An FDA program that certifies
MQSA
Mammography Quality Standards Act
FDA AND ACCREDITING BODIES
Food and Drug
Administration (FDA)
Responsible for advancing the public
health by helping to speed innovations
that make medical products more
effective, safer, and more affordable
and by helping the public get the
accurate, science-based information
they need to use medical products and
foods to improve their health. It is the
body that developed and oversees the
MQSA process.
ROLES AND RESPONSIBILITIES
Radiological Technologist (RT)
Operates the mammography device. Acquires
patient images for diagnostic review.
Responsible for the correct imaging of the
patient with a limited amount of rejected or
repeated exposures. Performs all required
Quality Control tasks.
Interpreting Physician/Radiologist
Reads the mammography images for
diagnosis. Focuses on maintaining the quality
of the RT staff, equipment, and documentation,
and that all procedures are being followed
correctly. May decide which Medical Physicist
will survey the site.
Medical Physicist (MP)
Performs the site survey for accreditation
and the yearly survey to maintain operation.
Responsible for testing any mammography
device to ensure correct and acceptable image
quality, patient dose, and safety concerns.
Field Service Engineer (FSE)
Installs, maintains, and repairs the mamm-
ography device. Ensures device operates and
functions correctly. Addresses concerns
brought up by the Medical Physicist.
Documents all complaints reported by the
customer and MP, providing the customer with
a timely service report.
mammography centers meet quality
standards for personnel, equipment,
radiation dosage, patient notification,
and record-keeping
Ensures all women have access to
quality mammography for the detection
of breast cancer in its earliest most
treatable stages
American College of
Radiology (ACR)
• Founded in 1923, ACR is
at the forefront of radiology
evolution, representing more than
38,000 radiologists, radiation
oncologists, nuclear medicine
physicians and medical physicists.
• Core Purpose: To serve patients and
society by empowering members to
advance the practice, science and
professions of radiological care.
• An Accrediting Body which allows a
site to perform mammography and
recertifies it up to every 3 years.
ACCREDITATION AND APPLICATION
Meeting federally developed
quality standards for
personnel qualifications,
equipment, radiation
dose, quality assurance
programs, and recordkeeping
and reporting
Veterans Administration (VA) hospitals
are exempt from the law.
VA has initiated its own quality
mammography program with standards as
strict as those required by MQSA.
All VA facilities are required to be accredited
by the American College of Radiology.
They are also inspected
annually by MQSA-trained
inspectors.
 WORKING WITH A MEDICAL PHYSICIST
A Medical Physicist (MP) Is Required:
• At installation of a new device (Mammographic
Equipment Evaluation or MEE)
• Relocation of an installed device requires MEE
• Yearly survey of installed device
• Major changes or repairs of X-ray tube,
collimator, filter, AEC or AEC Sensor, Digital
Image Receptor, etc.
What Do I Do When an MP Questions or Reports a
Failure Not Covered in the Appropriate QC Manual?
It is technically impossible for the MP to fail a system outside
of the procedures found in the appropriate QC Manual.
1. Contact technical support with a detailed
description of the issue. This may require opening
a call in the ticketing system if one does not
already exist. Issues will be handled on a case-by-
case basis.

• Evaluation requirements are always at the 2. Notify the customer and the MP that a
discretion of the MP representative from Hologic will be in contact to
discuss the issue for further steps.

3. Avoid disagreeing with the MP or saying anything

How Are Physicist Report Issues Handled? negative about the MP to the customer!

• A service request is generated and a service

call must be made to correct the issues on a
survey or evaluation report. Who Determines When an MP Visit Is Required?
FSE Customer MP
• Most corrections to the physicist’s findings
must be made within 30 days of the test date. Provides the Should call the Determines
customer with MP and explain the level of
• Exception: Image quality and average glandular the service what work was oversight,
dose must be corrected immediately. If the issue cannot report that done. if any is
be resolved, the system will be shut down describes what required.
until the issue is resolved to the satisfaction of the MP. work was done.

QUALITY CONTROL MANUALS

The ACR provides Quality Control Manuals for many imaging modalities.
It is the responsibility of the site to follow the appropriate QC manual to maintain accreditation.

ACR Mammography Manufacturer Hologic ACR 2018 Digital

QC Manuals QC Manuals QC Manuals Mammography QC Manual

• Sites using film for
mammography would follow
the ACR QC Manual to
maintain accreditation.
MQSA does not apply to
biopsy devices.
Devices such as Affirm
Prone Biopsy System and
Multicare do not have a QC
manual. There is an ACR
manual for stereotactic
biopsy, which can be used
to set ACR accreditation.
This is not mandatory.
• When digital mammography • For Hologic digital • A new ACR manual was
came into existence many QC mammography devices each released in 2018, replacing the
procedures provided by the device has its own Quality 2016 manual. This manual
ACR Mammography QC Control Manual. allows customers with
Manual were no longer valid. tomosynthesis to use the ACR
• Each version of software for manual instead of the
• The FDA ruled the that device might use a
manufacturer’s QC manual.
manufacturer would be different version of the QC
required to provide a Quality Manual. • Neither the FDA nor the ACR
Control Manual for any digital require you to use the 2018 ACR
• Newer version of QC Manual
mammography device and manual under the current FDA
may not be the correct manual
customers would follow those regulations.
to use if the system is still on
procedures rather than
an older version of software. • Whichever manual is used (ACR
the ACR manual.
or QC), the facility must use that
manual for all devices across
the organization.
ACR PHANTOM • Sites using CEDM cannot use
the ACR 2018 DM QC Manual.
The ACR uses a special mammography test phantom to
They must use Hologic’s QC
ensure image quality and patient dose. Manual.
The site is required to own a valid phantom.
That phantom is used by the RT, MP, and FSE for all testing.