From the Experts
Understanding the Science of Safety by Dr. Peter Pronovost
At the start of the twenty-first century, the Institute of Medicine’s (IOM) staggering estimation that up to 98,000 patients die annually from medical mistakes shook the U.S. healthcare system. While this 1999 IOM report was based on studies done up to a decade earlier, it has become one of the thrusts behind the current patient safety and quality movement. Early on in this movement, a gap in the quality of care delivered to patients was recognized. In particular, only half of patients receive evidence-based therapies known to improve their care. To the contrary, we know caregivers and hospitals are dedicated to saving lives, curing illnesses, and reducing patient suffering from chronic conditions. So why are patients still suffering preventable harm?
To understand the shortcomings of quality care and patient safety, we must view the delivery of healthcare as a science. As a science, we can organize healthcare delivery into systems; a system is a set of parts interacting to achieve a goal. For example, the medication delivery system involves the following parts: the doctor orders the drug, the pharmacy dispenses the drug, and the bedside caregiver administers the drug. Interjected in this oversimplified description is a clinician recognizing any medication allergies, the proper transmission of the order to the pharmacy, the delivery of the medication to the floor, and the time pressures dictated for best care (for example, the gold standard for antibiotic administration is one hour); any number of additional significant parts or caveats could of course be added to this list. Clearly this is a complex system for a single medication dose and errors can occur at any given time. If the fax machine, for example, to transmit a stat order to the pharmacy is damaged, or if a hospital is short staffed with no runner to transport the pill, the system is broken. Caregivers work in these complex systems, and as Paul Batalden aptly put it, “every system is perfectly designed to achieve the results it gets.” Thus, caregivers cannot be blamed when the system fails.
Mistakes are often thought of in terms of what one can see; a drug overdose, a patient’s health begins to fail, or a death occurs. These are outcomes, but what are the causes? We need to think about how to deliver care, how to organize our systems, and how to identify broken or risky systems. If we can fix broken systems, improvements in patient safety and quality of care will naturally follow. One solution is to separate systems of care into seven bins (often called factors).
These factors include:
- patient characteristics (for example, language barrier or severity of illness);
- task factors (like outdated protocol of evidence-based practices for mechanical ventilation);
- caregiver factors (including experience/skills level or degree of sleep deprivation);
- team factors (including poor communication);
- work environment factors (for example, a tube system to deliver medications broken);
- department factors (like no money to buy a needed fax machine); and
- institutional factors (for example, budget cuts which cause understaffing).
Caregivers need to view their work as a process that is embedded in the healthcare system or context; both of these must be addressed to improve patient outcomes.
The Comprehensive Unit-Based Safety Program, called CUSP, was designed to integrate safety and quality practices into daily work. CUSP follows this six step process:
- the measurement of culture;
- the explanation of the science of safety (as described above);
- the education of the staff to identify problems;
- the education of the staff to resolve problems;
- the bridging of the gap between senior hospital leaders and frontline staff; and
- the provision of tools for caregivers that can be used to improve the seven factors mentioned in the previous paragraph.
CUSP should be implemented in each patient care area (for example, the intensive care unit or the coronary care unit) and a patient safety team involving staff from the unit should be assembled to manage the program. To be most effective, this team should include the unit director or other physician of similar leadership ability, the nurse manager, another unit nurse and physician, a risk manager or patient safety officer, and a senior executive from the institution.
The need to improve patient safety is great and the resources devoted to such change are few. Efforts must be focused to identify and to mitigate hazards and to evaluate whether implemented changes are actually improving patient safety. With focused attention, disciplined interventions and rigorous evaluation, we can answer Sorrel’s haunting question, “Would Josie be less likely to die today than she would have a year ago?” with a resounding “Yes!”
By Lori Paine, RN
In his best-selling book, All I Really Need to Know I Learned in Kindergarten, Robert Fulghum writes about the value, and the challenge, of following simple life lessons—about sharing and apologizing, to name a couple. “I realized,” he writes, “that I already know most of what’s necessary to live a meaningful life—that it isn’t all that complicated. I know it. And have known it for a long, long time. Living it—well, that’s another matter.”
I submit that the same is true for patient safety.
When I entered nursing school in 1983 and took Nursing 101, I learned about the importance of frequent hand-washing for infection control. I was taught to ensure medication safety by ensuring that the five “rights”—the right patient, dose, drug, route and time—were verified before administration. I was trained to prevent patient falls through such practices as keeping bedrails up and the call-bell within the patient’s reach. I acquired communication skills, such as documenting treatment through SOAP notes. We were taught the value of checking one another’s work at critical points. To graduate, we had to demonstrate these fundamental skills throughout nursing school.
