The Legal and Regulatory Impact of Digital Mammography Presented by Bonnie Rush, RT(R)(M)(QM) President, BIS – Breast Imaging Specialists Consulting, Education.

The Legal and Regulatory Impact of Digital Mammography

Presented by Bonnie Rush, RT(R)(M)(QM)President, BIS – Breast Imaging SpecialistsConsulting, Education and Community Outreach

Author, MQSA Made [email protected]

858-277-2213 phone/fax

Monday, July 9,20072:30 – 4 PM

Co-sponsored by

Beekley CorporationRadiology Skin Markers

Breast Biopsy Accessories www.beekley.com

&Iron Mountain

Records Management Company www.ironmountain.com

The Impact of Digital Mammography

Mammography Is A Challenging Modality

Tight Balancing Act Between Requirements and Limitations

Why Transition At All?

Analog Has A Low PPV

Misses 10-15% of cancers overall

Misses 20-35% of cancers in dense breasts

Digital Mammography Has Many Advantages

Has Analog Reached It’s Peak Capabilities?

Fatty Tissue and Masses

Glandular Tissue and Microcalcifications

Film Characteristics – Tied to H&D CurveDensities are displayed in the toe of the curve =

low contrast and inability to delineate characteristics adequately

The Challenge Fibrous (dense) tissue and infiltrating ductal carcinoma

have almost the same attenuation making it difficult to “see” the pathology!

Advantages of Digital Mammography

Ability to manipulate images Not tied to H&D curve

Increase in perception of changes Reduces recall rates

Telemammography is availableReorganization possibilityExperts can be utilized

Soft copy is always an original

No lost images

Simple interface available to run CAD

The Digital Mammographic Imaging Screening Trial – DMIST (49.500 women)

Does this impact the timing of our transition to digital?

The DMIST

indicated 65% of women

would benefit from digital.

Who Are These Women?

Under 50

Pre- or peri-menopausal

Heterogeneously or extremely dense breasts

More Importantly

• Cancers detected by digital … and missed by film in the subset, included many invasive and high grade in situ malignancies.

• These are precisely the lesions that must be detected early to save more lives through screening.

» Digital vs. Film Mammography in the Digital Mammographic Screening Trial (DMIST): Questions and Answers http://www.acrin.org/dmist_qa.html

Maintaining Patient Base In Analog

"Fast Facts"

http://www.acrin.org/dmist_fastfacts.htmlEtta Pisano, Co-Principal Investigator, ACRIN DMIST

Film mammography has been successfully used as a screening tool for breast cancer

for over 35 years.

It would be better to have a film mammogram …than for her to delay her screening in order

to get a digital mammogram.

No woman should defer screening with mammography just because of a lack of access

to digital mammography.

A Consideration For the Analog Department

The identified improvement in accuracy is important to consider when providing services to this subset… especially if there are digital

units they could be referred to. Could be seen as a reason for delay in diagnosis if

analog does not find the cancers that are detected later.

Diagnostic Findings

RCC - Digital Image

RCC- Screen Film Image

Hologic

FFDM Stats • FFDM's market share rose from 3% in

2003 to 13.8% in 2006, – report from market research and consulting firm, Frost

& Sullivan of San Jose, CA ("North American X-Ray Mammography Markets," February 6, 2007).

• FDA stats 7/1/07– Total certified facilities / 8,836

• w/FFDM units / 1,991 = 22.5%

– Total accredited units / 13,405• FFDM units / 2,926 = 21.8%

Living in The Digital DivideOffering Both Digital and Analog

Patient Issues

Legal Issues

Productivity Issues

Choosing the Digital Divide

Some entities believes that it makes sense to start out with one digital unit, identify problems

that might arise, and then develop solutions before acquiring additional systems.

Others cannot afford to transition all at one time.

How will you triage your patients?

Offer Every Women a Choice?• ~ 2003 - Tried offering digital mammography on a

first-come, first-served basis. • As increasing numbers …are starting to ask for

digital mammograms, the staff now tries to accommodate those requests.

• The plan is to perform annual and follow-up’s on the digital unit if a patient's prior studies were done digitally.

Zeeshan Shah, MD, and other physicians at the Indiana University School of Medicine - Understanding Workflow in the FFDM Environment By Carol Daus Decisions in Imaging Economics October 2004

Before DMIST results but…

this was still not efficient!

Pre-screen Every Patient? ~2003 … the radiologists look at the previous year's films to see which women would benefit

from digital imaging. "If we have three patients coming in per hour, it is not hard to determine which one is better

suited to the digital unit," Laurie Fajardo, MD, chair of the department of radiology,

University of Iowa Health Care, Iowa City.

Understanding Workflow in the FFDM Environment

By Carol Daus Decisions in Imaging Economics October 2004

But you need about 6 per hour to support digital!

Educate Those That Fall Outside The DMIST Profile?

• For these women, – Over age 50– are no longer menstruating and   – do not have dense or heterogeneously

(very dense) breast tissue– there was not a statistically significant

difference between the sensitivity of digital vs. film mammography.

