Radiology Business Journal October November 2010

FOR LEADERS IN MEDICAL IMAGING SERVICES

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FOR LEADERS IN MEDICAL IMAGING SERVICES

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CONTENTS

October/November 2010 | Volume 3, Number 5

22

Features

22 Lean: Targeting Efficiency in Radiology

40

By Cat Vasko Process-improvement techniques imported from Japan find a natural fit in radiology, promoting quality, efficiency, and a focus on patients.

32

Will Decision Support Deflect Preauthorization?

By Kris Kyes As payors counter the precipitous growth of imaging with strategies to contain it, radiology decision support emerges as a viable tool to distinguish between growth and utilization.

40

The Quality Challenge

By Katie Robbins Measuring your practice’s worth and communicating that to the marketplace are key abilities in medical imaging today.

50 Breast Cancer: The Case for the Radiologist-centered Diagnostic Paradigm

By Rebecca G. Stough, MD With the introduction of breast MRI, the most efficient diagnostic workflow has a breast-imaging specialist at its core.

4 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

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www.fujimed.com © 2009 FUJIFILM Medical Systems USA, Inc.

CONTENTS

Departments

8

AdView

October/November 2010 | Volume 3, Number 5 Publisher Curtis Kauffman-Pickelle ckp@imagingbiz.com EDitor Cheryl Proval cproval@imagingbiz.com

Improving the Health-care Transaction

By Cheryl Proval

10

Art Director Patrick R. Walling pwalling@imagingbiz.com

The Bottom Line

The Opportunity Knocks Now: Lead or Be Led

12

Priors 12 Leadership | Institutionalizing Innovation 14 Legal Matters | Privileges at Stake in IR Lawsuit 18 Clinical Research | Keeping Radiology on the Cutting Edge

Technical Editor Kris Kyes

By Stephen Herman, MD

Associate Editor Cat Vasko cvasko@imagingbiz.com Contributing Writers Stephen Herman, MD Amit Mehta, MD; Katie Robbins Rebecca G. Stough, MD; George Wiley

By Amit Mehta, MD

18

56

Advertiser Index

58

Final Read

Image Gallery | Novel Biomarker Rivals SAP in Amyloid Imaging Using SPECT/CT

20 Imaging Informatics | The PACS Divorce: Rules of Engagement

Sales & Marketing Director Sharon Fitzgerald sfitzgerald@imagingbiz.com Production Coordinator Jean Lavich jlavich@imagingbiz.com Corporate Office imagingBiz 17291 Irvine Blvd., Suite 406, Tustin, CA 92780 (714) 832-6400 www.imagingbiz.com

Content Matters

By Curtis Kauffman-Pickelle

PResident/CEO Curtis Kauffman-Pickelle VP, Publishing Cheryl Proval VP, Administration Mary Kauffman

14 Radiology Business Journal is published bimonthly by imagingBiz, 17291 Irvine Blvd., Suite 406, Tustin, CA 92780. US Postage Paid at Lebanon Junction, KY 40150. October/November 2010, Vol 3, No 5 Š 2010 imagingBiz. All rights reserved. No part of this publication may be reproduced in any form without written permission from the publisher. POSTMASTER: Send address changes to imagingBiz, 17291 Irvine Blvd., Suite 406, Tustin, CA 92780. While the publishers have made every effort to ensure the accuracy of the materials presented in Radiology Business Journal, they are not responsible for the correctness of the information and/or opinions expressed.

18 6 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

AdView

Improving

the Health-care Transaction Diagnostic error is the next frontier

I

f there is one key thing that patients want from health care, this is it: that they come away from the encounter in better shape.

Payors—including the government, insurers, employers, and, increasingly, patients—are now demanding that these encounters be more affordable, and they are less tolerant of mistakes.

It wasn’t planned this way, but by happy accident, this issue simultaneously hits on three requisite ingredients for the safe delivery of reasonably priced radiology: quality, efficiency, and appropriateness.

Our cover story explores the use of leanmanufacturing techniques in radiology. The specialty, one radiologist says, is perfectly suited to standardization, a key instrument in the lean-services toolbox.

Another article looks at the considerable investment that one radiology practice has made in defining and measuring quality. A third article examines the need to manage the appropriate utilization of imaging and the results of Massachusetts General Hospital’s deployment of decision-support software to ensure that every imaging study ordered was clinically indicated.

It has been 11 years since the publication of the seminal report1 from the US Institute of Medicine (IOM) calling for a heightened commitment to safety from the medical community. The report estimated that medical error killed 44,000 to 98,000 people annually, and, naturally, the initial response of the medical community was somewhat defensive: The numbers are inflated; those nurses are killing a lot of people; if only those surgeons would learn to tell their left from their right. It took a few years before most physicians thought about how their decisions could contribute to a safer healthcare environment.

In an article in Health Affairs, Wachter2 partially attributes to the IOM report the

ensuing lack of attention to diagnostic (as opposed to medication) error, largely because medication error responds better to the systems solutions that are the focus of the authors. The other reason for this inattention to diagnostic error is that the solutions available are not as airtight as systems solutions, which are based largely on measurement and standardization.

The solutions that do exist for preventing diagnostic error are identified as appreciating the risks of cognitive shortcuts (heuristics) and using IT, both to aid decision making and to filter and organize clinical information better.

Clearly, diagnostic error has not been ignored because it is a small problem. The muted response is more a factor of the difficulty of the solutions. Wachter points out that the Harvard Medical Practice Survey (on which the IOM’s startling mortality estimates were based) identified diagnostic error as responsible for 17% of these events—far more than the percentage of deaths caused by medication error.

Wachter offers five suggestions: First, encourage research. Second, get regulators and accrediting bodies to promote those activities proven to reduce errors.

Third, make those proven solutions that involve health IT a part of the definition of meaningful use. Fourth, improve the teaching of diagnostic reasoning in medical school. Fifth, make this skill a focus of board certification.

An excellent new report3 from Pennsylvania Patient Safety Authority, produced by ECRI Institute (Plymouth Meeting, Pennsylvania) and the Institute for Safe Medication Practices (Horsham, Pennsylvania), cites a 2003 autopsy review that found diagnostic-error rates of 4% to 50%, with a median rate of 24%.

The report also cites a 2008 metaanalysis of diagnostic-error studies; it shows that diagnostic error is encountered, across specialties, at an average rate of 10% to 15%—but at an average rate of less than

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5% in specialties that rely heavily on visual interpretation (radiology, pathology, and dermatology).

The report looks at commonly misdiagnosed conditions; common causes of diagnostic error, including cognitiveprocessing errors, communication issues, and other system-related issues; and strategies for decreasing diagnostic errors.

It includes several tables and a selfassessment tool.

Diagnostic error is not the sole province of radiology, but because imaging is a primary tool in diagnostic decisions, it is central to radiology and is likely to be the subject of growing interest in years to come.

The work of such researchers as Elizabeth Krupinski, PhD, the current board chair of the Society for Imaging Informatics in Medicine, is a great foundation.

Radiology’s next frontier well may be the discovery of new solutions to diagnostic error.

Cheryl Proval, Editor cproval@imagingbiz.com References 1. Kohn LT, Corrigan JM, Donaldson MS, eds.

To Err Is Human: Building a Safer Health System. Washington, DC: National Academy Press; 1999.

2. Wachter R. Why diagnostic errors don’t get any respect—and what can be done about them. Health Aff (Millwood). 2010;29:16051610.

3. Diagnostic error in acute care.

Pennsylvania Patient Safety Authority. h t t p : / / p a t i e n t s a f e t y a u t h o r i t y. o r g / ADVI SO R I E S/AdvisoryLibrary/2010/ Sep7%283%29/Pages/76.aspx. Published September 2010. Accessed October 2, 2010.

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The Bottom Line

The Opportunity Knocks Now: Lead or Be Led

Radiologists are well positioned to play a key role in assembling accountable-care organizations within their practice communities

O

ver the past decade, economic forces driving health care in the United States have removed many patient-care decisions from the hands of physicians. Fortunately, payment reform might change this.

Physicians, including radiologists, have the potential to be rewarded for delivering appropriate, necessary care.

In medical imaging, radiologists are in the awkward position of receiving orders that referring physicians consider appropriate. In addition, we find ourselves being required to fill orders that are considered allowable by a radiology benefit management (RBM) company. This can be frustrating both to ordering physicians—who receive no reimbursement for time spent negotiating with an RBM—and to radiologists, who often lack adequate information to determine appropriateness.

To help solve this problem, recent legislation promotes quality and efficiency under accountable-care organizations (ACOs). You can become a leader in your organization by getting involved with evaluation, planning, and implementation of an ACO, thus positioning the radiology department in a prominent position in ACO discussions. You can help key decision makers in your organization understand that radiology’s role in the ACO will be critical to its success.

The Patient Protection and Affordable Care Act and the Health Care and Education Affordability and Reconciliation Act of 2010 introduced ACOs under the Medicare Shared Savings Program (section 3022), effective January 1, 2012.

The ACO model is designed to change the traditional adversarial relationships between payors and providers to create a more collaborative, higher-quality, lowercost health system for all.

To operate most effectively, ACOs will require sophisticated, electronic clinical decision-support tools. These tools exist to promote clinical efficacy. They use evidence-based medicine’s methods to reduce costs and improve quality, and are more efficient and provider friendly than

by stephen herman, md

current third-party call-center processes such as those administered by RBMs. Under proposed ACO gain-sharing arrangements, payors and providers share in the savings produced by working together to streamline medical administrative processes. For an ACO with at least 5,000 Medicare enrollees, CMS will establish a three-year contract. Both parties agree on a historically based inflationary trend line. A target goal is mutually determined.

Any savings produced below that target trend may be paid by CMS to the ACO and shared among the contracted payors and providers. Medicare’s criteria on the amount to be reimbursed under gain sharing are determined by the HHS secretary and will focus on improved quality, outcomes, and efficiency. To optimize capabilities to report back to the secretary and to maximize reimbursement, ACOs will rely on IT, including electronic medical records with embedded clinical decision support.

Leveraging Software

With ACO gain sharing, new approaches will help radiologists and the broader healthcare community more fully understand and address unnecessary imaging expenses.

As ACOs develop rapidly in the coming years, clinical decision-support tools will electronically provide clinicians with the appropriateness criteria upon which to base efficient, outcomes-oriented ordering of diagnostic tests.

In a retrospective review of medical records, Lehnert and Bree1 reported that nearly 26% of 459 nonurgent outpatient diagnostic-imaging tests ordered by primarycare physicians at a university medical center were unnecessary. The authors suggest that tools to help primary-care physicians improve the quality of their imaging requests could help improve both their choices in imaging examinations and their decisions to order imaging in the first place.

Is it likely that the 26% rate of unnecessary imaging holds true for your organization as well? That unnecessary expense might currently be costing your hospital or your at-risk physician group a significant amount of income. Could this loss be offset with the

10 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

effective use of clinical decision support?

Could an ACO’s use of clinical decision support help your organization optimize gain sharing—and more important, reduce unnecessary radiation exposure for your patients?

The ACO model offers radiologists the opportunity to reclaim both clinical and financial control of patient care. New radiology decision-support systems offer a necessary platform for maximizing reformbased gain-sharing revenue for both ACO payors and providers.

Now is the time for radiology’s clinical and business professionals to establish leadership positions in newly forming ACOs. Take a role in controlling your own destiny, and that of your patients, by helping to define cost- and care-management strategies for the ACO. You can play a part in driving discussions and decisions about the tools for clinical and financial management that will define your ACO destiny.

Speak with your practice’s or hospital’s executive leaders to offer your clinical expertise. Early teams are likely to be composed mostly of legal and financial executives.

Without strong clinical leadership, decisions will undoubtedly be made that will have an impact on how radiologists work in an ACO model. Balancing clinical and financial factors in day-to-day decisions requires immediate information, and the model fails financially if information is not available (or if unnecessary bureaucracy and expense are added to the mix).

As radiologists and radiology professionals, we can lead or be led. Now is when we have our opportunity to make that choice.

Stephen Herman, MD, is a radiologist at University Health Network and Mount Sinai Hospital, Toronto, Ontario, Canada.

Reference 1. Lehnert BE, Bree RL. Analysis of appropriateness of outpatient CT and MRI referred from primary care clinics at an academic medical center: how critical is the need for improved decision support? J Am Coll Radiol. 2010;7(3):192-197.

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Institutionalizing Innovation

W

hen the McKinsey Global Institute (London) asked more than 1,400 executives how important innovation was to their companies’ future growth, 70% said it was crucial, but only 35% were very confident in their ability to execute it.

The problem is that too many enterprises treat innovation as a sideshow, according to an article by McCreary1 published in the September 2010 issue of Harvard Business Review. “It may get its due in lip service without being appropriately supported or well understood,” he writes.

“Worse, it isn’t integrated into the fabric or behavior of business.”

One health-care organization is rewriting the book on innovation by going beyond the conventional pursuit of new technologies or tangible projects in search of new service-focused innovations. McCreary describes how Kaiser Permanente (KP), Oakland, California, implemented a thoroughly innovative new team, called the Innovation Consultancy, that has made a measurable difference in the efficient and safe delivery of health care throughout the organization, and perhaps even beyond it: The team invited 16 other notfor-profit health-care providers to join the Innovation Learning Network for the transfer of knowledge among peers through regular meetings.

KP’s Innovation Consultancy got its start during a three-month consultancy in 2003 with IDEO (Palo Alto, California), a design company known for practicing a method that calls for exploring how people work, live, think, and feel. The relationship turned into an 18-month immersion in IDEO design technique for the KP team; its first project tackled how information is exchanged during shifts— a terrifying time for critically ill patients and a vulnerable one for quality. Nurse

Knowledge Exchange resulted. It is a formula for passing information reliably to the next shift at the patient’s bedside.

McCreary details the development of KP’s MedRite program to illustrate how the team works and its potential effects.

Designed to eliminate medication errors and piloted in 2007, MedRite was rolled out in 75% of KP hospitals by early 2008.

It cost $470,000 to develop and has resulted in $965,000 in cost avoidance for care associated with treating the consequences of medication errors.

