Statement of Purpose

This is the first Newsletter of the Anesthesia Patient Safety Foundation, which was incorporated on September 30, 1985. The mission of the APSF is clear and simple-to encourage activities that will prevent patients from being harmed by the effects of anesthesia. Why such a foundation? What activities shall it promote to fulfill its mission? What resources will support those activities? What can you do to help?

It is generally agreed that anesthesia is safer than it has ever been, but that it still isn't safe enough. In the United States, annually some several thousand patients die or are seriously injured at least in part by their anesthetic experience. Them is strong evidence that more than half of these adverse outcomes are preventable by applying known precepts of anesthesia management. Yet, the causes of preventable deaths and injuries are diverse and complicated. There is no one evil and no simple cure.

The first step toward improvement is creating awareness that a problem exists. Education, training, application of current and developing technologies and acquiring new knowledge about the causes and prevention of mishaps are components of a solution matrix.

Anesthesia mortality is everybody's problem. Most people will be exposed to the risk several times in their life. When a bad outcome occurs, it affects not only the patient, but has a lasting impact on the family, the anesthetist, and the anesthetist's colleagues as well. It is also a problem for many other constituencies-the manufacturer and designer of equipment that is involved or implicated in an accident and the hospital administrator in whose operating room an accident occurred. For the companies that provide liability insurance, there is the clear and present danger that the malpractice crisis, caused at least in part by preventable injuries, may severely damage or cripple the viability of their organizations. That this crisis puts the entire health care system in jeopardy makes this a problem for the federal government also.

Because there has been no place that these constituencies can join forces to promote change, the Anesthesia Patient Safety Foundation was formed. Its goals are:

*To foster investigations that will provide a better understanding of preventable anesthetic injuries;

*To encourage programs that will reduce the number of anesthetic injuries; and

*To promote national and international communication of information and ideas about the causes and prevention of anesthetic injuries.

During the first year, the Foundation's aims are to start a communication vehicle (this newsletter) and to establish a research fund, awarding several grants. Committees have been created to implement these activities.

Who is the APSF? Its 30 -member Board of Directors includes representatives from anesthesiology, nurse anesthesia, device and pharmaceutical manufacturing, the insurance industry, hospitals, biomedical engineering, and the FDA (see page 5 of this newsletter for a complete list of the Board and committees). Membership in the APSF is open to any individual contributing at least $25 and any corporation contributing at least $500. Contributions will go toward funding the cost of producing and distributing this newsletter to the approximately 45,000 people who have a stake in preventing anesthesia injuries and toward the support of safety-related research activities.

You won't have to be a member of the APSF to benefit from its efforts but, yes, you will receive a certificate of membership if you join. The real reason to contribute $25 or more is because you want to make anesthesia safer. Because it can be. Because it should be. We think that some improvements, through increasing awareness and through implementing some new technologies, can be had in the short term-a few years. But, the ultimate goal of near-absolutely injury-free anesthesia will take longer because the impact of training, of education, and of innovative ideas derived from research take time to percolate through a culture. But, it can be done. We need your help.

Jeffrey B. Cooper, Ph.D.

Ellison C. Pierce, M.D.

For the Executive Committee

THE APSF EXECUTIVE COMMMEE recently met in Atlanta, GA. Left to right: Dr. ).S. Gravenstein, Dr. I. B. Cooper, Dr. E.S. Siker (Secretary), Mr. I.E Holzer, Dr. E.C. Pierce (President), Mr. B.A. Dole (Treasurer), and Mr. W.D. Rountree (Vice President).
 
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WHAT MONRMRING did Dr. W.T.C. Morton use during the first surgical operation under ether anesthesia October 16, 1846? (Also, what were his malpractice insurance premiums?)

Groups Publish Conventions

Physicians and nurses who devote their work to the practice of anesthesia have one common goal, namely to make anesthesia as safe for their patients as humanly possible. Despite these efforts the occasional disaster occurs and a patient suffers harm. Whenever this happens, an agonizing search begins: what could have been done to prevent the problem.

