Handout Mammography Take This Job State of Mammography

3/31/2011

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Mammography:Mammography:

Take This Job and Take This Job and

Love It !Love It !

Peggy Hoosier, M.Ed., RT (R) (M)Peggy Hoosier, M.Ed., RT (R) (M)

Sr. Vice President of Professional EducationSr. Vice President of Professional Education

Advanced Health Education Center ,Ltd.Advanced Health Education Center ,Ltd.

20112011

State of Mammography State of Mammography

20112011

• Money – Cost Control

• Increase Efficiency

• Improve Quality of Care

Driving Forces in

Health Care:

State of Mammography 2011State of Mammography 2011

• Money – Cost Control

• Same Number if

mammograms during

reduced hours

• Less staff to perform

mammograms


• Increase Efficiency

• Increase work load

• Perform exams more

efficiently

• What about quality?

• “Shoot’em & Scoot’em”


• Improved Quality

of Care

• Public Expectations

• Patient’s Expectations

• Quality Expectations

• Personal Expecations

The American Health care consumer has The American Health care consumer has

become more knowledgeable and informed become more knowledgeable and informed

regarding his or her care and is demanding regarding his or her care and is demanding

more for the dollars expended on health more for the dollars expended on health

care.care.

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US Leads in Medical ErrorsUS Leads in Medical Errors

“Thirty-four percent of U.S. patients received

wrong medication, improper treatment or

incorrect or delayed test results during the

last two years, the Commonwealth Fund

found.”

US Leads Way in Medical Errors, S. Heavy, Common

Dreams, November 23, 2005

The The “Swiss Cheese”“Swiss Cheese”Model of Accident Causation (Reason, 1990)Model of Accident Causation (Reason, 1990)

�Excessive cost cutting – staffing reduction

�Drive to Reduce Hospital Days

�Long Working hours

�Deficient training program

�Inexperienced X-Ray Tech

� Colleague Admitted Patient

� Poor Coordination & Communication

�Failed to review allergies

�Wrong X-ray marker used

�Wrong procedure

performed

Failures in the

System

Leadership

Policies/Procedures

Available Resources

Accident & InjuryAccident & Injury�Wrong Site Surgery

�Medication Error

� Fall

“Latent “Latent

Errors”Errors”

Barriers

to

Accidents

Communication

Healthcare SpendingHealthcare Spending

• 15 to 20 % of overall annual spending

is for imaging procedures

• 50 to 60 % of radiology spending is

attributable to high tech imaging

• 30 to 50 % over utilization estimate

• up to 700% practice pattern variability

Industry Influences for Industry Influences for

QualityQuality• Healthcare Reform

• Managed Care

• Quality Initiatives

• Insurance Provider’s

World Health OrganizationWorld Health Organization

• US health system has mediocre outcomes

for patients when measured by WHO

standard indicators

• Overall rank of the US in the WHO survey

----#37

• Country at #36 = Costa Rica

• Who is #1? France

New England Journal of MedicineNew England Journal of Medicine

2003 study by E McGlynn, PhD, et al2003 study by E McGlynn, PhD, et al

•Correct patient care

is delivered 55% of

the time!

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Healthcare ReformHealthcare Reform

Focus on Quality ImprovementFocus on Quality Improvement

• Institute for Healthcare Improvement (IHI)

Trigger Tools

• A trigger tool is a retrospective analysis

tool based on a set of “red flags”

prompting investigation of patient's records

for unintended harm from medical

treatment and care

Quality Improvement is derailed Quality Improvement is derailed

by:by:

�Organizational inertia

�Leadership buy off

�Disinterested governance

�Medical Politics

�Fatigue and resistance from staff

Time for a change?

Insurance ProvidersInsurance Providers

• Happening in all healthcare

• Already happened in mammography

• Mammography model for other

modalities

• Voluntary in other modalities

• Mammography first was voluntary

The 4 most common errors in The 4 most common errors in

radiologyradiology::

� WRONG SITE

�COMPLICATIONS

�MEDICAL ERRORS

�DELAY IN RX

12% result in harm to the patient.