The Whole Truth To begin getting to the fundamental problems in medication errors, the team used a technique intended to uncover the untold story. Instead of asking nurses what was wrong with the process of distributing medication (and being told that nothing was wrong with it), the team asked them to draw pictures of themselves in the process, some of which resulted in pictures of nurses with frazzled hair and sad faces.

When the nurses were asked why they drew themselves with their hair standing on end, the stories were forthcoming.

This was followed by an observation period in which team members observed multiple disruptions and distractions.

In the process of trying to give one person one medication, one nurse was interrupted 17 times.

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Because it was impossible to protect nurses from distractions completely, the team aimed to find a solution that would shield nurses during the medication-distribution process when they moved into the deep-dive phase of the innovation process, which took place in KP’s brainstorming and prototyping facility in Oakland. Nurses, physicians, pharmacists, and patients were enlisted, and the group, which numbered 70 codesigners, went at the problem, producing 400 ideas.

One idea conceived by a nurse—a smock that would read Leave Me Alone—resulted in one of the program’s key innovations: a bright-yellow sash that sends the message to stay clear, effectively creating an interruption-free zone for the wearer. The team also created a zone around the central medication dispensary, using color on the floor, that can be occupied by just one person at a time. A five-step process for ensuring the correct dispensing of medication was the central innovation.

Once an innovation has been devised, the team develops a change package that includes a set of detailed guidebooks that explain the innovation, the reasoning behind it, how it was developed, the anticipated benefits for staff and patients, user testimonials, and the measurements that will be used to evaluate its performance over time.

Far from the hue and cry of Washington, the creative work of the Innovation Consultancy is democratizing health care by giving patients and caregivers a greater role in designing its delivery, McCreary concludes.

—Staff Reference 1. McCreary L. Kaiser Permanente’s innovation on the front lines. Harv Bus Rev. 2010;88(9):92-97.

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Privileges at Stake in IR Lawsuit

T

he attorney for six interventional radiologists who have been barred, under an exclusivity contract, from practicing at three Sutter Health hospitals in the greater Sacramento, California, area is warning physicians that if Sutter Health prevails in these cases, subspecialists at other hospitals might find that their hospital privileges are no assurance that they can actually perform services.

William McD. Miller III, a partner in the Los Angeles offices of law firm Musick, Peeler & Garrett LLP, says, “This is pure economics. The extension of this is scary.” If Sutter Health wins, hospitals could decide which services should be granted exclusive contracts elsewhere, choosing with which groups they want to compete. “You can have privileges, but you’re barred,” Miller says.

Loss of privileges or practice rights for competitive reasons might be unlikely on a broad scale, but the lawsuits that Miller has filed on behalf of his clients do illustrate how service consolidation inside hospitals is putting pressure on physicians to adhere to hospital-centered delivery of care.

At the Sutter Health hospitals, Miller says, cardiologists and vascular surgeons who are not part of Sutter Health’s exclusive radiology provider group are allowed to perform exactly the same interventional procedures that the hospital’s contracted interventional radiologists do, but other outside interventional radiologists (such as his clients) are barred from performing the procedures.

“The reality here is that this is a blatant, obvious, and admitted act of discrimination against these physicians because they are radiologists—and it has been done for competitive reasons, because Sutter Health is trying to build a radiology practice,” Miller says.

Injunctions Denied The situation is complex. All six of Miller’s clients are partners in Radiological Associates of Sacramento (RAS), the radiology practice with which Sutter Health had a decades-long exclusive

contract prior to April 2010. Sutter Health allowed that contract to lapse and opted to build its own radiology practice—the Division of Medical Imaging within Sutter Medical Group (SMG)—and award it an exclusive contract.

Sutter Health contends that it can legally bar the six interventional radiologists who are part of RAS, since they are not included under the new radiology contract. Miller argues that the interventional radiologists, by virtue of the hands-on procedures that they perform on patients, are more like cardiologists and vascular surgeons than they are like diagnostic radiologists, and thus cannot legally be prevented from exercising their hospital privileges to perform interventional procedures at Sutter Health hospitals.

“If they called themselves cardiologists or vascular surgeons, they could do these procedures,” Miller says. “It demonstrates the absurdity of the position taken by Sutter Health. If you’re a vascular surgeon, it’s OK to take business away from SMG, but if you’re a radiologist, it’s not OK.” For now, however, the courts are agreeing with Sutter Health, not with the six RAS interventional radiologists who are barred. In August, in Sacramento and Placer counties (where the lawsuits were filed), preliminary injunctions were denied that would have let the physicians

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practice at the three Sutter Health hospitals named in the lawsuits—Sutter General Hospital and Sutter Memorial Hospital (both in Sacramento) and Sutter Roseville Medical Center.

Citing active litigation, Sutter Health officials are unwilling to comment on the lawsuits. According to an August 12 Sutter Health press release,1 however, the courts ruled in the hospitals’ favor because Sutter Health’s previous contract with RAS protected the exclusivity of the group—including its interventional radiologists—in the same way that the current Sutter Health contract protects its new radiology provider.

Margaret Wells, commissioner of Placer County’s Superior Court, is quoted by Sutter Health as ruling, “Plaintiff’s claim that defendant’s contract with [Sutter Medical Foundation]/SMG for radiology services is not an exclusive contract because nonradiologist physicians can perform interventional radiological procedures fails in that there was an identical exception under the RAS contract.”1 Judge Kevin Culhane of Sacramento County’s Superior Court is quoted as ruling, “Plaintiff’s interest in the right to practice interventional radiology benefited from plaintiff’s earlier exclusive contract, which lasted 15 years. Plaintiffs were given notice that the contract would not

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be renewed in November 2009. Although plaintiffs have not carried their burden with respect to either of the inquiries that inform a court’s decision on whether to issue a preliminary injunction, it is worth observing that plaintiffs benefited from the original hospital determination to institute an exclusive contract with plaintiffs’ medical group, yet here seek a mandatory injunction by challenging the factual predicate that gave rise to rise to the plaintiffs’ earlier contract under circumstances in which a similar contract has now been awarded to a competitor.”1 Although the courts denied preliminary injunctions, the case is not finished, Miller says. The next step will probably be a discovery phase in which both sides look for documentary evidence to support their arguments. After that—within 18 months or so, Miller suggests—could come a trial. That trial, he says, might establish precedent for treating interventional radiology as differing from diagnostic radiology when a radiology practice is closed (made exclusive).

Under California law, hospitals are allowed to close certain services by awarding exclusive contracts. Radiology is one of these, Miller says; others are anesthesia, emergency medicine, and pathology.

Miller argues that as long as Sutter Health allows cardiologists and vascular surgeons to place stents and perform other hands-on interventional procedures that its interventional radiologists under exclusive contract also perform, the interventionalradiology portion of its radiology service cannot be termed closed.

Therefore, his clients should be

allowed to perform the procedures, too.

“Our response is that they don’t have a closed service because cardiologists and vascular surgeons can do the same procedures, and therefore, the service can’t be closed,” Miller says.

He acknowledges, however, that since 2004, RAS had a similar provision allowing cardiologists and vascular surgeons to do interventional procedures at the Sutter Health hospitals that RAS served. Therefore, he says, under the RAS contract, interventional radiology wasn’t closed, either.

“Since 2004 there was no closed interventional radiology at either of these hospitals. They now contend that this is an exclusive contract,” Miller says, “but

“I would hope that physicians (and associations of physicians) would take a careful look at what’s going on here and ask themselves whether, if Sutter Health’s position is sustained, the whole structure—the security of medical staff privileges—might begin to crumble. All of a sudden, the economic interests of the hospital become the paramount concern, not the fact that the physicians have a vested property right in their privileges.”

Miller says that at one point, Sutter Health suggested, in its arguments to the courts, that if a Sutter Health hospital patient wanted to be treated by one of his interventional-radiology clients, that patient could transfer to an RAS clinic, be treated, and transfer back to the hospital.

Why is a hospital able to get away with barring the door to interventional radiologists, while it steps aside to let vascular surgeons and cardiologists through to do exactly the same procedures?

—William McD. Miller III, partner, Musick, Peeler & Garrett LLP, Los Angeles, CA

they say it’s not exclusive for cardiologists and vascular surgeons. Either closed means closed, or you are cherry-picking based on competitive-business means.”

Miller says that these lawsuits—filed on behalf of each of the six interventional radiologists, individually—could establish case law that effectively bifurcates interventional radiology and diagnostic radiology, when it comes to closing services.

“There is absolutely no precedent for the bifurcation of interventional radiology and diagnostic radiology,” he says. “This is the first time that I’m aware of that any hospital has argued that it can close medical procedures where medical staff privileges are given to three different categories of physicians, two are permitted to perform the procedures, and the third is not. That’s never happened.”

Wider Implications Miller says that subspecialists in all medical disciplines should take note of this case. “It should be serious and scary stuff for every physician who has medical-staff privileges,” he says.

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Miller says that this is unreasonable.

“The question is why we are being prevented from exercising privileges that the Supreme Court of the state of California has said are our vested property rights to exercise,” Miller says. “Why is a hospital able to get away with barring the door to interventional radiologists, while it steps aside to let vascular surgeons and cardiologists through to do exactly the same procedures?”

Miller says that it’s hard to predict how the arguments in the case will develop. “At this point, there’s at least the potential— depending on how a court were to rule on all of this—for there to be a fundamental change. If Sutter Health were to prevail, there could be a fundamental change in the security that physicians now feel in the medical-staff privileges they have. They could be massively more vulnerable if Sutter Health were to prevail,” he says.

—George Wiley Reference 1. Courts Rule in Favor of Sutter for Radiology Services. Sacramento, CA: Sutter Health; 2010.

IMAGING 2.0

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priors

clinical research

Keeping Radiology on the Cutting Edge

O

ver the past two decades, imaging has undergone revolutionary and evolutionary changes in both the clinical and nonclinical spheres. Part of this evolution has been the acceptance of imaging as an endpoint or marker for evaluation of the efficacy of therapy in clinical trials. As a result, new doors have opened for the involvement of radiologists in shaping the future of new therapies. This three-article series will review trial methodology, the role of imaging in clinical trials, and potential future developments for the use of imaging in clinical trials.

Amit Mehta, MD A clinical trial, at its most basic level, is a biomedical or health-related research study that is conducted in human beings and that follows a predefined set of steps or a protocol. In general, there are two types of clinical trials: interventional and observational studies. The former are executed through the assignment of research subjects, by an investigator,

to a treatment or other intervention, after which their outcomes are measured. An observational study is one where individuals are observed and their outcomes are measured by investigators.

Trial Types and Phases Within these general divisions of trials, there are various subsets and types of trials.

Prevention trials attempt to examine new methods to prevent disease and typically use medication, vaccines, or alteration of habits. Diagnostic trials are performed to elucidate better methods for diagnosing diseases.

Treatment trials attempt to study experimental treatments, adjunct therapies with novel combinations of drugs, or new approaches to conventional therapies.

Screening trials attempt to ascertain the most efficient manner of detecting diseases. Supportive-care trials investigate methods for improving the quality of life of patients with chronic illness.

All clinical trials are conducted in various phases. At each phase of the trial, the process attempts to answer a different (but specific) question. The phases are

By amit mehta, md generally numbered I through IV, with a recent rise in the popularity of phase-0 trials (human microdosing).

In a phase-I trial of (for instance) an experimental drug, investigators select a small group of people (fewer than 100) and try to evaluate drug safety while determining a safe dose, as well as identifying any side effects. In phase II, the experimental drug or treatment is given to a larger group of people (100 to 400), and further determination is made of its safety profile and treatment effectiveness.

In phase III, investigators administer the drug to a larger cohort of patients (thousands) and compare the test drug with other conventional treatments.

In addition, a safety-and-efficacy profile is studied. In phase IV, the FDA seeks to evaluate the drug after it has reached the market and has been used by the medical community.

Radiology’s Investigative Role A biomarker is defined as a detectable biological feature that provides information about the source from which it came. Specifically, an imaging biomarker represents a feature that can be detected,

image gallery

Novel Biomarker Rivals SAP in Amyloid Imaging Using SPECT/CT

The winning entry, left, in a recent vendor-sponsored preclinicalimaging competition presented at the World Molecular Imaging Conference in Kyoto, Japan, compared the amyloid-binding efficacy of the imaging agent 125ISAP (in use in Europe, but not approved for use in the United States) with a novel peptide tracer devised by the researchers, in a mouse model, using dual-energy SPECT/CT.

18 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

more quickly demonstratethese partial responses than they can improvements in survival and quality of life. By basing accelerated approval on these partialresponses, and allowing more definitive data to be developed after approval, FDA will make more cancer therapies available to patients more quickly.”1 This bulletin was followed, in 1997, by the FDA Modernization Act, which was designed to improve the regulatory process for medical products.

In section 112 of the act, authority was given to expedite approval for drugs that provide therapy for conditions, given that the therapy is shown to have an effect on a surrogate endpoint that indicates a clinical benefit.

There are other provisions in the act that enable companies to monitor products, following FDA approval, to study and ensure the efficacy of the surrogate endpoint that was used. It has become evident that the FDA is now committed to establishing programs that promote the development and use of surrogate endpoints for serious illnesses and diseases. This acceptance of

surrogate endpoints has begun a shift that is expanding the roles of radiology, radiologists, and the imaging chain in helping to guide drug discovery and development.

Clinical trials are an important part of the discovery and development of new therapies, and traditionally, radiology has not participated in the process. With the advent of imaging biomarkers and imaging endpoints for evaluating and testing therapeutic agents, however, we— as imaging experts—are poised to help guide the future of drug discovery.

Amit Mehta, MD, FRCP, is a radiologist with South Texas Radiology Group in San Antonio and is a consulting radiologist for a contract-research organization. He welcomes comments and questions at dramitmehta@ IntrinsicCRO.com.

Reference 1. US FDA. Accelerating approval and expanding access. http:// archive.hhs.gov/news/press/ 1996pres/960329b.html.Published March 29, 1996. Accessed September 27, 2010.

Overlaid dual-energy SPECT data for SAP (temperature) and p31 (gray): Note broader distribution of amyloid binding for the novel p31 radiotracer.