So why do studies suggest that handwashing habits among healthcare workers are woefully lacking? Why do we continue to see medication errors and patient falls? Why are communication failures responsible for the majority of sentinel events reported to the Joint Commission? Why do we see mistakes that could have been caught with simple cross-checks?
Simplicity has given way to complexity. Nurses and other caregivers are tending to very ill patients with complicated treatment plans, and doing so with greater dependence on other disciplines. Resident work-hour limitations have increased the number of patient handoffs—yet more opportunities for communication errors. We’re surrounded by technology intended to make work easier and less error-prone, but which can lead to new errors. We’re driven by long to-do lists that can distract us at critical points in patient care, such as medication administration or shift changes.
Demands on caregivers are greater now than ever. Our challenge, similar to Fulghum’s, is to re-acquaint ourselves with the fundamentals of patient care and safety and then find ways to give them priority with every patient, every time. We must find a way to step outside of the chaos, slow things down and ensure that the fundamentals are followed.
At Hopkins Hospital, intensive care units have demonstrated what’s possible when we focus on the basics. Simple steps, including handwashing and wearing full-barrier protection before inserting central catheters, were among simple steps that reduced bloodstream infections.
I think patient safety would benefit greatly if each of us decided, as a start, to “re-adopt” a fundamental practice that has become a challenge to follow in health care today.
A Conversation Between Rick Kidwell and Paul Bekman, Moderated by Sorrel King
Over the years many families, patients and healthcare providers have come to the Josie King Foundation in search of help. Sometimes they want more information on patient safety, sometimes they are looking for a sympathetic ear. Many times they have legal questions. I am so happy to have Rick Kidwell, an attorney on the hospital side, and Paul Bekman, a malpractice attorney, here to help: two lawyers from two different sides of the fence.
I know them both well. When Josie died Rick Kidwell was the lawyer representing Johns Hopkins. Richard P. Kidwell is Associate Counsel and Director of Risk Management at UPMC (University of Pittsburgh Medical Center). Rick joined UPMC in November 2004 after more than ten years at Johns Hopkins Medicine in Baltimore, Maryland, where he was Director of Risk Management and the Managing Attorney for Claims & Litigation. Rick is a 1976 graduate of Mount Saint Mary’s University in Emmitsburg, Maryland and a 1979 graduate of the University of Maryland School of Law. He was in private practice with the law firm of Miles & Stockbridge in Baltimore from 1979 to 1994. Rick was a member of Maryland Governor’s Medical Malpractice Task Force in 2004. He was president of the Maryland Society for Healthcare Risk Management in 2001-2002 and has been a speaker at ASHRM (American Society for Healthcare Risk Management) and American Health Lawyers meetings.
We hired Paul Bekman to represent us. Paul D. Bekman is a personal injury lawyer with Salsbury, Clements, Bekman, Marder & Adkins, LLC in Baltimore, Maryland. Paul is a graduate of the University of Maryland Law School. He has been recognized as a top lawyer in the field of medical malpractice, products liability, personal injury litigation, and alternative dispute resolution by Best Lawyers in America annually since 1989. Since 1997, Paul has been President of the American Board of Trial Advocates – a statewide organization of plaintiff and defense lawyers involved in handling serious cases of a civil nature. Paul was President of the Maryland State Bar Association from 1997-1998, the Bar Association of Baltimore City from 1993-1994, and the Maryland Trial Lawyers Association from 1986-1987. He is a Fellow of the American College of Trial Lawyers and currently serves as a Regent of the College for Maryland and the District of Columbia. Since 2002, he has been Chairman of the University of Maryland School of Law Board of Visitors. Paul has also served as a faculty member at MICPEL for the past twenty-eight years, lecturing on medical malpractice and complex civil cases.For fourteen months it was us against them. Since October of 2001 we have all come together to “fix the problem”. Both Paul and Rick have helped me help others since the beginning. Now it brings me great pleasure to share them with you.
The following are frequently asked questions. Some pertain more to families and some pertain more to healthcare providers. I hope you find them as helpful. Please contact us if you have specific questions.
Q. Over the years many patients and families have contacted the Josie King Foundation looking for advice. One question that is often asked is, “Who should I talk to with in the hospital when I believe a mistake was made?”
