SELENIA Dimensions Quality Control Manual Rev 010 Jan 2016

Selenia Dimensions System Quality Control Manual Table of Contents

Appendix A Quality Control Forms for the Medical Physicist ______________________113 Appendix B Quality Control Forms for the Radiologic Technologist ________________157 Appendix C Dose Conversion Tables for the Medical Physicist ____________________189 Appendix D CNR Correction Tables ____________________________________________193 D.1 D.2 D.3 D.4

CNR Correction - Conventional (Contact) ... 194 CNR Correction - Conventional (Magnification) ... 196 CNR Correction - Tomosynthesis Option... 198 Notes ... 200

Appendix E Technique Tables __________________________________________________201

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Selenia Dimensions System Quality Control Manual Chapter 1: Prologue

Chapter 1 Prologue 1:

1.1

Introduction This quality control manual provides the necessary information for a facility that uses the Selenia® Dimensions® 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 Selenia Dimensions systems:

• • •

Selenia Dimensions Digital Mammography (DM) system; Selenia Dimensions Breast Tomosynthesis (BT) system; Mobile versions of the above Selenia Dimensions systems

Note The DM QC tests need to be performed even on a system that is intended exclusively for BT plus C-View™ DM 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 Selenia Dimensions BT systems.

icon

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

1.2

Intended Use of the Selenia Dimensions Quality Control Manual This quality control manual describes all quality assurance and control tests proposed by the manufacturer, Hologic, Inc. for the Selenia Dimensions Digital Mammography (DM) and Selenia Dimensions Breast Tomosynthesis (BT) systems. Users of this manual should be the radiologic technologist and the medical physicist who are qualified to operate a Selenia Dimensions DM or Selenia Dimensions BT systems. For Mammography Screen Facilities in the United States This manual must be used by facilities in the United States using Selenia Dimensions DM or Selenia Dimensions BT 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.

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Selenia Dimensions System Quality Control Manual Chapter 1: Prologue

For Mammography Screen Facilities Outside the United States Facilities that use Selenia Dimensions DM or Selenia Dimensions BT 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.

1.3

How to Use the Quality Control Manual Chapter 2-Introduction on page 9: 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 Selenia Dimensions 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 Selenia Dimensions 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 21: 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 Selenia Dimensions 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 77: 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 screen-film mammography facilities.

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Appendix A-Quality Control Forms for the Medical Physicist on page 113: 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 157: Forms required for the Radiological Technologist’s quality control of the Selenia Dimensions system are provided here, or are available in the 1999 ACR Quality Control Manual. The radiologic technologist may also use their own forms (i.e. electronic) that resemble the forms listed in this appendix. Appendix C-Dose Conversion Tables for the Medical Physicist on page 189: Tungsten/rhodium (W/Rh) and tungsten/silver (W/Ag) dose conversion tables are provided in this appendix for calculating average glandular (AGD) dose on a Selenia Dimensions system. These dose conversion tables were derived for the 50 micron filters used on the Selenia Dimensions systems. Appendix D-CNR Correction Tables on page 193: Tables for dose conversion for AEC Function Performance. Appendix E-Technique Tables on page 201: Recommended manual technique tables for breast imaging using Selenia Dimensions system

1.4

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

• •

Hologic: Selenia Dimensions System User Guide American College of Radiology: Mammography Quality Control Manual, 1999 (ISBN 1-55903-142-5)

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Change Summary Revision 001

•

Added QC tests necessary for Tomosynthesis option to create a single manual for both Selenia Dimensions configurations.

• •

The Collimation Assessment test procedure was simplified.

• •

The Technologist’s Phantom Control Charts were reformatted for clarity.

An Alignment test for screening compression paddles was added to the Collimation Alignment test procedure. Tomosynthesis Technique Chart was added.

Revision 002

• • • •

Added training requirements for the digital breast tomosynthesis modality Identified the default CNR correction tables used on the system Classified the Detector Ghosting test as an optional troubleshooting test Identified the tests applied to the Digital Breast Tomosynthesis modality

Revision 003

•

Add further clarifications to the calculations needed in the Collimation Assessment test

•

Add further clarifications to the recommended performance criteria in the Phantom Image Quality Assessment (Chapter 2) and Phantom Image (Chapter 3) tests

• • •

Correct some errors to optional CNR correction tables listed in Appendix D Small miscellaneous editorial changes Changed the Artifact Evaluation test exposure for the Tomosynthesis Option from 28 kV to 30 kV.

Revision 004

• • • • • • • • •

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Added a new icon to identify tests intended only for diagnostic systems Clarifications to the DICOM Printer Quality Control Clarifications to the DICOM Printer Artifact Evaluation section Expanded White Level Performance to include additional displays Added missing W/Al columns in the Technologist’s Data Collection Worksheet Added an SNR worksheet for the radiologic technologist Improved the CNR Calculation Worksheet Added new CNR correction tables in Appendix D Updated Technologist's Worksheet Forms

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Revision 005

•

Clarification to the Artifact Evaluation section for the Radiologic Technologist

•

Updated the CNR correction tables in Appendix D

Revision 006

•

Updated the Tomosynthesis technique table in Appendix E.

