by Christopher M. Shively
Improving quality in radiology has the potential to reduce litigation, positively impact the health care of patients, and save the nation many millions of wasted dollars.
The purpose of this article is to introduce the importance of
creating and implementing a quality plan intended to reduce imaging
errors within an organization. Based on the research and findings
of Robert S. Pyatt, MD, and Chambersburg Imaging Associates (CIA),
Chambersburg, Pa, where Pyatt is CEO, implementing a structured
plan or template can pinpoint why imaging errors occur and bring
forth methods to reduce these errors. CIA advocates the development
of a group performance "dashboard" and measurement system specific
to the requirements of the individual organization. Critical to the
success of such an initiative is the creation of a culture where
all radiologists "own" the quality of diagnostic imaging and
actively pursue error-free results through practice-wide conformity
to American College of Radiology (ACR) standards and guidelines, as
well as other defined measures.
CIA is a group of 12 full-time and four part-time radiologists in
South Central Pennsylvania. In the past year, they have performed
more than 200,000 procedures in three hospitals and three
outpatient centers, managing the imaging needs of 200,000 people
and covering 2,000 square miles. Through unified management and a
structured outline of practice-wide protocols, the group has
developed a system of practice that emulates a pilot's checklist in
a preflight ritual. Just as a preflight checklist can save the
lives of a pilot and his passengers, a protocol-unifying template
can save the lives of patients and reduce errors. CIA devises many
different protocols, each one specific to a different quality
instrument. These checklists can be found in different forms in the
necessary locations in the department. Each member of the group
will face similar problems and also serve as a local expert for
radiologists who have questions on a case. This teamwork theory for
error reduction is evident not only in the medical profession but
has been instrumental in many national and international
corporations as well. Training and education in teamwork have shown
significant improvements in quality through major industry efforts
at such companies as General Electric, Motorola, Federal Express,
and Ritz Carlton. The use of performance teams, and other methods,
has earned some companies the prestigious Baldrige Award.
Whether an industry giant or a radiology group, every organization
should begin its quality improvement (QI) initiative with a vision.
To attain the vision, the group must first agree on what it means
to be the most-improving radiology group in the nation. This
requires full participation from every member, and each must be on
the same page in questioning what the group is trying to achieve.
CIA maintains, for instance, a monthly agenda that lists the areas
for QI for each member, with regular improvements expected.
Defining the Agenda
Once the specifics of the group's vision have been finalized, it is
necessary to implement a quality plan covering the agreed-on
quality measures. To continue the airplane analogy, instrument
readings useful in the practice of radiology might indicate whether
your tank of leadership is running full or if the gauge reads
empty. Leadership includes participating in key medical staff and
hospital committees, assuming leadership roles in the community,
mentoring prospective high school students, teaching skeletal
anatomy to elementary students, or funding scholarships in health
care for local high schools. For example, the radiologist
responsible for group-wide obstetric sonography would create a
reporting template based on referring physicians' needs (see Figure
1, page 64). Each radiologist must comply with all elements in his
or her dictation. Similarly, all other quality assurance (QA)
components are developed, implemented, and checked for compliance.
Instruments should be built to measure levels of customer
satisfaction, film quality, mammography-pathology correlations,
pulmonary CT angiography accuracy, carotid Doppler accuracy, stroke
diagnosis accuracy, stage of breast cancer at diagnosis, use of the
ACR Breast Imaging Reporting and Data System (BI-RADS®)
lexicon, compliance with reporting protocols (OB/GYN sonography),
sentinel lymph node (SLN) lymphoscintigraphy and outcomes, spiral
renal CT for calculi, thallium correlation with cardiac
catheterization, and arthroscopy with MRI.
Quality Improvement Initiative Checklist
To begin a quality improvement initiative:
List a common set of agreed-on quality measures and goals.
Choose group leaders to help the practice arrive at these goals.
Celebrate successes.
Mentor one another.
Comb the literature for information.
Work to reduce variation and improve the practice's baseline level.
Improve peer review.
Earn CME credit through this entire process.
Embrace teamwork.
As does a pilot, use checklists to ensure the patient's safety.
Provide leadership to other medical staff members and the community.