Must review old films for tissue density

Negatives • Time consuming to pre-screen and/or

educate

• Legal risk if cancer found next year on digital and had analog this year

• Technologists and radiologists living in analog/digital divide decreases overall productivity.

Analog or Digital Positioning and Interpretation

Brenner 2003Probably the two most important factors to

reconcile whether digital or film is better, have to do simply with who interpreted the study

and what they decided on management, and on positioning differences.

Dershaw 2005The experience and skill of the technologist

performing the exam and the expertise of the radiologist who evaluates it are at least as

crucial as whether the mammogram is done digitally or with traditional film.

MQSA

FFDM Guidance

DR and CR

What Units Are Approved/Available

Direct Radiography (DR)GE Senographe 2000D

GE Senographe DS GE Senographe Essentials

Hologic/Lorad Selenia FFDM System Siemens Mammomat Novation DR

Computed Radiography (CR)Fuji Computed Radiography Mammography (FCRm)

Accreditation and Certification How Do They Differ?

Only MQSA certified facilities can lawfully provide mammography services.

Issuance of an MQSA certificate occurs AFTER the Accrediting Body (AB) notifies the

Certifying Agency (CA) that the facility’s accreditation application is acceptable.

Accreditation The AB will accredit the facility once it establishes that the mammography facility meets the quality

standards established under MQSA.21 C.F.R. 900.4.

The regulations require the AB to review a mammography facility's equipment, personnel

(interpreting physicians, radiologic technologists, and medical physicists), and practices including a review

of clinical images and phantom and dose.

The Accreditation Process

Medical Equipment Evaluation (MEE) by Medical Physicist (MP)

Send in to AB w/application and

accreditation fees

AB notifies the CA w/in two business days of acceptance of application

Facility receives 6 month certificate

.

“New” To Mammography

Because your facility is not already certified, you MUST receive your

MQSA certificate before you begin patient exams

Check with your state in case they mandate applications before beginning

patients

Certified - Adding “New” Unit

CMS will not reimburse for examinations performed until the CA is notified by the AB

they received your application materials

Wait 3 business days – contact ABConfirm CA received info

Begin patient exams

Accreditation packet arrives

Submit hard copy clinical and phantom images and TLD (dosimeter) w/in 45 days

Wait and pray for about 60 days!!!

If pass receive 3 year accreditation and certification

And Then…. The Hard Part Begins

Submission Considerations

Positioning Training Is Essential

• … receptors as thick as 3.5 inches at the chest wall. … "dead space" between ... receptor edge (at) …chest wall and where the actual image is captured.

• …may make it difficult for some technologists to obtain as much tissue …as they were able to obtain with analog.

– Examine Mammography: A True TransitionBecoming proficient in a digital worldvol. 20, RT Image no. 13 -- March 26, 2007 By Tammy Coryell, RT(R)(M)

                              RMLO - Screen Film Image

RMLO - Digital Image

Nowhere to Hide!

Screen-Film and Digital Comparison

LCC - Screen Film Image

LCC - Digital Image

Hologic

Who Does It?

Accrediting Bodies (AB)ACR, Arkansas, Iowa and Texas

Your facility may accredit with the ACR or the State

Certifying Agencies (CA)FDA

Illinois, Iowa and South Carolina Your facility must use the state CA

Their requirements are the same as the FDA’s

AB Contact Information• American College of Radiology (ACR)

Mammography Accreditation Program1-800-227-6440

• Arkansas Department of Health and Human ServicesDivision of HealthRadiation SectionMammography Program1-501-661-2301 

• Iowa Department of Public HealthBureau of Radiological HealthMammography Program 1-515-281-3478 

• Texas Department of State Health ServicesRadiation Control Program1-512-834-6688

AB’s and Units They Approve

  As of February 21, 2007 Accreditation Body Effective Date

FFDM Unit ACR Arkansas Iowa Texas

GE Senographe 2000D 02/15/03 08/15/06 10/01/03 05/21/04

Fischer Imaging SenoScan 08/15/03

    05/21/04

Lorad/Hologic Selenia 09/15/03 08/15/06 10/01/03 05/21/04

GE Senographe DS 09/15/04 08/15/06 01/17/06 09/15/04

Siemens Mammomat Novation 10/15/05

  02/01/06 06/29/06

GE Senographe Essential 07/15/06 08/15/06 08/24/06 09/05/06

Fuji Computed Radiography for Mammography 11/15/06 10/12/06 11/13/06 11/13/06

CA Contact Information • MQSA

Facility hotline at 1-800-838-7715 or by e-mail to [email protected].