Of all the many steps that have been recommended to make anesthesia safe, few are universally accepted; indeed the measures urged by some for adoption as essential safety precautions are considered by others as being not all that helpful. For example, the esophageal (or precordial) stethoscope has been praised as being a wonderful monitor. It requires no electricity and is therefore immune to power outages and electrical artifacts. It allows the anesthetist to listen without interruption to heart sounds and breath sounds. Thus it becomes a monitor that alerts the anesthetist to the cardiac standstill as well as the disconnected ventilator. Indeed, it can help with more subtle diagnoses, such as the muffled cardiac sounds of a depressed heart or the wheezes of bronchospasm.

How could anyone denigrate the esophageal or precordial stethoscope? The critics love to recount stories in which the anesthetist failed to notice that breath and heart sounds had suddenly disappeared when the tube from chest to ear was furtively clamped. So what good is a monitor that depends solely on the attention of a human being who can be distracted or can become so inured to a monotonous sound that he no longer notices when the sound vanishes?

Clinical examples

Let us ask if we can identify monitors American anesthetists would agree on calling essential. Let us define as essential any monitor that would cause us to cancel an elective case should neither the monitor nor an equivalent be available. Let us also agree to focus on simple, short anesthetics in healthy patients. For example, imagine a general anesthetic needed for the placement of myringotomy tubes in a six year old boy, or a saddle block in a healthy 20 year-old man in lithotomy position for a hemorrhoidectomy.

A skilled anesthesiologist or anesthetist must be present in the operating room. Beyond that the question becomes more difficult to answer because now we have options. Those who insist on watching an ECG monitor and recording the arterial blood pressure might be challenged by others who say that a precordial stethoscope and a pulse oximeter could adequately replace the ECG and blood pressure monitor in healthy, young patients. Some might insist on monitoring the temperature, others would be satisfied with having a thermometer available should clinical suspicion call for a temperature measurement. Some insist on an oxygen analyzer in the breathing circuit, others are prepared to omit one when they use a Bain circuit. When the patient is awake, some believe that verbal communication maintained with the patient is as good a monitor as any, because an alert patient clearly demonstrates good cerebral perfusion and oxygenation. So where should the line be drawn? Should it be left to the judgment of every individual anesthetist?

Current Recommendations

While the majority of us still practice as we have been taught and as our clinical experience dictates, others have formed groups and in laborious discussions have developed monitoring conventions to which they plan to adhere. There are, for instance, the "Guidelines for Patient Care in Anesthesiology" developed and endorsed by the Arizona Society of Anesthesiologists, dated February 23, 1985. These recommend for patients undergoing general anesthesia:

1) Oxygen analyzer with low concentration alarm in the circuit.

2) Low pressure alarm on the anesthesia ventilator if used during the course of the anesthetic.

3) Two of the follou4ng three modalities.-

a) intermittent or continuous blood pressure monitoring

b) continuous electrocardiographic display

c) precordial esophageal stethoscope-

The Department of Anesthesia of the Harvard Medical School adopted on March 25, 1985 and revised on July 3, 1985 its "Standards of Practice 1; Minimal Monitoring" which include for preplanned anesthetics administered in designated anesthetizing locations where not clinically impractical.

Blood Pressure and Heart Rate

Every patient receiving general anesthesia, regional anesthesia, or monitored intravenous anesthesia shall have arrival blood pressure and heart rate measured at least every five minutes where not clinically impractical.

EKG

Every patient shall have the electrocardiogram continuously displayed from the induction or institution of anesthesia until preparing to leave the anesthetizing location, where not clinically impractical.

Continuous Monitoring

During every administration of general anesthesia, the anesthetist shall employ methods of continuously monitoring the patient's ventilation and circulation. The methods shall include, for ventilation and circulation each, at least one of the following or the equivalent.

For ventilation-palpation or observation of the reservoir breathing bag, auscultation of breath sounds, monitoring of respiratory gases such as end-tidal CO, or monitoring expiratory flow.

For circulation-palpation ofa pulse, auscultation of heart sounds, monitoring of a tracing of in&a-a,rtetial pressure, pulse plethysmography, or ultrasound peripheral pulse monitoring.