Accept the fact that in the current environment, improving quality means denying revenue that often comes to other groups.
Network with other radiologists to learn from one another.
Work with state radiology societies and the American College of Radiology to share experiences and improve performance among peers.
In launching its QI program, CIA began with just a few objectives
15 years ago. More protocols were developed over the years, and
today, the company keeps up-to-date with 15 total, five of which
are active at one time. As a program gets rolling, it is important
to update at least once a month, but if progress is made,
measurements may be updated once a year, more or less, depending
on the issues.
When developing these instruments for improved quality, it is
important for all members in the group to understand that everyone
owns quality. To facilitate these practices and promote ownership,
everyone in the group must be delegated to specialize in one or
more of the outlined ideas and empowered to ensure that the time
frames, expectations, and protocols of each are understood and
practiced by all participants. In most cases, you will need to
diversify, allocating each member a specific duty of specialty and
utilization management. Billing and other support staff can be
enlisted to assist in collecting data and charting. Federal law has
provided some guidance for developing quality improvement
initiatives in mammography through the Mammography Quality
Standards Act (MQSA), while the Joint Commission on Accreditation
of Healthcare Organizations (JCAHO) has created opportunities for
other QI initiatives. Through JCAHO, radiologists can utilize CME
educational programs, a journal, a Web site, and highly trained
consultants to reduce error.
The Role of Error
If an interest in excellence does not motivate a group to implement
a quality-improvement program, the threat of malpractice could be
the incentive. The issue is a constant threat, particularly in
states like Pennsylvania, where the malpractice insurance crisis is
most acute. Pennsylvania Medical Society Liability Insurance
Company (PMSLIC) malpractice data reveal Pennsylvania as ranking
among the top five most litigious states in the nation. Annual
settlements in Philadelphia recently exceeded those for the entire
state of California. In their lifetimes, one in five OB-GYNs, one
in six surgeons, and one in six radiologists lose a malpractice
suit.
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Figure 1. Complaints from referring physicians regarding highly variable reports with little consistency or completeness led CIA to create a customer-driven report compliant to all obstetric sonography (OB/sono) physicians' needs in the region. This customized worksheet is the result of informative meetings with all physicians who utilize OB/sono reports. A variety of in-services was necessary to educate physicians and technologists about all information found on the worksheet. After creating this protocol, CIA has received zero complaints about insufficient information in the past year.
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Of the suits, 70% result in no payment to the patient and cost
$20,000 on average to defend. If the case makes it to court, the
average cost escalates to $95,000, and the average indemnity and
defense total $213,000.1 Missed diagnosis accounts for 38% of paid
claims, and imaging is considered in this grouping. The category of
missed diagnosis can be broken into overriding and
misinterpretation (false positives and false negatives); faulty
reasoning with overriding and misinterpreting (true positives with
misclassification); and lack of knowledge (such as medical history,
symptoms, and unique imaging findings). According to Lucien Leape,
MD, an expert in quality improvement in medicine, "Errors may be
defined as an unintended act (by omission or commission) or one
that does not achieve its intended outcome."3 In medicine,
unintended acts and outcomes can be costly in many ways.
Despite advances in training and technique, little change in the
radiology error rate has occurred over the past 50 years. The
average significant error rate has been reported in the literature
to range around 2% to 20%.3 The internal error rate by the same
radiologist can range as high as 25% to 30%.4 Eighty percent of
errors are perceptual errors, which are present on the film but not
seen. Factors such as a busy or noisy reading room, or a fatigued
radiologist on call at 3 AM, can cause these perceptual errors.
Some radiologists report that their error rates have increased with
the marked increase of night-call duties and lengthened working
hours.5 These error rates can be diminished with the use of
dedicated nighthawk radiologists, who may be overseas or based in
the United States.
Major issues with errors can surface in radiology if a "preflight
checklist" is not used in dictating a radiology procedure. Often a
simple mistake could have been avoided if some basic protocol had
been followed. In the box on this page, some major issues of legal
vulnerability are identified, all representing lost litigation
cases that could have been avoided had a structured dictation
outline been followed by the radiologist.
