Legal Issues Related to Pressure Ulcers and Implications to Healthcare Providers By Diane L. Krasner, PhD, RN, CWCN, CWS, BCLNC, FAAN; Caroline E. Fife, MD and Kevin W. Yankowsky, JD 14 Healthy Skin
Survey Readiness Introduction Increased attention to pressure ulcers and the burden they place on the healthcare system has resulted in changes in healthcare policy. Law and medicine have always gone handin-hand in the American healthcare system, but the changing legal environment regarding pressure ulcer policy is a complex one and can expose clinicians and institutions to significant legal risk. The changing legal environment regarding pressure ulcer As part of the Deficit policy is a complex one and can expose clinicians and Reduction Act of institutions to significant legal risk. 2005, the Centers for Medicare & Medicaid Services (CMS) introduced a plan that rolled out in late 2007. It identified pressure ulcers among seven other preventable adverse events for which, under the plan, CMS would no longer pay the higher dollar amount associated with the upcoded diagnostic category when such events occur in acute-care facilities as a secondary diagnosis. Diane L. Krasner, PhD, RN, CWCN, CWS, BCLNC, FAAN The foundation of this ruling (that all pressure ulcers are preventable) and its inference (pressure ulcers occur because of poor-quality care) remains controversial. Even when aggressive measures are taken to prevent pressure ulcers, zero incidence is never achieved; in fact, one study found a floor effect, in that some institutions could effectively lower their rates of pressure ulcers but never prevent them entirely. Important legal issues related to pressure ulcers include pressure ulcer staging, documentation, organizational guidelines, prescribing rules, scope of practice, managing expectations and communication. Caroline E. Fife, MD Pressure ulcer staging The most commonly used tool for assessing pressure ulcers is based on the Shea Scale that was first described in 1975. In 1987 it was revised by the International Association for Enterostomal Therapy (IAET) which is now the Wound, Ostomy and Continence Nursesʼ Society (WOCN) and was adapted by the National Pressure Ulcer Advisory Panel (NPUAP) in 1989 to be used in the Agency for Healthcare Research and Quality (AHRQ) Guidelines of 1992 and 1994. In February 2007, the NPUAP released a revised version that is in practice today. This scale offers four stages of pressure ulcers and an inherent set of problems. Kevin W. Yankowsky, JD Improving Quality of Care Based on CMS Guidelines 15
Pressure ulcers are staged I to IV. The scale is supposed to describe the depth of the pressure ulcer rather than pinpoint the progress of the ulcer on a chronological continuum. Pressure ulcers do not progress up or down the numerical scale. For example, a Stage III pressure ulcer may have begun as a Stage I ulcer and, as it heals, it fills with granulation and scar tissue, not become a Stage II ulcer. The unstageable category is used when the a pressure ulcer is covered with necrotic tissue, which prevents the assessment of its depth. CMSʼs recent determinations regarding present on admission have implications regarding this category, since unstageable ulcers are not considered major co-morbidities, whereas Stage III and Stage IV ulcers are. This is confusing, since virtually all unstageable ulcers will be staged as either Stage III or IV ulcers when they are debrided. Another new addition to the staging terms is Suspected Deep Tissue Injury, a category that certainly warrants further study and research from both pathophysiologic and descriptive perspectives. In some cases, federal guidelines mandate that the pressure ulcer staging system be used outside of its design. For example, in long-term care even though it is not clinically correct federal regulations require that pressure ulcers be reverse staged when documenting their healing progress. The NPUAP Web site has a position statement and more useful information regarding this practice (www.npuap.org/positn5.htm). Overall, although the staging system is widely utilized in all care areas, it is not ideal, nor has validity and reliability been proven. The staging scale is clinically workable because most clinicians who deal extensively with pressure ulcers understand both its utility and limitations. Thus, clinicians are expected to know that a Stage IV pressure ulcer is not necessarily a Stage I pressure ulcer that has deteriorated. Yet, when attorneys or juries scrutinize patient records, they may interpret pressure ulcer staging in just such a way. EVERYTHING an institution and its staff put in writing has legal consequences. Documentation Legal risks extend far beyond misunderstanding