Breathing System Disconnect Monitoring

When ventilation is controlled by an automatic mechanimi ventilator, them shall be in continuous use a device that is capable of detecting disconnection of any component of the breathing system. ne device must give an audible signal when its alarm threshold is exceeded.

Oxygen Analyzer

During every administration of general anesthesia using an anesthesia machine, the concentration of oxygen in the patient breathing system will be measured by a functioning oxygen analyzer with a low concentration limit alarm in use.

Ability to Measure Temperature

During every administration of general anesthesia there shall be readily available a means to measure the patient's temperature.

More recently another group with representatives from industry and anesthesia, the Anesthesia Safety Consortium, drafted a set of recommendations designed to reduce the incidence of problems related to inadequate oxygenation of patients. The monitors that were recommended included:
1) an in-circuit oxygen analyzer with low alarm
2) capnography
3) means for the measurement oft the patient's oxgenation
4) means for the detection of undesirable airway pressure, both high and low.

What will you do clinically?

Let us now return to our patients and ask again, what monitors should we demand for our patients to have general anesthesia or a saddle block? We can answer the question with assurance if we are willing to embrace one or the other set of conventions. But which one? We will search in vain for scientific evidence demonstrating that this or that convention will indeed improve the lot of our average patient. Nevertheless, such conventions prepared by recognized experts, published by widely respected groups and obviously drawn up with the best of intentions of improving the safety of anesthesia will assume a life of their own. Ignoring such conventions will cause critics to ask whether applying those conventions could possibly hurt and whether they might not indeed help? And once we have to admit that they might, in fact, be helpful in reducing adverse incidents in anesthesia, we have taken the first step toward adopting them ourselves.

With the publication of these first conventions, we are entering a new phase in anesthesia. Can we expect the formulation and adoption of national conventions? It is too early to predict in detail the practices and monitors that are going to be included in such a national effort. But many assume that for the first time we will have minimal essentials that will influence our practice.

On the one hand, we will see much more uniformity in the practice of anesthesia. On the other, for the first time them will be occasions when we will say, sorry, I have to delay this case until this monitor has been repaired. Of course, there will have to be alternatives in emergencies or in clinical circumstances where one or the other convention cannot be met. But we will be expected to justify and document deviations from the conventions.

It is a fair bet that the monitoring modalities mentioned in the first guidelines published by the Arizona group, the standards of the Harvard Department, and the recommendations of the Patient Safety Consortium are going to come under close scrutiny for inclusion in any list of minimal essentials. The Anesthesia Patient Safety Foundation will closely examine proposed monitoring conventions and it will also tap the enormous clinical experience represented by the thousands of anesthesiologists and nurse anesthetists who practice in the United States. Therefore, the Foundation needs to hear from you! Please write and tell us your ideas on how to make anesthesia as safe as possible for the patients entrusted to our care.

I.S. Gravenstein, M.D.

For the Executive Committee

Anesthesia Patient Safety Foundation
 
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by Arthur S. Keats, M.D.

The Anesthesia Patient Safety Foundation Grant Program will support clinical research directed toward enhancing patient safety. Its major objective is to stimulate studies leading to anesthesia methods which will completely prevent anesthesia mishaps (also described as anesthesia accidents, misadventures, critical incidents and morbidity).

The major interest is in studies which can be completed within one year, those that concern problems of anesthesia for relatively healthy patients, those that primarily utilize existing medical knowledge, and those that promise improved methods of patient safety readily incorporated into clinical practice.

Areas of research interest include, but are not limited to, new clinical methods for prevention and/or early diagnosis of mishaps, evaluation of new and/or reevaluation of old technologies for prevention and diagnosis, and identification of predictors of patients and anesthetists at increased risk for mishaps. Potential research areas also in crude development of innovative methods for study of low frequency events as mishaps, particularly in community hospitals, and methods for measurement of cost effectiveness of techniques and equipment designed to increase patient safety.

Applications should be received no later than July 15, 1986. Requests should not exceed $35,000. Awards will be announced before October 1, 1986 for projects to begin January 1987. Guidelines for application for an APSF grant are available from:

Mr. Glenn W. Johnson

Administrator

Anesthesia Patient Safety Foundation

515 Busse Highway

Park Ridge, Illinois 60068

Dr Keats is Chief, Division of Cardiovascular Anesthesia at the Texas Heart Institute, Houston, and Clinical Professor of anesthesiology, University of Texas.

