

[]{.mark}

[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.]{.mark}

[]{.mark}

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

[]{.mark}

[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:]{.mark}

[]{.mark}

[FDA/CDRH/OHIP/DMQRP]{.mark}

[]{.mark}

[Attention: Closed Facility Notification of Records Retention]{.mark}

[1350 Piccard Drive, HFZ-240]{.mark}

[Rockville, MD 20850]{.mark}

[]{.mark}

[Facilities certified by States may send the above information
to:]{.mark}

[]{.mark}

[State of Iowa]{.mark}

[Bureau of Radiological Health]{.mark}

[Iowa Department of Public Health]{.mark}

[401 SW 7th Street, Suite D]{.mark}

[Des Moines, IA 50309]{.mark}

[515-281-3478]{.mark}

[]{.mark}

[State of Illinois]{.mark}

[Office of Radiation Safety]{.mark}

[Department of Nuclear Safety]{.mark}

[1035 Outer Park Drive]{.mark}

[Springfield, IL 62704]{.mark}

[217-785-9974]{.mark}

## Question 6: Our facility has several patient waiting areas. Can I photocopy our facility [MQSA]{.mark} certificate and place copies in each area?

While the Statute requires that the original [MQSA]{.mark} certificate
be prominently displayed, the photocopying of the [MQSA]{.mark}
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]{.mark} 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]{.mark} State ~~agencies~~ for their
policies regarding additional [MQSA]{.mark} certificates. Facilities are
reminded that, at a minimum, they must have the original [MQSA]{.mark}
certificate displayed even if they choose to display additional copies
of the [MQSA]{.mark} certificate. Mobile facilities must have at least
one original [MQSA]{.mark} 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.~~

**~~Discussion:~~**

~~[Accreditation]{.underline} is a process administered by an
FDA-approved \"Accreditation Body,\" a private, nonprofit organization
or state agency approved to accredit mammography facilities. Currently,
the FDA-approved accreditation bodies are:~~

~~American College of Radiology (ACR)~~

~~State of Arkansas~~

~~State of California~~

~~State of Iowa~~

~~State of Texas~~

~~The state accreditation bodies may accredit only those facilities that
are located in their respective states.~~

~~The accreditation body is charged with reviewing a mammography
facility\'s equipment, personnel (interpreting physicians, radiologic
technologists, and medical physicists), and practices. The materials
reviewed include details of the qualifications of the personnel involved
in mammography, a report of the physicist\'s survey of each X-ray unit
used for mammography, the results of dosimetry evaluations of each unit,
phantom images from each unit, results from various quality control (QC)
tests on the mammography equipment (including the film processor), and
clinical images from representative patients.~~

~~If the review establishes that, in the judgment of the accreditation
body, the mammography facility personnel, equipment, and practices meet
the quality standards established under MQSA, then the accreditation
body will \"accredit\" the facility.~~

~~[Certification]{.underline} is a separate process that is administered
by FDA. FDA issues an MQSA certificate upon notification by an approved
accreditation body that a mammography facility has been accredited by
that body.~~

~~Certification is valid for three years and can be renewed as long as
the facility remains properly accredited and successfully demonstrates
during its annual inspections that it continues to meet the MQSA quality
standards.~~

~~Only FDA certified facilities can lawfully provide mammography
services. The Health Care Financing Administration (HCFA) will reimburse
only for the mammography performed at an FDA certified facility.~~

## ~~Question 1: 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.~~

## ~~Question 2: 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 FDA certification may
be subject to civil money penalties of up to \$10,000 per examination.~~

~~MQSA provides for civil money penalties not to exceed \$10,000 for:~~

> ~~1) Failure to obtain a 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 a
> certificate.~~

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

## ~~Question 3: Since accreditation and certification are so closely linked, how will FDA synchronize its certification period with a facility's accreditation period?~~

~~Certification is linked to the accreditation of the first mammography
unit in a facility. The accreditation body notifies FDA of a facility's
first unit accreditation, which is for three years. FDA issues an
initial certificate that is effective on the date of notification by the
accreditation body and which expires three years from that date.~~

~~Facilities that wish to continue to lawfully provide mammography
services must be reaccredited [before]{.underline} the initial
certificate expires.~~

~~Certificates that are issued following the initial certificate are
effective for three years. The expiration date of the subsequent
certificates is three years from the expiration date of the initial
certification.~~

## ~~Question 4: By law, FDA certificates must be prominently displayed in all facilities. Where should they be displayed?~~ 

~~An FDA certificate should be displayed prominently where mammography
patients can easily see it, such as the patient reception area. If a
facility has more than one patient reception area, it may request an
additional certificate for each reception area from FDA. All
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 certificates.~~

## ~~Question 5: Are Spanish-language certificates available for facilities providing mammography services to a large Spanish-speaking population?~~

~~Yes. FDA will issue an additional certificate translated into Spanish
for those facilities serving a Spanish-speaking population. To obtain
this additional certificate, contact the FDA MQSA Facility Hotline at
1-800-838-7715. The Spanish-language certificate and the
English-language certificate should both be prominently displayed where
they can be viewed by mammography patients. []{.mark}~~

## ~~Question 6: Our facility has several patient waiting areas. Can I photocopy our facility certificate and place copies in each area?~~

~~While the Statute requires that the original certificate be
prominently displayed, the photocopying of the 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 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 State agencies for their policies
regarding additional certificates. Facilities are reminded that, at a
minimum, they must have the original certificate displayed even if they
choose to display additional copies of the certificate. Mobile
facilities must have at least one original certificate displayed
whenever the mobile unit is performing mammography.~~

# [Full Field Digital Mammography (FFDM) Certification]{.mark}

**[DiscussionDiscussion]{.mark}**

[]{.mark}

[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]{.underline} 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]{.underline} 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:]{.mark}

[]{.mark}

[Dr. Kish Chakrabarti\
Division of Mammography Quality and Radiation Programs\
FDA/CDRH/OHIP\
1350 Piccard Drive, HFZ-240, Room 230B\
Rockville, MD 20850\
Phone : 301-594-3332 or 3313\
Fax : 301-594-3306]{.mark}

[]{.mark}

[After a decision has been reached, you will receive either a Letter of
Acceptance or a Letter of Denial for your FFDM unit(s). If you receive a
Letter of Acceptance, your FFDM unit will be added to your certificate
and you may begin to use it for clinical examinations. Your facility
must maintain its accreditation status for at least one screen-film unit
in order to maintain its certification status when utilizing an FFDM
unit. Your facility is also subject to an annual onsite MQSA inspection
of its FFDM unit at the same time its screen-film unit(s) is/are being
inspected.]{.mark}

[]{.mark}

[If you receive a Letter of Denial, we will work with you to resolve the
problems preventing your acceptance.]{.mark}

## [Question 1: Does a facility have to have its FFDM unit accredited?]{.mark}

[]{.mark}

[Until notified by the FDA, facilities with FFDM units are exempt from
MQSA accreditation requirements. However, you must obtain FDA's
extension of your MQSA screen film certification to cover the FFDM unit
before you can use it clinically.]{.mark}

## [Question 2: What information will we need to provide in our request for FFDM certification extension?]{.mark}

[]{.mark}

[You need to provide a list of all personnel who began working in (i.e.,
interpreting, performing, and surveying) the FFDM mammographic modality
prior to April 28, 1999 (if any) as well as a list of personnel who
began or will begin working in the FFDM mammographic modality after
April 28, 1999. In addition, you need to provide a satisfactory FFDM
mammography equipment evaluation (including an evaluation of the Soft
Copy Display system, if applicable) performed by a qualified medical
physicist within 6 months prior to the date of your application.]{.mark}

