SELENIA Dimensions 3D Quality Control Manual Rev 011 Nov 2021

Selenia Dimensions 3Dimensions ®

™

Digital Mammography System

Digital Tomosynthesis System

Quality Control Manual

DM, BT, and CEDM Modalities For Software Versions 1.8, 1.9, 1.10, 1.11, 2.0, 2.1, or 2.2

Part Number MAN-03706 Revision 011 November 2021

®

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+1.877.371.4372

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+852 37487700

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+1 800 264 073

All Other:

+1 781 999 7750

Email:

[email protected]

© 2015-2021 Hologic, Inc. Printed in the USA. This manual was originally written in English. Hologic, 3Dimensions, Dimensions. Selenia, FAST Paddle, C-View, HTC, SecurView, SmartCurve, and associated logos are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries. All other trademarks, registered trademarks, and product names are the property of their respective owners. This product may be protected by one or more U.S. or foreign patents as identified at www.Hologic.com/patent-information.

Quality Control Manual for Selenia Dimensions and 3Dimensions Systems Table of Contents

Table of Contents 1: Prologue _____________________________________________________________________1 1.1 1.2 1.3 1.4 1.5 1.6 1.7

Introduction ... 1 Intended Use of the System Quality Control Manual... 2 How to Use the Quality Control Manual ... 3 Prerequisites ... 4 Change Summary ... 4 Terms and Definitions ... 7 Descriptions of Warnings, Cautions, and Notes ... 10

2: Introduction _________________________________________________________________11 2.1 2.2 2.3 2.4 2.5

Personnel Training... 11 Responsibilities ... 12 Alternative Quality Control Standard ... 14 Quality Control Activities for the Medical Physicist ... 19 Quality Control Activities for the Radiologic Technologist ... 21

3: Quality Control Activities for the Medical Physicist______________________________23 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 3.10 3.11 3.12 3.13

Mammographic Unit Assembly Evaluation ... 25 Collimation Assessment... 26 Artifact Evaluation... 37 kVp Accuracy and Reproducibility ... 44 Beam Quality Assessment-Half-Value Layer Measurement ... 46 Evaluation of System Resolution ... 49 Automatic Exposure Control (AEC) Function Performance... 52 Breast Entrance Exposure, AEC Reproducibility, and AGD ... 57 Radiation Output Rate ... 63 Phantom Image Quality Evaluation ... 66 Signal-To-Noise and Contrast-To-Noise Measurements ... 69 Diagnostic Review Workstation Quality Control ... 76 Detector Ghosting (Troubleshooting Use Only) ... 79

4: Quality Control Activities for the Radiologic Technologist _______________________83 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10

DICOM Printer Quality Control ... 85 Detector Flat Field Calibration ... 89 Geometry Calibration (Tomosynthesis Option) ... 92 Artifact Evaluation... 94 Phantom Image ... 100 Signal-To-Noise and Contrast-To-Noise Measurements ... 103 Compression Thickness Indicator ... 110 Diagnostic Review Workstation Quality Control ... 112 Viewboxes and Viewing Conditions ... 115 Visual Checklist... 116

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Quality Control Manual for Selenia Dimensions and 3Dimensions Systems Table of Contents

4.11 Repeat/Reject Analysis ... 117 4.12 Compression ... 119

Appendix A Quality Control Forms for the Medical Physicist ______________________121 Appendix B Quality Control Forms for the Radiologic Technologist ________________171 Appendix C Dose Conversion Tables for the Medical Physicist ____________________205 Appendix D CNR Correction Tables ____________________________________________211 D.1 D.2 D.3 D.4 D.5 D.6 D.7 D.8 D.9 D.10

CNR Correction - Conventional (Contact) ... 212 CNR Correction - Conventional (Magnification) ... 214 CNR Correction - Stereotactic Biopsy Option ... 216 CNR Correction - CE2D Option ... 216 CNR Correction - Tomosynthesis Option (15 Projections, STANDARD Mode)... 217 CNR Correction - Tomosynthesis Option (15 Projections, ENHANCED Mode) ... 219 CNR Correction - Tomosynthesis Option (30 Projections, STANDARD Mode)... 220 CNR Correction - Tomosynthesis Option (30 Projections, ENHANCED Mode) ... 221 CNR Correction - Contrast Enhanced Biopsy Option... 222 Notes ... 223