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Confidential Inquiry Into Perioperative Death-U.K.

John H. Lunn, M.D., FFARCS

University of Wales

College of Medicine, Cardiff

"The trouble is you haven't included the surgeons and your data will be valueless." That's what they said about Mortality Associated with Anesthesia before the report was published. But they were wrong. That study showed how safe anesthesia is (one in 10,000 operations followed by death wholly attributable to anesthesia) and that the few deaths were often avoidable and usually attributable to human error.

Encouraged by the response to this study, the Association of Anesthetists of Great Britain and Ireland sought and obtained funds (from the Snuffled Provincial Hospital Trust and the King's Fund for Hospitals) to support another large project which has recently started in the United Kingdom. This unique study involves all surgical disciplines as well as anesthesia and is a fully cooperative venture between the Association of Anesthetists of Great Britain and Ireland and the Association of Surgeons of Great Britain and Ireland. The aims of now the study are the same as before: mortality rates(perhaps for a few specific operations as well as to global rates), and to identify avoidable factors in that deaths which occur in hospital within 30 days of operation.

More than 400 assessors have been appointed University of Wales, in both disciplines. These experts will review all College of Medicine, Cardiff the deaths about which there is any doubt and a random sample of all other deaths. Their opinions will form the basis of the report which will be published after the study has continued for 12 months. Three Regions of the country have been selected (estimate 600,000 operations) and every hospital (60) visited by two clinical coordinators (a surgeon, H. B. Devlin) and an anesthetist (the writer). The response to this recruitment drive has exceeded our expectations and a total of about 96% of the consultant staff has agreed to cooperate; it is still a voluntary matter.

When a death occurs, each specialist completes a detailed questionnaire designed to provide information about the management of the case. These questionnaires are examined by the two clinical coordinators, stripped of their identity, and then sent to the appropriate assessors.

Questionnaires are arriving at the office daily and in the first six weeks of the project, over 1000 have been scrutinized. It is no exaggeration to claim that British anesthetists and surgeons are prepared to examine their own practice and expose it to peer review. We have evidence this audit process is already provoking the most recalcitrant to change and, we hope, to improve in practice.

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Editor's note: In each APSFNewsletter, a pertinent publication from the anesthesia patient safety literature will be summarized. Suggestions for future issues are welcome.

Keenan RL, Boyan CP: Cardiac arrest due to anesthesia. JAMA 253: 2373-2377, 1985.

At the Medical College of Virginia, Richmond, 27 cardiac arrests Judged due solely to anesthesia occurred in 163,240 total anesthetics over a fifteen-year period (1.7 per 10,000) causing fourteen deaths (0.9 per 10,000). Among the 27: six were under twelve years old, nineteen were 1265 years, and only two were over 65; also, ASA physical status classifications were 1-two, 11-five, III-ten, IV-ten, (V not included). Note that Classes I and 11 account for only seven arrests in 163,240 cases and only two deaths (I /81,620). Cardiac arrest during emergency surgery was six times more likely than during elective surgery. Of the 27 cases, nine had absolute overdoses of inhalation agent and six relative overdoses of intravenous agent. Twelve included inadequate ventilation: four difficult airway, four esophageal intubations, two ventilator disconnects, and one each displaced endotracheal tube and bronchospasm.

Judgments about the likely preventability of the accidents were recorded. Among the 2 7 cases of cardiac arrests: 20 were "avoidable" (eleven inadequate ventilation and nine inhalation overdoses), six were "questionable" (the relative intravenous overdoses in hemodynamically unstable patients three each cardiac and septic), and one was felt to be "unavoidable" (intractable asthma). Thus, a specific anesthetic "error" was identified in 75% (20 of 27) of the arrest cases. A strong point was made that progressive bradycardia preceded the cardiac arrest in all but one of the cases. The authors suggest that when there is unexplained bradycardia, increased ventilation with 100% oxygen should automatically be the first response considered. Drug idiosyncrasy, anaphylaxis, and succinylcholine induced hyperkalernia were seen but did not cause arrest. Malignant hyperthemia was not seen.