of pressure ulcer staging. Everything an institution and its staff put in writing has legal consequences, which can often be both unintended and unfavorable. Crucial to many medical lawsuits is the patientʼs chart. From the clinicianʼs point of view, the patientʼs chart is intended to be used contemporaneously with two other equally important sources of information: the patient and the clinical team. In that context, it is clear that omissions can occur in the patientʼs chart without necessarily impacting, much less diminishing, the quality of care rendered to the patient. However, from a legal standpoint, the plaintiffʼs argument is nearly always that what was not documented was not done. Clinically speaking, if a patientʼs wound size is not documented on a particular day, that chart omission in all likelihood has little or no impact on the patientʼs care because anyone with access to the patient and chart on that day can easily see the size of the wound. This omission in the chart is clinically irrelevant. However, in litigation which may occur years after the event the plaintiffʼs lawyer may argue that failure to document wound size on a particular date means that the wound was somehow neglected that day, adversely impacting the patientʼs care. Appropriately documenting patient care is a huge challenge, but not always for the reasons that clinicians think. Good documentation has to be consistent, concise, chronological, continuing and reasonably complete. However, the goal of reasonably complete documentation has to be balanced with good patient care. For example, in the course of caring for a patient with a pressure ulcer, such events as explaining heel pressure offloading to the patientʼs family, daily turning of the patient or daily skin assessments simply do not always get entered into the chart. Documenting every clinical action is not only an unreachably high standard, it could compromise patient care if clinicians become more focused on creating perfect charts than caring for patients. 16 Healthy Skin
On the other hand, clinicians must understand the legal ramifications of such chart omissions and should be cognizant that the charts they are handling today may be studied in the future in courts of law and that legal decisions often have often been based on what is not in the chart. Good pressure ulcer documentation should include a wound description, measurement and classification by the appropriate severity score, insofar as is possible. Clinicians who might be uncomfortable with wound classification and documentation should take advantage of various educational opportunities in this area. Organizational guidelines Preventative legal care involves reviewing all clinical documentation with an eye on legal ramifications. For example, healthcare organizations should draft guidelines to help guide clinicians in the care of patients. Naming these guidelines anything other than what they are (guidelines) may lead to unintended legal consequences. For instance, an organization with policies and procedures has created legally, at least a set of regulations rather than guidelines. Failure to abide by institutional policy can have serious legal implications. For instance, if the hospitalʼs policy requires a pressure ulcer patient to be turned every four hours, failure to do this within the four hour window even one time represents a breach of policy. Thus, healthcare organizations should formulate guidelines to assist rather than specifically regulate care. Such guidelines should be periodically reviewed and updated. A hospital that puts into writing how things should be done at the institution must realize that the name of that document could have legal ramifications beyond what the hospital intended. Calling this document hospital regulations or standards gives the written instructions far more legal weight than naming the document guidelines. Prescribing rules Clinicians also must also adhere to prescribing rules. For example, if a wound is debrided using an enzymatic debriding agent, a physician must sign the order, since such agents are pharmaceuticals. That is a matter of law. However, some facilities may have evolved standing orders incorporating for enzymatic debriding agents, which nurses can then implement without a physician signature. This practice, however, would be out of compliance with prescribing laws. For that reason, hospitals and clinicians should review such actions and standing orders prospectively to see if they would withstand legal scrutiny. Scope of practice Organizations interested in preventative legal care also must also consider cliniciansʼ scope of practice. Policies or practices may have evolved within organizations that encourage