Scope of Practice
John H. Eichhorn
Jay S. Grider
Key Points
Anesthesia trainees, and many postgraduates also, tend to lack sufficient knowledge (with sometimes unfortunate results) about modes of practice or employment, financial matters of all types, and the forces that shape them, but contracting in particular. They must educate themselves and also seek expert advice and counsel to survive (and hopefully flourish) in today’s exceedingly intricate medical practice milieu.
There are several very helpful detailed information resources concerning practice and OR management available from the American Society of Anesthesiologists and other sources. Factors influencing anesthesiology practice conditions are changing rapidly, and today’s anesthesia professionals must be armed with detailed information about concepts (such as “pay for performance” and “accountable care organizations”) that did not exist just a few years ago.
Securing hospital privileges is far more than a bureaucratic annoyance and must be taken seriously by anesthesiologists.
Anesthesiology is the leading medical specialty in establishing and promulgating standards of practice that have significantly influenced practice in a positive manner.
The immediate response to a major adverse anesthesia event is critical to the eventual result. An extremely valuable protocol is available at www.apsf.org, “Resource Center: Clinical Safety Tools.”
Anesthesiologists must be involved, concerned, active participants and leaders in their institution and medical community in order to enhance their practice function and image.
The threatened negative impact of “managed care” largely failed to materialize regarding anesthesiology practice, but the impact of the “Great Recession” on all of the health-care system has been substantial and will resonate for the foreseeable future on budgets, availability of resources, and the economics of medical practice.
Anesthesiologists must participate in operating room (OR) management in their facilities and should play a central leadership role. OR scheduling, staffing, utilization, and patient flow issues are complex, and anesthesiologists should work hard to both thoroughly understand and positively influence them.
Anesthesiology personnel issues involve an elaborate balancing act that is subject to complex conflicting forces. Anesthesiology groups/departments should give these issues, as well as their constituent personnel, more attention and energy than has been done traditionally in the past.
Attention to the many often-underemphasized details of infrastructure, organization, and administration can transform a merely endurable anesthesia practice into one that is efficient, effective, productive, collegial, and even fun.
Related Matter
AIMS
The structure and function of anesthesia practice, as well as of the entire health-care system, are evolving very rapidly in the United States. In the past, anesthesia professionals traditionally were little involved in the management of many components of their practice beyond the strictly medical elements of applied physiology and pharmacology, pathophysiology, and therapeutics. This was perhaps somewhat understandable because anesthesia professionals traditionally spent most of their usually very long work hours in a hospital operating room (OR). Business matters were often left to the one or two members of the traditional private practice group who were interested or willing to deal with an outside-contractor billing agency. In that era, very little formal teaching in practice management of any kind occurred. Today the Anesthesiology Residency Review Committee of the Accreditation Council on Graduate Medical Education requires that the didactic curricula of anesthesiology residencies include material on practice management. Most training programs offer at least a cursory introduction to issues of practice management, but these can be insufficient to prepare satisfactorily the professional being graduated for the real infrastructure, administrative, business, and management challenges of the modern practice of anesthesiology.
This chapter presents a wide variety of topics that, until recently, were not included in anesthesiology textbooks or residency program curricula. Outlined are several basic components of the background, administrative, organizational (including both practice arrangements and daily functioning of the OR), and financial aspects of anesthesiology practice in the complex modern environment. Although many issues are undergoing almost constant change, it is important to understand the basic vocabulary and principles in this dynamic universe. Lack of understanding of these issues may put anesthesia professionals at a disadvantage when attempting to maximize the efficiency and impact of their daily activities, to create and execute practice arrangements, and to secure fair compensation in an increasingly complex health-care system featuring greater and greater competition for scarcer and scarcer resources.
Administrative Components of Anesthesiology Practice
Operational and Information Resources
Outlined in this chapter is an overview summary intended as an introduction to organization, administration, and practice management in anesthesiology. Further, fortunately, the American Society of Anesthesiologists (ASA), the professional association for physician anesthesiologists in the United States, for many years has made available to its members extensive resource material regarding practice in general and specific arrangements for its execution. Citation and availability of this material can be found on the ASA web site, www.asahq.org. Elements are updated periodically by the ASA through its physician officers, committees, task forces, administrative and support staff, and its various offices. Although many of the documents and even the advice given in response to members’ requests for help contain broad-brush generalities that must be interpreted in each individual practice situation, these nonetheless stand as a foundation on which many anesthesiology practices can be based. Prospective familiarity with the principles outlined in the ASA material likely could help avoid some of the problems leading to calls for help. Selected key documents have been compiled and bound into one volume (1). Also, each spring, the ASA offers a Practice Management Conference at which both reviews and current updates of a wide variety of relevant administrative and financial topics are covered.
Background
The ASA publishes the Manual for Anesthesia Department Organization and Management1 that includes sections on physician responsibilities for medical care and on medical-administrative organization and responsibilities. Included are the ASA Guidelines for the Ethical Practice of Anesthesiology, which incorporate sections on the principles of medical ethics; the definition of medical direction of nonphysician personnel (including the specific statement that an anesthesiologist engaged in medical direction should not personally be administering another anesthetic); the anesthesiologist’s relationship to patients and other physicians; the anesthesiologist’s duties, responsibilities, and relationship to the hospital; and the anesthesiologist’s relationship to nurse anesthetists and other nonphysician personnel. Further, beyond summaries such as this textbook chapter, reference to the great body of material created and presented by the ASA is an excellent starting point to help young anesthesia professionals during training prepare for the increasing rigors of starting and managing a career in practice. On the ASA web site, within the “For Members” area, the “Practice Management” section is functionally a gold mine that includes extensive information on the organization, administration, and business of anesthesia practice with reference to an extensive catalog of webinars and podcasts, as well as a compendium of chapters from the annual ASA Practice Management Conference.2 Likewise, there is a great deal of information on the ASA web site concerning the most recent governmental regulations, rulings, and billing codes. Further, the ASA Newsletter contains the monthly columns “Washington Report” and “Practice Management,” which disseminate related current administrative, organizational, and financial developments (and which are reprinted on the ASA web site).
In addition to the ASA and the American Association of Nurse Anesthetists, most anesthesiology subspecialty societies and interest groups have web locations, as do most journals. Particularly, the web site of the Anesthesia Patient Safety Foundation, www.apsf.org, has been cited as especially useful in promoting safe clinical practice. Electronic bulletin boards allow anesthesiology practitioners from around the world to exchange ideas in real time on diverse topics, both medical and administrative. One of the original sites that remains available is “GASnet,” and a web search (“anesthesiology + bulletin board”) reveals a great number of sites that contain a variety of discussions about all manner of anesthesiology-related topics, including practice organization, administration, finance, and management. In addition, references to the entirety of the medical literature are readily accessible to any practitioner (such as by starting with www.nlm.nih.gov to access Medline). A modern anesthesiology practice cannot reasonably exist without readily available high-speed Internet connections.
The Credentialing Process and Clinical Privileges
The system of credentialing a health-care professional and granting clinical privileges in a health-care facility is motivated by a fundamental assumption that appropriate education, training, and experience, along with the absence of excessive numbers of bad patient outcomes, increase the chances that the individual
will deliver acceptable-quality care. The process of credentialing health-care professionals has been the focus of considerable public attention (particularly in the mass media), in part the result of very rare incidents of untrained persons (impostors) infiltrating the health-care system and sometimes harming patients. The more common situation, however, involves health professionals who exaggerate past experience and credentials or fail to disclose adverse past experiences. In the past, there was justified publicity concerning physicians who lost their licenses sequentially in several states and simply moved on each time to start practice elsewhere (which should be much, much more difficult today).
will deliver acceptable-quality care. The process of credentialing health-care professionals has been the focus of considerable public attention (particularly in the mass media), in part the result of very rare incidents of untrained persons (impostors) infiltrating the health-care system and sometimes harming patients. The more common situation, however, involves health professionals who exaggerate past experience and credentials or fail to disclose adverse past experiences. In the past, there was justified publicity concerning physicians who lost their licenses sequentially in several states and simply moved on each time to start practice elsewhere (which should be much, much more difficult today).