Abstracted by: John H. Eichhorn, M.D., Harvard Medical School

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Question Is monitoring for hypoxemia more important than for hypercarbia?

Answer Hypercarbia is, by itself, a serious but not usually life-threatening condition. If, however, hypoventillation leads to hypoxia, respiratory and/ or cardiac arrest often follow.

Hypercarbia may result from increased C02 production relative to C02 elimination (as in hyperthermia, emergence excitement, or excessive caloric intake from hyperalimentation solutions) or from hypoventillation due to incorrect ventilator settings, airway obstruction, depressed central respiratory drive (from anesthetic overdose), or inadequate mechanics of ventilation (residual muscle relaxation). The direct physiologic effect of hypercarbia is peripheral vasodilation. Indirectly, hypercarbia stimulates the sympathetic nervous system via the vasomotor center to increase myocardial contractility, heart rate, stroke volume, and blood pressure. The vigor of these responses is reduced by anesthesia.

Hypoxemia plus hypercarbia is extremely dangerous because acidosis (respiratory) potentiates the depressant effects of hypoxemia on myocardium and brain, and leads to bradycardia and cardiac arrest. Even with successful cardiac resuscitation, brain damage often results. To maintain oxygen transfer, more than oxygen content is required. A high enough PaO2 is needed to get oxygen into cells.

As soon as hypoxemia develops, anaerobic metabolism is utilized by cells to produce energy, a very inefficient method. Depending on the severity and duration of hypoxemia, vital functions fail. Thus, brain function diminishes, manifested by disorientation, obtundation, and coma; myocardial dysfunction reduces contractility, heart rate, blood pressure, and stroke volume and often leads to arrhythmias. Other organ functions deteriorate, though at a slower pace. Unlike in the unanesthetized situation when hypoxemia stimulates the vasomotor center via the carotid body chemoreflex to increase cardiac function, this mechanism is almost never operative when residual anesthesia let alone surgical levels of anesthesia are present. Of equal importance, the vigorous respiratory response to hypoxemia seen in unanesthetized intact preparations is essentially abolished by either narcotics or inhalation anesthetics. This can result in further hypoventillation, hypoxemia, and cardiac and/or respiratory arrest within minutes.

Thus, in answer to the question: Is monitoring for hypoxemia more important than for hypercarbia?, the answer is a qualified yes. Hypercarbia, if due to hypoventillation leads to hypoxemia, which in all cases from whatever cause, must be detected to initiate corrective therapy and prevent anesthesia related disasters.

Response by David J. Cullen, M.D. Harvard Medical School

Editors note: Please address patient saw related questions to John H. Eichhorm, M.D.

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EXECUTIVE COMMITTEE

President
Ellison C. Pierce, Jr., M.D.

Chairman, Anesthesia

New England Deaconess Hospital

Assistant Professor of Anesthesia

Harvard Medical School

Vice President

W. Dekle Rountree, Jr.

President

Ohmeda

Secretary

E.S. Siker, M.D.

Chairman, Anesthesiology

Mercy Hospital

Clinical Professor

University of Pittsburgh

Treasurer

Burton A. Dole, Jr.

President

Puritan-Bennett Corporation

Jeffrey B. Cooper, PhD.

Associate Director

Biomedical Engineering

Massachusetts General Hospital

Assistant Professor of Anesthesia

Harvard Medical School

Joachim S. Gravenstein, M.D.

Graduate Research Professor

University of Florida

James E Holzer, J.D.

Vice President

Risk Management Foundation

President, American Society for Hospital Risk Management of the American Hospital Association

DIRECTORS

Frederick W. Cheney, Jr., M.D.

Director, Critical Care Center

University Hospital

Professor

University of Washington School of Medicine

Stephanie M. Duberman, M.D.

Assistant Attending Anesthesiologist

Presbyterian Hospital

Assistant Professor of Anesthesiology

Columbia University

George Griffiths

Group Product Manager, Anesthesia Products

Janssen Pharmacutica

Marlene E Haffner, M.D.