Amyloidosis is a protein-folding pathology associated with Alzheimer disease, type 2 diabetes, chronic inflammation, and some plasmacell cancers. No routine clinical means currently exist, in the United States, for imaging the noncerebral amyloid deposits associated with these disorders. A team of researchers at the University of Tennessee—Jonathan Wall, PhD; Tina Richey; Emily Martin; Alan Stuckey; and Stephen Kennel, PhD—developed a peptide tracer (99mTc-p31) to address this lack of imaging agent.

The team then compared the biodistribution of the two agents in the same animal with systemic amyloidosis. Regions of interest were segmented from the CT images and overlaid on the coregistered SPECT data (above, left), and quantitative measurements of biodistribution were performed in harvested tissue (above, right). The team demonstrated that the p31 peptide, compared with SAP protein, was comparable in its ability to bind with amyloid in the liver (and, to a lesser degree, in the spleen), but much more efficient at imaging pancreatic and intestinal amyloid.

www.imagingbiz.com | October/November 2010 | Radiology Business Journal 19

Images courtesy of Siemens Healthcare Molecular Imaging.

evaluated, and followed using imaging modalities. For example, the detection of a dynamically enhancing mass in the liver, on MRI, can represent an imaging biomarker.

For a clinical trial that is investigating the efficacy of a novel antitumor agent, the shrinkage of a liver tumor can represent an excellent imaging biomarker.

The use of biomarkers (or surrogate endpoints) represented a shift in the methodology and thinking of regulatory bodies. Traditionally, endpoints (typically morbidity and mortality) were used to measure differences in groups within a clinical trial. As these endpoints can take significant time to reach, clinical trials began investing the use of biomarkers as surrogate endpoints—and specifically, the use of imaging biomarkers, given their precision and their objective (rather than subjective) capabilities.

In 1996, the FDA released a bulletin addressing the issue of using imaging as a biomarker or surrogate endpoint.

It stated, “FDA will begin to rely more on partial responses, such as shrinkage of a tumor, when considering drugs for accelerated approval. Through simpler clinical trials, manufacturers can

priors

i m ag i n g i n f o r m at i c s

The PACS Divorce: Rules of Engagement

M

aybe your PACS vendor is going out of business, or the system is so creaky that your vendor no longer offers support. Perhaps your hospital signed an exclusive purchasing agreement that requires a new PACS from a different vendor. Maybe your new department chair just prefers a different system. Any of these causes could conspire to put you in the unenviable position of having to replace your PACS. In the case of Steven Horii, MD, PhD, he’s been there three times.

“How easy does divorce sound?”

Horii asked the audience during “Divorce Counseling: Changing PACS,” which he presented on June 5, 2010, in Minneapolis, Minnesota, at the annual meeting of the Society for Imaging Informatics in Medicine. “It will be a major undertaking,” he says.

While a new PACS investment represents a significant cost, the major source of pain is not money, nor is it saying goodbye to the old vendor. Data migration is the number-one problem, and the minute you know you have to change PACS, you should start thinking about migration, according to Horii, professor of radiology and clinical director of medical informatics at the University of Pennsylvania in Philadelphia.

Mismatches will cause the biggest headaches, and all of the following data issues will require either manual intervention or processing through additional software: different names for the same people; head CT studies that actually contain exams of the head, chest, and abdomen; studies that go in with incorrect order numbers; and studies on read-only memory that had attributes on them.

In addition, all PACS interfaces with other information systems and imaging endpoints will have to be tested, which might add to transition costs. Another thorny potential issue is the changeover date: You might miss the target and need to continue using the old PACS, and if your service agreement has expired by then, the jilted vendor is unlikely to be

responsive in its support.

To ease future migration efforts, consider a vendorindependent archive, Horii Steven Horii, suggests, and MD, PhD store each item as a DICOM object. When you undergo your next transition, you might have to remap some of the mapping tables, but the migration is likely to be easier.

The PACS Prenuptial Agreement The best defense against unkind (and expensive) surprises is to craft a good prenuptial agreement with the new vendor that anticipates these potential pain points: • hitting—or missing—the data migration’s target date; • supporting clinical operations during the changeover; • who cleans up, and pays for, any data messes; and • the role of the new vendor in supporting its technology, in the event that it is jilted in the next PACS transition.

Horii recommends addressing 10 particularly important items in any contract with a new PACS vendor. First, insist on realistic, firm changeover dates, and negotiate penalties that will go into effect if the changeover is missed. Second, require access to the database and data if the vendor goes out of business. You want database schemata before the vendor shuts down, as well as the details of all DICOM interfaces.

Third, ask for an option to continue service contracts on month-to-month

20 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

basis; service during the transition should be provided on the same terms that were in effect during the system’s active life.

Fourth, request that the vendor guarantee engineering support in the event that there is a transition to a new vendor.

Horii says that this support should not be expected to be free, but negotiating a schedule of charges for engineering support for the old system should be part of cost of a new PACS. Fifth, when beginning database migration in advance of the changeover (which Horii recommends), set a target for the amount of information to be migrated prior to the changeover. Sixth, insist on sending exams to both old and new systems during the transition: It will cost more because you will have to run parallel systems, but double pitching will reduce the amount of time you spend on migration. Seventh, ask for confirmation that studies are being stored in, and are retrievable from, the new archive.

Eighth, determine who is going to do database cleanup. If it’s your team, negotiate a chargeback labor rate. Ninth, if you do a database survey to estimate mismatches (which Horii recommends), negotiate who will pay for this. Tenth, if you are reusing any of the old system’s equipment in the new system, what will you do during the parallel-systems phase? Consider using loaned or leased equipment.

Horii left attendees with a few choice suggestions: Consider consulting with a group experienced with change management. Don’t forget training requirements; it takes longer than you think. Understand the potential impact of transition on clinical operations (such as a slowdown in the movement of large datasets), and make sure that the administration is aware of and willing to support the full cost of making the change.

“Facing a change of PACS vendor is going to be painful,” Horii says. “You can do things to give analgesics for the pain: The most important is planning for the change.”

—Staff

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COVER | Lean Radiology

Lean L Targeting Efficiency in Radiology

Process-improvement techniques imported from Japan find a natural fit in radiology, promoting quality, efficiency, and a focus on patients By Cat Vasko

ean services, Six Sigma™, and continuous process improvement: Call them what you will, techniques derived from the nowfamous Toyota Production System (TPS) are growing in popularity as a means for health-care providers (and radiology, in particular) to reduce costs and improve efficiency and care—with minimal capital outlay.

As Howard Fleishon, MD, a radiologist at John C. Lincoln Health Network (JCLHN), Phoenix, Arizona, explains, “Lean services are really built upon developing standardized workflow, and aspects of radiology are very amenable to that mindset. Radiologists need to be aware that this is being popularized in the health-care industry. With so many other specialties wanting to be involved in medical imaging, we need to put ourselves in the position where we are seen as the best group to manage medical imaging throughout the entire enterprise.”

Fleishon believes that the implementation of lean tools can help—and he’s not alone. In Seattle, Washington, Virginia Mason Hospital & Medical Center (VMHMC) has pioneered the Virginia Mason Production System (VMPS), which has been used to apply continuous–processimprovement techniques to radiology for almost a decade. Seattle Children’s Hospital used lean techniques to refine

22 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

the design of its new clinic and reduce construction costs, and imaging centers and hospital radiology departments alike are increasingly working with lean consultants to optimize processes while improving customer service.

Ellen Ermer, MSE, senior performance engineer at JCLHN, says, “In continuous process improvement, you’re always asking, ‘What is the voice of the customer?’

In health care, that means the focus is the patient. Your goals should always be driven by what is best for patient care.”

Adapting to Lean Methods Ermer stresses that the implementation of lean methods represents a cultural shift that should not be taken lightly by managers. “To be successful, you need the buy-in, constant support, and push from leaders,” she says. “They have to understand it to believe in it and allow it to become part of the way you do things at your organization. If you don’t have that buy-in, you’re only going to achieve process improvement in pockets, here and there.”

Ermer further recommends that leaders choose terminology carefully when introducing lean processes to staff. “The lingo can be intimidating,” she notes. “Sometimes, the word lean alone can be misunderstood; when you say you’re going to go lean, people think it means you’re going to start laying off staff, and that’s not the focus at all.”

Anne Daley, a senior consultant at Chi Solutions Inc, Ann Arbor, Michigan, adds that even the most basic lean concepts might be met with resistance from seasoned health-care employees who are accustomed to doing things a certain way. She uses the example of scheduling to demonstrate the challenge: “In lean services, you staff based on when the volume comes in, and not necessarily when people want to work,” she says. “That’s very hard for people to get accustomed to; a lot of health-care schedules are based on the eight-hour work shift—and health-care organizations like full-time workers, so they limit their ability to be flexible.”

In 2002, VMHMC implemented its own production system, the VMPS. Lucy Glenn, MD, radiology-department

chair, recalls how the organization made the transition from lean theory to lean reality, beginning with leaders. All members of the executive team became certified leaders in lean services, she says, “and all the vice presidents and chiefs went to Japan for two weeks’ training as well. Pretty soon, we had the next layer of managers go through

the training, and then we started with week-long rapid–process-improvement workshops with staff.”

Glenn reiterates that the implementation of lean services represents a culture shift, adding that it’s important to supply employees with sufficient motivation to embrace the change. “You have to create the urgency—tell people

In lean services, you staff based on when the volume comes in, and not necessarily when people want to work . . . and health-care organizations like full-time workers, so they limit their ability to be flexible.

—Anne Daley, senior consultant, Chi Solutions Inc, Ann Arbor, MI

Getting Started

A

nne Daley, a senior consultant at Chi Solutions Inc, Ann Arbor, Michigan, offers a few examples of easy-to-implement lean activities that can lead to important process changes for radiology (while acclimating both leaders and staff to the new methods). “When you first start doing lean services, in my opinion, if you want to gain the biggest value, you should either have a leader formally trained or bring in an experienced lean facilitator.

To facilitate a group of people through a complex project like improving turnaround time, you need someone who’s done this before,” she says.

For radiology, in particular, Daley has found an activity called five S to be useful. The five basic components of five S are sorting, straightening, shining, standardizing, and sustaining. “It’s a systematic way to organize a workplace,” she says.

Her guide to using the five S steps begins with sorting. “It’s amazing how many items are useless in a workplace,” Daley notes.

“A fun exercise is to use colored dots to determine what you’re really using: green dots are for daily items, yellow dots are for items that are used weekly or are critical when needed, and red dots are things that don’t need to be in the work area at all. I often see radiology departments keeping a one-year supply of things in a work area, and then there’s no more room. A one-week

supply is more practical when space is at a premium.”

Straightening: Daley recommends arranging items in such a way that those most commonly needed are at hand, while those needed less often can be placed on a high shelf or in another out-of-theway storage area. “It sounds like common sense, but common sense is not always common practice,” she says. “That’s what lean services are all about: making common sense a common practice.”

Shining: This step is focused on keeping the items in a workspace clean and accessible for all potential users. “A lot of technical people don’t look at cleaning as their job, but housekeeping people can be afraid to touch anything in a technical area, so this is something that, many times, is overlooked in radiology,” Daley explains.

Standardizing: Daley says, “Many radiologists have personal preferences on how to set up a procedure room, which can also lead to wasted time and movement.

You can’t always standardize room setup 100%, but if you can get consensus on 80%, you will improve efficiency.”

Sustaining: This step consists of continually maintaining the changes enacted in the first four steps. “The end of a shift is a common time for a technologist to do a quick check to make sure everything has been put in order for the next person,” Daley notes.

Another useful exercise for radiology is spaghetti diagramming—visualizing the flow of people, materials, or information through a process. It can be easily accomplished using a blueprint of the workspace and colored pens that trace the flow within that workspace. This was a key component of Seattle Children’s Hospital’s design process for its Bellevue Clinic and Surgery Center, and it’s an activity that is often illuminating, Daley reports.

For example, in one hospital department, “Spaghetti diagramming revealed that during the day, a patient would come into the waiting room, sit down, go to registration in another area, sit down again, then go back to the front desk for paperwork, then sit down again—and then, finally, go in for imaging,” she recalls. “Consider a person in a wheelchair or on crutches doing all that.

It’s not good. In this case, the department decided reception and registration staff should be cross-trained so patients could avoid all the unnecessary extra steps.”

At Seattle Children’s Hospital, spaghetti diagramming (see figure) helped create the adjacencies and colocations that enabled the design team to minimize the Bellevue Clinic and Surgery Center’s size and cost while maximizing its capacity.

Lisa Brandenburg, CAO, recalls, “We drew the seven flows of medicine (patients, continued on page 24

www.imagingbiz.com | October/November 2010 | Radiology Business Journal 23

COVER | Lean Radiology

You’re taught, in medical school, to be an individual practitioner, whereas here, it’s a team model—we’re all collectively caring for the patient.

—Craig Blackmore, MD, Virginia Mason Hospital & Medical Center, Seattle, WA

Lean Services and Radiology Blackmore characterizes lean methods as “a cultural shift from the way in which radiology is historically practiced. You’re taught, in medical school, to be an individual practitioner, whereas here, it’s a team model—we’re all collectively caring for the patient. I’m not just reading an MRI, I’m participating in the entire progression of care,” he says.

He adds, however, that basic lean principles—maximizing efficiency, reducing costs, and focusing on the customer—strongly echo recent trends in imaging. “An important aspect of quality in radiology is not simply interpreting studies, but ensuring that the study you’re doing is the appropriate one for the patient,” he says. “That means seeing radiology as part of the global care process

why,” she says. “We knew health-care reform was coming and that we were going to be facing economic challenges in terms of Medicare and insurers, while every year, we were seeing a 5% increase in expenses.”

Craig Blackmore, MD, joined VMHMC’s radiology faculty three years ago, and he describes the VMPS as permeating the organization. “It’s not simply an overlay placed on the institution

by the leaders,” he notes. “It’s really part of the culture. Everyone who’s hired by VMHMC is exposed to the VMPS as part of his or her orientation, and every staff member has at least some exposure to it and understanding of what it means.

If you want to change something, you work through the VMPS. I’ve never been at any other center where everyone is so collaborative and standardized in approach to improving quality.”

continued from page 23 families, caregivers, supplies, equipment, medication, and information). We traced what the average radiologic technologist did in a day and counted the number of steps involved, then tried to reduce them as much as we could. Traveling more than necessary is waste.”