clinicians to act outside of their legal scope. An example might be a licensed vocational nurse or licensed practical nurse performing wound documentation, including pressure ulcer staging. Clinicians can expose themselves to legal action by doing things that exceed their competence or scope of practice and, likewise, facilities may be found liable by routinely demanding such activities from their staff. HEALTHCARE organizations should formulate guidelines to assist rather than specifically regulate care. From a legal standpoint, a nurse could vary somewhat from a guideline at her discretion. However, failure to adhere exactly to a regulation or standard is more like a violation than a variance. While the term protocol falls between regulation and guideline, it is actually closer to a regulation than most healthcare professionals might think. Of course, clinicians must be thoroughly familiar with their organizationʼs guidelines. Furthermore, it is prudent preventative legal care for a hospital to prospectively examine its organizational guidelines to ensure everyone in the organization is fully aware of them and their potential legal ramifications. Continued on Page 19 Improving Quality of Care Based on CMS Guidelines 17
Just one touch... Comfort-Aire Disposable Briefs One touch and you know Comfort-Aire disposable briefs are unique. Velvety soft side panels allow airflow for enhanced comfort and skin care. The comfortable outer cover helps prevent irritation. For more information about Comfort-Aire, contact your Medline representative or call us at 1-800-MEDLINE. Extra-wide, skin-safe refastenable tape tabs Breathable side panels One look and you can see the advantages. The wider hook tape tabs make it easier to grasp and won t stick to skin or gloves, and the compressed packaging is easier to handle. One try and you ll understand. Comfort-Aire s enhanced, superabsorbent core keeps skin dry, which helps to keep it healthy. Comfort-Aire. The right choice for ultimate patient comfort and protection. Enhanced, super-absorbent core Soft cloth-like outer cover www.medline.com
Managing expectations While the high dollar amounts in certain medical malpractice lawsuits suggest that litigation is ultimately about money, attorney Kevin W. Yankowsky of Fulbright & Jaworski LLP in Houston, Texas, claims says that most many medical malpractice lawsuits start out as a search for answers. If patients or families do not get satisfactory answers from their healthcare practitioners, they may seek answers instead from attorneys, whether out of frustration, anger or simply seeing no other viable option. For that reason, nurses and all healthcare practitioners are urged to be open and honest with patients and their families to help manage expectations. Patients and their families should be involved in making decisions about treatment, which means being cognizant of associated risks. Healthcare practitioners should listen carefully to what their patients have to say and document such conversations. Some lawsuits arise simply because a patientʼs family may have underestimated or misunderstood the risks of a particular procedure or condition. Patients and their families should be involved in making decisions about treatment, which means being cognizant of associated risks. While hospitals and healthcare practitioners should be open and honest with patients, such conversations must be handled carefully. On the one hand, it is vital to manage the expectations of patients and their families. Some lawsuits arise simply because a patientʼs family may have underestimated or misunderstood the risks of a particular procedure or condition. after the conversation. Poor word choice can infuse simple statements with unintended meaning. Thus, it is important to think about what is said in terms of how the patient and his family might perceive it and how an attorney or court might one day interpret it. IF PATIENTS OR FAMILIES do not get satisfactory answers from their healthcare practitioners, they may seek answers instead from attorneys. On the other hand, it is important to handle such conversations skillfully. Patients with challenging or sensitive questions should be referred to hospital personnel with more training such as colleagues in risk management or social services to avoid exacerbating an already difficult situation. Such conversations should be thoroughly documented. Communication Increasingly, nurses find themselves being caught in the legal crossfire. When any healthcare professional is deposed, it is important to appreciate the legal implications of word choice. It is possible to express something as a healthcare professional that could be taken by an attorney to mean more (or less) than was actually