Abstract
Mr. Shields has served as president and board member of the American Health Lawyers Association and of the Illinois Association of Healthcare Attorneys. He was a member of the Advisory Board of the Health Law Institutes of DePaul University School of Law and of Loyola University. A member of numerous legal task forces of the American Hospital Association, he serves as Chief Counsel to the Catholic Health Association of the United States. Mr. Shields is an active member of the American Health Lawyers Association and of the Health Law Committee of the Chicago Bar Association. He serves as an arbitrator in health care disputes under the Alternative Dispute Resolution Program sponsored by the American Health Lawyers Association, and frequently serves as a hearing officer in medical staff credentialing matters.
Mr. Shields is a trustee of the Cancer Research Foundation and of the Brother Louie and Fannie Roncoli Foundation, and serves as a Governing Member of Catholic Charities of Chicago and of the Chicago Zoological Society. The author of numerous articles on health and hospital law, Mr. Shields frequently speaks on health care issues.
QMHC: The last time we talked, in the summer of 1999, the interview focused on issues of medical staff structure, bylaws, and the processes of credentialing and delineation of privileges, as seen from your perspective as a health care lawyer. What are the issues at the top of the list today?
TCS: Well, there are a lot of things going on in health care. One of the big ones is the finance issue-how to finance readily accessible high quality care. It seems that from the government-both state and federal-point of view, we're standing at a major watershed. Previous strategies and prior attempts to control costs have been fairly ineffective. For example, we went from reasonable cost to prospective payment. And then there were the efforts to continue to move the prospective pay approach from inpatient care to ambulatory care, long-term care, and so forth. Managed care strategies haven't been completely effective in controlling costs. Another foreseeable major change is the development and spread of medical savings accounts. We're at a time when something is going to have to happen-perhaps at the level of the federal government.
And then there is the quality issue. Quality in health care is receiving much more public policy focus than it used to. At the same time, we face a dilemma as to how to improve the quality of care. In its landmark report, To Err is Human, the Institute of Medicine (IOM) emphasized the surprising (to me, at least) extent of patient care errors.
This past January the Centers for Medicare and Medicaid (CMS) issued its final rule (68 Fed. Reg. 3435, January 24, 2003) on the conditions for participation in Medicare, requiring that hospitals have plans in place to assess and improve quality of care. This represents a fundamental shift in CMS emphasis. In the past, hospitals were required to identify and correct problems in patient care. Now the hospitals must have a program that emphasizes not only monitoring and assessing quality but also steps to improve patient satisfaction and patient outcomes using a data-driven program. I see the difference but I'm not sure just what extra steps hospitals are required to take.
QMHC: In the 1970s, when the Joint Commission began requiring that hospital personnel collect patient care data and retrospectively evaluate their own performance, hospitals had never even made any budget provisions for this new activity, the "patient care audit."
TCS: Now quality management has been a regularly budgeted activity for some time. We have seen a shift in focus from process to outcomes. As Deming said, "Stop thinking in terms of quality control, and move forward to continuous quality improvement!!" It's still not entirely clear to me what steps a hospital will take in improving quality.
QMHC: Are you familiar with the technique of critical path analysis?
TCS: In a general way, yes. It applies Deming's ideas of reviewing the system.
QMHC: So the federal government has decided to implement a concept that's been knocking around for a generation or more.
TCS: Hospital medical staffs have always conducted at least retrospective reviews of patient care. Originally, they'd review a particular problem, seeking the reason for a specific individual problem or bad result. The medical staff would review all deaths. The practice of holding morbidity and mortality (M and M) conferences became universal. Then they began reviewing all cases in which normal tissue was removed at surgery. Then the so-called anesthesia standards were developed. In their earliest form, they simply required that a history and physical be performed and documented in the medical record before anesthesia was administered for surgery. Later, the physicians developed models and guidelines identified as best practices.
Now, the CMS is making it clear that just investigating and finding the flaws aren't enough-you still have to repair them. Remember W. Edwards Deming and his formulations. He laid the foundation for continuous quality improvement systems. Now the government is finally espousing concrete means for implementing this philosophy. However, it's going to be costly.
QMHC: Hasn't the array of variables to be assessed grown, too? Aren't there a lot of components in what we call quality of care?
TCS: Yes. For example, hospitals have become highly aware of the importance of patient satisfaction. Most hospitals conduct surveys to assess patient satisfaction. In these surveys it's no longer enough to ask about the coffee-you now have to measure and manage pain. Pain is a major concern. Doctors and hospitals must do a better job of managing pain.
QMHC: In complying with Joint Commission pain management standards, hospital nurses now ask the patient to evaluate his or her degree of pain on a scale of 1, low, to 10, high.