• State of Illinois - Office of Radiation Safety - MAPDepartment of Nuclear Safety1035 Outer Park DriveSpringfield, IL 62704217-785-9974

• Iowa Department of Public HealthLucas State Office Bldg., 5th Floor321 East 12th StreetDes Moines, Iowa 50319515-281-3478

• State of South CarolinaMammography Certification Program

Department of Health and Environmental Control2600 Bull StreetColumbia, SC 29201803-545-4400

CR Accreditation and Certification Specific to The Mammography Unit

If you have multiple S-F units and plan to use CR with more than one,

must submit for each unit you will use

even if they are the same make and model

Medical Physicist Involvement Initial Survey at Installation - MEE

Annual Surveys

Software Upgrades

Medical Physicist MEE

900.2(bb) Mammography equipment evaluation (MEE) means an onsite

assessment of mammography unit or image processor performance by a medical physicist

for the purpose of making a preliminary determination as to whether the equipment

meets all of the applicable standards in section 900.12(b) and (e).

QC is Manufacturer Specific

Physicist Training

Medical physicists who have met the new modality training requirement (8 hours)

should also receive training in any new unique features before beginning

to perform evaluations of other units

Document their FFDM training for your equipment

(DR v. CR surveys - differing manufacturer’s tests and testing procedures and updates - software

changes)

Medical Physicist's Equipment Evaluation and Annual Survey Forms

and Approved Alternative Requirements

For Each Manufacturer

Available at www.acr.org - link to the following Accreditation

MammographyForms

Med Phys Equip and Ann Survey Forms

Annual Surveys

At least once each year (up to 14 months between).

Signed by the qualified MP that performed or supervised the survey.

As of July 1, 2007 annual surveys no longer need

to be sent to the AB each year

Software Changes/Upgrades Considered Major Repairs

Approved software changes relates mainly to GE FFDM Units • The manufacturer will specify the tests and who

must perform them:– Some must be performed by the MP or under the direct

supervision of the MP – Some can be performed by the QC technologist under

MP oversight • Oversight = MP 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.

• The tests must be adequate for determining whether all standards are still met.

Equipment Evaluations/RepairsListed in the MQSA Policy Guidance Help System (PGHS)

Listed in the manual MQSA Made EasyExhibit 6: Medical Physicist Involvement in Equipment Repairs

Equipment evaluation of a unit or processor that has been disassembled and reassembled

All applicable tests and equipment requirements described in 900.12(b) and (e)

Alternately the decision can be made by the medical physicist

.

Equipment evaluation of a unit or processor that has undergone a major repair

Only those tests and equipment requirements described in 900.12(b) and (e) that are applicable to the repaired component of the unit or processor.

The decision as to what constitutes applicable tests and equipment requirements for the repaired component should be made by the medical physicist.

Personnel Requirements

Initial Modality Specific Training

Continuing Education

Initial Modality Specific Training All involved personnel must have

at least 8 hours of training

Personnel who use FFDM prior to January 1, 2006 will be considered to have met the 8

hour requirement. Such personnel can attest to or document this experience.

CR or DR - they should receive training on component differences

prior to using the unit clinically

Acceptable Training Documentation

Modality specific CME/CEU courses plus agenda, outline, or syllabus

Confirming letters from CME/CEU provider

Letters, certificates or other documents from manufacturer’s

or other formal training providers

Modality Specific Continuing Education

The FDA is to delete this requirement and will delay enforcement indefinitely

due to recommendations from the National Mammography Quality Assurance Advisory

Committee (NMQAAC) and the Institute of Medicine (IOM).

Recordkeeping

Retention

Transfer

FFDM Guidance • There are two sections of the

recordkeeping requirement that are affected by the introduction of FFDM– The first deals with retention of the

mammography images and in what format– The second deals with transferring of images.

What Constitutes a Mammogram For Image Retention Purposes?

• For digital imaging, – the facility must maintain, in retrievable form,

for the required retention timeframes either the• Original (raw)• lossless compressed data or • hard copy films that duplicate the soft copy

interpretive quality

Identification Mandate

The regulations require identifying information be indicated on each mammographic image, as with

hard copy film.

Lossless v. Lossy Image

Compression • Lossless compression accurately preserves

all the essential data from the original image and is mandated for mammography. – Reduces file size by compressing only the non-

essential area surrounding the actual breast image.

• Lossy compression does not preserve all the essential data and is acceptable for most imaging modalities– It averages a group of pixels to compress the

image

Lossy Compressed Images • From a risk-management perspective, it's

going to be extraordinarily difficult to defend a "failure to diagnose" case involving lossy-compressed images.

• Plaintiffs' attorneys are getting increasingly sophisticated with regards to these issues, and they will press this point.

– Spencer Studwell, a senior associate general counsel, director of risk management, University of Rochester Medical CenterVigilance key to managing risk in the digital world 5/15/2007 AuntMinnie By: Erik L. Ridley

Electronic Image Transfer

• Facilities may transfer, when it is acceptable to the recipient, such as a transfer between two FFDM facilities, the original or lossless compressed images electronically.

Comparison With Outside Digital Images

• There simply is not the ability to conveniently exhibit comparison digital images from different types of units

Cautionary Advice • Faithful reproduction of the processed

image may be subject to modest acceptable variations; – even current practices that compare images

from other institutions will identify differences in technique and accommodate for such differences.