JC JC Tracks Causes of Sentinel Events Tracks Causes of Sentinel Events

& Medication Errors& Medication Errors

• 2005 – 2006

Communication listed as cause in 65 to

80% of errors.

Other rising area is leadership, or lack

thereof, so will be focus in future.

United Healthcare MemoUnited Healthcare Memo

• Insurers such as United Healthcare and

Blue Cross got behind standards for

quality to make sure imaging providers

measured up

• Accreditation was the best method to

implement quality standards

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This This error rate has led the error rate has led the

insurers to stop paying for poor insurers to stop paying for poor

quality carequality care::

� United Healthcare not to pay if medical imaging facility not accredited

�Blue Cross/Blue Shield to stop paying for “Never Events”, wrong surgical procedures, leaving foreign objects in body after surgery

�Medicare to stop paying for certain conditions as of 9/1/08,i.e. decubitus ulcers

Pay For PerformancePay For Performance

P4PP4P

• The pay for performance model means

that those medical facilities that exceed

the quality standards can get more

reimbursement.

• The cost containment model no longer can

be applied and may be the wave that sinks

the hospital’s ship.

Health Care TsunamiHealth Care Tsunami

• Surfers who make things

happen

• Swimmers who watch things

happen

• Sinkers who wondered what

happened

Pay For PerformancePay For Performance

P4PP4P

• The pay for performance model means

that those medical facilities that exceed

the quality standards can get more

reimbursement.

• The cost containment model no longer can

be applied and may be the wave that sinks

the hospital’s ship.


• Surfers who make things

happen

• Swimmers who watch things

happen

• Sinkers who wondered what

happened


Cost control = “no margin”

“ no mission”

versus

P4P = “no outcomes”

“ no income”

Signals the end of blind health care purchasing.

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• Political

•Financial

• Psycho-Social

MammographyMammography: Fact or Fiction

•Mammography screening saves lives and

improves outcomes

•In the best hands, the average detection rate of

cancer in a screening setting is about 90-93%

NOT!

•Mammographic error is the cause of the greatest

amount of litigation against radiology; average

settlements $200,000

•Insurance companies pay poorly for

mammograms

•Residents are NOT choosing mammography

•Image quality has improved but at what cost

New York Times takes mammographers to task

6/27/02

Radiologists are the "weakest link" and a dangerous "loophole" in the fight

against breast cancer, according to a front- page article appearing in today's

New York Times. The article levels a number of grievances at the imaging

community, including lack of skills necessary to read mammograms; not actually

meeting U.S. breast screening standards; and a dearth of self-policing.

"The federal mammography standards have eliminated many of the most egregious

abuses and have made the breast x- rays much easier to read," the article stated.

"But an examination by The New York Times has found that they have largely failed to

remedy what many experts say is the biggest problem of all: the skill of the doctors

who interpret those x-ray films.

New York TimesNew York TimesBy MICHAEL MOSS

Ten years after the federal government set out to clean

up a mammography industry awash in scandal, many

women are still getting inaccurate examinations at

clinics bearing the federal seal of approval.

The federal mammography standards have eliminated

many of the most egregious abuses and have made

the breast X-rays much easier to read. But an

examination by The New York Times has found that

they have largely failed to remedy what many experts

say is the biggest problem of all: the skill of the

doctors who interpret those X-ray films.

Spotting Breast Cancer:

Doctors Are Weak Link

Not politically correct to stop Not politically correct to stop

performing mammography…performing mammography…

• Commitment to do it

• Community service

• Influences everything you do in

mammography

• Small community providing

mammography…at what cost?

Political…

Financial…

Emotional…

Expectations are high!

