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When research cannot answer a question—standards of care
SEPTEMBER 1999, VOL 70, NO 3 RESEARCH CORNER
When research cannot answer a questionstandards of care ur last few columns have addressed approaches to answering questions that have not been or cannot be answered by research. This column focuses on the role that standards of care play in making clinical decisions. Sometimes, standards of care are research- or evidence-based and reflect clinical expertise and knowledge. Other standards are developed based on legal or expert opinion or, in some instances, actually mandated by legislation or regulation. Regardless of the practice setting or specialty, nurses must know and practice according to the various standards of care that provide the framework for that practice. TYPES OF STANDARDS Standards are classified as regulatory, voluntary, and involuntary. Regulatory standards are based on regulation usually mandated by the government. Voluntary standards are those developed by health care practitioners and often are the work of a professional organization. Involuntary standards are those defined by professional liability insurance carriers. Standards also may be categorized according to their scope of influence (ie, national, state, local, institutional). Every nurse has a professional responsibility to maintain competencies and continually review any changes in the standards of care. For example, in the 1960s and early 1970s, it was not routine for health care practitioners
to provide cardiopulmonary resuscitation (CPR). In the last two decades, however, providing CPR has emerged as a standard of care in the event of a sudden cardiac arrest. Today, a nurse would be negligent if he or she did not provide CPR because of failure to stay competent in the skill or be knowledgeable about this clinical standard. DETERMINING AN APPROPRIATE STANDARD OF CARE Certain standards of care are not as well defined. In fact, many lawsuits argue the question, “What was the appropriate standard of care for a particular clinical situation?’’ At times, it seems such questions only arise when there is a negative patient outcome. In an ideal world, the standard of care should guide practice in a manner that avoids or eliminates negative outcomes; however, standards of care have not been developed for all clinical situations. Health care practitioners need to use their expert knowledge to guide their practice. For example, the diagnostic evaluation of certain health care problems has not been well defined or described. A recent lawsuit attempted to define the standard of care for a young woman’s diagnostic workup for unrelenting fevers.’ She died of lymphoma, and the diagnosis was made after her death. The plaintiff’s attorney argued that the physician did not meet the standard of care in his evaluation of 495 AORN JOURNAL
her complaints. In fact, he argued that the patient’s physician failed to meet the standard of care for evaluation and treatment of her condition. The defense presented expert witnesses who stated the physician did meet the standard of care. Regardless of the outcome of this case, the jury’s verdict will contribute to further defining a standard of care in a similar clinical situation. Clinical practice standards define what the reasonably prudent health care provider would do in the same or similar situation. Nurses are held to standards that relate to nursing, whereas other health care providers are held to the clinical standards of clinicians who have equivalent education, training, and experience. All health care practitioners may be held to standards that have been developed at the national, state, local, or institutional level. Each of these levels is appropriate in specifically defined situations. With the emergence of new knowledge and technology, there is a trend toward health care providers being held to national standards more than ever before. National standards may be developed by professionals, but also may be regulated by federal legislation or regulation. Standards of practice that were developed as a result of federal initiatives by the Agency for Health Care Policy and Research include guidelines on acute pain, the prevention of pressure ulcers,
SEPTEMBER 1999, VOL 70,NO 3
and smoking cessation. Nurses and faculty members attending national conferences, reading professional journals and textbooks, and using core, accredited curriculums have contributed to national nursing practice standards in the United States. In addition to these factors, most professional nursing organizations have developed and published clinical practice standards (Table 1). Most national standards are designed to guide-not regulateAlinica1 practice, but in a lawsuit, such standards often are relied on to help define a standard of care. Additionally, state legislatures and agencies define particular standards within their jurisdiction and, thus, regulate clinical practice. Each state has a board of nursing that regulates and defines nursing practice and determines a nurse’s scope of practice within that state. For example, some states do not allow a licensed practical nurse to practice independently as a school nurse; how-
ever, in many states this is an acceptable practice and standard. Obviously, nurses must know their state’s rules and regulations to practice within the law as well as meet the standard of care. As a nurse, if you move to another state, you should review the rules and regulations of that state’s board of nursing and obtain answers before assuming that a particular activity is within your scope of practice. A typical question that you might ask is, “Can an RN administer IV neuromuscular blocking agents?” If this is something you are asked to do in your work situation, it is best that you know whether you can do this in accordance with the laws in your state. It is not uncommon for nurses to be asked to perform procedures that are out of their scope of practice. When was the last time you looked at your state board of nursing’s rules and regulations? Local and institutional standards and hospital policies and procedures are integral to any
nurse’s practice and must be reflected in care delivery. In fact, hospital policy and procedure manuals are instrumental to providing nursing care. Most clinical agencies provide numerous hours of orientation and mandatory continuing education to inform and update personnel about key policies and procedures. Nurses often refer to an agency’s policy and procedure manual when they are performing less frequently practiced or unfamiliar skills. Unfortunately, many nurses have never looked at their facility’s policy and procedure manual and practice independently of the standards of care set within their institution. You may think “Not me,” but in conducting the simplest of chart audits for documentation, it can become clear that nurses often do not know when to document, what to document, or what the hospital policies are about this issue. In fact, nurses may be documenting according to the policies and procedures of a previous
Table 1 STANDARDS OF CARE PERTINENT TO PERIOPERATIVE NURSING
Standard
Organization
Description
Web address
The Code for Nurses with InterpretiveStatements
American Nurses Association (ANA)
Defines ethical conduct.