By using reporting protocols and, more important, by setting
dictation protocols, one can avoid most of these issues. With all
members of the group on the same page, it should be routine to
obtain prior films and reports as well as have more necessary
clinical information. With the aid of local expert readers, fewer
questions should arise in interpretation. Using the structure from
the ACR Communications Standards allows a radiologist to
standardize reports just as a pilot checks his preflight checklist
before taking off. Group practices can measure compliance with the
key elements of this standard to see how well they are doing and
find opportunities for improvement.
Know that these protocols need to be customer driven and defined by
each group because even specialties have specific needs. It is the
duty of the local experts to establish technique protocols for
intravenous pyelograms, MRI, CT, neck trauma, contrast
administration, pulmonary embolism algorithms, mammography and
accreditation standards, QC measures, and other radiology areas.
Through this added organization and structure, there is less
variation, and this is the basis for quality improvement. As in
industry, how much variation in construction would you tolerate as
a consumer? If a radiologist is five times more likely (a category
0 rate of 30% versus 6% for the rest of the group) to recommend
further mammographic views than other members of his or her
practice, is this completely acceptable? A radiologist who reads
3,000 mammograms a year with a category 0 rate of 30% will cause
720 women a year to have additional studies. While this earns
significant revenues for the practice, it is the result of less
than optimal quality. Sometimes, improving quality means
sacrificing group practice revenue to a significant degree. If the
CIA practice performed at the 30% level for category 0, they would
earn an additional $300,000 per year compared to its group-wide
category 0 rate of 6%. Unfortunately, the insurers would pay if the
entire practice had a category 0 rate of 30%. Most insurers have no
interest in or skills to help improve the quality of
radiology.
Further techniques for reducing error in imaging can be realized in
computer-assisted detection (CAD) technology or double reading for
mammography, more future CAD, and Internet access in the reading
room environment. A designed work cycle with logically placed night
duty is essential to keep fatigue at bay and the office error free.
Fatigue is one of the most commonly reported causes of errors,
throughout all industries. Long-distance, dedicated radiologists
working through the night in Australia and other nations, or in the
United States, are thus an instrumental element in improving
quality.
Issues Representing Lost Litigation
- Failure to consult prior study or report (a common cause of missed breast and lung cancers)
- Limitations in imaging technique (when a diagnostic procedure has limitations, it should be noted in the report, as per the ACR Communications Standards)
- Acquisition of inaccurate or incomplete medical history
- Lesion located outside area of interest (eg, lung base mass on a kidney-ureter-bladder film)
- Lack of knowledge (you might not see what you do not know)
- Failure to continue search after one finding (finding a large pneumothorax and missing a new lung nodule in the opposite lung)
- Failure to recognize a normal biological variant
- Failure to recommend other studies (This issue was pointed out at the ACR annual meeting in Washington, DC,6 recently. It includes other nonimaging studies where appropriate, such as colonoscopy for polyps seen at barium enema. Furthermore, the ACR Standards support this concept.)
The CIA Experience
Through quality improvement, significant reductions in error have
been noted at CIA. With the help of CIA neuroradiologist
subspecialist Henry Ching, MD, errors in diagnosing stroke on CT
have fallen from the national average of 15% to less than 1%. This
makes CIA one of the most accurate groups in the nation in
diagnosing stroke. Based on a recent JAMA article, 49% of
radiologists reading CT scans as part of a large study missed at
least one stroke.7 CIA achieves its excellent numbers through
extensive peer performance review and personal mentoring by Ching.
Other group experts help with body imaging, ultrasonography,
mammography, and nuclear medicine, for instance.
Further successful efforts include working as a team with the
emergency department physicians and trauma surgeons and becoming
more united through similar protocols. Efforts to improve imaging
of acute cervical spine injury have led to a consistent and
improved protocol, with no radiologist variation. In this instance,
three views of the neck are taken with the collar on, as opposed to
only one view in the past. Only with three views can an educated
decision be made to remove the collar. This has also satisfied the
trauma surgeons and statewide trauma protocols.