Intense public and political pressure has been brought to bear on various lawmaking bodies, regulatory and licensing agencies, and health-care institution administrations to discover and purge both (1) fraudulent, criminal, and deviant health-care providers and (2) incompetent or simply poor-quality practitioners whose histories show sufficient poor patient outcomes to attract attention, usually through malpractice suits. Identifying and avoiding or correcting an incompetent practitioner is the goal. Verification of appropriate education, training, and experience on the part of a candidate for a clinical anesthesia position assumes special importance in light of the legal doctrine of vicarious liability, which can be described as follows: if an individual, group, or institution hires an anesthesia professional or even simply approves of that person (e.g., by granting clinical privileges through a hospital medical staff), those involved in the decision may later be held liable in the courts, along with the individual, for the individual’s actions. This would be especially true if it were later discovered that the offending practitioner’s past adverse outcomes had not been adequately investigated during the credentialing process.
Out of these various long-standing concerns has arisen the sometimes cumbersome process of obtaining state licenses to practice and of obtaining hospital privileges. The stringent credentialing process for health-care practice is intended both to protect patients and to safeguard the integrity of the profession. Central credentialing systems have been developed, including those affiliated with the American Medical Association, American Osteopathic Association, and, particularly, the Federation Credentials Verification Service of the Federation of State Medical Boards. These systems verify a physician’s basic credentials (e.g., identity, citizenship or immigration status, medical education, postgraduate training, licensure examination history, prior licenses, and board actions) once, and then thereafter can certify the validity of these credentials to a state licensing board or medical facility. A few states do not yet accept this verification and most states seek specific supplemental information.
There are checklists of the requirements for the granting of medical staff privileges by hospitals (see the American Hospital Association Resource Center, www.aha.org/research/rc/index.shtml). In addition, the National Practitioner Data Bank and reporting system administered by the US government now contains many years’ worth of information. This data bank is a central repository of licensing and credentials information about physicians. Many adverse situations involving a physician—particularly instances of substance abuse, malpractice litigation, or the revocation, suspension, or limitation of that physician’s license to practice medicine or ability to hold hospital privileges—must be reported (via the particular state board of medical registration/licensure) to the National Practitioner Data Bank. It is a statutory requirement that all applications for hospital staff privileges be cross-checked against this national data bank. The potential medicolegal liability on the part of a facility’s medical staff, and the anesthesiology group in particular, for failing to do so is significant. The data bank, however, is not a complete substitute for direct documentation and background checking. Often, practitioners reach private negotiated solutions following quality-driven medical staff problems, thereby avoiding the mandatory public reporting. In such cases, a practitioner in question may be given the option to resign medical staff privileges and avoid data bank reporting rather than undergo full involuntary privilege revocation (although most license and privilege applications contain a question specifically about this).
Documentation
The documentation for the credentialing process for each anesthesia practitioner must be complete. Privileges to administer anesthesia must be officially granted and delineated in writing. This can be straightforward or it can be more complex to accommodate institutional needs to identify practitioners specially qualified to practice in designated anesthesia subspecialty areas such as cardiac, infant/pediatric, obstetric, intensive care, or pain management. Specific documentation of the process of granting or renewing clinical privileges is required and, unlike some other administrative records, the documentation likely is protected as confidential peer review information. Any questions about complex sensitive issues such as this should be referred to an experienced attorney familiar with applicable federal and state law. Verification of an applicant’s credentials and experience is mandatory. Because of another type of legal case, some examples of which have been highly publicized, medical practitioners may be hesitant to give an honest evaluation (or any evaluation at all) of individuals known to them who are seeking a professional position elsewhere. Obviously, someone writing a reference for a current or former coworker should be honest. Sticking to clearly documentable facts is advisable. Stating a fact that is in the public record (such as a malpractice case lost at trial) should not justify an objection from the subject of the reference. Whether such potentially “negative” facts can be omitted by a reference writer is complex. Including positive opinions and enthusiastic recommendations, of course, is no problem. Some fear that including facts that may be perceived as negative (e.g., the lost malpractice case or personal problems such as a history of treatment for substance abuse) and/or negative opinions will provoke a retaliatory lawsuit (such as for libel, defamation of character, or loss of livelihood) from the subject of the reference. Further, however, there have been cases of the facility doing the hiring suing reference writers for failing to mention (perceived as concealing) negative information about an applicant who later was charged with substandard practice. Because of the complexities and even apparent contradictions, many reference writers in these questionable situations confine their written material to brief, simple facts such as dates employed and position held. As always, questions about complex sensitive issues such as this should be referred to an experienced attorney familiar with applicable federal and state law.
Because there should be no hesitation for a reference writer to include positive facts and opinions, receipt of a reference that includes nothing more than dates worked and position held can be a suggestion that there may be more to the story (although some entities have adopted such a policy in all cases simply to eliminate any value judgments as to what is positive or negative information). Receipt of such a “dates/position only” reference about a person applying for a position should usually provoke a telephone call to the writer. A telephone call is likely advisable in all cases, independent of whatever the written reference contains. Frequently, pertinent questions over the telephone can elicit more candid information. In rare instances, there may be dishonesty through omission by the reference-giver even at this level. This may involve an applicant who an individual, a department or group, or an institution would like to see leave.
In all cases, new personnel in an anesthesia practice environment must be given a thorough and documented orientation and checkout. Policy, procedures, and equipment may be unfamiliar to even the most thoroughly trained, experienced, and safe practitioner. This may occasionally seem tedious, but it is a sound and critically important safety policy. Being in the midst of a crisis situation caused by unfamiliarity with a new setting is not the optimal orientation session.
After the initial granting of clinical privileges to practice anesthesia, anesthesia professionals must periodically renew their privileges within the institution or facility (e.g., annually or every other year). There are moral, ethical, and societal obligations on the part of the privilege-granting entity to take this process seriously. State licensing bodies often become aware of problems with health professionals very late in the evolution of any difficulties. An anesthesia professional’s peers in the hospital or facility are much more likely to notice untoward developments as they first appear. However, privilege renewals are often essentially automatic and receive little of the necessary attention. Judicious checking of renewal applications and awareness of relevant peer review information are absolutely necessary. The anesthesia professionals or administrators responsible for evaluating staff members and reviewing their practices and privileges may be justifiably concerned about retaliatory legal action by a staff member who is censured or denied privilege renewal. Accordingly, such evaluating groups must be thoroughly objective (totally eliminating any hint of political or financial motives) and must have documentation that the staff person in question is in fact practicing below the standard of care. Court decisions have found liability by a hospital, its medical staff, or both, when the incompetence of a staff member was known or should have been known and was not acted upon.3 Again, questions about complex sensitive issues such as this should be referred to an experienced attorney familiar with applicable federal and state law.
A major issue in the granting of clinical privileges, especially in procedure-oriented specialties such as anesthesiology, is whether it is reasonable to continue the common practice of “blanket” privileges. This process in effect authorizes the practitioner to attempt any treatment or procedure normally considered within the purview of the applicant’s medical specialty. These considerations may have profound political and economic implications within medicine, such as which type of surgeon should be doing carotid endarterectomies or lumbar discectomies. More important, however, is whether the practitioner being evaluated is qualified to do everything traditionally associated with the specialty. Specifically, should the granting of privileges to practice anesthesia automatically approve the practitioner to handle pediatric cardiac cases, critically ill newborns (such as a day-old premature infant with a large diaphragmatic hernia), ablative pain therapy (such as an alcohol celiac plexus block under fluoroscopy), high-risk obstetric cases, and so forth? This question raises the issue of procedure-specific or limited privileges. The quality assurance (QA) and risk management considerations in this question are weighty if inexperienced or insufficiently qualified practitioners are allowed or even expected, because of peer or scheduling pressures, to undertake major challenges for which they are not prepared. The likelihood of complications and adverse outcome will be higher, and the difficulty of defending the practitioner against a malpractice claim in the event of catastrophe will be significantly increased.