www.ana.org
Standards of Clinical Nursing Practice
ANA
Provide basic standards for nursing practice.
www.ana.org
AORN Standards, Recommended Practices, and Guidelines
AORN
Provide standards of perioperative clinical practice, perioperative administrative practice, and recommended practices for perioperative nursing.
www.aorn.org
Standards on Sterilization, Biomedical Equipment, and Biological Evaluation
Association for the Advancement of Medical Instrumentotion
Provide standards on medical instrumen- www.aami.org tation, including disinfection, sterilization, and decontamination.
Guideline for the Prevention of Surgical Site Infections
Centers for Disease Control and Prevention
Presents guidelines to minimize the risk of surgical site infections in acute care hospitals. 496
AORN JOURNAL
www.cdc.gov
SEPTEMBER 1999, VOL 70, NO 3
employer or school of nursing. Accrediting agencies (eg, Joint Commission on Accreditation of Healthcare Organizations [JCAHO], state boards of health) recommend that policies and procedures be updated periodically and reflect the latest research and knowledge. In that regard, local policies need to reflect national practice standards. Committee members working on a policy always should examine the literature and research before updating any policy. Committee members also may call other facilities to learn more about their standards of practice. Can you imagine working in isolation of others and determining a policy and procedure that makes sense to you but no one else? For example, what surgical department in the United States would want to use a microwave or toaster oven for flash sterilization? You would think none, but infection control experts report finding such devices in use for sterilization purposes in physicians’ offices. Obviously, the employees in the physicians’ offices were following their policy and procedure, but such procedures do not reflect current, well-established, research-based practice standards. A local or institutional standard should be dismissed if it is reflective of an outdated or substandard practice. An additional category of standards that nurses need to be aware of are those developed by regulatory agencies and other professional organizations. For example, nurses practicing in hospitals need to be aware of any
standards set forth by JCAHO. In the perioperative arena, nurses need to be aware of standards developed by the Association for the Advancement of Medical Instrumentation, American National Standards Institute, American Nurses Association, Occupational Safety and Health Administration, and other agencies to the degree these standards influence perioperative nursing practice. In some states, nurses need to consider the rules and regulations of other state agencies. For example, the board of pharmacy may have a regulation that dictates who and under what circumstances individuals can dispense medications. The nurse should consider this ruling, especially if the board of nursing is not clear on this issue. DETERMINING RELEVANT REGULATIONS AND STANDARDS Standards of care can provide a basis for decision making when there is no research to answer a specific question. Determining any pertinent regulations and standards are part of the clinical problem-solving process. For example, there is little research related to the practice of flash sterilizing implants; however, a number of organizations, including AORN, the Centers for Disease Control and Prevention, and JCAHO, have never recommended the routine flash sterilization of implants. Suppose the director of surgical services at your facility decides that these standards are not appropriate and recommends that staff members flash sterilize implants on a rou-
NOTE 1, N Meersman, ‘‘Jury weighs evidence in cancer
tine basis. In this instance, you might review the facility’s policy and procedure manual and determine what it says. Next, as a nurse, you might want to know what other hospitals in the area are doing about the flash sterilization of implants. If your hospital is the only hospital in the state flash sterilizing implants, perhaps the director’s decision needs to be questioned. One might ask, “Why do we have the lowest standard for flash sterilization on the local and state level, and why do we not practice in accordance with a number of national practice standards?” Like research, standards of care cannot answer all questions; however, they can provide valuable assistance in the decisionmaking process. More than ever before, standards of care are integral to nursing practice. They not only enhance professional practice, but they also are instrumental in the provision of quality nursing care. If you are not familiar with standards of practice, visit your library or check the Internet to find clinical practice guidelines pertinent to your practice and your own health care. Each of us has a professional responsibility to know the standard of care and provide it within our scope of practice. SUZANNE C. BEYEA RN, PHD, CS AORN CODIRECTOR OF PERIOPERATIVE RESEARCH
LESLIE H. NICOLL RN. MB4 PHD AORN CODIRECTOR OF PERIOPERATIVE RESEARCH
malpractice suit,” The Union Leader (Manchester, NH) 29 June 1999, sec C, 2.