•

Clarification to AEC Table 4 in the CNR Correction – Conventional (Magnification) section in Appendix D.

•

Corrected errors in prescribed techniques in Automatic Exposure Control (AEC) Function Performance tests for the Medical Physicist.

Revision 007

•

Added a note in Chapter 2 clarifying how to record measurements under the tomosynthesis option.

•

Added a note in Appendix D not to apply the CNR Correction factors when tracking AEC performance using AUTO TIME mode.

Revision 008

•

Corrected orientation of Phantom position on SNR Results Dialog Box image in Chapter 3.

•

Updated several Radiological Technologist QC forms in Appendix B.

Revision 009

•

Corrected resolution issues of the control charts in Appendix B used to record the Signal-to-Noise Ratio (SNR) and Control-To-Noise Ratio (CNR) measurements.

Revision 010

•

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".

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1.6

Terms and Definitions Accession Number AEC Ag AGD Al Biweekly BT C-View™ Collimator Combo Mode

Dialog Box

DICOM

Digital Marker

DM ESE FAST Paddle™ Grid HIS/RIS

HTC™ HVL

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A DICOM term that refers to a RIS generated number that uniquely identifies a visit to a site by a patient. Automatic Exposure Control. A method of limiting the amount of radiation a patient will receive. Silver Average Glandular Dose. Aluminum Every two weeks. Breast Tomosynthesis Hologic-generated digital mammogram (DM) image from data acquired during a breast tomosynthesis scan Device at the x-ray tube used to restrict the area of the receptor that is exposed. 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. 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. Digital Imaging and Communications in Medicine. An industry standard specification for inter-communication between medical imaging equipment. A software implemented mechanism for imprinting a mark within an image to indicate some information, usually orientation. Digital Mammography Entrance Skin Exposure Fully Automatic Self-Adjusting Tilt Paddle Element within the Digital Image Receptor which reduces scatter radiation during exposure Hospital Information System/Radiology Information System. Generic term for non-PACS systems that track patient demographics and ordered radiological studies. High Transmission Cellular Grid Beam Quality Half-Value Layer

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Image (Object)

kVp LFS Login/Logout

Mag mA mAs MQSA N OD Operating System (OS) Outputs

Procedure

Rh or Rho ROI Series

SFS SID Sign-in

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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). An electrical term used in setting x-ray exposure which stands for kilo-volt peak. Large Focal Spot 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. Magnification mode An electrical term used in setting x-ray exposure which stands for milliamperes An electrical term used in setting x-ray exposure which stands for milliampere-seconds. Mammography Quality Standards Act Newtons Optical Density The basic software control system which runs all functions of a computer. A list of devices the captured, accepted image will be sent to. Outputs consist of a combination of archives, workstations and film printers. 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. Rhodium Region of Interest 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. Small Focal Spot Source to Image Distance The process of a user identifying him/herself to the Acquisition Workstation application.

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Sign-out Technique Tomosynthesis (Tomo)

View

Visit

W

1.7

The process of a user exiting the Acquisition Workstation application, but not logging out of the OS. Combination of x-ray parameters (kV, mA, etc.) defined for a particular procedural view. 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. 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. 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. Tungsten

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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Selenia Dimensions System Quality Control Manual Chapter 2: Introduction

Chapter 2 Introduction 2:

A facility using the Selenia Dimensions 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 Selenia Dimensions system is described in this Quality Control Manual. All facilities in the United States that use the Selenia Dimensions 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 Selenia Dimensions system according to the manufacturer’s recommendations. This manual may be used independently of any software revision running on the system.

2.1

Personnel Training MQSA Final Regulations require that personnel must receive appropriate training before they qualify to use the Selenia Dimensions Digital Mammography (DM) or the Selenia Dimensions Breast Tomosynthesis (BT) systems. Facilities using a Selenia Dimensions DM system require training in the digital mammography. Facilities using the Selenia Dimensions BT 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 Digital 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 Selenia Dimensions system Equipment Evaluations before clinical use commences after the equipment is first installed, moved, or significantly modified-see CFR 900.12(e)(10). The Selenia Dimensions 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 system, the applicable tests in Section 900.12(b) are listed in Table 6 in the ACR Mammography Quality Control Manual (1999), with the exception of 11, 12, and 13. The applicable tests in Section 900.12(e) are listed in the table on page 11. 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 DM system to Selenia Dimensions BT system is considered to be a significant modification to the system. In the event of such an upgrade to an existing Selenia Dimensions DM system, the medical physicist is required to perform a full equipment evaluation after the upgrade as per the table on page 11. The medical physicist must provide operating levels and control limits to the technologist for the Quality Control tests pertained to the radiologic technologist, where appropriate, e.g., CNR Test. Such operating levels and control limits must follow the guidelines of the Selenia Dimensions 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 Selenia Dimensions 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)

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.