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Cost of Providing Cost of Providing

Mammography ServicesMammography Services

•Physical Resources

•Human Resources

•Compliance Cost

Diagnostic Imaging: Screening

Mammography Continues to Lose

Money

•Follow-up for benign findings accounts

for disproportionate chunk of overall costs

•Follow-up biopsy greatly increases the

cost of breast screening, regardless of

whether the ultimate findings are benign

or malignant

Cost of Providing

Mammography

Study Design

• Outpatient Center: 4 sites,

• 6 Radiologist

•215,888 Studies between 2001-2003

•Variable Cost Film Vs Fixed Cost

•Cost of Physician Services

•Average Radiologist read 86 per day

Cost of Providing

Mammography

Calculated Cost per Exam•Site: $48.57

•Overhead $23.11

•Physician $18.39

•Total = $90.17

•At that time average reimbursement

was $85.88

•$90.17 - $85.88 = $4.29 Lost on every

examination

IOM REPORTIOM REPORT

• 2005

Institute of Medicine

Summary of

Recommendations

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Summary of Recommendations to Summary of Recommendations to

Improve Breast Imaging QualityImprove Breast Imaging Quality

Improve mammography interpretation:

• Revise and standardize the required medical audit component of MQSA.

• Facilitate a voluntary advanced medical audit with feedback

• Designate specialized Breast Imaging Centers of Excellence

• Demonstration and evaluation projects.

• Further study the effects of CME, reader volume, double reading, and CAD

Revise MQSA regulations,

inspections and enforcement:

• Modify regulations to clarify the

intent and address current

technology.

• Streamline inspections and

strengthen enforcement for patient

protection.

Recommendation #1Recommendation #1

• The medical audit component of

MQSA should be revised and

standardized to make it more

meaningful and useful.

A) The required basic medical

audit of mammography

interpretation should be

enhanced to include the

collection of three core

measures for internal review

at the mammography facility

as follows:

• Positive predictive value 2 (PPV²; proportion of women recommended for biopsy (BIRADS 4,5) who are subsequently diagnosed with breast cancer

• Cancer detection rate per 1,000 women

• Abnormal interpretation rate (women whose mammogram interpretation leads to additional

imaging or biopsy)

The group of women that facilities are required to track should include not only women with BI-RADS 4 and 5 assessments, (what most facilities are currently doing)

BUT

ALSO, all women for whom additional imaging is recommended (cat 0) to facilitate resolution of all cases so that women for whom biopsy is recommended at final assessment will be included in the calculation of PPV².

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B) All performance measures (PPV² cancer detection, and abnormal interpretation rate) should be stratified by screening and diagnostic mammography

C) Facilities should have the option of combining medical audit measures for physicians interpreting at multiple facilities to allow for more meaningful data

D) Audit data collection and analysis should be verified at FDA inspection, but not collected by FDA

E) Reimbursement rates for mammography should be increased to account for the additional costs of these new audit procedures

Recommendation #2Recommendation #2

Facilities should be encouraged to

participate in a voluntary

advanced medical audit with

feedback. This should be

facilitated by incentives for

participation and the formation of

a data and statistical coordinating

center.

A) In addition to all tracking,

measurements, and assessments in

the enhanced basic required audit

described in Recommendation 1, the

voluntary advanced audit should

include the collection of patient

characteristics and tumor staging

information from pathology reports.

B) A central data and statistical coordinating center, independent of a

regulatory authority, should be established

• to collect and analyze the advanced audit

data

• provide feedback to interpreting

physicians for quality assurance and

interpretation improvement

• Increase funding to provide for

– (1) data collection, analysis and feedback;

– (2) appropriate hardware and software for data

management;

– (3) appropriate information technology support

personnel for data maintenance.

The coordinating center should:The coordinating center should:

• Help develop, implement, and evaluate corrective action plans for interpreting physicians who do not achieve performance benchmarks.

• Routinely release aggregate summary date on interpretive performance, including recall rates, PPV² and cancer detection.

The coordinating center The coordinating center

should:should:

• Electronically collect data

• Analyze

• Report advanced-level audit data

• Provide regular feedback to interpreting physicians.

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• Test different methods of delivering audit

results to improve interpretative

performance.

• Undertake studies of randomly selected

facilities using required basic audit

procedures to ascertain the impact of these

new measures on interpretative quality.

• Protect from discoverability the data

collected for purposes of quality assurance.

Medical Medical

Outcomes Outcomes

AuditAudit

What it is ….What it is ….