• The user is advised to validate such transmission, …so that significant image differences do not invite misinterpretation.

– Full Field Digital Mammography: Initial Medical

Legal Concerns R. James Brenner MD,JD,FACR

We’re Getting There

• Integrating the Health Enterprise (IHE) mammography subcommittee has been working with vendors to specify what needs to be done to ensure consistent display of images.

Integrating the Health Enterprise

IHE Mammowww.ihe.net/mammo/index.cfm

• The Mammography Image Integration Profile (MAMMO) specifies how DICOM Mammography images and evidence objects are created, exchanged and used. 

• It is currently published in a Trial Implementation draft, which will be used for testing at Connectathonsin 2007. 

Hard Copy Image Transfer

• For purposes of transferring images, – Upon request the facility must be able

to provide the medical institution, physician, healthcare provider, patient or patient’s representative, with hard copy films of primary interpretation quality.

• In order to conform to this requirement, all facilities need access to a printer.

Charging for Hardcopies• The facility may not charge for creating the

first hardcopy version of the mammogram.– However, if the patient requests a second one or

more additional hard copies of the mammogram, the facility may pass the costs of that reproduction on to the patient.

Printers and Monitors

Printer Requirements

Monitor Requirements

Requirements for FFDM Printers

• Printers no longer have to cleared by the FDA

• But they must be able pass all applicable QC tests established by the FFDM manufacturer

• Must pass the facility’s accreditation body’s phantom and clinical image review process.

• QC must be performed at their appropriate frequencies or, prior to printing clinical imagesfor patients and other health-care providers.

Printers - Dry Laser of Course

• Image quality depends on a number of factors including – resolution, noise, image color, interpolation

and overall contrast and density • Requirements are greater than

any other imaging need: – A Dmax of 3.5 or greater – A base plus-fog level of less than 0.25. – 16 bit images with at least 12 bit gray levels.– Image color blue/black like analog

IHE Considerations• Print composers should support true-size printing,

– since this ensures accurate measurements on printed film.

• Images should be justified so that the chest wall is printed as close to the edge of the film as the print server is capable of printing it.

• All annotations defined for image displays, along with a ruler or distance scale, should be burned into the pixel data.

• A pixel transmission of 12 bits or more to the print server should be specified.

» Digital Mammography: Integration Into a Practice

by Laurie L. Fajardo, MD, MBA; and Jeong Mi Park, MD Imaging Economics December 2006

MonitorsReview Workstations (RWS)

The Portal to Filmless Mammography

LORAD RWS

FDA Mandates 5K Monitors to achieve the resolution needed in mammography

Multi-Modality Makes Sense Multi-Modality Breast Image Review Station

Synapse®, Fuji’s web-based PACS

IHE Directives• The radiologists can specify image hanging protocols

– that fit their reading preferences

• The image hanging protocols allow – the combination of current and prior studies

• Appearance of the images – is accurate in the displayed gray levels

• Application of window level/width is smooth – And does not suddenly wash out the displayed information

• Changing the window level/width – does not change the background of the image

• Study information is displayed as on analog images • The RWS is able to display CAD marks

– on top of the corresponding images.

Monitors - QA Differences • QA can be a substantial time commitment

– Be informed about the manufacturer's recommended QA program and understand the amount of time required to perform all QA tasks associated with the display.

• …automated display calibration solutions are helping to decrease this burden.

Automated Display QA Delivers Peace of Mind... and More Health Imaging & IT June 1, 2006

QC Criteria

CR v. DR

Records

Retention Timeframes

QC Testing • 900.12(e)(6): For systems with image

receptor modalities other than screen-film, the QA program shall be substantially the same as the QA program recommended by the image receptor manufacturer,– except that the maximum allowable dose

shall not exceed the maximum allowable dose for screen-film systems in paragraph (e)(5)(vi) of this section.

Quality ControlDR or CR

Each manufacturer’s manual will explain

their required QC procedures

By regulation, facilities must follow these manuals (in terms of the frequency of the QC tests as well as the QC test procedures) when

performing their routine QC tests, mammography equipment evaluations (MEE),

and annual physics surveys.

Initially QC will take longer until the QC technologist is familiar with the tasks

S-F 11 tests – FFDM 15 (depends on manufacturer and modality approach)

Elimination of wet processing immediately reduces many of the daily QC concerns

There is the potential that eventually many of these tasks will becoming automated

i.e. Repeat Analysis:

Repeats are immediately entered and can be downloaded by category/individual.

Phantom TestingFor Weekly QC Record/Images:

Lorad/Hologic Selenia Siemens Mammomat NovationDR,

Phantom test passing score is 5, 4, 4 (or 4.5, 4, 3.5 under certain conditions).

For the phantom produced during the inspection for regulatory action:

Passing score is the same as was established by the FDA approved accreditation bodies

for S-F systems - 4, 3, 3

Some manufacturers (like GE and Lorad/Hologic) also instruct the facility to conduct and pass the flat field test before conducting the phantom image test.