[]{.mark}

[You will also need to follow the manufacturer\'s guidelines for quality
assurance and quality control tests as described by the manufacturer\'s
manual. No later than 9 months after you begin clinical examinations
using the FFDM unit, you must submit to the FDA the results of the tests
performed during the first 6 months after beginning clinical FFDM
examinations.]{.mark}

## [Question 3: How does a facility apply for FFDM certification extension?]{.mark} 

[]{.mark}

[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:]{.mark}

[]{.mark}

[Dr. Kish Chakrabarti\
Division of Mammography Quality and Radiation Programs\
FDA/CDRH/OHIP\
1350 Piccard Drive, HFZ-240, Room 230B\
Rockville, MD 20850\
Phone : 301-594-3332 or 3313\
Fax : 301-594-3306]{.mark}

## [Question 4: What is FDA's FFDM review process?]{.mark}

[]{.mark}

[Upon receipt of the completed FFDM package, FDA will review the
documentation. If the application is complete and satisfactory, FDA
grants an approval to the facility and sends a Letter of Acceptance. For
an incomplete or unsatisfactory application, FDA will send a Letter of
Denial or request additional information from the facility. FDA will
then work with the facility and/or the medical physicist to resolve
discrepancies and complete the application process.]{.mark}

## [Question 5: Does the FFDM unit have to be in the same location as the screen film unit?]{.mark}

[]{.mark}

[The FFDM unit must be located within the same inspection jurisdiction
as the certified screen film facility. In most cases, this means that
the FFDM unit must be located in the same State as the certified screen
film facility.]{.mark}

## [Question 6: Our FFDM unit is not at the same location as our screen film facility. Is our lead interpreting physician still responsible for the quality assurance program of the off-site FFDM unit?]{.mark}

[]{.mark}

[Yes. The lead interpreting physician must oversee the quality assurance
programs for both the screen film and off-site FFDM units.]{.mark}

[]{.mark}

## [Question 7: Which FFDM units have been approved by FDA?]{.mark} 

[]{.mark}

[FDA's Office of Device Evaluation has approved the following FFDM units
for commercial use:]{.mark}

[GE Senographe 2000D (approval date: 1/28/00)]{.mark}

[Fischer Imaging SensoScan (approval date: 9/25/01)]{.mark}

[Lorad Digital Breast Imager (approval date: 3/15/02)]{.mark}

## [Question 8: FDA has extended our certification to include our FFDM unit. Are there any special requirements we need to be aware of?]{.mark}

[]{.mark}

[Once you receive FDA's Letter of Acceptance, you may lawfully begin
using the FFDM unit for clinical examinations. However, you must meet
the following conditions while using the FFDM unit:]{.mark}

[]{.mark}

1.  [Maintain accreditation status for at least one screen-film unit to
    which the FFDM unit is linked. During the annual onsite MQSA
    inspection, both the screen film facility and the FFDM unit will be
    evaluated.]{.mark}

2.  [Upon completion of the first semi-annual quality control tests,
    provide FDA with the results of the weekly, monthly, quarterly, and
    semi-annual quality control tests outlined in the manufacturer's
    quality control manual. The report must include the results of the
    required QC tests for the Soft Copy Display system.]{.mark}

3.  [Send quality control test results to FDA no later than nine months
    after starting clinical examinations using the FFDM unit.]{.mark}

4.  [Have the FFDM unit surveyed annually by an MQSA qualified medical
    physicist.]{.mark}

[]{.mark}

## [Question 9: What will happen when the accreditation bodies start to accredit FFDM units?]{.mark}

[]{.mark}

[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.]{.mark}

[]{.mark}

# [MQSA Facility Certification Requirements For Use Of Full Field Digital Mammography (FFDM)]{.mark}

[]{.mark}

[[1. Facility Status Information]{.underline}]{.mark}

[a. Facility Name and FDA Facility ID Number]{.mark}

[b. FDA Certificate Expiration Date]{.mark}

[c. Current Accreditation Body for Screen-Film Unit(s)]{.mark}

[d. Accreditation Expiration Date]{.mark}

[e. Facility Contact Person for FFDM (if different from screen-film
contact)]{.mark}

[f. Contact Person's Title]{.mark}

[g. Contact Person's Telephone, Fax, E-mail]{.mark}

[h. Facility Address]{.mark}

[i. Facility Owner]{.mark}

[]{.mark}

[[2. FFDM Unit Identification]{.underline}]{.mark}

[a. Machine Manufacturer]{.mark}

[b. Machine Model]{.mark}

[c. Year of Manufacture]{.mark}

[d. Serial Number]{.mark}

[]{.mark}

[[3. Digital Image Receptor Identification (if
interchangeable)]{.underline}]{.mark}

[a. Receptor Manufacturer]{.mark}

[b. Receptor Model]{.mark}

[c. Year of Manufacture]{.mark}

[d. Serial Number (if applicable)]{.mark}

[]{.mark}

[[4. Identification of Printer for Hard Copy Output]{.underline}]{.mark}

[a. Printer Manufacturer]{.mark}

[b. Printer Model]{.mark}

[c. Year of Manufacture]{.mark}

[d. Serial Number]{.mark}

[]{.mark}

[[5. Monitor Identification (if soft copy display is
available)]{.underline}]{.mark}

[a. Monitor Manufacturer]{.mark}

[b. Monitor Model]{.mark}

[c. Year of Manufacture]{.mark}

[d. Serial Number]{.mark}

[]{.mark}

[[6. Phantom Identification]{.underline}]{.mark}

[a. Phantom Manufacturer]{.mark}

[b. Phantom Model]{.mark}

[]{.mark}

[[7. Personnel Qualifications]{.underline}]{.mark}

[a. Interpreting Physicians who are qualified to interpret hard and soft
copy digital mammograms (See page 4)]{.mark}

[b. Radiological Technologists who are qualified to perform digital
mammography examinations and the manufacturer recommended quality
assurance tests]{.mark}

[(See page 5)]{.mark}

[c. Medical Physicists who are qualified to perform equipment
evaluations and/or surveys of digital mammography units including tests
of the Soft Copy Display system (See page 6)]{.mark}

[]{.mark}

[[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)]{.underline}]{.mark}

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

[(1) Prohibited Equipment]{.mark}

[(2) Specifically Designed for Mammography]{.mark}

[(3) Motion of Tube-Image Receptor Assembly]{.mark}

[(4)(iii) Removable Grid (if applicable to the FFDM system used)]{.mark}

[(5) Beam Limitation and Light Fields]{.mark}

[(6) Magnification]{.mark}

[(7) Focal Spot Selection]{.mark}

[(8) Compression]{.mark}

[(9) Technique Factor Selection and Display (GE system may use AOP
instead of AEC in this requirement)]{.mark}

[(10) Automatic Exposure Control (GE system may use AOP instead
of]{.mark}

[AEC in this requirement)]{.mark}

[(14) Lighting (if hard copy display is used for image
evaluation)]{.mark}

[(15) Film Masking Devices (if hard copy display is used for image
evaluation)]{.mark}

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

[(4)(iii) Compression Device Performance]{.mark}

[(5)(i) Automatic Exposure Control Performance (if applicable to the
FFDM system used)]{.mark}

[(5)(ii) Kilovoltage Peak Accuracy and Reproducibility]{.mark}

[(5)(iii) Focal Spot Condition]{.mark}

[(5)(iv) Beam Quality and Half-Value Layer]{.mark}

[(5)(v) Breast Entrance Air Kerma and AEC Reproducibility (if applicable
to the FFDM system used)]{.mark}

[(5)(vi) Dosimetry]{.mark}

[(5)(vii) X-Ray Field/Light field/Image receptor/Compression paddle
alignment]{.mark}

[(5)(ix) System Artifacts]{.mark}

[(5)(x) Radiation Output]{.mark}

[(5)(xi) Decompression (or alternative standards allowed for these
requirements)]{.mark}