The The ONLYONLY way to measure way to measure

mammographic performance mammographic performance

in a manner that includes not in a manner that includes not

only only technicaltechnical but also but also

interpretive interpretive capabilities of the capabilities of the

system.system.

Raw (uncompressed) data recommended as minimum

requirements. It's necessary to calculate derived data for a

meaningful audit analysis

Derived data is calculated from raw data Audit analysis has

been useful as determinants of

-> prevalent vs incident cancer rates

-> predictive value of findings

-> significance of risk factors

CLINICAL PRACTICE GUIDELINES N0.13

STRONG RECOMMENDATION:

Certain essential raw data and derived data

should be obtained for a meaningful medical

audit.

ELEMENTS NECESSARY TO DEVELOP OR EVALUATE

MEDICAL OUTCOME AUDIT PROGRAMS

DEFINE regular procedures, methods, or ways in which you can

collect information about your patients

DECIDE the content or type of information you want to collect

about your patients

DECIDE which patients will be eligible for inclusion in the following

process .

THE MEDICAL OUTCOMES AUDIT

ESSENTIAL ELEMENTS

THE MEDICAL OUTCOMES AUDIT

ESSENTIAL ELEMENTS

DETERMINE the time frames used to collect your patient

information

SELECT the definitions for each piece of information you

choose to collect

ESTABLISH methods or ways to interpret or understand

what your outcome data can tell you

DECIDE how to use the data as a source of feedback to

improve mammography quality

MEDICAL OUTCOMES AUDITMEDICAL OUTCOMES AUDIT

Using the raw audit data, derived data can be calculated to provide

quantifiable evidence in the pursuit of the three major goals of

screening mammography.:

1. Finding a high percentage of the cancers that exist in a screening

population

Measurement: Cancer detection rate & sensitivity

2. Finding cancers within an acceptable range of requests for recall and

request for biopsy, in an effort to minimize cost and morbidity

Measurement: Recall rate and positive predictive value

3. Finding a high percentage of small node –negative cancers, which are more

likely to be curable

Measurement: Rates of minimal cancers found, axillary lymph node

positivity

Three Major Goals of Screening

Mammography

Three Major Goals of Screening

Mammography

%

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Expanding the Medical Expanding the Medical

Beyond the BasicsBeyond the Basics

• First time exam, or repeat exam

• Mammographic assessment and

recommendation

• Routine follow-up of category 1 and category

2

• Short interval follow-up of category 3

• Cancer data

– Mammographic findings: mass, calcifications

indirect signs of malignancy

Expanding the Medical Beyond Expanding the Medical Beyond

the Basicsthe Basics

• Derived data to be calculated

– True negatives; false negatives

– Sensitivity

– Specificity

– Cancer detection rate

– Prevalent vs. incident

– Overall

– Rates within various age groups

Medical Audit GoalsMedical Audit Goals

↓ False Positives & Call BacksFalse Positives & Call Backs

Identify False NegativesIdentify False Negatives

Procedures that Procedures that

increase risk of a increase risk of a

False PositiveFalse Positive

1.1.Long time between Long time between

mammogramsmammograms

2.2. Not comparing the mammogram to Not comparing the mammogram to

the previous examthe previous exam

When a mammogram is not compared When a mammogram is not compared

to a previous mammogram, the risk of to a previous mammogram, the risk of

a falsea false--positive increases by 74%positive increases by 74%

HIPAA & Release of Information for MQSA Purposes

Two Frequently Raised Issues

1. Protection of Patient Information during MQSA Inspections

2. Whether medical entities can release patient biopsy

information to mammo facilities for purposes of the MQSA

medical outcomes audit without obtaining patient authorization

Mammography at WorkMammography at Work

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Release of Biopsy Information Medical Entities

Section 164.512(b) of the HIPPA regulations allow a covered

entity (e.g., referring physician, pathology department, surgeon:

To release patient biopsy information to a mammography facility

for purposes of MQSA medical outcomes audit without patient

authorization because the disclosure:

1. is to "a person subject to FDA jurisdiction"

2. concerns an FDA regulated product or activity for which

the mammography facility has responsibility

3. relates to the quality, safety or effectiveness of the product

or program



Protection of Patient Information during MQSA Inspections

Section 164.512(b) & (d) of the HIPPA regulations allow a

mammography facility to release patient information to an MQSA

inspector without patient authorization because MQSA inspectors

are performing health

oversight activities required by law.