Appendix E Technique Tables __________________________________________________225 Appendix F Scoring a Phantom _________________________________________________229

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Quality Control Manual for Selenia Dimensions and 3Dimensions Systems Chapter 1: Prologue

Chapter 1 Prologue 1:

1.1

Introduction This quality control manual provides the necessary information for a facility that uses this mammography system to maintain an effective Quality Assurance and Quality Control (QA/QC) program, meet the requirements of the MQSA Final Regulations, and meet the requirements provided by the manufacturer of the Selenia Dimensions system. This QC manual applies to the following systems:

•

digital mammography (DM) system

• •

breast tomosynthesis (BT) system mobile versions of the above systems

Note The digital mammography QC tests need to be performed even on a system that is intended exclusively for breast tomosynthesis plus C-View™ software imaging. These tests are required to verify proper system operation.

Tests or sections marked as "Tomosynthesis Option" and indicated by the on the side of the page only apply to the breast tomosynthesis systems.

icon

icon on the side of the page only apply to the systems Sections indicated by the that are licensed to perform diagnostic procedures.

icon on the side of the Sections marked as “CE2D Option” and indicated by the page only apply to the systems that are licensed to perform contrast enhanced digital mammography procedures.

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1.2

Intended Use of the System Quality Control Manual This quality control manual describes all quality assurance and control tests proposed by the manufacturer (Hologic, Inc.) for their digital mammography and breast tomosynthesis systems. Users of this manual should be the radiologic technologist and the medical physicist who are qualified to operate digital mammography and breast tomosynthesis systems. For Mammography Screen Facilities in the United States This manual must be used by facilities in the United States using digital mammography or breast tomosynthesis systems to establish a Quality Assurance and Quality Control program to conform to the rules of the United States Mammography Quality Standards Act (MQSA) or to become accredited by an accreditation body. This manual can be substituted partially or to its entirety by new alternative standards approved to establish alternate Quality Assurance and Quality Control programs to conform to the rules of MQSA. For Mammography Screen Facilities Outside the United States Facilities that use the digital mammography or breast tomosynthesis systems and do not fall under the United States Mammography Standards Act (MQSA) should follow their local regulations for Quality Assurance and Quality Control. This manual may be used as a guide by these facilities to establish test protocols to conform to the applicable local regulations. Products, Modalities, and Software Versions Supported by this Manual This quality control manual supports these products:

• •

Selenia® Dimensions® mammography system 3Dimensions™ mammography system

This quality control manual supports these modalities:

• •

digital mammography (DM)

•

contrast enhanced digital mammography (CEDM)

breast tomosynthesis (BT)

This quality control manual supports these software levels:

•

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software versions 1.8 and later (refer to MAN-01965 for software versions prior to 1.8)