[(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)]{.mark}

[c. The results of the phantom image quality tests, including a sample
image]{.mark}

[d. If any of the requirements in 8 a, b, or c are not met, submit
documentation of successful corrective action]{.mark}

[e. If any of the requirements in 8 a or b are not performed, explain
why the requirement is not applicable]{.mark}

[f. Date of the evaluation]{.mark}

[g. Name and address of the physicist(s) who performed the
evaluation]{.mark}

[]{.mark}

[[9. Manufacturer's Quality Control Program]{.underline}]{.mark}

[a. Name of the Quality Control Manual]{.mark}

[b. Year published]{.mark}

[c. Revision number, if not the original]{.mark}

[d. Printing number, if not the original]{.mark}

[]{.mark}

[[10. Signature]{.underline}]{.mark}

[PERSONNEL QUALIFICATIONS: INTERPRETING PHYSICIANS WHO ARE]{.mark}

[QUALIFIED TO INTERPRET DIGITAL MAMMOGRAMS]{.mark}

[List the current interpreting physicians who:]{.mark}

[(1) meet all the requirements of CFR 900.12(a)(1) \"Mammography
Quality]{.mark}

[Standards; Final Rule\" that became effective on April 28, 1999 \*;
[AND]{.underline}]{.mark}

[(2) began interpreting digital mammograms [prior]{.underline} to April
28, 1999.]{.mark}

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

[List the current interpreting physicians who:]{.mark}

[(1) meet all the requirements of 21 CFR 900.12(a)(1) \"Mammography
Quality]{.mark}

[Standards; Final Rule\" that became effective on April 28, 1999
\*;]{.mark}

[(2) began interpreting digital mammograms [after]{.underline} April 28,
1999; [AND]{.underline}]{.mark}

[(3) have 8 hours of initial training in Full Field Digital
Mammography\*.]{.mark}

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

[\* Supporting documentation for these requirements will be checked
during annual MQSA inspections.]{.mark}

[PERSONNEL QUALIFICATIONS: RADIOLOGIC TECHNOLOGISTS WHO]{.mark}

[ARE QUALIFIED TO PERFORM DIGITAL MAMMOGRAMS]{.mark}

[List the current radiologic technologists who:]{.mark}

[(1) meet all the requirements of 21 CFR 900.12(a)(2) \"Mammography
Quality]{.mark}

[Standards; Final Rule\" that became effective on April 28, 1999 \*;
[AND]{.underline}]{.mark}

[(2) began performing digital mammography examinations
[prior]{.underline} to April 28,]{.mark}

[1999.]{.mark}

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

[List the current radiologic technologists who:]{.mark}

[(1) meet all the requirements of 21 CFR 900.12(a)(2) \"Mammography
Quality]{.mark}

[Standards; Final Rule\" that became effective on April 28, 1999
\*;]{.mark}

[(2) began performing digital mammography examinations
[after]{.underline} April 28, 1999;]{.mark}

####### [AND]{.mark}

[(3) have 8 hours of initial training in Full Field Digital
Mammography\*.]{.mark}

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

[\*Supporting documentation for these requirements will be checked
during annual MQSA inspections.]{.mark}

[PERSONNEL QUALIFICATIONS: MEDICAL PHYSICISTS WHO ARE]{.mark}

[QUALIFIED TO PERFORM FFDM SURVEYS]{.mark}

[List the current medical physicists who:]{.mark}

[(1) meet all the requirements of 21 CFR 900.12(a)(3) \"Mammography
Quality]{.mark}

[Standards; Final Rule\" that became effective on April 28, 1999 \*;
[AND]{.underline}]{.mark}

[(2) began performing equipment evaluations and/or surveys of
digital]{.mark}

[mammography units [prior]{.underline} to April 28, 1999]{.mark}

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

[List the current medical physicists who:]{.mark}

[(1) meet all the requirements of 21 CFR 900.12(a)(3) \"Mammography
Quality]{.mark}

[Standards; Final Rule\" that became effective on April 28, 1999
\*;]{.mark}

[(2) began performing equipment evaluations and/or surveys of
digital]{.mark}

[mammography units [after]{.underline} April 28, 1999;
[AND]{.underline}]{.mark}

[(3) have 8 hours of initial training in Full Field Digital
Mammography\*.]{.mark}

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

**[\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}**

[\* Supporting documentation for these requirements will be checked
during annual MQSA inspections.]{.mark}

[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.]{.mark}

[Signature (Lead Interpreting Physician)
\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}

[Print
Name\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}

[Date\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_]{.mark}

# 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]{.mark}
certificate should remain in effect unless the FDA [or the Certifying
State]{.mark} determines that the [MQSA]{.mark} certificate shall no
longer be in effect. If FDA [or the Certifying State]{.mark} determines
that the revocation of accreditation was justified, it may determine
that the [MQSA]{.mark} 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]{.mark} additional mammography review[s]{.mark} (AMR) ~~used for the same purpose as~~ [different from]{.mark} the reviews that are performed for accreditation, reaccreditation, or random clinical image review?

~~No.~~ AMR[s]{.mark} ~~is~~ [are]{.mark} performed in cases where FDA
[or the Certifying State]{.mark} 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]{.mark} 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.]{.mark}

## Question 2: Who ~~is responsible for performing~~ [can perform]{.mark} an AMR?

~~Either an~~ [An]{.mark} FDA approved accreditation body or an entity
approved by FDA ~~may~~ ~~be responsible for performing~~ [can
perform]{.mark} an AMR.

## Question 4: Will the facility be responsible for patient[/physician]{.mark} notification that may result following the AMR?

Yes. If [the AMR indicates that]{.mark} ~~patient~~ notification [of
patients and physicians]{.mark} is ~~among the~~ necessary ~~corrective
actions~~, the facility will be required to notify patients [and
physicians]{.mark} of the identified problems, consult with FDA [or the
Certifying State]{.mark} in developing the patient[/physician]{.mark}
notification, and ensure that the appropriate audience is reached. The
facility [may request the Certifying Agency]{.mark} to review its ~~has
the right to have a~~ determination ~~about~~ [that]{.mark}
patient[/physician]{.mark} notification [is required]{.mark} ~~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]{.mark} ~~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]{.mark}. 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[.]{.mark}

[]{.mark}

[In addition to these]{.mark} ~~While this policy only identifies~~ two
specific inspection [findings, other]{.mark} problems ~~that~~ could
result in FDA requiring AMR for a facility[.]{.mark}~~,~~ ~~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]{.mark}.

~~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]{.mark} ~~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.]{.mark}

~~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.]{.mark} ~~, in addition to specific corrective actions that the
facility must take, that~~ [FDA may require the facility to]{.mark}
~~undergo AMR and~~ notify patients and/or their referring physicians
[of facility problems]{.mark}, in the event [the AMR indicates]{.mark}
mammography quality problems are present that would justify such a
notification.