intended. For that reason, many legal experts recommend that clinicians meet with attorneys or their representatives prior to any deposition or court appearance to better understand the sometimes hidden legal nuances of their testimony. Words communicated in the hospital carry legal weight that can last years For example, if a patient falls, the nurse attending him might quite naturally want to express her regret, but the words she uses can have serious legal consequences. Iʼm sorry might be taken to mean that the nurse was apologizing to the patient or family for her role in the fall. Iʼm sorry we let that happen most likely would be taken to mean that the nurse was admitting that she or the facility was somehow at fault for the fall. The phrase, Iʼm sorry that happened, however, conveys the nurseʼs genuine sympathy without assuming responsibility for the fall. Improving Quality of Care Based on CMS Guidelines 19
Conclusion While clinicians often balk at having to deal with attorneys or even their own facilityʼs risk management team, the fact is that medical malpractice litigation is on the rise, and most clinicians are going to encounter it, in one form or another, over the course of their professional careers. Fortunately, there are many preventative legal strategies that can limit legal risk. Ironically, reducing the legal issues surrounding pressure ulcers will require more than just good clinical practice. Todayʼs clinicians need to understand how their clinical actions will be perceived in a court of law and adjust their behaviors accordingly. Good clinical practice is the beginning, not the end, of reducing the risk of legal action in the treatment of patients with pressure ulcers. Clinicians and their institutions must also prospectively embrace legal preventative strategies to mitigate their exposure to litigation. References Thomas DR. Prevention and treatment of pressure ulcers: what works? what doesnʼt? Cleveland Clinic J of Med. 2001; 68(8):704-722. Hagisawa S, Barbenel J. The limits of pressure sore prevention. J R Soc Med. 1999; 92(11):576-578. National Pressure Ulcer Advisory Panel. Pressure ulcers: incidence, economics, risk assessment. Consensus development conference statement. Decubitus. 1989; 2(2):24-28. The authors of this article Dr. Diane Kranser, Dr. Caroline Fife and Kevin Yankowsky, JD recently joined six additional members of the International Expert Wound Care Advisory Panel (Dr. Elizabeth Ayello, Dr. Gary Sibbald, Evonne Fowler, Dr. Jeffery Levine, Dr. Kathleen Capitulo and Dr. Gerit Mulder) to discuss the legal implications of pressure ulcers. The resulting white paper from this meeting will be released soon and featured in the next issue of Healthy Skin. TODAYʼS CLINICIANS need to understand how their clinical actions will be perceived in a court of law and adjust their behaviors accordingly. Diane L. Krasner, PhD, RN, CWCN, CWS, BCLNC, FAAN is a board-certified wound specialist with extensive experience in wound, ostomy and incontinence care. She is a wound and skin care consultant in York, Pennsylvania and works part-time at Rest Haven - York as the WOCN/special projects nurse. She is co-editor of Chronic Wound Care: A Clinical Source Book for Healthcare Professionals and currently serves on the editorial boards of WOUNDS, Kestrel Wound Product Sourcebook, The International Journal of Wound Care and World Wide Wounds. Since 1992, Dr. Krasner has served on the board of directors for The American Academy of Wound Management, The Association for the Advancement of Wound Care and the National Pressure Ulcer Advisory Panel. Caroline E. Fife, MD is the director of clinical research at the Memorial Hermann Center for Wound Healing and Hyperbaric Medicine and an associate professor at the University of Texas - Houston Medical School. She currently serves on the board of the American Academy of Wound Management. She is also co-editor of Wound Care Practice, a textbook on the assessment and management of chronic wounds. Kevin W. Yankowsky, JD is a partner in the Health Law Litigation group of Fulbright & Jaworski LLP, in Houston, Texas. His practice encompasses civil litigation facing the healthcare industry. He also routinely advises on a variety of electronic data and document retention issues. Combining his experience in both practice areas, he counsels healthcare providers on data and document challenges faced when attempting to minimize the dangers, uncertainties and expense of 21 st century litigation. He has also given several presentations to healthcare organizations regarding pressure ulcers and the law. He is a member of the American Health Lawyers Association and the American Society for Health Care Risk Management. 20 Healthy Skin