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1.3

How to Use the Quality Control Manual Chapter 2-Introduction on page 11: Facilities using x-ray systems other than screen-film mammography must maintain a QA/QC program substantially equivalent to the QA/QC program recommended by the manufacturer. This section lists the requirements that apply to the mammography system as specified by the manufacturer. Facilities that fail to follow the QA/QC program for the system as specified by the manufacturer in this Quality Control Manual may jeopardize their FDA/MQSA certification. The MQSA Final Regulations mandate that the recommended QA/QC program for the system must be maintained in addition to the existing Quality Assurance and Quality Control programs for screen-film mammography. Chapter 3-Quality Control Activities for the Medical Physicist on page 23: Specifies the Quality Control procedures, testing frequency, regulatory action levels and time limits for corrective action for each required Quality Control Activity that falls under the responsibility of the medical physicist. These Quality Control Activities performed by the medical physicist are required under MQSA Final Regulations or by the manufacturer of the Selenia Dimensions system. Detailed steps of how to perform the different tests are provided only for Quality Control procedures that are different from the standard Quality Control procedures already in use for screen-film mammography facilities. These detail steps are listed in this manual only to help guide the medical physicist as to how to perform the different tests on a system. The medical physicist may deviate from the steps of the procedures listed in this chapter as long as the final outcome is in full compliance with the Recommended Performance Criteria and Corrective Action defined for each test. Chapter 4-Quality Control Activities for the Radiologic Technologist on page 83: This section specifies the Quality Control procedures, testing frequency, regulatory action levels and time limits for corrective action for each required Quality Control Activity that falls under the responsibility of the radiologic technologist. These Quality Control Activities performed by the radiologic technologist are required under MQSA Final Regulations or by the manufacturer. Detailed steps are provided only for Quality Control procedures that are different from the standard Quality Control procedures already in use for screenfilm mammography facilities. Appendix A-Quality Control Forms for the Medical Physicist on page 121: All forms necessary for the medical physicist’s tests, including the medical physicist’s Mammography Quality Control Test Summary, are provided here. The medical physicist may also use their own forms (i.e. electronic) that resemble the forms listed in this appendix. Appendix B-Quality Control Forms for the Radiologic Technologist on page 171: Forms required for the Radiological Technologist’s quality control of the system are provided here. The radiologic technologist may also use their own forms (i.e. electronic) that resemble the forms listed in this appendix.

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Appendix C-Dose Conversion Tables for the Medical Physicist on page 205: Tungsten/rhodium (W/Rh), tungsten/silver (W/Ag), tungsten/aluminum (W/Al), and tungsten/copper (W/Cu) dose conversion tables are provided in this appendix for calculating average glandular (AGD) dose on a system. These dose conversion tables were derived for the filters used on the systems. Appendix D-CNR Correction Tables on page 211: Tables for dose conversion for AEC Function Performance. Appendix E-Technique Tables on page 225: Recommended manual technique tables for breast imaging using the system

1.4

Prerequisites The procedures in this manual may call for the following documents:

•

1.5

Hologic: Selenia Dimensions System User Guide or 3Dimensions System User Guide

Change Summary Revision 001 Initial release Revision 002

• •

Added an icon to identify tests specific to the CE2D Option Expanded the following tests in the medical physicist section to allow for testing under the CE2D Option:

• • • •

Artifact Evaluation Beam Quality Assessment Breast Entrance Exposure, AEC Reproducibility, and AGD

Expanded the Artifact Evaluation test in the technologist section to allow for testing under the CE2D Option

Revision 003

• •

Added a section describing the software versions supported by this manual Added CNR correction tables for:

• •

Tomosynthesis Option (15 Projections, STANDARD Mode) Tomosynthesis Option (15 Projections, ENHANCED)

Revision 004

•

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Clarification of one step in the Radiological Technologist and Medical Physicist Test Procedures for DICOM Printer Artifact Evaluation. When doing the Printer Artifact Evaluation, the Print Site Info is automatically checked and should remain checked.

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Revision 005

•

Corrected screen reference relating to Dose and AEC Reproducibility in Chapter 3 and in Tables 2, 3, and 40

•

Clarified the note on Frequency for the DICOM Printer Quality Control test for the Radiological Technologist

•

Revised Table 4 (Quality Control Activities for the Radiologic Technologist) to include Flat Field Calibration and removed Geometry Calibration

•

Revised the corrective actions text in the Compression test for the Radiological Technologist

•

Improved the layout and updated the test procedure for Signal-To-Noise and Contrast-To-Noise Measurements so the available options were made clearer. This change affected both the Medical Physicist and Radiological Technologist tests.

•

Standardized terminology throughout the manual: "2D" and "FFDM" were replaced by "Digital Mammography (DM)", "Digital Breast Tomosynthesis (DBT)" was replaced by "Breast Tomosynthesis (BT)", and "Combo" mode was replaced by "DM + BT".

