William

A. Murphy,

MD

Jr,

#{149} Judy

M. Destouet,

MD

#{149} Barbara

S. Monsees,

Professional Quality Assurance for Mammography Screening

P

have always been concerned about the provision of quality medical care. However, recent trends have focused even greater attention on quality of care issues and have renewed the commitment to quality assurance (QA). The result is a major thrust from within the profession and from outside interests to define appropriate QA goals and to develop quality assessment tools and programs. With regard to mammography, QA goals and assessment programs are currently best defined and developed for the technical aspects of the examination. For

example,

the American

ogy mammography gram has centered cations, technical amination, image limitation breast.

and

of radiation Importantly,

implementation

come and

A recent

HYSICIANS

mostly

gress

along

sequent

of Radiolprospecifiof the exand

the

within

to the design,

program

QA lines

improvement quality, it must

wide average nized that there is still a long before quality mammography assured for all American Although there have

has

the profession,

is voluntary. has been impressive

technical

apparent

exposure impetus,

of this

from

participation While there

College

accreditation on equipment performance characteristics,

with

con-

of nationbe recog-

way to go

culties

encountered

standards mented, jectively will be quality tion to al service Again, programs profession.

were developed and implethese were relatively easy to obquantify. The more difficult task to define QA goals and develop assessment methods for applicathe performance of the professionaspect of mammography. these commitments, tools, and must come from within the

QA

report

from

Association

Service

states:

the

Programs’ American

Council

“A

on Medical

comprehensive

pro-

gram for managing the quality of care includes not only quality assessment but quality assurance activities, designed to assist practitioners in modifying practice

behavior

found

to be deficient

by quality

assessment, to protect the public against incompetent practitioners, as well as to modify structural or resource deficiencies that may exist” (1). The Joint Commission on Accreditation of Healthcare Organizations also emphasizes the development of such standards (2). The key elements of a monitoring and evaluation program are identifying the important aspects of the

care delivered, able

enumerating

critical

lishing

indicators

thresholds

the quantifi-

of the for

care,

evaluation

indicators,

collecting

data, taking thresholds

action to improve are exceeded, and

and

Accordingly, recognize

the

care when then reeval-

important established

ally

QA program that we predict will be widely imitated and adopted.

Although

many

ultigener-

radiology

practices have performed informal medical audits in the past, the trend in the 1990s will be to develop more formal methods, giving greater attention to obtaming quantitative information and to

doing

are

mography should

the

important

interpretation, be collected?

cle by Sickles

aspects core

et al addressed

of the

Radiology

1990;

175:319-320

‘From the Mallinckrodt Institute of Radiology, 5105 Kingshighway Blvd. St Louis, MO 63110. Received February 12; accepted February 14. Address reprint requests to W.A.M. RSNA, 1990 See also the article by Sickles et al (pp 323327) in this issue.

up in a sample findings, individualization

stage,

of results

for

status, previous

weight,

family and cancer, parity,

prior

mammography.

demographic but research ests. Clinical

breast

examinations

to obtain

for

and

personal menarchal

and

are

because

negative

examinations

difficult

to document

the

plained

by

are much for the

Sickles

et al,

large numbers of examinations no abnormality was reported. equally important to discover the false-negative examinations an excellent education

more

reasons

including

exthe

for which Yet, it is and review for there-

opportunity and improved

pretations. The follow-up large number of “normals”

for conservice.

effort for the is difficult

Patients

each radi-

surgery, The

easiest

facility

We question the inclusion of most demographic data. Demographic data collected, tabulated, and evaluated for each included of breast

false-positive

cared

ologist.

screenee history

and

and time consuming.

negative

of tumor

spective interpretations regarding the presence or absence of a significant mammographic abnormality and the followup data regarding the presence or absence of breast cancer with pathologic or acceptable clinical verification. These combined data are used to construct the truth table with true- and false-positive and true- and false-negative results. The search for this information is time consuming and expensive. The numbers of

arti-

this issue

of cases with

tabulation

audit.