Director, Office of Health Affairs

Center for Devices & Radiological Health

U.S. food & Drug Administration

William K. Hamilton, M.D.

Associate Dean for Clinical Affairs Professor of Anesthesia

University of California, San Francisco

Harvey J. Hatchfield, M.D.

Anesthesiologist

Hackensack Medical Center

Clinical Assistant Professor

University of Medicine and Dentistry of New Jersey

Arthur S. Keats, M.D.

Chief, Cardiovascular Anesthesia

Texas Heart Institute

Clinical Professor of Anesthesiology

University of Texas

Mary Ann Kelly

Clinical Service Planner

Division of Technology, Management and Policy

American Hospital Association

Richard J. Kitz, M.D.

Anesthetist-in-Chief

Massachusetts General Hospital

David E. Lees, M.D.

Chief, Anesthesia

Westchester County Medical Center

Professor and Chairman

Department of Anesthesiology

New York Medical College

Robert C. Maynard

Attorney

Jacobson, Maynard, Tuschman & Kalur Company, LPA

Cleveland

John D. Michenfelder, M.D.

Professor of Anesthesiology

Mayo Medical School

William New, Jr., M.D.

Chairman of the Board

Nelicor, Incorporated

Clinical Assistant Professor of Anesthesia

Stanford University

Beverly K. Nichols, CRNA

Department of Anesthesiology

University of Texas Health Science Center

Alexander R. Rankin

General Manager

Waltham Division

Hewlett-Packard Company

Allen K. Ream, M.D.

Associate Professor of Anesthesia

Stanford University

Peter J. Schreiber

President

North American Drager, Incorporated

N. Ty Smith, M.D.

Professor of Anesthesiology

University of California, San Diego

Donald R. Stanski, M.D.

Associate Professor of Anesthesia and Medicine

Stanford University

Peter Sweetland

President

New Jersey Medical Underwriters Trustee and Administrator

Physician Insurers Association of America

Bernard V. Wetchier, M.D.

Director, Anesthesiology

Methodist Medical Center of Illinois

Clinical Professor

University of Illinois College of Medicine at Peoria

Mark D. Wood

Medical Services Manager

Risk Management Service

St. Paul Companies

COMMITTEES

EDITORIAL BOARD

John H. Eichhom, M.D.,Editor-in-Chief

Assistant Professor of Anesthesia

Harvard Medical School

Stanley J. Aukburg, M.D.

Associate Professor of Anesthesia

University of Pennsylvania

Ralph A. Epstein, M.D.

Professor & Chairman

Department of Anesthesia

University of Connecticut Health Center

David E. Lees, M.D.*

E. S. Siker, M.D.*

Mr. Mark D. Wood*

COMMITTEE ON DEVELOPMENT

Mr. Burton A. Dole, Jr.*, Chairman

Mr. Charles Aschauer

Executive Vice President

Abbott Laboratories

Mr. George Griffiths*

William New, Jr., M.D.*

Mr. Larry Saper

President

Datascope Corporation

E. S. Sliker, M.D.*

COMMITTEE ON EDUCATION AND TRAINING

Joachim S. Gravenstein, M.D.*, Chairman

Mr. Joseph A. Arcarese

Director

Training & Assistance

Center for Devices & Radiological Health

U.S. Food & Drug Administration

Paul E. Berkebile, M.D.

Chairman

Department of Anesthesia

Western University Hospital

Clinical Associate Professor

University of Pittsburgh School of Medicine

Stephanie M. Duberman, M.D.*

Harvey J. Hatchfield, M.D.*

Ms. Beverly K. Nichols*

Mr. Peter Schreiber*

N. Ty Smith, M.D.*

COMMITTEE ON SCIENTIFIC EVALUATION

Arthur S. Keats, M.D.,* Chairman

Mr. Peter B. Carstensen

Engineering Consultant

Center for Devices & Radiological Health

U.S. food & Drug Administration

Frederick W. Cheney, Jr., M.D.*

Jeffrey B. Cooper, Ph.D.*

Richard J. Kitz, M.D.*

John D. Michenfelder, M.D.*

William New, Jr., M.D.*

Donald R. Stanski, M.D.*

Ross C. Terrell, Ph.D.