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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/Radiation-EmittingProducts/MammographyQualityStandardsActandProgr am/Regulations/ucm110880.htm. 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 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:

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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.

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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.

•

Perform the mammography equipment evaluation and correct all test failures before the affected equipment is used for patient examinations.

•

Keep records of the test results and follow-up actions in accordance with 21 CFR 900.12(d)(2).

If all the above (1-8) conditions are met, 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. FDA’s acknowledgement as stated in item 7 above does not constitute approval of the type of testing of the software upgrade in question. FDA will contact the manufacturer if any issues arise concerning the upgrade in question. As a result, FDA may disallow testing the software upgrade under Medical Physicist Oversight if it determines that one or more of the above conditions were not met.

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2.3.2

Alternative Standard 9 Federal regulations, 900.12(e), specify that any time quality control test results fall outside of the action limits for systems with image receptor modalities other than screen-film, the source of the problem must be identified and corrective action must be taken before any further examinations are performed. If any test results fall outside the action limits according to this Alternative Standard, three different action categories apply: Category A: If any of the following quality control tests that evaluate the performance of the image acquisition components of the Selenia Dimensions system produces results that fall outside the action limits as specified by the manufacturer, the source of the problem must be identified and corrective action must be taken before any further examinations are performed. Applicable Quality Control tests: 1.

Evaluation of System Resolution

2.

Breast Entrance Exposure and Average Glandular Dose

3.

Phantom Image Quality Evaluation (Medical Physicist)

4.

Phantom Image (Radiologic Technologist)

5.

Signal-to-Noise and Contrast-to-Noise Measurements

6.

Detector Ghosting

7.

Detector Flat Field Calibration

8.

Geometry Calibration (Tomosynthesis Option)

9.

Compression

10. Post-Move and Pre-Examination Tests for Mobile Selenia Dimensions systems Category B: If any of the following quality control tests that evaluate the performance of a diagnostic device used for mammographic image interpretation (i.e. DICOM printer, physician’s review station) produces results that fall outside the action limits as specified by the manufacturer, the source of the problem must be identified and corrective action must be taken before that device can be used for mammographic image interpretation. Clinical imaging can be continued and alternative approved diagnostic devices must be used for mammographic image interpretation. Applicable Quality Control tests:

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1.

Phantom Image Quality Evaluation (Medical Physicist)

2.

Phantom Image (Radiologic Technologist)

3.

Diagnostic Review Workstation Quality Control

4.

DICOM Printer Quality Control

5.

Viewboxes and Viewing Conditions (Radiologic Technologist)

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Category C: If any of the following quality control tests that evaluate the performance of components other than the digital image receptor or the diagnostic devices used for mammographic image interpretation produces results that fall outside the action limits as specified by the manufacturer, the source of the problem must be identified and corrective action must be taken within thirty days of the test date. Clinical imaging and mammographic image interpretation can be continued during this period. Applicable Quality Control tests: 1.

Mammographic Unit Assembly Evaluation

2.

Collimation Assessment

3.

Artifact Evaluation

4.

kVp Accuracy and Reproducibility

5.

Beam Quality Assessment – HVL Measurement

6.

Automatic Exposure Control (AEC) Function Performance

7.

Automatic Exposure Control (AEC) Reproducibility

8.

Radiation Output Rate

9.

Viewbox Luminance and Room Illuminance (Radiologic Technologist)

10. Compression Thickness Indicator 11. Visual Checklist 12. Repeat/Reject Analysis

2.4

Quality Control Activities for the Medical Physicist The following table lists the Quality Control tests to be performed by a qualified medical physicist at the specified frequency. These tests cover Selenia Dimensions Digital Mammography (DM) and Breast Tomosynthesis (BT) systems. All tests listed in the following table describe the tests and procedures to be followed when testing a Selenia Dimensions DM or BT system. The table on page 17 lists a subset of the QC tests from the following table that have specific actions for performing quality control activities on a Selenia Dimensions BT system. The medical physicist performing the Quality Control Activities for the Selenia Dimensions DM or Selenia Dimensions BT systems must have met all appropriate MQSA personnel requirements as described in Personnel Training on page 10 of this chapter.