TCS: Physicians are becoming much more sophisticated about evaluating and alleviating pain. Pain is a relative phenomenon. Some people can stand more of it, some can't stand it at all. It's subjective and individual. Pain has an impact on healing. If his pain is reduced, the patient gets better more rapidly. There isn't necessarily a physiologic connection. Humor deserves consideration, too. A relative of mine wrote her doctoral dissertation on humor as a healing device. Same concept as that in the film about Patch Adams. There is definitely a growing belief that these things have a real impact, not just theoretical interest. So maybe humor, too, becomes a factor in good care. Are we going to ask nurses to put on funny noses?
QMHC: There's a lot of emphasis, currently, on patient safety and preventing errors.
TCS: Yes-just this past week, there was that sad episode at Duke. What a horrible experience!! This occurrence won't be dismissed quickly. It will wind up causing a lot of scrutiny of the whole transplant process around the country. Medical error is a phenomenon that is not widely understood. In the catastrophe at Duke [the death of Jessica Santillan] there was a breakdown in the process-basic checkpoints were completely missed.
It would be natural to wonder about the impact of this occurrence on the hospital. Anyhow, you have to give Duke credit for being so open and acknowledging its responsibility. A cover-up is never a good idea.
People don't realize how sophisticated this whole transplant process has become-all of the safeguards that are in place. And yet, in this case certain basic checkpoints were missed. It makes you wonder how often checkpoints are routinely missed. Checkpoints early on in a patient's course are carefully reviewed. But after the surgical procedure has started, split-second decisions have to be made, and it's too late to correct previous errors.
The whole scope of possible error is surprisingly broad. I certainly didn't realize how widespread this phenomenon is. So it's appropriate that there be an emphasis on preventing errors in the course of improving quality. For hospitals, there will be financial strains-they'll wonder where the money's going to come from. As you implied, it's a song that has been sung for a long time.
QMHC: In connection with patient safety, there's been a lot of discussion in the media recently about the frequency of hospital infections, the need for hand washing, and the claims that hospital personnel don't do enough of it.
TCS: It's inconvenient. They're supposed to do it between every two patients they treat, but in some of the older hospital buildings the sinks are too far apart. I wonder if there isn't some kind of bactericidal liquid for use in these circumstances. A little bottle you could just keep in your pocket.
QMHC: Actually, a small tissue has been developed for this purpose. They're supplied in packets, and the manufacturers claim that they fulfill the hygiene requirements. They're currently being tried out in some health care settings.
TCS: There have been dramatic changes in health care in the not too distant past. Look at this picture of a late nineteenth century clinic examining room-the title is "The Gross Clinic." You often see it reproduced in connection with historical accounts of medical practices. The surgeons and students are wearing business suits with aprons over them, and no masks. Can't tell whether there are gloves. This was the scene not very long after the Civil War. In a historical perspective, that wasn't really very long ago. The health care professions have come a long way since then.
The use of a standardized electronic medical record and bar coding would help to reduce errors, but they're still not widely available. The fact that there is no technical standard for electronic medical records and databases is a problem. We have technical standards in the media such as television. They have worked out a lot of the creative problems in devising such standards, but in many ways health care is still a cottage industry with disparate individual best practices. There are cultural aspects of medical behavior playing a role in connection with this. Some rural hospitals are operating in a different world from those in urban centers, especially with reference to expensive technology and equipment. For example, bar coding, which is an important safety measure, falls into that category.
You may not be able to have all the sophisticated equipment and devices throughout the country, but you still have to be able to provide basic local health care. Some of the basic devices-defibrillators, for example-can be operated by someone without any advanced training. That's an extreme example. But you'd think that in applying new technology we should have been able to make greater progress than we have. We've made a good deal of progress. It's not universal, though. Consider the idea of putting a bar code on a pill-that would be just one dramatic example. But many things are bar-coded now. Time-sensitive drug administration is facilitated by using bar codes. It's very important to come to grips with technological challenges.
Health care needs quick decision making-there's often a high level of urgency. Contrast the hospital setting with the business world. In part, it's dictated by the urgency of the moment. The physician is confronted with a series of symptoms and a patient who is in pain or discomfort, so he or she has got to decide on the next move, got to get on with it. Whereas, if you're confronted with a problem in the business world, if it isn't an emergency you try to gather as much information as you can, as quickly as you can, in order to be fully informed before you make a decision.
One thing I've noticed about young people coming into business for the first time is that they're not into long-range planning. Their approach is "Here's a hot idea-let's get everything done right now." On the other hand, the finance people, the sources of financing, say, "I want to see a business plan. What are the risks? Who are your competitors? How are you going to deal with this or that issue?" That's just a different decision-making process from the practice of medicine. That's why it's an art, really, to go from symptoms to diagnosis to treatment. So-the more experience you have at that kind of thing, the better you should be. Yet the older physicians are leaving the profession in droves, because they can no longer make the kind of money they're used to. So they're going on to other things. But I did see, in the recent funding resolution from Congress, that the budget for CMS will allow it to increase payments for physician services by as much as $40 million. That certainly is needed.