Mammography at Work


An imaging center in Nebraska is involved in

litigation over possible violations

of the privacy provisions HIPAA

If the reminder postcards show the patient’s

names and addresses as well as

your practice’s name and address, you may

accidentally disclose PHI that could subject you

to civil and criminal penalties

Quality is planned and systematic actions that provide

the optimum achievable care

Or"Getting people to do better all the worthwhile things they

ought to be doing anyway.“

Quality is defined in mammography more than in any

other area of imaging!

What Is Quality?What Is Quality?

If quality is to be managed, it must

be defined............

as conformance to requirements.

If nonconformance to requirements

is noted, there is an absence of

quality.

Some Organizations demanding

quality management in our

industry are:

• JC

• OSHA

• Insurance Providers

•MQSA

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Quality ManagementQuality Management

Quality management

focuses on the needs

of and expectations

of customers and the

continuous

improvement of the

product. This applies

to radiology as it

does to Fortune 500

industries.

Quality Control is the part of the QA program that deals

with techniques used in monitoring and maintenance of technical

elements

Continuous Quality Improvement

Focuses on the process or system in which employee operate

Problems & variability main cause of poor quality

Quality Management in

Mammography

Nuts & Bolts of QM

Quality Assurance::

• An all-encompassing management program

• Ensure excellence

• Systematic collection and evaluation of data


Mammography


Mammography

TQM is based upon the following TQM is based upon the following

premises:premises:

• Due to their knowledge of job conditions, those workers closest to the problem are more likely to know what is wrong with the process and how to fix it.

• Every person in an organizationwants to to be a valuable contributor and do a good job.

• Such opportunities provide the employee a sense of ownership and reduce the adversarial relationship between workers and management.

80/20 Principle asserts that a minority

of causes, inputs, or effort lead to a

majority of results, outputs or rewards.


Mammography

TQMTQM

• Processes, not people

are the root of quality

problems.

• Structured problem

solving using statistical

means produces better

long term solutions.

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Quality Management in Quality Management in

MammographyMammography

• Practicing in an environment of fear is

counterproductive and leads to poor performance.

• 80% of the problems are the result of 20% of the

causes of all the problems.

To develop a QA program, first delineate the scope of care

Next identify the important aspects of care and prioritize based on:

1. High volume procedures

2. High risk procedures

3. Problem Prone

4. Needs of patient/families

QA PROGRAM DEVELOPMENTQA PROGRAM DEVELOPMENT

Cycles for Improving Performance in CQI

(or whatever today’s acronym is for the process)

Identify the problem

Collect your data

Design

Measure

Assess

Improve

Quality Management in Mammography

Quality Control is the part of the QA program that deals

with techniques used in monitoring and maintenance of technical

elements

Continuous Quality Improvement

Focuses on the process or system in which employee operate

Problems & variability main cause of poor quality


Mammography


Identify the area target for improvement

What in your department could improve

the delivery of care?

Quality Management in Mammography Quality Management in Mammography


Collect the data

Is a real problem or is it perceived?

Are you always behind because of patients

scheduled in the wrong slot?

Tract it for several weeks and see what the data

tells you!

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Assess

Asses the data, talk with the parties involved and

document the progress of the program.

Sometimes this may be the end of the line! Some

initiatives aren’t successful.



Design a program

If the problem is real, then ask these three questions:

Will addressing the problem

1) reduce cost

2)increase efficiency

3)improve quality of care

If the answer is yes, it is a target for quality improvement!

Use structured problem solving; involve the people who

provide the service



Measure

After you have designed an “intervention” and put the

plan in place, re-evaluate by collecting data



Improve

Celebrate your successes! The process can be a

morale booster for everyone involved in the process.