[Note]{.underline}: 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~~**

### ~~Criteria - Phantom Image~~

~~[AMR Conducted by the Facility (AMRF)]{.underline}~~

~~If a facility has a Level 1 phantom image finding, but there is no
other evidence of serious problems relating to image quality, then it
may be asked to conduct AMRF. In the event that a facility refuses to
conduct AMRF, FDA may refer the facility to their AB for AMRAB.~~

~~[AMR Conducted by the Accreditation Body (AMRAB)]{.underline}~~

If a facility has a Level 1 phantom image finding [or a Level 1
interpreting physician finding,]{.mark} ~~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]{.mark}. [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.]{.mark}

[Evaluation of Inspection Findings Leading to an AMR and
Patient/Physician Notification]{.mark}

-   [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.]{.mark}

```{=html}
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```
-   [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.]{.mark}

```{=html}
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```
-   [After confirmation of the Level 1 finding(s), a Warning Letter may
    be sent to the facility.]{.mark}

```{=html}
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```
-   [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).]{.mark}

```{=html}
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```
-   [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.]{.mark}

```{=html}
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```
-   [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.]{.mark}

~~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.~~

### ~~Procedure for AMR - Phantom Image~~

~~Evaluation of Inspection Findings and Other Information~~

1\. All phantom image test results at Level 1 must 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 district or regional office, the Division of Mammography Quality
and Radiation Programs (DMQRP) could provide a second review.

> ~~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. The district would also indicate what
> arrangements were being made to have a second evaluation of the Level
> 1 phantom images from the inspection, if not already done.~~
>
> ~~3. [Level 1 finding only]{.underline}: If a facility inspection has
> a Level 1 finding for phantom image, the district should confirm that
> the Level 1 finding is correct. FDA should evaluate the findings,
> along with any other information, including complaints about clinical
> mammograms, to determine whether AMRF or AMRAB is appropriate.~~
>
> ~~4. [Level 1 finding with other findings and/or
> complaints:]{.underline} In the event that the facility has a Level 1
> finding for phantom image and there are other serious problems or
> complaints identified with this facility (see examples above), FDA may
> confer with the AB as to whether the AB should undertake AMRAB.~~
>
> ~~5. [If the facility does not agree to conduct AMRF or the conditions
> for AMRAB are met]{.underline}, 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, FDA may require the facility undergo
> AMRAB.~~

### ~~Follow-up Actions by FDA with the Facility~~

> 1\. ~~[If the conditions are met for AMRF]{.underline} (i.e., there is
> no other evidence of serious problems relating to image quality),~~
> ~~the district should send a Warning Letter to the facility. The
> letter would require that the facility conduct AMRF in response to the
> findings. The letter would also indicate that the facility would be
> responsible for the cost of the AMR.~~
>
> 2\. ~~[If the facility agrees to conduct AMRF]{.underline}, the
> district would monitor the progress of the review until completion.
> The review of images under AMRF could be on-site at the facility or by
> mail.~~
>
> ~~3. [If the facility does not agree to conduct AMRF or the conditions
> for AMRAB are met]{.underline}, FDA may confer with the AB as to
> whether the AB should undertake AMRAB. The district may send a Warning
> Letter to the facility that would indicate that FDA had asked the
> facility's AB to conduct AMRAB in response to the inspection 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, FDA may require the facility
> to undergo AMRAB (see note regarding expenses for AMRAB in the
> background section).~~
>
> ~~4. a. For both AMRF and AMRAB, the review should cover a sample of
> mammographic examinations produced using the same equipment (x-ray
> system and processor) that was tested and found to fail phantom image
> evaluation during the inspection. The review should be retrospective
> and start with the last set of mammographic images produced prior to
> the inspection phantom image test and proceed backward to earlier
> examinations. The review should concentrate on examinations conducted
> as close as possible to the date and time of the inspection. The
> review should encompass the appropriate number of examinations needed
> to effectively evaluate the impact on mammographic quality of the
> image quality problems discovered through phantom image evaluation.
> The review should extend back to the most recent date when the
> facility's weekly QC phantom images did not show a Level 1 finding.~~
>
> ~~b. If none of the facility's weekly QC phantom images showed a Level
> 1 finding without corrective action, then the review period should be
> from the date of inspection back to the date of the last QC phantom
> image.~~
>
> ~~c. While the size of the sample will vary with the situation, the
> sample should probably be no smaller than ten percent of the
> examinations conducted in the time period selected for evaluation.~~
>
> ~~d. In the event that the facility has not performed weekly QC
> phantom images, the review period could extend from the date of
> inspection back to the date of the last medical physicist survey
> (provided the physicist score was not the equivalent of a Level 1
> finding).~~
>
> ~~e. In the event that the facility has not performed weekly QC
> phantom images and the medical physicist survey showed either the
> equivalent of a Level 1 finding for the phantom image, as scored by
> the medical physicist, or the phantom image test was not done by the
> medical physicist, then the period for review could extend from the
> date of inspection back to the date of the previous inspection.~~
>
> ~~[Note:]{.underline} The decision for the time period covered for the
> AMR should be based on public health considerations for the patients
> who were examined.~~
>
> ~~5. The AMR should consist of reviewing a sample of mammograms (or
> all of the mammograms, if appropriate) from the specified period and,
> depending on the results of the review, the review may be extended.~~
>
> ~~6. The review of images under AMRAB would be on-site at the facility
> or by mail, as determined by the facility's AB in consultation with
> FDA.~~
>
> ~~7. If the results of the AMRF or AMRAB indicate that the quality of
> mammographic images or interpretations at the facility represent a
> serious risk to human health, the entity performing the AMR should
> notify FDA (FDA would notify the AB in the case of AMRF). If
> appropriate, FDA may ask the facility to undertake notification of
> patients and/or referring physicians. If the facility does not agree
> or does not have the means to perform a patient notification (PN), FDA
> would consider other methods of initiating a PN.~~
>
> ~~8. The district and DMQRP should coordinate implementation and
> monitoring of the notification process.~~
>
> ~~9. If the results of the AMR do not indicate a serious risk to human
> health, the entity performing the AMR should notify FDA (FDA would
> notify the AB in the case of AMRF). FDA will evaluate the results of
> the AMR to determine if additional follow-up or monitoring is
> necessary. FDA might require the AB to perform continued close
> monitoring of this facility.~~ ~~In the case of AMRF, FDA may require
> the AB to perform its own AMR.~~

### ~~Interpreting Physician - Level 1 Findings~~

**~~Criteria - Interpreting Physicianipcriteria~~**

**~~Procedure for AMR - Interpreting Physicianipamrprocedure~~**

**~~Follow-up Actions by FDA with the Facilityipfollowup~~**

### ~~Criteria - Interpreting Physician~~

~~[AMR Conducted by Facility (AMRF)]{.underline}~~

~~If a facility has a Level 1 finding for interpreting physician
qualifications, with no other inspection findings for the physician or
other significant evidence that the quality of interpretation of
mammograms is compromised, then FDA may ask the facility to conduct
AMRF. Currently, facilities may have a Level 1 finding for interpreting
physician qualifications if the physician is neither board certified nor
has the initial (two or three months) training in mammography and/or
never had a valid license to practice medicine.~~

~~[AMR Conducted by Accreditation Body (AMRAB)]{.underline}~~

~~If a facility has a Level 1 finding for interpreting physician
qualifications and has other problems that may relate to the
qualifications of the interpreting physician, then the facility may be
asked to conduct AMRAB. Some examples of other problems could include
complaints regarding the performance of the interpreting physician or
other inspection findings relating to the physician's qualifications. In