Vice President

Research and Development

Anaquest

COMMITTEE ON TECHNOLOGY

David B. Swedlow, M.D., Chairman

Assistant Professor of Anesthesia & Pediatrics

Children's Hospital of Philadelphia

Jerry M. Calkins, M.D.

Associate Professor & Vice Chairman

Department of Anesthesiology

School of Medicine

University of North Carolina, Chapel Hill

Mr. Burton A. Dole, Jr.*

Susan E. Dorsch, M.D.

Chief

Anesthesia Department

Riverside Hospital, Jacksonville

Marlene E. Haffner, M.D.*

David E. Lees, M.D.*

Ralph Milliken, M.D.

Director, Department of Anesthesia

Bronx Municipal Hospital Center

Associate Professor of Anesthesia

Albert Einstein College of Medicine

Chairman, Ad hoc Committee on Patient Safety and Risk Management, N.Y. State Soc. Anesth.

Mr. Alexander R. Rankin*

*Member, APSF Board

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B Robert J. Ward, M.D.

Improved patient safety! Such a noble goal rnust be in the very heart of every conscientious anesthesiologist-but how? It is only by knowing where the problems are that any concerted effort can be made to master them, and therein hangs the major obstacle to beginning the attack

The American Society of Anesthesiologists has initiated a massive review of closed claims against anesthesiologists, as found in the files of IS of the physician-owned insurance companies and of the St. Paul Fire and Marine Company. Acting through its Professional Liability Committee, chaired by Frederick W. Cheney, Jr., M.D., a practicing anesthesiologist will review each dosed claim in the individual state's files, extracting the data of importance to the clinician. The data will be collated by Richard J. Ward, M.D., a member of the Committee, and used by the Society in its many teaching activities

This project, like so many dynamic ones, had its start in the minds of several persons, whom chance brought together at the auspicious moment. An attorney friend (later the wife) of Richard Solazzi, M.D., suggested that considerable data on anesthetic malpractice problems could be found in the files of the insurance companies. Dr. Solazzi, then a resident in Anesthesiology at the University of Washington, suggested to Dr. Ward that they review the files of the Aetna Insurance Company to ascertain which clinical problems led to malpractice suits. The two reviewed a decade's experience in Washington State in the files of the Aetna Insurance Company, of the King County Medical Examiner, and of the two largest hospital systems, Group Health and the University of Washington. At the same time on the opposite coast, Ellison C. Pierce, Jr., M.D., was editing a book on anesthesia mishaps. The Washington state data was included in the book, but much more importantly, stirred the officers of the ASA to pursue a national survey, large enough to identify the common and not so common clinical problems that caused patient injury

Changes in the insurance coverage suggested that it would be best to approach the physician-owned insurance companies, and the St. Paul fire and Marine Company. The cooperation of the insurance companies has been outstanding, as it was with the Aetna Insurance Company in the original survey. To date 432 cases have been reviewed, and a preliminary estimate suggests that over 1000 may be available for review when the program is finished.

The program is unique in several ways. It is, by far, the largest review of anesthesia complications, and the resultant

malpractice suits, in America. Secondly, by having practicing anesthesiologists do the reviewing, it allows professional judgments to be made about many of the aspects of clinical care. Judgments are being made in several areas, such as: was the recorded preanesthesia evaluation adequate, would better preanesthetic evaluation probably have prevented the complications, would currently available monitors have prevented the complication (even though they were not available at the time of the complication), was the anesthesia care adequate or inadequate, could the anesthetic have caused the complication, was the treatment adequate if there was a cardiac arrest, and who was responsible for the complication (even though not preventable).

These professional judgments offer unique strength to the survey, and allow it to go far beyond the usual survey details, i.e., general or regional anesthesia administered, the type of complication noted, and the cost of any judgment. The identification of both preventable and non-preventable complications, and their causes, point the way to the proper targets of the ASA's educational programs for physicians. These targets have, to date, remained elusive, but they are now being identified.

