Transcript Slide 1

The Legal and Regulatory Impact
of Digital Mammography
Monday, July 9,2007
2:30 – 4 PM
Presented by Bonnie Rush, RT(R)(M)(QM)
President, BIS – Breast Imaging Specialists
Consulting, Education and Community Outreach
Author, MQSA Made Easy
www.mammobis.org
[email protected]
858-277-2213 phone/fax
Co-sponsored
by
Beekley Corporation
Radiology 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 Curve
Densities 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 available
Reorganization possibility
Experts 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.html
Etta 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
Hologic
RCC - Digital Image
RCC- Screen Film Image
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 Divide
Offering 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 2003
Probably 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 2005
The 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 AB
Confirm CA received info
Begin patient exams
And Then…. The Hard Part Begins
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
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 Transition
Becoming proficient in a digital world
vol. 20, RT Image no. 13 -- March 26, 2007
By Tammy Coryell, RT(R)(M)
Nowhere to Hide!
Screen-Film and Digital Comparison
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 Program
1-800-227-6440
• Arkansas Department of Health and Human Services
Division of Health
Radiation Section
Mammography Program
1-501-661-2301
• Iowa Department of Public Health
Bureau of Radiological Health
Mammography Program
1-515-281-3478
• Texas Department of State Health Services
Radiation Control Program
1-512-834-6688
AB’s and Units They Approve
Accreditation Body
Effective Date
As of February 21, 2007
FFDM Unit
GE Senographe 2000D
Fischer Imaging SenoScan
Lorad/Hologic Selenia
GE Senographe DS
Siemens Mammomat Novation
GE Senographe Essential
Fuji Computed Radiography for
Mammography
ACR
Arkansas
Iowa
Texas
02/15/03
08/15/06
10/01/03
05/21/04
08/15/03
05/21/04
09/15/03
08/15/06
10/01/03
05/21/04
09/15/04
08/15/06
01/17/06
09/15/04
02/01/06
06/29/06
10/15/05
07/15/06
08/15/06
08/24/06
09/05/06
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 - MAP
Department of Nuclear Safety
1035 Outer Park Drive
Springfield, IL 62704
217-785-9974
• Iowa Department of Public Health
Lucas State Office Bldg., 5th Floor
321 East 12th Street
Des Moines, Iowa 50319
515-281-3478
• State of South Carolina
Mammography Certification Program
Department of Health and Environmental Control
2600 Bull Street
Columbia, SC 29201
803-545-4400
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
Mammography
Forms
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/Repairs
Listed in the MQSA Policy Guidance Help System (PGHS)
Listed in the manual MQSA Made Easy
Exhibit 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 nonessential 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 lossycompressed 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 Center
Vigilance 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 Mammo
www.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 Connectathons
in 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 images
for 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
Monitors
Review 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 screenfilm, 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 Control
DR 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 Testing
For 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 Tests
Sample 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 forms
and
FDA Approved Alternative Requirements
For Each Manufacturer
Listed on ACR website – www.acr.org
Link to the following
Accreditation
Mammography
Forms
RT 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 Timeframes
Daily QC tests
Previous 30 days
Weekly QC tests
Previous 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 Check
MEE 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 Inspection
Phantom 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.org
step-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 Benefit
2005 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 Considerations
White Paper Available at Iron Mountain
“Taking Your Imaging Environment
Totally Filmless and Fully Compliant”
www.ironmountain.com
DR v. Analog Exam Time
SFM - Conventional Imaging Exam With Film
Patient
in Room
First
Exposure
Last
Exposure
First Film
Out of
Processor
Last Film
Out of
Processor
QC
Release
Patient
15.9 min*
2.30% Repeat Rate
DR - Exam Using Digital Imaging
Patient
in Room
First
Exposure
& QC
Last
Exposure
& QC
Release
Patient/
Send Study
to RWS
8.4 min*
0.43%
Repeat
Rate
Courtesy GE Medical Systems
DR = 45% Reduction average examination time
* 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.
Analog to Digital Interpretation Times
1.4 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
 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
Provider
Referring Physician/Patient
 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
– Better and faster
decisions about
treatment and diagnosis
 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 Outsourced
Visit 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 Transition
Analog CAD Processors
• Some … allow a user to digitize filmscreen 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 Interpretations
And 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, MD
Diagnostic Imaging Magazine
A Standardized Approach To A…
Marking Protocols @ UTMADCC: MLO Mags
Scar and Nipple Marking Study
A)
Man-o-Grams
So Important to Mark Correctly
brighamrad.harvard.edu/Cases
Archival Issues
“For Processing”
or
“For Presentation”
File Sizes Are Huge!!!
Digital Mammography: Integration Into a Practice
by 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
CAD
To 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 News
July 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 Reimbursement
Auntminnie.com 7/11/2007 By: Cynthia Keen
CAD Helps Support FFDM
• "The reimbursement is particularly
attractive when you add on computeraided 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 Wisdom
Must 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 world
AuntMinnie.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 System
http://www.fda.gov/cdrh/mammography
Facility Hotline - 1-800-838-7715.
For More Information
contact me at
[email protected]
To order the book
MQSA Made Easy
visit www.mammobis.org