There is also an interesting series of bills pending before Congress to encourage health care facilities to identify and report errors in an effort to reduce the number of errors through study and action. The major resistance to doing so from the health care industry is that these reports could constitute a roadmap for plaintiffs to sue and collect significant judgments against the health care facilities. For example, HR 663 passed by the House on March12, 2003, would protect those reports from discovery and from disclosure in litigation and otherwise [Section 922 of H.B. 663]. The Bill also provides for the creation of a national database for these reports which is to be referred to as a "national patient safety database" [Section 923 of H.R. 663]. This legislation might get bogged down in the attempts to impose caps on noneconomic damages awarded to injured patients. Nevertheless, this is a significant development in health care. It may simply add to the paper burden for health care providers. On the other hand, it may contribute to the reduction in errors and the development of programs focused on improving outcomes. Through the database, it may be possible to demonstrate that improvements in the delivery systems have actually improved patient outcomes and patient satisfaction.
Speaking of the role of experience in eliminating errors, did you read about that Florida study on errors in interpreting mammograms? It was a study conducted by Dr. Craig Bean, of the University of South Florida at Tampa, and originally reported in the Journal of the National Cancer Institute. You know, the theory has been that a radiologist's accuracy in interpreting mammograms increases with the number of them that he or she reads in a year. In the United States, the standard for continuing certification is 480 mammograms per year, while in the United Kingdom it is 5,000 per year. In Dr. Bean's study of the association between accuracy and the number read, as well as other factors, 110 radiologists read the mammograms of 148 patients, 43% of whom had breast cancer. Among other things, he found that the number of films read in the previous year had no statistically significant correlation with accuracy of interpretation. The researchers did find that there was a small but significant drop in the rate of accuracy in cancer detection for each year past the doctor's residency. While this is a small study sample, the findings raise some interesting questions. Are radiologists receiving adequate continuing education? Certainly, the findings suggest that the health care community may need to reevaluate the weight given to factors like seniority, experience, and ascribed authority. Nonetheless, I still believe experience can be a great teacher. You definitely think that in reading a test, or performing open heart surgery, the volume done must play some part in competence.
QMHC: Doesn't the concept of quality of care extend beyond the clinical aspects?
TCS: Yes, it does, and we're seeing an increasing amount of attention given to the nonclinical aspects of quality. One example is the patient's privacy and the confidentiality of his or her disclosures to health care personnel.
Together, the whole electronic medical record and the requirements of HIPAA [Health Insurance Portability and Accountability Act] are playing an increasingly important role in how care is provided and documented. Some people seem unaware of the fact that the changes related to the HIPAA requirements are imminent-they seem to think the implementation deadline is going to be extended beyond April 14, 2003. I don't think that's going to happen.
One interesting thing about HIPAA is that the fundamental concepts of confidentiality and privacy have been there all along-that's nothing new. But now computers make all this personal information widely available, and electronic transmission brings privacy issues to the fore. There is an appropriate concern that easy access to medical record data may be misused. Not necessarily intentionally. But for example, take an asthmatic patient who has recently seen his doctor and is subsequently deluged with ads for asthma medications. How did this happen? Did his doctor send the patient's name to some pharmacy? Or take the cases that were reported several months ago, involving pharmaceutical companies that routinely send out online prescription refill reminder notices to lists of patients with certain diagnoses who are voluntarily participating in the reminder program. Through a technical error, one of these companies inadvertently sent the reminder notice, online, to the e-mail addresses of several hundred additional patients who were not in the program.
Where's the harm in that? Is there harm there? Nobody lost his job, no harm was done to a patient. But the opportunity is there for the disclosure of sensitive or embarrassing information from the patient's record. As an example, suppose a pharmacy notifies a customer online that it is time to renew his or her prescription for an HIV medication. Or sends an online reminder notice about a pregnancy medication to an unmarried teenager. Given those possibilities, now we have to have detailed instructions about how to keep information confidential. Employees in doctors' offices as well as in hospitals must be instructed in methods for keeping patient information confidential.
The amount of money going into complying with HIPAA is enormous, but it's necessary. It is essential to have these safeguards in place. But despite all this attention, we still don't have something that's badly needed-a standardized electronic medical record.
QMHC: Thank you for your insights. If you ever have any spare time, how do you like to spend it?
TCS: My favorite pastimes are downhill skiing during the winter and golf and cycling during the rest of the year. My wife and I met skiing. Now the whole family enjoys this great outdoor sport.