There is no clear answer to the question of procedure-specific credentialing and granting of privileges. Ignoring issues regarding qualifications to undertake complex and challenging procedures has clear negative potential. On the other hand, stringent procedure-specific credentialing is impractical in smaller groups, and in larger groups encourages many small “fiefdoms,” with a consequent further atrophy of the clinical skills outside the practitioner’s specific area(s). Each anesthesia department or group needs to address these issues. At the very least, the common practice of every applicant for privileges (new or renewal) checking off every line on the printed list of anesthesia procedures should be reviewed. In addition, board certification for physicians is now essentially a standard of QA of the minimum skills required for the consultant practice of anesthesiology. Subspecialty boards, such as those in pain management, critical care, and transesophageal echocardiography, further objectify the credentialing process. This is now significant because initial board certification after the year 2000 by the American Board of Anesthesiology (ABA) is time-limited and subject to periodic testing and recertification (see Maintenance of Certification below). Many states, some institutions, and even some regulatory bodies have requirements for a minimum number of hours of continuing medical education (CME). Documentation of fulfilling such a standard again acts as one type of quality assurance mechanism for the individual practitioner, while providing another objective credentialing measurement for those granting licenses or privileges.
Maintenance of Certification in Anesthesiology
American anesthesiologists certified as diplomates by the ABA after January 1, 2000, are issued a “time-limited” board certification valid for 10 years. A formal process culminating in the recertification of an anesthesiologist for an additional and then subsequent 10-year intervals has evolved and now appropriately is called “Maintenance of Certification in Anesthesiology” (MOCA). Because certification by a medical specialty board is now often expected or actually required by medical staff bylaws in order to obtain and maintain medical facility privileges, even anesthesiologists who were certified (without a time limit) prior to the year 2000 likely will be engaging in the MOCA process.
In 1999, the American Board of Medical Specialties (ABMS) initiated a process to better insure continuing professional development of diplomates certified by the member boards. An enhancement of the traditional CME process, this initiative by the ABMS is designed to provide a transparent public system of accountability that physician skill and knowledge base do not wane while practicing after completion of formal training. Centered around the American Council for Graduate Medical Education core competencies of (1) patient-centered care, (2) medical knowledge, (3) interpersonal and communication skills, (4) professionalism, (5) system-based practice, and (6) practice-based learning improvement, each member board designs a curricular process to enhance and evaluate continued development of the competencies throughout the professional career of the certified clinician.
The MOCA program introduced in 2000 is subdivided into four components or modules: (1) professional standing, (2) lifelong learning and self-assessment, (3) cognitive examination, and (4) practice performance assessment and improvement.
Each module has specific requirements that must be completed within the 10-year cycle. For example, the professional standing component requires maintenance of an unrestricted medical license within the United States or Canada. The lifelong learning and self-assessment component includes up to 350 hours of category 1 CME from an accredited body with a recent requirement that 90 hours be from the ASA “Self Education and Evaluation” (SEE) or “Anesthesiology Continuing Education” (ACE) CME programs. Presently, the cognitive examination consists of 200 multiple-choice questions from the keyword content for
MOCA from the ABA. Practice performance assessment and improvement involves written evaluation of the practitioner’s skill by a department chair or other anesthesiology colleagues in leadership positions within an institution highly familiar with that individual’s clinical work. A newer component of the practice performance assessment and improvement module requires completion of a case scenario at one of the ASA-accredited simulation centers.
MOCA from the ABA. Practice performance assessment and improvement involves written evaluation of the practitioner’s skill by a department chair or other anesthesiology colleagues in leadership positions within an institution highly familiar with that individual’s clinical work. A newer component of the practice performance assessment and improvement module requires completion of a case scenario at one of the ASA-accredited simulation centers.
The ABA web site (www.theaba.org/home/MOCA Tutorial) provides a database for diplomates within the MOCA process which is referred to as a “portal account.” This portal account is a password-protected repository in which collected MOCA material may be compiled during the 10-year cycle period. The site includes the ability to track the CME hours obtained in each year of the cycle. If the CME credits are not obtained through one of the ABA-approved sources, these CME hours are subject to audit by the ABA. Persons with time-limited certificates issued between 2000 and 2010 may have differing requirements for recertification as the process has been in continuous evolution since being instituted. As noted and importantly, American anesthesiologists certified before 2000 are increasingly finding that their institutions or medical staff bylaws require participation in the MOCA process, even if not mandated by the ABA. All practitioners should consult their individual medical staff bylaws and institutional regulations as well as the ABA web site to determine the best course of action to maintain primary certification in anesthesiology.
Clinicians with subspecialty training in Critical Care and Pain Medicine also have a MOCA process available. At present there are no CME hours or simulation case scenarios required to sit for these subspecialty examinations, though it seems reasonable to expect that these components will be forthcoming in the future as the ABMS strongly encourages that lifelong learning/self-assessment as well as evaluation through simulation are key components to the recertification process.
It is reasonable to project that the MOCA process will continue to evolve and likely will become more comprehensive over time as the overall emphasis on assuring both quality and efficiency of medical care in the United States increases further due to the expectations of accrediting bodies, government regulators, third-party payers, malpractice insurers, and, above all, the public.
Professional Staff Participation and Relationships
All medical care facilities and practice settings depend on their professional staffs, of course, for daily activities of the delivery of health care but, very importantly, they also depend on those staffs to provide administrative structure and support. Medical staff activities are increasingly important in achieving favorable accreditation status from the “Joint Commission” (formerly known as the Joint Commission for the Accreditation of Healthcare Organizations or JCAHO) and in meeting a wide variety of governmental regulations and reviews. Principal medical staff activities involve sometimes time-consuming efforts, such as duties as a staff officer or committee member. Anesthesiologists should be participants in—in fact, should play a significant role in—credentialing, peer review, tissue review, transfusion review, OR management, and medical direction of same-day surgery units, postanesthesia care units (PACUs), intensive care units (ICUs), and pain management units. Also, it is very important that anesthesiology personnel be involved in fund-raising activities, benefits, community outreach projects sponsored by the facility, and social events of the facility staff.
Anesthesia professionals as a group have a reputation for lack of involvement in medical staff and facility issues, allegedly because of lack of time due to long hours in the OR or simply lack of interest. In fact, anesthesiology professionals are all-too-often perceived in a facility as the ones who slip in and out of the building essentially anonymously (often dressed very casually or even in the pajama-like comfort of scrub suits) and virtually unnoticed. This is an unfortunate state of affairs, and it has frequently come back in various painful ways to haunt those who have not been involved, or even noticed, within their own facility. Anesthesia professionals sometimes respond that the demands for anesthesiology service are so great that they simply never have the time or the opportunity to become involved in their facility and with their peers. If this is really true, it is clear that more anesthesia professionals must be added at that facility, even if doing so slightly reduces the income of those already there.
If anesthesia professionals are not involved and not perceived as interested, dedicated “team players,” they will be shut out of critical negotiations and decisions relevant to their practice. Although one obvious instance in which others could make decisions for uninvolved anesthesia professionals is the distribution of “bundled” practice fee income collected by a central “umbrella” medical practice organization, there are many such situations, and the excluded anesthesia professionals will be forced to comply with the resulting mandates.
Similarly, involvement with a facility, a professional staff, or a multispecialty group goes beyond formal organized governance and committee activity. Collegial relationships with professionals of other specialties and with administrators are central to maintenance of a recognized position and avoidance of the situation of exclusion just described. Being readily available for formal and informal consults, particularly regarding preoperative patient workup and the maximally efficient way to get surgeons’ patients to the OR in a timely, expedient manner, is extremely important. No one individual can be everywhere all the time, but an anesthesiology group or department should strive to be always responsive to any request for help from physicians or administrators. It often appears that anesthesia professionals fail to appreciate just how great a positive impact a relatively simple involvement (starting an intravenous line for a pediatrician, helping an internist manage an ICU ventilator, or helping a facility administrator unclog a jammed recovery room) may have.