Remember everyone wants to do a good job!


So, where should we be So, where should we be

looking?looking?

• Access – is care timely and

appropriate?

• Outcomes – state of patient’s health

resulting from care received.

• Patient’s experience and perception

of the quality of care.

Major Aims for Quality CareMajor Aims for Quality Care

1. Safe – care should not injure patient

2. Effective – avoiding underuse and overuse of

services

3. Patient centered – respectful and responsive

care to include needs, values, preferences of

patient

4. Timely – reduced waiting and delays for both

those who receive or give care

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Major Aims of Quality CareMajor Aims of Quality Care

5. Efficient - avoiding waste of equipment,

supplies, ideas, and energy

6. Equitable – care that does not vary in

quality because of gender, ethnicity,

geography, or socioeconomic status.

National Radiology Data RegistryNational Radiology Data Registry

(NRDR)(NRDR)

• The ability to document the quality of

services delivered by your facilities to

interested third parties

• The ability to measure impact of changes

in practice

• The ability to implement a data-driven

quality improvement program


(NRDR)(NRDR)

• By submitting your data to NRDR, your

practice will be provided with:

• Detailed and graphic reports in a

standardized format for comparing quality

• A tool for targeting specific areas of

improvement

• An accurate reflection of practice patterns


(NRDR)(NRDR)

• National Oncology PET Registry (NOPR)

• CT Colonoscopy Registry (CTC)

• General Radiology Improvement Database

(GRID)

• National Mammography Database

(NMD)

• Dose Index Registry (DIR)

• IV Contrast Extravasations Registry (ICE)

National Mammography Database National Mammography Database

(NMD)(NMD)

– ACR launched an updated version

of the National Mammography Database in

2009

– Database developed and is based on BI-

RADS

– NMD will collect data from mammography

facilities and provide benchmarks on

outcomes such as cancer detection rates

and positive predictive value

National Mammography National Mammography

Database (NMDDatabase (NMD))

NMD leverages data that radiology practices are already

collecting under federal mandate by providing them with

comparative information for national and regional

benchmarking.

Participants receive semi-annual feedback reports that

include Important benchmark data such as :

Cancer Detection Rates

Positive Predictive Value

Recall Rates

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National Mammography National Mammography

Database (NMD)Database (NMD)ACR User Guide posted in October, 2010

Data Submission

Software for audit must be NMD certified and conform to

the format as outlined by the ACR

Aggregate Reports

At the end of each reporting period, your facility will be

provided with a report comparing your data with

aggregated data from other NMD facilities.

(NMD)(NMD)

Outcomes MeasuresOutcomes Measures• Diagnostic Mammography PPV (2)

Measure Description: The percentage of diagnostic

mammograms recommended for biopsy or surgical

consultation. ( BI-RADS Category 4 or 5 that result

in a tissue diagnosis of cancer within 12 months)

• Screening Mammography PPV (2)

Measure Description: The percentage of screening

mammograms recommended for biopsy or surgical

consultation. ( BI-RADS 0, 4 or 5 that result in a

tissue diagnosis of cancer within 12 months)

.

(NMD)(NMD)

Outcomes MeasuresOutcomes Measures• Cancer Detection Rates


mammograms that were interpreted as positive

(BI-RADS 0, 4 or 5) and result in a tissue diagnosis

of cancer within 12 months

• Abnormal Interpretation Rate


mammograms interpreted as positive (BI-RADS 0, 4

or 5)

Breast Imaging Centers of Breast Imaging Centers of

ExcellenceExcellence

BICOEBICOE

ACR Breast Center of Excellence Designation

Facility must be accredited by ACR or

FDA approved state accrediting body

and obtain

Stereotactic Breast Biopsy by the ACR

and

Breast Ultrasound by the ACR

including the Ultrasound-Guided Breast Biopsy module

OpportunityOpportunity

• How does sharing data help advance

the practice of mammography?

It provides results on how you “measure

up” and provides data analysis that is

the impetus for change.

Documents

Handout Mammography Take This Job State of Mammography