The critical data that must be collected to achieve a valuable audit are the pro-

data

screening mammography. The components of that medical audit included patient demographic data, careful follow-up in all cases with positive findings, followIndex terms: Breast neoplasms, diagnosis, 00.32 #{149} Breast radiography, quality assurance, 00.11 #{149} Breast radiography, utilization, 00.11 Cancer screening #{149} Editorials #{149} Radiology and radiologists, observer performance

be mandatory for inclusion basic mammography

The medical audit described by Sickles et al likely underestimates the magnitude of false-negative mammographic inter-

of mam-

and what The

medical

in rests tinuing

so regularly.

What

facts may not in a responsible

mammography even these

original interpretation triggers the specific follow-up and because they are a small subset of the total. The true- and false-

to by

et al,

sional mately

when and where previous was performed. However,

generally

reported in this issue of Radiology (3). The medical audit of their screening mammography program includes many of the elements of a profesSickles

programs should seek patient information concerning personal and family history of breast cancer, the performance and results of prior breast surgery, and

true-

the effectiveness

it is highly foundation

the

estabof the

evaluating

uating the care to assess of the actions.

pro-

services are women. been many diffi-

as technologic

Medical

MD

for at the

underwent

same

mammography,

follow-up window

effort of time

may not be where

they

making

the

even harder. The narrow during which follow-up

is completed is inadequate to ensure the discovery of all false-negative results. This problem is compounded by extrapo-

lation of the false-negative fraction from a subset that may not be representative of the population screened. However, double reading all the “normal” mammograms might increase sensitivity but would be a massive effort of, as yet, unproved

more

benefit

costly

reading

that

would

screening

a statistically

result

program. valid

subset

in a

Double could

low-risk

data are superfluous to all programs with special interscreening mammography

Abbreviation:

QA

=

quality

assurance.

319

provide an estimate of the false-negative fraction attributable to a radiologist’s performance. Local, statewide, and national breast cancer registries with data that were cornplete, reliable, and timely might decrease the magnitude and duplication of effort encountered when overlapping screening programs registries

all seek follow-up might facilitate

data. a more

Such accurate

estimate of false-negative results. With proper safeguards, registries could enhance mammography audits, and their further

development

aged. Another reported

should

be

important

aspect

of the

Sickles

et al is the

by

encour-

audit

stratifica-

tion of data for each participating radiologist. For assessment of practice performance to be valuable and assurance to be effective, the data must be radiologist specific. Grouped data mask individual variations

requiring

practice

modification.

Identification of individual variance beyond threshold limits would trigger appropriate educational efforts. What are the appropriate thresholds for group and individual performance when interpreting mammograms? Current practice is to develop the audit indicators and thresholds locally. It is notable that in the report

by

Sickles

et al,

the

results

of their

medical audit are kept in local context. This approach may be adequate for the near future. However, it is likely that radiologists will eventually want to know

how

their

performance

compares

with

a

more general standard. Organizations outside of radiology may also request this information. The specialty of radiology will need, therefore, to address a national definition of assessment indicators and suggest thresholds at some future date, probably sooner rather than later. When the specialty considers national standards, issues are likely to include (a) ranges for the number of breast cancers expected in prevalence screens and in incidence screens, (b) the size and stage of each cancer, (c) the lymph node status, (d) the false-negative rate, (e) the truepositive biopsy rate, and (f) the rate of palpable cancers. However, any national standards must allow for local variations

due to patient age distribution

mix that would depend on and self-selection biases,

as well as differences in how “indeterminate” interpretations are defined and how they are assigned to positive and negative categories. What action should be taken when thresholds are reached or exceeded? It must be remembered that a medical audit or a professional QA program as generally conceived or specifically described for screening mammography is primarily a self-educational effort. There is no inherent intent

for

any

aspect

of this

program

to

elicit a punitive action. Performance of the medical audit is its own justification, for a review of personal results is the single best source of self-education. Moreover, radiologists must be aware that false-negative results will never completely disappear because some factors

320

Radiology

#{149}

are beyond us has

own

our

the

personal

or more

control.

opportunity

our

through

a screening

a more makes

of

one

programs.