Establishing Standards of Practice and Understanding the Standard of Care
The increasing frequency and intensity of “production pressure”,4 with the tacit (or even explicit) directive to anesthesia professionals to “go fast” no matter what and to “do more with less,” creates situations in which anesthesia professionals may conclude that they must cut corners and compromise safe patient care just to stay in business. This type of pressure has become even greater with the implementation of more and more protocols or parameters for practice, some from professional societies such as the ASA and some mandated by or developed in conjunction with purchasers of health care (government, insurance companies, or managed care organizations [MCOs]). Many of these protocols are devised to fast-track patients through the medical care system, especially when an elective procedure is involved, in as absolutely little time as possible, thus minimizing costs. Do these fast-track protocols constitute standards of care that health-care providers must implement? What are the implications of doing so? Of not doing so?
To better understand answers to such questions, it is important to have a basic background in the concept of the standard of care.
The standard of care is the conduct and skill of a prudent practitioner that can be expected by a reasonable patient. This is a very important medicolegal concept because a bad medical result due to failure to meet the standard of care is malpractice. Courts have traditionally relied on medical experts knowledgeable about the point in question to give opinions as to what is the standard of care and if it has been met in an individual case. This type of standard is somewhat different from the standards promulgated by various standard-setting bodies regarding, for example, the color of gas hoses connected to an anesthesia machine or the inability to open two vaporizers on that machine simultaneously. However, ignoring the equipment standards and tolerating an unsafe situation is a violation of the standard of care. Promulgated standards, such as the various safety codes and anesthesia machine specifications, rapidly become the standard of care because patients (through their attorneys, in the case of an untoward event) expect the published standards to be observed by the prudent practitioner.
Ultimately, the standard of care is what a jury says it is. However, it is possible to anticipate, at least in part, what knowledge and actions will be expected. There are two main sources of information as to exactly what is the expected standard of care. Traditionally, the beliefs offered by expert witnesses in medical liability lawsuits regarding what is actually being done in real life (de facto standards of care) were the main input juries had in deciding what was reasonable to expect from the defendant. The resulting problem is well known: except in the most egregious cases, it is usually possible for the lawyers to find experts who will support each of the two opposing sides, making the process more subjective than objective. (Because of this, there are even ASA Guidelines for Expert Witness Qualifications and Testimony and an equivalent document from the American Association of Nurse Anesthetists). Of course, there can be legitimate differences of opinion among thoughtful, insightful experts, but even in these cases the jury still must decide who is more believable, looks better, or sounds better. The second, much more objective, source for defining certain component parts of the standard of care is the published standards of care, guidelines, practice parameters, and protocols that have become more and more common since the idea was originally introduced.5 These serve as more objective evidence of what can be reasonably expected of practitioners and can make it easier for a jury evaluating whether a malpractice defendant failed to meet the applicable standard of care. Several types of documents exist and have differing implications.
Leading the Way
Anesthesiology may be the medical specialty most involved with published standards of care. It has been suggested that the nature of anesthesia practice (having certain central critical functions relatively clearly defined and common to all situations and also having an emphasis on technology) makes it the most amenable of all the fields of medicine to the use of published standards. The original intraoperative monitoring standards5 are a classic example. The ASA first adopted its own set of basic intraoperative monitoring standards in 1986 and has modified them several times. The text of all ASA standards, guidelines, statements, practice parameters, practice advisories, and other documents is readily available on the ASA web site home page under the “Practice Management” or “Patient Quality and Safety” tags.
The Standards for Basic Anesthetic Monitoring document includes clear specifications for the presence of personnel during an anesthetic episode and for continual evaluation of oxygenation, ventilation, circulation, and temperature. These ASA monitoring standards very quickly became part of the accepted standard of care in anesthesia practice. This means they are important to practice management because they have profound medicolegal implications: a catastrophic accident occurring while the standards are being actively ignored is very difficult to defend in the consequent malpractice suit, whereas an accident that occurs during well-documented full compliance with the standards will automatically have a strong defense because the standard of care was being met. Several states in the United States have made compliance with these ASA standards mandatory under state regulations or even statutes. Various malpractice insurance companies offer discounts on malpractice insurance policy premiums for compliance with these standards, something quite natural to insurers because they are familiar with the idea of managing known risks to help minimize financial loss to the company.
With many of the same elements of thinking, the ASA adopted “Basic Standards for Preanesthesia Care.” This was supplemented significantly by another type of document, the ASA Practice Advisory for Preanesthesia Evaluation.6 Also, the ASA adopted “Standards for Postanesthesia Care,” in which there was consideration of and collaboration with the very detailed standards of practice for PACU care published by the American Society of Post Anesthesia Nurses (another good example of the sources of standards of care). This also was later supplemented by an extensive Practice Guideline.7
A slightly different situation exists with regard to the standards for conduct of anesthesia in obstetrics. These standards were originally passed by the ASA in 1988, in the same manner as the other ASA standards, but the ASA membership eventually questioned whether they reflected a realistic and desirable standard of care. Accordingly, the obstetric anesthesia standards were downgraded in 1990 to guidelines, specifically to remove the mandatory nature of the document. Because there was no agreement as to what should be prescribed as the standard of care, the medicolegal imperative of published standards in this instance has been temporarily set aside. From a management perspective, this makes the guidelines no less valuable because the intent of optimizing care through the avoidance of complications is no less operative. However, in the event of the need to defend against a malpractice claim in this area, it is clear from this sequence of events that the exact standard of care is debatable and not yet finally established (an extremely important medicolegal consideration). A different ASA document has since been generated, Practice Guidelines for Obstetrical Anesthesia, with more detail and specificity as well as an emphasis on the meta-analytic approach.8
Practice Guidelines
An important type of related ASA document is the Practice Guideline (formerly “Practice Parameter”). This has some of the same elements as a standard of practice but is more intended to guide judgment, largely through algorithms with some element of guidelines, in addition to directing the details of specific procedures as would a formal standard. Beyond the details of the minimum standards for carrying out the procedure, these practice parameters set forth algorithms and guidelines for helping to determine under what circumstances and with what timing to perform it. Understandably, purchasers of health care (government, insurance companies, and MCOs) with a strong desire to limit the costs of medical care have great interest in practice parameters as potential vehicles for helping to eliminate “unnecessary” procedures and limit even the necessary ones.
The ASA has been very active in creating and publishing practice guidelines. The first published parameter (since revised) concerned
the use of pulmonary artery (PA) catheters.9 It considered the clinical effectiveness of PA catheters, public policy issues (costs and concerns of patients and providers), and recommendations (indications and practice settings). Also, the ASA Difficult Airway Algorithm was published in an updated form in 2003.10 This thoughtful document synthesizes a strategy summarized in a decision tree diagram for dealing acutely with airway problems. The difficult airway algorithm has been discussed extensively in the literature, including suggestions regarding the role of supraglottic airways and, more recently, adding the various airway video imaging technologies. This illustrates that all the ASA practice guidelines involve fluid concepts that are subject to reconsideration, reinterpretation, and revision as experience and technology evolve. Undoubtedly, the difficult airway algorithm has great clinical value and helps many patients. However, there is concern that, as with many modern things, that it starts to outdate as soon as it is published. Such considerations are important, both clinically and because all these documents are readily noticed by plaintiffs’ lawyers as relevant to establishing the applicable standard of care.
the use of pulmonary artery (PA) catheters.9 It considered the clinical effectiveness of PA catheters, public policy issues (costs and concerns of patients and providers), and recommendations (indications and practice settings). Also, the ASA Difficult Airway Algorithm was published in an updated form in 2003.10 This thoughtful document synthesizes a strategy summarized in a decision tree diagram for dealing acutely with airway problems. The difficult airway algorithm has been discussed extensively in the literature, including suggestions regarding the role of supraglottic airways and, more recently, adding the various airway video imaging technologies. This illustrates that all the ASA practice guidelines involve fluid concepts that are subject to reconsideration, reinterpretation, and revision as experience and technology evolve. Undoubtedly, the difficult airway algorithm has great clinical value and helps many patients. However, there is concern that, as with many modern things, that it starts to outdate as soon as it is published. Such considerations are important, both clinically and because all these documents are readily noticed by plaintiffs’ lawyers as relevant to establishing the applicable standard of care.