Revision 006

• •

Added support for the 3Dimensions™ mammography system

•

Reformatted, consolidated, and added several forms to Appendix B for easier use and for no longer needing to refer to the 1999 ACR Mammography Quality Control Manual for necessary forms

•

Added a new section in Chapter 2 about the 2016 ACR QC Manual and Phantom Alternative Standard

•

Added CNR Correction Tables for Tomo (30 Projections, Standard Mode) and Tomo (30 Projections, Enhanced Mode) in Appendix D

•

Added CNR Correction Table for Tomo (15 Projections, Low Dose Mode) in Appendix D

•

In Chapter 3, added a note about how to measure the accuracy of the compression breast thickness scale under the Quality Control Activities for the Medical Physicist

•

Further clarifications were made to the Diagnostic Review Workstation Quality Control test for the Medical Physicist and Radiologic Technologist

Added steps in several procedures so there is no longer a need to refer to the 1999 ACR Mammography Quality Control Manual on how to execute a test

Revision 007

•

Added information, procedures, and forms for the SmartCurve™ breast stabilization system

•

Added clarification for use of flat compression paddles versus SmartCurve compression paddles

•

Removed all references to permanent attachment of the acrylic disk to the phantom

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Revision 008

•

Clarified the information regarding the ACR QC Manual and the new DBT tests and our preference for the continued use of the original phantom

•

Clarified the procedure for Collimation Assessment with the SmartCurve paddle

•

Removed an unnecessary form

Revision 009

•

Removed the EC Representative address and CE mark from the back cover, as it is no longer needed for this manual

Revision 010

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•

Updated the (2018) ACR QC Manual and Phantom Alternative Standard section regarding the need to use the manufacturer’s quality control manual for QC testing of advanced imaging modalities in addition to the testing performed according to the ACR Digital Mammography Quality Control Manual for the modalities approved by the FDA alternative standard

•

Corrected Tables 13 and 35 to provide the proper settings for System Artifact Evaluation (CE2D Option) in the Medical Physicist and Radiological Technologist Test Procedures

•

Added the type of paddles under Suggested Equipment for the Compression test for the Radiologic Technologist. Also, under Frequency, updated recommendation to: "Semiannually, or whenever increased or reduced compression is suspected"

•

Clarified the test procedure for the Repeat/Reject Analysis for the Radiologic Technologist to indicate that the Repeat Analysis is done as separate steps from the Reject Analysis

•

Corrected several "Record Forms" topics so the proper form in the Appendices is referenced

•

Added an entry for the Combo mode AGD in the Medical Physicist’s Mammography QC Test Summary form and added a "Filter" line in the 4. kVp Accuracy and Reproducibility form, both in Appendix A.

•

Clarified the compression amount required in the Mammography Quality Control Checklist - DM and BT form in Appendix B

•

Added several CNR correction tables/subsections in Appendix D:

•

Under CNR Correction - Conventional (Contact), added AEC Table 7 (Enhanced Uniform CNR Screening Dose)

•

Under CNR Correction - Tomosynthesis Option (15 Projections, STANDARD Mode), broke out separate AEC table sections For Software Versions 1.8.2 – 1.9.x on Selenia Dimensions and 2.0.x on 3Dimensions and For Software Versions 1.10.x and above on Selenia Dimensions and 2.1.x and above on 3Dimensions

•

Added a new CNR Correction Tables section for the Contrast Enhanced Biopsy Option

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Revision 011

1.6

•

Updated CE Mark on back cover (was 0044; now 2797).

•

Update EC Rep address on back cover (was BVBA; nowBV).

Terms and Definitions Accession Number

A DICOM term that refers to a RIS generated number that uniquely identifies a visit to a site by a patient.

AEC

Automatic Exposure Control. A method of limiting the amount of radiation a patient will receive.

Ag

Silver

AGD

Average Glandular Dose.

Al

Aluminum

Biweekly

Every two weeks.