Rick: You should start with the doctors and nurses taking care of you or your child. Tell them your concerns in a non-confrontational, non-accusatory way. Ask them to explain what has happened and why and what will be done to help you or your child get better.
Paul: Rick’s response is a good one. It is always best to deal firsthand with the people who have direct responsibility for your child. In the event that you do not get satisfaction you should contact the Risk Management office, or even the Legal Department to express your concerns.
Q. What should they do if their concerns are being ignored?
Rick: Ask to speak to the nurse manager and the division/department chief. If that doesn’t work, ask to talk to patient relations so you can file a grievance which hospital regulations require a response. You could also ask to meet with the risk manager or hospital counsel if the patient relations route does not work.
Q. If a patient or family member wants medical records how do they go about retrieving them?
Rick: The patient or family member should send a written request to the hospital’s records department requesting the records. Local laws usually give hospitals a few weeks to copy and send the records. Keep in mind that there will be a delay if you ask for records while the patient is still in the hospital because the chart probably won’t be copied until after the patient has been discharged. The hospital does not want to interrupt access to the records by taking a chart away to be copied while the patient is still in the hospital. You may also ask your attending physician to go over the chart with you while you or your family member is in the hospital if you need immediate access to the chart. The hospital will require a caregiver to be with you while you review the chart to answer questions and to keep the chart in order.
Paul: I agree with Rick as to medical records. Many times a hospital may be reluctant to release medical records of the patient, particularly if the patient is still in the hospital. It is, therefore, likely that you will not be able to get a complete set of the medical records until such time as the patient has been discharged from the hospital. It is absolutely essential to get all medical records pertaining to the patient’s care. In these instances, what all of the records are may not be totally familiar to the person requesting them. If you believe that you have a legitimate claim and the issue is getting a complete set of records it may be advisable to consult with counsel even if it is for the limited purpose of obtaining a complete set of medical records.
Q. At what point should they hire a lawyer?
Paul: The decision to hire a lawyer is a personal one. Different people may be motivated by different considerations when they decide to hire a lawyer. The first concern should be the care and treatment of the patient in making sure that the patient receives optimal care under the best possible circumstances. If in fact it is believed that a mistake has been made, it would be advisable to consult with an attorney to have them explain what the patient’s legal rights are. Many times a phone call can be made by counsel to clear up any problems which have developed. On the other hand, it may be necessary to obtain medical records in order to evaluate whether in fact there is a viable claim that should be pursued. In any event, it is absolutely essential that if medical records are obtained that all of the medical records must be requested and obtained.
Rick: I agree with Paul. Circumstances will help steer the patient or family to the appropriate time to retain counsel.
Q. Paul, what is the best way to find a reputable lawyer?
Paul: There are many different ways to obtain counsel. In the area of medical negligence there generally is within a particular city a recognized group of individuals who do medical negligence work. It would be very easy to go to a local reference such as Martindale Hubbell, which is a law directory, but that will only give you basic information. Some of the sources that you should consult would be the following:
- The Best Lawyers in America
- The American Board of Trial Advocates
- The American College of Trial Lawyers
- The International Society of Trial Lawyers
- The International Society of Barristers
- The various local magazines around the country that have identified the Super Lawyers in that particular jurisdiction
It is essential in the medical negligence context to obtain not just any lawyer, but a lawyer who concentrates his or her practice in the medical negligence area.
Q. How many lawyers should they interview?
Paul: This is a matter of personal choice. Sometimes it may be one interview. Other times, just like any other serious decision that a person would make, it is a good idea to interview several individuals. It is important for those who are seeking counsel to be comfortable with the lawyer that they chose. This relates not only to competence, but in terms of being able to work with that particular person in what is likely to be an extremely emotional and difficult time.
Q. How do they know if they have found the right one?
Paul: This is a matter of comfort. You generally will know, particularly if you have engaged in the interview process, who the right lawyer is, or who is the right lawyer for you. There are many fine and competent lawyers who practice in this area, many of whom would be more than capable and able to handle such a case.
Q. When something goes wrong and the family feels they are being ignored by the hospital they often want to lash out and get the media involved. I know I felt that way. What are your thoughts on that?
Paul: My personal view is that there will be plenty of time later to involve the media if it is necessary. What needs to be done initially is to find out the facts and determine whether or not you have a viable case. This has to be done by good, hard work and preparation. Once a case is filed it becomes a public record and then can be subject to media interest. It is my practice not to involve the media, but rather to try to do the best job that I can for my clients.