An important and so-far undecided question is whether guidelines and practice parameters from recognized entities such as the ASA define the standard of care. There is no simple answer. This will be decided over time by practitioners’ actions, debates in the literature, mandates from malpractice insurers, and, of course, court decisions. Some guidelines, such as the concepts in the US Food and Drug Administration (FDA) preanesthetic apparatus checkout, are accepted as the standard of care. There will be debate among experts, but the practitioner must make the decision as to how to apply practice parameters and guidelines such as those from the ASA. Practitioners have incorrectly assumed that they must do everything specified. This is clearly not true, yet there is a valid concern that these will someday be held up as defining the standard of care. Accordingly, prudent attention within the bounds of reason to the principles outlined in guidelines and parameters will put the practitioner in at least a reasonably defensible position, whereas radical deviation from them should be based only on obvious exigencies of the situation at that moment or clear, defensible alternative beliefs (with documentation).
The most recent type of document has been the “practice advisory,” which can seem functionally similar to a guideline, but appears to have the implication of more consensus compromise than previous documents driven more by meta-analysis of the relevant literature. Examples of ASA Practice Advisories include “Intraoperative Awareness and Brain Function Monitoring,” “Perioperative Management of Patients with Cardiac Rhythm Management Devices: Pacemakers and Implantable Cardioverter-Defibrillators,” “Perioperative Visual Loss Associated with Spine Surgery,” and “Practice Advisory on Anesthetic Care for Magnetic Resonance Imaging.” At any given time, there are several additional topics under consideration and new advisories being prepared, indicating that anesthesia professionals would be wise to keep up to date on the documents published.
The potential QA and medicolegal implications of these documents are so important to anesthesia professionals and their practices that the ASA has what is essentially a guideline for the guidelines in its 2008 update of the “Policy Statement on Practice Parameters” in which the distinction is made between evidence-based documents and consensus-based documents with explanations of the background and formulation processes for each.
On the other hand, practice protocols, such as those for the fast-track management of coronary artery bypass graft patients, that are handed down by MCOs or health insurance companies are a different matter. Even though the desired implication is that practitioners must observe (or at least strongly consider) them, they do not have the same implications in defining the standard of care as the other documents. Practitioners must avoid getting trapped. It may well not be a valid legal defense to justify action or the lack of action because of a company or facility protocol. As difficult as it may be to reconcile with the payer, the practitioner still is subject to the classic definitions of standard of care.
The other types of standards associated with medical care are those of the Joint Commission, which is the best-known medical care quality regulatory agency. As noted, these standards were for many years concerned largely with structure (e.g., gas tanks chained down) and process (e.g., documentation complete), but in recent years they have been expanded to include reviews of the outcome of care. Joint Commission standards also focus on credentialing and privileges, verification that anesthesia services are of uniform quality throughout an institution, the qualifications of the director of the service, continuing education, and basic guidelines for anesthesia care (need for preoperative and postoperative evaluations, documentation, and so forth). Full Joint Commission accreditation of a health-care facility is usually for 3 years. Even the best hospitals and facilities receive some citations of problems or deficiencies that are expected to be corrected, and an interim report of efforts to do so is required. If there are enough problems, accreditation can be conditional for 1 year, with a complete reinspection at that time. Being ready for a Joint Commission inspection (which is unannounced and can come at any time) starts with verification that essential group/department structure is in place; an excellent outline/checklist exists.1 The process of “constant preparation” ultimately involves a great deal of work, but because the standards usually do promote high-quality care, the majority of this work is highly constructive and of benefit to the institution and its medical staff.
Review Implications
“Peer review organizations”11 were established in the 1980s and 1990s in every state, usually affiliated with state medical associations and/or state licensing agencies both to monitor quality of medical care and perform utilization reviews (URs), which were oriented to reducing health-care costs. These functions have migrated in recent years largely to the government insurers Medicare and Medicaid and have become fixated essentially exclusively on cost issues. Also, each private health insurance company has utilization review functions, whether internal or contracted out to a company that performs that function for the insurer.
The most likely interaction between a UR agency or office and anesthesia professionals will involve a request for perioperative admission of a patient whose care is mandated to be outpatient surgery (this could also occur in dealing with an MCO). If the anesthesiologist feels, for example, that either (1) preoperative admission for treatment to optimize cardiac, pulmonary, diabetic, or other medical status or (2) postoperative admission for monitoring of labile situations such as uncontrolled hypertension will reduce clear anesthetic risks for the patient, an application to UR for approval of admission must be made and vigorously supported. All too often, however, such issues surface a day or so before the scheduled procedure in a preanesthesia screening clinic or even in a preoperative holding area outside the OR on the day of surgery. This will continue to occur until anesthesia providers educate their constituent surgeon community as to what types of associated medical conditions may disqualify a proposed patient from the outpatient (ambulatory) surgical schedule. If adequate notice is given by the surgeon, the patient can be seen far enough in advance by an anesthesiologist to allow appropriate planning.
In the circumstance in which the first knowledge of a questionable patient comes 1 or 2 days before surgery, the anesthesiologist can try to have the procedure postponed, if possible, or can
undertake the time-consuming task of multiple telephone calls to get the surgeon’s agreement, get UR approval, and make the necessary arrangements. Because neither alternative is particularly attractive, especially from administrative and reimbursement perspectives, there may be a strong temptation to “let it slide” and try to deal with the patient as an outpatient even though this may be questionable. In almost all cases, it is likely that there would be no adverse result (the “get away with it” phenomenon). However, the patient might well be exposed to an avoidable risk. Both because of the workings of probability and because of the inevitable tendency to let sicker and sicker patients slip by as lax practitioners repeatedly “get away with it” and are lulled into a false sense of security, sooner or later there will be an unfortunate outcome or some preventable major morbidity or even mortality.
undertake the time-consuming task of multiple telephone calls to get the surgeon’s agreement, get UR approval, and make the necessary arrangements. Because neither alternative is particularly attractive, especially from administrative and reimbursement perspectives, there may be a strong temptation to “let it slide” and try to deal with the patient as an outpatient even though this may be questionable. In almost all cases, it is likely that there would be no adverse result (the “get away with it” phenomenon). However, the patient might well be exposed to an avoidable risk. Both because of the workings of probability and because of the inevitable tendency to let sicker and sicker patients slip by as lax practitioners repeatedly “get away with it” and are lulled into a false sense of security, sooner or later there will be an unfortunate outcome or some preventable major morbidity or even mortality.
The situation is worsened when the first contact with a questionable ambulatory patient is preoperatively (or possibly even already in the OR) on the day of surgery. There may be intense pressure from the patient, the surgeon, or the OR administrator and staff to proceed with a case for which the anesthesia practitioner believes the patient is poorly prepared. The arguments made regarding patient inconvenience and anxiety are valid. However, they should not outweigh the best medical interests of the patient. Although this is a point in favor of screening all outpatients before the day of surgery, the anesthesia professional facing this situation on the day of operation should state clearly to all concerned the reasons for postponing the surgery, stressing the issue of avoidable risk and standards of care, and then help with alternative arrangements (including, if necessary, dealing with UR or an MCO).
Potential liability in this regard is the other side of the standard of care issue. Particularly concerning is the question of postoperative admission of ambulatory patients who have been unstable. It is an extremely poor defense against a malpractice claim to state that the patient was discharged home, only later to suffer a complication, because the UR process or an MCO deemed that operative procedure outpatient and not inpatient surgery. As bureaucratically annoying as it may be, it is a prudent management strategy to admit the patient if there is any legitimate question, thus minimizing the chance for complications, and later haggle with the UR bureaucracy.
Policy and Procedure
One important organizational point that is often overlooked in anesthesia practice is the need for a complete policy and procedure manual. Such a compilation of documents is necessary for all practices, from the largest departments covering multiple hospitals to a single-room outpatient facility with one anesthesia provider. Such a manual can be extraordinarily valuable, as, for example, when it provides crucial information during an emergency. Organizational and procedural elements should be included.