Kaizen is the Japanese word for improvement. To keep lean principles alive in the workplace, Daley recommends holding periodic quick-and-easy kaizen (QEK) sessions, with rapid process improvement focused on specific applications within radiology. For example, the goal might be to reduce clutter on a busy work counter. Daley says, “Organizing binders on a counter isn’t a project in itself; it’s a QEK.” The most important thing to remember when implementing lean services is the emphasis on taking recommendations from the staff members who actually perform the processes to be improved. “A lot of these tools can be used à la carte, or when you have a more complex issue to take on, like patient throughput, you can use a number of them together, through a facilitated, team-based approach,” Daley says. “The key is to focus on the people side of the change, not just to go through the motions of using the tools. Unless you change your culture, the improvements you make are probably not going to be sustained over time.”

—C. Vasko

Figure. To ensure optimal adjacencies in the design of a new facility, Seattle Children’s Hospital in Washington used a conceptual tool to reflect the seven flows of medicine: patients, families, caregivers, supplies, equipment, medication, and information.

24 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

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COVER | Lean Radiology

Most of the best ideas come from the people actually doing the work; if you give them the tools and coach them, they just take off with phenomenal ideas.

—Ellen Ermer, MSE, senior performance engineer, John C. Lincoln Health Network, Phoenix, AZ

and being a radiologist who is a member of the team that’s caring for the patient.”

Fleishon concurs. He recalls a rapid– process-improvement event in MRI at JCLHN that was part of a larger three-day lean initiative. Process changes made by the supervisor and two MRI technologists resulted in a huge reduction in roomturnaround time—from an average of 17.1 minutes to just 4.2 minutes.

“These are the kinds of statistics that hospital administrators are hearing in the conferences they go to, and being able to show these improvements in radiology is critical,” he says. “Lean services also provide a common lexicon for hospital leaders, as well as for managers across all hospital departments. They can finally speak the same language.”

Daley, who frequently consults on process-improvement projects for radiology, says that in her experience, movement and general workplace organization are major issues in most imaging departments and practices.

“Anytime a person’s movement does not contribute to moving the care of a patient forward, it’s considered wasted activity,” she says. “Excessive movement slows down the process. You can see a lot of movement in imaging related to obtaining supplies for the various procedures; if the supplies are not easily accessible, this could result in wasted activity.”

Glenn observes that, presented the right way, lean services are a natural fit for radiology. “For radiologists, lean services are just the scientific method,” she says.

“You develop a hypothesis about what would make an improvement, test that hypothesis, and then measure again to assess whether you were correct. The method isn’t foreign—it makes sense on a basic level.”

Successful lean-services implementations at VMHMC have included improving CT throughput and decreasing

interruptions to radiologist workflow in the breast-imaging clinic. Glenn says that an easy way for imaging groups to apply lean methods is to identify issues on a modality-by-modality basis. “Identify things in each section that you want to improve, and make sure you touch on every area involved in the process— scheduling, image management, and so on,” she says.

Focus on People Though the lexicon of lean services has a decidedly mechanical feel—production system, process improvement, rework—

keeping employees engaged in them in the future is quick, visible follow-through action, Ermer says.

“Most of the best ideas come from the people actually doing the work; they just don’t know how to implement them,” she says. “If you give them the tools and coach them, they just take off with phenomenal ideas. Anything that needs to be changed to improve a process—from reorganizing cabinets or updating software to creating or revamping policies—you do right then and there. You’re empowering people to get what they need from leaders, and when they see changes right away, of course, they feel great about that.”

At Seattle Children’s Hospital, when Lisa Brandenburg, CAO, and Chuck Fritz, administrative director of radiology, joined together on the design committee for the hospital’s new outpatient clinic in Bellevue, Washington, they leveraged lean principles to create the most effective plan. “We set goals for ourselves, and

We set goals for ourselves, and those included improving both patients’ and providers’ experiences of being in the building. We studied the most common patient and provider flows to determine what services most needed to be adjacent to each other.

—Lisa Brandenburg, CAO, Seattle Children’s Hospital, Seattle, WA

the method is people focused, with an emphasis on serving the customer better by meeting the employee’s needs better.

Lean services work by empowering staff members to make rapid changes that will result in process improvements. “You work very closely with the staff,” Ermer says. “You work together to determine how to rid processes of waste and add as much value as possible—all while focusing on the patient.”

Rapid–process-improvement events are among the most important tools used in lean method. These events (in TPS terms, kaizen workshops) bring staff—often, from cross-functional departments—together to maximize efficiency and reduce waste in processes.

The key to making them successful and

26 RadioLogy Business JouRnaL | october/november 2010 | www.imagingbiz.com

those included improving both patients’ and providers’ experiences of being in the building,” Brandenburg says. “We studied the most common patient and provider flows to determine what services most needed to be adjacent to each other.”

When the committee had a proposed design ready, its members built a toscale cardboard model of the space and then invited staff to walk through it in simulated clinical scenarios—in essence, giving the layout a dry run. “When staff members told us something didn’t make sense or wouldn’t work for them, we moved it,” Fritz says. “We did several iterations of that to get the best design.

Lean methods really drove us to have our staff working collaboratively.”

Fleishon says that engaging staff with

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COVER | Lean Radiology

lean methods will yield ample dividends, in terms of employee enthusiasm and participation. “People are a critical part of this learning curve,” he says. “They are seen as a valuable resource. Showing that they’re participating in these types of changes improves the stability of their positions and provides them with valuable experience they can use throughout their careers.”

Smarter Design Improving design is a key component of any organization’s lean makeover, whether it’s overall facility design or simply the way that a single workspace

is organized. “Whenever I go into an imaging department and see boxes piled in hallways, I know there’s an opportunity there to do things better,” Daley says.

“When things aren’t organized, it decreases efficiency and drains energy within the work environment.”

In designing Seattle Children’s Hospital’s Bellevue Clinic and Surgery Center, Brandenburg, Fritz, and the team were faced with a tough imperative from leaders: Reduce costs by 25%, reduce space by 30%, and plan five years out when projecting capacity. “Our clinics are very dependent on services like radiology,” Fritz notes, “so we wanted to

$300,000 Leaner and 97% Happy

A

t Portsmouth Regional Hospital in New Hampshire, a team that included members of the radiology department, centralized scheduling, a floor nurse, and the COO entered a room with the goal of improving the satisfaction of customers (including patients, physicians, and nurses). The team emerged, five days later, with a plan to implement eight different kaizen (improvement) events that resulted in savings of $350,000 and in soaring customerand employee-satisfaction scores.

Robert White, MBA, CRA, and Elizabeth Vierra, both of Portsmouth Regional Hospital, described the process on August 23, 2010, in “How Lean Methodology Can Improve Customer and Employee Satisfaction” at the annual meeting of AHRA: The Association for Medical Imaging Management in Washington, DC. What sent the team into action was the fact that overall, 75% of patients were getting into the imaging rooms within 10 minutes. With CT, the figure was 33%.

Contending with physicians, nurses, and patients who always seemed upset, the team began by observing the department’s processes by using a stopwatch and writing down the number of steps that it was taking to perform each one.

Processes were categorized as direct patient care, indirect care (preparing a room), regulatory (required by the Joint Commission), or one of eight kinds of

Robert White, MBA, CRA

Elizabeth Vierra

waste: defects, overproduction (such as preparing contrast for patients not on the schedule), waiting, transporting, inventory, motion, confusion/lack of clarity, and excess processing.

The team made use of four kinds of lean tools: applying the five S process (see Getting Started, page 24); drawing spaghetti diagrams, making value-stream maps, and asking the five whys (to find out why someone does something the way that he or she does, ask why, then why, then why, then why, and then why).

After making observations (including the fact that the average technologist walked 7.5 miles each day) and collecting data, the team constructed pie charts for each modality to calculate how much of the process was categorized as waste. The team created a value-stream map that identified problems in scheduling, in transporting patients, in the availability of supplies, in name bands that technologists had to scan repeatedly, and in a confusing questionnaire.

Next followed a period of idea generation, and each person was asked to illustrate four continued on page 30

28 RadioLogy Business JouRnaL | october/november 2010 | www.imagingbiz.com

design, from the start, to support that.”

Colocation rapidly became a watchword for the team, which strove to make as many spaces as possible as multifunctional as possible. For example, “In pediatric MRI, a lot of patients go under anesthesia, so we developed the radiology space to be contiguous to anesthesia and to the operating area—so there would be less waste of movement among the anesthesia and nursing staff,” Fritz says.

Brandenburg adds that the line of sight offers a simple, intuitive way to determine whether a space will be as functional, for clinicians, as it should be. “The simplest way to understand how things are flowing in your department is to be able to see,” she says. “During the radiology mockup testing, staff members who worked in radiology were coming in and asking whether they would be able to see certain things from where they were.”

She continues, “We moved the planned main supply areas because the path was too convoluted. We also changed the relationship between the operating room and the recovery area so that we would have a single directional flow. The patient arrives on one side of the space, receives anesthesia (if necessary), receives the imaging study, and goes out a different exit, adjacent to the recovery space. The flow of that patient, through that area, was a huge design success.”

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COVER | Lean Radiology

You have to make sure your employees’ voices are heard to build trust in the process. The whole idea of lean services is that we don’t talk about change, we actually try it—and if it’s not working, then we just try again.

—Lucy Glenn, MD, radiology department chair, Virginia Mason Hospital & Medical Center, Seattle, WA

continued from page 28 ideas using crayons and paper. This process resulted in six action plans.

Problem 1: Patients were required to fill out a confusing and lengthy questionnaire upon entering. Impact: This took five to 15 minutes to complete, seriously limiting the department’s ability to get patients into an exam room within 10 minutes of arrival.

Countermeasures: The questionnaire was condensed to two sides of one piece of paper, and the questions were rewritten for clarity.

Problem 2: Supplies were scattered, particularly in the CT area and special areas. Impact: Technologists (particularly per-diem workers) were forced to rummage through cabinets looking for what they needed, and patients lost confidence in the process. Countermeasures: Managers spent several hundred dollars (the only capital cost for the improvements) on replacing the cabinet doors’ wooden inserts with glass, labeled each shelf, gave each item a place, put someone in charge, and made the staff accountable for order.

Problem 3: Name bands were scanned multiple times in exam rooms. Impact: Technologists were spending 30 minutes per month rescanning name bands; this was not just an imaging problem, but a problem affecting the entire hospital.

Countermeasure: The department called in the vendor, who did hospitalwide training on how to use the name bands.

Problem 4: Many orders were inaccurate.

Impact: Of CT exam orders, 70% were inaccurate, resulting in excess work (with

an impact on nursing staff of 10 minutes per defect). Countermeasures: An imagingservices reference guide was created and distributed to all referring physicians; the guide was also added to the internal website. “Did You Know” cards were created and were distributed to the relevant departments.

Problem 5: There were errors/difficulties in patient transport. Impact: The department experienced delayed turnaround time from order to report; downtime was expressed in empty tables and idle equipment; patients were being transferred in wheelchairs instead of on stretchers, resulting in staff injuries; excess work was created; and patients were being left alone. Countermeasure: A team was developed to find solutions, which are still being developed.

Problem 6: In scheduling, the next available exam did not reflect actual availability, exams were scheduled in clusters, and resources for exams did not match appointment times. Impact: Referring physicians were sending patients to competitors, and CT volumes were dramatically higher at 8 and 9 am.

Countermeasure: Appointment templates were reviewed and updated, improving the percentage of patients who were delivered to an exam room within 10 minutes of arrival from 33% to 72%.

Results, to date, have been impressive.

Customer satisfaction, which began at an anemic 47%, soared to 85%, exceeding the goal of 69%. Overall employee satisfaction is 97%, up from 60%.

—Cheryl Proval

Sustaining Change Many experts in lean services emphasize the continuous aspect of continuous process improvement. “To keep lean services alive, they have to be leader driven; leaders need to be involved and to hold people accountable,” Daley says.

“Someone must check to ensure changes are sustained, and if they are not, there must be consequences. If the changes do not stick, it is generally a failure of leaders to keep the momentum going.”

Ermer concurs. She says, “Leaders have to support lean services—to speak their language—and they have to be aware that they will encounter barriers as they move forward. That’s part of the process.” She adds that the biggest obstacle that organizations encounter in implementing lean services is dealing with the culture change inherent in the method. “Managing in a lean environment is a big adjustment because change is no longer top down; it’s bottom up,” she says.

“Leaders’ role is to guide and direct the team through the changes the employees have suggested, but they really do have to trust and believe in what their staff has come up with first.”

Glenn underscores the importance of trust, which she says is enforced, not undermined, by constant change.

“Knowing that things are not set in stone, and that processes will continually evolve, makes it a little easier to be able to try,” she says. “You have to make sure your employees’ voices are heard to build trust in the process. The whole idea of lean services is that we don’t talk about change, we actually try it—and if it’s not working, then we just try again.”

Fleishon is optimistic about the potential for continuous process improvement to enhance radiology’s role in overall care delivery. “The whole idea is to continue to experiment, to improve, and to change,” he says. “We currently have our MRI cycle time down to 4.2 minutes, but that doesn’t mean we’re done yet; next year, we may take a look again. These are statistics that have a serious impact, and that’s why hospital administrators are embracing this type of method.”

Cat Vasko is associate editor of Radiology Business Journal and editor of ImagingBiz.com.

30 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

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IMAGING | Utilization Management

Will Decision Support Deflect Preauthorization?

As payors counter the precipitous growth of imaging with strategies to contain it, radiology decision support emerges as a viable tool to distinguish between acceptable growth and overutilization By Kris Kyes

D

ecision support might be able to remove the target taped to radiology’s back, according to a tandem presentation that was made by two of the specialty’s respected leaders on May 3, 2010, at the annual meeting of the American Roentgen Ray Society in San Diego, California.

Pat A. Basu, MD, MBA, explained how that target came to be there in the first place; he presented “Overutilization: Background, Trends, and Causes.”