LoRad Daily and Weekly TestsSample from ACR website

Highlighted tests are specific to FFDM systems

Darkroom Cleanliness(daily, if app)

Processor QC(daily, if app)

Laser Printer QC(weekly-dry; daily-wet)

Viewboxes and Viewing Conditions(weekly, if app)

Artifact Evaluation(weekly)

SNR & CNR Measurements(weekly)

Phantom Image (weekly)

Detector Flat-Field Calibration(biweekly)

Review Workstation QC (See FDA Guidance)

LoRad Monthly, Quarterly & Semi-Annual Tests Sample from ACR website

Highlighted tests are specific to FFDM systems

Visual Checklist(monthly)

Analysis of Fixer Retention in Film(quarterly)

Repeat Analysis(quarterly)

Darkroom Fog (≤0.05)(semiannually)

Compression(25-45 lb)

(semiannually)

Review Workstation QC (See FDA guidance)

Remain Updated Because of continuing innovations in digital mammography and software

programs, FFDM system manufacturers typically issue updates

or revisions of their QC manuals to keep them current.

The facility must have on hand the most recent QC manual and follow

these testing procedures.

List of Mandated Tests and QC formsand

FDA Approved Alternative Requirements

For Each Manufacturer

Listed on ACR website – www.acr.orgLink to the following

Accreditation Mammography

FormsRT QC Forms

Correction Period for FFDM Failures

• If related to the image review components only, – images can continue to be acquired.

• If related to the acquisition of images only,

– the review of already acquired images can continue

• For FFDM specific component corrective action timeframes refer to the FDA website for approved alternatives – – http://www.fda.gov/cdrh/mammography/

or check with the unit manufacturer.

QC Test Retention TimeframesDaily QC tests Previous 30 days

Weekly QC testsPrevious 12 weeks

Monthly and Quarterly QC Tests Since the last inspection

Semi-Annual QC Tests Since the last inspection and/or until the test has

been performed two additional times at the required frequency,

whichever is longer

QC Tests - Record Retention • Keep records and all applicable

corrective actions for the longer of the below:– The last 12 months– since the last annual inspection which

verifies compliance

– until the test has been carried out an additional two times at the required frequency.

Inspections Dr and CR

All inspection tests similar to S-F will be performed by the inspector

Inspector Will CheckMEE or survey performed by the MP

Personnel Training Documents

Latest version of all QC manuals for system components issued to it by the manufacturer

Conducted all the QC tests listed in the manuals

Performed monitor and printer QC per manufacturer’s recommendations

Performed (and documented) timely corrective action(s) for the tests that failed.

The InspectionPhantom Test

The QC technologist will expose the facility’s phantom with the technique factors used clinically for the weekly phantom test

Displayed/scored on the AWS or the RWS depending on the FFDM unit

Displayed with the window level/width to the facility uses to review and score its phantom images.

Legal Considerations

"It takes a while for the legal system to catch up with medical technology.

The law hasn't caught up with digital radiology yet, but eventually it will." Leonard Berlin, MD, Radiology Chair, Rush North Shore

Medical Center Digital Images Meet the Law by Lisa Fratt September 2004 HEALTHIMAGING.COM

Reasonable Clinical Practice Patterns

• The potential legal issues derivative (offshoot) to such technology should be recognized so that reasonable clinical practice patterns may integrate such considerations into their approach.

» Full Field Digital Mammography: Initial Medical Legal Concerns R. James Brenner, MD,JD,FACR

Importance of QC Should Not Be Underestimated

The lack of uniformity of QC standards … ... invites a wider consideration of the

medical legal implications related to FFDM.

If a cancer is later detected on a different type (CR or DR) or FFDM unit (or with a different workstation), compliance with a

vendor defined QC program will likely survive objections.

Full Field Digital Mammography: Initial Medical Legal Concerns R. James Brenner, MD,JD,FACR

Interpretation Issues Image Manipulation

“An electronic image can be changed in a number of ways. Now, we’re introducing a whole new litany of potential allegations stemming from a radiologist’s failure to manipulate a digital image properly.”

Leonard Berlin, MD, chairman of radiology at Rush North Shore Medical Center (Skokie, Ill.), September 2004 HEALTHIMAGING.COM Digital

Images Meet the Law by Lisa Fratt

Room Lighting

Studies at the Baltimore VA

Match ambient room light to monitor light in a reading room,

Radiologists window/level images half as often

as when light isn’t balanced

Complaints of fatigue drop to zero from 50 percent.Dream Reading Rooms Require Team Effort

Health Imaging & IT - April 1, 2007 - By Cheryl Hall Harris, RN   

Radiology Reading Room of The Future

Leslie Fort, MD, sits in the ‘Radiology Reading Room of the Future’ at the Baltimore VA Medical Center that has Xybix furniture, chair and

ergonomic technology solutions and a GE Centricity PACS workstation.

Reading Room Essentials Health Imaging & IT December 1, 2006

The Subject Of Current Investigation

Reasonable manipulation: … may require an understanding of

limitations for certain types of lesions — and thus greater image manipulation.