The organizational elements that should be present include a chart of organization and responsibilities that is not just a call schedule but a clear explanation of who is responsible for what functions of the department and when, with attendant details such as expectations for the practitioner’s presence within the institution at designated hours, telephone availability, pager availability, the maximum permissible distance from the institution when on call, and so forth. Experience suggests it is especially important for there to be an absolutely clear specification of the availability of qualified anesthesiology personnel for emergency cesarean section, particularly in practice arrangements in which there are several people on call covering multiple locations. Sadly, these issues often are only considered after a disaster has occurred that involved miscommunication and the mistaken belief by one or more people that someone else would take care of an acute problem.
The organizational component of the policy and procedure manual should also include a clear explanation of the orientation and checkout procedure for new personnel, CME requirements and opportunities, the mechanisms for evaluating personnel and for communicating this evaluation to them, disaster plans (or reference to a separate disaster manual or protocol), QA activities of the department, and the format for statistical record keeping (number of procedures, types of anesthetics given, types of patients anesthetized, number and types of invasive monitoring procedures, number and type of responses to emergency calls, complications, or whatever the group/department decides).
The procedural component of the policy and procedure manual should give both handy practice tips and specific outlines of proposed courses of action for particular circumstances; it also should store little used but valuable information. Reference should be made to the statements, guidelines, practice parameters and advisories, and standards appearing on the ASA web site. Also included should be references to or specific protocols for the areas mentioned in the Joint Commission standards: preanesthetic evaluation, immediate preinduction reevaluation, safety of the patient during the anesthetic period, release of the patient from any PACU, recording of all pertinent events during anesthesia, recording of postanesthesia visits, guidelines defining the role of anesthesia services in hospital infection control, and guidelines for safe use of general anesthetic agents. Other appropriate topics include the following:
Recommendations for preanesthesia apparatus checkout, such as from the FDA12 (see Chapter 24)
Guidelines for admission to, minimal monitoring and duration of stay of an infant, child, or adult in, and then discharge from the PACU
Procedures for transporting patients to/from the OR, PACU, or ICU
Policy on ambulatory surgical patients—for example, screening, use of regional anesthesia, discharge home criteria
Policy on evaluation and processing of same-day admissions
Policy on ICU admission and discharge
Policy on physicians responsible for writing orders in recovery room and ICU
Policy on informed consent for anesthesia and its documentation
Policy on the use of patients in clinical research (if applicable)
Guidelines for the support of cadaveric organ donors and its termination (plus organ donation after cardiac death if applicable)
Guidelines on environmental safety, including pollution with trace gases and electrical equipment inspection, maintenance, and hazard prevention
Procedure for change of personnel during an anesthetic and documentation (particularly if a printed hand-off protocol is used)
Procedure for the introduction of new equipment, drugs, or clinical practices
Procedure for epidural and spinal narcotic administration and subsequent patient monitoring (e.g., type, minimum time, nursing units)
Procedure for initial treatment of cardiac or respiratory arrest (updated Advanced Cardiac Life Support guidelines)
Policy for handling patient’s refusal of blood or blood products, including the mechanism to obtain a court order to transfuse
Procedure for the management of malignant hyperthermia
Procedure for the induction and maintenance of barbiturate coma
Procedure for the evaluation of suspected pseudocholinesterase deficiency
Protocol for responding to an adverse anesthetic event (such as a copy of the update of the “Adverse Event Protocol”13)
Policy on resuscitation of do-not-resuscitate patients in the OR
Individual departments will add to and modify these suggestions as dictated by their specific needs. A thorough, carefully conceived policy and procedure manual is a valuable tool. The manual should be reviewed and updated as needed but at least annually. Each member of a group or department should review the manual at least annually and sign off in a log indicating familiarity with current policies and procedures.
Meetings and Case Discussion
There must be regularly scheduled departmental or group meetings. Although didactic lectures and continuing education meetings are valuable and necessary, there also must be regular opportunities for open clinical discussion about interesting cases and problem cases. Also, the Joint Commission requires that there be at least monthly meetings at which risk management and QA activities are documented and reported. Whether these meetings are called case conferences, morbidity and mortality conferences, or deaths and complications conferences, the entire department or group should gather for an interchange of ideas. More recently, these gatherings have been called QA meetings. An open review of departmental statistics should be done, including all complications, even those that may appear trivial. Unusual patterns of small events may point toward a larger or systematic problem, especially if they are more frequently associated with one individual practitioner.
A problem case presented at the departmental meeting might be an overt accident, a near accident (critical incident), or an untoward outcome of unknown origin. Honest but constructive discussion, even of an anesthesia professional’s technical deficiencies or lack of knowledge, should take place in the spirit of constructive peer review. The classic question, “What would you do differently next time?” is a good way to start the discussion. There may be situations in which inviting the surgeon or the internist involved in a specific case would be advantageous. The opportunity for each type of provider to hear the perspective of another discipline not only is inherently educational, but also can promote communication and cooperation in future potential problem cases.
Records of these meetings must be kept for accreditation purposes, but the enshrining of overly detailed minutes (potentially subject to discovery by a plaintiff’s attorney at a later date) may inhibit true educational and corrective interchanges about untoward events. In the circumstance of discussion of a case that seems likely to provoke litigation, it is appropriate to be certain that the meeting is classified as official “peer review” and possibly even invite the hospital attorney or legal counsel from the relevant malpractice insurance carrier (to guarantee the privacy of the discussion and minutes).
Support Staff
There is a fundamental need for support staff in every anesthesia practice. Even independent practitioners rely in some measure on facilities, equipment, and services provided by the organization maintaining the anesthetizing location. In large, well-organized departments, reliance on support staff is often very great. What is often overlooked, however, is a process analogous to that of credentialing and privileges for anesthesia professionals, although at a somewhat different level. The people expected to provide clinical anesthesia practice support must be qualified and must at all times understand what they are expected to do and how to do it. It is singularly unfortunate to realize only after an anesthesia catastrophe has occurred that basic details of simple work assignments, such as the changing of carbon dioxide absorbent, were routinely ignored. This indicates the need for supervision and monitoring of the support staff by the involved practitioners. Further, such support personnel are favorite targets of cost-cutting administrators who do not understand the function of anesthesia technicians or their equivalent. In the modern era, many administrators seem driven almost exclusively by the “bottom line” and cannot appreciate the connection between valuable workers such as these and the “revenue stream.” Even though it is obvious to all who work in an OR that the anesthesia support personnel make it possible for there to be patients flowing through the OR, it is their responsibility to convince the facility’s fiscal administrator that elimination of such positions is genuinely false economy because of the attendant loss in efficiency, particularly in turning over the room between surgeries. Further, it is also false economy to reduce the number of personnel below that genuinely needed to retrieve, clean, sort, disassemble, sterilize, reassemble, store, and distribute the tools of daily anesthesia practice. Vigorous defense (or initiation of new positions if the staff is inadequate) by the anesthesia professionals should be undertaken, even sometimes with the realization that it may be necessary in some circumstances for them to supplement the budget from the facility with some of their practice income to guarantee an adequate complement of competent workers.
Business and organizational issues in the management of an anesthesia practice are also critically dependent on the existence of a sufficient number of appropriately trained support staff. One frequently overlooked issue that contributes to the negative impression generated by some anesthesiology practices centers on being certain there is someone available to answer the telephone at all times during the hours surgeons, other physicians, and OR scheduling desks are likely to call. This seemingly trivial component of practice management is very important to the success of an anesthesiology practice as a business whose principal customers are the surgeons. Certainly there is a commercial server–client relationship both with the patient and the purchaser of health care; however, the uniquely symbiotic nature of the relationship between surgeons and anesthesiologists is such that availability even for simple “just wanted to let you know” telephone calls is genuinely important. The person who answers the telephone is the representative of the practice to the world and must take that responsibility seriously. From a management standpoint, significant impact on the success of the practice as a business often hinges on such details. Further, anesthesia professionals should always have permanent personal electronic pagers (preferably with text and even more preferably two way) and reliable mobile telephones (or the radio equivalent) to facilitate communications from other members of the department or group and from support or facility personnel. This may sound intrusive, but the unusual position of anesthesia professionals in the spectrum of health-care workers mandates this feature of managing an anesthesiology practice. Anesthesiology professionals should have no hesitation about spending their own practice income to do so. The symbolism alone is obvious.