these cases, FDA, in conjunction with the AB, may evaluate whether
quality at the facility may be sufficiently impaired for FDA to require
that the facility undergo AMR by the facility's AB (AMRAB).~~

~~Note: An interpreting physician, who fails to meet the qualifications
under the MQSA quality standards, may not continue to read and interpret
mammograms independently until he or she has received the necessary
training or experience to meet the qualifications.~~

### ~~Procedure for AMR -- Interpreting Physician~~

~~[Evaluation of Inspection Findings and Other
Information]{.underline}~~

> 1\. ~~[Level 1 finding only]{.underline}:~~ ~~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]{.underline}: 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]{.underline}, 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.~~

### ~~Follow-up Actions by FDA with the Facility~~

> ~~1. [If the conditions are met for AMRF]{.underline} (i.e., there is
> no other evidence of serious problems (findings, complaints, etc.)
> relating to the physician), the district should send a Warning Letter
> to the facility. The letter would require that the facility conduct
> AMRF in response to the findings. The letter would also indicate that
> the facility would be responsible for the cost of the AMRF.~~
>
> ~~2. [If the facility agrees to conduct AMRF]{.underline}, the
> district would monitor the progress of the review until completion.
> The review of images and reports under AMRF could be on-site at the
> facility or by mail.~~
>
> ~~3. [If the facility does not agree to conduct AMRF or the conditions
> for AMRAB are met]{.underline}, FDA may confer with the AB as to
> whether the AB should undertake AMRAB. The district may send a Warning
> Letter to the facility that would indicate that FDA had asked the
> facility's AB to conduct AMRAB in response to the inspection 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, FDA may require the facility
> to undergo AMRAB.~~
>
> ~~4. The AMR may encompass reinterpretation of all films or limit
> reinterpretation to a random sample of cases and could be either
> on-site or by mail. In either case, the facility should generate
> amended reports and notify appropriate physicians and patients of
> significant differences from original reports. While the size of the
> sample will vary with the situation, the sample should probably be no
> smaller than ten percent of the examinations conducted in the time
> period selected for evaluation.~~
>
> ~~5~~. ~~If the results of the AMRF or AMRAB indicate that the
> interpretation of mammograms at the facility represent a serious risk
> to human health, the entity performing the AMR should notify FDA (FDA
> would notify the AB in the case of AMRF). If appropriate, FDA may ask
> the facility to undertake a patient notification (PN) of patients
> and/or referring physicians, where the initial interpretation may have
> been deficient. If the facility does not agree or does not have the
> means to perform a PN, FDA would consider other methods of initiating
> a PN.~~
>
> ~~6. The district and DMQRP should coordinate implementation and
> monitoring of the notification process.~~
>
> ~~7. If the results of the AMR do not indicate a serious risk to human
> health, the entity performing the AMR should notify FDA (FDA would
> notify the AB in the case of AMRF). FDA will evaluate the results of
> the AMR to determine if additional follow-up or monitoring is
> necessary. FDA might require the AB to perform continued close
> monitoring of this facility. In the case of AMRF, FDA may require the
> AB to perform its own AMR.~~

# Approved Alternative Standards

# Daily Processor QC Tests

### **[Conducting the daily processor QC tests when the sensitometer is not available]{.mark}**

[]{.mark}

[T]{.mark}his 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]{.mark}**

[]{.mark}

[T]{.mark}his 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]{.mark}**

[]{.mark}

[T]{.mark}his 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]{.mark}**

[]{.mark}

[T]{.mark}his 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.

**Focal_Spot_Selection**

# [Manufacturer's software modification of the AEC]{.mark}

######## [Manufacturer's software modification of the AEC]{.mark}

[]{.mark}

[This alternative standard was approved on September 24, 2001. It has no
time limit.]{.mark}

[The final regulation and its alternative standard are stated
below:]{.mark}

[]{.mark}

[21 CFR 900.12(e)(10) states:]{.mark}

[]{.mark}

*[(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.]{.mark}*

[]{.mark}

[The alternative applies to the specific situations described below, in
which manufacturer's software modifications have been made to specific
units. In such cases, an onsite mammography equipment evaluation
performed by the medical physicist is not required. Instead, all that is
required is oversight by the medical physicist.]{.mark}

[]{.mark}

*[The approved alternative standard states that for:]{.mark}*

[]{.mark}

1.  [the modification of the AEC component of Senographe^TM^ 700T or
    800T mammography systems described in the GE Medical System's Field
    Modification Instruction (FMI) 11451, "Seno 700/800T Optical Density
    Optimization", and]{.mark}

[]{.mark}

2.  [the optimization of the AEC component of the Senographe^TM^ DMR
    mammography systems described in the GE Medical System's FMI 11450,
    "DMR V1/V2/+ Optical Density Optimization".]{.mark}

[]{.mark}

[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.]{.mark}

[]{.mark}

# [Conducting the Mammography Equipment Evaluation After a Software Upgrade Under Medical Physicist Oversight]{.mark}

[]{.mark}

[]{.mark}

**[Conducting the Mammography Equipment Evaluation After a Software
Upgrade Under Medical Physicist Oversight]{.mark}**

[]{.mark}

[This alternative standard was approved on May 31, 2002. It defines the
conditions under which the mammography equipment evaluations performed
after some computer software upgrades may be performed either by a
medical physicist on site or under the conditions of Medical Physicist
Oversight. If these conditions are not met the mammography equipment
evaluation after the upgrade must be performed by a medical physicist on
site.]{.mark}

[]{.mark}

[The original standard is contained within 21 CFR 900.12(e)(10).]{.mark}

[]{.mark}

> *[(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.]{.mark}*

[]{.mark}

[The approved alternative and the conditions for its use are:]{.mark}

[]{.mark}

> [Software changes or upgrades are considered by FDA to be major
> repairs, thus the facility must have a mammography equipment
> evaluation performed after installation of such a change or upgrade.
> The mammography equipment evaluation must be performed and all
> failures to meet the applicable standards must be corrected before the
> affected equipment is used for patient examinations. The tests to be
> included in the mammography equipment evaluation must be specified by
> the manufacturer. The specified tests must be adequate for determining
> whether all of the standards of 21 CFR 900.12(b) and (e) that are
> applicable to the upgrade are met. If the tests included in the
> mammography equipment evaluation are all tests that are performed by
> the quality control technologist as part of the quality assurance
> program required by the manufacturer, then the mammography equipment
> evaluation may be conducted either during an onsite visit by a medical
> physicist or under Medical Physicist Oversight. If any of the
> necessary tests after the software upgrade are required to be
> performed by the medical physicist, the mammography equipment
> evaluation must be performed in its entirety by the medical physicist
> on site.]{.mark}
>
> []{.mark}
>
> [Additional conditions for using this alternative requirement in
> association with a software upgrade are that:]{.mark}

1.  [The manufacturer must notify FDA of its intention to install the
    upgrade. The notification must include a brief description of the
    upgrade, the model(s) of the units that will be upgraded, and a copy
    of the information to be provided to each facility describing the
    upgrade and the facility's post installation responsibilities. The
    manufacturer must receive confirmation from FDA that the upgrade is
    covered by the alternative requirement before beginning
    installation.]{.mark}

2.  [By the completion of each individual upgrade, the manufacturer must
    inform the facility in writing of its post installation
    responsibilities under the alternative requirement, which are that
    the facility must:]{.mark}

-   [conduct a mammography equipment evaluation after installation of
    the upgrade, either during a medical physicist onsite visit or under
    Medical Physicist Oversight,]{.mark}

-   [include in its mammography equipment evaluation the tests specified
    by the manufacturer,]{.mark}

-   [perform the mammography equipment evaluation and correct all test
    failures before the affected equipment is used for patient
    examinations, and]{.mark}

-   [keep records of the test results and follow-up actions in
    accordance with 21 CFR 900.12(d)(2).]{.mark}

[]{.mark}

# [Correction Period When Components of the Senographe^TM^ 2000D Full Field Digital Mammography (FFDM) System Fail Quality Control Tests]{.mark}

[]{.mark}