Basu, an attending radiologist at Stanford University Medical Center and at the VA Palo Alto Health Care System in California, is Stanford University’s course director of health finance, policy, and economics. Now serving as a White House fellow and special assistant to the president, he is the first radiologist to be appointed to that position. By understanding the reasons for radiology’s current struggles, he says, both individual radiologists and health-care organizations can begin to find ways to identify and correct inappropriate utilization of imaging.

James H. Thrall, MD, provided a real-world example of how decision support could help decrease radiology’s vulnerability to external control (or outright attack) and declining reimbursement, presenting “Opportunities for Reducing Overutilization.” Thrall is radiologist-in-chief at Massachusetts General Hospital (MGH)

in Boston and Juan M. Taveras professor of radiology at Harvard Medical School.

Even if the overutilization of imaging is a problem created largely outside radiology by self-referring nonradiologists, patients’ underinformed demands, and referrers’ errors and malpractice worries, it has become radiology’s problem because radiologists bear the brunt of measures meant to curb utilization, Thrall notes. In clarifying the need for radiology practices to move beyond simply accepting overutilization as part of keeping referring physicians happy (or as part of maintaining current revenue levels), he says, “It’s not a sound business principle to try to build a practice or a business based on things people don’t need—on providing services that are unnecessary.”

Growth Versus Overutilization It is important, Basu says, to avoid confusing growth with overutilization in imaging, as this mistake has done much to damage the reputation of radiology in the eyes of lawmakers, regulatory agencies, insurers, and the public. Growth in procedural volumes can often represent completely appropriate increases in the utilization of imaging services in response to technological advances and to improving medical evidence of the best applications for imaging modalities and procedures.

32 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

Many of the major growth spurts that imaging volumes underwent in previous years were wrongly characterized by policymakers as the simple addition of yet another costly, high-tech, and possibly unnecessary study to the diagnostic protocol for a given disorder, with the economic effects of that addition then multiplied, across the nation, by the number of patients initially suspected of having that condition.

Basu point out that this oversimplified and erroneous model has harmed radiology both by exaggerating the cost of imaging and by overlooking its value (in clinical and monetary terms).

In many—or even most—cases, the imaging-utilization statistics could have been showing growth in the use of a procedure or modality for sound reasons.

Often, one type of imaging is substituted for another as its superiority becomes more obvious to referring physicians.

In such instances, figures demonstrating growth in that modality must be weighed against any declines seen in the utilization of other modalities, if any realistic conclusions are to be drawn. This is relatively obvious for analyses of the utilization of one modality versus another (but not often brought to broad attention, even so). This type of comparison has been far more difficult to make when one procedure largely replaces another within the same

modality, partly due to lack of data and partly because this kind of work hasn’t often been undertaken.

Radiologists in the field might see a strong trend toward one less-expensive but diagnostically equivalent study replacing a more costly one within a modality, for example, but this kind of positive change is unlikely to be tabulated anywhere—and still less likely to reach a level where it could gain the attention of policymakers.

The value of imaging in replacing diagnostic procedures outside radiology is even more pronounced, but just as often overlooked. How often, today, does anyone undergo exploratory surgery? It is still necessary, under some circumstances, but it is certainly far more rare than it once was—because the same exploration can be conducted using imaging.

Many of imaging’s steep gains in procedural volume happened because an imaging study could replace a diagnostic procedure that was less useful, but the most beneficial studies also replaced invasive procedures that were more likely to cause postprocedural complications, that were far more uncomfortable and unnerving for the patient, and that usually cost a great deal more than an imaging-based diagnostic progression.

For example, an MRI study might be perceived as expensive by payors, but it certainly never approaches the cost of the exploratory surgery, pathology work, and associated expenses that it can (and so often does) replace.

Any fair attempt by policymakers to assess the cost of growth in the utilization of imaging procedure must be certain to subtract the cost of all of the invasive diagnostic procedures that this additional imaging replaced (and the extra risk and pain that invasive procedures add to the patient’s burden should not go unnoticed, either).

Utilization Realities For these and similar reasons, Basu says, the frequently repeated claim that as much as a third of imaging is inappropriate is probably untrue. He adds, however, that there is reliable evidence (both direct and indirect) that overutilization is more than a figment of payors’ imaginations.

It’s not a sound business principle to try to build a practice or a business based on things people don’t need— on providing services that are unnecessary.

—James H. Thrall, MD, Massachusetts General Hospital, Boston, MA

It is real, but it has many causes; several of the reasons for overutilization have their roots outside radiology (and even outside medicine), but there are also factors driving overutilization within the specialty.

Overutilization is hard to quantify, but Basu explains that retrospective review of referring physicians’ imaging orders is one direct measure that can be used to verify the extent of the problem.

Analysis of the indications for imaging in individual cases will make overutilization more obvious, for example—often, in the form of duplicated exams.

Indirect clues to the presence of imaging overutilization are seen in the wide variance of procedural volumes for imaging, both from region to region and from one ordering-physician specialty to another.

In some places, the average annual cost of imaging per Medicare enrollee is twice the national average, for example.

Because the variance in imaging utilization among locales and specialties is large, Basu says, it is improbable that all of the lower-use areas and specialties represent underutilization (especially in a litigious society): The presence of overutilization is more likely to be the reason that the variance exists. A more localized indirect indicator of overutilization is the abrupt increase in the use of a modality that is sometimes seen when a physician has just acquired equipment in that modality for the first time.

Radiologists’ Actions Radiologists face multiple external pressures that can drive overutilization, but other influences favoring it come from within many practices and departments.

Some radiologists might feel that reviewing the appropriateness of a requested study is not their role, and might thus be unwilling to take this step.

Others could be willing, but not experienced enough to feel confident that they are able to perform such a review.

Unfortunately, some radiology practices also have a long tradition of self-referral that takes the form of recommending additional studies (which might not always be appropriate).

Less questionable motives, such as adherence to a clinical protocol or to a policy or standard previously established by the practice, can lead to recommending more imaging than necessary. In some cases, radiologists’ recommendations and/or referring physicians’ orders can be inappropriate because the imaging guidelines of specialty societies need to be updated to reflect evidence from recent studies.

In addition, Basu says, some radiologists remain unaware of the harmful long-term consequences that imaging overutilization could bring to patients, payors, providers, their practices, and themselves. Others are not yet convinced that these effects are bad enough to warrant changes in their day-to-day activities. These radiologists are unwilling to assume a gatekeeper’s role in determining whether an imaging order is appropriate, and they fail to see themselves as the expert consultants that such a role requires.

The research that would be expected to help more radiologists assume the expert consultant’s position with confidence has not been supported by policymakers to anything approaching the necessary degree. Evidence of effectiveness is needed, and the effort to tie imaging to patient outcomes requires more attention than it now receives. Lawmakers, Basu says, also have failed to enact measures that would substantially reduce the overutilization attributable to financially motivated self-referral outside radiology.

www.imagingbiz.com | October/November 2010 | Radiology Business Journal 33

IMAGING | Utilization Management

When such patients demand additional exams, too many physicians give in and order these inappropriate studies— and too many radiologists give in and perform them.

—Pat A. Basu, MD, MBA, Stanford University Medical Center, Stanford, CA

Patients’ Demands The public’s demand for imaging studies remains strong, while its understanding of what those studies can do generally remains poor. Consumers can feel cheated of the best possible health care if they are denied the most advanced imaging exams, even in cases where those exams are clearly inappropriate.

Because some health plans impose inconsequential (or no) deductibles or copayments for outpatient imaging— under rules left over from the era when insurers were working to discourage 1269_Rad_Sprd_RBJ_BOT.qxd:Layout 1 5/7/10 unnecessary inpatient admissions for

diagnostic testing—patients can be subject to financial detachment from the consequences of their imaging demands.

In the view of patients who have not been helped by their physicians to understand whether the results of an imaging study would have any effect on their treatment, more is always better. When such patients demand additional exams, too many physicians give in and order these inappropriate studies—and too many radiologists give in and perform them.

“Radiologists have the best clinical, operational, and economic understanding 3:06 PM Page 1 of when imaging is and is not useful.

To serve their patients and physician colleagues better, it is imperative that radiologists play a lead role in optimizing appropriate imaging and curtailing inappropriate imaging. Specifically, I encourage radiologists to hold meetings or seminars with referring-physician colleagues, payors, and policymakers to find solutions to these issues,” Basu says.

Taking Action Speaking after Basu, Thrall observes that even though imaging became the subject of fee-reduction measures due to growth—with actual overutilization being far less responsible than simple growth for attracting regulatory attention— imaging is, nonetheless, a handy target.

The probability of further cuts in imaging reimbursement, therefore, is high. Thrall defines genuine overutilization as the performance of imaging procedures that are not expected to improve patient outcomes (in light of the individual circumstances that apply to a case).

MAKING

The existence of overutilization is unquestionable, Thrall says, but there are no empirical data to indicate how prevalent it really is. The figures often cited for excess imaging could be too high, but might also be too low, and overutilization rates for different care settings (and among radiology practices) also vary a great deal.

Thrall reports that there appear to be three factors that are the main contributors to imaging overutilization.

These are self-referral, defensive medicine (including acquiescence to patients’ inappropriate preferences), and referring physicians’ poor understanding of appropriate imaging. This lack of knowledge is probably a factor in 10% to 15% of imaging referrals, Thrall says, with self-referral accounting for 8% to 12% of problem orders.

In the recent past, high levels of reimbursement for imaging studies tempted too many physicians into selfreferral for imaging; they might not

otherwise have bothered to offer imaging services. In particular, Thrall says, the Stark law—which was intended to combat self-referral—has, instead, encouraged and protected it through the inclusion of the in-office ancillary-services exemption.

This ineffective measure might have been replaced by more useful deterrents through the enactment of health-care reform, but that opportunity was lost during the creation of the new law.

The influence of defensive medicine on overutilization is the most variable of the three main drivers of inappropriate imaging, Thrall notes, partly because the states that have enacted tort-reform laws are less likely to see patients being encouraged by malpractice attorneys to sue their physicians. The percentage of imaging orders issued for fear of medical liability could, therefore, be as low as 5% in less litigation-prone areas, but as high as 25% in others.

These three overutilization-promoting problems often overlap in individual

cases, so their probable percentages cannot simply be added together to yield an estimate of total overutilization. All three factors could even be involved in persuading a physician to order one inappropriate imaging exam.

Educating Patients While Thrall acknowledges the difficulty that researchers have encountered in attempting to quantify the multiplying effect on imaging overutilization that patient requests can have, he also says that this is one area where individual referring physicians can have a considerable influence on improving the appropriateness of imaging orders. Naturally, educating themselves about the best uses of today’s imaging studies is the first step that both primary-care physicians and specialists should take to reduce their contributions to overutilization.

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IMAGING | Utilization Management

though. By educating their patients, referring physicians can help them understand what they should expect from imaging; that, in turn, should reduce the demand for unwarranted procedures.

For example, Thrall says, prior medical encounters have led many patients to expect imaging exams to be ordered for them whenever they report a new health problem to their physicians. Often, these patients then respond to the physician’s decision not to order any imaging studies by contending that their health-care needs are not being adequately met.

An investment of the physician’s time in letting such a patient know why imaging is not called for, in his or her current case, will not only reduce inappropriate utilization during that encounter, but will improve that patient’s satisfaction with the care provided (and could reduce the likelihood that he or she will demand unnecessary imaging studies during future medical visits).

Thrall adds that there is an overlapping effect between patients’ demands for imaging exams and physicians’ liability concerns: A patient whose demand for a medical service has not been heeded can become a patient whose poor (but unrelated) subsequent outcome then leads to a malpractice suit alleging that the necessary medical care was not provided.

For many physicians, this prospect can be threatening enough to prompt the ordering of imaging procedures that the physician knows are unlikely to be helpful.

Decision Support There is, Thrall says, a fourth reason for the overutilization of imaging studies, but unlike the other three factors, it is not a motive: It is the absence of the kinds of decision-support or utilizationmanagement systems that can reduce overutilization due to any of its other causes. This lack of access to useful systems means that there are still many unexploited, promising opportunities to address overutilization.

An ideal utilization-management system for imaging would have eight primary characteristics, Thrall says. First, it would be effective in helping to control the inappropriate utilization of imaging.

Second, it would be transparent, working

by applying criteria that are made known to referrers and to imaging providers before they try to issue or carry out an order for imaging.

Third, the ideal system would yield answers that are reproducible.

Whenever identical exams are ordered for any two patients who share the same characteristics, medical history, past studies, and suspected clinical problems, the utilization-management system should produce the same results.

Fourth, it would be efficient. This means that it creates no added costs that referrers or imaging providers are expected to bear; it also means, Thrall says, that its use can be adopted without disrupting workflow in the radiology department, imaging center, or referrer’s office.

Fifth, it would enhance safety for patients, alerting users to patients’ allergies or kidney problems and indicating that a proposed exam duplicates one that has already been performed. As a result, the risks of reactions to contrast media and of avoidable additional radiation would be reduced.

Sixth, it would be flexible, Thrall says, giving users a choice of alternative procedures to consider and accommodating unusual circumstances described by the ordering physician.

Seventh, it would be educational, allowing users to learn more about appropriate imaging each time they ordered a study (and, therefore, helping them improve their ordering patterns over time).

Eighth, it would be developmental.

In a field that is (when all goes well)

constantly evolving new technologies and new applications for established technologies, a utilization-management system must always reflect the state of the medical evidence for the benefits of imaging. Imaging providers and their organizations should be able to adjust the system, so that it can adapt as radiology’s knowledge grows.

A side-by-side comparison of the characteristics of computerized provider order entry (CPOE) augmented by decision support with the characteristics of the preauthorization-based approach taken by radiology benefit managers (RBMs) makes it clear that decision support is far more likely to be able to reach all eight of these ideals than an RBM model, based on its typical business structure and methods, ever could (see table).

Experience at MGH In mid-2003, MGH implemented its radiology order entry (ROE) system, following preliminary research and pilot programs undertaken in the preceding years. Some of that groundwork had been laid through observation of the effects that displaying information about quality and utilization during the ordering process had on the imaging-ordering patterns of primary-care physicians.