BT

Breast Tomosynthesis

C-View™

Hologic-generated digital mammogram (DM) image from data acquired during a breast tomosynthesis scan

CEDM

Contrast Enhanced Digital Mammography

CE2D

Hologic name for CEDM

Collimator

Device at the x-ray tube used to restrict the area of the receptor that is exposed.

Combo Mode

Hologic acquisition mode consisting of a traditional digital mammogram (DM) with a breast tomosynthesis (BT) scan under the same compression. Combo Mode is referred to as “DM + BT” in this manual.

Dialog Box

A pop-up which informs the user, may require a user decision, and requires the action of the user by mouse click or selection before any other activities can occur. It is used for important notices, warnings, and errors.

DICOM

Digital Imaging and Communications in Medicine. An industry standard specification for inter-communication between medical imaging equipment.

Digital Marker

A software implemented mechanism for imprinting a mark within an image to indicate some information, usually orientation.

DM

Digital Mammography

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ESE

Entrance Skin Exposure

FAST Paddle™

Fully Automatic Self-Adjusting Tilt Paddle

Grid

Element within the Digital Image Receptor which reduces scatter radiation during exposure

HIS/RIS

Hospital Information System/Radiology Information System. Generic term for non-PACS systems that track patient demographics and ordered radiological studies.

HTC™

High Transmission Cellular Grid

HVL

Beam Quality Half-Value Layer

Image (Object)

A set of modality specific binary data and identifying attributes which represents the result of an imaging procedure performed on a patient. DICOM uniquely identifies image objects with a globally unique identifier (UID).

kVp

An electrical term used in setting x-ray exposure which stands for kilo-volt peak.

LFS

Large Focal Spot

Login/Logout

The process of logging into and out of the Operating System of the Acquisition Workstation. Upon start-up, this occurs before a user signs into the Acquisition Workstation application, and upon exiting, occurs after a user signs out of the Acquisition Workstation.

Mag

Magnification mode

mA

An electrical term used in setting x-ray exposure which stands for milliamperes

mAs

An electrical term used in setting x-ray exposure which stands for milliampere-seconds.

MQSA

Mammography Quality Standards Act

N

Newtons

OD

Optical Density

Operating System (OS)

The basic software control system which runs all functions of a computer.

Outputs

A list of devices the captured, accepted image will be sent to. Outputs consist of a combination of archives, workstations and film printers.

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Procedure

A generic pre-defined medical protocol which contains a set of images (views) which are acquired under certain conditions, and are performed together for a singular purpose (e.g. standard screening). Because a procedure is a generic entity in DICOM, there is no procedure instance UID, but DICOM supports identification of requested procedures.

Rh or Rho

Rhodium

ROI

Region of Interest

Series

A set of images which have all been acquired by a single tech for a single patient and procedure on a particular modality with a fixed body part, laterality and view position. DICOM uniquely identifies series with a globally unique instance UID.

SFS

Small Focal Spot

SID

Source to Image Distance

Sign-in

The process of a user identifying him/herself to the Acquisition Workstation application.

Sign-out

The process of a user exiting the Acquisition Workstation application, but not logging out of the OS.

Technique

Combination of x-ray parameters (kV, mA, etc.) defined for a particular procedural view.

Tomosynthesis (Tomo)

An imaging technique that recombines a number of breast images taken at different angles through the breast to achieve various effects. Tomosynthesis images can be reconstructed to show planes or slices within the breast.

View

The combination of a single x-ray image and a specific set of conditions under which the image was acquired. View is not part of DICOM nomenclature, but in the context of DR, is approximately synonymous with a DICOM image object.

Visit

A set of studies identified in a locally unique manner and performed on a particular patient at a particular site for a singular reason. A visit is normally identified by an accession number or a Visit ID and is associated with a diagnosis. DICOM has no concept of a visit instance UID.

W

Tungsten

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1.7

Descriptions of Warnings, Cautions, and Notes Descriptions of Warnings, Cautions, and Notes used in this manual:

WARNING! The procedures that you must follow accurately to prevent possible dangerous or fatal injury. Warning: The procedures that you must follow accurately to prevent injury. Caution: The procedures that you must follow accurately to prevent damage to equipment, loss of data, or damage to files in software applications. Note Notes show additional information.