[This alternative standard was approved on June 27, 2002. It allows a 30
day period for corrective actions following the failure of specified
quality control tests by the Senographe^TM^ 2000D FFDM system. The
specified tests are equivalent to quality control tests for screen-film
systems for which a 30 day correction period is already allowed. The
alternative standard also divides into two groups the quality control
tests whose failure requires corrective action before the failing
component is used again during patient examinations. This division makes
it clear that when the test failure is related to the acquisition of
images only, the review of already acquired images can continue and when
the test failure is related to the image review components only, images
can continue to be acquired. The alternative was approved for an
indefinite period.]{.mark}

[]{.mark}

[The original standard is 21 CFR 900.12(e)(8)(ii), which states:]{.mark}

[]{.mark}

> *[21 CFR 900.12(e)(8): Use of test results]{.mark}*
>
> *[(ii) If the test results fall outside of the action limits, the
> source of the problem shall be identified and corrective actions shall
> be taken:]{.mark}*
>
> *[(A) Before any further examinations are performed or any films are
> processed using the component of the mammography system that failed
> any of the tests, described in paragraphs (e)(1), (e)(2), (e)(4)(i),
> (e)(4)(iii), (e)(5)(vi), (e)(6), or (e)(7) of this section;]{.mark}*

[]{.mark}

[The approved alternative is:]{.mark}

[]{.mark}

[21 CFR 900.12(e)(8): *Use of test results*.]{.mark}

[(ii) If the test results for the Senographe^TM^ 2000D FFDM fall outside
of the action limits, the source of the problem shall be identified and
corrective actions shall be taken:]{.mark}

[(A) Before any further mammographic images are acquired using the
Senographe^TM^ 2000D FFDM system that failed any of the following
tests:]{.mark}

[(1) Monitor cleaning for the Acquisition Work Station (AWS)]{.mark}

[(2) Flat Field Test]{.mark}

[(3) CNR Test]{.mark}

[(4) Phantom Image Quality Test for the AWS]{.mark}

[(5) MTF Measurement]{.mark}

[(6) AOP Mode and SNR Check]{.mark}

[(7) Visual Check List]{.mark}

[(8) Compression Force Test]{.mark}

[(9) Average Glandular Dose]{.mark}

[(10) Post-move, Pre-examination Tests for Mobile Senographe^TM^ 2000D
FFDM]{.mark}

[(B) Before any further mammographic images are reviewed or interpreted
or any films are printed or processed using the component of the
Senographe^TM^ 2000D FFDM system that failed any of the following
tests:]{.mark}

[(1) Monitor cleaning for the Review Work Station (RWS)]{.mark}

[(2) Viewing Conditions for the RWS (Radiologic Technologist's
test)]{.mark}

[(3) Viewing Conditions Check and Setting (Medical Physicist's test for
the]{.mark}

[RWS)]{.mark}

[(4) Phantom Image Quality Test for the RWS]{.mark}

[(5) Phantom Image Quality Test for the Printer]{.mark}

[(6) Viewbox and Viewing Conditions Test]{.mark}

[(7) Monitor Calibration Check (Radiologic Technologist's test for the
RWS)]{.mark}

[(8) Image Quality---SMPTE Pattern (Medical Physicist's test for the
RWS)]{.mark}

[(9) Printer QC]{.mark}

[(C) Within 30 days of the test date for the following tests:]{.mark}

[(1) Repeat Analysis]{.mark}

[(2) Collimation Assessment]{.mark}

[(3) Evaluation of Focal Spot Performance]{.mark}

[(4) Exposure and mAs Reproducibility]{.mark}

[(5) Artifact Evaluation; Flat Field Uniformity]{.mark}

[(6) Monitor Calibration (Medical Physicist's test for the RWS)]{.mark}

[(7) Analysis of the RWS Screen Uniformity]{.mark}

[(8) kVp Accuracy and Reproducibility]{.mark}

[(9) Beam Quality Assessment (Half-Value Layer Measurement)]{.mark}

[(10) Radiation Output]{.mark}

[(11) Mammographic Unit Assembly Evaluation]{.mark}

# Alternative Requirements

# Alternative Requirements Overview

## Discussion:

## Question 1: What process is FDA ~~currently~~ following to ~~arrive at a decision~~ [decide]{.mark} on a request for approval of an alternative requirement?

When a request is received, a staff member or members are assigned to
review it to determine if it meets the criteria for approval established
in 900.18(c). This individual or group may also consult with experts in
other parts of FDA, with members of the National Mammography Quality
Assurance Advisory Committee, and with FDA\'s Office of [the Chief
Counsel]{.mark} ~~General Council~~. The end result of this review is a
recommendation to the Chief of the [Accreditation and
Certification]{.mark} ~~Mammography Standards~~ Branch that the request
be accepted, rejected, or that more information be requested before a
decision is made. If the Chief of the ~~Mammography Standards~~
[Accreditation and Certification]{.mark} Branch agrees, the
recommendation is sent to the Director of the Division of Mammography
Quality and Radiation Programs for the final decision. The Branch Chief
and/or the Division Director may also seek information from additional
scientific or legal experts to aid in making their decisions.

# Breast Implants

900.12(g)(1)(2): Mammographic procedure and techniques for mammography
of patients with breast implants.

\(1\) Each facility shall have a procedure to inquire whether or not the
patient has breast implants prior to the actual mammographic exam.

\(2\) Except where contraindicated, or unless modified by a physician's
directions, patients with breast implants undergoing mammography shall
have mammographic views to maximize the visualization of breast tissue.

**Discussion:**

## Question 6: Is there a specific amount of training or number of mammograms of breast implant patients that the technologist must perform under direct supervision prior to performing these studies independently?

[All radiologic technologists whose starting dates are after April 28,
1999 must have received [some]{.underline} training in the imaging of
patients with breast implants as part of the 40 hours of required
initial training. No specific amount of breast implant imaging training
or performance of a specific number of studies is required~~,
however~~.]{.mark} Although there are no requirements referable to
implant training for those radiologic technologists whose starting dates
~~under MQSA~~ are before the effective date of the final regulations
(April 28, 1999), FDA recommends that all radiologic technologists have
training specific to the imaging of patients with breast implants.

# Consumer Complaints

900.12(h)(1)(2)(3)(4): Consumer complaint mechanism. Each facility
shall:

\(1\) Establish a written and documented system for collecting and
resolving consumer complaints.

\(2\) Maintain a record of each serious complaint received by the
facility for at least 3 years from the date the complaint was received.

\(3\) Provide the consumer with adequate directions for filing serious
complaints with the facility's accreditation body if the facility is
unable to resolve a serious complaint to the consumer's satisfaction.

\(4\) Report unresolved serious complaints to the accreditation body in
a manner and timeframe specified by the accreditation body.

**Discussion:**

## Question 6: What criteria ~~will~~ [does]{.mark} FDA use to determine ~~that~~ [if]{.mark} facilities meet the MQSA requirements for dealing with consumer complaints?

To meet the requirements for dealing with consumer complaints,
facilities must provide written documentation that describes their
system for recording, maintaining, and resolving patients\' complaints.
The documentation must include the instructions that are, or would be,
provided to patients describing how to proceed with referral of serious
unresolved complaints to the accreditation body. The documentation must
also include the procedures that are, or would be used by the facility
to report serious unresolved complaints to their accreditation
body[.]{.mark}

[]{.mark}

[I]{.mark}f the facility has received serious complaints after 4/28/99,
it must be able to produce records indicating that they are following
their system and are maintaining the serious complaint for 3 years.

## Question 9: What is an example of an acceptable system for collecting and resolving consumer complaints?

The MQSA final regulations require facilities to have a written and
documented standard operating procedure for responding to consumer
complaints. The facility may select its own format. An example of an
acceptable system for collecting and documenting the consumer complaint
is described below:

> 1\. The facility designates a facility contact person with whom
> consumers, the accreditation body, and FDA can interact regarding
> serious consumer complaints. The contact person and other health
> professionals at the facility develop a clear understanding of the
> definitions of "consumer," "adverse event," "serious adverse event,"
> and "serious complaint" so all parties are knowledgeable about the
> requirements of the consumer complaint mechanism.
>
> 2\. If the facility cannot resolve a complaint to the consumer's
> satisfaction, the facility provides the consumer with directions for
> filing serious complaints with the facility's accreditation body.
> These directions are to be provided in writing.
>
> The facility may wish to post a sign to explain how to file
> complaints. In this case, the facility could use messages such as, "We