497 AORN JOURNAL
When research cannot answer a questionstandards of care ur last few columns have addressed approaches to answering questions that have not been or cannot be answered by research. This column focuses on the role that standards of care play in making clinical decisions. Sometimes, standards of care are research- or evidence-based and reflect clinical expertise and knowledge. Other standards are developed based on legal or expert opinion or, in some instances, actually mandated by legislation or regulation. Regardless of the practice setting or specialty, nurses must know and practice according to the various standards of care that provide the framework for that practice. TYPES OF STANDARDS Standards are classified as regulatory, voluntary, and involuntary. Regulatory standards are based on regulation usually mandated by the government. Voluntary standards are those developed by health care practitioners and often are the work of a professional organization. Involuntary standards are those defined by professional liability insurance carriers. Standards also may be categorized according to their scope of influence (ie, national, state, local, institutional). Every nurse has a professional responsibility to maintain competencies and continually review any changes in the standards of care. For example, in the 1960s and early 1970s, it was not routine for health care practitioners
to provide cardiopulmonary resuscitation (CPR). In the last two decades, however, providing CPR has emerged as a standard of care in the event of a sudden cardiac arrest. Today, a nurse would be negligent if he or she did not provide CPR because of failure to stay competent in the skill or be knowledgeable about this clinical standard. DETERMINING AN APPROPRIATE STANDARD OF CARE Certain standards of care are not as well defined. In fact, many lawsuits argue the question, “What was the appropriate standard of care for a particular clinical situation?’’ At times, it seems such questions only arise when there is a negative patient outcome. In an ideal world, the standard of care should guide practice in a manner that avoids or eliminates negative outcomes; however, standards of care have not been developed for all clinical situations. Health care practitioners need to use their expert knowledge to guide their practice. For example, the diagnostic evaluation of certain health care problems has not been well defined or described. A recent lawsuit attempted to define the standard of care for a young woman’s diagnostic workup for unrelenting fevers.’ She died of lymphoma, and the diagnosis was made after her death. The plaintiff’s attorney argued that the physician did not meet the standard of care in his evaluation of 495 AORN JOURNAL
her complaints. In fact, he argued that the patient’s physician failed to meet the standard of care for evaluation and treatment of her condition. The defense presented expert witnesses who stated the physician did meet the standard of care. Regardless of the outcome of this case, the jury’s verdict will contribute to further defining a standard of care in a similar clinical situation. Clinical practice standards define what the reasonably prudent health care provider would do in the same or similar situation. Nurses are held to standards that relate to nursing, whereas other health care providers are held to the clinical standards of clinicians who have equivalent education, training, and experience. All health care practitioners may be held to standards that have been developed at the national, state, local, or institutional level. Each of these levels is appropriate in specifically defined situations. With the emergence of new knowledge and technology, there is a trend toward health care providers being held to national standards more than ever before. National standards may be developed by professionals, but also may be regulated by federal legislation or regulation. Standards of practice that were developed as a result of federal initiatives by the Agency for Health Care Policy and Research include guidelines on acute pain, the prevention of pressure ulcers,
SEPTEMBER 1999, VOL 70,NO 3
and smoking cessation. Nurses and faculty members attending national conferences, reading professional journals and textbooks, and using core, accredited curriculums have contributed to national nursing practice standards in the United States. In addition to these factors, most professional nursing organizations have developed and published clinical practice standards (Table 1). Most national standards are designed to guide-not regulateAlinica1 practice, but in a lawsuit, such standards often are relied on to help define a standard of care. Additionally, state legislatures and agencies define particular standards within their jurisdiction and, thus, regulate clinical practice. Each state has a board of nursing that regulates and defines nursing practice and determines a nurse’s scope of practice within that state. For example, some states do not allow a licensed practical nurse to practice independently as a school nurse; how-
ever, in many states this is an acceptable practice and standard. Obviously, nurses must know their state’s rules and regulations to practice within the law as well as meet the standard of care. As a nurse, if you move to another state, you should review the rules and regulations of that state’s board of nursing and obtain answers before assuming that a particular activity is within your scope of practice. A typical question that you might ask is, “Can an RN administer IV neuromuscular blocking agents?” If this is something you are asked to do in your work situation, it is best that you know whether you can do this in accordance with the laws in your state. It is not uncommon for nurses to be asked to perform procedures that are out of their scope of practice. When was the last time you looked at your state board of nursing’s rules and regulations? Local and institutional standards and hospital policies and procedures are integral to any
nurse’s practice and must be reflected in care delivery. In fact, hospital policy and procedure manuals are instrumental to providing nursing care. Most clinical agencies provide numerous hours of orientation and mandatory continuing education to inform and update personnel about key policies and procedures. Nurses often refer to an agency’s policy and procedure manual when they are performing less frequently practiced or unfamiliar skills. Unfortunately, many nurses have never looked at their facility’s policy and procedure manual and practice independently of the standards of care set within their institution. You may think “Not me,” but in conducting the simplest of chart audits for documentation, it can become clear that nurses often do not know when to document, what to document, or what the hospital policies are about this issue. In fact, nurses may be documenting according to the policies and procedures of a previous
Table 1 STANDARDS OF CARE PERTINENT TO PERIOPERATIVE NURSING
Standard
Organization
Description
Web address
The Code for Nurses with InterpretiveStatements
American Nurses Association (ANA)
Defines ethical conduct.