Rick: I think the urge to run to the media should be suppressed while you try to work things out directly with the hospital and nurses and doctors. First, you need to make sure you have all the facts. Second, you should give the hospital and its staff a chance to do the right thing. Third, if there is to be a claim or litigation, you’ve lost some leverage if you’ve already played the publicity card.
Q. I have been in contact via e-mail with many families who have been affected by medical errors and most of the time they want to partner with the hospital and help. Rick, how would you recommend they go about this? Where should they start? Who should they talk to?
Rick: Again, the best place to start is with the doctors and nurses. Let them know you want to help them improve care. You could also ask to speak to the risk manger with the same offer.
Q. Rick, you are a big proponent of full disclosure and apology after medical errors. When a doctor or a nurse makes a mistake and they know it, what is your advice to them? Should they apologize right off or do they need to talk to the Risk Manager at their organization?
Rick: They should notify risk management if possible before apologizing because the doctor or nurse, I hope, hasn’t had experience dealing with this situation while the risk manager probably has and can offer advice as how best to disclose, including who should do so, how to do so, and what will be done to analyze the error to try to prevent a recurrence. The risk manager may also be able to offer financial considerations for the patient or family to help get them through the effects of an error. That said, however, it is more important that the doctors and nurses communicate with their patients and families and not delay any needed discussion to track down risk management. Risk management will support the doctor or nurse who does the right thing by apologizing, explaining and assuring the patient/family.
Paul: I think it is extremely important that a line of communication be developed between the patient and the hospital staff, whether this be with the doctors who are caring for the patient, the Risk Management Office, or the Legal Department, open lines of communication should exist to enhance the partnership relationship. Here in Maryland an apology for a medical error is not going to be admissible in the subsequent proceeding. Maryland has recently passed a law which would permit a doctor or hospital to apologize for a medical mistake. It is my view that a doctor will reduce his chances of having a medical negligence case filed against him or her if he or she is open and honest about a mistake being made.
Q. Rick, I know UPMC and Hopkins have full disclosure policies. How many other hospitals in the country have that policy? What advice would you give a hospital that does not have such a policy?
Rick: Every hospital should have that policy. Regulations require it but more importantly it is the right thing to do. I would advise any hospital that doesn’t have that policy to look at this as just another phase of what should be ongoing communications between patients/families and doctors/nurses.
Q Has there been any research done on what relationship exists between disclosure and apology after medical errors and malpractice lawsuits?
Rick: There are some studies, including a recent one from Harvard that concludes that disclosure may actually increase the number of claims or dollars spent in lawsuits or both. Other studies reach a different result – disclosure may actually prevent lawsuits. It really doesn’t matter which view is accurate; what does matter is disclosure is the right thing to do regardless of the legal ramifications.
Paul: In the State of Maryland my advice would be to make a disclosure as soon as possible after an error occurs. This will enhance the patient’s trust of the physician and in many cases may be the main factor in having the patient not proceed with a medical negligence claim. As far as research is concerned relating to the relationship between the disclosure or an apology after medical errors and malpractice suits, my experience has been anecdotal. Many times I will see a patient who says that the doctor told them they made a mistake, but he has been a wonderful physician and they do not want to bring an action against him or her. That request is honored. On the other hand, there are many instances where an error may have resulted in a catastrophic result, such as serious personal injury or death. In those circumstances, although the apology has been made and the error admitted, it may enhance the resolution of the claim without having to undergo unnecessary and prolonged litigation.
Q. A final question for both of you. From a legal perspective, what needs to happen to prevent medical errors?
Paul: It is essential that doctors practice good medicine. I know some doctors who have been practicing for over thirty years and have never had a malpractice claim filed against them, because they are good, careful, competent, caring physicians. On the other hand, I have seen individuals who have had sixteen or seventeen lawsuits filed against them as a result of careless, slipshod and uncaring practices. Practice of good medicine eliminates errors.
Rick: Each state should have a mandatory reporting system like Pennsylvania’s so all hospitals can learn from events at other institutions. A hospital should be able to recover its costs when a physician whose privileges have been terminated because of unsafe practices unsuccessfully sues the hospital to regain his/her privileges. Tort reform is a controversial topic but there are ways to improve the court system to make litigation more about finding ways to improve care.
Please note: The Josie King Foundation provides this conversation for general informational purposes only. Please consult your own legal representation for any action specific to your situation and local jurisdiction.