> care about our patients. If you have comments and/or concerns, please
> direct them to (the name of the person in the facility who is
> responsible for complaints)."
>
> This would be in addition to the name and address of the accreditation
> body, which is listed on the facility's [MQSA]{.mark} certificate. The
> facility is required by law to post the [MQSA]{.mark} certificate
> prominently in the facility.
>
> 3\. The facility keeps documentation of the complaint on file for a
> period of three years from the date the complaint was received. The
> facility may develop a form to record, at a minimum, the following
> items concerning "serious complaints": name, address and telephone
> number of the person making the complaint; date of the complaint; date
> the serious adverse event occurred; precise description of the serious
> adverse event (including the name(s) of the individual(s) involved);
> how the complaint was resolved; and the date the complaint was
> resolved. This record can be either manual (written) or computerized,
> depending on the facility's preference.
>
> 4\. The facility acknowledges the consumer's complaint, investigates
> the complaint, makes every effort to resolve the complaint, and
> responds to the individual filing the complaint within a reasonable
> time frame (these steps can usually be accomplished within 30 days).
>
> 5\. The facility assures that the complaint and any information
> regarding the complaint or its followup will be shared only with those
> needed to resolve the complaint. In addition, facilities should design
> their complaint procedures to be responsive to the particular needs of
> the patients they serve. Patients or their representatives may
> complain in person or in writing.
>
> 6\. The facility reports unresolved serious complaints to its
> accreditation body in a manner and timeframe specified by the body.
> The facility may wish to contact their accreditation body regarding
> this requirement. For easy reference, facilities may want to keep a
> separate listing of unresolved serious complaints, with the date of
> referral, summary and date of response, if any, from the accreditation
> body. (This would be in addition to the record described in number 3,
> above[).]{.mark}

[]{.mark}

[F]{.mark}DA suggests that facilities analyze the complaints to
determine if persistent/recurrent problems exist and use this
information to help improve their mammography services[.]{.mark}

[]{.mark}

[T]{.mark}he primary responsibility for the consumer complaint mechanism
is with the facility. However, for complaints that cannot be resolved at
the facility, the consumer may choose to report the complaint to the
accreditation body or the FDA.

## Question 10: Does the complaint mechanism have to be posted?

No. The final regulations do not require facilities to post a sign
describing how consumers can file complaints. The MQSA certificate
includes the name and address of the facility's accreditation body, and
filing a complaint with the accreditation body is the next step for
consumers registering a complaint. The facility [is
required]{.underline} to post their [MQSA]{.mark} certificate
prominently within the view of patients[.]{.mark}

[]{.mark}

[T]{.mark}he final regulations also require the facility to give
consumers with [serious unresolved]{.underline} complaints directions
for filing such complaints with the facility\'s accreditation
[body.]{.mark}

[]{.mark}

[W]{.mark}hile not required, FDA encourages facilities to post a sign
informing their patients of the presence of its complaint mechanism.
Facilities can use messages such as, "We care about our patients. If you
have comments, compliments, and/or concerns, please direct them to (the
name of the person at the facility who is responsible for
complaints[)."]{.mark}

[]{.mark}

[A]{.mark}dditional suggestions for making patients aware of the
complaint mechanism include: providing information about the complaint
mechanism on the patient information sheet filled out before the exam,
and requesting that patients complete a comment card following the
mammography exam. FDA also encourages the facility to train its staff to
be receptive to patient concerns so that the patient will feel
comfortable in expressing those concerns.

**Serious_Complaint**

# [States as Certifiers]{.mark}

[]{.mark}

# [Scope]{.mark}

[Sec. 900.20 Scope.]{.mark}

[]{.mark}

[The regulations set forth in this part implement the Mammography
Quality Standards Act (MQSA) (42 U.S.C. 263b). Subpart C of this part
establishes procedures whereby a State can apply to become a
FDA-approved certification agency to certify facilities within the State
to perform mammography services. Subpart C of this part further
establishes requirements and standards for State certification agencies
to ensure that all mammography facilities under their jurisdiction are
adequately and consistently evaluated for compliance with quality
standards at least as stringent as the national quality standards
established by FDA.]{.mark}

# [Application for approval as a certification agency]{.mark}

[Sec. 900.21 Application for approval as a certification agency.]{.mark}

[]{.mark}

[(a) Eligibility. State agencies may apply for approval as a
certification agency if they have standards at least as stringent as
those of Sec. 900.12, qualified personnel, adequate resources to carry
out the States as Certifiers\' responsibilities, and the authority to
enter into a legal agreement with FDA to accept these
responsibilities.]{.mark}

[(b) Application for approval.]{.mark}

[(1) An applicant seeking FDA approval as a certification agency shall
inform the Division of Mammography Quality and Radiation Programs
(DMQRP), Center for Devices and Radiological Health (HFZ-240), Food and
Drug Administration, Rockville, MD 20850, marked Attn: States as
Certifiers Coordinator, in writing, of its desire to be approved as a
certification agency.]{.mark}

[(2) Following receipt of the written request, FDA will provide the
applicant with additional information to aid in the submission of an
application for approval as a certification agency.]{.mark}

[(3) The applicant shall furnish to FDA, at the address in paragraph
(b)(1) of this section, three copies of an application containing the
following information, materials, and supporting documentation:]{.mark}

[(i) Name, address, and phone number of the applicant;]{.mark}

[(ii) Detailed description of the mammography quality standards the
applicant will require facilities to meet and, for those standards
different from FDA\'s quality standards, information substantiating that
they are at least as stringent as FDA standards under Sec.
900.12;]{.mark}

[(iii) Detailed description of the applicant\'s review and
decisionmaking process for facility certification, including:]{.mark}

[(A) Policies and procedures for notifying facilities of certificate
denials and expirations;]{.mark}

[(B) Procedures for monitoring and enforcement of the correction of
deficiencies by facilities;]{.mark}

[(C) Policies and procedures for suspending or revoking a facility\'s
certification;]{.mark}

[(D) Policies and procedures that will ensure processing certificates
within a timeframe approved by FDA;]{.mark}

[(E) A description of the appeals process for facilities contesting
adverse certification status decisions;]{.mark}

[(F) Education, experience, and training requirements of the
applicant\'s professional and supervisory staff;]{.mark}

[(G) Description of the applicant\'s electronic data management and
analysis system;]{.mark}

[(H) Fee schedules;]{.mark}

[(I) Statement of policies and procedures established to avoid conflict
of interest;]{.mark}

[(J) Description of the applicant\'s mechanism for handling facility
inquiries and complaints;]{.mark}

[(K) Description of a plan to ensure that certified mammography
facilities will be inspected according to MQSA (42 U.S.C. 263b) and
procedures and policies for notifying facilities of inspection
deficiencies;]{.mark}

[(L) Policies and procedures for monitoring and enforcing the correction
of facility deficiencies discovered during inspections or by other
means;]{.mark}

[(M) Policies and procedures for additional mammography review and for
requesting such reviews from accreditation bodies;]{.mark}

[(N) Policies and procedures for patient notification;]{.mark}

[(O) If a State has regulations that are more stringent than those of
Sec. 900.12, an explanation of how adverse actions taken against a
facility under the more stringent regulations will be distinguished from
those taken under the requirements of Sec. 900.12; and]{.mark}

[(P) Any other information that FDA identifies as necessary to make a
determination on the approval of the State as a certification
agency.]{.mark}

[(c) Rulings on applications for approval.]{.mark}

[(1) FDA will conduct a review and evaluation to determine whether the
applicant substantially meets the applicable requirements of this
subpart and whether the certification standards the applicant will
require facilities to meet are the quality standards published under
subpart B of this part or at least as stringent as those of subpart
B.]{.mark}

[(2) FDA will notify the applicant of any deficiencies in the
application and request that those deficiencies be corrected within a
specified time period. If the deficiencies are not corrected to FDA\'s