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Quality Control Manual for Selenia Dimensions and 3Dimensions Systems Chapter 2: Introduction

Chapter 2 Introduction 2:

A facility using the system must establish a Quality Assurance and Quality Control program substantially equivalent to the Quality Assurance and Quality Control program recommended by the manufacturer-Hologic. The Quality Assurance and Quality Control program recommended for the system is described in this Quality Control Manual. All facilities in the United States that use the system must follow this Quality Control Manual in order to conform to MQSA Final Regulations and not jeopardize their FDA/MQSA certification or accreditation. Facilities outside the United States may follow this Quality Control Manual to establish a Quality Assurance and Quality Control program for the system according to the manufacturer’s recommendations.

2.1

Personnel Training MQSA Final Regulations require that personnel must receive appropriate training before they qualify to use digital mammography or breast tomosynthesis systems. Facilities using a digital mammography system require training in digital mammography. Facilities using the breast tomosynthesis system require training in both digital mammography and breast tomosynthesis modalities. Required training is as follows:

2.1.1

Required Training in Digital Mammography Medical Physicist Before a medical physicist may begin independently performing mammography surveys on digital mammography systems, the physicist must have received at least eight hours of training in the digital mammography modality.

Radiologic Technologist Before a radiologic technologist may begin independently performing digital mammographic imaging procedures, the technologist must have met all appropriate MQSA personnel requirements including having at least eight hours of continuing education units in digital mammography.

Interpreting Physician Before an interpreting physician may begin independently interpreting digital mammograms, the interpreting physician must have met all appropriate MQSA personnel requirements including having at least eight hours of training in digital mammography.

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2.1.2

Required Training in Breast Tomosynthesis Medical Physicist Before a medical physicist may begin independently performing mammography surveys on breast tomosynthesis systems, the physicist must have received at least eight hours of training in the breast tomosynthesis modality.

Radiologic Technologist Before a radiologic technologist may begin independently performing breast tomosynthesis imaging procedures, the technologist must have at least eight hours of training in the breast tomosynthesis modality.

Interpreting Physician Before an interpreting physician may begin independently interpreting breast tomosynthesis images, the interpreting physician must have at least eight hours of training in the breast tomosynthesis modality.

2.2

Responsibilities

2.2.1

Medical Physicist It is the responsibility of the medical physicist to carry out the system Equipment Evaluations before clinical use commences after the equipment is first installed, moved, or significantly modified-see CFR 900.12(e)(10). The system Equipment Evaluations must include all Quality Control tests listed under both Quality Control Activities for the Medical Physicist and Quality Control Activities for the Radiologic Technologist in accordance to 900.12(b) and 900.12(e) where applicable. For the installation of a new Selenia Dimensions or 3Dimensions system, the applicable tests in Section 900.12(b) are listed in Appendix A. In the event of system software upgrades, the list of tests required to be performed by either the medical physicist or the technologist will be given in the release notes describing the corresponding software changes according to the alternative standard described in section 2.3. The upgrade of a Selenia Dimensions or 3Dimensions DM system to a BT system is considered to be a significant modification to the system. The upgrade to the CEDM (IView) capability is also considered to be a significant modification to the system. In the event of such upgrades to an existing system, the medical physicist is required to perform a full equipment evaluation after the upgrade as per the table on page 13. The medical physicist must provide operating levels and control limits to the technologist for the Quality Control tests pertaining to the radiologic technologist, where appropriate, e.g., CNR Test. Such operating levels and control limits must follow the guidelines of this Quality Control Manual.