www.ana.org
Standards of Clinical Nursing Practice
ANA
Provide basic standards for nursing practice.
www.ana.org
AORN Standards, Recommended Practices, and Guidelines
AORN
Provide standards of perioperative clinical practice, perioperative administrative practice, and recommended practices for perioperative nursing.
www.aorn.org
Standards on Sterilization, Biomedical Equipment, and Biological Evaluation
Association for the Advancement of Medical Instrumentotion
Provide standards on medical instrumen- www.aami.org tation, including disinfection, sterilization, and decontamination.
Guideline for the Prevention of Surgical Site Infections
Centers for Disease Control and Prevention
Presents guidelines to minimize the risk of surgical site infections in acute care hospitals. 496
AORN JOURNAL
www.cdc.gov
SEPTEMBER 1999, VOL 70, NO 3
employer or school of nursing. Accrediting agencies (eg, Joint Commission on Accreditation of Healthcare Organizations [JCAHO], state boards of health) recommend that policies and procedures be updated periodically and reflect the latest research and knowledge. In that regard, local policies need to reflect national practice standards. Committee members working on a policy always should examine the literature and research before updating any policy. Committee members also may call other facilities to learn more about their standards of practice. Can you imagine working in isolation of others and determining a policy and procedure that makes sense to you but no one else? For example, what surgical department in the United States would want to use a microwave or toaster oven for flash sterilization? You would think none, but infection control experts report finding such devices in use for sterilization purposes in physicians’ offices. Obviously, the employees in the physicians’ offices were following their policy and procedure, but such procedures do not reflect current, well-established, research-based practice standards. A local or institutional standard should be dismissed if it is reflective of an outdated or substandard practice. An additional category of standards that nurses need to be aware of are those developed by regulatory agencies and other professional organizations. For example, nurses practicing in hospitals need to be aware of any
standards set forth by JCAHO. In the perioperative arena, nurses need to be aware of standards developed by the Association for the Advancement of Medical Instrumentation, American National Standards Institute, American Nurses Association, Occupational Safety and Health Administration, and other agencies to the degree these standards influence perioperative nursing practice. In some states, nurses need to consider the rules and regulations of other state agencies. For example, the board of pharmacy may have a regulation that dictates who and under what circumstances individuals can dispense medications. The nurse should consider this ruling, especially if the board of nursing is not clear on this issue. DETERMINING RELEVANT REGULATIONS AND STANDARDS Standards of care can provide a basis for decision making when there is no research to answer a specific question. Determining any pertinent regulations and standards are part of the clinical problem-solving process. For example, there is little research related to the practice of flash sterilizing implants; however, a number of organizations, including AORN, the Centers for Disease Control and Prevention, and JCAHO, have never recommended the routine flash sterilization of implants. Suppose the director of surgical services at your facility decides that these standards are not appropriate and recommends that staff members flash sterilize implants on a rou-
NOTE 1, N Meersman, ‘‘Jury weighs evidence in cancer
tine basis. In this instance, you might review the facility’s policy and procedure manual and determine what it says. Next, as a nurse, you might want to know what other hospitals in the area are doing about the flash sterilization of implants. If your hospital is the only hospital in the state flash sterilizing implants, perhaps the director’s decision needs to be questioned. One might ask, “Why do we have the lowest standard for flash sterilization on the local and state level, and why do we not practice in accordance with a number of national practice standards?” Like research, standards of care cannot answer all questions; however, they can provide valuable assistance in the decisionmaking process. More than ever before, standards of care are integral to nursing practice. They not only enhance professional practice, but they also are instrumental in the provision of quality nursing care. If you are not familiar with standards of practice, visit your library or check the Internet to find clinical practice guidelines pertinent to your practice and your own health care. Each of us has a professional responsibility to know the standard of care and provide it within our scope of practice. SUZANNE C. BEYEA RN, PHD, CS AORN CODIRECTOR OF PERIOPERATIVE RESEARCH
LESLIE H. NICOLL RN. MB4 PHD AORN CODIRECTOR OF PERIOPERATIVE RESEARCH
malpractice suit,” The Union Leader (Manchester, NH) 29 June 1999, sec C, 2.
497 AORN JOURNAL