Lack of comparison with prior studies is a proven contributor to
misdiagnosis, but CIA efforts to reduce error in chest radiographs
by comparing images with priors when available have met with
success. Radiologists consulted prior studies 88.2% of the time in
comparison with the previously reported 65%. As a result, there is
much less risk of missing lung cancer. Further efforts toward
compliance in the abdomen/pelvic CT reporting protocol resulted in
a jump from a baseline of 66.7% to a better value of 90%. This has
resulted in a sharp drop-off in complaints from referring
physicians, especially oncologists. Similarly, OB
sonography-reporting template (Figure 1, page 64) compliance has
soared to 99%, with a near complete elimination of complaints from
OB-GYN physicians.
Effective peer review and consistently reporting imaging findings
with less variation and a closer conformance to requirements are a
necessity in quality improvement and have long been established in
the world of business. The adage, "You can't manage what you can't
measure," should be well understood. One major imaging technology
vendor uses the Trotter Matrix system to identify "errors" in
customer service. This system ranks the best and the worst service
representatives, and the best teach the worst. The best scores are
outlined by a halo, and the worst worldwide scores are outlined by
a coffin. This improvement method uses the phrase, "Coffins call
Halos." That is, the worst performers call the best and find out
how they did it. In using the Six Sigma concepts, this company can
perform at very high-quality levels. Many companies spend 10% to
15% of actual working time on "methods to improve quality,"
resulting in the following quite remarkable benefits:Â lower cost,
happier customers, less repair work, repeat customers, and market
dominance.
The Health Policy Implications
At current quality levels, much can be improved in radiology
nationwide. If the category 0 rate can be improved for CIA, then it
can be improved nationwide, probably saving millions of dollars and
many thousands of stressed women from having to have more
unnecessary mammograms. Yet improved quality is not reimbursed by
insurers. Most radiology practices do not have a focused, strong
effort to improve quality. This quality improvement weakness is due
primarily to a lack of basic education, medical culture, and
ongoing CME in QI. Fortunately, there are some fine resources
available, such as the recently updated ACR Practice Guidelines and
Technical Standards, ACR CPI (continuous professional improvement)
modules, and other resources.
Why is this happening? A survey conducted by the Pennsylvania
Radiological Society revealed that most radiologists spend less
than an hour per month improving quality, and most radiologists
have never had any training in the discipline of quality
improvement.8 There is no medical school training in quality
improvement, nor is there any in residency or fellowship. QI is
nonexistent on the Radiology Board examinations. It is not required
for state licensure anywhere. A very small number of states require
a few hours in Category 1 CME in the topics of error reduction or
risk management. The Pennsylvania statewide radiology quality
survey results indicate that radiologists believe that they should
play a major role in decisions about imaging quality, particularly
in the areas of communications with referring physicians,
appropriateness of procedures, imaging outcomes, missed diagnosis
and malpractice, and radiologist skill with multiple
modalities.
Changes are slowly occurring with state licensing boards and board
reexaminations. They are increasing accountability for quality and
error reduction with all physicians, including radiologists,
through nationwide reporting services.9 Improving quality will
reduce litigation, ultimately improve the health care of patients,
and save the nation many millions of wasted dollars. In many ways,
radiology can be a role model for all medical specialty areas.
Christopher M. Shively is a contributing writer for Decisions in Imaging Economics. He can be reached at shivelycm@washjeff.edu.
References:
- Data supplied to Robert S. Pyatt, MD, from PMSLIC, 2000.
- Leape L. Error in medicine. JAMA. 1994;272:1851â€"1857.
- Berlin L. Reporting the missed radiologic diagnosis: medicolegal and ethical considerations. Radiology. 1994;192:183â€"7.
- Goddard P, Leslie A, Jones A, Wakeley C, Kabala J. Error in radiology. Br J Radiol. 2001;74(886):949â€"51.
- Pyatt RS. Personal reference. Quality Change. Pennsylvania Radiological Society; 2003.
- American College of Radiology Annual Meeting; May 2003; Washington, DC.
- Schriger DL, Kalafut M, Starkman S, Krueger M, Saver JL. Cranial computed tomography interpretation in acute stroke: physician accuracy in determining eligibility for thrombolytic therapy. JAMA. 1998;279:1293-1297.
- Pennsylvania Radiological Society Statewide Survey, 2000.
- Federation of Medical Boards. Available at: www.docinfo.org/alp_faq.htm. Accessed October 21, 2003.