As an example, of the 432 suits reviewed there were 29 patients who had an unrecognized esophageal intubation that caused the patient to die or have brain damage. Eighteen of these patients had bilateral auscultation of the chest. While it was surprising to note the comparatively high frequency of this complication, it was much more so to note that bilateral auscultation of the chest so frequently failed in making the diagnosis.

The efficacy of pulse oximetry and end tidal carbon dioxide analysis has been demonstrated in the findings to date. In a subset of 156 cases, it was estimated that these monitors, especially pulse oximetry, would have prevented 20% of the complications. This 20% represented almost 60% of the payments, $13,000,000 of the total of $24,000,000.

The costs of inadequate care are equally well demonstrated. 'Mere is no way that we can quantify the depth of the personal tragedy of severe complications or death, but we can quantify the dollar costs. The average settlement when the care was adjudged adequate was $88,597, while it jumped to $220,953 when the care was considered to be inadequate.

The primary goal of the study is to improve patient safety, by identifying the complications that occur during routine clinical anesthesia, and then developing study programs to communicate the findings to the clinicians. Recognizing that the study group may be a skewed population (although a growing number of complications seem to be followed by a suit), two derivative studies are being contemplated. Working with the Society of Academic Anesthesia Chairmen, a parallel study may be made compiling the clinical complications reported in the weekly mortality and morbidity conferences of a large number of training programs. The other would be a compilation of the data available from anesthetic deaths reviewed by participating medical examiners of the country. Almost half of the medical examiners said that they reviewed all or most of the anesthetic deaths reported to them. further, they feel that they hear about most of the anesthetic deaths in their comrnunity. These facts came from a survey of the members of the National Association of Medical Examiners by Drs. Richard J. Ward and Donald Reay, the King County, Washington, Medical Exarniner. Thus, a large number of anesthetic deaths are already being reviewed by the medical examiners, and a national survey of these could, and should, be made.

Data are being shared with the participating insurance companies who request it, and they will likewise work on improving patient safety in ways that they find most effective.

Dr. Ward is Professor of anesthesia, University of Washington School of Medicine, Seattle.

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by Ellison C. Pierce, Jr., M.D.

The fifth and sixth ASA Patient Safety videotapes, Human Error and Adverse Events, were filmed in December and are now being mailed. Earlier tapes in the series included, Overview, Prevention of Disconnections, Anesthesia Machine Check-Out, and Anesthesia Record-Keeping.

Human Error considers data from several studies here and abroad that examine why humans err and what preventive steps may be taken. Drs. Howard L. Zauder, Harry H. Bird, Susan E. Dorsch, William K. Hamilton and Maxwell H. Weingarten present in-depth reviews of various aspects of the problem in the 20-minute segment that was taped at the Bethesda Naval Hospital. Dr. Honorato F. Nicodemus, Chairman of Anesthesia at the hospital, his staff, and the operating room personnel were extraordinarily cooperative in aiding production.

Adverse Events In Anesthesia, filmed in the FDA studios, thoroughly examines the necessary steps involved in pre-, intra-, and post-operative management of patients undergoing anesthesia that will provide the best possible care for a patient when an adverse event does occur. In addition, it outlines the role these steps provide in lessening the likelihood of medical liability proceedings.

The patient safety videotape series is being received with enthusiasm in many quarters, especially including individuals in U.S. congressional staff offices, hospital risk management, and the medical liability insurance industry. In addition, arrangements are under way for its sale in Great Britain. Seventh and eighth tapes on functions and mechanisms of actions of monitoring are being planned.

Dr. Pierce is Chairman, ASA Committee on Patient Safety and Risk Management
 
 
 
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The Anesthesia Patient Safety Foundation Newsletter is the official publication of the non-profit Anesthesia Patient Safety Foundation and is published quarterly in March, June, September, and December at Overland Park, Kansas. All contributions to the Foundation are tax deductible.

The opinions expressed in this newsletter are not necessarily those of the Anesthesia Patient Safety Foundation or its members or board of directors.

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Address Newsletter comments, questions, letters, and suggestions to: John H. Eichhorn, M.D. Editor, APSF Newsletter Anesthesia, DA-717 Beth Israel Hospital Boston, MA 02 2 1 5