Anesthesia Equipment and Equipment Maintenance
Problems with anesthesia equipment have been discussed extensively in the past.14,15,16 However, compared with human error, overt equipment failure rarely causes intraoperative critical incidents17 or deaths resulting from anesthesia care. Aside from the obvious human errors involving misuse of or unfamiliarity with the equipment, when the rare equipment failure does occur, it often appears that correct maintenance and servicing of the apparatus has not been done. These issues are part of anesthesia practice management efforts, which could have significant liability implications because there can often be confusion or even disputes about precisely who is responsible for arranging maintenance of the anesthesia equipment—the facility or the practitioners who use it and collect practice income from that activity. In many cases, the facility assumes the responsibility. In situations in which that is not true, however, it is necessary for the practitioners to recognize that responsibility and seek help securing a service arrangement, because this is likely an unfamiliar obligation for clinicians.
Programs for anesthesia equipment maintenance and service have been outlined.1,18 A distinction is made between failure resulting from progressive deterioration of equipment, which should be preventable because it is observable and should provoke appropriate remedial action, and catastrophic failure, which, realistically, often cannot be predicted. Preventive maintenance for mechanical parts is critical and involves periodic performance checks every 4 to 6 months. Also, an annual safety inspection of each anesthetizing location and the equipment itself is necessary. For equipment service, an excellent mechanism is a relatively elaborate cross-reference system (possibly kept handwritten in a notebook but ideal for maintenance on an electronic spreadsheet program) to identify both the device needing service and also the mechanism to secure the needed maintenance or repair.
Equipment-handling principles are straightforward. Before purchase, it must be verified that a proposed piece of equipment meets all applicable standards, which will usually be true when dealing with new equipment from recognized major manufacturers. The renewed efforts of some facility administrators to save money by attempting to find “refurbished” anesthesia machines and monitoring systems (especially for “off-site,” “satellite,” or “office-based” locations) should provoke thorough review by the involved practitioners. On arrival, electrical equipment must be checked for absence of hazard (especially leakage of current) and compliance with applicable electrical standards. Complex equipment such as anesthesia machines and ventilators should be assembled and checked out by a representative from the manufacturer or manufacturer’s agent. There are potential adverse medicolegal implications when relatively untrained personnel certify a particular piece of new equipment as functioning within specification, even if they do it perfectly. On arrival, a sheet or section in the departmental master equipment log must be created with the make, model, serial number, and in-house identification for each piece of capital equipment (anything with a serial number). This not only allows immediate identification of any equipment involved in a future recall or product alert, but also serves as the permanent repository of the record of every problem, problem resolution, maintenance, and servicing occurring until that particular equipment is scrapped. This log must be kept up-to-date at all times. There have been rare but frightening examples of potentially lethal problems with anesthesia machines leading to product alert notices requiring immediate identification of certain equipment and its service status. It is also very important to involve the manufacturer’s representative in pre- and in-service training for those who will use the new equipment. Anesthesia systems with their ventilation and monitoring components have become significantly more integrated and more complex, particularly as they are increasingly electronic and less mechanical. Accordingly, it is critical that anesthesia professionals are properly trained to use their equipment safely. The perception that inadequate training is common and that this represents a threat to patient safety has led the Anesthesia Patient Safety Foundation to initiate a campaign urging anesthesia departments and groups to ensure organized verified complete training of all professionals who will use this new technology.19
Service
Beyond the administrative liability implications, precisely what type of support personnel should maintain and service major anesthesia equipment has been widely debated. Some groups or departments rely on factory service representatives from the equipment manufacturers for all attention to equipment, others engage independent service contractors, and still other (often larger) departments have access to personnel (either engineers and/or technicians) permanently within their facility. The single underlying principle is clear: The person(s) doing preventive maintenance and service on anesthesia equipment must be qualified. Anesthesia practitioners may wonder how they can assess these qualifications. The best way is to unhesitatingly ask pertinent questions about the education, training, and experience of those involved, including asking for references and speaking to supervisors and managers responsible for those doing the work. Whether an engineering technician who spent a week at a course at a factory can perform the most complex repairs depends on a variety of factors, which can be investigated by the practitioners ultimately using the equipment in the care of patients. Failure to be involved in this oversight function exposes the practice to increased liability in the event of an untoward outcome associated with improperly maintained or serviced equipment.
Replacement of obsolete anesthesia machines and monitoring equipment is a key element of a risk-modification program. Ten years is sometimes cited as an estimated useful life for an anesthesia machine, but although an ASA statement repeats that idea, it also notes that the ASA promulgated “Guidelines for Determining Anesthesia Machine Obsolescence” in 2004 that does not subscribe to any specific time interval. Very old anesthesia machines likely do not meet certain of the safety standards now in force (such as vaporizer lockout, fresh gas ratio protection, and automatic enabling of the oxygen analyzer). Further, it appears likely that this technology will continue to advance, particularly because of the adoption of anesthesia workstation standards by the European Economic Union that are affecting anesthesia machine design worldwide. Note that some anesthesia equipment manufacturers, anxious to minimize their own potential liability, have refused to support (with parts and service) some of the oldest of their pieces (particularly gas machines) still in use. This disowning of equipment by its own manufacturer is a very strong message to practitioners that such equipment must be replaced as soon as possible.
Should a piece of equipment fail, it must be removed from service and a replacement substituted. Groups, departments, and facilities are obligated to have sufficient backup equipment to cover any reasonable incidence of failure. The equipment removed from service must be clearly marked with a prominent label (so it is not returned into service by a well-meaning technician or practitioner) containing the date, time, person discovering, and the details of the problem. The responsible personnel
must be notified so they can remove the equipment, make an entry in the log, and initiate the repair. As indicated in the protocol for response to an adverse event,13 a piece of equipment involved or suspected in an anesthesia accident must be immediately sequestered and not touched by anybody—particularly not by any equipment service personnel. If a severe accident occurred, it may be necessary for the equipment in question to be inspected at a later time by a group consisting of qualified representatives of the manufacturer, the service personnel, the plaintiff’s attorney, the insurance companies involved, and the practitioner’s defense attorney. The equipment should thus be impounded following a catastrophic adverse event and treated similarly to any object in a forensic “chain of evidence,” with careful documentation of parties in contact with and responsible for securing the equipment in question following such an event. Also, major equipment problems may, in some circumstances, reflect a pattern of failure due to a design or manufacturing fault. These problems should be reported to the FDA’s Medical Device Problem Reporting system20 via MedWatch on Form 3500 (found at www.fda.gov/medwatch/index.html, or telephone 800-FDA-1088). This system accepts voluntary reports from users and requires reports from manufacturers when there is knowledge of a medical device being involved in a serious incident. Whether or not filing such a report will have a positive impact in subsequent litigation is impossible to know, but it is a worthwhile practice management point that needs to be considered in the unlikely but important instance of a relevant event involving equipment failure.
must be notified so they can remove the equipment, make an entry in the log, and initiate the repair. As indicated in the protocol for response to an adverse event,13 a piece of equipment involved or suspected in an anesthesia accident must be immediately sequestered and not touched by anybody—particularly not by any equipment service personnel. If a severe accident occurred, it may be necessary for the equipment in question to be inspected at a later time by a group consisting of qualified representatives of the manufacturer, the service personnel, the plaintiff’s attorney, the insurance companies involved, and the practitioner’s defense attorney. The equipment should thus be impounded following a catastrophic adverse event and treated similarly to any object in a forensic “chain of evidence,” with careful documentation of parties in contact with and responsible for securing the equipment in question following such an event. Also, major equipment problems may, in some circumstances, reflect a pattern of failure due to a design or manufacturing fault. These problems should be reported to the FDA’s Medical Device Problem Reporting system20 via MedWatch on Form 3500 (found at www.fda.gov/medwatch/index.html, or telephone 800-FDA-1088). This system accepts voluntary reports from users and requires reports from manufacturers when there is knowledge of a medical device being involved in a serious incident. Whether or not filing such a report will have a positive impact in subsequent litigation is impossible to know, but it is a worthwhile practice management point that needs to be considered in the unlikely but important instance of a relevant event involving equipment failure.