Full Field Digital Mammography: Initial Medical Legal Concerns R. James Brenner, MD,JD,FACR

Importance of the Audit

• But…prolonged and extensive windowing might not be routinely justified, – especially if audit-demonstrated

outcome data from standard manipulations yield results consistent with reasonable practice.

» Full Field Digital Mammography: Initial Medical Legal Concerns – R. James Brenner, MD,JD,FACR

The Effective Audit

The ACR web site – www.acr.orgstep-by-step educational guides for understanding

and initiating a standard breast imaging audit.

Benchmarking

• Benchmarking between like entities is important but ….difficult at best.– The National Consortium of Breast Centers

(NCBC) (www.breastcare.org) is recruiting member centers to join their database

– Emphasis is placed on ability to compare with same type of facilities.

Magnification Considerations

Geometric

v.

Electronic

Electronic Magnification

By distributing the imaged data over more pixels, an apparent increase in resolution

is anticipated.

However, clinical trials are lacking to validate this hypothesis.

Full Field Digital Mammography: Initial Medical Legal Concerns R. James Brenner, MD,JD,FACR

Legal Concerns

• Some users have employed electronic magnification for the diagnostic analysis of a specific focus.

• Where standard of care concerns would prompt (geometric) magnification views, this approach may be contested.

» Full Field Digital Mammography: Initial Medical Legal Concerns R. James Brenner, MD,JD,FACR

Electronic Magnification Benefit2005 Study

• Assessment of BI-RADS 4 or 5– Magnification recalls for microcalcifications

• 56.5% of SFM patients• 8.8% of FFDM patients

• In 91.2% of FFDM patients, recommendations for biopsy of suspicious microcalcifications were made without recall.

» Investigator Dr. Nancy Wilson, a staff radiologist at Sarasota Memorial Hospital, Sarasota, Florida

Comparison Issues Hard Copy Priors

Lossy v. Lossless Compression

Digitizing ConsiderationsWhite Paper Available at Iron Mountain “Taking Your Imaging Environment

Totally Filmless and Fully Compliant”www.ironmountain.com

* All exams were timed from patient arrival in the exam room through patient release.

** Indicated time includes the time for data entry, technologists’ explanation of the overall exam procedure to the patients, in addition to the above imaging chain.

*** The size (or %) of the reduction proven by the assessment may vary from institution to institution.

DR = 45% Reduction average examination time

DR - Exam Using Digital Imaging

8.4 min*Patientin Room

FirstExposure

& QC

Last Exposure

& QC

ReleasePatient/

Send Study to RWS

0.43% Repeat

Rate

SFM - Conventional Imaging Exam With Film

15.9 min*First FilmOut of

Processor

Patientin Room

FirstExposure

Last Exposure

Last FilmOut of

Processor

ReleasePatient

2.30% Repeat Rate

QC

DR v. Analog Exam Time

Courtesy GE Medical Systems

Analog to Digital Interpretation Times1.4 min for analog and 2.3 for digital

Average time for interpreting film-screen (light gray) and digital (dark gray) mammograms for each physician. Rad = radiologist. Berns EA, Hendrick RE, Solari M, Barke L, Reddy D, Wolfman J, Segal L, DeLeon P, Benjamin S, and Willis L, "Digital and Screen-Film Mammography: Comparison of Image Acquisition and Interpretation Times" AJR 2006; 187:38-41).

Prior Studies

• Persistent themes from recent malpractice claims in which the court decided in favor of the plaintiff include a failure to consult a prior study or report…,

– Spencer Studwell, senior associate general counsel, director of risk management, University of Rochester Medical Center AuntMinnie - Vigilance key to managing risk in the digital world 5/15/2007By: Erik L. Ridley

Comparing Hard Copy Priors

• … digital and analog images look so different,– a digital image is almost twice the size of a

film image,…– …contrast can be so different …, it's

sometimes difficult to tell if a certain cluster of calcification was really there on the prior film."

Zeeshan Shah, MD, and other physicians at the Indiana University School of Medicine Understanding Workflow in the FFDM Environment By Carol Daus Decisions in Imaging Economics October 2004

IHE – Digitization Expediting The Transition

• One possibility is to digitize the film and store it in the PACS archive, so the transition time to ‘softcopy’ reading is going to be reduced.

• A good reason to proceed with this approach is that changing eyes from lightbox to display takes some time and reduces sensitivity on the displays.