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Table 2: Quality Control Tests to be Performed by the Medical Physicist on Selenia Dimensions DM and Selenia Dimensions BT Systems Quality Control Test Frequency Action Chapter 2 Criteria Mammographic Unit Assembly Annually Category C Mammographic Unit Assembly Evaluation Evaluation on page 23 Collimation Assessment Artifact Evaluation kVp Accuracy and Reproducibility Beam Quality Assessment-HVL Measurement

Annually Annually Annually

Evaluation of System Resolution

Annually

Automatic Exposure Control (AEC) Function Performance Dose and AEC Reproducibility

Annually

Annually

Annually

Radiation Output Rate Annually Phantom Image Quality Annually Evaluation Signal-To-Noise and Annually Contrast-To-Noise Measurements Diagnostic Review Workstation Quality Control Detector Ghosting (troubleshooting use only)

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Annually -

Category C Collimation Assessment on page 24 Category C Artifact Evaluation on page 31 Category C kVp Accuracy and Reproducibility on page 37 Category C Beam Quality Assessment-Half-Value Layer Measurement on page 39 Category A Evaluation of System Resolution on page 41 Category C Automatic Exposure Control (AEC) Function Performance on page 44 Category A Breast Entrance Exposure, AEC Category C Reproducibility, and AGD on page 49 Category C Radiation Output Rate on page 55 Category A Phantom Image Quality Evaluation on page 58 Category A Signal-To-Noise and Contrast-To-Noise Measurements on page 97 Category B Diagnostic Review Workstation Quality Control on page 69 Category A Detector Ghosting (Troubleshooting Use Only) on page 72

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Table 3: Quality Control Tests with Tomosynthesis-Specific Options Quality Control Test Frequency Action Chapter 2 Criteria Collimation Assessment

Annually

Category C Collimation Assessment on page 24

Artifact Evaluation Beam Quality Assessment-HVL Measurement

Annually Annually

Evaluation of System Resolution

Annually

Automatic Exposure Control (AEC) Function Performance Dose and AEC Reproducibility

Annually

Phantom Image Quality Evaluation

Annually

Category C Artifact Evaluation on page 31 Category C Beam Quality Assessment-Half-Value Layer Measurement on page 39 Category A Evaluation of System Resolution on page 41 Category C Automatic Exposure Control (AEC) Function Performance on page 44 Category A Breast Entrance Exposure, AEC Category C Reproducibility, and AGD on page 49 Category A Phantom Image Quality Evaluation on page 58

Annually

Note Steps within a QC test labeled "Tomosynthesis Option" are only performed on Selenia Dimensions BT systems.

2.5

Quality Control Activities for the Radiologic Technologist The following table lists the Quality Control tests to be performed by a qualified radiologic technologist at the specified frequency. These tests cover Selenia Dimensions Digital Mammography (DM) and Breast Tomosynthesis (BT) systems. All tests listed in the following table describe the tests and procedures to be followed when testing a Selenia Dimensions DM or BT system. The table on page 18 lists a subset of the QC tests from the following table that have specific actions for performing quality control activities on a Selenia Dimensions BT system. The radiologic technologist performing the Quality Control Activities for the Selenia Dimensions DM or Selenia Dimensions BT systems must have met all appropriate MQSA personnel requirements as described in Personnel Training on page 9 of this chapter.

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Selenia Dimensions System Quality Control Manual Chapter 2: Introduction

Table 4: Quality Control Tests to be Performed by the Radiologic Technologist on Selenia Dimensions DM and Selenia Dimensions BT Systems Quality Control Test Frequency Action Chapter 3 Criteria DICOM Printer Quality Control Weekly Category B DICOM Printer Quality Control on page 78 Detector Flat Field Calibration Weekly Category A Detector Flat Field Calibration on page 83 Artifact Evaluation Weekly Category C Artifact Evaluation on page 88 Phantom Image Weekly Category A Phantom Image on page 93 Signal-To-Noise and Weekly Category A Signal-To-Noise and Contrast-To-Noise Contrast-To-Noise Measurements Measurements on page 97 Compression Thickness Biweekly Category C Compression Thickness Indicator Indicator on page 104 Diagnostic Review Workstation Weekly Category B Diagnostic Review Workstation Quality Control Quality Control on page 69 Viewboxes and Viewing Weekly Category B Viewboxes and Viewing Conditions Conditions on page 108 Visual Checklist Monthly Category C Visual Checklist on page 109 Repeat/Reject Analysis Quarterly Category C Repeat/Reject Analysis on page 110 Compression Semiannually Category A Compression on page 111 Table 5: Quality Control Tests with Tomosynthesis-Specific Options Quality Control Test Frequency Action Chapter 3 Criteria Geometry Calibration (Tomosynthesis Option) Artifact Evaluation Phantom Image

Semiannually Weekly Weekly

Category A Geometry Calibration (Tomosynthesis Option) on page 86 Category C Artifact Evaluation on page 88 Category A Phantom Image on page 93

Note Steps within a QC test labeled "Tomosynthesis Option" are only performed on Selenia Dimensions BT systems.

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MAN-01965 Revision 010