Other background work that informed the ROE project (some of it performed using the very large databases of major payors) included analysis of variation in radiologists’ recommendations for additional imaging for the same clinical indication, in addition to evaluation of

Table. Comparison of Two Methods Used to Manage Imaging Utilization

Criterion

Decision support

Radiology benefit management

Transparent

Yes

No

Reproducible

Yes

No

Efficient

Yes

No

Safe

Yes

No

Flexible

Yes

No

Educational

Yes

No

Developmental

Yes

No

Effective

Yes

Yes

36 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

IMAGING | Utilization Management

the reasons for unnecessary repetition of the same (or similar) exams for a patient.

MGH’s ROE is a utilizationmanagement system that uses CPOE to provide decision support at the point of care. It uses a modified version of the ACR® appropriateness criteria (which cover more than 160 topics and 800 variants). The ordering physician uses a simple, quickly learned interface to indicate the patient’s situation, primarily by clicking the relevant checkboxes.

Pull-down menus are used to choose the imaging modality to be used and the body part to be examined.

ROE makes it easy for users to alert the technologist and radiologist to any special consideration that might apply to the patient (such as the need to avoid contrast media or the presence of allergies, pregnancy, or implanted medical devices); this step serves as an extra safeguard. On every ROE screen, there are hyperlinks to further information on relevant topics,

Spine MRI is indicated for the clinical indications provided

9

7

8

5

6

Indicated 7–9

4

Marginal 4–6

3

2

1

Low utility 1–3

Alternate procedures to consider Radiography

CT

5

5

Figure 1. After all patient information has been entered and a procedure has been ordered, the user of the decision-support system is provided with a results screen that assigns a score to the probable diagnostic value of the ordered exam, as well as to possible alternatives. In this case, the MRI study that was ordered is scored as likely to be clinically useful, and it is also considered more likely to help than CT or radiography exams would be.

allowing ordering physicians to find out more, from authoritative sources, without leaving the CPOE system.

Boxes are also checked to indicate the specific requested exam, as well as the signs and symptoms that are the reason for the physician’s imaging order. The decision-support system then assigns a number that predicts the utility of the ordered exam, on a scale of 1 to 9; a traffic-light color is also assigned (Figure 1). Yellow, for example, is used to indicate an exam of intermediate probable utility, with a score of 4 to 6.

There is no prohibitive element involved in using ROE. Even if the system indicates that an exam is of low predicted utility, the physician always has the options of proceeding with the order, modifying it, or canceling it entirely. This makes the impact of ROE on overutilization (Figures 2 and 3) even more remarkable, in comparison with RBM methods, since those often rely on denying coverage for exams to produce the decreases in utilization with which they have been credited.

Protecting Good Growth Imaging’s growth is decelerating, despite ongoing demand for imaging

100% 90% 80% 70% 11% low appropriateness

2% low appropriateness

60% 50% 40% 30% 20% 10% 0% Quarter 4 2004

Quarter 1

Quarter 2

Quarter 3

Quarter 4

Quarter 1

2005

Quarter 2 2006

Quarter 3

Quarter 4

Quarter 1 2007

Figure 2. Trends in appropriateness of MRI orders following implementation of computerized provider order entry with decision support (based on modified ACR® appropriateness criteria).

38 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

Actual tests per 1,000 members

services and the aging of the population (which increases the need for medical services of all types). The slowing of growth, therefore, could be the response that policymakers predicted—and sought—when they imposed drastic payment decreases for imaging services.

395 390 385 380 375 370 365 360 355 350 345 340 335 330 325 320 315 310

2004

2005

Thrall says that multiple factors underlie growth in imaging. Undoubtedly, there was (and still is) bad growth, defined as profit-seeking activity on the part of imaging providers who do not care whether the services that they provide confer any medical benefit. Good growth,

2006

2007

2008

Figure 3. The impact of decision support on actual MRI, CT, and nuclear-cardiology procedures performed per 1,000 health-plan enrollees. The system was fully implemented in the second quarter of 2005.

in contrast, is a response by physicians to the growing clinical utility of imaging in the diagnosis and treatment of a constantly expanding list of disorders.

Because growth and overutilization have been mistaken for each other, that good growth has been placed at risk, both through direct payment cuts and through the implementation of burdensome preauthorization requirements. In taking aim at selfreferring physicians—using decreases in per-exam reimbursement—payors have, Thrall says, wounded the ethical providers of imaging services as well.

By adopting sound decision-support systems, he hopes, radiology will be able to make the difference between growth and utilization clear. That distinction would then help the specialty protect its beneficial utilization growth from getting caught in the crossfire of the battle against inappropriate imaging.

Kris Kyes is technical editor of Radiology Business Journal.

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30

QUality | The Practice Setting

The Quality Challenge

Measuring your practice’s worth and communicating that to the marketplace are key abilities in medical imaging today

By Katie Robbins

D

efining quality in radiology seems simple: It’s an accurate diagnosis or interpretation, provided in a timely manner, in a clear and easy-to-follow report. The devil is always in the details, though.

How do you measure accuracy? Are you consistently measuring your patient’s or referring physician’s experience?

What’s a good baseline? How are payors defining quality, and more important, how will they structure reimbursement plans around it? What resources will the practice have to devote to measuring quality and the revised processes that come out of it? How do you determine the return on investment in quality?

Our practice is one of the many radiology practices facing these

challenges. Charlotte Radiology, PA, is a private radiology practice in Charlotte, North Carolina, comprising more than 80 physicians. We, like many radiology practices, recognized the importance of quality long ago, but are now taking the necessary steps to define, measure, and communicate quality to our key audiences. Arl Van Moore Jr, MD, president of Charlotte Radiology, says, “We have always felt that we provided a valuable, high-quality service. Now, we have to prove it.”

Charlotte Radiology started its quality initiative 10 years ago, by creating a quality committee that broke down the topic into several critical areas; it is working to set benchmarks and strategies for measuring our future success. The

40 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

quality committee is composed of a few key staff members and radiologists representing different imaging modalities.

The Katie Robbins committee’s job is to ensure that all areas affecting quality outcomes are addressed.

Linda Cox, director of quality improvement and risk management for Charlotte Radiology, has been with the practice for 13 years and has worked in quality management for almost 20 years.

She says, “Anyone hoping for an easy solution is in for a surprise. The more we looked at how quality is affected by

QUality | The Practice Setting

We considered our options and installed a software program, designed to measure and benchmark radiologists’ work, that also met the requirements for RADPEER. —James Oliver, MD, quality-committee chair, Charlotte Radiology, PA, Charlotte, NC

various parts of our practice, the more we realized it’s a part of everyone’s job. We are working with all departments, in one way or another, as that relates to quality. Once we have thoroughly outlined how we are addressing, reporting, and measuring quality, we’ll develop a communication strategy to share our benchmarks and successes with our key customers.”

Assessing Clinical Quality Charlotte Radiology’s physicians have a strong commitment to ensuring the accuracy of their interpretations. They embraced subspecialty radiology early on, allowing for a more focused approach to care. In addition, our technologists are certified in their imaging modalities.

“Even with a great team, though, we know we aren’t immune to errors,” Cox says. “We have always looked at the accuracy of reports and analyzed where we can improve, but today, we have multiple tools at our fingertips to help us measure our success and benchmark ourselves against others.”

One of those tools is the ACR® RADPEER™ program. ACR interpretation guidelines state that comparison with older studies should always be done when reading an examination. Use of the ACR RADPEER program allows comparative peer review to be done on the older examination with a current study. The results are sent to the ACR for benchmarking and comparison purposes.

Charlotte Radiology has actively endorsed this peer-review program for more than three years.

“Currently, we use the data to look for areas and physicians needing improvement,” Cox says. “Sometimes, however, you find that what’s broken isn’t the physician, but rather, a process.

RADPEER has helped us to identify

several different departmental processes that needed revision, as well as to note an occasional system-hardware issue that needed adjustment.”

One process-improvement opportunity that the practice recognized was the need for the radiologist to identify situations readily in which timely communication of an unexpected (but not critical) finding could alter the patient’s surgical or medical management. We made patients’ histories more accessible to the radiologists while they are reading studies, and then we set up a process for notifying referring physicians, by phone, of unexpected findings. “Identifying such problems and developing appropriate solutions have helped improve the timeliness and efficiency of our radiologist workflow, thus improving service to clinicians and care rendered to patients,” Cox explains.

Charlotte Radiology quickly realized the benefits of RADPEER, but had to find a solution to support its infrastructure demands. James Oliver, MD, body radiologist and quality-committee chair for Charlotte Radiology, says, “We considered our options and installed a software program, designed to measure and benchmark radiologists’ work, that also met the requirements for RADPEER.” Charlotte Radiology voluntarily participated in the ACR’s General Radiology Improvement Database (GRID) program as a pilot group in 2008. The GRID program sets quality benchmarks by collecting key performance indicator (KPI) information from groups across the country. Some examples of collected KPIs are patients’ waiting times by modality, total exam-turnaround times, and time needed for dictated reports to be completed. Other GRID data look at various outcome measures, such as

42 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

lung-biopsy complications, contrast extravasations, deaths in a radiology department, and patient falls, to name a few.

“Participation in this program added manpower hours to our staff time, as some of the required data must be collected from a manual process,” Cox notes, “but Charlotte Radiology feels it is worth the resources because we recognize the need for uniform data-collection efforts across radiology groups to achieve data results that can be comparable. The data collected, we hope, will assist radiology groups in establishing reasonable and acceptable benchmarks for their own practices.”

Business-assessment tools such as KPIs are not altogether new to health care; they were adopted as more hospitals and health systems began approaching their industry in a more businesslike style. Private physician groups such as Charlotte Radiology, however, are just starting to look at these tools as ways to help them define and measure their quality indicators. “KPIs were a somewhat new approach for us,” Oliver comments.

“We have always paid attention to them in one way or another, but this was a different, more strategic approach than we were used to taking.”

The Quality Crucible While software programs can tabulate data on outcomes and KPIs, one quality indicator that still calls for a personal approach is customer service. Radiology practices used to compete based on technology. Today, competition is service driven, and service is a major part of quality.

Our marketing and practice-relations team at Charlotte Radiology addresses customer service alongside the operations and clinical teams—daily. As Charlotte Radiology has nearly 350 employees, the practice’s leaders recognize that they have regular opportunities to make or break customers’ expectations.

Addressing the most obvious customers first, Charlotte Radiology uses the products of an external company to measure patient satisfaction. Patients at all of our freestanding centers are invited to participate in an emailed survey.

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QUality | The Practice Setting

Because we are getting regular feedback, our teams are consistently assessing results and finding ways to improve. We involved employees from each of our sites, and they are using the surveys as a way to take ownership of their centers.

—Mark Farmer, director of operations, Charlotte Radiology

A good outcome of the radiationexposure stories in the news is that both physicians and patients are starting to ask good questions.

—Doug Sheafor, MD, Charlotte Radiology

Currently, we receive above a 90% satisfaction rating on a regular basis and a 30% to 40% response rate (which is higher than the typical survey-response rate of 5% to 10%).

To achieve such a high response rate and consistently positive ratings, we brought the operations team into the process and removed the marketing team from it. All too often, responsibility for patient satisfaction falls on the marketing team, but in reality, it’s the operations team that makes patient satisfaction happen.

Its members are the ones working with patients in clinical settings; they are the ones who can make the difference. The operations team took over the survey process and patient follow-up; the clinical teams not only embraced the process, but found new ways to improve the care that it offers.

Mark Farmer, director of operations, says, “Because we are getting regular feedback, our teams are consistently assessing results and finding opportunities to improve. We involved employees from each of our sites, and they are using the surveys as a way to take ownership of their centers; because they want the feedback, they are encouraging patients to fill out the surveys. It’s been a great approach for us.” Marketing is still involved in the process, but in the area where it should

be: communicating our positive scores to the public.

A more challenging customer to survey is the referring physician, and this is an objective that the practice is approaching one step at a time. We perform our own surveys and assess the data collected by our hospital’s physician surveys as well, but Charlotte Radiology’s challenges are reflected throughout the industry: Rapid growth within our own practice and the growth of the referring community, in the past few years, have had an impact on our referring-physician relationships.

The practice’s physicians don’t know the referring physicians as well as they did 15—or even 5—years ago. We are aware that satisfaction is more than getting a fast report; it’s having access to a trusted source when you have a question about that report.

Currently, we are working with a practice-relations committee that consists of marketing and public relations, along with a handful of key radiologists. The committee is developing a service-first initiative both to measure and to improve referring-physician satisfaction and relationships. We address everything from broken processes for call-back reports to helping radiologists end phone calls in a more positive manner. Some of our efforts seem so simple, but often, those are the

44 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

ones that can make the biggest impact on satisfaction scores.

Imaging Safety Nothing is more important than ensuring a patient’s safety. ACR accreditations, Mammography Quality Standards Act compliance, FDA certifications, and meeting center-ofexcellence standards are just a few of the extra steps taken in the past by Charlotte Radiology and other radiology practices and hospitals. Today, with radiology under the magnifying glass, practices are taking safety to new levels.

Doug Sheafor, MD, is a body radiologist and is one of several radiologists serving on Charlotte Radiology’s radiation-safety committee. He says, “A good outcome of the radiation-exposure stories in the news is that both physicians and patients are starting to ask good questions. Even before the radiation scare, our practice engaged in low-dose imaging protocols and worked with area physicians to provide ordering guidelines.”

From participating in the Image Gently campaign to observing protocols to keep dose as low as reasonably achievable to using breast shields, Charlotte Radiology’s physicians are looking for ways to protect their patients from unnecessary radiation exposure. Limiting radiation can be

QUality | The Practice Setting

challenging, however, and it sometimes requires more effort from the radiologist when reading the study.

“We’ve carefully managed the protocol changes to ensure image quality was maintained; it’s a delicate balance,” Sheafor says. Charlotte Radiology works closely with its key specialty referring physicians to ensure their satisfaction with the revised studies. It also is exploring a CME lunch-and-learn program for local referring physicians’ offices that are getting some questions from their patients about radiation exposure.

As awareness in the community increased, we took a more proactive approach to communicating about our radiation-safety efforts; we want to be seen as the experts on this topic. We have used resources provided by the ACR to help educate our community’s physicians and patients about safe imaging. We developed fliers for physicians’ offices and patients outlining what steps we have taken and the ACR’s list of questions to ask before being scanned. In addition, we developed a section on the topic for our website (www.cr-radiationsafety.com).