Elizabeth Wendy Breast Center

The Importance of Hybrid Information Management

• Compresses the time to a filmless environment

• Maximizes profitability: – Increase efficiencies, reduce costs & improve

productivity

• Potentially improves patient care

• Reallocates staff to more strategic initiatives

To Digitize or Not... The Positives Interpreting Physician Provider Referring Physician/Patient

Facilitates batch reading & report turnaround

Enhanced image manipulation

Increased accuracy of interpretations

Increased ease of peer/specialist consultation

Increased clinical efficiency – anytime, anywhere access to information

– Better and faster decisions about treatment and diagnosis

Deliver higher quality of care, positively impacting patient safety, access and affordability

Free up critical floor space

Lower film management costs

– To store, retrieve, hang, review, take down and refile

Reduce malpractice risks

Decrease in additional imaging/imaging studies

Faster turnaround times for patient results

Rapid access to reports and images

Optimize utilization of teleradiology/ telemammography

Increased access to specialized services/ expert consults

Increased patient/referring provider satisfaction

MQSA Regs on Digitization• Digitization of hard copy priors allowed for

comparison– Interpreting physician at same or other

facility must approve of quality

• Cannot be used/sent out for primary interpretation

• Cannot take place of hard copy for retention purposes– Not considered a mammogram according to

FDA definition so cannot be counted toward initial or continuing experience

Digitizer Mandates • FDA recommends:

– Digitizers approved or cleared by FDA’s Office of Device Evaluation

• Images must be of sufficient quality to pass phantom and clinical review if submitted to Accrediting body

Conversion Considerations

• Format: “MG (mammogram) for presentation” DICOM format– Ensures ability to upload/display on your

system

• Lossless not lossy image compression• Digitized image quality evaluated by

scanning previous true positive images and scan phantom

• Determine which films to digitize

Strategies – In-House or OutsourcedVisit Iron Mountain to See Digitization Demo

Booth 1007

• On-Demand Conversion – manages costs – Historical studies are stored in physical

format– Films are digitized as needed

• Hard copies are still retained

• Complete Conversion – too costly– All historical film studies are digitized

• Hard copies are still retained

Preparing For The TransitionAnalog CAD Processors

• Some … allow a user to digitize film-screen images for processing …and then store the digitized image as a standard DICOM “MG” (or digital mammography) object, – …allows the digitized image to be sent

to PACS or to other DICOM nodes on the network.

– Digital Mammography and Breast Imaging Implementation Guide – Release 7 – DR Systems 2007

Skin Marking In FFDM

Why Use Skin Markers?Standardization Increases both

Viability of InterpretationsAnd Productivity

Standardized Skin Markings Protocols

Available at Beekley Booth #1224

If you were not given a guideline as to what each pellet refers to, would you be able to tell?

Would have to refer to breast map or written patient history –

not efficient and/or could lead to wrong conclusion

In my medical practice, I have seen a number of cases in which mammographic markers were incorporated,

interpreted and harm to the patient resulted. Even within a single practice, I have seen different

technologists and radiologists taking a nonstandardized approach to marking…

These types of cases are difficult to defend, because the underlying malpractice reveals a lack of

standardization within the profession. Richard M. Chesbrough, MDDiagnostic Imaging Magazine

A Standardized Approach To A…

A)

Marking Protocols @ UTMADCC: MLO Mags Scar

and Nipple Marking Study

Man-o-GramsSo Important to Mark Correctly

brighamrad.harvard.edu/Cases

Archival Issues

“For Processing”

or

“For Presentation”

File Sizes Are Huge!!!

Digital Mammography: Integration Into a Practiceby Laurie L. Fajardo, MD, MBA; and JeongMi Park, MD

Imaging Economics, December ‘06

Archiving “For Presentation” (MG)

Since we should consider storage costs and bandwidth

For basic operation, archiving only the “For Presentation” images is adequate for most

facilities.IHE www.ihe.net/mammo/index.cfm

Archive “For Processing” (Raw)

• It is important to note that both review workstation and CAD systems may change their processing algorithm over time.

– It may be viewed as a benefit or liability to reprocess the “For Processing” archived images with a different algorithm.

– IHE www.ihe.net/mammo/index.cfm

– If store keep log of processing algorithm (software version) used at time of original interpretation.

IHE - Reasons to Store Both • Examples include:

– a specialty RWS that offers additional processing features that operate only on “For Processing” images.

• This usually only occurs when the acquisition modality vendor and review workstation vendor are of the same manufacturer.

– CAD results can be re-generated from the archived data.

• Storing the CAD structured reports which are compact representations is more efficient and practical.

» IHE www.ihe.net/mammo/index.cfm

CADTo CAD or Not To CAD

To Archive or Not To Archive

Strong Endorsement of CAD• ACR - CAD or Double Readings

– Double reading and computer-aided detection (CAD) may increase the sensitivity of mammography interpretation and may be utilized…

• realizing that cost and workforce issues make this difficult to accomplish at many facilities. 

– Practice Guidelines for Screening Mammography – effective 10/04

• Insurance Companies – 2004 – November - CIGNA announced

CAD had become a standard of care for larger radiology practices.

– 2005 - In April, Aetna announced that it now considers CAD a medically necessary adjunct to mammography

Not To CAD?

CAD took a hit …NEJM study found FP rate had a negative impact on the

accuracy of mammography screening.

Did the NEJM findings …have any effect on the role of mammography CAD at your facility?