professional

izing place

each

performance

of these

Establishing phy

However, to improve

QA

mammogra-

program

or formal-

already in is because mammography is the single best radiologic cancer detection test we have available. A quality technical study coupled with a quality interpretation is capable of regularly detecting very small cancers and favorably affecting patient morbidity and mortality. Radiologists are responsible for optimizing their professional performance and maximizing the benefit to the public. The prospect of instituting a professional QA program for screening mammography raises a number of additional considerations and questions. Among these are the ongoing nature of the process, the physical

informal program good sense. This

integration examination,

and QA of breast the potential

uses

and abuses of surveillance results, and the costs of such programs. Programs as described in this editorial are intended to be ongoing. The need for feedback never ends, but the design of the program need not always be the same. Any program should be reviewed periodically to determine if it meets current goals, and if not, changes should be

adopted. In our opinion, the issue of whether or not to include a physical examination in a mammography screening program is controversial cal factors

and (4).

dependent For example,

upon many loif all screen-

ees are referred by physicians following an office physical examination, it is costly and unnecessary to repeat the physical examination at mammography. Those who combine mammography and physical examination in their programs must realize they are responsible for the physical examination quality to the same extent that they are responsible for radiologic technical and interpretive quality. We question the ability to perform an adequate physical examination with the patient in a seated or standing position only. If a technologist or a nurse performs the examination, the radiologist must be

aware

of his/her

quality

of the

Radiologists should

responsibility examiner’s

who

review

the

on this

this

to be

structured

for practitioners such

systems

to “ensure

conducting who

are

acting

to reim-

The costs of mammographic professional QA programs could become great. To some degree, the details of the individual program will determine the costs. However, for any program, an employee will have to be assigned to the task. The major costs relate to locating and validating the medical care events occurring after mammography, and these take place outside the radiologist’s office. Therefore, telephone, stationery, postage, and computer costs must be added to the personnel

costs. The individual practice will have to decide how to pay these costs. Moreover, QA costs must be kept to a minimum and in line

with

the

concept

of low-cost,

ac-

cessible, mass-screening mammography. Eventually, we all will have to decide if the benefits are worth the added costs. For now, we believe it is appropriate to initiate

emphasize

programs

as discussed

the voluntary,

nonpunitive

nature

we think

that in many

above.

We

educational,

of the

process,

instances

and

such

pro-

grams may actually validate current quality performance. We believe that as more practices initiate screening mammography programs, their design should indude technical and professional QA aspects. These QA efforts need not be cum-

bersome radiologists screening

and should

not dissuade

from providing mammography.

low-cost U

References 1.

2.

3.

4.

and the

associated medicolegal aspects (5). Once gathered and analyzed, will QA data be used outside the department? While it is not the intent of such programs for data to be employed for external purposes, creative individuals may be tempted to do so. As indicated by the Council on Medical Service, it is important for a comprehensive audit such as

to tie results

bursement. In addition, competitive practices might attempt to use their data to gain a market advantage. These problems should be avoidable.

practice

of agency

laws

the data and desire

for the

performance.

rely

Even though the reasons to formalize ongoing review processes are altruistic and common sense, there are potential dangers. For example local, state, or federa! agencies could become interested in

5.

Council on Medical Service, American Medical Association. Guidelines for quality assurance. JAMA 1988; 259:2572-2573. Athanasoulis CA, Thnall JH. Standards of radiology practice: an approach to development. Radiology 1989; 173:613-614. Sickles EA, Ominsky SH, Sollitto RA, Galyin HB, Monticciolo DL. Medical audit of a rapid-throughput mammography screening practice: methodology and results of 27,114 examinations. Radiology 1990; 175:323-327. Monsees B, Destouet JM, Evens RG. The self-referred mammography patient: a new responsibility for radiologists. Radiology 1988; 166:69-70. James AE Jr. Greeson T, Price RR, et al. Le-

gal and ethical

issues

in a technologic

pline: the agency relationship. diol 1986; 21:815-817.

Invest

disciRa-

immunity

or applying in good

faith” (1). In fact, many state legislatures have enacted regulations meant to protect the confidentiality of quality assessment activities.

May

1990

Professional quality assurance for mammography screening programs.

William A. Murphy, MD Jr, #{149} Judy M. Destouet, MD #{149} Barbara S. Monsees, Professional Quality Assurance for Mammography Screening P...
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