Limiting unnecessary radiation extends to ensuring the appropriateness of orders.

Charlotte Radiology works with referring offices to ensure that appropriate studies are ordered. “We have a preservices team that checks orders to ensure preauthorizations

We have made major headway in the past 18 months, but the challenge is that no matter how much progress you make, the technology is a moving target, full of improvements and new applications; it’s a constant effort to keep up with it.

—Mike Sanchez, director of IT, Charlotte Radiology

are in place and accurate,” Farmer says.

“In addition, our technologists review orders prior to scanning to ensure the right study has been ordered based on the patients’ diagnosis codes. If there is an error, they work with our radiologists and the referring physician to get the order revised.”

Preventive Care The benefits of preventive medicine are widely acknowledged, and healthcare reform has mandated it as a part of providing quality care. Primarycare physicians will be tasked with ensuring that their patients are following preventive-care protocols, including obtaining radiology exams such as screening mammography.

With 12 breast-imaging centers, Charlotte Radiology has placed a major

The lobby of the Charlotte Breast Center—University, Charlotte, North Carolina.

46 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

emphasis on mammography for years.

Major educational advertising campaigns, comprehensive reminder programs, and community- and physician-outreach resources are a few of the key elements that have helped Charlotte Radiology maintain one of the largest screeningmammography programs in the country.

The added focus from health-care reform has prompted our practice to look at how we can increase our compliance and provide better outcomes data to our referring-physician community.

“Our practice is targeting noncompliant patients and assessing better ways to track and report patient-compliance data to our referring physicians,” Farmer says.

Five years ago, it was a major competitive advantage if you could turn around a report in 24 hours. Today, the expectation is that it will be ready in less than two hours. Turnaround times, easy-to-follow reports, results-delivery methods, and satisfaction are all factoring into the quality of radiology reporting.

Voice recognition, RIS, and PACS have all improved radiology reporting. Practices can track their turnaround times and results in their RIS, and can even report turnaround-time data to referring offices as a value-added service. Satisfying different customer segments is where things get tricky.

Mike Sanchez, director of IT, explains, “Some of our referring physicians want their studies via fax, others want them online, and still others want them to appear in their electronic medical record (EMR) automatically.” As more and more practices go paperless and health-care records go online, however, radiology practices will rely on their IT teams to ensure that a solid infrastructure is in

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QUality | The Practice Setting

We expect that once Medicareâ&#x20AC;&#x2122;s PQRI initiative becomes more of a pay-forperformance program, the various managed-care insurance companies will be close behind with their own qualitybased reimbursement initiatives. â&#x20AC;&#x201D;larry Mcintyre, billing manager, Charlotte Radiology

place to handle the HL7 connections needed to link them to multiple EMRs. â&#x20AC;&#x153;With a group our size, and serving so many locations, development of our IT infrastructure is a slower process,â&#x20AC;?

Sanchez says. â&#x20AC;&#x153;We have made major headway in the past 18 months, but the challenge is that no matter how much progress you make, the technology is a moving target, full of improvements and new applications; itâ&#x20AC;&#x2122;s a constant effort to keep up with it.â&#x20AC;?

Pay for Performance In 2007, Medicare took a positive

step toward ensuring that patients receive high-quality care from their healthcare providers. The Physician Quality Reporting Initiative (PQRI) established a financial incentive for eligible healthcare professionals to participate in a voluntary quality-reporting program.

PQRI reporting allows for a 2% bonus in Medicare reimbursements for those studies that qualify for the measures and meet dictation guidelines in 2010. The bonus is scheduled to decrease to 1.5% in 2011, however, and in each following yearâ&#x20AC;&#x201D;until 2014, when reporting becomes mandatory for full Medicare reimbursement.

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Larry McIntyre, billing manager, says, â&#x20AC;&#x153;Relatively speaking, the total potential bonus does not account for a large total dollar amount. For Charlotte Radiology, however, the larger goal is to refine the billing/dictation processes proactively over the next few years to enable us to be prepared for the future, when failure to report will result in lower Medicare reimbursement. We expect that once Medicareâ&#x20AC;&#x2122;s PQRI initiative becomes more of a pay-for-performance program, the various managed-care insurance companies will be close behind with their own quality-based reimbursement initiatives.â&#x20AC;?

As they would for any new process, health-care providers (including Charlotte Radiology) have faced, and will continue to face, challenges related to the PQRI program. â&#x20AC;&#x153;While we feel we are currently well positioned to participate in PQRI reporting to maximize positive clinical outcomes, radiologist processes, and current financial-incentive potential, the road to our success has not been without its bumps,â&#x20AC;? McIntyre reports.

Ensuring clinical quality from our physicians was the easy part. Ensuring that more than 80 radiologists all met the necessary dictation requirements for successful PQRI reportingâ&#x20AC;&#x201D;and then enabling our business office to identify and code appropriately for requirements based on the dictated physician reportâ&#x20AC;&#x201D; were both major challenges that we had to overcome. â&#x20AC;&#x153;Using our current billing system and coding software offered us an advantage, assisting our staff in proper identification of the necessary dictation requirements without letting it become overburdened by the addition of such a large, detailed task to our current daily processes,â&#x20AC;? McIntyre says. â&#x20AC;&#x153;We have also been successful in working with our radiologists to help standardize our dictation practices, often through the use of dictation macros that maximize their efficiency while still providing all the necessary information required in the dictated report.â&#x20AC;?

The practice understands and supports the need to provide and document highquality clinical care in todayâ&#x20AC;&#x2122;s health-care environment. The PQRI is only the tip of the iceberg when it comes to quality initiatives set forth by the insurance companies, but

There is no one person in our practice who can take on all the pieces of the puzzle. It’s a group effort, and it will take all of us to succeed.

—arl Van Moore Jr, MD, president, Charlotte Radiology

Charlotte Radiology has worked hard not only to accommodate the added workload, but to ensure that our radiologists, staff, and administration are all aware of the benefits of participating (and the future risks of not participating) in these kinds of pay-for-performance programs.

Packaging Quality While Charlotte Radiology is already sharing some of its quality data with various audiences, from payors to patients to referring physicians, we are aware that a more strategic communication plan is needed. We are looking at how to

provide consistent updates and reports to key audiences, and we are assessing which people need what information (and how they should receive it). Payors, for example, might need a regular report outlining key areas that they are measuring for payments, while information provided to patients might come in the form of an advertisement or a website (or might be used more generally as a branding tool).

These choices are not simple.

How do you move forward—with moving targets in technology, varying demands from providers, and a host of requirements for reimbursement? “We

do it as a team,” Moore says. “There is no one person in our practice who can take on all the pieces of this puzzle. It’s a group effort, and it will take all of us to succeed.” Moore’s advice to other groups just jumping into this process is to engage leaders from all parts of your practice, so that you don’t reinvent the wheel. Quality is not something new, but it is something that you now have to measure and communicate.

Katie Robbins is marketing and publicrelations director, Charlotte Radiology, PA, Charlotte, North Carolina.

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BREAST CANCER | The Radiologist-centered Diagnostic Paradigm

Breast Cancer:

The Case for the Radiologist-centered Diagnostic Paradigm

With the introduction of breast MRI, the most efficient diagnostic workflow has a breast-imaging specialist at its core By Rebecca G. Stough, MD

A

s the diagnostic work-up for breast cancer has become more complex, often involving multiple imaging modalities, the surgeon-centered diagnostic paradigm in breast care has become less efficient.

With the introduction of breast MRI into the diagnostic armamentarium, the need for a new radiologist-centered work-up became evident.

At Mercy Women’s Center in Oklahoma City, Oklahoma, our breast-MRI program began in 2002 with a breast coil on a body magnet. Within a very short time, preoperative breast MRI exposed unsuspected, more extensive multifocal, multicentric, and bilateral breast cancers that were virtually invisible using other modalities.

As I shared these findings with surgeons and the tumor board, and then with other facilities in the state, Mercy Women’s Center became a referral center for other breast centers in the region.

Since new-diagnosis breast-cancer patients were considered priority cases, the three or four additional patients a day produced a backlog on the body MRI unit and bumped many of the brain, spine, and extremity MRI studies to an older MRI scanner on a regular basis.

It soon became apparent that we needed our own MRI system. We

subsequently installed the only MRI designed specifically for breast imaging (with integrated breast computer-aided detection and biopsy capability) in our breast facility in 2003.

With the MRI system integrated into Mercy Women’s Center, the availability of MRI for our new-diagnosis breastcancer patients was greatly improved, as was the option to use the MRI system for other indications (including highrisk screening and follow-up imaging for breast cancer, breast implants, and induction chemotherapy). As our procedural volume grew, I became increasingly aware of how much we were unable to see with mammography and breast ultrasound.

In fact, mammography and breast ultrasound are not that sensitive. In an article regarding screening for breast cancer, Elmore et al1 compared the sensitivity of mammography, ultrasound, and MRI, based on numerous published studies. They found that mammography’s sensitivity was 13% to 40%, with a mean of 33%; ultrasound’s sensitivity was 13% to 33%, with a mean of 33%; and breast MRI’s sensitivity was 77% to 100%, with a mode of 100%.

In 2002, the medical literature finally supported what those of us who do mammography already knew: Good

50 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

mammography misses breast cancer in dense breasts. According to Kolb et al,2 in dense breasts, the sensitivity of mammography is 48%, and this does not include comparison with breast MRI. The more MRI studies I performed, the more aware I became that I was missing significant pathology on mammography and ultrasound. The question no longer was whether breast MRI was valuable, but how to select patients appropriately who really needed it, since the cost and technical expertise required to interpret breast MRI precluded performing it on everyone.

We now evaluate all new-diagnosis breast-cancer patients—as well as those with an atypical or discordant biopsy— with breast MRI. We evaluate patients with a past history of breast cancer about every two years. In addition, we contact patients with a greater than 20% to 25% lifetime risk of breast cancer and schedule them for annual breast MRI exams. We have found MRI invaluable in the work-up for those patients who have a new palpable mass with a negative mammogram and ultrasound, or multiple, probably benign masses in dense breasts.

In the past, many of those patients would have had multiple biopsies or would have gone to surgery. Instead, they have an MRI exam that accurately

identifies those who have cancer and need intervention, and those who are truly negative. The remarkable occurrence is the number of times that the palpable concern is negative, but an occult malignancy is discovered elsewhere.

Within a very short time, it became clear that just interpreting the MRI exam and sending the report to the surgeon was unacceptable. Long ago, the surgeons had requested that we not contact them to obtain orders for work-up of their patients at our breast center; instead, we were asked just to do whatever imaging studies or procedures were indicated, in our professional opinions.

The surgeons expected the same from us regarding breast MRI. Therefore, if the patient had additional findings on the MRI, we took the responsibility of contacting the patient and conducting a work-up for the abnormalities, including the performance of any necessary biopsies. This has created a shift from the traditional surgeon-centered breast work-up to a radiologist-centered breast work-up at our center.

The Traditional Pattern The surgeon-centered breast workup (Figure 1) represents the traditional workflow in diagnosing and staging breast cancer. The patient has a problem or an abnormality on a screening mammogram, and the primary-care provider refers the patient directly to the surgeon. The surgeon orders the imaging studies. Once that imaging has been completed, the surgeon makes the decision as to what kind of biopsy is to be performed (image guided versus surgical).

If the biopsy specimen is malignant, the surgeon then decides whether the patient is a candidate for breast conservation or mastectomy, and he or she orders breast MRI as deemed necessary to assist in that decision making. In many instances, the hospitalâ&#x20AC;&#x2122;s MRI system is solidly booked with brain, spine, and extremity studies, but even when breast MRI is obtainable, it might be interpreted by someone who is not an expert in breast MRI. Once the MRI exam has been performed, if there are new findings, then the entire process starts over, prolonging the time until surgery. In the meantime, the patient is like a ping-

pong ball, bouncing between the surgeon and the different imaging modalities.

The Breast-consultant Model The radiologist-centered breastconsultant model (Figure 2) offers those who adopt it the potential to streamline the breast work-up. The patient comes in for screening, or is referred (by the primarycare provider) directly to the breast center for a problem. The radiologist determines the appropriate steps to be taken in the

Patient with a problem

Primarycare physician

work-up, including the need for (and type of) any biopsy.

If the biopsy specimen is malignant or atypical, or results are discordant, the referring physician is notified. Our nurse navigator facilitates referral to the agreedupon surgeon and then schedules a breast MRI study and a pretreatment breast conference. Any abnormal findings on the MRI are dealt with promptly by the breast center. In most instances, a patient has had the entire work-up, MRI exam,

Surgeon

20% of patients have malignancy Surgery

Screening mammogram

Ultrasound Diagnostic mammogram

Stereotactic VAB

MRI VAB

Ultrasoundguided biopsy

Breast MRI

Radiologist interprets; has little control over ordered exams

Figure 1. The surgeon-centered breast work-up represents the traditional workflow in diagnosing and staging breast cancer; VAB = vacuum-assisted biopsy.

Primarycare physician

Surgeon

Nearly 100% surgery Surgery

Radiologist and primary-care physician co-refer to surgeon

Screening

Diagnostic mammographic work-up

Stereotactic biopsy

Ultrasound

Ultrasound biopsy

Breast MRI

MRI biopsy

Breast-imaging specialists direct, instigate, and supervise most appropriate and efficient work-up

Figure 2. In the radiologist-centered breast-consultant model, the radiologist determines the appropriate steps to be taken in the work-up, including the need for (and type of ) any biopsy. www.imagingbiz.com | October/November 2010 | Radiology Business Journal 51

BREAST CANCER | The Radiologist-centered Diagnostic Paradigm

and biopsy—and even presentation to the pretreatment breast conference—before the first available appointment with the surgeon.

This new paradigm has produced significant benefits for our breast center, our surgeons, and our hospital. We have now performed more than 10,000 breast MRI exams since 2002, as well as more than 1,000 breast MRI exams for local and regional staging.

Our surgeons used to spend hours with anxious women who had masses in their breasts, or abnormal mammograms,

only to discover that their problems were benign. Now, they see fewer patients, but the ones they do see almost all have either breast cancer or surgical lesions.