Poll Results

yes 0% no 100%

Advance For Imaging And Oncology Administrators May 12 2007

…two recent studies indicate that CAD still produces beneficial results when paired with a couple of new breast screening technologies,

CR mammography and full-field digital mammography.

Studies show CAD matches up well with CR mammo, FFDM

5/24/2007 - Auntminnie.com By: Wayne Forrest

Breaking NewsJuly 11.2007

CAD Reimbursement In Jeopardy

Not To CAD…an Oregon health insurer has stopped

offering reimbursement for CAD • "Based on (the NEJM study), ODS (…an Oregon health

insurer) will no longer be covering CAD for any indication ... effective July 22, 2007." – The decision could have major ramifications for the

CAD industry should it ripple to other third-party payors.

– "Until now, ODS has considered computer-aided detection experimental and investigational for all imaging services except when used in conjunction with mammograms," said medical director Dr. Csaba Mera.

– ODS is a provider of dental, medical, and professional liability insurance that serves more than 600,000 Oregonians.

» NEJM Study Prompts Oregon Payor To Cancel CAD ReimbursementAuntminnie.com 7/11/2007 By: Cynthia Keen

CAD Helps Support FFDM

• "The reimbursement is particularly attractive when you add on computer-aided detection [CAD].”

• How many patients will it take to payoff the FFDM machine w/CAD?– It would take approximately

6500 patients a year.» NCBC email answers

Courtesy Kodak - Carestream Health

Who Is Responsible For Missed Diagnosis?

• Most vendors’ purchase agreements specify that the hospital and/or physician is responsible since CAD is currently not intended as an exclusive image screener

• The best course of action is to understand the contract and avoid overreliance on CAD-assisted reads.

– Diane McKenzie, partner and chair of Neal, Gerber & Eisenberg’s information technology group (Chicago)September 2004 HEALTHIMAGING.COM Digital Images Meet the Law by Lisa Fratt

Implications

• If marked eliminate concern or work it up– …a lesion marked by CAD, but

disregarded by a radiologist, which ultimately turned out to be cancer, may constitute negligence by the radiologist.

» An Appellate Court Ruling and Potential Implications for CAD Technology in the Courtroom - Greenberg Am. J. Roentgenol..2006; 186: 52-53.

Important Point • Great screening mammography begins

and ends with great breast imaging, and CAD was always intended only to augment, never to replace the breast radiologist.

• Each practice … should assess the clinical value of CAD on an ongoing basis…in the same manner that it should be continually assessing the other performance metrics that define clinical quality."

– Jerry Kold, NEJM study pans CAD, draws attention and criticism 4/5/2007 - Auntminnie.com By: Erik L. Ridley

To Save or Not To Save?

• There is no clearly established medical-legal decisions or regulatory requirements– At this time the decision to archive or to dispose

of CAD findings is left with the breast imaging practice.

• Traditionally, most facilities have selected not to archive CAD findings…– A trend is emerging however, where facilities are

opting to archive CAD findings.– DR Systems Digital Mammography and Breast Imaging

Implementation Guide - Release 7 – Jan 07

Erasing Or Destroying May Put You At Risk

CAD marks vary with repeated processing of the same images due to

change in software or type of unit used.

Most experts believe that we should save the CAD marks.

An Appellate Court Ruling and Potential Implications for CAD Technology in the Courtroom –

Greenberg Am. J. Roentgenol..2006; 186: 52-53.

If Not Saved

• Indicate in facility records the software generation used

• Update records with software changes

Image courtesy of iCAD.

CAD Saved the Day • Plaintiff suing for delayed diagnosis

– CAD not performed by interpreting physician

• CAD performed by expert witness for the defense – It did not mark the area where the plaintiff

developed breast cancer – Jury returned a unanimous verdict for the

defendant » An Appellate Court Ruling and Potential Implications

for CAD Technology in the Courtroom - Greenberg Am. J. Roentgenol..2006; 186: 52-53.

• Plaintiff filed appeal stating “hearsay”– Appellate court upheld the trial judge's

admission of the evidence and affirmed the jury verdict,

– CAD results were "a scientific analysis conducted by computer, which performed a series of complex mathematic calculations based on detailed information it drew from an x-ray.“

» An Appellate Court Ruling and Potential Implications for CAD Technology in the Courtroom - Greenberg Am. J. Roentgenol..2006; 186: 52-53.

In Closing…Pearls of Digital WisdomMust Be Able To Establish The:

Quality Of The Image

Adequacy Of Equipment Including Workstation

Interpretation Environment

Competency Of The Reviewer

Spencer Studwell, senior associate general counsel, director of risk management,

University of Rochester Medical Center, NY

Vigilance key to managing risk in the digital worldAuntMinnie.com 5/15/2007 by Erik L. Ridley

              E-mail Updates – sign up on FDA home page

For policy questions, check the Policy Guidance Help Systemhttp://www.fda.gov/cdrh/mammography

Facility Hotline - 1-800-838-7715.

For More Information contact me at

[email protected]

To order the bookMQSA Made Easy

visit www.mammobis.org