satisfaction within the specified time period, FDA may deny the
application for approval as a certification agency.]{.mark}

[(3) FDA shall notify the applicant whether the application has been
approved or denied. The notification shall list any conditions
associated with approval or state the bases for any denial.]{.mark}

[(4) The review of any application may include a meeting between FDA and
representatives of the applicant at a time and location mutually
acceptable to FDA and the applicant.]{.mark}

[(5) FDA will advise the applicant of the circumstances under which a
denied application may be resubmitted.]{.mark}

[(d) Scope of authority. FDA may limit the scope of certification
authority delegated to the State in accordance with MQSA.]{.mark}

[]{.mark}

# [Standards for certification agencies]{.mark}

[Sec. 900.22 Standards for certification agencies.]{.mark}

[]{.mark}

[The certification agency shall accept the following responsibilities in
order to ensure quality mammography at the facilities it certifies and
shall perform these responsibilities in a manner that ensures the
integrity and impartiality of the certification agency\'s
actions:]{.mark}

[(a) Conflict of interest. The certification agency shall establish and
implement measures that FDA has approved in accordance with Sec.
900.21(b) to reduce the possibility of conflict of interest or facility
bias on the part of individuals acting on the certification agency\'s
behalf.]{.mark}

[(b) Certification and inspection responsibilities. Mammography
facilities shall be certified and inspected in accordance with statutory
and regulatory requirements that are at least as stringent as those of
MQSA and this part.]{.mark}

[(c) Compliance with quality standards. The scope, timeliness,
disposition, and technical accuracy of completed inspections and related
enforcement activities shall ensure compliance with facility quality
standards required under Sec. 900.12.]{.mark}

[(d) Enforcement actions.]{.mark}

[(1) There shall be appropriate criteria and processes for the
suspension and revocation of certificates.]{.mark}

[(2) There shall be prompt investigation of and appropriate enforcement
action for facilities performing mammography without
certificates.]{.mark}

[(e) Appeals. There shall be processes for facilities to appeal
inspection findings, enforcement actions, and adverse certification
decision or adverse accreditation decisions after exhausting appeals to
the accreditation body.]{.mark}

[(f) Additional mammography review. There shall be a process for the
certification agency to request additional mammography review from
accreditation bodies for issues related to mammography image quality and
clinical practice. The certification agency should request additional
mammography review only when it believes that mammography quality at a
facility has been compromised and may present a serious risk to human
health.]{.mark}

[(g) Patient notification. There shall be processes for the
certification agency to conduct, or cause to be conducted, patient
notifications should the certification agency determine that mammography
quality has been compromised to such an extent that it may present a
serious risk to human health.]{.mark}

[(h) Electronic data transmission. There shall be processes to ensure
the timeliness and accuracy of electronic transmission of inspection
data and facility certification status information in a format and
timeframe determined by FDA.]{.mark}

[(i) Changes to standards. A certification agency shall obtain FDA
authorization for any changes it proposes to make in any standard that
FDA has previously accepted under Sec. 900.21 before requiring
facilities to comply with the changes as a condition of obtaining or
maintaining certification.]{.mark}

[]{.mark}

# [Evaluation]{.mark}

[Sec. 900.23 Evaluation.]{.mark}

[]{.mark}

[FDA shall evaluate annually the performance of each certification
agency. The evaluation shall include the use of performance indicators
that address the adequacy of program performance in certification,
inspection, and enforcement activities. FDA will also consider any
additional information deemed relevant by FDA that has been provided by
the certification body or other sources or has been required by FDA as
part of its oversight mandate. The evaluation also shall include a
review of any changes in the standards or procedures in the areas listed
in Secs. 900.21(b) and 900.22 that have taken place since the original
application or the last evaluation, whichever is most recent. The
evaluation shall include a determination of whether there are major
deficiencies in the certification agency\'s regulations or performance
that, if not corrected, would warrant withdrawal of the approval of the
certification agency under the provisions of Sec. 900.24, or minor
deficiencies that would require corrective action.]{.mark}

[]{.mark}

# [Withdrawal of approval]{.mark}

[Sec. 900.24 Withdrawal of approval.]{.mark}

[]{.mark}

[If FDA determines, through the evaluation activities of Sec. 900.23, or
through other means, that a certification agency is not in substantial
compliance with this subpart, FDA may initiate the following
actions:]{.mark}

[(a) Major deficiencies. If, after providing notice and opportunity for
corrective action, FDA determines that a certification agency has
demonstrated willful disregard for public health, has committed fraud,
has failed to provide adequate resources for the program, has submitted
material false statements to the agency, has failed to achieve the MQSA
goals of quality mammography and access, or has performed or failed to
perform a delegated function in a manner that may cause serious risk to
human health, FDA may withdraw its approval of that certification
agency. The certification agency shall notify, within a time period and
in a manner approved by FDA, all facilities certified or seeking
certification by it that it has been required to correct major
deficiencies.]{.mark}

[(1) FDA shall notify the certification agency of FDA\'s action and the
grounds on which the approval was withdrawn.]{.mark}

[(2) A certification agency that has lost its approval shall notify
facilities certified or seeking certification by it, as well as the
appropriate accreditation bodies with jurisdiction in the State, that
its approval has been withdrawn. Such notification shall be made within
a timeframe and in a manner approved by FDA.]{.mark}

[(b) Minor deficiencies. If FDA determines that a certification agency
has demonstrated deficiencies in performing certification functions and
responsibilities that are less serious or more limited than the
deficiencies in paragraph (a) of this section, including failure to
follow the certification agency\'s own procedures and policies as
approved by FDA, FDA shall notify the certification agency that it has a
specified period of time to take particular corrective measures as
directed by FDA or to submit to FDA for approval the certification
agency\'s own plan of corrective action addressing the minor
deficiencies. If the approved corrective actions are not being
implemented satisfactorily or within the established schedule, FDA may
place the agency on probationary status for a period of time determined
by FDA, or may withdraw approval of the certification agency.]{.mark}

[(1) If FDA places a certification agency on probationary status, the
certification agency shall notify all facilities certified or seeking
certification by it of its probationary status within a time period and
in a manner approved by FDA.]{.mark}

[(2) Probationary status shall remain in effect until such time as the
certification agency can demonstrate to the satisfaction of FDA that it
has successfully implemented or is implementing the corrective action
plan within the established schedule, and that the corrective actions
have substantially eliminated all identified problems, or]{.mark}

[(3) If FDA determines that a certification agency that has been placed
on probationary status is not implementing corrective actions
satisfactorily or within the established schedule, FDA may withdraw
approval of the certification agency. The certification agency shall
notify all facilities certified or seeking certification by it, as well
as the appropriate accreditation bodies with jurisdiction in the State,
of its loss of FDA approval, within a timeframe and in a manner approved
by FDA.]{.mark}

[(c) Transfer of records. A certification agency that has its approval
withdrawn shall transfer facility records and other related information
as required by FDA to a location and according to a schedule approved by
FDA.]{.mark}

[]{.mark}

# [Hearings and appeals]{.mark}

[Sec. 900.25 Hearings and appeals.]{.mark}

[]{.mark}

[(a) Opportunities to challenge final adverse actions taken by FDA
regarding approval of certification agencies or withdrawal of approval
of certification agencies shall be communicated through notices of
opportunity for informal hearings in accordance with part 16 of this
chapter.]{.mark}

[(b) A facility that has been denied certification is entitled to an
appeals process from the certification agency. The appeals process shall
be specified in writing by the certification agency and shall have been
approved by FDA in accordance with Secs. 900.21 and 900.22.]{.mark}

######