Malpractice Insurance
All practitioners need liability insurance coverage specific for the specialty and role in which they are practicing. It is absolutely critical that applicants for medical liability insurance be completely honest in informing the insurer what duties and procedures they perform. Failure to do so, either from carelessness or from a foolishly misguided desire to reduce the resulting premium, may well result in retrospective denial of insurance coverage in the event of an untoward outcome from an activity the insurer did not know the insured engaged in.
Proof of adequate insurance coverage is usually required to secure or renew privileges to practice at a health-care facility. The facility may specify certain minimum policy limits in an attempt to limit its own liability exposure. It is difficult to suggest specific dollar amounts for policy limits because the details of practice vary so much among situations and locations. The malpractice crisis of the 1980s eased significantly in the early 1990s for anesthesia professionals, largely because of the decrease in number and severity of malpractice claims resulting from anesthesia catastrophes as anesthesia care in the United States became safer.21,22,23 The exact analysis of this phenomenon can be debated,24,25 but it is a simple fact that malpractice insurance risk ratings have been decreased and premiums for anesthesia professionals have not been increased at the same rate as for other specialties, in many cases, have actually decreased. Coverage limits of $1 million/$3 million were purchased by 72% of American anesthesiologists in 2010 (http://viewer.zmags.com/publication/68a45923#/68a45923/26). This policy specification usually means that the insurer will cover up to $1 million liability per claim and up to $3 million total per year, but this terminology is not necessarily universal. Therefore, anesthesia professionals must be absolutely certain what they are buying when they apply for malpractice insurance. Even though anesthesiologists have not recently suffered a great number of very large malpractice payments or jury verdicts,26 in specific parts of the United States known for a pattern of exorbitant settlements and jury verdicts, liability coverage limits of $2 million/$5 million or even greater may be considered prudent. An additional feature in this regard is the potential to employ “umbrella” liability coverage above the limits of the base policy, as will be noted.
Background
The fundamental mechanism of medical malpractice insurance changed significantly some years ago because of the need for insurance companies to have better ways to predict their “losses” (amounts paid in settlements and judgments). Traditionally, medical liability insurance was sold on an “occurrence” basis, meaning that if the insurance policy was in force at the time of the occurrence of an incident resulting in a claim, whenever within the statute of limitations that claim might be filed, the practitioner would be covered. Occurrence insurance was somewhat more expensive than the alternative “claims-made” policies, but was seen as worth it by some (many) practitioners. These policies created some open-ended exposure for the insurer that sometimes led to unexpected large losses, even some large enough to threaten the existence of the insurance company. As a result, medical malpractice insurers have converted almost exclusively to “claims-made” insurance, which covers only claims that are filed while the insurance is in force. Premium rates for the first year a physician is in practice are relatively low because there is less likelihood of a claim coming in (a majority of malpractice suits are filed 1 to 3 years after the event in question). The premiums usually increase yearly for the first 5 years and then the policy is considered “mature.” The issue comes when the physician later, for whatever reason, must change insurance companies (e.g., because of relocation to another state). If the physician simply discontinues the policy and a claim is filed the next year, there will be no insurance coverage. Therefore, the physician must secure “tail coverage,” sometimes for a minimum number of years (e.g., 5) or, more often, indefinitely to guarantee liability insurance protection for claims filed after the physician is no longer primarily covered by that insurance policy. It may be possible in some circumstances to purchase tail coverage from a different insurer than was involved with the primary policy, but by far the most common thing done is to simply extend the existing insurance coverage for the period of the tail. This very often yields a bill for the entire tail coverage premium, which can be quite sizable, potentially staggering a physician who simply wants to move to another state where his or her existing insurance company is not licensed to or refuses to do business. Individual situations will vary widely, but it is reasonable for anesthesiologists organized into a fiscal entity to consider this issue at the time of the inception of the group and record their policy decisions in writing, rather than facing the potentially difficult question of how to treat one individual later. Other strategies have occasionally been employed when insuring the tail period, including converting the previous policy to part-time status for a period of years, and purchasing “nose” coverage from the new insurer—that is, paying an initial higher yearly premium with the new insurer, who then will cover claims that may occur during the tail period. Whatever strategy is adopted, it is critical that the individual practitioner is absolutely certain through personal verification that he or she is thoroughly covered at the time of any transition. The potential stakes are much too great to leave such important issues solely to an office clerk. Further, a practitioner arriving in a new location is often filling a need or void and is urged to begin clinical work as soon as possible by others who have been shouldering an increased load. It is essential that the new arrival verify with confirmation in writing (often called a “binder”) that malpractice liability insurance coverage is in force before there is any patient contact.
Another component to the liability insurance situation is consideration of the advisability of purchasing yet another type of insurance called umbrella coverage, which is activated at the time of the need to pay a claim that exceeds the limits of coverage on the standard malpractice liability insurance policy. Because such an enormous claim is extremely unlikely, many practitioners are tempted to forgo the comparatively modest cost of such insurance coverage in the name of economy. As before, it is easy to see that this is potentially a very false economy—if there is a huge claim. Practitioners should consult with their financial managers and advisors, but it is likely that it would be considered wise management to purchase “umbrella” liability insurance coverage.
Medical malpractice insurers are becoming increasingly active in trying to prevent incidents that will lead to insurance claims. They often sponsor risk management seminars to teach practices and techniques to lessen the chances of liability claims and, in some cases, suggest (or even mandate) specific practices, such as strict documented compliance with the ASA “Standards for Basic Anesthetic Monitoring.” In return for attendance at such events and/or the signing of contracts stating that the practitioner will follow certain guidelines or standards, the insurer often gives a discount on the liability insurance premium. Clearly, it is sound practice management strategy for practitioners to participate maximally in such programs. Likewise, some insurers make coverage conditional on the consistent implementation of certain strategies such as minimal monitoring, even stipulating that the practitioner will not be covered if it is found that the guidelines were being consciously ignored at the time of an untoward event. Again, it is obviously wise from a practice management standpoint to cooperate fully with such stipulations.
Response to an Adverse Event
In spite of the decreased incidence of anesthesia catastrophes, even with the very best of practice, it is statistically likely that each anesthesiologist at least once in his or her professional life will be involved in a major anesthesia accident (see Chapter 4). Precisely because such an event is rare, very few are prepared for it. It is probable that the involved personnel will have no relevant past experience regarding what to do. Although an obvious resource is another anesthetist who has had some exposure or experience, one of these may not be available either. Various authors have discussed what to do in that event.27,28,29 Cooper et al.30 thoughtfully presented the appropriate immediate response to an accident in a straightforward, logical, compact format (that has been updated13 that should periodically be reviewed by all anesthesiology practitioners and should be included in all anesthesia policy and procedure manuals. This “adverse events protocol” is also always immediately available at www.apsf.org (“Resource Center,” then “Clinical Safety Tools”). Unfortunately, however, the principal personnel involved in a significant untoward event may react with such surprise or shock as to temporarily lose sight of logic. At the moment of recognition that a major anesthetic complication has occurred or is occurring, help must be called. A sufficient number of people to deal with the situation must be assembled on site as quickly as possible. For example, in the unlikely but still possible event that an esophageal intubation goes unrecognized long enough to cause a cardiac arrest, the immediate need is for enough skilled personnel to conduct the resuscitative efforts, including making the correct diagnosis and replacing the tube into the trachea. Whether the anesthesiologist apparently responsible for the complication should direct the immediate remedial efforts will depend on the person and the situation. In such a circumstance, it would seem wise for a senior or supervising anesthesiologist quickly to evaluate the scenario and make a decision. This person becomes the “incident supervisor” and has responsibility for helping prevent continuation or recurrence of the incident, for investigating the incident, and for ensuring documentation while the original and helping anesthesiologists focus on caring for the patient. As noted, involved equipment must be sequestered and not touched until such time as it is certain that it was not involved in the incident.