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The medical physicist is also responsible to perform all Quality Control tests listed under Quality Control Activities for the medical physicist at least annually and monitor the overall Quality Assurance and Quality Control program for the system. The medical physicist must review the results of the technologist’s Quality Control tests at least annually. The results of the overall Quality Assurance and Quality Control program must be reviewed by the medical physicist with the responsible interpreting physician at least annually. Table 1: Medical Physicist Installation Quality Control Tests Quality Control Tests To Be Performed by the Medical Physicist Upon Installation (MEE) Mammographic Unit Assembly Evaluation Collimation Assessment Artifact Evaluation kVp Accuracy & Reproducibility Beam Quality Assessment – HVL Evaluation of System Resolution AEC Function Performance Breast Entrance Exposure, AEC Reproducibility and Average Glandular Dose Radiation Output Rate Phantom Image Quality Evaluation Signal to Noise and Contrast to Noise Diagnostic Review Workstation Quality Control DICOM Printer Quality Control (Radiologic Technologist section) Detector Flat Field Calibration (Radiologic Technologist section) Geometry Calibration for Tomosynthesis Option (Radiologic Technologist section) Compression Thickness Indicator (Radiologic Technologist section) Compression (Radiologic Technologist section)

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2.2.2

Radiologic Technologist It is the responsibility of the radiologic technologist to carry out the Quality Control tests listed in the Quality Control Activities for the Radiologic Technologist at the specified frequency, review the results and request timely corrective action as necessary. The technologist must review the Quality Control results with the medical physicist and supervising interpreting physician at least annually and consult with the medical physicist any time there are questions about the procedure or the results of these Quality Control tests. In the event of system software upgrades, the list of tests required to be performed by either the medical physicist or the technologist will be given in the release notes describing the corresponding software changes according to the alternative standard described in section 2.3.

2.2.3

Interpreting Physician The supervising interpreting physician must review the results of the quality control program with the medical physicist and radiologic technologist at least annually.

2.2.4

Facility As is the case for screen-film Quality Control, the facility must keep records of all Quality Control Activities and all applicable corrective actions for at least 12 months since the last annual inspection which verified compliance (until the next physicist’s and inspector’s visits), or until the test has been done two additional times at the required frequency, whichever is longer. If the test results exceed the control limits, corrective action must be taken within time frames as specified for each Quality Control test in this Quality Control Manual. The facility is also responsible to follow the QC instructions given in the release notes of performed software upgrades and notify the medical physicist to have the opportunity to review the QC test results.

2.3

Alternative Quality Control Standard

2.3.1

Alternative Standard 6 Note The information provided below is derived from specific sections of the FDA’s published Approved Alternative Requirements and is provided as a reference only. For the complete text, go to http://www.fda.gov/RadiationEmittingProducts/MammographyQualityStandardsActandProgram/Regulations/ucm110880.htm.

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Federal regulations, 900.12(e)(10), specify that additional evaluations of mammography units must be conducted after major component changes or repairs. Software changes or upgrades are considered by the 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 and must meet the following conditions: 1.

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.

2.

All the tests included in the mammography equipment evaluation must be either tests that are performed by the quality control technologist as part of the quality assurance program required by the manufacturer, or tests specific to the upgrade which are of no greater complexity than those performed by the quality control technologist as part of the quality assurance program required by the manufacturer.

3.

None of the necessary tests after the software upgrade are required to be performed by the medical physicist. Additional conditions for using this alternative requirement in association with a software upgrade are that:

4.

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, a list of the post installation tests that the facility needs to perform, and a copy of the information to be provided to each facility describing the upgrade and the facility's post installation responsibilities.

5.

The manufacturer must confirm in the notification to FDA that the tests to be performed for the mammography equipment evaluation are either tests that are performed by the quality control technologist as part of the quality assurance program required by the manufacturer or tests specific to the upgrade which are of no greater complexity than those performed by the quality control technologist as part of that quality assurance program.

6.

The manufacturer must confirm that none of the required tests must be performed by a medical physicist.

7.

The manufacturer must receive an acknowledgement from FDA of receipt of the upgrade notification before beginning the upgrade installation.

8.

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:

•

Conduct a mammography equipment evaluation after installation of the upgrade, either during a medical physicist onsite visit or under Medical Physicist Oversight.

•

Include in its mammography equipment evaluation the tests specified by the manufacturer.

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