The patients arrive already aware of their diagnoses, educated and prepared to discuss treatment options. The fact that the MRI study has already been performed, and any incidental findings have already been worked up, facilitates surgical planning and scheduling. Instead of prolonging the time to surgery, this method makes the process much more efficient.

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52 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

Our 300-bed community hospital has become the primary referral center for breast-cancer diagnosis and treatment in our region. Mercy Health Center now sees about 500 breast-cancer patients per year; there are only about 1,000 cases per year in the entire Central Oklahoma region.

Alan Hollingsworth, MD, medical director for Mercy Women’s Center, carefully compiles our results, in real time, during our pretreatment breast conferences. We now have collected information on more than 1,000 breastcancer patients who had breast MRI exams for local and regional staging. As the breast-MRI discussion heated up, we were invited to discuss our findings.3 This new paradigm requires radiologists to become experts not only in breast imaging, but also in the implications of the patient’s pathology.

They must correlate the biopsy results with the expected results, based on the imaging, and persist in the work-up if the results are discordant. They must be able to interpret the MRI exams and correlate them with imaging studies from other modalities, and they must be able to perform biopsies or localization based on the roadmaps that MRI provides.

Radiologists must participate materially in the pretreatment conference and must help make decisions regarding appropriate follow-up and treatment for (for example) wider surgical excision for atypical ductal hyperplasia (ADH) and peripheral papilloma. They must review lumpectomy pathology to determine that all of the identified disease has been dealt with, and they must coordinate with the pathologist and the surgeon if there is discordance. They must also take responsibility for referring patients for risk evaluation and genetic testing, if indicated.

Case Example On a screening mammogram, several new, discrete masses were identified on the left side (Figure 3). The patient was contacted and invited back for additional mammographic imaging and ultrasound.

The ultrasound revealed larger, wellcircumscribed, hypoechoic solid masses with increased vascularity, plus smaller masses that had irregular margins and

thickened echogenic rims (Figure 4).

The final determination indicated a likelihood of malignancy of more than 95% (BI-RADS® 5), and the patient was scheduled for an ultrasound-guided biopsy of two of the lesions. The two larger masses were biopsied. The final pathology report indicated intraductal papillomatosis with ADH. This was considered a discordant biopsy by the breast radiologist, so a breast MRI exam was ordered for further evaluation.

The MRI exam revealed extensive, bizarre-appearing nodular and linear enhancement involving a hot-dog– shaped segment of the left breast. Much of the enhancement had a washout curve confirming and correlating with the ultrasound appearance.

In the right breast, the only MRI abnormality was an irregular 8-mm mass at the 12 o’clock position (Figure 5). The patient was contacted and was scheduled for a second-look ultrasound of both breasts, with biopsies as indicated. Two biopsies were performed of suspicious lesions on the left side; however, no mass

Figure 3. On a routine screening mammogram for a 52–year-old female with heterogeneous breasts, several new, discrete masses were identified on the left side. The patient was asked to return for diagnostic mammography and an ultrasound examination.

Our 300-bed community hospital has become the primary referral center for breast-cancer diagnosis and treatment in our region. Mercy Health Center now sees about 500 breast-cancer patients per year; there are only about 1,000 cases per year in the entire Central Oklahoma region.

—Rebecca G. Stough, MD, Mercy Women’s Center, Oklahoma City, OK

could be confirmed on the right side.

The pathology reported for the left side was papillomatosis with ADH and ductal carcinoma in situ (DCIS), compatible with a complex sclerosing lesion.

The patient met with her surgeon, and they decided to attempt a lumpectomy on the left side. The long, narrow segment of regional enhancement was bracketed at localization by the radiologist, and MRIguided localization of the enhancing 8-mm mass on the right side was performed.

The final pathology report showed, for the left breast, a 5-mm focal, well-differentiated, infiltrating ductal carcinoma with diffuse ADH and DCIS, low to intermediate grade, and a complex sclerosing lesion. The anterior margin was positive for DCIS and the sentinel lymph node was negative. Subsequent repeated resection was negative for residual DCIS. For the right breast, the report showed a 9-mm infiltrating lobular carcinoma, poorly differentiated grade 3, with ADH

Figure 4. The patient’s ultrasound exam revealed larger, well-circumscribed, hypoechoic solid masses with increased vascularity, plus smaller masses that had irregular margins and thickened, echogenic rims. The final determination indicated a likelihood of malignancy of more than 95% (BI-RADS® 5), and the patient underwent an ultrasound-guided biopsy of two of the lesions, which were papillomata with atypical ductal hyperplasia. This was considered a discordant biopsy by the breast radiologist, so a breast-MRI exam was ordered for further evaluation. www.imagingbiz.com | October/November 2010 | Radiology Business Journal 53

BREAST CANCER | The Radiologist-centered Diagnostic Paradigm

R

L

Figure 5. Multiplanar reconstruction of bilateral breast MRI exam revealed extensive, unusual nodular and linear enhancement involving a hot-dog–shaped segment of the left breast. The upper-left image demonstrates axial bilateral view, with multiple enhancing masses in the left breast and an unsuspected 8-mm mass in the right. The upper-right image is a sagittal view, with extensive enhancing lesions in the left breast. The lower-left coronal view shows only the enhancing process on the left side and nothing on the right. Much of the enhancement had a washout curve confirming and correlating with the ultrasound appearance. In the right breast, the only MRI abnormality was an irregular 8-mm mass at the 12 o’clock position.

and a complex sclerosing lesion. Right axillary-node biopsy revealed that one of four lymph nodes was positive.

Without the persistence of the radiologist, the patient would not have had an MRI exam. She would have had wider excision on the left for ADH with upgrade to DCIS with invasion and positive margins, a second resection (also with positive margins), and then, a mastectomy. In the meantime, the life-threatening occult malignancy with positive lymph nodes on the right side would have remained undiscovered.

This patient (five years after her bilateral lumpectomies) has no evidence of cancer recurrence on follow-up studies.

Dedicated breast MRI produces exquisite detail of the breast, exposing the true size and extent of malignancies—including previously unsuspected multifocal, multicentric, and synchronous contralateral malignancies, as well as the true intraductal extension of DCIS. Nonetheless, a 2009 article4 calls preoperative breast MRI contentious.

The article summarizes five studies, three of which reached conclusions against the use of preoperative breast MRI,

We have seen many women who were determined to have mastectomies convert to having lumpectomies because of a focal, solitary malignancy proven by MRI. citing an increase in the mastectomy rate, no change in the re-excision rate, and prolonged time to surgery as some of the major complaints. Two studies reached conclusions in favor of preoperative breast MRI, including our data,5 which reveal a decrease in the mastectomy rate, a decrease in the re-excision rate, and a shortened time to surgery.

Detractors are saying that breast MRI increases the mastectomy rate. Our response is that our lumpectomy rate, before the institution of breast MRI, was 48%; following MRI implementation, it increased to 60%. We have seen many women who were determined to have mastectomies convert to having lumpectomies because of a focal, solitary malignancy proven by MRI.5 Clearly, the MRI exam affects the surgical plan. Bedrosian et al6 found

54 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

an alteration of the planned surgical procedure in approximately 26% of cases.

As seen in the case example, bracketing localization to assist the surgeon in obtaining clear margins is a benefit of the road map provided by breast MRI. We have had patients undergo more extensive lumpectomy, double lumpectomy, and bilateral lumpectomies as a result of MRI findings.

We have also had patients who were presumed lumpectomy candidates (based on mammography, ultrasound, and physical examination), but who had such extensive multifocal or multicentric disease on MRI, confirmed by subsequent work-up, that lumpectomy was no longer an option.

Detractors are saying that false-positive MRI results force patients inappropriately toward mastectomy (with false-positive

BREAST CANCER | The Radiologist-centered Diagnostic Paradigm

results defined as any call-back). Our response is that in those patients with ipsilateral false-positive results on preoperative MRI, 70% underwent breast conservation, as opposed to 60% overall.

In addition, if the patient actually had a biopsy, 86% opted for breast conservation after a negative biopsy for suspected multicentric disease.5 Detractors cite the COMICE Trial,7 which stated that preoperative MRI does not affect the re-excision rate. The investigators in that trial randomized 1,623 patients from 45 sites to preoperative MRI (816 patients) or no further imaging (807 patients). They concluded that preoperative breast MRI did not produce a significant alteration in the reoperation rate (19%) for those who had MRI versus those who did not.

Our response, based on our published data,5 is that in those patients undergoing preoperative MRI followed by breast conservation, only 8.8% of our 600 patients required re-excision because of positive or unacceptably close margins.

All of our patients were evaluated at a single site on a dedicated breast MRI system with experienced interpreters, which might explain some of this difference.

Detractors are saying that MRIdiscovered cancers are insignificant. In our 2008 study,5 however, we found that of the 3.4% of breast cancers discovered to be bilateral entirely by preoperative staging with MRI, 91% were invasive. In 66.5%, the stage was equal to or more advanced than the index cancer.

The application of the breastconsultant paradigm, with an integrated breast-MRI system, into our breast center

has produced a very successful and efficient model for the evaluation and diagnosis of breast cancer in our patients.

It has contributed to the success of our breast facility, as well as helping to define our community hospital as the primary referral center for breast cancer in the region.

Our dedicated breast surgeon has had to take a partner. The breast-consultant model has affected the acceptance and use of breast MRI for local and regional staging (and other indications) in our community, and our published data strongly support the use of breast MRI initially on every patient with a new diagnosis of breast cancer.

Rebecca G. Stough, MD, is director of Breast MRI of Oklahoma, LLC, Oklahoma City, Oklahoma, and director of imaging at Mercy Women’s Center, Oklahoma City.

References 1. Elmore JG, Armstrong K, Lehman CD, Fletcher SW. Screening for breast cancer.

JAMA. 2005;293(10):1245-1256.

2. Kolb TM, Lichy J, Newhouse JH. Comparison of performance of screening mammography, physical examination, and breast US and evaluation of factors that influence them: an analysis of 27,825 patient evaluations. Radiology.

2002;225:165-175.

3. Hollingsworth AB, Stough RG. Conflicting outcomes with preoperative breast MRI: differences in technology or methodology? Breast Diseases.

2010;21(2):109-112.

4. Hede K. Preoperative MRI in breast cancer grows contentious. J Natl Cancer Inst. 2009;101(24):1667-1669.

5. Hollingsworth AB, Stough RG, O’Dell CA, Brekke CE. Breast magnetic resonance imaging for preoperative locoregional staging. Am J Surg. 2008;196(3):389397.

6. Bedrosian I, Mick R, Orel SG, et al.

Changes in the surgical management of patients with breast carcinoma based on preoperative magnetic resonance imaging. Cancer. 2003;98(3):468-473.

7. Turnbull L, Brown S, Harvey I, et al. Comparative effectiveness of MRI in breast cancer (COMICE) trial: a randomised controlled trial. Lancet.

2010;375(9714):563-571.

56 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

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FinalREAD

Content Matters

Connecting with readers hinges on giving them a reason to read By Curtis Kauffman-Pickelle

T

here is a growing national discussion focused on the business model of publishing, in this era of niche media—especially as it relates to how we, as information consumers, prefer to receive and access this information. Actually, the discussion is not new at all, since so-called narrowcasting has been in the media-management lexicon for a number of years. Niche marketers have always looked for ways to channel their messages in what media scholars once referred to as a hypodermic-needle model (rather than a shotgun-blast model) of outreach. Extremely narrow audience segmentation has been the goal of every business-to-business publisher.

Targeting an audience that is receptive to—and interested in—the message is how communicators strive to penetrate an increasing noise level that exists in our hyperactive world. It is part science, part art, and mostly dependent on the sender’s ability to connect with the audience in a unique way that will build actual readership and, in turn, loyalty to the medium.

As a student of the media since the early 1970s, I have found each new twist in this basic enterprise of developing meaningful information and connecting to a targeted audience both fascinating and intellectually rewarding. It never ceases to amaze me that entrepreneurs continue to find new and exciting ways to reach and influence those hungry for direction, advice, community, education, and support. Social media are but the latest developments in the quest for connectivity.

Even more important than how information is delivered, though, are the issues of exactly what that information is and what it contains; the quality of the message; its depth, relevance, and credibility; and its ability to offer something different. These remain of supreme importance in a publisher’s ability to build community.

As with the newest social-media

concepts, the idea of building community is paramount in order for the concept to thrive. In order to build community, one needs to offer a reason for members (in our case, readers) to want to be a part of it. How does this happen? It’s done by bringing readers something new and original that cannot be found elsewhere. The idea, as in most things, is to be unique.

When I created the editorial concept for Radiology Business Journal, it was clear that the envisioned target audience (grouppractice radiologists, hospital executives and department heads, imaging-center executives, health IT executives, medical directors, and those in similar positions) would develop a sense of loyalty to the publication if—and only if—we created unique content that would make it a mustread journal.

In other words, we needed to penetrate the noise level by developing and offering content that was meaningful and important, and that would connect with extremely high levels of credibility. The idea of connecting the clinical side with the administrative side in a forum that would enhance the overall strength and understanding of the business of medical imaging is something to which I have dedicated my career. In itself, it is a unique media concept—and one that has truly resonated.

I am pleased to report to our readers that in just three short years, we have more than achieved our goal of building reader loyalty among the members of this important and influential dual audience.

You have told us that you like what you see, and that you find RBJ to be credible and worthy of your attention—and loyalty.

For that, we are extremely appreciative and grateful.

The issue that you have before you is our most successful thus far, and there are strong indicators that we will continue to grow, bringing you bigger issues packed with content that matters. You are a member of an audience that has been carefully selected, and we are excited that we are now considered an important part of your professional life.

Stay tuned.

58 Radiology Business Journal | October/November 2010 | www.imagingbiz.com

As with the newest social-media concepts, the idea of building community is paramount in order for the concept to thrive. In order to build community, one needs to offer a reason for members (in our case, readers) to want to be a part of it. How does this happen? It’s done by bringing readers something new and original that cannot be found elsewhere.

The idea, as in most things, is to be unique.

Curtis Kauffman-Pickelle is publisher of imagingBiz and Radiology Business Journal, and is a 25-year veteran of the medicalimaging industry. He facilitates strategicplanning retreats for radiology groups.

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